1976L0768 — EN — 21.04.2002 — 003.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCILDIRECTIVE
of27July1976
ontheapproximationofthelawsoftheMember Statesrelating tocosmetic products
(76/768/EEC)
(OJ L 262, 27.9.1976, p. 169)
Amended by:
Official Journal
No page date
►M1Council Directive of 24 July 1979 (79/661/EEC) L 192 35 31.7.1979
►M2Commission Directive of 11 February 1982 (82/147/EEC) L 63 26 6.3.1982
►M3Council Directive of 17 May 1982 (82/368/EEC) L 167 1 15.6.1982
►M4Second Commission Directive of 30 March 1983 (83/191/EEC) L 109 25 26.4.1983
►M5Third Commission Directive of 29 June 1983 (83/341/EEC) L 188 15 13.7.1983
►M6Fourth Commission Directive of 22 September 1983 (83/496/EEC) L 275 20 8.10.1983
►M7Council Directive of 26 October 1983 (83/574/EEC) L 332 38 28.11.1983
►M8Fifth Commission Directive of 18 July 1984 (84/415/EEC) L 228 31 25.8.1984
►M9Sixth Commission Directive of 16 July 1985 (85/391/EEC) L 224 40 22.8.1985
►M10Seventh Commission Directive of 28 February 1986 (86/179/EEC) L 138 40 24.5.1986
►M11Eighth Commission Directive of 26 March 1986 (86/199/EEC) L 149 38 3.6.1986
►M12Ninth Commission Directive of 2 February 1987 (87/137/EEC) L 56 20 26.2.1987
►M13Tenth Commission Directive of 2 March 1988 (88/233/EEC) L 105 11 26.4.1988
►M14Council Directive of 21 December 1988 (88/667/EEC) L 382 46 31.12.1988
►M15Eleventh Commission Directive of 21 February 1989 (89/174/EEC) L 64 10 8.3.1989
►M16Council Directive of 21 December 1989 (89/679/EEC) L 398 25 30.12.1989
►M17Twelfth Commission Directive of 20 February 1990 (90/121/EEC) L 71 40 17.3.1990
►M18Thirteenth Commission Directive of 12 March 1991 (91/184/EEC) L 91 59 12.4.1991
►M19Fourteenth Commission Directive of 18 February 1992 (92/8/EEC) L 70 23 17.3.1992
►M20Fifteenth Commission Directive of 21 October 1992 (92/86/EEC) L 325 18 11.11.1992
►M21Council Directive of 14 June 1993 (93/35/EEC) L 151 32 23.6.1993
►M22Sixteenth Commission Directive of 22 June 1993 (93/47/EEC) L 203 24 13.8.1993
►M23Seventeenth Commission Directive of 29 June 1994 (94/32/EC) L 181 31 15.7.1994
►M2418th Commission Directive of 10 July 1995 (95/34/EC) L 167 19 18.7.1995
►M25Nineteenth Commission Directive of 25 June 1996 (96/41/EC) L 198 36 8.8.1996
►M2620th Commission Directive of 10 January 1997 (97/1/EC) L 16 85 18.1.1997
►M27Commission Directive of 17 April l997 (97/18/EC) L 114 43 1.5.1997
►M2821st Commission Directive of 14 July 1997 (97/45/EC) L 196 77 24.7.1997
►M29Twenty-second Commission Directive of 5 March 1998 (98/16/EC) L 77 44 14.3.1998
1976L0768 — EN — 21.04.2002 — 003.001 — 2
►M3023rd Commission Directive of 3 September 1998 (98/62/EC) L 253 20 15.9.1998
►M31Twenty-Fourth Commission Directive 2000/6/EC of 29 February 2000 L 56 42 1.3.2000
►M32Twenty-Fifth Commission Directive 2000/11/EC of 10 March 2000 L 65 22 14.3.2000
►M33Commission Directive 2000/41/EC of 19 June 2000 L 145 25 20.6.2000
►M34Twenty-sixth Commission Directive 2002/34/EC of 15 April 2002 L 102 19 18.4.2002
Amended by:
►A1Act of Accession of Greece L 291 17 19.11.1979
►A2Act of Accession of Spain and Portugal L 302 23 15.11.1985
Corrected by:
►C1Corrigendum, OJ L 255, 25.9.1984, p. 28 (84/415/EEC)
►C2Corrigendum, OJ L 157, 24.6.1988, p. 38 (88/233/EEC)
►C3Corrigendum, OJ L 199, 13.7.1989, p. 23 (89/174/EEC)
►C4Corrigendum, OJ L 273, 25.10.1994, p. 38 (94/32/EC)
▼B
COUNCILDIRECTIVE
of27July1976
on the approximationof the lawsofthe Member States relating to
cosmeticproducts
(76/768/EEC)
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(
1),
Having regard to the opinion of the Economic and Social
Committee(2),
Whereas the provisions laid down by law, regulation or administrative
action in force in the Member Statesdefine the compos ition character-istics to which cosmetic products must conform and prescribe rules fortheir labelling and for their packaging; whereas these provisions differ
from one Member State to another;
Whereasthe differencesbetween thes e lawsoblige Community
cosmetic producers to vary their production according to the Member
State for which the products are intended; whereas, consequently, theyhinder trade in these products and, as a result, have a direct effect onthe establishment and functioning of the common market;
Whereas the main objective of these laws is the safeguarding of public
health and whereas, as a result, the pursuit of the same objective mustinspire Community legislation in this sector; whereas, however, this
objective must be attained by means which also take account of
economic and technological requirements;
Whereas it is necessary to determine at Community level the regula-
tions which must be observed as regards the composition, labellingand packaging of cosmetic products;
WhereasthisDirective relatesonly to cos metic productsand not to
pharmaceutical specialities and medicinal products; whereas for thispurpose it is necessary to define the scope of the Directive by deli-miting the field of cosmetics from that of pharmaceuticals; whereasthisdelimitation followsin particular from the detailed definition of
cosmetic products, which refers both to their areas of application and
to the purposes of their use; whereas this Directive is not applicableto the productsthat fall under the definition of cos metic product butare exclusively intended to protect from disease; whereas, moreover, itis advisable to specify that certain products come under this definition,
whilst products containing substances or preparations intended to be
ingested, inhaled, injected or implanted in the human body do notcome under the field of cosmetics;
Whereas in the present state of research, it is advisable to exclude
cosmetic products containing one of the substances listed in Annex Vfrom the scope of this Directive;
Whereas cosmetic products must not be harmful under normal or fore-
seeable conditions of use; whereas in particular it is necessary to takeinto account the possibility of danger to zones of the body that are
contiguousto the area of application;
Whereas, in particular, the determination of the methods of analysis
together with possible modifications or additions which may have to
be made to them on the basis of the results of scientific and technicalresearch, are implementing measures of a technical nature; whereas it1976L0768 — EN — 21.04.2002 — 003.001 — 3
(1) OJ No C 40, 8. 4. 1974, p. 71.
(2) OJ No C 60, 26. 7. 1973, p. 16.
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is advisable to entrust their adoption to the Commission, subject to
certain conditions specified in this Directive, for the purpose of simpli-fying and accelerating the procedure;
Whereas technical progress necessitates rapid adaptation of the tech-
nical provisions defined in this Directive and in subsequent Directivesin thisfield; whereasit isadvis able, in order to facilitate implementa-tion of the measures necessary for this purpose, to provide for a
procedure establishing close cooperation between the Member States
and the Commission within the Committee for adaptation to technicalprogress of Directives aimed at the removal of technical obstacles totrade in the cosmetic products sector;
Whereas it is necessary, on the basis of scientific and technical
research, to draw up proposals for lists of authorized substances which
could include antioxidants, hair dyes, preservatives and ultravioletfilters, taking into account in particular the problem of sensitization;
Whereasit could happen that although conforming to the provis ionsof
this Directive and its Annexes, cosmetic products placed on the market
might endanger public health; whereasit istherefore advis able toprovide for a procedure intended to remove thisdanger,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. A ‘cosmetic product’ shall mean any substance or preparation
intended to be placed in contact with the variousexternal partsof the
human body (epidermis, hair system, nails, lips and external genitalorgans) or with the teeth and the mucous membranes of the oral cavitywith a view exclusively or mainly to cleaning them, perfuming them,changing their appearance and/or correcting body odoursand/orprotecting them or keeping them in good condition.
2. The products to be considered as cosmetic products within the
meaning of thisdefinition are lis ted in Annex I.
3. Cosmetic products containing one of the substances listed in
Annex V shall be excluded from the scope of this Directive. Member
States may take such measures as they deem necessary with regard tothose products.
Article 2
A cosmetic product put on the market within the Community must not
cause damage to human health when applied under normal or reason-ably foreseeable conditions of use, taking account, in particular, of the
product's presentation, its labelling, any instructions for its use and
disposal as well as any other indication or information provided bythe manufacturer or his authorized agent or by any other person respon-sible for placing the product on the Community market.
The provision of such warnings shall not, in any event, exempt any
person from compliance with the other requirements laid down in thisDirective.
Article 3
Member States shall take all necessary measures to ensure that only
cosmetic products which conform to the provisions of this Directiveand itsAnnexesmay be put on the market.1976L0768 — EN — 21.04.2002 — 003.001 — 4
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Article 4
1. Without prejudice to their general obligationsderiving from
Article 2, Member States shall prohibit the marketing of cosmeticproductscontaining:
(a) substances listed in Annex II;
(b) substances listed in the first part of Annex III, beyond the limits
and outside the conditions laid down;
(c) colouring agents other than those listed in Annex IV, Part 1, with
the exception of cosmetic products containing colouring agentsintended solely to colour hair;
(d) colouring agents listed in Annex IV, Part 1, used outside the condi-
tionslaid down, with the exception of cos metic productscontainingcolouring agentsintended s olely to colour hair;
(e) preservatives other than those listed in Annex VI, Part 1;
(f) preservatives listed in Annex VI, Part 1, beyond the limits and
outside the conditions laid down, unless other concentrations are
used for specific purposes apparent from the presentation of the
product;
(g) UV filters other than those listed in Part 1 of Annex VII;
(h) UV filterslis ted in Part 1 of Annex VII, beyond the limitsand
outside the conditions laid down therein;
(i) ingredientsor combinationsof ingredientstes ted on animalsafter
►
M3330 June 2002 ◄in order to meet the requirementsof this
Directive.
If there has been insufficient progress in developing satisfactory
methods to replace animal testing, and in particular in those caseswhere alternative methods of testing, despite all reasonable endea-
vours, have not been scientifically validated as offering an
equivalent level of protection for the consumer, taking into accountOECD toxicity test guidelines, the Commission shall, by 1 January1997, submit draft measures to postpone the date of implementa-tion of this provision, for a sufficient period, and in any case forno less than two years, in accordance with the procedure laid
down in Article 10. Before submitting such measures, the Commis-
sion will consult the Scientific Committee on Cosmetology.
The Commission shall present an annual report to the European
Parliament and the Council on progress in the development, valida-tion and legal acceptance of alternative methodsto thos e involvingexperiments on animals. That report shall contain precise data on
the number and type of experimentsrelating to cos metic products
carried out on animals. The Member States shall be obliged tocollect that information in addition to collecting statistics as laiddown by Directive 86/609/EEC on the protection of animalsus edfor experimental and other scientific purposes. The Commissionshall in particular ensure the development, validation and legal
acceptance of experimental methods which do not use live animals.
2. The presence of traces of the substances listed in Annex II shall
be allowed provided that such presence is technically unavoidable ingood manufacturing practice and that it conformswith Article 2.
Article 5
Member States shall allow the marketing of cosmetic products
containing:
(a) the substances listed in Annex III, Part 2, within the limits and
under the conditionslaid down, up to the datesin column (g) ofthat Annex;1976L0768 — EN — 21.04.2002 — 003.001 — 5
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(b) the colouring agentslis ted in Annex IV, Part 2, within the limits
and under the conditions laid down, until the admission dates givenin that Annex;
(c) the preservatives listed in Annex VI, Part 2, within the limits and
under the condition laid down, until the datesgiven in column (f)of that Annex. However, some of these substances may be used in
other concentrations for specific purposes apparent from the
presentation of the product;
(d) the UV filterslis ted in Part 2 of Annex VII, within the limitsand
under the conditionslaid down, until the datesgiven in column (f)
of that Annex.
At these dates, these substances, colouring agents, preservatives and
UV filterss hall be:
— definitively allowed, or
— definitively prohibited (Annex II), or— maintained for a given period specified in Part 2 of Annexes III, IV,
VI and VII, or
— deleted from all the Annexes, on the basis of available scientific
information or because they are no longer used.
Article 5a
1. No later than 14 December 1994 the Commission shall, under the
procedure laid down in Article 10, compile an inventory of ingredientsemployed in cosmetic products, on the basis in particular of informa-tion supplied by the industry concerned.
For the purposes of this Article, ‘cosmetic ingredient’ shall mean any
chemical substance or preparation of synthetic or natural origin, except
for perfume and aromatic compositions, used in the composition of
cosmetic products.
The inventory shall be divided into two sections: one concerning
perfume and aromatic raw materialsand the s econd concerning othersubstances.
2. The inventory shall contain informtion on:
— the identity of each ingredient, in particular itschemical name, the
CTFA name, the European Pharmacopoeia name, the internationalnon-proprietary namesrecommended by the World Health Organi-zation, the Einecs, Iupac, CAS and colour index numbers, and the
common name referred to in Article 7 (2),
— the usual function(s) of the ingredient in the final product,
— where appropriate, restrictions and conditions of use and warnings
which must be printed on the label by reference to the Annexes.
3. The Commission shall publish the inventory and shall update it
periodically under the procedure provided for in Article 10. The inven-tory shall be indicative and shall not constitute a list of the substancesauthorized for use in cosmetic products.
