Key changes for companies related to the new General Product Safety Regulation
On 30 March 2023, the European Parliament adopted the General Product Safety Regulation for consumer products, which replaces the General Product Safety Directive of 2001 (2001/95/EC). The Council must formally approve the text before it can be published in the Official Journal of the EU and enter into force. The Regulation's validity begins 18 months after it enters into force.
One of the most significant changes to the European non-food consumer product safety landscape in years, here are the 16 key changes:
1. Recognition of the fulfillment service provider as an economic operator
The fulfillment service provider will be considered an economic operator and will thus become the addressee of many requirements from the General Product Safety Regulation for the first time.
2. Forward displacement of the scope of application in online trade
Consumer products are already considered to be made available on the market if they are offered by way of distance selling (i.e. generally online). This is a considerable forward displacement of the point in time from which obligations under the General Product Safety Regulation take effect. Companies will need to be prepared to make their products compliant at this early stage.
3. Extension of the "safe product" assessment criteria
Economic operators may only make products available on the European market if these products are safe. The safety assessment criteria that need to be taken into account are extended and refined by the General Product Safety Regulation. Relevant factors to consider in the future include the potential impact of other products on the product being evaluated; cybersecurity features; and the changing, evolving and predictive functions of a product (i.e. self-learning, AI-like aspects, but also the impact of gender differences and the attractiveness of the product to children).
4. Obligation of manufacturers to perform risk analysis and to prepare technical documentation for non-harmonised products
For non-harmonised products (e.g. the simple table or chair, the bookshelf, a glass bottle, etc.), manufacturers are subject to obligations that did not exist previously (e.g. the obligation to conduct a risk analysis and to prepare technical documentation). The technical documentation must be kept up to date, retained for ten years, and made available to the authorities. Importers must ensure compliance with the requirements.
5. Marketability of a product requires the existence of an economic operator established in the EU
In the future, there will be an obligation to have an economic operator established in the EU. Otherwise, products cannot be placed on the EU market. The European Market Surveillance Regulation (EU/2019/1020) has already introduced this obligation across the board for harmonised products and this obligation is now also being extended to non-harmonised products.
6. Obligation to establish internal product compliance processes
In the future, economic operators will be required to set up processes to ensure that the requirements of the General Product Safety Regulation applicable to them in each case are complied with. Furthermore, manufacturers must ensure that serial products are always manufactured in accordance with the safety requirements of the General Product Safety Regulation. This new aspect of having concrete procedures in place will give market surveillance authorities opportunities to ultimately conduct reviews in companies independently of individual products.
7. Obligation to provide communication channels for consumer complaints
Manufacturers are required to provide a complaints portal, for example by telephone, email, website, etc. This should also make it possible to inform manufacturers of any accidents or safety issues in connection with a product. Importers must verify compliance with the requirements. If necessary, they must set up appropriate channels themselves.
8. Obligation to maintain an internal complaints register
Manufacturers are required to keep an internal record of complaints as well as product recalls and any corrective measures that have been taken.
9. Significant (digital) modification of a product creates manufacturer responsibility
For the first time, whoever substantially modifies a product is also considered the manufacturer. Interestingly, a "digital modification" of a product can also be significant, which can result in a considerable extension of manufacturer responsibility even for those companies that only "optimise" the digital side of a product (e.g. using add-ons).
10. Obligation to maintain a special traceability system for certain products
For products likely to pose a serious health risk, the Commission may establish a traceability system to be adopted by economic operators placing and making those products available on the market.
11. New and early (information) obligations for online traders
The General Product Safety Regulation sets out a number of obligations that economic operators must comply with when making products available online or via another form of distance selling. For example, a clear and visible warning indication and safety information must be affixed to or enclosed with the product.
12. Special obligations for online marketplaces
Operators of online marketplaces (e.g. the obligation to maintain a single point of contact for market surveillance authorities and consumers) must respond to market surveillance instructions within two working days, monitor and take into account notifications in the Rapid Alert System (formerly RAPEX) or inform customers about product recalls and market surveillance authorities about dangerous products and to report accidents.
13. New reporting obligations for accidents
In the future, the manufacturer will be required to immediately report accidents caused by a product through the Safety Business Gateway if the accident has resulted in death or serious adverse effects. Importers and distributors are also required to report accidents, but this report must be made to the manufacturer. The manufacturer must then either report the accident or instruct the importer or one of the dealers to make this report. Online marketplaces, however, have their own reporting obligation.
14. Extension of the information obligations of economic operators and providers of online marketplaces regarding product safety
In the event of a product safety recall or safety warnings, economic operators and online marketplace providers must, in line with their respective obligations, ensure that all identified affected consumers are informed directly without undue delay. Product registration systems or customer loyalty programmes are also to be used. In these systems or programmes, customers must also be given the option of storing separate contact data solely for security purposes.
15. New requirements for handling product recalls
As has been the case up to now, three key aspects must always be observed immediately where a hazardous product is concerned: corrective action (e.g. recall or warning), information to consumers, and notifying the market surveillance authority.
The requirements for handling a recall have been clarified. A recall notice must be available in the language of the member state where the product was placed on the market. The recall notice must be easy to understand and include the heading "Product Safety Recall", a clear description of the recalled product with an image, the name and brand of the product, and information about when and where the product was sold. Certain elements may no longer be used such as "voluntary," "precautionary," "discretionary," "in rare/specific situations," and the statement that no accidents have yet been reported.
16. "Rectification" as a result of a recall
The economic operator initiating the recall must offer the consumer an effective, free and timely remedy in the event of a recall. In concrete terms, this means the repair of the recalled product, the replacement of the recalled product and the reimbursement of the value of the recalled product. Up to now, these forms of remedy have only been known in the field of contract law. Specifically, in light of the fact that the obligation for remedial action is aimed at all economic operators, this may result in a duplication of claims and at least a detachment of remedies from existing contractual relationships.
Conclusion: timely adjustments reflecting the new General Product Safety Regulation are recommended
After the regulation enters into force, there will still be a transition period of 18 months before being applicable. Since it takes time to develop and manufacture products, and due to the additional operational obligations such as the handling of hazardous products or complaints in general, companies are strongly advised to act now to prepare for the changes that are coming their way.
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