1976L0768 — EN — 11.03.2003 — 007.001 — 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 79/661/EEC of 24 July 1979 L 192 35 31.7.1979
►M2Commission Directive 82/147/EEC of 11 February 1982 L 63 26 6.3.1982
►M3Council Directive 82/368/EEC of 17 May 1982 L 167 1 15.6.1982
►M4Commission Directive 83/191/EEC of 30 March 1983 L 109 25 26.4.1983
►M5Commission Directive 83/341/EEC of 29 June 1983 L 188 15 13.7.1983
►M6Commission Directive 83/496/EEC of 22 September 1983 L 275 20 8.10.1983
►M7Council Directive 83/574/EEC of 26 October 1983 L 332 38 28.11.1983
►M8Commission Directive 84/415/EEC of 18 July 1984 L 228 31 25.8.1984
►M9Commission Directive 85/391/EEC of 16 July 1985 L 224 40 22.8.1985
►M10Commission Directive 86/179/EEC of 28 February 1986 L 138 40 24.5.1986
►M11Commission Directive 86/199/EEC of 26 March 1986 L 149 38 3.6.1986
►M12Commission Directive 87/137/EEC of 2 February 1987 L 56 20 26.2.1987
►M13Commission Directive 88/233/EEC of 2 March 1988 L 105 11 26.4.1988
►M14Council Directive 88/667/EEC of 21 December 1988 L 382 46 31.12.1988
►M15Commission Directive 89/174/EEC of 21 February 1989 L 64 10 8.3.1989
►M16Council Directive 89/679/EEC of 21 December 1989 L 398 25 30.12.1989
►M17Commission Directive 90/121/EEC of 20 February 1990 L 71 40 17.3.1990
►M18Commission Directive 91/184/EEC of 12 March 1991 L 91 59 12.4.1991
►M19Commission Directive 92/8/EEC of 18 February 1992 L 70 23 17.3.1992
►M20Commission Directive 92/86/EEC of 21 October 1992 L 325 18 11.11.1992
►M21Council Directive 93/35/EEC of 14 June 1993 L 151 32 23.6.1993
►M22Commission Directive 93/47/EEC of 22 June 1993 L 203 24 13.8.1993
►M23Commission Directive 94/32/EC of 29 June 1994 L 181 31 15.7.1994
►M24Commission Directive 95/34/EC of 10 July 1995 L 167 19 18.7.1995
►M25Commission Directive 96/41/EC of 25 June 1996 L 198 36 8.8.1996
►M26Commission Directive 97/1/EC of 10 January 1997 L 16 85 18.1.1997
►M27Commission Directive 97/18/EC of 17 April l997 L 114 43 1.5.1997
►M28Commission Directive 97/45/EC of 14 July 1997 L 196 77 24.7.1997
►M29Commission Directive 98/16/EC of 5 March 1998 L 77 44 14.3.1998
1976L0768 — EN — 11.03.2003 — 007.001 — 2
►M30Commission Directive 98/62/EC of 3 September 1998 L 253 20 15.9.1998
►M31Commission Directive 2000/6/EC of 29 February 2000 L 56 42 1.3.2000
►M32Commission 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
►M34Commission Directive 2002/34/EC of 15 April 2002 L 102 19 18.4.2002
►M35Commission Directive 2003/1/EC of 6 January 2003 L 5 14 10.1.2003
►M36Commission Directive 2003/16/EC of 19 February 2003 L 46 24 20.2.2003
►M37Directive 2003/15/EC of the European Parliament and of the Council of
27 February 2003L 66 26 11.3.2003
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)
►C5Corrigendum, OJ L 341, 17.12.2002, p. 71 (2002/34/EC)
►C6Corrigendum, OJ L 151, 19.6.2003, p. 44 (2002/34/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 — 11.03.2003 — 007.001 — 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 — 11.03.2003 — 007.001 — 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 agents
intended 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 areused for specific purposes apparent from the presentation of theproduct;
(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.
2. The presence of traces of the substances listed in Annex II shall
be allowed provided that such presence is technically unavoidable in
good manufacturing practice and that it conformswith Article 2.
Article 4a
1. Without prejudice to the general obligationsderiving from Article
2, Member Statess hall prohibit:
(a) the marketing of cosmetic products where the final formulation, in
order to meet the requirementsof thisDirective, hasbeen thesubject of animal testing using a method other than an alternativemethod after such alternative method has been validated andadopted at Community level with due regard to the development
of validation within the OECD;
(b) the marketing of cosmetic products containing ingredients or
combinationsof ingredientswhich, in order to meet the require-
ments of this Directive, have been the subject of animal testingusing a method other than an alternative method after such alterna-tive method hasbeen validated and adopted at Community levelwith due regard to the development of validation within the OECD;
(c) the performance on their territory of animal testing of finished
cosmetic products in order to meet the requirements of this Direc-
tive;
(d) the performance on their territory of animal testing of ingredients
or combinationsof ingredientsin order to meet the requirements
of this Directive, no later than the date on which such tests arerequired to be replaced by one or more validated alternativemethodslis ted in Annex V to Council Directive 67/548/EEC of27 June 1967 on the approximation of laws, regulations and admin-istrative provisions relating to the classification, packaging and1976L0768 — EN — 11.03.2003 — 007.001 — 5
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labelling of dangerous substances (1)or in Annex IX to thisDirec-
tive.
No later than 11 September 2004 the Commission shall, in accordance
with the procedure referred to in Article 10(2) and after consultation of
the Scientific Committee on Cosmetic Products and Non-Food Products
intended for consumers (SCCNFP) establish the contents of Annex IX.
