1976L0768 — EN — 23.06.2000 — 002.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COUNCIL DIRECTIVE
of 27July 197 6
on the approximation of the laws of the Member States relating to cosmetic products
(76/768/EEC)
(OJ L 262, 27.9.1976, p. 169)
Amended by:
Official Journal
No page date
►M1Council Directive of 24 July 1979 (79/661/EEC) L 192 35 31.7.1979
►M2Commission Directive of 11 February 1982 (82/147/EEC) L 63 26 6.3.1982
►M3Council Directive of 17 May 1982 (82/368/EEC) L 167 1 15.6.1982
►M4Second Commission Directive of 30 March 1983 (83/191/EEC) L 109 25 26.4.1983
►M5Third Commission Directive of 29 June 1983 (83/341/EEC) L 188 15 13.7.1983
►M6Fourth Commission Directive of 22 September 1983 (83/496/EEC) L 275 20 8.10.1983
►M7Council Directive of 26 October 1983 (83/574/EEC) L 332 38 28.11.1983
►M8Fifth Commission Directive of 18 July 1984 (84/415/EEC) L 228 31 25.8.1984
►M9Sixth Commission Directive of 16 July 1985 (85/391/EEC) L 224 40 22.8.1985
►M10Seventh Commission Directive of 28 February 1986 (86/179/EEC) L 138 40 24.5.1986
►M11Eighth Commission Directive of 26 March 1986 (86/199/EEC) L 149 38 3.6.1986
►M12Ninth Commission Directive of 2 February 1987 (87/137/EEC) L 56 20 26.2.1987
►M13Tenth Commission Directive of 2 March 1988 (88/233/EEC) L 105 11 26.4.1988
►M14Council Directive of 21 December 1988 (88/667/EEC) L 382 46 31.12.1988
►M15Eleventh Commission Directive of 21 February 1989 (89/174/EEC) L 64 10 8.3.1989
►M16Council Directive of 21 December 1989 (89/679/EEC) L 398 25 30.12.1989
►M17Twelfth Commission Directive of 20 February 1990 (90/121/EEC) L 71 40 17.3.1990
►M18Thirteenth Commission Directive of 12 March 1991 (91/184/EEC) L 91 59 12.4.1991
►M19Fourteenth Commission Directive of 18 February 1992 (92/8/EEC) L 70 23 17.3.1992
►M20Fifteenth Commission Directive of 21 October 1992 (92/86/EEC) L 325 18 11.11.1992
►M21Council Directive of 14 June 1993 (93/35/EEC) L 151 32 23.6.1993
►M22Sixteenth Commission Directive of 22 June 1993 (93/47/EEC) L 203 24 13.8.1993
►M23Seventeenth Commission Directive of 29 June 1994 (94/32/EC) L 181 31 15.7.1994
►M2418th Commission Directive of 10 July 1995 (95/34/EC) L 167 19 18.7.1995
►M25Nineteenth Commission Directive of 25 June 1996 (96/41/EC) L 198 36 8.8.1996
►M2620th Commission Directive of 10 January 1997 (97/1/EC) L 16 85 18.1.1997
►M27Commission Directive of 17 April l997 (97/18/EC) L 114 43 1.5.1997
►M2821st Commission Directive of 14 July 1997 (97/45/EC) L 196 77 24.7.1997
►M29Twenty-second Commission Directive of 5 March 1998 (98/16/EC) L 77 44 14.3.1998
1976L0768 — EN — 23.06.2000 — 002.001 — 2
►M3023rd Commission Directive of 3 September 1998 (98/62/EC) L 253 20 15.9.1998
►M31Twenty-Fourth Commission Directive 2000/6/EC of 29 February 2000 L 56 42 1.3.2000
►M32Twenty-Fifth Commission Directive 2000/11/EC of 10 March 2000 L 65 22 14.3.2000
►M33Commission Directive 2000/41/EC of 19 June 2000 L 145 25 20.6.2000
Amended by:
►A1Act of Accession of Greece L 291 17 19.11.1979
►A2Act of Accession of Spain and Portugal L 302 23 15.11.1985
Corrected by:
►C1Corrigendum, OJ L 255, 25.9.1984, p. 28 (84/415/EEC)
►C2Corrigendum, OJ L 157, 24.6.1988, p. 38 (88/233/EEC)
►C3Corrigendum, OJ L 199, 13.7.1989, p. 23 (89/174/EEC)
►C4Corrigendum, OJ L 273, 25.10.1994, p. 38 (94/32/EC)
▼B
COUNCIL DIRECTIVE
of 27July 197 6
on the approximation of the laws of the Member States relating to
cosmetic products
(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 compositioncharacteristics to which cosmetic products must conform and prescriberules for their labelling and for their packaging; whereas theseprovisions 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, they hinder
trade in these products and, as a result, have a direct effect on theestablishment 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, thisobjective must be attained by means which also take account of
economic and technological requirements;
Whereas it is necessary to determine at Community level the regulations
which must be observed as regards the composition, labelling and
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 delimitingthe field of cosmetics from that of pharmaceuticals; whereas thisdelimitation follows in particular from the detailed definition ofcosmetic products, which refers both to their areas of application and
to the purposes of their use; whereas this Directive is not applicable to
the products that fall under the definition of cosmetic product but areexclusively intended to protect from disease; whereas, moreover, it isadvisable 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 not come
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
foreseeable conditions of use; whereas in particular it is necessary totake into account the possibility of danger to zones of the body that arecontiguous 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 technical
research, are implementing measures of a technical nature; whereas it isadvisable to entrust their adoption to the Commission, subject to certain1976L0768 — EN — 23.06.2000 — 002.001 — 3
(1) OJ No C 40, 8. 4. 1974, p. 71.
(2) OJ No C 60, 26. 7. 1973, p. 16.
▼B
conditions specified in this Directive, for the purpose of simplifying and
accelerating the procedure;
Whereas technical progress necessitates rapid adaptation of the technical
provisions defined in this Directive and in subsequent Directives in thisfield; whereas it is advisable, in order to facilitate implementation of the
measures necessary for this purpose, to provide for a procedure
establishing close cooperation between the Member States and theCommission within the Committee for adaptation to technical progressof Directives aimed at the removal of technical obstacles to trade in thecosmetic products sector;
Whereas it is necessary, on the basis of scientific and technical research,
to draw up proposals for lists of authorized substances which couldinclude antioxidants, hair dyes, preservatives and ultraviolet filters,
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 publichealth; whereas it is therefore advisable to
provide 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 thehuman 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/or
protecting 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. MemberStates may take such measures as they deem necessary with regard to
those 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 reasonablyforeseeable conditions of use, taking account, in particular, of theproduct's presentation, its labelling, any instructions for its use and
disposal as well as any other indication or information provided by the
manufacturer or his authorized agent or by any other person responsiblefor 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 Directive andits Annexes may be put on the market.1976L0768 — EN — 23.06.2000 — 002.001 — 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 cosmeticproducts 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 intendedsolely to colour hair;
(d) colouring agents listed in Annex IV, Part 1, used outside the
conditions laid down, with the exception of cosmetic productscontaining 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 are
used for specific purposes apparent from the presentation of the
product;
(g) UV filters other than those listed in Part 1 of Annex VII;
(h) UV filters listed in Part 1 of Annex VII, beyond the limits and
outside the conditions laid down therein;
(i) ingredients or combinations of ingredients tested on animals after
►
M3330 June 2002 ◄in order to meet the requirements of this
Directive.
