CELEX: 51990PC0488
Language: en
Date: 1991-02-05
Title: 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

No C 52/6                              Official Journal of the European Communities                                 28.2. 91
                                                              II
                                                       (Preparatory Acts)
                                                 COMMISSION
               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
                                               COM(90) 488 final — SYN 307
                                    (Submitted by the Commission on 12 February 1991)
                                                         (91/C 52/06)
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                           Whereas greater transparency is needed regarding the
                                                                   ingredients employed in cosmetics if the latter are to be
                                                                   placed on the market without any prior procedure and in
                                                                   order to obtain the necessary information on the finished
Having regard to the Treaty establishing the European              product solely at the place of manufacture or of initial
Economic Community, and in particular Article 100a                 importation into the Community and provide better
thereof,                                                           information to the consumer; whereas such transparency
                                                                   should be attained by indicating the product's function
                                                                   and by indicating the ingredients used in a cosmetic
Having regard to the proposal from the Commission,                 product on its packaging; whereas where for practical
                                                                   reasons it is impossible to indicate the ingredients and
                                                                   any warnings regarding use on the container or the
                                                                   packaging, such indications should be given on an
In cooperation with the European Parliament,                       enclosed leaflet with a suitable symbol;
Having regard to the opinion of the Economic and
Social Committee,
                                                                   Whereas, with regard to the finished cosmetic product, it
                                                                   should be made clear which information is to be made
Whereas legal ambiguities in Council Directive                     available to the monitoring authorities of the place of
76/768/EEC ('), as last amended by Directive                       manufacture or of initial importation into the
 89/679/EEC (2), particularly in Articles 1 and 2, should          Community market; whereas this information should
be removed;                                                        include all the necessary elements relating to identity,
                                                                   quality, safety for human health and the claimed effects
                                                                    of the cosmetic product;
Whereas it has become apparent that it is desirable that
data on the ingredients employed in cosmetic products
be gathered with a view to the assessment of all issues
 relating to their use and of the resulting action at
 Community level with a view particularly to the estab-
                                                                   Whereas the competent authority should be apprised of
 lishment of a common nomenclature of ingredients used
 in cosmetic products; whereas the gathering of this data           the place of manufacture, for reasons of monitoring, and
 can be facilitated if the Commission compiles an                   of the information needed for rapid and appropriate
 inventory of the ingredients concerned; whereas this               medical treatment in case of difficulties;
 inventory is indicative and is not intended to constitute a
 definitive list of substances used in cosmetic products;
                                                                    Whereas the Commission should be authorized to amend
 (') OJ No L 262, 27. 9. 1976, p. 169.                              Annexes I and VIII to Directive 76/768/EEC, in view of
 (2) OJ No L 398, 30. 12. 1989, p. 25.                              their illustrative and technical natures;
 ---pagebreak--- 28. 2.91                               Official Journal of the European Communities                               No C 52/7
Whereas assessment of the safety of use of the ingre-                 2.     The inventory shall contain information on:
dients employed in cosmetics and of the final product
must take account of the requirements of Council                      — the identity of the ingredient, in particular its
Directive 86/609/EEC (*) regarding the protection of
                                                                          chemical name and, where appropriate, the
animals used for experimental and other scientific
                                                                          Einecs, CAS and Colour Index numbers,
purposes, and in particular Article 7 (2) thereof,
                                                                      — the function(s) of the ingredient in the final
                                                                          product,
HAS ADOPTED THIS DIRECTIVE:
                                                                      — where appropriate, restrictions and conditions of
                           Article 1                                      use and warnings which must be printed on the
                                                                          label.
Directive 76/768/EEC is hereby amended as follows:
                                                                      3.     The Commission shall publish the inventory
  1. Article 1 (1) is replaced by the following:                      and shall update it periodically. The inventory is
                                                                      indicative and does not constitute a list of the
                                                                      substances authorized for use in cosmetic products
     '1.    A "cosmetic product" means any substance or               or an exhaustive list of substances used in these
     preparation intended for placing in contact with the             products.'
     various external parts of the human body (epidermis,
     hair system, nails, lips and external genital organs)
     or with the teeth and the mucous membranes of the             4. In Article 6 (1), the introductory phrase is replaced
     oral cavity with a view to cleaning them, perfuming              by the following:
     them, protecting them, keeping them in good
     condition, changing their appearance            and/or
                                                                      'Member States shall take all measures necessary to
     correcting body odours.'
