DIRECTIVE 2005/90/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 18 January 2006
amending, for the 29th time, Council Directive 76/769/EEC on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (substances classified as carcinogenic, mutagenic or toxic to reproduction - c/m/r)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social Committee (1),
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
(1)
The measures provided for in this Directive fall within the framework of the action plan adopted in Decision No 1786/2002/EC of the European Parliament and of the Council of 23 September 2002 adopting a programme of Community action in the field of public health (2003 to 2008) (3). According to that Decision the Community is committed to promoting and improving health, preventing disease, and countering potential threats to health, with a view to reducing avoidable morbidity and premature mortality and activity-impairing disability.
(2)
The substances which appear in Annex I to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (4) and are classified as carcinogens category 1 or 2 may cause cancer. The substances which appear in Annex I to Directive 67/548/EEC and are classified as mutagens category 1 or 2 may cause heritable genetic damage. The substances which appear in Annex I to Directive 67/548/EEC and are classified as toxic to reproduction category 1 or 2 may cause birth defects or may impair fertility.
(3)
In order to improve human health protection and consumer safety, the use of substances newly-classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2 should be regulated and the placing on the market of substances and preparations containing them should be subject to restriction for sale to the general public.
(4)
Council Directive 76/769/EEC of 27 July 1976 on the approximation of the laws, regulations and administrative provisions of the Member States relating to restrictions on the marketing and use of certain dangerous substances and preparations (5) lays down restrictions on the marketing and use of certain dangerous substances and preparations, with the objective, among others, to improve human health protection and consumer safety.
(5)
Directive 94/60/EC of the European Parliament and of the Council (6) amending for the 14th time Directive 76/769/EEC, establishes, in the form of an Appendix to Annex I to Directive 76/769/EEC, a list containing substances classified as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2. Such substances and preparations containing them should be subject to restriction for sale to the general public.
(6)
Directive 94/60/EC provides that, no later than six months after publication in the Official Journal of the European Union of an adaptation to technical progress of Annex I to Directive 67/548/EEC, which contains substances classified as carcinogenic, mutagenic or toxic to reproduction in category 1 or 2, the Commission will submit to the European Parliament and Council a proposal for a directive regulating these newly-classified substances, so as to update the Appendix of Annex I to Directive 76/769/EEC. The proposal from the Commission will take account of the risks and advantages of the newly-classified substances, as well as of the Community legislative provisions on risk analysis.
(7)
Commission Directive 2004/73/EC of 29 April 2004 adapting to technical progress for the 29th time Council Directive 67/548/EEC, and more particularly Annex I thereto, includes 146 entries containing substances newly-classified as carcinogenic category 1, 21 entries containing substances newly-classified as carcinogenic category 2, 152 entries containing substances newly-classified as mutagenic category 2 and 24 entries containing substances newly-classified as toxic to reproduction category 2.
(8)
Directive 2004/73/EC also amends the notes relating to the identification, classification and labelling ascribed to four substances classified as carcinogenic category 1, thirty-six entries containing substances classified as carcinogenic category 2, six entries containing substances classified as mutagenic category 2, two entries containing substances classified as toxic to reproduction category 1 and three entries containing substances classified as toxic to reproduction category 2. The lists in the Appendix of Annex I to Directive 76/769/EEC should be amended accordingly.
(9)
The risks and advantages of the substances newly-classified by Directive 2004/73/EC as carcinogenic, mutagenic or toxic to reproduction of category 1 or 2 have been taken into account, in particular those relating to the substances which were not yet subject to a restriction for use in substances and preparations placed on the market for sale to the general public (due to an earlier classification). This analysis concluded that these newly-classified substances could be inserted in the Appendix of Annex I to Directive 76/769/EEC.
(10)
This Directive should apply without prejudice to Community legislation laying down minimum requirements for the protection of workers contained in Council Directive 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work (7), and individual directives based thereon, in particular Directive 2004/37/EC of the European Parliament and of the Council of 29 April 2004 on the protection of workers from the risks related to exposure to carcinogens or mutagens at work (8),
HAVE ADOPTED THIS DIRECTIVE:
Article 1
The Appendix of Annex I to Directive 76/769/EEC shall be amended as set out in the Annex to this Directive.
Article 2
1. Member States shall adopt and publish the laws, regulations and administrative provisions necessary to comply with this Directive before 24 February 2007. They shall forthwith communicate to the Commission the text of those measures and a correlation table between those measures and this Directive.
They shall apply those measures from 24 August 2007.
When Member States adopt these measures, they shall contain a reference to this Directive or be accompanied by such reference on the occasion of their official publication. The methods of making such reference shall be determined by the Member States.
2. Member States shall communicate to the Commission the text of the main provisions of national law which they adopt in the field covered by this Directive.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Strasbourg, 18 January 2006.