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Document 01976L0768-20050913
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC)
Consolidated text: Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC)
Council Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (76/768/EEC)
1976L0768 — EN — 13.09.2005 — 013.001
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
COUNCIL DIRECTIVE of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (OJ L 262, 27.9.1976, p.169) |
Amended by:
Amended by:
L 291 |
17 |
19.11.1979 |
||
L 302 |
23 |
15.11.1985 |
Corrected by:
COUNCIL DIRECTIVE
of 27 July 1976
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 composition characteristics to which cosmetic products must conform and prescribe rules for their labelling and for their packaging; whereas these provisions differ from one Member State to another;
Whereas the differences between these laws oblige Community cosmetic producers to vary their production according to the Member State for which the products are intended; whereas, consequently, they hinder trade in these products and, as a result, have a direct effect on the establishment and functioning of the common market;
Whereas the main objective of these laws is the safeguarding of public health and whereas, as a result, the pursuit of the same objective must inspire Community legislation in this sector; whereas, however, this objective must be attained by means which also take account of economic and technological requirements;
Whereas it is necessary to determine at Community level the 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 this purpose it is necessary to define the scope of the Directive by delimiting the field of cosmetics from that of pharmaceuticals; whereas this delimitation follows in particular from the detailed definition of cosmetic products, which refers both to their areas of application and to the purposes of their use; whereas this Directive is not applicable to the products that fall under the definition of cosmetic product but are exclusively intended to protect from disease; whereas, moreover, it is advisable to specify that certain products come under this definition, whilst products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do 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 V from 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 to take into account the possibility of danger to zones of the body that are contiguous to the area of application;
Whereas, in particular, the determination of the methods of analysis together with possible modifications or additions which may have to be made to them on the basis of the results of scientific and technical research, are implementing measures of a technical nature; whereas it is advisable to entrust their adoption to the Commission, subject to certain 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 this field; 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 the Commission within the Committee for adaptation to technical progress of Directives aimed at the removal of technical obstacles to trade in the cosmetic products sector;
Whereas it is necessary, on the basis of scientific and technical research, to draw up proposals for lists of authorized substances which could include antioxidants, hair dyes, preservatives and 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 public health; 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 the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with 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. Member States 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 reasonably foreseeable conditions of use, taking account, in particular, of the product's presentation, its labelling, any instructions for its use and disposal as well as any other indication or information provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the Community market.
The provision of such warnings shall not, in any event, exempt any person from compliance with the other requirements laid down in this Directive.
Article 3
Member States shall take all necessary measures to ensure that only cosmetic products which conform to the provisions of this Directive and its Annexes may be put on the market.
Article 4
1. Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic products containing:
(a) substances listed in Annex II;
(b) substances listed in the first part of Annex III, beyond the limits and outside the conditions laid down;
(c) colouring agents other than those listed in Annex IV, Part 1, with the exception of cosmetic products containing colouring agents intended solely to colour hair;
(d) colouring agents listed in Annex IV, Part 1, used outside the conditions laid down, with the exception of cosmetic products containing colouring agents intended solely to colour hair;
(e) preservatives other than those listed in Annex VI, Part 1;
(f) preservatives listed in Annex VI, Part 1, beyond the limits and outside the conditions laid down, unless other concentrations 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.
▼M37 —————
2. The presence of traces of the substances listed in Annex II shall be allowed provided that such presence is technically unavoidable in good manufacturing practice and that it conforms with Article 2.
Article 4a
1. Without prejudice to the general obligations deriving from Article 2, Member States shall prohibit:
(a) the marketing of cosmetic products where the final formulation, in order to meet the requirements of this Directive, has been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;
(b) the marketing of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Directive, have been the subject of animal testing using a method other than an alternative method after such alternative method has been validated and adopted at Community level with due regard to the development of validation within the OECD;
(c) the performance on their territory of animal testing of finished cosmetic products in order to meet the requirements of this Directive;
(d) the performance on their territory of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Directive, no later than the date on which such tests are required to be replaced by one or more validated alternative methods listed in Annex V to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances ( 3 )or in Annex IX to this Directive.
No later than 11 September 2004 the Commission shall, in accordance with the procedure referred to in Article 10(2) and after consultation of the Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers (SCCNFP) establish the contents of Annex IX.
2. The Commission, after consultation of the SCCNFP and of the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the OECD, shall establish timetables for the implementation of the provisions under paragraph 1(a), (b) and (d), including deadlines for the phasing-out of the various tests. The timetables shall be made available to the public not later than 11 September 2004 and be sent to the European Parliament and the Council. The period for implementation shall be limited to a maximum of six years after the entry into force of Directive 2003/15/EC in relation to paragraph 1(a), (b) and (d).
(2.1) In relation to the tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration, the period for implementation of paragraph 1(a) and (b) shall be limited to a maximum of 10 years after the entry into force of Directive 2003/15/EC.
(2.2) The Commission shall study possible technical difficulties in complying with the ban in relation to tests, in particular those concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, for which there are no alternatives yet under consideration. Information about the provisional and final results of these studies should form part of the yearly reports presented pursuant to Article 9.
On the basis of these annual reports, the timetables established in accordance with paragraph 2 may be adapted within a maximum time limit of six years as referred to in paragraph 2 or 10 years as referred to in paragraph 2.1 and after consultation of the entities referred to in paragraph 2.
(2.3) The Commission shall study progress and compliance with the deadlines as well as possible technical difficulties in complying with the ban. Information about the provisional and final results of the Commission studies should form part of the yearly reports presented pursuant to Article 9. If these studies conclude, at the latest two years prior to the end of the maximum period referred to in paragraph 2.1, that for technical reasons one or more tests referred to in paragraph 2.1 will not be developed and validated before the expiry of the period referred to in paragraph 2.1 it shall inform the European Parliament and the Council and shall put forward a legislative proposal in accordance with Article 251 of the Treaty.
(2.4) In exceptional circumstances where serious concerns arise as regards the safety of an existing cosmetic ingredient a Member State may request the Commission to grant a derogation from paragraph 1. The request shall contain an evaluation of the situation and indicate the measures necessary. On this basis, the Commission may, after consultation of the SCCNFP and by means of a reasoned decision, authorise the derogation in accordance with the procedure referred to in Article 10(2). This authorisation shall lay down the conditions associated with this derogation in terms of specific objectives, duration and reporting of the results.
A derogation shall only be granted if:
(a) the ingredient is in wide use and cannot be replaced by another ingredient able to perform a similar function;
(b) the specific human health problem is substantiated and the need to conduct animal tests is justified and is supported by a detailed research Protocol proposed as the basis for the evaluation.
The decision on the authorisation, the conditions associated with it and the final result achieved shall be part of the annual report to be presented by the Commission in accordance with Article 9.
3. For the purposes of this Article:
(a) ‘finished cosmetic product’ means the cosmetic product in its final formulation, as placed on the market and made available to the final consumer, or its prototype.
(b) ‘prototype’ means a first model or design that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed.
Article 4b
The use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction, of category 1, 2 and 3, under Annex I to Directive 67/548/EEC shall be prohibited. To that end the Commission shall adopt the necessary measures in accordance with the procedure referred to in Article 10(2). A substance classified in category 3 may be used in cosmetics if the substance has been evaluated by the SCCNFP and found acceptable for use in cosmetic products.
Article 5
Member States shall allow the marketing of cosmetic products containing:
(a) the substances listed in Annex III, Part 2, within the limits and under the conditions laid down, up to the dates in column (g) of that Annex;
(b) the colouring agents listed in Annex IV, Part 2, within the limits and under the conditions laid down, until the admission dates given in that Annex;
(c) the preservatives listed in Annex VI, Part 2, within the limits and under the condition laid down, until the dates given in column (f) of that Annex. However, some of these substances may be used 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 ingredients employed in cosmetic products, on the basis in particular of information supplied by the industry concerned.
For the purposes of this Article, ‘cosmetic ingredient’ shall mean any chemical substance or preparation of synthetic or natural origin, except for perfume and aromatic compositions, used in the composition of cosmetic products.
The inventory shall be divided into two sections: one concerning perfume and aromatic raw materials and the second concerning other substances.
2. The inventory shall contain informtion on:
— the identity of each ingredient, in particular its chemical name, the CTFA name, the European Pharmacopoeia name, the international non-proprietary names recommended by the World Health Organization, the Einecs, Iupac, CAS and colour index numbers, and the common name referred to in Article 7 (2),
— the usual function(s) of the ingredient in the final product,
— where appropriate, restrictions and conditions of use and warnings which must be printed on the label by reference to the Annexes.
3. The Commission shall publish the inventory and shall update it periodically under the procedure provided for in Article 10. The inventory shall be indicative and shall not constitute a list of the substances authorized for use in cosmetic products.
Article 6
1. Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if the container and packaging bear the following information in indelible, easily legible and visible lettering; the information mentioned in point (g) may, however, be indicated on the packaging alone:
(a) the name or style and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product who is established within the Community. Such information may be abbreviated in so far as the abbreviation makes it generally possible to identify the undertaking. Member States may require that the country of origin be specified for goods manufactured outside the Community;
b) the nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than five grams or five millilitres, free samples and single-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 not be given provided the number of items appears on the packaging. This information need not be given if the number of items is easy to see from the outside or if the product is normally only sold individually;
(c) the date of minimum durability shall be indicated by the words: ‘best used before the end of’ followed by either:
— the date itself, or
— details of where it appears on the packaging.
The date shall be clearly expressed and shall consist of either the month and year or the day, month and year in that order. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.
Indication of the date of durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product can be used without any harm to the consumer. This information shall be indicated by the symbol given in Annex VIIIa followed by the period (in months and/or years);
(d) particular precautions to be observed in use, especially those listed in the column ‘Conditions of use and warnings which must be printed on the label’ in Annexes III, IV, VI and VII, which must appear on the container and packaging, as well as any special precautionary information on cosmetic products for professional use, in particular in hairdressing. Where this is impossible for practical reasons, an enclosed leaflet, label, tape or card must contain that information to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII, which must appear on the container and the packaging;
(e) the batch number of manufacture or the reference for identifying the goods. Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging;
(f) the function of the product, unless it is clear from the presentation of the product;
(g) a list of ingredients in descending order of weight at the time they are added. That list shall be preceded by the word ‘ingredients’. Where that is impossible for practical reasons, an enclosed leaflet, label, tape or card must contain the ingredients to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII, which must appear on the packaging.
The following shall not, however, be regarded as ingredients:
— impurities in the raw materials used,
— subsidiary technical materials used in the preparation but not present in the final product,
— materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions.
Perfume and aromatic compositions and their raw materials shall be referred to by the word ‘perfume’ or ‘aroma’. However, the presence of substances, the mention of which is required under the column ‘other limitations and requirements’ in Annex III, shall be indicated in the list irrespective of their function in the product.
Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %.
Colouring agents may be listed in any order after the other ingredients, in accordance with the colour index number or denomination adopted in Annex IV. For decorative cosmetic products marketed in several colour shades, all colouring agents used in the range may be listed, provided that the words ‘may contain’ or the symbol ‘+/-’ are added.
An ingredient must be identified by the common name referred to in Article 7(2) or, failing that, by one of the names referred to in Article 5a(2), first indent.
In accordance with the procedure referred to in Article 10(2), the Commission may adapt the criteria and conditions set out in Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products ( 4 ) 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, those particulars shall appear on a label, tape or card which is enclosed or attached to the cosmetic product.
In the case of soap, bath balls and other small products where it is impraticable, for reasons of size or shape, for the particulars referred to in point (g) to appear on a label, tag, tape or card or in an enclosed leaflet, those particulars shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.
2. For cosmetic products that are not pre-packaged, are packaged at the point of sale at the purchaser's request, or are pre-packaged for immediate sale, Member States shall adopt detailed rules for indication of the 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 not used to imply that these products have characteristics which they do not have. ►M37 ————— ◄
Furthermore, the manufacturer or the person responsible for placing the product on the Community market may take advantage, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the product, of the fact that no animal tests have been carried out only if the manufacturer and his suppliers have not carried out or commissioned any animal tests on the finished product, or its prototype, or any of the ingredients contained in it, or used any ingredients that have been tested on animals by others for the purpose of developing new cosmetic products. Guidelines shall be adopted in accordance with the procedure referred to in Article 10(2) and published in the Official Journal of the European Union. The European Parliament shall receive copies of the draft measures submitted to the Committee.
Article 7
1. Member States may not, for reasons related to the requirements laid down in this Directive and the Annexes thereto, refuse, prohibit or restrict the marketing of any cosmetic products which comply with the requirements of this Directive and the Annexes thereto.
2. They may, however, require that the particulars provided for in Article 6 (1) (b), (c), (d) and (f) be expressed at least in their own national 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 shall adopt a common ingredients nomenclature in accordance with the Article 10 procedure.
3. Furthermore, a Member State may, for purposes of prompt and appropriate medical treatment in the event of difficulties, require that appropriate and adequate information on substances used in cosmetic products be made available to the competent authority, which shall ensure that that information is used only for the purposes of such treatment.
Each Member State shall designate a competent authority and send details thereof to the Commission, which shall publish that information in the Official Journal of the European Communities.
Article 7a
1. The manufacturer or his agent or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Community market shall for control purposes keep the following information readily accessible to the competent authorities of the Member State concerned at the address specified on the label in accordance with Article 6 (1) (a):
(a) the qualitative and quantitative composition of the product; in the case of perfume compositions and perfumes, the name and code number 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 microbiological 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 for manufacture or first importation into the Community must possess an appropriate level of professional qualification or experience in accordance with the legislation and practice of the Member State which is the place of manufacture or first importation;
(d) assessment of the safety for human health of the finished product. To that end the manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure. It shall take particular account of the specific exposure characteristics of the areas on which the product will be applied or of the population for which it is intended. There shall be inter alia a specific assessment for cosmetic products intended for use on children under the age of three and for cosmetic products intended exclusively for use in external intimate hygiene.
Should the same product be manufactured at several places within Community territory, the manufacturer may choose a single place of manufacture where that information will be available. In this connection, and when so requested for monitoring purposes, it shall be obliged to indicate the place so chosen to the monitoring authority or authorities concerned. In this case this information shall be easily accessible;
(e) the name and address of the qualified person or persons responsible for the assessment referred to in (d). That person must hold a diploma as defined in Article 1 of Directive 89/48/EEC in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline;
(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;
(h) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of non-member countries.
Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, Member States shall ensure that the information required under (a) and (f) shall be made easily accessible to the public by any appropriate means, including electronic means. The quantitative information required under (a) to be made publicly accessible shall be limited to dangerous substances covered by Directive 67/548/EEC.
2. The assessment of the safety for human health referred to in paragraph 1 (d) shall be carried out in accordance with the principle of good laboratory practice laid down in Council Directive 87/18/EEC of 18 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 tests on chemical substances ( 5 ).
3. The information referred to in paragraph 1 must be available in the national language or languages of the Member State concerned, or in a language readily understood by the competent authorities.
4. The manufacturer or his agent, or the person to whose order a cosmetic product is manufactured, or the person responsible for placing imported cosmetic products on the Community market, shall notify the competent authority of the Member State of the place of manufacture or of the initial importation of the address of the place of manufacture or of initial importation into the Community of the cosmetic products before the latter are placed on the Community market.
5. Member States shall designate the competent authorities referred to in paragraphs 1 and 4 and shall send details thereof to the Commission, 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 to the smooth application of this Directive.
Article 8
1. In accordance with the procedure laid down in Article 10 the following shall be determined:
— the methods of analysis necessary for checking the composition of cosmetic products,
— the criteria of microbiological and chemical purity for cosmetic products and methods for checking compliance with those criteria.
2. The common nomenclature of ingredients used in cosmetic products and, after consultation of the ►M37 Scientific Committee for Cosmetic Products and Non-Food Products intended for Consumers ◄ , the amendments necessary for the adaptation to technical progress of the Annexes shall be adopted in accordance with the same procedure, as appropriate.
Article 8a
1. Notwithstanding Article 4 and without prejudice to Article 8 (2), a Member State may authorize the use within its territory of other substances not contained in the lists of substances allowed, for certain cosmetic products specified in its national authorization, subject to 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 of which 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 taken pursuant to paragraph 1 within two months of the date on which it came into effect.
3. Before expiry of the three-year period provided for in paragraph 1, the Member State may submit to the Commission a request for the inclusion in a list of permitted substances of the substance given national authorization in accordance with paragraph 1. At the same time, it shall supply supporting documents setting out the grounds on which it deems such 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 scientific and technical knowledge, after consultation, at the initiative of the Commission or of a Member State, of the ►M37 Scientific Committee for Cosmetic Products and Non-Food Products intended for Consumers ◄ and in accordance with the procedure laid down in Article 10 as to whether the substance in question may be included in a list of permitted substances or whether the national authorization should be revoked. Notwithstanding paragraph 1 (a), the national authorization shall remain in force until a decision is taken on the request for inclusion in the list.
Article 9
Every year the Commission shall present a report to the European Parliament and the Council on:
(a) progress made in the development, validation and legal acceptance of alternative methods. The report shall contain precise data on the number and type of experiments relating to cosmetic products carried out on animals. The Member States shall be obliged to collect that information in addition to collecting statistics as laid down by Council Directive 86/609/EEC of 24 November 1986 on the approximation of laws, regulations and administrative provisions of the Member States regarding the protection of animals used for experimental and other scientific purposes ( 6 ). The Commission shall in particular ensure the development, validation and legal acceptance of alternative test methods which do not use live animals;
(b) progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by non-member countries of the results of the safety tests carried out in the Community using alternative methods, in particular within the framework of cooperation agreements between the Community and these countries;
(c) the manner in which the specific needs of small and medium-sized enterprises have been taken into account.
Article 10
1. The Commission shall be assisted by the Standing Committee on Cosmetic Products.
2. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
3. The Committee shall adopt its rules of procedure.
Article 11
Without prejudice to Article 5 and not later than one year after expiry of the period laid down in Article 14 (1) for implementation of this Directive 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 may provisionally prohibit the marketing of that product in its territory or subject it to special conditions. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision.
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 either the Commission or the Council in accordance with the procedure laid down in Article 10. In that event, the Member State which has adopted safeguard measures may maintain them until entry into force of 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 with particulars of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such 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 and shall forthwith inform the Commission thereof.
2. Member States may, however, for a period of 36 months from notification of this Directive, authorize the marketing in their territory of cosmetic products which do not conform to the requirements of the Directive.
3. Member States shall ensure that the texts of such provisions of national law as they adopt in the field governed by this Directive are communicated to the Commission.
Article 15
This Directive is addressed to the Member States.
ANNEX I
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, hygienic powders, etc.
