CELEX: 51992PC0364
Language: en
Date: 1992-09-02
Title: Amended proposal for a COUNCIL DIRECTIVE amending for the sixth time Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products

26 . 9. 92                              Official Journal of the European Communities                           No C 249/5
                                                               II
                                                       (Preparatory Acts)
                                                   COMMISSION
             Amended 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 (')
                                                        (92 /C 249/04)
                                                  COM(92) 364 final — SYN 307
             (Submitted by the Commission pursuant to Article 149 (3) of the EEC Treaty on 3 September
                                                             1992)
             C) OJ No C 52 , 28 . 2 . 1991 , p. 6
                    ORIGINAL PROPOSAL                                                   AMENDED PROPOSAL
Proposal for a Council Directive amending for the sixth            Amended proposal for a Council Directive amending for
time Council Directive 76/768 of 27 July 1976 on the               the sixth time Council Directive 76/768 of 27 July 1976
approximation of the laws of the Member States relating            on the approximation of the laws of the Member States
                  to cosmetic products                                           relating to cosmetic products
THE COUNCIL OF THE EUROPEAN COMMUNITIES,                           Unchanged
Having regard to the Treaty establishing the European
Economic Community, and in particular Article 100a
thereof,
Having regard to the proposal from the Commission,
In cooperation with the European Parliament,
Having regard to the opinion of the Economic and
Social Committee ,
Whereas legal ambiguities in Council Directive
76/768/EEC O , as last amended by Directive
89/679/EEC (2), particularly in Articles 1 and 2, should
be removed ;
C) OJ No L 262, 27 . 9 . 1976 , p. 169.
O OJ No L 398 , 30. 12 . 1989, p. 25 .
 ---pagebreak---  No C 249/6                             Official Journal of the European Communities                26 . 9 . 92
                      ORIGINAL PROPOSAL                                            AMENDED PROPOSAL
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, on the one
hand, of all issues relating to their use and, on the other,
of the resulting action at Community level, with a view
particularly to the establishment of a common nomen­
clature of ingredients used in cosmetic products ; whereas
the gathering of this data can be facilitated if the
Commission compiles an inventory of the ingredients
concerned ; whereas this inventory is indicative and is not
intended to constitute a definitive list of substances used
in cosmetic products ;
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
products solely at the place of manufacture or of initial
importation into the Community and provide better
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
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
enclosed leaflet with a suitable symbol ;
Whereas, with regard to the finished cosmetic product, it
should be made clear which information is to be made
available to the monitoring authorities of the place of
manufacture or of initial importation into the
Community market; whereas this information should
include all the necessary elements relating to identity,
quality, safety for human health and the claimed effects
of the cosmetic product ;
Whereas the competent authority should be apprised of
the place of manufacture, for reasons of monitoring, and
of the information needed for rapid and appropriate
medical treatment in case of difficulties ;
Whereas the Commission should be authorized to amend
Annexes I and VIII to Directive 76 /768 /EEC, in view of
their illustrative and technical natures ;
 ---pagebreak--- 26 . 9 . 92                                Official Journal of the European Communities                                   No C 249 / 7
                          ORIGINAL PROPOSAL                                                    AMENDED PROPOSAL
Whereas assessment of the safety of use of the ingre­                Whereas assessment of the safety of use of the ingre­
dients employed in cosmetics and of the final product                dients employed in cosmetics and of the final product
must take account of the requirements of Council                     must take account of the requirements of Council
Directive 86/609/EEC (') regarding the protection of                 Directive 86/609/EEC (') regarding the protection of
animals used for experimental and other scientific                   animals used for experimental and other scientific
purposes, and in particular Article 7 (2) thereof,                   purposes, and in particular Article 7 (2) thereof; whereas
                                                                     experiments involving the use of ingredients on animals
                                                                     in order to satisfy the requirements of Directive
                                                                     76 /768 / EEC as referred to above must cease after 1
                                                                     January 1998 ; whereas, however, deferment of this date
                                                                     would have to be considered if satisfactory methods have
                                                                     not been legally accepted prior to that date ; whereas the
                                                                     Commission must report on progress achieved in this
                                                                     regard ;
                                                                     Whereas specific criteria for cosmetics not tested on
                                                                     animals must be drawn up,
HAS ADOPTED THIS DIRECTIVE :                                         HAS ADOPTED THIS DIRECTIVE :
                              Article 1                                                            Article 1
Directive 76/768 /EEC is hereby amended as follows :                 Directive 76/768 /EEC is hereby amended as follows :
  1 . Article 1 ( 1 ) is replaced by the following :                   1 . Article 1 ( 1 ) is replaced by the following :
      ' 1 . A "cosmetic product" means any substance or                    ' 1 . A "cosmetic product" means any substance or
      preparation intended for placing in contact with the                 preparation intended for placing in contact with the
      various external parts of the human body (epidermis,                 various external parts of the human body (epidermis,
      hair system, nails, lips and external genital organs)                hair system, nails, lips and external genital organs)
      or with the teeth and the mucous membranes of the                    or with the teeth and the mucous membranes of the
      oral cavity with a view to cleaning them, perfuming                  oral cavity exclusively or principally with a view to
      them, protecting them, keeping them in good                          cleaning them, perfuming them, protecting them,
      condition, changing their appearance and/or                          keeping them in good condition, changing their
      correcting body odours.'                                             appearance and/or correcting body odours.'
