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
Date: 1993-05-18
Institutions: European Commission
Subjects: approximation of laws, cosmetic product

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): 

3) The  following point  is added  to 
Article 4(1): 

"(i) ingredients or combinations of 

"(i) ingredients or combinations of 

ingredients  tested on  animals 
after  1 January  1998  in order  to 
meet  the requirements of  this 
Direct ive. 

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 

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