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EUROPEAN PARLIAMENT 1999 2004 Committee on the Environment, Public Health and Consumer Policy PRELIMINARY 2000/0006(COD) 8 September 2000 ***I DRAFT REPORT on the proposal for a European Parliament and Council directive amending for the 21st time 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) (COM(1999) 746 – C5-0017/2000 – 2000/0006(COD)) Committee on the Environment, Public Health and Consumer Policy Rapporteur: Giuseppe Nisticò PR\417118EN.doc EN PE 293.672 EN Symbols for procedures * **I **II *** ***I ***II ***III Consultation procedure majority of the votes cast Cooperation procedure (first reading) majority of the votes cast Cooperation procedure (second reading) majority of the votes cast, to approve the common position majority of Parliament’s component Members, to reject or amend the common position Assent procedure majority of Parliament’s component Members except in cases covered by Articles 105, 107, 161 and 300 of the EC Treaty and Article 7 of the EU Treaty Codecision procedure (first reading) majority of the votes cast Codecision procedure (second reading) majority of the votes cast, to approve the common position majority of Parliament’s component Members, to reject or amend the common position Codecision procedure (third reading) majority of the votes cast, to approve the joint text (The type of procedure depends on the legal basis proposed by the Commission) PE 293.672 EN 2/7 PR\417118EN.doc CONTENTS Page PROCEDURAL PAGE .............................................................................................................. 4 LEGISLATIVE PROPOSAL ..................................................................................................... 5 DRAFT LEGISLATIVE RESOLUTION .................................................................................. 5 EXPLANATORY STATEMENT.............................................................................................. 6 PR\417118EN.doc 3/7 PE 293.672 EN PROCEDURAL PAGE By letter of 6 January 2000 the Commission submitted to Parliament, pursuant to Article 251(2) and Article 95 of the EC Treaty, the proposal for a European Parliament and Council directive amending for the 21st time 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) (COM(1999) 746 2000/0006 (COD)). At the sitting of 21 January 2000 the President of Parliament announced that she had referred the proposal to the Committee on the Environment, Public Health and Consumer Policy as the committee responsible (C5-0017/2000). The Committee on the Environment, Public Health and Consumer Policy appointed Giuseppe Nisticò rapporteur at its meeting of 22 February 2000. It considered the Commission proposal and draft report at its meeting(s) of ... and ... . At the latter/last meeting it adopted the draft legislative resolution by .. votes to ..., with ... abstention(s)/unanimously. The following were present for the vote: ..., chairman/acting chairman; ... (and ...), vicechairman/vice-chairmen; ..., rapporteur; ..., ... (for ...), ... (for ... pursuant to Rule 153(2)), ... and ... . The report was tabled on …. The deadline for tabling amendments will be indicated in the draft agenda for the relevant part-session/is ... p.m. on …. PE 293.672 EN 4/7 PR\417118EN.doc LEGISLATIVE PROPOSAL Proposal for a European Parliament and Council directive amending for the 21st time 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) (COM(1999) 746 – C5-0017/2000 – 2000/0006(COD)) The proposal is approved. DRAFT LEGISLATIVE RESOLUTION European Parliament legislative resolution on the proposal for a European Parliament and Council directive amending for the 21st time 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) (COM(1999) 746 – C5-0017/2000 – 2000/0006(COD)) (Codecision procedure: first reading) The European Parliament, – having regard to the Commission proposal to the European Parliament and the Council (COM(1999) 7461), – having regard to Article 251(2) and Article 95 of the EC Treaty, pursuant to which the Commission submitted the proposal to Parliament (C5-0017/2000), – having regard to Rule 67 of its Rules of Procedure, – having regard to the report of the Committee on the Environment, Public Health and Consumer Policy (A5-0000/2000), 1. Approves the Commission proposal; 2. Asks to be consulted again should the Commission intend to amend its proposal substantially or replace it with another text; 3. Instructs its President to forward its position to the Council and Commission. 1 OJ C 116, 26.4.2000, p. 54. PR\417118EN.doc 5/7 PE 293.672 EN EXPLANATORY STATEMENT The objectives of the Treaty establishing the European Community include the approximation of national legislation to the extent that this is necessary for the functioning of the internal market, and Article 95(3) of the Treaty stipulates that the pursuit of this objective shall be based on a high level of protection for health and environmental protection, taking account of any new development based on scientific facts. The proposal which we are examining for a European Parliament and Council directive, submitted by the Commission, must be seen within this general context since it is the 21st amendment to Council Directive 76/769/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations and in particular substances classified as carcinogens, mutagens or substances toxic to reproduction. The proposal deals specifically, as mentioned in the Annex, with two category 2 carcinogens, namely 4-chloroaniline and refractory ceramic fibres, and one category 2 substance toxic to reproduction, namely a derivative of 6-silaundecane, 6-(2-chloroethyl)-6(2-methoxyethoxy)2,5,7,10-tetraoxa-6-silaundecane; etacelasil. With regard to 4-choroaniline, there is experimental evidence to show that it may damage the liver, kidneys, spleen and blood and evidence that it is implicated in the incidence of cancer of the bladder in workers exposed to substances such as chlorinated aniline derivatives. With regard to refractory ceramic fibres (aluminium silicate fibres, used for insulation), there is evidence showing that, after long exposure, lung fibrosis, lung cancer and mesotheliomas have been confirmed in workers who have come into contact with the fibres. Similarly, for the above-mentioned derivative of 6-silaundecane, there is scientific evidence that it is toxic to reproduction. In the light of new scientific knowledge on the danger of the three substances mentioned above, it has become necessary to update the list of substances classified as mutagenic, carcinogenic or toxic to reproduction in the previous directives (Directive 76/769/EEC, Directive 94/60/EC and Directive 97/69/EC), by means of the proposal for a directive that we must approve. The approval of this directive therefore constitutes an obligation upon the European Union in order to protect the health of citizens, and as far as two of the substances are concerned, in order to reduce the risk of incidence of cancer through exposure to carcinogens. In addition, there is a clear positive cost/benefit ratio, since there will be huge gains for human health with no extra costs. On the other hand, there will be no particular problems for trade or industry, as none of the three substances is placed on the market for consumer use. PE 293.672 EN 6/7 PR\417118EN.doc Only refractory ceramic fibres could be obtained by the general public for hobby use, but this is an unlikely prospect. Furthermore, the Commission has consulted experts from Member States and industry, and they did not oppose the directive. For the above reasons it is proposed that this directive should be approved without any amendments. PR\417118EN.doc 7/7 PE 293.672 EN