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1997/2093(COS)

Cosmetics: development, validation and legal acceptance of alternative methods to animal experiments. 1996 report

Procedure completed

1997/2093(COS) Cosmetics: development, validation and legal acceptance of alternative methods to animal experiments. 1996 report
RoleCommitteeRapporteurShadows
Lead ENVI ROTH-BEHRENDT Dagmar (PSE)
Lead committee dossier: ENVI/4/08919
Legal Basis RoP 119
Subjects
Links

Activites

  • 1997/11/10 Final act published in Official Journal
  • 1997/10/22 Text adopted by Parliament, single reading
    • T4-0495/1997 summary
    • OJ C 339 10.11.1997, p. 0047-0061
  • 1997/09/24 Committee report tabled for plenary, single reading
  • 1997/09/24 Committee report tabled for plenary, single reading
  • 1997/08/22 Committee draft report
    • PE223.450
  • 1997/07/18 Committee referral announced in Parliament, 1st reading/single reading
  • 1997/05/05 Non-legislative basic document published
    • COM(1997)0182 summary
  • 1997/05/05 Non-legislative basic document
    • COM(1997)0182 summary

Documents

History

(these mark the time of scraping, not the official date of the change)

2012-02-10
activities added
  • date
    1997-05-05
    docs
    • url
      http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=1997&nu_doc=0182
      text
      • OBJECTIVE: this third annual Commission report (1996) on the development, validation and legal
        acceptance of alternative methods to animal experiments in the field of cosmetics reviews the
        situation on the eve of the date by which the Commission has to present draft measures postponing
        the date for the ban on animal testing if alternative methods have not been scientifically validated
        (1 January 1998).
        SUBSTANCE: the report comprises two parts. The first describes the objectives and anticipated
        constraints concerning legal acceptance on the eve of the date (1 January 1998) from which the ban
        on cosmetic products containing ingredients or combinations of ingredients tested on animals is due
        to be introduced. The second part is more scientific and describes the initiatives taken with a view
        to the development, validation and legal acceptance of alternative methods.
        (1) Objectives and constraints: two principal objectives are pursued:
        - the safety of cosmetic products with regard to human health: in this connection the basic
        'Cosmetics' Directive (93/35/EEC) requires manufacturers, as from 1 January 1995, to keep certain
        information on product safety readily accessible to the competent authorities. It also establishes a
        system of lists of prohibited products, products subject to certain limitations and authorized
        products.
        These lists are regularly adapted to technical progress. The Commission believes that a blanket ban
        on the use of new substances would not obviate the need for tests. Furthermore, putting a stop to
        innovation in this area would spell ruin for many SMEs;
        - reduction/elimination of animal suffering: the Commission recognizes the fact that it is a question
        of ethical imperatives, even though tests of this type account for a mere 0.03% of all animal tests.
        However, it feels that the use of human volunteers cannot in itself replace animal tests across the
        board.
        The constraints which have to be taken into account concerning acceptance of alternative methods
        fall into two categories:
        - compatibility with the rules of international trade (especially WTO rules): any measure that leads
        to banning products from third countries because they have been tested on animals is likely to prove
        incompatible with these rules. The Commission is therefore proposing to review the basic
        'Cosmetics' Directive in order to resolve this problem;
        - the interests of SMEs must be safeguarded, particularly with regard to jobs created in this sector.
        (2) Existing and expected results: a distinction must be made between ingredients (and/or
        combinations of ingredients) and finished cosmetic products:
        - ingredients/combinations of ingredients: the report notes that no alternative method offering an
        equivalent degree of protection are available as yet, nor are they expected to become available by
        1 January 1998. However, alternative methods should progressively become available in the
        domains
        pertaining to percutaneous absorption and local risks to the eye and skin: photoirritation, eye
        irritation and skin irritation (same conclusions as the 1995 report - see COS0505). By contrast, in
        the case of tests relating to systemic effects, there is no hope of replacing animal testing in the
        foreseeable future, although the reduction in the number of animals used for tests should continue;
        - finished cosmetic products: after 1 January 1998 it will be possible to evaluate these products
        without animal testing as a result of available knowledge on the safety of their ingredients.
        However,
        the report notes that there are grounds to fear toxic effects as a result of interaction between
