On 12 June 2023, the new EU General Product Safety Regulation entered into force. As of 13 December 2024, products must comply with this regulation. What are the consequences of the new Product Safety Regulation? Which entrepreneurs should start taking measures now?
In 2001, the European Union introduced the General Product Safety Directive to protect buyers from unsafe products. But with increasing technical developments, this directive became obsolete. Therefore, it has now been replaced by the new Product Safety Regulation. EU member states must incorporate this regulation into national law by 13 December 2024. If they fail to meet the deadline, the regulation will have direct effect.
The new Product Safety Regulation affects everyone within the trade chain. New obligations are introduced for both manufacturers and (online) shops. They have to ensure that unsafe products no longer reach the market and can be recalled faster. ‘Placing on the market’ refers to making products available for sale for the first time within the EU. Here, it does not matter whether the products are new or second-hand. All products offered for sale are therefore covered.
All participants in the trade chain have an independent obligation to ensure that the products they market are safe. If a product does not meet safety regulations, manufacturers, importers, distributors and online shops can be obliged to recall the product.
All economic operators must be able to quickly identify users of the product in order to send them a safety alert. To this end, they have to keep proper sales records. However, these records must continue to meet the conditions set out in the GDPR. The company responsible for the recall must offer consumers the choice between:
The new regulation requires manufacturers to carry out internal product risk analyses. They must also draw up technical documentation, a general description and a risk assessment of the products manufactured. This documentation must be kept for ten years. The manufacturer must be able to produce the documentation if requested by a supervisor. It is also mandatory for manufacturers to provide safety instructions with the product. In addition, manufacturers must keep a complaints register. In this complaints register, they must record all complaints received as well as all recalls and measures taken.
Manufacturers may appoint an authorised representative to keep risk assessments and technical data. A manufacturer may set up a company and appoint it as authorized representative. This is particularly attractive for manufacturers who market products in a country other than where they are based. The authorised representative can be appointed as a contact point for complaints from buyers. If there is an authorised representative, consumers can no longer contact the manufacturer directly. They will then have to submit their complaint to the authorized representative.
Importers and distributors of products are subject to a monitoring obligation. They have a duty to prevent unsafe products from entering the market and cannot simply assume that a product is safe. They must therefore also check and test the products themselves. Only when the importer and distributor are sure of the safety can they put the product on the market. Furthermore, they have to put their details on the product. If this is not possible or desirable, they can indicate their details in documentation accompanying the product.
Furthermore, the importer and distributor must attach safety instructions to the product in a language the consumer understands. These will often be the languages of the country where the product is imported or distributed.
Like manufacturers or authorised representatives, importers and distributors of products are obliged to maintain a complaints point and must investigate complaints received. They also have to record these complaints, as well as product recalls and remedial actions taken.
Online shops are required to designate a contact point for the supervisory body in the country to which they sell products. In the Netherlands, this is the Consumer and Market Authority (ACM). Under the new regulation, the supervisory body will have the power to oblige online shops to remove an unsafe product and all products identical to it from their website. Besides removing products, online shops can also be obliged to block access to a product or display a warning with the product. Online shops must comply with this order within two days. If they fail to do so, an appropriate sanction can be imposed on them.
The regulation does not only affect the supervisor-online shop relationship, but also the online shop-consumer relationship. Online shops must maintain a direct contact point for consumers. This contact point must allow consumers to report complaints and safety concerns. Online shops must respond to these complaints within three days.
The new regulation particularly affects the non-food industry. Manufacturers will have to keep internal documentation and a complaints register. However, it is possible to appoint an authorised representative for this purpose. Online shops may be obliged to remove products from their shops. Furthermore, they must respond to a consumer notification within three days. The regulation will come into force on 13 December 2024. This means all operators must have their records in order before that day. If they fail to do so, they risk a penalty.
Do you have any questions about how the new EU General Product Safety Regulation may affect your company? Are you being held liable by a buyer of your product? We will be happy to give you advice. We are also happy to assist you in setting up a company that can become your agent. Please contact us:
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