1976L0768 — EN — 01.07.2002 — 004.001 — 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 March1983 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 March1986 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 March1988 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 March1991 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 March1998 L 77 44 14.3.1998
1976L0768 — EN — 01.07.2002 — 004.001 — 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 March2000 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
►M35Directive 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 States define the composition 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;
Whereas the differences between these laws oblige 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;
Whereas this Directive relates only to cosmetic products and 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; whereasthis delimitation follows in 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 products that fall under the definition of cosmetic 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
contiguous to 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 — 01.07.2002 — 004.001 — 3
(1) OJ No C 40, 8. 4. 1974, p. 71.
(2) OJ No C 60, 26. 7. 1973, p. 16.
▼B
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 this field; whereas it is advisable, 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;
Whereas it could happen that although conforming to the provisions of
this Directive and its Annexes, cosmetic products placed on the market
might endanger public health; whereas it is therefore advisable toprovide for a procedure intended to remove this danger,
HAS ADOPTED THIS DIRECTIVE:
Article 1
1. A ‘cosmetic product’ shall mean any substance or preparation
intended to be placed in contact with the various external parts of 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 odours and/orprotecting them or keeping them in good condition.
2. The products to be considered as cosmetic products within the
meaning of this definition are listed 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 suchmeasures as th ey deem necessary withregard 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 its Annexes may be put on the market.1976L0768 — EN — 01.07.2002 — 004.001 — 4
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Article 4
1. Without prejudice to their general obligations deriving from
Article 2, Member States shall prohibit the marketing of cosmetic
products containing:
(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-
tions laid down, withth e exception of cosmetic products containing
colouring agents intended solely 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 filters listed in Part 1 of Annex VII, beyond the limits and
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 ingood manufacturing practice and that it conforms with Article 2.
Article 5
Member States shall allow the marketing of cosmetic products
containing:
(a) the substances listed in Annex III, Part 2, within the limits and
under the conditions laid down, up to the dates in column (g) of
that Annex;
(b) the colouring agents listed in Annex IV, Part 2, within the limits
and under the conditions laid down, until the admission dates given
in that Annex;
(c) the preservatives listed in Annex VI, Part 2, within the limits and
under the condition laid down, until the dates given 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 filters listed in Part 2 of Annex VII, within the limits and
under the conditions laid down, until the dates given in column (f)of that Annex.
At these dates, these substances, colouring agents, preservatives and
UV filters shall 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, or1976L0768 — EN — 01.07.2002 — 004.001 — 5
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— 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 materials and the second concerning other
substances.
2. The inventory shall contain informtion on:
— the identity of each ingredient, in particular its chemical name, the
CTFA name, the European Pharmacopoeia name, the internationalnon-proprietary names recommended by the World Health Organi-
zation, the Einecs, Iupac, CAS and colour index numbers, and the
common name referred to in Article 7 (2),
— the usual function(s) of the ingredient in the final product,
— where appropriate, restrictions and conditions of use and warnings
which must be printed on the label by reference to the Annexes.
3. The Commission shall publish the inventory and shall update it
periodically under the procedure provided for in Article 10. The inven-
tory shall be indicative and shall not constitute a list of the substances
authorized 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 and
visible lettering; the information mentioned in point (g) may, however,be indicated on the packaging alone:
(a) the name or style and the address or registered office of the manu-
facturer or the person responsible for marketing the cosmetic
product who is established within the Community. Such informa-
tion may be abbreviated in so far as the abbreviation makes itgenerally possible to identify the undertaking. Member States mayrequire that the country of origin be specified for goods manufac-tured outside the Community;
b) the nominal content at the time of packaging, given by weight or
by volume, except in the case of packaging containing less than
five grams or five millilitres, free samples and single-applicationpacks; for pre-packages normally sold as a number of items, forwhich details of weight or volume are not significant, the contentneed not be given provided the number of items appears on thepackaging. This information need not be given if the number of
items is easy to see from the outside or if the product is normally
only sold individually;
c) the date of minimum durability. The date of minimum durability of
a cosmetic product shall be the date until which this product, storedunder appropriate conditions, continues to fulfil its initial functionand, in particular, remains in conformity withArticle 2.
The date of minimum durability shall be indicated by the words:
‘Best used before the end of…’ followed by either:
— the date itself, or1976L0768 — EN — 01.07.2002 — 004.001 — 6
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— details of where the date appears on the packaging.
If necessary, this information shall be supplemented by an indica-
tion of the conditions which must be satisfied to guarantee thestated durability.
The date shall be clearly expressed and shall consist of the month
and the year in that order. Indication of the date of durability shall
not be mandatory for cosmetic products the minimum durability of
which exceeds 30 months;
(d) particular precautions to be observed in use, especially those listed
in the column ‘Conditions of use and warnings which must beprinted on the label’ in Annexes III, IV, VI and VII, which mustappear on the container and packaging, as well as any special
precautionary information on cosmetic products for professional
use, in particular in hairdressing. Where this is impossible for prac-tical reasons, an enclosed leaflet, label, tape or card must containthat information to which the consumer is referred either by abbre-viated information or the symbol given in Annex VIII, which mustappear on the container and the packaging;
(e) the batch number of manufacture or the reference for identifying
the goods. Where this is impossible for practical reasons becausethe cosmetic products are too small, such information need appearonly on the packaging;
(f) the function of the product, unless it is clear from the presentation
of the product;
(g) a list of ingredients in descending order of weight at the time they
are added. That list shall be preceded by the word ‘ingredients’.
Where that is impossible for practical reasons, an enclosed leaflet,
label, tape or card must contain the ingredients to which theconsumer is referred either by abbreviated information or thesymbol given in Annex VIII, which must appear on the containerand the packaging.
The following shall not, however, be regarded as ingredients:— impurities in the raw materials used,
— subsidiary technical materials used in the preparation but not
present in the final product,
— materials used in strictly necessary quantities as solvents or as
carriers for perfume and aromatic compositions.
Perfume and aromatic compositions and their raw materials shall
be referred to by the word ‘perfume’ or ‘flavour’. Ingredients inconcentrations of less than 1 % may be listed in any order afterthose in concentrations of more than 1 %. Colouring agents maybe listed in any order after the other ingredients, in accordance
withth e colour index number or denomination adopted in Annex
IV.
For decorative cosmetic products marketed in several colour
shades, all colouring agents used in the range may be listed,provided that the terms ‘may contain’ are added.
An ingredient must be identified by the common name referred to
in Article 7 (2) or, failing that, by one of the names referred to inArticle 5a (2), first indent.
In accordance with the procedure laid down in Article 10, the
Commission shall, no later than 14 December 1994, adopt thecriteria and conditions under which a manufacturer may, for
reasons of trade secrecy, apply not to include one or more ingredi-
ents on the abovementioned list.
Where it is impracticable, for reasons of size or shape, for the particu-
lars referred to in points (d) and (g) to appear in an enclosed leaflet,1976L0768 — EN — 01.07.2002 — 004.001 — 7
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those particulars shall appear on a label, tape or card which is enclosed
or 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 referred
to in point (g) to appear on a label, tag, tape or card or in an enclosedleaflet, those particulars shall appear on a notice in immediate proxi-mity to the container in which the cosmetic product is exposed for sale.
2. For cosmetic products that are not pre-packaged, are packaged at
the point of sale at the purchaser's request, or are pre-packaged forimmediate sale, Member States shall adopt detailed rules for indicationof the particulars referred 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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must state clearly whether the tests carried out involved the finishedproduct and/or its ingredients. ◄
Article 7
1. Member States may not, for reasons related to the requirements
laid down in this Directive and the Annexes thereto, refuse, prohibitor restrict the marketing of any cosmetic products which comply with
the requirements of this Directive and the Annexes thereto.
2. They may, however, require that the particulars provided 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 accordancewithth e Article 10 procedure.
3. Furthermore, a Member State may, for purposes of prompt and
appropriate medical treatment in the event of difficulties, require that
appropriate and adequate information on substances used in cosmetic
products be made available to the competent authority, which shallensure that that information is used only for the purposes of such treat-ment.
Each Member State shall designate a competent authority and send
details thereof to the Commission, which shall publish that information
in theOfficial Journal of the European Communities .
