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EU PPWR Compliance Checklist
August 2026 Requirements Check your readiness for the first Packaging and Packaging Waste Regulation obligations.
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Insights
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Practical guidance on product risk, compliance, and global market access. Structured insights across product development, manufacturing, and international regulation.
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What is product risk?
Product risk refers to any potential vulnerability or uncertainty that could negatively impact a product’s safety, quality, compliance, environmental sustainability, performance, or timely delivery to market. These risks can arise at any stage, from design and development to manufacturing and even after the product reaches customers or at the products end of life. The source or root cause of many in-market issues requiring business intervention can often be traced back to the development or manufacturing phases, even though they may not become visible until later.
What is product development risk?
Product development risks are obstacles that can delay your product’s launch or cause problems during manufacturing or after the product reaches the market. Examples include missed design deadlines, unforeseen technical or safety challenges, and rework due to non-compliance. These issues can lead to significant delays and lost sales opportunities. Poor design or inadequate verification decisions may not become apparent until later stages, creating costly complications down the line.
What is manufacturing risk?
Once the product design has been finalised, the next challenge is for that design to be reliably transformed into a quality product. Manufacturing risks such as quality control issues, supply chain disruptions, production delays, or process inconsistencies can lead to faulty products, missed delivery deadlines, increased costs, and potential damage to brand reputation.
What are in-market product risks?
Even after a product has reached the market, risks continue to exist. Quality issues, safety concerns, or non-compliance with regulatory requirements--if not identified and addressed during design or manufacturing--can result in costly recalls, litigation, and damage to reputation. Additionally, how issues that arise in the market are managed plays a critical role. Forward planning and effective response strategies are essential, as the handling of in-market problems significantly influences the impact on the business.
What is product risk management?
Product risk management is the discipline of anticipating and addressing potential issues that could undermine a product’s safety, quality, compliance, performance, or success in the market. It spans the full product journey, from the earliest idea, through development and manufacturing, to customer use and end-of-life.
For CEOs and business leaders, strong product risk management prevents delays, recalls, regulatory setbacks, costly warranty claims, and reputational crises. More importantly, it builds customer trust, protects profitability, and ensures your business is positioned to grow with confidence.
Applied effectively, it develops the capability within your business to manage risks intuitively, strengthening decision-making, resilience, and long-term competitiveness.
For CEOs and business leaders, strong product risk management prevents delays, recalls, regulatory setbacks, costly warranty claims, and reputational crises. More importantly, it builds customer trust, protects profitability, and ensures your business is positioned to grow with confidence.
Applied effectively, it develops the capability within your business to manage risks intuitively, strengthening decision-making, resilience, and long-term competitiveness.
What are the signs of unmanaged product risk?
Product risks evolve as your business grows. This often leads to new challenges, leaving many business leaders wondering: Why are these problems emerging now when they weren’t an issue before?
Here are some common warning signs:
These aren’t random problems, they’re symptoms of business growth and market expectation evolution. Gaps emerge, risks increase, and without a proactive approach, they can escalate.
For example, as your product footprint grows, so does the probability of product related injury and therefore your exposure to litigation—especially in markets without no-fault personal injury insurance. Consumers may sue for medical costs or lost income. Injuries could also result in the need for product recalls.
An injury could be caused by a product failure, poor design, unanticipated misuse, or sheer probability. For example, if you sell ten pairs of scissors, the chances of someone running with them are low. If you sell 100 pairs, perhaps one person does. At 1,000 pairs, maybe ten people do, but only one falls over. By the time you sell 10,000 pairs, maybe 10 fall-over while running with scissors, and one of the 10 gets injured. I don’t have the exact statistics on running with scissors (although it does appear that cutting with scissors is statistically more hazardous than running with them), but you can see the pattern: the more products in the market, the more likely it is that rare but foreseeable incidents will occur.
The question is: Did you anticipate and mitigate risks in line with market expectations? Consumers understand that some risk comes with a pair of scissors, but their expectations would be different for a cuddly toy, or a safety product like a helmet, for example.
Increased market visibility also brings increased scrutiny:
Even if readily resolved, these issues consume valuable time and resources.
Another challenge is manufacturing and product complexity. As businesses expand, production changes can introduce variations in quality. More complex products also mean higher risks of non-compliance, product failures, and development delays.
If these challenges sound familiar, it’s time to strengthen your product risk management strategy.
Here are some common warning signs:
- Product recalls or litigation due to incidents, non-compliance, product misuse, or injury.
- Regulatory scrutiny, such as investigations, cease-and-desist letters, or products stopped at customs.
- Increased competitive pressure, including aggressive tactics from competitors and negative consumer reports.
- Rising warranty claims, recurring quality issues, or increasing product rework.
- Loss of distribution channels due to certification demands or product removals.
- Product development delays, with new products failing to meet launch timelines.
These aren’t random problems, they’re symptoms of business growth and market expectation evolution. Gaps emerge, risks increase, and without a proactive approach, they can escalate.
For example, as your product footprint grows, so does the probability of product related injury and therefore your exposure to litigation—especially in markets without no-fault personal injury insurance. Consumers may sue for medical costs or lost income. Injuries could also result in the need for product recalls.
An injury could be caused by a product failure, poor design, unanticipated misuse, or sheer probability. For example, if you sell ten pairs of scissors, the chances of someone running with them are low. If you sell 100 pairs, perhaps one person does. At 1,000 pairs, maybe ten people do, but only one falls over. By the time you sell 10,000 pairs, maybe 10 fall-over while running with scissors, and one of the 10 gets injured. I don’t have the exact statistics on running with scissors (although it does appear that cutting with scissors is statistically more hazardous than running with them), but you can see the pattern: the more products in the market, the more likely it is that rare but foreseeable incidents will occur.
The question is: Did you anticipate and mitigate risks in line with market expectations? Consumers understand that some risk comes with a pair of scissors, but their expectations would be different for a cuddly toy, or a safety product like a helmet, for example.
Increased market visibility also brings increased scrutiny:
- Regulators conduct surveillance, and non-compliant products may face recalls or restrictions.
- Competitors may see you as a threat and report compliance issues to authorities.
Even if readily resolved, these issues consume valuable time and resources.
Another challenge is manufacturing and product complexity. As businesses expand, production changes can introduce variations in quality. More complex products also mean higher risks of non-compliance, product failures, and development delays.
If these challenges sound familiar, it’s time to strengthen your product risk management strategy.
What is a product recall?
A product recall is a formal process to either remedy, replace or refund and remove a product from the market due to a safety issue, non-compliance, or defect that could harm people, animals, the environment, or violate legal requirements.
Recalls are high-risk events. They can be costly, damage your reputation, disrupt operations, and lead to legal consequences. Many are preventable with strong product development controls, clear compliance strategies, and early identification of potential risks.
Recalls are high-risk events. They can be costly, damage your reputation, disrupt operations, and lead to legal consequences. Many are preventable with strong product development controls, clear compliance strategies, and early identification of potential risks.
What is EU safety gate and how can I use it to prevent recalls?
Safety Gate is the rapid alert system for non-food products in the EU that may present a hazard to the public. Safety Gate alerts cover consumer products and products for professional use but excludes pharmaceuticals, medical devices, food or animal feed (which have their own alert systems). Threats to human health and safety, such as choking, strangulation and damage to hearing or sight, electric shock and burns, or various hazards caused by chemicals. Products that pose a security risk or risks to the environment and/or animals are also included.
National authorities (the relevant authority in each EU market + Iceland, Norway and Liechtenstein) carry out inspections and test products on the market under their national market surveillance programmes. They also act on any complaints or information they receive. Additionally, where manufacturers, retailers, importers or other businesses become aware they have inadvertently placed products on the market that may pose a danger, they must report this to the authorities. If a national authority detects or becomes aware of a dangerous product on the market, it may ban or restrict its sale, stop it at the border or order for it to be recalled. When one national authority takes such a measure, it has to inform all the other countries in the EU, which happens through Safety Gate. The Safety Gate rapid alert enables swift and effective action to be taken across the EU when a dangerous or potentially dangerous product is found.
The alerts contain information about the product, the risks it poses, and the measures taken to stop or restrict its sale. The measures can be imposed by the authorities (compulsory measures) or taken directly by the economic operators (voluntary measures).
National authorities are responsible for monitoring the alerts in the system and checking whether the product identified as dangerous is also for sale in their own country. They are required to report on the results of their checks with a follow-up notification on the Safety Gate. The notifications report any additional measures taken and any additional information available e.g. on distribution channels and affected batches. The public website is updated to show in which countries the product has been found and additional measures taken.
Online marketplaces that have signed the Product Safety Pledge also check the Safety Gate to make sure they are not selling dangerous products online. The Pledge also commits them to remove such products from their listings within 2 days when requested by a national authority. In those cases, that measure is also inputted on Safety Gate in the form of a follow-up notification
Reviewing product recalls of products similar to yours or of risks that have the potential to be found in your products under certain situations, can be helpful input to your product risk assessments and continuous improvement programs. Market expectations can change overtime and what might be considered acceptable at one point in time can change as new information comes to light. Reviewing product recall information will help you to spot trends and pre-empt potential legislation or standards changes that are likely to occur overtime as they are updated to address newly identified risks.
National authorities (the relevant authority in each EU market + Iceland, Norway and Liechtenstein) carry out inspections and test products on the market under their national market surveillance programmes. They also act on any complaints or information they receive. Additionally, where manufacturers, retailers, importers or other businesses become aware they have inadvertently placed products on the market that may pose a danger, they must report this to the authorities. If a national authority detects or becomes aware of a dangerous product on the market, it may ban or restrict its sale, stop it at the border or order for it to be recalled. When one national authority takes such a measure, it has to inform all the other countries in the EU, which happens through Safety Gate. The Safety Gate rapid alert enables swift and effective action to be taken across the EU when a dangerous or potentially dangerous product is found.
The alerts contain information about the product, the risks it poses, and the measures taken to stop or restrict its sale. The measures can be imposed by the authorities (compulsory measures) or taken directly by the economic operators (voluntary measures).
National authorities are responsible for monitoring the alerts in the system and checking whether the product identified as dangerous is also for sale in their own country. They are required to report on the results of their checks with a follow-up notification on the Safety Gate. The notifications report any additional measures taken and any additional information available e.g. on distribution channels and affected batches. The public website is updated to show in which countries the product has been found and additional measures taken.
Online marketplaces that have signed the Product Safety Pledge also check the Safety Gate to make sure they are not selling dangerous products online. The Pledge also commits them to remove such products from their listings within 2 days when requested by a national authority. In those cases, that measure is also inputted on Safety Gate in the form of a follow-up notification
Reviewing product recalls of products similar to yours or of risks that have the potential to be found in your products under certain situations, can be helpful input to your product risk assessments and continuous improvement programs. Market expectations can change overtime and what might be considered acceptable at one point in time can change as new information comes to light. Reviewing product recall information will help you to spot trends and pre-empt potential legislation or standards changes that are likely to occur overtime as they are updated to address newly identified risks.
What is a product risk assessment?
A product risk assessment is a systematic process in which potential risks related to a product are identified, analysed, and prioritised. It involves evaluating possible issues during design, manufacturing, and market phases to determine their likelihood and impact. This assessment guides decision-making and the implementation of measures to minimise or control risks before they affect product safety, quality, compliance, or delivery timelines.
What is product compliance?
Product compliance means meeting the legal requirements for your product, including its design, packaging, labelling, and user instructions, so it can be sold in your target markets. It proves you’ve taken the necessary steps to ensure your product is safe, lawful, and does not harm people, animals, the environment, or (for connected products) their privacy.
Each country or region has its own regulations and referenced standards, which are regularly updated. Compliance is not just a final check, it needs to be built into your development process from the start to avoid costly rework or delays.
Product compliance is separate from, but related to, export, import, and transport requirements. While freight partners often manage those, ensuring your product meets regulatory standards is your responsibility.
Each country or region has its own regulations and referenced standards, which are regularly updated. Compliance is not just a final check, it needs to be built into your development process from the start to avoid costly rework or delays.
Product compliance is separate from, but related to, export, import, and transport requirements. While freight partners often manage those, ensuring your product meets regulatory standards is your responsibility.
What is product regulatory intelligence?
Product Regulatory Intelligence is the proactive process of tracking and analysing regulatory changes, product recalls, and emerging standards in the markets where you operate, or plan to. It goes beyond basic compliance checks by helping you anticipate changes, adapt early, and avoid costly surprises like fines, shipment delays, or recalls.
Good Regulatory Intelligence strengthens product resilience, keeps your teams aligned with evolving requirements, and gives you a strategic edge, especially in fast-changing or fragmented markets. It’s not a one-off task, but an ongoing commitment to staying informed and prepared.
Good Regulatory Intelligence strengthens product resilience, keeps your teams aligned with evolving requirements, and gives you a strategic edge, especially in fast-changing or fragmented markets. It’s not a one-off task, but an ongoing commitment to staying informed and prepared.
What does product safety data tell us about risk?
The volume of product safety alerts in Europe has reached its highest level on record. But the more important signal is not the number itself. It is what it reveals about how product risk is now being detected, enforced, and anticipated in real time.
A recent report from the European Commission on the Safety Gate system highlights this clearly.
The 2025 data shows:
On the surface, this looks like a growing problem. But there is another way to interpret it.
More alerts does not just mean more unsafe products
Systems like Safety Gate are becoming more effective, more connected, and more actively enforced. As a result, increases in alerts reflect both product risk and improved detection capability.
The rise in alerts is partly driven by:
In other words, visibility is increasing. And with it, regulatory responsiveness is accelerating.
This distinction matters, because it changes how these alerts should be interpreted inside product organisations.
Recalls and alerts are leading indicators, not historical noise
Product recalls and safety alerts are often treated as historical information. In reality, they are forward signals.
They tell you:
For example, the strong focus on chemical risks in cosmetics is not just a cosmetics issue. It is a broader indicator of regulatory attention shifting toward chemical safety, ingredient transparency, and long-term health impacts across product categories.
Why this matters for risk assessments
In many organisations, risk assessments are still largely internal documents. They rely heavily on design assumptions, historical testing, and supplier declarations.
But external signals are often the missing layer in structured risk assessments.
Recalls, alerts, and enforcement actions should be treated as structured inputs into risk assessments, particularly for:
Foreseeable misuse is already visible in recall data
One of the clearest applications of this external data is in identifying foreseeable misuse patterns.
Recalls frequently reveal:
Foreseeable misuse is not accidental edge behaviour. It is predictable, repeatable, and often visible in prior recall data. Which means it should be actively designed for, tested for, and assessed within risk frameworks.
Where regulation is likely heading next
When you step back from the detail, three signals are clear:
For product-based businesses, this shifts risk management from a gatekeeping function to a continuous intelligence function.
A practical resource worth knowing
One of the most useful consolidated sources of global recall intelligence I have found is put together by SGS (subscribe here).
Their global recall summaries bring together data from:
Final thought
Product recalls are often treated as evidence of failure.
But they are also one of the richest datasets for understanding emerging regulatory direction, real-world product behaviour, shifting consumer expectations, and hidden design assumptions.
For leaders responsible for product risk, the question is not whether to monitor this data, but how to embed it into decision making. Because by the time a risk shows up in your own product, it has usually already appeared somewhere else first.
A recent report from the European Commission on the Safety Gate system highlights this clearly.
The 2025 data shows:
- 4,671 product safety alerts, the highest since the system began in 2003
- A 13% increase on 2024, and more than double the level seen in 2022
- 5,794 follow-up actions by national authorities, up 35% year on year
- The most reported product categories were cosmetics (36%), toys (16%), and electrical products (11%)
- More than half of all risks were linked to hazardous chemicals
On the surface, this looks like a growing problem. But there is another way to interpret it.
More alerts does not just mean more unsafe products
Systems like Safety Gate are becoming more effective, more connected, and more actively enforced. As a result, increases in alerts reflect both product risk and improved detection capability.
The rise in alerts is partly driven by:
- Improved surveillance and detection tools
- Faster cross-border information sharing
- Stronger enforcement under the General Product Safety Regulation
- Increased scrutiny of online marketplaces
In other words, visibility is increasing. And with it, regulatory responsiveness is accelerating.
This distinction matters, because it changes how these alerts should be interpreted inside product organisations.
Recalls and alerts are leading indicators, not historical noise
Product recalls and safety alerts are often treated as historical information. In reality, they are forward signals.
They tell you:
- What regulators are currently prioritising
- Which failure modes are emerging more frequently
- Where enforcement focus is tightening
- How consumer harm is being classified and understood
For example, the strong focus on chemical risks in cosmetics is not just a cosmetics issue. It is a broader indicator of regulatory attention shifting toward chemical safety, ingredient transparency, and long-term health impacts across product categories.
Why this matters for risk assessments
In many organisations, risk assessments are still largely internal documents. They rely heavily on design assumptions, historical testing, and supplier declarations.
But external signals are often the missing layer in structured risk assessments.
Recalls, alerts, and enforcement actions should be treated as structured inputs into risk assessments, particularly for:
- New product development
- Market expansion into regulated regions
- Supplier selection and validation
- Design verification and compliance planning
Foreseeable misuse is already visible in recall data
One of the clearest applications of this external data is in identifying foreseeable misuse patterns.
Recalls frequently reveal:
- Incorrect assembly or installation patterns
- Use in environments not originally intended
- Cultural or regional differences in product usage
- Overriding or ignoring of safety instructions
Foreseeable misuse is not accidental edge behaviour. It is predictable, repeatable, and often visible in prior recall data. Which means it should be actively designed for, tested for, and assessed within risk frameworks.
Where regulation is likely heading next
When you step back from the detail, three signals are clear:
- Regulation is increasing in pace and scope
- Surveillance is becoming continuous and data-driven
- Online distribution channels are becoming a primary enforcement focus
For product-based businesses, this shifts risk management from a gatekeeping function to a continuous intelligence function.
A practical resource worth knowing
One of the most useful consolidated sources of global recall intelligence I have found is put together by SGS (subscribe here).
Their global recall summaries bring together data from:
- EU Safety Gate and RASFF
- United Kingdom OPSS
- United States CPSC
- Canada Health Canada
- Australia ACCC
Final thought
Product recalls are often treated as evidence of failure.
But they are also one of the richest datasets for understanding emerging regulatory direction, real-world product behaviour, shifting consumer expectations, and hidden design assumptions.
For leaders responsible for product risk, the question is not whether to monitor this data, but how to embed it into decision making. Because by the time a risk shows up in your own product, it has usually already appeared somewhere else first.
What is the Smart Risk Playbook framework?
The Smart Risk Playbook framework was developed from more than 25 years of observing product businesses across multiple countries and industries. A common pattern repeatedly emerged: businesses would encounter a crisis once products reached the market, such as goods stopped at customs, cease-and-desist notices from regulators, product recalls, or market access delays caused by missing certifications. The immediate issue would be resolved, operations would stabilise, and then another problem would arise elsewhere in the product lifecycle.
Over time, it became clear that many of these crises shared common root causes in product development, manufacturing, compliance, and business decision-making. This led to the development of a five-step framework designed to help businesses identify, prioritise, and reduce product risk before problems escalate.
The first observation was that product risks often present themselves as warning signs long before businesses take action. Ignoring these early indicators increases both the likelihood and severity of future problems. Step one of the framework identifies the 10 most common warning signs of unmanaged product risk, providing businesses with a starting point for a more proactive risk management approach.
The second observation was that many product risks are driven by change. As businesses grow, expand into new markets, adopt new technologies, or increase operational complexity, their internal systems and processes often fail to evolve at the same pace. Step two outlines the 12 most common business changes responsible for the majority of product-related risks experienced by growing businesses. Understanding how change creates risk allows leaders to anticipate challenges and plan more strategically.
The final observation was that many risks can be significantly reduced through relatively simple process improvements, and that businesses frequently under-resource the area of greatest exposure: products already in-market. The final three steps of the framework focus on strengthening practical risk management processes across the product lifecycle, beginning with products in-market, then logistics and manufacturing, and finally product development.
Over time, it became clear that many of these crises shared common root causes in product development, manufacturing, compliance, and business decision-making. This led to the development of a five-step framework designed to help businesses identify, prioritise, and reduce product risk before problems escalate.
The first observation was that product risks often present themselves as warning signs long before businesses take action. Ignoring these early indicators increases both the likelihood and severity of future problems. Step one of the framework identifies the 10 most common warning signs of unmanaged product risk, providing businesses with a starting point for a more proactive risk management approach.
The second observation was that many product risks are driven by change. As businesses grow, expand into new markets, adopt new technologies, or increase operational complexity, their internal systems and processes often fail to evolve at the same pace. Step two outlines the 12 most common business changes responsible for the majority of product-related risks experienced by growing businesses. Understanding how change creates risk allows leaders to anticipate challenges and plan more strategically.
The final observation was that many risks can be significantly reduced through relatively simple process improvements, and that businesses frequently under-resource the area of greatest exposure: products already in-market. The final three steps of the framework focus on strengthening practical risk management processes across the product lifecycle, beginning with products in-market, then logistics and manufacturing, and finally product development.
What is the role of leadership in managing product risk?
In many product businesses, after a period of smooth sailing, things often start to unravel. The cause isn’t always obvious, it’s rarely just one thing.
As a business grows, the risks evolve as well. Alongside increased litigation and financial pressures, there are rising regulatory demands, competitive pressures, and often, product quality issues that can erode brand trust. Product development timelines can spiral out of control, and leadership may start to lose confidence in their teams or supply chains.
Understanding risks isn’t just the responsibility of technical teams or compliance officers, it’s a strategic concern that affects the entire business. Businesses that take a structured and strategic approach to risk management gain a competitive edge. They prevent costly setbacks, build trust with customers and partners, and ensure long-term resilience.
For leaders, it’s about having enough awareness of product-related risks to ask the right questions and challenge the answers. Specialists within the business need to focus narrowly on their specific areas to achieve their goals, which is why effective risk management needs to start at the top. Risk management requires a broad view. When leaders engage, ask the right questions, and ensure the right strategies are in place across the business, the business as a whole learns and evolves. This process of improvement reduces uncertainty and builds confidence in the business’s product decisions.
As a business grows, the risks evolve as well. Alongside increased litigation and financial pressures, there are rising regulatory demands, competitive pressures, and often, product quality issues that can erode brand trust. Product development timelines can spiral out of control, and leadership may start to lose confidence in their teams or supply chains.
Understanding risks isn’t just the responsibility of technical teams or compliance officers, it’s a strategic concern that affects the entire business. Businesses that take a structured and strategic approach to risk management gain a competitive edge. They prevent costly setbacks, build trust with customers and partners, and ensure long-term resilience.
For leaders, it’s about having enough awareness of product-related risks to ask the right questions and challenge the answers. Specialists within the business need to focus narrowly on their specific areas to achieve their goals, which is why effective risk management needs to start at the top. Risk management requires a broad view. When leaders engage, ask the right questions, and ensure the right strategies are in place across the business, the business as a whole learns and evolves. This process of improvement reduces uncertainty and builds confidence in the business’s product decisions.
How do data security risks relate to products?
Whether a business manufactures smart devices, children’s safety monitors, wearable tech, or even seemingly simple connected tools, it's product may be collecting, transmitting, or storing personal data. That means it is now also in the data protection business.
Many countries and regions around the world are introducing regulations related to data protection. For example, in the EU, the GDPR (General Data Protection Regulation) applies to all businesses that collect data from EU residents. In 2023 alone, breaches of the GDPR resulted in over €1 billion in fines.
Under GDPR, a business is responsible for:
Failure to comply can cost a business up to 2% of it's global annual turnover.
On the 1 August 2025, the new EU cybersecurity standards (EN 18031 series) became mandatory under the Radio Equipment Directive (RED). These regulations apply to any connected product that can transmit data via the internet. This includes mobile phones, smartwatches, tablets, children’s toys, safety equipment, and baby monitors. Non-compliance could mean:
The EN 18031 series of standards introduces security requirements for:
Their goals are threefold:
To comply, developers must test for network security, data integrity, and resilience to unauthorised access.
Acting proactively means:
Even small actions, like reviewing consent processes, checking the breach response plan, or confirming data risk assessments are up to date, can make a big difference.
See also:
Many countries and regions around the world are introducing regulations related to data protection. For example, in the EU, the GDPR (General Data Protection Regulation) applies to all businesses that collect data from EU residents. In 2023 alone, breaches of the GDPR resulted in over €1 billion in fines.
Under GDPR, a business is responsible for:
- Notifying authorities within 72 hours of a personal data breach
- Providing full transparency to users about how their data is used
- Deleting data when no longer needed, or if a user revokes consent
- Obtaining clear, freely given consent, especially from users under 16
- Documenting risk assessments and ensuring data is processed lawfully
Failure to comply can cost a business up to 2% of it's global annual turnover.
On the 1 August 2025, the new EU cybersecurity standards (EN 18031 series) became mandatory under the Radio Equipment Directive (RED). These regulations apply to any connected product that can transmit data via the internet. This includes mobile phones, smartwatches, tablets, children’s toys, safety equipment, and baby monitors. Non-compliance could mean:
- Blocked access to EU markets
- Delays in product certification
- Costly redesigns and reputational damage
- Legal exposure if user data is compromised
The EN 18031 series of standards introduces security requirements for:
- Internet-connected products
- Products processing sensitive personal data (e.g. children’s devices, toys, wearables)
- Devices used for monetary transactions (e.g. virtual wallets)
Their goals are threefold:
- Prevent harm to communication networks
- Protect personal data and user privacy
- Reduce fraud risk, particularly for devices that handle payments
To comply, developers must test for network security, data integrity, and resilience to unauthorised access.
Acting proactively means:
- Building products that comply with EN 18031 and GDPR and other regulations relevant to markets of sale
- Documenting a data security risk assessment
- Managing data consent and withdrawal
- Knowing what happens if a product is hacked
- Having a breach response plan
- Knowing who in the business is accountable for data protection
Even small actions, like reviewing consent processes, checking the breach response plan, or confirming data risk assessments are up to date, can make a big difference.
See also:
How to manage development timeline risk
In product development, there’s a common joke that a project manager’s job is simply to track failure. All too often deadlines slip, schedules get reset, and frustration builds.
The most common reason for this isn’t poor project management, it’s a failure to understand which aspects of a product’s design carry the most risk of not being realised on time and then planning for those aspects.
Why Understanding Risk is Key
Think about a new product your business has recently developed or is currently developing. If it’s an iteration of an existing product with minor aesthetic updates and small refinements, you can fairly easily set and stick to a predictable timeline. But if it’s a completely new product with unresolved technical challenges or uncertainties, timelines can quickly become meaningless.
Most product development projects fall somewhere between these two extremes, of minor adjustments to current products to creating something entirely novel. Within those projects, usually some aspects of the design are well understood and therefore low risk in terms of blowing out a timeline, while others push into new territory meaning timelines are largely unable to be predicted. To manage a timeline effectively, you need to break down the product into its individual components, features, or functions (whatever makes sense for that particular product) and assess the level of risk to sticking to the timeline that each one presents.
The Risk Spectrum
Every component, feature, or function in your product sits somewhere on the following risk spectrum, from 1 (low risk) to 8 (high risk):
1. Proven in market – Currently used in your products with a positive track record in market.
2. Proven in market, but with some adaptation needed – Used in similar products made by others with a positive track record in market OR used in your products but with some issues in market needing resolution.
3. Proven in market, but with moderate adaptation needed – Used in similar products with some issues in market OR proven for different applications, with a positive track record in market.
4. Proven in market, but with significant adaptation needed – Used in different applications with known issues in market requiring resolution.
5. Proven at scale, but not in market – A new concept that has been successfully scaled, but lacks market history.
6. Prototyped, but unproven at scale – A new concept that has worked in prototype form but hasn’t been proven at production scale.
7. Technically feasible, but not prototyped –Modelling or similar has proven the technical feasibly, but it hasn’t been fully built and tested yet.
8. Technical Uncertainty – A new concept with unresolved technical challenges.
What This Means for Your Timeline
1-2: Low risk. These components should stick to the planned schedule. For 2, extra work is required.
3-4: Medium risk. Requires problem-solving—either improving on an existing product or adapting something from a different industry. For 4, more work is required.
5: Higher risk. Since there’s no market history, expect learning curves during verification. A staged market entry can help manage risk.
6-8: High risk. These require significant validation. Anything rated 8 is an R&D activity and should be handled separately from product development. It should only be integrated once the technical uncertainty is resolved.
Managing High-Risk Elements
For anything rated 5-7, assume a high chance of delays. To prevent these from derailing the entire product launch:
Timeline failures in product development aren’t random, they result from underestimating risk. By assessing each component and planning accordingly, you can take control of your development schedule and avoid costly surprises.
And as a business leader, you don’t need to guess. You just need to ask the right questions, about proof, about what’s been validated, and about where the unknowns lie. This is how you keep projects moving and avoid the costly trap of delays that no one saw coming.
The most common reason for this isn’t poor project management, it’s a failure to understand which aspects of a product’s design carry the most risk of not being realised on time and then planning for those aspects.
Why Understanding Risk is Key
Think about a new product your business has recently developed or is currently developing. If it’s an iteration of an existing product with minor aesthetic updates and small refinements, you can fairly easily set and stick to a predictable timeline. But if it’s a completely new product with unresolved technical challenges or uncertainties, timelines can quickly become meaningless.
Most product development projects fall somewhere between these two extremes, of minor adjustments to current products to creating something entirely novel. Within those projects, usually some aspects of the design are well understood and therefore low risk in terms of blowing out a timeline, while others push into new territory meaning timelines are largely unable to be predicted. To manage a timeline effectively, you need to break down the product into its individual components, features, or functions (whatever makes sense for that particular product) and assess the level of risk to sticking to the timeline that each one presents.
The Risk Spectrum
Every component, feature, or function in your product sits somewhere on the following risk spectrum, from 1 (low risk) to 8 (high risk):
1. Proven in market – Currently used in your products with a positive track record in market.
2. Proven in market, but with some adaptation needed – Used in similar products made by others with a positive track record in market OR used in your products but with some issues in market needing resolution.
3. Proven in market, but with moderate adaptation needed – Used in similar products with some issues in market OR proven for different applications, with a positive track record in market.
4. Proven in market, but with significant adaptation needed – Used in different applications with known issues in market requiring resolution.
5. Proven at scale, but not in market – A new concept that has been successfully scaled, but lacks market history.
6. Prototyped, but unproven at scale – A new concept that has worked in prototype form but hasn’t been proven at production scale.
7. Technically feasible, but not prototyped –Modelling or similar has proven the technical feasibly, but it hasn’t been fully built and tested yet.
8. Technical Uncertainty – A new concept with unresolved technical challenges.
What This Means for Your Timeline
1-2: Low risk. These components should stick to the planned schedule. For 2, extra work is required.
3-4: Medium risk. Requires problem-solving—either improving on an existing product or adapting something from a different industry. For 4, more work is required.
5: Higher risk. Since there’s no market history, expect learning curves during verification. A staged market entry can help manage risk.
6-8: High risk. These require significant validation. Anything rated 8 is an R&D activity and should be handled separately from product development. It should only be integrated once the technical uncertainty is resolved.
Managing High-Risk Elements
For anything rated 5-7, assume a high chance of delays. To prevent these from derailing the entire product launch:
- Run development work in parallel. Treat these elements as separate workstreams rather than dependencies.
- Have proven contingencies. If the risky feature isn’t ready in time, you should have a fallback option that ensures the product can still launch on schedule.
- Pull in high-risk elements only when ready. If a new concept is successfully validated during development, great, incorporate it. If not, you have a solid alternative in place.
Timeline failures in product development aren’t random, they result from underestimating risk. By assessing each component and planning accordingly, you can take control of your development schedule and avoid costly surprises.
And as a business leader, you don’t need to guess. You just need to ask the right questions, about proof, about what’s been validated, and about where the unknowns lie. This is how you keep projects moving and avoid the costly trap of delays that no one saw coming.
How Lean Product Development can reduce risk
In many product businesses, product development is still treated as an overhead rather than a strategic investment. That mindset often hides some of the biggest risks a business faces. Inefficiencies, slow learning, delayed decisions, and wasted effort all increase the likelihood of missed deadlines, cost overruns, and products that struggle in the market.
Lean Product Development directly addresses these risks. It focuses on value-adding work, reduces waste, and helps teams make better decisions earlier, when change is cheaper and options are still open. When development work is misaligned with business goals or customer needs, the consequences usually appear later as delays, rework, or in-market problems. Lean principles help create more predictable, outcome-focused development by improving information flow, enabling fast learning, and supporting decision-making under uncertainty. The goal is not just to work efficiently, but to reduce the risk of failure by choosing better paths sooner.
As part of my International Industrial Management studies in Germany, I wrote my master’s thesis on Lean Management in Indirect Areas, meaning Lean applied beyond the factory floor. I also worked as a Lean Navigator at Bosch, applying Lean principles within engineering and central quality teams. That experience reinforced an important point. Lean Product Development is not simply Lean Manufacturing applied earlier in the process.
Manufacturing focuses on repeatable, physical outputs. Once a product is in production, the aim is consistency, efficiency, and minimal variation. Product development is different. It is a knowledge-based process filled with uncertainty, learning, and iteration. The biggest sources of waste are rarely physical. They tend to be unnecessary complexity, late decisions, poor communication, or rework caused by problems discovered too late.
Understanding this distinction is essential if Lean is going to reduce risk rather than create frustration.
Although Lean originated in manufacturing, its principles apply anywhere value, services, or information flow to meet customer demand. While there is no single definition of Lean, five core principles are widely recognised:
The purpose of Lean is not cost cutting for its own sake. Waste reduction is a means to improving quality, responsiveness, and reliability, not the end goal. A genuinely Lean organisation is usually characterised by two things:
When Lean principles are embedded across product development, they improve efficiency and reduce risk by creating clarity, consistency, and faster learning. In practice, I see the greatest impact when teams start by focusing on a small set of guiding principles:
Transparency deserves special attention. Visibility into progress, risks, decisions, and assumptions allows organisations to respond earlier and more effectively. This does not mean more reporting or micromanagement. It means shared, simple systems that make work visible and encourage honest conversations. Tools like decision registers, design logs, or risk dashboards can help. So can regular check-ins that focus on learning rather than performance.
When everyone, from engineers to leadership, can see how development is really tracking, small issues are addressed before they become major problems. Trust improves, decisions get better, and learning accelerates.
If you want to get started with Lean Product Development, keep it simple. Pick one project. Make the work visible. Ask where decisions are being delayed and why. Look for rework and late surprises and trace them back to their source. Small changes applied consistently can significantly reduce risk over time.
You do not need to transform everything at once. Lean is built through practice, reflection, and steady improvement. Each better decision made earlier strengthens your development process and your confidence in what you are putting into the market.
Lean Product Development directly addresses these risks. It focuses on value-adding work, reduces waste, and helps teams make better decisions earlier, when change is cheaper and options are still open. When development work is misaligned with business goals or customer needs, the consequences usually appear later as delays, rework, or in-market problems. Lean principles help create more predictable, outcome-focused development by improving information flow, enabling fast learning, and supporting decision-making under uncertainty. The goal is not just to work efficiently, but to reduce the risk of failure by choosing better paths sooner.
As part of my International Industrial Management studies in Germany, I wrote my master’s thesis on Lean Management in Indirect Areas, meaning Lean applied beyond the factory floor. I also worked as a Lean Navigator at Bosch, applying Lean principles within engineering and central quality teams. That experience reinforced an important point. Lean Product Development is not simply Lean Manufacturing applied earlier in the process.
Manufacturing focuses on repeatable, physical outputs. Once a product is in production, the aim is consistency, efficiency, and minimal variation. Product development is different. It is a knowledge-based process filled with uncertainty, learning, and iteration. The biggest sources of waste are rarely physical. They tend to be unnecessary complexity, late decisions, poor communication, or rework caused by problems discovered too late.
Understanding this distinction is essential if Lean is going to reduce risk rather than create frustration.
Although Lean originated in manufacturing, its principles apply anywhere value, services, or information flow to meet customer demand. While there is no single definition of Lean, five core principles are widely recognised:
- Identify what the customer values
- Analyse which activities truly add value
- Create continuous flow
- Establish pull, where work is triggered by downstream demand
- Eliminate waste
The purpose of Lean is not cost cutting for its own sake. Waste reduction is a means to improving quality, responsiveness, and reliability, not the end goal. A genuinely Lean organisation is usually characterised by two things:
- Responsibility is placed as close as possible to value creation
- Problems are traced back to root causes through structured problem-solving
When Lean principles are embedded across product development, they improve efficiency and reduce risk by creating clarity, consistency, and faster learning. In practice, I see the greatest impact when teams start by focusing on a small set of guiding principles:
- Question assumptions, especially early ones
- Enable decision-making where the action and information sit
- Use root cause analysis rather than quick fixes
- Capture knowledge so learning is not lost between projects
- Identify risks early, before they become expensive
- Understand customer requirements, both internal and external
- Build transparency into the development process
Transparency deserves special attention. Visibility into progress, risks, decisions, and assumptions allows organisations to respond earlier and more effectively. This does not mean more reporting or micromanagement. It means shared, simple systems that make work visible and encourage honest conversations. Tools like decision registers, design logs, or risk dashboards can help. So can regular check-ins that focus on learning rather than performance.
When everyone, from engineers to leadership, can see how development is really tracking, small issues are addressed before they become major problems. Trust improves, decisions get better, and learning accelerates.
If you want to get started with Lean Product Development, keep it simple. Pick one project. Make the work visible. Ask where decisions are being delayed and why. Look for rework and late surprises and trace them back to their source. Small changes applied consistently can significantly reduce risk over time.
You do not need to transform everything at once. Lean is built through practice, reflection, and steady improvement. Each better decision made earlier strengthens your development process and your confidence in what you are putting into the market.
How a good design brief improves product development outcomes
The Product Design Brief (or Product Scope), is a critical document for reducing product risks during the product development phase. This document accompanies the concept throughout development and is referenced and updated as the project progresses. Each business typically develops its own template for this document, containing targets and outcomes relevant to their specific products.
Let’s explore why this document is so important for managing product risks:
The Product Design Brief serves as a single source of truth for product targets, helping to avoid discrepancies across different documents. The details captured in this brief will be used:
The teams involved in these activities are typically involved in developing the design brief from the outset.
Below is a list of sections commonly found within a Product Design Brief.
Some of these elements will be included in the design brief from the outset, while others will emerge as the concept evolves. It’s also highly beneficial to explain the reasoning behind each requirement. For example, are the size targets driven by airline carry-on luggage restrictions? Is the weight target influenced by the offerings of competing products at similar price points?
As the concept progresses, trade-offs and concessions may need to be made. Having the rationale for each requirement ensures that decisions can be made with the best possible understanding.
When the importance of a product design brief is underestimated, or when it's hastily created and never revisited, various risks can arise. One common issue is when configurations, accessories, and the possible combinations of both are not considered. For example, if you have more than two configurations and any accessories, it’s crucial to map out the possible combinations in a matrix. This helps identify which combinations are feasible and which are not.
Updating the design brief as the concept evolves is just as critical as its initial detailing. For instance, if it’s determined that the weight target cannot be met, it’s essential to revisit the design brief, assess the implications of this change, and agree on a new target. This process helps prevent scope creep, which poses a significant risk to product development outcomes and timelines.
Over time, small decisions can accumulate, subtly shifting the concept further away from the original targets. Ultimately, this can result in a product that no longer aligns with the initial objectives, potentially rendering it unsellable. Any changes to the design brief should be agreed upon by the individuals responsible for defining it in the first place, as they understand the rationale behind the original requirements.
The product design brief serves as the foundation for successful product development. It sets clear expectations, aligns the team, and provides a roadmap to follow as the product moves through its lifecycle. By ensuring that the brief is comprehensive, regularly updated, and aligned with the product's evolving needs, businesses can minimise risks, prevent costly mistakes, and improve the chances of bringing a product to market that meets both customer expectations and regulatory requirements. The importance of a well-detailed and flexible product design brief cannot be overstated, as it guides decision-making, ensures consistency, and ultimately helps create a product that is both functional and viable.
Let’s explore why this document is so important for managing product risks:
The Product Design Brief serves as a single source of truth for product targets, helping to avoid discrepancies across different documents. The details captured in this brief will be used:
- by designers and engineers during product development
- as input to creating the product verification plan
- to guide the product risk assessment
- to determine applicable regulatory requirements and standards
- by the marketing team to develop marketing materials, labelling, user instructions, and packaging
The teams involved in these activities are typically involved in developing the design brief from the outset.
Below is a list of sections commonly found within a Product Design Brief.
- Product Description: A high-level description of what the product is and does from the consumer’s perspective, setting a clear, shared vision early.
- Functionality & Performance Targets: A detailed list of what the product must do, including measurable expectations that shape design and testing.
- Unique Selling Features: Non-negotiable features that differentiate the product and are critical for market positioning.
- Target User(s): Definition of the intended user group(s), enabling user-centred design and meeting compliance obligations.
- Use Environment: Expected exposure conditions (e.g., heat, salt, chemicals), guiding durability and verification efforts.
- Target Markets: Countries or regions of sale, which determine regulatory and customer expectations.
- Product Type & Category: Classification of the product, which determines applicable standards and regulatory pathways.
- Size, Weight & Packaging: Target dimensions and weight, including packaged form, influencing usability, logistics, and costs.
- Loading Requirements: Expected mechanical loads the product must withstand, guiding strength and durability design.
- Cost Target: Planned production cost, informing choices around materials, processes, and design scope.
- Materials & Components (Known): Any predetermined materials or parts known from the outset, shaping sourcing and design decisions.
- Configurations & Accessories: Expected product states (e.g., folded/unfolded) and accessories, ensuring complete system design.
- Use Scenarios: Likely and edge-case handling or usage conditions, informing safety and robustness.
- Actuation & Force Requirements: Methods and effort required to operate the product, shaping usability and safety features.
- Maintenance & Repairability: Expected maintenance tasks or repairs, driving decisions around access and safety.
- Life Expectancy: Target operational lifespan, informing durability design and warranty planning.
- End-of-Life Disposal: Plans for disassembly, recycling, or safe disposal, promoting sustainable design and compliance.
- Applicable Regulations & Standards: Relevant legal and technical requirements across markets, shaping early design decisions.
- Market Variations: Known differences in regulations, expectations, or product variants across markets, supporting efficient planning.
Some of these elements will be included in the design brief from the outset, while others will emerge as the concept evolves. It’s also highly beneficial to explain the reasoning behind each requirement. For example, are the size targets driven by airline carry-on luggage restrictions? Is the weight target influenced by the offerings of competing products at similar price points?
As the concept progresses, trade-offs and concessions may need to be made. Having the rationale for each requirement ensures that decisions can be made with the best possible understanding.
When the importance of a product design brief is underestimated, or when it's hastily created and never revisited, various risks can arise. One common issue is when configurations, accessories, and the possible combinations of both are not considered. For example, if you have more than two configurations and any accessories, it’s crucial to map out the possible combinations in a matrix. This helps identify which combinations are feasible and which are not.
