CELEX: 51975PC0147
Language: en
Date: 1975-04-10
Title: Alteration of the proposal for a Council Directive on the approximation of the laws of Member States relating to cosmetic products (presented by the Commission to the Council pursuant to the second paragraph of Article 149 of the EEC Treaty)

ARCHIVES HISTORIQUES
DE LA COMMISSION
COLLECTION RELIEE DES
DOCUMENTS "COM"
COM (75) 147
Vol. 1975/0051
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                             COM(75)147 final
                                        Brussels * 10 April 1975
          Alteration of the proposal for a Council Directive
          on the approximation of the laws of Member States
                     relating to cosmetic products
          (presented by the Commission to the Council pursuant
           to the second paragraph of Article 149 of the EEC
                               Treaty )
  COM(75 ) 1H7 final
 ---pagebreak---                                  EXPLA1TAT0RY IGI-'ORAITDUM
                         •i
1 . The main objective of the directive dealing -with Cosmetic Products which
        was sent to the Council in October 1972^" was the elimination of trade
        "barriers to ensure a "better protection of consumers "by forbidding the
      • marketing of cosmetic products which are harmful to health. In putting
        into practice the latter principle the Commission had to decide whether
        to list substances that could be regarded as harmful , that is a negative
        list , or substances which could be regarded as safe , that is a positive
                                                                        i
        list , both as used in formulated products .
        It is necessary to have much more information about a substance to
        declare that it is safe to use than it is to declare that it is harmful ;
        accordingly the Commission decided that it was appropriate to make a
    • general list of forbidden substances , that is Annex II , and a limiting
        and positive list , that is Annex III , to the directive , only whore the
        evidence was soundly based and complete . Where toxicological testing
        was not yet complete a time limit of three years was imposed for the
        review of a number of permitted substances and they were placed in
        Annex IV .
        The form of the directive is such that it can be readily modified by
        the addition of further positive lists where these are thought necessary
        for the improved protection of public health. The Commission considers
        that as a first stage these lists could cover, . for instance , antioxidants ,
   . colorants , hair dyes , preservatives and . ultra violet filters .
        In giving its advice on the Directive the European Parliament , both in
                              2                                                 *
        its initial report and its complementary report , recommended the rapid
        adoption of positive lists. The Economic and Social Committee3 made a
        similar recommendation while recognising the problems which arise in
    «
       ~the préparation of such liste .
                            /
          OJ ïïo C 133 , 23 December 1972
          OJ Ilo C 62, 31 July 1973
        3 OJ Ho C 60/17, 26 July 1973
 ---pagebreak--- Since October 1972 , the date of transmission of the proposal to the
Council , the services of the Commission ha,ve , therefore , studied more
deeply the toxicological characteristics of certain categories of sub­
stances .  As a result of these studies and in taking note of the views
expressed by the European Parliament , the Economic and Social Committee
and consumer organisations , the Commission proposed to insert a new
Article 11 " bis" in the proposition in order to add subsequently posi­
tive lists for certain substances .
In compiling the negative list appearing in Annex II it was further
extended by the first proposition of modification proposed by the
Commission following the receipt of the advice of the European
Parliament .   In compiling this Annex II it was not desirable or
practicable to include the many tens of thousands of substances exist­
ing which are harmful to health , but only those which in the opinion
of the experts of the Member States and of the Commission had occured
or could occur as such or as contaminants in cosmetic products .     Annex
II mast , therefore , be interpreted as an extension of Article 2 of the
directive by which the use of toxic substances in harmful concentrations
would be forbidden .
The Commission, therefore , considers that Article 12 , which allows immediate
action to be taken in the event of further substances being introduced into
the cosmetic field which are harmufl to health , is essential to the directive .
It is , therefore , proposing a new version of this clause based on the agree­
ment for safeguard clauses in directives in the field of technical barriers
to trade .
Cosmetic products have a wide variety of uses and while it v/ould be unreason­
able to say that they should not be harmful under any conditions of misuse ,
it is necessary to provide for the possibility of damage to areas of the
body contingent or capable of contacting the site of application .      Thus
a shampoo should not be harmful to the eyes , nor a dentifrice poisonous
if swallowed .   The Commission , therefore , proposes a new version of
Article 2 in v/hich forseeable conditions o£ use in the sense explained
above are taken into account .
 ---pagebreak--- In considering the possibilities of poisoning 'by a complete misuse of a
product the Commission is of the opinion that there should be a require­
ment for the necessary information for prompt treatment to be available .
The ways in which anti-poison information is available vary in the Member
States and the Commission" does not consider that it should propose a
harmonisation of these procedures which are peculiar to and are the resp­
onsibility of each Keraber State ,  Nevertheless , the Commission considers
that it is appropriate to envisage at Community level dispositions
which impose an obligation on the manufacturers to provide such inform­
ation, . imposing a parallel obligation on the relevant authorities in
order to respect trade secrets^ to release to third parties only that
information which is essential to the effective treatment of the condition.
The Commission, therefore , proposes to add a further sub-paragraph to •
Artiole 7 giving effect to this requirement .
 ---pagebreak---                            Altération of
        •                                         *
  the proposal fort a Council Directive on "the approximation of the laws
   of the Kember States relating to oosmetio produots
                • •             •                                   . A
  The proposal for a Directive forwarded to the Council on 19 October
  1972 is amended by the following:
  – a rewording of Article 2
  – the addition of a further paragraph (number 3) to Article 7 «
  – a nev; Article 11 " bis".                                .
                                                         . »
  - a rewording of Article 12 .
                              Article 2
  The following text shall replace the text of this article :
                                            •       «          •
  Cosmetics products put on the market within . the Community must not be
  liable to cause damage to human health when they are applied under normal
  conditions of use .
                              Article 7
             ».
  The following paragraph is added to the text of this article :          J!
                                                                          è
  Furthermore , a Member State may require that in order that prompt and
  appropriate, treatment is available for cases of poisoning, adequate
  and sufficient information regarding harmful substances contained in
  cosmetic products is made available to the competent authority who
  shall ensure that this information shall only be used for the
•                                              •.
.proposes of treatmsnt .             .           >
                    Jm            *     ~ ■                '                ' "
                              Article 11 "bis"                         ,
 One year at the latest after the expiry of ..the period provided for in        ^
 Article 14 . paragraph 1 , for the implementation by the ICember States
 ---pagebreak--- of the present directive , the- Commission , on the "basis of results of
the latest scientific and technical research , will send to the Council
appropriate propositions establishing lists of permitted substances .
                           Article 12
The following text shall replace the text of this article :
1.   Where a Ilember State finds that a cosmetic product , although satis­
     fying the requirements of this Directive , presents a health or safety
     risk , it may , temporarily , prohibit within its territory the placing
     on the market of that cosmetic product .    It shall immediately inform
     the Commission and the other liember States of this action and give
     reasons therefore .
2. . The Commission shall within six weeks consult with the Kembcr State
     concerned, then express without delay its opinion and take the
     appropriate steps .
3.   According to the procedure laid down in Article 1 1 of the Directive
     of 27 June 19^7 it shall be immediately decided if technical amend­
     ments to the Annex(s) of the Directive are necessary.     The Member
     State can maintain its interdiction until a decision has been taken ,
     either by the Council or by the Commission according to the afore­
     mentioned procedure .