CELEX: 51979PC0250
Language: en
Date: 1979-05-16
Title: Proposal for a COUNCIL DIRECTIVE amending for the first time Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (submitted to the Council by the Commission)

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COM (79) 250
Vol. 1979/0099
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 ---pagebreak---  COMMISSION OF THE EUROPEAN COMMUNITIES
                                                        COM(79 ) 250 final .
                                                        Brussels , 16 May 1979
                                  Proposal for a
                                COUNCIL DIRECTIVE
 amending for the first time Council Directive 76/ 768/ EEC of 27 July 1976
 on the approximation of the laws of the Member States relating to cosmetic
                                     products
                                              • «
                 ( submitted to the Council by the Commission)
                                                       \ •
                                                     .  \
                                                        11
                                                   • -V :
                                                     ;//
                                                  V
COM ( 79 ) 250 final .
 ---pagebreak---             PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING FOR THE FIRST
            TIME THE COUNCIL DIRECTIVE 76/768/EEC of 27 JULY 1976
            ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES
                         RELATING TO COSMETIC PRODUCTS
EXPLANATORY MEMORANDUM
This proposal is designed to :
1.    correct certain errors which were incorporated into the text of
      Council Directive 76/768/EEC of 27 July 1976 ;
2.    tighten up some of the provisions of the above directive ;
3.    comply with Article 5 thereof ;
4.    adopted a list of substances which may be used as preservatives ;
5.    adopt all the annexes to technical progress , according to the
      Committee 's procedure .
( 1 ) When Directive 76/768/EEC of 27 July 1976 was implemented ,
      it emerged that a number of errors had found their way not
      only into the text of the Directive , chiefly the list of colour
      index numbers for colouring agents , but also into some of the
      different language versions . These errors should be corrected .
( 2 ) Implementation also showed that some provisions would have to
      be tightened up , or even improved . I&r way of an example ,
      Directive 76/768/EEC required no warning with regard to the
      use of thioglycollic acid and its salts and ethers whereas , in
      order to protect public health , there should be proper labelling
      to warn the consumer that the cosmetic product does contain these
      substances and that he should follow the instructions very carefully .
 ---pagebreak---                                      - 2 -
      The Directive restricted the application and/or use of hydrogen
      peroxide to oxidizing colouring agents even though the substance
      is used widely in hair care products . It did not restrict the
      application and/or use of hydroquinone although this substance
      should only be used as an oxydizing colouring agent for hair
      dyeing . It did not stipulate a maximum authorized potassium
      or sodium hydroxide concentration whereas the concentration
      should "be restricted to a maximum pH value of 12.65 « It
      prohibited the marketing of cosmetic products containing substances
      listed in Annex II whereas their presence is technologically
      unavoidable in correct manufacturing processes because some of
      these substances are naturally present in raw materials . A
      second paragraph has been added to Article 4 to take account of
      this .
( 3 ) Article 5 of Directive 76/768/EEC states that on expiry of a
      period of three years from its notification , the substances and
      colouring agents listed in Annex IV shall :
      – either be definitively permitted ,
      – or definitively prohibited (Annex II ),
      – or retained for a further period of three years in Annex IV ,
      – or deleted from all Annexes to this Directive .
      Based on what is known at present , a decision may be taken on
      the substances listed in Part 1 of Annex IV , with the exception
      of :
      – methanol
      – monoglyceric ester of p-aminobenzoic acid
      – 8-hydroxi quinol iniura and its sulphate
      – 1.1.1–trichloroethane (methylchloroform )
      which should be kept in Annex IV until 31 December 1982 .
 ---pagebreak---                                     - 3 -
      A more detailed examination of Parts 2 and 3 of Annex IV reveals
      that they do not correspond with the list of colouring agents
     actually used in the production of cosmetic products . To
     begin with, therefore , these two parts will have to be revised
     and kept in Annex IV until 31 December 1982 , so allowing time
     for scientific information to be collected so that a decision
     can then be taken on them in accordance with Article 5 of
     Directive 76/768/EEC .
(4 ) Article 11 and the penultimate recital of Directive 76/768/EEC
     require the Commission, on the basis of the results of the latest
     scientific and technical research , to submit to the Council
     appropriate proposals establishing lists of permitted substances
     which could include antioxidants , hair dyes , preservatives and
     ultraviolet filters . A start could be made by drawing up a list
     of substances authorized for use as preservatives . As a
     precautionary measure , the vast majority of these substances
     should be authorized only provisionally so that the additional
     information required for a final assessment of the health risks
     can be collected although the information available indicates
     that such risks are unlikely . In any case , this procedure should
     help to provide better consumer protection since , in the future ,
     preservatives used in the production of cosmetio products will
     be fully identified and their conditions of use accurately defined .
     The next step will be to draw up lists of substances authorized
     for use as antioxidants and ultraviolet filters , as very
     satisfactory progress is being made . A list of substances
     authorized for use as hair dyes will be oompiled at a l&ter
     stage , in view of the complexity of the problem and the large
     number of substances to be examined (about 300).
 ---pagebreak---                                        - 4 -
      That is why , in the interests of consumer protection, it is
      "better to propose these lists in stages , since scientific
      research is not equally advanced for each category of substances .
( 5 ) In actual fact , the annexes to Directive 76/76 8/EEC consist
      of lists of substances banned ( Annex II ) and provisionally
      allowed ( the present Annexes III and IV and Annex VI which is
      to be added ). The procedure for amending these Annexes should
      preferably be swift and flexible , chiefly so that :
         ( i ) a substance which would constitute a risk to public
               health if used in cosmetic products can be banned ;
       ( ii ) a new substance can be added to the list of authorized
               substances if , for example , the use thereof would improve
               consumer protection or constitute technological progress -
               long and costly research would be discouraged if unwieldy
               procedures were involved in implementing the results .
               In this respect , the Committee procedure for adapting the
               Annexes of Directive 76/768/EEC to technical progress is
               preferable to a Council Decision .
( 6 ) When preparing its proposal , the Commission sought the opinions
      of national experts and consulted representatives of the industry
      and consumers . The section on preservatives is largely based on
      the work done by the Council of Europe *s Committee of Experts .
( 7 ) The proposal is based on Article 100 which means that the
      European Parliament and the Economic and Social Committee have
      to be consulted .
 ---pagebreak---      PROPOSAL FOR A COUNCIL DIRECTIVE AMENDING FOR THE FIRST
    TIME COUNCIL DIRECTIVE 76/768/EEC OF 27 JULY 1976 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 ,
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  the implementation of Council Directive 76/768/EEC of
27 July 1976 on the approximation of the laws of the Member
States relating to cosmetic products showed that certain
amendments should be made to Annexes II , III and IV ;
Whereas , in order to protect public health , measures should be
taken with regard to mandatory warnings on the labels of cosmetic
products containing thioglycollic acid , its salts and esters ;
Whereas the use of hydrogen peroxide is not restricted to
oxydizing colouring agents for hair dyeing and whereas the use
of this substance should therefore also be authorized for hair
care products , with the requirement that certain warnings be
printed on the label to safeguard health;
 OJ L 262 of 17 September 1976 , p. 169
 ---pagebreak---                               - 2
Whereas in certain circumstances it is not necessary to mention
the formaldehyde content on the label when this substance is
not used as an ingredient of a cosmetic product "but is inevitably
present as a residue from the processing of raw materials ;
Whereas the field of application and/or use of hydroquinone
should be specified ;
Whereas the maximum authorized concentration of potassium or
sodium hydroxide in depilatories should be specified ;
Whereas a decision may be taken with regard to > the substances
listed in Part 1 of Annex IV of Council Directive 76/768/EEC of
27 July 1976 , in accordance with Article 5 thereof ;
Whereas Parts 2 and 3 of Annex IV of the same directive do not
correspond with the list of colouring agents actually used in
the preparation of cosmetic products and whereas this list should
therefore be updated ;
Whereas a list of substances authorized for use as preservatives
can be drawn up on the basis of the latest scientific and
technical research ;
Whereas a procedure for updating the annexes rapidly should be
introduced ;
Whereas the presence of traces of substances which cosmetic
products must not contain according to Annex II of Council
Directive 76/768/EEC is technologically inevitable with correct
manufacturing processes and whereas therefore certain provisions
should be made in this connection :
 ---pagebreak---    whereas the English , German and Dutch versions of Council
  Directive 76/768/EEC of 27 July I976 contain typographical
  errors which should be corrected :
  HAS ADOPTED THIS DIRECTIVE :
                                Article 1
  Council Directive 76/768/EEC of 27 July 1976 is amended in
  accordance with the following provisions *
                                Article 2
 Annex II is amended as follows :                  >
 – Replace "350» Tetrabromosalicylanilides " try :
 "350. Tetrabromosalicylanilides except as impurities of
 tribromosalicylanilide acoording to the criteria laid down in
 Part 1 of Annex III ."