Updating the design brief as the concept evolves is just as critical as its initial detailing. For instance, if it’s determined that the weight target cannot be met, it’s essential to revisit the design brief, assess the implications of this change, and agree on a new target. This process helps prevent scope creep, which poses a significant risk to product development outcomes and timelines.
Over time, small decisions can accumulate, subtly shifting the concept further away from the original targets. Ultimately, this can result in a product that no longer aligns with the initial objectives, potentially rendering it unsellable. Any changes to the design brief should be agreed upon by the individuals responsible for defining it in the first place, as they understand the rationale behind the original requirements.
The product design brief serves as the foundation for successful product development. It sets clear expectations, aligns the team, and provides a roadmap to follow as the product moves through its lifecycle. By ensuring that the brief is comprehensive, regularly updated, and aligned with the product's evolving needs, businesses can minimise risks, prevent costly mistakes, and improve the chances of bringing a product to market that meets both customer expectations and regulatory requirements. The importance of a well-detailed and flexible product design brief cannot be overstated, as it guides decision-making, ensures consistency, and ultimately helps create a product that is both functional and viable.
How drawing quality reduces product risk
Have you ever been in a situation where a part arrives from a supplier that is not fit for purpose? Maybe the tolerances are off, the clearances do not work, or there are tooling marks on a critical face.
If your part drawings are clear, you can send the parts back as non-conforming. But if your drawings fail to communicate the critical aspects of your product, you may have no recourse.
Clear, unambiguous part and product drawings are an important tool for reducing product risk. They ensure everyone involved, from internal teams to external suppliers, has the same understanding of what is required.
Good drawings or specifications are also essential for diagnosing problems, both in production and once a product is in the market. They make it easier for suppliers to provide feedback, raise concerns, or suggest improvements early, before costly tooling or production errors occur. As your business grows, they help maintain consistency by reducing reliance on verbal instructions or institutional knowledge.
Your product drawings also form a key part of the contractual agreement between you and your supplier. They define whether the supplier has met their obligations if something goes wrong.
To reduce risk and protect both parties, every drawing should include a few essential elements:
Your drawings are also valuable intellectual assets and should be treated as such. In litigation or regulatory investigations, you may be required to submit them as part of your documentation.
The quality of your drawings says more than just what a part looks like. It signals:
Poorly prepared or inconsistent drawings suggest product development may have been rushed, poorly controlled, or not fully understood.
In contrast, clear, complete, and professionally presented drawings reflect a business that takes its responsibilities seriously. They demonstrate a culture of rigour and accountability, qualities that carry weight with legal counsel, investigators, and insurers.
In high-stakes situations, your drawings are not just tools for manufacturing, they are evidence of how well you manage product risk.
If your part drawings are clear, you can send the parts back as non-conforming. But if your drawings fail to communicate the critical aspects of your product, you may have no recourse.
Clear, unambiguous part and product drawings are an important tool for reducing product risk. They ensure everyone involved, from internal teams to external suppliers, has the same understanding of what is required.
Good drawings or specifications are also essential for diagnosing problems, both in production and once a product is in the market. They make it easier for suppliers to provide feedback, raise concerns, or suggest improvements early, before costly tooling or production errors occur. As your business grows, they help maintain consistency by reducing reliance on verbal instructions or institutional knowledge.
Your product drawings also form a key part of the contractual agreement between you and your supplier. They define whether the supplier has met their obligations if something goes wrong.
To reduce risk and protect both parties, every drawing should include a few essential elements:
- Unique drawing or part number and revision: Ensures tooling and production are based on the correct and current design, avoiding errors from outdated references.
- Exact specification of material and key properties: Prevents substitutions that compromise performance or compliance.
- Part finish and coating thickness: Surface finish affects function, aesthetics, and corrosion resistance. Coating thickness impacts fit and durability.
- Part colour: Helps avoid rework or scrap caused by incorrect colour batches and informs tooling or surface preparation decisions.
- Product size dimensions as reference: Confirms the part has not been inadvertently scaled during file handling or translation.
- All critical dimensions and tolerances: These affect performance, safety, and durability.
- Interface dimensions, tolerances, and fit types (for example, interference, sliding): Ensure correct fit with mating parts.
- Dimensions tied to regulatory compliance: Prevents non-compliance, liability, or recalls.
- Dimensions to be checked on first-off or start-of-batch parts: Catches early issues before full production.
- Reference to the 3D model file and revision: Links the drawing to the exact geometry used for tooling.
- Identification of primary or critical faces: Ensures cosmetic or functional surfaces are protected and properly handled throughout manufacture.
Your drawings are also valuable intellectual assets and should be treated as such. In litigation or regulatory investigations, you may be required to submit them as part of your documentation.
The quality of your drawings says more than just what a part looks like. It signals:
- the level of design maturity within your business
- the thoroughness of your engineering processes
- your team’s approach to safety, compliance, and traceability
Poorly prepared or inconsistent drawings suggest product development may have been rushed, poorly controlled, or not fully understood.
In contrast, clear, complete, and professionally presented drawings reflect a business that takes its responsibilities seriously. They demonstrate a culture of rigour and accountability, qualities that carry weight with legal counsel, investigators, and insurers.
In high-stakes situations, your drawings are not just tools for manufacturing, they are evidence of how well you manage product risk.
How a good product verification plan can prevent failures
The product verification plan is a roadmap for testing and validating a product’s performance throughout the development phase. It outlines how your business will demonstrate that your product meets its targets and is safe, durable, and fit for purpose.
The plan defines pass/fail criteria for each requirement and will likely include some of the following:
The design of the product verification plan is critical. Careful thought must be given not only to the design of each individual test but also to the sequence in which tests are performed. One sample product may be subject to multiple consecutive tests to ensure the worst-case scenario.
A well-designed product verification plan is more than just a series of tests; it is a comprehensive, dynamic system that safeguards the integrity of your product and your business. It ensures that every stage of development, from prototype to first-off production units, is rigorously evaluated against clearly defined criteria. By incorporating both controlled lab tests and real-world simulation testing, you can comprehensively assess how your product will perform under ideal conditions and in unpredictable, real-world scenarios.
The value of a product verification plan also extends far beyond the immediate product cycle. It becomes a strategic asset that builds on the lessons of previous iterations, fortifying your business’s expertise and protecting against costly failures.
Additionally, it provides invaluable insights that improve not only your product but your entire development process. By continuously refining your verification plans based on real-world feedback, your organisation improves its product development and maintains a competitive edge.
Ensuring you have a good process around creating, updating and using product verification plans is an essential aspect of effective product risk management. These activities will pay dividends in preventing failures in market, warranty costs and potential product recalls.
The plan defines pass/fail criteria for each requirement and will likely include some of the following:
- Size and weight verification: Confirms that the product meets dimensional and weight specifications, including checks on the packaged size.
- Functionality testing: Verifies that the product performs as required, confirming that all functions, features, and capabilities meet the intended use and user needs.
- Configuration and accessory matrix verification: Verifies that the product works correctly with all compatible configurations and accessories, ensuring proper fit, functionality, and performance when used with optional components.
- Actuation force testing: Ensures that all actuators (such as buttons, levers, and pedals) require an appropriate force for operation, verifying both functionality and ergonomic usability.
- Environmental testing: Simulates real-life environmental conditions by exposing the product to factors such as UV radiation, salt spray, dust ingress, humidity, and temperature fluctuations. Accelerated ageing parameters are used to mimic the long-term environmental exposure the product will experience over its lifespan.
- Static loading testing: Assesses the product’s ability to withstand static loads or pressures, ensuring it can support expected stresses without failure. This includes freight loading tests, which simulate the pressures of being stacked during transportation, such as at the bottom of a shipping container.
- Packaging and drop testing: Evaluates the durability of the packaging and the product itself by simulating drops, impacts, and handling during shipping and distribution. This ensures the product can withstand typical logistics hazards and arrive safely and undamaged to the end user. It also ensures that dropping the product does not create hazards for the user.
- Shaker table testing: Simulates transportation conditions to ensure that fasteners, assemblies, and other components do not loosen or malfunction due to vibration during shipping and handling.
- Safety mechanism and critical component testing: Focuses on the durability and reliability of critical components and safety features, verifying they remain functional throughout the product’s lifecycle, even after extended or intensive use.
- Strength, durability, endurance, and wear testing: Simulates real-world use by subjecting the product to continuous use or repeated cycles until failure (where appropriate). This evaluates longevity, strength, and durability across all configurations and accessory combinations.
- Life expectancy testing: Estimates the product’s overall lifespan by assessing performance and durability over extended use. This includes evaluating wear, failure modes, and verifying that the product meets the life expectancy targets.
- Regulatory compliance testing: Ensures the product meets all relevant material and product regulations, safety standards, and certifications at the local, regional, and global levels.
The design of the product verification plan is critical. Careful thought must be given not only to the design of each individual test but also to the sequence in which tests are performed. One sample product may be subject to multiple consecutive tests to ensure the worst-case scenario.
A well-designed product verification plan is more than just a series of tests; it is a comprehensive, dynamic system that safeguards the integrity of your product and your business. It ensures that every stage of development, from prototype to first-off production units, is rigorously evaluated against clearly defined criteria. By incorporating both controlled lab tests and real-world simulation testing, you can comprehensively assess how your product will perform under ideal conditions and in unpredictable, real-world scenarios.
The value of a product verification plan also extends far beyond the immediate product cycle. It becomes a strategic asset that builds on the lessons of previous iterations, fortifying your business’s expertise and protecting against costly failures.
Additionally, it provides invaluable insights that improve not only your product but your entire development process. By continuously refining your verification plans based on real-world feedback, your organisation improves its product development and maintains a competitive edge.
Ensuring you have a good process around creating, updating and using product verification plans is an essential aspect of effective product risk management. These activities will pay dividends in preventing failures in market, warranty costs and potential product recalls.
How to design for manufacture (DFM)
Even the smartest product ideas fall flat if they can’t be built efficiently. Yet, it happens all too often, even in experienced teams. Teams get deep into development only to discover that their design isn’t practical to produce, or needs major changes to suit real-world constraints. The result? Delays, redesign loops, and frustration for everyone involved.
Design for Manufacture isn’t just about technical know-how, it’s about timing, collaboration, and process. The earlier manufacturing considerations are brought into the design process, the better the outcomes. Too often, manufacturing input is left until the end, when changes are harder, costlier, and more disruptive.
One of the most effective ways to design with manufacturing in mind is to build closer working relationships between engineering, design, and production teams. When designers and engineers spend time on the workshop floor or with suppliers, they start to internalise what works, what doesn’t, and why. That insight helps prevent mismatches between intent and execution. Involving key suppliers as partners, rather than simply vendors, can unlock design improvements and cost savings that would otherwise be missed.
Designing for manufacture means understanding how design choices affect production efficiency, tooling costs, material use, and quality outcomes. It’s a balancing act, and a process of continuous feedback between disciplines.
The insights gained through close collaboration with manufacturing teams can be captured in a set of design guidelines tailored specifically to your products and business. These internal guidelines are where all the small but important lessons live, the ones learned the hard way, through experience. They help ensure consistency, reduce errors, and keep design aligned with real-world production constraints.
Design for Manufacture typically falls into three key focus areas:
Let’s look at each of those in detail:
Designing for Part Production
Designing parts with manufacturing in mind means considering how each component will be made, ideally using the processes and equipment already available, or with minimal new investment. This includes avoiding overly tight tolerances unless absolutely necessary, designing features that are easy to machine, mould, or form, and thinking about material availability and suitability early on. A very small reduction to the maximum dimension of a part for example, could mean the part can be produced in a smaller machine which can reduce part costs considerably. There are countless examples where a minor change to a part can save you money and make the part easier to make, which reduces manufacturing risk.
Ask your teams:
Designing for Assembly
Even if individual parts are well-designed, the real test is how they come together. Design for Assembly focuses on making that process simple, fast, and foolproof. That often means reducing the number of parts, ensuring they only go together one way, and making it easy for operators to perform tasks consistently.
Good assembly design minimises reliance on skill and maximises clarity. Think of features that self-locate, fasteners that don’t require juggling different tools, and components that can’t be installed upside down. Less handling, fewer steps, and fewer decisions mean less errors and faster throughput.
A product with multiple screw types or sizes can slow down assembly. It can also increase the risk of the wrong fastener being used in the wrong place. Parts that are handed (mirror images of each other) can be confusing for people to identify correctly so should always be marked in some way. This is also true for parts that look similar. Ultimately it should not be possible to put the wrong part in the wrong place.
Ask your teams:
Designing for Production Efficiency
This involves ensuring that production can run smoothly, with as little waste, downtime, and variability as possible. This includes designing parts and assemblies that align with standard batch sizes, tooling setups, and material dimensions. It also means thinking about how designs affect machine uptime, changeover times, and scrap rates.
Good design supports high yield and predictable performance. It’s about helping your manufacturing team maintain flow, without needing to constantly adapt or stop to troubleshoot.
For example, the design of a plastic part so that the injection moulding tool incorporates a lifter rather than a slide, can speed up production time and therefore reduce part cost.
Ask your teams:
By bringing manufacturing into the design process early, fostering strong team collaboration, and using shared knowledge to guide decisions, businesses can develop more efficient, cost-effective, and resilient products.
Design for Manufacture isn’t just about technical know-how, it’s about timing, collaboration, and process. The earlier manufacturing considerations are brought into the design process, the better the outcomes. Too often, manufacturing input is left until the end, when changes are harder, costlier, and more disruptive.
One of the most effective ways to design with manufacturing in mind is to build closer working relationships between engineering, design, and production teams. When designers and engineers spend time on the workshop floor or with suppliers, they start to internalise what works, what doesn’t, and why. That insight helps prevent mismatches between intent and execution. Involving key suppliers as partners, rather than simply vendors, can unlock design improvements and cost savings that would otherwise be missed.
Designing for manufacture means understanding how design choices affect production efficiency, tooling costs, material use, and quality outcomes. It’s a balancing act, and a process of continuous feedback between disciplines.
The insights gained through close collaboration with manufacturing teams can be captured in a set of design guidelines tailored specifically to your products and business. These internal guidelines are where all the small but important lessons live, the ones learned the hard way, through experience. They help ensure consistency, reduce errors, and keep design aligned with real-world production constraints.
Design for Manufacture typically falls into three key focus areas:
- Design for Part Production: Create parts that can be manufactured using existing processes, equipment, and materials, without unnecessary complexity, risk, or cost.
- Design for Assembly: Simplify and streamline how components fit together by reducing part count and variation, preventing assembly errors, and enabling faster, more reliable assembly.
- Design for Production Efficiency: Make the most of your equipment and materials by designing for efficient setup, minimal waste, and smooth throughput across production steps.
Let’s look at each of those in detail:
Designing for Part Production
Designing parts with manufacturing in mind means considering how each component will be made, ideally using the processes and equipment already available, or with minimal new investment. This includes avoiding overly tight tolerances unless absolutely necessary, designing features that are easy to machine, mould, or form, and thinking about material availability and suitability early on. A very small reduction to the maximum dimension of a part for example, could mean the part can be produced in a smaller machine which can reduce part costs considerably. There are countless examples where a minor change to a part can save you money and make the part easier to make, which reduces manufacturing risk.
Ask your teams:
- Can this part be made without specialist equipment or excessive hand-finishing?
- Are the tolerances appropriate for the manufacturing method?
- Is the material easy to source, and does it suit both the product requirements and the production process?
- What small changes could be made that have a big impact on manufacturing?
Designing for Assembly
Even if individual parts are well-designed, the real test is how they come together. Design for Assembly focuses on making that process simple, fast, and foolproof. That often means reducing the number of parts, ensuring they only go together one way, and making it easy for operators to perform tasks consistently.
Good assembly design minimises reliance on skill and maximises clarity. Think of features that self-locate, fasteners that don’t require juggling different tools, and components that can’t be installed upside down. Less handling, fewer steps, and fewer decisions mean less errors and faster throughput.
A product with multiple screw types or sizes can slow down assembly. It can also increase the risk of the wrong fastener being used in the wrong place. Parts that are handed (mirror images of each other) can be confusing for people to identify correctly so should always be marked in some way. This is also true for parts that look similar. Ultimately it should not be possible to put the wrong part in the wrong place.
Ask your teams:
- Can parts be assembled easily, without forcing or adjusting?
- Can they only go together one way?
- Can you reduce the number of different parts or fasteners used?
Designing for Production Efficiency
This involves ensuring that production can run smoothly, with as little waste, downtime, and variability as possible. This includes designing parts and assemblies that align with standard batch sizes, tooling setups, and material dimensions. It also means thinking about how designs affect machine uptime, changeover times, and scrap rates.
Good design supports high yield and predictable performance. It’s about helping your manufacturing team maintain flow, without needing to constantly adapt or stop to troubleshoot.
For example, the design of a plastic part so that the injection moulding tool incorporates a lifter rather than a slide, can speed up production time and therefore reduce part cost.
Ask your teams:
- Does this design make the best use of raw material dimensions or standard stock sizes?
- Will it create unnecessary waste, changeovers, or downtime?
- Have we made it easy to inspect, test, or pack consistently?
By bringing manufacturing into the design process early, fostering strong team collaboration, and using shared knowledge to guide decisions, businesses can develop more efficient, cost-effective, and resilient products.
How to design out common failures that lead to injury
Here are four common failures that often lead to injury and how you can reduce those risks:
1. Actuator Failures
TIP: Keep Actuators Close to the Action
The more components between the actuator (e.g., a handle or switch) and the action (e.g., folding or locking), the more failure points. Minimise distance and complexity, especially in safety-critical mechanisms.
For example, when the actuator is physically integrated with the action, such as a simple sliding latch found on a door, the mechanism is very reliable. As the distance and number of components between the actuator and the action increase, so does the potential for failure. Each additional link or moving part introduces a new failure mode. The more safety-critical the function, the more important it is to minimise these points of failure. This may involve reducing the distance or simplifying the connection between the actuator and the action to ensure the mechanism remains robust and dependable.
2. Failure Under Load
TIP: The loaded configuration of a product should be the most robust
Pins and latches should not bear significant loads. Ideally, they should hold a product in a particular configuration when it is unloaded. For a folding product, or any product designed to be disassembled, it’s important to consider how it will be used under typical conditions. Ask yourself: if a key component fails during normal use (eg, when loaded), will the geometry of the product help maintain safety, or will it create a hazard?
For example, consider a folding chair. When the chair is in use, ideally the user's weight should act to keep the chair in its deployed, stable configuration. Their sitting on it should not be working to collapse it, and failure of a small latch or pin should not result in them ending up on the floor. If a latch or pin is keeping the product in the unfolded configuration, it may be bearing a significant load, which could compromise both the product’s durability and its safety over time. Ideally, the product should be designed so that the user must first remove the load, by standing up, before the product can be folded. This ensures that the structure remains stable and secure under normal use and that failure is far less likely to result in injury.
The key questions with any product that is designed to be loaded, are:
3. Injury as a Result of Uncontrolled Movement
TIP: Moving parts, particularly those that can have some momentum behind them, should always be controlled
If you review a wide range of product incident reports, you’ll notice that injuries frequently occur as a result of uncontrolled movement of a component. For example, let’s say that someone picks up a ladder and one half suddenly swings towards them. In such a moment, there may not be enough time to move fingers out of the way, leading to crushing or even amputation injuries.
A typical mitigation strategy involves adding latches or ties to secure parts of the product during handling or transport. However, if these mechanisms are used, they must automatically engage to be effective, only to be manually released once the product is back in a safe configuration for use. Furthermore, these solutions must accommodate real-world variability, such as situations where the product isn’t fully folded or extended. In such cases, the latch should still engage securely over a range of folding or unfolding angles.
An alternative or complementary approach is the use of dampers or similar mechanisms that slow down component movement, particularly near points of contact where injury could occur. Ensuring there are gaps between components can further reduce these types of risks.
This type of design not only protects users from sudden impacts but also contributes to a perception of control and quality in the product experience.
4. Injury through the Unpredictability of Product Handling
TIP: Guide Safe Use of a Product through Ergonomic Design
Ergonomics is not just about product comfort, it’s about influencing how users interact with your product. It’s a critical tool in designing for safety. If your product is likely to be picked up, moved, handled, or repositioned, there are multiple ways a user might choose to interact with it. By intentionally designing your product with a clear, intuitive, and comfortable method for handling, you reduce risk. This design choice allows you to guide user behaviour and ensure that any potential hazards are either minimised or eliminated. Conversely, if there is no obvious or comfortable way to handle or use the product, users will improvise and that improvisation can lead to misuse, product damage, or injury.
For example, comfortable handles on a product, that are in the ideal location to balance the weight of the product when being carried and that keep hands away from any moving parts or pinch points can reduce risks of injury significantly.
Conversely, sometimes unintentionally, a part of a product lends itself to being a natural handle even though it was never intended to be. This has been the result of many injuries as users consistently picked up or held a product in a way that was completely intuitive, but was also hazardous. This highlights the need to:
1. Actuator Failures
TIP: Keep Actuators Close to the Action
The more components between the actuator (e.g., a handle or switch) and the action (e.g., folding or locking), the more failure points. Minimise distance and complexity, especially in safety-critical mechanisms.
For example, when the actuator is physically integrated with the action, such as a simple sliding latch found on a door, the mechanism is very reliable. As the distance and number of components between the actuator and the action increase, so does the potential for failure. Each additional link or moving part introduces a new failure mode. The more safety-critical the function, the more important it is to minimise these points of failure. This may involve reducing the distance or simplifying the connection between the actuator and the action to ensure the mechanism remains robust and dependable.
2. Failure Under Load
TIP: The loaded configuration of a product should be the most robust
Pins and latches should not bear significant loads. Ideally, they should hold a product in a particular configuration when it is unloaded. For a folding product, or any product designed to be disassembled, it’s important to consider how it will be used under typical conditions. Ask yourself: if a key component fails during normal use (eg, when loaded), will the geometry of the product help maintain safety, or will it create a hazard?
For example, consider a folding chair. When the chair is in use, ideally the user's weight should act to keep the chair in its deployed, stable configuration. Their sitting on it should not be working to collapse it, and failure of a small latch or pin should not result in them ending up on the floor. If a latch or pin is keeping the product in the unfolded configuration, it may be bearing a significant load, which could compromise both the product’s durability and its safety over time. Ideally, the product should be designed so that the user must first remove the load, by standing up, before the product can be folded. This ensures that the structure remains stable and secure under normal use and that failure is far less likely to result in injury.
The key questions with any product that is designed to be loaded, are:
- under what configuration(s) does loading occur?
- during this loading, what component is taking the load?
3. Injury as a Result of Uncontrolled Movement
TIP: Moving parts, particularly those that can have some momentum behind them, should always be controlled
If you review a wide range of product incident reports, you’ll notice that injuries frequently occur as a result of uncontrolled movement of a component. For example, let’s say that someone picks up a ladder and one half suddenly swings towards them. In such a moment, there may not be enough time to move fingers out of the way, leading to crushing or even amputation injuries.
A typical mitigation strategy involves adding latches or ties to secure parts of the product during handling or transport. However, if these mechanisms are used, they must automatically engage to be effective, only to be manually released once the product is back in a safe configuration for use. Furthermore, these solutions must accommodate real-world variability, such as situations where the product isn’t fully folded or extended. In such cases, the latch should still engage securely over a range of folding or unfolding angles.
An alternative or complementary approach is the use of dampers or similar mechanisms that slow down component movement, particularly near points of contact where injury could occur. Ensuring there are gaps between components can further reduce these types of risks.
This type of design not only protects users from sudden impacts but also contributes to a perception of control and quality in the product experience.
4. Injury through the Unpredictability of Product Handling
TIP: Guide Safe Use of a Product through Ergonomic Design
Ergonomics is not just about product comfort, it’s about influencing how users interact with your product. It’s a critical tool in designing for safety. If your product is likely to be picked up, moved, handled, or repositioned, there are multiple ways a user might choose to interact with it. By intentionally designing your product with a clear, intuitive, and comfortable method for handling, you reduce risk. This design choice allows you to guide user behaviour and ensure that any potential hazards are either minimised or eliminated. Conversely, if there is no obvious or comfortable way to handle or use the product, users will improvise and that improvisation can lead to misuse, product damage, or injury.
For example, comfortable handles on a product, that are in the ideal location to balance the weight of the product when being carried and that keep hands away from any moving parts or pinch points can reduce risks of injury significantly.
Conversely, sometimes unintentionally, a part of a product lends itself to being a natural handle even though it was never intended to be. This has been the result of many injuries as users consistently picked up or held a product in a way that was completely intuitive, but was also hazardous. This highlights the need to:
- design the product to ensure users engage with it in the way you intend
- performing user testing to verify that they don’t naturally do something different
How safety mechanism design can reduce product risk
A safety mechanism is any added feature, mechanical, electrical, or visual, that reduces the likelihood of harm. It acts as a backup to core design functions and is especially important where the consequences of failure are severe.
Examples include:
These should not be relied on as the only protection, they are most effective when paired with inherently safe design.
Key Considerations for Good Safety Mechanisms:
Robust safety mechanism design is about more than just ticking compliance boxes, it’s about actively protecting users in real-world conditions. A good safety mechanism should be:
Examples include:
- Physical guards over moving parts
- Interlock switches
- Automatic shutdown systems
- Pressure relief valves
- Latches or catches
- Visual indicators (e.g., colour tabs or flags)
- Alarms or buzzers
These should not be relied on as the only protection, they are most effective when paired with inherently safe design.
Key Considerations for Good Safety Mechanisms:
- Visibility and Feedback
- Self-indicating Mechanisms
- Visual Indicators
- Performance Across Configurations
- A guard must stay in place regardless of whether the product is upright, on its side, or mounted in an unusual orientation.
- A childproof lock should work whether a cabinet is full or empty, upright or tipped.
- A shutdown mechanism should still engage in edge-case scenarios like overheating, power surges, or unusual user actions.
- Built-in Redundancy
Robust safety mechanism design is about more than just ticking compliance boxes, it’s about actively protecting users in real-world conditions. A good safety mechanism should be:
- Intuitive – Users shouldn’t need a manual to understand it.
- Reliable – It works in all expected conditions.
- Integrated – Part of the product, not an afterthought.
- Communicative – Clearly signals its status to the user.
How to apply fail-safe design
Good design plays a critical role in reducing product risks, especially the risk of injury. Injuries don’t just affect users; they can also trigger product recalls, legal action, and reputational damage. The EU Safety Gate 2023 Annual Report highlighted that injuries were the second most common reason for product recalls (after chemical risks), accounting for 21% of all cases.
While thorough risk assessments are essential, applying sound design principles from the outset can significantly reduce the chance of mechanical failure and resulting harm. One powerful approach is fail-safe design.
The Principle of Fail-Safe Design
Fail-safe design ensures that when a component or a product fails, it does not create a hazardous situation. Ideally, failure should make the product unusable--not dangerous.
There are a number of key ideas behind this principle:
1. The first point of failure should not lead to harm.
As a product nears the end of its usable life, the most likely failure point should not expose the user to risk. Instead, it should make the product unusable in a way that clearly signals it has reached the end of its life.
This is also particularly important in the context of product repairability, which is being actively encouraged (and regulated) through frameworks such as the EU Ecodesign Directive. Repairable products must be designed so that replacing a single part doesn’t lead to a subsequent, more dangerous failure at a later time. Refurbishment (the preferred activity for a product nearing the end of its life) should include assessment of all high-risk components, not just the visibly damaged ones.
2. Failure of multi-state components should default to a safe state.
For systems with multiple states (for example on or off), like brakes or latches, failure should result in the safest configuration being locked in. Brakes, for example, in most instances, should fail in the "on" position. While this may be frustrating for a user, this ensures a product without a working brake system cannot be used. A product where the brake fails in the off position may be continued to be used until the situation presents itself where engaging the brake is necessary to prevent an injury or other harm. A quick-release wheel for example should fail by staying secured (inconvenient but not hazardous), not falling off mid-use.
When designing a product with different states, go through each use state and identify whether a failure could freeze a component in an unsafe state as this is a very common cause of subsequent injuries.
3. Failures must be visible.
Users must be able to recognise when something is wrong. Subtle or hidden failures are especially dangerous, as users may continue to use a product that is no longer safe.
A good design might include a secondary mechanism that prevents total collapse of a product while clearly showing the product is no longer safe to use through its partial change in geometry. A bad design hides the failure until injury occurs.
4. Avoid secondary hazards.
A failure should not create new dangers such as sharp edges, exposed moving parts, or pinch points. Unfortunately, many users will continue to use damaged products. Design with this reality in mind.
Tip: Durability testing is a valuable tool to simulate long-term wear and identify likely failure points and hazards created as a result of failure. It can help you build safer end-of-life scenarios into your design.
By integrating fail-safe principles into product design from the start, businesses can significantly reduce injury risks, meet regulatory expectations, and create safer, more reliable products.
While thorough risk assessments are essential, applying sound design principles from the outset can significantly reduce the chance of mechanical failure and resulting harm. One powerful approach is fail-safe design.
The Principle of Fail-Safe Design
Fail-safe design ensures that when a component or a product fails, it does not create a hazardous situation. Ideally, failure should make the product unusable--not dangerous.
There are a number of key ideas behind this principle:
1. The first point of failure should not lead to harm.
As a product nears the end of its usable life, the most likely failure point should not expose the user to risk. Instead, it should make the product unusable in a way that clearly signals it has reached the end of its life.
This is also particularly important in the context of product repairability, which is being actively encouraged (and regulated) through frameworks such as the EU Ecodesign Directive. Repairable products must be designed so that replacing a single part doesn’t lead to a subsequent, more dangerous failure at a later time. Refurbishment (the preferred activity for a product nearing the end of its life) should include assessment of all high-risk components, not just the visibly damaged ones.
2. Failure of multi-state components should default to a safe state.
For systems with multiple states (for example on or off), like brakes or latches, failure should result in the safest configuration being locked in. Brakes, for example, in most instances, should fail in the "on" position. While this may be frustrating for a user, this ensures a product without a working brake system cannot be used. A product where the brake fails in the off position may be continued to be used until the situation presents itself where engaging the brake is necessary to prevent an injury or other harm. A quick-release wheel for example should fail by staying secured (inconvenient but not hazardous), not falling off mid-use.
When designing a product with different states, go through each use state and identify whether a failure could freeze a component in an unsafe state as this is a very common cause of subsequent injuries.
3. Failures must be visible.
Users must be able to recognise when something is wrong. Subtle or hidden failures are especially dangerous, as users may continue to use a product that is no longer safe.
A good design might include a secondary mechanism that prevents total collapse of a product while clearly showing the product is no longer safe to use through its partial change in geometry. A bad design hides the failure until injury occurs.
4. Avoid secondary hazards.
A failure should not create new dangers such as sharp edges, exposed moving parts, or pinch points. Unfortunately, many users will continue to use damaged products. Design with this reality in mind.
Tip: Durability testing is a valuable tool to simulate long-term wear and identify likely failure points and hazards created as a result of failure. It can help you build safer end-of-life scenarios into your design.
By integrating fail-safe principles into product design from the start, businesses can significantly reduce injury risks, meet regulatory expectations, and create safer, more reliable products.
How to apply user-centric design
Poor user-centric design might not cause harm, but it can lead to:
What is good user-centric design?
Have you ever picked up a hammer and instantly realised that every hammer you’ve used before was subpar? Consumers don’t always know how to describe what they want, but when they experience a product that simply works better, it’s unforgettable. Once you’ve used a well-balanced hammer, you never want to go back to one that isn’t.
It’s remarkable how many products could be substantially improved simply by repositioning the centre of mass or by adding handles or grips that allow the user to hold the product in alignment with its centre of mass. By addressing this one small detail, you can create a product that’s actually heavier than your competitor’s, yet feels lighter and more comfortable to use. This can have good cost and durability advantages also. The same goes for general comfort. While square edges and straight lines may be aesthetically pleasing, they can make the product uncomfortable to hold and use.
Another often-overlooked consideration is the design of parts that users regularly attach or remove. It should be intuitive to fit them correctly the first time, without needing to figure out which side or orientation is right.
The best way to understand these subtle but impactful details is to ensure that people within your business are regular users of the product themselves. They should be familiar with a range of competitors’ products and actively use your own products. While observing other users can also provide valuable insights, surveys and questionnaires are often less useful. People may know they like or dislike something but struggle to explain why. Users don’t know what they don’t know. If they’ve never experienced a particular feature, they won’t be able to tell you that they want it.
The first step in user-centric design is defining your customer in detail, which should be a core part of your design brief. The second is mapping out the handling and use scenarios to understand how your product will be interacted with in real life.
Defining the Customer
Products are often designed for the 50th percentile user, but the real risk lies in how well your product works for users at both ends of the spectrum. Depending on your market, the average user may vary significantly. For example, if your product is optimised for the 50th percentile user, people between the 20th and 80th percentile might still use it comfortably, but with some compromises in ease or comfort. At the extremes of the bell curve, however, use might become unsafe or the product might be more prone to damage.
This variability needs to be captured by your team in the product’s risk assessment. They will need to consider how to mitigate risks for outliers, whether through design adjustments or by making it very clear that the product is not suitable for certain users. Often, the best option is to ensure that those outside your defined user range cannot physically use the product.
Defining Handling and Use Scenarios
Having people in your business regularly use both your own and competitors’ products will help define realistic use scenarios. This will include how they handle, transport and store the product when they are not using it. However, it’s important to recognise that use scenarios can vary significantly by market. Understanding these variations is part of understanding user expectations.
For example, a product in the USA that lacks multiple cup holders can frustrate American consumers. The same product in many European countries might be seen as cluttered or unattractive if it does include multiple cup holders. In parts of Europe where homes are smaller and storage is limited, products may need to fold away for compact storage, whereas in other markets, that same product might never be folded at all.
Unfortunately, some businesses either skip usability testing or allocate insufficient resources to the process, viewing it as an unnecessary expense or a step that can be taken later in development. This is a risky mindset. While it may seem like a shortcut, skipping usability testing can have consequences that outweigh the initial savings.
Maintenance and Lifecycle Risks
When designing a product, it’s easy to just focus on the immediate user experience, the product's appeal, ease of use, and functionality at the point of purchase. However, one of the most overlooked areas in product risk management is how a product performs over time, especially in terms of maintenance, cleaning, and part replacement. A product that starts off user-friendly can quickly become a source of frustration if it's difficult to maintain or doesn't stand up to the wear and tear of regular use. This can lead to premature abandonment, negative reviews, and even increased customer support costs. All of which carry significant risks for a product's long-term success.
Some key aspects your development teams need to consider include:
User-centric design is an essential yet often overlooked aspect of product development. While safety, durability, and manufacturability are top priorities, the user experience over time can make or break a product. Whether it's the ease of use, maintenance, or ensuring a seamless first-time experience, a product that works well for the user will see greater customer satisfaction, fewer returns, and better long-term success. Good design is about creating products that fit into users' lives in an intuitive and lasting way. By considering all aspects of usability, from initial interactions to long-term maintenance, you mitigate risks that could lead to costly redesigns, lost revenue, or even reputation damage.
- Negative reviews: Users who struggle with a product may take to social media or other sites to share their frustrations, harming your brand's reputation.
- Product returns: A frustrating user experience often leads to higher return rates in certain markets, which can directly impact your bottom line and damage brand loyalty.
- Increased support costs: If users cannot figure out how to use the product correctly, it can result in a higher volume of customer support inquiries, diverting valuable resources.
- Lost sales potential: When a product is difficult to use, even if it’s priced well, potential customers may opt for a competitor’s product that offers a more intuitive experience.
What is good user-centric design?
Have you ever picked up a hammer and instantly realised that every hammer you’ve used before was subpar? Consumers don’t always know how to describe what they want, but when they experience a product that simply works better, it’s unforgettable. Once you’ve used a well-balanced hammer, you never want to go back to one that isn’t.
It’s remarkable how many products could be substantially improved simply by repositioning the centre of mass or by adding handles or grips that allow the user to hold the product in alignment with its centre of mass. By addressing this one small detail, you can create a product that’s actually heavier than your competitor’s, yet feels lighter and more comfortable to use. This can have good cost and durability advantages also. The same goes for general comfort. While square edges and straight lines may be aesthetically pleasing, they can make the product uncomfortable to hold and use.
Another often-overlooked consideration is the design of parts that users regularly attach or remove. It should be intuitive to fit them correctly the first time, without needing to figure out which side or orientation is right.
The best way to understand these subtle but impactful details is to ensure that people within your business are regular users of the product themselves. They should be familiar with a range of competitors’ products and actively use your own products. While observing other users can also provide valuable insights, surveys and questionnaires are often less useful. People may know they like or dislike something but struggle to explain why. Users don’t know what they don’t know. If they’ve never experienced a particular feature, they won’t be able to tell you that they want it.
The first step in user-centric design is defining your customer in detail, which should be a core part of your design brief. The second is mapping out the handling and use scenarios to understand how your product will be interacted with in real life.
Defining the Customer
Products are often designed for the 50th percentile user, but the real risk lies in how well your product works for users at both ends of the spectrum. Depending on your market, the average user may vary significantly. For example, if your product is optimised for the 50th percentile user, people between the 20th and 80th percentile might still use it comfortably, but with some compromises in ease or comfort. At the extremes of the bell curve, however, use might become unsafe or the product might be more prone to damage.
This variability needs to be captured by your team in the product’s risk assessment. They will need to consider how to mitigate risks for outliers, whether through design adjustments or by making it very clear that the product is not suitable for certain users. Often, the best option is to ensure that those outside your defined user range cannot physically use the product.
Defining Handling and Use Scenarios
Having people in your business regularly use both your own and competitors’ products will help define realistic use scenarios. This will include how they handle, transport and store the product when they are not using it. However, it’s important to recognise that use scenarios can vary significantly by market. Understanding these variations is part of understanding user expectations.
For example, a product in the USA that lacks multiple cup holders can frustrate American consumers. The same product in many European countries might be seen as cluttered or unattractive if it does include multiple cup holders. In parts of Europe where homes are smaller and storage is limited, products may need to fold away for compact storage, whereas in other markets, that same product might never be folded at all.
Unfortunately, some businesses either skip usability testing or allocate insufficient resources to the process, viewing it as an unnecessary expense or a step that can be taken later in development. This is a risky mindset. While it may seem like a shortcut, skipping usability testing can have consequences that outweigh the initial savings.
Maintenance and Lifecycle Risks
When designing a product, it’s easy to just focus on the immediate user experience, the product's appeal, ease of use, and functionality at the point of purchase. However, one of the most overlooked areas in product risk management is how a product performs over time, especially in terms of maintenance, cleaning, and part replacement. A product that starts off user-friendly can quickly become a source of frustration if it's difficult to maintain or doesn't stand up to the wear and tear of regular use. This can lead to premature abandonment, negative reviews, and even increased customer support costs. All of which carry significant risks for a product's long-term success.
Some key aspects your development teams need to consider include:
- Ease of cleaning: Products that collect dust, grime, or food particles (such as kitchen appliances, fitness equipment, or baby products) need to be easy to clean. Complicated nooks and crannies or hard-to-remove parts should be avoided.
- Accessible replacement parts: If the product’s parts wear out over time, ensuring that replacements are easy to obtain and simple to install is crucial. Making it hard for users to replace a battery, filter, or a worn-out part can lead to dissatisfaction and, ultimately, the product being abandoned.
- Clear maintenance guidelines: Include clear instructions on how to clean, care for, and replace parts. Providing users with an easy-to-follow maintenance plan can enhance the longevity of the product and reduce frustration.
User-centric design is an essential yet often overlooked aspect of product development. While safety, durability, and manufacturability are top priorities, the user experience over time can make or break a product. Whether it's the ease of use, maintenance, or ensuring a seamless first-time experience, a product that works well for the user will see greater customer satisfaction, fewer returns, and better long-term success. Good design is about creating products that fit into users' lives in an intuitive and lasting way. By considering all aspects of usability, from initial interactions to long-term maintenance, you mitigate risks that could lead to costly redesigns, lost revenue, or even reputation damage.
How to include sustainability in product design
When people talk about sustainable product design, they are usually referring to environmental sustainability, rather than economic, or social sustainability. More specifically, the sustainability of the ecosystems that products interact with and depend on for their creation. This includes aspects such as the depletion of natural resources, pollution, climate change and the long-term health of air, water, soil, and biodiversity.
To fully understand a product's sustainability, a business must look beyond any single feature or use-phase and consider the products entire lifecycle, including how it interacts with and affects the broader ecosystem.
Often, the word sustainability is immediately associated with carbon emissions. But the concept is, of course, much broader. At its core, something is unsustainable if it cannot continue indefinitely. Unsustainability typically arises when we:
Most products manufactured today contribute to one or both of these concepts to varying degrees. Manufacturing, by its nature, consumes resources, concentrates substances, and often results in products that cannot be returned to their original material states, so are fundamentally changing the eco system.
Sustainability is complex. Unlike product safety, which focuses on individual harm, sustainability considers planetary and systemic impacts. It's grounded in global-scale risks: climate change, declining fossil fuels, mineral scarcity, and localised environmental degradation. These risks may be harder to visualise, but they will eventually affect your business.
A linear economy, which consists of extraction, manufacturing, transportation, use, and disposal, assumes unlimited resources and an unlimited ability to meet rising energy demands. Neither assumption holds.
Resource Depletion
Some of the most pressing environmental consequences come from the depletion of natural resources that entire ecosystems depend on. When these resources are used faster than they can regenerate, or when natural systems are disrupted, the resulting degradation can be severe and long-lasting.
For example, deforestation reduces biodiversity, disrupts water cycles, causes soil erosion, and limits carbon absorption, accelerating environmental degradation. In agriculture, intensive farming depletes soil fertility, leading to erosion, lower yields, and greater reliance on fertilisers that can harm waterways. Overfishing depletes stocks faster than they can recover, disrupting marine food webs and threatening ocean biodiversity.
When natural systems are pushed beyond their limits, the result is environmental degradation. Designing products and systems that reduce pressure on these resources, or that actively support regeneration, will be key to creating a truly sustainable future.
While many forms of depletion, such as soil degradation or deforestation, have direct ecological impacts, other forms create systemic risks that are just as urgent.
The European Commission, along with other governments globally, maintains a list of Critical Raw Materials (CRMs). These materials are essential to economic development but face serious risks due to geological scarcity or highly concentrated and fragile supply chains. Examples include tellurium, used in thin-film solar panels, and phosphorus, which is vital for industrial agriculture. Both are non-renewable and often sourced in ways that pose environmental and geopolitical risks.
Although the depletion of CRMs may not always lead to direct ecosystem collapse, it often results in extraction practices with significant environmental consequences. These include water pollution, habitat destruction, and substantial carbon emissions. In regions such as the Western Sahara, phosphorus mining has contributed to geopolitical tension and conflict, showing how resource scarcity can also create social instability.