If there has been insufficient progress in developing satisfactory
methods to replace animal testing, and in particular in those caseswhere alternative methods of testing, despite all reasonable
endeavours, have not been scientifically validated as offering an
equivalent level of protection for the consumer, taking into accountOECD toxicity test guidelines, the Commission shall, by 1 January1997, submit draft measures to postpone the date of implementationof this provision, for a sufficient period, and in any case for no lessthan two years, in accordance with the procedure laid down in
Article 10. Before submitting such measures, the Commission will
consult the Scientific Committee on Cosmetology.
The Commission shall present an annual report to the European
Parliament and the Council on progress in the development,validation and legal acceptance of alternative methods to thoseinvolving experiments on animals. That report shall contain precise
data on the number and type of experiments relating to cosmetic
products carried out on animals. The Member States shall be obligedto collect that information in addition to collecting statistics as laiddown by Directive 86/609/EEC on the protection of animals used forexperimental and other scientific purposes. The Commission shall inparticular ensure the development, validation and legal acceptance
of experimental methods which do not use live animals.
2. The presence of traces of the substances listed in Annex II shall be
allowed provided that such presence is technically unavoidable in goodmanufacturing 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 thatAnnex;1976L0768 — EN — 23.06.2000 — 002.001 — 5
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(b) the colouring agents listed in Annex IV, Part 2, within the limits and
under the conditions laid down, until the admission dates given inthat 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) ofthat Annex. However, some of these substances may be used in
other concentrations for specific purposes apparent from the
presentation of the product;
(d) the UV 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, or
— deleted from all the Annexes, on the basis of available scientific
information or because they are no longer used.
Article 5a
1. No later than 14 December 1994 the Commission shall, under the
procedure laid down in Article 10, compile an inventory of ingredientsemployed in cosmetic products, on the basis in particular of informationsupplied by the industry concerned.
For the purposes of this Article, ‘cosmetic ingredient’ shall mean any
chemical substance or preparation of synthetic or natural origin, except
for perfume and aromatic compositions, used in the composition of
cosmetic products.
The inventory shall be divided into two sections: one concerning
perfume and aromatic raw materials and the second concerning othersubstances.
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. Theinventory shall be indicative and shall not constitute a list of thesubstances authorized for use in cosmetic products.
Article 6
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M21Member States shall take all measures necessary to ensure
that cosmetic products may be marketed only if the container andpackaging bear the following information in indelible, easily legible andvisible lettering; the information mentioned in point (g) may, however,be indicated on the packaging alone: ◄
(a) the name or style and the address or registered office of the
manufacturer or the person responsible for marketing the cosmetic
product who is established within the Community. Such informationmay be abbreviated in so far as the abbreviation makes it generallypossible to identify the undertaking. Member States may require thatthe country of origin be specified for goods manufactured outsidethe Community;1976L0768 — EN — 23.06.2000 — 002.001 — 6
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b) the nominal content at the time of packaging, given by weight or by
volume, except in the case of packaging containing less than fivegrams or five millilitres, free samples and single-application packs;
for pre-packages normally sold as a number of items, for which
details of weight or volume are not significant, the content need notbe given provided the number of items appears on the packaging.This information need not be given if the number of items is easy tosee 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 with Article 2.
The date of minimum durability shall be indicated by the words:
‘Best used before the end of…’ followed by either:
— the date itself, or
— details of where the date appears on the packaging.
If necessary, this information shall be supplemented by an indication
of the conditions which must be satisfied to guarantee the stateddurability.
The date shall be clearly expressed and shall consist of the month
and the year in that order. Indication of the date of durability shallnot be mandatory for cosmetic products the minimum durability ofwhich 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 specialprecautionary information on cosmetic products for professional use,in particular in hairdressing. Where this is impossible for practical
reasons, an enclosed leaflet, label, tape or card must contain that
information to which the consumer is referred either by abbreviatedinformation or the symbol given in Annex VIII, which must appearon the container and the packaging;
(e) the batch number of manufacture or the reference for identifying the
goods. Where this is impossible for practical reasons because thecosmetic products are too small, such information need appear onlyon the packaging;
(f) the function of the product, unless it is clear from the presentation of
the product;
(g) a list of ingredients in descending order of weight at the time they
are added. That list shall be preceded by the word ‘ingredients’.Where that is impossible for practical reasons, an enclosed leaflet,label, tape or card must contain the ingredients to which the
consumer is referred either by abbreviated information or the symbol
given in Annex VIII, which must appear on the container and thepackaging.
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 aromaticc ompositions and their raw materials shall be
referred to by the word ‘perfume’ or ‘flavour’. Ingredients in
concentrations of less than 1 % may be listed in any order after thosein concentrations of more than 1 %. Colouring agents may be listedin any order after the other ingredients, in accordance with thecolour index number or denomination adopted in Annex IV.1976L0768 — EN — 23.06.2000 — 002.001 — 7
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For decorative cosmetic products marketed in several colour shades,
all colouring agents used in the range may be listed, provided thatthe 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 ingredients on the
abovementioned list.
Where it is impracticable, for reasons of size or shape, for the particulars
referred to in points (d) and (g) to appear in an enclosed leaflet, thoseparticulars shall appear on a label, tape or card which is enclosed orattached 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 toin point (g) to appear on a label, tag, tape or card or in an enclosedleaflet, those particulars shall appear on a notice in immediate proximityto 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 do nothave.►
M21Furthermore, any reference to testing on animals must
state clearly whether the tests carried out involved the finished product
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, prohibit orrestrict 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 Commission shalladopt a common ingredients nomenclature in accordance with theArticle 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 cosmeticproducts be made available to the competent authority, which shallensure that that information is used only for the purposes of suchtreatment.
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 the1976L0768 — EN — 23.06.2000 — 002.001 — 8
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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 by
the law of the Member State concerned; the person responsible formanufacture or first importation into the Community must possessan appropriate level of professional qualification or experience inaccordance with the legislation and practice of the Member Statewhich 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 the
general toxicological profile of the ingredient, its chemical structureand its level of exposure.
Should the same product be manufactured at several places within
Community territory, the manufacturer may choose a single place ofmanufacture where that information will be kept available. In thisconnection, and when so requested for monitoring purposes, he shallbe obliged to indicate the place so chosen to the monitoring
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 similardiscipline;
(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 justified
by the nature of the effect or product.
2. The assessment of the safety for human health referred to in
paragraph 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 for testson 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, or in alanguage readily understood by the competent authorities.
4. The manufacturer or his agent, or the person to whose order a
cosmetic product is manufactured, or the person responsible for placing
imported cosmetic products on the Community market, shall notify thecompetent authority of the Member State of the place of manufacture orof the initial importation of the address of the place of manufacture or ofinitial importation into the Community of the cosmetic products beforethe 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 theCommission, which shall publish that information in the Official
Journal of the European Communities .
The Member States shall ensure that the abovementioned authorities
continue to cooperate in areas where such cooperation is necessary tothe smooth application of this Directive.1976L0768 — EN — 23.06.2000 — 002.001 — 9
(1) OJ No L 15, 17. 1. 1987, p. 29.
