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Directive 2001/95/EC and a new General Product Safety Regulation 2023/988/EU

Consumer products that do not fall within the scope of any CE marking legislation, must meet the requirements defined by the General Product Safety Directive 2001/95/EC. On 12 June 2023 the renewed EU general product safety legislation has been finally adopted and entered into force as General Product Safety Regulation (GPSR) 2023/988/EU. Key changes 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 authorised representative (responsible person) established in the EU. The application of the GPSR and the repeal of existing Directive 2001/95/EC will only be effective after a transitional period expiring on 13 December 2024, however, the GAP-analysis as the preparation, can be already done.

At this moment the Directive 2001/95/EC will be applicable in so far as there is no specific European legislation regarding the safety of certain product categories. Affixing a CE marking to these products is not mandatory, but they must still meet the safety requirements of the general safety for consumer products before they are placed on the European market and/or put into use.

The General Product Safety Directive does not require affixing the CE marking or the issuance of an EU Declaration of Assessment. Manufacturers, however, must comply with this Directive. In The Netherlands this Directive has been transposed into the Dutch Commodities Act General Product Safety (Warenwetbesluit Algemene Productveiligheid).

General Product Safety Directive

In accordance with the General Product Safety Directive manufacturers are required to place only safe products on the EU market.

Economic operator classification

The General Product Safety Directive requires manufacturers to place non other than safe products on the European market. A product is safe, when it meets all the relevant safety requirements under European law.

Manufacturers must provide consumers with the relevant information enabling them to assess the risks inherent in a product throughout the normal or reasonably foreseeable period of its use. Manufacturers must also take the appropriate actions against those risks, such as withdrawal from the market, adequately and effectively warning consumers, or a recall of the relevant products.

Distributors must do their utmost to comply with product safety, by avoiding to supply products of which they know or ought to know, on the basis of information in their possession, and as professionals, that these are incompatible with the essential safety requirements.

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Five Steps to Conformity Assessment Procedure General Product Safety

01 Product classification

Determine whether the product falls within the scope of the General Product Safety Directive.
02 Economic operator classification

Determine the role and responsibilities.
03 Risk analysis

An analysis in order to determine the risks and essential health and safety requirements that apply to the relevant product
04 Conformity assessment procedure

Determine the requirements established in step 3 in accordance with European harmonised standards.
05 Technical Documentation

Compile or verify the Technical Documentation, including descriptions, instruction manuals and the performed risk analyses.
06 Declaration of Conformity

Draw up the Declaration of Conformity in order to confirm compliance of the product with the General Product Safety Directive.