CELEX: 51973PC1733
Language: en
Date: 1973-10-17
Title: AMENDMENT TO 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 E.E.C. Treaty)

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COM (73) 1733
Vol. 1973/0299
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 ---pagebreak--- COMMISSION OF THE EUROPEAN COMMUNITIES
                                                    COM(73 ) 1733 Final
                                                    Brussels , 17 October 1973
                              , . AMENDMENT TO
           the proposal for a Council Directive on the approximation
               of the laws of Member States relating to cosmetic
                                   products .
        i
          (Presented by the Commission to the Council pursuant to the
           second paragraph of Article 149 of the E.S.C. Treaty )
   COM (73 ) 1733 final
 ---pagebreak---                                 EXPLANATORY MEMORANDUM
As part of the General Programme for the removal of technical obstacles
                                                    1
to trade adopted by the Council on 28 May 19^9 > the Commission addressed
to the Council on 19 October 1972 a proposal for a Directive on the
approximation of the laws of the Member States relating to cosmetic
product s .
The European Parliament delivered its opinion on this proposal for a
                                                 2
Directive during its session of 6 July 1973 .         The Commission has
carefully examined the comments contained in the opinion and has decided
to take appropriate action on some of them , and , to this end , in pursuance
of Article 149 ? second paragraph of the Treaty , to put forward the
following proposals for amendments to the original proposal for a
Direct ive :
          ■- Article 6 ( 3 ) and ( 4);
          - Article 11 ( 2 );
          ■- Article 12 *
          -  Article 14 ;
These proposals for amendments are intended to give greater clarity to
Certain requirements relating to the labelling and presentation for sale
of cosmetic products , to make clearer and more practical the Community
safeguard procedure provided for cases in which a cosmetic product which
complies with these provisions constitutes a hazard to human health .
They are also intended to remove from the proposal the additional period
provided for the sale of old stocks ,
Furthermore they arc for the purpose of amending , in connection with
the Community's enlargement , the distribution of votes in the Committee 's
procedure .
The Commission also proposes the amendment and expansion of Annexes II
( List of substances which cosmetic products must not contain), III , Part
1 ( List of substances which, cosmetic products must not contain, except
subject to the restrictions laid down) and IV , Part 1 ( List of substances
provisionally allowed).
In formulating the last mentioned proposals for amendments , the Commission
has taken account of the opinions of the experts who assist it in drawing
up the technical annexes to the proposal for a Directive .
 1 0J No C 76 , 17 June 1969       OJ No C 62 , 31 July 1973 .
 ---pagebreak---                                AyFrTDE;3.^'n TC
                               «s- rssc-^t~sx^ in :aiyi
the proposal for a Council Directive on the approximation of the laws of
Member States relating to cosmetic products
the Commission on 19 October 1972
The proposal for a Directive forwarded to the Councix on 19 October 1972
is amended by the following:
– amendments to Article 6 ( 3 ) and ( 4) j
- a correction to Article 11 ( 2 );
-  the rewording of Article 12 ;
-- deletion of Article 14 ( 2 );
-  amendments to Annexes II , III and IV .
                                   Artic le 6
The text of paragraphs ( 3 ) and ( 4) is expanded as follows :
3.  The special precautions of use , and , in particular , those indicated in
the column " Conditions of use and warnings tdiich must appear on the label"
in Annexes III and IV shall appear legibly on the container ;     where this
is impossible for practical reasons , these indications shall appear on
the outside packaging and on an enclosed leaflet , but in this case an
abbreviated external indication must appear on the container , referring
to the indications mentioned .
4.  The use , both in the labelling and in the presentation for sale of
the products covered by Article 1 and in the publicity concerning them,
in whatever form this may be , of names , trademarks , images or other
signs , visual , cinematographic or other displays , suggesting a characteristic
which the products considered do not possess , or at t ribut ing thereto
effects which are not , or are insuffi ciently established sclerrtifically ,
shall be prohibited .
                                   Article 11
The text of the second paragraph shall be amended as follows :
2.  The representative of the Commission Bhall submit to the Committee
    a draft of the measures to be taken . The Committee shall render
    its Opinion on this draft within a period of time which the Chairman
    may fix according to the urgency of the matter in hand .     It shall
    act by a majority of 41 votes , the votes of the Member States being
    weighted as laid down in Article 148 ( 2) of the Treaty.     The
    Chairman shall not vote .
 ---pagebreak---                                        2
                                   Article 12
The text of this Article is replaced "by the following:
1.    If a Member State ascertains that a cosmetic product constitutes a
      hazard to health , although conforming to the requirements of this
      Directive and "being used as directed, this State may , for a maximum
      period of one year , prohibit in its territory the sale , putting into circula?-
      tion or use of the cosmetic .product in question.   It shall immediately
      communicate this to the other Member States and to the Commission ,
      acoompanied by a statement of grounds ,
2.    The Commission shall consult the Member States involved within six:
      weeks .    It shall deliver its opinion without delay and take the
      necessary measures .    On the initiative of the Commission it shall
    • be decided without delay , in accordance with the procedure provided
      for in Jkrtiole 100 of the EEC Treaty or with that specified in
      Article 11 of this Directive , whether the Directive must be amended.
