The GPSD 2001/95/EC (General Product Safety Directive) was published on January 15, 2004. In order to place products in the European Economic Area, distributors and manufacturers must comply with this directive. The aims of the directive are to protect consumers’ health and safety and to ensure the EEA functions properly in relation to this directive.
The GPSD 2001/95/EC is designed to protect consumers from unsafe products. These harmonized standards and essential requirements must be met for products to be placed in the European Economic Area. Some examples of products that fall under this directive include sports equipment and household products. Specifically, any product that will be used by consumers or may be used by them unintentionally must comply with this directive.
A “safe” product is defined in this directive as any product, when used under normal circumstances, that does not contain any risk to the users or the risks are minimized that is compatible with the product’s use. The product will undergo a safety assessment, and only when the product is deemed ‘’safe’’ will it be allowed to be placed in the EEA. Along with this, producers must provide the necessary information on the product warning the user of the risks associated with the product. This must include:
- Relevant information to enable consumers to assess the risks inherent in the product throughout the normal or reasonably foreseeable period of its use
- Information to consumers of risks which the product might pose
- Choose to take appropriate action including, if necessary to avoid these risks, withdrawal from the market, adequately and effectively warning consumers or recall from consumers
Under certain conditions, if a product is deemed to be unsafe, the European Commission can ban the marketing of it, recall it from customers and withdraw it from the market.
The Member States of the EU must enforce the requirements of the GPSD on manufacturers and distributors of products. They must also appoint authorities to be in charge of market surveillance.
The directive provides an alert system, the RAPEX system, which ensures the exchange of information about risk assessments, dangerous products and scientific development amongst other aspects necessary for control of safety of products. It also helps to promote joint testing and surveillance projects, the exchange of expertise and cooperation within the EU.
The GPSD applies in a complementary way to products covered by product safety rules specific to their sector. A list of the sector specific legislation can be found in the “Pink Book” made by the Directorate-General for Enterprise and Industry. From a consumer point of view, the most important pieces of legislation are for cosmetics, toys, chemicals, personal protective equipment, pharmaceuticals, machinery and recreational craft. For any product that is not covered by a specific piece of legislation, the GPSD will apply by default.
The manufacturer shall determine the applicable standards for the product, at national, European or the international level, and then identify the appropriate conformity assessment module according to the product classification. Finally, a full “Quality System” shall be implemented, which includes post-market surveillance, vigilance and traceability, a risk analysis report and a safety assessment report.
Technical File Data & Declarations:
- “Risk Analysis report”
- “Safety Assessment”: You need to identify what kind of test your product was submitted to and test report(s).
- Complete (exhaustive) list of standards your product is currently complying with. (US, EN, ISO, others…)
- US standards certificates, ISO certificates, if any.
- A Declaration of Conformity that you have appointed a “European Authorized Representative”.
- Copy of your “Quality Manual”
- Copy of your product package insert/instructions of use: (a) please note that according to the European Directive 2001/95/EC, you should specify, very clearly, which are the possible risks your product could expose the end user to. A Warning/Caution should be clearly stated in your product package insert. Moreover, the Competent Authorities insisted that your product package insert should clearly mention the exact and safe intended use of your product and possible side effects, if any.
(b) Language requirements: The Royal Decree (Implementation of the directive in the Belgian law) on “General Product Safety” article 8, requires the manufacturer to release the product if it is an end user’s product, with all relevant labeling and package insert at least in one of the national languages (Belgium: French, Dutch or German). As language requirements are left to each EU Member State specific regulation, you should keep available labeling and package inserts in each EU Member state official language(s). Of course, we will be able to help you identifying all EU Member States specific language requirements.
- Labeling: (a) This labeling should clearly mention both manufacturer’s name and complete details (address, tel., fax, email address) and the “European Authorized Representative” complete details (address, tel., fax, email address)
(b) Language requirements: see above product package insert.
- Post Market Surveillance: Complete file (procedures, forms, etc.)
- Vigilance & Traceability: description. (Read carefully 2001/95/EC European Council Directive, chapter III, article 5)
For non-EU manufacturers: Appoint a European Authorized Representative established within the European Community.
The directive portrays European Law enforced within the European Economic Area (EEA); non-compliance with the directive’s requirements will result in the removal of the product from the market.