Explanatory Memorandum to COM(1999)746 - Amendment of Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations (substances classified as carcinogens, mutagens or substances toxic to reproduction - c/m/r) - Main contents
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dossier | COM(1999)746 - Amendment of Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances ... |
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source | COM(1999)746 ![]() |
date | 06-01-2000 |
European Parliament and Council Directive 94/60/EC i amending for the 14th time Directive 76/769/EEC i (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) adds a list of substances classified as category 1 or 2 carcinogens, mutagens or substances toxic to reproduction (c/m/r) to Annex I of Directive 76/769/EEC. It stipulates that these substances may not be used in substances or preparations placed on the market for sale to the general public. The c/m/r-classification of these substances has been defined in Annex I of Directive 67/548/EEC i on classification, packaging and labelling of dangerous substances. This Annex is regularly updated by way of adaptation to technical progress.
Directive 94/60/EC also imposes on the Commission the obligation to submit further proposals to the European Parliament and Council to add additional c/m/r substances to Annex I of Directive 76/769 no later than six months after the publication of new classifications as c/m/r (categories 1 and 2) in the framework of Council Directive 67/548/EEC. The European Parliament and Council Directive 97/56/EC i, 16th amendment to Directive 76/769/EEC, updates and consolidates the Appendix of c/m/r-substances to Annex I to the Directive.
Commission Directive 97/69/EC i (23rd adaptation) added 1 substance newly classified as carcinogenic category 2 to Annex I of Directive 67/548/EEC and Commission Directive 98/73/EC i (24th adaptation) added 1 substance newly classified as carcinogenic category 2 and 1 substance newly classified as toxic for reproduction category 2. It is proposed to add these substances to the appendix to points 29 and 31.
2. JUSTIFICATION FOR PROPOSAL AND CONSIDERATIONS OF SUBSIDIARITY
What are the objectives of the proposal in relation to the Community's obligations -
Within the framework for action in the field of public health, the European Parliament and the Council have adopted an action plan to combat cancer (Decision N° 646/96 i). Due to the fact that use of chemicals by consumers cannot be controlled safety can only be ensured by prohibiting use by consumers of c/m/r substances and preparations. Following the adoption of the Directive 94/60/EC the Commission is required to propose Directives prohibiting use by consumers of substances newly classified as c/m/r categories 1 or 2.
The objectives of the proposal are to preserve the Internal Market and to protect the health of the consumers.
Does the initiatives arise out of an exclusive Community competence or a shared competitiveness -
The action to preserve the Internal Market for dangerous substances falls within the exclusive competence of the Community. This competence was established by Council Directive 76/769/EEC.
What are the courses of action available to the Community -
The only course of action available is a proposal for an amendment to Directive 76/769/EEC, the twenty-first amendment, providing for harmonised rules on the use of substances and preparations classified as category 1 or 2 c/m/r's.
Are uniform rules necessary - Is it not sufficient to establish targets to be implemented by Member States -
The proposed 21st amendment establishes uniform rules for the circulation of substances and preparations classified as c/m/r. It also guarantees high level of protection of health and safety of consumers. The proposed 21st amendment is the only way to meet these goals. Targets would be insufficient.
3. RATIONALE OF THE PROPOSAL
The proposed 21st amendment would extend the appendix of c/m/r substances to Annex I to Directive 76/769 by adding the substances classified as c/m/r category 1 or category 2 in the 23rd and 24th adaptations to technical progress of Directive 67/548/EEC. Use by consumers of all these substances is thus prohibited.
4. COSTS AND BENEFITS
4.1. Costs
None of the 3 substances is known to be placed on the market for consumer uses. Refractory ceramic fibres could however, although extremely rare and unlikely, be obtained by the general public for hobby use. The proposed Directive should not pose any problems to the industry or trade.
4.2. Benefits
The proposed ban will ensure that the carcinogenic substances and preparations are not placed on the market for consumer use either now or in the future. The benefit of the proposal is to protect the health of consumers.
5. PROPORTIONALITY
The 21st amendment would yield benefits in terms of protecting the health of consumers. This would be achieved at no costs.
PERFORMED IN RPEPARING THE DRAFT 21ST AMENDMENT
Advice on the preparation of the proposal was sought through several meetings involving experts from Member States and industry. Industry, represented by CEFIC (European Chemical Industry Council) and CERAME-UNI did not oppose the proposal, in so far as it does not concern articles containing the substances.
7. CONFORMITY WITH THE TREATY
This proposal is intended to facilitate a high level of protection of health of the consumers and is therefore in conformity with Article 95§3 of the Treaty.
The proposal does not call for any special provisions of the kind referred to in Article 15 of the Treaty.
It is in conformity with Article 5.
8. CONSULTATION OF THE EUROPEAN PARLIAMENT AND THE ECONOMIC AND SOCIAL COMMITTEE
In compliance with Article 95 of the Treaty, the Codecision Procedure with the European Parliament is applicable. The Economic and Social Committee has to be consulted.