Navigating compliance with the General Product Safety Regulation: Key obligations for manufacturers

In our previous blog, 'Preparing for the EU’s new General Product Safety Regulation in 2024', we explored the transformative impact of the General Product Safety Regulation (EU) 2023/988 (GPSR) on businesses operating in the EU. As we discussed, the GPSR, effective from 13 December 2024, introduces comprehensive updates to align with modern market realities.

Building on that overview, we delve deeper into the specific obligations applicable to manufacturers. From ensuring product safety and traceability to complying with new monitoring and accident reporting requirements, we outline what manufacturers need to know to adapt to this regulatory shift. Whether operating within the EU or exporting to it, understanding these responsibilities is vital for maintaining compliance and market access in an increasingly stringent regulatory environment.

What Products are covered by the GPSR?

The GPSR will apply to all products made available on the EU market whether new, used, repaired, or reconditioned. It will cover every type of product, whether or not it is interconnected with other items, supplied, or made available to consumers. For products already governed by other sector specific rules i.e. toys, the GPSR will still apply but only to the extent that the existing sector specific legislation does not address aspects covered under the GPSR.

The range of products within the scope of the GPSR is clearly extremely wide-ranging. A non-exhaustive list of products within scope includes furniture; household items including lighting and kitchenware, through to pet products, fitness equipment, power tools, vehicles and accessories.

Exempt products:

Certain products are explicitly exempt such as food, medicines, veterinary medicines, plants and plant protection products, antiques, aircraft and public transport.

What is a Manufacturer under the GPSR?

Any person or business is regarded as a manufacturer if they manufacture a product or market a product under their name or trademark. This definition extends the scope of who is considered a manufacturer and requires those who hold a product out as their own, such as retailers, to be subject to the additional obligations placed on manufacturers under the GPSR.

Product Safety Standards and Risk Assessments

Manufacturers are required to ensure that only safe products are made available on the EU market. There is a presumption of conformity if manufacturers can demonstrate compliance with applicable EU standards and specific product safety requirements. In general, this will require manufacturers to assess a range of risk factors such as:

• the product's design and features.
• the intended (and foreseeable) use of the product.
• its packaging, labelling, and instructions for safe use and disposal.
• how the product interacts with other products, particularly when a product may be used with or connected to external devices or components.
• any risks posed to vulnerable consumers, such as children, older persons, and individuals with disabilities, while accounting for gender-specific health and safety impacts.

The GPSR will also require manufacturers to design products that remain safe throughout their intended lifespan and accommodate risks from foreseeable modifications, updates, or repairs. Substantial modifications to a product that affect its compliance may result in the product being classified as a new product, shifting regulatory responsibilities to the modifying party. Any product that appears similar to food or objects attractive to children must also be designed to prevent misuse, for example accidental ingestion.

Technical Documentation

The GPSR introduces a requirement for manufacturers to create and maintain thorough technical documentation for their products. This documentation serves as evidence that a product meets the safety standards under the GPSR. Manufacturers must ensure the documentation is up to date and accessible to market surveillance authorities for a period of 10 years after the product is first made available for distribution, consumption or use on the EU market.

It is important to note that the level of detail required in the documentation must align with the product's complexity and associated safety risks. For example, simple low-risk products (for example, books or basic kitchenware such as plates, bowls and utensils without sharp edges), would require less detail than those deemed to be high-risk or complex (for example, electric toy cars or washing machines) which require greater safety testing and would need comprehensive instructions for safe use and maintenance requirements set out in accompanying documentation.

Traceability

Product traceability is a central aspect of the GPSR and applies to both online and offline sales channels. The rationale is that by enabling prompt identification of both the product and responsible manufacturers, as well as the removal of unsafe products, this will advance consumer safety and promote an enhanced recall process for non-compliant products.

Product traceability

Products must bear a type, batch, serial number, or another identifier that allows the product to be traced.

The identifying information must be easily visible and legible and be on the product, unless the size or nature of the product makes this impractical. In such cases, the information may be provided on the packaging or in accompanying documentation.

Product labelling

Manufacturers are also required to display their contact details, which include:

• the full name or registered trade name of the manufacturer; and
• the postal and electronic addresses of the manufacturer or contact details for a single point of contact for consumer or official inquiries.

Again, this information must be placed on the product itself wherever possible but may be placed on the packaging or in accompanying documentation if the size or nature of the product does not make this possible.

Monitoring and Reporting

The GPSR also places obligations on manufacturers to ensure ongoing compliance with safety standards, effective risk management, and prompt communication of safety issues.

If a manufacturer discovers, or is informed, that a product they have placed on the market is dangerous they are required to take immediate action. This includes:

• taking corrective measures in order to bring the product into compliance, such as withdrawal or recall.
• notifying consumers of the non-compliance, including any identified safety risks and any necessary actions to mitigate them.
• informing market surveillance authorities via the Safety Business Gateway reporting the details of the product, the circumstances of any reported accident and adverse effects on a person's health and safety, ongoing health and safety concerns, the corrective measures already undertaken and the quantity of products still on the market. This information will then be publicly made available to consumers to alert them to the dangerous product.

Manufacturers are also required to notify all relevant economic operators, including distributors, authorised representatives, and online marketplace providers, of identified safety issues. This ensures a coordinated response across the supply chain to minimise risks and prevent further distribution of unsafe products.

What about Manufacturers not based in the EU?

In order to place a product on the market there must be an EU-based economic operator to act as the responsible person to ensure compliance with the GPSR. If a manufacturer is not based in the EU, this role can be fulfilled by an importer, an authorised representative appointed through a written mandate, or a fulfilment service provider based in the EU where there is no EU importer or authorised representative appointed.

This responsible person must be clearly identified on the product, its packaging, or an accompanying document. Their responsibilities include:

• acting as the point of contact for market surveillance authorities to ensure unbroken communication during any enforcement actions or compliance checks.
• facilitating compliance with GPSR obligations and verifying the product’s documentation and safety information to ensure conformity.
• informing the manufacturer of any compliance issues related to a product.

By requiring an EU-based responsible person, the GPSR ensures accountability within the EU market for all products, regardless of the manufacturer’s location.

Final Thoughts

The introduction of the GPSR represents a significant development in EU product safety standards, reflecting the complexities of modern markets, technological advancements, and evolving consumer needs. By establishing stringent obligations for manufacturers (including product safety standards, enhanced traceability, continuous monitoring, and comprehensive accident reporting) the GPSR sets a new benchmark for ensuring consumer safety across the EU.

Manufacturers based outside the EU (including those in the UK) face additional challenges, including the need to appoint an EU-based responsible person. This requirement ensures that every product entering the EU market is backed by a reliable entity accountable for compliance, bolstering consumer protection and market surveillance. In our next blog, we will explore the role of the responsible person in greater detail.

For more information on the GPSR and how your business can prepare for the new rules coming into effect on 13 December 2024 or EU law generally, please contact Grant Strachan or your usual Brodies contact.