 - Replace "351 * Díbromosalicylanilides , e.g. metabromsalan
    and dibromsalan " by :
   351 * Dibromosal icylani1ides , e.g. metabromsalan and dibromsalan
 except as impurities of tribromosalicylanilide acoording to the
 criteria laid down in Part 1 of Annex III ."
– byReplace
      :
             "360. Sassafras –––––.
                              officinale –Nees oil containin/r safrole"
 "360. Safrole except for normal content in the natural essences
used    and provided the concentration in the finished product does
not exceed 100 ppm ."
- Add :
"362 Chloroform".
                              Article 3
1 « Part 1 of Annex III is replaced "by "the annex given in
Annex 1 to this directive .
 ---pagebreak--- 2.    Part 2 of Annex III is amended as follows !
( a ) Reds
      - In the third and sixth columns delete :
        "E 180" against colouring agent No 10 corresponding to
        colour index number 15 850 .
        "E 420" against colouring agent Kb 26 corresponding to
        colour index number 77 015 .
      – In the second column , replace :
        "15 630(Ba )"  by "15 630 : 1"
        "15 630(Sr )"  by "15 630 : 3"
        "15  865(Sr )" by "15 865 : 3"
        "45  l70(Ba)"  by "45 170 : 1"
(b ) Oranges and yellows
      For colouring agent No 23 , replace the colour index number
      "45 395 " in "the second column by "45 396 "*
( c ) Oreens and blues
      For colouring agent No 4 corresponding to colour index
      number 44 090 enter the number "E 142" in the third and
      sixth columns .
(d ) Violets , browns , blacks and whites
      Delete colouring agent No 8 corresponding to colour index
      number 77 OO5 .
      In the third and sixth columns delete the number "E 153" for
      colouring agents Nos 12 and 13 corresponding to colour index
      numbers 77 266 and 77 267 .
      Add reference number " 26 " and enter number "E 153 " in the
      third and sixth columns corresponding to this reference
      number .
 ---pagebreak---                                   - 5 -
                                Article 4
1.    Part 1 of Annex IV is replaced by the annex given in
Annex 2 to this directive .
2 . . Part 2 of Annex IV is amended as follows :
(a) Reds
      – Delete the following colouring agents :
          Reference number                Colour index number
                 2                              12 350
                 3                              12 385
                14                              75 580
      – For reference number 5 replace the numbers " 15 500" and
        "15 500 ( Ba )" "by "17 200" and delete the reference to
        the field of application in the fourth column .
      – For colouring agent No 6 replace "15 5^5 ( Ba)" in "th©
        second column by "15 5^5 • !"•
(b ) Oranges and .yellows
      – For reference number 2, replace colour index number
        "45 340 " in the second column by "40 85O" and add the
        number "E I6lg" in the third and sixth columns .
 (d ) Violets , browns , blacks and whites
      – Delete colouring agent No 8 corresponding to colour index
        number 77 718 .
3.    Part 3 of Annex IV is replaced ty the annex given in Annex 3
      to this directive .
 ---pagebreak---                               Article 5
In Annex V :
– Replace :
   "6 . Zirconium and its derivatives'*.
   qy :
   "5 . Zirconium and its compounds ".
– Delete the following:
                   *
   "7 . Thiomersal and phenylmercuric compounds (for use as
   preservatives in concentrated shampoos and creams containing
   non-ionic emulsifiers which render other preservatives
   ineffective ;   maximum concentration 0.003% calculated as Hg)."
                    ι
                              Article 6
An Annex VI listing substances which may be used as preservatives
in the manufacture of cosmetic products has been added . It is
given in Annex 4 to this directive .
                              Article 7
Article 4 is amended to read as follows !
"1 .    Without prejudice to their general obligations deriving
        from Article 2 , Member States shall prohibit the marketing
        of cosmetic products containing:
 ---pagebreak---        (a )   ( unchanged.)
       (b )   (unchanged )
       (c )   (unchanged )
       (d )   (unchanged )
       (e)   preservatives other than those listed in the first part
             of Annex VI .
       (f)   preservatives listed in the first part of Annex VI
             "beyond the limits and outside the conditions laid down .
2.    The presence of traces of the substances listed in Annex II
      may be allowed provided that it is technically unavoidable
      when correct manufacturing techniques are used and that it
      conforms with Article 2 of this directive .    The maximum
      authorized concentrations of these substances will be fixed -
       in accordance with the procedure provided for in Article 10 –
      "by 31 December 1982 at the latest .   On the other hand , the
      use of the substances listed in Annex II in the manufacture
      of cosmetic products is prohibited ".
                               Article 8
Article 5 18 amended to read as follows :
"Until 31 December 1982 , Member States shall accept the
marketing of cosmetic products containing ?
(a)     ( unchanged )
(b)     (unchanged )
(c )    ( unchanged )
( d ) the preservatives listed in the second part of Annex VI
        within the limits and conditions laid down .
On 1 January 1983 » these substances , colouring agents and
preservatives shatlls
 ---pagebreak---                               - 8 -
– either "be definitively permitted ,
– or definitively prohibited (Annex II ),
– or retained for a further period as specified in Annex IV or VI ,
– or deleted from all Annexes to this directive ."
                           Article 9
The second paragraph of Article 8 is amended to read as follows :
"2.   The amendments necessary for adapting Annexes II and VI to
      technical progress shall be adopted in accordance with the
      same procedure . "
                           Article 10
1.  The English–language version is corrected m accordance
    with Annex 5 of this directive .
2.  The German-language version is corrected in accordance
    with Annex 6 of this directive .
3.  The Dutch-language version is corrected in accordance with
    Annex 7 of this directive .
                           Article 11
1.  Member States shall bring into force the provisions needed
    in order to comply with this directive on 27 July 1979
    and shall forthwith inform the Commission thereof .
2.  Once notified of this directive , Member States shall
    undertake to inform the Commission , in good time for the
    latter to make its own observations , of ariy other draft
    laws , regulations or administrative provisions which they
    intend to adopt in the field covered by this Directive .
 ---pagebreak---                              - 9 -
                          Article 12
This Directive is addressed to the Member States .
 ---pagebreak---                                                                                      ANNEX 1
                                                                                   ANNEX III
                                                                                     PART 1
                                      List of substances which cosmetic products must not contain except subject to the restrictions
                                                                            and conditions laid down
     :                                       I                                            Restrictions                                    r~~"–■––n
Référencé                                                                                                                                           Conditions of use and
                       Substance                                                      Maximum authorized                                          warnings which must be
 number                                               Field ot application        concentration in the finished
                                                                                                                       Other limitations
                                                           and'or use                                                  and requirements              printed on the label
                                                                                       cosmetic product
                                                                              i                           . •
                           b                                   c                               d                              e
     1      Boric acid                         (a) Talcs                        (a) 5%                          (a) Not to be used in      (a) Not to be used for babies
                                               (b) Products for oral            (b) 0-5%                            products for children
                                                   hygiene                                                          under three years old
                                               (c) Other products               (c) 3%
     2      Thioglycollic acid and             (a) Hair waving or                                                                           ( a) Contains thloglycolllc acid.
            its salts and esters                   straightening products :                                                                      Follow the Instructions
                                                   – home use                   (a) – 8 % ready for use
                                                                                       pH £ 9-5
                                                   – professional use               – 11% ready for use
                                                                                       pH £ 9-5
                                               (b) Depilatories                 (b) 5%                                                     ( b) Contains thloglycolllc add.
                                                                                    pH ^ 12-65                                                   Follow the instructions
          i
                                               (c) Other hair care produces     (c) 2%                                                     ( c) Contains thloglycolllc acid.
