Cosmetics and Alternative Methods

1
Cosmetics and Alternative Methods - Achievements
and Prospects in the framework of the Directive
76/768
Paul Weissenberg Enterprise Directorate-General B
russels, 10 July 2002
2
Cosmetics and Alternative Methods

• How many animals are used for testing of
  cosmetic ingredients?
• How many alternative methods are used in testing
  cosmetic ingredients?
• How can we reduce the number of animals while
  ensuring consumer health protection?

3
Cosmetics and Alternative Methods6th Amendment

• Council Directive 76/768/EEC of 27 July 1976
  introducing Article 4 (1) (i) by the 6th
  amendment 93/35/EEC of 14 June 1993
• Member States shall prohibit the marketing of
  cosmetic products containing ingredients or
  combinations of ingredients tested on animals
  after 30 June 2002

4
Cosmetics and Alternative Methods Achievements

• Acute toxicity 3 reduction and refinement
  methods accepted by OECD and EU
• Percutaneous absorption 1 replacement method
  accepted by OECD and EU
• Skin corrosivity 3 replacement methods accepted
  by OECD and EU
• Skin Sensitisation 1 refinement method accepted
  by OECD and EU
• Mutagenicity/Genotoxicity various replacement
  tests for genotoxicity accepted by OECD and EU
• Phototoxicity 1 replacement method accepted by
  OECD and EU
• Teratogenicity 3 in vitro embryotoxicity tests
  accepted by ESAC

5
Cosmetics and Alternative Methods Failures

• Skin Irritation
• Eye Irritation
• Subchronic and Long-term Toxicity
• Toxicokinetics and Metabolism Data
• Reproduction Toxicity
• Carcinogenicity

6
Cosmetics and Alternative Methods Marketing Ban

• Marketing Ban has come into force!
• This ban is not compliant with WTO rules!
• Another Postponement?!

7
Cosmetics and Alternative Methods7th Amendment

• Adoption of the proposal by the Commission
• 5 April 2000
• Opinion of the Economic and Social Committee
• 22 September 2000
• Opinion of the European Parliament at first
  reading
• 3 April 2001
• Date of adoption of the Commission amended
  proposal
• 22 November 2001
• Date of adoption of the Council common position
  
• 14 February 2002
• Communication from the Commission concerning the
  common position
• 22 February 2002
• Recommendation of EP for a second reading
• 11 June 2002

8
Cosmetics and Alternative Methods7th Amendment

• Adoption of the Council Common Position
• (14 February 2002)
• a marketing ban
• with no cut-off date
• linked to the acceptance of alternative methods
  at OECD
• aim to reduce the risk of a challenge at WTO,
  even if not totally WTO secured

9
Cosmetics and Alternative Methods7th Amendment

• EUROPEAN PARLIAMENT
• 2nd READING (11 June 2002)
• - Adopted by absolute majority of its members -
• Marketing ban as soon as alternative methods
  exist - but no later than 5 years after adoption
  of the Directive
• Exception for 3 toxicological endpoints
  specifically mentioned with a final cut-off date
  no later than 10 years adoption of the Directive
• No reference to OECD validation
• Full EU testing ban for ingredients as from
  31.12.2004

10
Cosmetics and Alternative Methods7th Amendment

• Opinion of the Commission
• Opinion of the Commission to the Council on the
  EPs amendments according to Article 251(2), 3st
  subparagraph, point (c) of EC Treaty
• Difficult conciliation procedure

11
Cosmetics and Alternative Methods7th Amendment

• TOPICS FOR DISCUSSION
• Marketing ban / Testing ban
• Cut-off date ?
• 5-10-15years ?
• Validation
• OECD ?
• ECVAM ?
• Exception for certain test ?
• WTO and Trade aspects

12
Cosmetics and Alternative Methods Conciliation
Procedure

• The Commission in the Conciliation Procedure
  plays ONLY a role of active and dynamic broker.
• The right to take initiatives cannot be exerted
  via amendment of the proposal in the Conciliation
  committee.
• However, if the joint project of the EP and
  the Council, resulting from conciliation,
  misrepresented the Commission proposal, it could
  withdraw its proposal.
• In the event of adoption by the EP and the
  Council of the joint project, examination for
  an action in the Court of Justice.

13
Cosmetics and Alternative MethodsProspects

• ANIMAL TESTING
• The need to reconcile different political
  objectives.
• To protect the health of consumers while reducing
  animal suffering.
• Realism promoting research does not mean that
  science can always deliver !
• Promoting the discussions with different
  stakeholders consumers, industry
  representatives and animal welfaregroups.

14
Cosmetics and Alternative MethodsProspects

• ANIMAL TESTING
• Proceed with scientific development
• Set priorities in research
• Increase the Research efforts to produce
  alternative methods
• Speed up process of validation
• Accelerate the process at OECD level
• Ensure a maximum consistency between ECVAM and
  OECD
• Set up a timetable