Article 7a
1. The manufacturer or his agent or the person to whose order a
cosmetic product is manufactured or the person responsible for placingan imported cosmetic product on the Community market shall forcontrol purposes keep the following information readily accessible to
the competent authorities of the Member State concerned at the address
specified on the label in accordance with Article 6 (1) (a):
(a) the qualitative and quantitative composition of the product; in the
case of perfume compositions and perfumes, the name and codenumber of the composition and the identity of the supplier;
(b) the physico-chemical and microbiological specifications of the raw
materials and the finished 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 formanufacture or first importation into the Community must possessan appropriate level of professional qualification or experience in1976L0768 — EN — 01.07.2002 — 004.001 — 8
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accordance with the legislation and practice of the Member State
which is the place of manufacture or first 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 ingredient, its chemical struc-ture and its level of exposure.
Should the same product be manufactured at several places within
Community territory, the manufacturer may choose a single placeof manufacture where that information will be kept available. Inthis connection, and when so requested for monitoring purposes,he shall be obliged to indicate the place so chosen to the moni-
toring authority/authorities concerned;
(e) the name and address of the qualified person or persons responsible
for the assessment referred to in (d). That person must hold adiploma as defined in Article 1 of Directive 89/48/EEC in the fieldof pharmacy, toxicology, dermatology, medicine or a similar disci-
pline;
(f) existing data on undesirable effects on human health resulting from
use of the cosmetic product;
(g) proof of the effect claimed for the cosmetic product, where justi-
fied by the nature of the effect or product.
2. The assessment of the safety for human health referred to in para-
graph 1 (d) shall be carried out in accordance with the principle ofgood laboratory practice laid down in Council Directive 87/18/EEC of18 December 1986 on the harmonization of laws, regulations and
administrative provisions relating to the application of the principles
of good laboratory practice and the verification of their application fortests on chemical substances (
1).
3. The information referred to in paragraph 1 must be available in
the national language or languages of 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 the
competent 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
products and methods for checking compliance with those criteria.
2. The common nomenclature of ingredients used in cosmetic
products and, after consultation of the Scientific Committee on Cosme-tology, the amendments necessary for the adaptation to technical1976L0768 — EN — 01.07.2002 — 004.001 — 9
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progress of the Annexes shall be adopted in accordance with the same
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 other
substances not contained in the lists of substances allowed, for certain
cosmetic 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 of
which it has authorized;
(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 States the next of any authorization decision takenpursuant to paragraph 1 within two months of the date on which itcame into effect.
3. Before expiry of the three-year period provided for in paragraph
1, the Member State may submit to the Commission a request for theinclusion in a list of permitted substances of the substance givennational authorization in accordance with paragraph 1. At the sametime, it shall supply supporting documents setting out the grounds on
which it deems such inclusion justified and shall indicate the uses for
which 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 the Scientific
Committee for Cosmetology and in accordance withth e procedure
laid down in Article 10 as to whether the substance in question maybe included in a list of permitted substances or whether the nationalauthorization should be revoked. Notwithstanding paragraph 1 (a), thenational authorization shall remain in force until a decision is taken onthe request for inclusion in the list.
Article 9
1. The Committee on the Adaptation to Technical Progress of the
Directives on the Removal of Technical Barriers to Trade in the
Cosmetic Products Sector, hereinafter called ‘the Committee’, is herebyset up. It shall consist of representatives of the Member States with arepresentative of the Commission as chairman.
2. The Committee shall adopt its own rules of procedure.
Article 10
1. Where the procedure laid down in this Article is to be followed,
matters shall be referred to the Committee by the chairman, either onhis own initiative or at the request of the representative of a MemberState.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be adopted. The Committee shalldeliver its opinion on the draft within a time limit set by the chairmanaccording to the urgency of the matter. Opinions shall be adopted by a
majority of ►
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weighted as provided for in Article 148 (2) of the Treaty. The chairmanshall not vote.
3. (a) The Commission shall adopt the proposed measures when they
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(b) Where the proposed measures are not in accordance with the
opinion of the Committee, or if no opinion is adopted, theCommission shall without delay propose to the Council the
measures to be adopted. The Council shall act by a qualified
majority.
(c) If, within three months of the proposal being submitted to it, the
Council has not acted, the proposed measures shall be adopted
by the Commission.
Article 11
Without prejudice to Article 5 and not later than one year after expiry
of the period laid down in Article 14 (1) for implementation of this
Directive by the Member States, the Commission shall, on the basisof the results of the latest scientific and technical research, submit tothe Council appropriate proposals establishing lists of permittedsubstances.
Article 12
1. If a Member State notes, on the basis of a substantiated justifica-
tion, that a cosmetic product, although complying with the
requirements of the Directive, represents a hazard to health, it may
provisionally prohibit the marketing of that product in its territory orsubject it to special conditions. It shall immediately inform the otherMember States and the Commission thereof, stating the grounds forits decision.
2. The Commission shall as soon as possible consult the Member
States concerned, following which it shall deliver its opinion 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 has adopted
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 this Directive. It shall be notified to the party concerned togetherwith particulars of the remedies available to him under the laws in
force in the Member States and of the time limits allowed for the exer-
cise of suchremedies.
Article 14
1. Member States shall bring into force the provisions needed in
order to comply with this Directive within 18 months of its notificationand shall forthwith inform the Commission thereof.
2. Member States may, however, for a period of 36 months from
notification of this Directive, 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 as they adopt in the field governed by this Directive arecommunicated to the Commission.
Article 15
This Directive is addressed to the Member States.1976L0768 — EN — 01.07.2002 — 004.001 — 11
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ANNEX I
ILLUSTRATIVELISTBYCATEGORYOFCOSMETICPRODUCTS
— Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.).
— Face masks (withth e exception of peeling products).
— Tinted bases (liquids, pastes, powders).
— Make-up powders, after-bathpowders, h ygienic powders, etc.— Toilet soaps, deodorant soaps, etc.— Perfumes, toilet waters and eau de Cologne.— Bathand sh ower preparations (salts, foams, oils, gels, etc.).— Depilatories.— Deodorants and anti-perspirants.— Hair care products:
— hair tints and bleaches,
— products for waving, straightening 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.).— Products for making up and removing make-up from the face and the eyes.— Products intended for application to the lips.— Products for care of the teeth and the mouth.— Products for nail care and make-up.— Products for external intimate hygiene.— Sunbathing products.— Products for tanning without sun.— Skin-whitening products.
— Anti-wrinkle products.1976L0768 — EN — 01.07.2002 — 004.001 — 12
▼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
its salts◄
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 its salts8. Cinchophen*, its salts, derivatives and salts of these derivatives9. Thyropropic acid* and its salts
10. Trichloroacetic acid11.Aconitum napellus L. (leaves, roots and galenical preparations)
12. Aconitine (principal alkaloid of Aconitum napellus L. ) and its salts
13.Adonis vernalis L . and its preparations
14. Epinephrine*15.Rauwolfia serpentina alkaloids and their salts
16. Alkyne alcohols, their esters, ethers and salts17. Isoprenaline*18. Allyl isothiocyanate19. Alloclamide* and its salts20. Nalorphine*, its salts and 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, its salts and its halogenated and sulphonated derivatives23. Betoxycaine* and its salts24. Zoxazolamine*25. Procainamide*, its salts and derivatives26. Benzidine27. Tuaminoheptane*, its isomers and salts28. Octodrine* and its salts29.►
M32-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts ◄
30. 1,3-dimethylpentylamine and its salts31. 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 its galenical preparations
36. 2,3-Dichloro-2-methylbutane
37. Substances withandrogenic effect38. Anthracene oil39. Antibiotics ►
M17 ◄1976L0768 — EN — 01.07.2002 — 004.001 — 13
(*) 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 its compounds
41.Apocynum cannabinum L . and its preparations
42.►M3Apomorphine (R 5,6,6a, 7-tetrahydro-6-methyl-4 H-dibenzo
[de,g]quinoline-10,11-diol) and its salts ◄
43. Arsenic and its compounds
44.Atropa belladonna L . and its preparations
45. Atropine, its salts and 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 agents listed with the reference (5) in Annex
III, Part 2 and Annex IV, Part 2.