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Article 8
1. In accordance with the procedure laid down in Article 10 the
following shall be determined:
— the methods of analysis necessary for checking the composition of
cosmetic products,
— the criteria of microbiological and chemical purity for cosmetic
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 onCosmetology, the amendments necessary for the adaptation to technicalprogress 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 othersubstances not contained in the lists of substances allowed, for certaincosmetic products specified in its national authorization, subject to the
following conditions:
(a) the authorization must be limited to a maximum period of three
years;
(b) the Member State must carry out an official check on cosmetic
products manufactured from the substance or preparation use ofwhich it has authorized;
(c) cosmetic products thus manufactured must bear a distinctive
indication 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 it cameinto 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 the
inclusion in a list of permitted substances of the substance given nationalauthorization in accordance with paragraph 1. At the same time, it shallsupply supporting documents setting out the grounds on which it deemssuch inclusion justified and shall indicate the uses for which the
substance or preparation is intended. Within 18 months of submission of
the request, a decision shall be taken on the basis of the latest scientificand technical knowledge, after consultation, at the initiative of theCommission or of a Member State, of the Scientific Committee forCosmetology and in accordance with the procedure laid down in Article10 as to whether the substance in question may be included in a list of
permitted substances or whether the national authorization should be
revoked. Notwithstanding paragraph 1 (a), the national authorizationshall remain in force until a decision is taken on the request for inclusionin 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.1976L0768 — EN — 23.06.2000 — 002.001 — 10
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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 on hisown initiative or at the request of the representative of a Member State.
2. The representative of the Commission shall submit to the
Committee a draft of the measures to be adopted. The Committee shall
deliver its opinion on the draft within a time limit set by the chairmanaccording to the urgency of the matter. Opinions shall be adopted by amajority of ►
A254◄votes, the votes of Member States being
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
are in accordance with the opinion of the Committee.
(b) Where the proposed measures are not in accordance with the
opinion of the Committee, or if no opinion is adopted, theCommission shall without delay propose to the Council themeasures to be adopted. The Council shall act by a qualified
majority.
(c) If, within three months of the proposal being submitted to it, the
Council has not acted, the proposed measures shall be adopted bythe 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 thisDirective by the Member States, the Commission shall, on the basis of
the results of the latest scientific and technical research, submit to the
Council appropriate proposals establishing lists of permitted substances.
Article 12
1. If a Member State notes, on the basis of a substantiated
justification, that a cosmetic product, although complying with the
requirements of the Directive, represents a hazard to health, it mayprovisionally 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 for itsdecision.
2. The Commission shall as soon as possible consult the Member
States concerned, following which it shall deliver its opinion without
delay and take the appropriate steps.
3. If the Commission is of the opinion that technical adaptations to
the Directive are necessary, such adaptations shall be adopted by eitherthe Commission or the Council in accordance with the procedure laiddown in Article 10. In that event, the Member State which has adopted
safeguard measures may maintain them until entry into force of the
adaptations.
Article 13
Precise reasons shall be stated for any individual measures placing a
restriction or ban on the marketing of cosmetic products taken pursuant
to this Directive. It shall be notified to the party concerned together withparticulars of the remedies available to him under the laws in force inthe Member States and of the time limits allowed for the exercise ofsuch remedies.
Article 14
1. Member States shall bring into force the provisions needed in order
to comply with this Directive within 18 months of its notification andshall forthwith inform the Commission thereof.1976L0768 — EN — 23.06.2000 — 002.001 — 11
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2. Member States may, however, for a period of 36 months from
notification of this Directive, authorize the marketing in their territory ofcosmetic 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 atecommunicated to the Commission.
Article 15
This Directive is addressed to the Member States.1976L0768 — EN — 23.06.2000 — 002.001 — 12
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ANNEXI
ILLUSTRATIVE LIST BY CATEGORY OF COSMETIC PRODUCTS
— Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.).
— Face masks (with the exception of peeling products).
— Tinted bases (liquids, pastes, powders).
— Make-up powders, after-bath powders, hygienicpowders, etc .— Toilet soaps, deodorant soaps, etc.— Perfumes, toilet waters and eau de Cologne.— Bath and shower preparations (salts, foams, oils, gels, etc.).— Depilatories.— Deodorants and anti-perspirants.— Hair care products:
— hair 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 makeup 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 — 23.06.2000 — 002.001 — 13
▼B
ANNEXII
List of substances which must not form part of the composition of cosmetic
products
1. N-5-Chlorobenzoxazol-2-ylacetamide
2.►M32-Acetoxyethyltrimethylammonium hydroxide (acetylcholine) and
its salts◄
3. Deanol aceglumate*(1)
4. Spironolactone*
5.►M3[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid and its
salts◄
6. Methotrexate*7. Aminocaproic acid* and its salts8. Cinchophen*, its salts, derivatives and salts of these derivatives
9. Thyropropicac id* 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 salts
20. Nalorphine*, its salts and ethers
21. 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 derivatives
26. 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 derivatives33. 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-methylbutane37. Substances with androgenic effect38. Anthracene oil39. Antibiotics ►
M17 ◄
40. Antimony and its compounds1976L0768 — EN — 23.06.2000 — 002.001 — 14
(1) In this Directive, names followed by an asterisk are those published in ‘Computer print-
out 1975, International Non-proprietary Names (INN) for pharmaceutical products, Lists
1-33 of proposed INN’, WHO, Geneva, August 1975.▼M3
▼B
▼B
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. Arsenicand its c ompounds
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 derivatives
54. 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,25)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalicanhydride (c antharidin)
71. Phenprobamate*72.►
M3Nitroderivatives of carbazole ◄
73. Carbon disulphide
74. Catalase
75. Cephaeline and its salts76.Chenopodium ambrosioides (essential oil)
77. 2,2,2-Trichloroethane-1,1-diol
78. Chlorine
79. 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 salts
85. Clofenamide*
86.►
M3N,N-bis(2-chloroethyl)methylamine N-oxide and its salts ◄
87. Chlormethine* and its salts88. Cyclophosphamide* and its salts1976L0768 — EN — 23.06.2000 — 002.001 — 15
▼M4
▼B
▼B
89. Mannomustine* and its salts
90. Butanilicaine* and its salts
91.►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. Chloroethane
97. 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 derivatives
103. Colchicoside and its derivatives104.Golchicum autumnale L . and its galenical preparations
105. Convallatoxin
106.Anamirta cocculus L . (fruit)
107.Croton tiglium (oil)
108. 1-Butyl-3-( N-crotonoylsulphanilyl)urea
109. Curare and curarine110. Syntheticc urarizants
111. Hydrogen cyanide and its salts
112.►
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 salts
119.►M35-(αβ-Dibromophenethyl)-5-methylhydantoin ◄
120.►M3N,N'-Pentamethylenebis (trimethylammonium salts), e.g. penta-
methonium bromide* ◄
121.►M3N,N'-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts,
e.g. azamethonium bromide* ◄
122. Cyclarbamate*123. Clofenotane* DDT (ISO)
124.►
M3N,N'-Hexamethylenebis(trimethylammonium) salts, e.g. hexametho-
nium bromide* ◄
125. Dichloroethanes (ethylene chlorides)
126. Dichloroethylenes (acetylene chlorides)127. Lysergide* and its salts
128.►
M32-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and 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 .