        ingredients or where skin penetration by ingredients is facilitated by the vehicle used. In such cases
        animal testing is likely to remain necessary.
        (3) Conclusions: while research has made progress, no alternative test methods have yet been
        scientifically validated and accepted. The situation is unlikely to change before 1 January 1998. The
        Commission is therefore proposing:
        - postponement of the ban on products tested on animals until 30 June 2000,
        - presentation of draft measures before 1 January 2000, taking account of progress made by that
        date,
        - promotion of research into and validation of alternative methods,
        - dissemination among SMEs of testing methods for finished products which do not involve the use
        of animals,
        - presentation of a proposal banning animal testing for finished cosmetic products as of
        1 January 1998 (to be adopted by the Codecision Procedure with the European Parliament; also
        covers aspects relating to products from third countries).
      type
      Non-legislative basic document published
      title
      COM(1997)0182
    body
    type
    Non-legislative basic document published
  • date
    1997-05-05
    docs
    • url
      http://eur-lex.europa.eu/smartapi/cgi/sga_doc?smartapi!celexplus!prod!DocNumber&lg=EN&type_doc=COMfinal&an_doc=1997&nu_doc=0182
      text
      • OBJECTIVE: this third annual Commission report (1996) on the development, validation and legal
        acceptance of alternative methods to animal experiments in the field of cosmetics reviews the
        situation on the eve of the date by which the Commission has to present draft measures postponing
        the date for the ban on animal testing if alternative methods have not been scientifically validated
        (1 January 1998).
        SUBSTANCE: the report comprises two parts. The first describes the objectives and anticipated
        constraints concerning legal acceptance on the eve of the date (1 January 1998) from which the ban
        on cosmetic products containing ingredients or combinations of ingredients tested on animals is due
        to be introduced. The second part is more scientific and describes the initiatives taken with a view
        to the development, validation and legal acceptance of alternative methods.
        (1) Objectives and constraints: two principal objectives are pursued:
        - the safety of cosmetic products with regard to human health: in this connection the basic
        'Cosmetics' Directive (93/35/EEC) requires manufacturers, as from 1 January 1995, to keep certain
        information on product safety readily accessible to the competent authorities. It also establishes a
        system of lists of prohibited products, products subject to certain limitations and authorized
        products.
        These lists are regularly adapted to technical progress. The Commission believes that a blanket ban
        on the use of new substances would not obviate the need for tests. Furthermore, putting a stop to
        innovation in this area would spell ruin for many SMEs;
        - reduction/elimination of animal suffering: the Commission recognizes the fact that it is a question
        of ethical imperatives, even though tests of this type account for a mere 0.03% of all animal tests.
        However, it feels that the use of human volunteers cannot in itself replace animal tests across the
        board.
        The constraints which have to be taken into account concerning acceptance of alternative methods
        fall into two categories:
        - compatibility with the rules of international trade (especially WTO rules): any measure that leads
        to banning products from third countries because they have been tested on animals is likely to prove
        incompatible with these rules. The Commission is therefore proposing to review the basic
        'Cosmetics' Directive in order to resolve this problem;
        - the interests of SMEs must be safeguarded, particularly with regard to jobs created in this sector.
        (2) Existing and expected results: a distinction must be made between ingredients (and/or
        combinations of ingredients) and finished cosmetic products:
        - ingredients/combinations of ingredients: the report notes that no alternative method offering an
        equivalent degree of protection are available as yet, nor are they expected to become available by
        1 January 1998. However, alternative methods should progressively become available in the
        domains
        pertaining to percutaneous absorption and local risks to the eye and skin: photoirritation, eye
        irritation and skin irritation (same conclusions as the 1995 report - see COS0505). By contrast, in
        the case of tests relating to systemic effects, there is no hope of replacing animal testing in the
        foreseeable future, although the reduction in the number of animals used for tests should continue;
        - finished cosmetic products: after 1 January 1998 it will be possible to evaluate these products
        without animal testing as a result of available knowledge on the safety of their ingredients.
        However,