— Toilet soaps, deodorant soaps, etc.
— Perfumes, toilet waters and eau de Cologne.
— Bath and shower preparations (salts, foams, oils, gels, etc.).
— Depilatories.
— Deodorants and anti-perspirants.
— Hair care products:
—— hair tints and bleaches,
— products for waving, straightening and fixing,
— setting products,
— cleansing products (lotions, powders, shampoos),
— conditioning products (lotions, creams, oils),
— hairdressing products (lotions, lacquers, brilliantines).
— Shaving products (creams, foams, lotions, etc.).
— Products for making up and removing make-up from the face and the eyes.
— Products intended for application to the lips.
— Products for care of the teeth and the mouth.
— Products for nail care and make-up.
— Products for external intimate hygiene.
— Sunbathing products.
— Products for tanning without sun.
— Skin-whitening products.
— Anti-wrinkle products.
ANNEX II
LIST OF SUBSTANCES WHICH MUST NOT FORM PART OF THE COMPOSITION OF COSMETIC PRODUCTS
1. N-5-Chlorobenzoxazol-2-ylacetamide
2. ►M3 2-Acetoxyethyltrimethylammonium hydroxide (acetylcholine) and its salts ◄
3. Deanol aceglumate ( 7 )
4. Spironolactone*
5. ►M3 [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid and its salts ◄
6. Methotrexate*
7. Aminocaproic acid* and its salts
8. Cinchophen*, its salts, derivatives and salts of these derivatives
9. Thyropropic acid* and its salts
10. Trichloroacetic acid
11. 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 salts
17. Isoprenaline*
18. Allyl isothiocyanate
19. 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 derivatives
23. Betoxycaine* and its salts
24. Zoxazolamine*
25. Procainamide*, its salts and derivatives
26. Benzidine
27. Tuaminoheptane*, its isomers and salts
28. Octodrine* and its salts
29. ►M3 2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts ◄
30. 1,3-dimethylpentylamine and its salts
31. 4-Aminosalicylic acid and its salts
32. Toluidines, their isomers, salts and halogenated and sulphonated derivatives
33. Xylidines, their isomers, salts and halogenated and sulphonated derivatives
34. ►M3 Imperatorin (9-(3-methoxylbut-2-enyloxy)furo[3,2-g]chromen-7-one) ◄
35. Ammi majus and its galenical preparations
36. 2,3-Dichloro-2-methylbutane
37. Substances with androgenic effect
38. Anthracene oil
39. Antibiotics ►M17 ◄
40. Antimony and its compounds
41. Apocynum cannabinum L. and its preparations
42. ►M3 Apomorphine (R 5,6,6a, 7-tetrahydro-6-methyl-4H-dibenzo [de,g]quinoline-10,11-diol) and its salts ◄
43. Arsenic and its compounds
44. Atropa belladonna L. and its preparations
45. Atropine, its salts and derivatives
46. Barium salts, with the exception of barium sulphate, barium sulphide under the conditions laid down in Annex III, Part 1, and lakes, salts and pigments prepared from the colouring agents listed with the reference (5) in Annex III, Part 2 and Annex IV, Part 2.
47. Benzene
48. ►M3 Benzimidazol-2(3H)-one ◄
49. ►M3 Benzazepines and benzodiazepines ◄
50. ►M3 1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts ◄
51. ►M3 2,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and its salts ◄
52. ►M3 Isocarboxazid* ◄
53. Bendroflumethiazide* and its derivatives
54. Beryllium and its compounds
55. Bromine, elemental
56. Bretylium tosilate*
57. Carbromal*
58. Bromisoval*
59. Brompheniramine* and its salts
60. Benzilonium bromide*
61. Tetrylammonium bromide*
62. Brucine
63. Tetracaine* and its salts
64. Mofebutazone*
65. Tolbutamide*
66. Carbutamide*
67. Phenylbutazone*
68. Cadmium and its compounds
69. Cantharides, Cantharis vesicatoria
70. (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin)
71. Phenprobamate*
72. ►M3 Nitroderivatives of carbazole ◄
73. Carbon disulphide
74. Catalase
75. Cephaeline and its salts
76. Chenopodium ambrosioides (essential oil)
77. 2,2,2-Trichloroethane-1,1-diol
78. Chlorine
79. Chlorpropamide*
80. ►M3 Diphenoxylate* 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. ►M3 N,N-bis(2-chloroethyl)methylamine N-oxide and its salts ◄
87. Chlormethine* and its salts
88. Cyclophosphamide* and its salts
89. Mannomustine* and its salts
90. Butanilicaine* and its salts
91. ►M3 Chlormezanone* ◄
92. Triparanol*
93. 2-[2(4-Chiorophenyl)-2-phenylacetyl] indane-1,3-dione (chlorophacinone-ISO)
94. Chlorphenoxamine*
95. ►M3 2-[2-(4-Chlorophenyl)-2-phenylacetyl]indan 1,3-dione (chlorophacinone - ISO) ◄
96. Chloroethane
97. Chromium; chromic acid and its salts
98. 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 derivatives
104. 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 curarine
110. Synthetic curarizants
111. Hydrogen cyanide and its salts
112. ►M3 2-α-Cyclohexylbenzyl(N,N,N',N',-tetraethyl)trimethylenediamine (phenetamine) ◄
113. Cyclomenol* and its salts
114. Sodium hexacyclonate*
115. Hexapropymate*
116. Dextropropoxyphene*
117. ►M3 O,O'-Diacetyl-N-allyl-N-normorphine ◄
118. Pipazetate* and its salts
119. ►M3 5-(αβ-Dibromophenethyl)-5-methylhydantoin ◄
120. ►M3 N,N'-Pentamethylenebis (trimethylammonium salts), e.g. pentamethonium bromide* ◄
121. ►M3 N,N'-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, e.g. azamethonium bromide* ◄
122. Cyclarbamate*
123. Clofenotane*; DDT (ISO)
124. ►M3 N,N'-Hexamethylenebis(trimethylammonium) salts, e.g. hexamethonium bromide* ◄
125. Dichloroethanes (ethylene chlorides)
126. Dichloroethylenes (acetylene chlorides)
127. Lysergide* and its salts
128. ►M3 2-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and its salts ◄
129. Cinchocaine* and its salts
130. 3-Diethylaminopropyl cinnamate
131. ►M3 O,O'-Diethyl O-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 salts
137. Piprocurarium*
138. Propyphenazone*
139. Tetrabenazine* and its salts
140. Captodiame*
141. Mefeclorazine* and its salts
142. Dimethylamine
143. ►M3 1,1-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. Malononitrile
150. Succinonitrile
151. Dinitrophenol isomers
152. Inproquone*
153. Dimevamide* and its salts
154. Diphenylpyraline* and its salts
155. Sulfinpyrazone*
156. ►M3 N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethyl-ammonium salts, e.g. isopropamide iodide* ◄
157. Benactyzine*
158. Benzatropine* and its salts
159. Cyclizine* and its salts
160. ►M3 5,5-Diphenyl-4-imidazolidone ◄
161. Probenecid*
162. Disulfiram*; thiram (ISO)
163. Emetine, its salts and derivatives
164. Ephedrine and its salts
165. Oxanamide* and its derivatives
166. Eserine or physostigmine and its salts
167. Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in ►M9 Annex VII, Part 2 ◄
168. Choline salts and their esters, e.g. choline chloride
169. Caramiphen* and its salts
170. Diethyl 4-nitrophenyl phosphate
171. 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 and 4-ethoxyphenol
179. Parethoxycaine* and its salts
180. Fenozolone*
181. Glutethimide* and its salts
182. Ethylene oxide
183. Bemegride* and its salts
184. Valnoctamide*
185. Haloperidol*
186. Paramethasone*
187. Fluanisone*
188. Trifluperidol*
189. Fluoresone*
190. Fluorouracil*
191. Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III, Part 1
192. Furfuryltrimethylammonium salts, e.g. furtrethonium iodide*
193. Galantamine*
194. Progestogens ►M17 ◄
195. 1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)
196. ►M3 (1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-6,7-epoxy-1,4,4a,5,6,7,8,8a-octahydro-1,4:5,8-dimethano-naphthalene (endrin-ISO) ◄
197. 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 salts
200. Hydrazides and their salts
201. Hydrazine, its derivatives and their salts
202. Octamoxin* and its salts
203. Warfarin* and its salts
204. ►M3 Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl) acetate and salts of the acid ◄
205. Methocarbamol*
206. Propatylnitrate*
207. ►M3 4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin ◄
208. Fenadiazole*
209. Nitroxoline* and its salts
210. Hyoscyamine, its salts and derivatives
211. Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)
212. Pemoline* and its salts
213. Iodine
214. ►M3 Decamethylenebis(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. ►M3 α-Santonin [(3S,5aR,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 salts
220. Barbiturates
221. Mercury and its compounds, except those special cases included ►M18 in Annex VI, Part 1 ◄
222. 3,4,5-Trimethoxyphenethylamine and its salts
223. Metaldehyde
224. 2-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts
225. Coumetarol*
226. Dextromethorphan* and its salts
227. 2-Methylheptylamine and its salts
228. Isometheptene* and its salts
229. Mecamylamine*
230. Guaifenesin*
231. Dicoumarol*
232. Phenmetrazine*, its derivatives and salts
233. Thiamazole*
234. ►M3 3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-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-Naphthol
242. 1-and 2-Naphthylamines and their salts
243. ►M3 3-(1-Naphthyl)-4-hydroxycoumarin ◄
244. Naphazoline* and its salts
245. Neostigmine and its salts (e.g. neostigmine bromide*)
246. Nicotine and its salts
247. Amyl nitrites
248. Inorganic nitrites, with the exception of sodium nitrite
249. Nitrobenzene
250. Nitrocresols and their alkali metal salts
251. Nitrofurantoin*
252. Furazolidone*
253. Propane-1,2,3-triyl trinitrate
254. Acenocoumarol*
255. Alkali pentacyanonitrosylferrate (2-)
256. Nitrostilbenes, their homologues and their derivatives
257. Noradrenaline and its salts
258. Noscapine* and its salts
159. Guanethidine* and its salts
260. Oestrogens ►M15 ◄
261. Oleandrin
262. Chlortalidone*
263. Pelletierine and its salts
264. Pentachloroethane
265. Pentaerithrityl tetranitrate*
266. Petrichloral*
267. Octamylamine* and its salts
268. Picric acid
269. Phenacemide*
270. Difendoxazine*
271. ►M3 2-Phenylindan-1,3-dione (phenindione) ◄
272. Ethylphenacemide*
273. Phenprocoumon*
274. Fenyramidol*
275. Triamterene* and its salts
276. ►M3 Tetraethyl pyrophosphate; TEPP (ISO) ◄
277. Tritolyl phosphate
278. Psilocybine*
279. Phosphorus and metal phosphides
280. Thalidomide* and its salts
281. Physostigma venenosum Balf.
282. Picrotoxin
283. Pilocarpine and its salts
284. ►M3 α-Piperidin-2-ylbenzyl acette (SIC! acetate) laevorotatory threoform (levophacetoperane) and its salts ◄
285. Pipradrol* and its salts
286. Azacyclonol* and its salts
287. Bietamiverine*
288. Butopiprine* and its salts
289. Lead and its compounds
290. Coniine
291. Prunus laurocerasus L. (‘cherry laurel water’)
292. Metyrapone*
293. Radioactive substances, as defined by Directive 96/29/Euratom ( 8 ) laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation.
294. Juniperus sabina L. (leaves, essential oil and galenical preparations)
295. Hyoscine, its salts and derivatives
296. Gold salts
297. Selenium and its compounds with the exception of selenium disulphiele under the conditions set out under reference No 49 in Annex Ill, Part 1
298. Solanum nigrum L. and its galenical preparations
299. Sparteine and its salts
300. Glucocorticoids
301. 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 salts
305. Strychnos species and their galenical preparations
306. Narcotics, natural and synthetic: All substances listed in Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March 1961
307. ►M3 Sulphonamides (sulphanilamide and its derivatives…) and their salts obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts ◄
308. Sultiame*
309. Neodymium and its salts
310. Thiotepa*
311. Pilocarpus jaborandi Holmes and its galenical preparations
312. Tellurium and its compounds
313. ►M3 Xylometazoline* and its salts ◄
314. Tetrachloroethylene
315. Carbon tetrachloride
316. Hexaethyl tetraphosphate
317. Thallium and its compounds
318. 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 esters
323. Vaccines, toxins or serums listed in the Annex to the second Council Directive of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary 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 salts
328. Tretamine*
329. Gallamine triethiodide*
330. Urginea scilla Stern. and its galenical preparations
331. Veratrine, its salts and galenical preparations
332. Schoenocaulon olficinale Lind. (seeds and galenical preparations)
333. Veratrum Spp. and their preparations
334. Vinyl chloride monomer
335. Ergocalciferol* and cholecalciferol (vitamins D2 and 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. ►M3 2-[4-Methoxybenzyl-N-(2-pyridyl)amino]ethyldimethylamine maleate ◄
347. Tripelennamine*
348. Tetrachlorosalicylanilides
349. Dichlorosalicylanilides
350. Tetrabromosalicylanilides ►M13 ◄
351. Dibromosalicylanilides ►M13 ◄
352. Bithionol*
353. Thiuram monosulphides
354. Thiuram disulphides
355. 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 dihypoiodite
▼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.
▼M32 —————
365. Aristolochic acid and its salts; Aristolochia spp. and their preparations
366. Chloroform
▼M32 —————
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)
▼M32 —————
372. 6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide (minoxidil) and its salts
373. 3,4',5-Tribromosalicylanilide
374. Phytolacca spp. and their preparations
375. Tretinoin (retinoic acid and its salts)
376. 1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole - CI 76050) ►M17 and their salts ◄
377. 1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) ►M17 and their salts ◄
378. Colouring agent CI 12140
379. 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))
▼M39 —————
383. 2-Amino.4-nitrophenol
384. 2-Amino-5-nitrophenol
385. 11 α-Hydroxypregn-4-ene-3,20-dione and its esters
385. 11α-Hydroxypregn-4-ene-3, 20-dione) and its esters
▼M32 —————
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
▼M32 —————
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 3
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 15585
402. Strontium lactate
403. Strontium nitrate
404. Strontium polycarboxylate
405. Pramocaine
406. 4-ethoxy-m-phenylenediamine and its salts
407. 2,4-diaminophenylethanol and its salts
408. Catechol
409. Pyrogallol
410. Nitrosamines
411. Secondary alkyl- and alkanolamines and their salts
412. 4-Amino-2-nitrophenol
413. 2-Methyl-m-phenylenediamine
414. 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette)
▼M28 —————
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. ►M35
From the date referred to in Article 22(1) of Regulation (EC) No 999/2001 of the European Parliament and of the Council ( 9 ), the specified risk materials as designated in Annex V to that Regulation, and ingredients derived therefrom.
Until that date, the specified risk materials as designated in Annex XI Part A to Regulation (EC) No 999/2001, and 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 °C 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 °C for three hours
— or
— Continuous process: at 140 °C, 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).
423. Alanroot oil (Inula helenium) (CAS No 97676-35-2), when used as a fragrance ingredient.
424. Benzyl cyanide (CAS No 140-29-4), when used as a fragrance ingredient.
425. Cyclamen alcohol (CAS No 4756-19-8), when used as a fragrance ingredient.
426. Diethyl maleate (CAS No 141-05-9), when used as a fragrance ingredient.
427. Dihydrocoumarine (CAS No 119-84-6), when used as a fragrance ingredient.
428. 2,4-Dihydroxy-3-methylbenzaldehyde (CAS No 6248-20-0), when used as a fragrance ingredient.
429. 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) (CAS No 40607-48-5), when used as a fragrance ingredient.
430. 4,6-Dimethyl-8-tert-butylcoumarin (CAS No 17874-34-9), when used as a fragrance ingredient.
431. Dimethyl citraconate (CAS No 617-54-9), when used as a fragrance ingredient.
432. 7,11-Dimethyl-4,6,10-dodecatrien-3-one (CAS No 26651-96-7), when used as a fragrance ingredient.
433. 6,10-Dimethyl-3,5,9-undecatrien-2-one (CAS No 141-10-6), when used as a fragrance ingredient.
434. Diphenylamine (CAS No 122-39-4), when used as a fragrance ingredient.
435. Ethyl acrylate (CAS No 140-88-5), when used as a fragrance ingredient.
436. Fig leaf absolute (Ficus carica) (CAS No 68916-52-9), when used as a fragrance ingredient.
437. trans-2-Heptenal (CAS No 18829-55-5), when used as a fragrance ingredient.
438. trans-2-Hexenal diethyl acetal (CAS No 67746-30-9), when used as a fragrance ingredient.
439. trans-2-Hexenal dimethyl acetal (CAS No 18318-83-7), when used as a fragrance ingredient.
440. Hydroabietyl alcohol (CAS No 13393-93-6), when used as a fragrance ingredient.
441. 6-Isopropyl-2-decahydronaphthalenol (CAS No 34131-99-2), when used as a fragrance ingredient.
442. 7-Methoxycoumarin (CAS No 531-59-9), when used as a fragrance ingredient.
443. 4-(4-Methoxyphenyl)-3-butene-2-one (CAS No 943-88-4), when used as a fragrance ingredient.
444. 1-(4-Methoxyphenyl)-1-penten-3-one (CAS No 104-27-8), when used as a fragrance ingredient.
445. Methyl trans-2-butenoate (CAS No 623-43-8), when used as a fragrance ingredient.
446. 7-Methylcoumarin (CAS No 2445-83-2), when used as a fragrance ingredient.
447. 5-Methyl-2,3-hexanedione (CAS No 13706-86-0), when used as a fragrance ingredient.
448. 2-Pentylidenecyclohexanone (CAS No 25677-40-1), when used as a fragrance ingredient.
449. 3,6,10-Trimethyl-3,5,9-undecatrien-2-one (CAS No 1117-41-5), when used as a fragrance ingredient.
450. Verbena oil (Lippia citriodora Kunth.) (CAS No 8024-12-2), when used as a fragrance ingredient.
►C5 451. Methyleugenol (CAS No 93-15-2) ◄ except for normal content in the natural essences used and provided that the concentration does not exceed:
(a) 0,01 % in fine fragrance
(b) 0,004 % in eau de toilette
(c) 0,002 % in fragrance cream
(d) 0,001 % in rinse-off products
(e) 0,0002 % in other leave-on products and oral hygiene products.