47. Benzene
48.►M3Benzimidazol-2(3 H)-one◄
49.►M3Benzazepines and benzodiazepines ◄
50.►M31-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and
its salts◄
51.►M32,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and its salts ◄
52.►M3Isocarboxazid* ◄
53. Bendroflumethiazide* and its derivatives54. Beryllium and its compounds55. Bromine, elemental56. Bretylium tosilate*57. Carbromal*
58. Bromisoval*
59. Brompheniramine* and its salts60. Benzilonium bromide*61. Tetrylammonium bromide*62. Brucine63. Tetracaine* and its salts64. Mofebutazone*
65. Tolbutamide*
66. Carbutamide*67. Phenylbutazone*68. Cadmium and its compounds69. Cantharides, Cantharis vesicatoria
70. (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (canthar-
idin)
71. Phenprobamate*72.►
M3Nitroderivatives of carbazole ◄
73. Carbon disulphide74. Catalase75. Cephaeline and its salts
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 its salts85. Clofenamide*
86.►
M3N,N-bis(2-chloroethyl)methylamine N-oxide and its salts ◄1976L0768 — EN — 01.07.2002 — 004.001 — 14
▼M4
▼B
▼B
87. Chlormethine* and its salts
88. Cyclophosphamide* and its salts89. Mannomustine* and its salts90. Butanilicaine* and its salts91.►
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 its salts98.Claviceps purpurea Tul., its alkaloids and galenical preparations
99.Conium maculatum L. (fruit, powder, galenical preparations)
100. Glycyclamide*
101. Cobalt benzenesulphonate
102. Colchicine, its salts and derivatives103. Colchicoside and its derivatives104.Golchicum autumnale L . and its galenical 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 its salts112.►
M32-α-Cyclohexylbenzyl( N,N,N',N', -tetraethyl)trimethylenediamine
(phenetamine) ◄
113. Cyclomenol* and its salts114. Sodium hexacyclonate*115. Hexapropymate*116. Dextropropoxyphene*117.►
M3O,O'-Diacetyl- N-allyl-N-normorphine ◄
118. Pipazetate* and its salts119.►
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 its salts ◄
129. Cinchocaine* and its salts130. 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 its salts
134. Digitaline and all heterosides of Digitalis purpurea L .1976L0768 — EN — 01.07.2002 — 004.001 — 15
▼B
135. 7-[2-Hydroxy-3-(2-hydroxyethyl- N-methylamino)propyl]theophylline
(xanthinol)
136. Dioxethedrin* and its salts137. Piprocurarium*138. Propyphenazone*139. Tetrabenazine* and its salts140. Captodiame*141. Mefeclorazine* and its salts142. Dimethylamine143.►
M31,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine,
alypine) and its salts ◄
144. Methapyrilene* and its salts145. Metamfepramone* and its salts146. Amitriptyline* and its salts147. Metformin* and its salts148. Isosorbide dinitrate*149. Malononitrile150. Succinonitrile151. Dinitrophenol isomers152. Inproquone*153. Dimevamide* and its salts154. Diphenylpyraline* and its salts155. Sulfinpyrazone*156.►
M3N-(3-Carbamoyl-3,3-diphenylpropyl)- N,N-diisopropylmethyl-ammo-
nium salts, e.g. isopropamide iodide* ◄
157. Benactyzine*158. Benzatropine* and its salts159. Cyclizine* and its salts160.►
M35,5-Diphenyl-4-imidazolidone ◄
161. Probenecid*162. Disulfiram*; thiram (ISO)163. Emetine, its salts and derivatives164. Ephedrine and its salts165. Oxanamide* and its derivatives166. Eserine or physostigmine and its salts167. Esters of 4-aminobenzoic acid, withth e free amino group, withth e excep-
tion of that given in ►
M9Annex VII, Part 2 ◄
168. Choline salts and their esters, e.g. choline chloride169. Caramiphen* and its salts170. Diethyl 4-nitrophenyl phosphate171. Metethoheptazine* and its salts172. Oxpheneridine* and its salts173. Ethoheptazine* and its salts174. Metheptazine* and its salts175. Methylphenidate* and its salts176. Doxylamine* and its salts177. Tolboxane*
178. 4-Benzyloxyphenol, 4-methoxyphenol and 4-ethoxyphenol
179. Parethoxycaine* and its salts
180. Fenozolone*181. Glutethimide* and its salts182. Ethylene oxide183. Bemegride* and its salts1976L0768 — EN — 01.07.2002 — 004.001 — 16
▼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. Hydrazides and their salts
201. Hydrazine, its derivatives and their salts202. Octamoxin* and its salts203. Warfarin* and its salts204.►
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 its salts210. Hyoscyamine, its salts and derivatives211.Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)
212. Pemoline* and its salts213. 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 its galenical preparations
219. Lobeline* and its salts220. Barbiturates
221. Mercury and its compounds, except those special cases included ►
M18in
Annex VI, Part 1 ◄
222. 3,4,5-Trimethoxyphenethylamine and its salts
223. Metaldehyde224. 2-(4-Allyl-2-methoxyphenoxy)- N,N-diethylacetamide and its salts
225. Coumetarol*226. Dextromethorphan* and its salts227. 2-Methylheptylamine and its salts228. Isometheptene* and its salts1976L0768 — EN — 01.07.2002 — 004.001 — 17
▼M3
▼B
▼M11
▼B
▼B
229. Mecamylamine*
230. Guaifenesin*
231. Dicoumarol*
232. Phenmetrazine*, its derivatives and salts233. 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 its salts238. Arecoline239. Poldine metilsulfate*240. Hydroxyzine*241. 2-Naphthol242. 1-and 2-Naphthylamines and their salts243.►
M33-(1-Naphthyl)-4-hydroxycoumarin ◄
244. Naphazoline* and its salts
245. Neostigmine and its salts (e.g. neostigmine bromide*)246. Nicotine and its salts247. Amyl nitrites248. Inorganic nitrites, withth e 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 its salts258. Noscapine* and its salts159. Guanethidine* and its salts260. Oestrogens ►
M15 ◄
261. Oleandrin
262. Chlortalidone*263. Pelletierine and its salts264. Pentachloroethane265. Pentaerithrityl tetranitrate*266. Petrichloral*267. Octamylamine* and its salts
268. Picric acid269. Phenacemide*
270. Difendoxazine*271.►
M32-Phenylindan-1,3-dione (phenindione) ◄
272. Ethylphenacemide*
273. Phenprocoumon*274. Fenyramidol*275. Triamterene* and its salts276.►
M3Tetraethyl pyrophosphate; TEPP (ISO) ◄
277. Tritolyl phosphate278. Psilocybine*279. Phosphorus and metal phosphides1976L0768 — EN — 01.07.2002 — 004.001 — 18
▼M3
▼B
▼B
280. Thalidomide* and its salts
281.Physostigma venenosum Balf.
