General Product safety directive
The General Product safety directive (GPSD) establishes essential requirements for consumer products that are not covered by specific sector legislation (e.g., toys, cosmetics, medical devices) to protect consumer health and safety and to ensure the proper functioning of the internal European market.
The Directive provides a generic definition of a safe product, namely that products must be safe under normal or reasonably foreseeable conditions of use by consumers. Products must comply with this definition. If there are no specific national rules governing the safety of a product, then safety of a product is assessed in accordance with:
- European standards pursuant to the product, then
- Community technical specifications, then
- Codes of good practice, then
- State-of-the-art and consumer expectations.
Absorbent Hygiene Products (excluding incontinence products) are not subject to sector-specific EU legislation. The General Product Safety Directive (GPSD) thus requires that manufacturers follow any existing national rules, standards, technical specifications and/or codes of good practice in order to establish the safety of the product.
Obligations of producers and distributors
Producers must inform consumers of the risks associated with the products they supply. They must take appropriate measures to prevent such risks and be able to trace dangerous products.
To comply with the GPSD requirements, such measures include a rigorous in-house risk assessment of the overall product and its chemical constituents. The results of this activity are typically stored in an in-house product dossier which can be presented to Member State authorities in the event of enforcement actions.
Obligations of Member States
Under the GPSD, Member States are obliged to enforce the requirements on producers and distributors. They must appoint the authorities in charge of market surveillance and enforcement. In addition to the power to impose penalties, the Directive gives the surveillance authorities a wide range of monitoring and intervention powers.
Exchange of information via a rapid alert system
The Directive provides for a rapid alert system (the RAPEX system) between Member States and the Commission. The RAPEX system ensures that the relevant authorities are rapidly informed of dangerous products. Subject to certain conditions, rapid alert notifications can also be exchanged with non-EU countries. In the case of serious product risks, the Directive provides for temporary decisions to be taken on EU-wide measures.
Emergency measures
Under certain conditions, the Commission may adopt a formal decision requiring the Member States to ban the marketing of an unsafe product, to recall it from consumers or to withdraw it from the market. A decision of this kind is only valid for a maximum of one year.
More information in the EU Commission website