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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 a product posing a serious risk, 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 a product;
- where urgency is required to deal with the serious risk of the product, and where no other Community law can achieve this;
- where the serious risk can effectively be eliminated only by a Community measure.
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:
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a Decision on Phthalates (substances which soften 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.
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. The ban is now included in Annex XVII of REACH (entries No 51 and 52).
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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 are child-resistant (With the exception of refillable lighters that are sold with a 2 year written guarantee and can be repaired by a EU based after-sales service such as to ensure a continual use of the lighters of at least 5 years)
Novelty lighters are no longer placed on the market (For a definition of novelty lighter, please see the Guidelines.)
Please be aware that a child-resistant lighter is not a child-proof lighter. A child-resistant lighter is a lighter that, in the appropriate test, cannot be operated by at least 85% of children under 51 months of age . 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
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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
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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" inside a 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 even require oral
corticosteroids (instead of the usual topical steroids).
Press release: EU to ban dimethylfumarate (DMF) in consumer products, such as sofas and shoes
A restriction dossier prepared under REACH, including a risk assessment and a socio-economic analysis, confirmed the need for a permanent ban of DMF. Such ban was included on 15 May 2012 in Annex XVII of REACH.
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.
Risk
assessment - Comparison of risk assessment methods used by authorities
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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:
Guidance document
The Commission department has drafted a guide to the practical
application of the GPSD to many areas where specific sector legislation
exists.
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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.
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Annex
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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.
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
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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.
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