135. 7-[2-Hydroxy-3-(2-hydroxyethyl- N-methylamino)propyl]theophylline
(xanthinol)
136. Dioxethedrin* and its salts1976L0768 — EN — 23.06.2000 — 002.001 — 16
▼B
137. Piprocurarium*
138. Propyphenazone*
139. Tetrabenazine* and its salts
140. Captodiame*
141. Mefeclorazine* and its salts
142. Dimethylamine
143.►M31,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine,
alypine) and its salts ◄
144. Methapyrilene* and its salts
145. Metamfepramone* and its salts
146. Amitriptyline* and its salts
147. Metformin* and its salts
148. Isosorbide dinitrate*
149. Malononitrile150. Succinonitrile
151. Dinitrophenol isomers
152. Inproquone*
153. Dimevamide* and its salts
154. Diphenylpyraline* and its salts
155. Sulfinpyrazone*
156.►
M3N-(3-Carbamoyl-3,3-diphenylpropyl)- N,N-diisopropylmethyl-ammo-
nium salts, e.g. isopropamide iodide* ◄
157. Benactyzine*158. Benzatropine* and its salts
159. Cyclizine* and its salts
160.►
M35,5-Diphenyl-4-imidazolidone ◄
161. Probenecid*
162. Disulfiram* thiram (ISO)
163. Emetine, its salts and derivatives
164. Ephedrine and its salts165. Oxanamide* and its derivatives
166. Eserine or physostigmine and its salts
167. Esters of 4-aminobenzoicac id, with the free amino group, with the
exception of that given in ►
M9Annex VII, Part 2 ◄
168. Choline salts and their esters, e.g. choline chloride
169. Caramiphen* and its salts
170. Diethyl 4-nitrophenyl phosphate171. Metethoheptazine* and its salts
172. Oxpheneridine* and its salts
173. Ethoheptazine* and its salts
174. Metheptazine* and its salts
175. Methylphenidate* and its salts
176. Doxylamine* and its salts
177. Tolboxane*
178. 4-Benzyloxyphenol, 4-methoxyphenol and 4-ethoxyphenol
179. Parethoxycaine* and its salts
180. Fenozolone*
181. Glutethimide* and its salts
182. Ethylene oxide
183. Bemegride* and its salts184. Valnoctamide*
185. Haloperidol*
186. Paramethasone*1976L0768 — EN — 23.06.2000 — 002.001 — 17
▼M9
▼B
▼B
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. Hexachloroethane
198. (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-
dimethano-naphthalene (isodrin-ISO)
199. Hydrastine, hydrastinine and their salts200. Hydrazides and their salts201. Hydrazine, its derivatives and their salts202. Octamoxin* and its salts
203. Warfarin* and its salts
204.►
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-Methyiheptylamine and its salts228. Isometheptene* and its salts229. Mecamylamine*230. Guaifenesin*231. Dicoumarol*1976L0768 — EN — 23.06.2000 — 002.001 — 18
▼M3
▼B
▼M11
▼B
▼B
232. Phenmetrazine*, its derivatives and salts
233. Thiamazole*
234.►M33,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5 H-pyrano [3,2-c]-
[1] benzopyran-5-one (cyclocoumarol) ◄
235. Carisoprodol*236. Meprobamate*237. Tefazoline* and its salts
238. Arecoline
239. Poldine metilsulfate*240. Hydroxyzine*241. 2-Naphthol242. 1-and 2-Naphthylamines and their salts243.►
M33-(1-Naphthyl)-4-hydroxycoumarin ◄
244. Naphazoline* and its salts245. Neostigmine and its salts (e.g. neostigmine bromide*)246. Nicotine and its salts
247. Amyl nitrites
248. Inorganicnitrites, with the exc eption of sodium nitrite249. Nitrobenzene250. Nitrocresols and their alkali metal salts251. Nitrofurantoin*252. Furazolidone*253. Propane-1,2,3-triyl trinitrate254. Acenocoumarol*255. Alkali pentacyanonitrosylferrate (2-)
256. Nitrostilbenes, their homologues and their derivatives
257. Noradrenaline and its salts258. Noscapine* and its salts159. Guanethidine* and its salts260. Oestrogens, ►
M15 ◄
261. Oleandrin262. Chlortalidone*263. Pelletierine and its salts
264. Pentachloroethane
265. 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 salts
276.►
M3Tetraethyl pyrophosphate; TEPP (ISO) ◄
277. Tritolyl phosphate278. Psilocybine*279. Phosphorus and metal phosphides280. Thalidomide* and its salts281.Physostigma venenosum Balf.
282. Picrotoxin1976L0768 — EN — 23.06.2000 — 002.001 — 19
▼M3
▼B
▼B
283. Pilocarpine and its salts
284.►M3α-Piperidin-2-ylbenzyl acette (SIC! acetate) laevorotatory threoform
(levophacetoperane) and its salts ◄
285. Pipradrol* and its salts286. 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. Conjine
291.Prunus laurocerasus L. (‘cherry laurel water’)
292. Metyrapone*293. Radioactive substances(
1)
294.Juniperus sabina L. (leaves, essential oil and galenical preparations)
295. Hyoscine, its salts and derivatives296. 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. Glucocorticoids301.Datura stramonium L. and its galenical preparations
302. Strophantines, their aglucones and their respective derivatives
303.Strophantus species and their galenical preparations
304. Strychnine and its salts305.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 salts310. Thiotepa*311.Pilocarpus jaborandi Holmes and its galenical preparations
312. Tellurium and its compounds313.►
M3Xylometazoline* and its salts ◄
314. Tetrachloroethylene
315. Carbon tetrachioride
316. Hexaethyl tetraphosphate317. Thallium and its compounds318.Thevetia neriifolia Juss. , glycoside extract
319. Ethionamide*320. Phenothiazine* and its compounds
321. Thiourea and its derivatives, with the exception of the one listed in Annex
III, Part 1
322. Mephenesin* and its esters1976L0768 — EN — 23.06.2000 — 002.001 — 20
(1) The presence of natural radioactive substances and of radioactive substances caused by
artificial contamination from the environment is permitted, provided that the radioactivesubstances are not enriched for the manufacture of cosmetic products and that theirconcentration falls within the limits set in the Directive laying down the basic standardsfor the protection of the health of workers and the general public against the dangers
arising from ionizing radiations (OJ No 11, 20. 2. 1959, p. 221/59).▼M9
▼B
▼M3
▼B
▼B
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 medicinal
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 salts328. 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 salts
338. 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 monosulphides354. Thiuram disulphides
355. Dimethylformamide
356. 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,
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 dihypoiodite1976L0768 — EN — 23.06.2000 — 002.001 — 21
▼M8
▼B
▼M3
▼B
▼M24
▼B
▼M3
▼B
▼M32
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-Tribromosalicylanilide
374.Phytolacca spp. and their preparations
375. Tretinoin (retinoicac id and its salts)
376. 1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole - CI 76050)
►
M17and their salts ◄
377. 1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) ►M17and their
salts◄
378. Colouring agent CI 12140379. Colouring agent CI 26105
380. Colouring agent CI 42555
Colouring agent CI 42555-1
Colouring agent CI 42555-2
381. Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN))
382. Benzoyl peroxide
383. 2-Amino.4-nitrophenol
384. 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 42 535
389. Colouring agent CI 61 554
390. Anti-androgens of steroidal structure
391. Zirconium and its compounds, with the exception of the substances listed
under reference number 50 in Annex III, Part One, and the zirconium lakes,
pigments or salts of the colouring agents listed in Annex IV, Part One, with
reference number 31976L0768 — EN — 23.06.2000 — 002.001 — 22
▼M5
▼M8
▼M32
▼M10
▼M32
▼M10
▼M12
▼M32
▼M13
▼M15
▼M17
▼M32
▼M17
▼M32
▼M32
393. Acetonitrile
394. 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 15585402. 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-phenylenediamine414. 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
therefrom.