The growing dependence on CRMs in electronics and clean energy technologies, combined with low recycling rates and linear product lifecycles, is worsening both environmental and social unsustainability. In 2022 alone, 62 million metric tonnes of electronic waste were generated (UNITAR et al., 2024). Much of this ends up in landfills or is exported to countries with limited environmental protections.
This highlights a broader truth. Unsustainable resource use, whether biological or mineral, has wide-reaching consequences. Depleting any critical resource puts pressure on the systems that support life, social stability, and economic resilience.
Our dependence on energy must also be viewed as a depletion issue. Fossil fuels, although still central to global energy systems, are finite and increasingly difficult and energy-intensive to extract. As conventional oil and gas sources decline, the world is relying more on unconventional reserves such as tar sands or deepwater drilling. These options carry greater environmental costs and lower energy returns.
At the same time, renewable energy, while essential to reducing emissions, has its own limitations. These include challenges related to storage, material requirements, and energy intermittency. Even with expanding capacity, renewable energy cannot keep up with unchecked consumption without creating pressure elsewhere in the system.
Energy, whether fossil-based or renewable, comes with environmental costs. From extraction and manufacturing through to transportation and end-of-life processing. Every stage of a product’s life requires energy. If current trends continue, we will eventually reach a limit, not only in fossil fuel availability but also in our capacity to build and maintain energy systems that meet demand.
For this reason, ensuring your business is designing products for lower overall energy demand is essential.
Thinking about resource depletion isn’t just about reducing harm. It’s about building a business that can thrive no matter how the world changes. When you understand what your products consume and the systems they depend on, you can make smarter design choices, strengthen supply resilience, and unlock opportunities your competitors might overlook.
Accumulation
In natural ecosystems, the concept of waste does not exist. Every material and nutrient cycles through biological and chemical processes, continuously reused and transformed in ways that sustain life. Waste, as we understand it, is a human invention. A byproduct of industrial processes and product systems that leave behind substances in forms or concentrations nature never intended.
This accumulation of materials and chemicals outside natural cycles leads to pollution, toxicity, and long-term harm to ecosystems and human health.
Throughout a product’s lifecycle, from:
During extraction and processing, resource-intensive activities can generate pollution and concentrate toxic substances. In use, products may shed microplastics or release chemicals that enter air, water, or soil. At end-of-life, landfilling or incineration can lead to further accumulation and leaching of hazardous substances, as well as the loss of valuable materials that could otherwise be recovered.
Understanding and managing these flows of materials and pollutants is critical to reducing environmental and health risks. It requires careful selection of product materials, thoughtful design to minimise waste and shedding, and strategies that anticipate the product’s full lifecycle impacts, including what happens when it reaches disposal.
Below are some key examples of how accumulation manifests and why it matters for sustainable product design:
The principles of the circular economy offer a strong starting point for many product businesses. These are:
However, without a deeper understanding of a product’s environmental impact, businesses can easily oversimplify and misapply these principles. A common pitfall is focusing solely on recyclability as a way to “close the loop,” with little consideration for the toxin accumulation and environmental degradation that can occur over repeated cycles. Circulation alone is not enough. Overlooking the phrase at their highest value, leads to downcycling rather than true value preservation. The third principle, regenerate nature, is frequently absent from circular strategies, resulting in outcomes that contribute to environmental degradation rather than repair. The circle should be spiralling upwards and not be a spiral to the bottom.
True circularity demands on more than just keeping materials moving; it requires thoughtful, regenerative design that acknowledges limits and builds back value at every stage.
Reference: UNITAR et al. (2024) Global E-waste Monitor 2024: Electronic Waste Rising Five Times Faster than Documented E-waste Recycling. Bonn, Germany. Available at: https://unitar.org/about/news-stories/press/global-e-waste-monitor-2024-electronic-waste-rising-five-times-faster-documented-e-waste-recycling (Accessed: 17 July 2025).
To fully understand a product's sustainability, a business must look beyond any single feature or use-phase and consider the products entire lifecycle, including how it interacts with and affects the broader ecosystem.
Often, the word sustainability is immediately associated with carbon emissions. But the concept is, of course, much broader. At its core, something is unsustainable if it cannot continue indefinitely. Unsustainability typically arises when we:
- Deplete a resource: because eventually, it runs out, or becomes increasingly costly or damaging to access,
- Accumulate or concentrate something: to the point that it becomes toxic or harmful.
Most products manufactured today contribute to one or both of these concepts to varying degrees. Manufacturing, by its nature, consumes resources, concentrates substances, and often results in products that cannot be returned to their original material states, so are fundamentally changing the eco system.
Sustainability is complex. Unlike product safety, which focuses on individual harm, sustainability considers planetary and systemic impacts. It's grounded in global-scale risks: climate change, declining fossil fuels, mineral scarcity, and localised environmental degradation. These risks may be harder to visualise, but they will eventually affect your business.
A linear economy, which consists of extraction, manufacturing, transportation, use, and disposal, assumes unlimited resources and an unlimited ability to meet rising energy demands. Neither assumption holds.
Resource Depletion
Some of the most pressing environmental consequences come from the depletion of natural resources that entire ecosystems depend on. When these resources are used faster than they can regenerate, or when natural systems are disrupted, the resulting degradation can be severe and long-lasting.
For example, deforestation reduces biodiversity, disrupts water cycles, causes soil erosion, and limits carbon absorption, accelerating environmental degradation. In agriculture, intensive farming depletes soil fertility, leading to erosion, lower yields, and greater reliance on fertilisers that can harm waterways. Overfishing depletes stocks faster than they can recover, disrupting marine food webs and threatening ocean biodiversity.
When natural systems are pushed beyond their limits, the result is environmental degradation. Designing products and systems that reduce pressure on these resources, or that actively support regeneration, will be key to creating a truly sustainable future.
While many forms of depletion, such as soil degradation or deforestation, have direct ecological impacts, other forms create systemic risks that are just as urgent.
The European Commission, along with other governments globally, maintains a list of Critical Raw Materials (CRMs). These materials are essential to economic development but face serious risks due to geological scarcity or highly concentrated and fragile supply chains. Examples include tellurium, used in thin-film solar panels, and phosphorus, which is vital for industrial agriculture. Both are non-renewable and often sourced in ways that pose environmental and geopolitical risks.
Although the depletion of CRMs may not always lead to direct ecosystem collapse, it often results in extraction practices with significant environmental consequences. These include water pollution, habitat destruction, and substantial carbon emissions. In regions such as the Western Sahara, phosphorus mining has contributed to geopolitical tension and conflict, showing how resource scarcity can also create social instability.
The growing dependence on CRMs in electronics and clean energy technologies, combined with low recycling rates and linear product lifecycles, is worsening both environmental and social unsustainability. In 2022 alone, 62 million metric tonnes of electronic waste were generated (UNITAR et al., 2024). Much of this ends up in landfills or is exported to countries with limited environmental protections.
This highlights a broader truth. Unsustainable resource use, whether biological or mineral, has wide-reaching consequences. Depleting any critical resource puts pressure on the systems that support life, social stability, and economic resilience.
Our dependence on energy must also be viewed as a depletion issue. Fossil fuels, although still central to global energy systems, are finite and increasingly difficult and energy-intensive to extract. As conventional oil and gas sources decline, the world is relying more on unconventional reserves such as tar sands or deepwater drilling. These options carry greater environmental costs and lower energy returns.
At the same time, renewable energy, while essential to reducing emissions, has its own limitations. These include challenges related to storage, material requirements, and energy intermittency. Even with expanding capacity, renewable energy cannot keep up with unchecked consumption without creating pressure elsewhere in the system.
Energy, whether fossil-based or renewable, comes with environmental costs. From extraction and manufacturing through to transportation and end-of-life processing. Every stage of a product’s life requires energy. If current trends continue, we will eventually reach a limit, not only in fossil fuel availability but also in our capacity to build and maintain energy systems that meet demand.
For this reason, ensuring your business is designing products for lower overall energy demand is essential.
Thinking about resource depletion isn’t just about reducing harm. It’s about building a business that can thrive no matter how the world changes. When you understand what your products consume and the systems they depend on, you can make smarter design choices, strengthen supply resilience, and unlock opportunities your competitors might overlook.
Accumulation
In natural ecosystems, the concept of waste does not exist. Every material and nutrient cycles through biological and chemical processes, continuously reused and transformed in ways that sustain life. Waste, as we understand it, is a human invention. A byproduct of industrial processes and product systems that leave behind substances in forms or concentrations nature never intended.
This accumulation of materials and chemicals outside natural cycles leads to pollution, toxicity, and long-term harm to ecosystems and human health.
Throughout a product’s lifecycle, from:
- raw material extraction and processing,
- through manufacturing and use,
- to end-of-life disposal,
During extraction and processing, resource-intensive activities can generate pollution and concentrate toxic substances. In use, products may shed microplastics or release chemicals that enter air, water, or soil. At end-of-life, landfilling or incineration can lead to further accumulation and leaching of hazardous substances, as well as the loss of valuable materials that could otherwise be recovered.
Understanding and managing these flows of materials and pollutants is critical to reducing environmental and health risks. It requires careful selection of product materials, thoughtful design to minimise waste and shedding, and strategies that anticipate the product’s full lifecycle impacts, including what happens when it reaches disposal.
Below are some key examples of how accumulation manifests and why it matters for sustainable product design:
- Water: Plastics from products and packaging break down into micro- and nano-particles that bioaccumulate in organisms and disrupt aquatic ecosystems. Heavy metals and chemical additives, released during manufacturing, use, or disposal, persist in water and sediments, accumulating in organisms and causing toxicity through the food chain.
- Soil: Toxic substances such as pesticides, fertilisers, and heavy metals from product use or disposal contaminate soil, reduce fertility, and enter food chains.
- Air: Emissions from manufacturing, product use, and landfill release particulates, Volatile Organic Compounds (VOCs), and greenhouse gases, degrading air quality and driving climate change.
- Bioaccumulation: Hazardous chemicals in products, including Persistent Organic Pollutants (POPs) and Short-Chain Chlorinated Paraffins (SCCPs), persist in living organisms, concentrating up the food chain and causing toxicity.
- Landfill: Complex or poorly designed products often end up in landfill, where valuable resources are lost, and toxic substances leach into soil and water. Organic waste and composites emit methane, a potent greenhouse gas.
The principles of the circular economy offer a strong starting point for many product businesses. These are:
- Eliminate waste and pollution (addressing accumulation)
- Circulate products and materials at their highest value (addressing depletion)
- Regenerate nature (reversing degradation)
However, without a deeper understanding of a product’s environmental impact, businesses can easily oversimplify and misapply these principles. A common pitfall is focusing solely on recyclability as a way to “close the loop,” with little consideration for the toxin accumulation and environmental degradation that can occur over repeated cycles. Circulation alone is not enough. Overlooking the phrase at their highest value, leads to downcycling rather than true value preservation. The third principle, regenerate nature, is frequently absent from circular strategies, resulting in outcomes that contribute to environmental degradation rather than repair. The circle should be spiralling upwards and not be a spiral to the bottom.
True circularity demands on more than just keeping materials moving; it requires thoughtful, regenerative design that acknowledges limits and builds back value at every stage.
Reference: UNITAR et al. (2024) Global E-waste Monitor 2024: Electronic Waste Rising Five Times Faster than Documented E-waste Recycling. Bonn, Germany. Available at: https://unitar.org/about/news-stories/press/global-e-waste-monitor-2024-electronic-waste-rising-five-times-faster-documented-e-waste-recycling (Accessed: 17 July 2025).
How Life Cycle Assessment (LCA) helps improve sustainability
Many organisations are already measuring their operational carbon emissions. But for product-based businesses, these emissions often represent only a small portion, sometimes less than 10% (McKinsey & Company, 2024), of the total footprint when the full product lifecycle is considered.
A Lifecycle Assessment (LCA) captures this broader view. It evaluates environmental impacts across the entire lifecycle of a product, from material extraction to manufacturing, use, and end-of-life. LCAs cover more than carbon emissions, including human toxicity and impacts on water, air, and soil. These insights are essential for prioritising product improvements and avoiding situations where one activity reduces carbon emissions but creates greater harm elsewhere.
Energy use is often concentrated in upstream stages such as material extraction and manufacturing, and downstream stages such as waste and recycling. These areas may remain invisible if you only track operational emissions. Lifecycle assessment helps reveal these blind spots and ensures product decisions are made with the full picture in mind.
A simple way to begin is to select one product and:
Regulation is increasingly shaping product and packaging requirements. Recent EU measures, such as the Ecodesign for Sustainable Products Regulation (ESPR) (EU 2024/1781, 2024) and the Packaging and Packaging Waste Regulation (PPWR) (EU 2025/40, 2024), set a clear direction:
Sustainable design goes further than making a product recyclable or reducing energy use. It requires considering materials, processes, and impacts across the full lifecycle. Many improvements can be made immediately through smarter design, including:
Sources:
EU 2024/1781 (2024) Regulation (EU) 2024/1781 establishing a framework for setting ecodesign requirements for sustainable products, Official Journal of the European Union. Available at: https://eur-lex.europa.eu/eli/reg/2024/1781/oj (Accessed: 17 July 2025).
EU 2025/40 (2024) Regulation (EU) 2025/40 on packaging and packaging waste. Available at: https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng (Accessed: 17 July 2025).
McKinsey & Company (2024) What are Scope 1, 2, and 3 emissions? Available at: https://www.mckinsey.com/featured-insights/mckinsey-explainers/what-are-scope-1-2-and-3-emissions (Accessed: 17 July 2025).
A Lifecycle Assessment (LCA) captures this broader view. It evaluates environmental impacts across the entire lifecycle of a product, from material extraction to manufacturing, use, and end-of-life. LCAs cover more than carbon emissions, including human toxicity and impacts on water, air, and soil. These insights are essential for prioritising product improvements and avoiding situations where one activity reduces carbon emissions but creates greater harm elsewhere.
Energy use is often concentrated in upstream stages such as material extraction and manufacturing, and downstream stages such as waste and recycling. These areas may remain invisible if you only track operational emissions. Lifecycle assessment helps reveal these blind spots and ensures product decisions are made with the full picture in mind.
A simple way to begin is to select one product and:
- Gather product information: Use the bill of materials (BOM) or disassemble a product for reference.
- Map the lifecycle: Identify key upstream, assembly, and downstream activities, including material extraction, manufacturing, transport, use, and end-of-life.
- Identify environmental loads: For each stage, note major inputs and outputs such as energy use, emissions, and waste.
- Link to impacts: Connect these with common categories like climate change, resource depletion, human toxicity, or water and soil pollution.
Regulation is increasingly shaping product and packaging requirements. Recent EU measures, such as the Ecodesign for Sustainable Products Regulation (ESPR) (EU 2024/1781, 2024) and the Packaging and Packaging Waste Regulation (PPWR) (EU 2025/40, 2024), set a clear direction:
- Products must be designed for longer lifespans, easier repair, and higher recyclability.
- Packaging must be minimised, reusable, recyclable, or compostable.
Sustainable design goes further than making a product recyclable or reducing energy use. It requires considering materials, processes, and impacts across the full lifecycle. Many improvements can be made immediately through smarter design, including:
- Reduce material usage: Conserve resources and lower costs through lightweighting or substitution.
- Minimise part count: Simplify designs to cut waste, improve repairability, and make recycling easier.
- Improve durability: Design products to last longer, reducing replacements and waste.
- Design for repair: Make common failure points accessible and replaceable to extend product life.
- Standardise components: Use shared parts (e.g., batteries, adapters) across products to reduce total material demand.
- Reduce packaging and single-use consumables: Minimise size and layers, and favour reusable, recyclable, or compostable options.
- Design for end-of-life recovery: Choose separable materials, avoid harmful coatings, and label for reuse or recycling.
- Lower energy use, including digital services: Improve operational efficiency and reduce unnecessary data transmission, which drives energy use in servers and cloud storage.
Sources:
EU 2024/1781 (2024) Regulation (EU) 2024/1781 establishing a framework for setting ecodesign requirements for sustainable products, Official Journal of the European Union. Available at: https://eur-lex.europa.eu/eli/reg/2024/1781/oj (Accessed: 17 July 2025).
EU 2025/40 (2024) Regulation (EU) 2025/40 on packaging and packaging waste. Available at: https://eur-lex.europa.eu/eli/reg/2025/40/oj/eng (Accessed: 17 July 2025).
McKinsey & Company (2024) What are Scope 1, 2, and 3 emissions? Available at: https://www.mckinsey.com/featured-insights/mckinsey-explainers/what-are-scope-1-2-and-3-emissions (Accessed: 17 July 2025).
How to use safety or product standards strategically
Product standards are often either mandated by particular regulations or serve as a key way for you to demonstrate compliance.
Standards can be grouped by function in relation to safety. The International Organisation for Standardisation (ISO) for example classifies safety-related standards into three categories:
Using the right combination of type A, B, and C standards makes your product design more robust, defensible, and aligned with industry best practice.
If you are developing an innovative product for which no type C standard exists, you can still apply type A and B standards to demonstrate safety and manage risk. In these cases, thorough risk assessments and well-documented design decisions are critical. Standards become one of several tools for demonstrating due diligence, not the sole indicator of product safety.
Product standards also offer valuable technical knowledge that can enhance your products. International standards such as ISO, IEC, ASTM, CEN, and AS/NZS are developed through collaboration among industry experts, academics, and consumer organisations. This gives them credibility and ensures they reflect current best practices and technical understanding. As a result, they are a powerful resource in product development. Fundamentally, product standards should raise the bar, ensuring that products meet minimum safety and performance expectations, that protect users, the environment, and others affected by their use.
Standards are not just about checking compliance boxes, they help your business anticipate known risks and embed preventive measures into your design and manufacturing processes. Most standard requirements are grounded in past incidents or known failure modes. Type B and C standards often include test methods and even specifications for test equipment. These tests can be integrated into your product verification plans.
When working with suppliers or outsourced manufacturers, referencing relevant standards in contracts and technical specifications helps ensure product consistency and safety. It also reduces ambiguity and strengthens your position if disputes or failures occur.
Like regulations, standards are regularly updated. Ensure your teams are subscribing to update alerts or notifications from relevant bodies. This allows your business to incorporate updates into future product revisions and avoid falling behind evolving expectations.
Product standards are more than technical documents, they’re strategic tools that support quality, safety, and trust. Used well, they help you anticipate problems, reduce risk, and build products that meet both regulatory expectations and customer needs. Whether you're referencing them for compliance, design assurance, or supplier alignment, standards offer a defensible foundation for decision-making in a complex and evolving global market.
Standards can be grouped by function in relation to safety. The International Organisation for Standardisation (ISO) for example classifies safety-related standards into three categories:
- Type A Standards – Fundamental Safety Principles: These outline general principles for risk assessment and risk reduction. They apply across a wide range of products and technologies. Example: ISO 12100.
- Type B Standards – Generic Safety Aspects: These address specific safety aspects or safeguards that are applicable across many product types.
- Type B1: Standards for general safety aspects (e.g. safety distances, surface temperature limits).
- Type B2: Standards for safety devices (e.g. guards, emergency stops).
- Type C Standards – Product-Specific Standards: These apply to particular product categories or machines and contain detailed requirements tailored to those products. Where a Type C standard exists, it generally takes precedence over Type A or B for the same risks.
Using the right combination of type A, B, and C standards makes your product design more robust, defensible, and aligned with industry best practice.
If you are developing an innovative product for which no type C standard exists, you can still apply type A and B standards to demonstrate safety and manage risk. In these cases, thorough risk assessments and well-documented design decisions are critical. Standards become one of several tools for demonstrating due diligence, not the sole indicator of product safety.
Product standards also offer valuable technical knowledge that can enhance your products. International standards such as ISO, IEC, ASTM, CEN, and AS/NZS are developed through collaboration among industry experts, academics, and consumer organisations. This gives them credibility and ensures they reflect current best practices and technical understanding. As a result, they are a powerful resource in product development. Fundamentally, product standards should raise the bar, ensuring that products meet minimum safety and performance expectations, that protect users, the environment, and others affected by their use.
Standards are not just about checking compliance boxes, they help your business anticipate known risks and embed preventive measures into your design and manufacturing processes. Most standard requirements are grounded in past incidents or known failure modes. Type B and C standards often include test methods and even specifications for test equipment. These tests can be integrated into your product verification plans.
When working with suppliers or outsourced manufacturers, referencing relevant standards in contracts and technical specifications helps ensure product consistency and safety. It also reduces ambiguity and strengthens your position if disputes or failures occur.
Like regulations, standards are regularly updated. Ensure your teams are subscribing to update alerts or notifications from relevant bodies. This allows your business to incorporate updates into future product revisions and avoid falling behind evolving expectations.
Product standards are more than technical documents, they’re strategic tools that support quality, safety, and trust. Used well, they help you anticipate problems, reduce risk, and build products that meet both regulatory expectations and customer needs. Whether you're referencing them for compliance, design assurance, or supplier alignment, standards offer a defensible foundation for decision-making in a complex and evolving global market.
How to address product regulations effectively
Meeting relevant regulatory requirements, in each of your target markets, is essential for legally selling your product. Non-compliance can result in costly product recalls or, at the very least, having your product removed from shelves until it is brought into compliance. If the product causes injury, or worse, you may also face fines for negligence.
Beyond legality, the activities associated with compliance demonstrate that your business has taken appropriate steps to ensure your product is safe (does not pose harm to humans, animals, the environment, or property) and that it protects personal privacy (such as with connected products). Understanding, complying, and staying up to date with regulatory requirements is an important part of any risk management strategy, both to prevent disruption to sales and as a step towards harm prevention.
Typical product regulatory requirements cover aspects such as:
Regulations generally fall into two categories: prescriptive and risk-based. Understanding which approach applies to your product can help you interpret and implement compliance requirements effectively.
Prescriptive regulations spell out in detail what you must do, down to precise measurements, materials, and testing methods. For example, a regulation might specify the exact format of a warning label or set out defined flammability limits.
Risk-based regulations set performance goals rather than specific instructions. They ask you to identify risks and demonstrate that you have adequately mitigated them. For example, the EU’s General Product Safety Regulation requires that products be safe under normal or reasonably foreseeable use but allows flexibility in how businesses achieve and prove that.
Risk-based frameworks require more judgment, and often more documentation to prove that your risk assessments and mitigations are sound. Prescriptive frameworks are generally more straightforward to follow but may limit your design flexibility.
Regulations are often long and detailed because they serve multiple audiences: enforcement authorities, manufacturers, importers, retailers, and sometimes even consumers. They typically include technical requirements, enforcement procedures, and legal definitions, as well as administrative provisions. They may also indicate future proposed activities such as research or further refinement of regulatory requirements.
A useful feature for you to pay attention to is the background or preamble section, which often explains the purpose and intent of the regulation. This context can help your business understand not just what the rules are, but why they exist, offering valuable insight into the risks or market issues that prompted the regulation in the first place.
Taking the time to understand the relevant regulations, not just their content, but their intent and history, provides valuable insight into target markets. By studying regulations closely, it is possible to gain a clearer picture of consumer behaviour, safety concerns, and shifting societal expectations in each market. For example, strict rules around child safety in certain regions reflect both historical incidents and heightened public sensitivity. Likewise, evolving data privacy laws show how consumer trust and digital security have become core market concerns.
As a product business, you also need to focus on the sections of the regulation that outline the responsibilities of manufacturers and importers. These sections will detail what you need to do to comply, such as product testing, documentation, labelling, safety requirements, and obligations to monitor products once they are on the market. It’s also worth checking whether the regulation contains any clauses about penalties or consequences for non-compliance.
If your business also acts as a distributor or retailer, make sure to review those sections too, as responsibilities can overlap, particularly around traceability, record-keeping, and corrective actions (like recalls).
When reading a regulation for the first time, it can be helpful to:
By reading regulations with these points in mind, you will get a clearer picture of your compliance obligations and avoid missing key requirements that could lead to delays or penalties.
During product development, it’s crucial to incorporate relevant regulation and standards requirements early. Doing so fosters better design, stronger safety outcomes, and more secure market positioning. It prevents redesign work at a later date and ultimately ensures a better product.
In short, regulations are not just legal hurdles, they are signals. They help an organisation:
Finally, it is also important to remember that compliance isn’t a one-and-done task. Regulations evolve in response to new risks, technological advances, political changes, and societal concerns. For example, shifts in data privacy laws, environmental priorities, or product safety concerns can trigger updates that directly affect your obligations.
To stay compliant, it’s essential to monitor for relevant changes. Many regulatory bodies provide mailing lists or update bulletins. If your business operates across multiple regions, a compliance calendar or tracking system can help you stay on top of updates and ensure your product documentation reflects the latest requirements.
In practice, this means:
Ultimately, robust regulatory compliance is both a legal requirement and a strategic tool. By embedding compliance early and maintaining vigilance throughout your product’s lifecycle, you not only safeguard your business against fines, recalls, and reputational damage, you also build trust with regulators, partners, and consumers. Done well, compliance becomes a mark of credibility that sets your product apart in competitive markets.
Beyond legality, the activities associated with compliance demonstrate that your business has taken appropriate steps to ensure your product is safe (does not pose harm to humans, animals, the environment, or property) and that it protects personal privacy (such as with connected products). Understanding, complying, and staying up to date with regulatory requirements is an important part of any risk management strategy, both to prevent disruption to sales and as a step towards harm prevention.
Typical product regulatory requirements cover aspects such as:
- The physical product design
- The materials and substances it is made from
- Its packaging, including everything written on it and any other point-of-sale information (online or in-store)
- The product’s labelling
- The product’s user instructions
- Any data collected by or related to the product, including how that data is processed
Regulations generally fall into two categories: prescriptive and risk-based. Understanding which approach applies to your product can help you interpret and implement compliance requirements effectively.
Prescriptive regulations spell out in detail what you must do, down to precise measurements, materials, and testing methods. For example, a regulation might specify the exact format of a warning label or set out defined flammability limits.
Risk-based regulations set performance goals rather than specific instructions. They ask you to identify risks and demonstrate that you have adequately mitigated them. For example, the EU’s General Product Safety Regulation requires that products be safe under normal or reasonably foreseeable use but allows flexibility in how businesses achieve and prove that.
Risk-based frameworks require more judgment, and often more documentation to prove that your risk assessments and mitigations are sound. Prescriptive frameworks are generally more straightforward to follow but may limit your design flexibility.
Regulations are often long and detailed because they serve multiple audiences: enforcement authorities, manufacturers, importers, retailers, and sometimes even consumers. They typically include technical requirements, enforcement procedures, and legal definitions, as well as administrative provisions. They may also indicate future proposed activities such as research or further refinement of regulatory requirements.
A useful feature for you to pay attention to is the background or preamble section, which often explains the purpose and intent of the regulation. This context can help your business understand not just what the rules are, but why they exist, offering valuable insight into the risks or market issues that prompted the regulation in the first place.
Taking the time to understand the relevant regulations, not just their content, but their intent and history, provides valuable insight into target markets. By studying regulations closely, it is possible to gain a clearer picture of consumer behaviour, safety concerns, and shifting societal expectations in each market. For example, strict rules around child safety in certain regions reflect both historical incidents and heightened public sensitivity. Likewise, evolving data privacy laws show how consumer trust and digital security have become core market concerns.
As a product business, you also need to focus on the sections of the regulation that outline the responsibilities of manufacturers and importers. These sections will detail what you need to do to comply, such as product testing, documentation, labelling, safety requirements, and obligations to monitor products once they are on the market. It’s also worth checking whether the regulation contains any clauses about penalties or consequences for non-compliance.
If your business also acts as a distributor or retailer, make sure to review those sections too, as responsibilities can overlap, particularly around traceability, record-keeping, and corrective actions (like recalls).
When reading a regulation for the first time, it can be helpful to:
- Start with the scope and definitions: This clarifies whether the regulation applies to your product and how key terms are defined.
- Look at the specific obligations for your business role: Focus on what is required before placing a product on the market and what ongoing obligations exist.
- Note references to standards: Identify any product safety standards that are linked to or referenced within the regulation and determine whether they are mandatory, or voluntary.
- Check transitional arrangements or deadlines: Some regulations have phased implementation periods that may affect your timeline.
- Pay attention to annexes or appendices: These sections often contain the technical detail, test methods or limits, or specific requirements that are critical for compliance.
By reading regulations with these points in mind, you will get a clearer picture of your compliance obligations and avoid missing key requirements that could lead to delays or penalties.
During product development, it’s crucial to incorporate relevant regulation and standards requirements early. Doing so fosters better design, stronger safety outcomes, and more secure market positioning. It prevents redesign work at a later date and ultimately ensures a better product.
In short, regulations are not just legal hurdles, they are signals. They help an organisation:
- Anticipate emerging risks
- Understand where products fit within the market landscape
- Design with both compliance and consumer expectations in mind
Finally, it is also important to remember that compliance isn’t a one-and-done task. Regulations evolve in response to new risks, technological advances, political changes, and societal concerns. For example, shifts in data privacy laws, environmental priorities, or product safety concerns can trigger updates that directly affect your obligations.
To stay compliant, it’s essential to monitor for relevant changes. Many regulatory bodies provide mailing lists or update bulletins. If your business operates across multiple regions, a compliance calendar or tracking system can help you stay on top of updates and ensure your product documentation reflects the latest requirements.
In practice, this means:
- Regularly reviewing regulations and standards relevant to your products
- Updating design files, safety documentation, and marketing materials as needed
- Communicating changes with your manufacturing partners and distributors to ensure compliance across the supply chain
Ultimately, robust regulatory compliance is both a legal requirement and a strategic tool. By embedding compliance early and maintaining vigilance throughout your product’s lifecycle, you not only safeguard your business against fines, recalls, and reputational damage, you also build trust with regulators, partners, and consumers. Done well, compliance becomes a mark of credibility that sets your product apart in competitive markets.
How to conduct effective product risk assessments
Product risk assessments can be a contentious topic. They are often dismissed as a box-ticking exercise and a drain on resources that delivers little real benefit. I won’t deny that I’ve seen plenty of risk assessments performed that fit that description. However, when used well, they become a systematic framework that helps uncover risks you may have otherwise missed.
A risk assessment as a standalone risk mitigation exercise is never enough. It should support your other risk mitigation activities that are achieved through:
By carrying out a formal risk assessment, your business is taking a pause in its development activities, to specifically think about potential failures and risks. We all know, when you are in the thick of it, it is easy to overlook things that might otherwise seem obvious.
Many product regulations require some form of risk assessment or risk analysis. For example:
Additionally, more specific standards can supplement these frameworks, such as ISO 13849-1, which focuses on Safety of Machinery, Safety-related Parts of Control Systems. This standard delves deeper into functional safety, particularly control systems that detect and respond to failures (e.g., emergency stop functions and interlocks). It defines performance levels, which are informed by ISO 12100 assessments, ensuring that if a failure occurs, the control system detects the issue and mitigates harm.
Failure Modes Effects Analysis (FMEA) is another widely used risk assessment method, particularly in the automotive industry, although it’s also useful for non-automotive products. The AIAG & VDA FMEA Handbook defines three key types of FMEA:
FMEA-Monitoring and System Response is also covered in the handbook and focuses on how a system monitors itself and responds to failures during operation. This is particularly relevant for safety-critical systems, such as Advanced Driver-Assistance Systems. It relates to Design FMEA in a similar way that ISO 13849-1:2015 relates to ISO 12100.
The principles of these FMEA types can be adapted to create a model that best addresses the specific risks you need to capture. For example, incorporating guidelines from ISO 12100 to break down lifecycle risks, including shipping, unpacking, commissioning, usage, maintenance, and disposal, can add significant value.
Some keys to ensuring an effective risk assessment process include:
A risk assessment as a standalone risk mitigation exercise is never enough. It should support your other risk mitigation activities that are achieved through:
- Compliance with regulations and standards (particularly the intent of those)
- Tailored verification testing
- Integration of learnings from your business’s own experiences and that of others in your industry
- Your teams sound engineering design practices
By carrying out a formal risk assessment, your business is taking a pause in its development activities, to specifically think about potential failures and risks. We all know, when you are in the thick of it, it is easy to overlook things that might otherwise seem obvious.
Many product regulations require some form of risk assessment or risk analysis. For example:
- Machinery Regulation (EU): Requires a risk assessment to be carried out. The key harmonised standard is ISO 12100, which outlines principles and methodologies for identifying hazards and evaluating risks across the machinery lifecycle.
- Low Voltage Directive (EU): Mandates an adequate analysis and assessment of risks, though it does not provide a specific harmonised standard for risk assessment.
- General Product Safety Regulation (EU): Requires internal risk analysis for consumer products but does not prescribe a specific harmonised risk assessment standard.
- Toy Safety Directive (EU): Requires a safety assessment but leaves the method and format of the assessment to the discretion of the manufacturer.
- Pressure Equipment Directive (EU): Requires hazard and risk analysis to determine the appropriate conformity assessment route.
- Medical Device Regulation (EU): Requires a comprehensive risk management system throughout the product lifecycle. The harmonised standard ISO 14971 provides the framework for identifying, evaluating, and managing risks in medical devices.
Additionally, more specific standards can supplement these frameworks, such as ISO 13849-1, which focuses on Safety of Machinery, Safety-related Parts of Control Systems. This standard delves deeper into functional safety, particularly control systems that detect and respond to failures (e.g., emergency stop functions and interlocks). It defines performance levels, which are informed by ISO 12100 assessments, ensuring that if a failure occurs, the control system detects the issue and mitigates harm.
Failure Modes Effects Analysis (FMEA) is another widely used risk assessment method, particularly in the automotive industry, although it’s also useful for non-automotive products. The AIAG & VDA FMEA Handbook defines three key types of FMEA:
- System FMEA: Conducted on the entire system or product.
- Design FMEA: Conducted on the product design often at component level.
- Process FMEA: Conducted on the manufacturing or assembly process.
FMEA-Monitoring and System Response is also covered in the handbook and focuses on how a system monitors itself and responds to failures during operation. This is particularly relevant for safety-critical systems, such as Advanced Driver-Assistance Systems. It relates to Design FMEA in a similar way that ISO 13849-1:2015 relates to ISO 12100.
The principles of these FMEA types can be adapted to create a model that best addresses the specific risks you need to capture. For example, incorporating guidelines from ISO 12100 to break down lifecycle risks, including shipping, unpacking, commissioning, usage, maintenance, and disposal, can add significant value.
Some keys to ensuring an effective risk assessment process include:
- Starting with objectives and tailoring the risk assessment accordingly: Unless your teams first clarify what it is they want to assess, they risk overlooking the very issues that matter most.
- Keeping the assessment up to date: The initial assessment identifies and prioritises risks, followed by actions to mitigate them. Then the risks must be reassessed to confirm they’ve been addressed and to check that no new risks have been introduced. When product changes occur later, such as post-market improvements, the risk assessment must be revisited for the same reason.
- Supporting assessments with data: For critical risks, it’s worth actively working on how to obtain that data, whether through testing or simulation methods.
- Ensuring foreseeable misuse is included in the assessment: Foreseeable misuse involves uses that are unintended but can be reasonably anticipated based on the product’s design, instructions, or context of use. These are scenarios where misuse is predictable, allowing the manufacturer to take steps to mitigate the associated risks.
- Eliminating serious risks identified entirely: The goal for serious risks such as death, permanent injury, or injuries requiring medical attention, must be to eliminate the risk entirely, not just reduce its likelihood to make it appear acceptable.
How to ensure continuous improvement
Developing a safe, high-quality product involves a great deal of behind-the-scenes work. Teams test ideas, work through problems, follow false leads, and gradually identify what works and what doesn’t. If those insights are not captured within the organisation, the business risks repeating the same mistakes and wasting time revisiting options that were already ruled out.
As a product development business or manufacturer, you’re not just designing and making products. You’re learning how to make them safer, more reliable, and better over time. Businesses that do this well treat product development as a continuous learning process, using past experience to drive improvement. That discipline is what separates industry leaders from the rest and helps them stay competitive over the long term.
Creating internal resources, such as product development guidelines, tailored to your products and industry, will:
Once a product is on the market, it can be relatively easy for others to copy what they see. What is far harder to replicate is the quality and reliability you have achieved through months or years of refinement, and the way your team approaches product development. Competitors still face a learning curve, which limits their ability to perform at the same level. Your product development guidelines and similar internal documents are trade secrets. They capture how you consistently design great products, not just what those products look like or how they function.
Documenting your trade secrets is only half the equation. You also need to protect them. Many businesses focus on patents but do not always consider how to safeguard their trade secrets or even recognise what they are. Anything that gives your products their quality and consistency and that a competitor would struggle to replicate can be considered a trade secret.
To protect these valuable assets, consider the following practices:
The key is to retain your hard-won knowledge within your business and protect it carefully. Make sure your teams share only what is strictly necessary and always understand why the information is being requested. The less you expose externally, the lower the risk of misinterpretation, mishandling, or misuse. Once a trade secret or valuable insight leaves your control, it cannot be undone. By capturing knowledge internally and safeguarding it, you ensure your business maintains its competitive edge, product quality, and consistency for the long term.
As a product development business or manufacturer, you’re not just designing and making products. You’re learning how to make them safer, more reliable, and better over time. Businesses that do this well treat product development as a continuous learning process, using past experience to drive improvement. That discipline is what separates industry leaders from the rest and helps them stay competitive over the long term.
Creating internal resources, such as product development guidelines, tailored to your products and industry, will:
- Protect and retain high-value, hard-to-recreate knowledge
- Streamline the development process
- Serve to standardise proven design solutions
- Act as a training and onboarding resource
- Contribute to your business’s intangible assets
- Improve consistency across product lines
Once a product is on the market, it can be relatively easy for others to copy what they see. What is far harder to replicate is the quality and reliability you have achieved through months or years of refinement, and the way your team approaches product development. Competitors still face a learning curve, which limits their ability to perform at the same level. Your product development guidelines and similar internal documents are trade secrets. They capture how you consistently design great products, not just what those products look like or how they function.
Documenting your trade secrets is only half the equation. You also need to protect them. Many businesses focus on patents but do not always consider how to safeguard their trade secrets or even recognise what they are. Anything that gives your products their quality and consistency and that a competitor would struggle to replicate can be considered a trade secret.
To protect these valuable assets, consider the following practices:
- Implement access control and user permissions: Limit access to internal guidelines and sensitive information based on roles and responsibilities. This prevents unauthorised access or accidental exposure.
- Use secure, encrypted platforms: Transmit and store data securely using platforms that meet industry-standard security certifications such as ISO/IEC 27001. This protects against external threats and unauthorised parties.
- Regularly review and update security protocols: Keep access controls, encryption methods, and backup procedures up-to-date. Regular reviews help mitigate risks as your business grows and new vulnerabilities emerge.
- Ensure employee awareness: Train your team on best practices for handling, sharing, and storing proprietary knowledge. Promote a culture of trust and responsibility around sensitive product information.
- Use legal protections and non-disclosure agreements: When working with external partners, consultants, or contractors, put NDAs and other legal safeguards in place before sharing critical information to reduce the risk of unauthorised disclosure.
The key is to retain your hard-won knowledge within your business and protect it carefully. Make sure your teams share only what is strictly necessary and always understand why the information is being requested. The less you expose externally, the lower the risk of misinterpretation, mishandling, or misuse. Once a trade secret or valuable insight leaves your control, it cannot be undone. By capturing knowledge internally and safeguarding it, you ensure your business maintains its competitive edge, product quality, and consistency for the long term.
How to manage supply chain risk
Many product businesses assume compliance is something you simply “design into” a product.
The truth is your product can be compliant today and non-compliant tomorrow without you changing a thing. A supplier might swap a material, change a coating, or alter a process. Often these changes are made with the best of intentions, as suppliers may be dealing with obsolescence, availability issues, cost pressures, or process improvements.
However, even well-intentioned changes can create unexpected product risk, especially when they affect regulatory requirements. Supply chains are complex and often stretch across regions, countries, and cultures. Changes are not always communicated, particularly when suppliers do not fully understand where your product is sold or what regulations apply.
There are two key actions you can take to mitigate this risk:
1. Control changes
All modifications that impact the product or its production should follow a documented change management process. Suppliers should formally propose and document any changes before implementation. Internally, changes should be reviewed, assessed, and approved before rollout. A strong change control system keeps specifications, product performance, and risk management aligned. Ensure this process is clearly documented in your supply agreements.
2. Set clear expectations around compliance
Even with disciplined change management, you need a framework to ensure every material, component, and process meets regulatory requirements. This includes:
When these two actions work together, the supply chain remains stable and predictable, reducing the likelihood of costly disruptions, recalls, or compliance breaches.
Ethical and sustainable sourcing has also become an essential consideration in supply chain management. Businesses are increasingly held accountable for the social and environmental impacts of their products. Sourcing materials and components responsibly helps reduce risks such as reputational damage, legal penalties, and supply interruptions caused by unsustainable practices or unethical labour conditions. Transparency and due diligence are required to ensure suppliers comply with labour laws, environmental regulations, and recognised sustainability standards. Embedding these principles into supplier selection and ongoing management not only supports a resilient and future-proof supply chain, but also aligns with growing consumer expectations and regulatory demands across global markets. When supply chains are complex and lack transparency, traceability is reduced, creating challenges in demonstrating compliance. This can, in turn, affect import licences, product registrations, and broader product compliance obligations.
Improved traceability within the supply chain significantly enhances the ability to respond swiftly and effectively to product issues. By maintaining clear records that link every component or material to its origin, batch, and production details, businesses can quickly identify the specific sources of non-compliance or quality failures. This reduces the time spent investigating problems and allows targeted actions, such as product recalls or supplier corrections, to be implemented without unnecessary delays or disruption to unaffected products. Greater traceability also supports regulatory reporting requirements and builds confidence with customers and regulators by demonstrating a well-controlled and transparent supply chain. Ultimately, better traceability minimises the scope and cost of issues, protects brand reputation, and ensures consumer safety is prioritised.
In practice, traceability and transparency do not exist on their own. They are only achievable when businesses deliberately design them into how suppliers are selected, approved, and managed.
A key starting point is having a structured supplier approval process in place before any components, materials, or products are sourced or manufactured. This process helps ensure that only capable and reliable suppliers are onboarded, and that expectations around quality, compliance, traceability, and communication are clearly established from the outset.
Key steps in the supplier approval process typically include:
By investing in a thorough supplier approval process, the risk of non-compliance, quality failures, or miscommunication is significantly reduced, paving the way for long-term, collaborative supplier relationships.
The truth is your product can be compliant today and non-compliant tomorrow without you changing a thing. A supplier might swap a material, change a coating, or alter a process. Often these changes are made with the best of intentions, as suppliers may be dealing with obsolescence, availability issues, cost pressures, or process improvements.
However, even well-intentioned changes can create unexpected product risk, especially when they affect regulatory requirements. Supply chains are complex and often stretch across regions, countries, and cultures. Changes are not always communicated, particularly when suppliers do not fully understand where your product is sold or what regulations apply.
There are two key actions you can take to mitigate this risk:
1. Control changes
All modifications that impact the product or its production should follow a documented change management process. Suppliers should formally propose and document any changes before implementation. Internally, changes should be reviewed, assessed, and approved before rollout. A strong change control system keeps specifications, product performance, and risk management aligned. Ensure this process is clearly documented in your supply agreements.
