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Product safety: general rules

European legislation ensures a consistent, high level of protection for the health and safety of consumers. Products placed on the market in the internal market are subject to general safety requirements. The European Union (EU) has also introduced a rapid alert system (RAPEX) for products which pose a serious risk to consumers.

ACT

Directive 2001/95/EC of the European Parliament and the Council of 3 December 2001 on general product safety [Official Journal L 11 of 15.1.2002].

SUMMARY

This Directive applies in the absence of specific European regulations, governing the safety of certain categories of products or if specific regulations (sectoral) are insufficient. Furthermore, it is to be applied without prejudice to Directive 85/374/EEC concerning liability for defective products.

General safety requirement

The Directive imposes a general safety requirement on any product put on the market for consumers or likely to be used by them, including all products that provide a service. Second-hand products that have antique value or those that need to be repaired are not subject to this requirement.

A safe product is one which poses no threat or only a reduced threat in accordance with the nature of its use and which is acceptable in view of maintaining a high level of protection for the health and safety of persons.

A product is deemed safe once it conforms to the safety provisions provided in European legislation, or, in the absence of such rules, if it complies with the specific national regulations of the Member State in which it is being marketed or sold. The product is also deemed safe if it complies with the European standard established according to the procedures in this Directive. In the absence of such regulations or standards, the product's compliance is determined according to the following:

  • the voluntary national standards (transposing other relevant European standards), the Commission recommendations (setting 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.

Manufacturer and distributor obligations

Manufacturers must put on the market products which comply with the general safety requirement. In addition, they must:

  • provide consumers with the necessary information in order to assess a product's inherent threat, particularly when this is not directly obvious;
  • take the necessary measures to avoid such threats (e.g. withdraw products from the market, inform consumers, recall products which have already been supplied to consumers, etc.).

Distributors are also obliged to:

  • supply products that comply with the general safety requirement;
  • monitor the safety of products on the market;
  • provide the necessary documents ensuring that the products can be traced.

If the manufacturers or the distributors discover that a product is dangerous, they must notify the competent authorities and, if necessary, cooperate with them. This obligation to inform the competent authorities is clarified in Annex I of the Directive.

Member States' obligations

The Member States ensure that the manufacturers and the distributors comply with their obligations. They put in place structures which are responsible for:

  • monitoring product compliance with the safety requirement;
  • taking the necessary measures as regards risk products (e.g. prohibiting such products being marketed) and informing the Commission of the details.

Member States set out rules to punish offenders and ensure that consumers benefit from a system which investigates complaints.

The Commission's role

The Commission takes into consideration the general safety requirement when defining mandates for the European standardisation organisations and publishes European standardisation references in the Official Journal of the European Union, which must conform to the general safety standard. The Commission manages the Rapid Information System RAPEX and can adopt “emergency measures” in cooperation with Member States.

RAPEX system: rapid intervention where products pose a serious risk

Member States identify products which pose a serious risk to health and safety. They take rapid intervention measures to protect consumers. In this case they immediately inform the Commission via the RAPEX system. This system is a means for rapidly exchanging information between the Member States and the Commission. It enables the distribution of dangerous products to be limited or prevented. The operation procedures for RAPEX are described in Annex II to the Directive.

Food, pharmaceutical and medical products are governed by other intervention systems.

When using the RAPEX system, Member States must provide the Commission with at least the following information:

  • information enabling the product to be identified;
  • a description of the risk inherent in the product, as well as any documents enabling its assessment;
  • details of measures already taken;
  • information on distribution of the product.

The Commission can also implement rapid measures at European level when it is aware that a certain product poses a serious threat. After consulting the Member States, the Commission can adopt decisions of a one-year duration, with the possibility of extending this by periods of the same duration. In particular, these decisions can:

  • impose specific safety limitations;
  • prohibit the use of certain substances; or
  • require manufacturers to affix warnings to their products.

Comitology

The Commission is assisted by a Regulatory Committee on the Safety of Consumable Products when taking “emergency measures” and decisions on standardisation.

The Commission is also assisted by an Advisory Committee on the Safety of Consumable Products responsible for the other aspects of the Directive.

Transparency

Information on the risks presented by products must be provided to the public. Professional secrecy is limited to justified cases.