Article 6
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M21Member States shall take all measures necessary to
ensure that cosmetic products may be marketed only if the containerand packaging bear the following information in indelible, easilylegible and visible lettering; the information mentioned in point (g)may, however, be indicated on the packaging alone: ◄
(a) the name or style and the address or registered office of the manu-
facturer or the person responsible for marketing the cosmetic
product who is established within the Community. Such informa-tion may be abbreviated in so far as the abbreviation makes itgenerally possible to identify the undertaking. Member States mayrequire that the country of origin be specified for goods manufac-tured outside the Community;1976L0768 — EN — 21.04.2002 — 003.001 — 6
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b) the nominal content at the time of packaging, given by weight or
by volume, except in the case of packaging containing less thanfive grams or five millilitres, free samples and single-application
packs; for pre-packages normally sold as a number of items, for
which detailsof weight or volume are not s ignificant, the contentneed not be given provided the number of itemsappearson thepackaging. Thisinformation need not be given if the number ofitems is easy to see from the outside or if the product is normally
only sold individually;
c) the date of minimum durability. The date of minimum durability of
a cosmetic product shall be the date until which this product, storedunder appropriate conditions, continues to fulfil its initial functionand, in particular, remainsin conformity with Article 2.
The date of minimum durability shall be indicated by the words:
‘Best used before the end of…’ followed by either:
— the date itself, or
— detailsof where the date appearson the packaging.
If necessary, this information shall be supplemented by an indica-
tion of the conditions which must be satisfied to guarantee the
stated durability.
The date shall be clearly expressed and shall consist of the month
and the year in that order. Indication of the date of durability shallnot be mandatory for cosmetic products the minimum durability ofwhich exceeds30 months ;
(d) particular precautions to be observed in use, especially those listed
in the column ‘Conditions of use and warnings which must beprinted on the label’ in AnnexesIII, IV, VI and VII, which mus tappear on the container and packaging, aswell asany s pecial
precautionary information on cosmetic products for professional
use, in particular in hairdressing. Where this is impossible for prac-tical reasons, an enclosed leaflet, label, tape or card must containthat information to which the consumer is referred either by abbre-viated information or the symbol given in Annex VIII, which mustappear on the container and the packaging;
(e) the batch number of manufacture or the reference for identifying
the goods. Where this is impossible for practical reasons because
the cosmetic products are too small, such information need appear
only on the packaging;
(f) the function of the product, unless it is clear from the presentation
of the product;
(g) a list of ingredients in descending order of weight at the time they
are added. That list shall be preceded by the word ‘ingredients’.
Where that is impossible for practical reasons, an enclosed leaflet,label, tape or card must contain the ingredients to which theconsumer is referred either by abbreviated information or thesymbol given in Annex VIII, which must appear on the container
and the packaging.
The following shall not, however, be regarded as ingredients:
— impuritiesin the raw materialsus ed,
— subsidiary technical materials used in the preparation but not
present in the final product,
— materials used in strictly necessary quantities as solvents or as
carriers for perfume and aromatic compositions.
Perfume and aromatic compositions and their raw materials shall
be referred to by the word ‘perfume’ or ‘flavour’. Ingredientsin
concentrations of less than 1 % may be listed in any order afterthose in concentrations of more than 1 %. Colouring agents maybe listed in any order after the other ingredients, in accordancewith the colour index number or denomination adopted in AnnexIV.1976L0768 — EN — 21.04.2002 — 003.001 — 7
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For decorative cosmetic products marketed in several colour
shades, all colouring agents used in the range may be listed,provided that the terms‘may contain’ are added.
An ingredient must be identified by the common name referred to
in Article 7 (2) or, failing that, by one of the namesreferred to inArticle 5a (2), first indent.
In accordance with the procedure laid down in Article 10, the
Commission shall, no later than 14 December 1994, adopt thecriteria and conditionsunder which a manufacturer may, for
reasons of trade secrecy, apply not to include one or more ingredi-
entson the abovementioned lis t.
Where it is impracticable, for reasons of size or shape, for the particu-
larsreferred to in points(d) and (g) to appear in an enclos ed leaflet,those particulars shall appear on a label, tape or card which is enclosedor attached to the cosmetic product.
In the case of soap, bath balls and other small products where it is
impraticable, for reasons of size or shape, for the particulars referredto in point (g) to appear on a label, tag, tape or card or in an enclosedleaflet, those particulars shall appear on a notice in immediate proxi-mity to the container in which the cosmetic product is exposed for sale.
2. For cosmetic products that are not pre-packaged, are packaged at
the point of sale at the purchaser's request, or are pre-packaged forimmediate sale, Member States shall adopt detailed rules for indicationof the particularsreferred to in paragraph 1.
3. Member States shall take all measures necessary to ensure that, in
the labelling, putting up for sale and advertising of cosmetic products,
text, names, trade marks, pictures and figurative or other signs are notused to imply that these products have characteristics which they donot have. ►
M21Furthermore, any reference to testing on animals
must state clearly whether the tests carried out involved the finished
product and/or itsingredients . ◄
Article 7
1. Member Statesmay not, for reas onsrelated to the requirements
laid down in thisDirective and the Annexesthereto, refus e, prohibitor restrict the marketing of any cosmetic products which comply with
the requirementsof thisDirective and the Annexesthereto.
2. They may, however, require that the particularsprovided for in
Article 6 (1) (b), (c), (d) and (f) be expressed at least in their ownnational or official language or languages; they may also require that
the particulars provided for in Article 6 (1) (g) be expressed in a
language easily understood by the consumer. To that end, the Commis-sion shall adopt a common ingredients nomenclature in accordancewith the Article 10 procedure.
3. Furthermore, a Member State may, for purposes of prompt and
appropriate medical treatment in the event of difficulties, require that
appropriate and adequate information on substances used in cosmeticproductsbe made available to the competent authority, which s hallensure that that information is used only for the purposes of such treat-ment.
Each Member State shall designate a competent authority and send
details thereof to the Commission, which shall publish that information
in theOfficial Journal of the European Communities .
Article 7a
1. The manufacturer or his agent or the person to whose order a
cosmetic product is manufactured or the person responsible for placingan imported cosmetic product on the Community market shall forcontrol purposes keep the following information readily accessible to1976L0768 — EN — 21.04.2002 — 003.001 — 8
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the competent authoritiesof the Member State concerned at the addres s
specified on the label in accordance with Article 6 (1) (a):
(a) the qualitative and quantitative composition of the product; in the
case of perfume compositions and perfumes, the name and codenumber of the composition and the identity of the supplier;
(b) the physico-chemical and microbiological specifications of the raw
materialsand the finis hed product and the purity and microbiolo-gical control criteria of the cosmetic product;
(c) the method of manufacture complying with the good manufacturing
practice laid down by Community law or, failing that, laid down by
the law of the Member State concerned; the person responsible formanufacture or first importation into the Community must possessan appropriate level of professional qualification or experience inaccordance with the legislation and practice of the Member Statewhich isthe place of manufacture or firs t importation;
(d) assessment of the safety for human health of the finished product.
To that end the manufacturer shall take into consideration the
general toxicological profile of the ingredient, itschemical s truc-ture and itslevel of expos ure.
Should the same product be manufactured at several places within
Community territory, the manufacturer may choose a single placeof manufacture where that information will be kept available. Inthis connection, and when so requested for monitoring purposes,he shall be obliged to indicate the place so chosen to the moni-
toring authority/authoritiesconcerned;
(e) the name and address of the qualified person or persons responsible
for the assessment referred to in (d). That person must hold adiploma asdefined in Article 1 of Directive 89/48/EEC in the fieldof pharmacy, toxicology, dermatology, medicine or a similar disci-pline;
(f) existing data on undesirable effects on human health resulting from
use of the cosmetic product;
(g) proof of the effect claimed for the cosmetic product, where justi-
fied by the nature of the effect or product.
2. The assessment of the safety for human health referred to in para-
graph 1 (d) shall be carried out in accordance with the principle ofgood laboratory practice laid down in Council Directive 87/18/EEC of18 December 1986 on the harmonization of laws, regulations and
administrative provisions relating to the application of the principles
of good laboratory practice and the verification of their application fortests on chemical substances(
1).
3. The information referred to in paragraph 1 must be available in
the national language or languagesof the Member State concerned, orin a language readily understood by the competent authorities.
4. The manufacturer or his agent, or the person to whose order a
cosmetic product is manufactured, or the person responsible for placing
imported cosmetic products on the Community market, shall notify thecompetent authority of the Member State of the place of manufactureor of the initial importation of the address of the place of manufactureor of initial importation into the Community of the cosmetic productsbefore the latter are placed on the Community market.
5. Member States shall designate the competent authorities referred
to in paragraphs 1 and 4 and shall send details thereof to the Commis-sion, which shall publish that information in the Official Journal of the
European Communities .
The Member States shall ensure that the abovementioned authorities
continue to cooperate in areas where such cooperation is necessary tothe smooth application of this Directive.1976L0768 — EN — 21.04.2002 — 003.001 — 9
(1) OJ No L 15, 17. 1. 1987, p. 29.
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Article 8
1. In accordance with the procedure laid down in Article 10 the
following shall be determined:
— the methods of analysis necessary for checking the composition of
cosmetic products,
— the criteria of microbiological and chemical purity for cosmetic
productsand methodsfor checking compliance with thos e criteria.
2. The common nomenclature of ingredients used in cosmetic
products and, after consultation of the Scientific Committee on Cosme-tology, the amendments necessary for the adaptation to technicalprogress of the Annexes shall be adopted in accordance with the sameprocedure, asappropriate.
Article 8a
1. Notwithstanding Article 4 and without prejudice to Article 8 (2),
a Member State may authorize the use within its territory of othersubstances not contained in the lists of substances allowed, for certaincosmetic products specified in its national authorization, subject to thefollowing conditions:
(a) the authorization must be limited to a maximum period of three
years;
(b) the Member State must carry out an official check on cosmetic
products manufactured from the substance or preparation use ofwhich it hasauthorized;
(c) cosmetic products thus manufactured must bear a distinctive indica-
tion which will be defined in the authorization.
2. The Member Stats shall forward to the Commission and to the
other Member Statesthe next of any authorization decis ion takenpursuant to paragraph 1 within two months of the date on which itcame into effect.
3. Before expiry of the three-year period provided for in paragraph
1, the Member State may submit to the Commission a request for theinclusion in a list of permitted substances of the substance given
national authorization in accordance with paragraph 1. At the same
time, it shall supply supporting documents setting out the grounds onwhich it deems such inclusion justified and shall indicate the uses forwhich the substance or preparation is intended. Within 18 months ofsubmission of the request, a decision shall be taken on the basis ofthe latest scientific and technical knowledge, after consultation, at the
initiative of the Commission or of a Member State, of the Scientific
Committee for Cosmetology and in accordance with the procedurelaid down in Article 10 as to whether the substance in question maybe included in a list of permitted substances or whether the nationalauthorization should be revoked. Notwithstanding paragraph 1 (a), the
national authorization shall remain in force until a decision is taken on
the request for inclusion in the list.
Article 9
1. The Committee on the Adaptation to Technical Progress of the
Directiveson the Removal of Technical Barriersto Trade in the
Cosmetic Products Sector, hereinafter called ‘the Committee’, is hereby
set up. It shall consist of representatives of the Member States with arepresentative of the Commission as chairman.
2. The Committee shall adopt its own rules of procedure.
Article 10
1. Where the procedure laid down in thisArticle isto be followed,
matterss hall be referred to the Committee by the chairman, either on1976L0768 — EN — 21.04.2002 — 003.001 — 10
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his own initiative or at the request of the representative of a Member
State.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be adopted. The Committee shall
deliver itsopinion on the draft within a time limit s et by the chairman
according to the urgency of the matter. Opinionss hall be adopted by amajority of ►
A254◄votes, the votes of Member States being
weighted asprovided for in Article 148 (2) of the Treaty. The chairmanshall not vote.
3. (a) The Commission shall adopt the proposed measures when they
are in accordance with the opinion of the Committee.
(b) Where the proposed measures are not in accordance with the
opinion of the Committee, or if no opinion isadopted, theCommission shall without delay propose to the Council themeasures to be adopted. The Council shall act by a qualified
majority.
(c) If, within three months of the proposal being submitted to it, the
Council has not acted, the proposed measures shall be adoptedby the Commission.
Article 11
Without prejudice to Article 5 and not later than one year after expiry
of the period laid down in Article 14 (1) for implementation of this
Directive by the Member States, the Commission shall, on the basis
of the results of the latest scientific and technical research, submit tothe Council appropriate proposals establishing lists of permittedsubstances.
Article 12
1. If a Member State notes, on the basis of a substantiated justifica-
tion, that a cosmetic product, although complying with therequirementsof the Directive, repres entsa hazard to health, it mayprovisionally prohibit the marketing of that product in its territory or
subject it to special conditions. It shall immediately inform the other
Member States and the Commission thereof, stating the grounds foritsdecis ion.
2. The Commission shall as soon as possible consult the Member
Statesconcerned, following which it s hall deliver itsopinion withoutdelay and take the appropriate steps.
3. If the Commission is of the opinion that technical adaptations to
the Directive are necessary, such adaptations shall be adopted by eitherthe Commission or the Council in accordance with the procedure laiddown in Article 10. In that event, the Member State which hasadoptedsafeguard measures may maintain them until entry into force of theadaptations.
Article 13
Precise reasons shall be stated for any individual measures placing a
restriction or ban on the marketing of cosmetic products taken pursuant
to thisDirective. It s hall be notified to the party concerned together
with particularsof the remediesavailable to him under the lawsinforce in the Member Statesand of the time limitsallowed for the exer-cise of such remedies.
Article 14
1. Member States shall bring into force the provisions needed in
order to comply with thisDirective within 18 monthsof itsnotificationand shall forthwith inform the Commission thereof.
2. Member Statesmay, however, for a period of 36 monthsfrom
notification of thisDirective, authorize the marketing in their territory1976L0768 — EN — 21.04.2002 — 003.001 — 11
▼M14
▼B
▼B
of cosmetic products which do not conform to the requirements of the
Directive.