2. Set clear expectations around compliance
Even with disciplined change management, you need a framework to ensure every material, component, and process meets regulatory requirements. This includes:
- making suppliers aware of all markets where the product will be sold
- specifying regulatory requirements in agreements
- requiring Declarations of Conformity that are updated at least every two years
- requiring these are backed with test certification from accredited laboratories
- performing your own risk-based verification testing
When these two actions work together, the supply chain remains stable and predictable, reducing the likelihood of costly disruptions, recalls, or compliance breaches.
Ethical and sustainable sourcing has also become an essential consideration in supply chain management. Businesses are increasingly held accountable for the social and environmental impacts of their products. Sourcing materials and components responsibly helps reduce risks such as reputational damage, legal penalties, and supply interruptions caused by unsustainable practices or unethical labour conditions. Transparency and due diligence are required to ensure suppliers comply with labour laws, environmental regulations, and recognised sustainability standards. Embedding these principles into supplier selection and ongoing management not only supports a resilient and future-proof supply chain, but also aligns with growing consumer expectations and regulatory demands across global markets. When supply chains are complex and lack transparency, traceability is reduced, creating challenges in demonstrating compliance. This can, in turn, affect import licences, product registrations, and broader product compliance obligations.
Improved traceability within the supply chain significantly enhances the ability to respond swiftly and effectively to product issues. By maintaining clear records that link every component or material to its origin, batch, and production details, businesses can quickly identify the specific sources of non-compliance or quality failures. This reduces the time spent investigating problems and allows targeted actions, such as product recalls or supplier corrections, to be implemented without unnecessary delays or disruption to unaffected products. Greater traceability also supports regulatory reporting requirements and builds confidence with customers and regulators by demonstrating a well-controlled and transparent supply chain. Ultimately, better traceability minimises the scope and cost of issues, protects brand reputation, and ensures consumer safety is prioritised.
In practice, traceability and transparency do not exist on their own. They are only achievable when businesses deliberately design them into how suppliers are selected, approved, and managed.
A key starting point is having a structured supplier approval process in place before any components, materials, or products are sourced or manufactured. This process helps ensure that only capable and reliable suppliers are onboarded, and that expectations around quality, compliance, traceability, and communication are clearly established from the outset.
Key steps in the supplier approval process typically include:
- Initial Capability Assessment: Review the supplier’s technical capability, capacity, relevant certifications, and compliance history. For critical suppliers, an in-person or virtual audit may be useful.
- Quality and Compliance Documentation Review: Request and review the supplier’s quality management systems, material declarations, and regulatory compliance documentation. Address any gaps before approval is granted.
- Pilot Production or Sample Evaluation: Request sample parts or materials for evaluation against specifications. This validates the supplier’s ability to deliver consistent quality that meets the business’s requirements.
- Agreement of Supply Terms: Formalise supply agreements, including expectations around compliance, quality control, traceability communication protocols, documentation, and issue resolution processes.
- Approval and Ongoing Monitoring: Once approved, add the supplier to an approved supplier list (ASL) and record key information. Ongoing monitoring should be risk-based and proportionate to the supplier’s role and history.
By investing in a thorough supplier approval process, the risk of non-compliance, quality failures, or miscommunication is significantly reduced, paving the way for long-term, collaborative supplier relationships.
How to create supply chain resilience
Many businesses make the mistake of treating supplier approval as a one-time activity. Once a supplier has been assessed and approved, the assumption is often that the risk has been managed.
In reality, supply chains are dynamic. Suppliers grow, distributors change ownership, staff come and go, and regulatory requirements continue to evolve. A supplier that was a good fit three years ago may present a very different risk profile today.
When reviewing supply chain risk, it is important to look beyond the component itself and consider the organisations behind it.
1. Capability Must Continue to Grow
As businesses expand into new markets, their understanding of regulatory requirements typically increases. New regulations emerge, customer expectations change, and additional compliance evidence may be required.
The question is whether your suppliers and distributors are keeping pace.
This is particularly important when relying on distributors and importers to support market access activities. If they are not maintaining their own regulatory knowledge, they may fail to identify changes that affect your product or provide incorrect guidance on local requirements.
The flow of compliance information throughout the supply chain is only as strong as the least capable organisation involved. Regular engagement and periodic reassessment of key partners can help ensure capability continues to develop alongside your own business.
2. Growth Changes Risk
There is often an assumption that larger suppliers represent lower risk because they have formal systems, certifications, and documented procedures.
In practice, both small and large organisations present different types of risk.
Smaller suppliers may rely heavily on a small number of experienced individuals. The loss of key personnel can significantly affect quality, technical capability, or responsiveness.
Larger organisations often have mature management systems and extensive documentation. However, they may also experience higher staff turnover, greater organisational complexity, and reduced visibility of what is actually happening on the production floor.
Neither model is inherently better. The key is understanding how the organisation manages its own operational risks and whether those controls remain effective as the business grows.
3. Ownership Change and the Stability of Your Network
A supplier or distributor can change significantly without changing its name.
Mergers, acquisitions, restructures, and private equity ownership can all alter business priorities, internal processes, capability, and risk tolerance.
A supplier that once prioritised responsiveness and technical support may become part of a much larger organisation where your product is a small account rather than a strategic relationship. Experienced personnel may leave, communication pathways may change, and long-standing informal knowledge can be lost.
Distribution networks are affected in a similar way. Importers, authorised representatives, and fulfilment providers are increasingly embedded within broader regulatory frameworks, particularly in markets such as the European Union.
In some regulatory systems, obligations and expectations can vary depending on the size and role of the economic operator. As a result, when an importer or distributor is acquired or transitions into a larger corporate structure, the compliance environment surrounding your product may also change, even if the product itself has not.
Ownership change is therefore not just a commercial event. It can influence capability, responsiveness, compliance processes, and the stability of your market access pathway.
For critical suppliers and distributors, it is also worth considering whether agreements should include a review mechanism if ownership or control changes materially. Not because change is inherently negative, but because the risk profile often changes with it.
4. Compliance Data Is Becoming More Dynamic
Historically, many compliance records were treated as static documents. A test report was completed, a declaration was signed, and the information was filed away until needed.
Increasingly, regulatory systems are moving towards greater transparency and lifecycle traceability.
Initiatives such as the Digital Product Passport reflect this shift in approach in certain sectors, requiring more structured and, in some cases, machine-readable product information covering materials, substances, and supply chain data.
This increases the importance of change control across the supply chain. If a supplier alters a material, process, or source of supply, that change must be identified and assessed before it affects downstream compliance data.
The challenge is no longer simply maintaining documentation. It is maintaining accurate, current, and connected information across a changing supply chain.
Looking Beyond the Component
Most supply chain systems focus on products, materials, and specifications. These remain essential, but they only represent part of the risk picture.
The organisations that design, manufacture, import, distribute, and support those products are also changing continuously. Their capability, ownership, structure, and systems all influence your ability to maintain compliance and access markets.
The most resilient businesses do not treat suppliers and distributors as transactional links in a chain. They treat them as extensions of their own organisation. They invest time in understanding how these partners operate, how they are evolving, and what risks they are managing themselves.
Strong relationships create visibility. Visibility creates early warning. Early warning creates options.
Supply chain resilience is not built through documentation alone. It is built through understanding the organisations behind your product, maintaining active relationships with them, and recognising when change is beginning to shift the risk profile.
In many cases, the most significant risks do not appear in the component itself, but in the organisations that surround it.
Further Reading:
How to manage supply chain risk
Ecodesign for Sustainable Products Regulation (ESPR)
Get the book: The Smart Risk Playbook: A Five-Step Framework for Business Leaders to Master Product Risk
In reality, supply chains are dynamic. Suppliers grow, distributors change ownership, staff come and go, and regulatory requirements continue to evolve. A supplier that was a good fit three years ago may present a very different risk profile today.
When reviewing supply chain risk, it is important to look beyond the component itself and consider the organisations behind it.
1. Capability Must Continue to Grow
As businesses expand into new markets, their understanding of regulatory requirements typically increases. New regulations emerge, customer expectations change, and additional compliance evidence may be required.
The question is whether your suppliers and distributors are keeping pace.
This is particularly important when relying on distributors and importers to support market access activities. If they are not maintaining their own regulatory knowledge, they may fail to identify changes that affect your product or provide incorrect guidance on local requirements.
The flow of compliance information throughout the supply chain is only as strong as the least capable organisation involved. Regular engagement and periodic reassessment of key partners can help ensure capability continues to develop alongside your own business.
2. Growth Changes Risk
There is often an assumption that larger suppliers represent lower risk because they have formal systems, certifications, and documented procedures.
In practice, both small and large organisations present different types of risk.
Smaller suppliers may rely heavily on a small number of experienced individuals. The loss of key personnel can significantly affect quality, technical capability, or responsiveness.
Larger organisations often have mature management systems and extensive documentation. However, they may also experience higher staff turnover, greater organisational complexity, and reduced visibility of what is actually happening on the production floor.
Neither model is inherently better. The key is understanding how the organisation manages its own operational risks and whether those controls remain effective as the business grows.
3. Ownership Change and the Stability of Your Network
A supplier or distributor can change significantly without changing its name.
Mergers, acquisitions, restructures, and private equity ownership can all alter business priorities, internal processes, capability, and risk tolerance.
A supplier that once prioritised responsiveness and technical support may become part of a much larger organisation where your product is a small account rather than a strategic relationship. Experienced personnel may leave, communication pathways may change, and long-standing informal knowledge can be lost.
Distribution networks are affected in a similar way. Importers, authorised representatives, and fulfilment providers are increasingly embedded within broader regulatory frameworks, particularly in markets such as the European Union.
In some regulatory systems, obligations and expectations can vary depending on the size and role of the economic operator. As a result, when an importer or distributor is acquired or transitions into a larger corporate structure, the compliance environment surrounding your product may also change, even if the product itself has not.
Ownership change is therefore not just a commercial event. It can influence capability, responsiveness, compliance processes, and the stability of your market access pathway.
For critical suppliers and distributors, it is also worth considering whether agreements should include a review mechanism if ownership or control changes materially. Not because change is inherently negative, but because the risk profile often changes with it.
4. Compliance Data Is Becoming More Dynamic
Historically, many compliance records were treated as static documents. A test report was completed, a declaration was signed, and the information was filed away until needed.
Increasingly, regulatory systems are moving towards greater transparency and lifecycle traceability.
Initiatives such as the Digital Product Passport reflect this shift in approach in certain sectors, requiring more structured and, in some cases, machine-readable product information covering materials, substances, and supply chain data.
This increases the importance of change control across the supply chain. If a supplier alters a material, process, or source of supply, that change must be identified and assessed before it affects downstream compliance data.
The challenge is no longer simply maintaining documentation. It is maintaining accurate, current, and connected information across a changing supply chain.
Looking Beyond the Component
Most supply chain systems focus on products, materials, and specifications. These remain essential, but they only represent part of the risk picture.
The organisations that design, manufacture, import, distribute, and support those products are also changing continuously. Their capability, ownership, structure, and systems all influence your ability to maintain compliance and access markets.
The most resilient businesses do not treat suppliers and distributors as transactional links in a chain. They treat them as extensions of their own organisation. They invest time in understanding how these partners operate, how they are evolving, and what risks they are managing themselves.
Strong relationships create visibility. Visibility creates early warning. Early warning creates options.
Supply chain resilience is not built through documentation alone. It is built through understanding the organisations behind your product, maintaining active relationships with them, and recognising when change is beginning to shift the risk profile.
In many cases, the most significant risks do not appear in the component itself, but in the organisations that surround it.
Further Reading:
How to manage supply chain risk
Ecodesign for Sustainable Products Regulation (ESPR)
Get the book: The Smart Risk Playbook: A Five-Step Framework for Business Leaders to Master Product Risk
How to control product risk through assembly design
Many leaders assume product quality is determined through inspection.
In reality, quality is often decided on the assembly line itself, through good process.
Even today, many products are still partially or fully assembled by hand. Automation has reduced error rates, but it has not eliminated them. Missing components, incorrect orientation, inconsistent torque, and damaged parts caused by excessive handling are rarely “operator problems.” They are system design problems.
Product quality must be designed into both the product and the assembly process from the start.
That means designing parts that only fit the correct way, designing equipment that prevents incorrect assembly, and designing workflow that makes mistakes difficult to make and easy to detect.
When quality is embedded into the system, the assembly line becomes more reliable, more efficient, and less dependent on inspection to catch errors after the fact.
A good assembly line leaves nothing to chance.
Parts come together consistently; products flow at a steady rate, and output quality is predictable. If expectations cannot be met, the system is improved.
Some markers of a robust assembly line include:
Inspection does not create quality. It only detects failure.
The real determinant of quality is system design. Assembly line design directly influences defect rates, rework, warranty risk, and brand reputation.
If you are experiencing repeated or escalating quality issues, ask yourself: “Could this be resolved through improved assembly processes?” Don’t underestimate the impact a focus on the assembly line can have in mitigating product risk.
A well-designed assembly line does not just produce products, it produces confidence.
In reality, quality is often decided on the assembly line itself, through good process.
Even today, many products are still partially or fully assembled by hand. Automation has reduced error rates, but it has not eliminated them. Missing components, incorrect orientation, inconsistent torque, and damaged parts caused by excessive handling are rarely “operator problems.” They are system design problems.
Product quality must be designed into both the product and the assembly process from the start.
That means designing parts that only fit the correct way, designing equipment that prevents incorrect assembly, and designing workflow that makes mistakes difficult to make and easy to detect.
When quality is embedded into the system, the assembly line becomes more reliable, more efficient, and less dependent on inspection to catch errors after the fact.
A good assembly line leaves nothing to chance.
Parts come together consistently; products flow at a steady rate, and output quality is predictable. If expectations cannot be met, the system is improved.
Some markers of a robust assembly line include:
- Parts fit together immediately without adjustment.
- Part fit meets quality expectations. Not loose enough to rattle, not so tight that assembly causes damage.
- Products function correctly straight off the line, with adjustments completed before assembly starts using appropriate jigs.
- Adhesives are avoided where possible and tightly controlled when essential.
- Unnecessary rotation or handling between stations is eliminated.
- Fasteners are tightened using torque-controlled tools.
- Assemblies with missing or incorrect parts cannot progress.
- Work content is balanced across stations to maintain smooth flow.
- Jigs and fixtures reduce variation between operators.
- Workstations are designed for operator comfort and visibility.
- Repetitive strain and high-force tasks are reduced through tool selection and layout
Inspection does not create quality. It only detects failure.
The real determinant of quality is system design. Assembly line design directly influences defect rates, rework, warranty risk, and brand reputation.
If you are experiencing repeated or escalating quality issues, ask yourself: “Could this be resolved through improved assembly processes?” Don’t underestimate the impact a focus on the assembly line can have in mitigating product risk.
A well-designed assembly line does not just produce products, it produces confidence.
How to build quality into an assembly line through using a process risk assessment (PFMEA)
Many aspects of a product’s quality are determined on the assembly line. In the previous newsletter, we looked at the importance of good assembly line design. Here, we will explore a tool that can help you further improve that design.
Whether you are setting up an entirely new assembly line or addressing a problematic one, a process risk assessment provides a structured way to evaluate risk. You work through each station or process, identify, assess, and rate potential risks. You can then target improvements to ensure that faults are caught early or, ideally, prevented altogether.
Faults should be caught before they move to the next station, or at the very next step before additional value is added. If a missed fastener, uninstalled part, or assembly error is not detected immediately, it can move down the line, causing bigger problems and higher costs. The later a fault is discovered, the more expensive it is to fix. If errors are not found until the product reaches the customer, the impact can be severe. This is where a process risk assessment adds significant value.
The most effective way to carry out a process risk assessment is to walk the line (cue Johnny Cash), taking photos or videos to capture each process. This allows you to thoroughly analyse the process later with your risk assessment team and determine what actions are needed.
Process Failure Modes and Effects Analysis (PFMEA) is a great framework for this assessment because it considers both the likelihood of a fault occurring and the likelihood it will be detected. Insights from this process also allow the development of a robust control plan with the necessary checks and processes at critical stages of production. This proactive approach helps prevent quality issues, ensuring consistency and minimising defects in the final product.
The second key to making sure the risk assessment truly adds value is keeping it up to date. Minor product changes can impact the assembly process and unintentionally create new risks that were not captured in the original assessment. When product changes occur, such as post-market improvements, it is important to consider their impact on assembly and revisit the risk assessment if needed. Think of the process as a safety net that catches issues that get through your first line of defence - good assembly line design.
By identifying risks early and taking steps to eliminate or control them, businesses can save time, reduce costs, and consistently deliver high-quality outcomes.
Whether you are setting up an entirely new assembly line or addressing a problematic one, a process risk assessment provides a structured way to evaluate risk. You work through each station or process, identify, assess, and rate potential risks. You can then target improvements to ensure that faults are caught early or, ideally, prevented altogether.
Faults should be caught before they move to the next station, or at the very next step before additional value is added. If a missed fastener, uninstalled part, or assembly error is not detected immediately, it can move down the line, causing bigger problems and higher costs. The later a fault is discovered, the more expensive it is to fix. If errors are not found until the product reaches the customer, the impact can be severe. This is where a process risk assessment adds significant value.
The most effective way to carry out a process risk assessment is to walk the line (cue Johnny Cash), taking photos or videos to capture each process. This allows you to thoroughly analyse the process later with your risk assessment team and determine what actions are needed.
Process Failure Modes and Effects Analysis (PFMEA) is a great framework for this assessment because it considers both the likelihood of a fault occurring and the likelihood it will be detected. Insights from this process also allow the development of a robust control plan with the necessary checks and processes at critical stages of production. This proactive approach helps prevent quality issues, ensuring consistency and minimising defects in the final product.
The second key to making sure the risk assessment truly adds value is keeping it up to date. Minor product changes can impact the assembly process and unintentionally create new risks that were not captured in the original assessment. When product changes occur, such as post-market improvements, it is important to consider their impact on assembly and revisit the risk assessment if needed. Think of the process as a safety net that catches issues that get through your first line of defence - good assembly line design.
By identifying risks early and taking steps to eliminate or control them, businesses can save time, reduce costs, and consistently deliver high-quality outcomes.
How to transport lithium batteries
Current as of 2024-10-14
Developing products with batteries requires the addressing of risks related to the transportation of the product.
In what products are Lithium-Ion batteries commonly used?
Lithium-Ion batteries are rechargable batteries that are generally found in products such smart phones, laptops, scooters and E-bikes.
In what products are Lithium metal batteries commonly used?
Lithium metal batteries use lithium metal as an anode and are commonly used in items such as watches, car key fobs, remote controls and some toys.
What is the risk?
Lithium batteries present a safety risk to aviation because they use a positively charged electrode that contains oxygen and if the battery is exposed to excessive heat or pressure, it can catch fire. Currently there is more than one aviation incident a week related to lithium batteries in the USA alone. Additionally, the number of batteries in increasing rapidly across the globe as is the energy density in the batteries which is further increasing the risk.
What requirements must my product fulfill for air freighting?
It is important to talk to your shipping company or freight forwarder to make sure they are across the requirements for shipping of batteries in or with your products. They will need to be providing a shippers declaration in most instances. The key requirements you will need to be aware of are:
Developing products with batteries requires the addressing of risks related to the transportation of the product.
In what products are Lithium-Ion batteries commonly used?
Lithium-Ion batteries are rechargable batteries that are generally found in products such smart phones, laptops, scooters and E-bikes.
In what products are Lithium metal batteries commonly used?
Lithium metal batteries use lithium metal as an anode and are commonly used in items such as watches, car key fobs, remote controls and some toys.
What is the risk?
Lithium batteries present a safety risk to aviation because they use a positively charged electrode that contains oxygen and if the battery is exposed to excessive heat or pressure, it can catch fire. Currently there is more than one aviation incident a week related to lithium batteries in the USA alone. Additionally, the number of batteries in increasing rapidly across the globe as is the energy density in the batteries which is further increasing the risk.
What requirements must my product fulfill for air freighting?
It is important to talk to your shipping company or freight forwarder to make sure they are across the requirements for shipping of batteries in or with your products. They will need to be providing a shippers declaration in most instances. The key requirements you will need to be aware of are:
- All cells and batteries much be tested in accordance with the UN manual of tests and criteria Part III Subsection 38.3 (DGR 3.9.2.6) – and a test summary must be provided to your shipper
- For rechargable batteries, the maximum state of charge for the shipment must be 30%
- When Lithium batteries are not installed in the equipment they power, they must be carried on a cargo aircraft (or if they are over the weight restriction – see below)
- All terminals must be protected against short circuits and inner and outer packaging must be appropriate as per the Wh rating
- See the tables below for further requirements:
The above table is based on the provisions set out in the 2023-2024 Edition of the ICAO Technical Instructions for the Safe Transport of Dangerous Goods by Air (Technical Instructions) and the 65th Edition (2024) of the IATA Dangerous Goods Regulations (DGR): http://www.iata.org/dgr
The provisions of the DGR with respect to lithium batteries may also be found in the IATA lithium Battery Shipping Regulations (LBSR) 11th Edition: http://www.iata.org/lbsr
Further Reading:
Battery Regulation (EU)
Reese's Law for Button or Coin Cell Batteries (USA)
CPSC eFiling mandate (2026) (USA)
SB 1215 (2022) Embedded Battery Compliance (California)
AB 2440 Responsible Battery Recycling Act (California)
ACCC Button Cell Battery Instruments (Australia)
SB 244 Right to Repair Act (California)
The provisions of the DGR with respect to lithium batteries may also be found in the IATA lithium Battery Shipping Regulations (LBSR) 11th Edition: http://www.iata.org/lbsr
Further Reading:
Battery Regulation (EU)
Reese's Law for Button or Coin Cell Batteries (USA)
CPSC eFiling mandate (2026) (USA)
SB 1215 (2022) Embedded Battery Compliance (California)
AB 2440 Responsible Battery Recycling Act (California)
ACCC Button Cell Battery Instruments (Australia)
SB 244 Right to Repair Act (California)
What are the different types of product legislation and standards, and how do they relate to products?
There are a number of different documents that contain requirements for developing safe products. In satisfying Global Regulatory Product Safety Compliance requirements, we are exposed to a lot of different terms and pieces of legislation. How they all relate to one another can be confusing. Different countries seem to use different terms and have different ways of working, so what are the basics?
If we sort things into Primary Legislation, Secondary Legislation and Product Standards as a starting point we can begin to see how things relate to one another and this can help us make sure we in compliance with all mandatory requirements.
What is an Act?
Acts are laws that have been passed by a Parliament, Congress or State/Provincial Legislatures. For example, the Consumer Guarantees Act. These can also be called Statutes and are sometimes referred to as Primary Legislation. Acts protect everyone. For the EU, Treaties are the fundamental laws. All treaties must be ratified (passed and agreed) by member states. An Act will be people focused so will not usually refer directly to a product.
What is a Regulation or Directive?
Regulations are made under the delegated authority of an Act (or Treaty for the EU), such as an administrative agency. They can be considered to be supplementary to the Act or Treaty. They are designed to aid in the application of the principles of the primary Act. Regulations provide protection in specific areas. For example, the Electrical (Safety) Regulations. Regulations are sometimes referred to as Secondary legislation, Subordinate Legislation or Delegated Legislation. In the UK the term Statutory Instrument is used. In the EU Regulations are legal acts that apply automatically and uniformly to all EU countries as soon as they enter into force, without needing to be transposed into national law. They are binding in their entirety across all EU countries. The EU also generate Directives which differ from regulations in that they are a legislative act that sets out a goal that EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. Regulations can include some requirements that relate directly to specific or general categories of products. As a product development business you should understand the relevant regulations.
How do Acts and Regulations Differ?
An Act is generally a broader piece of legislation that outlines the general principles and rules of law, while a regulation is a more specific set of rules and requirements to enforce the provisions of the Act. Regulations are usually more specific and prescriptive, often providing detailed guidance on how the provisions of the Act should be implemented in practice. However, it is possible for an Act to be prescriptive also and in some instances to refer directly to a product safety standard. This means there may not always be a relevant Regulation.
What is a Product Safety Standard?
A Product Safety Standard is not, of itself, mandatory or legally required. A standard has to be incorporated by reference in an Act or delegated legislation in order to be mandatory. Once referenced, it becomes part of the technical regulation framework. In the EU, this is done through publication in the Official Journal of the European Union (OJEU) with respect to a particular Directive or Regulation. The product standard can then be used to derive a presumption of conformity with the essential requirements of that Directive or Regulation. This is what is referred to as a harmonised standard. In the UK these are called designated standards and their reference is published on GOV.UK in a formal notice of publication. In other countries standards are usually referenced from within an Act or Regulation. In Australia the ACCC (Australian Competition and Consumer Commission) release what they refer to as Mandatory Safety Standards (formally Consumer Protection Notices) directly under the Competition and Consumer Act 2010. These standards could be considered to be a cross between a Regulation and a Standard as they usually reference or duplicate sections of existing safety standards while also adding additional requirements. Product safety standards may prescribe a products form, construction, finish or packaging; tests the products must go through; and the form and content of any markings, warnings or instructions that must accompany the product.
Do I need to be aware of the Acts and Regulations that apply to my products or can I just apply the relevant Standards?
Acts often contain definitions which are important for the interpretation of Regulations and in some instances can refer directly to product safety standards, mandating them. Therefore, having a quick scan over the Act(s) that are relevant to your products is useful. Regulations can directly reference Standards and Regulations or Directives can often contain general requirements relating to your product or your responsibilities as a product developer/manufacturer, importer, distributor or retailer. It is also important to understand how your product standard(s) relate to the regulation. Are they referenced or harmonised? Which version is mandated or which clauses? Note that in different countries, slightly different versions of product standards may be referenced and it is important to ensure you cover the correct version of standard for each market you are selling in, in reference to that countries Regulation or similar.
If we sort things into Primary Legislation, Secondary Legislation and Product Standards as a starting point we can begin to see how things relate to one another and this can help us make sure we in compliance with all mandatory requirements.
What is an Act?
Acts are laws that have been passed by a Parliament, Congress or State/Provincial Legislatures. For example, the Consumer Guarantees Act. These can also be called Statutes and are sometimes referred to as Primary Legislation. Acts protect everyone. For the EU, Treaties are the fundamental laws. All treaties must be ratified (passed and agreed) by member states. An Act will be people focused so will not usually refer directly to a product.
What is a Regulation or Directive?
Regulations are made under the delegated authority of an Act (or Treaty for the EU), such as an administrative agency. They can be considered to be supplementary to the Act or Treaty. They are designed to aid in the application of the principles of the primary Act. Regulations provide protection in specific areas. For example, the Electrical (Safety) Regulations. Regulations are sometimes referred to as Secondary legislation, Subordinate Legislation or Delegated Legislation. In the UK the term Statutory Instrument is used. In the EU Regulations are legal acts that apply automatically and uniformly to all EU countries as soon as they enter into force, without needing to be transposed into national law. They are binding in their entirety across all EU countries. The EU also generate Directives which differ from regulations in that they are a legislative act that sets out a goal that EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals. Regulations can include some requirements that relate directly to specific or general categories of products. As a product development business you should understand the relevant regulations.
How do Acts and Regulations Differ?
An Act is generally a broader piece of legislation that outlines the general principles and rules of law, while a regulation is a more specific set of rules and requirements to enforce the provisions of the Act. Regulations are usually more specific and prescriptive, often providing detailed guidance on how the provisions of the Act should be implemented in practice. However, it is possible for an Act to be prescriptive also and in some instances to refer directly to a product safety standard. This means there may not always be a relevant Regulation.
What is a Product Safety Standard?
A Product Safety Standard is not, of itself, mandatory or legally required. A standard has to be incorporated by reference in an Act or delegated legislation in order to be mandatory. Once referenced, it becomes part of the technical regulation framework. In the EU, this is done through publication in the Official Journal of the European Union (OJEU) with respect to a particular Directive or Regulation. The product standard can then be used to derive a presumption of conformity with the essential requirements of that Directive or Regulation. This is what is referred to as a harmonised standard. In the UK these are called designated standards and their reference is published on GOV.UK in a formal notice of publication. In other countries standards are usually referenced from within an Act or Regulation. In Australia the ACCC (Australian Competition and Consumer Commission) release what they refer to as Mandatory Safety Standards (formally Consumer Protection Notices) directly under the Competition and Consumer Act 2010. These standards could be considered to be a cross between a Regulation and a Standard as they usually reference or duplicate sections of existing safety standards while also adding additional requirements. Product safety standards may prescribe a products form, construction, finish or packaging; tests the products must go through; and the form and content of any markings, warnings or instructions that must accompany the product.
Do I need to be aware of the Acts and Regulations that apply to my products or can I just apply the relevant Standards?
Acts often contain definitions which are important for the interpretation of Regulations and in some instances can refer directly to product safety standards, mandating them. Therefore, having a quick scan over the Act(s) that are relevant to your products is useful. Regulations can directly reference Standards and Regulations or Directives can often contain general requirements relating to your product or your responsibilities as a product developer/manufacturer, importer, distributor or retailer. It is also important to understand how your product standard(s) relate to the regulation. Are they referenced or harmonised? Which version is mandated or which clauses? Note that in different countries, slightly different versions of product standards may be referenced and it is important to ensure you cover the correct version of standard for each market you are selling in, in reference to that countries Regulation or similar.
How does product categorisation shape global compliance and market access?
A key step in managing product risks is ensuring your business is correctly identifying which regulations and standards apply to your products. Many compliance failures and costly delays stem from overlooking or misunderstanding these requirements early on. The first step in determining what is relevant is understanding the general regulatory product categories your product fits into.
Ensuring your business is correctly categorising its products makes it much easier for the relevant legal, safety, and performance requirements to be determined. It also helps in identifying where multiple sets of requirements might apply if your product fits into more than one category. This is an essential part of effective product risk management and ensures your business can plan ahead to meet all necessary obligations.
As products become more complex over time, they tend to enter additional categories. For example, a company might start with a simple mechanical product (machinery or consumer product) and later decide to motorise it (electrical and electronic equipment). They might then add a battery (battery product) and incorporate Bluetooth functionality (communications equipment). You can see how, as the product evolves, it spans more and more regulatory categories. When these additions are overlooked from a compliance perspective, the risk of non-compliance, and associated penalties or safety issues, increases significantly.
For a business to accurately determine where its product fits, it needs to be clear on who the customer is, what the product’s intended use is (and in what environment), and any specific claims made about the product. If you claim a product is, for example, “non-toxic”, “hypoallergenic “, “fire-resistant”, “clinically-proven” or “alleviates pain”, you can inadvertently be categorising your product in a way you haven’t intended. As an example, if you were marketing a walking stick, how you position and communicate that product will influence its category. If you promote it as an aid for a disability or for injury rehabilitation, it becomes a medical device or a therapeutic good. However, if it’s simply marketed as a general walking stick for fitness or leisure, with no therapeutic claims, it would be classified as a consumer product.
Regulatory categories do vary by market or the terminology may be slightly different, but these are some common categories that your products may fit into:
That is in no way an exhaustive list, but you may already notice that your products fit into more than one category.
Another common pitfall, using our walking stick example, is when a product is initially classified as a non-medical device, but later, the marketing team promotes it for use in hospitals or for injury recovery. Even though the product itself hasn’t changed, its intended use and market positioning have, which can introduce significant compliance risks for the business. Ensure that your marketing teams understand that changing users, use environments or making specific claims can have regulatory implications.
The right categorisation ensures that your business can identify the applicable legal, safety, and performance requirements early in the process. Once you are clear on your product categories, you are in a much better place to accurately identify relevant product regulations and standards.
Ensuring your business is correctly categorising its products makes it much easier for the relevant legal, safety, and performance requirements to be determined. It also helps in identifying where multiple sets of requirements might apply if your product fits into more than one category. This is an essential part of effective product risk management and ensures your business can plan ahead to meet all necessary obligations.
As products become more complex over time, they tend to enter additional categories. For example, a company might start with a simple mechanical product (machinery or consumer product) and later decide to motorise it (electrical and electronic equipment). They might then add a battery (battery product) and incorporate Bluetooth functionality (communications equipment). You can see how, as the product evolves, it spans more and more regulatory categories. When these additions are overlooked from a compliance perspective, the risk of non-compliance, and associated penalties or safety issues, increases significantly.
For a business to accurately determine where its product fits, it needs to be clear on who the customer is, what the product’s intended use is (and in what environment), and any specific claims made about the product. If you claim a product is, for example, “non-toxic”, “hypoallergenic “, “fire-resistant”, “clinically-proven” or “alleviates pain”, you can inadvertently be categorising your product in a way you haven’t intended. As an example, if you were marketing a walking stick, how you position and communicate that product will influence its category. If you promote it as an aid for a disability or for injury rehabilitation, it becomes a medical device or a therapeutic good. However, if it’s simply marketed as a general walking stick for fitness or leisure, with no therapeutic claims, it would be classified as a consumer product.
Regulatory categories do vary by market or the terminology may be slightly different, but these are some common categories that your products may fit into:
- Animal Feed: Substances or mixtures intended for consumption by animals to provide nutrition, support growth, or maintain health.
- Aviation/Aerospace Products: Aircraft, drones (often separately regulated), and all certified parts and systems used in flight.
- Battery Powered Products: Products containing batteries.
- Biocides: Any chemical substance or microorganism intended to destroy, deter, render harmless, or control harmful organisms by chemical or biological means.
- Chemicals / Hazardous Substances: Any substance or mixture (raw material or final product) with intrinsic hazardous properties (e.g., corrosives, carcinogens, flammables, toxins).
- Child Care Articles: Consumer products designed or intended primarily for children 12 years of age or younger.
- Communications Equipment: Electrical or electronic products that intentionally emit and/or receive radio waves for communication or location purposes (e.g., Wi-Fi routers, Bluetooth devices, mobile phones).
- Construction Products: Products manufactured for incorporation in a permanent way in construction works (e.g., cement, structural steel, insulation materials, plumbing materials).
- Consumer Products: Non-food, non-medicine products intended for use by the general public (e.g., clothing, household goods, DIY tools).
- Cosmetic Products: Substances or preparations intended for contact with external parts of the human body (e.g., skin, hair, nails) for the purpose of cleaning, perfuming, changing appearance, or correcting body odours.
- Electrical and Electronic Equipment: Products that require electric current or electromagnetic fields to operate, including household appliances, IT equipment, and lighting.
- Equipment for Explosive Atmospheres: Equipment and protective systems intended for use in potentially explosive atmospheres, such as environments with flammable gases or dust (commonly referred to as ATEX equipment).
- Fertilising Products: Substances or mixtures intended to supply nutrients to plants or fungi, improve crop yield, or enhance soil properties.
- Food: Substances intended for human consumption, including beverages and chewing gum, but excluding medicinal products.
- Food Contact Materials (FCM): Materials that are intended to come into contact with food (e.g., plastic containers, cutlery, coffee mugs, processing machinery surfaces).
- Gas Appliances: Appliances burning gaseous fuels for purposes such as heating, hot water, cooking, refrigeration, or lighting.
- Lifts: Equipment permanently serving buildings or construction sites, designed to move people or goods between different levels.
- Machinery: Products with parts that move via a drive system other than human or animal power. Typically designed to perform a specific function or task (e.g., industrial machines, agricultural equipment).
- Marine Equipment: Products intended for use on ships, subject to international conventions (e.g., SOLAS) (e.g., life-saving appliances, navigation equipment, fire protection systems).
- Measuring Instruments: Devices intended to determine a quantity, size, or other measurable property, often subject to accuracy requirements (e.g., weighing scales, gas meters).
- Medical Devices or Therapeutic Goods: Products designed to interact with the body for medical or physiological purposes, such as diagnosis, prevention, or managing body functions, but that do not rely mainly on drugs or chemicals to work (e.g., syringes, diagnostic kits, prosthetics).
- Medicinal Product: Substances or combinations of substances intended to treat or prevent disease, or to restore, correct, or modify physiological functions by exerting a pharmacological, immunological, or metabolic action.
- Motor Vehicles and Components: Cars, trucks, motorcycles, trailers, and their essential safety-critical parts (e.g., brakes, lights, emissions systems, safety glass).
- Packaging: Products made of any materials used to contain, protect, handle, deliver, and present goods, from raw materials to processed goods, across the supply chain (e.g., bottles, boxes, pallets).
- Personal Protective Equipment (PPE): Equipment designed to be worn or held by a person to protect against health and safety risks (e.g., helmets, gloves, respirators).
- Pressure Equipment: Vessels, piping, safety accessories, and other components that operate under pressure, typically above 0.5 bar (e.g., boilers, pressure cookers).
- Pyrotechnics: Products designed to produce heat, light, sound, gas, smoke, or a combination of these effects through exothermic chemical reactions (e.g., fireworks, flares).
- Toys: Products designed or intended for use in play by children under 14 years of age.
That is in no way an exhaustive list, but you may already notice that your products fit into more than one category.
Another common pitfall, using our walking stick example, is when a product is initially classified as a non-medical device, but later, the marketing team promotes it for use in hospitals or for injury recovery. Even though the product itself hasn’t changed, its intended use and market positioning have, which can introduce significant compliance risks for the business. Ensure that your marketing teams understand that changing users, use environments or making specific claims can have regulatory implications.
The right categorisation ensures that your business can identify the applicable legal, safety, and performance requirements early in the process. Once you are clear on your product categories, you are in a much better place to accurately identify relevant product regulations and standards.
How do I determine a products regulatory categories, particularly for novel or innovative products?
2026-05-14
Product categorisation is the first step in determining which regulatory frameworks apply to your product.
Regulatory frameworks may apply to:
Many products fit into multiple categories simultaneously.
To determine all potentially applicable categories, you should identify:
Once those aspects are clearly defined, categorisation becomes far more straightforward.
If your product looks like a duck and quacks like a duck, regulators will generally treat it as a duck and you cannot “de-duck” a product through creative semantics.
Regulators routinely look past:
Regulators will assess products using the same underlying characteristics, functionalities, risks, foreseeable uses, and market presentation that you should have used to categorise the product yourself.
In most situations, attempting to argue that a duck is not a duck is simply not credible.
Additionally, if relevant categories are overlooked, the consequences can include non-compliance findings, recalls, enforcement action, litigation, or fines. Taking the time to get categorisation right is a critical up-front activity, particularly for products entering multiple international markets.
The Rare Exception – When Is a Duck Not a Duck?
However, genuine innovation can create products that do not fit neatly within existing regulatory assumptions.
This typically occurs because regulations and harmonised or referenced standards are generally developed around known technologies and established risk profiles. Innovation often moves faster than those frameworks evolve.
In limited cases, a product may appear to fit within an existing category while the underlying assumptions behind that framework no longer apply appropriately.
But this is only credible when several conditions exist simultaneously.
For example:
Without those elements, arguing that “the duck is not a duck” is unlikely to withstand scrutiny.
In practice, this means the product should achieve a safety outcome at least equivalent to, and preferably better than, current state-of-the-art solutions.
Evidence Matters More Than Opinion
In these situations, businesses need evidence, not semantics.
That typically means:
The objective is not to avoid safety obligations. The objective is to demonstrate that the product achieves the intent of the regulation through a different technological approach.
Innovation sometimes requires frameworks to evolve to appropriately address new technologies and risk profiles.
Businesses developing genuinely novel technologies should also consider participating in standards committees, industry working groups, and regulatory consultations to help frameworks evolve appropriately.
One final point: categorisation varies between markets.
What is considered a duck in one jurisdiction may be treated as a goose in another. Categorisation should be assessed market by market.
Product categorisation is the first step in determining which regulatory frameworks apply to your product.
Regulatory frameworks may apply to:
- specific product groupings (eg. machinery, toys, medical devices), or
- specific features, functionalities, or risks that span multiple categories (eg. radio equipment, batteries, low voltage, cyber security, hazardous substances).
Many products fit into multiple categories simultaneously.
To determine all potentially applicable categories, you should identify:
- The target product user (eg. child, general consumer, trained professional)
- The use environment (eg. indoor, outdoor, marine, explosive atmosphere)
- The key functionalities (eg. connectivity, mains powered, moving parts)
- The key materials used (eg. hazardous substances where relevant)
- The inherent hazards or risks (eg. thermal, vibration, noise, pressure)
- All claims, branding, and instructional materials that define the product’s intended purpose
- Expected use and foreseeable misuse (for example, if a product clearly looks like a toy, it is foreseeable that it may be used like a toy regardless of how it is labelled)
Once those aspects are clearly defined, categorisation becomes far more straightforward.
If your product looks like a duck and quacks like a duck, regulators will generally treat it as a duck and you cannot “de-duck” a product through creative semantics.
Regulators routinely look past:
- marketing euphemisms (“gadget” instead of “medical device”),
- strategic disclaimers (“for novelty use only”),
- arbitrary age grading (labelling a clear toy as “14+” to avoid toy safety requirements), or
- simply stating “this is not a duck” on the label.
Regulators will assess products using the same underlying characteristics, functionalities, risks, foreseeable uses, and market presentation that you should have used to categorise the product yourself.
In most situations, attempting to argue that a duck is not a duck is simply not credible.
Additionally, if relevant categories are overlooked, the consequences can include non-compliance findings, recalls, enforcement action, litigation, or fines. Taking the time to get categorisation right is a critical up-front activity, particularly for products entering multiple international markets.
The Rare Exception – When Is a Duck Not a Duck?
However, genuine innovation can create products that do not fit neatly within existing regulatory assumptions.
This typically occurs because regulations and harmonised or referenced standards are generally developed around known technologies and established risk profiles. Innovation often moves faster than those frameworks evolve.
In limited cases, a product may appear to fit within an existing category while the underlying assumptions behind that framework no longer apply appropriately.
But this is only credible when several conditions exist simultaneously.
For example:
- The risk the framework was designed to address is not actually present in the innovation
- Applying the framework literally would reduce safety, create unintended consequences, or be technically infeasible for the innovation
- The innovation achieves the regulatory intent through a different but demonstrably effective approach and there is strong technical evidence supporting that position
- The business can clearly justify why the product falls outside the intended scope or assumptions of the framework
Without those elements, arguing that “the duck is not a duck” is unlikely to withstand scrutiny.
In practice, this means the product should achieve a safety outcome at least equivalent to, and preferably better than, current state-of-the-art solutions.
Evidence Matters More Than Opinion
In these situations, businesses need evidence, not semantics.
That typically means:
- test evidence and engineering analysis,
- documented risk assessments,
- clear technical justification,
- consistent product communications, and
- a well-maintained technical dossier.
The objective is not to avoid safety obligations. The objective is to demonstrate that the product achieves the intent of the regulation through a different technological approach.
Innovation sometimes requires frameworks to evolve to appropriately address new technologies and risk profiles.
Businesses developing genuinely novel technologies should also consider participating in standards committees, industry working groups, and regulatory consultations to help frameworks evolve appropriately.
One final point: categorisation varies between markets.