  2. Article 2 is replaced by the following :                        Unchanged
       Article 2
      Cosmetic products put on the market within the
      Community must not cause damage to human health
      when they are applied under normal or reasonably
      foreseeable conditions of use, taking account, in
      particular, of every communication made in this
      regard by the manufacturer or his authorized agent
      or by all others responsible for placing these
      products on the Community market.'
(') OJ No L 358, 18 . 12 . 1986, p. 1 .                               O OJ No L 358, 18 . 12. 1986, p. 1 .
 ---pagebreak--- No C 249 / 8                           Official Journal of the European Communities                                    26 . 9 . 92
                    ORIGINAL PROPOSAL                                                    AMENDED PROPOSAL
                                                                   2a. The following point (g) is added to Article 4 ( 1 ):
                                                                        '(g) Ingredients or combinations of ingredients
                                                                              tested on animals after 1 January 1998 in order
                                                                              to meet the requirements of this Directive. In
                                                                              accordance with progress achieved in
                                                                              developing satisfactory methods to replace
                                                                              experiments on animals, the Commission may,
                                                                              in accordance with Article 100a of the EEC
                                                                              Treaty, present a proposal to the Council to
                                                                              defer the entry into force of this provision. The
                                                                              Commission shall present an annual report to
                                                                              the European Parliament and the Council on
                                                                              progress in the development, validation and
                                                                              legal acceptance of alternative methods to
                                                                              those involving experiments on animals . The
                                                                              report shall contain precise data on the number
                                                                              and type of experiments relating to cosmetic
                                                                              products carried out on animals . The Member
                                                                              States shall be obliged to collect this infor­
                                                                              mation in addition to collecting statistics , as
                                                                              laid down by Council Directive 86 /609 / EEC
                                                                              regarding the protection of animals used for
                                                                              experimental and other scientific purposes . The
                                                                              Commission shall in particular ensure the
                                                                              development, validation and legal acceptance
                                                                              of experimental methods which do not use live
                                                                              animals .'
                                                                   2b . The following paragraph 1 (a) is added to Article 4 :
                                                                        'Ingredients tested on animals exclusively for
                                                                        purposes other than their use in cosmetic products
                                                                        shall be authorized, on condition that no additional
                                                                        testing on animals is carried out in order to meet
                                                                        the requirements of this Directive.'
 3 . The following Article 5a is inserted :                        3. The following Article 5a is inserted :
     'Article 5a                                                       'Article 5a
     1.    Not later than     31    December      1993 , the           1 . Not later than two years following the
     Commission shall, on the basis in particular of infor­            adoption of this Directive, the Commission shall, on
     mation supplied by the Member States, compile an                  the basis in particular of information supplied by the
     inventory of ingredients employed in cosmetic                     Member States, compile an inventory of ingredients
     products .                                                        employed in cosmetic products.
     For the purposes of this Article "cosmetic                        For the purposes of this Article "cosmetic
     ingredient" means any chemical substance or prep­                 ingredient" means any chemical substance or prep­
     aration of synthetic or natural origin, except for                aration of synthetic or natural origin, except for
     perfume and aromatic compositions, used in the                    perfume and aromatic compositions, used in the
     composition of cosmetic products.                                 composition of cosmetic products.
 ---pagebreak--- 26 . 9 . 92                              Official Journal of the European Communities                            No C 249/9
                        ORIGINAL PROPOSAL                                                AMENDED PROPOSAL
                                                                       The inventory shall be divided into two parts : one
                                                                       relating to aromatic and perfume ingredients, and
                                                                       one relating to other ingredients used in cosmetics .'