                                                   which are removed after          percentages calculated                                       Follow the instructions
                                                   application                      as thloglycolllc acid
       3     Oxalic acid , its esters and      Hair treatment products          5%                                                         For hairdressers only
             alkaline salts
 ---pagebreak---                                                                                   Restrictions                                  I                       :          –i
Reference                                                                                                                                 Conditions of use and
                       Substance                                            Maximum authorized                                           warnings which must be
 number                                          Field of application                                         Other limitations
                                                      and / or use       concentration in the finished                                     printed on the label
                                                                                                             and requirements
                                                                              cosmetic product
    <     I                b                                                           d                              e
    4       Ammonia                                                   6% calculated as NH«                                        Above 2% : Contains ammonia          j
    5       Tosylchloramide sodium *                                  0-2%
                                                                                                                                                                     f
    6       Chlorates of alkall           (a) Toothpaste               (a) 5%
            mecals
                                          ( b) Other uses             (b) 3 %
    7       Dichioromethane                                           35%                              0*2% as maximum             For preparations in aerosol dis­
                                                                      (when mixed with 1,1,1-          impurity content            pensers.   Do    not spray   on a
                                                                      trichloroerhane, total                                       naked flame or any incandescent
                                                                      concentration must not                                       material
                                                                      exceed 35% )                                                                                        I
                                                                                                                                                                         rs>
                                                                                                                                                                          I
    8       o and m-Phenylenediamines     Oxidizing colouring agents  6% calculated as free base                                   Can cause an allergic reaction .
            their N-substituted           for hair dyeing                                                                          Sensitivity test advisable before
            derivatives and their salts ;                                                                                          use
            N-substituted derivatives of                                                                                           Contains phenylenediamines. Do
            p-phenylenediamines ( ' )                                                                                              not use to dye eyelashes or eye­
                                                                                                                                   brows
 ---pagebreak--- I             I1                                 π                                                          Restrictions                                                    1                                            Ί
  Référencé                                                                                                                                                                            Conditions of use and
                             Substance                                                                 Maximum authorized                        Other limitations                    warnings which must be
   number                                                      Field of application                concentration in the finished
                                                                 v and/or use                                                                    and requirements                        printed on the label
                                                                                                         cosmetic product
                                              .       !
                                 b                    I                  C                                        d                                       e                                        i
      9           Methylphenylenediamines,               Oxidizing colouring agents             10 % calculated as free base                                                  Can cause an allergic reaction .
                  their N-substituted deriva­            for hair dyeing                                                                                                      Sensitivity test advisable before
                  tives and their salts f 1)                                                                                                                                  use
                                                                                                                                                                              Contains phenylenediamines. Do
                                                                                                                                                                              not use to dye eyelashes or
                                                                                                                                                                              eyebrows
    10           Diaminophenols (')                      Oxidizing colouring agents             10% calculated as free base                                                i
                                                                                                                                                                              Can cause an allergic reaction.
                                                        for hair dyeing                                                                                                       Sensitivity test advisable before use
                                                                                                                                                                              Contains diaminophenols. Do not
                                                                     y
                                                                                                                                                                              use to dye eyelashes or eyebrows
I 11         I   Dichlorophen *                                                                0-5% maximum
                                                                                               ( except as a preservative )
                                                                                                                                                                              Contains dichlorophen*.
                                                                                                                                                                              be used for babies .
                                                                                                                                                                                                                 Not to
                                                      i                                      [
    12         | Hydrogen peroxide                      Haïr care products                      40% volume, i.e. 12% H*Oa                                                     Contains x% hydrogen peroxide .
                                                                                                                                                                              Not to come Into contact with
                                                                                                                                                                              eyes. Rinse eyes Immediately
               i
                                                                                                                                                                              If product comes Into contact
               i
                                                                                                                                                                              with them
               i
   O These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product at the maximum level authorized for each of them does not exceed 1.
 ---pagebreak---                                                         ι                                                      Restrictions
   Reference                                                                                                                                                                             Conriirions of use and
    number                    Substance                          Field of application                    Maximum authorized                        Other limitations                   warnings which must be
                                                                      and/or use                      concentration in the finished                and requirements                       printed on the label
                                                                                                           cosmetic product
                                   b                                      c
                                                                                               I                    d                   iI                 «                                        '
     13            Formaldehyde                           Nail hardeners                         5% calculated as                                                               (a) Protect cuticles with grease or
               i
                                                                                                 formal dehyde                                                                      oil. Contains x%           formalde­
                                                                                                                                                                                    hyde if concentration
                                                                                                                                                                                     exceeds 0,05£
     H             Hydroquinone (*}                       Oxidizing colouring                  ' 2%                                                                             Do not use to dye eyelashes or
                                                                                               I                                                                                eyebrows
                                                          agents for hair dyeing
                                                                                               I .                                                                              Rinse eyes immediately if product
                                                                                                                                         i
                                                                                                                                                                                comes into contact with them
                                                                                                                                         |                         :            Contains hydroquinone
                                                                                                                                         i                                   ;
                                                      -,
     15            Potassium or sodium                     (a) Nail cuticle solvent                (a) 5% by weignt ( ' ) -                                                     (a) Avoid contact with eyes . Can
                   hydroxide                                                                                                                                                        cause blindness. Keep away
                                                          ( b) Haïr straightener                    ( b) 2% by veight C )                                                           from children
                                                          ( c) Depilatories                         ( c) up to pH 12.65                                                         (b) Avoid contact with eyes Can
                                                                                                                                                                                    cause blindness. Keep away
                                                          ( d) Other uses as a                     ( d) up to pH 11                                                                 from children
                                                               neutral izer
(') The sum of rhe two hydroxides expressed by weight as sodium hydro>ide.
(*) These substances may be used singly or in combination provided that the sum of the ratios of the levels of the content of each of them in the cosmetic product at the maximum level authorized for each of them does nor
    exceed 2.
 ---pagebreak---                                                                                                         Restrictions
                                                                                                                                 I
Référence                                                                                                                                                                          Conditions of use and
                            Substance                                                             Maximum authorized
 number                                                      Field of application                                                           Other limitations                     warnings which must be
                                                                  and/or use                  concentration in the finished                                                          printed on the label
                                                                                                                                            and requirements
                                                                                                    cosmetic product
                                b                                                                            d
                                                                      c                                                                              6                                         «
   16           Lano in
                                                                                                                                                                          Contains lanolin                           J
   17           a-NaphthoI                            Hair dye                             0-5%                                                                           Contains a-naphthol
   18           Sodium nitrite                        Rust Inhibitor                       0-2%                                     Do not use uith
                                                                                                                                    secondary amines
   19            Nitromethane                         Rust Inhibitor                        0-3%
   20            Phenol and Its alkaline              Soaps and shampoos                    1% calculated as phenol                                                       Contains phenol
                 salts
   21            Picric acid                          Rust Inhibitor                        1%                                                                            Contains picric acid
   22            Pyrôgallol ( ' )                     Hair dye                              5%                                                                            Do not use to dye eyelashes or
                                                                                                                                                                          eyebrows. Rinse eyes immediately
                                                                                                                                                                          if product comes into contact with
                                                                                                                                                                          them . Contains pyrogallol
         These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product at the maximum level authorized for each of them does not exceed 2,
 ---pagebreak--- I               I                                                                                                    Restrictions                                                   i                      :                ~n
                                                                                                                                               l                                                  Conditions of use and -
  Référencé
   number
                                 Substance
                                                                     Field or application                       Maximum authorized                       Other limitations                       warnings which must be
                                                                           and/or use                      concentration in the finished                 and requirements                          printed on the label
                                                                                                                  cosmetic product
                                      b                                                               '                   d                                       e
                                                                                                                                                                                                             f
     23             Quinine and its salts                      (a) Shampoos                           1 (a) 0-5% calculated as
                                                                                                              quinine base
                                                               (b) Hair lotions                          (b) 0-2 % calculated as
                                                                                                              quinine base
     24             Resorcinol (l)                            (a) Hair dyes                              (a) 5%                                                                          (a) Can cause an allergic reaction.
                                                                                                                                                                                              Contains resorcinol. Rinse hair
                                                                                                                                                                                              well after application . Do not
                                                                                                                                                                                              use to dye eyelashes or eye­
                                                                                                                                                                                              brows. Rinse eyes immediately
                                                                                                                                                                                              if product comes into contact
                                                                                                                                                                                              with them
                                                              (b) Hair lotions                           (b) 0-5 %                                                                       ( b) Can cause an allergic reaction .
                                                                                                                                                                                              Contains resorcinol
                                                              (c) Shampoos                               (c) 0-5%                                                                        (c) Can cause an allergic reaction.
                                                                                                                                                                                              Contains resorcinol. Rinse hair
                                                                                                                                                                                              well after application
   (*) These substances may be used singly or in combination provided that the sum of the ratios of the levels of the content of each of them in the cosmetic product at the maximum level authorized for each of them does not exceed 2.
