GPSR: What the regulation requires of you

Product Safety 9 minuten lezen
Short answer

The GPSR is Regulation (EU) 2023/988. It has applied since December 13, 2024, and replaced the old Product Safety Directive. It requires a responsible economic operator in the EU, an internal risk analysis with technical documentation, and four fixed pieces of information for every online offer.

Without a responsible person in the EU, a product under the GPSR may not be placed on the market.

What the GPSR regulates

The GPSR acts as a safety net. It applies to consumer products insofar as there are no specific provisions with the same objective in Union law. If your product is already covered by harmonisation legislation, the regulation continues to apply to risks not covered by that legislation.

Regulation (EU) 2023/988 dates from May 10, 2023. It applies from December 13, 2024. On that same date, the old General Product Safety Directive 2001/95/EC and Directive 87/357/EEC were repealed. The scope excludes, among others, medicinal products, food, animal feed, and living plants and animals.

The most common misconception is this: my product has CE marking, so the GPSR does not apply to me. Article 2 says otherwise. For covered risks, specific legislation applies; for all other aspects, the GPSR remains in force. Both therefore apply side by side.

Who your responsible person in the EU is

Article 16 is strictly worded. A product may not be placed on the market unless there is an economic operator established in the Union who is responsible for it. If the manufacturer is established outside the EU, that role falls to the importer, an authorised representative, or a fulfilment service provider.

The sequence is set out in Article 4 of the Market Surveillance Regulation (EU) 2019/1020. If the manufacturer is in the EU, it is the manufacturer themselves. If they are outside, it is the importer’s turn. If there is no importer in the EU, there must be an authorised representative with a written mandate for these tasks.

That person is not a mere mailbox. They regularly check whether the product conforms to the technical documentation and whether the requirements of Article 9 are being met. At the request of the market surveillance authority, they provide documented evidence of those checks. Their name and contact details appear on the product, the packaging, the parcel, or in an accompanying document.

An address on the box is not yet a formalised role

We regularly see a European address on the packaging without any underlying agreements. Who performs the checks? Who retains the evidence? Who responds to the regulator within what timeframe? Without those agreements, the listing is a risk rather than a solution.

What must be included in your online offer

Article 19 sets four requirements for every distance offer. The name and the postal and email address of the manufacturer. For a manufacturer outside the EU, also those details of the responsible person. Information to identify the product, including an image. And all warnings or safety information.

This is the provision that most often visibly goes wrong. Not because it is complicated, but because it is on the product page itself. Anyone can check it: a regulator, a trading platform, a competitor filing a report. No one from the outside sees the rest of your file, but everyone sees your product page.

Pay particular attention to the warnings. These should be in the offer, i.e., before someone buys. A warning that only appears on the product inside the box comes too late for this provision.

The documentation you retain for ten years

Before placing the product on the market, the manufacturer performs an internal risk analysis and prepares technical documentation. This contains at least a general description of the product and the characteristics relevant to safety. The documentation remains up to date and available to the authorities for ten years.

If there are risks associated with the product, more should be included: an analysis of those risks, the measures you took to eliminate or reduce them, the results of test reports, and a list of the European standards you have applied. If you apply a standard only partially, you indicate which parts those are.

That last sentence is often skipped. A test report that refers to a standard without stating which clauses were tested is difficult to defend during an inspection.

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    What a recall requires of you

    In the event of a recall for safety reasons, you must offer the consumer an effective, free, and timely solution. In doing so, you provide a choice of at least two out of three possibilities: repair, replacement with an equivalent safe product, or a refund of at least the price paid by the consumer.

    Offering only one option is only permitted when the others are impossible or involve disproportionately high costs. That is an exception you must be able to substantiate, not a standard choice.

    Furthermore, the recall notice has a prescribed format. It bears the heading ‘Product Safety Recall’, is drawn up in the language of the Member State where the product was placed on the market, and contains a clear description of the product with an image. Reporting to the regulator is done via the Safety Business Gateway.

    Trading platforms and the Safety Gate

    If you sell via a trading platform, your listing is part of a chain of surveillance. If the platform receives an order from a market surveillance authority to remove an offer or make it inaccessible, it must execute this within two working days of receipt and inform the authority.

    That pace determines your risk. Your turnover will come to a standstill faster than an objection can be processed. That is why the sequence is important: first get the information from Article 19 in order and the file complete, only then scale. Platforms themselves are also increasingly asking for the same information before a listing is allowed to go live.

    What you should check now

    Start with the question of who your responsible person in the EU is and whether that role has actually been assigned. Then, review a sample of your product pages for the four mandatory pieces of information. Finally, check whether you can find the corresponding documentation for each article number.

    1. Determine for each supplier who the responsible person in the EU is. Record in writing who performs the checks and who retains the evidence.
    2. Check ten random product pages for the four pieces of information from Article 19. What you find for ten almost always applies to the rest.
    3. Place the warnings in the offer itself, not just on the product or in the manual.
    4. Request the risk analysis and test reports for each product. Check whether they state which parts of the standards have been applied.
    5. Establish how you file a report via the Safety Business Gateway and who within your organisation is authorised to do so.

    Your product range according to the GPSR

    We determine which requirements apply per product group, assign the role of responsible person, and build the documentation to help you pass an inspection. Fixed price in advance.

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