     2.     The inventory shall contain information on :           Unchanged
          the identity of the ingredient, in particular its
          chemical name and, where appropriate, the
          EINECS, CAS and Color index numbers,
     — the function(s) of the ingredient in the final
          product,
     — where appropriate, restrictions and conditions of
          use and warnings which must be printed on the
          label .
      3.    The Commission shall publish the inventory
     and shall update it periodically. The inventory is
     indicative and does not constitute a list of the
     substances authorized for use in cosmetic products
     or an exhaustive list of substances used in these
     products .'
 4. In Article 6 ( 1 ), the introductory phrase is replaced
     by the following :
      '1.    Member      States   shall  take   all  measures
      necessary to ensure that cosmetic products may be
      marketed only if the container and packaging bear
      the following information in indelible, easily legible
      and visible lettering, except for the information
      mentioned in (g) hereafter which may be indicated
      on the packaging alone :'.
 5. Article 6 ( 1 ) (d) is replaced by the following :
      '(d) particular precautions to be observed in use,               '(d) particular precautions to be observed in use,
            and especially those listed in the column                        and especially those listed in the column
            "Conditions of use and warnings which must be                    "Conditions of use and warnings which must be
            printed on the label" in Annexes III, IV, VI and                 printed on the label" in Annexes III, IV, VI and
            VII, which must appear on the container and                      VII, which must appear on the container and
            packaging as well as any special precautionary                   packaging as well as any special precautionary
            information      on    cosmetic    products    for               information on cosmetic products for
            professional use, in particular in hairdressing.                 professional use, in particular in hairdressing.
            Where this is impossible for practical reasons,                  Where this is impossible for practical reasons,
            this information must appear on an enclosed                      this information must appear on an enclosed
            leaflet, with either abbreviated information on                  leaflet, label or card, with either abbreviated
            the container and the packaging or the symbol                    information on the container and the packaging
            given in Annex VIII referring the consumer to                    or the symbol given in Annex VIII referring the
            the information specified .'                                     consumer to the information specified.'
 ---pagebreak--- No C 249/ 10                          Official Journal of the European Communities                                   26 . 9 . 92
                     ORIGINAL PROPOSAL                                                  AMENDED PROPOSAL
 6. The following points (f) and (g) are added to Article         6. The following points (f) and (g) are added to Article
    6(1 ):                                                           6(1 ):
    '(f) the function of the product, unless it is clear             '(f) the function of the product, unless it is clear
          from the description of the product;                             from the presentation of the product;
      (g) a list of ingredients in descending order of                 (g) a list of ingredients in descending order of
          weight at the time they are added. This list shall               weight at the time they are added. This list shall
          be preceded by an appropriate indication                         be preceded by the word "ingredients". Where
          including the word "ingredients". Where this is                  this is impossible for practical reasons, the
          impossible for practical reasons, the ingredients                ingredients must appear on a leaflet, label or
          must appear on an enclosed leaflet, with either                  card, with either abbreviated information on the
          abbreviated information on the container and                     packaging or the symbol given in Annex VIII
          the packaging or the symbol given in Annex VII                   referring the consumer to the ingredients
          referring the consumer to the ingredients                        specified. The leaflet may be supplied with the
          specified. Perfume and aromatic compositions                     product if the customer is to be advised at the
          and their raw materials shall be referred to by                  point of sale . For products sold without external
          the word "perfume". Ingredients of a concen­                     packaging on trays or display stands, the ingre­
          tration of less than 1 % may be listed in any                    dients may appear on a separate leaflet which
          order after those of a concentration of more                     must be presented or supplied in a pocket
          than 1 % . Colouring agents may be listed in                     attached to the display unit. Perfume and
          any order after the other ingredients.                           aromatic compositions and their raw materials
                                                                           shall be referred to by the words "perfume" or
                                                                           "aroma". Ingredients of a concentration of less
                                                                           than 1 % may be listed in any order after those
                                                                           of a concentration of more than 1 % . Colouring
                                                                           agents may be listed in any order after the other
                                                                           ingredients . For products marketed in several
                                                                           colour shades, all colouring agents used in the
                                                                           range may be listed, provided that the words
                                                                           "may contain" are added.
                                                                           Instead of information on the ingredients of
                                                                           colouring agents added to each product, the
                                                                           colouring agents in an assortment of cosmetic
                                                                           products sold together in the same packaging
                                                                           may be listed in any order in a single list,
                                                                           provided that this is not misleading and that it is
                                                                           pointed out that the list applies to all the
                                                                           products .