What is considered a duck in one jurisdiction may be treated as a goose in another. Categorisation should be assessed market by market.
What are phthalates and are they in my products?
06-01-2025
Globally, there are a number of regulations that restrict the amount of specific Phthalates that are allowed to be present in different types of products.
How do I pronounce Phthalate?
Phthalate is pronounced “Fell-late”
What is a phthalate?
Phthalates are a group of man-made chemicals that are structurally related to the organic acid, phthalic acid.
What are phthalates used for?
The most common use of phthalates is in plastics, especially PVC, where they act as plasticisers. A plasticiser is a chemical additive that makes materials softer and more flexible. As an additive they will generally not appear on product or material labels. Another common use is in products that contain fragrances. Phthalates are used as solvents and fixatives to help preserve fragrances and help them to linger.
As well as being found in plastics and vinyl products, and products containing fragrances, they are also found in safety glass, lubricating oils, food packaging, adhesives, paints, inks, medical tubing, blood bags, pharmaceuticals, footwear, electrical cables, stationery, nail polish. Here is a list of some common phthalates and their applications:
Globally, there are a number of regulations that restrict the amount of specific Phthalates that are allowed to be present in different types of products.
How do I pronounce Phthalate?
Phthalate is pronounced “Fell-late”
What is a phthalate?
Phthalates are a group of man-made chemicals that are structurally related to the organic acid, phthalic acid.
What are phthalates used for?
The most common use of phthalates is in plastics, especially PVC, where they act as plasticisers. A plasticiser is a chemical additive that makes materials softer and more flexible. As an additive they will generally not appear on product or material labels. Another common use is in products that contain fragrances. Phthalates are used as solvents and fixatives to help preserve fragrances and help them to linger.
As well as being found in plastics and vinyl products, and products containing fragrances, they are also found in safety glass, lubricating oils, food packaging, adhesives, paints, inks, medical tubing, blood bags, pharmaceuticals, footwear, electrical cables, stationery, nail polish. Here is a list of some common phthalates and their applications:
What are the risks associated with the use of phthalates?
Exposure to phthalates happens through food, skin, and air. Phthalates are not chemically bound in the materials they are added to, so they can easily leach out or evaporate.
Several phthalates, for example DEHP, DBP, DIBP and BBP may damage fertility or the unborn baby and interfere with our hormonal system (Endocrine Disrupting). In particular, they affect the sexual development of boys which can lead to infertility in adults. Pregnant women and young children have been found to be the most vulnerable groups to the effects of phthalates. DEHP, DBP and BBP, are also harmful to the environment, more specifically are very toxic to aquatic life, and often with long lasting effects.
What bans and restrictions exist around the use of phthalates? (non-exhaustive list of some key regulations):
Exposure to phthalates happens through food, skin, and air. Phthalates are not chemically bound in the materials they are added to, so they can easily leach out or evaporate.
Several phthalates, for example DEHP, DBP, DIBP and BBP may damage fertility or the unborn baby and interfere with our hormonal system (Endocrine Disrupting). In particular, they affect the sexual development of boys which can lead to infertility in adults. Pregnant women and young children have been found to be the most vulnerable groups to the effects of phthalates. DEHP, DBP and BBP, are also harmful to the environment, more specifically are very toxic to aquatic life, and often with long lasting effects.
What bans and restrictions exist around the use of phthalates? (non-exhaustive list of some key regulations):
How do I know if my products contain phthalates?
Talk to your material suppliers and ask for declarations or certification for the relevant regulations. You can also send samples of your products to a test laboratory for testing.
Talk to your material suppliers and ask for declarations or certification for the relevant regulations. You can also send samples of your products to a test laboratory for testing.
What should I consider before adding Bluetooth to a product?
2026-04-30
"Everything is better with Bluetooth!"? Some of you may recognise that title as a quote from Sheldon Cooper in a 2009 episode of The Big Bang Theory. Since the mid-2010s, annual shipments of Bluetooth-enabled products have grown significantly, now reaching around 5 billion units per year (Bluetooth SIG market data).
On a daily basis, many of us use Bluetooth regularly, but we also interact with products that offer Bluetooth without ever using the feature. This applies across both consumer and industrial products where Bluetooth is used as part of the system design.
So what does adding Bluetooth actually mean in terms of regulatory burden?
To use the Bluetooth name or logo on a product or packaging, the company responsible for the finished product must complete the Bluetooth qualification and listing process through the Bluetooth Special Interest Group.
In practice, most companies do not implement Bluetooth from scratch. They use pre-certified modules or chips from suppliers such as Nordic Semiconductor, Texas Instruments, or Qualcomm. This significantly reduces RF and protocol testing requirements because much of the radio compliance work has already been completed.
However, using a certified module does not remove end-product responsibility. The finished product must still be properly listed through the Bluetooth qualification process (even when using a pre-certified module), a declaration completed, and in most cases a per-design listing fee (often in the order of USD 10,000–12,000 depending on membership structure and listing approach) paid before using the Bluetooth name or logo on packaging or marketing. You will also need to comply with the Bluetooth trademark usage rules.
Adding Bluetooth to a product also triggers broader regulatory obligations, particularly around radio frequency compliance.
In all major markets, Bluetooth products must meet radio frequency (RF) and electromagnetic compatibility (EMC) requirements before sale.
Across these regions, third-party RF and EMC testing typically ranges from around USD 3,000–15,000 per design per market, depending on complexity and test outcomes. Retesting is required if hardware, antenna design, or other RF-relevant aspects of the product change. Retesting due to small mechanical change can be a hidden cost driver. Certification and administrative fees are generally lower (often around USD 1,000 per design per market, depending on jurisdiction and pathway).
Where products are approved via self-declaration frameworks (for example EU and UK CE/UKCA pathways), manufacturers must maintain technical documentation demonstrating compliance with applicable standards and essential requirements.
Bluetooth-enabled products may form part of systems that communicate locally and, in some architectures, connect indirectly to the internet via a smartphone or gateway. Where a product is network-connected or processes user data, cybersecurity and privacy obligations may also apply, depending on the nature of the data.
In the EU, under the Radio Equipment Directive (RED), certain connected radio products must meet cybersecurity requirements introduced through Delegated Regulation (EU) 2022/30. Compliance may be demonstrated using harmonised standards such as the EN 18031 series, which addresses risks including unauthorised access, network integrity, data protection, and fraud prevention. This typically requires structured risk assessment, technical documentation, and evidence of conformity.
Depending on the product, the EU Cyber Resilience Act (CRA) may also apply as a broader lifecycle cybersecurity framework for products with digital elements, introducing obligations around vulnerability handling, security updates, and secure-by-design practices. In addition, the EU General Data Protection Regulation (GDPR) may apply where personal data is collected or processed via your product or app.
Globally, data privacy and cybersecurity requirements vary significantly by jurisdiction but increasingly focus on secure data handling, vulnerability management, and system resilience for connected products.
While many of these obligations apply across both consumer and industrial products, the intensity and regulatory triggers can vary depending on the product context and intended use.
From a technical perspective Bluetooth products often introduce, firmware update mechanisms, app dependency, version compatibility management and the need for vulnerability patching processes and update support windows.
Another subtle shift is that once a product is “connected” users and regulators expect security-by-design. Failure modes are interpreted harshly (e.g. hacks, spoofing, device takeover) increasing recall sensitivity, reputational risk and legal exposure in negligence claims.
Overall, Bluetooth does introduce a meaningful regulatory and compliance burden in most markets. While it delivers clear user benefits in many applications, in others it can be more of a feature than a necessity.
The key question for businesses is not whether Bluetooth is possible, but whether it will be consistently used, genuinely valued by customers, and commercially justified against the cost and complexity of product compliance and risk.
And in some cases, the answer may simply be: not everything is better with Bluetooth.
See also:
"Everything is better with Bluetooth!"? Some of you may recognise that title as a quote from Sheldon Cooper in a 2009 episode of The Big Bang Theory. Since the mid-2010s, annual shipments of Bluetooth-enabled products have grown significantly, now reaching around 5 billion units per year (Bluetooth SIG market data).
On a daily basis, many of us use Bluetooth regularly, but we also interact with products that offer Bluetooth without ever using the feature. This applies across both consumer and industrial products where Bluetooth is used as part of the system design.
So what does adding Bluetooth actually mean in terms of regulatory burden?
To use the Bluetooth name or logo on a product or packaging, the company responsible for the finished product must complete the Bluetooth qualification and listing process through the Bluetooth Special Interest Group.
In practice, most companies do not implement Bluetooth from scratch. They use pre-certified modules or chips from suppliers such as Nordic Semiconductor, Texas Instruments, or Qualcomm. This significantly reduces RF and protocol testing requirements because much of the radio compliance work has already been completed.
However, using a certified module does not remove end-product responsibility. The finished product must still be properly listed through the Bluetooth qualification process (even when using a pre-certified module), a declaration completed, and in most cases a per-design listing fee (often in the order of USD 10,000–12,000 depending on membership structure and listing approach) paid before using the Bluetooth name or logo on packaging or marketing. You will also need to comply with the Bluetooth trademark usage rules.
Adding Bluetooth to a product also triggers broader regulatory obligations, particularly around radio frequency compliance.
In all major markets, Bluetooth products must meet radio frequency (RF) and electromagnetic compatibility (EMC) requirements before sale.
- In the United States, devices must be certified under FCC Part 15 through a Telecommunications Certification Body (TCB), based on accredited lab testing.
- In Canada, certification is managed through Innovation, Science and Economic Development (ISED), using standards aligned with FCC requirements.
- In South Africa, ICASA type approval is required and typically relies on accredited test reports.
- In the EU, products must meet CE marking requirements under the Radio Equipment Directive (RED).
- In the UK, UKCA marking is required under equivalent radio equipment regulations.
- In Australia and New Zealand, compliance is managed through the RCM framework, which generally requires supporting technical evidence such as test reports and supplier declarations (business registration for the responsible supplier is required).
Across these regions, third-party RF and EMC testing typically ranges from around USD 3,000–15,000 per design per market, depending on complexity and test outcomes. Retesting is required if hardware, antenna design, or other RF-relevant aspects of the product change. Retesting due to small mechanical change can be a hidden cost driver. Certification and administrative fees are generally lower (often around USD 1,000 per design per market, depending on jurisdiction and pathway).
Where products are approved via self-declaration frameworks (for example EU and UK CE/UKCA pathways), manufacturers must maintain technical documentation demonstrating compliance with applicable standards and essential requirements.
Bluetooth-enabled products may form part of systems that communicate locally and, in some architectures, connect indirectly to the internet via a smartphone or gateway. Where a product is network-connected or processes user data, cybersecurity and privacy obligations may also apply, depending on the nature of the data.
In the EU, under the Radio Equipment Directive (RED), certain connected radio products must meet cybersecurity requirements introduced through Delegated Regulation (EU) 2022/30. Compliance may be demonstrated using harmonised standards such as the EN 18031 series, which addresses risks including unauthorised access, network integrity, data protection, and fraud prevention. This typically requires structured risk assessment, technical documentation, and evidence of conformity.
Depending on the product, the EU Cyber Resilience Act (CRA) may also apply as a broader lifecycle cybersecurity framework for products with digital elements, introducing obligations around vulnerability handling, security updates, and secure-by-design practices. In addition, the EU General Data Protection Regulation (GDPR) may apply where personal data is collected or processed via your product or app.
Globally, data privacy and cybersecurity requirements vary significantly by jurisdiction but increasingly focus on secure data handling, vulnerability management, and system resilience for connected products.
While many of these obligations apply across both consumer and industrial products, the intensity and regulatory triggers can vary depending on the product context and intended use.
From a technical perspective Bluetooth products often introduce, firmware update mechanisms, app dependency, version compatibility management and the need for vulnerability patching processes and update support windows.
Another subtle shift is that once a product is “connected” users and regulators expect security-by-design. Failure modes are interpreted harshly (e.g. hacks, spoofing, device takeover) increasing recall sensitivity, reputational risk and legal exposure in negligence claims.
Overall, Bluetooth does introduce a meaningful regulatory and compliance burden in most markets. While it delivers clear user benefits in many applications, in others it can be more of a feature than a necessity.
The key question for businesses is not whether Bluetooth is possible, but whether it will be consistently used, genuinely valued by customers, and commercially justified against the cost and complexity of product compliance and risk.
And in some cases, the answer may simply be: not everything is better with Bluetooth.
See also:
Is Product Compliance and Global Market Access Getting Harder?
2026-05-27
Short answer: yes.
Global markets continue to open commercially, but regulatory frameworks are accelerating faster than ever. What is different this time is a structural shift in how international laws are made, and it is removing the traditional grace periods businesses once relied on.
For example, historically the EU relied heavily on directives. A directive sets an outcome, but leaves each member state to define how it is implemented into national law. In practice, this created a staggered rollout across Europe, giving manufacturers years of incremental adjustment as rules were transposed country by country.
Today, the EU is increasingly favouring regulations over directives. Regulations bypass national parliaments entirely. They apply directly, uniformly, and simultaneously across all 27 member states as soon as they take effect.
This shift is already reshaping the market:
When a regulation comes into force, the entire European market changes at once. Increasingly, these instruments are also being finalised before detailed implementation guidance or harmonised standards are fully established.
The result is a regulatory environment where businesses must adapt in real time, often without the historical benefit of mature compliance pathways.
At the same time, enforcement is becoming more data-driven and responsive. Europe’s Safety Gate system recorded 4,671 product safety alerts in 2025, a 13% increase on 2024. The rise in alerts is being driven by:
The strategic question is no longer whether regulation is increasing, the real question is: how do we reduce compliance burden through product strategy?
I have spoken with some New Zealand businesses that are currently avoiding the EU market because it feels too difficult or uncertain.
However, with the speed of regulatory change now occurring in Europe, ignoring the market may actually increase long-term risk. The gap between current product capability and future EU expectations can widen quickly, potentially making later market entry significantly more difficult and expensive.
Rather than reacting to regulatory complexity, businesses need structural strategies that reduce exposure while improving speed, resilience, and scalability.
Strategy 1: Product and Feature Rationalisation
The fastest way to reduce compliance burden is to reduce what needs to be certified.
Every stock keeping unit (SKU) and every unique feature exported into regulated markets adds another layer of testing, documentation, supplier assurance, and ongoing compliance monitoring.
Product rationalisation is the deliberate process of simplifying product portfolios by removing low-value variants and non-essential features.
A product variant contributing only a small percentage of revenue, while requiring separate testing, documentation, or supply chain transparency reporting, may ultimately become a net negative for the business.
Adding a wireless module introduces radio compliance and cybersecurity obligations. Adding a battery introduces lifecycle, transport, sustainability, and end-of-life requirements.
A useful design question is:
Does this feature deliver enough customer value to justify its lifetime compliance cost?
Strategy 2: Product Family Structuring
Simplification does not always require removing products. In many cases, it comes from structuring them more intelligently.
Many modern regulatory systems allow similar products to be assessed as a product family or series, provided they share core design characteristics.
When designed deliberately, this can significantly reduce duplicated testing and documentation effort.
For example, testing the smallest enclosure for thermal constraints and the largest enclosure for mechanical stress may allow the full product range to be certified without testing every intermediate size.
However, changing a critical component in just one variant can break the family structure entirely, forcing standalone certification and increasing regulatory overhead.
Strategy 3: Using pre-certified modules
Using pre-certified modules can significantly reduce testing scope, documentation effort, and approval costs.
For example, selecting a Bluetooth or Wi-Fi module that already holds approvals across major target markets can substantially simplify compliance activities for radio, EMC, and sometimes cybersecurity-related requirements.
This approach can also reduce project risk by leveraging components with established technical documentation, existing test reports, and mature supply chains.
The businesses that will perform best over the next decade are unlikely to be those with the largest compliance teams.
They will be the businesses that design products strategically around regulatory complexity from the beginning.
Focusing on the most demanding global market requirements may initially feel overwhelming. However, it often produces stronger products, more resilient architectures, clearer documentation structures, and better long-term scalability across multiple markets.
The key is not simply understanding regulations. It is understanding how to structure products, features, architectures, and compliance pathways in a way that minimises cost and effort while protecting long-term market access.
Market access is increasingly becoming a design input, not a final checkpoint.
See also:
Short answer: yes.
Global markets continue to open commercially, but regulatory frameworks are accelerating faster than ever. What is different this time is a structural shift in how international laws are made, and it is removing the traditional grace periods businesses once relied on.
For example, historically the EU relied heavily on directives. A directive sets an outcome, but leaves each member state to define how it is implemented into national law. In practice, this created a staggered rollout across Europe, giving manufacturers years of incremental adjustment as rules were transposed country by country.
Today, the EU is increasingly favouring regulations over directives. Regulations bypass national parliaments entirely. They apply directly, uniformly, and simultaneously across all 27 member states as soon as they take effect.
This shift is already reshaping the market:
- The former Batteries Directive has been replaced by the EU Batteries Regulation
- The General Product Safety framework has been replaced by the General Product Safety Regulation (GPSR)
- Upcoming Ecodesign requirements and Digital Product Passports are being introduced as directly applicable regulations
When a regulation comes into force, the entire European market changes at once. Increasingly, these instruments are also being finalised before detailed implementation guidance or harmonised standards are fully established.
The result is a regulatory environment where businesses must adapt in real time, often without the historical benefit of mature compliance pathways.
At the same time, enforcement is becoming more data-driven and responsive. Europe’s Safety Gate system recorded 4,671 product safety alerts in 2025, a 13% increase on 2024. The rise in alerts is being driven by:
- Improved surveillance and detection tools
- Faster cross-border information sharing
- Stronger enforcement activity
- Increased scrutiny of online marketplaces
The strategic question is no longer whether regulation is increasing, the real question is: how do we reduce compliance burden through product strategy?
I have spoken with some New Zealand businesses that are currently avoiding the EU market because it feels too difficult or uncertain.
However, with the speed of regulatory change now occurring in Europe, ignoring the market may actually increase long-term risk. The gap between current product capability and future EU expectations can widen quickly, potentially making later market entry significantly more difficult and expensive.
Rather than reacting to regulatory complexity, businesses need structural strategies that reduce exposure while improving speed, resilience, and scalability.
Strategy 1: Product and Feature Rationalisation
The fastest way to reduce compliance burden is to reduce what needs to be certified.
Every stock keeping unit (SKU) and every unique feature exported into regulated markets adds another layer of testing, documentation, supplier assurance, and ongoing compliance monitoring.
Product rationalisation is the deliberate process of simplifying product portfolios by removing low-value variants and non-essential features.
- Focus on high-value cores
A product variant contributing only a small percentage of revenue, while requiring separate testing, documentation, or supply chain transparency reporting, may ultimately become a net negative for the business.
- Control feature proliferation (“feature creep”)
Adding a wireless module introduces radio compliance and cybersecurity obligations. Adding a battery introduces lifecycle, transport, sustainability, and end-of-life requirements.
A useful design question is:
Does this feature deliver enough customer value to justify its lifetime compliance cost?
Strategy 2: Product Family Structuring
Simplification does not always require removing products. In many cases, it comes from structuring them more intelligently.
Many modern regulatory systems allow similar products to be assessed as a product family or series, provided they share core design characteristics.
When designed deliberately, this can significantly reduce duplicated testing and documentation effort.
- Design for the worst-case variant
For example, testing the smallest enclosure for thermal constraints and the largest enclosure for mechanical stress may allow the full product range to be certified without testing every intermediate size.
- Standardise critical components across variants
- Power supplies
- Wireless modules
- Batteries
- Enclosure materials
However, changing a critical component in just one variant can break the family structure entirely, forcing standalone certification and increasing regulatory overhead.
Strategy 3: Using pre-certified modules
Using pre-certified modules can significantly reduce testing scope, documentation effort, and approval costs.
For example, selecting a Bluetooth or Wi-Fi module that already holds approvals across major target markets can substantially simplify compliance activities for radio, EMC, and sometimes cybersecurity-related requirements.
This approach can also reduce project risk by leveraging components with established technical documentation, existing test reports, and mature supply chains.
The businesses that will perform best over the next decade are unlikely to be those with the largest compliance teams.
They will be the businesses that design products strategically around regulatory complexity from the beginning.
Focusing on the most demanding global market requirements may initially feel overwhelming. However, it often produces stronger products, more resilient architectures, clearer documentation structures, and better long-term scalability across multiple markets.
The key is not simply understanding regulations. It is understanding how to structure products, features, architectures, and compliance pathways in a way that minimises cost and effort while protecting long-term market access.
Market access is increasingly becoming a design input, not a final checkpoint.
See also:
What do I need to consider for packaging compliance?
Last updated: 2026-06-24
Is your packaging ready for the EU 12 August 2026 deadline?
If you place products on the European market, the EU Packaging and Packaging Waste Regulation (PPWR) requirements begin to apply from 12 August 2026.
Packaging requirements are becoming significantly more complex, and many businesses are only now realising that packaging itself is becoming a heavily regulated component of the product.
To help businesses prepare for this specific milestone, I have created a practical PPWR Compliance Checklist focused on the requirements that apply from 12 August 2026. It is designed to help you confirm readiness for that date. However, it is important to note that this is only the starting point. A wider set of requirements will continue to phase in over the following years and your business can benefit for including as many of those as possible now.
Download the checklist here.
For decades, packaging outside the food and beverage sector has largely been treated as a supporting element of the product.
Its role was straightforward: protect the product, communicate information, support branding, and survive transportation and storage.
Historically, most product related regulation have focused on protecting consumers from direct harm. Over time, however, regulators have increasingly recognised that environmental impacts can also affect human health and wellbeing. As a result, requirements are expanding beyond safety and performance to include resource consumption, waste generation, recyclability, and producer responsibility.
Packaging is one of the clearest examples of this shift.
Around the world, governments are introducing requirements covering material composition, recyclability, recycled content, packaging minimisation, labelling, and documentation. California's SB 54 legislation is one example. The European Union's PPWR is the most significant, given its scale and its likely influence on global supply chains.
The direction of travel is clear. Packaging is no longer just something wrapped around the product. It is increasingly becoming a product in its own right.
But this does not mean packaging decisions should be driven by compliance alone.
Packaging still has to perform. It protects products from damage, preserves shelf life where required, supports regulatory labelling obligations, and contributes to customer experience and brand perception. Poorly considered packaging changes can introduce serious unintended consequences, including product damage, higher return rates, spoilage, and even safety risks.
As businesses respond, many are already moving beyond minimum compliance requirements and incorporating future requirements into current redesign programmes. This is a practical response to the fact that packaging changes are slow, time consuming, and often constrained by supply chain realities.
Key considerations now include:
As requirements evolve, access to compliant packaging materials will become a limiting factor. For example, certified post-consumer recycled (PCR) content for plastics is expected to become increasingly important. However, supply of verified, high-quality PCR material is not unlimited. Businesses that delay supplier engagement may find themselves competing for constrained supply or facing significant cost escalation.
This makes supplier relationships a compliance issue, not just a procurement activity. Securing access to compliant materials early will be a key factor in maintaining market access over time.
Packaging changes should also be treated as formal engineering changes, not cosmetic updates.
Changes to materials, structure, or dimensions can affect product protection, manufacturing processes, transport performance, shelf life, and regulatory compliance. These changes should be managed through established engineering change processes, with appropriate risk assessment, verification, validation, and formal sign-off from quality and compliance functions.
Packaging compliance is also not something any single function can solve in isolation.
The businesses that respond early will not only reduce compliance risk but also reduce exposure to future supply chain disruption.
The box around your product now requires the same engineering discipline, supplier management, and risk thinking as the product inside it.
If Europe is one of your markets, the clock is already ticking.
Download the PPWR Compliance Checklist to confirm your readiness for 12 August 2026, and start preparing for the changes still to come.
Further Reading:
Is your packaging ready for the EU 12 August 2026 deadline?
If you place products on the European market, the EU Packaging and Packaging Waste Regulation (PPWR) requirements begin to apply from 12 August 2026.
Packaging requirements are becoming significantly more complex, and many businesses are only now realising that packaging itself is becoming a heavily regulated component of the product.
To help businesses prepare for this specific milestone, I have created a practical PPWR Compliance Checklist focused on the requirements that apply from 12 August 2026. It is designed to help you confirm readiness for that date. However, it is important to note that this is only the starting point. A wider set of requirements will continue to phase in over the following years and your business can benefit for including as many of those as possible now.
Download the checklist here.
For decades, packaging outside the food and beverage sector has largely been treated as a supporting element of the product.
Its role was straightforward: protect the product, communicate information, support branding, and survive transportation and storage.
Historically, most product related regulation have focused on protecting consumers from direct harm. Over time, however, regulators have increasingly recognised that environmental impacts can also affect human health and wellbeing. As a result, requirements are expanding beyond safety and performance to include resource consumption, waste generation, recyclability, and producer responsibility.
Packaging is one of the clearest examples of this shift.
Around the world, governments are introducing requirements covering material composition, recyclability, recycled content, packaging minimisation, labelling, and documentation. California's SB 54 legislation is one example. The European Union's PPWR is the most significant, given its scale and its likely influence on global supply chains.
The direction of travel is clear. Packaging is no longer just something wrapped around the product. It is increasingly becoming a product in its own right.
But this does not mean packaging decisions should be driven by compliance alone.
Packaging still has to perform. It protects products from damage, preserves shelf life where required, supports regulatory labelling obligations, and contributes to customer experience and brand perception. Poorly considered packaging changes can introduce serious unintended consequences, including product damage, higher return rates, spoilage, and even safety risks.
As businesses respond, many are already moving beyond minimum compliance requirements and incorporating future requirements into current redesign programmes. This is a practical response to the fact that packaging changes are slow, time consuming, and often constrained by supply chain realities.
Key considerations now include:
- Material selection and restricted substances
- Recyclability, recycled content, and emerging requirements for certified post-consumer waste inputs
- Packaging minimisation and optimisation of empty space
- Reuse systems and end-of-life pathways
- Labelling and traceability requirements
- Technical documentation and evidence of compliance
- Packaging performance in transport, storage, and retail environments
As requirements evolve, access to compliant packaging materials will become a limiting factor. For example, certified post-consumer recycled (PCR) content for plastics is expected to become increasingly important. However, supply of verified, high-quality PCR material is not unlimited. Businesses that delay supplier engagement may find themselves competing for constrained supply or facing significant cost escalation.
This makes supplier relationships a compliance issue, not just a procurement activity. Securing access to compliant materials early will be a key factor in maintaining market access over time.
Packaging changes should also be treated as formal engineering changes, not cosmetic updates.
Changes to materials, structure, or dimensions can affect product protection, manufacturing processes, transport performance, shelf life, and regulatory compliance. These changes should be managed through established engineering change processes, with appropriate risk assessment, verification, validation, and formal sign-off from quality and compliance functions.
Packaging compliance is also not something any single function can solve in isolation.
- Engage packaging suppliers early to secure material availability and compliance data
- Work closely with distributors, importers, and retailers, noting that EU-based economic operators carry their own reporting and compliance responsibilities
- Rationalise packaging where possible to reduce complexity, variants, and material usage
- Align packaging strategy with both current requirements and known future regulatory direction
The businesses that respond early will not only reduce compliance risk but also reduce exposure to future supply chain disruption.
The box around your product now requires the same engineering discipline, supplier management, and risk thinking as the product inside it.
If Europe is one of your markets, the clock is already ticking.
Download the PPWR Compliance Checklist to confirm your readiness for 12 August 2026, and start preparing for the changes still to come.
Further Reading:
Note that regulations are continuously being updated and the below was current at the time of writing but things may change over time.
Cyber Security Requirements under the Radio Equipment Directive (RED)
2026-05-10
What are the EN18031 series of standards?
EN 18031-1:2024 Common security requirements for radio equipment - Part 1: Internet connected radio equipment
EN 18031-2: 2024 Common security requirements for radio equipment - Part 2: radio equipment processing data, namely Internet connected radio equipment, childcare radio equipment, toys radio equipment and wearable radio equipment
EN 18031-3:2024 Common security requirements for radio equipment - Part 3: Internet connected radio equipment processing virtual money or monetary value
When did these product standards become mandatory under the RED?
1 August 2025.
What are the objectives of compliance with these product standards?
From Article 3.3 of the RED, these standards seek to:
What products are covered by these standards?
Connected products. Any devices capable of communicating over the internet, either directly or through other equipment. This includes devices that may handle sensitive data, including personal data, traffic data and location data. Examples include: mobile phones, tablets, laptops, wireless toys, children’s safety equipment (such as baby monitors) and wearable devices, such as smartwatches and fitness trackers.
What are the product testing requirements?
Product Developers or manufacturers must conduct tests focusing on network security, data protection, and the integrity of communication protocols. Devices should be evaluated for their resilience against unauthorized access and potential fraud scenarios.
See also:
What are the EN18031 series of standards?
EN 18031-1:2024 Common security requirements for radio equipment - Part 1: Internet connected radio equipment
EN 18031-2: 2024 Common security requirements for radio equipment - Part 2: radio equipment processing data, namely Internet connected radio equipment, childcare radio equipment, toys radio equipment and wearable radio equipment
EN 18031-3:2024 Common security requirements for radio equipment - Part 3: Internet connected radio equipment processing virtual money or monetary value
When did these product standards become mandatory under the RED?
1 August 2025.
What are the objectives of compliance with these product standards?
From Article 3.3 of the RED, these standards seek to:
- Enhance network protection by requiring devices to have features that prevent harm to communication networks and avoid disrupting the functionality of websites or services.
- Strengthen the protection of personal data and privacy. This includes measures to prevent unauthorized access or transmission of consumers' personal data.
- Reduce the risk of fraud, through mandating features like improved user authentication controls to minimise fraudulent electronic payments and monetary transfers
What products are covered by these standards?
Connected products. Any devices capable of communicating over the internet, either directly or through other equipment. This includes devices that may handle sensitive data, including personal data, traffic data and location data. Examples include: mobile phones, tablets, laptops, wireless toys, children’s safety equipment (such as baby monitors) and wearable devices, such as smartwatches and fitness trackers.
What are the product testing requirements?
Product Developers or manufacturers must conduct tests focusing on network security, data protection, and the integrity of communication protocols. Devices should be evaluated for their resilience against unauthorized access and potential fraud scenarios.
See also:
Ecodesign for Sustainable Products Regulation (ESPR)
2024-08-05
What is the Ecodesign for Sustainable Products Regulation (ESPR)?
The ESPR regulation supersedes the current EU ecodesign directive (2009/125/EC) and introduces additional ecodesign criteria applicable to a broader range of products sold on the EU market. Broadly speaking it says that all products should be designed for extended lifespans and be more easily repairable, upgradeable, and recyclable. This Regulation establishes a framework for the setting of ecodesign requirements that products have to comply with.
What products are covered by this regulation?
This Regulation applies to any physical goods that are placed on the market or put into service, including components and intermediate products.
What products are excluded?
Food; feed; medicinal products; living plants, animals and micro-organisms; products of human origin; products of plants and animals relating directly to their future reproduction; vehicles (but not including scooters and bicycles – these are included); items for defense.
From when does it apply?
This regulation entered into force on the 18th of July 2024 and enforcement will begin in 2 years from that date. However, if you are developing new product, now is the time to ensure you are aware of the requirements.
What are some of the requirements?
Product durability, reusability, upgradability and repairability, as well as the use of substances that inhibit circularity are mentioned. Additionally, it covers energy and resource efficiency, recycled content, remanufacturing and recycling, and the carbon and environmental footprints of products. This Regulation also establishes a ‘digital product passport’, provides for the setting of mandatory green public procurement requirements and creates a framework to prevent unsold consumer products from being destroyed. An EU declaration of conformity will also be needed for your product, along with CE marking. There are also a number of information requirements that must accompany a product.
What is a Digital Product Passport?
A 'Digital Product Passport' requires a QR code on a product that takes a consumer to information that enables them to make informed purchasing decisions by offering details about a product's environmental sustainability. It thereby allows consumers to access and compare information contained within these product passports.
What ‘unsold products’ can no longer be destroyed under this regulation?
The regulation imposes a direct ban on the destruction of unsold textiles and footwear, which will take effect two years after enactment. Small and micro companies are exempt, while medium-sized companies have a six-year exemption. It also authorizes the Commission to introduce similar bans for other products in the future. From 19 July 2030, medium sized enterprizes that discard unsold consumer products directly or have unsold consumer products discarded on their behalf must disclose the amount, the reason and any recovery actions taken annually on their websites.
What is ‘ecodesign’?
The regulation defines ecodesign as “the integration of environmental sustainability considerations into the characteristics of a product and the processes taking place throughout the product’s value chain”
What ecodesign requirements will be implemented?
Further detailed requirements will be adopted going forward to improve the following product aspects:
(a) durability;
(b) reliability;
(c) reusability;
(d) upgradability;
(e) repairability;
(f) the possibility of maintenance and refurbishment;
(g) the presence of substances of concern;
(h) energy use and energy efficiency;
(i) water use and water efficiency;
(j) resource use and resource efficiency;
(k) recycled content;
(l) the possibility of remanufacturing;
(m) recyclability;
(n) the possibility of the recovery of materials;
(o) environmental impacts, including carbon footprint and environmental footprint;
(p) expected generation of waste.
What products are the priorities for what is yet to come?
(a) iron and steel;
(b) aluminium;
(c) textiles, in particular garments and footwear;
(d) furniture, including mattresses;
(e) tyres;
(f) detergents;
(g) paints;
(h) lubricants;
(i) chemicals;
(j) energy related products;
(k) information and communication technology products and other electronics.
What is the Ecodesign for Sustainable Products Regulation (ESPR)?
The ESPR regulation supersedes the current EU ecodesign directive (2009/125/EC) and introduces additional ecodesign criteria applicable to a broader range of products sold on the EU market. Broadly speaking it says that all products should be designed for extended lifespans and be more easily repairable, upgradeable, and recyclable. This Regulation establishes a framework for the setting of ecodesign requirements that products have to comply with.
What products are covered by this regulation?
This Regulation applies to any physical goods that are placed on the market or put into service, including components and intermediate products.
What products are excluded?
Food; feed; medicinal products; living plants, animals and micro-organisms; products of human origin; products of plants and animals relating directly to their future reproduction; vehicles (but not including scooters and bicycles – these are included); items for defense.
From when does it apply?
This regulation entered into force on the 18th of July 2024 and enforcement will begin in 2 years from that date. However, if you are developing new product, now is the time to ensure you are aware of the requirements.
What are some of the requirements?
Product durability, reusability, upgradability and repairability, as well as the use of substances that inhibit circularity are mentioned. Additionally, it covers energy and resource efficiency, recycled content, remanufacturing and recycling, and the carbon and environmental footprints of products. This Regulation also establishes a ‘digital product passport’, provides for the setting of mandatory green public procurement requirements and creates a framework to prevent unsold consumer products from being destroyed. An EU declaration of conformity will also be needed for your product, along with CE marking. There are also a number of information requirements that must accompany a product.
What is a Digital Product Passport?
A 'Digital Product Passport' requires a QR code on a product that takes a consumer to information that enables them to make informed purchasing decisions by offering details about a product's environmental sustainability. It thereby allows consumers to access and compare information contained within these product passports.
What ‘unsold products’ can no longer be destroyed under this regulation?
The regulation imposes a direct ban on the destruction of unsold textiles and footwear, which will take effect two years after enactment. Small and micro companies are exempt, while medium-sized companies have a six-year exemption. It also authorizes the Commission to introduce similar bans for other products in the future. From 19 July 2030, medium sized enterprizes that discard unsold consumer products directly or have unsold consumer products discarded on their behalf must disclose the amount, the reason and any recovery actions taken annually on their websites.
What is ‘ecodesign’?
The regulation defines ecodesign as “the integration of environmental sustainability considerations into the characteristics of a product and the processes taking place throughout the product’s value chain”
What ecodesign requirements will be implemented?
Further detailed requirements will be adopted going forward to improve the following product aspects:
(a) durability;
(b) reliability;
(c) reusability;
(d) upgradability;
(e) repairability;
(f) the possibility of maintenance and refurbishment;
(g) the presence of substances of concern;
(h) energy use and energy efficiency;
(i) water use and water efficiency;
(j) resource use and resource efficiency;
(k) recycled content;
(l) the possibility of remanufacturing;
(m) recyclability;
(n) the possibility of the recovery of materials;
(o) environmental impacts, including carbon footprint and environmental footprint;
(p) expected generation of waste.
What products are the priorities for what is yet to come?
(a) iron and steel;
(b) aluminium;
(c) textiles, in particular garments and footwear;
(d) furniture, including mattresses;
(e) tyres;
(f) detergents;
(g) paints;
(h) lubricants;
(i) chemicals;
(j) energy related products;
(k) information and communication technology products and other electronics.
Deforestation Regulation (EUDR)
2025-06-10
EU 2023/1115
What is the EUDR?
The European Union Deforestation Regulation is a mandatory law designed to ensure that specific products placed on, made available on, or exported from the EU market are not contributing to global deforestation or forest degradation.
Who does it affect?
For developers, manufacturers and importers whose products use 'in-scope' commodities, preparing your supply chain and documentation is essential for continued market access.
What Products and Commodities are in Scope?
The regulation applies to seven key commodities and a wide range of derivative products made from them (listed under specific CN/HS codes in Annex I).
Commodities include: Cattle, Cocoa, Coffee, Oil Palm, Rubber, Soy, and Wood.
Examples of Derived Products include: Beef, leather, chocolate, furniture, certain printed paper products such as books and magazines, palm oil derivatives used in various consumer goods, and rubber-based products like tyres and gloves.
Are the packaging and the user instructions of my product included?
Packaging used exclusively to protect or carry another product is generally not covered by the EUDR. This includes things like: The cardboard box a consumer product is shipped in. Wooden pallets or crates used for transport, as long as they are not the product being sold. Packaging in a closed-loop system (e.g., reusable pallets). User manuals, assembly instructions, or warranty cards that simply accompany the main product shipment are typically not covered by the EUDR, as they are not the primary product being placed on the market.
When Does It Take Effect?
The regulation entered into force in June 2023, but the main compliance deadlines for mandatory due diligence are phased:
These above dates are currently under review and it is possible that they will be moved out by 1 year. Check the European Commission's official pages for the definitive final application dates
For an enterprise to be considered small it must satisfy 2 of these 3 requirements:
What are the Key Compliance Requirements?
Check if any component or material in your product is derived from one of these seven commodities.
To be compliant, your product must meet three strict conditions, which you must prove through a rigorous Due Diligence System:
Deforestation-Free: The product must have been produced on land that was not deforested or subject to forest degradation after 31 December 2020.
Legal Production: The product must have been produced in accordance with all relevant laws of the country of production (including land use rights, labour laws, environmental protection, etc.).
Covered by a Due Diligence Statement (DDS): A formal declaration must be submitted to the EU's Information System (TRACES NT) before the product can be placed on the EU market or exported from it. Note that this submission is waived for small or micro-operator processing a product already covered by DDS. They only need to collect the reference number of the already-submitted DDS from their supplier.
What is the Mandatory Due Diligence System?
Operators (the company first placing the product on the EU market or exporting it) must establish and implement a formal three-step Due Diligence System.
Step 1. Information Collection
Collect, verify, and store information for at least five years, including: Product description (including HS/CN code). Quantity (net mass/volume). Country of production. Geolocation coordinates (latitude and longitude) of the plots of land where the commodity was produced or harvested. Date or time range of production/harvest. Supplier and recipient details. Evidence of legal production.
Step 2. Risk Assessment
Use the collected information to assess the risk of non-compliance (deforestation or illegality). Factors to consider include:
Step 3. Risk Mitigation
If the risk is assessed as not negligible, you must take action to reduce it to a negligible level. This may involve:
The EUDR also introduces a crucial country benchmarking system that classifies countries, or parts thereof, into three risk categories, low, standard, and high, based on their association with deforestation and forest degradation linked to seven key commodities. For countries classified as low risk, operators can implement a simplified due diligence procedure, exempting them from the full risk assessment and mitigation steps, though they must still collect all essential information like geolocation data and submit a Due Diligence Statement.
EU 2023/1115
What is the EUDR?
The European Union Deforestation Regulation is a mandatory law designed to ensure that specific products placed on, made available on, or exported from the EU market are not contributing to global deforestation or forest degradation.
Who does it affect?
For developers, manufacturers and importers whose products use 'in-scope' commodities, preparing your supply chain and documentation is essential for continued market access.
What Products and Commodities are in Scope?
The regulation applies to seven key commodities and a wide range of derivative products made from them (listed under specific CN/HS codes in Annex I).
Commodities include: Cattle, Cocoa, Coffee, Oil Palm, Rubber, Soy, and Wood.
Examples of Derived Products include: Beef, leather, chocolate, furniture, certain printed paper products such as books and magazines, palm oil derivatives used in various consumer goods, and rubber-based products like tyres and gloves.
Are the packaging and the user instructions of my product included?
Packaging used exclusively to protect or carry another product is generally not covered by the EUDR. This includes things like: The cardboard box a consumer product is shipped in. Wooden pallets or crates used for transport, as long as they are not the product being sold. Packaging in a closed-loop system (e.g., reusable pallets). User manuals, assembly instructions, or warranty cards that simply accompany the main product shipment are typically not covered by the EUDR, as they are not the primary product being placed on the market.
When Does It Take Effect?
The regulation entered into force in June 2023, but the main compliance deadlines for mandatory due diligence are phased:
- Large and Medium Enterprises: 30 December 2026
- Small and Micro Enterprises: 30 June 2027
These above dates are currently under review and it is possible that they will be moved out by 1 year. Check the European Commission's official pages for the definitive final application dates
For an enterprise to be considered small it must satisfy 2 of these 3 requirements:
- Staff Headcount <50
- Annual Global Turnover ≤€10 million
- Annual Global Balance Sheet Total ≤€10 million
What are the Key Compliance Requirements?
Check if any component or material in your product is derived from one of these seven commodities.
To be compliant, your product must meet three strict conditions, which you must prove through a rigorous Due Diligence System:
Deforestation-Free: The product must have been produced on land that was not deforested or subject to forest degradation after 31 December 2020.
Legal Production: The product must have been produced in accordance with all relevant laws of the country of production (including land use rights, labour laws, environmental protection, etc.).
Covered by a Due Diligence Statement (DDS): A formal declaration must be submitted to the EU's Information System (TRACES NT) before the product can be placed on the EU market or exported from it. Note that this submission is waived for small or micro-operator processing a product already covered by DDS. They only need to collect the reference number of the already-submitted DDS from their supplier.
What is the Mandatory Due Diligence System?
Operators (the company first placing the product on the EU market or exporting it) must establish and implement a formal three-step Due Diligence System.
Step 1. Information Collection
Collect, verify, and store information for at least five years, including: Product description (including HS/CN code). Quantity (net mass/volume). Country of production. Geolocation coordinates (latitude and longitude) of the plots of land where the commodity was produced or harvested. Date or time range of production/harvest. Supplier and recipient details. Evidence of legal production.