452. 6-(2-Chloroethyl)-6-(2-methoxyethoxy)-2,5,7,10-tetraoxa-6-silaundecane (Cas No. 37894-46-5)
453. Cobalt dichloride (Cas No. 7646-79-9)
454. Cobalt sulphate (Cas No 10124-43-3)
455. Nickel monoxide (Cas No 1313-99-1)
456. Dinickel trioxide (Cas No 1314-06-3)
457. Nickel dioxide (Cas No 12035-36-8)
458. Trinickel disulphide (Cas No 12035-72-2)
459. Tetracarbonylnickel (Cas No 13463-39-3)
460. Nickel sulphide (Cas No 16812-54-7)
461. Potassium bromate (Cas No 7758-01-2)
462. Carbon monoxide (Cas No 630-08-0)
463. Buta-1,3-diene (Cas No 106-99-0)
464. Isobutane (Cas No 75-28-5), if it contains ≥ 0,1 % w/w Butadiene
465. Butane (Cas No 106-97-8), if it contains ≥ 0,1 % w/w Butadiene
466. Gases (petroleum), C3-4 (Cas No 68131-75-9), if they contain > 0,1 % w/w Butadiene
467. Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber (Cas No 68307-98-2), if it contains > 0,1 % w/w Butadiene
468. Tail gas (petroleum), catalytic polymn. naphtha fractionation stabiliser (Cas No 68307-99-3), if it contains > 0,1 % w/w Butadiene
469. Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser, hydrogen sulfide-free (Cas No 68308-00-9), if it contains > 0,1 % w/w Butadiene
470. Tail gas (petroleum), cracked distillate hydrotreater stripper (Cas No 68308-01-0), if it contains > 0,1 % w/w Butadiene
471. Tail gas (petroleum), gas oil catalytic cracking absorber (Cas No 68308-03-2), if it contains > 0,1 % w/w Butadiene
472. Tail gas (petroleum), gas recovery plant (Cas No 68308-04-3), if it contains > 0,1 % w/w Butadiene
473. Tail gas (petroleum), gas recovery plant deethaniser (Cas No 68308-05-4), if it contains > 0,1 % w/w Butadiene
474. Tail gas (petroleum), hydrodesulfurised distillate and hydrodesulfurised naphtha fractionator, acid-free (Cas No 68308-06-5), if it contains > 0,1 % w/w Butadiene
475. Tail gas (petroleum), hydrodesulfurised vacuum gas oil stripper, hydrogen sulfide-free (Cas No 68308-07-6), if it contains > 0,1 % w/w Butadiene
476. Tail gas (petroleum), isomerised naphtha fractionation stabiliser (Cas No 68308-08-7), if it contains > 0,1 % w/w Butadiene
477. Tail gas (petroleum), light straight-run naphtha stabiliser, hydrogen sulfide-free (Cas No 68308-09-8), if it contains > 0,1 % w/w Butadiene
478. Tail gas (petroleum), straight-run distillate hydrodesulferised, hydrogen sulfide-free (Cas No 68308-10-1), if it contains > 0,1 % w/w Butadiene
479. Tail gas (petroleum), propane-propylene alkylation feed prep deethaniser (Cas No 68308-11-2), if it contains > 0,1 % w/w Butadiene
480. Tail gas (petroleum), vacuum gas oil hydrodesulferised, hydrogen sulfide-free (Cas No 68308-12-3), if it contains > 0,1 % w/w Butadiene
481. Gases (petroleum), catalytic cracked overheads (Cas No 68409-99-4), if they contain > 0,1 % w/w Butadiene
482. Alkanes, C1-2 (Cas No 68475-57-0), if they contain > 0,1 % w/w Butadiene
483. Alkanes, C2-3 (Cas No 68475-58-1), if they contain > 0,1 % w/w Butadiene
484. Alkanes, C3-4 (Cas No 68475-59-2), if they contain > 0,1 % w/w Butadiene
485. Alkanes, C4-5 (Cas No 68475-60-5), if they contain > 0,1 % w/w Butadiene
486. Fuel-gases (Cas No 68476-26-6), if they contain > 0,1 % w/w Butadiene
487. Fuel gases, crude oil distillates (Cas No 68476-29-9), if they contain > 0,1 % w/w Butadiene
488. Hydrocarbons, C3-4 (Cas No 68476-40-4), if they contain > 0,1 % w/w Butadiene
489. Hydrocarbons, C4-5 (Cas No 68476-42-6), if they contain > 0,1 % w/w Butadiene
490. Hydrocarbons, C2-4, C3-rich (Cas No 68476-49-3), if they contain > 0,1 % w/w Butadiene
491. Petroleum gases, liquefied (Cas No 68476-85-7), if they contain > 0,1 % w/w Butadiene
492. Petroleum gases, liquefied, sweetened (Cas No 68476-86-8), if they contain > 0,1 % w/w Butadiene
493. Gases (petroleum), C3-4, isobutane-rich (Cas No 68477-33-8), if they contain > 0,1 % w/w Butadiene
494. Distillates (petroleum), C3-6, piperylene-rich (Cas No 68477-35-0), if they contain > 0,1 % w/w Butadiene
495. Gases (petroleum), amine system feed (Cas No 68477-65-6), if they contain > 0,1 % w/w Butadiene
496. Gases (petroleum), benzene unit hydrodesulferised off (Cas No 68477-66-7), if they contain > 0,1 % w/w Butadiene
497. Gases (petroleum), benzene unit recycle, hydrogen-rich (Cas No 68477-67-8), if they contain > 0,1 % w/w Butadiene
498. Gases (petroleum), blend oil, hydrogen-nitrogen-rich (Cas No 68477-68-9), if they contain > 0,1 % w/w Butadiene
499. Gases (petroleum), butane splitter overheads (Cas No 68477-69-0), if they contain > 0,1 % w/w Butadiene
500. Gases (petroleum), C2-3 (Cas No 68477-70-3), if they contain > 0,1 % w/w Butadiene
501. Gases (petroleum), catalytic-cracked gas oil depropaniser bottoms, C4-rich acid-free (Cas No 68477-71-4), if they contain > 0,1 % w/w Butadiene
502. Gases (petroleum), catalytic-cracked naphtha debutaniser bottoms, C3-5-rich (Cas No 68477-72-5), if they contain > 0,1 % w/w Butadiene
503. Gases (petroleum), catalytic cracked naphtha depropaniser overhead, C3-rich acid-free (Cas No 68477-73-6), if they contain > 0,1 % w/w Butadiene
504. Gases (petroleum), catalytic cracker (Cas No 68477-74-7), if they contain > 0,1 % w/w Butadiene
505. Gases (petroleum), catalytic cracker, C1-5-rich (Cas No 68477-75-8), if they contain > 0,1 % w/w Butadiene
506. Gases (petroleum), catalytic polymd. naphtha stabiliser overhead, C2-4-rich (Cas No 68477-76-9), if they contain > 0,1 % w/w Butadiene
507. Gases (petroleum), catalytic reformed naphtha stripper overheads (Cas No 68477-77-0), if they contain > 0,1 % w/w Butadiene
508. Gases (petroleum), catalytic reformer, C1-4-rich (Cas No 68477-79-2), if they contain > 0,1 % w/w Butadiene
509. Gases (petroleum), C6-8 catalytic reformer recycle (Cas No 68477-80-5), if they contain > 0,1 % w/w Butadiene
510. Gases (petroleum), C6-8 catalytic reformer (Cas No 68477-81-6), if they contain > 0,1 % w/w Butadiene
511. Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich (Cas No 68477-82-7), if they contain > 0,1 % w/w Butadiene
512. Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed (Cas No 68477-83-8), if they contain > 0,1 % w/w Butadiene
513. Gases (petroleum), C2-return stream (Cas No 68477-84-9), if they contain > 0,1 % w/w Butadiene
514. Gases (petroleum), C4-rich (Cas No 68477-85-0), if they contain > 0,1 % w/w Butadiene
515. Gases (petroleum), deethaniser overheads (Cas No 68477-86-1), if they contain > 0,1 % w/w Butadiene
516. Gases (petroleum), deisobutaniser tower overheads (Cas No 68477-87-2), if they contain > 0,1 % w/w Butadiene
517. Gases (petroleum), depropaniser dry, propene-rich (Cas No 68477-90-7), if they contain > 0,1 % w/w Butadiene
518. Gases (petroleum), depropaniser overheads (Cas No 68477-91-8), if they contain > 0,1 % w/w Butadiene
519. Gases (petroleum), dry sour, gas-concn.-unit-off (Cas No 68477-92-9), if they contain > 0,1 % w/w Butadiene
520. Gases (petroleum), gas concn. reabsorber distn. (Cas No 68477-93-0), if they contain > 0,1 % w/w Butadiene
521. Gases (petroleum), gas recovery plant depropaniser overheads (Cas No 68477-94-1), if they contain > 0,1 % w/w Butadiene
522. Gases (petroleum), Girbatol unit feed (Cas No 68477-95-2), if they contain > 0,1 % w/w Butadiene
523. Gases (petroleum), hydrogen absorber off (Cas No 68477-96-3), if they contain > 0,1 % w/w Butadiene
524. Gases (petroleum), hydrogen-rich (Cas No 68477-97-4), if they contain > 0,1 % w/w Butadiene
525. Gases (petroleum), hydrotreater blend oil recycle, hydrogen-nitrogen-rich (Cas No 68477-98-5), if they contain > 0,1 % w/w Butadiene
526. Gases (petroleum), isomerised naphtha fractionator, C4-rich, hydrogen sulfide-free (Cas No 68477-99-6), if they contain > 0,1 % w/w Butadiene
527. Gases (petroleum), recycle, hydrogen-rich (Cas No 68478-00-2), if they contain > 0,1 % w/w Butadiene
528. Gases (petroleum), reformer make-up, hydrogen-rich (Cas No 68478-01-3), if they contain > 0,1 % w/w Butadiene
529. Gases (petroleum), reforming hydrotreater (Cas No 68478-02-4), if they contain > 0,1 % w/w Butadiene
530. Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich (Cas No 68478-03-5), if they contain > 0,1 % w/w Butadiene
531. Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich (Cas No 68478-04-6), if they contain > 0,1 % w/w Butadiene
532. Gases (petroleum), thermal cracking distn. (Cas No 68478-05-7), if they contain > 0,1 % w/w Butadiene
533. Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked vacuum residue fractionation reflux drum (Cas No 68478-21-7), if it contains > 0,1 % w/w Butadiene
534. Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber (Cas No 68478-22-8), if it contains > 0,1 % w/w Butadiene
535. Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulferised combined fractionater (Cas No 68478-24-0), if it contains > 0,1 % w/w Butadiene
536. Tail gas (petroleum), catalytic cracker refractionation absorber (Cas No 68478-25-1), if it contains > 0,1 % w/w Butadiene
537. Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser (Cas No 68478-26-2), if it contains > 0,1 % w/w Butadiene
538. Tail gas (petroleum), catalytic reformed naphtha separator (Cas No 68478-27-3), if it contains > 0,1 % w/w Butadiene
539. Tail gas (petroleum), catalytic reformed naphtha stabiliser (Cas No 68478-28-4), if it contains > 0,1 % w/w Butadiene
540. Tail gas (petroleum), cracked distillate hydrotreater separator (Cas No 68478-29-5), if it contains > 0,1 % w/w Butadiene
541. Tail gas (petroleum), hydrodesulfurised straight-run naphtha separator (Cas No 68478-30-8), if it contains > 0,1 % w/w Butadiene
542. Tail gas (petroleum), saturate gas plant mixed stream, C4-rich (Cas No 68478-32-0), if it contains > 0,1 % w/w Butadiene
543. Tail gas (petroleum), saturate gas recovery plant, C1-2-rich (Cas No 68478-33-1), if it contains > 0,1 % w/w Butadiene
544. Tail gas (petroleum), vacuum residues thermal cracker (Cas No 68478-34-2), if it contains > 0,1 % w/w Butadiene
545. Hydrocarbons, C3-4-rich, petroleum distillate (Cas No 68512-91-4), if they contain > 0,1 % w/w Butadiene
546. Gases (petroleum), catalytic reformed straight-run naphtha stabiliser overheads (Cas No 68513-14-4), if they contain > 0,1 % w/w Butadiene
547. Gases (petroleum), full-range straight-run naphtha dehexaniser off (Cas No 68513-15-5), if they contain > 0,1 % w/w Butadiene
548. Gases (petroleum), hydrocracking depropaniser off, hydrocarbon-rich (Cas No 68513-16-6), if they contain > 0,1 % w/w Butadiene
549. Gases (petroleum), light straight-run naphtha stabiliser off (Cas No 68513-17-7), if they contain > 0,1 % w/w Butadiene
550. Gases (petroleum), reformer effluent high-pressure flash drum off (Cas No 68513-18-8), if they contain > 0,1 % w/w Butadiene
551. Gases (petroleum), reformer effluent low-pressure flash drum off (Cas No 68513-19-9), if they contain > 0,1 % w/w Butadiene
552. Residues (petroleum), alkylation splitter, C4-rich (Cas No 68513-66-6), if they contain > 0,1 % w/w Butadiene
553. Hydrocarbons, C1-4 (Cas No 68514-31-8), if they contain > 0,1 % w/w Butadiene
554. Hydrocarbons, C1-4, sweetened (Cas No 68514-36-3), if they contain > 0,1 % w/w Butadiene
555. Gases (petroleum), oil refinery gas distn. off (Cas No 68527-15-1), if they contain > 0,1 % w/w Butadiene
556. Hydrocarbons, C1-3 (Cas No 68527-16-2), if they contain > 0,1 % w/w Butadiene
557. Hydrocarbons, C1-4, debutanizer fraction (Cas No 68527-19-5), if they contain > 0,1 % w/w Butadiene
558. Gases (petroleum), benzene unit hydrotreater depentaniser overheads (Cas No 68602-82-4), if they contain > 0,1 % w/w Butadiene
559. Gases (petroleum), C1-5, wet (Cas No 68602-83-5), if they contain > 0,1 % w/w Butadiene
560. Gases (petroleum), secondary absorber off, fluidised catalytic cracker overheads fractionator (Cas No 68602-84-6), if they contain > 0,1 % w/w Butadiene
561. Hydrocarbons, C2-4 (Cas No 68606-25-7), if they contain > 0,1 % w/w Butadiene
562. Hydrocarbons, C3 (Cas No 68606-26-8), if they contain > 0,1 % w/w Butadiene
563. Gases (petroleum), alkylation feed (Cas No 68606-27-9), if they contain > 0,1 % w/w Butadiene
564. Gases (petroleum), depropaniser bottoms fractionation off (Cas No 68606-34-8), if they contain > 0,1 % w/w Butadiene
565. Petroleum products, refinery gases (Cas No 68607-11-4), if they contain > 0,1 % w/w Butadiene
566. Gases (petroleum), hydrocracking low-pressure separator (Cas No 68783-06-2), if they contain > 0,1 % w/w Butadiene
567. Gases (petroleum), refinery blend (Cas No 68783-07-3), if they contain > 0,1 % w/w Butadiene
568. Gases (petroleum), catalytic cracking (Cas No 68783-64-2), if they contain > 0,1 % w/w Butadiene
569. Gases (petroleum), C2-4, sweetened (Cas No 68783-65-3), if they contain > 0,1 % w/w Butadiene
570. Gases (petroleum), refinery (Cas No 68814-67-5), if they contain > 0,1 % w/w Butadiene
571. Gases (petroleum), platformer products separator off (Cas No 68814-90-4), if they contain > 0,1 % w/w Butadiene
572. Gases (petroleum), hydrotreated sour kerosine depentaniser stabiliser off (Cas No 68911-58-0), if they contain > 0,1 % w/w Butadiene
573. Gases (petroleum), hydrotreated sour kerosine flash drum (Cas No 68911-59-1), if they contain > 0,1 % w/w Butadiene
574. Gases (petroleum), crude oil fractionation off (Cas No 68918-99-0), if they contain > 0,1 % w/w Butadiene
575. Gases (petroleum), dehexaniser off (Cas No 68919-00-6), if they contain > 0,1 % w/w Butadiene
576. Gases (petroleum), distillate unifiner desulfurisation tripper off (Cas No 68919-01-7), if they contain > 0,1 % w/w Butadiene
577. Gases (petroleum), fluidised catalytic cracker fractionation off (Cas No 68919-02-8) if they contain > 0,1 % w/w Butadiene
578. Gases (petroleum), fluidised catalytic cracker scrubbing secondary absorber off (Cas No 68919-03-9), if they contain > 0,1 % w/w Butadiene
579. Gases (petroleum), heavy distillate hydrotreater desulfurisation stripper off (Cas No 68919-04-0), if they contain > 0,1 % w/w Butadiene
580. Gases (petroleum), light straight run gasoline fractionation stabiliser off (Cas No 68919-05-1), if they contain > 0,1 % w/w Butadiene
581. Gases (petroleum), naphtha unifiner desulfurisation stripper off (Cas No 68919-06-2), if they contain > 0,1 % w/w Butadiene
582. Gases (petroleum), platformer stabiliser off, light ends fractionation (Cas No 68919-07-3), if they contain > 0,1 % w/w Butadiene
583. Gases (petroleum), preflash tower off, crude distn. (Cas No 68919-08-4), if they contain > 0,1 % w/w Butadiene
584. Gases (petroleum), straight-run naphtha catalytic reforming off (Cas No 68919-09-5), if they contain > 0,1 % w/w Butadiene
585. Gases (petroleum), straight-run stabiliser off (Cas No 68919-10-8), if they contain > 0,1 % w/w Butadiene
586. Gases (petroleum), tar stripper off (Cas No 68919-11-9), if they contain > 0,1 % w/w Butadiene
587. Gases (petroleum), unifiner stripper off (Cas No 68919-12-0), if they contain > 0,1 % w/w Butadiene
588. Gases (petroleum), fluidised catalytic cracker splitter overheads (Cas No 68919-20-0), if they contain > 0,1 % w/w Butadiene
589. Gases (petroleum), catalytic cracked naphtha debutanizer (Cas No 68952-76-1), if they contain > 0,1 % w/w Butadiene
590. Tail gas (petroleum), catalytic cracked distillate and naphtha stabiliser (Cas No 68952-77-2), if it contains > 0,1 % w/w Butadiene
591. Tail gas (petroleum), catalytic hydrodesulfurised naphtha separator (Cas No 68952-79-4), if it contains > 0,1 % w/w Butadiene
592. Tail gas (petroleum), straight-run naphtha hydrodesulferised (Cas No 68952-80-7), if it contains > 0,1 % w/w Butadiene
593. Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber (Cas No 68952-81-8), if it contains > 0,1 % w/w Butadiene
594. Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabiliser, petroleum coking (Cas No 68952-82-9), if it contains > 0,1 % w/w Butadiene
595. Gases (petroleum), light steam-cracked, butadiene conc. (Cas No 68955-28-2), if they contain > 0,1 % w/w Butadiene
596. Gases (petroleum), sponge absorber off, fluidised catalytic cracker and gas oil desulfuriser overhead fractionation (Cas No 68955-33-9), if they contain > 0,1 % w/w Butadiene
597. Gases (petroleum), straight-run naphtha catalytic reformer stabiliser overhead (Cas No 68955-34-0), if they contain > 0,1 % w/w Butadiene
598. Gases (petroleum), crude distn. and catalytic cracking (Cas No 68989-88-8), if they contain > 0,1 % w/w Butadiene
