The general safety of products placed on the market is guaranteed by EU legislation, which ensures a consistent, high level of protection for the health and safety of consumers.
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The EU has introduced a rapid alert system for products which pose a serious risk (RAPEX), and provisions for products to be withdrawn from the market if they are likely to put the health and safety of consumers at risk (Foods and pharmaceuticals are covered by other intervention systems).
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
Directive 2001/95/EC repeals Directive 92/59/EEC on general product safety from 15 January 2004.
Application of the Directive
This Directive applies in the absence of specific provisions among the Community regulations governing the safety of products concerned or if sectoral legislation is 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 specific Community provisions governing its safety. In the absence of such provisions, the product must comply with the specific national regulations of the Member State in which it is being marketed or sold, or with the voluntary national standards which transpose the European standards. In the absence of these, the product’s compliance is determined according to the following:
- the voluntary national standards which transpose other relevant European standards and the Commission recommendations which set 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, and 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, to monitor the safety of products on the market and to 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 and taking the necessary measures as regards risk products (e.g. prohibiting such products being marketed), whose details must be submitted to the Commission. Furthermore, they 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 when publishing European standardisation references in the Official Journal of the European Communities, 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 in line with Article 13 of this Directive.
Moreover, the Commission is committed to setting up a European product safety network between the competent authorities of the Member States in order to monitor the consumable products market, to reinforce cooperation between these authorities and to promote the exchange of information and expertise.
RAPEX system. Rapid intervention where products pose a serious risk
If a product poses a serious threat calling for quick action, the Member State involved immediately informs the Commission on the measures taken via the RAPEX system, a system for the rapid exchange of information between the Member States and the Commission. The application procedures for RAPEX are described in Annex II to the Directive.
When using the RAPEX system, Member States must provide the Commission with at least the following information (by completing the standard form referred to in point 3, Annex II of the Directive):
- information enabling the product to be identified;
- a description of the risk inherent in the product, and details of risk assessment studies;
- details of measures already taken;
- information on distribution of the product, including destination countries.
The Commission can also approve rapid measures at Community 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 additional periods of the same duration. In certain cases, the product concerned is prohibited from being exported.
Comitology
The Commission is assisted by a Regulatory Committee on the Safety of Consumable Products when taking emergency measures according to Article 13 of the Directive and with regard to decisions on standardisation following Article 4 of the Directive. 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.
Application reports
Every three years, the Commission submits a report to the Parliament and the Council on the application of the Directive.
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 and takes into account the problems which resulted from it.
REFERENCES
Directive 2001/95/EC [adoption: codecision COD/2000/0073] – 15.1.2002- 15.1.2004 – OJ L 11 of 15.1.2002
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 producers or distributors obligation to identify products;
- surveillance of the market, thanks to better coordination between Member States based on the exchange of information and best practice (including in the field of customs cooperation), and 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 consumer services. It has been transposed in all Member States.
RAPEX
COMMISSION DECISION 2004/418/EC of 29 April 2004 laying down guidelines for the management of the Community Rapid Information System (RAPEX) and for notifications presented in accordance with Article 11 of Directive 2001/95/EC [Official Journal L 151 of 30.4.2004; corrigendum: Official Journal L 208 of 10.6.2004].
The Annex to this Decision adopts guidelines for the management of the RAPEX system. It provides, inter alia, criteria for identifying “serious risk” and for classifying and indexing notifications according to the degree of urgency. Its Annex also includes notification forms (including a form specifically for toys) and the deadlines for national contact points and the Commission contact point.
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 [notified under document number C(2009) 2078] (Text with EEA relevance).
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 25 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 ensurethat 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.
TOYS
Commission Decision 2008/329/EC of 21 April 2008 requiring Member States to ensure that magnetic toys placed or made available on the market display a warning about the health and safety risks they pose [Official Journal L 114 of 26.4.2008].
The safety of toys is currently regulated by Directive 88/378/EC, Directive 2001/95/EC and in particular by the standard EN 71-1:2005 relating to the safety of toys Part I: mechanical and physical properties. This standard does not cover risks associated with magnetic toys. The Commission has requested that the European Committee for Standardisation (CEN) revises the standard to take into account these risks.
Whilst awaiting this revision, the Decision foresees that all magnetic toys placed on the market should be accompanied by a clearly visible and easily understandable warning at the time of purchase; the wording should be in the official language(s) of the Member State in which the product is placed on the market.
This Decision is taken on a temporary basis to cover the risk associated with toys containing magnets. The Decision is applicable from 21 July 2008 to 21 April 2009.
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 or making available on the market of products containing DMF are prohibited. They shall withdraw products already available on the market and inform consumers of the risks. 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.