                                                                           Where there is an existing or foreseeable
                                                                           shortage of ingredients, the declaration may
                                                                            name a substitute ingredient, which must be
                                                                            listed directly after the ingredient normally used
                                                                            and preceded by the word "or".
 ---pagebreak--- 26 . 9 . 92                            Official Journal of the European Communities                                 No C 249 / 11
                       ORIGINAL PROPOSAL                                                    AMENDED PROPOSAL
                                                                                Where the product is sold by mail order, infor­
                                                                                mation on the ingredients may be given in a
                                                                                brochure or catelogue sent to each purchaser,
                                                                                provided that the purchaser is thereby able to
                                                                                identify the information relating to each
                                                                                product.
                                                                                Samples used for testing and free samples are
                                                                                not required to have a label listing the ingre­
                                                                                dients .
            In accordance with the Article 10 procedure,                        In accordance with the Article 10 procedure,
            the   Commission    shall, no   later than      31                  the Commission shall, no later than two years
            December 1993 , adopt the criteria and                              following the adoption of this Directive, adopt
            conditions under which a manufacturer may,                          the criteria and conditions under which a manu­
            for reasons of trade secrecy, apply not to                          facturer may, for reasons of trade secrecy, apply
            include one or more ingredients on the                              not to include one or more ingredients on the
            abovementioned list.'                                               abovementioned list.'
                                                                   6 . (a) Article 6 (3) is replaced by the following :
                                                                             '3 .    Member     States shall take   all  measures
                                                                             necessary to ensure that in the labelling, presen­
                                                                             tation for sale and advertising of cosmetic
                                                                             products, the wording, use of names, trade marks,
                                                                             images or other signs, figurative or otherwise,
                                                                             suggesting a characteristic which the products in
                                                                             question do not possess, shall be prohibited. In
                                                                             particular, any reference to testing on animals
                                                                             must state clearly whether the tests carried out
                                                                             involved the finished product or its ingredients ,
                                                                             specifying, in the latter case, whether they are
                                                                             used exclusively in cosmetics or whether they
                                                                             have previously been used for other categories of
                                                                             products .'
 7. Article 7 (2) is replaced by the following :                   7 . Article 7 (2) is replaced by the following :
      '2 . They may, however, require that the                           '2.      They     may,    however,   require   that   the
      particulars provided for in Article 6 ( 1 ) (b), (c) and           particulars provided for in Article 6 ( 1 ) (b), (c), (d)
      (d) be expressed at least in their own national or                 and (f) be expressed at least in their own national or
      official language or languages, they may also require              official language or languages, they may also require
      that the particulars provided for in Article 6 ( 1 ) (f)           that the particulars provided for in Article 6 ( 1 ) (g)
      and (g) be expressed in a language easily understood               be expressed in a language easily understood by the
      by the consumer. To this end, the Commission shall                 consumer. To this end, the Commission shall adopt a
      adopt a common ingredients nomenclature in                         common ingredients nomenclature in accordance
      accordance with the Article 10 procedure .'                        with the Article 10 procedure.'
 ---pagebreak--- No C 249/ 12                             Official Journal of the European Communities                                    26 . 9 . 92
                        ORIGINAL PROPOSAL                                                  AMENDED PROPOSAL
 8 . Article 7 (3) is replaced by the following :                    8 . Article 7 (3) is replaced by the following :
     '3 . Furthermore, a Member State may require, for                   '3. Furthermore, a Member State may require, for
     purposes of prompt and appropriate medical                          purposes of prompt and appropriate medical
     treatment in the event of difficulties, that the quali­             treatment in the event of difficulties, that adequate
     tative and quantitative formula of the product be                   and sufficient information on the product be made
     made available to the competent authority, which                    available to the competent authority, which shall
     shall ensure that this formula is used only for the                 ensure that this information is used only for the
     purposes of such treatment.                                         purposes of such treatment. The generic formulae of
                                                                         the product and specific details relating to the
                                                                         various individual ingredients shall be provided .
     Member States shall designate that competent                  Unchanged
     authority and send details thereof to the
     Commission, which shall publish this information in
     the Official Journal of the European Communities '
 9. The following Article is inserted :
      !Article 7a
     1 . The manufacturer or his agent provided he is
     established in the Community, or the person
     responsible for placing imported cosmetic products
     on the Community market, shall, for control
     purposes, keep the following information readily
     available to the competent authorities of the Member
     State concerned at the place of manufacture or, in
     the case of importation from a non-member country,
     at the place of initial importation into Community
     territory :
     (a) the qualitative and quantitative formula of the                 (a) The qualitative and quantitative formula of the
          product ;                                                          product ; with regard to aromatic compositions
                                                                             and perfumes, this information shall be limited
                                                                             to the name and code number of the compo­
                                                                             sition and the identity of the supplier, except for
                                                                             those substances listed in Annexes III, IV, VI
                                                                             and VII of Council         Directive  76 / 768 / EEC
                                                                             referred to above .