Context

This Directive follows the Commission Report to the European Parliament and to the Council of 29 March 2000 on the experience gained through the application of Directive 92/59/EEC regarding the general safety of products. It repeals Directive 92/59/EEC on the general safety of products, from 15 January 2004.

REFERENCES

Act Entry into force Deadline for transposition into the Member States Official Journal
Directive 2001/95/EC [adoption: codecision COD/2000/0073]

15.1.2002

15.1.2004

OJ L 11 of 15.1.2002

Amending act (s) Entry into force Transposition in the Member States Official Journal

Regulation (EC) No 765/2008

1.1.2010

-

OJ L 218 of 13.8.2008

Regulation (EC) No 596/2009

7.8.2009

-

OJ L 188 of 18.7.2009

RELATED ACTS

Commission communication in the framework of the implementation of the Directive 2001/95/EC of the European Parliament and of the Council on general product safety (Text with EEA relevance) [Official Journal C 38 of 17.2.2009].
The Commission publishes titles and references of standards under Directive 2001/95/EC.

Report from the Commission to the European Parliament and to the Council of 14 January 2009 on the implementation of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety [COM(2008) 905 final – Not published in the Official Journal].
The effectiveness of the Community framework for product safety has increased since the implementation of Directive 2001/95/EC. The European information and alert system has enabled a large number of dangerous products to be withdrawn from the market. However, some aspects can be improved in order to ensure full consumer protection. This report identifies priorities in the areas of:

  • the safety of consumer products, in particular from the perspective of traceability, by reinforcing the producer’s or distributor’s obligation to identify products;
  • surveillance of the market on the one hand, as a result of better coordination between Member States based on the exchange of information and best practice (including in the field of customs cooperation). And on the other by opening the RAPEX system to participation by international, region or national organisations of third countries;
  • standardisation, by simplifying procedures concerning certain categories of products, and by establishing a presumption of conformity of those standards with the general safety requirements;
  • emergency measures taken under the rapid alert system, which can be made definitive in order to ensure the withdrawal of dangerous products.

The scope of Directive 2001/95/EC also covers the safety of services provided to consumer. It has been transposed in all Member States.

RAPEX

Commission Decision 2010/15 of 16 December 2009 laying down guidelines for the management of the Community Rapid Information System RAPEX established under Article 12 and of the notification procedure established under Article 11 of Directive 2001/95/EC (the General Product Safety Directive) [Official Journal L 22 of 26.1.2010].
The Commission adopted new guidelines which should facilitate the management of the RAPEX system and the notification procedure for dangerous products. These guidelines are for national authorities responsible for market monitoring.

PERSONAL MUSIC PLAYERS

Commission Decision 2009/490/EC of 23 June 2009 on the safety requirements to be met by European standards for personal music players pursuant to Directive 2001/95/EC of the European Parliament and of the Council (Text with EEA relevance) [Official Journal L 161 of 24.6.2009].
The Commission has established a safety requirement aimed at preventing the levels of sound from personal music players causing hearing damage to consumers using them under normal usage conditions. This requirement should be taken in account when designing and manufacturing personal music players. The requirement helps to define the standards set by standardisation bodies. Warnings must also be added to products in order to inform consumers about existing risks.

LIGHTERS

Commission Decision 2009/298/EC of 26 March 2009 prolonging the validity of Decision 2006/502/EC requiring Member States to take measures to ensure that only lighters which are child-resistant are placed on the market and to prohibit the placing on the market of novelty lighters (Text with EEA relevance) [notified under document number C(2009) 2078].

Commission Decision 2006/502/EC (amended by Decisions 2007/731/EC and 2008/322/EC) of 11 May 2006 requiring Member States to take measures to ensure that only lighters which are child-resistant are placed on the market and to prohibit the placing on the market of novelty lighters (Text with EEA relevance) [Official Journal L 198 of 20.7.2006].
Incorrect use of lighters – as toys – by young children accounts for between 1 500 and 1 900 injuries and 34 to 40 deaths a year in the EU States. Child-resistance mechanisms exist to prevent such accidents. The use of these mechanisms has been obligatory in the United States of America, Canada, Australia and New Zealand for over ten years. The introduction of child-resistance requirements in the United States of America resulted in a 60% reduction in the number of accidents.
To prevent future accidents, the Commission adopted Decision 2006/502/EC on 11 May 2006 requiring Member States to take measures to ensure that only lighters which are child-resistant are placed on the market and to prohibit the placing on the market of novelty lighters.

