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EUROPEAN PARLIAMENT
1999
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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
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Symbols for procedures
*
**I
**II
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***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)
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CONTENTS
Page
PROCEDURAL PAGE .............................................................................................................. 4
LEGISLATIVE PROPOSAL ..................................................................................................... 5
DRAFT LEGISLATIVE RESOLUTION .................................................................................. 5
EXPLANATORY STATEMENT.............................................................................................. 6
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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 ….
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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.
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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.
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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.
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