• The General Product Safety Directive (GPSD)
• Sector-specific legislation
• Other related legislation (food imitating products)

The General Product Safety Directive (GPSD)

The GPSD aims at ensuring that only safe consumer products are sold in the EU.

Objective and scope

A revised GPSD (2001/95/EC) is applicable as from 15 January 2004. The objectives of the Directive are both to protect consumer health and safety and to ensure the proper functioning of the internal market.

The GPSD is intended to ensure a high level of product safety throughout the EU for consumer products that are not covered by specific sector legislation (e.g. toys, chemicals, cosmetics, machinery). The Directive also complements the provisions of sector legislation which do not cover certain matters, for instance in relation to producers’ obligations and the authorities’ powers and tasks.

The Directive provides a generic definition of a safe product. Products must comply with this definition. If there are no specific national rules, the safety of a product is assessed in accordance with:

• European standards,
• Community technical specifications,
• codes of good practice,
• the state of the art and the expectations of consumers.

Report on the implementation of the GPSD (January 2009)

A public consultation on the revision of the current General Product Safety Directive 2001/95/EC was launched in 2010. Click here for all details.

Obligations of producers and distributors

In addition to the basic requirement to place only safe products on the market, 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.

Obligations of Member States

Under the GPSD, the 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 an 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 Community-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. Such Decisions at Community level can be taken:

• where the Member States have different approaches to dealing with the risks posed by such dangerous products;
• where urgency is required due to the risk posed by the product, and where no other Community laws deal with that risk;
• where such Decisions are the most effective way of eliminating the risk.

A Decision of this kind is only valid for a maximum of one year. To date, four Decisions of this kind have been taken at Community level:

• a Decision on Phthalates (substances which are used as softeners in plastics)

  In 1999, a number of Member States expressed concern about the potential adverse effects that phthalates could have on the health of children. This led to a Decision which temporarily banned the use of six phthalates in toys and childcare articles. Due to its temporary status, the Decision had to be regularly renewed. In the meantime, Member States have also implemented national measures banning the use of phthalates in toys.
  
  A series of risk assessments confirmed the safety concerns, and the need for a permanent ban became evident. In July 2005, a permanent Directive banned the use of phthalates in toys.
  
  

• a Decision on lighters

  On 11 May 2006, the Commission adopted Decision 2006/502/EC requiring Member States to ensure that, as of 11 March 2008:

  Cigarette lighters placed on the EU market must be child resistant
  (With the exception of lighters which are sold with a 2 year written guarantee, are refillable and can be repaired by a European-based after-sales service organisation)

  Novelty lighters can no longer be placed on the market
  (For a definition of novelty lighter, please see the Guidelines.)

  All lighters must be safe
  (This has already been the case since 1992. Lighters which comply with all requirements of ISO9994 are presumed to be safe.)

  Please be aware that a child-resistant lighter is not a child-proof lighter. A child-resistant lighter is a lighter that at least 85% of children under 51 months of age cannot operate. This means that up to 15% of children may still be able to operate such a lighter. Therefore adults should always ensure that young children cannot get hold of lighters, even if they are child-resistant.

  EU bans sale of non-child resistant and novelty cigarette lighters

  Read more




• a Decision on magnetic toys

  On 21 April 2008, the Commission adopted Decision 2008/329/EC requiring Member States to ensure that, as of 21 July 2008, magnetic toys placed on the EU market must carry warning labels. This applies to all toys that contain or consist of loose or detachable magnets, or magnetic components of such size and shape that they can be swallowed by children. The warning label must be carried on the packaging or be otherwise attached to the toy, explaining the risks that it poses to children. The warning is a temporary solution to bridge the gap until the CEN (European Standardisation Committee) produces the revised safety standard for magnetic toys.

