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General Product Safety Directive 2001/95/EC

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. This directive 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).

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. In the absence of specific regulations, the product safety must be assessed taking into account, e.g.:

• non-binding national standards;
• recommendations from the European Commission including guidelines for assessing the product safety;
• product safety codes of good practice of the relevant sector;
• the current state of professional expertise;
• the state of the art and / or the safety level which the consumer may reasonably expect.

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.

Five Steps to Conformity Assessment Procedure General Product Safety

01Product classification

Determine whether the product falls within the scope of the General Product Safety Directive.

02Economic operator classification

Determine the role and responsibilities.

03Risk analysis

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

04Conformity assessment procedure

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

05Technical Documentation

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

06Declaration of Conformity

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

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