 ---pagebreak--- Γ                                      1                                          Restrictions                           Γ                             :
  Reference
                      Substance                                     |        Maximum authorized                          [       Conditions of use and
   Dumber                                     Field of application                                     Other limitations I       warning vvhich musr bc
                                                   and/ or use           concentration in the finished                   !        printed on ( he label
                                                                                                       and requirement**
                                       i
                                                                    J         cosmetic product
                          b                             ■                              d                       c                            f
    25      Ammonium sulphides, al­                                   2% in pastes
            kali and    alkaline earth                                20% for monosulphides in
            sulphides                                                 aqueous solution without
                                                                      additive
     26      Zinc salts except for                                    1X calculated as zinc
             zinc salts of fatty
             acids , zinc 4-hydroxy-
             benzene-sulphonate and
             zinc pyri thl one
     2?      Zinc 4-hydroxybenzene-      (a) Astringent               (a) 6% calculated as the                             (a) Avoid contact with eyes
             sulphonate                                                    anhydrous substance
                                         (b) Deodorant                (b) 6 % calculated as the                            (b) Do not spray into eyes
                                                                   i
                                                                   i       anhydrous substance
      28     Ammonium mononuoro-         Oral hygiene products        0-15%                                                Contains ammonium mononuoro-
             phosphate                                                Calculated as F. When mixed                          phosphate
                                                      \
                                                                      with other fluorine
                                                                      compounds permitted under
                                                                       this Annex , total F concen­
                                                                      tration     must     not exceed
                                                                      0- 1 5 %
 ---pagebreak---                                                                      Restrictions
Référencé                                                                                                            Conditions of u*c and
 ourober              Substance       Field of application      Maximum authorized         Other limitations        warning which must be
                                           and/or use        concentration in the finished and requirements           printed on the label
                                                                  cosmetic product
          I                                    c                           d                       e
                                                                                                             I                  '
  29        Sodium mononuoro-   Ditto                      0-15%                                               Contains sodium
            phosphate                                      Ditto                                               monofluorophosphate
   30       Potassium           Ditto                      015%                                                Contains potassium
            monofluorophosphate                            Ditto                                               monofluorophosphate
  31        Calcium             Ditto '                    0-15%                                               Contains calcium
            monofluorophosphate                            Ditto                                               monofluorophosphate
  32        Calcium fluoride    Ditto                      015%                                                Contains calcium fluoride
                                                           Ditto
  33        Sodium fluoride     Ditto                      015%                                                Contains sodium fluoride
                                                           Ditto
   3*       Potassium fluoride  Ditto                      0-15%                                               Contains potassium fluoride
                                                           Ditto
   35       Ammonium Ruoride    Ditto                      0-15%                                               Contains ammonium fluoride
                                                           Ditto
   36       Aluminium fluoride  Ditto                      0-15%                                               Contains aluminium fluoride
                                                           Ditto
 ---pagebreak--- Γ           I                 Γ                                                        Restrictions                                  i                                   n
  Rcfcrcnce                                                                                                                                    Conditions of use and
  •numher                Substance
                                                     Field of application !      Maximum authorized            Other limitations              warnings which must be
                                                          and /or use     |   concentration in the finished    and requirements                 printed on the label
                                                                          <        cosmetic product
_j          !                >             J                   c          i '               d                          β
     37       Stannous fluoride               Ditto                         0-15%                                                      Contains stannous fluoride
                                                                            Ditto                                                    i
                                                                                                            ■■               .   ■. j
     38        Hexadecyl-trimethyl-         ' Dttro                         0-15%                                                      Contains hexadecyl-trimethyl-
               ammonium fluoride                                            Ditto                                                      ammonium fluoride
     39        3-( N- Hexadecyl - N-2-        Ditto                         0-15%                                                      Contains 3 -( N - Hexadecyl -N-2-
               hydroxyethylammonio)                                         Ditto                                                      hydroxycthylammonio ) propylbis
               propylbis (2-hydroxyethyl)                                                                                              (2-hydroxvethyl ) ammonium
               ammonium difluoride                                                                                                     difluoride
      40       NN'N*-Tris(polyoxyethy-        Ditto                         015%                                                       Contains NN'N'-tris(polyoxyethy-
               lene)-N -hexadccyIpropvlene-                                 Ditto                                                      lene)- N-hexadecylpropy!enedia-
              diamine      dihydrofluoride                                                                                             mine dihydrofluoride
      «        Octadecyl-ammonium             Ditto.                        0-15%                                                      Contains octadecyl-ammonium
               fluoride                                                     Ditto                                                      fluoride
      «        Sodium fluorosilicate          Ditto                         0-15%                                                      Contains sodium fluorosilicate
                                                                            Ditto
      «        Potassium fluorosilicate       Ditto                         0-15%                                                      Contains potassium fluorosilicate
                                                                            Ditto
 ---pagebreak---                                                                                   Kc trierions                     ______         –    I
                                                                                                                                                  Conditions of use and
Refcrcncc                                                                                                                                        warnings which must be
                        Subitanee                                           Maximum authorised
 numher                                       Field of application                                              Other limitations                  printed t»n the
                                                   and'or use           concent carton in the finished          and requirement *
                                                                             cosmetic product
                           b
                                     I                 c           I■                  d               i                 ~              I
   h''       Ammonium nuorosilicate     Ditto                         0-15%
                                                                                                                                           Contains ammonium fluorosilicate
                                                                      Ditto
   45        Magnesium nuorosilicate   Dirto                          0-15%                                                                Contains magnesium fluorosmeate
                                                                      Ditro
   *6        1 »3-Bi$£hydroxymethyl)   ( a) Haïr care                 (a) Up to 2%                       (a) Prohibited in aerosol         (a) Contains i^-bisfhydroxyme-
             imidazolidine-2-thione                                                                          dispensers                        thyl) imidazohdine-2-thione
                                             préparations
                                                                                                                                           (b) – Rinse hair thoroughly after
                                       ( fa) Hair care                (b) From 2 to 8 %                  (b) Ditro                                 use
                                             preparations rfnsed                                                                               – Contains M-bistfiydroxy-
                                             after use
                                                                                                                                         i
                                                                                                                                                   methyl) imidj7.olidinc-2-
                                                                                                                                                   rhione
          I                                                        i
   *7     I Tribromosalicylanilide     Soap                                                                                                Contains tri bromosal t cyl anî 1 1 de
                                                                      M                                   Purity crlteria :
            (e.g. Trffaromsalan*}                                                                         3,       5 tribroniosall-
                                                                                                          cylanilide : 98% maxi raum
                                                                                                          Other bromosai icylani-
                                                                                                          lides : 2? maximum
                                                                                                               5 dibromosali-
                                                                                                          cyl anîl î de : 0.1? maximum
                                                                                                          Inorganic bromide:
                                                                                                         0.1? maxT rount exprsssed
                                                                                                          as Na Br
 ---pagebreak---                                                                                        ANNEX 2
                                                                                      ANNEX /V
                                                                                        PART 1
                                                                LIST OF SUBSTANCES PROVISIONALLY ALLOWED
I            Γ                             Π                                      Restrictions                                      Condi 1 5 ons of use and
                                               Field of application        Maximum authorized           Other limitations          warnings which must be
  Reference
                       Substance                                           concentration in the
   number                                            and/or use            finished cosmetic product
                                                                                                        and requirements            printed on the label
      a     I!  ■         b                 I            c       '       I             d                        e            I                   f
               Merhanol                       Denaturant for ethanol and    5%      -
      1
                                              isonropyl alcohol             Calculated   as  a %   of
                                                                            ethanol and isopropyl
                                                                            alcohol
                                                                            5%                                                  Contains 2 f 3-d1hydroxypropyl
      5        2,3-01 hydroxypropyl
               4-ammobenzoate                                                                                                   4-ammobenzoate
                                                                            0. 3% in base             Not to be used in
      6        Ouinolin-8-ol and bis
               ( 8-hydroxyqui nol I nl urn)                                                           products applied after   Not to be used for babies         j
               sul phate                                                                              sunbathing. Net to be
                                                                                                      used fn talcum powder
                                                                                                      for babies
     32        1 , 1 , 1 Trichloroe thane      Sol vent for aérosol         35%                                                Do not spray on a naked flarae !
               ( methyl chloroform)            dispensers                   When mixed with dichloro­                          or any incandescent material    I
                                                                            methane , total
                                                                            concentration must not
                                                                                                                       f
                                                                            exceed 35%
                                                                                    !