Step 2. Risk Assessment
Use the collected information to assess the risk of non-compliance (deforestation or illegality). Factors to consider include:
- Country-level risk (to be benchmarked by the EU Commission).
- Supply chain complexity.
- Proximity of the land to protected areas.
- Substantiated concerns about supplier compliance.
Step 3. Risk Mitigation
If the risk is assessed as not negligible, you must take action to reduce it to a negligible level. This may involve:
- Implementing on-site audits or field inspections.
- Switching to more compliant suppliers.
- Using satellite monitoring for verification.
- Contractual clauses with suppliers.
The EUDR also introduces a crucial country benchmarking system that classifies countries, or parts thereof, into three risk categories, low, standard, and high, based on their association with deforestation and forest degradation linked to seven key commodities. For countries classified as low risk, operators can implement a simplified due diligence procedure, exempting them from the full risk assessment and mitigation steps, though they must still collect all essential information like geolocation data and submit a Due Diligence Statement.
Packaging and Packaging Waste Regulation (PPWR)
2025-02-11
This regulation (EU 2025/40) aims to minimize packaging waste, improve recycling rates, and reduce environmental impact. Non-compliant packaging could result in restricted market access or penalties—so taking action now is crucial.
What Does This Regulation Apply To?
The new rules apply to all packaging and packaging waste of products placed on the European market, including product packaging, some shipping materials, and retail packaging. Note that reusable packaging is not classified as waste. Waste refers to packaging that is not reusable.
When Does It Take Effect?
The new regulation officially applies from 12 August 2026, but compliance deadlines vary depending on specific requirements.
What are the Key Compliance Requirements?
1. Material Restrictions
2. Labeling & Information Requirements
3. Packaging Design Rules
4. Recyclability Requirements
5. Reusability of Packaging
6. Compostability Rules
7. Documentation Requirements
What Should You Do Next?
As a product developer selling in the EU, your packaging may require redesign to comply with these regulations. Don’t wait until the last minute, have a look at the below video on how to get started.
This regulation (EU 2025/40) aims to minimize packaging waste, improve recycling rates, and reduce environmental impact. Non-compliant packaging could result in restricted market access or penalties—so taking action now is crucial.
What Does This Regulation Apply To?
The new rules apply to all packaging and packaging waste of products placed on the European market, including product packaging, some shipping materials, and retail packaging. Note that reusable packaging is not classified as waste. Waste refers to packaging that is not reusable.
When Does It Take Effect?
The new regulation officially applies from 12 August 2026, but compliance deadlines vary depending on specific requirements.
What are the Key Compliance Requirements?
1. Material Restrictions
- The combined concentration of lead, cadmium, mercury, and hexavalent chromium in packaging must not exceed 100 mg/kg.
- Food-contact packaging cannot contain per- and polyfluorinated alkyl substances (PFAS) above specified limits.
- Plastic packaging must contain a minimum amount of recycled material (ranging from 10–35%, depending on the product) from 1 January 2030. These percentages will increase by 2040. (Exemptions apply to food-contact materials and plastic components under 5% of the total packaging weight.)
2. Labeling & Information Requirements
- Packaging must include a type, batch, or serial number for identification.
- Manufacturers must display their name, registered trade name, trademark, and contact details (postal address + electronic contact method, if available).
- From 12 August 2028, packaging must include a label specifying its material composition to aid recycling.
3. Packaging Design Rules
- By 1 January 2030, packaging must be optimized for minimal weight and volume, ensuring functionality while limiting empty space to 50% max.
4. Recyclability Requirements
- From 1 January 2030, all packaging must be recyclable (if not reusable) with a minimum 70% recycling performance grade.
- This percentage will increase in 2035 and 2038.
5. Reusability of Packaging
- From 12 February 2029, reusable packaging must include a label informing consumers of its reusability, with additional details accessible via a QR code or similar method.
6. Compostability Rules
- From 12 February 2028, certain items—such as fruit & vegetable stickers and tea/beverage bags—must be compostable.
7. Documentation Requirements
- Manufacturers must prepare an EU Declaration of Conformity and technical documentation for their packaging.
What Should You Do Next?
As a product developer selling in the EU, your packaging may require redesign to comply with these regulations. Don’t wait until the last minute, have a look at the below video on how to get started.
Battery Regulation
2024-07-10
(EU) 2023/1542
Is your organisation ready for the new EU battery regulation? If you are developing or manufacturing batteries, or products containing batteries, of any type, and are planning to sell that product in the EU, you need to prepare for a range of new mandatory safety and environmental requirements with enforcement dates that start in August 2024, with additional or increasing requirements being added incrementally over the next 12 years.
What are the regulations key objectives?
Are all batteries included?
Who is responsible for complying with this regulation?
What sort of battery requirements are included?
What is the timeline for new requirements? (refer to the regulation for full details, this list is not exhaustive)
(EU) 2023/1542
Is your organisation ready for the new EU battery regulation? If you are developing or manufacturing batteries, or products containing batteries, of any type, and are planning to sell that product in the EU, you need to prepare for a range of new mandatory safety and environmental requirements with enforcement dates that start in August 2024, with additional or increasing requirements being added incrementally over the next 12 years.
What are the regulations key objectives?
- Global demand for batteries is increasing rapidly and the new Batteries Regulation’s objective is to minimise the environmental impact of this exponential growth by bringing forward the circular economy and zero pollution ambitions of the EU
- The aim is to make batteries sustainable throughout their entire life cycle – from the sourcing of materials to their collection, recycling and repurposing
Are all batteries included?
- The only exceptions are batteries for military, space, and nuclear purposes
- Rechargeable and non-rechargeable batteries; cells, battery modules, and battery systems (including stationary systems) are all included
- The regulation divides batteries into the following categories:
- portable batteries - a battery that is sealed, weighs 5 kg or less, is not designed specifically for industrial use and doesn’t fit into one of the below categories
- starting, lighting and ignition batteries (SLI batteries) – that can also be used for auxiliary or backup purposes in vehicles, other means of transport or machinery
- light means of transport batteries (LMT batteries) - a battery that is sealed, weighs 25 kg or less and is specifically designed to provide electric power for the traction of wheeled vehicles but is not an EV battery
- electric vehicle batteries (EV batteries)
- industrial batteries – for industrial purposes or any other battery that weighs more than 5 kg and that is neither an electric vehicle battery, an LMT battery, nor an SLI battery
Who is responsible for complying with this regulation?
- The regulation specifies obligations of the product developer/manufacturer, importer and distributor of batteries and products containing batteries.
What sort of battery requirements are included?
- Requirements include safety performance and durability requirements as well as requirements for the detachability and replaceability of portable batteries and Light Means Transport (LMT) batteries, substance restriction and labelling. Carbon footprinting and battery passports come later for some battery types.
What is the timeline for new requirements? (refer to the regulation for full details, this list is not exhaustive)
Further Reading:
How to transport lithium batteries
Reese's Law for Button or Coin Cell Batteries (USA)
CPSC eFiling mandate (2026) (USA)
SB 1215 (2022) Embedded Battery Compliance (California)
AB 2440 Responsible Battery Recycling Act (California)
ACCC Button Cell Battery Instruments (Australia)
SB 244 Right to Repair Act (California)
General Product Safety Regulation (GPSR)
2024-07-16
(EU) 2023/988
What products does it cover?
The General Product Safety Regulation covers non-food consumer products (as opposed to industrial products) that are not covered in other EU product legislation, or where certain aspects of a product are not covered by other legislation, and includes products sold through all sales channels. This Regulation includes digital products and products that could be used by consumers even though that may not be the intention.
What products are excluded?
When does it come into effect?
On 13 December 2024 it will replace the current General Product Safety Directive and the Food Imitating Product Directive
What are its objectives?
What is new?
Being a regulation rather than a directive means that this imposes clear and detailed rules without risks of divergent transposition by Member States.
Some specific new requirements include (this is not an exhaustive list, refer to the regulation for further detail):
How should you prepare as a product development business?
4. Have a plan in place for reporting to the EU Safety Business Gateway and carrying out a product recall
See all:
(EU) 2023/988
What products does it cover?
The General Product Safety Regulation covers non-food consumer products (as opposed to industrial products) that are not covered in other EU product legislation, or where certain aspects of a product are not covered by other legislation, and includes products sold through all sales channels. This Regulation includes digital products and products that could be used by consumers even though that may not be the intention.
What products are excluded?
- medicinal products
- food and feed
- living plants and animals, genetically modified (micro)organisms and products of plants and animals relating directly to their future reproduction
- animal by-products and derived products
- plant protection products
- equipment on which consumers ride or travel but are not operated by the consumers themselves
- various aircraft
- antiques
When does it come into effect?
On 13 December 2024 it will replace the current General Product Safety Directive and the Food Imitating Product Directive
What are its objectives?
- To ensure products remain safe throughout their lifespan
- To protect consumers shopping online and provide extra protection from dangerous products imported from outside of the EU
- To ensure recalls of dangerous products are more effective
What is new?
Being a regulation rather than a directive means that this imposes clear and detailed rules without risks of divergent transposition by Member States.
Some specific new requirements include (this is not an exhaustive list, refer to the regulation for further detail):
- There must be a named responsible economic operator present in the EU for all non-harmonised products sold on or off line, to act as a contact point for consumers and market surveillance authorities.
- There are additional product labelling requirements eg. the e-mail or website address of the manufacturer must be present on the product; the name, postal and electronic address of the responsible economic operator present in the EU must also be present
- There is more specificity around risk analysis which must be carried out for all products (eg, considerations for cyber security and risks to physical, mental and social well-being)
- Technical documentation is required to be maintained for all products
- There are new specific product safety obligations for both economic operators and providers of online marketplaces
- There are clearer requirements relating to incident reporting and recalls
How should you prepare as a product development business?
- Ensure you have an adequate risk analysis procedure in place and that you have carried out a risk analysis for all products to be sold in the EU
- Ensure the following procedures are in place and current (to mitigate the risk of product recalls):
- Product Design Validation Procedures
- Product Control and Quality Plans and Procedures
- Complaints/feedback System
- Corrective and Preventative Action Procedure
- Appropriate Procurement Procedures and Supplier Agreements
4. Have a plan in place for reporting to the EU Safety Business Gateway and carrying out a product recall
See all:
Product Liability Directive (PLD 2024)
2025-10-07
Directive (EU) 2024/2853 (New PLD)
What is it?
The new EU Product Liability Directive modernises the EU's strict liability regime, ensuring that consumers who suffer damage from a defective product can claim compensation without having to prove the fault, or negligence of the manufacturer. Its primary goal is to adapt liability rules to the digital age, the circular economy, and global value chains.
Who Does It Affect?
The Directive affects a wider range of economic operators than the previous rules, with the core aim of ensuring there is always an EU-based entity that can be held liable.
Liable parties now explicitly include:
What Counts as a 'Product' and What is 'Defective'?
The scope of what constitutes a 'product' has been significantly broadened.
When Does It Take Effect?
The new Directive entered into force in December 2024. However, Member States have a period to integrate it into their national laws. The new rules will apply to products placed on the market from 9 December 2026 onwards. Products placed on the market before this date remain subject to the old 1985 Directive.
What are the Key Changes that Relate to Injured Parties?
The Directive introduces major changes to lower the burden of proof for claimants, particularly in complex digital or scientific cases.
Damage
Previous Regime (1985 Directive): Physical injury, death, and property damage (subject to a EUR500 threshold).
New PLD (2024/2853): Includes medically recognised psychological damage and the destruction or corruption of data (non-professional use). The EUR500 minimum threshold for property damage is removed.
Burden of Proof
Previous Regime (1985 Directive): Claimant must prove the defect, the damage, and the causal link between them.
New PLD (2024/2853): The new law makes it easier for a person to prove their case in court, even without perfect evidence. The court will now assume the product was defective, or that the defect caused the injury, if:
Evidence Disclosure
Previous Regime (1985 Directive): No explicit harmonised right to disclosure.
New PLD (2024/2853): Courts can order the disclosure of relevant evidence from the defendant to the claimant, provided the claim is plausible and the request is necessary and proportionate.
Limitation Period
Previous Regime (1985 Directive): 10 years "long-stop" from when the product was placed on the market.
New PLD (2024/2853): Extends the "long-stop" to 25 years in cases of latent personal injury where the injury only becomes apparent after the standard 10-year period has expired.
What Does It Mean for My Product Business?
This change significantly increases the risk and liability for companies that place products on the EU market, especially those involving software, AI, or advanced technology.
What Should I Be Doing in Light of These Changes?
You need to shift from a reactive to a proactive approach in how you design, document, and defend your products.
Directive (EU) 2024/2853 (New PLD)
What is it?
The new EU Product Liability Directive modernises the EU's strict liability regime, ensuring that consumers who suffer damage from a defective product can claim compensation without having to prove the fault, or negligence of the manufacturer. Its primary goal is to adapt liability rules to the digital age, the circular economy, and global value chains.
Who Does It Affect?
The Directive affects a wider range of economic operators than the previous rules, with the core aim of ensuring there is always an EU-based entity that can be held liable.
Liable parties now explicitly include:
- Manufacturers (or "quasi-manufacturers" who brand a product).
- Developers or Producers of Software and AI systems.
- Importers placing a product onto the EU market.
- Authorised Representatives of non-EU manufacturers.
- Fulfilment Service Providers (under subsidiary liability, if no importer or authorised representative exists).
- Online Platforms (in specific circumstances where the platform appears to be the provider).
- Any entity that substantially modifies a product (e.g., through remanufacturing) and places it on the market.
What Counts as a 'Product' and What is 'Defective'?
The scope of what constitutes a 'product' has been significantly broadened.
- Product Definition: Now also explicitly covers software (including operating systems, firmware, applications, and AI systems), digital manufacturing files (e.g., for 3D printing), raw materials, components, and electricity. It also covers related services (integrated digital services necessary for a product to function, like a health monitoring service for a wearable device).
- Defectiveness: A product is defective if it does not provide the safety a person is entitled to expect. Courts must now specifically consider:
- Cybersecurity requirements and other mandatory safety laws.
- The effect of the product's ability to learn (e.g., an AI system acquiring new, unforeseen features).
- The time the manufacturer retains control over the product (e.g., via software updates), extending liability beyond the point of initial sale.
When Does It Take Effect?
The new Directive entered into force in December 2024. However, Member States have a period to integrate it into their national laws. The new rules will apply to products placed on the market from 9 December 2026 onwards. Products placed on the market before this date remain subject to the old 1985 Directive.
What are the Key Changes that Relate to Injured Parties?
The Directive introduces major changes to lower the burden of proof for claimants, particularly in complex digital or scientific cases.
Damage
Previous Regime (1985 Directive): Physical injury, death, and property damage (subject to a EUR500 threshold).
New PLD (2024/2853): Includes medically recognised psychological damage and the destruction or corruption of data (non-professional use). The EUR500 minimum threshold for property damage is removed.
Burden of Proof
Previous Regime (1985 Directive): Claimant must prove the defect, the damage, and the causal link between them.
New PLD (2024/2853): The new law makes it easier for a person to prove their case in court, even without perfect evidence. The court will now assume the product was defective, or that the defect caused the injury, if:
- The case is so complex (like with advanced AI or tech products) that it's extremely hard for the injured person to find proof.
- The company that made the product refuses to hand over important evidence that the court asked for.
Evidence Disclosure
Previous Regime (1985 Directive): No explicit harmonised right to disclosure.
New PLD (2024/2853): Courts can order the disclosure of relevant evidence from the defendant to the claimant, provided the claim is plausible and the request is necessary and proportionate.
Limitation Period
Previous Regime (1985 Directive): 10 years "long-stop" from when the product was placed on the market.
New PLD (2024/2853): Extends the "long-stop" to 25 years in cases of latent personal injury where the injury only becomes apparent after the standard 10-year period has expired.
What Does It Mean for My Product Business?
This change significantly increases the risk and liability for companies that place products on the EU market, especially those involving software, AI, or advanced technology.
- Your Burden of Proof is Higher: In a complex case, an injured person no longer has to do all the heavy lifting to prove the defect. The court can assume your product was defective, and you must then provide clear, strong evidence to disprove that assumption.
- Software is Now a "Product": The new rules explicitly cover standalone software, AI systems, and digital manufacturing files. This means software developers and AI providers now face the same strict liability as makers of physical goods.
- New Reasons for a Defect: A product can now be considered defective if you fail to provide necessary security updates, if it has a weak cybersecurity defence, or if an AI system's self-learning behaviour leads to harm.
- Evidence is Crucial: If a court thinks you have relevant internal documents or data, they can order you to disclose that evidence. Refusing to hand it over can lead directly to the court assuming the product was defective.
What Should I Be Doing in Light of These Changes?
You need to shift from a reactive to a proactive approach in how you design, document, and defend your products.
- Product Design
- Documentation
- Supply Chain
- Legal Preparedness
- Compliance
Construction Products Regulation (CPR)
2025-10-15
What is the New Construction Products Regulation (CPR)?
The Construction Products Regulation (CPR) sets harmonised rules for placing construction products on the EU Market. The new CPR (Regulation (EU) 2024/3110) modernises the existing framework (Regulation (EU) No 305/2011) by placing a strong emphasis on sustainability, digitalisation, and market surveillance, making it a key element of the EU's Green Deal.
What is Classified as a Construction Product?
"Any formed or formless physical item, including -printed products, or a kit that is produced and placed on the market... for incorporation in a permanent manner in construction works or parts thereof, and the performance of which has an effect on the performance of the construction works with respect to the basic requirements for construction works."
Construction Works includes both buildings (like houses, offices, and factories) and civil engineering works (like bridges, roads, and dams).
Excluded are:
Who Does It Affect?
The regulation affects all economic operators in the construction product supply chain, including:
Note that micro-enterprises (having fewer than 10 employees and an annual turnover or balance sheet total of less than EUR2 million) benefit from simplified procedures for the product assessment process.
What are the Key Changes and Requirements?
The new CPR introduces fundamental shifts in product information, environmental reporting, and market access:
1. Environmental Sustainability
The CPR significantly expands beyond traditional safety and technical performance to include new essential requirements related to environmental sustainability.
2. Digital Product Passport (DPP)
One of the most significant changes is the introduction of the Digital Product Passport (DPP).
3. CE Marking
The CE marking remains the product's "passport" for the EU market, but its meaning is expanded. The CE marking now indicates conformity with both technical performance and environmental sustainability requirements as outlined in the new CPR.
What is the Timeline for Application?
The application of different provisions is phased:
What Should You Do Now?
To prepare for compliance and maintain market access, companies should take proactive steps:
What is the New Construction Products Regulation (CPR)?
The Construction Products Regulation (CPR) sets harmonised rules for placing construction products on the EU Market. The new CPR (Regulation (EU) 2024/3110) modernises the existing framework (Regulation (EU) No 305/2011) by placing a strong emphasis on sustainability, digitalisation, and market surveillance, making it a key element of the EU's Green Deal.
What is Classified as a Construction Product?
"Any formed or formless physical item, including -printed products, or a kit that is produced and placed on the market... for incorporation in a permanent manner in construction works or parts thereof, and the performance of which has an effect on the performance of the construction works with respect to the basic requirements for construction works."
Construction Works includes both buildings (like houses, offices, and factories) and civil engineering works (like bridges, roads, and dams).
Excluded are:
- Individually Manufactured or Custom-Made Products
- Heritage Products
Who Does It Affect?
The regulation affects all economic operators in the construction product supply chain, including:
- Manufacturers: Primarily responsible for the product's compliance.
- Importers and Distributors: Must ensure products bear the CE marking and are accompanied by the required documentation.
- Fulfilment Service Providers and Online Marketplace Operators: Now subject to specific obligations for the first time.
Note that micro-enterprises (having fewer than 10 employees and an annual turnover or balance sheet total of less than EUR2 million) benefit from simplified procedures for the product assessment process.
What are the Key Changes and Requirements?
The new CPR introduces fundamental shifts in product information, environmental reporting, and market access:
1. Environmental Sustainability
The CPR significantly expands beyond traditional safety and technical performance to include new essential requirements related to environmental sustainability.
- Mandatory Environmental Reporting: Manufacturers will be required to declare and report on the environmental performance of their products, initially focusing on climate change impacts (e.g., CO2 emissions and energy consumption) over the product's lifecycle.
- Expanded Scope of the Declaration of Performance (DoP): The DoP must now incorporate this environmental data, aligning with standards like EN 15804 (which defines rules for Environmental Product Declarations - EPDs).
- Future Requirements: The Commission is empowered to define additional product requirements on durability, repairability, and recyclability through delegated acts for specific product families.
2. Digital Product Passport (DPP)
One of the most significant changes is the introduction of the Digital Product Passport (DPP).
- The DPP is an electronic record that will store and provide access to all the product-specific information required by the CPR (including the Declaration of Performance and environmental data).
- The information will be accessible via a data carrier (like a QR code or RFID tag) affixed to the product or its packaging alongside the CE marking.
- It aims to enhance transparency, improve traceability throughout the value chain (from production to end-of-life), and facilitate market surveillance.
3. CE Marking
The CE marking remains the product's "passport" for the EU market, but its meaning is expanded. The CE marking now indicates conformity with both technical performance and environmental sustainability requirements as outlined in the new CPR.
What is the Timeline for Application?
The application of different provisions is phased:
- 8 January 2026 Most of the new regulatory articles become applicable (e.g., new operator obligations).
- Within 18 months of relevant delegated act the Digital Product Passport (DPP) becomes mandatory for the specific product category covered by the act. (Expect first delegated acts to be issued in the coming years).
- Two years after entry into force penalty provisions for non-compliance will become applicable.
- Ongoing (2025 onwards), harmonised product standards are gradually reviewed and updated. The old and new CPR regulations will coexist until all new standards are in place.
What Should You Do Now?
To prepare for compliance and maintain market access, companies should take proactive steps:
- Review your Product Portfolio: Determine which products fall under harmonised technical specifications and assess your current DoP and CE marking compliance.
- Begin Environmental Data Collection: Start calculating and collecting the necessary life-cycle environmental data, especially CO2 emissions and energy consumption, aligned with EN 15804. This data is the foundation for the new environmental DoP and the DPP.
- Plan for Digital Product Passport: Begin planning the required data infrastructure and carrier solution (e.g., QR codes, data management systems) to store and provide access to the DPP information seamlessly.
- Ensure your compliance, product development, sustainability, and legal teams are aligned and trained on the new requirements and their staggered application.
Persistent Organic Pollutants Regulation (POPs)
2025-03-13
(EU) 2019/1021
Many consumer products have been recalled in Europe in recent months do to non-compliance with the EU POPs Regulation. Many of these for containing SCCPs.
What are POPs?
POPs (Persistent organic pollutants), are substances that persist in the environment and accumulate in living organisms, posing a risk to our health.
How are they regulated?
POPs are regulated globally by the Stockholm Convention and the Aarhus Protocol. These treaties are implemented in the EU by the POPs Regulation.
What does the regulation do?
The Regulation prohibits or severely restricts the production, the placing on the market and use of POPs. The use of around 30 different substances and their derivatives or salts are prohibited.
Could there be POPs in my products?
This is a list of some of the most commonly found POPs and in what products they can often be found:
Polychlorinated Biphenyls (PCBs)
Older transformers, capacitors, industrial oils, hydraulic fluids, some paints, sealants, adhesives
Polybrominated Diphenyl Ethers (PBDEs) (DecaBDE, PentaBDE, OctaBDE)
Electronics (circuit boards, casings), upholstered furniture, mattresses, car seats, textiles, children’s toys
Hexabromocyclododecane (HBCDD)
Insulation foams, building materials, upholstered furniture, textiles, automotive parts
Short-Chain Chlorinated Paraffins (SCCPs)
PVC cables, wiring insulation, electronic casings, lubricants, adhesives, industrial metalworking fluids
Perfluorooctane Sulfonic Acid (PFOS) & Perfluorooctanoic Acid (PFOA)
Stain-resistant and waterproof textiles, non-stick cookware, food packaging (fast-food wrappers, popcorn bags), firefighting foams, coatings
Per- and polyfluoroalkyl substances (PFAS, broader group)
Cosmetics (waterproof mascaras, eyeliners), automotive coatings, food packaging, firefighting foams
Pentachlorophenol (PCP)
Wood preservatives, treated lumber, agricultural pesticides (historically used)
Lindane, Chlordane, DDT, Mirex (Legacy Pesticides)
Insecticides, termite treatments, soil and grain treatments (historical use, some legacy contamination)
How is this regulation being enforced?
In recent months there have been a spate of product recalls across Europe related to POPs. The most common of these has been from the use of SCCPs (short-chain chlorinated paraffins) in everything from electronic cables such as USB cables, toys and children’s products, stationery and sports equipment and games.
What other countries have regulations around POPs?
Most other countries have regulations that include bans or restrictions on POPs.
What should I be doing?
Make sure your supply chain is aware of these bans, and for any soft plastics you have on your products, ensure you or your supplier has tested them for SCCPs.
(EU) 2019/1021
Many consumer products have been recalled in Europe in recent months do to non-compliance with the EU POPs Regulation. Many of these for containing SCCPs.
What are POPs?
POPs (Persistent organic pollutants), are substances that persist in the environment and accumulate in living organisms, posing a risk to our health.
How are they regulated?
POPs are regulated globally by the Stockholm Convention and the Aarhus Protocol. These treaties are implemented in the EU by the POPs Regulation.
What does the regulation do?
The Regulation prohibits or severely restricts the production, the placing on the market and use of POPs. The use of around 30 different substances and their derivatives or salts are prohibited.
Could there be POPs in my products?
This is a list of some of the most commonly found POPs and in what products they can often be found:
Polychlorinated Biphenyls (PCBs)
Older transformers, capacitors, industrial oils, hydraulic fluids, some paints, sealants, adhesives
Polybrominated Diphenyl Ethers (PBDEs) (DecaBDE, PentaBDE, OctaBDE)
Electronics (circuit boards, casings), upholstered furniture, mattresses, car seats, textiles, children’s toys
Hexabromocyclododecane (HBCDD)
Insulation foams, building materials, upholstered furniture, textiles, automotive parts
Short-Chain Chlorinated Paraffins (SCCPs)
PVC cables, wiring insulation, electronic casings, lubricants, adhesives, industrial metalworking fluids
Perfluorooctane Sulfonic Acid (PFOS) & Perfluorooctanoic Acid (PFOA)
Stain-resistant and waterproof textiles, non-stick cookware, food packaging (fast-food wrappers, popcorn bags), firefighting foams, coatings
Per- and polyfluoroalkyl substances (PFAS, broader group)
Cosmetics (waterproof mascaras, eyeliners), automotive coatings, food packaging, firefighting foams
Pentachlorophenol (PCP)
Wood preservatives, treated lumber, agricultural pesticides (historically used)
Lindane, Chlordane, DDT, Mirex (Legacy Pesticides)
Insecticides, termite treatments, soil and grain treatments (historical use, some legacy contamination)
How is this regulation being enforced?
In recent months there have been a spate of product recalls across Europe related to POPs. The most common of these has been from the use of SCCPs (short-chain chlorinated paraffins) in everything from electronic cables such as USB cables, toys and children’s products, stationery and sports equipment and games.
What other countries have regulations around POPs?
Most other countries have regulations that include bans or restrictions on POPs.
What should I be doing?
Make sure your supply chain is aware of these bans, and for any soft plastics you have on your products, ensure you or your supplier has tested them for SCCPs.
Restriction of Hazardous Substances (RoHS)
2025-01-27
2011/65/EU
What is RoHS?
RoHS stands for Restriction of Hazardous Substances. It is a European directive that restricts the use of certain hazardous materials in electrical and electronic equipment (EEE).
What is its objective?
The goal of RoHS is to reduce environmental and health risks associated with various substances, particularly during the production, recycling, and disposal processes of electronic devices.
What products need to comply with RoHS?
RoHS applies to almost all electronic and electrical equipment, including household appliances, IT equipment, lighting, toys and medical devices with some specific exclusions. The restrictions therefore also apply to all materials or components that will be used in EEE products.
What does RoHS restrict?
RoHS limits the use of the following hazardous materials in electronic products:
What are the concentration limits?
The maximum allowable concentration of these substances in each material is:
Does it only apply to the EU?
The UK RoHS requirements mirror those of the EU. China and India have similar regulations.
How do I comply?
Key requirements include ensuring each of the materials in your EEE meet the requirements, create your technical documentation, create your EU declaration of conformity and affix a CE mark to your EEE product.
If I supply components or materials for EEE products, what are my obligations?
If your customers are selling their products into countries with RoHS regulations, they will need to ensure all of the materials they use comply. Therefore they will likely ask you for test certificates or declarations before they purchase from you. They could also choose to test your materials themselves. If you are placing your components directly onto the EU market or a market with RoHS requirements, and they are very obviously components for EEE (such as cables) then they need to comply with RoHS although they will not necessarily need a CE mark.
2011/65/EU
What is RoHS?
RoHS stands for Restriction of Hazardous Substances. It is a European directive that restricts the use of certain hazardous materials in electrical and electronic equipment (EEE).
What is its objective?
The goal of RoHS is to reduce environmental and health risks associated with various substances, particularly during the production, recycling, and disposal processes of electronic devices.
What products need to comply with RoHS?
RoHS applies to almost all electronic and electrical equipment, including household appliances, IT equipment, lighting, toys and medical devices with some specific exclusions. The restrictions therefore also apply to all materials or components that will be used in EEE products.
What does RoHS restrict?
RoHS limits the use of the following hazardous materials in electronic products:
- Lead (Pb)
- Mercury (Hg)
- Cadmium (Cd)
- Hexavalent chromium (Cr⁶⁺)
- Polybrominated biphenyls (PBBs)
- Polybrominated diphenyl ethers (PBDEs)
- Four phthalates (DEHP, BBP, DBP, and DIBP)
What are the concentration limits?
The maximum allowable concentration of these substances in each material is:
- 0.1% (1,000 ppm) for all substances except cadmium.
- 0.01% (100 ppm) for cadmium.
Does it only apply to the EU?
The UK RoHS requirements mirror those of the EU. China and India have similar regulations.
How do I comply?
Key requirements include ensuring each of the materials in your EEE meet the requirements, create your technical documentation, create your EU declaration of conformity and affix a CE mark to your EEE product.
If I supply components or materials for EEE products, what are my obligations?
If your customers are selling their products into countries with RoHS regulations, they will need to ensure all of the materials they use comply. Therefore they will likely ask you for test certificates or declarations before they purchase from you. They could also choose to test your materials themselves. If you are placing your components directly onto the EU market or a market with RoHS requirements, and they are very obviously components for EEE (such as cables) then they need to comply with RoHS although they will not necessarily need a CE mark.
General Data Protection Regulation (GDPR)
2024-08-12
EU 2016/679
What is the GDPR?
The GDPR defines precise rules on the management of security incidents such as data breaches, the use and erasing of collected personal data, and the keeping of records relating to data processing activities.
When did the GDPR take effect?
The General Data Protection Regulation (GDPR), took effect on the 25th of May 2018, and last year (2023) there were over a billion euros in fines for breaches, demonstrating there is still some work to do to ensure that everyone is in compliance.
What are the rules around the reporting of data breaches?
The regulation requires that personal data breaches (this includes all personal data such as contact details) must be reported to the competent supervisory authority within 72 hours. Data subjects must also be notified. Violation of the duty to report data breaches, can be punished by fines of up to EUR 1 million or, in case of companies, of up to 2 % of the total global annual turnover of the preceding financial year, whichever is the higher.
What information am I obliged to provide when collecting personal data from subjects via my product or other means?
The identity of the controller and deputy controller of the data and their contact details, the purpose and categories of recipient, contact details of the data protection officer, the controller’s legitimate interests, any intention to transfer data to a third country or to an international organisation (and the Commission’s associated adequacy decision), how long the data will be stored, the data subjects’ rights to information, erasure, correction, restriction the right to revoke consent, the right to appeal to a supervisory authority and so forth. Additionally, the reasoning behind, and consequences of, any profiling activities that may be performed.
How long can personal data be held for?
Personal data must be held only for as long as it is necessary to carry out the purpose for which the data is processed. Once the data is no longer needed for the purpose for which it was collected, personal data must be deleted. If data subjects withdraw their consent to the use or processing of their personal data, organizations are obliged to delete the relevant information.
Under this regulation, when is it lawful to process personal data?
This is only lawful when at least one of the following criteria has been fulfilled:
The data subject is entitled to revoke their consent at any time. This process must be as simple as granting consent. The awarding of a contract, or provision of a service, may not be made dependent on the data subject’s consent, unless the data processing to which the data subject is to give his consent is required in order to fulfill the contract.
The processing of sensitive data is forbidden as a matter of principle unless the data subject’s consent has been obtained.
What are my requirements as a product development business in terms of protecting personal data?
The controller responsible for processing is required to take appropriate technical and organisational measures in order to ensure that personal data is processed in conformity with this regulation and must provide evidence that this is the case. A (documented) risk assessment is required.
EU 2016/679
What is the GDPR?
The GDPR defines precise rules on the management of security incidents such as data breaches, the use and erasing of collected personal data, and the keeping of records relating to data processing activities.
When did the GDPR take effect?
The General Data Protection Regulation (GDPR), took effect on the 25th of May 2018, and last year (2023) there were over a billion euros in fines for breaches, demonstrating there is still some work to do to ensure that everyone is in compliance.
What are the rules around the reporting of data breaches?
The regulation requires that personal data breaches (this includes all personal data such as contact details) must be reported to the competent supervisory authority within 72 hours. Data subjects must also be notified. Violation of the duty to report data breaches, can be punished by fines of up to EUR 1 million or, in case of companies, of up to 2 % of the total global annual turnover of the preceding financial year, whichever is the higher.
What information am I obliged to provide when collecting personal data from subjects via my product or other means?
The identity of the controller and deputy controller of the data and their contact details, the purpose and categories of recipient, contact details of the data protection officer, the controller’s legitimate interests, any intention to transfer data to a third country or to an international organisation (and the Commission’s associated adequacy decision), how long the data will be stored, the data subjects’ rights to information, erasure, correction, restriction the right to revoke consent, the right to appeal to a supervisory authority and so forth. Additionally, the reasoning behind, and consequences of, any profiling activities that may be performed.
How long can personal data be held for?
Personal data must be held only for as long as it is necessary to carry out the purpose for which the data is processed. Once the data is no longer needed for the purpose for which it was collected, personal data must be deleted. If data subjects withdraw their consent to the use or processing of their personal data, organizations are obliged to delete the relevant information.
Under this regulation, when is it lawful to process personal data?
This is only lawful when at least one of the following criteria has been fulfilled:
- consent has been obtained for one or more purposes (by someone over 16 years of age)
- processing is required on the basis of a contract (or pre-contractual measures)
- a legal basis is present OR
- processing personal data is necessitated by a legitimate interest of the controller or of a third party
The data subject is entitled to revoke their consent at any time. This process must be as simple as granting consent. The awarding of a contract, or provision of a service, may not be made dependent on the data subject’s consent, unless the data processing to which the data subject is to give his consent is required in order to fulfill the contract.
The processing of sensitive data is forbidden as a matter of principle unless the data subject’s consent has been obtained.
What are my requirements as a product development business in terms of protecting personal data?
The controller responsible for processing is required to take appropriate technical and organisational measures in order to ensure that personal data is processed in conformity with this regulation and must provide evidence that this is the case. A (documented) risk assessment is required.
Artificial Intelligence Act (AI Act)
2025-04-10
(EU) 2024/1689
What is the purpose of this new AI regulation?
To set clear, consistent rules for how AI systems are developed, used, and sold in the EU. The goal is to encourage human-centred, trustworthy AI while protecting people’s health, safety, rights, democracy, and the environment—and supporting innovation.
Who does this regulation apply to?
It applies to anyone who develops, sells, or uses AI systems or general-purpose AI models in the EU market.
What counts as an AI system?
An AI system is any machine-based system that uses data to make predictions, create content, give recommendations, or make decisions—on its own or with limited human input—and can adapt.
What types of AI are banned under this regulation?
The following AI uses are not allowed in the EU:
What is a high-risk AI system (subject to restrictions)?
High-risk AI systems are:
Systems built into products that are regulated in the EU, as a safety component and are required to undergo a 3rd party conformity assessment or are themselves regulated products that are required to undergo a 3rd party conformity assessment.
What kinds of AI are likely to be considered high-risk (subject to restrictions or other requirements)?
These AI systems could be high-risk if they can significantly harm people or unfairly influence decisions:
What do I need to do if I consider an AI system (that may be high-risk) to be not high-risk?
You’ll need to document your assessment before placing the system on the market or putting it into service. You'll also be subject to a registration obligation.
What are the requirements for a high-risk AI system?
What else does a provider need to do?
When do these rules apply?
The regulation’s main obligations apply from 2 August 2026.
However, prohibited AI practices must cease from 2 February 2025.
(EU) 2024/1689
What is the purpose of this new AI regulation?
To set clear, consistent rules for how AI systems are developed, used, and sold in the EU. The goal is to encourage human-centred, trustworthy AI while protecting people’s health, safety, rights, democracy, and the environment—and supporting innovation.
Who does this regulation apply to?
It applies to anyone who develops, sells, or uses AI systems or general-purpose AI models in the EU market.
What counts as an AI system?
An AI system is any machine-based system that uses data to make predictions, create content, give recommendations, or make decisions—on its own or with limited human input—and can adapt.
What types of AI are banned under this regulation?
The following AI uses are not allowed in the EU:
- Manipulative AI: AI that uses hidden or deceptive techniques to influence decisions in harmful ways.
- Exploiting vulnerabilities: AI that takes advantage of a person’s age, disability, or social/economic status to influence decisions in harmful ways.
- Social scoring: AI that ranks people based on behaviour or traits, leading to unfair treatment.
- Predicting crime: AI that judges whether someone might commit a crime based only on profiling or personality traits (except when supporting decisions based on verified facts).
- Mass facial recognition: AI that builds facial recognition databases by scraping the internet or CCTV footage.
- Emotion detection at work or school: AI that reads emotions in workplaces or education settings, unless it’s for medical or safety reasons.
- Biometric categorisation: AI that categorises people using sensitive data (like race or beliefs), unless it’s part of a lawful, specific dataset for law enforcement.
- Real-time biometric ID in public spaces by law enforcement, unless strictly necessary for things like searching for a missing child or preventing a terrorist threat.
What is a high-risk AI system (subject to restrictions)?
High-risk AI systems are:
Systems built into products that are regulated in the EU, as a safety component and are required to undergo a 3rd party conformity assessment or are themselves regulated products that are required to undergo a 3rd party conformity assessment.
What kinds of AI are likely to be considered high-risk (subject to restrictions or other requirements)?
These AI systems could be high-risk if they can significantly harm people or unfairly influence decisions:
- Biometric tech: Systems for identifying people remotely or categorising them based on sensitive traits.
- Emotion recognition: AI that detects emotions in people.
- Critical infrastructure: AI used to manage roads, electricity, water, gas, or digital systems.
- Education: AI used for admissions, evaluating students, guiding learning, or monitoring test conduct.
- Employment: AI used for hiring, promotions, firing, monitoring workers, or assigning tasks.
- Essential services: AI that decides access to public services like healthcare or financial support.
- Credit and insurance: AI used to assess credit scores or determine life/health insurance risk.
- Emergency response: AI used to assess emergency calls, triage patients, or dispatch services.
- Law enforcement: AI used to assess crime risk, detect lies, evaluate evidence, or create profiles.
- Migration and border control: AI used to assess risks, review visa/asylum applications, or identify people crossing borders.
- Justice system: AI used by judges to apply laws, assess evidence, or help resolve disputes.
- Elections: AI used to influence voting decisions or election outcomes.
What do I need to do if I consider an AI system (that may be high-risk) to be not high-risk?
You’ll need to document your assessment before placing the system on the market or putting it into service. You'll also be subject to a registration obligation.
What are the requirements for a high-risk AI system?
- A risk management system
- Data governance and management practices
- Technical documentation
- Specific record-keeping
- Transparency and provision of information to users
- Human oversight
- Accuracy, robustness, and cybersecurity throughout the system’s lifecycle
What else does a provider need to do?
- Indicate their trade name and address on the product, packaging, or accompanying documentation
- Have a quality management system in place
- Keep logs
- Undergo a conformity assessment procedure
- Draw up an EU declaration of conformity
- Affix the CE mark
- Register the product and authorised representative
- Appoint an authorised representative in the EU (if not established there already)
When do these rules apply?
The regulation’s main obligations apply from 2 August 2026.
However, prohibited AI practices must cease from 2 February 2025.
Cyber Resilience Act (CRA)
2026-05-26
Regulation (EU) 2024/2847
What is the purpose of the Cyber Resilience Act?
Who does this regulation apply to?
Any economic operator, specifically manufacturers, importers, and distributors, placing products with digital elements on the EU market
What counts as a product with digital elements?
Any software or hardware product, including its standalone components, whose intended purpose or reasonably foreseeable use includes a direct or indirect logical or physical data connection to a device or network
What digital functionality or products are exempt?
If I already comply with the Radio Equipment Directive (RED), am I covered?
When do these rules take effect for product businesses?
Does the EU Declaration of Conformity (DoC) need to physically accompany the product?
Is there a standard for the mandatory Risk Assessment?
Are there future updates or changes on the horizon?
See also:
Cyber Security Requirements under the Radio Equipment Directive (RED)
General Data Protection Regulation (GDPR)
Regulation (EU) 2024/2847
What is the purpose of the Cyber Resilience Act?
- To establish a unified, horizontal EU framework for the design, development, and production of products with digital components
- To legally mandate continuous post-market vulnerability handling, lifecycle monitoring, and security updates for these products
Who does this regulation apply to?
Any economic operator, specifically manufacturers, importers, and distributors, placing products with digital elements on the EU market
What counts as a product with digital elements?
Any software or hardware product, including its standalone components, whose intended purpose or reasonably foreseeable use includes a direct or indirect logical or physical data connection to a device or network
What digital functionality or products are exempt?
- Existing Sector Regulations: Digital elements built directly into medical devices, civil aviation systems, or type-approved automotive vehicles are exempt because they are covered by distinct safety laws
- True Cloud/SaaS Infrastructure: Purely cloud-based software or website backends are exempt from the CRA and fall instead under the organisational scope of the NIS2 Directive
- The Exception: Cloud software is in scope if it functions as a “remote data processing solution” designed by the manufacturer, the absence of which prevents the physical product or local app from performing its core functions
- Data Context: Functionality is never exempt based on data collection. Even if a local mobile app or connected device collects zero personal data, it is fully in scope because the law targets network/device security rather than data privacy
If I already comply with the Radio Equipment Directive (RED), am I covered?
- Only partially for core product engineering; it is not an automatic pass
- The CRA explicitly repeals and replaces the cybersecurity framework established under RED when full enforcement begins
- While existing technical security barriers (such as encrypted radio links under EN 18031) serve as an excellent design foundation, the CRA introduces new business and operational requirements not covered by the RED, including a Software Bill of Materials (SBOM) and mandatory active update support periods
When do these rules take effect for product businesses?