                                                                      ensure that cosmetic products may be marketed only
                                                                      if the container and packaging bear the following
                                                                      information in indelible, easily legible and visible
  2. Article 2 is replaced by the following:
                                                                      lettering, except for the information mentioned in
                                                                      (g) hereafter which may be indicated on the
     'Article 2                                                       packaging alone:'.
     Cosmetic products put on the market within the
     Community must not cause damage to human health               5. Article 6 (d) is replaced by the following:
     when they are applied under normal or reasonably
     foreseeable conditions of use, taking account, in
                                                                      '(d) particular precautions to be observed in use,
     particular, of every communication made in this
                                                                            and especially those listed in the column
     regard by the manufacturer or his authorized agent
                                                                            "Conditions of use and warnings which must be
     or by all others responsible for placing these
                                                                            printed on the label" in Annexes III, IV, VI and
     products on the Community market.'                                     VII, which must appear on the container and
                                                                            packaging as well as any special precautionary
                                                                            information     on    cosmetic    products     for
  3. The following Article is inserted:
                                                                            professional use, in particular in hairdressing.
                                                                            Where this is impossible for practical reasons,
     'Article 5a                                                            this information must appear on an enclosed
                                                                            leaflet, with either abbreviated information on
      1.    Not later than 31 December 1993, the                            the container and the packaging or the symbol
     Commission shall, on the basis in particular of infor-                 given in Annex VIII referring the consumer to
     mation supplied by the Member States, compile an                       the information specified.'.
     inventory of ingredients employed in cosmetic
     products.
                                                                   6. The following points (f) and (g) are added to Article
                                                                      6(1):
     For the purposes of this Article "cosmetic
     ingredient" means any chemical substance or prep-
     aration of synthetic or natural origin, except for               '(f) the function of the product, unless it is clear
     perfume and aromatic compositions, used in the                         from the description of the product;
     composition of cosmetic products.
                                                                       (g) A list of ingredients in descending order of
                                                                            weight at the time they are added. This list shall
                                                                            be preceded by an appropriate indication
(') OJ No L 358, 18. 12. 1986, p. 1.                                        including the word "ingredients". Where this is
 ---pagebreak--- No C 52/8                             Official Journal of the European Communities                                 28.2.91
          impossible for practical reasons, the ingredients         purposes, keep the following information readily
          must appear on an enclosed leaflet, with either           available to the competent authorities of the Member
          abbreviated information on the container and              State concerned at the place of manufacture or, in
          the packaging or the symbol given in Annex                the case of importation from a non-member country,
          VIII referring the consumer to the ingredients            at the place of initial importation into Community
          specified. Perfume and aromatic compositions              territory:
          and their raw materials shall be referred to by
          the word "perfume". Ingredients of a concen-
          tration of less than 1 % may be listed in any             (a) the qualitative and quantitative formula of the
          order after those of a concentration of more                   product;
          than 1 %. Colouring agents may be listed in
          any order after the other ingredients.
                                                                    (b) the physico-chemical and microbiological specifi-
                                                                         cations of the raw materials and the finished
          In accordance with the Article 10 procedure,                   product and the purety and microbiological
          the Commission shall, no later than 31                         control criteria of the cosmetic product;
          December 1993, adopt the criteria and
          conditions under which a manufacturer may,
                                                                    (c) the method of manufacture complying with the
          for reasons of trade secrecy, apply not to
                                                                         good manufacturing practice laid down by
          include one or more ingredients on the
                                                                         Community law or, failing that, laid down by
          abovementioned list.'.