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
appropriate corresponding pressure, for 20 minutes (glycerol, fatty
acids and fatty acid esters),
— Saponification with NaOH 12M (glycerol and soap):
— Batch process: at 95 ºC for three hours
or
— Continuous process: at 140 ºC, two bars (2 000 hPa) for eight
minutes or equivalent conditions.
420. Crude and refined coal tars
421. 1,1,3,3,5,-Pentamethyl-4,6-dinitroindane (moskene)
422. 5-tert-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (musk tibetene).1976L0768 — EN — 23.06.2000 — 002.001 — 23
▼M18
▼M20
▼M22
▼M23
▼M24
▼M28
▼M24
▼M25
▼M29
▼M31
▼M29
▼M28
▼M30
ANNEXIII
PART 1
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS AND CONDITIONS LAID DOWN
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 Boricac id, 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 boricac id)(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 bath
products and hair waving
products)(c) 3 % (by mass/mass as boric
acid)(c) 1. Not to be used in products
for children under 3 years of age
2. Not to be used on peeling or
irritated skin if the concentration
of free soluble borates exceeds
1,5 % (by mass/mass as boricac id)(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) Bath products (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
children under 3 years of age
(b) Hair waving products (b) 8 % (by mass/mass as boric
acid)(b) Rinse well▼B1976L0768 — EN — 23.06.2000 — 002.001 — 24▼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 sentenses:
— Avoid contact with eyes
— In the event of contact with
eyes, rinse immediately with
plenty of water and seek
medical advice
— Wear suitable gloves ((a) and
(c) only)(a): — Contains thioglycolate
— Follow the instructions
— Keep out of reach of chil-
dren
— For professional use only
(b) and (c):
— Contains thioglycolate
— Follow the instructions— Keep out of reach of chil-
dren— general use — 8 % ready for use pH 7 to 9,5
— professional use — 11 % ready for use pH 7 to 9,5
(b) Depilatories — 5 % ready for use pH 7 to 12,7
(c) Other hair-caire products
which are removed after appli-
cation— 2 % ready for use pH 6 to 9,5
The abovementioned percen-
tages 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 with eyes— 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 reach of children — general use — 8 % ready for use pH 6 to 9,5
— professional use — 11 % ready for use pH 6 to 9,5 — For professional use only
The abovementioned percentages
are calculated 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 — 23.06.2000 — 002.001 — 25▼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-
trichloroethane, total concentration
must not exceed 35 %)0·2 % as maximum impurity
content
8►M5m- and p-Phenylenedia-
mines, their N-substituted
derivatives and their salts; N-
substituted derivatives of o-
phenylenediamines (1)◄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 derivattives and
their salts (1)with the exeption 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 — 23.06.2000 — 002.001 — 26
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 %12 Hydrogen peroxide, and other
compounds or mixtures that
release hydrogen peroxide,
including carbamide peroxide and
zincperoxide(a) Hair-caire preparations 12 % of H
2O2(40 volumes),
present or released►M22(a): Wear suitable
gloves◄
(b) Skin-care preparations 4 % of H2O2present or released (b) (c):
Contains hydrogen peroxide.
(c) Nail hardening preparations 2 % of H2O2present or released Avoid contact with eyes. Rinse
immediately if product comes into
contact with them
(d) Oral hygiene products 0,1 % of H2O2present or released
13 Formaldehyde Nail hardeners 5 % calculated as formaldehyde Protect cuticles with grease or oil.
Contains formaldehyde (3).▼M31976L0768 — EN — 23.06.2000 — 002.001 — 27▼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 (2) (a) Oxidizing colouring agent for
hair-dyeing:►M310,3 %◄ (a)
1. General use 1. Do not use to dye eyedasches or
eybrows
Rinse the eyes immediately if the
product 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 cuticule solvent (a) 5 % by weight (4) (a) Contains alkali. Avoid contact
with eyes. Can cause blindness.
Keep out of reach of children
(b) Hair straightener (b) (b)
1. General use 1. 2 % by weight (4) 1. Contains alkali. Avoid contact
with eyes. Can cause blindness.
Keep out of reach of children
2. Professional use 2. 4,5 % by weight (4) 2. For professional use only. Avoid
contact with eyes. Can cause
blindness.
(c) pH adjuster
— depilatories(c) Up to pH 12,7 (c) Keep out of reach of children.
Avoid contact with eyes
(d) Other uses as pH adjuster (d) Up to pH 11▼M31976L0768 — EN — 23.06.2000 — 002.001 — 28▼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 straightener
1. General use 1. 2 % by weight (4) 1. Contains alkali. Avoid contact
with eyes. Can cause blindness.
Keep out of reach of children
2. Professional use 2. 4,5 % by weight (4) 2. For professional use only. Avoid
contact with eyes. Can cause
blindness
(b) Other uses
15c Calcium hydroxide (a) Hair straighteners containing
two components: calcium
hydroxide and a guanidine salt
(b) Other uses7 % by weight calcium hydroxide Contains alkali. Avoid contact with
eyes. Can cause blindness. Keep out
of reach of children.
16 α-naphtol Colouring agent for hair dyeing 0,5 % Contains α-naphtol
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▼M251976L0768 — EN — 23.06.2000 — 002.001 — 29▼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 (2) (a) Oxidizing colouring agent for
hair dyeing(a) 5 % (a)
1. general use 1. Contains resorcinol. Rinse hair
well after application. Do not use
to dye eyelashes or eyebrows.
Rinse eyes immediately if
product comes into contact with
them
2. professional use 2. For professional use only.
Contains resorcinol.
Rinse eyes immediately if
product comes into contact with
them
(b) Hair lotions and shampoos (b) 0,5 % (b) Contains resorcinol
23 (a) Alkali sulphides (a) Depilatories (a) 2 % calculated as sulphur
pH≤12,7(a) Keep out of reach of children.
Avoid contact with eyes
(b) Alkaline earth sulphides (b) Depilatories (b) 6 % calculated as sulphur
pH≤12,7(b) Keep out of reach of children.