2. The Commission, after consultation of the SCCNFP and of the
European Centre for the Validation of Alternative Methods(ECVAM)and with due regard to the development of validation within theOECD, shall establish timetables for the implementation of the provi-
sions under paragraph 1(a), (b) and (d), including deadlines for the
phasing-out of the various tests. The timetables shall be made availableto the public not later than 11 September 2004 and be sent to theEuropean Parliament and the Council. The period for implementationshall be limited to a maximum of six years after the entry into forceof Directive 2003/15/EC in relation to paragraph 1(a), (b) and (d).
(2.1) In relation to the tests concerning repeated-dose toxicity, repro-
ductive toxicity and toxicokinetics, for which there are no alternatives
yet under consideration, the period for implementation of paragraph1(a) and (b) shall be limited to a maximum of 10 years after the entryinto force of Directive 2003/15/EC.
(2.2) The Commission shall study possible technical difficulties in
complying with the ban in relation to tests, in particular thoseconcerning repeated-dose toxicity, reproductive toxicity and toxicoki-
netics, for which there are no alternatives yet under consideration.
Information about the provisional and final results of these studiesshould form part of the yearly reports presented pursuant to Article 9.
On the basis of these annual reports, the timetables established in
accordance with paragraph 2 may be adapted within a maximum timelimit of s ix yearsasreferred to in paragraph 2 or 10 yearsasreferred
to in paragraph 2.1 and after consultation of the entities referred to in
paragraph 2.
(2.3) The Commission shall study progress and compliance with the
deadlines as well as possible technical difficulties in complying withthe ban. Information about the provisional and final results of theCommission studies should form part of the yearly reports presentedpursuant to Article 9. If these studies conclude, at the latest two years
prior to the end of the maximum period referred to in paragraph 2.1,
that for technical reasons one or more tests referred to in paragraph2.1 will not be developed and validated before the expiry of the periodreferred to in paragraph 2.1 it shall inform the European Parliamentand the Council and shall put forward a legislative proposal in accor-dance with Article 251 of the Treaty.
(2.4) In exceptional circumstances where serious concerns arise as
regards the safety of an existing cosmetic ingredient a Member State
may request the Commission to grant a derogation from paragraph 1.The request shall contain an evaluation of the situation and indicatethe measures necessary. On this basis, the Commission may, afterconsultation of the SCCNFP and by means of a reasoned decision,
authorise the derogation in accordance with the procedure referred to
in Article 10(2). This authorisation shall lay down the conditions asso-ciated with this derogation in terms of specific objectives, duration andreporting of the results.
A derogation shall only be granted if:
(a) the ingredient isin wide us e and cannot be replaced by another
ingredient able to perform a similar function;
(b) the specific human health problem is substantiated and the need to
conduct animal tests is justified and is supported by a detailedresearch Protocol proposed as the basis for the evaluation.1976L0768 — EN — 11.03.2003 — 007.001 — 6
(1) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive
2001/59/EC (OJ L 225, 21.8.2001, p. 1).
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The decision on the authorisation, the conditions associated with it and
the final result achieved shall be part of the annual report to bepresented by the Commission in accordance with Article 9.
3. For the purposes of this Article:
(a) ‘finished cosmetic product’ means the cosmetic product in its final
formulation, asplaced on the market and made available to the
final consumer, or its prototype.
(b) ‘prototype’ means a first model or design that has not been
produced in batches, and from which the finished cosmetic product
iscopied or finally developed.
Article 4b
The use in cosmetic products of substances classified as carcinogenic,
mutagenic or toxic for reproduction, of category 1, 2 and 3, under
Annex I to Directive 67/548/EEC shall be prohibited. To that end theCommission shall adopt the necessary measures in accordance with theprocedure referred to in Article 10(2). A substance classified in cate-gory 3 may be used in cosmetics if the substance has been evaluated
by the SCCNFP and found acceptable for use in cosmetic products.
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) of
that Annex;
(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 inother concentrations for specific purposes apparent from thepresentation 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, exceptfor 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.1976L0768 — EN — 11.03.2003 — 007.001 — 7
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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 thecommon 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
1. Member States shall take all measures necessary to ensure that
cosmetic products may be marketed only if the container and packa-
ging bear the following information in indelible, easily legible andvisible 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;
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 normallyonly sold individually;
(c) 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 it appearson the packaging.
The date shall be clearly expressed and shall consist of either the
month and year or the day, month and year in that order. If neces-
sary, this information shall be supplemented by an indication of theconditions which must be satisfied to guarantee the stateddurability.
Indication of the date of durability shall not be mandatory for
cosmetic products with a minimum durability of more than 30months. For such products, there shall be an indication of theperiod of time after opening for which the product can be usedwithout any harm to the consumer. This information shall be indi-
cated by the symbol given in Annex VIIIa followed by the period
(in monthsand/or years );
(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 pecialprecautionary information on cosmetic products for professional1976L0768 — EN — 11.03.2003 — 007.001 — 8
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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 must
appear 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 becausethe 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 the
consumer is referred either by abbreviated information or thesymbol given in Annex VIII, which must appear on 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 ‘aroma’. However, the
presence of substances, the mention of which is required under the
column ‘other limitations and requirements’ in Annex III, shall beindicated in the list irrespective of their function in the product.
Ingredients in concentrations of less than 1 % may be listed in any
order after those in concentrations of more than 1 %.