      If necessary , the necessary amendments shall be adopted by Directive .
 . , Th.e time limit referred to in Paragraph ( 1 ) shall be extended until
      the procedure initiated has been' completed, but not for more than
      one year .
                                   Article 14
Section 2 is deleted .
Annex II - list of substances which cosmetic products must not contain .
The following substances have been added to the lists
426 . Diphenhydramine (2 Benzhydroxy--N,Dimetbylethylamine ) and its salts .
427 •   p-tert butyl phenol and its allergenic    derivatives .
428 .   p-tert butyl pyrocatechin
429 « Dihydrotachi sterol (AT 10 ) ...
 ---pagebreak---                                           3
  430 .   Thiourea
  431 .  Derivatives of "thiourea , except those expressly mentioned in
         Annex IV .
  432 . Dioxane (1 »4 diethylene dioxide ).
  433 .  Morpholine .
  434 •  Preparations based on pyre thrum .
  435 .  Pyriamino-amsole moleate .
  436 .  P;/.âbenz aminé .
  437 •  Tetrachlorosalicylanilide .
  43S .  Dichlorosalicylanilide .
  439 ?  Tetrabromosalicylanilide .
  440 .  Dxbromosalicylamide .
  441 *  Bithionol .                                        ;
  44-2 . Tin I--aiui c mono sulphides .
  443 »  Tliiramic disulphidcs .
  444 »  Bimethylforiaamide .
  445 •  Xylidines ( all isomers ).                       ;
  446 .  Benzylidene acetone .
  447 .  Coniferyl benzoate , except for normal content in natural essences
         used .
  443 »  Furocumarin , except for normal content in natural essences used »
  449 »  Laurel 01I .
  450 *  Sassafras oil containing safrole .
  45 ^»  Iodothymol .
  Annex III :      Part 1
                   List of substances which cosmetic products must not contain ,
                   except subject to the restrictions laid down .
• Item -No 27 – -Hoxachlorophene - .is deleted ..             . .   . •
  The words " and muds" are deleted on Page 4 } note ( 1 ), beginning of
  second paragraph .
  The substances cruoted below are added .
 ---pagebreak---                                                      4
                                             Restrictions                  :
I                                                                          !
I Reference           Product           Use          Maximum               jOther                 j Conditions!
  Nuinber   j                                        permissible               limiterions I           of use andj
                                                     concentration            and                      warnings
                                                                            I.
                                                                             !"
                                                                                 requirements •whi ch must
                                                !
                                                i
                                                             -      •    , I 1
                                                                                                   }
                                                                                                   i
                                                                                                       be printedl
                                                !
                                                I                                         ■   '
                                                                                                         on the   I
                                                                                                         label
     a                   b                                  d"                                              f
                                         c
                                                                                                   I
    27             Quinine      ( a) shampoos 0,§%) expressed                                           contains
                   and          (b ) hair       j 0,2% (  0
                                                               as quinine                              quinine
                   its salts           lotions                 base
                                                                                                     »
                                                  !                            i                     I
              ι
    28
              j Hydroxy-8-                           0.3$ expreséed                    not for
                   qumolme                                  as base              luse m                I
                                I                                                                      I
                   and its                                                       I anti-
                                                                                 i
                                                                       ■
                   sulphate                                                            sunburn
                              i
                                                                                 S products,' ' |
                                                                                       post
                                                                                       sunbathing
                                                                                 mroducts
                                                                                       ahd baby
                                                                                       powders
              τ
     11           Formai-                                                             prohibited
                                                  I
                                                                                   I­
                   deliyde                                                        i         ■
                                                                                       aerosols
              ]
     29         iNitro            solely            I 0.31o
                                                                                   i
                unethane          as                                               i
                                                                                   t .. ■
                                  corrossion
                                  inhibitor
                 I
                 !                jfor                                              t
                                                                                    i
                                  aérosol                                           I
                                                                                    i
                                                                                     i
                 I                packs                                                                  II
                .1         ■
 ---pagebreak---                                            5
  Annex IV i Pari; 1
»
              List of provisionally acceptable substances .
  The following is added to item 22 ~ xylocaine :
                                           Restrictions
     Reference  i Product                                           Conditions of
     nuraber                          Use  i-icucinium             use and warnings
                                           permissible              to be printed on
                                            concentration           the label
                                                                         e
        22        xylocaine    after shave 0.1%
                  ( lidocaine   lotion      allowed
                  USP )        after sun
                  ( lignocaine lotion
                  BP )
  ■ The following substances have been added :
                               i ( a)
        23        hexochlo-                                           contains
                               jfcoaps and   \/0
                  rophane      jpliajnpoos                            hexachlorophone
                               !(d )                                  not for use
                               .aerosol
                                                                      on children
                               jSprays
                               ;( c )                                 below the âge of
                               jbody           0.5/o                  10
                               deodorants
                               !( d )
                               btlier           0.1£
                               Uses
                                                other rastnetions      Products for
                                               prohibited in           intimate
                                                cosmetic products      hygiene not to
                                                for use on children    be used
                                              > elow the age of 10     during pregnanclr
       24                                       maximum content
                                                100 ppm in the
                                                finished product