                                                                         the law of the Member State concerned;
 7. Article 7 (2) is replaced by the following:                     (d) assessment of the safety for human health of the
                                                                         finished product. To this end, the manufacturer
                                                                         shall take into consideration the general toxico-
    '2.     They may, however, require that the                          logical profile of the ingredient, its chemical
    particulars provided for in Article 6 (1) (b), (c) and               structure and its level of exposure. Should the
    (d) be expressed at least in their own national or                   same product be manufactured at several places
    official language or languages; they may also require                on Community territory, the manufacturer may
    that the particulars provided for in Article 6 (1) (f)               choose a single place of manufacture where this
    and (g) be expressed in a language easily understood                 information will be kept available. With regard
    by the consumer. To this end, the Commission shall                   to this, and when so requested for monitoring
    adopt a common ingredients nomenclature in                           purposes, he shall be obliged to indicate the
    accordance with the Article 10 procedure.'.                          place so chosen to the monitoring authority/
                                                                         authorities concerned;
 8. Article 7 (3) is replaced by the following:
                                                                    (e) the name and address of the qualified person or
                                                                         persons responsible for the assessment referred
    '3.     Furthermore, a Member State may require, for                 to at (d). This person must have received
    purposes of prompt and appropriate medical                           university training in the field of natural
    treatment in the event of difficulties, that the quali-              sciences;
    tative and quantitative formula of the product be
    made available to the competent authority, which
    shall ensure that this formula is used only for the             (f) existing data on undesirable effects on human
    purposes of such treatment.                                          health resulting from use of the cosmetic
                                                                         product;
    Member States shall designate that competent
    authority and send details thereof to the                       (g) proof of the effect claimed for the cosmetic
    Commission, which shall publish this information in                  product, where this is justified by the nature of
    the Official Journal of the European Communities.'                   the product.
 9. The following Article is inserted:                              2.     The assessment of the safety for human health
                                                                    referred to in paragraph 1 (d) of this Article shall be
                                                                    carried out in accordance with the principles of good
    'Article 7a                                                     laboratory practice laid down in Council Directive
                                                                    87/18/EEC of 18 December 1986 on the harmon-
    1.     The manufacturer or his agent, provided he is            ization of laws, regulations and administrative
    established in the Community, or the person                     provisions relating to the application of the principles
    responsible for placing imported cosmetic products              of good laboratory practice and the verification of
    on the Community market, shall, for control                     their application for tests on chemical substances (').
 ---pagebreak--- 28. 2. 91                              Official Journal of the European Communities                             No C 52/9
    3.     The information referred to in paragraph 1                                     Article 2
    must be available in the national language or
                                                                  1.   Member States shall take all necessary measures to
    languages of the Member State concerned, or in a
                                                                 ensure that from 1 January 1997 neither manufacturers
     language readily understood by the competent auth-
                                                                 nor importers established within the Community place
    orities.
                                                                 on the market products which fail to comply with the
                                                                 provisions of this Directive.
    4.     The manufacturer or his agent, provided he is
    established in the Community, or the person
    responsible for placing imported cosmetic products           2.    Member States shall take all necessary measures to
    on the Community market, shall notify the                    ensure that the products referred to in paragraph 1
    competent national authority of the place of manu-           cannot be sold or disposed of to the ultimate consumer
    facture or of the initial importation of the address of      after 31 December 1997.
    the place of manufacture or of initial importation
    into the Community of the cosmetic products before
    the latter are placed on the Community-market.                                        Article 3
                                                                  1.   Member States shall bring into force the laws,
    5.     Member States shall designate the competent           regulations and administrative provisions necessary to
    authorities referred to in paragraphs 1 and 4 and            comply with this Directive not later than 31 December
    shall send details thereof to the Commission, which           1993 and shall inform the Commission thereof forthwith.
    shall publish this information in the Official Journal
     of the European Communities.
                                                                 When Member States adopt these provisions, these shall
                                                                 contain a reference to this Directive or shall be accom-
    (*) O J N o L 15, 17. 1. 1987, p. 29.'                       panied by such reference at the time of their official
                                                                 publication. The procedure for such reference shall be
10. Article 8 (2) is replaced by the following:                  adopted by Member States.
    '2.     The amendments necessary for adapting to
    technical progress the Annexes to this Directive and         2.    Member States shall communicate to the
    the common nomenclature of ingredients used in               Commission the texts of the provisions of national law
    cosmetic products shall be adopted in accordance             which they adopt in the field governed by this Directive.
    with the same procedure, after consultation of the
    Scientific Committee on Cosmetology.'.
                                                                                          Article 4
11. The Annex is added as Annex VIII.                            This Directive is addressed to the Member States.
                                                           ANNEX
                                                         Annex VIII