Colouring agentsmay be lis ted in any order after the other ingredi-
ents, in accordance with the colour index number or denominationadopted in Annex IV. For decorative cosmetic products marketedin several colour shades, all colouring agents used in the rangemay be listed, provided that the words ‘may contain’ or the symbol‘+/-’ 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 referred to in Article 10(2), the
Commission may adapt the criteria and conditions set out in
Commission Directive 95/17/EC of 19 June 1995 laying down
detailed rulesfor the application of Council Directive 76/768/EECas regards the non-inclusion of one or more ingredients on the listused for the labelling of cosmetic products (
1) under which a manu-
facturer may, for reasons of trade secrecy, apply not to include oneor more ingredientson 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 referred1976L0768 — EN — 11.03.2003 — 007.001 — 9
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to in point (g) to appear on a label, tag, tape or card or in an enclosed
leaflet, 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 for
immediate sale, Member States shall adopt detailed rules for indication
of 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. ►
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Furthermore, the manufacturer or the person responsible for placing the
product on the Community market may take advantage, on the productpackaging or in any document, notice, label, ring or collar accompa-
nying or referring to the product, of the fact that no animal tests have
been carried out only if the manufacturer and hiss uppliershave notcarried out or commissioned any animal tests on the finished product,or itsprototype, or any of the ingredientscontained in it, or us ed anyingredients that have been tested on animals by others for the purpose
of developing new cosmetic products. Guidelines shall be adopted in
accordance with the procedure referred to in Article 10(2) andpublished in the Official Journal of the European Union . The European
Parliament shall receive copies of the draft measures submitted to theCommittee.
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 withthe 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 thatappropriate and adequate information on substances used in cosmeticproductsbe made available to the competent authority, which s hall
ensure 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 informationin 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 placing
an imported cosmetic product on the Community market shall forcontrol purposes keep the following information readily accessible tothe competent authoritiesof the Member State concerned at the addres sspecified 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;1976L0768 — EN — 11.03.2003 — 007.001 — 10
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(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 bythe law of the Member State concerned; the person responsible for
manufacture or first importation into the Community must possess
an 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 thegeneral toxicological profile of the ingredients, their chemical
structure and their level of exposure. It shall take particular account
of the specific exposure characteristics of the areas on which theproduct will be applied or of the population for which it isintended. There shall be inter alia a specific assessment for
cosmetic products intended for use on children under the age of
three and for cosmetic products intended exclusively for use in
external intimate hygiene.
Should the same product be manufactured at several places within
Community territory, the manufacturer may choose a single place
of manufacture where that information will be available. In this
connection, and when so requested for monitoring purposes, it shallbe obliged to indicate the place so chosen to the monitoringauthority or authoritiesconcerned. In thiscas e thisinformationshall be easily accessible;
(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 field
of 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;
(h) data on any animal testing performed by the manufacturer, his
agents or suppliers, relating to the development or safety evaluationof the product or its ingredients, including any animal testing
performed to meet the legislative or regulatory requirements of
non-member countries.
Without prejudice to the protection, in particular, of commercial
secrecy and of intellectual property rights, Member States shall
ensure that the information required under (a) and (f) shall bemade easily accessible to the public by any appropriate means,including electronic means. The quantitative information requiredunder (a) to be made publicly accessible shall be limited todangerous substances covered by Directive 67/548/EEC.
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 of
good laboratory practice laid down in Council Directive 87/18/EEC of18 December 1986 on the harmonization of laws, regulations andadministrative provisions relating to the application of the principlesof good laboratory practice and the verification of their application fortests on chemical substances (
1).1976L0768 — EN — 11.03.2003 — 007.001 — 11
(1) OJ No L 15, 17. 1. 1987, p. 29.▼M37
▼M21
▼M37
▼M21
▼M21
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.
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
productsand, after cons ultation of the ►
M37Scientific Committee
for Cos metic Productsand Non-Food Productsintended for
Consumers ◄, the amendments necessary for the adaptation to tech-
nical progress of the Annexes shall be adopted in accordance with thesame procedure, as appropriate.
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 taken
pursuant 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 givennational authorization in accordance with paragraph 1. At the same
time, it shall supply supporting documents setting out the grounds on
which 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 theinitiative of the Commission or of a Member State, of the1976L0768 — EN — 11.03.2003 — 007.001 — 12
▼M3
▼M21
▼M3
▼M3
►M37Scientific Committee for Cosmetic Products and Non-Food
Productsintended for Cons umers ◄and in accordance with the proce-
dure laid down in Article 10 as to whether the substance in question
may be included in a list of permitted substances or whether the
national authorization should be revoked. Notwithstanding paragraph 1(a), the national authorization shall remain in force until a decision istaken on the request for inclusion in the list.
Article 9
Every year the Commission shall present a report to the European
Parliament and the Council on:
(a) progress made in the development, validation and legal acceptance
of alternative methods. The 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 Council Directive 86/609/EEC of 24 November 1986 onthe approximation of laws, regulations and administrative provi-sions of the Member States regarding the protection of animals
used for experimental and other scientific purposes (
1). The
Commission shall in particular ensure the development, validationand legal acceptance of alternative test methods which do not uselive animals;
(b) progress made by the Commission in its efforts to obtain accep-
tance by the OECD of alternative methodsvalidated atCommunity level and recognition by non-member countriesof the
results of the safety tests carried out in the Community using alter-
native methods, in particular within the framework of cooperationagreements between the Community and these countries;
(c) the manner in which the specific needs of small and medium-sized
enterprises have been taken into account.
Article 10
1. The Commission shall be assisted by the Standing Committee on
Cosmetic Products.
2. Where reference ismade to thisparagraph, Articles5 and 7 of
Decision 1999/468/EC shall apply, having regard to the provisions of
Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be
set at three months.