3. Member States shall ensure that the texts of such provisions of
national law asthey adopt in the field governed by thisDirective ate
communicated to the Commission.
Article 15
This Directive is addressed to the Member States.1976L0768 — EN — 21.04.2002 — 003.001 — 12
▼B
ANNEX I
ILLUSTRATIVELISTBYCATEGORYOFCOSMETICPRODUCTS
— Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.).
— Face masks (with the exception of peeling products).
— Tinted bases (liquids, pastes, powders).
— Make-up powders, after-bath powders, hygienic powders, etc.— Toilet soaps, deodorant soaps, etc.— Perfumes, toilet waters and eau de Cologne.— Bath and shower preparations (salts, foams, oils, gels, etc.).— Depilatories.— Deodorants and anti-perspirants.— Hair care products:
— hair tintsand bleaches ,
— productsfor waving, s traightening and fixing,— setting products,— cleansing products (lotions, powders, shampoos),— conditioning products (lotions, creams, oils),
— hairdressing products (lotions, lacquers, brilliantines).
— Shaving products (creams, foams, lotions, etc.).— Productsfor making up and removing makeup from the face and the eyes .— Productsintended for application to the lips .— Productsfor care of the teeth and the mouth.— Productsfor nail care and make-up.— Productsfor external intimate hygiene.— Sunbathing products.— Productsfor tanning without s un.— Skin-whitening products.
— Anti-wrinkle products.1976L0768 — EN — 21.04.2002 — 003.001 — 13
▼B
ANNEX II
Listofsubstanceswhichmustnotformpartofthecompositionofcosmetic
products
1. N-5-Chlorobenzoxazol-2-ylacetamide
2.►M32-Acetoxyethyltrimethylammonium hydroxide (acetylcholine) and
itss alts◄
3. Deanol aceglumate*(1)
4. Spironolactone*5.►
M3[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid and its
salts◄
6. Methotrexate*7. Aminocaproic acid* and itss alts8. Cinchophen*, its salts, derivatives and salts of these derivatives9. Thyropropic acid* and itss alts
10. Trichloroacetic acid11.Aconitum napellus L. (leaves, roots and galenical preparations)
12. Aconitine (principal alkaloid of Aconitum napellus L. ) and itss alts
13.Adonis vernalis L . and itspreparations
14. Epinephrine*15.Rauwolfia serpentina alkaloidsand their s alts
16. Alkyne alcohols, their esters, ethers and salts17. Isoprenaline*18. Allyl isothiocyanate19. Alloclamide* and itss alts20. Nalorphine*, itss altsand ethers21. Sympathicomimetic amines acting on the central nervous system: any
substance contained in the first list of medicaments which are subject to
medical prescription and are referred to in resolution AP (69) 2 of the
Council of Europe
22. Aniline, itss altsand itshalogenated and s ulphonated derivatives23. Betoxycaine* and itss alts24. Zoxazolamine*25. Procainamide*, itss altsand derivatives26. Benzidine27. Tuaminoheptane*, its isomers and salts28. Octodrine* and itss alts29.►
M32-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts ◄
30. 1,3-dimethylpentylamine and itss alts31. 4-Aminosalicylic acid and its salts32. Toluidines, their isomers, salts and halogenated and sulphonated deriva-
tives
33. Xylidines, their isomers, salts and halogenated and sulphonated derivatives34.►
M3Imperatorin (9-(3-methoxylbut-2-enyloxy)furo[3,2-g]chromen-7-
one)◄
35.Ammi majus and itsgalenical preparations
36. 2,3-Dichloro-2-methylbutane
37. Substances with androgenic effect38. Anthracene oil39. Antibiotics ►
M17 ◄1976L0768 — EN — 21.04.2002 — 003.001 — 14
(1) In this Directive, names followed by an asterisk are those published in ‘Computer print-
out 1975, International Non-proprietary Names(INN) for pharmaceutical products ,
Lists 1-33 of proposed INN’, WHO, Geneva, August 1975.▼M3
▼B
▼B
40. Antimony and itscompounds
41.Apocynum cannabinum L . and itspreparations
42.►M3Apomorphine (R 5,6,6a 7-tetrahydro-6-methyl-4 H-dibenzo
[de,g]quinoline-10,11-diol) and itss alts ◄
43. Arsenic and its compounds
44.Atropa belladonna L . and itspreparations
45. Atropine, itss altsand derivatives
46. Barium salts, with the exception of barium sulphate, barium sulphide under
the conditions laid down in Annex III, Part 1, and lakes, salts and pigments
prepared from the colouring agentslis ted with the reference (5) in Annex
III, Part 2 and Annex IV, Part 2.
47. Benzene
48.►M3Benzimidazol-2(3 H)-one◄
49.►M3Benzazepinesand benzodiazepines ◄
50.►M31-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and
itss alts◄
51.►M32,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and itss alts ◄
52.►M3Isocarboxazid* ◄
53. Bendroflumethiazide* and itsderivatives54. Beryllium and itscompounds55. Bromine, elemental
56. Bretylium tosilate*
57. Carbromal*58. Bromisoval*59. Brompheniramine* and itss alts
60. Benzilonium bromide*
61. Tetrylammonium bromide*62. Brucine63. Tetracaine* and itss alts64. Mofebutazone*
65. Tolbutamide*
66. Carbutamide*67. Phenylbutazone*68. Cadmium and itscompounds
69. Cantharides, Cantharis vesicatoria
70. (1R,25)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin)71. Phenprobamate*72.►
M3Nitroderivativesof carbazole ◄
73. Carbon disulphide
74. Catalase75. Cephaeline and itss alts76.Chenopodium ambrosioides (essential oil)
77. 2,2,2-Trichloroethane-1,1-diol
78. Chlorine79. Chlorpropamide*80.►
M3Diphenoxylate* hydrochloride ◄
81. 4-Phenylazophenylene-1,3-diamine citrate hydrochloride (chrysoidine
citrate hydrochloride)
82. Chlorzoxazone*83. 2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO)
84. Chlorprothixene* and itss alts
85. Clofenamide*86.►
M3N,N-bis(2-chloroethyl)methylamine N-oxide and itss alts ◄
87. Chlormethine* and itss alts1976L0768 — EN — 21.04.2002 — 003.001 — 15
▼M4
▼B
▼B
88. Cyclophosphamide* and its salts
89. Mannomustine* and its salts
90. Butanilicaine* and itss alts91.►
M3Chlormezanone* ◄
92. Triparanol*
93. 2-[2(4-Chiorophenyl)-2-phenylacetyl] indane-1,3-dione (chlorophacinone-
ISO)
94. Chlorphenoxamine*95.►
M32-[2-(4-Chlorophenyl)-2-phenylacetyl]indan 1,3-dione (chlorophaci-
none - ISO) ◄
96. Chloroethane97. Chromium; chromic acid and itss alts
98.Claviceps purpurea Tul., itsalkaloidsand galenical preparations
99.Conium maculatum L. (fruit, powder, galenical preparations)
100. Glycyclamide*
101. Cobalt benzenesulphonate
102. Colchicine, itss altsand derivatives103. Colchicoside and its derivatives
104.Golchicum autumnale L . and itsgalenical preparations
105. Convallatoxin106.Anamirta cocculus L . (fruit)
107.Croton tiglium (oil)
108. 1-Butyl-3-( N-crotonoylsulphanilyl)urea
109. Curare and curarine
110. Synthetic curarizants
111. Hydrogen cyanide and itss alts
112.►
M32-α-Cyclohexylbenzyl( N,N,N',N', -tetraethyl)trimethylenediamine
(phenetamine) ◄
113. Cyclomenol* and itss alts
114. Sodium hexacyclonate*
115. Hexapropymate*116. Dextropropoxyphene*
117.►
M3O,O'-Diacetyl- N-allyl-N-normorphine ◄
118. Pipazetate* and itss alts119.►
M35-(αβ-Dibromophenethyl)-5-methylhydantoin ◄
120.►M3N,N'-Pentamethylenebis (trimethylammonium salts), e.g. penta-
methonium bromide* ◄
121.►M3N,N'-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts,
e.g. azamethonium bromide* ◄
122. Cyclarbamate*
123. Clofenotane* DDT (ISO)
124.►M3N,N'-Hexamethylenebis(trimethylammonium) salts, e.g. hexametho-
nium bromide* ◄
125. Dichloroethanes(ethylene chlorides )126. Dichloroethylenes(acetylene chlorides )
127. Lysergide* and its salts
128.►
M32-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and itss alts ◄
129. Cinchocaine* and itss alts
130. 3-Diethylaminopropyl cinnamate
131.►M3O,O'-DiethylO-4-nitrophenyl phosphorothioate (parathion-lSO) ◄
132.►M3[Oxalylbisiminoethylene)]bis[( o-chlorobenzyl)diethylammonium
salts], e.g. ambenomium cloride* ◄
133. Methyprylon* and itss alts134. Digitaline and all heterosides of Digitalis purpurea L .
135. 7-[2-Hydroxy-3-(2-hydroxyethyl- N-methylamino)propyl]theophylline
(xanthinol)1976L0768 — EN — 21.04.2002 — 003.001 — 16
▼B
136. Dioxethedrin* and itss alts
137. Piprocurarium*
138. Propyphenazone*
139. Tetrabenazine* and itss alts
140. Captodiame*
141. Mefeclorazine* and itss alts
142. Dimethylamine143.►
M31,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine,
alypine) and itss alts ◄
144. Methapyrilene* and itss alts
145. Metamfepramone* and itss alts
146. Amitriptyline* and itss alts
147. Metformin* and itss alts
148. Isosorbide dinitrate*149. Malononitrile
150. Succinonitrile
151. Dinitrophenol isomers
152. Inproquone*
153. Dimevamide* and itss alts
154. Diphenylpyraline* and itss alts
155. Sulfinpyrazone*156.►
M3N-(3-Carbamoyl-3,3-diphenylpropyl)- N,N-diisopropylmethyl-ammo-
nium salts, e.g. isopropamide iodide* ◄
157. Benactyzine*
158. Benzatropine* and itss alts
159. Cyclizine* and itss alts
160.►M35,5-Diphenyl-4-imidazolidone ◄
161. Probenecid*
162. Disulfiram* thiram (ISO)
163. Emetine, itss altsand derivatives164. Ephedrine and itss alts
165. Oxanamide* and itsderivatives
166. Eserine or physostigmine and its salts
167. Esters of 4-aminobenzoic acid, with the free amino group, with the excep-
tion of that given in ►
M9Annex VII, Part 2 ◄
168. Choline salts and their esters, e.g. choline chloride
169. Caramiphen* and itss alts170. Diethyl 4-nitrophenyl phosphate
171. Metethoheptazine* and itss alts
172. Oxpheneridine* and itss alts
173. Ethoheptazine* and itss alts
174. Metheptazine* and itss alts
175. Methylphenidate* and itss alts
176. Doxylamine* and itss alts177. Tolboxane*
178. 4-Benzyloxyphenol, 4-methoxyphenol and 4-ethoxyphenol179. Parethoxycaine* and itss alts
180. Fenozolone*
181. Glutethimide* and itss alts
182. Ethylene oxide183. Bemegride* and itss alts
184. Valnoctamide*
185. Haloperidol*1976L0768 — EN — 21.04.2002 — 003.001 — 17
▼M9
▼B
▼B
186. Paramethasone*
187. Fluanisone*
188. Trifluperidol*
189. Fluoresone*190. Fluorouracil*
191. Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with
the exception of those given in Annex III, Part 1
192. Furfuryltrimethylammonium salts, e.g. furtrethonium iodide*
193. Galantamine*194. Progestogens, ►
M17 ◄
195. 1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)
196.►M3(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-
1,4,4a,5,6,7,8,8a-octahydro-1,4: 5,8-dimethano-naphthalene (endrin-
ISO)◄
197. Hexachloroethane198. (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-
dimethano-naphthalene (isodrin-ISO)
199. Hydrastine, hydrastinine and their salts200. Hydrazidesand their s alts201. Hydrazine, itsderivativesand their s alts
202. Octamoxin* and itss alts
203. Warfarin* and itss alts204.►
M3Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl) acetate and salts of
the acid ◄
205. Methocarbamol*206. Propatylnitrate*
207.►
M34,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin ◄
208. Fenadiazole*209. Nitroxoline* and itss alts210. Hyoscyamine, its salts and derivatives211.Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)
212. Pemoline* and itss alts213. Iodine214.►
M3Decamethylenebis(trimethylammonium) salts, e.g. decamethonium
bromide ◄
215. Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots,
powder and galenical preparations)
216. (2-Isopropylpent.4-enoyl)urea (apronalide)
217.►M3α-Santonin [(3S,5a R,9bS)-3,3a,4,5,5a,9b-hexahydro-3,5a,9-
trimethylnaphto [1,2-b] furan-2,8-dione] ◄
218.Lobelia inflata L . and itsgalenical preparations
219. Lobeline* and itss alts220. Barbiturates
221. Mercury and its compounds, except those special cases included ►
M18in
Annex VI, Part 1 ◄
222. 3,4,5-Trimethoxyphenethylamine and itss alts
223. Metaldehyde224. 2-(4-Allyl-2-methoxyphenoxy)- N,N-diethylacetamide and itss alts
225. Coumetarol*226. Dextromethorphan* and itss alts227. 2-Methyiheptylamine and itss alts228. Isometheptene* and its salts229. Mecamylamine*230. Guaifenesin*1976L0768 — EN — 21.04.2002 — 003.001 — 18
▼M3
▼B
▼M11
▼B
▼B
231. Dicoumarol*
232. Phenmetrazine*, itsderivativesand s alts
233. Thiamazole*
234.►M33,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5 H-pyrano [3,2-c]-
[1] benzopyran-5-one (cyclocoumarol) ◄
235. Carisoprodol*236. Meprobamate*
237. Tefazoline* and itss alts
238. Arecoline239. Poldine metilsulfate*240. Hydroxyzine*241. 2-Naphthol242. 1-and 2-Naphthylaminesand their s alts243.►
M33-(1-Naphthyl)-4-hydroxycoumarin ◄
244. Naphazoline* and itss alts245. Neostigmine and its salts (e.g. neostigmine bromide*)
246. Nicotine and itss alts
247. Amyl nitrites248. Inorganic nitrites, with the exception of sodium nitrite249. Nitrobenzene250. Nitrocresols and their alkali metal salts251. Nitrofurantoin*252. Furazolidone*253. Propane-1,2,3-triyl trinitrate254. Acenocoumarol*
255. Alkali pentacyanonitrosylferrate (2-)
256. Nitrostilbenes, their homologues and their derivatives257. Noradrenaline and itss alts258. Noscapine* and its salts159. Guanethidine* and itss alts260. Oestrogens, ►
M15 ◄
261. Oleandrin262. Chlortalidone*
263. Pelletierine and itss alts
264. Pentachloroethane265. Pentaerithrityl tetranitrate*266. Petrichloral*267. Octamylamine* and itss alts
268. Picric acid269. Phenacemide*
270. Difendoxazine*271.►
M32-Phenylindan-1,3-dione (phenindione) ◄
272. Ethylphenacemide*273. Phenprocoumon*
274. Fenyramidol*
275. Triamterene* and itss alts276.►
M3Tetraethyl pyrophosphate; TEPP (ISO) ◄
277. Tritolyl phosphate278. Psilocybine*279. Phosphorus and metal phosphides280. Thalidomide* and itss alts281.Physostigma venenosum Balf.1976L0768 — EN — 21.04.2002 — 003.001 — 19
▼M3
▼B
▼B
282. Picrotoxin
283. Pilocarpine and itss alts
284.►M3α-Piperidin-2-ylbenzyl acette (SIC! acetate) laevorotatory threoform
(levophacetoperane) and itss alts ◄
285. Pipradrol* and itss alts
286. Azacyclonol* and itss alts287. Bietamiverine*
288. Butopiprine* and itss alts
289. Lead and its ►
M17compounds, with the exception of that mentioned in
Annex III, No 55 under the conditionss tated ◄
290. Conjine
291.Prunus laurocerasus L. (‘cherry laurel water’)
292. Metyrapone*
293. Radioactive substances, as defined by Directive 96/29/Euratom(1) laying
down basic safety standards for the protection of the health of workers
and the general public against the dangers arising from ionising radiation.
