CELEX: 51987PC0156
Language: en
Date: 1987-04-09
Title: Proposal for a FIFTH COUNCIL DIRECTIVE adapting to technical progress Annex III to Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products (submitted to the Council by the Commission)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (87) 156
Vol. 1987/0094
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                               COM(87 ) 156 final
                                               Brussels , 9 April 1987
                                   Proposai for a
                              FIFTH COUNCIL DIRECTIVE
      adapting to technical progress Annex III to Directive 76 / 768 / EEC
       on the approximation of the laws of the Member States relating
                                to cosmetic products
                  ( submitted to the Council by the Commission )
  C0MC87 ) 156 final
 ---pagebreak--- EXPLANATORY MEMORANDUM
1 . The aim of the proposal is to authorize, under certain conditions and
    subject to certain restrictions , the use of benzoyl peroxide in lotions ,
    creams and gels for cleaning and improving the appearance of greasy skin .
2 . The use of benzoyl peroxide in cosmetic products is neither prohibited nor
    restricted by Directive 76 / 768 / EEC . Two Member States have invoked the
    safeguard clause in order to prohibit the use of benzoyl peroxide in
    cosmetic products on the grounds of its irritating and sensitising
                                  1
    properties .  In the opinions    it delivered on 29 November 1983 and 17
    December 1984 , the Scientific Committee on Cosmetology accepted the use of
    benzoyl peroxide in cosmetic products at a maximum concentration of 3% in
    the finished product , provided that certain warnings appeared on the
    labelling, although several members took the view that benzoyl peroxide
    should be used only under medical supervision . In the meantime, the industry
    has reduced the concentration used to 2% .     Following the opinion of the
    Scientific Committee on Cosmetology , the Commission referred a draft to the
    Committee for the Adaptation to Technical Progress of Directive 76 / 768 / EEC
    for its opinion .  This draft authorizes the use of benzoyl peroxide in
    certain cosmetic products with a maximum concentration of 2% in the finished
    product , provided that the set of mandatory warnings appears on the
     labelling and subject to certain requirements , in particular that the
    finished product must not be presented in such a way as to claim or imply
    that it can cure and prevent acne ; this would be an improvement on the
    present situation from the public health viewpoint .     The Committee was
    unable to deliver an opinion because the delegations are divided on whether
    products containing benzoyl peroxide should be classified as cosmetics or
    medicinal products . Failing an opinion from the Committee , it is up to the
    Commission , pursuant to Article 10 of Directive 76/ 768/ EEC , to refer a
    proposal to the Council , which will have to decide by a qualified majority
    within three months of the proposal being submitted to it .
 1 Report EUR 10305
 ---pagebreak---                                         3
                                    Proposai for a
                               FIFTH COUNCIL DIRECTIVE
                   adapting to technical progress Annexe III to
           Directive 76 / 768 / EEC on the approximation of the laws of
                 the Member States relating to cosmetic products
THE COUNCIL OF THE EUROPEAN COMMUNITIES ,
Having regard to the Treaty establishing the European Economic Community ,
Having regard to Council Directive 76 / 768 / EEC of 27 July 1976 on the
approximation of the laws of the Member States relating to cosmetic
         1                                             2
products , as last amended by Directive 87 / 137 / EEC , and in particular
Article 8(2 ) thereof ,
Having   regard to the proposal from the Commission ,
Whereas , on the basis of the results of the most recent scientific and
technical research , the use of benzoyl peroxide to improve the appearance of
greasy skin may be authorized under certain conditions ;
Whereas the Committee for the Adaptation to Technical Progress of the
Directives for Removal of Technical Barriers to Trade in the Cosmetics
Sector was unable to deliver an opinion on the proposed measures referred to
 it by the Commission ,
HAS ADOPTED THIS DIRECTIVE :
                                       Article 1
The following is hereby added to Annex III , part 1 of Directive 76 / 768 / EEC /
1 OJ No . L 262 , 27.9.1976 , p. 169
2 OJ No . L 56 , 26.2.1987 , p. 20
 ---pagebreak---                                            -4 -
  a        b         c                d                      e                       f
I 53 Benzoyl    Lotions , creaos and  2%      - In accordance with the    - Contains benzoyl peroxide .
     peroxide   gels for cleaning               definition of a cosnetic  - Avoid all contact with the
                and inproving the               product in Article 1(1 ),   eyes and nouth .
                appearance of                   it nay not be stated or   - Discontinue use if irri-
                greasy skin                     implied that the finished   tation occurs .
                                                product can cure or       - Avoid prolonged exposure
                                                prevent acne .              to the sun .
                                              - Not to be used in
                                                ethanol preparations
                                          Article 2
     1.       Member States shall take all necessary measures to ensure that from
         1 January 1990 neither manufacturers nor importers established in the
         Community place on the market products which do not satisfy the
         requirements of this Directive .
     2.       Member States shall take all necessary measures to ensure that the
         products referred to in paragraph 1 can no longer be sold or disposed of
         to the final consumer after 31 December 1991 .
                                          Article 3
     1.       Member States shall bring into force the laws , regulations and
         administrative provisions necessary to comply with this
         Directive not later than 31 December 1988 and shall forthwith inform the
         Commission thereof .
     2.       Member States shall communicate the text of the provisions of national
          law which they adopt in the field governed by this Directive to the
          Commission .
 ---pagebreak---                                     -5-
                                  Article 4
This Directive is addressed to the Member States .
Done at Brussels ,
                                                   For the Council
 ---pagebreak---                                   FICHE D' IMPACT SUR LA COMPETITIVITE ET L' EMPLOI
          I - GueUe est la justification principale de la mesure ?                (1 }
       II * Carac .é r i st i gués des entreprises concernées
              En particulier         :
              ” T a - t - il un grand nombre de PME ?         oui
              ~ note t on des concentrations dans des régions
                  éligibles aux aides régionales des-E /M . ?           néant
                - éligibles au Feder ? néant
    III . Quelles sent les obligations imposées directement au * enr r~--.r i ses ?
                   néant
     IV . Quelles sont les obligations susceptibles cêrre imposées in                  i recteme-.t
             aux entreprises via les autorités locales ?
                   néant
      v - * 3~t -il des mesures spéciales peur les PME ?
            - Lesquelles        ?      néant
   VI . Quel est l' effet prévisible ?               néant
              Sur la compétitivité des entreprises ?              //
          ~ sur l 'emploi ?                                       //
V * I. Les partenaires sociaux cnr -ils été consultés ?                 ou^
             avis des partenaires sociaux            ■ accord
  (1 ) This DroDosal will allow, under certain conditions and restrictions , the use of
        .          ^        . .        .. manufacture of cosmetics . Only a few businesses will be
        5S3 dP^”sin« t!: EETSEnE ^ relaxation! these effects will be
        beneficial ! 'the proposal has no othar implications for business compel, tiveness
         or employaient .