3. The Committee shall adopt its rules of procedure.
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 thisDirective by the Member States, the Commission shall, on the basis
of the results of the latest scientific and technical research, submit to
the 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 orsubject it to special conditions. It shall immediately inform the other1976L0768 — EN — 11.03.2003 — 007.001 — 13
(1) OJ L 358, 18.12.1986, p. 1.▼M37
▼B
▼B
Member States and the Commission thereof, stating the grounds for its
decision.
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 laid
down in Article 10. In that event, the Member State which hasadopted
safeguard 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 pursuantto thisDirective. It s hall be notified to the party concerned togetherwith particularsof the remediesavailable to him under the lawsin
force 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 territoryof 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 arecommunicated to the Commission.
Article 15
This Directive is addressed to the Member States.1976L0768 — EN — 11.03.2003 — 007.001 — 14
▼M14
▼B
▼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 make-up 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 — 11.03.2003 — 007.001 — 15
▼B
ANNEX II
LIST OF SUBSTANCES WHICH MUST NOT FORM PART OF THE
COMPOSITIONOFCOSMETICPRODUCTS
1. N-5-Chlorobenzoxazol-2-ylacetamide
2.►M32-Acetoxyethyltrimethylammonium hydroxide (acetylcholine) and
itss alts◄
3. Deanol aceglumate*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 — 11.03.2003 — 007.001 — 16
(*) 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, elemental56. Bretylium tosilate*57. Carbromal*
58. Bromisoval*
59. Brompheniramine* and itss alts60. Benzilonium bromide*61. Tetrylammonium bromide*62. Brucine63. Tetracaine* and itss alts64. Mofebutazone*
65. Tolbutamide*
66. Carbutamide*67. Phenylbutazone*68. Cadmium and itscompounds69. Cantharides, Cantharis vesicatoria
70. (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (canthar-
idin)
71. Phenprobamate*72.►
M3Nitroderivativesof carbazole ◄
73. Carbon disulphide74. Catalase75. Cephaeline and itss alts
76.Chenopodium ambrosioides (essential oil)
77. 2,2,2-Trichloroethane-1,1-diol78. 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 alts85. Clofenamide*
86.►
M3N,N-bis(2-chloroethyl)methylamine N-oxide and itss alts ◄1976L0768 — EN — 11.03.2003 — 007.001 — 17
▼M4
▼B
▼B
87. Chlormethine* and itss alts
88. Cyclophosphamide* and its salts89. Mannomustine* and its salts90. 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 alts98.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 derivatives104.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 curarizants111. Hydrogen cyanide and itss alts112.►
M32-α-Cyclohexylbenzyl( N,N,N',N', -tetraethyl)trimethylenediamine
(phenetamine) ◄
113. Cyclomenol* and itss alts114. 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 salts128.►
M32-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and itss alts ◄
129. Cinchocaine* and itss alts130. 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 alts
134. Digitaline and all heterosides of Digitalis purpurea L .1976L0768 — EN — 11.03.2003 — 007.001 — 18
▼B
135. 7-[2-Hydroxy-3-(2-hydroxyethyl- N-methylamino)propyl]theophylline
(xanthinol)
136. Dioxethedrin* and itss alts137. Piprocurarium*138. Propyphenazone*139. Tetrabenazine* and itss alts140. Captodiame*141. Mefeclorazine* and itss alts142. Dimethylamine143.►
M31,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine,
alypine) and itss alts ◄
144. Methapyrilene* and itss alts145. Metamfepramone* and itss alts146. Amitriptyline* and itss alts147. Metformin* and itss alts148. Isosorbide dinitrate*149. Malononitrile150. Succinonitrile151. Dinitrophenol isomers152. Inproquone*153. Dimevamide* and itss alts154. Diphenylpyraline* and itss alts155. Sulfinpyrazone*156.►
M3N-(3-Carbamoyl-3,3-diphenylpropyl)- N,N-diisopropylmethyl-ammo-
nium salts, e.g. isopropamide iodide* ◄
157. Benactyzine*158. Benzatropine* and itss alts159. Cyclizine* and itss alts160.►
M35,5-Diphenyl-4-imidazolidone ◄
161. Probenecid*162. Disulfiram*; thiram (ISO)163. Emetine, itss altsand derivatives164. Ephedrine and itss alts165. Oxanamide* and itsderivatives166. Eserine or physostigmine and its salts167. 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 chloride169. Caramiphen* and itss alts170. Diethyl 4-nitrophenyl phosphate171. Metethoheptazine* and itss alts172. Oxpheneridine* and itss alts173. Ethoheptazine* and itss alts174. Metheptazine* and itss alts175. Methylphenidate* and itss alts176. Doxylamine* and itss alts177. Tolboxane*
178. 4-Benzyloxyphenol, 4-methoxyphenol and 4-ethoxyphenol
179. Parethoxycaine* and itss alts
180. Fenozolone*181. Glutethimide* and itss alts182. Ethylene oxide183. Bemegride* and itss alts1976L0768 — EN — 11.03.2003 — 007.001 — 19
▼M9
▼B
▼B
184. Valnoctamide*
185. Haloperidol*
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 salts
200. Hydrazidesand their s alts
201. Hydrazine, itsderivativesand their s alts202. Octamoxin* and itss alts203. 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-Methylheptylamine and itss alts228. Isometheptene* and its salts1976L0768 — EN — 11.03.2003 — 007.001 — 20
▼M3
▼B
▼M11
▼B
▼B
229. Mecamylamine*
230. Guaifenesin*
231. Dicoumarol*
232. Phenmetrazine*, itsderivativesand s alts233. 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 alts238. Arecoline239. Poldine metilsulfate*240. Hydroxyzine*241. 2-Naphthol242. 1-and 2-Naphthylaminesand their s alts243.►
M33-(1-Naphthyl)-4-hydroxycoumarin ◄
244. Naphazoline* and itss alts
245. Neostigmine and its salts (e.g. neostigmine bromide*)246. Nicotine and itss alts247. 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 trinitrate
254. 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. Oleandrin
262. Chlortalidone*263. Pelletierine and itss alts264. 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 phosphides1976L0768 — EN — 11.03.2003 — 007.001 — 21
▼M3
▼B
▼B
280. Thalidomide* and itss alts
281.Physostigma venenosum Balf.
