EU General Product Safety Regulation Entered into Force
After years of discussions on the subject and amid much expectation, the reform of the EU general product safety legislation has been finally adopted and entered into force on 12 June 2023. It seeks to address some of the major new societal challenges that emerged over the past two decades, including the increasing digitalization, the development of new technological and globalization of the supply chains.
Key changes brought by the reform include the introduction of product safety obligations for online marketplaces, the obligation on manufacturers to conduct an internal risk assessment and draw up a technical documentation for their products; the obligation to have a responsible person established in the EU; the introduction of product safety obligations for online marketplaces; or the enhancement of rules on product recalls.
1. The overall context
The entry into force of Regulation (EU) 2023/988 ('General Product Safety Regulation' or 'GPSR') on 12 June 2023 is the culmination of a long-awaited revision of the EU general product safety framework legislation. This reform was announced by the Commission in the New Consumer Agenda and formally proposed on 30 June 2021, almost a decade after a previous attempt to overhaul the General Product Safety Directive ('GPSD') stalled in the early 2010s.
This instrument repeals the General Product Safety Directive ('GPSD'), which had been in force since 2001, and the Food-Imitating Product Directive, which is subsumed into the scope of the GPSR. However, the application of the GPSR and the repeal of the above-mentioned EU Directives will only be effective after a transitional period expiring on 13 December 2024.
The new GPSR provides a horizontal legal framework for the safety of non-food consumer products, i.e., items intended or reasonably expected to be used by the consumers. It is specifically intended to address the safety challenges posed by new technologies and online selling. It also seeks to close the gap between the market surveillance rules for harmonized products and the relative absence of rules for non-harmonized products.
As its predecessor, the GPSR is designed to act as a 'safety net' for the consumers that apply in addition to all the specific product safety rules, to provide for a rapid alert system for unsafe products, etc. However, whilst there is certainly some continuity in the spirit and text of the GPSR, there are important changes and specific new requirements, which deserve full attention by economic operators and rising actors such as providers of online marketplaces.
2. Main points
Some of the main important changes and points of interest that business should timely consider include the following:
• New technologies
The scope of application of the new GPSR is expanded to expressly include products based on new technologies. The definition of 'product' in the GPSR now reads as "any item, whether or not it is interconnected to other items (…)". There are some additional elements to assess a product's safety: cybersecurity features necessary to protect the product against external influences, or the evolving, learning and predictive functionalities of the product.
• Online sales and marketplaces
The GPSR makes it clear that products are made available on the market, and thus caught by the product safety rules, when they are offered through distance sales means targeted at an EU audience. The GPSR contains specific information requirements for offers in distance sales, which adds another compliance checkpoint before the product is supplied.
Also regarding online selling, specific obligations are imposed on providers of online marketplaces, which are supplementary to those set forth in the Digital Services Act. To name just a few, providers of online marketplaces shall register with the Safety Gate Rapid Alert System (formerly, RAPEX) and designate a single point of contact; timely comply with orders from the market surveillance authorities; and design their interfaces to enable traders to provide a minimum safety information for each product listed.
• Safety assessment
The understanding of what constitutes a safe product is virtually the same as in the GPSD, but the safety assessment criteria are refined and now include, inter alia, the effect on other products by way of their interconnection (as noted in the preamble, the connections with external items should not jeopardise a product's safety).
The GPSR reiterates the rule according to which the feasibility of obtaining higher levels of safety for a given product or the availability of less risky products should not be a ground for considering this product as dangerous.
Also regarding safety assessment, the GPSR places the obligation on manufacturers to draw up technical documentation regarding their products before these are placed on the market. To draw up this file, manufacturers shall first carry out an internal risk analysis. The content of the technical documentation will vary from product to product depending on the complexity of the product and the possible risks identified.
• Obligations of economic operators
The obligations of the economic operators who intervene in the supply chain are revised in line with the standard obligations stemming from the 2008 New legislative framework. There is an obligation on all economic operators to ensure that only products which are safe and in conformity are made available in the EU. Accordingly, they should implement internal procedures, tailored to their role in the chain.