294.Juniperus sabina L. (leaves, essential oil and galenical preparations)
295. Hyoscine, its salts and derivatives
296. Gold salts
297. Selenium and its compounds with the exception of selenium disulphiele
under the conditionss et out under reference No 49 in Annex Ill, Part 1
298.Solanum nigrum L. and itsgalenical preparations
299. Sparteine and itss alts300. Glucocorticoids
301.Datura stramonium L. and itsgalenical preparations
302. Strophantines, their aglucones and their respective derivatives303.Strophantus species and their galenical preparations
304. Strychnine and itss alts
305.Strychnos species and their galenical preparations
306. Narcotics, natural and synthetic: All substances listed in Tables I and II of
the single Convention on narcotic drugs signed in New York on 30 March
1961
307.►
M3Sulphonamides (sulphanilamide and its derivatives…) and their
salts obtained by substitution of one or more H-atoms of the -NH2groups)
and their salts ◄
308. Sultiame*
309. Neodymium and itss alts310. Thiotepa*
311.Pilocarpus jaborandi Holmes and itsgalenical preparations
312. Tellurium and itscompounds313.►
M3Xylometazoline* and itss alts ◄
314. Tetrachloroethylene
315. Carbon tetrachioride316. Hexaethyl tetraphosphate317. Thallium and itscompounds
318.Thevetia neriifolia Juss. , glycoside extract
319. Ethionamide*320. Phenothiazine* and itscompounds
321. Thiourea and its derivatives, with the exception of the one listed in Annex
III, Part 11976L0768 — EN — 21.04.2002 — 003.001 — 20
(1) OJ L 159, 29.6.1996, p. 1.▼M34
▼B
▼M9
▼B
▼M3
▼B
322. Mephenesin* and its esters
323. Vaccines, toxins or serums listed in the Annex to the second Council
Directive of 20 May 1975 on the approximation of provisions laid down
by law, regulation or administrative action relating to proprietary medic-
inal products(OJ No L 147, 9. 6. 1975, p. 13)
324. Tranylcypromine* and itss alts325. Trichloronitromethane (chloropicrine)326. 2,2,2-Tribromoethanol (tribromoethyl alcohol)327. Trichiormethine* and itss alts328. Tretamine*329. Gallamine triethiodide*330.Urginea scilla Stern. and itsgalenical preparations
331. Veratrine, itss altsand galenical preparations332.Schoenocaulon olficinale Lind. (seeds and galenical preparations)
333.Veratrum Spp . and their preparations
334. Vinyl chloride monomer
335. Ergocalciferol* and cholecalciferol (vitaminsD
2and D3)
336. Saltsof O-alkyldithiocarbonic acids
337. Yobimbine and itss alts338. Dimethyl sulfoxide*339. Diphenhydramine* and itss alts340. 4-tert-Butylphenol341. 4-tert-Butylpyrocatechol342. Dihydrotachysterol343. Dioxane344. Morpholine and itss alts345.Pyretbrum album L. and itsgalenical preparations
346.►
M32-[4-Methoxybenzyl- N-(2-pyridyl)amino]ethyldimethylamine
maleate◄
347. Tripelennamine*348. Tetrachlorosalicylanilides349. Dichlorosalicylanilides
350. Tetrabromosalicylanilides ►
M13 ◄
351. Dibromosalicylanilides, ►M13 ◄
352. Bithionol*
353. Thiuram monosulphides354. Thiuram disulphides355. Dimethylformamide356. 4-Phenylbut-3-en-2-one357. Benzoatesof 4-hydroxy-3-methoxycinnamyl alcohol except for normal
content in natural essences used
358. Furocoumarines (e.g. trioxysalan*, 8-methoxypsoralen, 5-methoxypsoralen)
except for normal content in natural essences used.
In sun protection and in bronzing products, furocoumarines shall be below
1 mg/kg.
359. Oil from the seeds of Laurus nobilis L .
360. Safrole except for normal content in the natural essences used and
provided the concentration doesnot exceed:
100 ppm in the finished product,
50 ppm in productsfor dental and oral hygiene, and provided that Safrole
is not present in toothpastes intended specifically for children1976L0768 — EN — 21.04.2002 — 003.001 — 21
▼M8
▼B
▼M3
▼B
▼M24
▼B
▼M3
▼B
361. 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite
362. 3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone or 7-
acetyl-6-ethyl-1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphtalen
363.O-phenylenediamine and itss alts
364. 4-methyl-m-phenylenediamine and its salts.
365. Aristolochic acid and its salts; Aristolochia spp. and their preparations
366. Chloroform
367. 2,3,7,8-Tetra chlorodibenzo-p-dioxin368. 2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane)
369. Pyrithione sodium (INNM)
370.N-(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (captan)
371. 2,2'-Dihydroxy-3,3',5,5',6,6'-hexachlorodiphenylmethane (hexachlorophene)
372. 6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide (minoxidil) and itss alts
373. 3,4',5-Tribromosalicylanilide374.Phytolacca spp. and their preparations
375. Tretinoin (retinoic acid and its salts)
376. 1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole - CI 76050)
►
M17and their salts ◄
377. 1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) ►M17and their
salts◄
378. Colouring agent CI 12140379. Colouring agent CI 26105
380. Colouring agent CI 42555
Colouring agent CI 42555-1Colouring agent CI 42555-2
381. Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN))
382. Benzoyl peroxide
383. 2-Amino.4-nitrophenol384. 2-Amino-5-nitrophenol
385. 11 α-Hydroxypregn-4-ene-3,20-dione and itses ters
385. 11 α-Hydroxypregn-4-ene-3, 20-dione) and itses ters
386. Colouring agent C.I. 42 640
387. Colouring agent CI 13 065
388. Colouring agent CI 42 535389. Colouring agent CI 61 554
390. Anti-androgens of steroidal structure391. Zirconium and its compounds, with the exception of the substances listed
under reference number 50 in Annex III, Part One, and the zirconium
lakes, pigments or salts of the colouring agents listed in Annex IV, Part
One, with reference number 31976L0768 — EN — 21.04.2002 — 003.001 — 22
▼M32
▼M5
▼M8
▼M32
▼M10
▼M32
▼M10
▼M12
▼M32
▼M13
▼M15
▼M17
▼M32
▼M17
▼M32
▼M32
393. Acetonitrile
394. Tetrahydrozoline and itss alts
395. Hydroxy-8-quinoline and its sulphate, except for the uses provided for in
No 51 in Annex III, Part 1
396. Dithio-2,2-bispyridine-dioxide 1,1' (additive with trihydrated magnesium
sulphate) - (pyrithione disulphide + magnesium sulphate)
397. Colouring agent CI 12075 and its lakes, pigments and salts
398. Colouring agent CI 45170 and CI 45170:1399. Lidocaine
400. 1,2-epoxybutane
401. Colouring agent CI 15585
402. Strontium lactate403. Strontium nitrate404. Strontium polycarboxylate405. Pramocaine406. 4-ethoxy-m-phenylenediamine and itss alts407. 2,4-diaminophenylethanol and itss alts
408. Catechol
409. Pyrogallol410. Nitrosamines411. Secondary dialkanolamines
412. 4-Amino-2-nitrophenol
413. 2-Methyl-m-phenylenediamine
414. 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette)
416. Cells, tissues or products of human origin
417. 3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein*)
418. 3-Imidazol-4-ylacrylic acid and itsethyl es ter (urocanic acid)
419. (a) the skull, including the brain and eyes, tonsils and spinal cord of:
— bovine animalsaged 12 months ,
— ovine and caprine animalswhich are aged over 12 monthsor have
a permanent incissor tooth erupted through the gum;
(b) the spleens of ovine and caprine animals and ingredients derived there-
from.
However, tallow derivativesmay be us ed provided that the following
methods have been used and strictly certified by the producer:
— Transesterification or hydrolysis at at least 200 ºC and at an appro-
priate corresponding pressure, for 20 minutes (glycerol, fatty acids
and fatty acid esters),
— Saponification with NaOH 12M (glycerol and soap):
— Batch process: at 95 ºC for three hours
or
— Continuous process: at 140 ºC, two bars (2 000 hPa) for eight
minutesor equivalent conditions .
420. Crude and refined coal tars
421. 1,1,3,3,5,-Pentamethyl-4,6-dinitroindane (moskene)
422. 5-tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (musk tibetene).1976L0768 — EN — 21.04.2002 — 003.001 — 23
▼M18
▼M20
▼M22
▼M23
▼M24
▼M28
▼M24
▼M25
▼M29
▼M31
▼M29
▼M28
▼M30
▼M34
423. Alanroot oil ( Inula helenium ) (CAS No 97676-35-2), when used as a
fragrance ingredient.
424. Benzyl cyanide (CAS No 140-29-4), when used as a fragrance ingredient.
425. Cyclamen alcohol (CAS No 4756-19-8), when used as a fragrance ingre-
dient.
426. Diethyl maleate (CAS No 141-05-9), when used as a fragrance ingredient.
427. Dihydrocoumarine (CAS No 119-84-6), when used as a fragrance ingre-
dient.
428. 2,4-Dihydroxy-3-methylbenzaldehyde (CAS No 6248-20-0), when used as
a fragrance ingredient.
429. 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) (CAS No 40607-48-5),
when used as a fragrance ingredient.
430. 4,6-Dimethyl-8- tert-butylcoumarin (CAS No 17874-34-9), when used as a
fragrance ingredient.
431. Dimethyl citraconate (CAS No 617-54-9), when used as a fragrance ingre-
dient.
432. 7,11-Dimethyl-4,6,10-dodecatrien-3-one (CAS No 26651-96-7), when used
asa fragrance ingredient.
433. 6,10-Dimethyl-3,5,9-undecatrien-2-one (CAS No 141-10-6), when used as
a fragrance ingredient.
434. Diphenylamine (CAS No 122-39-4), when used as a fragrance ingredient.
435. Ethyl acrylate (CAS No 140-88-5), when used as a fragrance ingredient.
436. Fig leaf absolute ( Ficus carica ) (CAS No 68916-52-9), when used as a
fragrance ingredient.
437.trans-2-Heptenal (CAS No 18829-55-5), when used as a fragrance ingre-
dient.
438.trans-2-Hexenal diethyl acetal (CAS No 67746-30-9), when used as a
fragrance ingredient.
439.trans-2-Hexenal dimethyl acetal (CAS No 18318-83-7), when used as a
fragrance ingredient.
440. Hydroabietyl alcohol (CAS No 13393-93-6), when used as a fragrance
ingredient.
441. 6-Isopropyl-2-decahydronaphthalenol (CAS No 34131-99-2), when used as
a fragrance ingredient.
442. 7-Methoxycoumarin (CAS No 531-59-9), when used as a fragrance ingre-
dient.
443. 4-(4-Methoxyphenyl)-3-butene-2-one (CAS No 943-88-4), when used as a
fragrance ingredient.
444. 1-(4-Methoxyphenyl)-1-penten-3-one (CAS No 104-27-8), when used as a
fragrance ingredient.
445. Methyl trans-2-butenoate (CAS No 623-43-8), when used as a fragrance
ingredient.
446. 7-Methylcoumarin (CAS No 2445-83-2), when used as a fragrance ingre-
dient.
447. 5-Methyl-2,3-hexanedione (CAS No 13706-86-0), when used as a
fragrance ingredient.
448. 2-Pentylidenecyclohexanone (CAS No 25677-40-1), when used as a
fragrance ingredient.
449. 3,6,10-Trimethyl-3,5,9-undecatrien-2-one (CAS No 1117-41-5), when used
asa fragrance ingredient.