     (b) the physico-chemical and microbiological specifi-         Unchanged
           cations of the raw materials and the finished
           product and the purity and microbiological
           control criteria of the cosmetic product ;
     (c) the method of manufacture complying with the
           good manufacturing practice laid down by
           Community law or, failing that, laid down by
           the law of the Member State concerned ;
     (d) assessment of the safety for human health of the
           finished product. To this end, the manufacturer
           shall take into consideration the general toxico­
           logical profile of the ingredient, its chemical
           structure and its level of exposure .
 ---pagebreak--- 26 . 9 . 92                              Official Journal of the European Communities                No C 249 / 13
                        ORIGINAL PROPOSAL                                           AMENDED PROPOSAL
           Should the same product be manufactured at
           several places on Community territory, the
           manufacturer may choose a single place of
           manufacture where this information will be kept
           available. With regard to this, and when so
           requested for monitoring purposes, he shall be
           obliged to indicate the place so chosen to the
           monitoring authority/ authorities concerned ;
     (e) the name and address of the qualified person or
           persons responsible for the assessment referred
           to at (d). This person must have received
           university training in the field of natural
           sciences ;
     (f) existing data on undesirable effects on human
           health resulting from use of the cosmetic
           product ;
     (g) proof of the effect claimed for the cosmetic
           product, where this is justified by the nature of
           the product.
     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
     laboratory practice laid down in Council Directive
     87 / 18 / EEC of 18 December 1986 on the harmon­
     ization of laws, regulations and administrative
     provisions relating to the application of the principles
     of good laboratory practice and the verification of
     their application for tests on chemical substances (1).
     3 . The information referred to in paragraph 1
     must be available in the national language or
     languages of the Member State concerned, or in a
     language readily understood by the competent auth­
     orities .
     4 . The manufacturer or his agent, provided he is
     established in the Community, or the person
     responsible for placing imported cosmetic products
     on the Community market, shall notify the
     competent national authority of the address of the
     place of manufacture or of initial importation into
     the Community of cosmetic products before the
     latter are placed on the Community market.
     5 . Member States shall designate the competent
     authorities referred to in paragraphs 1 and 4 and
     shall send details thereof to the Commission, which
     shall publish this information in the Official Journal
     ofthe European Communities.
     O OJ No L 15 , 17 . 1 . 1987 , p. 29 .'
 ---pagebreak--- No C 249 / 14                           Official Journal of the European Communities                              26 . 9 . 92
                       ORIGINAL PROPOSAL                                             AMENDED PROPOSAL
10 . Article 8 (2) is replaced by the following :
     ' 2 . The amendments necessary for adapting to
     technical progress the Annexes to this Directive and
     the common nomenclature of ingredients used in
     cosmetic products shall be adopted in accordance
     with the same procedure, after consultation of the
     Scientific Committee on Cosmetology'
11 . The Annex is added as Annex VIII .
                           Article 2
1.      Member States shall take all necessary measures to
ensure that from 1 January 1997 neither manufacturers
nor importers established within the Community place
on the market products which fail to comply with the
provisions of the Directive .
2 . Member States shall take all necessary measures to
ensure that the products referred to in paragraph 1
cannot be sold or disposed of to the ultimate consumer
after 31 December 1997 .
                           Article 3                                                      Article 3
1 . Member States shall bring into force the laws ,               1 . Member States shall bring into force the laws ,
regulations and administrative provisions necessary to            regulations and administrative provisions necessary to
comply with this Directive not later , than 31 December           comply with this Directive not later than two years after
1993 and shall inform the Commission thereof forthwith .          the adoption of this Directive and shall inform the
                                                                  Commission thereof forthwith .
When Member States adopt these provisions, these shall            Unchanged
contain a reference to this Directive or shall be accom­
panied by such reference at the time of their official
publication . The procedure for such reference shall be
adopted by Member States .
2.     Member      States    shall   communicate    to   the
Commission the texts of the provisions of national law
which they adopt in the field governed by this Directive.
                           Article 4
This Directive is addressed to the Member States .
 ---pagebreak--- 26 . 9 . 92 Official Journal of the European Communities No C 249 / 15
                                ANNEX
                               Annex VIII