282. Picrotoxin283. Pilocarpine and its salts
284.►
M3α-Piperidin-2-ylbenzyl acette (SIC! acetate) laevorotatory threoform
(levophacetoperane) and its salts ◄
285. Pipradrol* and its salts
286. Azacyclonol* and its salts287. Bietamiverine*
288. Butopiprine* and its salts
289. Lead and its ►
M17compounds, with the exception of that mentioned in
Annex III, No 55 under the conditions stated ◄
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 conditions set out under reference No 49 in Annex Ill, Part 1
298.Solanum nigrum L. and its galenical preparations
299. Sparteine and its salts300. Glucocorticoids
301.Datura stramonium L. and its galenical preparations
302. Strophantines, their aglucones and their respective derivatives303.Strophantus species and their galenical preparations
304. Strychnine and its salts
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 its salts
310. Thiotepa*
311.Pilocarpus jaborandi Holmes and its galenical preparations
312. Tellurium and its compounds
313.►
M3Xylometazoline* and its salts ◄
314. Tetrachloroethylene315. Carbon tetrachloride
316. Hexaethyl tetraphosphate
317. Thallium and its compounds318.Thevetia neriifolia Juss. , glycoside extract
319. Ethionamide*
320. Phenothiazine* and its compounds1976L0768 — EN — 01.07.2002 — 004.001 — 19
(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 its salts
325. Trichloronitromethane (chloropicrine)
326. 2,2,2-Tribromoethanol (tribromoethyl alcohol)
327. Trichiormethine* and its salts
328. Tretamine*
329. Gallamine triethiodide*330.Urginea scilla Stern. and its galenical preparations
331. Veratrine, its salts and galenical preparations
332.Schoenocaulon olficinale Lind. (seeds and galenical preparations)
333.Veratrum Spp . and their preparations
334. Vinyl chloride monomer
335. Ergocalciferol* and cholecalciferol (vitamins D
2and D3)
336. Salts of O-alkyldithiocarbonic acids
337. Yobimbine and its salts338. Dimethyl sulfoxide*
339. Diphenhydramine* and its salts
340. 4-tert-Butylphenol
341. 4-tert-Butylpyrocatechol
342. Dihydrotachysterol
343. Dioxane
344. Morpholine and its salts
345.Pyretbrum album L. and its galenical 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. Benzoates of 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 does not exceed:
100 ppm in the finished product,1976L0768 — EN — 01.07.2002 — 004.001 — 20
▼B
▼M8
▼B
▼M3
▼B
▼M24
▼B
▼M3
▼M3
50 ppm in products for 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 its salts
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 its salts373. 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 its esters
385. 11 α-Hydroxypregn-4-ene-3, 20-dione) and its esters
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 — 01.07.2002 — 004.001 — 21
▼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, withreference number 3
393. Acetonitrile394. Tetrahydrozoline and its salts
395. Hydroxy-8-quinoline and its sulphate, except for the uses provided for in
No 51 in Annex III, Part 1
396. Dithio-2,2-bispyridine-dioxide 1,1' (additive with trihydrated magnesium
sulphate) - (pyrithione disulphide + magnesium sulphate)
397. Colouring agent CI 12075 and its lakes, pigments and salts
398. Colouring agent CI 45170 and CI 45170:1
399. Lidocaine
400. 1,2-epoxybutane
401. Colouring agent CI 15585
402. Strontium lactate403. Strontium nitrate
404. Strontium polycarboxylate
405. Pramocaine406. 4-ethoxy-m-phenylenediamine and its salts
407. 2,4-diaminophenylethanol and its salts
408. Catechol409. Pyrogallol410. Nitrosamines
411. 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 its ethyl ester (urocanic acid)
419. (a) the skull, including the brain and eyes, tonsils and spinal cord of:
— bovine animals aged 12 months,
— ovine and caprine animals which are aged over 12 months or have
a permanent incissor tooth erupted through the gum;
(b) the spleens of ovine and caprine animals and ingredients derived there-
from.
However, tallow derivatives may be used 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 withNaOH 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
minutes or equivalent conditions.
420. Crude and refined coal tars1976L0768 — EN — 01.07.2002 — 004.001 — 22
▼M18
▼M20
▼M22
▼M23
▼M24
▼M28
▼M24
▼M25
▼M29
▼M31
▼M29
▼M28
▼M30
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
as a 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
as a 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 toilette
(c) 0,002 % in fragrance cream
(d) 0,001 % in rinse-off products1976L0768 — EN — 01.07.2002 — 004.001 — 23
▼M34
▼M34
(e) 0,0002 % in other leave-on products and oral hygiene products.1976L0768 — EN — 01.07.2002 — 004.001 — 24
ANNEX III
PART1
LISTOFSUBSTANCESWHICHCOSMETICPRODUCTSMUSTNOTCONTAINEXCEPTSUBJECTTOTHERESTRICTIONSANDCONDITIONSLAIDDOWN
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and requirements
ab c d e f
1a Boric acid, borates and 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 years of 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 years of age
(c) Other products (excluding
bathproducts and h air 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 years of age
2. Not to be used on peeling or
irritated skin
1b Tetraborates (a) Bathproducts (a) 18 % (by mass/mass as boric
acid)(a) Not to be used in products for
children under 3 years of age(a) Not to be used of bathing chil-
dren under 3 years of age
(b) Hair waving products (b) 8 % (by mass/mass as boric
acid)(b) Rinse well▼B1976L0768 — EN — 01.07.2002 — 004.001 — 25▼M3
▼M31
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and requirements
ab c d e f
2a Thioglycollic acid and its salts (a) Hair waving or straightening
products:(a) (b) (c):
The directions for use drawn up in
the national or official language(s)
must obligatorily incorporate the
following sentences:
— Avoid contact witheyes
— 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):
— Contains thioglycolate
— Follow the instructions— Keep out of reachof ch ildren— For professional use only
(b) and (c):
— Contains thioglycolate
— Follow the instructions— Keep out of reachof ch ildren— 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 use
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 as thioglycollic acid
2b Thioglycollic acid esters Hair waving or straightening
products:The directions for use 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 witheyes— In the event of contact with
eyes, rinse immediately with
plenty of water and seek
medical advice
— Wear suitable gloves— Contains thioglycolate
— Follow the instructions
— Keep out of reachof ch ildren — 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 as thioglycollic acid
3 Oxalic acid, its esters and alcaline
saltsHair care products 5 % For professional use only
4 Ammonia 6 % calculated as NH
3Above 2 %: contains ammonia
5 Tosylchloramide sodium (*) 0·2 %▼M311976L0768 — EN — 01.07.2002 — 004.001 — 26▼M13
▼M3
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and requirements
ab c d e f
6 Chlorates of alkali metals (a) Toothpaste
(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 % as maximum impurity
content
8►M34m- and p-Phenylenedia-
mines, their N-substituted
derivatives and their salts; N-
substituted derivatives of o-
Phenylenediamines (5), withth e
exception of those derivatives
listedelsewhere in this Annex ◄Oxidizing colouring agents for
hair dyeing6 % calculated as free base
(a) general use (a) Can cause an allergic reaction.
►M20 ◄
Contains phenylenediamines.
Do not use to dye eyelashes or
eyebrows
(b) professional use (b) For professional use only.
Contains phenylenediamines.
Can cause an allergic reaction.
►M20 ◄
►M22Wear suitable
gloves.◄
9►M5Methylphenylenediamines,
theirN-substituted derivatives and
their salts(1) withth e exception of
substance No 364 in Annex II ◄Oxidizing colouring agents for
hair dyeing10 % calculated as free base
(a) general use (a) Can cause an allergic reaction.
►M20 ◄
Contains phenylenediamines.
Do not use to dye eyelashes or
eyebrows
(b) professional use (b) For professional use only.
Contains phenylenediamines.
Can cause en allergic reaction.
►M20 ◄
►M22Wear suitable
gloves.◄▼M31976L0768 — EN — 01.07.2002 — 004.001 — 27
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and requirements
ab c d e f
10 Diaminophenols (1) Oxidizing colouring agents for
hair dyeing10 % calculated as free base
(a) general use (a) Can cause an allergic reaction.
►M20 ◄
Contains diaminophenols. Do
not use to dye eyelashes or
eyebrows
(b) professional use (b) For professional use only.
Contains diaminophenols. Can
cause allergic reaction.
►M20 ◄
►M22Wear suitable
gloves.◄
11 Dichlorophen (*) 0,5 % Contains dichlorophen12 Hydrogen peroxide, and other
compounds or mixtures that
release hydrogen peroxide,
including carbamide peroxide and
zinc peroxide(a) Hair-caire preparations 12 % of H
2O2(40 volumes),
present or released►M22(a): Wear suitable
gloves◄
(b) Skin-care preparations 4 % of H2O2, present or released (a) (b) (c):
Contains hydrogen peroxide.
(c) Nail hardening preparations 2 % of H2O2, present or released Avoid contact witheyes.
Rinse immediately if product comes
into contact withth em
(d) Oral hygiene products 0,1 % of H2O2, present or released
13 Formaldehyde Nail hardeners 5 % calculated as formaldehyde Protect cuticles with grease or oil.
Contains formaldehyde (2).▼M31976L0768 — EN — 01.07.2002 — 004.001 — 28▼M12
▼M20
▼M3
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and 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 comes into contact with
them.
Contains hydroquinone
2.Professional use 2. For professional use only
Contains hydroquinone
Rinse the eyes immediately if the
product comes into contact with
them
►M31 ◄ (b)►M31 ◄► M31 ◄ (b)►M31 ◄
15a Potassium or sodium hydroxide (a) Nail cuticle solvent (a) 5 % by weight (4) (a) Contains alkali. Avoid contact
witheyes. Can cause blindness.
