The new General Product Safety Regulation applies in the European Union from 13 December 2024. The Regulation replaces the current Directive (GPSD) as well as the Food Imitating Product Directive, and does not foresee transitional periods. However, products compliant with the Directive can be placed on the market until 12 December 2024 and can stay on the market.
Key changes for general products’ manufacturers
One the key changes of this Regulation is the introduction of an internal Quality Management System (QMS), mandatory internal processes including, among others, complaints’ registers. This requirement applies to manufacturers placing products on the EU market, either through online sales channels or offline. The GPSR defines manufacturers as “any natural or legal person who manufactures a product or has a product designed or manufactured, and markets that product under that person’s name or trademark“. Also, any natural or legal person that substantially modifies the product becomes manufacturer.
QMS with complaint register
According to Article 14, economic operators, including manufacturers, must have internal processes for product safety in place. Such internal processes have to allow them to comply with the Regulation’s requirements. Moreover, Article 9 on manufacturers’ obligations states that manufacturers must have an internal register of complaints. Additionally, manufacturers must ensure that procedures are in place for products produced in series to remain in conformity with the applicable general safety requirements.
Specifically, manufacturers must investigate complaints received and information on accidents when they concern safety and products are alleged to be dangerous by the complainant. An internal register has to include such complaints as well as related corrective actions, including product recalls. The internal register has to store exclusively personal data necessary for the manufacturer to investigate complaints about dangerous products. Moreover, such data must be kept only for the time necessary for investigation and never for longer than five years.
GPSR compliance in the EU
From 13 December 2024, all products placed on the EU market must be compliant with the GPSR and have a Responsible Person, which is indicated on the product or on its packaging, the parcel or an accompanying document. The Responsible Person must also be displayed in the online offer of the product in case of distance sales. Your authorised representative can be appointed as your Responsible Person on the Union market.
Do you have questions on the new GPSR? Contact us here.
PRODlaw membership is free!
References:
EUR-Lex (2023). Regulation (EU) 2023/988 of the European Parliament and of the Council of 10 May 2023 on general product safety, amending Regulation (EU) No 1025/2012 of the European Parliament and of the Council and Directive (EU) 2020/1828 of the European Parliament and the Council, and repealing Directive 2001/95/EC of the European Parliament and of the Council and Council Directive 87/357/EEC. Retrieved on 19/08/2024.
Leave a Reply