450. Verbena oil ( Lippia citriodora Kunth.) (CAS No 8024-12-2), when used as
a fragrance ingredient.
451. Methyleugenol (CAS No 95-15-2) except for normal content in the natural
essences used and provided that the concentration does not exceed:
(a) 0,01 % in fine fragrance
(b) 0,004 % in eau de toilette
(c) 0,002 % in fragrance cream
(d) 0,001 % in rinse-off products
(e) 0,0002 % in other leave-on productsand oral hygiene products .1976L0768 — EN — 21.04.2002 — 003.001 — 24
ANNEX III
PART1
LISTOFSUBSTANCESWHICHCOSMETICPRODUCTSMUSTNOTCONTAINEXCEPTSUBJECTTOTHERESTRICTIONSANDCONDITIONSLAIDDOWN
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
1a Boric acid, boratesand tetrabo-
rates(a) Talc (a) 5 % (by mass/mass as boric
acid)(a) 1. Not to be used in products
for children under 3 yearsof age
2. Not to be used on peeling or
irritated skin if the concentration
of free soluble borates exceeds
1,5 % (by mass/mass as boric
acid)(a) 1. Not to be used for children
under 3 yearsof age
2. Not to be used on peeling or irri-
tated skin
(b) Products for all hygiène (b) 0,1 % (by mass/mass as boric
acid)(b) 1. Not to be used in products
for children under 3 yearsof age(b) 1. Not to be swallowed
2. Not to be used for children under
3 yearsof age
(c) Other products(excluding bath
productsand hair waving
products)(c) 3 % (by mass/mass as boric
acid)(c) 1. Not to be used in products
for children under 3 yearsof age
2. Not to be used on peeling or
irritated skin if the concentration
of free soluble borates exceeds
1,5 % (by mass/mass as boric
acid)(c) 1. Not to be used for children
under 3 yearsof age
2. Not to be used on peeling or irri-
tated skin
1b Tetraborates (a) Bath products (a) 18 % (by mass/mass as boric
acid)(a) Not to be used in products for
children under 3 yearsof age(a) Not to be used of bathing chil-
dren under 3 yearsof age
(b) Hair waving products (b) 8 % (by mass/mass as boric
acid)(b) Rinse well▼B1976L0768 — EN — 21.04.2002 — 003.001 — 25▼M3
▼M31
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
2a Thioglycollic acid and its salts (a) Hair waving or straightening
products:(a) (b) (c):
The directionsfor us e drawn up in
the national or official language(s)
must obligatorily incorporate the
following sentenses:
— Avoid contact with eyes
— In the event of contact with
eyes, rinse immediately with
plenty of water and seek
medical advice
— Wear suitable gloves ((a) and
(c) only)(a): — Containsthioglycolate
— Follow the instructions
— Keep out of reach of chil-
dren
— For professional use only
(b) and (c):
— Containsthioglycolate
— Follow the instructions— Keep out of reach of chil-
dren— general use — 8 % ready for use pH 7 to 9,5
— professional use — 11 % ready for use pH 7 to
9,5
(b) Depilatories— 5 % ready for us e pH 7 to
12,7
(c) Other hair-caire products
which are removed after
application— 2 % ready for use pH 6 to 9,5
The abovementioned percen-
tagesare calculated as
thioglycollic acid
2b Thioglycollic acid esters Hair waving or straightening
products:The directionsfor us e drawn up in
the national or official language(s)
must obligatorily incorporate the
following sentences:
— May cause sensitization in the
event of skin contact
— avoid contact with eyes— In the event of contact with
eyes, rinse immediately with
plenty of water and seek
medical advice
— Wear suitable gloves— Containsthioglycolate
— Follow the instructions
— Keep out of reach of children — general use — 8 % ready for use pH 6 to 9,5
— professional use — 11 % ready for use pH 6 to
9,5— For professional use only
The abovementioned percentages
are calculated asthioglycollic acid
3 Oxalic acid, itses tersand alcaline
saltsHair care products 5 % For professional use only
4 Ammonia 6 % calculated asNH
3Above 2 %: containsammonia
5 Tosylchloramide sodium (*) 0-2 %▼M311976L0768 — EN — 21.04.2002 — 003.001 — 26▼M13
▼M3
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
6 Chloratesof alkali metals (a) Toothpas te
(b) Other uses(a) 5 %
(b) 3 %
7 Dichloromethane 35 % (when mixed with 1,1,1-
trichloroethane, total concentra-
tion must not exceed 35 %)0·2 % asmaximum impurity
content
8►M34m- and p-Phenylenedia-
mines, their N-substituted
derivatives and their salts; N-
substituted derivatives of o-
Phenylenediamines(1), with the
exception of those derivatives
listedelsewhere in thisAnnex ◄Oxidizing colouring agentsfor
hair dyeing6 % calculated asfree bas e
(a) general use (a) Can cause an allergic reaction.
►M20 ◄
Containsphenylenediamines .
Do not use to dye eyelashes or
eyebrows
(b) professional use (b) For professional use only.
Containsphenylenediamines .
Can cause an allergic reaction.
►M20 ◄
►M22Wear suitable
gloves.◄
9►M5Methylphenylenediamines,
theirN-substituted derivattives
and their salts (1)with the exeption
of substance No 364 in Annex
II◄Oxidizing colouring agentsfor
hair dyeing10 % calculated asfree bas e
(a) general use (a) Can cause an allergic reaction.
►M20 ◄
Containsphenylenediamines .
Do not use to dye eyelashes or
eyebrows
(b) professional use (b) For professional use only.
Containsphenylenediamines .
Can cause en allergic reaction.
►M20 ◄
►M22Wear suitable
gloves.◄▼M31976L0768 — EN — 21.04.2002 — 003.001 — 27
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
10 Diaminophenols(1) Oxidizing colouring agentsfor
hair dyeing10 % calculated asfree bas e
(a) general use (a) Can cause an allergic reaction.
►M20 ◄
Containsdiaminophenols . Do
not use to dye eyelashes or
eyebrows
(b) professional use (b) For professional use only.
Containsdiaminophenols . Can
cause allergic reaction.
►M20 ◄
►M22Wear suitable
gloves.◄
11 Dichlorophen (*) 0,5 %12 Hydrogen peroxide, and other
compoundsor mixturesthat
release hydrogen peroxide,
including carbamide peroxide and
zinc peroxide(a) Hair-caire preparations12 % of H
2O2(40 volumes),
present or released►M22(a): Wear suitable
gloves◄
(b) Skin-care preparations4 % of H2O2present or released (b) (c):
Containshydrogen peroxide.
(c) Nail hardening preparations2 % of H2O2present or released Avoid contact with eyes. Rinse
immediately if product comesinto
contact with them
(d) Oral hygiene products0,1 % of H2O2present or released
13 Formaldehyde Nail hardeners5 % calculated as formaldehyde Protect cuticles with greas e or oil.
Containsformaldehyde (3).▼M31976L0768 — EN — 21.04.2002 — 003.001 — 28▼M12
▼M20
▼M3
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
14 Hydroquinone (2) (a) Oxidizing colouring agent for
hair-dyeing:►M310,3 %◄ (a)
1. General use 1. Do not use to dye eyedasches or
eybrows
Rinse the eyes immediately if the
product comesinto contact with
them.
Containshydroquinone
2. Professional use 2. For professional use only
Containshydroquinone
Rinse the eyes immediately if the
product comesinto contact with
them
►M31 ◄ (b)►M31 ◄► M31 ◄ (b)►M31 ◄
15a Potassium or sodium hydroxide (a) Nail cuticule solvent (a) 5 % by weight (4) (a) Containsalkali. Avoid contact
with eyes. Can cause blindness.
Keep out of reach of children
(b) Hair straightener (b) (b)
1. General use 1. 2 % by weight (4) 1. Containsalkali. Avoid contact
with eyes. Can cause blindness.
Keep out of reach of children
2. Professional use 2. 4,5 % by weight (4) 2. For professional use only. Avoid
contact with eyes. Can cause
blindness.
(c) pH adjuster
— depilatories(c) Up to pH 12,7 (c) Keep out of reach of children.
Avoid contact with eyes
(d) Other uses as pH adjuster (d) Up to pH 11▼M31976L0768 — EN — 21.04.2002 — 003.001 — 29▼M8
▼M25
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
15b Lithium hydroxide (a) Hair straighteners (a) (a)
1. General use 1. 2 % (5) by weight 1. Containsalkali
Avoid contact with eyesCan cause blindness
Keep out of reach of children
2. Professional use 2. 4,5 % (
5) by weight 2. For professional use only
Avoid contact with eyes
Can cause blindness
(b) pH ajuster — for depilatories (b) pH value not to exceed pH
12,7(b) Containsalkali
Keep out of reach of childrenAvoid contact with eyes
(c) Other uses — as pH adjuster
(for rinse-off products only)(c) pH value not to exceed pH 11
15c Calcium hydroxide Hair straighteners containing two
components: calcium hydroxide
and a guanidine salt(a) 7 % by weight of calcium
hydroxide(a) Containsalkali
Avoid contact with eyes
Keep out of reach of children
Can cause blindness
(b) pH ajuster — for depilatories (b) pH value not to exceed pH
12,7(b) Containsalkali
Keep out of reach of children
Avoid contact with eyes
(c) Other uses (e.g. pH adjuster,
processing aid)(c) pH value not to exceed pH 11▼M251976L0768 — EN — 21.04.2002 — 003.001 — 30▼M34
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
16 1-Naphthol (CAS No 90-15-3)
and itss altsOxidising colouring agents for
hair dyening2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application is
1,0 %Can cause allergie reaction
17 Sodium nitrite Rust inhibitor 0,2 % Do not use with secondary and/or
tertiary amines or other substances
forming nitrosamines
18 Nitromethane Rust inhibitor 0,3 %
19 Phenol and its alkali salts Soaps and shampoos 1 % calculated as phenol Contains phenol
►M20
◄
21 Quinine and itss alts (a) Shampoos (a) 0,5 % calculated as quinine
base
(b) Hair lotions(b) 0,2 % calculated as quinine
base▼M341976L0768 — EN — 21.04.2002 — 003.001 — 31▼M3
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
22 Resorcinol (2) (a) Oxidizing colouring agent for
hair dyeing(a) 5 % (a)
1. general use 1. Contains resorcinol. Rinse hair
well after application. Do not
use to dye eyelashes or
eyebrows.
Rinse eyes immediately if
product comesinto contact with
them
2. professional use 2. For professional use only.
Containsres orcinol.
Rinse eyes immediately if
product comesinto contact with
them
(b) Hair lotions and shampoos (b) 0,5 % (b) Contains resorcinol
23 (a) Alkali sulphides (a) Depilatories (a) 2 % calculated as sulphur
pH≤12,7(a) Keep out of reach of children.
Avoid contact with eyes
(b) Alkaline earth sulphides (b) Depilatories (b) 6 % calculated as sulphur
pH≤12,7(b) Keep out of reach of children.
Avoid contact with eyes
24 Water-soluble zinc salts with the
exception of zinc 4-hydroxy-
benzenesulphonate and zinc
pyrithione1 % calculated aszinc
25 Zinc 4-hydroxybenzene sulpho-
nateDeodorants, antiperspirants and
astringent lotions6 % calculated as% of anhydrous
substanceAvoid contact with eyes
26 Sodium monofluorophosphate Oral hygiene products 0,15 % calculated as F. When
mixed with other fluorine
compoundspermitted under this
Annex, total F concentration must
not exceed 0,15 %Containsammonium monofluoro-
phosphate▼M31976L0768 — EN — 21.04.2002 — 003.001 — 32
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
27 Sodium monofluorophosphate Ditto 0,15 % Ditto Contains sodium monofluoropho-
sphate
28 Potassium monofluorophosphate Ditto 0,15 % Ditto Contains potassium monofluoropho-
sphate
29 Calcium monofluorophosphate Ditto 0,15 % Ditto Contains calcium monofluoropho-
sphate
30 Calcium fluoride Ditto 0,15 % Ditto Containscalcium fluoride
31 Sodium fluoride Ditto 0,15 % Ditto Containss odium fluoride
32 Potassium fluoride Ditto 0,15 % Ditto Contains potassium fluoride33 Ammonium fluoride Ditto 0,15 % Ditto Containsammonium fluoride34 Aluminium fluoride Ditto 0,15 % Ditto Containsaluminium fluoride
35 Stannousfluoride Ditto 0,15 % Ditto Containss tannousfluoride
36 Hexadecyl ammonium fluoride Ditto 0,15 % Ditto Containshexadecyl ammonium
fluoride
37 3-(N-Hexadecyl-N-2-hydroxyethy-
lammonio) propylbis(2-
hydroxyethyl) ammonium
difluorideDitto 0,15 % Ditto Contains3-(N-Hexadecyl-N-2-
hydroxyethylammonio) propylbis
(2-hydroxyethyl) ammonium
difluoride
38 NN'N'-Tris(polyoxyethylene)- N-
hexadecylpropylenediamine dihy-
drofluorideDitto 0,15 % Ditto Contains NN'N'-tris(polyoxyethy-
lene)-N-hexadecylpropylenediamine
dihydrofluoride
39 Octadecenyl-ammonium fluoride Ditto 0,15 % Ditto Containsoctadecenyl-ammonium
fluoride▼M31976L0768 — EN — 21.04.2002 — 003.001 — 33
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
40 Sodium fluorosilicate Ditto 0,15 % Ditto Contains sodium fluorosilicate
41 Potassium fluorosilicate Ditto 0,15 % Ditto Contains potassium fluorosilicate
42 Ammonium fluorosilicate Ditto 0,15 % Ditto Contains ammonium fluorosilicate
43 Magnesium fluorosilicate Ditto 0,15 % Ditto Containes (SIC! Contains) magne-
sium fluorosilicate
44 1,3-Bis(hydroxymethyl)-imidazo-
lidine-2-thione(a) Hair-caire preparations
(b) Nail-care preparations(a) Up to 2 %
(b) Up to 2 %(a) Prohibited in aerosol dispen-
sers (sprays)
(b) The pH of the product as
applied must be less than 4Contains1,3-bis(hydroxymethyl)
immidazolidine-2-thione
45 Benzyl alcohol Solvents, perfumes and flavour-
ings
46 6-methylcoumarin Oral hygiene products0,003 %
47 Nicomethanol hydrofluride Oral hygiene products0,15 % calculated as F
When mixed with other fluorine
compoundspermitted under this
Annex, total F concentration must
not exceed 0,15 %Containsnicomethanol hydro-
fluoride
48 Silver nitrate Solely for productsintended for
colouring eyelashes and eyebrows4 % — Containss ilver nitrate
— Rinse the eyes immediately if
product comesinto contact with
them▼M31976L0768 — EN — 21.04.2002 — 003.001 — 34▼M10
▼M3
▼M4
▼M8
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
49 Selenium disulphide Antidandruff shampoos 1 % — Contains selenium disulphide
— Avoid contact with eyesor
damaged skin
50 Aluminium zirconium chloride
hydroxyde complexes
AlxZr(OH)yCIz and the alumi-
nium zirconium chloride
sydroxide glycine complexesAntiperspirants 20 % as anhydrous aluminium
zirconium chloride hydroxide
5,4 % aszirconium
5,4 % aszirconium1. The ratio of the number of
aluminium atomsto that of
zirconium atomsmus t be
between two an 10
2. The ratio of the number of
(Al + Zr) atomsto that of
chlorine atomsmus t be
between 0,9 and 2,1
3. Prohibited in aerosol dispen-
sers (sprays)Do not apply to irritated or damaged
skin
51 Quinolin-8-old and bis(8-
hydroxy-quinolium) sulphateStabilizer for hydrogen peroxide
in rinse-off hair-care preparations0,3 % calculated asbas e
Stabilizer for hydrogen peroxide
in non-rinse-off hair-care prepara-
tions0,03 % calculated asbas e
52 Methanol Denaturant for ethanol and
isopropyl alcohol5 % calculated asa % ethanol and
isopropyl acohol
53 Etidronic acid (1-hydroxyethyli-
dene-di-phosphonic acid and its
salts)(a) Hair-care 1,5 % expressed as etidronic acid ►M15 ◄
(b) Soap 0,2 % expressed as etidronic acid
54 1-Phenoxy-propzan-2-ol — Rinse-off products only 2,0 % As a preservative, see Annex VI,
Part 1, No 43
— Prohibited in oral hygiene
products▼M81976L0768 — EN — 21.04.2002 — 003.001 — 35▼M9
▼M13
▼M12
▼M13
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
55 Lead acetate Only for hair-dyeing 0,6 % calculated in lead Keep away from children. Avoid all
contact with the eyes. Wash hands
after use. Contains lead acetate. Do
not use to dye eyelashes, eyebrows
or moustasches. If irritation
develops, discountinue use.