Avoid contact with eyes
24 Water-soluble zincsalts with the
exception of zinc 4-hydroxy-
benzenesulphonate and zinc
pyrithione1 % calculated as zinc
25 Zinc4-hydroxybenzene sulphonate Deodorants, antiperspirants and
astringent lotions6 % calculated as % of anhydrous
substanceAvoid contact with eyes
26 Sodium monofluorophosphate Oral hygiene products 0,15 % calculated as F. When
mixed with other fluorine
compounds permitted under this
Annex, total F concentration must
not exceed 0,15 %Contains ammonium monofluoro-
phosphate▼M31976L0768 — EN — 23.06.2000 — 002.001 — 30
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 % Ditto Contains sodium monofluoropho-
sphate
28 Potassium monofluorophosphate Ditto 0,15 % Ditto Contains potassium monofluoropho-
sphate
29 Calcium monofluorophosphate Ditto 0,15 % Ditto Contains calcium monofluoropho-
sphate
30 Calcium fluoride Ditto 0,15 % Ditto Contains calcium fluoride
31 Sodium fluoride Ditto 0,15 % Ditto Contains sodium fluoride
32 Potassium fluoride Ditto 0,15 % Ditto Contains potassium fluoride33 Ammonium fluoride Ditto 0,15 % Ditto Contains ammonium fluoride34 Aluminium fluoride Ditto 0,15 % Ditto Contains aluminium fluoride
35 Stannous fluoride Ditto 0,15 % Ditto Contains stannous fluoride
36 Hexadecyl ammonium fluoride Ditto 0,15 % Ditto Contains hexadecyl ammonium
fluoride
37 3-(N-Hexadecyl-N-2-hydroxyethy-
lammonio) propylbis (2-
hydroxyethyl) ammonium
difluorideDitto 0,15 % Ditto Contains 3-(N-Hexadecyl-N-2-
hydroxyethylammonio) propylbis
(2-hydroxyethyl) ammonium
difluoride
38NN'N'-Tris(polyoxyethylene)- N-
hexadecylpropylenediamine dihy-
drofluorideDitto 0,15 % Ditto Contains NN'N'-tris(polyoxyethy-
lene)-N-hexadecylpropylenediamine
dihydrofluoride
39 Octadecenyl-ammonium fluoride Ditto 0,15 % Ditto Contains octadecenyl-ammonium
fluoride▼M31976L0768 — EN — 23.06.2000 — 002.001 — 31
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
40 Sodium fluorosilicate Ditto 0,15 % Ditto Contains sodium fluorosilicate
41 Potassium fluorosilicate Ditto 0,15 % Ditto Contains potassium fluorosilicate
42 Ammonium fluorosilicate Ditto 0,15 % Ditto Contains ammonium fluorosilicate
43 Magnesium fluorosilicate Ditto 0,15 % Ditto Containes (SIC! Contains) magne-
sium fluorosilicate
44 1,3-Bis (hydroxymethyl)-imidazo-
lidine-2-thione(a) Hair-caire preparations
(b) Nail-care preparations(a) Up to 2 %
(b) Up to 2 %(a) Prohibited in aerosol dispen-
sers (sprays)
(b) The pH of the product as
applied must be less than 4Contains 1,3-bis (hydroxymethyl)
immidazolidine-2-thione
45 Benzyl alcohol Solvents, perfumes and flavour-
ings
46 6-methylcoumarin Oral hygiene products 0,003 %
47 Nicomethanol hydrofluride 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▼M31976L0768 — EN — 23.06.2000 — 002.001 — 32▼M10
▼M3
▼M4
▼M8
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
49 Selenium disulphide Antidandruff shampoos 1 % — Contains selenium disulphide
— Avoid contact with eyes or
damaged skin
50 Aluminium zirconium chloride
hydroxyde complexes
AlxZr(OH)yCIz and the alumi-
nium zirconium chloride
sydroxide glycine complexesAntiperspirants 20 % as anhydrous aluminium
zirconium chloride hydroxide
5,4 % as zirconium
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 dispensers
(sprays)Do not apply to irritated or damaged
skin
51 Quinolin-8-old and bis (8-
hydroxy-quinolium) sulphateStabilizer for hydrogen peroxide in
rinse-off hair-care preparations0,3 % calculated 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 Etidronicac id (1-hydroxyethyli-
dene-di-phosphonicac id and its
salts)(a) Hair-care 1,5 % expressed as etidronic acid ►M15 ◄
(b) Soap 0,2 % expressed as etidronicac id
54 1-Phenoxy-propzan-2-ol — Rinse-off products only 2,0 % As a preservative, see Annex VI,
Part 1, No 43
— Prohibited in oral hygiene
products▼M81976L0768 — EN — 23.06.2000 — 002.001 — 33▼M9
▼M13
▼M12
▼M13
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
55 Lead acetate Only for hair-dyeing 0,6 % calculated in lead Keep away from children. Avoid all
contact with the eyes. Wash hands
after use. Contains lead acetate. Do
not use to dye eyelashes, eyebrows
or moustasches. If irritation
develops, discountinue use.
56 Magnesium fluoride Dental hygiene products 0,15 % calculated as F. When
mixed with other fluorine
compounds permitted under this
Annex, total F concentration must
not exceed 0,15 %Contains magnesium fluoride
57 Strontium chloride hexahydrate (a) Toothpaste 3,5 %, calculated as strontium.
When mixed with other permitted
strontium products the total stron-
tium content must not exceed
3,5 %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▼M131976L0768 — EN — 23.06.2000 — 002.001 — 34▼M17
▼M18
▼M30
▼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
59 Talc: Hydrated magnesium silicate (a) Powdery products intended to
be used for children under
three years of age
(b) other products►C4a) Keep powder away from
children's nose and mouth ◄
60 Fatty acid dialkanolamides Maximum dialkanolamine content:
0,5 %— Do not use with nitrosating
systems
— Maximum dialkanolamine
content: 5 % (concerns raw
materials)
— Maximum N-nitroso-dialkano-
lamine content: 50 µg/kg
— Keep in nitrite-free containers
61 Monoalkanolamines Maximum dialkanolamine content:
0,5 %— Do not use with nitrosating
systems
— Minimum purity: 99 %— Maximum secondary alkanola-
mine content: 0,5 % (concerns
raw materials)
— Maximum N-nitrosodialkano-
lamine content: 50 µg/kg
— Keep in nitrite-free containers
62 Trialkanolamines (a) non-rinse-off products
(b) other products(a) 2,5 % (a) (b):
— Do not use with nitrosating
systems
— Minimum purity: 99 %— Maximum secondary alkanola-
mine content: 0,5 % (concerns
raw materials)
— maximum N-nitrosodialkano-
lamine content: 50 µg/kg
— Keep in nitrate-free containers▼M201976L0768 — EN — 23.06.2000 — 002.001 — 35▼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
63 Strontium hydroxide pH-regulator in depilatory
products3,5 % calculated as strontium,
max. pH of 12,7— Keep out of reach of children
— Avoid contact with the eyes
64 Strontium peroxide Rinse-off hair care preparations
professional use4,5 % calculated as strontium in
the ready-for-use preparationAll products must meet the
hydrogen peroxide release require-
ments— Avoid contact with eyes
— Rinse eyes immediately if
product comes into contact with
them
— For professional use only— Wear suitable gloves
65 Benzalkonium Chloride, bromide
and saccharinate(a) Rinse-off hair (head) care
products(a) 3 % (as benzalkonium
chloride)(a) In the final products the
concentrations of benzalkonium
chloride, bromide and saccharinate
with an alkyl chain of C
14, or less
must not exceed 0,1 % (as
benzalkonium chloride)(a) Avoid contact with the eyes
(b) Other products (b) 0,1 % (as benzalkonium
chloride)(b) Avoid contact with the eyes
(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) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not
exceed 2.
