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) 
- 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. 
_ 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 
Article 4(1): 
"(i) ingredients or combinations of 
ingredients tested on animals 
after 1 January 1998 in order to 
meet the requirements of this 
Direct ive. 3) The following point is added to 
Article 4(1): 
"(i) ingredients or combinations of 
ingredients tested on animals 
after 1 January 1998 in order 
to assess their safety or 
efficacy for use in cosmetic 
products or to comply with the 
requirements of this Directive 
-i 
Article 1, point 3, second and third subparagraphs unchanged 
Article 1, points 4-14 unchanged. 
Articles 2, 3 and 4 unchanged. 
Annex unchanged. 
-H--
Amendments by the European Parliament relected by the Commission 
(Amendment 2) 
Article 1, point 3, second subparagraph 
If there has been insufficient 
progress in developing satisfactory 
methods to replace animal testing, and 
in particular in those cases where 
alternative methods of testing, 
despite all reasonable endeavours, 
have not been scientifically validated 
as offering an equivalent level of 
protection for the consumer, taking 
into account OECD toxicity test 
gui de Iines. the Commission shalI. by 1 
January 1997, submit draft measures to 
postpone the date of implementation of 
this provision, for a sufficient 
period, and in any case for no less 
than two years, in accordance with the 
procedure laid down in Article 10. 
Before submitting such measures, the 
Commission will consult the Scientific 
Committee on Cosmetology. If there has been insufficient 
progress in developing satisfactory 
methods to replace animal testing, 
the Commission may, by 1 January 
1997, submit draft measures to 
postpone the date of implementation 
of this provision, for a per iod not 
exceeding two years. Such 
postponement shall be limited to 
specific types of test. Any 
proposal for a postponement shall be 
made to the Council, pursuant to 
Article 100a of the EEC Treaty. 
Before submitting such measures, the 
Commission shall consult the 
Scientific Committee on Cosmetology 
and the European Centre for the 
Validation of Alternative Methods. 
It shall take particular account of. 
standards of validation and non-
animal test methods acceptable_to..EC 
author it ies and Member States. 

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 
L-2985 Luxembourg