56 Magnesium fluoride Dental hygiene products 0,15 % calculated as F. When
mixed with other fluorine
compoundspermitted under this
Annex, total F concentration must
not exceed 0,15 %Containsmagnes ium fluoride
57 Strontium chloride hexahydrate (a) Toothpaste 3,5 %, calculated as strontium.
When mixed with other permitted
strontium products the total stron-
tium content must not exceed
3,5 %Containss trontium chloride.
Frequent use by children is not
advisable
(b) Shampoo and face care
products2,1 %, calculated ass trontium.
When mixed with other permitted
strontium products the total stron-
tium content must not exceed
2,1 %
58 Strontium acetate hemihydrate Toothpaste 3,5 %, calculated as strontium.
When mixed with other permitted
strontium products the total stron-
tium content must not exceed
3,5 %Containss trontium acetate. Frequent
use by children is not advisable▼M131976L0768 — EN — 21.04.2002 — 003.001 — 36▼M17
▼M18
▼M30
▼M20
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
59 Talc: Hydrated magnesium sili-
cate(a) Powdery productsintended to
be used for children under
three yearsof age
(b) other products►C4a) Keep powder away from
children'snos e and mouth ◄
60 Fatty acid dialkanolamidesMaximum dialkanolamine
content: 0,5 %— Do not use with nitrosating
systems
— Maximum dialkanolamine
content: 5 % (concernsraw
materials)
— Maximum N-nitroso-dialkano-
lamine content: 50 µg/kg
— Keep in nitrite-free containers
61 MonoalkanolaminesMaximum dialkanolamine
content: 0,5 %— Do not use with nitrosating
systems
— Minimum purity: 99 %— Maximum secondary alkanola-
mine content: 0,5 % (concerns
raw materials)
— Maximum N-nitrosodialkano-
lamine content: 50 µg/kg
— Keep in nitrite-free containers
62 Trialkanolamines(a) non-rins e-off products
(b) other products(a) 2,5 % (a) (b):
— Do not use with nitrosating
systems
— Minimum purity: 99 %— Maximum secondary alkanola-
mine content: 0,5 % (concerns
raw materials)
— maximum N-nitrosodialkano-
lamine content: 50 µg/kg
— Keep in nitrate-free containers▼M201976L0768 — EN — 21.04.2002 — 003.001 — 37▼M23
▼M20
Reference
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitationsand requirements
AB C D E F
63 Strontium hydroxide pH-regulator in depilatory
products3,5 % calculated ass trontium,
max. pH of 12,7— Keep out of reach of children
— Avoid contact with the eyes
64 Strontium peroxide Rinse-off hair care preparations
professional use4,5 % calculated ass trontium in
the ready-for-use preparationAll productsmus t meet the
hydrogen peroxide release
requirements— Avoid contact with eyes
— Rinse eyes immediately if
product comesinto contact with
them
— For professional use only— Wear suitable gloves
65 Benzalkonium Chloride, bromide
and saccharinate(a) Rinse-off hair (head) care
products(a) 3 % (asbenzalkonium
chloride)(a) In the final productsthe
concentrationsof benzalkonium
chloride, bromide and sacchari-
nate with an alkyl chain of C
14,
or less must not exceed 0,1 % (as
benzalkonium chloride)(a) Avoid contact with the eyes
(b) Other products(b) 0,1 % (as benzalkonium
chloride)(b) Avoid contact with the eyes
66 Polyacrylamides(a) Body-care leave-on products (a) Maximum res idual acrylamide
content 0,1 mg/kg
(b) Other cosmetic products (b) Maximum residual acrylamide
content 0,5 mg/kg▼M201976L0768 — EN — 21.04.2002 — 003.001 — 38▼M23
▼M31
▼M34
►M34(1) 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 expressed with reference to the maximum level authorised for each of
them doesnot exceed 1. ◄
(2) 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 expressed with reference to the maximum level authorized for each of them does
not exceed 2.
(3) Only if the concentration exceeds0,05 %.
(4) The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limitsgiven in column d.
►M34(5) The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not excee d the limitsgiven in column d. ◄▼M31976L0768 — EN — 21.04.2002 — 003.001 — 39▼M25
▼B
►M14 Part2 ◄
LISTOFSUBSTANCESPROVISIONALLYALLOWED
Refer-
ence
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitationsand requirements
AB C D E F G
►M24
◄
1 Basic Blue 7 (CAS No 2390-60-
5)Non-oxidising colouring agents
for hair dyeing0,2 % Can cause allergic reaction 30.9.2004
2 2-Amino-3-nitrophenol (CAS No
603-85-0) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 3,0 %
3 4-Amino-3-nitrophenol (CAS No
610-81-1) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 3,0 %
4 2,7-Naphthalenediol (CAS no
582-17-2) and itss altsOxidising colouring agents for
hair dyeing1,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,5 %30.9.2004
5 m-Aminophenol (CAS no 591-
27-5) and itss altsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %Can cause allergic reaction 30.9.2004
6 2,6-Dihydroxy-3,4-dimethylpyri-
dine (CAS No 84540-47-6) and
itss altsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %Can cause allergic reaction 30.9.2004▼M111976L0768 — EN — 21.04.2002 — 003.001 — 40▼M34
Refer-
ence
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitationsand requirements
AB C D E F G
7 4-Hydroxypropylamino-3-nitro-
phenol (CAS No 92952-81-3)
and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 5,2 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is2,6 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 2,6 %
8 6-Nitro-2,5-pyridinediamine
(CAS No 69825-83-8) and its
saltsNon-oxidising colouring agent
for hair dyeing3,0 % Can cause allergic reaction 30.9.2004
9 HC Blue No 11 (CAS No
23920-15-2) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 2,0 %
10 Hydroxyethyl-2-nitro-p-toluidine
(CAS No 100418-33-5) and its
salts(a) Oxidising colouring agents
for hair dyeing(a) 2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 1,0 %
11 2-Hydroxyethylpicramic acid
(CAS No 99610-72-7) and its
salts(a) Oxidising colouring agents
for hair dyeing(a) 3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon applicationis1,5 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 2,0 %
12 p-Methylaminophenol (CAS No
150-75-4) and itss altsOxidising colouring agent for
hair dyeing3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %Can cause allergic reaction 30.9.2004
13 2,4-Diamino-5-methylphenox-
yethanol (CAS No 141614-05-3)
and itss altsOxidising colouring agent for
hair dyeing3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %Can cause allergic reaction 30.9.2004▼M341976L0768 — EN — 21.04.2002 — 003.001 — 41
Refer-
ence
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitationsand requirements
AB C D E F G
14 HC Violet No 2 CAS No
104226-19-9) and itss altsNon-oxidising colouring agent
for hair dyeing2,0 % 30.9.2004
15 Hydroxyethyl-2,6-dinitro-p-anisi-
dine (CAS No 122252-11-3) and
itss altsNon-oxidising colouring agent
for hair dyeing3,0 % Can cause allergic reaction 30.9.2004
16 HC Blue No 12 (CAS No
104516-93-0) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 1,5 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,75 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 1,5 %
17 2,4-Diamino-5-methylphenetol
(CAS No 141614-04-2) and its
saltsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %Can cause allergic reaction 30.9.2004
18 1,3-Bis-(2,4-diaminophenoxy)-
propane (CAS No 81892-72-0)
and itss altsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %Can cause allergic reaction 30.9.2004
19 3-Amino-2,4-dichlorophenol
(CAS No 61693-42-3) and its
saltsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %Can cause allergic reaction 30.9.2004
20 Phenyl methyl pyrazolone (CAS
No 89-25-8) and itss altsOxidising colouring agents for
hair dyeing0,5 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,25 %30.9.2004
21 2-Methyl-5-hydroxyethylamino-
phenol (CAS No 55302-96-0)
and itss altsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %Can cause allergic reaction 30.9.2004▼M341976L0768 — EN — 21.04.2002 — 003.001 — 42
Refer-
ence
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitationsand requirements
AB C D E F G
22 Hydroxybenzomorpholine (CAS
No 26021-57-8) and itss altsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %Can cause allergic reaction 30.9.2004
23 1,7-Naphthalenediol (CAS No
575-38-2) and itss altsOxidising colouring agents for
hair dyeing1,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,5 %Can cause allergic reaction 30.9.2004
24 HC Yellow No 10 (CAS No
109023-83-8) and itss altsNon-oxidising colouring agents
for hair dyeing0,2 % 30.9.2004
25 2,6-Dimethoxy-3,5-pyridinedia-
mine (CAS No 85679-78-3) and
itss altsOxidising colouring agents for
hair dyeing0,5 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,25 %Can cause allergic reaction 30.9.2004
26 HC Orange No 2 (CAS No
85765-48-6) and itss altsNon-oxidising colouring agents
for hair dyeing1,0 % 30.9.2004
27 HC Violet No 1 (CAS No
82576-75-8) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 0,5 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,25 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 0,5 %
28 3-Methylamino-4-nitro-phenox-
yethanol (CAS No 59820-63-2)
and itss altsNon-oxidising colouring agents
for hair dyeing1,0 % 30.9.2004
29 2-Hydroxy-ethylamino-5-nitro-
anisole (CAS No 66095-81-6)
and itss altsNon-oxidising colouring agents
for hair dyeing1,0 % 30.9.2004▼M341976L0768 — EN — 21.04.2002 — 003.001 — 43
Refer-
ence
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitationsand requirements
AB C D E F G
30 2-Chloro-5-nitro-N-hydro-
xyethyl-p-phenylenediamine
(CAS No 50610-28-1) and its
salts(a) Oxidising colouring agents
for hair dyeing(a) 2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 1,0 %
31 HC Red No 13 (CAS No 29705-
39-3) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 2,5 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,25 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 2,5 %
32 1,5-Naphthalenediol (CAS No
83-56-7) and itss altsOxidising colouring agents for
hair dyeing1,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,5 %30.9.2004
33 Hydroxypropyl bis(N-hydro-
xyethyl-p-phenylenediamine)
(CAS No 128729-30-6) and its
saltsOxidising colouring agents for
hair dyeing3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %Can cause allergic reaction 30.9.2004
34 o-Aminophenol (CAS No 95-55-
6) and itss altsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %30.9.2004
35 4-Amino-2-hydroxytoluene
(CAS No 2835-95-2) and its
saltsOxidising colouring agents for
hair dyeing3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %30.9.2004
36 2,4-Diaminophenoxyethanol
(CAS No 70643-19-5) and its
saltsOxidising colouring agents for
hair dyeing4,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is2,0 %30.9.2004▼M341976L0768 — EN — 21.04.2002 — 003.001 — 44
Refer-
ence
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitationsand requirements
AB C D E F G
37 2-Methylresorcinol (CAS No
608-25-3) and itss altsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %30.9.2004
38 4-Amino-m-cresol (CAS No
2835-99-6) and itss altsOxidising colouring agents for
hair dyeing3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %30.9.2004
39 2-Amino-4-hydroxyethylaminoa-
nisole (CAS No 83763-47-7) and
itss altsOxidising colouring agents for
hair dyeing3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %30.9.2004
40 3,4-Diamino-benzoicacid (CAS
No 619-05-6) and itss altsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %30.9.2004
41 6-Amino-o-cresol (CAS No
17672-22-9) and itss altsOxidising colouring agents for
hair dyeing3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %30.9.2004
42 2-Aminomethyl-p-aminophenol
(CAS No 79352-72-0) and its
saltsOxidising colouring agents for
hair dyeing3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %30.9.2004
43 Hydroxyethylamino-methyl-p-
aminophenol (CAS No 110952-
46-0) and itss altsOxidising colouring agents for
hair dyeing3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %30.9.2004▼M341976L0768 — EN — 21.04.2002 — 003.001 — 45
Refer-
ence
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitationsand requirements