- Vulnerability & Incident Reporting: Manufacturers must ensure that a single point of contact for reporting vulnerabilities is publicly available and accessible to customers and researchers. The product must include instructions with a clear, dedicated point of contact for reporting and tracking cybersecurity vulnerabilities discovered in the product. — Prior to 11 September 2026
- Vulnerability & Incident Reporting: Manufacturers must report actively exploited product vulnerabilities or severe security incidents to ENISA within 24 hours. — 11 September 2026
- Full Enforcement & CE Mark: Products entering the market must have a completed risk assessment and technical file, an SBOM, a signed DoC, and display the CE mark. — 11 December 2027
Does the EU Declaration of Conformity (DoC) need to physically accompany the product?
- Yes, but businesses can meet this requirement through a digital alternative
- Manufacturers can either include the full DoC inside the packaging or provide a simplified single-sentence statement of conformity that links directly to an online URL where the full DoC is hosted
- For products subject to multiple CE-marking directives (e.g. RoHS, EMC, RED), a single, comprehensive EU Declaration of Conformity document must be created
Is there a standard for the mandatory Risk Assessment?
- Manufacturers must perform a documented cybersecurity risk assessment to map out foreseeable threats and integrate them into their technical documentation
- While specific “harmonised European CRA standards” are still undergoing final drafting by CEN/CENELEC, standard technical frameworks such as EN ISO/IEC 27005 (risk management) and IEC 62443-4-1 (secure lifecycle development) represent accepted criteria for building this risk matrix
Are there future updates or changes on the horizon?
- Open Source Guidance: The European Commission published finalised draft guidance regarding Free and Open-Source Software (FOSS) to clarify exactly when an open-source component transitions into a commercial activity subject to full CRA liability
- The Cybersecurity Act 2 Link: The European Commission introduced a proposed overhaul to the EU Cybersecurity Act (CSA). Once finalised, this update allows companies to use CSA organisational security certifications to satisfy parts of their product verification obligations, significantly simplifying third-party testing burdens
See also:
Cyber Security Requirements under the Radio Equipment Directive (RED)
General Data Protection Regulation (GDPR)
Waste Electrical and Electronic Equipment (WEEE) Directive
Last Updated: 2026-06-16
What is the WEEE Directive?
The Waste Electrical and Electronic Equipment (WEEE) Directive is an environmental regulation governing electrical and electronic products sold in the European Union. Similar requirements also apply in the United Kingdom through UK WEEE legislation.
Its purpose is to reduce electronic waste by encouraging the collection, recycling, recovery, and responsible disposal of products at the end of their life.
The regulation is based on the principle of Extended Producer Responsibility (EPR), which means businesses placing electrical or electronic products on the market are responsible for funding and managing their end-of-life collection and recycling.
For manufacturers, importers, and brand owners, WEEE creates obligations that extend beyond product launch and continue throughout the product’s lifecycle.
Which Products Are Covered?
WEEE applies to most products that require electricity or batteries to function.
This includes a wide range of electrical and electronic equipment such as:
If your product contains electrical or electronic components and is placed on the EU or UK market, it is likely to fall within scope.
Are Any Products Exempt?
A limited number of product categories are excluded, including:
Exemptions are narrow and should be assessed carefully on a case-by-case basis.
How WEEE Fits With Ecodesign (ESPR)
EU environmental regulation is increasingly structured around two distinct lifecycle phases: product design (upstream) and end-of-life management (downstream).
To avoid overlapping requirements, EU policy separates responsibilities across the product lifecycle.
ESPR (Ecodesign for Sustainable Products Regulation) governs the upstream phase (design and production).
It sets requirements before products are placed on the market, focusing on improving environmental performance through design. This includes:
In practical terms, ESPR is about how products are designed and built.
WEEE governs the downstream phase (end-of-life management).
WEEE does not regulate product design. Instead, it governs what happens once products become waste, including:
In practical terms, WEEE is about what happens after a product is discarded.
This separation is intentional and reflects the EU’s approach to avoid duplicating environmental requirements. Historically, WEEE included some design-related expectations, such as encouraging easier dismantling. This created overlap with ecodesign policy.
The current regulatory direction is to reduce duplication by:
The intent is to ensure manufacturers follow one consistent framework for product design (ESPR), while WEEE remains focused on end-of-life responsibility.
What is the Role of the Digital Product Passport?
A key convergence point between ESPR and WEEE is the Digital Product Passport (DPP).
WEEE already requires manufacturers to provide recyclers with information about product composition and hazardous substances. In practice, this information has often been difficult to access at end-of-life, particularly in mixed waste streams.
The Digital Product Passport, introduced under ESPR, addresses this by providing structured product data in a digital format, typically accessed via a QR code or similar data carrier on the product.
Over time, this is expected to support both frameworks:
This improves access to critical product information at end-of-life and reduces reliance on fragmented documentation.
What Do Manufacturers Need To Do?
If you place electrical or electronic products on the EU or UK market, WEEE obligations typically include:
Design for end-of-life recovery
While WEEE is not a design regulation, products should still consider end-of-life handling, including safe access to batteries, electronic assemblies, and materials that require separation during recycling.
Product marking requirements
Manufacturers may be required to provide recyclers with relevant information about product composition, materials, and hazardous substances to support safe treatment and recovery.
Registration, reporting, and financial responsibility
One of the most commonly misunderstood aspects of WEEE is who is responsible for compliance.
Under WEEE rules, the responsible entity is the “producer”, which is not always the manufacturer. It is the first party that places the product on the EU or UK market.
Depending on the supply chain, the producer may be:
If you manufacture outside the EU but sell through an importer or distributor, that EU-based entity is often legally responsible for registration, reporting, and payment of recycling fees.
However, contractual arrangements can shift financial responsibility between commercial parties, even though regulators will always identify a single legal “producer” in each jurisdiction.
Because of this, it is essential to clearly define:
Failure to clarify this allocation is one of the most common causes of non-compliance in cross-border supply chains.
How Do I Meet WEEE Obligations?
WEEE obligations are not demonstrated through a single declaration or certification. Instead, they require ongoing participation in national systems.
Compliance generally requires:
Requirements vary by country. For example, businesses operating across both the EU and the UK require separate registrations, as the UK operates an independent WEEE compliance regime post-Brexit.diction.
What Happens If You Do Not Comply?
Non-compliance can result in:
What Should Businesses Do Now?
If you are developing or selling electronic products in the EU or UK:
Early clarity on WEEE responsibility is critical. Most compliance issues arise not from lack of awareness, but from ambiguity in commercial supply chain arrangements.
Further Reading:
Ecodesign for Sustainable Products Regulation (ESPR)
Packaging and Packaging Waste Regulation (PPWR)
SB 54 The Plastic Pollution Prevention and Packaging Producer Responsibility Act (California)
What is the WEEE Directive?
The Waste Electrical and Electronic Equipment (WEEE) Directive is an environmental regulation governing electrical and electronic products sold in the European Union. Similar requirements also apply in the United Kingdom through UK WEEE legislation.
Its purpose is to reduce electronic waste by encouraging the collection, recycling, recovery, and responsible disposal of products at the end of their life.
The regulation is based on the principle of Extended Producer Responsibility (EPR), which means businesses placing electrical or electronic products on the market are responsible for funding and managing their end-of-life collection and recycling.
For manufacturers, importers, and brand owners, WEEE creates obligations that extend beyond product launch and continue throughout the product’s lifecycle.
Which Products Are Covered?
WEEE applies to most products that require electricity or batteries to function.
This includes a wide range of electrical and electronic equipment such as:
- Consumer electronics
- Household appliances
- IT and telecommunications equipment
- Lighting products
- Smart devices and IoT products
- Industrial and professional electrical equipment
- Products where electronics are a secondary feature (for example, connected toys or illuminated products)
If your product contains electrical or electronic components and is placed on the EU or UK market, it is likely to fall within scope.
Are Any Products Exempt?
A limited number of product categories are excluded, including:
- Military and security equipment
- Space-related equipment
- Certain large-scale fixed industrial installations
- Certain transport vehicles
- Specific non-road mobile machinery used in professional contexts
- Certain medical devices
Exemptions are narrow and should be assessed carefully on a case-by-case basis.
How WEEE Fits With Ecodesign (ESPR)
EU environmental regulation is increasingly structured around two distinct lifecycle phases: product design (upstream) and end-of-life management (downstream).
To avoid overlapping requirements, EU policy separates responsibilities across the product lifecycle.
ESPR (Ecodesign for Sustainable Products Regulation) governs the upstream phase (design and production).
It sets requirements before products are placed on the market, focusing on improving environmental performance through design. This includes:
- Material efficiency and recycled content
- Product durability and lifespan
- Repairability and upgradeability
- Energy efficiency and carbon footprint
- Transparency of product composition and sustainability data
In practical terms, ESPR is about how products are designed and built.
WEEE governs the downstream phase (end-of-life management).
WEEE does not regulate product design. Instead, it governs what happens once products become waste, including:
- Collection and take-back systems
- Recycling and recovery infrastructure
- Handling of hazardous components
- Financing of waste management through producer responsibility schemes
In practical terms, WEEE is about what happens after a product is discarded.
This separation is intentional and reflects the EU’s approach to avoid duplicating environmental requirements. Historically, WEEE included some design-related expectations, such as encouraging easier dismantling. This created overlap with ecodesign policy.
The current regulatory direction is to reduce duplication by:
- Moving design-related requirements into ESPR
- Keeping WEEE focused on collection, recycling, and financing systems
- Aligning both frameworks with the shift toward more durable and repairable products
The intent is to ensure manufacturers follow one consistent framework for product design (ESPR), while WEEE remains focused on end-of-life responsibility.
What is the Role of the Digital Product Passport?
A key convergence point between ESPR and WEEE is the Digital Product Passport (DPP).
WEEE already requires manufacturers to provide recyclers with information about product composition and hazardous substances. In practice, this information has often been difficult to access at end-of-life, particularly in mixed waste streams.
The Digital Product Passport, introduced under ESPR, addresses this by providing structured product data in a digital format, typically accessed via a QR code or similar data carrier on the product.
Over time, this is expected to support both frameworks:
- ESPR stores design, material, and sustainability information
- WEEE-related processes use this data to support safer and more efficient disassembly and recycling
This improves access to critical product information at end-of-life and reduces reliance on fragmented documentation.
What Do Manufacturers Need To Do?
If you place electrical or electronic products on the EU or UK market, WEEE obligations typically include:
Design for end-of-life recovery
While WEEE is not a design regulation, products should still consider end-of-life handling, including safe access to batteries, electronic assemblies, and materials that require separation during recycling.
Product marking requirements
- Products must generally display the crossed-out wheeled bin symbol, indicating that the product must not be disposed of with household waste.
- If space or design constraints prevent this, the symbol may be placed on packaging, instructions, or warranty documentation.
- Products must also carry producer identification, such as a brand name or registered trademark.
- Recycling information obligations
Manufacturers may be required to provide recyclers with relevant information about product composition, materials, and hazardous substances to support safe treatment and recovery.
Registration, reporting, and financial responsibility
One of the most commonly misunderstood aspects of WEEE is who is responsible for compliance.
Under WEEE rules, the responsible entity is the “producer”, which is not always the manufacturer. It is the first party that places the product on the EU or UK market.
Depending on the supply chain, the producer may be:
- An EU-based importer bringing the product into the market
- A distributor or reseller placing the product on the market under their own name or brand
- A brand owner established in the EU
- In some cases, a non-EU manufacturer selling directly into the EU through a direct-to-market or fulfilment model (who must legally appoint a domestic WEEE Authorised Representative to handle registration and compliance on their behalf)
If you manufacture outside the EU but sell through an importer or distributor, that EU-based entity is often legally responsible for registration, reporting, and payment of recycling fees.
However, contractual arrangements can shift financial responsibility between commercial parties, even though regulators will always identify a single legal “producer” in each jurisdiction.
Because of this, it is essential to clearly define:
- Who is importing the product into each country
- Whose name or trademark appears on the product
- Who holds the WEEE registration in each jurisdiction
- Who is responsible for reporting and financing obligations
Failure to clarify this allocation is one of the most common causes of non-compliance in cross-border supply chains.
How Do I Meet WEEE Obligations?
WEEE obligations are not demonstrated through a single declaration or certification. Instead, they require ongoing participation in national systems.
Compliance generally requires:
- Registration with national WEEE authorities (performed by the "producer")
- Participation in approved Producer Responsibility Organisations (PROs) or compliance schemes
- Ongoing reporting of products placed on the market
- Payment of applicable collection and recycling fees
Requirements vary by country. For example, businesses operating across both the EU and the UK require separate registrations, as the UK operates an independent WEEE compliance regime post-Brexit.diction.
What Happens If You Do Not Comply?
Non-compliance can result in:
- Market access restrictions or customs delays
- Product withdrawal or recall
- Financial penalties that vary by jurisdiction
- Disruption of distributor and retailer relationships
- Reputational damage due to enforcement actions
What Should Businesses Do Now?
If you are developing or selling electronic products in the EU or UK:
- Confirm whether your products fall within WEEE scope
- Identify who holds “producer” responsibility in each market
- Ensure product marking requirements are addressed early in design
- Confirm registration before placing products on the market
- Establish arrangements with approved compliance schemes
- Define reporting and financial responsibilities clearly across the supply chain
- Build internal systems for ongoing reporting and data tracking
Early clarity on WEEE responsibility is critical. Most compliance issues arise not from lack of awareness, but from ambiguity in commercial supply chain arrangements.
Further Reading:
Ecodesign for Sustainable Products Regulation (ESPR)
Packaging and Packaging Waste Regulation (PPWR)
SB 54 The Plastic Pollution Prevention and Packaging Producer Responsibility Act (California)
CPSC eFiling mandate (2026)
2026-02-16
The U.S. Consumer Product Safety Commission (CPSC) requires electronic filing (eFiling) of safety certificate data. Instead of just keeping a PDF on file, importers (or manufacturers on their behalf) must now submit digital proof that their products meet U.S. safety standards at the exact moment the goods enter the country.
Who is the "Importer"?
For these rules, the Importer of Record (usually the U.S. company buying the goods) is the responsible party. They must create the CPSC Business Account. While a Customs Broker is often hired by the importer to handle the digital paperwork at the border, the legal burden of providing accurate safety data and maintaining the original test records falls on the importer.
Do manufacturers need to do anything?
Manufacturers cannot create their own independent "Global ID." Instead, you work as a Collaborator within your customers' (importers) accounts.
What products are impacted?
Any products that require a General Certificate of Conformity (GCC) or a Children’s Product Certificate (CPC) must be eFiled. This includes, but is not limited to:
Low-Value Shipments: A major change is that low-value shipments (those valued under $800) are no longer exempt from safety paperwork. If your product is regulated, it must be eFiled, even if it is a single small package or a "de minimis" shipment that previously entered the country with no documentation.
Special Mention: Reese’s Law (Battery Products): If you sell products containing button cell or coin batteries, they are now subject to strict safety standards (16 CFR § 1263). Because these products require a GCC or CPC, they fall directly under this new eFiling mandate. Impacted battery products include:
What is the deadline?
July 8, 2026: Mandatory eFiling begins for all standard imports. After this date, shipments missing this digital data will likely be flagged, delayed, or seized at the port.
How should Manufacturers Prepare?
Further Reading:
Reese's Law for Button and Coin Cell Batteries
The U.S. Consumer Product Safety Commission (CPSC) requires electronic filing (eFiling) of safety certificate data. Instead of just keeping a PDF on file, importers (or manufacturers on their behalf) must now submit digital proof that their products meet U.S. safety standards at the exact moment the goods enter the country.
Who is the "Importer"?
For these rules, the Importer of Record (usually the U.S. company buying the goods) is the responsible party. They must create the CPSC Business Account. While a Customs Broker is often hired by the importer to handle the digital paperwork at the border, the legal burden of providing accurate safety data and maintaining the original test records falls on the importer.
Do manufacturers need to do anything?
Manufacturers cannot create their own independent "Global ID." Instead, you work as a Collaborator within your customers' (importers) accounts.
- You can use one email address to manage data across multiple importer accounts.
- To avoid manual entry, manufacturers should maintain a Master CSV file. You can upload this file into each importer's account to generate their specific Reference IDs instantly.
- Request that importers use the "Trade Party Privacy" setting so your data is only visible to that specific customer.
What products are impacted?
Any products that require a General Certificate of Conformity (GCC) or a Children’s Product Certificate (CPC) must be eFiled. This includes, but is not limited to:
- Apparel: Children's sleepwear and most "general wear" clothing.
- Children's Goods: Toys, strollers, high chairs, and juvenile furniture.
- Home & Safety: Mattresses, bicycle helmets, lighters, and paint/surface coatings.
- Furniture: Clothing storage units (due to tip-over standards).
- Products containing coin cell or button batteries
Low-Value Shipments: A major change is that low-value shipments (those valued under $800) are no longer exempt from safety paperwork. If your product is regulated, it must be eFiled, even if it is a single small package or a "de minimis" shipment that previously entered the country with no documentation.
Special Mention: Reese’s Law (Battery Products): If you sell products containing button cell or coin batteries, they are now subject to strict safety standards (16 CFR § 1263). Because these products require a GCC or CPC, they fall directly under this new eFiling mandate. Impacted battery products include:
- Electronics: Remote controls, key fobs, and digital watches.
- Household Items: Kitchen scales, thermometers, and lighted decorations.
- Children's Products: Any battery-operated toy (requires a CPC).
- Wearables: Fitness trackers and small medical devices.
What is the deadline?
July 8, 2026: Mandatory eFiling begins for all standard imports. After this date, shipments missing this digital data will likely be flagged, delayed, or seized at the port.
How should Manufacturers Prepare?
- Identify Regulated Goods: Audit your inventory for anything containing button/coin batteries or subject to CoC/CPC requirements.
- Use the Product Registry: Upload your certificate data to the CPSC Product Registry in advance. This creates a "Master File" for your products (https://www.cpsc.gov/eFiling-CPSC-Product-Registry)
- Provide the Reference ID: Include this ID number clearly on your Commercial Invoice and Packing List. This allows the importer’s Customs Broker to clear your goods instantly without needing to manually re-type your test data into the U.S. system.
- Talk to Your Freight Forwarder: Ensure they know the Reference ID is a critical piece of shipping documentation, just like a tracking number.
Further Reading:
Reese's Law for Button and Coin Cell Batteries
Proposition 65 (California)
2024-08-18
What is Proposition 65 (also known as Prop65) and how does it relate to products?
Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a proposition of the State of California enacted as a ballot initiative in November 1986. The proposition protects the state's drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals. These chemicals are found in many products.
What is the Proposition 65 List?
The Proposition 65 list is a list of a wide range of naturally occurring and synthetic chemicals that cause cancer or birth defects or other reproductive harm. These chemicals include additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes, such as motor vehicle exhaust. They could also occur as contaminants in commonly used materials. In plastics and electronics, fire retardants, heavy metals and phthalates are commonly used.
What is included in the current list?
The current list includes over 1000 chemicals and is regularly updated. Many of these can be found in plastics, coatings, textiles and electronic components.
What do I have to do as a product developer, supplier or manufacturer?
If you supply products to the USA that may be sold in California, whether through a physical store or online, you need to ensure warnings are provided that relate to any of the chemicals in the list that may be found in your products. The warning must be present at the point of sale and must be in a particular format.
How do I know whether my products contain any of the listed chemicals?
There are a number of different ways you can determine this. The first step is to talk to your supply chain and request certifications or declarations as to the Proposition65 status of the materials or parts you purchase. If your product contains batteries, plastics, electronics, metal coatings, dyes or fire retardants, there is a higher chance that your product will contain some of the listed chemicals. Contaminants, particularly in recycled plastics, may also be a source.
Are there any exemptions for the warning label requirements?
The OEHHA has developed safe harbor levels for many Proposition 65 chemicals under which a warning would not be required. Where the OEHHA has not established a safe harbor level for a chemical, businesses that expose individuals to that chemical would be required to provide a Proposition 65 warning, unless the business can show that the anticipated exposure level will not pose a significant risk of cancer or reproductive harm.
How does the process of compliance benefit my product development business?
While the process of determining what chemicals are found in your products can seem like a lot of work, greater transparency into your supply chain and the composition of your products is part of the process of building greater knowledge within your business. Gaining this level of insight and detail can help you make better product decisions that benefit your customers and the environment, and can also protect the health of those throughout your supply chain. Additionally, you can better anticipate future scarcities around materials, further future restrictions in other markets and improve the properties of your products.
What is Proposition 65 (also known as Prop65) and how does it relate to products?
Proposition 65, officially known as the Safe Drinking Water and Toxic Enforcement Act of 1986, is a proposition of the State of California enacted as a ballot initiative in November 1986. The proposition protects the state's drinking water sources from being contaminated with chemicals known to cause cancer, birth defects or other reproductive harm, and requires businesses to inform Californians about exposures to such chemicals. These chemicals are found in many products.
What is the Proposition 65 List?
The Proposition 65 list is a list of a wide range of naturally occurring and synthetic chemicals that cause cancer or birth defects or other reproductive harm. These chemicals include additives or ingredients in pesticides, common household products, food, drugs, dyes, or solvents. Listed chemicals may also be used in manufacturing and construction, or they may be byproducts of chemical processes, such as motor vehicle exhaust. They could also occur as contaminants in commonly used materials. In plastics and electronics, fire retardants, heavy metals and phthalates are commonly used.
What is included in the current list?
The current list includes over 1000 chemicals and is regularly updated. Many of these can be found in plastics, coatings, textiles and electronic components.
What do I have to do as a product developer, supplier or manufacturer?
If you supply products to the USA that may be sold in California, whether through a physical store or online, you need to ensure warnings are provided that relate to any of the chemicals in the list that may be found in your products. The warning must be present at the point of sale and must be in a particular format.
How do I know whether my products contain any of the listed chemicals?
There are a number of different ways you can determine this. The first step is to talk to your supply chain and request certifications or declarations as to the Proposition65 status of the materials or parts you purchase. If your product contains batteries, plastics, electronics, metal coatings, dyes or fire retardants, there is a higher chance that your product will contain some of the listed chemicals. Contaminants, particularly in recycled plastics, may also be a source.
Are there any exemptions for the warning label requirements?
The OEHHA has developed safe harbor levels for many Proposition 65 chemicals under which a warning would not be required. Where the OEHHA has not established a safe harbor level for a chemical, businesses that expose individuals to that chemical would be required to provide a Proposition 65 warning, unless the business can show that the anticipated exposure level will not pose a significant risk of cancer or reproductive harm.
How does the process of compliance benefit my product development business?
While the process of determining what chemicals are found in your products can seem like a lot of work, greater transparency into your supply chain and the composition of your products is part of the process of building greater knowledge within your business. Gaining this level of insight and detail can help you make better product decisions that benefit your customers and the environment, and can also protect the health of those throughout your supply chain. Additionally, you can better anticipate future scarcities around materials, further future restrictions in other markets and improve the properties of your products.
SB 54 The Plastic Pollution Prevention and Packaging Producer Responsibility Act
The Plastic Pollution Prevention and Packaging Producer Responsibility Act (SB 54) is California’s extended producer responsibility (EPR) law for single-use packaging and plastic food service ware.
Effective from 1 May 2026 under California Public Resources Code §42051 and 14 CCR §18980.5, the law shifts the financial and operational responsibility for packaging waste management from local governments to the companies that place covered materials on the California market.
The legislation establishes legally binding targets for:
Who does SB 54 apply to?
SB 54 applies to producers of covered materials that are sold, offered for sale, imported, or distributed in California.
A physical presence in California, or even within the United States, is not required. Selling products into California through distributors, retailers, or e-commerce channels may be sufficient to trigger obligations.
The law determines “producer” responsibility through a cascading hierarchy.
Tier 1 — Product manufacturer and brand owner: The producer is the manufacturer of the product if they also own or license the brand under which the product is sold in California.
Tier 2 — Brand owner or exclusive licensee: If no qualifying manufacturer exists, the brand owner or exclusive licensee becomes the producer, regardless of location.
Tier 3 — Importer or first distributor: If no identifiable brand owner exists, the importer or first distributor selling the product into California becomes the producer.
What packaging materials are covered?
SB 54 covers the packaging associated with a product, rather than the product itself.
Covered materials include:
Examples of covered materials may include:
What materials are excluded or exempt?
SB 54 distinguishes between excluded materials and exempt materials.
Excluded materials fall completely outside the law and are generally not subject to fees or reporting obligations.
Examples include:
Food and agricultural packaging exclusions:
Some food and agricultural packaging may qualify for exclusion where compliant packaging alternatives are not reasonably possible while still meeting mandatory USDA or FDA requirements.
Examples may include packaging necessary to:
Small producer exemption:
Producers with less than USD 1 million in annual gross California sales may qualify for exemptions from certain reporting and fee obligations.
However:
What are the key compliance deadlines under SB 54?
1 June 2026 — Registration deadline. Producers must register through one of the following pathways:
1 August 2026 — Source reduction plans due. Producers must submit individual source reduction plans describing how reduction obligations will be achieved. The approved PRO is expected to confirm final submission timing following the regulations becoming effective.
1 January 2027 — Sales restrictions and 10% plastic reduction target. From this date:
1 January 2028 — 30% recycling rate targetPlastic covered materials must achieve a 30% recycling rate.
1 January 2030 — 20% reduction and 40% recycling targetBy 2030:
1 January 2032 — Full compliance targets by 2032:
How do producers register for compliance?
Registration is managed through the Packaging Extended Producer Responsibility System (PEPRS), CalRecycle’s online compliance portal.
Producer Responsibility Organisation (PRO) pathway. Most producers are expected to comply through Circular Action Alliance (CAA), the approved PRO for California.
Under this model, CAA manages:
Producers are required to submit 2023 packaging supply data during registration.
Independent producer pathway: Producers may alternatively comply independently without joining CAA.
To do so, they must demonstrate to CalRecycle that they can independently achieve:
What are the penalties for non-compliance?
SB 54 includes significant enforcement powers.
Civil penalties may reach up to USD 50,000 per day, per violation, beginning 30 days after a Notice of Violation is issued by CalRecycle.
Under the legislation:
Effective from 1 May 2026 under California Public Resources Code §42051 and 14 CCR §18980.5, the law shifts the financial and operational responsibility for packaging waste management from local governments to the companies that place covered materials on the California market.
The legislation establishes legally binding targets for:
- Reducing single-use plastic packaging
- Improving recyclability and compostability
- Increasing recycling rates through to 2032
Who does SB 54 apply to?
SB 54 applies to producers of covered materials that are sold, offered for sale, imported, or distributed in California.
A physical presence in California, or even within the United States, is not required. Selling products into California through distributors, retailers, or e-commerce channels may be sufficient to trigger obligations.
The law determines “producer” responsibility through a cascading hierarchy.
Tier 1 — Product manufacturer and brand owner: The producer is the manufacturer of the product if they also own or license the brand under which the product is sold in California.
Tier 2 — Brand owner or exclusive licensee: If no qualifying manufacturer exists, the brand owner or exclusive licensee becomes the producer, regardless of location.
Tier 3 — Importer or first distributor: If no identifiable brand owner exists, the importer or first distributor selling the product into California becomes the producer.
What packaging materials are covered?
SB 54 covers the packaging associated with a product, rather than the product itself.
Covered materials include:
- Single-use packaging
- Single-use plastic food service ware
- Plastic
- Paper and fibre
- Glass
- Metal
- Wood and other organic materials
- Ceramic
Examples of covered materials may include:
- Smartphone boxes
- Foam inserts
- Plastic film wrap
- Blister packaging
- Shipping protection materials
What materials are excluded or exempt?
SB 54 distinguishes between excluded materials and exempt materials.
Excluded materials fall completely outside the law and are generally not subject to fees or reporting obligations.
Examples include:
- Beverage containers already regulated under California’s bottle bill
- Certain prescription drug packaging
- Medical device packaging
- Infant formula packaging
- Refillable or reusable packaging systems
- Hazardous material containers
- Packaging already regulated under specific California stewardship programmes, such as paint
Food and agricultural packaging exclusions:
Some food and agricultural packaging may qualify for exclusion where compliant packaging alternatives are not reasonably possible while still meeting mandatory USDA or FDA requirements.
Examples may include packaging necessary to:
- Prevent microbial contamination
- Maintain structural integrity
- Preserve food safety compliance
Small producer exemption:
Producers with less than USD 1 million in annual gross California sales may qualify for exemptions from certain reporting and fee obligations.
However:
- Registration with CalRecycle is still required
- The exemption is not automatic
- Packaging must still meet recyclability or compostability requirements by 1 January 2032
What are the key compliance deadlines under SB 54?
1 June 2026 — Registration deadline. Producers must register through one of the following pathways:
- Join the approved Producer Responsibility Organisation (PRO)
- Register independently with CalRecycle
- Register and apply for the small producer exemption
1 August 2026 — Source reduction plans due. Producers must submit individual source reduction plans describing how reduction obligations will be achieved. The approved PRO is expected to confirm final submission timing following the regulations becoming effective.
1 January 2027 — Sales restrictions and 10% plastic reduction target. From this date:
- Unregistered producers may no longer legally sell covered materials in California
- Producer fees commence
- Single-use plastic covered materials must be reduced by 10% against the 2023 baseline
1 January 2028 — 30% recycling rate targetPlastic covered materials must achieve a 30% recycling rate.
1 January 2030 — 20% reduction and 40% recycling targetBy 2030:
- Single-use plastic volumes must be reduced by 20% from the 2023 baseline
- Plastic covered materials must achieve a 40% recycling rate
1 January 2032 — Full compliance targets by 2032:
- All covered materials sold in California must be recyclable or compostable
- Single-use plastic must be reduced by 25% from the 2023 baseline
- Plastic covered materials must achieve a 65% recycling rate
How do producers register for compliance?
Registration is managed through the Packaging Extended Producer Responsibility System (PEPRS), CalRecycle’s online compliance portal.
Producer Responsibility Organisation (PRO) pathway. Most producers are expected to comply through Circular Action Alliance (CAA), the approved PRO for California.
Under this model, CAA manages:
- Registration coordination
- Reporting processes
- Fee collection
- Certain compliance submissions
Producers are required to submit 2023 packaging supply data during registration.
Independent producer pathway: Producers may alternatively comply independently without joining CAA.
To do so, they must demonstrate to CalRecycle that they can independently achieve:
- Source reduction obligations
- Recycling performance targets
- Compliance reporting requirements
What are the penalties for non-compliance?
SB 54 includes significant enforcement powers.
Civil penalties may reach up to USD 50,000 per day, per violation, beginning 30 days after a Notice of Violation is issued by CalRecycle.
Under the legislation:
- Each day of non-compliance may constitute a separate violation
- Each non-compliant product may also constitute a separate violation
FCC Covered List (2026 Updates)
2026-06-09
The Federal Communications Commission (FCC) maintains a “Covered List” of communications equipment and services determined to pose an unacceptable risk to U.S. national security. Under the Secure Equipment Act framework and the Secure and Trusted Communications Networks Act (47 U.S.C. § 1601), equipment or services placed on this list are generally ineligible for new FCC equipment authorisations.
This affects manufacturers, importers, and compliance teams involved in certifying radiofrequency (RF) and communications equipment for the U.S. market.
In 2025–2026, the Covered List expanded beyond its original focus on named companies to include specific categories of equipment defined by national security determinations, including uncrewed aircraft systems (UAS) and certain foreign-produced networking equipment.
Who is impacted?
The compliance burden falls on:
Do manufacturers need to do anything?
Yes. The key change is that compliance is no longer limited to avoiding named companies — it now also requires assessing system-level and supply chain risk in certain equipment categories.
1. Review supply chain exposure
Manufacturers should assess whether:
2. Understand category-based restrictions
Recent Covered List updates include category-defined entries where risk is determined by system type and origin, not just company name.
This includes:
3. Conditional approvals and exemptions
Some Covered List entries include limited exemptions, typically where:
What products are impacted?
Historically, the Covered List focused on named entities such as Huawei, ZTE, Hikvision, Dahua, Hytera, and Kaspersky.
Recent updates have introduced broader equipment categories based on national security determinations, including:
Uncrewed Aircraft Systems (UAS) and critical components (Dec 22, 2025)
The FCC added:
The entry is based on a national security determination incorporated into FCC action under 47 U.S.C. § 1601 and related statutory authority.
Certain exemptions may apply, including:
Consumer networking equipment (Routers) (March 23, 2026)
The Covered List was updated to include:
The entry includes limited exemptions where equipment has received specific government approval or falls within defined exception criteria.
What is NOT changing?
It is important to distinguish what the Covered List does not do:
What are the critical compliance implications?
1. System-level screening is now required
Compliance teams must assess not only device-level RF compliance but also whether the system falls into a Covered List equipment category.
2. Supply chain transparency is increasingly important
Manufacturers should document:
3. Authorisation risk is now broader than entity lists
Even if a supplier is not on the Covered List, equipment may still be ineligible if it falls within a restricted category.
Key takeaway
The FCC Covered List has evolved from a purely entity-based restriction list into a hybrid framework that includes:
The Federal Communications Commission (FCC) maintains a “Covered List” of communications equipment and services determined to pose an unacceptable risk to U.S. national security. Under the Secure Equipment Act framework and the Secure and Trusted Communications Networks Act (47 U.S.C. § 1601), equipment or services placed on this list are generally ineligible for new FCC equipment authorisations.
This affects manufacturers, importers, and compliance teams involved in certifying radiofrequency (RF) and communications equipment for the U.S. market.
In 2025–2026, the Covered List expanded beyond its original focus on named companies to include specific categories of equipment defined by national security determinations, including uncrewed aircraft systems (UAS) and certain foreign-produced networking equipment.
Who is impacted?
The compliance burden falls on:
- Manufacturers of RF and connected devices
- Importers and distributors of wireless equipment
- Certification bodies and test laboratories (TCBs)
- Compliance and regulatory affairs teams preparing FCC applications
Do manufacturers need to do anything?
Yes. The key change is that compliance is no longer limited to avoiding named companies — it now also requires assessing system-level and supply chain risk in certain equipment categories.
1. Review supply chain exposure
Manufacturers should assess whether:
- RF modules or communication subsystems are sourced from Covered List entities
- UAS or networking equipment falls within newly listed categories
- critical communications functions rely on prohibited components
2. Understand category-based restrictions
Recent Covered List updates include category-defined entries where risk is determined by system type and origin, not just company name.
This includes:
- Uncrewed aircraft systems (UAS) and certain critical components
- specific communications equipment types identified in national security determinations
- foreign-produced consumer networking equipment (e.g. routers), subject to defined exceptions
3. Conditional approvals and exemptions
Some Covered List entries include limited exemptions, typically where:
- equipment is listed under approved defence procurement frameworks (e.g. Blue UAS programme participation)
- a U.S. Government agency (e.g. Department of Homeland Security or Department of War) issues a specific determination
- equipment qualifies under defined transitional arrangements (such as Buy American–aligned categories, where applicable)
What products are impacted?
Historically, the Covered List focused on named entities such as Huawei, ZTE, Hikvision, Dahua, Hytera, and Kaspersky.
Recent updates have introduced broader equipment categories based on national security determinations, including:
Uncrewed Aircraft Systems (UAS) and critical components (Dec 22, 2025)
The FCC added:
- Uncrewed aircraft systems produced in foreign countries
- UAS critical components produced in foreign countries
The entry is based on a national security determination incorporated into FCC action under 47 U.S.C. § 1601 and related statutory authority.
Certain exemptions may apply, including:
- systems on approved defence procurement lists (e.g. Blue UAS programme), subject to time-limited transitional provisions
- cases where DHS or DoW issues a specific determination
- defined procurement or origin-based exceptions where applicable
Consumer networking equipment (Routers) (March 23, 2026)
The Covered List was updated to include:
- Consumer-grade routers produced in a foreign country
The entry includes limited exemptions where equipment has received specific government approval or falls within defined exception criteria.
What is NOT changing?
It is important to distinguish what the Covered List does not do:
- It does not ban all foreign electronics
- It does not regulate non-communications mechanical components (e.g. motors or batteries in isolation)
- It does not function as a general import ban regime
- It does not replace customs, trade, or procurement laws
What are the critical compliance implications?
1. System-level screening is now required
Compliance teams must assess not only device-level RF compliance but also whether the system falls into a Covered List equipment category.
2. Supply chain transparency is increasingly important
Manufacturers should document:
- RF module origin
- firmware and communications subsystem sourcing
- manufacturing location for defined equipment categories
3. Authorisation risk is now broader than entity lists
Even if a supplier is not on the Covered List, equipment may still be ineligible if it falls within a restricted category.
Key takeaway
The FCC Covered List has evolved from a purely entity-based restriction list into a hybrid framework that includes:
- entity-based restrictions (legacy structure)
- category-based equipment restrictions (newer national security determinations)
- limited, tightly defined exemptions for government-approved or transitional use cases
Reese's Law for Button and Coin Cell Batteries
2026/06/15
Public Law 117-171 • 15 U.S.C. § 2056e • 16 CFR Part 1263
What is Reese's Law?
Reese's Law is a United States product safety law designed to reduce the risk of serious injury or death caused by children swallowing button cell or coin batteries. The law requires consumer products containing button cell or coin batteries to meet mandatory safety and warning requirements. It also requires child-resistant packaging for button cell and coin batteries sold separately. Reese's Law applies to products sold in the United States and is enforced by the U.S. Consumer Product Safety Commission (CPSC).
Which products are covered?
Reese's Law applies to most consumer products that contain or are designed to use one or more button cell or coin batteries.
Examples include:
Are any products exempt?
Some products are outside the scope of, or treated differently under, Reese’s Law:
Toys
Toys intended for children under 14 years of age are exempt from Reese’s Law product requirements where they already comply with the battery accessibility and marking requirements of the toy safety standard ASTM F963.
Medical devices
Products regulated as medical devices by the U.S. Food and Drug Administration (FDA) are generally outside the scope of Reese’s Law, as they are not regulated as consumer products under the Consumer Product Safety Act. Where products have dual-use or mixed classification, regulatory scope should be confirmed.
Zinc-air batteries
Zinc-air button cell batteries are exempt from certain product performance and warning requirements due to their different chemical risk profile compared with other button cell battery chemistries.
What do manufacturers and importers need to do?
Products covered by Reese’s Law must comply with the safety requirements of ANSI/UL 4200A.
Key requirements include:
Secure battery compartments
Battery compartments must require either:
Pass mechanical safety testing
Battery compartments must remain secure after testing designed to simulate normal use and foreseeable misuse, including:
Provide warning labels
Required warnings must be placed on:
How do I demonstrate compliance?
Manufacturers and importers must maintain evidence that their products comply with the applicable requirements.
General consumer products
A General Certificate of Conformity (GCC) is typically required, supported by appropriate testing and technical documentation.
Children's products that are not toys
A Children's Product Certificate (CPC) is required and must be supported by testing conducted by a CPSC-accepted third-party laboratory.
Electronic filing requirements
Where a GCC or CPC is required, certificate information may also need to be submitted through the CPSC eFiling system for imported products. Read more about CPSC eFiling requirements.
What are the penalties for non-compliance?
Failure to comply with Reese’s Law can result in significant enforcement action by the CPSC, including:
What should businesses do now?
If your products contain button cell or coin batteries and are sold in the United States, you should:
Futher Reading:
How to transport lithium batteries
Battery Regulation (EU)
CPSC eFiling mandate (2026) (USA)
SB 1215 (2022) Embedded Battery Compliance (California)
AB 2440 Responsible Battery Recycling Act (Califoria)
ACCC Button Cell Battery Instruments (Australia)
SB 244 Right to Repair Act (California)
Public Law 117-171 • 15 U.S.C. § 2056e • 16 CFR Part 1263
What is Reese's Law?
Reese's Law is a United States product safety law designed to reduce the risk of serious injury or death caused by children swallowing button cell or coin batteries. The law requires consumer products containing button cell or coin batteries to meet mandatory safety and warning requirements. It also requires child-resistant packaging for button cell and coin batteries sold separately. Reese's Law applies to products sold in the United States and is enforced by the U.S. Consumer Product Safety Commission (CPSC).
Which products are covered?
Reese's Law applies to most consumer products that contain or are designed to use one or more button cell or coin batteries.
Examples include:
- Remote controls
- Key fobs
- Kitchen and bathroom scales
- Smart home devices
- Wearable electronics
- Musical greeting cards
- Small electronic consumer products
- Installed in the product
- Supplied separately in the packaging
- Sold as a replacement battery
Are any products exempt?
Some products are outside the scope of, or treated differently under, Reese’s Law:
Toys
Toys intended for children under 14 years of age are exempt from Reese’s Law product requirements where they already comply with the battery accessibility and marking requirements of the toy safety standard ASTM F963.
Medical devices
Products regulated as medical devices by the U.S. Food and Drug Administration (FDA) are generally outside the scope of Reese’s Law, as they are not regulated as consumer products under the Consumer Product Safety Act. Where products have dual-use or mixed classification, regulatory scope should be confirmed.
Zinc-air batteries
Zinc-air button cell batteries are exempt from certain product performance and warning requirements due to their different chemical risk profile compared with other button cell battery chemistries.
What do manufacturers and importers need to do?
Products covered by Reese’s Law must comply with the safety requirements of ANSI/UL 4200A.
Key requirements include:
Secure battery compartments
Battery compartments must require either:
- A tool, such as a screwdriver, to open, or
- Two separate and simultaneous hand movements
Pass mechanical safety testing
Battery compartments must remain secure after testing designed to simulate normal use and foreseeable misuse, including:
- Drop testing
- Impact testing
- Crush testing
- Torque testing
Provide warning labels
Required warnings must be placed on:
- The product (where practical)
- Retail packaging
- User instructions
How do I demonstrate compliance?
Manufacturers and importers must maintain evidence that their products comply with the applicable requirements.
General consumer products
A General Certificate of Conformity (GCC) is typically required, supported by appropriate testing and technical documentation.
Children's products that are not toys
A Children's Product Certificate (CPC) is required and must be supported by testing conducted by a CPSC-accepted third-party laboratory.
Electronic filing requirements
Where a GCC or CPC is required, certificate information may also need to be submitted through the CPSC eFiling system for imported products. Read more about CPSC eFiling requirements.
What are the penalties for non-compliance?
Failure to comply with Reese’s Law can result in significant enforcement action by the CPSC, including:
- Product recalls
- Import detention or refusal at the U.S. border
- Sales restrictions
- Civil penalties
What should businesses do now?
If your products contain button cell or coin batteries and are sold in the United States, you should:
- Review whether your products fall within the scope of Reese’s Law
- Confirm battery compartments comply with ANSI/UL 4200A requirements
- Verify warning labels meet current requirements
- Ensure battery packaging is compliant
- Maintain appropriate test reports and compliance certificates
Futher Reading:
How to transport lithium batteries
Battery Regulation (EU)
CPSC eFiling mandate (2026) (USA)
SB 1215 (2022) Embedded Battery Compliance (California)
AB 2440 Responsible Battery Recycling Act (Califoria)
ACCC Button Cell Battery Instruments (Australia)
SB 244 Right to Repair Act (California)
SB 1215 (2022) Embedded Battery Compliance (California)
Last Updated: 2026-06-18
What is the California's Senate Bill 1215 (SB 1215) of 2022?