(3) Only if the concentration exceeds 0,05 %.
(4) The quantity of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In cases of mixtures, the sum should not exceed the limits given in column d.▼M201976L0768 — EN — 23.06.2000 — 002.001 — 36▼M23
▼M31
▼M3
▼M25
►M14 Part 2 ◄
LIST OF SUBSTANCES PROVISIONALLY ALLOWED
Refer-
ence
numberSubstanceRestrictions
Conditions of use and warnings
which must be printed on the
labelAllowed until
Field of application and/or useMaximum authorized concentra-
tion in the finished cosmetic
productOther limitations and require-
ments
AB C D E F G
►M24
◄▼M111976L0768 — EN — 23.06.2000 — 002.001 — 37
▼B
ANNEXIV
►M14 PART 1 ◄
LIST OF COLOURING AGENTS ALLOWED FOR USE IN COSMETIC PRODUCTS (1)
Field of application
Column 1 = Colouring agents allowed in all cosmetic products.
Column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in
the vicinity of the eyes, in particular eye make-up and eyemake-up remover.
Column 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into
contact with the mucous membranes.
Column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact
only briefly with the skin.
Colour index number
or denominationColourField of applicationOther 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 X14720 Red X E 122
14815 Red X E 125
15510 (
3) Orange X
15525 Red X
15580 Red X
►M18 ◄
15620 Red X
15630 (3) Red X 3 % maximum
concentration in the
finished product
15800 Red X ►M15 ◄
15850 (3) Red X
15865 Red X1976L0768 — EN — 23.06.2000 — 002.001 — 38
▼M10
▼M10
Colour index number
or denominationColourField of applicationOther limitations and
requirements (2)1234
15880 Red X
15980 Orange X E 11115985 (
3) Yellow X E 110
16035 Red X
16185 Red X E 123
16230 Orange X16255 (
3) Red X E 124
16290 Red X E 12617200
►
M17(3)◄Red X
18050 Red X
18130 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 E 152
27755 Black X E 15228440 Black X E 151
40215 Orange X
40800 Orange X40820 Orange X E 160 e40825 Orange X E 160 f40850 Orange X E 161 z1976L0768 — EN — 23.06.2000 — 002.001 — 39
▼M20
▼M10
▼M10
Colour index number
or denominationColourField of applicationOther limitations and
requirements (2)1234
42045 Blue ►M17
X
◄►M17 ◄
42051 (3) Blue X E 131
42053 Green X
42080 Blue X X
42090 Blue
42100 Green X
42170 Green X ►M15 ◄
42510 Violet X
42520 Violet X 5 ppm maximum
concentration in the
finished product
►M17 ◄
42735 Blue X44045 Blue ►
M17
X
◄►M17 ◄
44090 Green X E 142
45100 Red X
►M18 ◄
►M18 ◄
45190 Violet X ►M15 ◄
45220 Red X
45350 Yellow X 6 % maximum
concentration in the
finished product
45370 (3) Orange X not more than 1 %
2-(6-hdroxy-3-oxo-
3H-xanthen-9-y1)
benzoicac id and
2 % 2-(bromo-6-
hydroxy-3-oxo-3H-
xanthen-9-yl)
benzoicac id
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) benzoicac id and
2 % 2-(bromo-6-
hydroxy-3-oxo-3H-
xanthen-9-yl)
benzoicac id
45410 (3) Red X ditto1976L0768 — EN — 23.06.2000 — 002.001 — 40
▼M10
Colour index number
or denominationColourField of applicationOther limitations and
requirements (2)1234
45425 Red X not more than 1 %
2-(6-hydrxy-3-oxo-
3H-xanthen-9-yl)
benzoicac id and
3 % 2-(iodo-6-
hydroxy-3-oxo-3H-
xanthen-9-yl)
benzoicac id
45430 (3) Red X E 127 ditto
47000 Yellow X ►M15 ◄
47005 Yellow X E 10450325 Violet X50420 Black X51319 Violet X58000 Red X59040 Green X60724 Violet X60725 Violet X60730 Violet X61565 Green X61570 Green X61585 Blue X62045 Blue X69800 Blue X E 130
69825 Blue X
71105 Orange X73000 Blue X73015 Blue X E 13273360 Red X73385 Violet X73900 Violet X ►
M20 ◄
73915 Red X74100 Blue X74160 Blue X74180 Blue X ►
M20 ◄
74260 Green X75100 Yellow X75120 Orange X E 160 b75125 Yellow X E 160 d75130 Orange X E 160 a
75135 Yellow X E 161 d
75170 White X75300 Yellow X E 10075470 Red X E 12075810 Green X E 140 and E 14177000 White X E 17377002 White X77004 White X77007 Blue X1976L0768 — EN — 23.06.2000 — 002.001 — 41
▼M10
Colour index number
or denominationColourField of applicationOther limitations and
requirements (2)1234
77015 Red X
77120 White X
77163 White X
77220 White X E 170
77231 White X
77266 Black X
77267 Black X
77268:1 Black X E 153
77288 Green X free from chromate
ion
77289 Green X free from chromate
ion
77346 Green X
77400 Brown X
77480 Brown X E 175
77489 Orange X E 172
77491 Red X E 172
77492 Yellow X E 172
77499 Black X E 172
77510 Blue X free from cyanide
ions
77713 White X
77742 Violet X77745 Red X
77820 White X E 174
77891 White X E 171
77947 White X
Lactoflavin Yellow X E 101
Caramel Brown X E 150
Capsanthin, capsor-
ubinOrange X E 160 g
Beetroot red Red X E 162
Anthocyanins Red X E 162
Aluminium, zinc,
magnesium and
calcium stearatesWhite X
Bromothymol blue Blue X
Bromocresol green Green X
Acid red 195 Red X
(1) Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded under
Annex V from the scope of this Directive are equally allowed.
(2) Colouring 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 in Article8.1976L0768 — EN — 23.06.2000 — 002.001 — 42
▼M12
▼M10
▼M13
▼B
▼M10
PART 2
LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR USE IN COSMETIC
PRODUCTS (1)
Field of application
Column 1 = Colouring agents allowed in all cosmetic products.
Column 2 = Colouring agents allowed in all cosmetic products except those intended to be applied in
the vicinity of the eyes, in particular eye make-up and eye make-up remover
Column 3 = Colouring agents allowed exclusively in cosmetic products intended not to come into
contact with the mucous membranes.
Column 4 = Colouring agents allowed exclusively in cosmetic products intended to come into contact
only briefly with the skin.
Colour index number or
denominationColourField of application Other limita-
tions and
requirementsAuthorization
valid until1234
►M20 ◄
(1) Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded under
Annex V from the scope of this Directive are equally allowed.1976L0768 — EN — 23.06.2000 — 002.001 — 43
▼B
ANNEXV
LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE
DIRECTIVE
5. Strontium and its compounds, with the exception of strontium lactate,
strontium nitrate and strontium polycarboxylate listed in Annex II, strontium
sulphide, strontium chloride, strontium acetate, strontium hydroxide, strontium
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)i n
Annex IV, Part 1.1976L0768 — EN — 23.06.2000 — 002.001 — 44
▼M17
▼M12
▼M17
▼M5
▼M23
▼M17
▼M18
▼M17
▼M10
▼M8
▼M11
ANNEXVI
LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY
CONTAIN
PREAMBLE
1. Preservatives are substances which may be added to cosmetic products for the
primary purpose of inhibiting the development of micro-organisms in such
products.
