CELEX: 51993PC0239
Language: en
Date: 1993-05-18
Title: Re-examined proposal for a Council Directive amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products

COMMISSION OF THE EUROPEAN COMMUNITIES
                                           C0M(93) 239 final - SYN 307
                                           Brussels, 28 May 1993
                    Re-examined proposal for a
                         CounciI Direct ive
         amending for the sixth time Directive 76/768/EEC
      on the approximation of the laws of the Member States
                   relating to cosmetic products
     (presented by the Commission pursuant to Article 149.2(d)
                         of the EEC treaty)
 ---pagebreak---                                       - 1 -
                             Explanatory memorandum
On 20 and 21 April 1993, the European Parliament completed the second reading
of the proposal for a Council Directive amending for the sixth time Directive
76/768/EEC on the approximation of the laws of the Member States relating to
                                                             :
cosmetic products.
The European Parliament approved two amendments (Nos 1 and 2) to the common
position adopted by the Council of Ministers on 17 December 1992.
The Commission accepted amendment 1 introducing an explicit ban on tests on
animals for purposes other than compliance with the requirements of the
Directive.
Amendment 2 was rejected by the Commission.
This amendment would have allowed the European Parliament to take part in the
decision-making process concerning the deferment of the date of 1 January
 1998 for the imposition of the ban on animal testing. The Commission was
unable to accept such a proposal because, in view of the technical nature of
 the question of developing alternative methods, it had agreed at the first
reading by the Council of Ministers that where alternative methods had not
been scientifically validated, any deferment of the date of 1 January 1998
would be based on the procedure set out in Article 10 of Directive 76/768/EEC
 rather than Article 100a of the Treaty.
A further aim of amendment 2 was to take into account the work carried out by
 the European Centre for the Validation of Alternative Methods (ECVAM).
When the vote in plenary session was taken, the Commission acknowledged that,
with regard to the latter point, there were grounds for supplementing the
 reference to OECD toxicity test directives already included in the common
 position with a reference to the fact that ECVAM's results would be taken
 into account.
 The European Parliament also wished an element of transparency to be
 introduced in the decision-making process relating to deferment of the date
 for imposition of the ban on animal testing.
 This was unacceptable to the Commission because it went too far. The
 Commission, however, pointed out that it was prepared to seek a little more
 transparency through a formula which, without prejudice to the protection of
 trade secrecy, would give the public access to the available scientific and
 technical information prior to the meeting of the Committee referred to in
 Article 10 to discuss deferment of the date of 1 January 1998.
 The Commission proposed a compromise text along these lines. Despite the
 fact that the European Parliament did not accept this compromise, the
 Commission declared that It was still prepared to ask the Council to
  incorporate both these points.
 ---pagebreak---                                        _ 2 _
                            Re-examined proposal for a
                                 CounciI Direct Ive
                amending for the sixth time Directive 76/768/EEC
             on the approximation of the laws of the Member States
                          relating to cosmetic products
                           (submitted by the Commission
           under the terras of Article 149(2)(d) of the EEC Treaty)
Counc11's common DOS 11 ion                  Re-examined proposal
                                Recitals unchanged
                       Article 1, points 1 and 2 unchanged
                     Article 1, point 3, first subparagraph
3) The following point is added to           3) The following point is added to
Article 4(1):                                Article 4(1):
"(i) ingredients or combinations of          "(i) ingredients or combinations of
      ingredients tested on animals                ingredients tested on animals
     after 1 January 1998 in order to             after 1 January 1998 in order
     meet the requirements of this                to assess their safety or
     Direct ive.                                  efficacy for use in cosmetic
                                                  products or to comply with the
                                                  requirements of this Directive
 ---pagebreak---                             -i
Article 1, point 3, second and third subparagraphs unchanged
             Article 1, points 4 - 1 4 unchanged.
                Articles 2, 3 and 4 unchanged.
                       Annex unchanged.
 ---pagebreak---                                       -H--
        Amendments by the European Parliament relected by the Commission
                                  (Amendment 2)
                     Article 1, point 3, second subparagraph
If there has been insufficient              If there has been insufficient
progress in developing satisfactory        progress in developing satisfactory
methods to replace animal testing, and     methods to replace animal testing,
in particular in those cases where          the Commission may, by 1 January
alternative methods of testing,             1997, submit draft measures to
despite all reasonable endeavours,          postpone the date of implementation
have not been scientifically validated     of this provision, for a per iod not
as offering an equivalent level of         exceeding two years. Such
protection for the consumer, taking         postponement shall be limited to
into account OECD toxicity test             specific types of test. Any
gui de Iines. the Commission shalI. by 1    proposal for a postponement shall be
January 1997, submit draft measures to     made to the Council, pursuant to
postpone the date of implementation of      Article 100a of the EEC Treaty.
this provision, for a sufficient            Before submitting such measures, the
period, and in any case for no less         Commission shall consult the
than two years, in accordance with the      Scientific Committee on Cosmetology
procedure laid down in Article 10.          and the European Centre for the
Before submitting such measures, the        Validation of Alternative Methods.
Commission will consult the Scientific      It shall take particular account of.
Committee on Cosmetology.                   standards of validation and non-
                                            animal test methods acceptable_to..EC
                                            author it ies and Member States.
 ---pagebreak---  ---pagebreak---                                                                      ISSN 0254-1475
                                                              COM (93) 239 final
                                                      DOCUMENTS
EN                                                                              06
                                 Catalogue number : CB-CO-93-270-EN-C
                                                             ISBN 92-77-56188-2
Office for Official Publications of the European Communities
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