                                                                                 ,/
 ---pagebreak---                                   7Vnnex    3
                               ANNEX IV Part 3 *
A. LIST OP COLOURING AGEHTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS
    WHICH DO NOT COME INTO " CONTACT WITH THE MUCOUS MEMBRANES.
    Reds                                           .       .
    11.215 , 12.310 , 12.420 , 16.150 , 18.050 , 18.065 ,.
    18.810 , 26.105 , 45.100 , 50.240 and acid red 195 .
    Oranqes and .yellows
    11.020 , 11 . 021 , 11.680 , 11.700 , 11.710 , 13.065 , 16.230 ,
    18.690 , 18.736 , 19.120 , 21.230 , 71.105 .
    Blues and greens
    10.006 , 10.020 ,    42.045 , 42.080 ,     44.025 , 62.095 , 63.000 ,
    74.100 ,  74.220 , 74 . 350 , 77 . 420 , bleu de bromothymol , vert
    de bromocrésol .
    Violets ,  browns , "blacks and whites
•   12.010 , 12.480 , 42.555 , 46 . 500 , 50 . 420 , 51.319 , 61.710 ,
    Brown FK .
B . LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR COSMETIC PRODUCTS
    WHICH COME INTO CONTACT ONLY BRIEFLY WITH THE SKIN.
    Reds
    11.210 , 12.459 , 12.485 , 12.512 , 12.513 , 12.715 , 14.895 ,
    14.905 , 16.045 , 18.125 , 18 . 130 , 23 . 266 , 24.790 , 27.300 ,
    27.306 , 28.160 , 45.110 , 45 . 150 , 45 . 220 , 60.710 , 62.015 ,
    69.025 , 71.100 , 73.312 , 73.915 , Pigment Red 144 , Pigment
    Red 166 , Pigment Red 170 , Pigment Red 188 .
    Yellows and oranqes
    11.725 , 11.730 , 11.765 , 11.767 , 11.855 , 11.870 , 12.055 ,
    12.140 , 12.700 , 12.790 , 14 . 600 , 14 . 690 , 15 . 970 , . 18 . 820 ,
     20.040 , 21.096 , 21 . 100 , ' 21 . 105 , 21.108 , 21.110 , 21.115 ,
 ---pagebreak---                                    2
                                                      Annex   IV
                                                        part 3
22.910 , 23.900 , 25,135 , 25.220 , 26.090 , 29-020 , 40.215 ,
41.000 , 48.040 , 48.045 , 48 . 055 , ' 56.205 , 75 , 560 , 77.199 ,
77.878 , Acid yellow 127 , Pigment Yellow 93 , Pigment Yellow
98 , Pigment orange 31 , 77.955 .
Blues and greens                                   ■
12.775 ,  34.230 ,    42.052 ,  42.085 , 42.095 , 42.100 , 50.315 ,
50.405 ,  52.015 ,    52.020 ,  61.135 , 61.505 , 61.525 , 61.585 ,
62.005 ,  62.045 ,    62.105 ,  62.560 , 69.810 , 74.180 , 74.255 ,
Solvent  Blue 2 ,     Solvent  Blue 19 , Acid Elue 82 , Acid Blue 181
Acid Blue 272 .
Violets , "browns , "blacks and whites
14.805 , 17.580 , 20.285 , 20.470 , 21.010 , 25.410 ,
42.510 , 42.520 ," 42.535 , 42.650 , 45.175 , 50.325 , 60.010 ,
60.730 , 61.105 , 62.030 , Acid Brown 19 , Acid Brown
82 , Disperse Violet 23 , Acid Brown 104 , Acid Brown 106 ,
Pigment violet 37 , Pigment brown - 30 .
 ---pagebreak---                             AKTJEX 4
                            mmx vi
LIST OP PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN
PREAMBLE
 1 . Preservatives are substances which may "be added, to cosmetic
 products , in the maximum concentrations authorized "by thiB Annex ,
 for the primary purpose of inhibiting the development of micro­
 organisms in such products .
  2 . The substances marked with an asterisk may also be       added to
  cosmetic products in higher concentrations for specific      purposes ,
  e.g. as deodorants in soaps or as anti-dandruff agents       in shampoos .
  In addition to their preservative function, therefore ,      they can
  also have antiseptic , antifungal or other properties .
   3 . Other substances used in the formulation of cosmetic products
   also have anti-microbial properties and thus help in the
   preservation of the products , as , for instance , many essential oils
   and some alcohols .   These substances are not included in this
   annex .
   4.  For the purposes of this list :
   - "Salts " is taken to mean :   salts of the cations sodiufii , potassium ,
                                   calcium, magnesium , ammonium   and
                                  ethanolomines ; salts of the     anions
                                   chloride , bromide , sulphate , acetate .
   - "Esters " is taken to mean:    esters of methyl , ethyl , propyl ,
                                    isopropyl , butyl , isobutyl , phenyl .
 ---pagebreak---                                                        I
                                                      α
                                       PART 1 - LIST OF DEFINITIVELY PERMITTED SUBSTANCES
                                                                                                              Conditions of use and
                                                         Maximum authorized               Limitations and
                Substances
                                                         concentration
                                                                                                              warnings which must
                                                                                          requirements
                                                                                                              appear on the label
Benzoic acid , salts and esters *                                0.%
      (
Propionic acid and its salts                                     2$> ( acid)
Salicyclic acid and its salts*                                   Q.% ( acid)          Not to be - used in
                                                                                      preparations for
                                                                                      children , except for
                                                                                      shampoos
Sortie acid and its salts*                                       0. 6f0 ( acid )
                                                         Not to be cumulated with
                                                         the concentration
                                                         specified for esters
Formai dehyde*                                                   0 . 2fo ( except for Prohibited in aerosol  Contains formaldehyde
                                                         products for oral hygiene ) dispensers , except for if the concentration
                                                                                      foams                  exceeds 0.05$
                                                                 0.1% (products
                                                         for oral hygiene )
                                                         expressed as free
                                                         formaldehyde
2,2' –Dihydroxy-3 ,3 , » 5t5 l » 6,6'-                           0.1%                 Prohibited in products Not to be used for
hexachlorodiphenylmethane* (Hexachloroph,ene )                                        for children and       babies .