599. Hydrocarbons, C4 (Cas No 87741-01-3), if they contain > 0,1 % w/w Butadiene
600. Alkanes, C1-4, C3-rich (Cas No 90622-55-2), if they contain > 0,1 % w/w Butadiene
601. Gases (petroleum), gas oil diethanolamine scrubber off (Cas No 92045-15-3), if they contain > 0,1 % w/w Butadiene
602. Gases (petroleum), gas oil hydrodesulfurisation effluent (Cas No 92045-16-4), if they contain > 0,1 % w/w Butadiene
603. Gases (petroleum), gas oil hydrodesulfurisation purge (Cas No 92045-17-5), if they contain > 0,1 % w/w Butadiene
604. Gases (petroleum), hydrogenator effluent flash drum off (Cas No 92045-18-6), if they contain > 0,1 % w/w Butadiene
605. Gases (petroleum), naphtha steam cracking high-pressure residual (Cas No 92045-19-7), if they contain > 0,1 % w/w Butadiene
606. Gases (petroleum), residue visbreaking off (Cas No 92045-20-0), if they contain > 0,1 % w/w Butadiene
607. Gases (petroleum), steam-cracker C3-rich (Cas No 92045-22-2), if they contain > 0,1 % w/w Butadiene
608. Hydrocarbons, C4, steam-cracker distillate (Cas No 92045-23-3), if they contain > 0,1 % w/w Butadiene
609. Petroleum gases, liquefied, sweetened, C4 fraction (Cas No 92045-80-2), if they contain > 0,1 % w/w Butadiene
610. Hydrocarbons, C4, 1,3-butadiene- and isobutene-free (Cas No 95465-89-7), if they contain > 0,1 % w/w Butadiene
611. Raffinates (petroleum), steam-cracked C4 fraction cuprous ammonium acetate extn., C3-5 and C3-5 unsatd., butadiene-free (Cas No 97722-19-5), if they contain > 0,1 % w/w Butadiene
612. Benzo[def]chrysene (=benzo[a]pyrene) (Cas No 50-32-8)
613. Pitch, coal tar-petroleum (Cas No 68187-57-5), if it contains > 0,005 % w/w benzo[a]pyrene
614. Distillates (coal-petroleum), condensed-ring arom. (Cas No 68188-48-7), if they contain > 0,005 % w/w benzo[a]pyrene
615. Distillates (coal tar), upper, fluorene-free (Cas No 84989-10-6), if they contain > 0,005 % w/w benzo[a]pyrene
616. Distillates (coal tar), upper, fluorene-rich (Cas No 84989-11-7), if they contain > 0,005 % w/w benzo[a]pyrene
617. Creosote oil, acenaphthene fraction, acenaphthene-free (Cas No 90640-85-0), if it contains > 0,005 % w/w benzo[a]pyrene
618. Pitch, coal tar, low-temp. (Cas No 90669-57-1), if it contains > 0,005 % w/w benzo[a]pyrene
619. Pitch, coal tar, low-temp., heat-treated (Cas No 90669-58-2), if it contains > 0,005 % w/w benzo[a]pyrene
620. Pitch, coal tar, low-temp., oxidised (Cas No 90669-59-3), if it contains > 0,005 % w/w benzo[a]pyrene
621. Extract residues (coal), brown (Cas No 91697-23-3), if they contain > 0,005 % w/w benzo[a]pyrene
622. Paraffin waxes (coal), brown-coal high-temp. tar (Cas No 92045-71-1), if they contain > 0,005 % w/w benzo[a]pyrene
623. Paraffin waxes (coal), brown-coal high-temp. tar, hydrotreated (Cas No 92045-72-2), if they contain > 0,005 % w/w benzo[a]pyrene
624. Waste solids, coal-tar pitch coking (Cas No 92062-34-5), if they contain > 0,005 % w/w benzo[a]pyrene
625. Pitch, coal tar, high-temp., secondary (Cas No 94114-13-3), if it contains > 0,005 % w/w benzo[a]pyrene
626. Residues (coal), liq. solvent extn. (Cas No 94114-46-2), if they contain > 0,005 % w/w benzo[a]pyrene
627. Coal liquids, liq. solvent extn. soln. (Cas No 94114-47-3), if they contain > 0,005 % w/w benzo[a]pyrene
628. Coal liquids, liq. solvent extn. (Cas No 94114-48-4), if they contain > 0,005 % w/w benzo[a]pyrene
629. Paraffin waxes (coal), brown-coal high-temp. tar, carbon-treated (Cas No 97926-76-6), if they contain > 0,005 % w/w benzo[a]pyrene
630. Paraffin waxes (coal), brown-coal high-temp tar, clay-treated (Cas No 97926-77-7), if they contain > 0,005 % w/w benzo[a]pyrene
631. Paraffin waxes (coal), brown-coal high-temp tar, silicic acid-treated (Cas No 97926-78-8), if they contain > 0,005 % w/w benzo[a]pyrene
632. Absorption oils, bicyclo arom. and heterocylic hydrocarbon fraction (Cas No 101316-45-4), if they contain > 0,005 % w/w benzo[a]pyrene
633. Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene polypropylene pyrolysis-derived (Cas No 101794-74-5), if they contain > 0,005 % w/w benzo[a]pyrene
634. Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene pyrolysis-derived (Cas No 101794-75-6), if they contain > 0,005 % w/w benzo[a]pyrene
635. Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polystyrene pyrolysis-derived (Cas No 101794-76-7), if they contain > 0,005 % w/w benzo[a]pyrene
636. Pitch, coal tar, high-temp., heat-treated (Cas No 121575-60-8), if it contains > 0,005 % w/w benzo[a]pyrene
637. Dibenz[a,h]anthracene (Cas No 53-70-3)
638. Benz[a]anthracene (Cas No 56-55-3)
639. Benzo[e]pyrene (Cas No 192-97-2)
640. Benzo[j]fluoranthene (Cas No 205-82-3)
641. Benz(e)acephenanthrylene (Cas No 205-99-2)
642. Benzo(k)fluoranthene (Cas No 207-08-9)
643. Chrysene (Cas No 218-01-9)
644. 2-Bromopropane (Cas No 75-26-3)
645. Trichloroethylene (Cas No 79-01-6)
646. 1,2-Dibromo-3-chloropropane (Cas No 96-12-8)
647. 2,3-Dibromopropan-1-ol (Cas No 96-13-9)
648. 1,3-Dichloropropan-2-ol (Cas No 96-23-1)
649. α,α,α-Trichlorotoluene (Cas No 98-07-7)
650. α-Chlorotoluene (Cas No 100-44-7)
651. 1,2-Dibromoethane (Cas No 106-93-4)
652. Hexachlorobenzene (Cas No 118-74-1)
653. Bromoethylene (Cas No 593-60-2)
654. 1,4-Dichlorobut-2-ene (Cas No 764-41-0)
655. Methyloxirane (Cas No 75-56-9)
656. (Epoxyethyl)benzene (Cas No 96-09-3)
657. 1-Chloro-2,3-epoxypropane (Cas No 106-89-8)
658. R-1-Chloro-2,3-epoxypropane (Cas No 51594-55-9)
659. 1,2-Epoxy-3-phenoxypropane (Cas No 122-60-1)
660. 2,3-Epoxypropan-1-ol (Cas No 556-52-5)
661. R-2,3-Epoxy-1-propanol (Cas No 57044-25-4)
662. 2,2′-Bioxirane (Cas No 1464-53-5)
663. ►C8 (2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophenyl)-[1H-1,2,4-triazol-1-yl)methyl]oxirane (CAS No 133855-98-8) ◄
664. Chloromethyl methyl ether (Cas No 107-30-2)
665. 2-Methoxyethanol (Cas No 109-86-4)
666. 2-Ethoxyethanol (Cas No 110-80-5)
667. Oxybis[chloromethane], bis (Chloromethyl) ether (Cas No 542-88-1)
668. 2-Methoxypropanol (Cas No 1589-47-5)
669. Propiolactone (Cas No 57-57-8)
670. Dimethylcarbamoyl chloride (Cas No 79-44-7)
671. Urethane (Cas No 51-79-6)
672. 2-Methoxyethyl acetate (Cas No 110-49-6)
673. 2-Ethoxyethyl acetate (Cas No 111-15-9)
674. Methoxyacetic acid (Cas No 625-45-6)
675. Dibutyl phthalate (Cas No 84-74-2)
676. bis(2-Methyoxyethyl) ether (Cas No 111-96-6)
677. bis(2-Ethylhexyl) phthalate (Cas No 117-81-7)
678. bis(2-Methoxyethyl) phthalate (Cas No 117-82-8)
679. 2-Methoxypropyl acetate (Cas No 70657-70-4)
680. 2-Ethylhexyl[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]-methyl]thio]acetate (Cas No 80387-97-9)
681. Acrylamide, unless regulated elsewhere in this Directive (Cas No 79-06-1)
682. Acrylonitrile (Cas No 107-13-1)
683. 2-Nitropropane (Cas No 79-46-9)
684. Dinoseb (Cas No 88-85-7), its salts and esters with the exception of those specified elsewhere in this list
685. 2-Nitroanisole (Cas No 91-23-6)
686. 4-Nitrobiphenyl (Cas No 92-93-3)
687. 2,4-Dinitrotoluene (Cas No 121-14-2)
688. Binapacryl (Cas No 485-31-4)
689. 2-Nitronaphthalene (Cas No 581-89-5)
690. 2,3-Dinitrotoluene (Cas No 602-01-7)
691. 5-Nitroacenaphthene (Cas No 602-87-9)
692. 2,6-Dinitrotoluene (Cas No 606-20-2)
693. 3,4-Dinitrotoluene (Cas No 610-39-9)
694. 3,5-Dinitrotoluene (Cas No 618-85-9)
695. 2,5-Dinitrotoluene (Cas No 619-15-8)
696. Dinoterb (Cas No 1420-07-1), its salts and esters
697. Nitrofen (Cas No 1836-75-5)
698. Dinitrotoluene (Cas No 25321-14-6)
699. Diazomethane (Cas No 334-88-3)
700. 1,4,5,8-Tetraaminoanthraquinone (Disperse Blue 1) (Cas No 2475-45-8)
701. Dimethylnitrosoamine (Cas No 62-75-9)
702. 1-Methyl-3-nitro-1-nitrosoguanidine (Cas No 70-25-7)
703. Nitrosodipropylamine (Cas No 621-64-7)
704. 2,2′-(Nitrosoimino)bisethanol (Cas No 1116-54-7)
705. 4,4′-Methylenedianiline (Cas No 101-77-9)
706. 4,4′-(4-Iminocyclohexa-2,5-dienylidenemethylene) dianiline hydrochloride (Cas No 569-61-9)
707. 4,4′-Methylenedi-o-toluidine (Cas No 838-88-0)
708. o-Anisidine (Cas No 90-04-0)
709. 3,3′-Dimethoxybenzidine (Cas No 119-90-4)
710. Salts of o-dianisidine
711. o-Dianisidine based azo dyes
712. 3,3′-Dichlorobenzidine (Cas No 91-94-1)
713. Benzidine dihydrochloride (Cas No 531-85-1)
714. [[1,1′-Biphenyl]-4,4′-diyl]diammonium sulphate (Cas No 531-86-2)
715. 3,3′-Dichlorobenzidine dihydrochloride (Cas No 612-83-9)
716. Benzidine sulphate (Cas No 21136-70-9)
717. Benzidine acetate (Cas No 36341-27-2)
718. 3,3′-Dichlorobenzidine dihydrogen bis(sulphate) (Cas No 64969-34-2)
719. 3,3′-Dichlorobenzidine sulphate (Cas No 74332-73-3)
720. Benzidine based azo dyes
721. 4,4′-Bi-o-toluidine (Cas No 119-93-7)
722. 4,4′-Bi-o-toluidine dihydrochloride (Cas No 612-82-8)
723. [3,3′-Dimethyl[1,1′-biphenyl]-4,4′-diyl]diammonium bis(hydrogen sulphate) (Cas No 64969-36-4)
724. 4,4′-Bi-o-toluidine sulphate (Cas No 74753-18-7)
725. o-Tolidine based dyes
726. Biphenyl-4-ylamine (Cas No 92-67-1) and its salts
727. Azobenzene (Cas No 103-33-3)
728. (Methyl-ONN-azoxy)methyl acetate (Cas No 592-62-1)
729. Cycloheximide (Cas No 66-81-9)
730. 2-Methylaziridine (Cas No 75-55-8)
731. Imidazolidine-2-thione (Cas No 96-45-7)
732. Furan (Cas No 110-00-9)
733. Aziridine (Cas No 151-56-4)
734. Captafol (2425-06-1)
735. Carbadox (Cas No 6804-07-5)
736. Flumioxazin (Cas No 103361-09-7)
737. Tridemorph (Cas No 24602-86-6)
738. Vinclozolin (Cas No 50471-44-8)
739. Fluazifop-butyl (Cas No 69806-50-4)
740. Flusilazole (Cas No 85509-19-9)
741. 1,3,5-Tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (Cas No 2451-62-9)
742. Thioacetamide (Cas No 62-55-5)
743. N,N-Dimethylformamide (Cas No 68-12-2)
744. Formamide (Cas No 75-12-7)
745. N-Methylacetamide (Cas No 79-16-3)
746. N-Methylformamide (Cas No 123-39-7)
747. N,N-Dimethylacetamide (Cas No 127-19-5)
748. Hexamethylphosphoric-triamide (Cas No 680-31-9)
749. Diethyl sulphate (Cas No 64-67-5)
750. Dimethyl sulphate (Cas No 77-78-1)
751. 1,3-Propanesultone (Cas No 1120-71-4)
752. Dimethylsulphamoyl-chloride (Cas No 13360-57-1)
753. Sulfallate (Cas No 95-06-7)
754. A mixture of: 4-[[bis-(4-Fluorophenyl)methylsilyl]methyl]-4H-1,2,4-triazole and 1-[[bis-(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole (EC No 403-250-2)
755. (+/–)-Tetrahydrofurfuryl –(R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate (Cas No 119738-06-6)
756. 6-Hydroxy-1-(3-Isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrile (Cas No 85136-74-9)
757. (6-(4-Hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazine-2,4-diyl)bis[(amino-1-methylethyl)ammonium] formate (Cas No 108225-03-2)
758. Trisodium [4′-(8-acetylamino-3,6-disulfonato-2-naphthylazo)-4″-(6-benzoylamino-3-Sulfonato-2-naphthylazo)-biphenyl-1,3′,3″,1‴-tetraolato-O,O′,O″,O‴]copper(II) (EC No 413-590-3)
759. A mixture of: N-[3-Hydroxy-2-(2-methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamideand N-2,3-bis-(2-Methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide and methacrylamide and 2-methyl-N-(2-methylacryloylaminomethoxymethyl)-acrylamide and N-(2,3-dihydroxypropoxymethyl)-2-methylacrylamide (EC No 412-790-8)
760. 1,3,5-tris-[(2S and 2R)-2,3-Epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (Cas No 59653-74-6)
761. Erionite (Cas No 12510-42-8)
762. Asbestos (Cas No 12001-28-4)
763. Petroleum (Cas No 8002-05-9)
764. Distillates (petroleum), heavy hydrocracked (Cas No 64741-76-0), if they contain > 3 % w/w DMSO extract
765. Distillates (petroleum), solvent-refined heavy paraffinic (Cas No 64741-88-4), if they contain > 3 % w/w DMSO extract
766. Distillates (petroleum), solvent-refined light paraffinic (Cas No 64741-89-5), if they contain > 3 % w/w DMSO extract
767. Residual oils (petroleum), solvent deasphalted (Cas No 64741-95-3), if they contain > 3 % w/w DMSO extract
768. Distillates (petroleum), solvent-refined heavy naphthenic (Cas No 64741-96-4), if they contain > 3 % w/w DMSO extract
769. Distillates (petroleum), solvent-refined light naphthenic (Cas No 64741-97-5), if they contain > 3 % w/w DMSO extract
770. Residual oils (petroleum), solvent-refined (Cas No 64742-01-4), if they contain > 3 % w/w DMSO extract
771. Distillates (petroleum), clay-treated heavy paraffinic (Cas No 64742-36-5), if they contain > 3 % w/w DMSO extract
772. Distillates (petroleum), clay-treated light paraffinic (Cas No 64742-37-6), if they contain > 3 % w/w DMSO extract
773. Residual oils (petroleum), clay-treated (Cas No 64742-41-2), if they contain > 3 % w/w DMSO extract
774. Distillates (petroleum), clay-treated heavy naphthenic (Cas No 64742-44-5), if they contain > 3 % w/w DMSO extract
775. Distillates (petroleum), clay-treated light naphthenic (Cas No 64742-45-6), if they contain > 3 % w/w DMSO extract
776. Distillates (petroleum), hydrotreated heavy naphthenic (Cas No 64742-52-5), if they contain > 3% w/w DMSO extract
777. Distillates (petroleum), hydrotreated light naphthenic (Cas No 64742-53-6), if they contain > 3 % w/w DMSO extract
778. Distillates (petroleum), hydrotreated heavy paraffinic (Cas No 64742-54-7), if they contain > 3 % w/w DMSO extract
779. Distillates (petroleum), hydrotreated light paraffinic (Cas No 64742-55-8), if they contain > 3 % w/w DMSO extract
780. Distillates (petroleum), solvent-dewaxed light paraffinic (Cas No 64742-56-9), if they contain > 3 % w/w DMSO extract
781. Residual oils (petroleum), hydrotreated (Cas No 64742-57-0), if they contain > 3 % w/w DMSO extract
782. Residual oils (petroleum), solvent-dewaxed (Cas No 64742-62-7), if they contain > 3 % w/w DMSO extract
783. Distillates (petroleum), solvent-dewaxed heavy naphthenic (Cas No 64742-63-8), if they contain > 3 % w/w DMSO extract
784. Distillates (petroleum), solvent-dewaxed light naphthenic (Cas No 64742-64-9), if they contain > 3 % w/w DMSO extract
785. Distillates (petroleum), solvent-dewaxed heavy paraffinic (Cas No 64742-65-0), if they contain > 3 % w/w DMSO extract
786. Foots oil (petroleum) (Cas No 64742-67-2), if it contains > 3 % w/w DMSO extract
787. Naphthenic oils (petroleum), catalytic dewaxed heavy (Cas No 64742-68-3), if they contain > 3 % w/w DMSO extract
788. Naphthenic oils (petroleum), catalytic dewaxed light (Cas No 64742-69-4), if they contain > 3 % w/w DMSO extract
789. Paraffin oils (petroleum), catalytic dewaxed heavy (Cas No 64742-70-7), if they contain > 3 % w/w DMSO extract
790. Paraffin oils (petroleum), catalytic dewaxed light (Cas No 64742-71-8), if they contain > 3 % w/w DMSO extract
791. Naphthenic oils (petroleum), complex dewaxed heavy (Cas No 64742-75-2), if they contain > 3 % w/w DMSO extract
792. Naphthenic oils (petroleum), complex dewaxed light (Cas No 64742-76-3), if they contain > 3 % w/w DMSO extract
793. Extracts (petroleum), heavy naphthenic distillate solvent, arom. conc. (Cas No 68783-00-6), if they contain > 3 % w/w DMSO extract
794. Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent (Cas No 68783-04-0), if they contain > 3 % w/w DMSO extract
795. Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted (Cas No 68814-89-1), if they contain > 3 % w/w DMSO extract
796. Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity (Cas No 72623-85-9), if they contain > 3 % w/w DMSO extract
797. Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based (Cas No 72623- 86-0), if they contain > 3 % w/w DMSO extract
798. Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based (Cas No 72623- 87-1), if they contain > 3 % w/w DMSO extract
799. Lubricating oils (Cas No 74869-22-0), if they contain > 3 % w/w DMSO extract
800. Distillates (petroleum), complex dewaxed heavy paraffinic (Cas No 90640-91-8), if they contain > 3 % w/w DMSO extract
801. Distillates (petroleum), complex dewaxed light paraffinic (Cas No 90640-92-9), if they contain > 3 % w/w DMSO extract
802. Distillates (petroleum), solvent dewaxed heavy paraffinic, clay-treated (Cas No 90640-94-1), if they contain > 3 % w/w DMSO extract
803. Hydrocarbons, C20-50, solvent dewaxed heavy paraffinic, hydrotreated (Cas No 90640-95-2), if they contain > 3 % w/w DMSO extract
804. Distillates (petroleum), solvent dewaxed light paraffinic, clay-treated (Cas No 90640-96-3), if they contain > 3 % w/w DMSO extract
805. Distillates (petroleum), solvent dewaxed light paraffinic, hydrotreated (Cas No 90640-97-4), if they contain > 3 % w/w DMSO extract
806. Extracts (petroleum), heavy naphthenic distillate solvent, hydrotreated (Cas No 90641-07-9), if they contain > 3 % w/w DMSO extract