Commission Decision 2008/357/EC of 23 April 2008 on specific child safety requirements to be met by European standards for lighters pursuant to Directive 2001/95/EC of the European Parliament and of the Council [Official Journal L 120 of 7.5.2008].
The child safety requirements for lighters must be established in accordance with the provisions of Article 4 of Directive 2001/95/EC with the aim to request the standardisation bodies to revise the standard EN 13869 and to allow the publication of the reference of the revised standard in the Official Journal.
This Decision lays down the safety requirements on the basis of which the CEN (European Committee for Standardisation) must revise the standard EN 13869 regarding the safety of lighters and test methods.

CIGARETTES

Commission Decision 2008/264/EC of 25 March 2008 on the fire safety requirements to be met by European standards for cigarettes pursuant to Directive 2001/95/EC of the European Parliament and of the Council [Official Journal L 83 of 26.3.2008].
Lit cigarettes which are left unattended present a significant risk for the safety of consumers. It is estimated that in the European Community around 1 000 fatalities a year are caused by lit and unattended cigarettes. However there are techniques which can slow down the burning of cigarettes with the aim of extinguishing them through the integration of bands of paper in the cigarette paper. As a result of this technique the fire of an unattended cigarette is extinguished in the majority of cases through lack of air.
This Decision lays down safety requirements. Based on these the CEN (European Committee for Standardisation) fulfils the request to adopt a standard to reduce the ignition propensity of cigarettes. This safety requirement for cigarettes is based on the Directive 2001/95/EC.
The effectiveness of this standard will be established through checking of batches of cigarettes with the aim that no more than 25 % of cigarettes shall burn through their whole length.

INFANTS AND YOUNG CHILDREN

Commission Decision 2010/9/EU of 6 January 2010 on the safety requirements to be met by European standards for bath rings, bathing aids and bath tubs and stands for infants and young children pursuant to Directive 2001/95/EC of the European Parliament and of the Council (notified under document C(2009) 10290) (Text with EEA relevance).
Products to be used for bathing babies and young children must comply with the general product safety requirement. In this respect, European standardisation bodies shall establish safety standards for:

  • bath seats: used only for children who are able to sit upright, but who cannot stand up;
  • accessories for bathing aids: products allowing to keep a child in a reclined or lying position for use from birth and until the child is able to sit upright unassisted;
  • bath tubs used from birth up to 12 months: namely products which are placed in or on the rim of a regular bathtub, placed stand-alone on the floor or used with a stand.

Commission Decision 2010/11/EU of 7 January 2010 on the safety requirements to be met by European standards for consumer-mounted childproof locking devices for windows and balcony doors pursuant to Directive 2001/95/EC of the European Parliament and of the Council (notified under document C(2009) 10298) (Text with EEA relevance).
Certain devices used for child-proof locking windows and other openings are sold in detachable “consumer-mounted” parts. European safety standards should be adopted for these devices to be used for children under 51 months of age.

BIOCIDES

Commission Decision 2009/251/EC of 17 March 2009 requiring Member States to ensure that products containing the biocide dimethylfumarate are not placed or made available on the market [Official Journal L 74 of 20.3.2009] (Text with EEA relevance).
Dimethylfumarate (DMF) is a biocide intended for the preservation of certain consumer goods during storage or transport (furniture, footwear, leather clothing, etc.). DMF can cause serious skin reactions (contact dermatitis). Its harmful effects have been determined by clinical studies.
With effect from 1 May 2009, Member States shall ensure that the placing on the market of products containing DMF is prohibited. Products already available on the market should be withdrawn and consumers should be informed of the risks linked to these products. A "product containing DMF" contains more than 0.1 mg of DMF per kg of the product or per kg of part of the product.
The Decision shall be applicable until 15 March 2010. It may be extended where appropriate.

Last updated: 10.02.2010
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