                                                                                      intimate hygiene       Contains hexachlorophene
                                                                                      products
 ---pagebreak---                                    PART 1 - LIST OF DEFINITIVELY PERMITTED SUBSTANCES ( contd)
                     Substances                        Maximum authorized           Limitations and   Conditions of use and
                                                       concentration                requi rement s    warnings which must
                                                                                                      appear on the label
  o -Pherryl phenol and its salts*                             0.2%
                                                     expressed as phenol
8 Pyridine-1-oxide-2-thio1 ( zinc pyrithione )                                   Only in products
                                                                                 rinsed off after use
  Inorganic sulphites and bisulphites*                         0.2$
                                                     expressed as free SO ,
  Sodium iodate
                                                               0.1%              Only for products
                                                                                 rinsed off after use
  Chi orbutanol
                                                               0.5%             Prohibited in         Contains chlorobutanol
                                                                                 aerosols
 ---pagebreak---                                                 PART 2 - LIST OP PROVISIONALLY PERMITTED SUBSTANCES
                                                                                                                       Conditions of use and
Ref .                                                              Maximum authorized            Limitations and
                           Substances                              concentration
                                                                                                                      warnings which must
No                                                                                               requi rement s
                                                                                                                       appear on the label
 1       6-Acetoxy-2 , 4-dimethyl-1 , 3-dioxane                    0.2%
         (Dimethoxane )
 2      Boric acid*                                                3-036                     Not to be used in        Not to be used for
                                                                                             preparations for         "bahies
                                                                                             children under three
                                                                                             years of age , since
                                                                                             there may "be absorption
                                                                                             of products that come
                                                                                             into contact with the
                                                                                             mucous membranes
 3      p-Chl orophenyl-a-glyceryl ethe r* ( Chi orphene sin )     0. %
 4      Dehydroacetic acid and its salts                           O.Sfo ( acid)
 5      Formic acid*                                             . 0 . 5$ ( acid )
 6      p-Hydroxybenzoic acid , salts and esters except            0.4$ ( acid ) for 1 ester
        "benzyl ester*                                             0.8$ ( acid) for mixtures
                                                                                   of esters
 7      p-Hydroxybenzoic acid , benzyl ester                       0.1$ ( acid)
 8       1 ,6-Di (4-amidinophenoxy )-n-hexane and its salts        0.1%                        I»
         ( including isethionate + p-hydroxybenzoate )*
      I
 ---pagebreak---                                                      PART 2 - LIST OP PROVISIONALLY PERMITTED SUBSTANCES ( contd 1
                                                                                                                    Conditions of use and
ef .                                                            Maximum authorized         Limitations and
                            Substances                                                                               warnings which must
No                                                                concentration             reçruirements            appear on the label
 9        1 , 6-Di (4-affiid ino-2-br omophenoxy )-n-hexane            0.1%
          and its salts ( including isethionate )
10        1 , 3-Di (4-amidino-2-bromophenoxy )-n-pr opane              0.1%
          and its salts ( including isethionate )
11        Sodium ethylmercurithiosalicylate                       0.0077® ( of Hg)     For eye make-up only        Contains ethylmercurithio-
          (Thiomersal )                                       If mixed with other                                  salicylate
                                                              mercurial compounds
                                                              authorized by this
                                                              Directive , the maximum
                                                              concentration of Hg
                                                              remains fixed at 0.007%
                                                                  0.003$ ( of Hg)      Only in creams with non­    Contains ethylmercurithio-
                                                              If mixed with other      ionic bases and in          salicylate
                                                              mercurial compounds      concentrated shampoos
                                                              authorized by this       where other preservatives
                                                              Directive , the maximum  are ineffective
                                                              concentration of Hg
                                                              remains fixed at 0.003$
          Phenylmercury       and its salts ( including                ditto                     ditto             Contains phenylmercurial
12 I borate        )                                                                                               compounds
     i
     I          r
13        Sorbic acid - esters*                                  0.5% ( acid )
                                                              Must not. be cumulated
                                                              with the concentration
                                                              specified for the acid
                                                              and its salts
      j
      !                                                                                                       ι
        i
 ---pagebreak---                                               PART 2 - LIST OP PROVISIONALLY FERMI TTiSD SUESTAîlCg. '.contd 2 )
                                                              I
                                                              I                                                  Conditions of use and
Ref .                                                         I Maximum authorized       Limitations and
                          Substance s                        i                                                    warnings which must
 No                                                               concentration           requirements
                                                                                                                  appear on the label
14    Undecylenic acid :        salts , esters , the amide ,
      the mono- and di-ethanolamides and their                     0.2$ ( acid)
      sulphosuccinates *
                                                                                   I
15    Usnic acid and its salts ( including the                     0.2$            |
      copper salt )*
16    5-Amino-1 , 3-di ( 2-ethy1hexy1 )-hexahydro-                 0.2%
      5-methylpyriraidine*           ( Hexetidine )
17    Benzylformal                                                 0.2%
18    2-Benzyl-4-chlorophenol ( Clorofene )                        0.2%
19    5-Bromo-5-nitro-1 , 3-dioxane *                              0.1%               Only for products
                                                                                      rinsed off after use
20    2-Eromo-2-nitropropane-1 , 3-diol ( Bronopol )*              0.1%
21    3 1 3' -Dibromo-5-5 , -dichloro-2-2 *-
      dihydroxydiphenyl methane*             ( Bromophen)          0.1%
22    Tetra bromo–o–cresol*                                        0.3%
23    Chloracetamide                                               0.3%
24    3 , 4-Dichl or obenzy1 alcohol                               0'.15%
25    3 , 4 , 4 «-Tr ichloroc arbani 1 ide*                        0.2%
26    4-Chloro-m-cresol                                            0.2%
27    4 ,4 '-Bichloro-3-trifluoromethylcarbanilide*                0.3%               Maximum concentration
      ( Halo carbon )                                                                 in aerosols :  0.2$
28     2,4,4 ,-Trichloro-2 ,-hydroxydiphenylether *                0.5%
       ( Triclosan)
                                                                                    I
29     5 , 5 f-Dichlor o-2-2 , -dihydroxydiphenylmethane *         0.2%
                                                                                    I
                                                                                    i
 ---pagebreak---                                                PART 2 - LIST OF PROVISIONALLY PERMITTED SUBSTANCES ( contd 3 )
                                                                                                               Conditions of use and
Ref .                                                     Maximum authonzed          Limitations and
                          Substances                                                                            warnings which must
 No                                                         concentration             requirements
                                                                                                                appear on the label
 30       N-( Trichloromethylthio )-4–cyclohexene-                0.5%
          1 . 2-dicarboximide *    ( Captan)
 31       1 jó-DiCN-p-chlorophenyl-N' -diguanido^-n-
          hexane , digluconate , diacetate and                    0.3% *
          dihydrochloride *     ( Chlorhexidine )
32        p-Chloro-m-xylenol                                      0.5%
33        Dichloro-m-xylenol                                      0.1%
34        Paraformaldehyde                               0.2% ( except products   Prohibited in aerosol        Contains formaldehyde if
                                                         for oral hygiene )       dispensers , except for      the concentration exceeds
                                                                                  foams                        0.05%
                                                         0.1# ( products for
                                                         oral hygiene )
                                                         Concentrations calcu­
                                                         lated as theoretically
                                                         available formaldehyde .
                                                         Not to be cumulated
                                                         with the concentration
                                                         specified for formal­
                                                         dehyde .
35        8-Hydroxyquinoline and its salts                        0.3%            Not to be used m             Not to be used for babies
                                                                                  products applied after
                                                                                  siu>-bathing , nor in
                                                                                  talcum powders for
                                                                                  babies
36        Tri (p -hydroxyethyl )-hexahydrotriazine                0.3%
37        Imidazolidimrl urea                                     0.6%
      I
      i
        Η
        *
 ---pagebreak---                                                   PART 2 - LIST OF PROVISONALLY PERMITTED SUBSTANCES ( contd 4 J
Ref .                                                          Maximum authorized       Limitations and            Conditions of use and
                             Substances
 No                                                              concentration           requirements              warnings which must
       i                   ■                                                                                       appear on the label
       j             '
38        4-Isopropyl 3-oethyl phenol                                  0.1%
39     !l N-Kethylolchloracetamide                                     0.3%
                                             ■*           I
40        Monomethylol-dimethylhydantoin                               0.2%          Only for products rinsed
                                                            expressed as free        off after use
                                                            formaldehyde or
                                                            theoretically available
                                                            formaldehyde
41        Pyridine- 1 -oxide-2-thiol - sodium                          0.5%
          salt (Sodium pyrithione )*
42        ■bis ( Pyridine-l -oxide )–2,2'- disulphide ,
        ! addition product with magnesium sulfate                      0.5%
        ! trihydrate
43        Poly(hexamethylene diguanide ) hydro­                       0.3%
          chloride *
44        Phenoxyethanol *                                             1.0%
45        Hexaroethylenetetramine *       ( Methenamine )             0.2%
                                                            expressed as free
                                                            formaldehyde or
                                                            theoretically available
                                                            formaldehyde
46        5–chloro–2-methyl-4-isothiazoline-3-                      0.005%
          one + 2-methyl-^4-isothiazoline-4-*one,
          with magnesium and calcium chloride
      1
          (Kathon CG )
47        2–Hydr oxypyr id ine-1 -oxid e                               0.5%          Only for products
                                                                                     rinsed off after use
48        Di ( N-oxopyridyl-2-thio ) aluminium                         0.2%
          camphosulphonate
                                                                                                                 I
 ---pagebreak---                                                 PART 2 - LIST OP PROVISIONALLY PERMITTED SUBSTANCES ( contd 5 )
                                                                                                                Conditions of use and
Ref .                                                          Maximum authorized         Limitations and
                               Substances                                                                        warnings which must
 No                                                              concentration              requirements
                                                                                                                 appear on the label
 49       1~( 3-chloroallyl )-3 , 5 ,7-triaza-1 -azonia              0.2%
          adawantane chloride ( Dowicil 200 )
 50       1 -Imidazolyl-1 -(4-chlorophenoxy ) 3,3-                   2.0%
         d ime thy1-but ane–2-one
 51       Dimethylol-dimethylhydantoin                               0.2%
                                                            expressed as free
                                                            formaldehyde or
        /                                                   theoretically available
                                                            formaldehyde
 52       Benzyl alcohol *                                           1%
         Dodecylguanidine acetate*                                   0.57°             For products rinsed
      I                                                                                off after use
      I                                                              0.1%              For other uses
      i
 54      Diisobutyl phenoxy ethoxy ethyl
         dimethylbenzylamrnonium chloride                            0.1%
      !
 55       Alkyl ( C8-018 ) dimethylbenzyl
          ammonium chloride , bromide , saccharinate                 0.5%
 56   I Alkyl ( C12-C22 ) trimethyl ammonium
          bromide , chloride                                         0.1%
      !