Keep out of reachof ch ildren
(b) Hair straightener (b) (b)
1.General use 1. 2 % by weight (4) 1.Contains alkali. Avoid contact
witheyes. Can cause blind-
ness. Keep out of reachof
children
2.Professional use 2. 4,5 % by weight (4) 2.For professional use only.
Avoid contact witheyes. Can
cause blindness.
(c) pH adjuster
— depilatories(c) Up to pH 12,7 (c) Keep out of reachof ch ildren.
Avoid contact witheyes
(d) Other uses as pH adjuster (d) Up to pH 11▼M31976L0768 — EN — 01.07.2002 — 004.001 — 29▼M8
▼M25
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and requirements
ab c d e f
15b Lithium hydroxide (a) Hair straighteners (a) (a)
1.General use 1. 2 % (6) by weight 1.Contains alkali
Avoid contact witheyesCan cause blindness
Keep out of reachof ch ildren
2.Professional use 2. 4,5 % (
6) by weight 2.For professional use only
Avoid contact witheyes
Can cause blindness
(b) pH ajuster — for depilatories (b) pH value not to exceed pH
12,7(b) Contains alkali
Keep out of reachof ch ildrenAvoid contact witheyes
(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) Contains alkali
Avoid contact witheyes
Keep out of reachof ch ildren
Can cause blindness
(b) pH ajuster — for depilatories (b) pH value not to exceed pH
12,7(b) Contains alkali
Keep out of reachof ch ildren
Avoid contact witheyes
(c) Other uses (e.g. pH adjuster,
processing aid)(c) pH value not to exceed pH 11▼M251976L0768 — EN — 01.07.2002 — 004.001 — 30▼M34
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and requirements
ab c d e f
16 1-Naphthol (CAS No 90-15-3)
and its saltsOxidising colouring agents for
hair dyening2,0 % In combination withh ydrogen
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 its salts (a) Shampoos (a) 0,5 % calculated as quinine
base
(b) Hair lotions (b) 0,2 % calculated as quinine
base▼M341976L0768 — EN — 01.07.2002 — 004.001 — 31▼M3
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and 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 comes into contact
withth em
2.professional use 2.For professional use only.
Contains resorcinol.
Rinse eyes immediately if
product comes into contact
withth em
(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 reachof ch ildren.
Avoid contact witheyes
(b) Alkaline earth sulphides (b) Depilatories (b) 6 % calculated as sulphur
pH≤12,7(b) Keep out of reachof ch ildren.
Avoid contact witheyes
24 Water-soluble zinc salts withth e
exception of zinc 4-hydroxy-
benzenesulphonate and zinc
pyrithione1 % calculated as zinc
25 Zinc 4-hydroxybenzene sulpho-
nateDeodorants, antiperspirants and
astringent lotions6 % calculated as % of anhydrous
substanceAvoid contact witheyes
26 Sodium monofluorophosphate Oral hygiene products 0,15 % calculated as F. When
mixed withoth er fluorine
compounds permitted under this
Annex, total F concentration must
not exceed 0,15 %Contains ammonium monofluoro-
phosphate▼M31976L0768 — EN — 01.07.2002 — 004.001 — 32
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and requirements
ab c d e f
27 Sodium monofluorophosphate Ditto 0,15 %
DittoContains sodium monofluoropho-
sphate
28 Potassium monofluorophosphate Ditto 0,15 %
DittoContains potassium monofluoropho-
sphate
29 Calcium monofluorophosphate Ditto 0,15 %
DittoContains calcium monofluoropho-
sphate
30 Calcium fluoride Ditto 0,15 %
DittoContains calcium fluoride
31 Sodium fluoride Ditto 0,15 %
DittoContains sodium fluoride
32 Potassium fluoride Ditto 0,15 %
DittoContains potassium fluoride
33 Ammonium fluoride Ditto 0,15 %
DittoContains ammonium fluoride
34 Aluminium fluoride Ditto 0,15 %
DittoContains aluminium fluoride
35 Stannous fluoride Ditto 0,15 %
DittoContains stannous fluoride
36 Hexadecyl ammonium fluoride Ditto 0,15 %
DittoContains hexadecyl ammonium
fluoride▼M31976L0768 — EN — 01.07.2002 — 004.001 — 33
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and requirements
ab c d e f
37 3-( N-Hexadecyl- N-2-hydroxyethy-
lammonio) propylbis (2-
hydroxyethyl) ammonium
difluorideDitto 0,15 %
DittoContains 3-( 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 %
DittoContains octadecenyl-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 %
DittoContains ammonium fluorosilicate
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 4Contains 1,3-bis (hydroxymethyl)
immidazolidine-2-thione
45 Benzyl alcohol Solvents, perfumes and flavour-
ings▼M31976L0768 — EN — 01.07.2002 — 004.001 — 34
▼M10
▼M3
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and requirements
ab c d e f
46 6-methylcoumarin Oral hygiene products 0,003 %
47 Nicomethanol hydrofluoride Oral hygiene products 0,15 %
calculated as F
When mixed with other fluorine
compounds permitted under this
Annex, total F concentration must
not exceed 0,15 %Contains nicomethanol hydro-
fluoride
48 Silver nitrate Solely for products intended for
colouring eyelashes and eyebrows4 % — Contains silver nitrate
— Rinse the eyes immediately if
product comes into contact with
them
49 Selenium disulphide Antidandruff shampoos 1 % — Contains selenium disulphide
— Avoid contact witheyes or
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 % as zirconium1. The ratio of the number of
aluminium atoms to that of
zirconium atoms must be
between two an 10
2. The ratio of the number of
(Al + Zr) atoms to that of
chlorine atoms must be
between 0,9 and 2,1
3. Prohibited in aerosol dispen-
sers (sprays)Do not apply to irritated or damaged
skin▼M31976L0768 — EN — 01.07.2002 — 004.001 — 35▼M4
▼M8
▼M9
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and 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 as base
Stabilizer for hydrogen peroxide
in non-rinse-off hair-care prepara-
tions0,03 % calculated as base
52 Methanol Denaturant for ethanol and
isopropyl alcohol5 % calculated as a % ethanol and
isopropyl acohol
53 Etidronic acid and its salts (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 withoth er fluorine
compounds permitted under this
Annex, total F concentration must
not exceed 0,15 %Contains magnesium fluoride▼M91976L0768 — EN — 01.07.2002 — 004.001 — 36▼M13
▼M12
▼M13
▼M17
▼M18
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and 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 %Contains strontium chloride.
Frequent use by children is not
advisable
(b) Shampoo and face care
products2,1 %, calculated as strontium.
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 %Contains strontium acetate. Frequent
use by children is not advisable
59 Talc: Hydrated magnesium sili-
cate(a) Powdery products intended to
be used for children under
three years of age
(b) other products►C4(a) Keep powder away from
children's nose and mouth ◄
60 Fatty acid dialkanolamides Maximum dialkanolamine
content: 0,5 %— Do not use withnitrosating
systems
— Maximum dialkanolamine
content: 5 % (concerns raw
materials)
— Maximum N-nitroso-dialkano-
lamine content: 50 µg/kg
— Keep in nitrite-free containers▼M181976L0768 — EN — 01.07.2002 — 004.001 — 37▼M30
▼M20
▼M23
▼M20
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and requirements
ab c d e f
61 Monoalkanolamines Maximum dialkanolamine
content: 0,5 %— Do not use withnitrosating
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-rinse-off products
(b) other products(a) 2,5 % (a) (b):
— Do not use withnitrosating
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 as strontium,
max. pH of 12,7— Keep out of reachof ch ildren
— Avoid contact withth e eyes
64 Strontium peroxide Rinse-off hair care preparations
professional use4,5 % calculated as strontium in
the ready-for-use preparationAll products must meet the
hydrogen peroxide release
requirements— Avoid contact witheyes
— Rinse eyes immediately if
product comes into contact with
them
— For professional use only
— Wear suitable gloves▼M201976L0768 — EN — 01.07.2002 — 004.001 — 38
▼M23
Reference
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelField of application and/or useMaximum authorized concentration in
the finished cosmetic productOther limitations and requirements
ab c d e f
65 Benzalkonium Chloride, bromide
and saccharinate(a) Rinse-off hair (head) care
products(a) 3 % (as benzalkonium
chloride)(a) In the final products the
concentrations of benzalko-
nium chloride, bromide and
saccharinate with an alkyl
chain of C14, or less must not
exceed 0,1 % (as benzalko-
nium chloride)(a) Avoid contact withth e eyes
(b) Other products (b) 0,1 % (as benzalkonium
chloride)(b) Avoid contact withth e eyes
66 Polyacrylamides (a) Body-care leave-on products (a) Maximum residual acrylamide
content 0,1 mg/kg
(b) Other cosmetic products (b) Maximum residual acrylamide
content 0,5 mg/kg
(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 exceeds 0,05 %.
