CELEX: 51981PC0653
Language: en
Date: 1981-11-11
Title: Proposal for a COUNCIL DIRECTIVE amending 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 (81) 653
Vol. 1981/0195
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 ---pagebreak---  COMMISSION OF THE EUROPEAN COMMUNITIES
                                                  COM ( 81 ) 653 final
                                                  Brussels , 11 November 1981
                                     Proposal for a
                                   COUNCIL DIRECTIVE
       amending 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 )
                                                              7
C0M(81 ) 653 final
 ---pagebreak--- EXPLANATORY MEMORANDUM
1 . the proposal amends for the fourth time Council Directive 76 / 768 / EEC of
      27 July 1976 on the approximation of the laws of the Member States
      relating to cosmetic products . Its purpose . is to authorize two substan­
      ces ( nicomethanol hydrof luoride and 6-methyl coumarin ) for use in cos­
      metic products subject to certain restrictions and conditions ( entry in
   - Annex III ) .          ..               '         .1 -            v-
2 . Directive 76 / 768 / EEC authorizes a number of fluorine compounds for use
      in oral hygiene products up to a maximum concentration of 0.5% calcu­
      lated as F in the finished cosmetic product and subject to certain con­
      ditions of use and warnings which must be printed on the label . Accord­
      ing to the file submitted by the manufacturer , nicomethanol hydrof luo-
      ride appears to have some advantage in fixing fluorine on tooth enamel
      while at^tl>e same time it has no toxicity or pharmacological action
      under normal conditions of use and even beyond . It is therefore proposed
      that it be added to the list of fluorine compounds already authorized
      by the Directive , under the same conditions .
3 . In the United States 6-methyl coumarin has been prohibited in 'cosmetic
      products because it can induce photosensitization reactions . For the
      same reason the International Fragrance Association ( IFRA ) recommends -
      that 6-methyl coumarin should not be used as a raw material for perfu­
      mery . However , the Council of Europe ( 1 ) allows the presence of 6-methyl
      coumarin in foods up to a concentration of 30 ppm . As far as cosmetic
    1 products are concerned ,. it is therefore proposed that the use of
      6-methyl coumarin be authorized solely in oral hygiene products , where
 -    there is no risk of photosensitization , and at a maximum concentration
      of 30 ppm in the finished product , the limit authorized for foodstuffs ,
      which corresponds to normal practice in the Community .        •
                 > "r     '                                 .. " • .
 v1 ) Blue book . Natural flavouring substances , their sources and added
       artificial flavouring substances . 1974 edition .
 ---pagebreak--- In drafti ";» the proposal / the Commission obtained the opinio " of
national experts and cor, suit fed industry ®nd consumars .
The proposai. is based on Article 100 . Consultation of the European
Parliament and of the Economic and Social Committee is required .
 ---pagebreak---                         PROPOSAL FOR A COUNCIL DIRECTIVE
                      AMENDING 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,
 and in particular Article 100 thereof ,                                        1
 Having regard to the proposal from the Commission ,
 Having regard to the opinion of the European Parliament ,
 Having regard to the opinion of the Economic and Social Committee ,
 Whereas Council Directive 76/768 / EEC C1 ), as last amended by Directive
 79/ 661 / EEC (2 ), shoul be further amended to take account of the results of the
 most recent scientific and technical research ;                              -
 Whereas according to these results the use of nicomethanol hydrof luori de
 and 6-methyl coumarin in cosmetic products may be-v authorized under certain
 conditions ;
                                                                    (
HAS ADOPTED THIS DIRECTIVE :
 ( 1 ) OJ No L 262 , 27.9.1976, p. 169
 ( 2 ) OJ No L 192 , 31.7.1979 , p. 35
 ---pagebreak---                                      Article   I
The following substances are hereby added to Annex III           Part 1 to Direc­
tive 76 / 768 / EEC :
 Ref .    Substance                    RESTRICTIONS                    Conditions of
 No .                                                                  use and warn­
                        Field of       Maxi mum        Other limit­    ing which must
                        application    authori zed ·   ations and      be printed on
                        and / or use   concent rati on requi re~       the  label
                                       in the          ments
                                       finished cos-
                                       metic product
   a            b               c              d              e               f
          ni come-      oral           0.15% calcu-                    contai ns
          thanol        hygi ene       lated as F.                     ni comethanol
          hydro-        products       When mixed                      hydrof luori de
          f luori de                   with other
                                       fluorine com­
                                       pounds per-
                                       mitted under
                                       this Annex ,
                                       total F con­
                                       centration
                                       must   not
                                       exceed 0.15%
          6-methyl      oral           0.00_%
          coumari η     hygi ene
                        products
                                      Arti c le 2
The Member States shall bring into force the laws , regulations and admin­
istrative provi si ons necessary to comply with this Directive not later than
30 April 1982 .       They shall forthwith inform the Commission thereof .
                                      Article 3
This Directive is addressed to the Member States .