AB C D E F G
44 Hydroxyethyl-3,4-methylene-
dioxyaniline (CAS No 81329-90-
0) and itss altsOxidising colouring agents for
hair dyeing3,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,5 %30.9.2004
45 Acid Black 52 (CAS No 16279-
54-2) and itss altsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %30.9.2004
46 2-Nitro-p-phenylenediamine
(CAS No 5307-14-2) and its
salts(a) Oxidising colouring agents
for hair dyeing(a) 0,3 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,15 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 0,3 %
47 HC Blue No 2 (CAS No 33229-
34-4) and itss altsNon-oxidising colouring agents
for hair dyeing2,8 % 30.9.2004
48 3-Nitro-p-hydroxyethylamino-
phenol (CAS No 65235-31-6)
and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 6,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is3,0 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 6,0 %
49 4-Nitrophenyl aminoethylurea
(CAS No 27080-42-8) and its
salts(a) Oxidising colouring agents
for hair dyeing(a) 0,5 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,25 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 0,5 %
50 HC Red No 10 + HC Red No 11
(CAS No 95576-89-9 + 95576-
92-4) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 1,0 %▼M341976L0768 — EN — 21.04.2002 — 003.001 — 46
Refer-
ence
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitationsand requirements
AB C D E F G
51 Yellow No 6 (CAS No 104333-
00-8) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 1,0 %
52 HC Yellow No 12 (CAS No
59320-13-7) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 1,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,5 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 0,5 %
53 HC Blue No 10 (CAS No
173994-75-7) and itss altsOxidising colouring agents for
hair dyeing2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %30.9.2004
54 HC Blue No 9 (CAS No
114087-47-1) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 1,0 %
55 2-Chloro-6-ethylamino-4-nitro-
phenol (CAS No 131657-78-8)and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 3,0 % In combination with hydrogen
peroxide the maximum useconcentration upon application
is1,5 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 3,0 %
56 2-Amino-6-chloro-4-nitrophenol
(CAS No 6358-09-4) and its
salts(a) Oxidising colouring agents
for hair dyeing(a) 2,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is1,0 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 2,0 %▼M341976L0768 — EN — 21.04.2002 — 003.001 — 47
Refer-
ence
numberSubstanceRestrictions
Conditionsof us e and warningswhich
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitationsand requirements
AB C D E F G
57 Basic Blue 26 (CAS No 2580-
56-5) (CI 44045) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 0,5 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,25 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 0,5 %
58 Acid Red 33 (CAS No 3567-66-
6) (CI 17200) and itss altsNon-oxidising colouring agents
for hair dyeing2,0 % 30.9.2004
59 Ponceau SX (CAS No 4548-53-
2) (CI 14700) and itss altsNon-oxidising colouring agents
for hair dyeing2,0 % 30.9.2004
60 Basic Violet 14 (CAS No 632-
99-5) (CI 42510) and itss alts(a) Oxidising colouring agents
for hair dyeing(a) 0,3 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is0,15 %30.9.2004
(b) Non-oxidising colouring
agentsfor hair dyeing(b) 0,3 %
61 Musk xylene (CAS no 81-15-2) All cosmetic products, with the
exception of oral care products(a) 1,0 % in fine
fragrance28.2.2003
(b) 0,4 % in eau
de toilette
(c) 0,03 % in
other products
62 Musk ketone (CAS No 81-14-1) All cosmetic products, with the
exception of oral care products(a) 1,4 % in fine
fragrance28.2.2003
(b) 0,56 % in eau
de toilette
(c) 0,042 % in
other products▼M341976L0768 — EN — 21.04.2002 — 003.001 — 48
▼B
ANNEX IV
►M14 PART1 ◄
LISTOFCOLOURINGAGENTSALLOWEDFORUSEINCOSMETICPRODUCTS (1)
Fieldofapplication
Column 1 = Colouring agents allowed in all cosmetic products.
Column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied
in the vicinity of the eyes, in particular eye make-up and eyemake-up remover.
Column 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into
contact with the mucousmembranes .
Column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into
contact only briefly with the skin.
Colour index number
or denominationColourField of applicationOther limitationsand
requirements(2)1234
10006 Green X
10020 Green X
10316 (3) Yellow X
11680 Yellow X
11710 Yellow X
11725 Orange X
11920 Orange X
12010 Red X
►M18 ◄
12085 (3) Red X 3 % maximum
concentration in the
finished product
12120 Red X
12150 Red X
12370 Red X
12420 Red X
12480 Brown X
12490 Red X
12700 Yellow X ►M15 ◄
13015 Yellow X E 105
►M13 ◄
14270 Orange X E 103
14700 Red X
14720 Red X E 122
14815 Red X E 125
15510 (3) Orange X
15525 Red X
15580 Red X
►M18 ◄
15620 Red X
15630 (3) Red X 3 % maximum
concentration in the
finished product
15800 Red X ►M15 ◄
15850 (3) Red X
15865 Red X
15880 Red X1976L0768 — EN — 21.04.2002 — 003.001 — 49
▼M10
▼M10
Colour index number
or denominationColourField of applicationOther limitationsand
requirements(2)1234
15980 Orange X E 111
15985 (3) Yellow X E 110
16035 Red X16185 Red X E 123
16230 Orange X
16255 (
3) Red X E 124
16290 Red X E 126
17200
►M17(3)◄Red X
18050 Red X
18130 Red X18690 Yellow X
18736 Red X
18820 Yellow X18965 Yellow X
19140 (
3) Yellow X E 102
20040 Yellow X maximum 3,3'-
dimethylbenzidine
concentration in the
colouring agent:
5 ppm
20170 Orange X
20470 Black X ►M15 ◄
21100 Yellow X maximum 3,3'-
dimethylbenzidine
concentration in the
colouring agent:
5 ppm
21108 Yellow X ditto
21230 Yellow X
24790 Red X
26100 Red X Purity criteria:
aniline≤0,2 %
2-naphtol ≤0,2 %
4-aminoazobenzene
≤0,1 %
1-(phenylazo)-2-
naphtol≤3%
1-[2-(phenylazo)-
phenylazo]-2-
napthalenol ≤2%
27290 (3) Red X E 152
27755 Black X E 15228440 Black X E 151
40215 Orange X
40800 Orange X40820 Orange X E 160 e
40825 Orange X E 160 f
40850 Orange X E 161 z1976L0768 — EN — 21.04.2002 — 003.001 — 50
▼M20
▼M10
▼M10
Colour index number
or denominationColourField of applicationOther limitationsand
requirements(2)1234
42045 Blue ►M17
X
◄►M17 ◄
42051 (3) Blue X E 131
42053 Green X
42080 Blue X X
42090 Blue
42100 Green X
42170 Green X ►M15 ◄
42510 Violet X
42520 Violet X 5 ppm maximum
concentration in the
finished product
►M17 ◄
42735 Blue X44045 Blue ►
M17
X
◄►M17 ◄
44090 Green X E 142
45100 Red X
►M18 ◄
►M18 ◄
45190 Violet X ►M15 ◄
45220 Red X
45350 Yellow X 6 % maximum
concentration in the
finished product
45370 (3) Orange X not more than 1 %
2-(6-hdroxy-3-oxo-
3H-xanthen-9-y1)
benzoic acid and
2 % 2-(bromo-6-
hydroxy-3-oxo-3H-
xanthen-9-yl)
benzoic acid
45380 (3) Red X ditto
45396 Orange X when used in
lipstick, the
colouring agent is
allowed only in free
acid form and in a
maximum concen-
tration of 1 %
45405 Red X not more than 1 %
2-(6-hydroxy-3-
oxo-3Ηxanthen-9-
yl) benzoic acid
and 2 % 2-(bromo-
6-hydroxy-3-oxo-
3H-xanthen-9-yl)
benzoic acid
45410 (3) Red X ditto1976L0768 — EN — 21.04.2002 — 003.001 — 51
▼M10
Colour index number
or denominationColourField of applicationOther limitationsand
requirements(2)1234
45425 Red X not more than 1 %
2-(6-hydrxy-3-oxo-
3H-xanthen-9-yl)
benzoic acid and
3 % 2-(iodo-6-
hydroxy-3-oxo-3H-
xanthen-9-yl)
benzoic acid
45430 (3) Red X E 127 ditto
47000 Yellow X ►M15 ◄
47005 Yellow X E 10450325 Violet X50420 Black X51319 Violet X58000 Red X59040 Green X60724 Violet X60725 Violet X60730 Violet X61565 Green X61570 Green X61585 Blue X62045 Blue X69800 Blue X E 130
69825 Blue X
71105 Orange X73000 Blue X73015 Blue X E 13273360 Red X73385 Violet X73900 Violet X ►
M20 ◄
73915 Red X74100 Blue X74160 Blue X74180 Blue X ►
M20 ◄
74260 Green X75100 Yellow X75120 Orange X E 160 b75125 Yellow X E 160 d75130 Orange X E 160 a
75135 Yellow X E 161 d
75170 White X75300 Yellow X E 10075470 Red X E 12075810 Green X E 140 and E 14177000 White X E 17377002 White X77004 White X77007 Blue X1976L0768 — EN — 21.04.2002 — 003.001 — 52
▼M10
Colour index number
or denominationColourField of applicationOther limitationsand
requirements(2)1234
77015 Red X
77120 White X
77163 White X
77220 White X E 170
77231 White X
77266 Black X
77267 Black X
77268:1 Black X E 153
77288 Green X free from chromate
ion
77289 Green X free from chromate
ion
77346 Green X
77400 Brown X
77480 Brown X E 175
77489 Orange X E 172
77491 Red X E 172
77492 Yellow X E 172
77499 Black X E 172
77510 Blue X free from cyanide
ions
77713 White X
77742 Violet X77745 Red X
77820 White X E 174
77891 White X E 171
77947 White X
Lactoflavin Yellow X E 101
Caramel Brown X E 150
Capsanthin, capsor-
ubinOrange X E 160 g
Beetroot red Red X E 162
AnthocyaninsRed X E 162
Aluminium, zinc,
magnesium and
calcium stearatesWhite X
Bromothymol blue Blue X
Bromocresol green Green X
Acid red 195 Red X
(1) Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded under
Annex V from the scope of this Directive are equally allowed.
(2) Colouring agentswhos e number ispreceded by the letter ‘E’ in accordance whith the EEC Directive of 1962
concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives.
They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerningcolouring matterswhere the letter ‘E’ hasbeen deleted therefrom.
(
3) The insoluble barium, strontium and zirconium lakes, salts and pigments of these colouring agents shall also be
permitted. They must pass the test for insolubility which will be determined by the procedure laid down in
Article 8.1976L0768 — EN — 21.04.2002 — 003.001 — 53
▼M12
▼M10
▼M13
▼B
▼M10
PART2
LIST OF COLOURING AGENTS PROVISIONALLY ALLOWEDFOR USE IN COSMETIC
PRODUCTS (1)
Fieldofapplication
Column 1 = Colouring agents allowed in all cosmetic products.
Column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied
in the vicinity of the eyes, in particular eye make-up and eye make-up remover
Column 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into
contact with the mucousmembranes .
Column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into
contact only briefly with the skin.
Colour index number or
denominationColourField of application Other limita-
tionsand
requirementsAuthorization
valid until1234
►M20 ◄
(1) Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded under
Annex V from the scope of this Directive are equally allowed.1976L0768 — EN — 21.04.2002 — 003.001 — 54
▼B
ANNEX V
LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE
DIRECTIVE
5. Strontium and its compounds, with the exception of strontium lactate, stron-
tium nitrate and strontium polycarboxylate listed in Annex II, strontium
sulphide, strontium chloride, strontium acetate, strontium hydroxide, stron-
tium peroxide, under the conditionslaid down in Annex III, Part 1 and of
strontium lakes, pigments and salts of the colouring agents listed with the
reference (3) in Annex IV, Part 1.1976L0768 — EN — 21.04.2002 — 003.001 — 55
▼M17
▼M12
▼M17
▼M5
▼M23
▼M17
▼M18
▼M17
▼M10
▼M8
▼M11
ANNEX VI
LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY
CONTAIN
PREAMBLE
1. Preservatives are substances which may be added to cosmetic products for
the primary purpose of inhibiting the development of micro-organisms in
such products.
2. The substances marked with the symbol (*) may also be added to cosmetic
productsin concentration other than thos e laid down in thisAnnex for other
specific purposes apparent from the presentation of the products, e.g. as
deodorants in soaps or as anti-dandruff agents in shampoos.
3. Other substances used in the formulation of cosmetic products may 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 thisAnnex.
4. For the purposes of this list:
— ‘Salts’ is taken to mean: salts of the cations sodium, potassium, calcium,
magnesium, ammonium and ethanolamines; salts of the anions chloride,
bromide, sulphate, acetate.
— ‘Esters’ is taken to mean: esters of methyl, ethyl, propyl, isopropyl, butyl,
isobutyl, phenyl.