 ---pagebreak---                                                                           _
                                                                                      ANNEX
                                                                                      –––1
                                                                                              5
     ACTIONS TO ENGLISH TEXT OF. COUNCIL DIRECTIVE 76/768/EEC OF 27 JULY 1976
ANi'JEX II ( correct names shown below ) The following points read as- indicated .
  2.     2-Acetoxyethyltrimethylammonium hydroxide (acetylcholine ) and its salts
  5       P»-(^Hydroxy-3-iodophenoxy )-3,5-diiodophenylJ acetic acid and its salts
29       2-Araino-1 , 2~bis0t-raethoxyphenyl)ethanol and its salts
If'-     Imperatorin ( 9- ( 3-Diethylbut-2-enyloxy ) furo [3 » 2-g] chromen-7-one
39      Antibiotics , with the exception of that given in Annex V
 h2      Apomorphine (5 , 6 , 6a , 7-tetrahydro-6-methyl-^H-dibenzo [de , gj quinoline-
           10,11-dihydric alcohol ) and its salts
  3      Benzimidazol-2 ( 3H)-one                                 '   •
/t9      Benzazepines and benzodiazepines
 50      1-Dimethylaminomethyl-1 -niethylpropyl benzoate ( amylocaine ) and its salts
51 '    -2,2,6-Trimethyl-^-piperidyl benzoate (benzamine ) and its salts
 52      Isocarboxazid *
 72      Nitroderivatives of carbazole
 80      Diphenoxylate * hydrochloride                       . .
 86      N,N-bis ( 2- chloroethyl )raethylamine N-oxide and its salts
 9»      Chlorraezanone *
 9>      2-[2>-(^-Chlorophenyl )~2~pheaylacetylj indan-1 , 3-dione          ( chlorophacinone - ISO)
112      2- a..CycIoa«?.ylbenzyl(NiN,N \ N'-tetraethylJtrimethylenediamine (phenetaraine )
 ---pagebreak--- 117   0,0 ' -Diac e tyl-N-allyl-f!-nornorphine
119   5-( a , P -Dibromophenethyl )-5-nethylhydanto'in "
120 . N^,K_'-Pentaxaethylenebis(trimethylaiamoniuxD ) salts , e.g. pentamethonium bromide*
121   ^N'-^KethylimincOdiethyleneJbisCethyldimethylainRionium) Baits , e.g." ■
          azanethoniun bromide *
12**  N^N'-HexanethylenebisCtrimethylammoniun ) salts , e.g. hexamethoniwri bromide *
128   2-Diethylaminoethyl 3-hydroxy-If-phenylbenzoate and its 6alt3
131   (3,0-Diethyl O-^-aitrophenyl phosphorothioate                     (parathioa - ISO)
132      [Oxalylbis ( ininoe ihylene )] bis [( o-chlorobenzyl ) diethylarainoniu.'T]i salts ,
           e.g» arobenoaina chloride *
       1 f 1-Bis(dimethylaminoaethyl)propyl fcenzoate ( aoydricain^alypine ) ard its salts
156   N-( >-Carbamoyl-3,5-diphenylpropyl )-I^1 TUdiÌGopropylmethylajmrioniuni salts *
           e«g» isopropamide iodide *
150   5»5-Diphenyl-'f-inidasolidone
196    ( 1K,^S,5H,8S)-1 , 2,3 , tv,10,10-Kexachloro-6,7-epox5'-1 ,               ^3,5,6 , 7»8 , 8a-
           octahydro-1 ,^: 5»8-dinethanonaphthalene                 ( endrin - ISO )
204    Ethyl bi6 ( ^-hydroxy-2-oxo-1-ben2opyran-3-yl ) acetate and salts of the acid
207    ^ f 4 , -Dihydroxy-.3i3 , ~(3--raethyltliiopropylidene)dicoumarin
21 ^   DecaaethylenebisCtrimethylaEmoniuni ) salts , e.g . decamethoniun bromide
217   <* -Santonin [( 3s » 5a£ , 90S ) -3 , 3a * ** % 5 » 5^ « 9b-hexahydro-3 » 5a. ? 9-
                                                                                                    . »• *
           trimethylnaphtho f1 , 2-b] furan-2 , 8-dioneJ
23^    3 »l4-Dihydrr>-?-raethoxy-2--iethyl-^~phen7l- 2 r[ , 5jl~pyrano [3 , 2-c] - M] benr.opyran-5-ore
           (cyclocounarol )
 ---pagebreak---     1                                                               * .
   t
&J,   3-\ /'-Nsiphthyl )-H-hydroxycoumarin
268   Phenol and its alkali salts , excluding the exceptions listed in Annex III
271   2~Phenylindan-1 t 3-dione ( phenindione )
276   Tetraethyl pyrophosphate ; TEPP ( ISO )
28^   a -Piperidin-2-ylbenzyl acetate laevorotatory threoform ( levophacetoperane )
        and its salts
307   Sulphonamide3 ( sulphanilamide and its derivatives ...•) and their salts
                                                              (rest of entry is correct )
313   Xylometazoline * and its salts
J>k&  2- [^-Methoxybenzyl-TJ-( 2-pyridyl )aznino ] ethyldimethylamine maleate
358   Furo f3 »2-g] chromen-7-one and its     •••••         (re3t of entry is correct )
 ---pagebreak---                                                                                        Annex         6
            Red aktio ncllc Andrr-unr;on r* R r, d cjut r^cho n Text es ■
                                               v~' r -            .        . .
                                           ; Änderungen un-fccrr.trichen
 Anha ng II \                                ' *   '    '.
           Nachstehende Punkte sollten wie folgt gelesen werden :
   51.' 2,2,6 - Trimcthyl-piporifliri-'i -yl^onzoot
• 67 . Phenylbutazonum *                                           ■ " ■
   72 . lTitroderivn te dos Cp.rba7.olr-
   81 . 2^4-DloTnironzobcnzol -hy.drochlorid-citrnt ( Chrysoidin-lvd
                                         .                                     chlorid-citra 0
 1?8 . 2~Mathvlarvinoathyl - /! -phonyl- 3-hyd.ro":y-benzoa'b v.rid roino
 1 70 . o-Di a thylaninopropy l~cxnnp.no t
 1 p2 . N , II 1 - Bl r- ( d lathy1 ) -II , N ' -bio- ( o-chlorbon zy1 ) -K             '!■ , '>~»1 io
          . 7 < G-dlaza -octamethylen ) ~di.nmnonifiTrì~Galzo ( z.B. A^nbcnonii
            chloridum *)                         "
 3./! •">. 1 , ]. -Bi G- ( dirnotliylominoncthyl )-propy].-bcnzont ( At'-ydrirni •' -
            unci sain c ionize                                •
 IFVJ . I7-(4- Apixno- ^ -o'ro- J>, J-D J.I)honyl-bnty3.)- • ••>•••••
 106                        . . . . . ( E)?.d vin )
 2Q4 . i'i11x7 1 -2 , 2~b i g- ( *1 -byd ro xy- - cumo riily1 ) -
 21<':· . 2- 1 ηορτοτ^' 1 -Λ-ροηΙ; οηο -Γ 1~]ΤΤ! νη Γ.Ί;Ο.Γ ί ( Αρρο Η33.1(1 )
 2jyi .            'Dihvdro-- 2-motho::?/~2-nni;lT/l~ /l~T>bnnyl~2lI < 5II-yy rgno /3j , '
                   bcnrop.vran- S-on               ( C-yclocunarol )
 21" vl . Ar. frl oc onmaro3.un *
 281 . l'hr/ r.ostirona vcncnosun Bp.lf .                                .
 284 . (-)-L-Thrc ^ - «C_ -"ohen?/ 1- 2- T> lr>cpld I non C bliano 1- ?. r' 'V'on i, ( Ti -v
            phacctoi">cran ) und scine Galzo
 51&. Gly co gl ri e dor Thcvotia neriifolin Juce .
 y(7 . Tyr 1b GI'i z DIT' inum *
 V'.O. p-i;cr l: . ~Bu 1;y 1-phcnol und r.ßine Dcrj.vatc
 741 . p- l;ort.. - Bu.tyl-bronzcatG!cIiin
 2^6 . . Fu vocuTnovi no /7..B. T:i?lo; yrr.lormp * 8-H' •hho'rypc'ornlpiy , £?ur
            nomiaon normale Gr'hnlor. i.u nntiirliclivn älihorir.ohrr) i-3 ' »•
 ;')60 . fjr r r, ri frn r. r. o Tf"i cd'ip'lv^            , 03 , rnfj'olhnltic .
