The New Product Safety Regulation 2023/988: What you need to know if you work in the Food & Feed sector
March 2025
With the introduction of the Product Safety Regulation (EU) 2023/988, the European Union (EU) has reached another consumer protection milestone. The New Product Safety Regulation, which was adopted on 10 May 2023 and entered into force on 13 December 2024, brings significant changes to regulation and enforcement relating to product safety. Hereunder, the key aspects of the New Product Safety Regulation, including what it regulates, which parties are affected, which products it covers, the main changes and the entry into force date are highlighted. And, of course, the significance of the regulation for the food sector is discussed as well.
What does the New Product Safety Regulation regulate?
Product safety is the protection of consumers from all types of risks when using a product. The New Product Safety Regulation aims to ensure consumer safety in the European Union through stricter rules and improved enforcement in the field of product safety. Among other things, this New Product Safety Regulation replaces the General Product Safety Directive (EC) 2001/95 and strengthens the market surveillance and product safety framework across the EU. It is notable that the New Product Safety Regulation is adapted to the consumer market in which sales via digital platforms have become ubiquitous.
For whom is the New Product Safety Regulation relevant?
The New Product Safety Regulation is relevant to a wide range of market players, including manufacturers, producers, importers, distributors, fulfilment centres and consumers.
On what products does the New Product Safety Regulation apply?
The New Product Safety Regulation applies to almost all consumer products placed on the European Union market. This includes electronics, clothing, toys, furniture and household appliances. Both products manufactured in the EU and imported products fall under the scope of the New Product Safety Regulation. It is also important to mention that the Regulation not only applies to new products, but also to second-hand products, repaired products and 'refurbished' products. The latter are now explicitly covered by the scope of the New Product Safety Regulation.
Demarcation with food safety regulations
The New Product Safety Regulation does not seem to interfere with feed and food law. After all, the New Product Safety Regulation does not apply to:
a) medicinal products for human or veterinary use;
b) foodstuffs;
c) animal feed;
d) live plants and animals, genetically modified organisms and genetically modified micro-organisms for contained use as well as products of plant and animal origin directly related to their future propagation;
e) animal by-products and derived products; and
f) plant protection products.
Nevertheless, the impact of the New Product Safety Regulation is not to be underestimated. Even though the New Product Safety Regulation does apply to products covered by so-called harmonisation legislation (see Regulation EU) 2019/1020) which includes food contact materials legislation (such as straws, cups, napkins, and food packaging materials and food contact) numerous chapters of the New Product Safety Regulation indeed do apply to these products. This includes Chapter VIII which regulates safety information and recalls, in addition to harmonised legislation.
Tip: In practice, it will be important to swiftly identify the nature of a potential security incident:
- In case of non-compliance with regulations relating to the subjects mentioned above (a to f), the New Product Safety Regulation does not apply. Think, for instance, of a violation of an MRL (maximum residue level).
- In case of non-compliance with so-called harmonised regulations, only part of the New Product Safety Regulation applies. Consider, for example, exceeding migration limits of regulated food contact materials.
- If there is an safety issue that is not regulated by legislation as mentioned above, the New Product Safety Regulation applies in full. An example is a manufacturing defect in a coffee mug as a result of which the handle is not properly attached and could fall off.
The five most important changes
Stricter liability and responsibility: The New Product Safety Regulation places greater responsibility on producers, importers, and distributors to ensure that their products comply with established safety standards. They must actively take measures to identify and mitigate risks. Moreover, an economic operator responsible for safety must be designated for each product and based in the EU. If there is none, an EU-based fulfilment service provider (definition 'fulfilment service provider' Article 3(12) Regulation) is designated in its place.
Improved monitoring and reporting: There will be an improved system for market monitoring and enforcement. Manufacturers and other parties must report incidents involving unsafe products. National authorities will have greater authority to remove non-compliant products from the market and impose sanctions.
Strengthened role of online sales platforms: Online marketplaces and platforms will be required to provide information on the identity of the seller (or manufacturer or responsible person) and to cooperate with manufacturers and authorities in addressing unsafe products sold on their platforms.
Improved traceability and identification: Products should have clear and accurate identification marks, facilitating traceability. This helps with the rapid detection and recall of unsafe products. In addition, a recall notice itself must meet specific requirements under the Regulation.
Tougher penalties and fines: The New Product Safety Regulation introduces tougher sanctions for non-compliance with safety standards. This includes higher fines and other punitive measures to ensure that compliance is taken seriously.
Entry into force of the New Product Safety Regulation
The New Product Safety Regulation has now entered into force from 13 December 2024 and will apply throughout the EU. In the Netherlands, the regulation will be embedded in the system of the Commodities Act. Because it is a regulation, it is directly applicable in every member state. This means that all parties involved, including producers, importers, distributors and online sales platforms, should already comply with the new regulations and responsibilities imposed by the New Product Safety Regulation. This may require adjusting agreements between market participants and reassessing (taken out) insurance policies.
For completeness’ sake: the New Product Safety Regulation does not change the Dutch supervisory and enforcement framework; the Dutch Food and Consumer Product Safety Authority (NVWA) will enforce the statutory rules in the Netherlands as regulator, cooperating with national regulators in other EU countries. This also means that enforcement can be strict: from turnover-related fines and imposed recalls to confiscation of goods and sometimes even criminal prosecution of managers. Forewarned is forearmed!