2. The substances marked with the symbol (*) may also be added to cosmetic
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 — 23.06.2000 — 002.001 — 45
PART 1
LIST OF PRESERVATIVES ALLOWED
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
shampoosNot 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)
0,2 % expressed as the phenolProhibited in aerosol dispensers (sprays)
►M12
◄
7 Biphenyl-2-ol (o-phenylphenol) and its salts
(*)0,2 % expressed as the phenol
8 Pyrithione zinc(INN) (*) 0,5 % Authorized in produc ts rinsed off Forbidden
in products for oral hygiene
9 Inorganicsulphites 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 chlorobutanol12 4-Hydroxybenzoicac id and its salts and
esters (*)4 % (acid) for 1 ester,
0,8 % (acid) for mixtures of esters▼M111976L0768 — EN — 23.06.2000 — 002.001 — 46
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
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 with other 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 819 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 nitrosamines
22 2,4-Dichlorobenzyl alcohol (*) 0,15 %
23 Triclocarban (INN) (*) 0,2 % Purity criteria:
3,3',4,4'-Tetrachloroazobenzene <1 ppm
3,3',4,4'-Tetrachloroazoxybenzene <1 ppm▼M111976L0768 — EN — 23.06.2000 — 002.001 — 47▼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
24 4-Chloro-m-cresol (*) 0,2 % Prohibited in the products intended to come
into contact with mucous 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)-1,14-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
36 1,2-Dibromo-2,4-dicyanobutane 0,1 % ►M20Not to be used in cosmetic sunsc-
reen products at a concentration exceeding
0,025 % ◄▼M111976L0768 — EN — 23.06.2000 — 002.001 — 48
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
37 6,6-Dibromo-4,4-dichloro2,2‘-methylene-
diphenol (Bromochlorophen) (*)0,1 %
38 4-Isopropyl-m-cresol 0,1 %
39 Mixture of 5-Chloro-2-methyl-isothiazol-
3(2H)-one and 2-methylisothiazol-3(2H)-
one with magnesium chloride and magne-
sium nitrate►M150,0015 % ◄(of a mixture in the
ratio 3:1 of 5-chloro-2-methylisothiazol
3(2H)-one and 2-methylisothiazol-3 (2H)-
one
40 2-Benzyl-4-chlorophenol (clorophene) 0.2 %41 2-Chloroacetamide 0,3 % 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 products
44 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 %
47 1,6-Di (4-amidinophenoxy)-n-hexane
(Hexamidine) and its salts (including
isethionate and p-hydroxybenzoate) (+)0,1 %▼M111976L0768 — EN — 23.06.2000 — 002.001 — 49▼M12
▼M13
▼M18
▼M20
Reference
numberSubstance Maximum authorized concentration Limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
48 Glutaraldehyde (Pentane-1,5-dial) 0,1 % Prohibited in aerosols (sprays) Contains glutaraaldehyde (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 with
mucous 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 AgCI 20 % AgCI (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 only
54 Belzalkonium chloride, bromide and
saccharinate (+)0,1% calculated as benzalkonium chloride Not for oral hygiene and lip products
55 Benzylhemiformal 0,15 % Only for products to be removed by rinsing▼M201976L0768 — EN — 23.06.2000 — 002.001 — 50▼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 — 23.06.2000 — 002.001 — 51▼B
PART 2
LIST OF PRESERVATIVES PROVISIONALLY ALLOWED
Reference number Substance Maximum authorized concentration Limitations and requirementsConditions of use and warnings
which must be printed on the labelAllowed until
ABGDEF
►M15 ◄
►M25 ◄
►M15 ◄
►M18 ◄
►M15 ◄
►M18 ◄
►M13 ◄
►M12 ◄
►M13 ◄
►M12 ◄
►M13 ◄
►M24 ◄
►M30 ◄
►M18 ◄
►M13 ◄
►M15 ◄
►M20 ◄▼M111976L0768 — EN — 23.06.2000 — 002.001 — 52
Reference number Substance Maximum authorized concentration Limitations and requirementsConditions of use and warnings
which must be printed on the labelAllowed until
ABGDEF
►M13 ◄
►M15 ◄
►M23 ◄▼M111976L0768 — EN — 23.06.2000 — 002.001 — 53▼M31
▼M23
▼M11
▼M31
▼M25
▼M7
ANNEXVII
List of UV filters which cosmetic products may contain
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 — 23.06.2000 — 002.001 — 54
PART 1
List of permitted UV filters which cosmetic products may contain
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-Aminobenzoicac id 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-sulphonicac id
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-
methanesulfonicac id and its salts10 %
(expressed as acid)
8 1-(4-tert-butylphrnyl)-3-(4-methoxyphe-
nyl)propane-1,3-dione5%
9 alpha-(2-Oxoborn-3-ylidene)-toluene-4-
sulphonicac id 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 — 23.06.2000 — 002.001 — 55
▼M23
▼M22
▼M23
▼M24
Reference
NoSubstances Maximum authorized concentration Other limitations and requirementsConditions of use and warnings which must be
printed on the label
AB C D E
11 Polymer of N-{(2 and 4)-[(2-oxoborn-3-
ylidene)methyl]benzyl}acrylamide6%
12 Octyl methoxycinnamate 10 %
13 Ethoxylated Ethyl-4-Aminobenzoate (PEG-
25 PABA)10 %
14 Isopentyl-4-methoxycinnamate (Isoamyl p-
Methoxycinnamate)10 %
15 2,4,6-Trianilino-(p-Carbo-2‘-Ethylhexyl-
1‘Oxy)-1,3,5-Triazine (Octyl Triazone)5%
16 Phenol,2-(2H-Benzotriazol-2-yl)-4-Methyl-
6-(2-Methyl-3-(1,3,3,3-Tetra-methyl-I-
(Trimethylsilyl)Oxy)-Disilo-xanyl)Propyl)
(Drometrizole Trisiloxane)15 %
17 Benzoicac id, 4,4-((6-(((1,1-dimethyl-ethy-
l)amino)carbonyl)phenyl)amino) 1,3,5-
triazine-2,4-diyl)diimino)bis-,bis-(2-ethyl-
hexyl)ester)10 %
18 3-(4‘-Methylbenxylidene)-d-1 camphor (4-
Methylbenzylidene Camphor)4%
19 3-Benzylidene camphor (3-Benzylidene
Camphor)2%
20 2-Ethylhexyl salicylate (Octyl-salicylate) 5 %
21 4-Dimethyl-amino-benzoate of ethyl-2-
hexyl (octyl dimethyl PABA)8%▼M241976L0768 — EN — 23.06.2000 — 002.001 — 56▼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-
sulfonicac id (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 %
(1) Not requiered if concentration is 0,5 % or less and when it is used only for product protection purposes.▼M311976L0768 — EN — 23.06.2000 — 002.001 — 57▼M30
PART 2
LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MAY PROVISIONALLY CONTAIN
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 — 23.06.2000 — 002.001 — 58▼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 — 23.06.2000 — 002.001 — 59
▼M21
ANNEXVIII
1976L0768 — EN — 23.06.2000 — 002.001 — 60