This bill expanded the state's Electronic Waste Recycling Act on 1 January 2026 to include a new category of products known as Covered Battery-Embedded Products (CBEPs).
If your products contain batteries that are not designed to be removed by the user with common household tools, you may have obligations relating to product classification, retailer notifications, labelling, and annual reporting.
Failure to comply can create supply chain disruptions, expose businesses to penalties, and add significant administrative burdens. Understanding whether your products are covered and establishing the necessary processes should be a priority for any company selling battery-powered products in California.
Who Is Responsible for Compliance?
One aspect of SB 1215 that often surprises manufacturers is that responsibility does not follow the same model used in many European Extended Producer Responsibility (EPR) schemes.
Under California's program:
In practice, manufacturers may still rely on importers, distributors, or retailers to provide California sales information needed for annual reporting. However, unlike many European battery and WEEE schemes, the legal responsibility remains with the manufacturer or brand owner.
For companies selling globally, this difference makes it important to clearly define data-sharing responsibilities within distribution agreements.
Is My Product Covered?
Manufacturers are responsible for determining whether their products fall within the scope of the law.
A Covered Battery-Embedded Product (CBEP) is generally an electronic device containing a battery that cannot be easily removed by the user using common household tools such as:
Examples of Covered Products
Products likely to fall within the scope include:
What Products Are Exempt?
Several categories are exempt, including:
Because the law contains several exceptions and definitions, manufacturers should carefully review product classifications rather than relying on assumptions.
What Are My Ongoing Obligations?
Although retailers collect the recycling fee at the point of sale, manufacturers provide the information that drives the system.
Annual Retailer Notifications
SB 1215 established an ongoing annual notification process. The first notices were required by 1 July 2025, ahead of the launch of the point-of-sale fee in 2026. Manufacturers must continue this process each year, submitting notifications to retailers and providing a copy to CalRecycle by 1 July.
The notification should identify:
Including UPCs or other identifying information can help retailers correctly apply the fee and reduce the risk of errors.
Product Labelling Requirements
Covered products sold in California must display:
Battery chemistry information may appear:
Manufacturers should also ensure recyclers and other downstream handlers can readily obtain information describing how batteries can be safely removed and managed at end of life. Providing this information through technical documentation or a publicly accessible website can help support recycling and safe battery handling.
Manufacturers should verify that packaging artwork, instructions and product markings are aligned with these requirements before shipping inventory into California.
Annual Reporting to CalRecycle
Beginning 1 July 2027, manufacturers must submit annual reports covering the previous calendar year.
These reports require companies to maintain records relating to:
Companies without systems for tracking California-specific sales, battery configurations, and material content may need to establish new internal processes to support reporting requirements.
Should Future Products Use Replaceable Batteries?
SB 1215 introduces an important strategic consideration for product developers.
While the law does not prohibit embedded batteries, products with non-user-removable batteries carry ongoing obligations, including:
For future products, engineering teams may wish to evaluate whether replaceable batteries could provide a simpler compliance pathway while also supporting repairability and sustainability goals. The EU battery regulations already require the battery to be removable unless specific derogations are met.
What Should I Include in Distribution Agreements?
Although importers and distributors do not have direct reporting obligations under SB 1215, manufacturers may depend on them to obtain the information needed for annual reporting.
For companies selling through third parties, incorporating California compliance data-sharing requirements into distribution agreements can help avoid scrambling for information when reporting season arrives.
California Sales Volumes
Manufacturers should consider requiring distributors or importers to provide:
Retailer Information
Information relating to retailers or sub-distributors supplied within California can help manufacturers maintain records associated with retailer notifications.
Record Retention and Audit Support
Distribution agreements may also include provisions requiring trading partners to retain records and cooperate if additional information is needed to support regulatory filings or respond to inquiries from CalRecycle.
Embedding these requirements into commercial agreements can significantly reduce compliance risk.
What Should Manufacturers Do Now?
If your company sells battery-powered products in California, now is the time to:
The compliance burden created by SB 1215 is manageable, but only if it is addressed proactively rather than after products are already in the market.
Further Reading:
How to transport lithium batteries
Battery Regulation (EU)
Reese's Law for Button or Coin Cell Batteries (USA)
CPSC eFiling mandate (2026) (USA)
AB 2440 Responsible Battery Recycling Act (California)
ACCC Button Cell Battery Instruments (Australia)
SB 244 Right to Repair Act (California)
What is the California's Senate Bill 1215 (SB 1215) of 2022?
This bill expanded the state's Electronic Waste Recycling Act on 1 January 2026 to include a new category of products known as Covered Battery-Embedded Products (CBEPs).
If your products contain batteries that are not designed to be removed by the user with common household tools, you may have obligations relating to product classification, retailer notifications, labelling, and annual reporting.
Failure to comply can create supply chain disruptions, expose businesses to penalties, and add significant administrative burdens. Understanding whether your products are covered and establishing the necessary processes should be a priority for any company selling battery-powered products in California.
Who Is Responsible for Compliance?
One aspect of SB 1215 that often surprises manufacturers is that responsibility does not follow the same model used in many European Extended Producer Responsibility (EPR) schemes.
Under California's program:
- Manufacturers and brand owners are responsible for determining whether products are covered, notifying retailers, maintaining records, and submitting annual reports to CalRecycle.
- Retailers are responsible for collecting the recycling fee from consumers at the point of sale.
- Importers and distributors are not specifically assigned reporting or fee collection obligations under the legislation.
In practice, manufacturers may still rely on importers, distributors, or retailers to provide California sales information needed for annual reporting. However, unlike many European battery and WEEE schemes, the legal responsibility remains with the manufacturer or brand owner.
For companies selling globally, this difference makes it important to clearly define data-sharing responsibilities within distribution agreements.
Is My Product Covered?
Manufacturers are responsible for determining whether their products fall within the scope of the law.
A Covered Battery-Embedded Product (CBEP) is generally an electronic device containing a battery that cannot be easily removed by the user using common household tools such as:
- A standard Phillips or flat-head screwdriver.
- A coin.
- A paper clip.
- A hex key.
Examples of Covered Products
Products likely to fall within the scope include:
- Wireless earbuds and headphones.
- Smartwatches and fitness trackers.
- Electric toothbrushes.
- Rechargeable smart home sensors.
- Battery-powered toys and gadgets.
- Power tools with permanently installed batteries.
What Products Are Exempt?
Several categories are exempt, including:
- Video display devices already covered under California's existing e-waste program.
- Certain medical devices, including Class II and Class III devices.
- Certain energy storage systems.
- Electronic nicotine delivery systems.
Because the law contains several exceptions and definitions, manufacturers should carefully review product classifications rather than relying on assumptions.
What Are My Ongoing Obligations?
Although retailers collect the recycling fee at the point of sale, manufacturers provide the information that drives the system.
Annual Retailer Notifications
SB 1215 established an ongoing annual notification process. The first notices were required by 1 July 2025, ahead of the launch of the point-of-sale fee in 2026. Manufacturers must continue this process each year, submitting notifications to retailers and providing a copy to CalRecycle by 1 July.
The notification should identify:
- Covered products by brand and model number.
- Products that are exempt from the definition.
- Confirmation that covered products are subject to California's recycling fee.
Including UPCs or other identifying information can help retailers correctly apply the fee and reduce the risk of errors.
Product Labelling Requirements
Covered products sold in California must display:
- The manufacturer's brand name or logo.
- Information identifying the battery chemistry.
Battery chemistry information may appear:
- On the product itself.
- On the packaging.
- On the manufacturer's website, provided consumers can easily access it.
Manufacturers should also ensure recyclers and other downstream handlers can readily obtain information describing how batteries can be safely removed and managed at end of life. Providing this information through technical documentation or a publicly accessible website can help support recycling and safe battery handling.
Manufacturers should verify that packaging artwork, instructions and product markings are aligned with these requirements before shipping inventory into California.
Annual Reporting to CalRecycle
Beginning 1 July 2027, manufacturers must submit annual reports covering the previous calendar year.
These reports require companies to maintain records relating to:
- California sales volumes for covered products.
- Battery chemistries used in covered products.
- Evidence that required retailer notifications were provided.
- Recycled content information and other materials data required by CalRecycle.
- Information supporting product recyclability and broader design-for-recycling initiatives.
Companies without systems for tracking California-specific sales, battery configurations, and material content may need to establish new internal processes to support reporting requirements.
Should Future Products Use Replaceable Batteries?
SB 1215 introduces an important strategic consideration for product developers.
While the law does not prohibit embedded batteries, products with non-user-removable batteries carry ongoing obligations, including:
- Annual notifications.
- Labelling requirements.
- Data collection and reporting.
- Retailer coordination.
- Additional compliance administration.
For future products, engineering teams may wish to evaluate whether replaceable batteries could provide a simpler compliance pathway while also supporting repairability and sustainability goals. The EU battery regulations already require the battery to be removable unless specific derogations are met.
What Should I Include in Distribution Agreements?
Although importers and distributors do not have direct reporting obligations under SB 1215, manufacturers may depend on them to obtain the information needed for annual reporting.
For companies selling through third parties, incorporating California compliance data-sharing requirements into distribution agreements can help avoid scrambling for information when reporting season arrives.
California Sales Volumes
Manufacturers should consider requiring distributors or importers to provide:
- Model numbers.
- SKUs.
- UPCs.
- Quantities sold or distributed into California.
Retailer Information
Information relating to retailers or sub-distributors supplied within California can help manufacturers maintain records associated with retailer notifications.
Record Retention and Audit Support
Distribution agreements may also include provisions requiring trading partners to retain records and cooperate if additional information is needed to support regulatory filings or respond to inquiries from CalRecycle.
Embedding these requirements into commercial agreements can significantly reduce compliance risk.
What Should Manufacturers Do Now?
If your company sells battery-powered products in California, now is the time to:
- Review your product portfolio.
- Identify products with non-user-removable batteries.
- Verify labelling and packaging requirements.
- Establish annual notification processes.
- Build reporting systems for sales and battery chemistry data.
- Ensure distribution agreements provide access to California sales information.
- Consider whether future designs should incorporate replaceable batteries.
The compliance burden created by SB 1215 is manageable, but only if it is addressed proactively rather than after products are already in the market.
Further Reading:
How to transport lithium batteries
Battery Regulation (EU)
Reese's Law for Button or Coin Cell Batteries (USA)
CPSC eFiling mandate (2026) (USA)
AB 2440 Responsible Battery Recycling Act (California)
ACCC Button Cell Battery Instruments (Australia)
SB 244 Right to Repair Act (California)
AB 2440 Responsible Battery Recycling Act
Last Updated: 2026-06-18
What is the California Assembly Bill 2440 (AB 2440), the Responsible Battery Recycling Act?
This act addresses loose batteries and batteries designed to be easily removed by consumers.
Unlike SB 1215, which relies on a point-of-sale fee collected by retailers, AB 2440 establishes an Extended Producer Responsibility (EPR) framework. Producers are responsible for funding and managing battery collection and recycling programs.
For hardware manufacturers and brands selling products into California, understanding whether batteries fall under AB 2440 or SB 1215 is critical because the obligations, costs, and supply chain responsibilities differ significantly.
Who Is Responsible for Compliance and Who Joins the Stewardship Program?
AB 2440 assigns responsibility to the "producer", and that entity must join an approved Battery Stewardship Organization (BSO).
In most cases, the producer is the company that sells or distributes covered batteries under its own brand or trademark in California.
However, California applies a cascading hierarchy to ensure there is always a responsible entity located in the United States.
Companies with a U.S. Presence
If your company has a U.S. subsidiary or other legal presence, that entity will typically act as the producer. It is responsible for:
Companies Without a U.S. Presence
Overseas manufacturers with no U.S. presence cannot simply register from abroad and assume producer responsibilities.
Instead, responsibility may shift to an exclusive licensee, importer, distributor, or seller located in the United States. That entity becomes the legal producer and assumes responsibility for registration, reporting, and stewardship fees.
Because these obligations can carry significant costs and liabilities, manufacturers and their U.S. partners should clearly define responsibilities before products enter the California market.
Unlike SB 1215, where importers are not specifically assigned compliance obligations, AB 2440 ensures there is always a responsible entity located in the United States.
Is My Battery Covered?
AB 2440 covers both loose batteries and batteries packaged with products when those batteries are designed to be easily removed using common household tools such as:
What Battery Chemistries Are Covered?
Examples include:
What Products Are Exempt?
Exemptions include:
Because the distinction between removable and embedded batteries determines which regulatory scheme applies, product designers should assess battery accessibility early in the development process.
What Are My Compliance Obligations?
Producers cannot comply individually. They must participate in an approved Battery Stewardship Organization (BSO) responsible for collection, recycling, public education, and regulatory reporting.
Join an Approved Battery Stewardship Organization
An example is Call2Recycle, one of North America's leading battery stewardship organisations.
Pay Stewardship Fees
Unlike SB 1215, where consumers pay a separate fee at the point of sale, AB 2440 places the costs on producers.
Stewardship fees are generally based on the weight or volume of batteries introduced into the California market and fund:
Maintain Active Registration
CalRecycle maintains a public registry of compliant producers.
Failure to maintain active participation can make products ineligible for sale within California.
Provide Battery Identification and Recycling Information
Manufacturers should ensure consumers and downstream handlers have access to information that supports the safe removal, handling, and recycling of batteries.
This information may include:
Many manufacturers provide this information through user manuals, technical documentation, product support pages, or publicly accessible websites.
Providing clear battery information can help support stewardship objectives and improve collection and recycling outcomes.
Can Retailers and Distributors Continue Selling Non-Compliant Products?
No. California maintains a public list of compliant producers and brands. Beginning January 1, 2027, retailers and distributors are prohibited from selling covered batteries or battery-containing products if the producer is not participating in an approved Battery Stewardship Organisation.
As a result, non-compliance can affect an entire distribution network and may lead to stop-sale actions.
For many brands, maintaining compliance is therefore not only a regulatory issue but also a commercial necessity.
January 1, 2027 Is the Key Deadline
Although stewardship programs are being implemented during 2026, January 1, 2027 marks the point at which the law's sales prohibitions fully take effect.
After that date, removable batteries and products containing them cannot legally be sold in California unless the producer is actively participating in an approved Battery Stewardship Organisation and appears on the state's compliance registry.
For manufacturers and importers, this means compliance should be established well before 2027 to avoid disruptions to existing distribution channels.
What Should Be Included in Distribution Agreements?
Because producer responsibility may shift to a U.S. importer when an overseas manufacturer lacks a U.S. presence, distribution agreements should clearly define responsibilities.
Producer Designation
Contracts should specify which party will:
Stewardship Fee Arrangements
Where an importer assumes producer responsibilities, agreements should clearly define how stewardship fees will be allocated or reimbursed.
Sales Data Sharing
Because fees are based on the amount of batteries entering California, manufacturers and importers should establish processes for exchanging:
Regular reporting helps ensure stewardship fees are accurately calculated and reported.
What Systems Should Manufacturers Put in Place?
Successful compliance requires coordination between engineering, supply chain, legal, and finance functions.
Engineering
Engineering teams should determine whether batteries are user-removable or embedded, as this determines whether AB 2440 or SB 1215 applies.
Product development teams should also consider how battery information and removal instructions will be communicated to users and downstream recyclers. Addressing these requirements early can avoid late changes to packaging, technical documentation, and support materials.
Supply Chain and Sales
Companies should establish processes to track:
Legal and Commercial Teams
Distribution agreements should clearly allocate responsibilities and establish mechanisms for sharing sales and compliance data.
Finance
Finance teams should recognise stewardship fees as an ongoing cost of doing business and establish processes to forecast and monitor these expenses.
What Should Manufacturers Do Now?
If your company sells batteries or battery-powered products into California, now is the time to:
The distinction between SB 1215 and AB 2440 ultimately comes down to battery accessibility. Products with embedded batteries fall under one system, while products with removable batteries fall under another. Understanding which framework applies, and ensuring there is a clearly identified U.S.-based producer, are essential for maintaining uninterrupted access to the California market.
Further Reading:
How to transport lithium batteries
Battery Regulation (EU)
Reese's Law for Button or Coin Cell Batteries (USA)
CPSC eFiling mandate (2026) (USA)
SB 1215 (2022) Embedded Battery Compliance (California)
ACCC Button Cell Battery Instruments (Australia)
SB 244 Right to Repair Act (California)
What is the California Assembly Bill 2440 (AB 2440), the Responsible Battery Recycling Act?
This act addresses loose batteries and batteries designed to be easily removed by consumers.
Unlike SB 1215, which relies on a point-of-sale fee collected by retailers, AB 2440 establishes an Extended Producer Responsibility (EPR) framework. Producers are responsible for funding and managing battery collection and recycling programs.
For hardware manufacturers and brands selling products into California, understanding whether batteries fall under AB 2440 or SB 1215 is critical because the obligations, costs, and supply chain responsibilities differ significantly.
Who Is Responsible for Compliance and Who Joins the Stewardship Program?
AB 2440 assigns responsibility to the "producer", and that entity must join an approved Battery Stewardship Organization (BSO).
In most cases, the producer is the company that sells or distributes covered batteries under its own brand or trademark in California.
However, California applies a cascading hierarchy to ensure there is always a responsible entity located in the United States.
Companies with a U.S. Presence
If your company has a U.S. subsidiary or other legal presence, that entity will typically act as the producer. It is responsible for:
- Joining an approved Battery Stewardship Organization.
- Paying stewardship fees.
- Maintaining compliance.
- Supporting reporting requirements.
Companies Without a U.S. Presence
Overseas manufacturers with no U.S. presence cannot simply register from abroad and assume producer responsibilities.
Instead, responsibility may shift to an exclusive licensee, importer, distributor, or seller located in the United States. That entity becomes the legal producer and assumes responsibility for registration, reporting, and stewardship fees.
Because these obligations can carry significant costs and liabilities, manufacturers and their U.S. partners should clearly define responsibilities before products enter the California market.
Unlike SB 1215, where importers are not specifically assigned compliance obligations, AB 2440 ensures there is always a responsible entity located in the United States.
Is My Battery Covered?
AB 2440 covers both loose batteries and batteries packaged with products when those batteries are designed to be easily removed using common household tools such as:
- A standard screwdriver.
- A coin.
- A hex key.
What Battery Chemistries Are Covered?
Examples include:
- Lithium-ion batteries.
- Nickel-cadmium batteries.
- Alkaline batteries.
- Primary batteries.
- Button cell batteries.
- Common consumer formats such as AA, AAA and 9V batteries.
What Products Are Exempt?
Exemptions include:
- Lead-acid vehicle batteries.
- Batteries contained in medical devices.
- Embedded batteries covered under California's SB 1215 program.
Because the distinction between removable and embedded batteries determines which regulatory scheme applies, product designers should assess battery accessibility early in the development process.
What Are My Compliance Obligations?
Producers cannot comply individually. They must participate in an approved Battery Stewardship Organization (BSO) responsible for collection, recycling, public education, and regulatory reporting.
Join an Approved Battery Stewardship Organization
An example is Call2Recycle, one of North America's leading battery stewardship organisations.
Pay Stewardship Fees
Unlike SB 1215, where consumers pay a separate fee at the point of sale, AB 2440 places the costs on producers.
Stewardship fees are generally based on the weight or volume of batteries introduced into the California market and fund:
- Collection systems.
- Transportation and recycling.
- Public awareness programmes.
- Program administration.
Maintain Active Registration
CalRecycle maintains a public registry of compliant producers.
Failure to maintain active participation can make products ineligible for sale within California.
Provide Battery Identification and Recycling Information
Manufacturers should ensure consumers and downstream handlers have access to information that supports the safe removal, handling, and recycling of batteries.
This information may include:
- Battery chemistry and type.
- Instructions for safely removing replaceable batteries.
- Guidance on appropriate collection and recycling pathways.
- Safety precautions for handling damaged or end-of-life batteries.
Many manufacturers provide this information through user manuals, technical documentation, product support pages, or publicly accessible websites.
Providing clear battery information can help support stewardship objectives and improve collection and recycling outcomes.
Can Retailers and Distributors Continue Selling Non-Compliant Products?
No. California maintains a public list of compliant producers and brands. Beginning January 1, 2027, retailers and distributors are prohibited from selling covered batteries or battery-containing products if the producer is not participating in an approved Battery Stewardship Organisation.
As a result, non-compliance can affect an entire distribution network and may lead to stop-sale actions.
For many brands, maintaining compliance is therefore not only a regulatory issue but also a commercial necessity.
January 1, 2027 Is the Key Deadline
Although stewardship programs are being implemented during 2026, January 1, 2027 marks the point at which the law's sales prohibitions fully take effect.
After that date, removable batteries and products containing them cannot legally be sold in California unless the producer is actively participating in an approved Battery Stewardship Organisation and appears on the state's compliance registry.
For manufacturers and importers, this means compliance should be established well before 2027 to avoid disruptions to existing distribution channels.
What Should Be Included in Distribution Agreements?
Because producer responsibility may shift to a U.S. importer when an overseas manufacturer lacks a U.S. presence, distribution agreements should clearly define responsibilities.
Producer Designation
Contracts should specify which party will:
- Register with the Battery Stewardship Organization.
- Maintain compliance.
- Pay stewardship fees.
- Provide evidence of registration when requested.
Stewardship Fee Arrangements
Where an importer assumes producer responsibilities, agreements should clearly define how stewardship fees will be allocated or reimbursed.
Sales Data Sharing
Because fees are based on the amount of batteries entering California, manufacturers and importers should establish processes for exchanging:
- California sales volumes.
- Product and SKU information.
- Battery weights and chemistries.
- Forecast information where appropriate.
Regular reporting helps ensure stewardship fees are accurately calculated and reported.
What Systems Should Manufacturers Put in Place?
Successful compliance requires coordination between engineering, supply chain, legal, and finance functions.
Engineering
Engineering teams should determine whether batteries are user-removable or embedded, as this determines whether AB 2440 or SB 1215 applies.
Product development teams should also consider how battery information and removal instructions will be communicated to users and downstream recyclers. Addressing these requirements early can avoid late changes to packaging, technical documentation, and support materials.
Supply Chain and Sales
Companies should establish processes to track:
- Battery weights.
- Battery chemistries.
- California sales volumes.
- Product SKUs.
Legal and Commercial Teams
Distribution agreements should clearly allocate responsibilities and establish mechanisms for sharing sales and compliance data.
Finance
Finance teams should recognise stewardship fees as an ongoing cost of doing business and establish processes to forecast and monitor these expenses.
What Should Manufacturers Do Now?
If your company sells batteries or battery-powered products into California, now is the time to:
- Determine whether your batteries are removable or embedded.
- Identify which U.S.-based entity will act as the legal producer.
- Check the "producer" has joined an approved Battery Stewardship Organisation.
- Verify that your brand is listed as compliant before the January 1, 2027 sales prohibition takes effect.
- Establish systems to track battery weights and California sales volumes.
- Ensure battery identification and removal information is readily available to users and recyclers.
- Update commercial agreements to define compliance responsibilities.
- Coordinate with importers and distributors to avoid disruptions to sales channels.
The distinction between SB 1215 and AB 2440 ultimately comes down to battery accessibility. Products with embedded batteries fall under one system, while products with removable batteries fall under another. Understanding which framework applies, and ensuring there is a clearly identified U.S.-based producer, are essential for maintaining uninterrupted access to the California market.
Further Reading:
How to transport lithium batteries
Battery Regulation (EU)
Reese's Law for Button or Coin Cell Batteries (USA)
CPSC eFiling mandate (2026) (USA)
SB 1215 (2022) Embedded Battery Compliance (California)
ACCC Button Cell Battery Instruments (Australia)
SB 244 Right to Repair Act (California)
SB 244 Right to Repair Act (California)
Last Updated: 2026-06-21
What is the Right to Repair Act and how does it relate to products?
California's Right to Repair Act (SB 244) is designed to give consumers and independent repair businesses access to the same parts, tools, software, and repair information provided to authorised repair providers.
The law aims to reduce electronic waste, extend product life, and prevent manufacturers from restricting repairs through limited access to spare parts or proprietary repair tools.
Which products are covered?
The Act applies to electronic and appliance products manufactured on or after 1 July 2021 and sold or used in California, provided they have a wholesale value of at least US$50. The threshold is based on the manufacturer's wholesale price to the retailer, not the final retail price paid by the consumer.
Examples include:
Are any products exempt?
Yes. Excluded products include:
The Act also does not require manufacturers to disclose trade secrets or source code.
How does the Act address repair safety and manufacturer liability?
Unlike some European regulations, which permit manufacturers to restrict certain repairs to professional repairers where specialist skills are needed to maintain safety or performance, California's Right to Repair Act takes a broader approach.
If manufacturers provide specialised tools, software, parts, or repair procedures to authorised repair providers, they must generally make those same resources available to independent repair businesses and consumers on fair and reasonable terms. Technical complexity, waterproofing requirements, adhesives, or calibration requirements are not, by themselves, reasons to withhold repair materials for covered consumer products.
Rather than restricting access, the Act addresses safety concerns by clarifying responsibility.
Manufacturers and authorised repair providers are explicitly shielded from liability for personal injury, product degradation, or property damage that occurs as a direct result of repairs, adjustments, or modifications attempted by consumers or independent repair businesses. For example, if a battery replacement is performed incorrectly, waterproof seals are not properly restored, or a repair causes loss of functionality, the manufacturer is generally not responsible for the resulting damage. Damage caused by unsuccessful repair attempts would also generally not be covered under the manufacturer's warranty.
However, manufacturers remain responsible for design defects and manufacturing flaws that existed independently of the repair.
Independent repair businesses that are not authorised by the manufacturer are required to provide written notice to customers that they are not an authorised repair provider and disclose the use of any third-party replacement parts.
This approach is intended to extend product life and increase repairability while ensuring that responsibility for repair quality rests with the party performing the repair.
How does this law connect to California's battery regulations (AB 2440 and SB 1215)?
California's battery regulations focus on ensuring batteries are properly collected and recycled at end of life. The Right to Repair Act complements these requirements by helping products remain in service longer.
The interaction between the laws is important:
Together, these laws support California's broader circular economy objectives by encouraging both repair and responsible recycling.
What do manufacturers and product developers need to do?
Manufacturers of covered products must make repair materials available to owners and independent repair providers on fair and reasonable terms.
This includes:
These obligations apply regardless of warranty status.
How long do the obligations last?
The availability period depends on the product wholesale price to the retailer:
These periods may extend beyond the product warranty.
How do I demonstrate compliance?
California's framework focuses on making repair materials readily accessible rather than requiring manufacturers to register with a government authority.
For manufacturers
For independent repair businesses
What are the penalties for non-compliance?
Civil penalties may be imposed for each day a violation continues:
Enforcement powers are held by the California Attorney General and California courts.
What should businesses do now?
Businesses selling products into California should:
Further Reading:
How to transport lithium batteries
Battery Regulation (EU)
Reese's Law for Button or Coin Cell Batteries (USA)
CPSC eFiling mandate (2026) (USA)
SB 1215 (2022) Embedded Battery Compliance (California)
AB 2440 Responsible Battery Recycling Act (California)
ACCC Button Cell Battery Instruments (Australia)
What is the Right to Repair Act and how does it relate to products?
California's Right to Repair Act (SB 244) is designed to give consumers and independent repair businesses access to the same parts, tools, software, and repair information provided to authorised repair providers.
The law aims to reduce electronic waste, extend product life, and prevent manufacturers from restricting repairs through limited access to spare parts or proprietary repair tools.
Which products are covered?
The Act applies to electronic and appliance products manufactured on or after 1 July 2021 and sold or used in California, provided they have a wholesale value of at least US$50. The threshold is based on the manufacturer's wholesale price to the retailer, not the final retail price paid by the consumer.
Examples include:
- Smartphones, tablets, and laptops
- Televisions and audio/video equipment
- Cameras and accessories
- Household appliances such as refrigerators, washing machines, and dryers
Are any products exempt?
Yes. Excluded products include:
- Video game consoles
- Alarm systems and fire protection equipment
- Agricultural, construction, mining, forestry, and industrial equipment
- Commercial lawn and garden equipment
The Act also does not require manufacturers to disclose trade secrets or source code.
How does the Act address repair safety and manufacturer liability?
Unlike some European regulations, which permit manufacturers to restrict certain repairs to professional repairers where specialist skills are needed to maintain safety or performance, California's Right to Repair Act takes a broader approach.
If manufacturers provide specialised tools, software, parts, or repair procedures to authorised repair providers, they must generally make those same resources available to independent repair businesses and consumers on fair and reasonable terms. Technical complexity, waterproofing requirements, adhesives, or calibration requirements are not, by themselves, reasons to withhold repair materials for covered consumer products.
Rather than restricting access, the Act addresses safety concerns by clarifying responsibility.
Manufacturers and authorised repair providers are explicitly shielded from liability for personal injury, product degradation, or property damage that occurs as a direct result of repairs, adjustments, or modifications attempted by consumers or independent repair businesses. For example, if a battery replacement is performed incorrectly, waterproof seals are not properly restored, or a repair causes loss of functionality, the manufacturer is generally not responsible for the resulting damage. Damage caused by unsuccessful repair attempts would also generally not be covered under the manufacturer's warranty.
However, manufacturers remain responsible for design defects and manufacturing flaws that existed independently of the repair.
Independent repair businesses that are not authorised by the manufacturer are required to provide written notice to customers that they are not an authorised repair provider and disclose the use of any third-party replacement parts.
This approach is intended to extend product life and increase repairability while ensuring that responsibility for repair quality rests with the party performing the repair.
How does this law connect to California's battery regulations (AB 2440 and SB 1215)?
California's battery regulations focus on ensuring batteries are properly collected and recycled at end of life. The Right to Repair Act complements these requirements by helping products remain in service longer.
The interaction between the laws is important:
- AB 2440 generally applies where batteries can be removed using common household tools.
- SB 1215 applies to products with embedded batteries that are not readily removable and introduces point-of-sale recycling fees.
- SB 244 requires manufacturers to provide repair information, tools, software, and replacement parts, enabling independent repairers and consumers to replace worn batteries and extend product life.
Together, these laws support California's broader circular economy objectives by encouraging both repair and responsible recycling.
What do manufacturers and product developers need to do?
Manufacturers of covered products must make repair materials available to owners and independent repair providers on fair and reasonable terms.
This includes:
- Documentation, such as service manuals, schematics, diagnostic information, and error codes. Electronic copies must generally be provided free of charge.
- Tools and software, including diagnostic and calibration tools.
- Replacement parts, which must be offered on terms comparable to those available to authorised repair providers.
These obligations apply regardless of warranty status.
How long do the obligations last?
The availability period depends on the product wholesale price to the retailer:
- US$50 to US$99.99: 3 years after the last manufacturing date
- US$100 or more: 7 years after the last manufacturing date
These periods may extend beyond the product warranty.
How do I demonstrate compliance?
California's framework focuses on making repair materials readily accessible rather than requiring manufacturers to register with a government authority.
For manufacturers
- Provide publicly accessible portals for ordering replacement parts.
- Make repair manuals and documentation available for download.
- Provide access to diagnostic software and specialised tools on fair and reasonable terms.
For independent repair businesses
- Provide a conspicuous written notice to consumers before servicing a device stating that they are not an authorised repair provider.
- Disclose when third-party replacement parts are used.
What are the penalties for non-compliance?
Civil penalties may be imposed for each day a violation continues:
- First violation: up to US$1,000 per day.
- Second violation: up to US$2,000 per day.
- Third and subsequent violations: up to US$5,000 per day.
Enforcement powers are held by the California Attorney General and California courts.
What should businesses do now?
Businesses selling products into California should:
- Identify products covered by the Act and determine whether three-year or seven-year support obligations apply.
- Ensure battery designs have been assessed under AB 2440 and SB 1215 requirements.
- Establish processes for providing repair documentation, software, and tools.
- Develop spare-parts strategies to support products throughout the required service period.
- Review agreements with repair networks to ensure compliance with disclosure requirements.
- Consider how California's approach differs from the EU Battery Regulation and Ecodesign requirements, particularly where products rely on waterproof seals, specialised adhesives, or calibration procedures.
Further Reading:
How to transport lithium batteries
Battery Regulation (EU)
Reese's Law for Button or Coin Cell Batteries (USA)
CPSC eFiling mandate (2026) (USA)
SB 1215 (2022) Embedded Battery Compliance (California)
AB 2440 Responsible Battery Recycling Act (California)
ACCC Button Cell Battery Instruments (Australia)
Cyber Security Act 2024 and Smart Device Security Rules 2025
2026-02-19
The Australian Government has introduced mandatory security requirements under the Cyber Security Act 2024 and the Cyber Security (Security Standards for Smart Devices) Rules 2025. These standards ensure that internet connected devices are secure by design, protecting consumers from common cyber threats.
When do these changes come into effect?
The new standards apply to all in-scope products manufactured on and from 4 March 2026.
What products are covered?
The rules apply to "relevant connectable products." These are smart devices that connect to the internet either directly or indirectly (such as via a Bluetooth phone app). This includes products intended for personal, domestic, or household use, or those that could reasonably be expected to be acquired for such use.
What products are excluded?
Specific categories are exempt because they are managed under other regulations. These include:
What are the four key requirements?
What must be included in the Statement of Compliance?
At minimum, the statement must include:
Disclaimer: This information is a general summary for informational purposes only. For definitive requirements, the official regulatory documents, including the Cyber Security Act 2024 and associated Rules, should always be referred to.
The Australian Government has introduced mandatory security requirements under the Cyber Security Act 2024 and the Cyber Security (Security Standards for Smart Devices) Rules 2025. These standards ensure that internet connected devices are secure by design, protecting consumers from common cyber threats.
When do these changes come into effect?
The new standards apply to all in-scope products manufactured on and from 4 March 2026.
What products are covered?
The rules apply to "relevant connectable products." These are smart devices that connect to the internet either directly or indirectly (such as via a Bluetooth phone app). This includes products intended for personal, domestic, or household use, or those that could reasonably be expected to be acquired for such use.
What products are excluded?
Specific categories are exempt because they are managed under other regulations. These include:
- Desktop computers, laptops, smartphones, and tablet computers.
- Therapeutic goods as defined by the Therapeutic Goods Act 1989.
- Road vehicles and road vehicle components under the Road Vehicle Standards Act 2018.
What are the four key requirements?
- Provided passwords must be unique per product or defined by the user. This applies to the device hardware and any pre-installed software required for its intended use. This requirement ensures that a single leaked password cannot be used to compromise thousands of different devices. Note: this requirement only applies to products that use a password for the smart device’s hardware or pre-installed software and where software is required to be installed for the product’s intended usage
- Manufacturers must publish a clear way for people to report security vulnerabilities. This reporting process must be available in English, free of charge, and accessible without requiring personal information from the reporter (email address only). Manufacturers must also provide status updates on the resolution of any reported issues.
- Manufacturers must be transparent about how long a device will receive security updates. This information must be clear and accessible to consumers before they buy the product. The security standards require the defined support period to be a period of time with an end date, rather than an end to a period of time. Examples of fixed end dates are "no earlier than 30 June 2027" or "ending on 30 June 2029".
- Every in-scope product must be accompanied by a formal Statement of Compliance (SoC). This document must be provided with the supply of the product and can also be published on the manufacturer's website. Both manufacturers and suppliers are required to retain a copy of this statement for five years. The Statement of Compliance must accompany the product. This can be achieved by including a physical copy in the box or by providing a prominent QR code or URL on the packaging or in the user manual that links directly to the digital statement.
What must be included in the Statement of Compliance?
At minimum, the statement must include:
- The product type and batch identifier.
- The name and address of the manufacturer.
- The name and address of an authorised representative of the manufacturer, including any representatives located in Australia.
- A declaration that the statement was prepared by or for the manufacturer.
- A declaration that, in the manufacturer's opinion, the product complies with the security standards.
- The defined support period for the product at the date the statement is issued.
- The signature, name, and function of the signatory.
- The place and date of issue.
Disclaimer: This information is a general summary for informational purposes only. For definitive requirements, the official regulatory documents, including the Cyber Security Act 2024 and associated Rules, should always be referred to.
Source: https://www.homeaffairs.gov.au/cyber-security-subsite/files
ACCC Button Cell Battery Instruments
2026-06-15
What are the Australian button battery regulations?
In 2024 the Australian Government enforced world-first mandatory safety and information standards for button/coin batteries and consumer goods that contain them. Administered and enforced by the Australian Competition and Consumer Commission (ACCC), these laws reduce the risk of death and severe internal injury caused by young children swallowing or inserting button batteries.
The regulations are split into four distinct mandatory instruments legislated under the Australian Consumer Law:
Which products are covered?
The standards apply across the entire supply chain (including manufacturers, importers, distributors, wholesalers, and retailers) and encompass both brand-new and second-hand items. They cover:
What materials or products are excluded or exempt?
The Australian standards clearly define specific exclusions where the safety and packaging mandates do not apply:
What do manufacturers and importers need to do?
If you supply consumer goods or batteries to the Australian marketplace, you must satisfy rigorous design, testing, and labeling metrics:
How do I demonstrate compliance?
Suppliers must proactively verify compliance before any product is placed on the market. Unlike other regulatory systems that rely entirely on self-declaration certificates, the ACCC and state consumer protection agencies heavily police this framework by requesting formal laboratory test reports. To demonstrate compliance, a business must be able to produce legitimate, up-to-date test reports from an accredited laboratory proving that both the product construction and its battery packaging have successfully undergone the specified mechanical and informational standard testing.
What are the penalties for non-compliance?
Australia enforces some of the strictest financial penalties in the world for product safety breaches. Failure to comply with a mandatory safety or information standard is a violation of the Australian Consumer Law and can result in:
See also:
How to transport lithium batteries
Battery Regulation (EU)
Reese's Law for Button or Coin Cell Batteries (USA)
CPSC eFiling mandate (2026) (USA)
SB 1215 (2022) Embedded Battery Compliance (California)
AB 2440 Responsible Battery Recycling Act (California)
What are the Australian button battery regulations?
In 2024 the Australian Government enforced world-first mandatory safety and information standards for button/coin batteries and consumer goods that contain them. Administered and enforced by the Australian Competition and Consumer Commission (ACCC), these laws reduce the risk of death and severe internal injury caused by young children swallowing or inserting button batteries.
The regulations are split into four distinct mandatory instruments legislated under the Australian Consumer Law:
- Consumer Goods (Button/Coin Batteries) Safety Standard 2020
- Consumer Goods (Button/Coin Batteries) Information Standard 2020
- Consumer Goods (Products Containing Button/Coin Batteries) Safety Standard 2020
- Consumer Goods (Products Containing Button/Coin Batteries) Information Standard 2020
Which products are covered?
The standards apply across the entire supply chain (including manufacturers, importers, distributors, wholesalers, and retailers) and encompass both brand-new and second-hand items. They cover:
- Standalone Batteries: Any loose or replacement button/coin cell battery where the battery diameter is greater than its height, regardless of chemistry (lithium, alkaline, silver oxide, etc.).
- Consumer Goods: Any consumer product, accessory, or novelty item that uses, is powered by, or is supplied with a button or coin cell battery. Common examples include car key fobs, remote controls, digital notepads, kitchen/bathroom scales, smart home accessories, and light-up novelty products.
What materials or products are excluded or exempt?
The Australian standards clearly define specific exclusions where the safety and packaging mandates do not apply:
- Zinc-Air Hearing Aid Batteries: Zinc-air button batteries specifically intended for hearing aids are explicitly exempt from the safety standard (meaning they do not require child-resistant blister packaging), though they must still comply with the warning requirements of the information standard.
- Soldered Batteries: Audio-visual, information technology, and communications equipment where the button/coin batteries are permanently soldered into place are exempt.
- Bulk Industrial Supply: Batteries or products supplied in bulk exclusively for trades, professions, or industries (such as watchmakers or jewellers replacing batteries on behalf of a consumer) are excluded, provided they are never sold directly to the general public and are not used around children.
What do manufacturers and importers need to do?
If you supply consumer goods or batteries to the Australian marketplace, you must satisfy rigorous design, testing, and labeling metrics:
- Secure Compartments: For consumer goods with replaceable batteries, the battery compartment must be designed to be child-resistant. It must require a tool (such as a screwdriver) to open, or require at least two independent and simultaneous hand movements. Additionally, captive screws must be used so that the screws remain attached to the battery cover when unscrewed.
- Mechanical Safety Testing: Products cannot be assessed on a visual inspection alone. They must pass mandatory physical "use and abuse" testing conducted against recognized international testing standards (such as UL 4200A, AS/NZS 62115, or AS/NZS 8124.1). This involves stress tests including drop, impact, crush, torque, and specific probe manipulation testing to guarantee the battery is never exposed or liberated.
- Child-Resistant Battery Packaging: Standalone or spare batteries must be wrapped in tested child-resistant packaging. This applies to all lithium batteries of any size, and any other battery chemistry with a diameter of 16mm or larger. If multiple batteries are in a pack, the blister packaging must be designed to release only one battery at a time.
- Mandatory Warning Labels: Specific, highly visible safety warnings must be displayed. The front panel of product packaging must feature a safety alert symbol and a "keep out of reach of children" symbol. Furthermore, lithium batteries with a diameter of 20mm or larger must have the "keep out of reach of children" symbol permanently marked directly on the cell itself. Packaging must also feature explicit emergency text, including the contact details for the Australian Poisons Information Centre (13 11 26).
How do I demonstrate compliance?
Suppliers must proactively verify compliance before any product is placed on the market. Unlike other regulatory systems that rely entirely on self-declaration certificates, the ACCC and state consumer protection agencies heavily police this framework by requesting formal laboratory test reports. To demonstrate compliance, a business must be able to produce legitimate, up-to-date test reports from an accredited laboratory proving that both the product construction and its battery packaging have successfully undergone the specified mechanical and informational standard testing.
What are the penalties for non-compliance?
Australia enforces some of the strictest financial penalties in the world for product safety breaches. Failure to comply with a mandatory safety or information standard is a violation of the Australian Consumer Law and can result in:
- Mandatory, public product recalls
- Immediate import detentions and border seizures
- Formal court-enforceable undertakings and infringement notices
- Substantial Fines: For individuals, criminal and civil penalties can reach up to AUD $500,000. For corporations, the maximum financial penalty per breach is the greater of AUD $10,000,000, three times the value of any benefit derived, or 10% of the company's annual turnover. The Federal Court imposes multi-million-dollar penalties on retailers for distributing non-compliant button battery goods, demonstrating that regulators treat these standards as an absolute priority.
See also:
How to transport lithium batteries
Battery Regulation (EU)
Reese's Law for Button or Coin Cell Batteries (USA)
CPSC eFiling mandate (2026) (USA)
SB 1215 (2022) Embedded Battery Compliance (California)
AB 2440 Responsible Battery Recycling Act (California)