 ---pagebreak---     Anhang III , Erster Teil                              •"                                 •         - -
    4 . €hlorobutnnolum                             Spalto e : In Aerosolpackunreen vorbotcm-'
    9 . .0 - ,n-Phonylondinmine , ihre
         U-rAibstituicrten Derivate Spalte c : Oxidations-Haarfärbcmittel ■.
         und ihre Salze . N-sub-
       ' stituierte Derivate des                                                          ■'< . ■'       ,    ' .
         p-Phcnvlendiamins
  10 . 0 - , tn- , p-Toluylendiflmiiie , ; Spalte c : Oxid atións-Haarfarbemittel-
         ihre U-cubstituierten~~l)e- .
         rivate "und ihre Salze                                      '•      ■<■'                                '
  11 . Dxarainophenole                             ' Spalte c : : Oxid ations-Haarfärberaittel
                                                     '/ Spalte - f ; Erzeugnis kann eine allergi-
                                                                  ( . -... sehe Reaktion hervorrufen .
                                                               V:..,' ; Vorherige AlIerrie-pro.be rat­
                                               '■ • i • ' - ' •                   sara . Enthält ....
  13 . Wasserstoffperoxid
          •                  •.  •
  15 . Hexachlorophenum                            *\ Spalte f : . Nicht zur Babypflege verwen­
                                                                                  den
                                             • v                              '.'Enthält Hexachlorophen         ' '
  16 . Hydrochinon                    .       .. Spalte f : Nicht zur Färbung von Wim­
                                      ' . ,v •                     . . ,y . " pern und Augenbrauen ver-
                                              V          V                       wenden .
                                                             . .        . ... Sofort Augen
. 19 . cu-Naphthol •'                      . . Spalte c.i                         Oxidations-Haarfarbemittel
  24 . Pyrogallol                           - ■■- Spalte c :". Oxidations-Haarfarbemittel
  26 . Resorcin          .          •   Spalte es a) Oxidations-Haarfärbcmittel
                                        Spalte » fs ■ a) ;' Erzeugnis kann eine allergi-
                                      \.            ;; •                          sehe Reaktion hervorrufen .
                                                                     'r'         Enthält Resorcin . I-T ach An­
                                                /;                           '••'Wendung 'die Haare gut spülen
                                                                            ;r Nicht zur Färbung von Wim- '.,
                                                                                pern und Augenbrauen verwen-,
                                                 i                               den . . Sofort ...
  Anhnnp; III , Zvreiter Teil                                   ;                                              y
  d ) Violett , braun , schwarz und weiß :
       Hr. 21.       77 891 E 171 , Titandioxid ("und seine • Gemische mit .
       Glimmer)        .        ' '                            ' •         "          'i     '     ' .
       Nr . 25       75 170      Guanin oder Perlrclanz-Mittel
                                                                                                        1 • I
 ---pagebreak---       h o no g1yz e^nc s t o r der          Spalte t'. Ent halt I1onoclyg3.y j r»n st
      ' p- Ami notenzoeeàure                              der    p~Arainobenzoesri ure
 6 . 8-Quinolinol und' sein Sulfat
  7 , Aiamoniummonofluor-                   Spaite f « Enthalt Ammoniummono-
        phoßphat                                          fluorphosphat
  o * Katrivunmonofluor-                    Spaite f : Enthalt Uatriummono-
        phosphat .     ~    '             ,               fl uorphosphat
" 9 « KqI i ununonofluor-                     Spaite f : Enthalt Kaliummono - •
                                                            fluorphosphat
        phoephat                        •
10 , CalciummonofluorphoBphat               Spaite f : Enthalt Calciummono-'
                                                          fluorphosphat
17 » Cetylami n-hy drofluorid
        ( Hexade cylamin- hy drofluorid ) 1 Spaite f : Enthalt Cetylawin-
                                                          hy drofluorid
18 . Bjs- ( hydroxyathyl z-aminopropyl-     Spaite fs Enthalt Bis- ( hy doxyathyl )-
        N–hy droxya thyl - ok tadecylamin–              _ aminopropyl-U - hy droxygthyl-
        dihydrofluorid                                    okt adecylamin - di hydrofluor - d
19 , N,N' f N' -Tri - ( polyoxyathylen )-   Spaite fs Enthrilt H.N' . N' -Tri - ( po ly -•
        H- hexadocyl ~pr opylendiamin-                    oxyathylen)-I.- hexadecyl-
         dihydrofluorid                                   propylendiarain-dihydrofluori d
20 . Oktadecylamin- hy drofluorid           Spalte f : Enthält Octadecylamin- ,
                                                          hydrof luorid
26 . 1 , 3- Di s- ( hydroxyme t hyl ) -       Spalte e * a ) in Aero solpackunp;cn
        iraidaaolidin- 2 - thion                                verboten
                                                            b ) idem
                                            Spalte f : Enthält 1 .3- Bis -( .hxaroxy-
                                             (a und b ) methylJ -imidazolidin - S^thT on
27 . 1 . VBi B- Chy droxymethyljr-,          Spalte f : • Entholt 1 , 3- Bi s-(hydroxy-
         thioharnstof f
                                                          methyl)-thioharDGtof f
29 , l~IIydroxyraethylimidazolidin,;         Spalte f : Enthalt 1-lIydroxymethyl-
                                                           imidasoli di n-2 - tion
         2-thion
5O . i-(Morpholinomethyl )-                  Spalte  f : Enthalt 1-(Morpholinomethyl )-
                                                           thioharnetoff
         thioharnstof f
 ---pagebreak--- J1 . 1 , 3- ^.i5-(Horpholino~                         "Spalt® fJ linthnlt 1 , 3'"^ s -( Morpholino «
      inethyl)~thioharnctoff                                      me t hy1 ) - 1 hi o h a r n & t o t £
52 . 1 .1 . 1-1' richlorp.thoft
       ( i-.e thy Ichloro form )                       Spalte c : Aérosols ckun,Ton
55 * iribro niso.licylanilid                           Spalte fo Enthält Tribromsalicylanilid
       ( ZURI Ueispiel
      ^'ri br omsalanum* )
Anhang IV , Zweiter Teil
Fußnote ( 2 ) zur "Überschrift :                            .
. .. . ; daß der Farbstoff nicht zur Herstellung von kosmetischen Mitteln
verwende t v/erden darf t die mit den Schlei inhäuten des Auf*cs in Berührung
kommen können ..»..               .                     •
d ) Violett , braun , schv»ara und weißs
    ■Mr . 6        77 165     Wismutoxi chlorid ( und seine
                             Verbindungen mit Glimmer )               •. i " ,
                                                                         >          ,
                                     .  .                            . < .
                                                          '        ' v\        •• •   *
               \                                                        V
Anhang V                                             ., *          - fr .
     Ti-Phenvlnndiamin und seine Salze                                            '
 ---pagebreak---                                               /
                                                                            ANNEX       7
    LIJST VAN KORREKTIES op de Nederlandse tekst
  33i.il rare 77
    15 . iRouvJolfia                                    Iíauwolf ia
    34 . . goïjzopyran
                                        wordt   gelezen
                                                        bc.i;sopyran
  132     litiieonorydG                                 fithyleenoxido
  215     Xpocf.cuanba Uragoga Bailloen                 Uvc.^oga ipoeacnanha Baill .
  220     I3c-ib5.tuur7.uur                             Barbi t-uu r;raur
  221      .«• bijlage IV                               bi^la^'on 'IV en V
  250      ... alkalische: zon ten .                    alka'l i z onji í en
  268      ... alkalische mouten                        alkali sou ten
  291     Prunun Laurocerasua                           Prunu n 1 aur o c c ra fi u s >
  3Ν      ïetrachlooretheen                             Tetrachloorethyl eon
  515 Tetrahcl oorkool stof                             Tetrachloox%koolsto£
  340 p-butyltort .-                                    p-tert , butyl^,
  341 p-butyl tert .-                                   p-tert , butyl
 Ei .ila /?e 'flip eerste " flecl .
   4 » kolora    es  .. . aercsolgenera toren     wordt . . . spuitbussen
   β . kolozi    bt  Hethyleenchlox'idü         gelezen Bi chlooruc thaan
- 13 , kolom     bs  Vater b tofperoxyde                Waterstofpe r oxide
  14 , koloiQ    et  . * . aerosolgencratoren           . . . spuitbussen
  26 , kolom     b en f : reaorcine                     resorcinol