(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 limits given 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 withreference to th e maximum level auth orised for eachof
them does not 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 limits given in column d. ◄▼M231976L0768 — EN — 01.07.2002 — 004.001 — 39▼M31
▼M34
▼M3
►M14 Part2 ◄
LISTOFSUBSTANCESPROVISIONALLYALLOWED
Refer-
ence
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitations and 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 its salts(a) Oxidising colouring agents
for hair dyeing(a) 3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 3,0 %
3 4-Amino-3-nitrophenol (CAS No
610-81-1) and its salts(a) Oxidising colouring agents
for hair dyeing(a) 3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 3,0 %
4 2,7-Naphthalenediol (CAS no
582-17-2) and its saltsOxidising colouring agents for
hair dyeing1,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 0,5 %30.9.2004
5 m-Aminophenol (CAS no 591-
27-5) and its saltsOxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %Can cause allergic reaction 30.9.2004
6 2,6-Dihydroxy-3,4-dimethylpyri-
dine (CAS No 84540-47-6) and
its saltsOxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %Can cause allergic reaction 30.9.2004▼M111976L0768 — EN — 01.07.2002 — 004.001 — 40▼M34
Refer-
ence
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitations and requirements
ab c d e f g
7 4-Hydroxypropylamino-3-nitro-
phenol (CAS No 92952-81-3)
and its salts(a) Oxidising colouring agents
for hair dyeing(a) 5,2 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 2,6 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agents for 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 its salts(a) Oxidising colouring agents
for hair dyeing(a) 3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agents for 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 withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agents for 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 withh ydrogen
peroxide the maximum use
concentration upon applicationis 1,5 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 2,0 %
12 p-Methylaminophenol (CAS No
150-75-4) and its saltsOxidising colouring agent for
hair dyeing3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %Can cause allergic reaction 30.9.2004
13 2,4-Diamino-5-methylphenox-
yethanol (CAS No 141614-05-3)
and its saltsOxidising colouring agent for
hair dyeing3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %Can cause allergic reaction 30.9.2004▼M341976L0768 — EN — 01.07.2002 — 004.001 — 41
Refer-
ence
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitations and requirements
ab c d e f g
14 HC Violet No 2 CAS No
104226-19-9) and its saltsNon-oxidising colouring agent
for hair dyeing2,0 % 30.9.2004
15 Hydroxyethyl-2,6-dinitro-p-anisi-
dine (CAS No 122252-11-3) and
its saltsNon-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 its salts(a) Oxidising colouring agents
for hair dyeing(a) 1,5 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 0,75 %(a) (b) Can cause allergic reac-
tion30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 1,5 %
17►C62,4-Diamino-5 methyphe-
netol (CAS No 113715-25-6)
and its salts ◄Oxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %Can cause allergic reaction 30.9.2004
18 1,3-Bis-(2,4-diaminophenoxy)-
propane (CAS No 81892-72-0)
and its saltsOxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %Can cause allergic reaction 30.9.2004
19►C63-Amino-2,4-dichloro-
phenol (CAS No 61693-43-4)
and its salts ◄Oxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %Can cause allergic reaction 30.9.2004
20 Phenyl methyl pyrazolone (CAS
No 89-25-8) and its saltsOxidising colouring agents for
hair dyeing0,5 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 0,25 %30.9.2004
21 2-Methyl-5-hydroxyethylamino-
phenol (CAS No 55302-96-0)
and its saltsOxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %Can cause allergic reaction 30.9.2004▼M341976L0768 — EN — 01.07.2002 — 004.001 — 42
Refer-
ence
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitations and requirements
ab c d e f g
22 Hydroxybenzomorpholine (CAS
No 26021-57-8) and its saltsOxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %Can cause allergic reaction 30.9.2004
23 1,7-Naphthalenediol (CAS No
575-38-2) and its saltsOxidising colouring agents for
hair dyeing1,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 0,5 %Can cause allergic reaction 30.9.2004
24 HC Yellow No 10 (CAS No
109023-83-8) and its saltsNon-oxidising colouring agents
for hair dyeing0,2 % 30.9.2004
25 2,6-Dimethoxy-3,5-pyridinedia-
mine (CAS No 85679-78-3) and
its saltsOxidising colouring agents for
hair dyeing0,5 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 0,25 %Can cause allergic reaction 30.9.2004
26 HC Orange No 2 (CAS No
85765-48-6) and its saltsNon-oxidising colouring agents
for hair dyeing1,0 % 30.9.2004
27 HC Violet No 1 (CAS No
82576-75-8) and its salts(a) Oxidising colouring agents
for hair dyeing(a) 0,5 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 0,25 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 0,5 %
28 3-Methylamino-4-nitro-phenox-
yethanol (CAS No 59820-63-2)
and its saltsNon-oxidising colouring agents
for hair dyeing1,0 % 30.9.2004
29 2-Hydroxy-ethylamino-5-nitro-
anisole (CAS No 66095-81-6)
and its saltsNon-oxidising colouring agents
for hair dyeing1,0 % 30.9.2004▼M341976L0768 — EN — 01.07.2002 — 004.001 — 43
Refer-
ence
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitations and 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 withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 1,0 %
31►C6HC Red No 13 (CAS No
94158-13-1) and its salts ◄(a) Oxidising colouring agents
for hair dyeing(a) 2,5 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,25 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 2,5 %
32 1,5-Naphthalenediol (CAS No
83-56-7) and its saltsOxidising colouring agents for
hair dyeing1,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 0,5 %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 withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %Can cause allergic reaction 30.9.2004
34 o-Aminophenol (CAS No 95-55-
6) and its saltsOxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %30.9.2004
35 4-Amino-2-hydroxytoluene
(CAS No 2835-95-2) and its
saltsOxidising colouring agents for
hair dyeing3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %30.9.2004
36►C62,4-Diaminophenox-
yethanol (CAS No 66422-95-5)
and its salts ◄Oxidising colouring agents for
hair dyeing4,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 2,0 %30.9.2004▼M341976L0768 — EN — 01.07.2002 — 004.001 — 44
Refer-
ence
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitations and requirements
ab c d e f g
37 2-Methylresorcinol (CAS No
608-25-3) and its saltsOxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %30.9.2004
38 4-Amino-m-cresol (CAS No
2835-99-6) and its saltsOxidising colouring agents for
hair dyeing3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %30.9.2004
39 2-Amino-4-hydroxyethylaminoa-
nisole (CAS No 83763-47-7) and
its saltsOxidising colouring agents for
hair dyeing3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %30.9.2004
40 3,4-Diamino-benzoicacid (CAS
No 619-05-6) and its saltsOxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %30.9.2004
41 6-Amino-o-cresol (CAS No
17672-22-9) and its saltsOxidising colouring agents for
hair dyeing3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %30.9.2004
42 2-Aminomethyl-p-aminophenol
(CAS No 79352-72-0) and its
saltsOxidising colouring agents for
hair dyeing3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %30.9.2004
43 Hydroxyethylamino-methyl-p-
aminophenol (CAS No 110952-
46-0) and its saltsOxidising colouring agents for
hair dyeing3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %30.9.2004▼M341976L0768 — EN — 01.07.2002 — 004.001 — 45
Refer-
ence
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitations and requirements
ab c d e f g
44 Hydroxyethyl-3,4-methylene-
