Product Compliance - Is your company prepared for the new product safety regulations?

From 13 December 2024, the new General Product Safety Regulation (Regulation (EU) 2023/988) (‘PS Regulation’) will come into force. The PS Regulation brings significant changes for companies that manufacture, import or distribute products in the European Union and therefore affects all companies involved in supply chains. In this newsletter, we would like to give you an overview of the most important regulations and areas of action that may be relevant for your company. Please feel free to contact us.

When do the obligations of the PS Regulation have to be implemented?

The requirements of the PS Regulation must generally be implemented from 13 December 2024 for all products that are placed on the Union market for the first time from 13 December 2024. The requirements of the PSR must also be implemented for products that were placed on the market before 13 December 2024 if they do not fall within the scope of the still applicable Product Safety Directive 2001/95/EC or do not comply with the product safety requirements of the still applicable Product Safety Directive 2001/95/EC.

Is my company affected by the PS Regulation?

The extent to which the obligations of the PS Regulation apply to your company depends on the role your company plays within a supply chain. The catalogue of obligations is aimed at a large number of participants within supply chains. The economic operators defined in the PS Regulation include manufacturers, authorised representatives, importers, distributors, fulfilment service providers or any person subject to obligations in connection with the manufacture of products or their making available on the market in accordance with the PS Regulation. The PS Regulation also imposes obligations on providers of online marketplaces. We help you to determine the role of your company within a specific supply chain in order to identify and properly fulfil the catalogue of obligations under product safety law that apply to your company.

What are the core elements?

1) Preventive manufacturer obligations

All manufacturers are subject to a comprehensive catalogue of obligations, which includes labelling and risk analysis obligations in the supply chain. In particular, the manufacturer's obligations emphasise that the PS Regulation now places a special focus on preventive measures to guarantee the safety of a product. Manufacturers must therefore subject their products to a comprehensive safety assessment before they are placed on the market. We have special tools to implement a solid safety assessment process and to document every step so that proof can be provided. The riskier and more complex a product is, the more detailed and comprehensive the risk analysis should be before the product is placed on the market. In addition the stricter labelling requirements must be taken into account. It should be ensured that your products are fully labelled and that all traceability data is available.

2) The status of manufacturer

Manufacturers are primarily subject to obligations, but other economic operators are also subject to secondary obligations to ensure, guarantee and control.

3) Safeguarding and warranty obligations of other economic operations

The obligations of other economic operators essentially consist of ensuring, monitoring and guaranteeing that manufacturers fulfil their obligations. Against this background, the other economic operators must also be aware of the existing manufacturer obligations and their own obligations.

4) Recall management

The PS Regulation sets out comprehensive regulations with regard to recall management in the event that a dangerous product has been placed on the market.

What do I have to consider in distance selling?

Another new aspect is that labelling and information obligations now apply not only to the product itself, but also to online shops (distance selling). Every offer of online products must contain the information set out in the PS Regulation.

We will be happy to advise you on the successful implementation of the PS-VO

The new PS-VO requires companies to take proactive measures and define clear responsibilities. It is advisable to adapt internal procedures and processes to the new provisions of the PS-VO now in order to be prepared for the new requirements in good time. We will be happy to support you in implementing the new regulations:

• Determining the role of your company in the supply chain;
• Identifying the product safety obligations that apply to your company;
• Support in the fulfilment of these obligations, in particular by implementing internal procedures and processes;
• Establishment of a recall management system;
• Reviewing and adapting your supplier contracts with regard to product safety responsibilities.