282. Picrotoxin283. 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. Coniine
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 alts
310. Thiotepa*
311.Pilocarpus jaborandi Holmes and itsgalenical preparations
312. Tellurium and itscompounds
313.►
M3Xylometazoline* and itss alts ◄
314. Tetrachloroethylene315. Carbon tetrachloride
316. Hexaethyl tetraphosphate
317. Thallium and itscompounds318.Thevetia neriifolia Juss. , glycoside extract
319. Ethionamide*
320. Phenothiazine* and itscompounds1976L0768 — EN — 11.03.2003 — 007.001 — 22
(1) OJ L 159, 29.6.1996, p. 1.▼M34
▼B
▼M9
▼B
▼M3
321. Thiourea and its derivatives, with the exception of the one listed in Annex
III, Part 1
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 alts
325. Trichloronitromethane (chloropicrine)
326. 2,2,2-Tribromoethanol (tribromoethyl alcohol)
327. Trichiormethine* and itss alts
328. Tretamine*
329. Gallamine triethiodide*330.Urginea scilla Stern. and itsgalenical preparations
331. Veratrine, itss altsand galenical preparations
332.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 alts
340. 4-tert-Butylphenol
341. 4-tert-Butylpyrocatechol
342. Dihydrotachysterol
343. Dioxane
344. Morpholine and itss alts
345.Pyretbrum album L. and itsgalenical preparations
346.►
M32-[4-Methoxybenzyl- N-(2-pyridyl)amino]ethyldimethylamine
maleate◄
347. Tripelennamine*348. Tetrachlorosalicylanilides
349. Dichlorosalicylanilides
350. Tetrabromosalicylanilides ►
M13 ◄
351. Dibromosalicylanilides ►M13 ◄
352. Bithionol*
353. Thiuram monosulphides
354. Thiuram disulphides
355. Dimethylformamide356. 4-Phenylbut-3-en-2-one
357. 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,1976L0768 — EN — 11.03.2003 — 007.001 — 23
▼B
▼M8
▼B
▼M3
▼B
▼M24
▼B
▼M3
▼M3
50 ppm in productsfor dental and oral hygiene, and provided that Safrole
is not present in toothpastes intended specifically for children
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-dioxin
368. 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 alts373. 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 26105380. Colouring agent CI 42555
Colouring agent CI 42555-1Colouring agent CI 42555-2
381. Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN))
382. Benzoyl peroxide383. 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 structure1976L0768 — EN — 11.03.2003 — 007.001 — 24
▼B
▼M32
▼M5
▼M32
▼M10
▼M32
▼M10
▼M12
▼M32
▼M13
▼M15
▼M17
▼M32
▼M17
▼M32
▼M32
391. 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 3
393. Acetonitrile394. 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 salts398. Colouring agent CI 45170 and CI 45170:1399. Lidocaine
400. 1,2-epoxybutane
401. Colouring agent CI 15585402. Strontium lactate403. Strontium nitrate404. Strontium polycarboxylate405. Pramocaine406. 4-ethoxy-m-phenylenediamine and itss alts407. 2,4-diaminophenylethanol and itss alts408. Catechol409. 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.►
M35From the date referred to in Article 22(1) of Regulation (EC) No
999/2001 of the European Parliament and of the Council (1), the specified
risk materials as designated in Annex V to that Regulation, and ingredients
derived therefrom.
Until that date, the specified risk materials as designated in Annex XI Part
A to Regulation (EC) No 999/2001, and ingredientsderived therefrom. ◄
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 .1976L0768 — EN — 11.03.2003 — 007.001 — 25
(1) OJ L 147, 31.5.2001, p. 1.▼M18
▼M20
▼M22
▼M23
▼M24
▼M28
▼M24
▼M25
▼M29
▼M31
▼M29
▼M28
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).
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.
►
C5451. Methyleugenol (CAS No 93-15-2) ◄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 toilette1976L0768 — EN — 11.03.2003 — 007.001 — 26
▼M30
▼M34
▼M34
(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 — 11.03.2003 — 007.001 — 27
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 years
of 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
irritated 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 years
of 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 years
of 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
irritated 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 — 11.03.2003 — 007.001 — 28▼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 sentences:
— 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 children— For professional use only
(b) and (c):
— Containsthioglycolate
— Follow the instructions— Keep out of reach of children— 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 to 9,5
The abovementioned percentages
are calculated asthioglycollic 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 — 11.03.2003 — 007.001 — 29▼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-trichlor-
oethane, total concentration 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(5), 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 derivatives and
their salts (1) with the exception 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 — 11.03.2003 — 007.001 — 30
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 % Containsdichlorophen12 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 H2O2, present or released (a) (b) (c):
Containshydrogen peroxide.
(c) Nail hardening preparations2 % of H2O2, present or released Avoid contact with eyes.
