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General Product Safety Directive – 2001/95/EC – EU Directive on general product safety (general requirements for all consumer products, including those not govern by a specific EU Directive)

For a certain product category, compliance with the corresponding Directive(s) specifically addressing it does not release the importer / manufacturer from responsibility in cases of accidents/injuries where evidences are found that the product contains hazards causing dangers to users, because all consumer products are governed by the Directive on general product safety – 2001/95/EC.

Whereas it is difficult to adopt legislation for every product which exists or may be developed, general (horizontal) legislation to protect consumers' health and safety has been installed. Directive 92/59/EEC first introduced requirements for general product safety. In December 2001 the EU adopted Directive 2001/95/EC, which replaced the old Directive on 15 January 2004, also the deadline for the Member States to implement the new Directive on products safety into national law.

Directive 2001/95/EC prohibits the placing on the market of products which pose a risk for consumers’ health, caused by dangerous substances or by unsafe construction.

Based on the Directive, standards are developed and adopted. One example is EN 1400, which covers all safety aspects relevant to teats and soothers.

The Directive applies to all products on the market for consumers or products likely to be used by consumers (including products that provide a service), unless:

-          The product is subject to specific safety requirements imposed by Community legislation. For these products, the Directive only applies to the aspects and risks or categories of risks not covered by those requirements. For example, the Low Voltage Directive does not cover the need to notify authorities about dangerous products, but the Product Safety Directive does. Concerning this aspect, the Product Safety Directive applies also to the product groups within the scope of the Low Voltage Directive.

-          The product is second hand and has antique value or needs to be repaired.

Requirements of the Directive

The Directive lays down safety requirements for a product put on the EU market. According to the Directive a safe product can be described as: A product that under reasonably foreseeable conditions of use does not present any risks or minimum risk compatible with the product’s use.

To be more specific, a product is safe when it meets the EU provisions concerning product safety. For several products, standards have been developed in the framework of Product Safety Directive. Standards are listed for various child / baby articles, such as cradles (furniture), but also for other products such as lighters and decorative oil lamps.

In the absence of such provisions, the product must comply with the specific national requirements of the Member State in which it is being marketed or sold, or with the voluntary national standards which transpose the European standards or legislation. In the absence of these, the product's compliance is determined according to the following:

• the voluntary national standards which transpose other relevant European standards or legislation and the Commission recommendations which set out guidelines on the assessment of product safety;
• the standards of the Member State in which the product is being marketed or sold;
• the codes of good practice as regards health and safety;
• the current state of the art;
• the consumers' safety expectations.

Use of EU standards

With the introduction of European voluntary standards in the amended GPSD, the directive adds a new dimension to the notion of product safety by giving “presumption of conformity” to those products manufactured to a European voluntary standard. The difference is that national standards are not recognized outside the country of adoption whereas European standards, as published by the Commission in its Official Journal, are recognized as EU-wide standards. The latter type of standard can be easily recognized because its number is preceded by EN (European Norm) followed by the code of the national standards body which is required to nationally adopt the EN standard, e.g. NF for a French standard, DIN for a German standard, So for example: NF P 90 503 is a national French standard while EN NF 12790:2002 is a French-adopted EU standard.

The advantage of using a European voluntary standard adopted by all EU countries as a national standard is that manufacturers, in theory, have to deal with only one set of standards rather than several national standards to demonstrate that their product is safe. The claims of safety made by the manufacturer made to EU standards will be accepted throughout the EU.

With input from the European standards organization CEN and member states, the Commission created a proposed list of standards references to be considered as European standards linked to the GPSD. This list was submitted for consultation just before the summer 2004. Following analysis of the outcome of reactions from stakeholders, member states, and industry, the European Commission published the references of standards giving presumption of conformity in the Official Journal in early 2004. More lists of EN standards references are likely to follow.

What is the role of the local importer?

The importer has to warn the competent authorities about known safety hazards. The importer also has to verify whether the exporter has complied with the different aspects contributing to a “safe product” such as correct labeling, instructions for use in the local language, etc. It is advisable for either the manufacturer or the importer to keep a record of complaints, if they exist, and to note how any problem was solved. Importers may recall consumer goods, if necessary, or be asked to withdraw them from the market with possible penalties in case of safety issues, followed by a report to the RAPEX system.

The EU Standards giving “Presumption of Conformity” for different product catagories

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