807. Extracts (petroleum), heavy paraffinic distillate solvent, hydrotreated (Cas No 90641-08-0), if they contain > 3 % w/w DMSO extract
808. Extracts (petroleum), light paraffinic distillate solvent, hydrotreated (Cas No 90641-09-1), if they contain > 3 % w/w DMSO extract
809. Residual oils (petroleum), hydrotreated solvent dewaxed (Cas No 90669-74-2), if they contain > 3 % w/w DMSO extract
810. Residual oils (petroleum), catalytic dewaxed (Cas No 91770-57-9), if they contain > 3 % w/w DMSO extract
811. Distillates (petroleum), dewaxed heavy paraffinic, hydrotreated (Cas No 91995-39-0) if they contain > 3 % w/w DMSO extract
812. Distillates (petroleum), dewaxed light paraffinic, hydrotreated (Cas No 91995-40-3), if they contain > 3 % w/w DMSO extract
813. Distillates (petroleum), hydrocracked solvent-refined, dewaxed (Cas No 91995-45-8), if they contain > 3 % w/w DMSO extract
814. Distillates (petroleum), solvent-refined light naphthenic, hydrotreated (Cas No 91995-54-9), if they contain > 3 % w/w DMSO extract
815. Extracts (petroleum), hydrotreated light paraffinic distillate solvent (Cas No 91995- 73-2), if they contain > 3 % w/w DMSO extract
816. Extracts (petroleum), light naphthenic distillate solvent, hydrodesulfurised (Cas No 91995-75-4), if they contain > 3 % w/w DMSO extract
817. Extracts (petroleum), light paraffinic distillate solvent, acid-treated (Cas No 91995-76-5), if they contain > 3 % w/w DMSO extract
818. Extracts (petroleum), light paraffinic distillate solvent, hydrodesulfurised (Cas No 91995-77-6), if they contain > 3 % w/w DMSO extract
819. Extracts (petroleum), light vacuum gas oil solvent, hydrotreated (Cas No 91995-79-8), if they contain > 3 % w/w DMSO extract
820. Foots oil (petroleum), hydrotreated (Cas No 92045-12-0), if it contains > 3 % w/w DMSO extract
821. Lubricating oils (petroleum), C17-35, solvent-extd., dewaxed, hydrotreated (Cas No 92045-42-6), if they contain > 3 % w/w DMSO extract
822. Lubricating oils (petroleum), hydrocracked nonarom solvent-deparaffined (Cas No 92045-43-7), if they contain > 3 % w/w DMSO extract
823. Residual oils (petroleum), hydrocracked acid-treated solvent-dewaxed (Cas No 92061-86-4), if they contain > 3 % w/w DMSO extract
824. Paraffin oils (petroleum), solvent-refined dewaxed heavy (Cas No 92129-09-4), if they contain > 3 % w/w DMSO extract
825. Extracts (petroleum), heavy paraffinic distillate solvent, clay-treated (Cas No 92704- 08-0), if they contain > 3 % w/w DMSO extract
826. Lubricating oils (petroleum), base oils, paraffinic (Cas No 93572-43-1), if they contain > 3 % w/w DMSO extract
827. Extracts (petroleum), heavy naphthenic distillate solvent, hydrodesulfurised (Cas No 93763-10-1), if they contain > 3 % w/w DMSO extract
828. Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent, hydrodesulfurised (Cas No 93763-11-2), if they contain > 3 % w/w DMSO extract
829. Hydrocarbons, hydrocracked paraffinic distn. residues, solvent-dewaxed (Cas No 93763-38-3), if they contain > 3 % w/w DMSO extract
830. Foots oil (petroleum), acid-treated (Cas No 93924-31-3), if it contains > 3 % w/w DMSO extract
831. Foots oil (petroleum), clay-treated (Cas No 93924-32-4), if it contains > 3 % w/w DMSO extract
832. Hydrocarbons, C20-50, residual oil hydrogenation vacuum distillate (Cas No 93924- 61-9), if they contain > 3 % w/w DMSO extract
833. Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated (Cas No 94733-08-1), if they contain > 3 % w/w DMSO extract
834. Distillates (petroleum), solvent-refined hydrocracked light (Cas No 94733-09-2), if they contain > 3 % w/w DMSO extract
835. Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based (Cas No 94733-15-0), if they contain > 3 % w/w DMSO extract
836. Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrogenated raffinate-based (Cas No 94733-16-1), if they contain > 3 % w/w DMSO extract
837. Hydrocarbons, C13-30, arom.-rich, solvent-extd. naphthenic distillate (Cas No 95371-04-3), if they contain > 3 % w/w DMSO extract
838. Hydrocarbons, C16-32, arom. rich, solvent-extd. naphthenic distillate (Cas No 95371-05-4), if they contain > 3 % w/w DMSO extract
839. Hydrocarbons, C37-68, dewaxed deasphalted hydrotreated vacuum distn. Residues (Cas No 95371-07-6), if they contain > 3 % w/w DMSO extract
840. Hydrocarbons, C37-65, hydrotreated deasphalted vacuum distn. Residues (Cas No 95371-08-7), if they contain > 3 % w/w DMSO extract
841. Distillates (petroleum), hydrocracked solvent-refined light (Cas No 97488-73-8), if they contain > 3 % w/w DMSO extract
842. Distillates (petroleum), solvent-refined hydrogenated heavy (Cas No 97488-74-9), if they contain > 3 % w/w DMSO extract
843. Lubricating oils (petroleum), C18-27, hydrocracked solvent-dewaxed (Cas No 97488-95-4), if they contain > 3 % w/w DMSO extract
844. Hydrocarbons, C17-30, hydrotreated solvent-deasphalted atm. distn. residue, distn. lights (Cas No 97675-87-1), if they contain > 3 % w/w DMSO extract
845. Hydrocarbons, C17-40, hydrotreated solvent-deasphalted distn. residue, vacuum distn. lights (Cas No 97722-06-0), if they contain > 3 % w/w DMSO extract
846. Hydrocarbons, C13-27, solvent-extd. light naphthenic (Cas No 97722-09-3), if they contain > 3 % w/w DMSO extract
847. Hydrocarbons, C14-29, solvent-extd. light naphthenic (Cas No 97722-10-6), if they contain > 3 % w/w DMSO extract
848. Foots oil (petroleum), carbon-treated (Cas No 97862-76-5), if it contains > 3 % w/w DMSO extract
849. Foots oil (petroleum), silicic acid-treated (Cas No 97862-77-6), if it contains > 3 % w/w DMSO extract
850. Hydrocarbons, C27-42, dearomatised (Cas No 97862-81-2), if they contain > 3 % w/w DMSO extract
851. Hydrocarbons, C17-30, hydrotreated distillates, distn. Lights (Cas No 97862-82-3), if they contain > 3 % w/w DMSO extract
852. Hydrocarbons, C27-45, naphthenic vacuum distn. (Cas No 97862-83-4), if they contain > 3 % w/w DMSO extract
853. Hydrocarbons, C27-45, dearomatised (Cas No 97926-68-6), if they contain > 3 % w/w DMSO extract
854. Hydrocarbons, C20-58, hydrotreated (Cas No 97926-70-0), if they contain > 3 % w/w DMSO extract
855. Hydrocarbons, C27-42, naphthenic (Cas No 97926-71-1), if they contain > 3 % w/w DMSO extract
856. Extracts (petroleum), light paraffinic distillate solvent, carbon-treated (Cas No 100684-02-4), if they contain > 3 % w/w DMSO extract
857. Extracts (petroleum), light paraffinic distillate solvent, clay-treated (Cas No 100684- 03-5), if they contain > 3 % w/w DMSO extract
858. Extracts (petroleum), light vacuum, gas oil solvent, carbon-treated (Cas No 100684-04-6), if they contain > 3 % w/w DMSO extract
859. Extracts (petroleum), light vacuum gas oil solvent, clay-treated (Cas No 100684-05-7), if they contain > 3 % w/w DMSO extract
860. Residual oils (petroleum), carbon-treated solvent-dewaxed (Cas No 100684-37-5), if they contain > 3 % w/w DMSO extract
861. Residual oils (petroleum), clay-treated solvent-dewaxed (Cas No 100684-38-6), if they contain > 3 % w/w DMSO extract
862. Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated (Cas No 101316-69-2), if they contain > 3 % w/w DMSO extract
863. Lubricating oils (petroleum), C17-32, solvent-extd., dewaxed, hydrogenated (Cas No 101316-70-5), if they contain > 3 % w/w DMSO extract
864. Lubricating oils (petroleum), C20-35, solvent-extd., dewaxed, hydrogenated (Cas No 101316-71-6), if they contain > 3 % w/w DMSO extract
865. Lubricating oils (petroleum), C24-50, solvent-extd., dewaxed, hydrogenated (Cas No 101316-72-7), if they contain > 3 % w/w DMSO extract
866. Distillates (petroleum), sweetened middle (Cas No 64741-86-2), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
867. Gas oils (petroleum), solvent-refined (Cas No 64741-90-8), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
868. Distillates (petroleum), solvent-refined middle (Cas No 64741-91-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
869. Gas oils (petroleum), acid-treated (Cas No 64742-12-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
870. Distillates (petroleum), acid-treated middle (Cas No 64742-13-8), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
871. Distillates (petroleum), acid-treated light (Cas No 64742-14-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
872. Gas oils (petroleum), chemically neutralised (Cas No 64742-29-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
873. Distillates (petroleum), chemically neutralised middle (Cas No 64742-30-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
874. Distillates (petroleum), clay-treated middle (Cas No 64742-38-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
875. Distillates (petroleum), hydrotreated middle (Cas No 64742-46-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
876. Gas oils (petroleum), hydrodesulfurised (Cas No 64742-79-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
877. Distillates (petroleum), hydrodesulfurised middle (Cas No 64742-80-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
878. Distillates (petroleum), catalytic reformer fractionator residue, high-boiling (Cas No 68477-29-2), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
879. Distillates (petroleum), catalytic reformer fractionator residue, intermediate-boiling (Cas No 68477-30-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
880. Distillates (petroleum), catalytic reformer fractionator residue, low-boiling (Cas No 68477-31-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
881. Alkanes, C12-26-branched and linear (Cas No 90622-53-0), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
882. Distillates (petroleum), highly refined middle (Cas No 90640-93-0), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
883. Distillates (petroleum), catalytic reformer, heavy arom. conc. Cas No 91995-34-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
884. Gas oils, paraffinic (Cas No 93924-33-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
885. Naphtha (petroleum), solvent-refined hydrodesulfurised heavy (Cas No 97488-96-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
886. Hydrocarbons, C16-20, hydrotreated middle distillate, distn. Lights (Cas No 97675- 85-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
887. Hydrocarbons, C12-20, hydrotreated paraffinic, distn. lights (Cas No 97675-86-0), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
888. Hydrocarbons, C11-17, solvent-extd. light naphthenic (Cas No 97722-08-2), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
889. Gas oils, hydrotreated (Cas No 97862-78-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
890. Distillates (petroleum), carbon-treated light paraffinic (Cas No 100683-97-4), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
891. Distillates (petroleum), intermediate paraffinic, carbon-treated (Cas No 100683-98-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
892. Distillates (petroleum), intermediate paraffinic, clay-treated (Cas No 100683-99-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
893. Lubricating greases (Cas No 74869-21-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
894. Slack wax (petroleum) (Cas No 64742-61-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
895. Slack wax (petroleum), acid-treated (Cas No 90669-77-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
896. Slack wax (petroleum), clay-treated (Cas No 90669-78-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
897. Slack wax (petroleum), hydrotreated (Cas No 92062-09-4), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
898. Slack wax (petroleum), low-melting (Cas No 92062-10-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
899. Slack wax (petroleum), low-melting, hydrotreated (Cas No 92062-11-8), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
900. Slack wax (petroleum), low-melting, carbon-treated (Cas No 97863-04-2), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
901. Slack wax (petroleum), low-melting, clay-treated (Cas No 97863-05-3), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
902. Slack wax (petroleum), low-melting, silicic acid-treated (Cas No 97863-06-4), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
903. Slack wax (petroleum), carbon-treated (Cas No 100684-49-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
904. Petrolatum (Cas No 8009-03-8), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
905. Petrolatum (petroleum), oxidised (Cas No 64743-01-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
906. Petrolatum (petroleum), alumina-treated (Cas No 85029-74-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
907. Petrolatum (petroleum), hydrotreated (Cas No 92045-77-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
908. Petrolatum (petroleum), carbon-treated (Cas No 97862-97-0), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
909. Petrolatum (petroleum), silicic acid-treated (Cas No 97862-98-1), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
910. Petrolatum (petroleum), clay-treated (Cas No 100684-33-1), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
911. Distillates (petroleum), light catalytic cracked (Cas No 64741-59-9)
912. Distillates (petroleum), intermediate catalytic cracked (Cas No 64741-60-2)
913. Distillates (petroleum), light thermal cracked (Cas No 64741-82-8)
914. Distillates (petroleum), hydrodesulfurised light catalytic cracked (Cas No 68333-25-5)
915. Distillates (petroleum), light steam-cracked naphtha (Cas No 68475-80-9)
916. Distillates (petroleum), cracked steam-cracked petroleum distillates (Cas No 68477-38-3)
917. Gas oils (petroleum), steam-cracked (Cas No 68527-18-4)
918. Distillates (petroleum), hydrodesulfurised thermal cracked middle (Cas No 85116-53-6)
919. Gas oils (petroleum), thermal-cracked, hydrodesulfurised (Cas No 92045-29-9)
920. Residues (petroleum), hydrogenated steam-cracked naphtha (Cas No 92062-00-5)
921. Residues (petroleum), steam-cracked naphtha distn. (Cas No 92062-04-9)
922. Distillates (petroleum), light catalytic cracked, thermally degraded (Cas No 92201-60-0)
923. Residues (petroleum), steam-cracked heat-soaked naphtha (Cas No 93763-85-0)
924. Gas oils (petroleum), light vacuum, thermal-cracked hydrodesulfurised (Cas No 97926-59-5)
925. Distillates (petroleum), hydrodesulfurised middle coker (Cas No 101316-59-0)
926. Distillates (petroleum), heavy steam-cracked (Cas No 101631-14-5)
927. Residues (petroleum), atm. Tower (Cas No 64741-45-3)
928. Gas oils (petroleum), heavy vacuum (Cas No 64741-57-7)
929. Distillates (petroleum), heavy catalytic cracked (Cas No 64741-61-3)
930. Clarified oils (petroleum), catalytic cracked (Cas No 64741-62-4)
931. Residues (petroleum), catalytic reformer fractionator (Cas No 64741-67-9)
932. Residues (petroleum), hydrocracked (Cas No 64741-75-9)
933. Residues (petroleum), thermal cracked (Cas No 64741-80-6)
934. Distillates (petroleum), heavy thermal cracked (Cas No 64741-81-7)
935. Gas oils (petroleum), hydrotreated vacuum (Cas No 64742-59-2)
936. Residues (petroleum), hydrodesulfurised atmospheric tower (Cas No 64742-78-5)
937. Gas oils (petroleum), hydrodesulfurised heavy vacuum (Cas No 64742-86-5)
938. Residues (petroleum), steam-cracked (Cas No 64742-90-1)
939. Residues (petroleum), atmospheric (Cas No 68333-22-2)
940. Clarified oils (petroleum), hydrodesulfurised catalytic cracked (Cas No 68333-26-6)
941. Distillates (petroleum), hydrodesulfurised intermediate catalytic cracked (Cas No 68333-27-7)
942. Distillates (petroleum), hydrodesulfurised heavy catalytic cracked (Cas No 68333-28-8)
943. Fuel oil, residues-straight-run gas oils, high-sulfur (Cas No 68476-32-4)
944. Fuel oil, residual (Cas No 68476-33-5)
945. Residues (petroleum), catalytic reformer fractionator residue distn. (Cas No 68478-13-7)
946. Residues (petroleum), heavy coker gas oil and vacuum gas oil (Cas No 68478-17-1)
947. Residues (petroleum), heavy coker and light vacuum (Cas No 68512-61-8)
948. Residues (petroleum), light vacuum (Cas No 68512-62-9)
949. Residues (petroleum), steam-cracked light (Cas No 68513-69-9)
950. Fuel oil, No 6 (Cas No 68553-00-4)
951. Residues (petroleum), topping plant, low-sulfur (Cas No 68607-30-7)
952. Gas oils (petroleum), heavy atmospheric (Cas No 68783-08-4)
953. Residues (petroleum), coker scrubber, condensed-ring-arom.-contg (Cas No 68783-13-1)