Rinse immediately if product comes
into contact with them
(d) Oral hygiene products0,1 % of H2O2, present or released
13 Formaldehyde Nail hardeners5 % calculated as formaldehyde Protect cuticles with greas e or oil.
Containsformaldehyde (2).▼M31976L0768 — EN — 11.03.2003 — 007.001 — 31▼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 (3) (a) Oxidizing colouring agent for
hair-dyeing:►M310,3 %◄ (a)
1. General use 1. Do not use to dye eyelashes or
eyebrows
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 cuticle 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 blind-
ness. 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 — 11.03.2003 — 007.001 — 32▼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 % (6) by weight 1. Containsalkali
Avoid contact with eyesCan cause blindness
Keep out of reach of children
2. Professional use 2. 4,5 % (
6) 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 — 11.03.2003 — 007.001 — 33▼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 — 11.03.2003 — 007.001 — 34▼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 (3) (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 — 11.03.2003 — 007.001 — 35
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 %
DittoContainss odium monofluoropho-
sphate
28 Potassium monofluorophosphate Ditto 0,15 %
DittoContains potassium monofluoropho-
sphate
29 Calcium monofluorophosphate Ditto 0,15 %
DittoContainscalcium monofluoropho-
sphate
30 Calcium fluoride Ditto 0,15 %
DittoContainscalcium fluoride
31 Sodium fluoride Ditto 0,15 %
DittoContainss odium fluoride
32 Potassium fluoride Ditto 0,15 %
DittoContains potassium fluoride
33 Ammonium fluoride Ditto 0,15 %
DittoContainsammonium fluoride
34 Aluminium fluoride Ditto 0,15 %
DittoContainsaluminium fluoride
35 Stannousfluoride Ditto 0,15 %
DittoContainss tannousfluoride
36 Hexadecyl ammonium fluoride Ditto 0,15 %
DittoContainshexadecyl ammonium
fluoride▼M31976L0768 — EN — 11.03.2003 — 007.001 — 36
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
37 3-( N-Hexadecyl- N-2-hydroxyethy-
lammonio) propylbis(2-
hydroxyethyl) ammonium
difluorideDitto 0,15 %
DittoContains3-( N-Hexadecyl- N-2-
hydroxyethylammonio) propylbis
(2-hydroxyethyl) ammonium
difluoride
38 NN'N'-Tris(polyoxyethylene)- N-
hexadecylpropylenediamine dihy-
drofluorideDitto 0,15 %
DittoContains NN'N'-tris(polyoxyethy-
lene)-N-hexadecylpropylenediamine
dihydrofluoride
39 Octadecenyl-ammonium fluoride Ditto 0,15 %
DittoContainsoctadecenyl-ammonium
fluoride
40 Sodium fluorosilicate Ditto 0,15 %
DittoContains sodium fluorosilicate
41 Potassium fluorosilicate Ditto 0,15 %
DittoContains potassium fluorosilicate
42 Ammonium fluorosilicate Ditto 0,15 %
DittoContainsammonium fluoros ilicate
43 Magnesium fluorosilicate Ditto 0,15 %
DittoContaines(SIC! Contains ) magne-
sium fluorosilicate
44 1,3-Bis(hydroxymethyl)imidazoli-
dine-2-thione(a) Hair-care 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▼M31976L0768 — EN — 11.03.2003 — 007.001 — 37
▼M10
▼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
46 6-methylcoumarin Oral hygiene products0,003 %
47 Nicomethanol hydrofluoride Oral hygiene products0,15 %
calculated asF
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
49 Selenium disulphide Antidandruff shampoos 1 % — Contains selenium disulphide
— Avoid contact with eyesor
damaged skin
50 Aluminium zirconium chloride
hydroxyde complexes
AlxZr(OH)yClzand the aluminium
zirconium chloride sydroxide
glycine complexesAntiperspirants 20 % as anhydrous aluminium
zirconium chloride hydroxide
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▼M31976L0768 — EN — 11.03.2003 — 007.001 — 38▼M4
▼M8
▼M9
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
51 Quinolin-8-ol 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 and itss alts(1-
hydroxyethylidene-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-propan-2-ol — Rinse-off products only 2 % As a preservative, see Annex VI,
Part 1, No 43
— Prohibited in oral hygiene
products
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▼M91976L0768 — EN — 11.03.2003 — 007.001 — 39▼M13
▼M12
▼M13
▼M17
▼M18
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
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
59 Talc: Hydrated magnesium sili-
cate(a) Powdery productsintended to
be used for children under
three yearsof age
(b) other products►C4(a) 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▼M181976L0768 — EN — 11.03.2003 — 007.001 — 40▼M30
▼M20
▼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
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
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▼M201976L0768 — EN — 11.03.2003 — 007.001 — 41
▼M23
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
65 Benzalkonium Chloride, bromide
and saccharinate(a) Rinse-off hair (head) care
products(a) 3 % (asbenzalkonium
chloride)(a) In the final productsthe
concentrationsof benzalko-
nium chloride, bromide and
saccharinate with an alkyl
chain of C14, or less must not
exceed 0,1 % (asbenzalko-
nium 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 acryla-
mide content 0,1 mg/kg
(b) Other cosmetic products (b) Maximum residual acryla-
mide content 0,5 mg/kg
67 Amyl cinnamal
(CAS No 122-40-7)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
68 Benzyl alcohol
(CAS No 100-51-6)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products▼M231976L0768 — EN — 11.03.2003 — 007.001 — 42▼M31
▼M34
▼M37
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
69 Cinnamyl alcohol
(CAS No 104-54-1)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
70 Citral
(CAS No 5392-40-5)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
71 Eugenol
(CAS No 97-53-0)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
72 Hydroxy-citronellal
(CAS No 107-75-5)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentrationexceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products▼M371976L0768 — EN — 11.03.2003 — 007.001 — 43