dioxyaniline (CAS No 81329-90-
0) and its saltsOxidising colouring agents for
hair dyeing3,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,5 %30.9.2004
45►C6Acid Black 52 (CAS No
3618-58-4) and its salts ◄Oxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %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 withh ydrogen
peroxide the maximum use
concentration upon application
is 0,15 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 0,3 %
47 HC Blue No 2 (CAS No 33229-
34-4) and its saltsNon-oxidising colouring agents
for hair dyeing2,8 % 30.9.2004
48 3-Nitro-p-hydroxyethylamino-
phenol (CAS No 65235-31-6)
and its salts(a) Oxidising colouring agents
for hair dyeing(a) 6,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 3,0 %30.9.2004
(b) Non-oxidising colouring
agents for 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 withh ydrogen
peroxide the maximum use
concentration upon application
is 0,25 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 0,5 %
50 HC Red No 10 + HC Red No 11
(CAS No 95576-89-9 + 95576-
92-4) and its salts(a) Oxidising colouring agents
for hair dyeing(a) 2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 1,0 %▼M341976L0768 — EN — 01.07.2002 — 004.001 — 46
Refer-
ence
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitations and requirements
ab c d e f g
51 Yellow No 6 (CAS No 104333-
00-8) and its salts(a) Oxidising colouring agents
for hair dyeing(a) 2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 1,0 %
52 HC Yellow No 12 (CAS No
59320-13-7) and its salts(a) Oxidising colouring agents
for hair dyeing(a) 1,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 0,5 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 0,5 %
53►C6HC Blue No 10 (CAS No
102767-27-1) and its salts ◄Oxidising colouring agents for
hair dyeing2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %30.9.2004
54 HC Blue No 9 (CAS No
114087-47-1) and its salts(a) Oxidising colouring agents
for hair dyeing(a) 2,0 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 1,0 %
55 2-Chloro-6-ethylamino-4-nitro-
phenol (CAS No 131657-78-8)and its salts(a) Oxidising colouring agents
for hair dyeing(a) 3,0 % In combination withh ydrogen
peroxide the maximum useconcentration upon application
is 1,5 %30.9.2004
(b) Non-oxidising colouring
agents for 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 withh ydrogen
peroxide the maximum use
concentration upon application
is 1,0 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 2,0 %▼M341976L0768 — EN — 01.07.2002 — 004.001 — 47
Refer-
ence
numberSubstanceRestrictions
Conditions of use and warnings which
must be printed on the labelAllowed until
Field of application and/or useMaximum authorized
concentration in the
finished cosmetic
productOther limitations and requirements
ab c d e f g
57 Basic Blue 26 (CAS No 2580-
56-5) (CI 44045) and its salts(a) Oxidising colouring agents
for hair dyeing(a) 0,5 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 0,25 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 0,5 %
58 Acid Red 33 (CAS No 3567-66-
6) (CI 17200) and its saltsNon-oxidising colouring agents
for hair dyeing2,0 % 30.9.2004
59 Ponceau SX (CAS No 4548-53-
2) (CI 14700) and its saltsNon-oxidising colouring agents
for hair dyeing2,0 % 30.9.2004
60 Basic Violet 14 (CAS No 632-
99-5) (CI 42510) and its salts(a) Oxidising colouring agents
for hair dyeing(a) 0,3 % In combination withh ydrogen
peroxide the maximum use
concentration upon application
is 0,15 %30.9.2004
(b) Non-oxidising colouring
agents for hair dyeing(b) 0,3 %
61 Musk xylene (CAS no 81-15-2) All cosmetic products, withth e
exception of oral care products(a) 1,0 % in fine
fragrance28.2.2003
(b) 0,4 % in eau
de toilette
(c) 0,03 % in
other products
62 Musk ketone (CAS No 81-14-1) All cosmetic products, withth e
exception of oral care products(a) 1,4 % in fine
fragrance28.2.2003
(b) 0,56 % in eau
de toilette
(c) 0,042 % in
other products▼M341976L0768 — EN — 01.07.2002 — 004.001 — 48
▼B
ANNEX IV
►M14 PART1 ◄
LISTOFCOLOURINGAGENTSALLOWEDFORUSEINCOSMETICPRODUCTS (1)
Fieldofapplication
Column 1 = Colouring agents allowed in all cosmetic products.
Column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied
in the vicinity of the eyes, in particular eye make-up and eye make-up remover.
Column 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into
contact withth e mucous membranes.
Column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into
contact only briefly withth e skin.
Colour index number or
denominationColourField of applicationOther limitations and
requirements (2)1234
10006 Green X
10020 Green X
10316 (3) Yellow X
11680 Yellow X
11710 Yellow X
11725 Orange X
11920 Orange X
12010 Red X►
M18 ◄
12085 (3) Red X 3 % maximum
concentration in the
finished product
12120 Red X
12150 Red X
12370 Red X
12420 Red X
12480 Brown X
12490 Red X
12700 Yellow X ►M15 ◄
13015 Yellow X E 105
►M13 ◄
14270 Orange X E 103
14700 Red X
14720 Red X E 122
14815 Red X E 125
15510 (3) Orange X
15525 Red X
15580 Red X
►M18 ◄
15620 Red X
15630 (3) Red X 3 % maximum
concentration in the
finished product
15800 Red X ►M15 ◄
15850 (3) Red X
15865 (3) Red X
15880 Red X1976L0768 — EN — 01.07.2002 — 004.001 — 49
▼M10
▼M10
Colour index number or
denominationColourField of applicationOther limitations and
requirements (2)1234
15980 Orange X E 111
15985 (3) Yellow X E 110
16035 Red X16185 Red X E 12316230 Orange X16255 (
3) Red X E 124
16290 Red X E 126
17200►M17(3)◄Red X
18050 Red X18130 Red X18690 Yellow X18736 Red X18820 Yellow X18965 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 152
28440 Black X E 151
40215 Orange X40800 Orange X40820 Orange X E 160 e40825 Orange X E 160 f40850 Orange X E 161 g42045 Blue ►
M17
X
◄►M17 ◄1976L0768 — EN — 01.07.2002 — 004.001 — 50
▼M20
▼M10
▼M10
Colour index number or
denominationColourField of applicationOther limitations and
requirements (2)1234
42051 (3) Blue X E 131
42053 Green X
42080 Blue X
42090 Blue X
42100 Green X
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 ◄1976L0768 — EN — 01.07.2002 — 004.001 — 51
▼M10
Colour index number or
denominationColourField of applicationOther limitations and
requirements (2)1234
47005 Yellow X E 104
50325 Violet X
50420 Black X51319 Violet X58000 Red X
59040 Green X
60724 Violet X60725 Violet X60730 Violet X
61565 Green X
61570 Green X61585 Blue X
62045 Blue X
69800 Blue X E 13069825 Blue X71105 Orange X
73000 Blue X
73015 Blue X E 13273360 Red X73385 Violet X
73900 Violet X ►
M20 ◄
73915 Red X74100 Blue X
74160 Blue X
74180 Blue X ►
M20 ◄
74260 Green X75100 Yellow X
75120 Orange X E 160 b
75125 Yellow X E 160 d75130 Orange X E 160 a
75135 Yellow X E 161 d
75170 White X75300 Yellow X E 10075470 Red X E 120
75810 Green X E 140 and E 141
77000 White X E 17377002 White X77004 White X
77007 Blue X
77015 Red X77120 White X
77163 White X
77220 White X E 17077231 White X77266 Black X
77267 Black X
77268:1 Black X E 1531976L0768 — EN — 01.07.2002 — 004.001 — 52
▼M10
Colour index number or
denominationColourField of applicationOther limitations and
requirements (2)1234
77288 Green X free from chromate
ion
77289 Green X free from chromate
ion
77346 Green X
77400 Brown X
77480 Brown X E 175
77489 Orange X E 172
77491 Red X E 172
77492 Yellow X E 172
77499 Black X E 172
77510 Blue X free from cyanide
ions
77713 White X
77742 Violet 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 162Anthocyanins Red X E 163
Aluminium, zinc,
magnesium and calcium
stearatesWhite X
Bromothymol blue Blue X
Bromocresol green Green X
Acid red 195 Red X
(1) Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded under
Annex V from the scope of this Directive are equally allowed.
(2) Colouring agents whose number is preceded 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 matters where the letter ‘E’ has been 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 — 01.07.2002 — 004.001 — 53
▼M12
▼M10
▼M13
▼B
▼M10
PART2
LIST OF COLOURING AGENTS PROVISIONALLY ALLOWEDFOR USE IN COSMETIC
PRODUCTS (1)
Fieldofapplication
Column 1 = Colouring agents allowed in all cosmetic products.