Manufacturers (and legal manufacturers, who trade with products under their own name or trademark, or who have modified a product by physical or digital means in a way that safety is affected) are imposed the most stringent obligations.
• Mandatory EU representative
To tackle the safety concerns arising from products coming from non-EU markets, the GPSR requires that for every product placed on the EU market there is an economic operator established in the EU who is expressly responsible for the safety related tasks. This responsible person should be identified on the product or its packaging, or in an accompanying document.
The responsible person should perform the tasks set out in Article 4(3) of Regulation 2019 1020 ('Market Surveillance Regulation'). For example, ensuring that the technical documentation can be made available to the market surveillance authorities upon request or informing and cooperating with those authorities when the responsible person has reasons to believe that a product presents a risk. In addition to that, he or she should perform checks regarding compliance with the technical documentation and the information requirements.
• Traceability rules and products identification
As regards traceability, there is a new obligation for manufacturers to ensure that their products come with information to identify the product (e.g., batch or serial number), which is easily visible and legible for consumers. For designated products likely to present a serious risk to the health and safety of consumers, the Commission may set up a specific traceability system requiring economic operators to collect and store data.
Also on the traceability side, the GPSR requires economic operators to be able to provide information about the product, and to identify any party from whom they have sourced or to whom they have supplied, during 10 and 6 years after supply, respectively.
• Accidents, product recalls and market surveillance
The GPSR introduces reinforced obligations when it comes to actions that economic operators (and, in certain circumstances, also providers of online marketplaces) shall take to address product safety issues, and to market surveillance actions. Namely:
(i) Accidents. Manufacturers shall timely notify through the Safety Business Gateway any serious accidents that it knows about, or that are reported by other operators or by consumers (for which appropriate communication channels shall be publicly available). Online marketplaces shall also notify through the portal and let the manufacturer know when they are informed of a serious accident.
(ii) Recalls of dangerous products:
o In case of a product recall or where a safety warning has to be shared with consumers, economic operators and online marketplaces must notify authorities and all affected consumers. Consumers may be informed individually (to that effect, loyalty programmes and similar shall give consumers the option to provide their contact details for product safety purposes) or by disseminating a recall notice, which shall meet some format and content requirements.
o In case of a product recall, consumers shall be offered “an effective, cost-free and timely remedy”, being able to choose between at least two of the following remedies: (i) repair; (ii) replacement; or (iii) refund of the value, except where impossible or disproportionate.
(iii) Market surveillance actions:
o The Commission can act as referee where market surveillance of different Member States disagree as to the identification or level of the risk of a product. Upon request by any Member State or on its own initiative, the Commission shall without undue delay issue an opinion which Member States shall follow.
o The GPSR foresees the possibility to carry out joint inspection activities on product safety agreed between authorities or with representative organizations, and also simultaneous coordinated control actions ('sweeps') targeting particular products or categories of products and coordinated by the Commission.
• Clarified borderlines with other legislation
Finally, the GPSR contains some provisions to bring together the hitherto independent and sometimes overlapping legal regimes for non-harmonized and harmonized products. To this end:
o The GPSR remains applicable to harmonized products insofar as there are safety aspects therein that are not covered by their sectorial legislation ('safety net'); but also regarding its rules on obligations of online marketplaces, obligations in case of accidents, information rights and remedies or products recalls, which shall apply in absence of like provisions in the EU harmonization legislation.
o In turn, the GPSR clarifies which of the provisions in the Market Surveillance Regulation are also applicable to products falling within the scope of the GPSR not subject to other harmonized rules. These provisions relate to market surveillance activities, obligations, powers, measures and cooperation among market surveillance activities.
3. Final observations
In sum, the GPSR represents a profound revision of the product safety rules in the EU. It provides legal certainty by resolving the overlap with regulations for harmonized products, and it contains a wide array of revised or brand new obligations for economic operators and providers of online marketplaces who make available products in the EU market.
4. How we can help?
Mayer Brown's EU Regulatory team has extensive experience in product safety matters. We work with a broad range of companies, industries and trade associations to stay abreast of legislative changes and to devise response strategies to regulatory challenges. Our team stands ready to advise on the requirements, practical implementation and potential implications of the revised GPSR.