954. Distillates (petroleum), petroleum residues vacuum (Cas No 68955-27-1)
955. Residues (petroleum), steam-cracked, resinous (Cas No 68955-36-2)
956. Distillates (petroleum), intermediate vacuum (Cas No 70592-76-6)
957. Distillates (petroleum), light vacuum (Cas No 70592-77-7)
958. Distillates (petroleum), vacuum (Cas No 70592-78-8)
959. Gas oils (petroleum), hydrodesulfurised coker heavy vacuum (Cas No 85117-03-9)
960. Residues (petroleum), steam-cracked, distillates (Cas No 90669-75-3)
961. Residues (petroleum), vacuum, light (Cas No 90669-76-4)
962. Fuel oil, heavy, high-sulfur (Cas No 92045-14-2)
963. Residues (petroleum), catalytic cracking (Cas No 92061-97-7)
964. Distillates (petroleum), intermediate catalytic cracked, thermally degraded (Cas No 92201-59-7)
965. Residual oils (petroleum) (Cas No 93821-66-0)
966. Residues, steam cracked, thermally treated (Cas No 98219-64-8)
967. Distillates (petroleum), hydrodesulfurised full-range middle (Cas No 101316-57-8)
968. Distillates (petroleum), light paraffinic (Cas No 64741-50-0)
969. Distillates (petroleum), heavy paraffinic (Cas No 64741-51-1)
970. Distillates (petroleum), light naphthenic (Cas No 64741-52-2)
971. Distillates (petroleum), heavy naphthenic (Cas No 64741-53-3)
972. Distillates (petroleum), acid-treated heavy naphthenic (Cas No 64742-18-3)
973. Distillates (petroleum), acid-treated light naphthenic (Cas No 64742-19-4)
974. Distillates (petroleum), acid-treated heavy paraffinic (Cas No 64742-20-7)
975. Distillates (petroleum), acid-treated light paraffinic (Cas No 64742-21-8)
976. Distillates (petroleum), chemically neutralised heavy paraffinic (Cas No 64742-27-4)
977. Distillates (petroleum), chemically neutralised light paraffinic (Cas No 64742-28-5)
978. Distillates (petroleum), chemically neutralised heavy naphthenic (Cas No 64742-34-3)
979. Distillates (petroleum), chemically neutralised light naphthenic (Cas No 64742-35-4)
980. Extracts (petroleum), light naphthenic distillate solvent (Cas No 64742-03-6)
981. Extracts (petroleum), heavy paraffinic distillate solvent (Cas No 64742-04-7)
982. Extracts (petroleum), light paraffinic distillate solvent (Cas No 64742-05-8)
983. Extracts (petroleum), heavy naphthenic distillate solvent (Cas No 64742-11-6)
984. Extracts (petroleum), light vacuum gas oil solvent (Cas No 91995-78-7)
985. Hydrocarbons, C26-55, arom. Rich (Cas No 97722-04-8)
986. Disodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)] bis(4-aminonaphthalene-1- sulphonate) (Cas No 573-58-0)
987. Disodium 4-amino-3-[[4′-[(2,4-diaminophenyl)azo] [1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (Cas No 1937-37-7)
988. Tetrasodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[5-amino-4- hydroxynaphthalene-2,7-disulphonate] (Cas No 2602-46-2)
989. 4-o-Tolylazo-o-toluidine (Cas No 97-56-3)
990. 4-Aminoazobenzene (Cas No 60-09-3)
991. Disodium[5-[[4′-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulphophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]salicylato(4-)]cuprate(2-) (Cas No 16071-86-6)
992. Resorcinol diglycidyl ether (Cas No 101-90-6)
993. 1,3-Diphenylguanidine (Cas No 102-06-7)
994. Heptachlor-epoxide (Cas No 1024-57-3)
995. 4-Nitrosophenol (Cas No 104-91-6)
996. Carbendazim (Cas No 10605-21-7)
997. Allyl glycidyl ether (Cas No 106-92-3)
998. Chloroacetaldehyde (Cas No 107-20-0)
999. Hexane (Cas No 110-54-3)
1000. 2-(2-Methoxyethoxy)ethanol (Cas No 111-77-3)
1001. (+/–)-2-(2,4-Dichlorophenyl)-3-(1H-1,2,4-triazol-1-yl)propyl-1,1,2,2-tetrafluoroethylether (Cas No 112281-77-3)
1002. 4-[4-(1,3-Dihydroxyprop-2-yl)phenylamino]-1,8-dihydroxy-5-nitroanthraquinone (Cas No 114565-66-1)
1003. 5,6,12,13-Tetrachloroanthra(2,1,9-def:6,5,10-d’e’f’)diisoquinoline-1,3,8,10(2H,9H)-tetrone (Cas No 115662-06-1)
1004. tris(2-Chloroethyl) phosphate (Cas No 115-96-8)
1005. 4′-Ethoxy-2-benzimidazoleanilide (Cas No 120187-29-3)
1006. Nickel dihydroxide (Cas No 12054-48-7)
1007. N,N-Dimethylaniline (Cas No 121-69-7)
1008. Simazine (Cas No 122-34-9)
1009. Bis(cyclopentadienyl)-bis(2,6-difluoro-3-(pyrrol-1-yl)-phenyl)titanium (Cas No 125051-32-3)
1010. N,N,N′,N′-Tetraglycidyl-4,4′-diamino-3,3′-diethyldiphenylmethane (Cas No 130728-76-6)
1011. Divanadium pentaoxide (Cas No 1314-62-1)
1012. Alkali salts of pentachlorophenol (Cas Nos 131-52-2 and 7778-73-6)
1013. Phosphamidon (Cas No 13171-21-6)
1014. N-(Trichloromethylthio)phthalimide (Cas No 133-07-3)
1015. N-2-Naphthylaniline (Cas No 135-88-6)
1016. Ziram (Cas No 137-30-4)
1017. 1-Bromo-3,4,5-trifluorobenzene (Cas No 138526-69-9)
1018. Propazine (Cas No 139-40-2)
1019. 3-(4-Chlorophenyl)-1,1-dimethyluronium trichloroacetate; monuron-TCA (Cas No 140-41-0)
1020. Isoxaflutole (Cas No 141112-29-0)
1021. Kresoxim-methyl (Cas No 143390-89-0)
1022. Chlordecone (Cas No 143-50-0)
1023. 9-Vinylcarbazole (Cas No 1484-13-5)
1024. 2-Ethylhexanoic acid (Cas No 149-57-5)
1025. Monuron (Cas No 150-68-5)
1026. Morpholine-4-carbonyl chloride (Cas No 15159-40-7)
1027. Daminozide (Cas No 1596-84-5)
1028. Alachlor (Cas No 15972-60-8)
1029. UVCB condensation product of: tetrakis-hydroxymethylphosphonium chloride, urea and distilled hydrogenated C16-18 tallow alkylamine (Cas No 166242-53-1)
1030. Ioxynil (Cas No 1689-83-4)
1031. 3,5-Dibromo-4-hydroxybenzonitrile (Cas No 1689-84-5)
1032. 2,6-Dibromo-4-cyanophenyl octanoate (Cas No 1689-99-2)
1033. [4-[[4-(Dimethylamino)phenyl][4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt (Cas No 1694-09-3)
1034. 5-Chloro-1,3-dihydro-2H-indol-2-one (Cas No 17630-75-0)
1035. Benomyl (Cas No 17804-35-2)
1036. Chlorothalonil (Cas No 1897-45-6)
1037. N′-(4-Chloro-o-tolyl)-N,N-dimethylformamidine monohydrochloride (Cas No 19750-95-9)
1038. 4,4′-Methylenebis(2-ethylaniline) (Cas No 19900-65-3)
1039. Valinamide (Cas No 20108-78-5)
1040. [(p-Tolyloxy)methyl]oxirane (Cas No 2186-24-5)
1041. [(m-Tolyloxy)methyl]oxirane (Cas No 2186-25-6)
1042. 2,3-Epoxypropyl o-tolyl ether (Cas No 2210-79-9)
1043. [(Tolyloxy)methyl]oxirane, cresyl glycidyl ether (Cas No 26447-14-3)
1044. Di-allate (Cas No 2303-16-4)
1045. Benzyl 2,4-dibromobutanoate (Cas No 23085-60-1)
1046. Trifluoroiodomethane (Cas No 2314-97-8)
1047. Thiophanate-methyl (Cas No 23564-05-8)
1048. Dodecachloropentacyclo[5.2.1.02,6.03,9.05,8]decane (Cas No 2385-85-5)
1049. Propyzamide (Cas No 23950-58-5)
1050. Butyl glycidyl ether (Cas No 2426-08-6)
1051. 2,3,4-Trichlorobut-1-ene (Cas No 2431-50-7)
1052. Chinomethionate (Cas No 2439-01-2)
1053. (R)-α-Phenylethylammonium (-)-(1R,2S)-(1,2-epoxypropyl)phosphonate monohydrate (Cas No 25383-07-7)
1054. 5-Ethoxy-3-trichloromethyl-1,2,4-thiadiazole (Cas No 2593-15-9)
1055. Disperse Yellow 3 (Cas No 2832-40-8)
1056. 1,2,4-Triazole (Cas No 288-88-0)
1057. Aldrin (Cas No 309-00-2)
1058. Diuron (Cas No 330-54-1)
1059. Linuron (Cas No 330-55-2)
1060. Nickel carbonate (Cas No 3333-67-3)
1061. 3-(4-Isopropylphenyl)-1,1-dimethylurea (Cas No 34123-59-6)
1062. Iprodione (Cas No 36734-19-7)
1063. 4-Cyano-2,6-diiodophenyl octanoate (Cas No 3861-47-0)
1064. 5-(2,4-Dioxo-1,2,3,4-tetrahydropyrimidine)-3-fluro-2-hydroxymethylterahydrofuran (Cas No 41107-56-6)
1065. Crotonaldehyde (Cas No 4170-30-3)
1066. Hexahydrocyclopenta(c)pyrrole-1-(1H)-ammonium N-ethoxycarbonyl-N-(p-olylsulfonyl)azanide (EC No 418-350-1)
1067. 4,4′-Carbonimidoylbis[N,N-dimethylaniline] (Cas No 492-80-8)
1068. DNOC (Cas No 534-52-1)
1069. Toluidinium chloride (Cas No 540-23-8)
1070. Toluidine sulphate (1:1) (Cas No 540-25-0)
1071. 2-(4-tert-Butylphenyl)ethanol (Cas No 5406-86-0)
1072. Fenthion (Cas No 55-38-9)
1073. Chlordane, pur (Cas No 57-74-9)
1074. Hexan-2-one (Cas No 591-78-6)
1075. Fenarimol (Cas No 60168-88-9)
1076. Acetamide (Cas No 60-35-5)
1077. N-cyclohexyl-N-methoxy-2,5-dimethyl-3-furamide (Cas No 60568-05-0)
1078. Dieldrin (Cas No 60-57-1)
1079. 4,4′- Isobutylethylidenediphenol (Cas No 6807-17-6)
1080. Chlordimeform (Cas No 6164-98-3)
1081. Amitrole (Cas No 61-82-5)
1082. Carbaryl (Cas No 63-25-2)
1083. Distillates (petroleum), light hydrocracked . (Cas No 64741-77-1)
1084. 1-Ethyl-1-methylmorpholinium bromide (Cas No 65756-41-4)
1085. (3-Chlorophenyl)-(4-methoxy-3-nitrophenyl)methanone (Cas No 66938-41-8)
1086. Fuels, diesel (Cas No 68334-30-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen
1087. Fuel oil, no. 2 (Cas No 68476-30-2)
1088. Fuel oil, no. 4 (Cas No 68476-31-3)
1089. Fuels, diesel, no. 2 (Cas No 68476-34-6)
1090. 2,2-Dibromo-2-nitroethanol (Cas No 69094-18-4)
1091. 1-Ethyl-1-methylpyrrolidinium bromide (Cas No 69227-51-6)
1092. Monocrotophos (Cas No 6923-22-4)
1093. Nickel (Cas No 7440-02-0)
1094. Bromomethane (Cas No 74-83-9)
1095. Chloromethane (Cas No 74-87-3)
1096. Iodomethane (Cas No 74-88-4)
1097. Bromoethane (Cas No 74-96-4)
1098. Heptachlor (Cas No 76-44-8)
1099. Fentin hydroxide (Cas No 76-87-9)
1100. Nickel sulphate (Cas No 7786-81-4)
1101. 3,5,5-Trimethylcyclohex-2-enone (Cas No 78-59-1)
1102. 2,3-Dichloropropene (Cas No 78-88-6)
1103. Fluazifop-P-butyl (Cas No 79241-46-6)
1104. (S)-2,3-Dihydro-1H-indole-carboxylic acid (Cas No 79815-20-6)
1105. Toxaphene (Cas No 8001-35-2)
1106. (4-Hydrazinophenyl)-N-methylmethanesulfonamide hydrochloride (Cas No 81880-96-8)
1107. ►C8 C.I Solvent yellow 14 (CAS No 842-07-9) ◄
1108. Chlozolinate (Cas No 84332-86-5)
1109. Alkanes, C10-13, chloro (Cas No 85535-84-8)
1110. Pentachlorophenol (Cas No 87-86-5)
1111. 2,4,6-Trichlorophenol (Cas No 88-06-2)
1112. Diethylcarbamoyl-chloride (Cas No 88-10-8)
1113. 1-Vinyl-2-pyrrolidone (Cas No 88-12-0)
1114. Myclobutanil; 2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile (Cas No 88671-89-0)
1115. Fentin acetate (Cas No 900-95-8)
1116. Biphenyl-2-ylamine (Cas No 90-41-5)
1117. Trans-4-cyclohexyl-L-proline monohydro-chloride (Cas No 90657-55-9)
1118. 2-Methyl-m-phenylene diisocyanate (Cas No 91-08-7)
1119. 4-Methyl-m-phenylene diisocyanate (Cas No 584-84-9)
1120. m-Tolylidene diisocyanate (Cas No 26471-62-5)
1121. Fuels, jet aircraft, coal solvent extn., hydrocracked hydrogenated (Cas No 94114-58-6)
1122. Fuels, diesel, coal solvent extn., hydrocracked hydrogenated (Cas No 94114-59-7)
1123. Pitch (Cas No 61789-60-4), if it contains > 0,005 % w/w benzo[a]pyrene
1124. 2-Butanone oxime (Cas No 96-29-7)
1125. Hydrocarbons, C16-20, solvent-dewaxed hydrocracked paraffinic distn. Residue (Cas No 97675-88-2)
1126. α,α-Dichlorotoluene (Cas No 98-87-3)
1127. ►C8 Mineral wool, with the exception of those specified elsewhere in this Annex; [Man-made vitreous (silicate)fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O + K2O + CaO + MgO + BaO) content greater than 18 % by weight] ◄
1128. ►C8 Reaction product of acetophenone, formaldehyde, cyclohexylamine, methanol and acetic acid (EC No 406-230-1) ◄
1129. Salts of 4,4′-carbonimidoylbis[N,N-dimethylaniline]
1130. 1,2,3,4,5,6-Hexachlorcyclohexanes with the exception of those specified elsewhere in this Annex
1131. ►C8 Trisodium bis(7-acetamido-2-(4-nitro-2-oxidophenylazo)-3-sulfonato-1-naphtholato)chromate(1-) (EC No 400-810-8) ◄
1132. ►C8 A mixture of: 4-allyl-2,6-bis(2,3-epoxypropyl)phenol, 4-allyl-6-(3-(6-(3-(6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)-phenoxy)2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)-phenoxy-2-hydroxypropyl-2-(2,3-epoxypropyl)phenol, 4-allyl-6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2- hydroxypropyl)-2-(2,3-epoxypropyl)phenoxy)phenol and 4-allyl-6-(3-(6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)-phenoxy)-2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)phenoxy)2-hydroxypropyl)-2-(2,3-epoxypropyl)phenol (EC No 417-470-1) ◄
1133. Costus root oil (Saussurea lappa Clarke) (CAS No 8023-88-9), when used as a fragrance ingredient
1134. 7-Ethoxy-4-methylcoumarin (CAS No 87-05-8), when used as a fragrance ingredient
1135. Hexahydrocoumarin (CAS No 700-82-3), when used as a fragrance ingredient
1136. Peru balsam (INCI name: Myroxylon pereirae; CAS No 8007-00-9), when used as a fragrance ingredient
ANNEX III
PART 1
LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS AND CONDITIONS LAID DOWN
Reference number |
Substance |
Restrictions |
Conditions of use and warnings which must be printed on the label |
||
Field of application and/or use |
Maximum authorized concentration in the finished cosmetic product |
Other limitations and requirements |
|||
a |
b |
c |
d |
e |
f |
1a |
Boric acid, borates and tetraborates |
(a) Talc |
(a) 5 % (by mass/mass as boric acid) |
(a) 1. Not to be used in products for children under 3 years of age 2. Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (by mass/mass as boric acid) |
(a) 1. Not to be used for children under 3 years of age 2. Not to be used on peeling or irritated skin |
(b) Products for all hygiène |
(b) 0,1 % (by mass/mass as boric acid) |
(b) 1. Not to be used in products for children under 3 years of age |
(b) 1. Not to be swallowed 2. Not to be used for children under 3 years of age |
||
(c) Other products (excluding 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 boric acid) |
(c) 1. Not to be used for children under 3 years of age 2. Not to be used on peeling or irritated skin |
||
1b |
Tetraborates |
(a) 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 |
|||
2a |
Thioglycollic acid and its salts |
(a) Hair waving or straightening products: |
(a) (b) (c): The directions for use drawn up in the national or official language(s) must obligatorily incorporate the following sentences: — Avoid contact 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 children — For professional use only (b) and (c): — Contains thioglycolate — Follow the instructions — Keep out of reach of children |
|
— general use |
— 8 % ready for use — pH 7 to 9,5 |
||||
— professional use |
— 11 % ready for use — pH 7 to 9,5 |
||||
(b) Depilatories |
— 5 % ready for use — pH 7 to 12,7 |
||||
(c) Other hair-caire products which are removed after application |
— 2 % ready for use — pH to 9,5 The abovementioned percentages are calculated as thioglycollic acid |
||||
2b |
Thioglycollic acid esters |
Hair waving or straightening products: |
The directions for use drawn up in the national or official language(s) must obligatorily incorporate the following sentences: — May cause sensitization in the event of skin contact — Avoid contact 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 salts |
Hair care products |
5 % |
For professional use only |
|
4 |
Ammonia |
6 % calculated as NH3 |
Above 2 %: contains ammonia |
||
5 |
Tosylchloramide sodium (*) |
0·2 % |
|||
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 |
►M34 m- and p-Phenylenediamines, their N-substituted derivatives and their salts; N-substituted derivatives of o-Phenylenediamines (5), with the exception of those derivatives listed elsewhere in this Annex ◄ |
Oxidizing colouring agents for hair dyeing |
6 % 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 ◄ ►M22 Wear suitable gloves. ◄ |
||||
9 |
►M5 Methylphenylenediamines, their N-substituted derivatives and their salts (1) with the exception of substance No 364 in Annex II ◄ |
Oxidizing colouring agents for hair dyeing |
10 % 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 ◄ ►M22 Wear suitable gloves. ◄ |
||||
10 |
Diaminophenols (1) |
Oxidizing colouring agents for hair dyeing |
10 % 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 ◄ ►M22 Wear suitable gloves. ◄ |
||||
11 |
Dichlorophen (*) |
0,5 % |
Contains dichlorophen |
||
12 |
Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide |
(a) Hair-caire preparations |
12 % of H2O2 (40 volumes), present or released |
►M22 (a): Wear suitable gloves ◄ |
|
(b) Skin-care preparations |
4 % of H2O2, present or released |
(a) (b) (c): Contains hydrogen peroxide. |
|||
(c) Nail hardening preparations |
2 % of H2O2, present or released |
Avoid contact with eyes. Rinse immediately if product comes into contact with them |
|||
(d) Oral hygiene products |
0,1 % of H2O2, present or released |
||||
13 |
Formaldehyde |
Nail hardeners |
5 % calculated as formaldehyde |
Protect cuticles with grease or oil. Contains formaldehyde (2). |
|
14 |
Hydroquinone (3) |
(a) Oxidising colouring agent for hair-dying: |
0,3 % |
(a) 1. — Do not use to dye eyelashes or eyebrows |
|
1. General use |
— 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 |
||||
(b) Artificial nail systems |