Column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied
in the vicinity of the eyes, in particular eye make-up and eye make-up remover
Column 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into
contact withth e mucous membranes.
Column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into
contact only briefly withth e skin.
Colour index number or
denominationColourField of application Other limita-
tions and
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 ◄
(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 agents whose number is preceded 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 concerningcolouring matters where the letter ‘E’ has been deleted therefrom.1976L0768 — EN — 01.07.2002 — 004.001 — 54
▼B
ANNEX V
LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE
DIRECTIVE
5. Strontium and its compounds, withth e 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 conditions laid 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 — 01.07.2002 — 004.001 — 55
▼M17
▼M12
▼M17
▼M5
▼M23
▼M17
▼M18
▼M17
▼M10
▼M8
▼M11
ANNEX VI
LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY
CONTAIN
PREAMBLE
1. Preservatives are substances which may be added to cosmetic products for
the primary purpose of inhibiting the development of micro-organisms in
suchproducts.
2. The substances marked with the symbol (*) may also be added to cosmetic
products in concentration other than those laid down in this Annex 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 this Annex.
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 exceeds 0,05 %.1976L0768 — EN — 01.07.2002 — 004.001 — 56
PART 1
LISTOFPRESERVATIVESALLOWED
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
ab c d e
1 Benzoic acid, its salts and esters (*) 0,5 % (acid)
2 Propionic acid and its salts (*) 2 % (acid)3 Salicylic acid and its salts (*) 0,5 % (acid) Not to be used in preparations for children
under three years of age, except for sham-
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 products for oral
hygiene)
0,1 % (products for 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 products rinsed off
Forbidden in products for 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 — 01.07.2002 — 004.001 — 57
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
ab c d e
12 4-Hydroxybenzoic acid and its salts and
esters (*)4 % (acid) for 1 ester,
0,8 % (acid) for mixtures of esters
13 3-Acetyl-6-methylpyran-2,4 (3H)-dione
(Dehydracetic acid) and its salts0,6 % (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 withoth er mercurial compounds
authorized by this Directive, the maximum
concentration of Hg remains fixed at
0,007 %For eye make-up and eye make-up remover
onlyContains thiomersal
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 — 01.07.2002 — 004.001 — 58▼M23
▼M11
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
ab c d e
23 Triclocarban (INN) (*) 0,2 % Purity criteria:
3,3',4,4'-Tetrachloroazobenzene <1 ppm
3,3',4,4'-Tetrachloroazoxybenzene <1 ppm
24 4-Chloro-m-cresol (*) 0,2 % Prohibited in the products intended to
come into contact withmucous membranes
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 %Products rinsed off
For other products▼M111976L0768 — EN — 01.07.2002 — 004.001 — 59
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
ab c d e
36 1,2-Dibromo-2,4-dicyanobutane 0,1 % ►M20Not to be used in cosmetic sunsc-
reen products at 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 withmagnesium ch loride 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 % Contains chloroacetamide
42 Chlorhexidine (INN) and its digluconate,
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 — 01.07.2002 — 004.001 — 60▼M12
▼M13
▼M18
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
ab c d e
47 1,6-Di (4-amidinophenoxy)-n-hexane
(Hexamidine) and its salts (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
exceeds 0,05 %)
49 5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0]
octane0,3 % Prohibited in oral hygiene products and in
products intended to come into contact
withmucous membranes
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 as AgCl 20 % AgCl (W/W) on TiO2. Prohibited in
products for children under three years of
age, in oral hygiene products and in
products intended for application around
the eyes and on the lips
53 Benzethonium chloride 0,1 % Rinse-off products only54 Belzalkonium chloride, bromide and
saccharinate (+)0,1% calculated as benzalkonium chloride Avoid contact with eyes
55 Benzylhemiformal 0,15 % Only for products to be removed by rinsing▼M181976L0768 — EN — 01.07.2002 — 004.001 — 61▼M20
▼M23
▼M25
▼M28
▼M30
▼M31
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
ab c d e
56 3-Iodo-2-propynylbutylcarbamate 0,05 % 1. Not to be used for oral hygiene and
lipcare products
2. If the concentration in products intended
to remain on the skin exceeds 0,02 %
add the phrase: Contains iodineContains iodine
(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 — 01.07.2002 — 004.001 — 62▼B
PART 2
LISTOFPRESERVATIVESPROVISIONALLYALLOWED
Reference number Substance Maximum authorized concentration Limitations and requirementsConditions of use 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 — 01.07.2002 — 004.001 — 63
Reference number Substance Maximum authorized concentration Limitations and requirementsConditions of use and warnings
which must be printed on the labelAllowed until
abcdef
►M13 ◄
►M15 ◄
►M23 ◄▼M111976L0768 — EN — 01.07.2002 — 004.001 — 64▼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 conditions laid down in this Annex.
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 — 01.07.2002 — 004.001 — 65
PART1
ListofpermittedUVfilterswhichcosmetic productsmaycontain
Reference
NoSubstances Maximum authorized concentration Other limitations and requirementsConditions of use and warnings which must be
printed on the label
ab c d e
1 4-Aminobenzoic acid 5 %
2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidene-
methyl) anilinium methyl sulphate6%
3 Homosalate (INN) 10 %
4 Oxybenzone (INN) 10 % Contains oxybenzone (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 — 01.07.2002 — 004.001 — 66
▼M23
▼M22
▼M23
▼M24
Reference
NoSubstances Maximum authorized concentration Other limitations and requirementsConditions of use and warnings which must be
printed on the label
ab c d e
11 Polymer of N-{(2 and 4)-[(2-oxoborn-3-
ylidene)methyl]benzyl}acrylamide6%
12 Octyl methoxycinnamate 10 %
13 Ethoxylated Ethyl-4-Aminobenzoate (PEG-
25 PABA)10 %
14 Isopentyl-4-methoxycinnamate (Isoamyl p-
Methoxycinnamate)10 %
15 2,4,6-Trianilino-(p-Carbo-2‘-Ethylhexyl-
1‘Oxy)-1,3,5-Triazine (Octyl Triazone)5%
16 Phenol,2-(2H-Benzotriazol-2-yl)-4-Methyl-
6-(2-Methyl-3-(1,3,3,3-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 — 01.07.2002 — 004.001 — 67▼M25
▼M28
▼M30
▼M31
Reference
NoSubstances Maximum authorized concentration Other limitations and requirementsConditions of use and warnings which must be
printed on the label
ab c d e
22 2-Hydroxy-4-methoxybenzophenone-5-
sulfonic acid (Benzophenone-5) and its
sodium salt5 % (of acid)
23 2,2'-Methylene-bis-6-(2H-benzotriazol-
2yl)-4-(tetramethyl-butyl)-1,1,3,3-phenol10 %
24 Monosodium salt of 2-2'-bis-(1,4-pheny-
lene)1H-benzimidazole-4,6-disulphonic
acid)10 % (of acid)
25 (1,3,5)-Triazine-2,4-bis((4-(2-ethyl-hexy-
loxy)-2-hydroxy)-phenyl)-6-(4-methoxy-
phenyl)10 %
26 Dimethicodiethylbenzalmalonate (CAS No
207574-74-1)10 %
27 Titanium dioxide 25 %
(1) Not requiered if concentration is 0,5 % or less and when it is used only for product protection purposes.▼M311976L0768 — EN — 01.07.2002 — 004.001 — 68▼M34
▼M7
PART2
LISTOFUVFILTERSWHICHCOSMETICPRODUCTSMAYPROVISIONALLYCONTAIN
Reference number Substances Maximum authorized concentration Other limitations and requirementsConditions of use 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 — 01.07.2002 — 004.001 — 69▼M31
▼M15
▼M31
▼M15
▼M31
▼M15
Reference number Substances Maximum authorized concentration Other limitations and requirementsConditions of use and warnings
which must be printed on the labelAllowed until
abcdef
►M25 ◄▼M151976L0768 — EN — 01.07.2002 — 004.001 — 70
▼M21
ANNEX VIII
1976L0768 — EN — 01.07.2002 — 004.001 — 71