  Press release: EU requires "magnetic toys" to carry a warning label

  Read more

• a Decision on dimethylfumarate (DMF)

  On 17 March 2009, the Commission adopted Decision 2009/251/EC requiring Member States to ensure that, as of 1 May 2009, all consumer products containing DMF are banned (maximum limit: 0.1 mg DMF per kg of product or part of the product). DMF is a powerful anti-mould chemical that has been applied to consumer products by placing it into "desiccant" sachets accompanying the products. DMF evaporates from the sachets into/onto the products, and from there penetrates through consumers' clothes onto their skin. DMF can provoke allergic reactions causing skin itching, irritation, redness, burns and rheumatic pain. The dermatitis can be particularly difficult to heal in severe cases, and may require oral corticosteroids (instead of the usual topical steroids).

  Press release: EU to ban dimethylfumarate (DMF) in consumer products, such as sofas and shoes

Comparative inventory of the national transposition measures of the General Product Safety Directive
This report was produced by Baker & McKenzie LLP, Frankfurt/Main (17 March 2006) for the Directorate-General for Health and Consumer Protection of the European Commission. The report and its conclusions (including possible factual errors) are the responsibility of the contractor and do not reflect the opinion of the European Commission or one of its Services. The European Commission does not guarantee the accuracy of the data included in the report, and the Commission has been advised that the data concerning, in particular, Belgium, France, Hungary and Slovenia, are partly incomplete and/or outdated.

• Part A: General part (14,3 MB)
• Part B: Annexes(22,4 MB)

Risk assessment - Comparison of risk assessment methods used by authorities

To Top

Sector-specific legislation

In general, the GPSD applies in a complementary way to products and/or risks covered by sector-specific product safety legislation.

A structured list of legislation relevant to specific sectors has been drafted by the Directorate-General for Enterprise and Industry. This list is known as the Pink Book. It is updated annually to incorporate legislative developments.

The most important pieces of legislation from a consumer point of view are listed below:

• Chemicals
• Toys
• Personal protective equipment
• Cosmetics
• Pharmaceuticals
• Machinery
• Recreational craft
• Liability for defective products

Guidance document

The Commission department has drafted a guide to the practical application of the GPSD to many areas where specific sector legislation exists.

• Guidance document (1st chapter) covers the Toys Directive, the Directive on Low Voltage Equipment (LVD), the Directive on Personal Protective Equipment (PPE), and the Directive on Cosmetic Products.
• Annex
• Guidance document (2nd chapter) covers the Directives on Medical Devices, the Directive on Construction Products, the Directive on Machinery, the Directive on Medicinal Products and the Directive on Motor Vehicles (translations will be available at a later stage).

The European Commission has published a guide to clarify the relationship between the GPSD and the horizontal rules on market surveillance.

• Guidance document

Specific questions about the relationship between the GPSD and sector Directives and GPSD and the horizontal rules on market surveillance can be sent by email to: Sanco-unit-B3@ec.europa.eu

To Top

Other related legislation

The Directive on dangerous imitations prohibits the marketing, import and manufacture of products that look like foodstuffs but that are not in fact edible.

Directive (87/357/EEC) applies to products which are not edible, but could easily be confused with foodstuffs by their appearance, smell or packaging. Member States must carry out checks to ensure that no such products are marketed. If a Member State bans a product under the terms of this Directive, it must inform the Commission and provide the details needed to inform the other Member States.

Some examples of food-imitating products against which the Member States have taken measures

The soaps, candles and other decorative articles on the pictures below are all food-imitating and as a consequence pose a risk of choking, poisoning or perforation of the digestive tract, in particular to young children, because they can be mistaken for food and be sucked or ingested given their shape, colour, appearance and size.

In these cases, the main corrective measure taken by the national authorities (or sometimes on a voluntary basis by the producer or distributor) to prevent the risk to consumers has been the withdrawal of the food-imitating products from the market.

Directive 87/357/EEC on dangerous imitations prohibits the marketing, import and manufacture of products that look like foodstuffs but that are not edible.

To Top