        the report notes that there are grounds to fear toxic effects as a result of interaction between
        ingredients or where skin penetration by ingredients is facilitated by the vehicle used. In such cases
        animal testing is likely to remain necessary.
        (3) Conclusions: while research has made progress, no alternative test methods have yet been
        scientifically validated and accepted. The situation is unlikely to change before 1 January 1998. The
        Commission is therefore proposing:
        - postponement of the ban on products tested on animals until 30 June 2000,
        - presentation of draft measures before 1 January 2000, taking account of progress made by that
        date,
        - promotion of research into and validation of alternative methods,
        - dissemination among SMEs of testing methods for finished products which do not involve the use
        of animals,
        - presentation of a proposal banning animal testing for finished cosmetic products as of
        1 January 1998 (to be adopted by the Codecision Procedure with the European Parliament; also
        covers aspects relating to products from third countries).
      type
      Non-legislative basic document
      title
      COM(1997)0182
    body
    EC
    commission
      type
      Non-legislative basic document
    • date
      1997-07-18
      body
      EP
      type
      Committee referral announced in Parliament, 1st reading/single reading
      committees
      • body
        EP
        responsible
        True
        committee
        ENVI
        date
        1997-07-02
        committee_full
        Environment, Public Health and Consumer Protection
        rapporteur
        • group
          PSE
          name
          ROTH-BEHRENDT Dagmar
    • date
      1997-08-22
      docs
      • type
        Committee draft report
        title
        PE223.450
      body
      EP
      type
      Committee draft report
    • date
      1997-09-24
      docs
      • url
        http://www.europarl.europa.eu/sides/getDoc.do?type=REPORT&mode=XML&reference=A4-1997-0277&language=EN
        type
        Committee report tabled for plenary, single reading
        title
        A4-0277/1997
      body
      type
      Committee report tabled for plenary, single reading
    • date
      1997-09-24
      docs
      text
      • The EU should press for a change to world trade guidelines in order to accommodate environmental concerns and animal welfare, the Environment, Public Health and Consumer Protection Committee urged.
        The committee adopted unanimously a motion for a resolution drafted by Mrs Dagmar ROTH-BEHRENDT (PES, D) on the Commission's recently published report for 1996 which deals with the development of alternatives to animal experiments in the field of cosmetics.
        "With regard to GATT/WTO, the EU should formulate a definitive position without further delay and test GATT guidelines to the limit," the draft states. "In parallel, it should press for a positive change to GATT guidelines in order to reconcile trade and valid environmental and animal welfare concerns."
        The problem is that some countries insist that cosmetics be tested on animals before they can be sold. The EU is a major exporter of cosmetics.
        Nevertheless, the draft resolution, adopted as part of a non-legislative report on the subject drafted by Mrs Roth-Behrendt, calls on the European Commission to bring forward a proposal to ban animal testing of cosmetic products and ingredients by 1 January 1998, as laid down in earlier EU legislation. Parliament has previously taken the view that the production of new cosmetics should not cause animals to suffer.
        The draft resolution is a direct challenge to the Council of Ministers, which has accepted a Commission proposal to postpone the date of implementation of a ban until 1 June 2000 to allow further time for the development of alternatives.
        The committee believes that not enough research is being done to find alternatives.
        Accordingly, there is a call for the Community's fifth research framework programme to be amended to research outside the Commission into alternatives.
      body
      EP
      type
      Committee report tabled for plenary, single reading
    • date
      1997-10-22
      docs
      body
      EP
      type
      Text adopted by Parliament, single reading
    • date
      1997-11-10
      type
      Final act published in Official Journal
    committees added
    • body
      EP
      responsible
      True
      committee
      ENVI
      date
      1997-07-02
      committee_full
      Environment, Public Health and Consumer Protection
      rapporteur
      • group
        PSE
        name
        ROTH-BEHRENDT Dagmar
    links added
    other added
      procedure added
      dossier_of_the_committee
      ENVI/4/08919
      reference
      1997/2093(COS)
      title
      Cosmetics: development, validation and legal acceptance of alternative methods to animal experiments. 1996 report
      legal_basis
      • Rules of Procedure of the European Parliament EP 119
      stage_reached
      Procedure completed
      subtype
      Commission strategy paper
      type
      COS - Procedure on a strategy paper (historic)
      subject