0,02 % (after mixing for use) |
Professional use only |
(b) — For professional use only — Avoid skin contact — Read directions for use carefully |
||
15a |
Potassium or sodium hydroxide |
(a) Nail cuticle 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 |
||||
15b |
Lithium hydroxide |
(a) Hair straighteners |
(a) |
(a) |
|
1. General use |
1. 2 % (6) by weight |
1. Contains alkali Avoid contact with eyes Can cause blindness Keep out of reach of children |
|||
2. Professional use |
2. 4,5 % (6) by weight |
2. For professional use only Avoid contact with eyes Can cause blindness |
|||
(b) pH ajuster — for depilatories |
(b) pH value not to exceed pH 12,7 |
(b) Contains alkali Keep out of reach of children Avoid contact with eyes |
|||
(c) Other uses — as pH adjuster (for rinse-off products only) |
(c) pH value not to exceed pH 11 |
||||
15c |
Calcium hydroxide |
Hair straighteners containing two components: calcium hydroxide and a guanidine salt |
(a) 7 % by weight of calcium hydroxide |
(a) Contains alkali Avoid contact with eyes Keep out of reach of children Can cause blindness |
|
(b) pH ajuster — for depilatories |
(b) pH value not to exceed pH 12,7 |
(b) Contains alkali Keep out of reach of children Avoid contact with eyes |
|||
(c) Other uses (e.g. pH adjuster, processing aid) |
(c) pH value not to exceed pH 11 |
||||
16 |
1-Naphthol (CAS No 90-15-3) and its salts |
Oxidising colouring agents for hair dyening |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
Can cause allergie reaction |
17 |
Sodium nitrite |
Rust inhibitor |
0,2 % |
Do not use with secondary and/or tertiary amines or other substances forming nitrosamines |
|
18 |
Nitromethane |
Rust inhibitor |
0,3 % |
||
19 |
Phenol and its alkali salts |
Soaps and shampoos |
1 % calculated as phenol |
Contains phenol |
|
►M20 ◄ |
|||||
21 |
Quinine and its salts |
(a) Shampoos |
(a) 0,5 % calculated as quinine base |
||
(b) Hair lotions |
(b) 0,2 % calculated as quinine base |
||||
22 |
Resorcinol (3) |
(a) Oxidizing colouring agent for hair dyeing |
(a) 5 % |
(a) | |
1. general use |
1. Contains resorcinol. Rinse hair well after application. Do not use to dye eyelashes or eyebrows. Rinse eyes immediately if product comes into contact 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 zinc salts with the exception of zinc 4-hydroxy-benzenesulphonate and zinc pyrithione |
1 % calculated as zinc |
|||
25 |
Zinc 4-hydroxybenzene sulphonate |
Deodorants, antiperspirants and astringent lotions |
6 % calculated as % of anhydrous substance |
Avoid 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 monofluorophosphate |
|
27 |
Sodium monofluorophosphate |
Ditto |
0,15 % Ditto |
Contains sodium monofluorophosphate |
|
28 |
Potassium monofluorophosphate |
Ditto |
0,15 % Ditto |
Contains potassium monofluorophosphate |
|
29 |
Calcium monofluorophosphate |
Ditto |
0,15 % Ditto |
Contains calcium monofluorophosphate |
|
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 fluoride |
|
33 |
Ammonium fluoride |
Ditto |
0,15 % Ditto |
Contains ammonium fluoride |
|
34 |
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-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride |
Ditto |
0,15 % Ditto |
Contains 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride |
|
38 |
NN'N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride |
Ditto |
0,15 % Ditto |
Contains NN'N'-tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride |
|
39 |
Octadecenyl-ammonium fluoride |
Ditto |
0,15 % Ditto |
Contains octadecenyl-ammonium fluoride |
|
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) magnesium fluorosilicate |
|
44 |
1,3-Bis (hydroxymethyl)imidazolidine-2-thione |
(a) Hair-care preparations (b) Nail-care preparations |
(a) Up to 2 % (b) Up to 2 % |
(a) Prohibited in aerosol dispensers (sprays) (b) The pH of the product as applied must be less than 4 |
Contains 1,3-bis (hydroxymethyl) immidazolidine-2-thione |
45 |
Benzyl alcohol |
Solvents, perfumes and flavourings |
|||
46 |
6-methylcoumarin |
Oral hygiene products |
0,003 % |
||
47 |
Nicomethanol hydrofluoride |
Oral hygiene products |
0,15 % calculated as F When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 % |
Contains nicomethanol hydrofluoride |
|
48 |
Silver nitrate |
Solely for products intended for colouring eyelashes and eyebrows |
4 % |
— Contains silver nitrate — Rinse the eyes immediately if product comes into contact with them |
|
49 |
Selenium disulphide |
Antidandruff shampoos |
1 % |
— Contains selenium disulphide — Avoid contact with eyes or damaged skin |
|
50 |
Aluminium zirconium chloride hydroxyde complexes AlxZr(OH)yClz and the aluminium zirconium chloride sydroxide glycine complexes |
Antiperspirants |
20 % as anhydrous aluminium zirconium chloride hydroxide 5,4 % as zirconium |
1. 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-ol and bis (8-hydroxy-quinolium) sulphate |
Stabilizer for hydrogen peroxide in rinse-off hair-care preparations |
0,3 % calculated as base |
||
Stabilizer for hydrogen peroxide in non-rinse-off hair-care preparations |
0,03 % calculated as base |
||||
52 |
Methanol |
Denaturant for ethanol and isopropyl alcohol |
5 % calculated as a % ethanol and isopropyl acohol |
||
53 |
Etidronic acid and its salts (1-hydroxyethylidene-di-phosphonic acid and its salts) |
(a) Hair-care |
1,5 % expressed as etidronic acid |
►M15 ◄ |
|
(b) Soap |
0,2 % expressed as etidronic acid |
||||
54 |
1-Phenoxy-propan-2-ol |
— Rinse-off products only |
2 % |
As a preservative, see Annex VI, Part 1, No 43 |
|
— Prohibited in oral hygiene products |
|||||
▼M43 ————— |
|||||
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 strontium content must not exceed 3,5 % |
Contains strontium chloride. Frequent use by children is not advisable |
|
(b) Shampoo and face care products |
2,1 %, calculated as strontium. When mixed with other permitted strontium products the total strontium 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 strontium content must not exceed 3,5 % |
Contains strontium acetate. Frequent use by children is not advisable |
|
59 |
Talc: Hydrated magnesium silicate |
(a) Powdery products intended to be used for children under three years of age (b) other products |
►C4 (a) Keep powder away from children's nose and mouth ◄ |
||
60 |
Fatty acid dialkylamides and dialkanolamides |
Maximum secondary amine content: 0,5 % |
— Do not use with nitrosating systems — Maximum secondary amine content: 5 % (applies to raw materials) — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers |
||
61 |
Monoalkylamines, monoalkanolamines and their salts |
Maximum secondary amine content: 0,5 % |
— Do not use with nitrosating systems — Minimum purity: 99 % — Maximum secondary amine content: 0,5 % (applies to raw materials) — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers |
||
62 |
Trialkylamines, trialkanolamines and their salts |
(a) Non-rinse-off products (b) Other products |
(a) 2,5 % |
(a) (b) — Do not use with nitrosating systems — Minimum purity: 99 % — Maximum secondary amine content: 0,5 % (applies to raw materials) — Maximum nitrosamine content: 50 μg/kg — Keep in nitrite-free containers |
|
63 |
Strontium hydroxide |
pH-regulator in depilatory products |
3,5 % 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 use |
4,5 % calculated as strontium in the ready-for-use preparation |
All products must meet the hydrogen peroxide release requirements |
— 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 C14, or less must not exceed 0,1 % (as benzalkonium chloride) |
(a) Avoid contact with the eyes |
(b) Other products |
(b) 0,1 % (as benzalkonium chloride) |
(b) Avoid contact with the eyes |
|||
66 |
Polyacrylamides |
(a) Body-care leave-on products |
(a) Maximum residual acrylamide content 0,1 mg/kg |
||
(b) Other cosmetic products |
(b) Maximum residual acrylamide content 0,5 mg/kg |
||||
67 |
Amyl cinnamal (CAS No 122-40-7) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
68 |
Benzyl alcohol (CAS No 100-51-6) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
69 |
Cinnamyl alcohol (CAS No 104-54-1) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
70 |
Citral (CAS No 5392-40-5) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
71 |
Eugenol (CAS No 97-53-0) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
72 |
Hydroxy-citronellal (CAS No 107-75-5) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
73 |
Isoeugenol (CAS No 97-54-1) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
74 |
Amylcin namyl alcohol (CAS No 101-85-9) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
75 |
Benzyl salicylate (CAS No 118-58-1) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
76 |
Cinnamal (CAS No 104-55-2) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
77 |
Coumarin (CAS No 91-64-5) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
78 |
Geraniol (CAS No 106-24-1) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
79 |
Hydroxy-methylpentylcyclohexenecarboxaldehyde (CAS No 31906-04-4) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
80 |
Anisyl alcohol (CAS No 105-13-5) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
81 |
Benzyl cinnamate (CAS No 103-41-3) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
82 |
Farnesol (CAS No 4602-84-0) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
83 |
2-(4-tert-Butylbenzyl) propionaldehyde (CAS No 80-54-6) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
84 |
Linalool (CAS No 78-70-6) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
85 |
Benzyl benzoate (CAS No 120-51-4) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
86 |
Citronellol (CAS No 106-22-9) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
87 |
Hexyl cinnam-aldehyde (CAS No 101-86-0) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
88 |
d-Limonene (CAS No 5989-27-5) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
89 |
Methyl heptin carbonate (CAS No 111-12-6) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
90 |
3-Methyl-4-(2,6,6-tri-methyl-2-cyclohexen-1-yl)-3-buten-2-one (CAS No 127-51-5) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
91 |
Oak moss extract (CAS No 90028-68-5) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
92 |
Treemoss extract (CAS No 90028-67-4) |
The presence of the substance must be indicated in the list of ingredients referred to in Article 6(1)(g) when its concentration exceeds: — 0,001 % in leave-on products — 0,01 % in rinse-off products |
|||
93 |
2,4-Diamino-pyrimidine-3-oxide (CAS No 74638-76-9) |
Hair care formulations |
1,5 % |
||
94 |
Benzoyl peroxide |
Artificial nail systems |
0,7 % (after mixing) |
Professional use only |
— For professional use only — Avoid skin contact — Read directions for use carefully |
95 |
Hydroquinone methylether |
Artificial nail systems |
0,02 % (after mixing for use) |
Professional use only |
— For professional use only — Avoid skin contact — Read directions for use carefully |
96 |
Musk xylene (CAS No 81-15-2) |
All cosmetic products, with the exception of oral care products |
(a) 1,0 % in fine fragrance (b) 0,4 % in eau de toilette (c) 0,03 % in other products |
||
97 |
Musk ketone (CAS No 81-14-1) |
All cosmetic products, with the exception of oral care products |
(a) 1,4 % in fine fragrance (b) 0,56 % in eau de toilette (c) 0,042 % in other products |
||
(1) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not exceed 1. (2) Only if the concentration exceeds 0,05 %. (3) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorized for each of them does not exceed 2. (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. (5) These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1. (6) The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column d. |
►M14 Part 2 ◄
LIST OF SUBSTANCES PROVISIONALLY ALLOWED
Reference number |
Substance |
Restrictions |
Conditions of use and warnings which must be printed on the label |
Allowed until |
||
Field of application and/or use |
Maximum authorized concentration in the finished cosmetic product |
Other limitations and requirements |
||||
a |
b |
c |
d |
e |
f |
g |
1 |
Basic Blue 7 (CAS No 2390-60-5) |
Non-oxidising colouring agents for hair dyeing |
0,2 % |
Can cause allergic reaction |
►M46 31.08.2006 ◄ |
|
2 |
2-Amino-3-nitrophenol (CAS No 603-85-0) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
(a) (b) Can cause allergic reaction |
►M46 31.08.2006 ◄ |
(b) Non-oxidising colouring agents for hair dyeing |
(b) 3,0 % |
|||||
3 |
4-Amino-3-nitrophenol (CAS No 610-81-1) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
(a) (b) Can cause allergic reaction |
►M46 31.12.2006 ◄ |
(b) Non-oxidising colouring agents for hair dyeing |
(b) 3,0 % |
|||||
4 |
2,7-Naphthalenediol (CAS no 582-17-2) and its salts |
Oxidising colouring agents for hair dyeing |
1,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 % |
►M46 31.12.2006 ◄ |
|
5 |
m-Aminophenol (CAS no 591-27-5) and its salts |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
Can cause allergic reaction |
►M46 31.12.2006 ◄ |
6 |
2,6-Dihydroxy-3,4-dimethylpyridine (CAS No 84540-47-6) and its salts |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
Can cause allergic reaction |
►M46 31.12.2006 ◄ |
7 |
4-Hydroxypropylamino-3-nitrophenol (CAS No 92952-81-3) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 5,2 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 2,6 % |
(a) (b) Can cause allergic reaction |
►M46 31.12.2006 ◄ |
(b) Non-oxidising colouring agents for hair dyeing |
(b) 2,6 % |
|||||
8 |
6-Nitro-2,5-pyridinediamine (CAS No 69825-83-8) and its salts |
Non-oxidising colouring agent for hair dyeing |
3,0 % |
Can cause allergic reaction |
►M46 31.08.2006 ◄ |
|
9 |
HC Blue No 11 (CAS No 23920-15-2) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
(a) (b) Can cause allergic reaction |
►M46 31.12.2006 ◄ |
(b) Non-oxidising colouring agents for hair dyeing |
(b) 2,0 % |
|||||
10 |
Hydroxyethyl-2-nitro-p-toluidine (CAS No 100418-33-5) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
(a) (b) Can cause allergic reaction |
►M46 31.12.2006 ◄ |
(b) Non-oxidising colouring agents for hair dyeing |
(b) 1,0 % |
|||||
11 |
2-Hydroxyethylpicramic acid (CAS No 99610-72-7) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
(a) (b) Can cause allergic reaction |
►M46 31.12.2006 ◄ |
(b) Non-oxidising colouring agents for hair dyeing |
(b) 2,0 % |
|||||
12 |
p-Methylaminophenol (CAS No 150-75-4) and its salts |
Oxidising colouring agent for hair dyeing |
3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
Can cause allergic reaction |
►M46 31.12.2006 ◄ |
13 |
2,4-Diamino-5-methylphenoxyethanol (CAS No 141614-05-3) and its salts |
Oxidising colouring agent for hair dyeing |
3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
Can cause allergic reaction |
►M46 31.08.2006 ◄ |
14 |
HC Violet No 2 CAS No 104226-19-9) and its salts |
Non-oxidising colouring agent for hair dyeing |
2,0 % |
►M46 31.12.2006 ◄ |
||
15 |
Hydroxyethyl-2,6-dinitro-p-anisidine (CAS No 122252-11-3) and its salts |
Non-oxidising colouring agent for hair dyeing |
3,0 % |
Can cause allergic reaction |
►M46 31.08.2006 ◄ |
|
16 |
HC Blue No 12 (CAS No 104516-93-0) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 1,5 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,75 % |
(a) (b) Can cause allergic reaction |
►M46 31.12.2006 ◄ |
(b) Non-oxidising colouring agents for hair dyeing |
(b) 1,5 % |
|||||
17 |
►C6 2,4-Diamino-5 methyphenetol (CAS No 113715-25-6) and its salts ◄ |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
Can cause allergic reaction |
►M46 31.08.2006 ◄ |
18 |
1,3-Bis-(2,4-diaminophenoxy)propane (CAS No 81892-72-0) and its salts |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
Can cause allergic reaction |
►M46 31.12.2006 ◄ |
19 |
►C6 3-Amino-2,4-dichlorophenol (CAS No 61693-43-4) and its salts ◄ |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
Can cause allergic reaction |
►M46 31.12.2006 ◄ |
20 |
Phenyl methyl pyrazolone (CAS No 89-25-8) and its salts |
Oxidising colouring agents for hair dyeing |
0,5 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % |
►M46 31.12.2006 ◄ |
|
21 |
2-Methyl-5-hydroxyethylaminophenol (CAS No 55302-96-0) and its salts |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