5. All finished products containing formaldehyde or substances in this Annex
and which release formaldehyde must be labelled with the warning ‘contains
formaldehyde’ where the concentration of formaldehyde in the finished
product exceeds0,05 %.1976L0768 — EN — 21.04.2002 — 003.001 — 56
PART 1
LISTOFPRESERVATIVESALLOWED
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
1 Benzoic acid, its salts and esters (*) 0,5 % (acid)
2 Propionic acid and itss alts(*) 2 % (acid)3 Salicylic acid and its salts (*) 0,5 % (acid) Not to be used in preparations for children
under three yearsof age, except for s ham-
poosNot to be used for children under three years
of age (
1)
4 Sorbic acid (hexa-2,4-dienoic acid) and its
salts (*)0,6 % (acid)
5 Formaldehyde paraformaldehyde 0,2 % (except for productsfor oral
hygiene)
0,1 % (productsfor oral hygiene)
0,2 % expressed as the phenolProhibited in aerosol dispensers (sprays)
►M12
◄
7 Biphenyl-2-ol (o-phenylphenol) and its
salts (*)0,2 % expressed as the phenol
8 Pyrithione zinc (INN) (*) 0,5 % Authorized in productsrins ed off
Forbidden in productsfor oral hygiene
9 Inorganic sulphites and hydrogen- sulphites
(*)0,2 % expressed as free SO2
10 Sodium iodate 0,1 % Rinse-off products only
11 Chlorobutanol (INN) 0,5 % Prohibited in aerosol dispensers (sprays) Contains chlorobutanol▼M111976L0768 — EN — 21.04.2002 — 003.001 — 57
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
12 4-Hydroxybenzoic acid and itss altsand
esters (*)4 % (acid) for 1 ester,
0,8 % (acid) for mixturesof es ters
13 3-Acetyl-6-methylpyran-2,4 (3H)-dione
(Dehydracetic acid) and itss alts0,6 % (acid) Prohibited in aerosol dispensers (sprays)
14 Formic acid and its sodium salt (+) 0,5 % (expressed as acid)
15 3,3‘-Dibromo-4,4‘-hexamethylenedioxydi-
benzamidine (Dibromohexamidine) and its
salts (including isethionate)0,1 %
16 Thiomersal (INN) 0,007 % (of Hg)
If mixed with other mercurial compounds
authorized by thisDirective, the maximum
concentration of Hg remainsfixed at
0,007 %For eye make-up and eye make-up remover
onlyContainsthiomers al
17 Phenylmercuric salts (including borate) Ditto Ditto Contains phenylmercuric compounds
18 Undec-10-enoic acid and salts (*) 0,2 % (acid) See Annex VI, Part 2, No 8
19 Hexetidine (INN) (*) 0,1 % ►M13 ◄
20 5-Bromo-5-nitro-1,3-dioxane 0,1 % Rinse-off products only
Avoid formation of nitrosamines
►M15 ◄
21 Bronopol (INN) (*) 0,1 % Avoid formation of nitrosamines22 2,4-Dichlorobenzyl alcohol (*) 0,15 %▼M111976L0768 — EN — 21.04.2002 — 003.001 — 58▼M23
▼M11
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
23 Triclocarban (INN) (*) 0,2 % Purity criteria:
3,3',4,4'-Tetrachloroazobenzene <1 ppm
3,3',4,4'-Tetrachloroazoxybenzene <1 ppm
24 4-Chloro-m-cresol (*) 0,2 % Prohibited in the products intended to
come into contact with mucousmembranes
25 Tricolosan (INN) (*) 0,3 %
26 4-Chloro-3,5-xylenol (*) 0,5 %27 3,3'-Bis(1-hydroxymethyl-2,5-dioxoimida-
zolidin-4-yl)-1,14-methylenediurea
(‘Imidazolidinyl urea’) (*)0,6 %
28 Poly (1-hexamethylenebiguanide hydro-
chloride (*)0,3 %
29 2-Phenoxyethanol (*) 1,0 %
30 Hexamethylenetetramine (*) (methena-
mine) (INN)0,15 %
31 Methenamine 3-chloroallylochloride
(INNM)0,2 %
32 1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-
dimethylbutan-2-one (*)0,5 %
33 1,3-Bis(hydroxymethyl)-5,5-dimethylimi-
dazolidine-2,4-dione (*)0,6 %
34 Benzyl alchohol (*) 1,0 %
35 1-Hydroxy-4-methyl-6(2,4,4-trimethyl-
pentyl) 2-pyridon and its
monoethanolamine salt (*)1,0 %
0,5 %Productsrins ed off
For other products▼M111976L0768 — EN — 21.04.2002 — 003.001 — 59
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
36 1,2-Dibromo-2,4-dicyanobutane 0,1 % ►M20Not to be used in cosmetic sunsc-
reen productsat a concentration exceeding
0,025 % ◄
37 6,6-Dibromo-4,4-dichloro2,2‘-methylene-
diphenol (Bromochlorophen) (*)0,1 %
38 4-Isopropyl-m-cresol 0,1 %
39 Mixture of 5-Chloro-2-methyl-isothiazol-
3(2H)-one and 2-methylisothiazol-3(2H)-
one with magnesium chloride and magne-
sium nitrate►M150,0015 % ◄(of a mixture in the
ratio 3:1 of 5-chloro-2-methylisothiazol
3(2H)-one and 2-methylisothiazol-3 (2H)-
one
40 2-Benzyl-4-chlorophenol (clorophene) 0.2 %41 2-Chloroacetamide 0,3 % Containschloroacetamide
42 Chlorhexidine (INN) and itsdigluconate,
diacetate and dihydrochloride (+)0,3 % expressed as clorhexidine
43 1-Phenoxypropan-2-ol 1,0 % Only for rinse-off products44 Alkyl (C12-C22) trimethyl ammonium,
bromide and chloride (*)0,1 %
45 4,4-dimethyl-1,3-oxizalidine 0,1 % The pH of the finished product must not be
lower than 6
46 N-(Hydroxymethyl)-N-(dihydroxymethyl-
1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydro-
xymethyl) urea0,5 %▼M111976L0768 — EN — 21.04.2002 — 003.001 — 60▼M12
▼M13
▼M18
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
47 1,6-Di (4-amidinophenoxy)-n-hexane
(Hexamidine) and itss alts(including
isethionate and p-hydroxybenzoate) (+)0,1 %
48 Glutaraldehyde (Pentane-1,5-dial) 0,1 % Prohibited in aerosols (sprays) Contains glutaraaldehyde (where glutaralde-
hyde concentration in the finished product
exceeds0,05 %)
49 5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0]
octane0,3 % Prohibited in oral hygiene productsand in
productsintended to come into contact
with mucousmembranes
50 3-(p-chlorophenoxy)-propane-1,2 diol
(chlorphenesin)0,3 %
51 Sodium hydroxymethylamino acetate
(Sodium Hydroxymethylglycinate)0,5 %
52 Silver chloride deposited on titanium
dioxide0,004 % calculated asAgCI 20 % AgCI (W/W) on TiO2. Prohibited in
productsfor children under three yearsof
age, in oral hygiene productsand in
productsintended for application around
the eyesand on the lips
53 Benzethonium chloride 0,1 % Rinse-off products only54 Belzalkonium chloride, bromide and
saccharinate (+)0,1% calculated asbenzalkonium chloride Not for oral hygiene and lip products
55 Benzylhemiformal 0,15 % Only for productsto be removed by rins ing▼M181976L0768 — EN — 21.04.2002 — 003.001 — 61▼M20
▼M23
▼M25
▼M28
▼M30
▼M31
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
56 3-Iodo-2-propynylbutylcarbamate 0,05 % 1. Not to be used for oral hygiene and
lipcare products
2. If the concentration in productsintended
to remain on the skin exceeds 0,02 % add
the phrase: Contains iodineContainsiodine
(1) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin.▼M311976L0768 — EN — 21.04.2002 — 003.001 — 62▼B
PART 2
LISTOFPRESERVATIVESPROVISIONALLYALLOWED
Reference number Substance Maximum authorized concentration Limitations and requirementsConditionsof us e and warnings
which must be printed on the labelAllowed until
ABGDEF
►M15 ◄
►M25 ◄
►M15 ◄
►M18 ◄
►M15 ◄
►M18 ◄
►M13 ◄
►M12 ◄
►M13 ◄
►M12 ◄
►M13 ◄
►M24 ◄
►M30 ◄
►M18 ◄
►M13 ◄
►M15 ◄
►M20 ◄▼M111976L0768 — EN — 21.04.2002 — 003.001 — 63
Reference number Substance Maximum authorized concentration Limitations and requirementsConditionsof us e and warnings
which must be printed on the labelAllowed until
ABGDEF
►M13 ◄
►M15 ◄
►M23 ◄▼M111976L0768 — EN — 21.04.2002 — 003.001 — 64▼M31
▼M23
▼M11
▼M31
▼M25
▼M7
ANNEX VII
ListofUVfilterswhichcosmetic productsmaycontain
For the purposes of this Directive, UV filters are substances which, contained in
cosmetic sun-screen products, are specifically intended to filter certain UV rays
in order to protect the skin from certain harmful effects of these rays.
These UV filters may be added to other cosmetic products within the limits and
under the conditionslaid down in thisAnnex.
Other UV filters used in cosmetic products solely for the purpose of protecting
the product against UV rays are not included in this list.1976L0768 — EN — 21.04.2002 — 003.001 — 65
PART1
ListofpermittedUVfilterswhichcosmetic productsmaycontain
Reference
NoSubstances Maximum authorized concentration Other limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
1 4-Aminobenzoic acid 5 %
2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidene-
methyl) anilinium methyl sulphate6%
3 Homosalate (INN) 10 %
4 Oxybenzone (INN) 10 % Containsoxybenzone (1)
►M22
◄
6 2-phenylbenzimidazole-5-sulphonic acid
and its potassium, sodium and triethanola-
mine salts8%
(expressed as acid)
7 3,3'-(1,4-Phenylenedimethylene) bis(7, 7-
dimethyl-2-oxobicyclo-[2,2,1]hept-1-yl-
methanesulfonic acid and its salts10 %
(expressed as acid)
8 1-(4-tert-butylphrnyl)-3-(4-methoxyphe-
nyl)propane-1,3-dione5%
9 alpha-(2-Oxoborn-3-ylidene)-toluene-4-
sulphonic acid and its salts6%
(expressed as acid)
10 2-cyano-3,3-diphenyl acrylic acid, 2-ethyl-
hexyl ester (Octocrylene)10 %
(expressed as acid)▼M71976L0768 — EN — 21.04.2002 — 003.001 — 66
▼M23
▼M22
▼M23
▼M24
Reference
NoSubstances Maximum authorized concentration Other limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
11 Polymer of N-{(2 and 4)-[(2-oxoborn-3-
ylidene)methyl]benzyl}acrylamide6%
12 Octyl methoxycinnamate 10 %
13 Ethoxylated Ethyl-4-Aminobenzoate (PEG-
25 PABA)10 %
14 Isopentyl-4-methoxycinnamate (Isoamyl p-
Methoxycinnamate)10 %
15 2,4,6-Trianilino-(p-Carbo-2‘-Ethylhexyl-
1‘Oxy)-1,3,5-Triazine (Octyl Triazone)5%
16 Phenol,2-(2H-Benzotriazol-2-yl)-4-Methyl-
6-(2-Methyl-3-(1,3,3,3-Tetra-methyl-I-
(Trimethylsilyl)Oxy)-Disilo-xanyl)Propyl)
(Drometrizole Trisiloxane)15 %
17 Benzoic acid, 4,4-((6-(((1,1-dimethyl-ethy-
l)amino)carbonyl)phenyl)amino) 1,3,5-
triazine-2,4-diyl)diimino)bis-,bis-(2-ethyl-
hexyl)ester)10 %
18 3-(4‘-Methylbenxylidene)-d-1 camphor (4-
Methylbenzylidene Camphor)4%
19 3-Benzylidene camphor (3-Benzylidene
Camphor)2%
20 2-Ethylhexyl salicylate (Octyl-salicylate) 5 %
21 4-Dimethyl-amino-benzoate of ethyl-2-
hexyl (octyl dimethyl PABA)8%▼M241976L0768 — EN — 21.04.2002 — 003.001 — 67▼M25
▼M28
▼M30
▼M31
Reference
NoSubstances Maximum authorized concentration Other limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
22 2-Hydroxy-4-methoxybenzophenone-5-
sulfonic acid (Benzophenone-5) and its
sodium salt5 % (of acid)
23 2,2'-Methylene-bis-6-(2H-benzotriazol-
2yl)-4-(tetramethyl-butyl)-1,1,3,3-phenol10 %
24 Monosodium salt of 2-2'-bis-(1,4-pheny-
lene)1H-benzimidazole-4,6-disulphonic
acid)10 % (of acid)
25 (1,3,5)-Triazine-2,4-bis((4-(2-ethyl-hexy-
loxy)-2-hydroxy)-phenyl)-6-(4-methoxy-
phenyl)10 %
26 Dimethicodiethylbenzalmalonate (CAS No
207574-74-1)10 %
27 Titanium dioxide 25 %
(1) Not requiered if concentration is 0,5 % or less and when it is used only for product protection purposes.▼M311976L0768 — EN — 21.04.2002 — 003.001 — 68▼M34
▼M30
PART2
LISTOFUVFILTERSWHICHCOSMETICPRODUCTSMAYPROVISIONALLYCONTAIN
Reference number Substances Maximum authorized concentration Other limitations and requirementsConditionsof us e and warnings
which must be printed on the labelAllowed until
ABCDEF
►M20 ◄
►M30 ◄
►M20 ◄
►M30 ◄
►M30 ◄
►M28 ◄
►M20 ◄
►M23 ◄
►M30 ◄
►M30 ◄
►M23 ◄
►M22 ◄
►M30 ◄▼M151976L0768 — EN — 21.04.2002 — 003.001 — 69▼M31
▼M15
▼M31
▼M15
▼M31
▼M15
Reference number Substances Maximum authorized concentration Other limitations and requirementsConditionsof us e and warnings
which must be printed on the labelAllowed until
ABCDEF
►M25 ◄▼M151976L0768 — EN — 21.04.2002 — 003.001 — 70
▼M21
ANNEX VIII
1976L0768 — EN — 21.04.2002 — 003.001 — 71