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
73 Isoeugenol
(CAS No 97-54-1)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
74 Amylcin namyl alcohol
(CAS No 101-85-9)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
75 Benzyl salicylate
(CAS No 118-58-1)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
76 Cinnamal
(CAS No 104-55-2)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentrationexceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products▼M371976L0768 — EN — 11.03.2003 — 007.001 — 44
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
77 Coumarin
(CAS No 91-64-5)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
78 Geraniol
(CAS No 106-24-1)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
79 Hydroxy-methylpentylcyclohexe-
necarboxaldehyde
(CAS No 31906-04-4)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
80 Anisyl alcohol
(CAS No 105-13-5)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentrationexceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products▼M371976L0768 — EN — 11.03.2003 — 007.001 — 45
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
81 Benzyl cinnamate
(CAS No 103-41-3)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
82 Farnesol
(CAS No 4602-84-0)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
83 2-(4-tert-Butylbenzyl) propional-
dehyde
(CAS No 80-54-6)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
84 Linalool
(CAS No 78-70-6)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentrationexceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products▼M371976L0768 — EN — 11.03.2003 — 007.001 — 46
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
85 Benzyl benzoate
(CAS No 120-51-4)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
86 Citronellol
(CAS No 106-22-9)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
87 Hexyl cinnam-aldehyde
(CAS No 101-86-0)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
88 d-Limonene
(CAS No 5989-27-5)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentrationexceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products▼M371976L0768 — EN — 11.03.2003 — 007.001 — 47
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
89 Methyl heptin carbonate
(CAS No 111-12-6)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
90 3-Methyl-4-(2,6,6-tri-methyl-2-
cyclohexen-1-yl)-3-buten-2-one
(CAS No 127-51-5)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
91 Oak moss extract
(CAS No 90028-68-5)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentration
exceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products
92 Treemoss extract
(CAS No 90028-67-4)The presence of the substance
must be indicated in the list of
ingredientsreferred to in Article
6(1)(g) when itsconcentrationexceeds:
— 0,001 % in leave-on products
— 0,01 % in rinse-off products▼M371976L0768 — EN — 11.03.2003 — 007.001 — 48
(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 authorized for each of them does
not exceed 1.
(2) Only if the concentration exceeds0,05 %.
(3) 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.
►M25(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) 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. ◄
►M34(6) 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 — 11.03.2003 — 007.001 — 49
►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
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 — 11.03.2003 — 007.001 — 50▼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 — 11.03.2003 — 007.001 — 51
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►C62,4-Diamino-5 methyphe-
netol (CAS No 113715-25-6)
and itss alts ◄Oxidising 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►C63-Amino-2,4-dichloro-
phenol (CAS No 61693-43-4)
and itss alts ◄Oxidising 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 — 11.03.2003 — 007.001 — 52
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 — 11.03.2003 — 007.001 — 53
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►C6HC Red No 13 (CAS No
94158-13-1) 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►C62,4-Diaminophenox-
yethanol (CAS No 66422-95-5)
and itss alts ◄Oxidising colouring agents for
hair dyeing4,0 % In combination with hydrogen
peroxide the maximum use
concentration upon application
is2,0 %30.9.2004▼M341976L0768 — EN — 11.03.2003 — 007.001 — 54
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 — 11.03.2003 — 007.001 — 55
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►C6Acid Black 52 (CAS No
3618-58-4) and itss alts ◄Oxidising 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 — 11.03.2003 — 007.001 — 56
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►C6HC Blue No 10 (CAS No
102767-27-1) and itss alts ◄Oxidising 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 — 11.03.2003 — 007.001 — 57
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
fragrance►M36
30.9.2004
◄(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
fragrance►M36
30.9.2004
◄(b) 0,56 % in eau
de toilette
(c) 0,042 % in
other products▼M341976L0768 — EN — 11.03.2003 — 007.001 — 58
▼B
ANNEX IV
►M14 PART1 ◄
LISTOFCOLOURINGAGENTSALLOWEDFORUSEINCOSMETICPRODUCTS (1)
Fieldofapplication
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 X12420 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 (3) Red X
15880 Red X
15980 Orange X E 11115985 (
3) Yellow X E 110
16035 Red X
16185 Red X E 123
16230 Orange X1976L0768 — EN — 11.03.2003 — 007.001 — 59
▼M10
▼M10
Colour index number or
denominationColourField of applicationOther limitationsand
requirements(2)1234
16255 (3) Red X E 124
16290 Red X E 12617200►
M17(3)◄ Red X
18050 Red X18130 Red X18690 Yellow X18736 Red X
18820 Yellow X
18965 Yellow X19140 (
3) Yellow X E 102
20040 Yellow X maximum 3,3'-
dimethylbenzidine
concentration in the
colouring agent:
5 ppm
