Changes To General Product Liability Regulations in EU and UK

General Product Liability is a catchall term for anything that doesn’t have its own set of regulations.  Cosmetics do, of course, have their own regulations.  But a lot of cosmetic companies also make products that aren’t strictly cosmetics – things like scrubbing brushes, room sprays and false eyelashes, for a few cases.  There are a few things that seem to be candidates to be cosmetics, medicines or nothing in particular.  Nobody seems to have worked out what intimate products are, for example – and I’ve seen them on the same shelf with different brands opting for different regulatory regimes.

The key EU legislation governing product liability at time of writing (but not for much longer)  is the EU Product Liability Directive (85/374/EEC), which was implemented in the UK through the Consumer Protection Act 1987. This establishes a no-fault/strict liability regime, where producers can be held liable for damage caused by defective products regardless of negligence. The no-fault/strict liability approach means the focus is solely on whether the product was defective, rather than on the producer’s conduct. As long as the claimant can demonstrate the product was defective and this caused their injury or damage, they can recover compensation – the producer’s level of care or intent is irrelevant. This shifts the burden of risk away from consumers and onto producers, who are expected to ensure the safety of the products they place on the market. The rationale is that producers are in the best position to prevent defects and should bear the costs of any harm caused. The strict liability nature also means consumers do not have to prove how or why the product became defective – the mere fact it was defective and caused harm is sufficient. This is seen as advantageous for claimants, who may struggle to access information about the product’s design and manufacture. However, the strict liability regime is not absolute – producers can still raise certain defenses, such as the “state of the art” defense if the defect could not have been discovered given the scientific and technical knowledge at the time. But the burden is on the producer to prove this. So in summary, the no-fault/strict liability approach aims to make it easier for consumers to obtain compensation when harmed by defective products, by removing the need to prove negligence on the part of the producer. The focus is solely on the product’s safety, not the producer’s conduct.

In practice it is up to the producer to decide what kind of package of data they need to put together.  This is governed basically by the need to be able to, ultimately, be able to stand up in court and justify that what you’ve done as appropriate.  Say you are putting false eyelashes on the market.  For false eyelashes specifically, producers would need to ensure the product is safe and meets consumer expectations. This could include:

• Carefully formulating the eyelash adhesive to avoid potential skin irritants or toxins that could cause injury.
• Providing clear and accurate labeling, including any relevant safety warnings (e.g. not for use on eyelids).
• Maintaining robust quality control and documentation to demonstrate the product’s safety if a claim arises.
• Reviewing document retention policies to be prepared for potential disclosure orders from claimants.

Ultimately, the strict liability regime places a high onus on producers to ensure the safety of their products. Careful design, manufacturing, and documentation will be crucial for false eyelash producers to meet their liabilities.

This has been the state of play for around 30 years so it isn’t surprising that the rules are being revised and updated.  There are two main new developments.

Article 4 of Regulation (EU) 2023/988 addresses the general safety requirements for products. It mandates that all products made available on the market must be safe. It specifies that the safety of products should primarily be achieved through their design and manufacturing, taking into account the intended and foreseeable usage. Additionally, the remaining risks should be minimized through protective measures such as warnings and instructions. The assessment of product safety must consider various aspects including the product’s characteristics, its presentation, and the particular vulnerabilities of potential users, especially children, the elderly, and persons with disabilities. The overall aim of Article 4 is to ensure a high level of protection for consumer health and safety across the EU market.

Article 16 of Regulation (EU) 2023/988 outlines the requirements for economic operators to provide essential traceability and safety information on products. This includes ensuring that products carry details that allow for their identification, such as the name and contact address of the economic operator. Additionally, the products must include safety information that is clear and understandable, assisting consumers in identifying and avoiding potential risks associated with the product’s use under normal or reasonably foreseeable conditions. Instructions and safety information must also be presented in a language that consumers and users in the member state where the product is sold can easily understand. These requirements are designed to enhance product safety and compliance throughout the EU market.

The Economic Operator in Article 16 comparable to the Responsible Person referred to in the cosmetic regulation 2009/1223 – albeit it is a bit of a wider range of responsibilities.  It covers anything to do with safety, not just the specifics in the regulations.  I’d hope that this wouldn’t make any difference in practice.  You really shouldn’t turn a blind eye to safety issues arising from cosmetics just because the legislators didn’t include them in the regulations.  There is no notification process for general products, so that is another difference.  But is basically the same idea. It is a requirement for a company selling its products to have a legal entity to take responsibility for what is being sold.  A safety assessment is required, but no format is laid down for them.  The iteration of the cosmetic regulations that introduced the requirement for safety assessments didn’t have a format either.  Those of us who were around at the time had to work out what to do ourselves.

Overall I think that the cosmetics industry won’t have much trouble with the new rules.  There is nothing that we aren’t already familiar with and I suspect that a lot of the new requirements are already being met by cosmetic companies.   The new rules come into force in December of 2024 in the EU.  It is likely that the UK will follow with comparable regulations.