20170 Orange X20470 Black X ►
M15 ◄
21100 Yellow X maximum 3,3'-
dimethylbenzidine
concentration in the
colouring agent:
5 ppm
21108 Yellow X ditto21230 Yellow X24790 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
27755 Black X E 15228440 Black X E 15140215 Orange X40800 Orange X40820 Orange X E 160 e40825 Orange X E 160 f
40850 Orange X E 161 g
42045 Blue ►
M17
X
◄►M17 ◄
42051 (3) Blue X E 131
42053 Green X42080 Blue X42090 Blue X42100 Green X1976L0768 — EN — 11.03.2003 — 007.001 — 60
▼M20
▼M10
▼M10
Colour index number or
denominationColourField of applicationOther limitationsand
requirements(2)1234
42170 Green X ►M15 ◄
42510 Violet X
42520 Violet X 5 ppm maximum
concentration in the
finished product
►M17 ◄
42735 Blue X
44045 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 ditto
45425 Red X not more than 1 %
2-(6-hydroxy-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 104
50325 Violet X
50420 Black X
51319 Violet X
58000 Red X1976L0768 — EN — 11.03.2003 — 007.001 — 61
▼M10
Colour index number or
denominationColourField of applicationOther limitationsand
requirements(2)1234
59040 Green X
60724 Violet X60725 Violet X
60730 Violet X
61565 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 X
74100 Blue X74160 Blue X74180 Blue X ►
M20 ◄
74260 Green X75100 Yellow X75120 Orange X E 160 b
75125 Yellow X E 160 d
75130 Orange X E 160 a75135 Yellow X E 161 d75170 White X75300 Yellow X E 10075470 Red X E 120
75810 Green X E 140 and E 141
77000 White X E 17377002 White X77004 White X77007 Blue X77015 Red X77120 White X
77163 White X
77220 White X E 17077231 White X77266 Black X77267 Black X77268:1 Black X E 153
77288 Green X free from chromate
ion
77289 Green X free from chromate
ion1976L0768 — EN — 11.03.2003 — 007.001 — 62
▼M12
▼M12
Colour index number or
denominationColourField of applicationOther limitationsand
requirements(2)1234
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 X
77745 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, capsorubin Orange X E 160 c
Beetroot red Red X E 162
AnthocyaninsRed X E 163Aluminium, zinc,
magnesium and calciumstearatesWhite X
Bromothymol blue Blue X
Bromocresol green Green X
Acid red 195 Red X
Column 1 = Colouring agentsallowed in all cos metic 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.
(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 concerning
colouring 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 inArticle 8.1976L0768 — EN — 11.03.2003 — 007.001 — 63
▼M10
▼M13
▼B
▼M10
PART2
LIST OF COLOURING AGENTS PROVISIONALLY ALLOWEDFOR USE IN COSMETIC
PRODUCTS (1)
Fieldofapplication
Colour index number or
denominationColourField of application Other limita-
tionsand
require-
ments(2)Authorization
valid until1234
►M13 ◄
►M17 ◄
►M20 ◄
►M15 ◄
►M17 ◄
►M15 ◄
►M20 ◄
►M17 ◄
►M15 ◄
►M17 ◄
►M13 ◄
►M17 ◄
►M15 ◄
►M17 ◄
►M13 ◄
►M20 ◄
►M15 ◄
►M20 ◄
►M15 ◄
►M12 ◄
►M13 ◄
►M20 ◄
Column 1 = Colouring agentsallowed in all cos metic 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.
(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 with 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 concerning
colouring matterswhere the letter ‘E’ hasbeen deleted therefrom.1976L0768 — EN — 11.03.2003 — 007.001 — 64
▼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 — 11.03.2003 — 007.001 — 65
▼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 — 11.03.2003 — 007.001 — 66
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)
expressed as free formaldehydeProhibited 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 — 11.03.2003 — 007.001 — 67
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 — 11.03.2003 — 007.001 — 68▼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)-1,1'-methylenediurea (‘Imida-
zolidinyl 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 — 11.03.2003 — 007.001 — 69
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 — 11.03.2003 — 007.001 — 70▼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 glutaraldehyde (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 asAgCl 20 % AgCl (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 Avoid contact with eyes
55 Benzylhemiformal 0,15 % Only for productsto be removed by rins ing▼M181976L0768 — EN — 11.03.2003 — 007.001 — 71▼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 — 11.03.2003 — 007.001 — 72▼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
abcdef
►M15 ◄
►M25 ◄
►M15 ◄
►M18 ◄
►M15 ◄
►M18 ◄
►M13 ◄
►M12 ◄
►M13 ◄
►M12 ◄
►M13 ◄
►M24 ◄
►M30 ◄
►M18 ◄
►M13 ◄
►M15 ◄
►M20 ◄▼M111976L0768 — EN — 11.03.2003 — 007.001 — 73
Reference number Substance Maximum authorized concentration Limitations and requirementsConditionsof us e and warnings
which must be printed on the labelAllowed until
abcdef
►M13 ◄
►M15 ◄
►M23 ◄▼M111976L0768 — EN — 11.03.2003 — 007.001 — 74▼M31
▼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 — 11.03.2003 — 007.001 — 75
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-butylphenyl)-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 — 11.03.2003 — 007.001 — 76
▼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-Tetramethyl-I-
(Trimethylsilyl)Oxy)-Disiloxanyl)Propyl)
(Drometrizole Trisiloxane)15 %
17 Benzoic acid, 4,4-((6-(((1,1-dimethylethy-
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 — 11.03.2003 — 007.001 — 77▼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 — 11.03.2003 — 007.001 — 78▼M34
▼M7
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 — 11.03.2003 — 007.001 — 79▼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 — 11.03.2003 — 007.001 — 80
▼M21
ANNEX VIII
1976L0768 — EN — 11.03.2003 — 007.001 — 81
▼M37
ANNEX VIIIa
An Annex VIIIa shall be added, consisting of a symbol representing an open
cream jar. The Commission shall, in accordance with the procedure referred to
in Article 10(2) establish this symbol by 11 September 2003 at the latest.1976L0768 — EN — 11.03.2003 — 007.001 — 82