Can cause allergic reaction |
►M46 31.12.2006 ◄ |
22 |
Hydroxybenzomorpholine (CAS No 26021-57-8) and its salts |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
Can cause allergic reaction |
►M46 31.12.2006 ◄ |
23 |
1,7-Naphthalenediol (CAS No 575-38-2) and its salts |
Oxidising colouring agents for hair dyeing |
1,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 % |
Can cause allergic reaction |
►M46 31.08.2006 ◄ |
24 |
HC Yellow No 10 (CAS No 109023-83-8) and its salts |
Non-oxidising colouring agents for hair dyeing |
0,2 % |
►M46 31.12.2006 ◄ |
||
25 |
2,6-Dimethoxy-3,5-pyridinediamine (CAS No 85679-78-3) and its salts |
Oxidising colouring agents for hair dyeing |
0,5 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % |
Can cause allergic reaction |
►M46 31.12.2006 ◄ |
26 |
HC Orange No 2 (CAS No 85765-48-6) and its salts |
Non-oxidising colouring agents for hair dyeing |
1,0 % |
►M46 31.12.2006 ◄ |
||
27 |
HC Violet No 1 (CAS No 82576-75-8) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 0,5 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % |
►M46 31.12.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 0,5 % |
|||||
28 |
3-Methylamino-4-nitro-phenoxyethanol (CAS No 59820-63-2) and its salts |
Non-oxidising colouring agents for hair dyeing |
1,0 % |
►M46 31.12.2006 ◄ |
||
29 |
2-Hydroxy-ethylamino-5-nitro-anisole (CAS No 66095-81-6) and its salts |
Non-oxidising colouring agents for hair dyeing |
1,0 % |
►M46 31.12.2006 ◄ |
||
30 |
2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine (CAS No 50610-28-1) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
►M46 31.08.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 1,0 % |
|||||
31 |
►C6 HC Red No 13 (CAS No 94158-13-1) and its salts ◄ |
(a) Oxidising colouring agents for hair dyeing |
(a) 2,5 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,25 % |
►M46 31.12.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 2,5 % |
|||||
32 |
1,5-Naphthalenediol (CAS No 83-56-7) and its salts |
Oxidising colouring agents for hair dyeing |
1,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 % |
►M46 31.12.2006 ◄ |
|
33 |
Hydroxypropyl bis (N-hydroxyethyl-p-phenylenediamine) (CAS No 128729-30-6) and its salts |
Oxidising colouring agents for hair dyeing |
3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
Can cause allergic reaction |
►M46 31.12.2006 ◄ |
34 |
o-Aminophenol (CAS No 95-55-6) and its salts |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
►M46 31.08.2006 ◄ |
|
35 |
4-Amino-2-hydroxytoluene (CAS No 2835-95-2) and its salts |
Oxidising colouring agents for hair dyeing |
3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
►M46 31.12.2006 ◄ |
|
36 |
►C6 2,4-Diaminophenoxyethanol (CAS No 66422-95-5) and its salts ◄ |
Oxidising colouring agents for hair dyeing |
4,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 2,0 % |
►M46 31.12.2006 ◄ |
|
37 |
2-Methylresorcinol (CAS No 608-25-3) and its salts |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
►M46 31.12.2006 ◄ |
|
38 |
4-Amino-m-cresol (CAS No 2835-99-6) and its salts |
Oxidising colouring agents for hair dyeing |
3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
►M46 31.12.2006 ◄ |
|
39 |
2-Amino-4-hydroxyethylaminoanisole (CAS No 83763-47-7) and its salts |
Oxidising colouring agents for hair dyeing |
3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
►M46 31.12.2006 ◄ |
|
40 |
3,4-Diamino-benzoicacid (CAS No 619-05-6) and its salts |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
►M46 31.08.2006 ◄ |
|
41 |
6-Amino-o-cresol (CAS No 17672-22-9) and its salts |
Oxidising colouring agents for hair dyeing |
3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
►M46 31.08.2006 ◄ |
|
42 |
2-Aminomethyl-p-aminophenol (CAS No 79352-72-0) and its salts |
Oxidising colouring agents for hair dyeing |
3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
►M46 31.08.2006 ◄ |
|
43 |
Hydroxyethylamino-methyl-p-aminophenol (CAS No 110952-46-0) and its salts |
Oxidising colouring agents for hair dyeing |
3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
►M46 31.08.2006 ◄ |
|
44 |
Hydroxyethyl-3,4-methylenedioxyaniline (CAS No 81329-90-0) and its salts |
Oxidising colouring agents for hair dyeing |
3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
►M46 31.12.2006 ◄ |
|
45 |
►C6 Acid Black 52 (CAS No 3618-58-4) and its salts ◄ |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
►M46 31.08.2006 ◄ |
|
46 |
2-Nitro-p-phenylenediamine (CAS No 5307-14-2) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 0,3 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,15 % |
►M46 31.08.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 0,3 % |
|||||
47 |
HC Blue No 2 (CAS No 33229-34-4) and its salts |
Non-oxidising colouring agents for hair dyeing |
2,8 % |
►M46 31.12.2006 ◄ |
||
48 |
3-Nitro-p-hydroxyethylaminophenol (CAS No 65235-31-6) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 6,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 3,0 % |
►M46 31.12.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 6,0 % |
|||||
49 |
4-Nitrophenyl aminoethylurea (CAS No 27080-42-8) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 0,5 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % |
►M46 31.12.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 0,5 % |
|||||
50 |
HC Red No 10 + HC Red No 11 (CAS No 95576-89-9 + 95576-92-4) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
►M46 31.12.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 1,0 % |
|||||
51 |
Yellow No 6 (CAS No 104333-00-8) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
►M46 31.08.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 1,0 % |
|||||
52 |
HC Yellow No 12 (CAS No 59320-13-7) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 1,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 % |
►M46 31.08.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 0,5 % |
|||||
53 |
►C6 HC Blue No 10 (CAS No 102767-27-1) and its salts ◄ |
Oxidising colouring agents for hair dyeing |
2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
►M46 31.08.2006 ◄ |
|
54 |
HC Blue No 9 (CAS No 114087-47-1) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
►M46 31.08.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 1,0 % |
|||||
55 |
2-Chloro-6-ethylamino-4-nitrophenol (CAS No 131657-78-8) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 3,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 % |
►M46 31.12.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 3,0 % |
|||||
56 |
2-Amino-6-chloro-4-nitrophenol (CAS No 6358-09-4) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 2,0 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 % |
►M46 31.12.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 2,0 % |
|||||
57 |
Basic Blue 26 (CAS No 2580-56-5) (CI 44045) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 0,5 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 % |
►M46 31.08.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 0,5 % |
|||||
58 |
Acid Red 33 (CAS No 3567-66-6) (CI 17200) and its salts |
Non-oxidising colouring agents for hair dyeing |
2,0 % |
►M46 31.12.2006 ◄ |
||
59 |
Ponceau SX (CAS No 4548-53-2) (CI 14700) and its salts |
Non-oxidising colouring agents for hair dyeing |
2,0 % |
►M46 31.08.2006 ◄ |
||
60 |
Basic Violet 14 (CAS No 632-99-5) (CI 42510) and its salts |
(a) Oxidising colouring agents for hair dyeing |
(a) 0,3 % |
In combination with hydrogen peroxide the maximum use concentration upon application is 0,15 % |
►M46 31.08.2006 ◄ |
|
(b) Non-oxidising colouring agents for hair dyeing |
(b) 0,3 % |
|||||
ANNEX IV
►M14 PART 1 ◄
LIST OF COLOURING AGENTS ALLOWED FOR USE IN COSMETIC PRODUCTS (1)
Field of application
Colour index number or denomination |
Colour |
Field of application |
Other limitations and requirements (2) |
|||
1 |
2 |
3 |
4 |
|||
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 |
||||
▼M45 ————— |
||||||
12370 |
Red |
X |
||||
12420 |
Red |
X |
||||
12480 |
Brown |
X |
||||
12490 |
Red |
X |
||||
12700 |
Yellow |
X |
►M15 ◄ |
|||
13015 |
Yellow |
X |
E 105 |
|||
►M13 ◄ |
||||||
14270 |
Orange |
X |
E 103 |
|||
14700 |
Red |
X |
||||
14720 |
Red |
X |
E 122 |
|||
14815 |
Red |
X |
E 125 |
|||
15510 (3) |
Orange |
X |
||||
15525 |
Red |
X |
||||
15580 |
Red |
X |
||||
►M18 ◄ |
||||||
15620 |
Red |
X |
||||
15630 (3) |
Red |
X |
3 % maximum concentration in the finished product |
|||
15800 |
Red |
X |
►M15 ◄ |
|||
15850 (3) |
Red |
X |
||||
15865 (3) |
Red |
X |
||||
15880 |
Red |
X |
||||
15980 |
Orange |
X |
E 111 |
|||
15985 (3) |
Yellow |
X |
E 110 |
|||
16035 |
Red |
X |
||||
16185 |
Red |
X |
E 123 |
|||
16230 |
Orange |
X |
||||
16255 (3) |
Red |
X |
E 124 |
|||
16290 |
Red |
X |
E 126 |
|||
Red |
X |
|||||
18050 |
Red |
X |
||||
18130 |
Red |
X |
||||
18690 |
Yellow |
X |
||||
18736 |
Red |
X |
||||
18820 |
Yellow |
X |
||||
18965 |
Yellow |
X |
||||
19140 (3) |
Yellow |
X |
E 102 |
|||
20040 |
Yellow |
X |
maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm |
|||
▼M45 ————— |
||||||
20470 |
Black |
X |
►M15 ◄ |
|||
21100 |
Yellow |
X |
maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm |
|||
21108 |
Yellow |
X |
ditto |
|||
21230 |
Yellow |
X |
||||
24790 |
Red |
X |
||||
26100 |
Red |
X |
Purity criteria: aniline ≤ 0,2 % 2-naphtol ≤ 0,2 % 4-aminoazobenzene ≤ 0,1 % 1-(phenylazo)-2-naphtol ≤ 3 % 1-[2-(phenylazo)phenylazo]-2-napthalenol ≤ 2 % |
|||
▼M45 ————— |
||||||
27755 |
Black |
X |
E 152 |
|||
28440 |
Black |
X |
E 151 |
|||
40215 |
Orange |
X |
||||
40800 |
Orange |
X |
||||
40820 |
Orange |
X |
E 160 e |
|||
40825 |
Orange |
X |
E 160 f |
|||
40850 |
Orange |
X |
E 161 g |
|||
42045 |
Blue |
►M17 X ◄ |
►M17 ◄ |
|||
42051 (3) |
Blue |
X |
E 131 |
|||
42053 |
Green |
X |
||||
42080 |
Blue |
X |
||||
42090 |
Blue |
X |
||||
42100 |
Green |
X |
||||
42170 |
Green |
X |
►M15 ◄ |
|||
42510 |
Violet |
X |
||||
42520 |
Violet |
X |
5 ppm maximum concentration in the finished product |
|||
►M17 ◄ |
||||||
42735 |
Blue |
X |
||||
44045 |
Blue |
►M17 X ◄ |
►M17 ◄ |
|||
44090 |
Green |
X |
E 142 |
|||
45100 |
Red |
X |
||||
►M18 ◄ |
||||||
►M18 ◄ |
||||||
45190 |
Violet |
X |
►M15 ◄ |
|||
45220 |
Red |
X |
||||
45350 |
Yellow |
X |
6 % maximum concentration in the finished product |
|||
45370 (3) |
Orange |
X |
not more than 1 % 2-(6-hdroxy-3-oxo-3H-xanthen-9-y1) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid |
|||
45380 (3) |
Red |
X |
ditto |
|||
45396 |
Orange |
X |
when used in lipstick, the colouring agent is allowed only in free acid form and in a maximum concentration of 1 % |
|||
45405 |
Red |
X |
not more than 1 % 2-(6-hydroxy-3-oxo-3Η xanthen-9-yl) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid |
|||
45410 (3) |
Red |
X |
ditto |
|||
45425 |
Red |
X |
not more than 1 % 2-(6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid and 3 % 2-(iodo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid |
|||
45430 (3) |
Red |
X |
E 127 ditto |
|||
47000 |
Yellow |
X |
►M15 ◄ |
|||
47005 |
Yellow |
X |
E 104 |
|||
50325 |
Violet |
X |
||||
50420 |
Black |
X |
||||
51319 |
Violet |
X |
||||
58000 |
Red |
X |
||||
59040 |
Green |
X |
||||
60724 |
Violet |
X |
||||
60725 |
Violet |
X |
||||
60730 |
Violet |
X |
||||
61565 |
Green |
X |
||||
61570 |
Green |
X |
||||
61585 |
Blue |
X |
||||
62045 |
Blue |
X |
||||
69800 |
Blue |
X |
E 130 |
|||
69825 |
Blue |
X |
||||
71105 |
Orange |
X |
||||
73000 |
Blue |
X |
||||
73015 |
Blue |
X |
E 132 |
|||
73360 |
Red |
X |
||||
73385 |
Violet |
X |
||||
73900 |
Violet |
X |
►M20 ◄ |
|||
73915 |
Red |
X |
||||
74100 |
Blue |
X |
||||
74160 |
Blue |
X |
||||
74180 |
Blue |
X |
►M20 ◄ |
|||
74260 |
Green |
X |
||||
75100 |
Yellow |
X |
||||
75120 |
Orange |
X |
E 160 b |
|||
75125 |
Yellow |
X |
E 160 d |
|||
75130 |
Orange |
X |
E 160 a |
|||
75135 |
Yellow |
X |
E 161 d |
|||
75170 |
White |
X |
||||
75300 |
Yellow |
X |
E 100 |
|||
75470 |
Red |
X |
E 120 |
|||
75810 |
Green |
X |
E 140 and E 141 |
|||
77000 |
White |
X |
E 173 |
|||
77002 |
White |
X |
||||
77004 |
White |
X |
||||
77007 |
Blue |
X |
||||
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 |
X |
||||
77745 |
Red |
X |
||||
77820 |
White |
X |
E 174 |
|||
77891 |
White |
X |
E 171 |
|||
77947 |
White |
X |
||||
Lactoflavin |
Yellow |
X |
E 101 |
|||
Caramel |
Brown |
X |
E 150 |
|||
Capsanthin, capsorubin |
Orange |
X |
E 160 c |
|||
Beetroot red |
Red |
X |
E 162 |
|||
Anthocyanins |
Red |
X |
E 163 |
|||
Aluminium, zinc, magnesium and calcium stearates |
White |
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 Article 8. 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. |
PART 2
LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR USE IN COSMETIC PRODUCTS (1)
Field of application
Colour index number or denomination |
Colour |
Field of application |
Other limitations and requirements (2) |
Authorization valid until |
|||
1 |
2 |
3 |
4 |
||||
►M13 ◄ |
|||||||
►M17 ◄ |
|||||||
►M20 ◄ |
|||||||
►M15 ◄ |
|||||||
►M17 ◄ |
|||||||
►M15 ◄ |
|||||||
►M20 ◄ |
|||||||
►M17 ◄ |
|||||||
►M15 ◄ |
|||||||
►M17 ◄ |
|||||||
►M13 ◄ |
|||||||
►M17 ◄ |
|||||||
►M15 ◄ |
|||||||
►M17 ◄ |
|||||||
►M13 ◄ |
|||||||
►M20 ◄ |
|||||||
►M15 ◄ |
|||||||
►M20 ◄ |
|||||||
►M15 ◄ |
|||||||
►M12 ◄ |
|||||||
►M13 ◄ |
|||||||
►M20 ◄ |
|||||||
(1) Lakes or salts of these colouring agents using substances not prohibited under Annex II or not excluded under Annex V from the scope of this Directive are equally allowed. (2) Colouring agents whose number is preceded by the letter ‘E’ in accordance with the EEC Directive of 1962 concerning foodstuffs and colouring matters must fulfil the purity requirements laid down in those Directives. They continue to be subject to the general criteria set out in Annex III to the 1962 Directive concerning colouring matters where the letter ‘E’ has been deleted therefrom. 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. |
ANNEX V
LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE DIRECTIVE
▼M17 —————
▼M12 —————
▼M17 —————
▼M5 —————
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) in Annex IV, Part 1.
▼M17 —————
▼M18 —————
▼M17 —————
▼M10 —————
ANNEX VI
LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN
PREAMBLE
1. Preservatives are substances which may be added to cosmetic products for the primary purpose of inhibiting the development of micro-organisms in such products.
2. The substances marked with the symbol (*) may also be added to cosmetic 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 %.
PART 1
LIST OF PRESERVATIVES ALLOWED
Reference number |
Substance |
Maximum authorized concentration |
Limitations and requirements |
Conditions of use and warnings which must be printed on the label |
a |
b |
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 shampoos |
Not to be used for children under three years of age (1) |
4 |
Sorbic acid (hexa-2,4-dienoic acid) and its salts (*) |
0,6 % (acid) |
||
5 |
Formaldehyde paraformaldehyde |
0,2 % (except for products for oral hygiene) 0,1 % (products for oral hygiene) expressed as free formaldehyde |
Prohibited in aerosol dispensers (sprays) |
|
►M12 ◄ |
||||
7 |
Biphenyl-2-ol (o-phenylphenol) and its salts (*) |
0,2 % expressed as the phenol |
||
8 |
Pyrithione zinc (INN) (*) |
0,5 % |
Authorized in products rinsed off Forbidden in products for oral hygiene |
|
9 |
Inorganic sulphites and hydrogen- sulphites (*) |
0,2 % expressed as free SO2 |
||
10 |
Sodium iodate |
0,1 % |
Rinse-off products only |
|
11 |
Chlorobutanol (INN) |
0,5 % |
Prohibited in aerosol dispensers (sprays) |
Contains chlorobutanol |
12 |
4-Hydroxybenzoic acid and its salts and esters (*) |
0,4 % (acid) for 1 ester, 0,8 % (acid) for mixtures of esters |
||
13 |
3-Acetyl-6-methylpyran-2,4 (3H)-dione (Dehydracetic acid) and its salts |
0,6 % (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 only |
Contains thiomersal |
17 |
Phenylmercuric salts (including borate) |
Ditto |
Ditto |
Contains phenylmercuric compounds |
18 |
Undec-10-enoic acid and salts (*) |
0,2 % (acid) |
See Annex VI, Part 2, No 8 |
|
19 |
Hexetidine (INN) (*) |
0,1 % |
►M13 ◄ |
|
20 |
5-Bromo-5-nitro-1,3-dioxane |
0,1 % |
Rinse-off products only Avoid formation of nitrosamines ►M15 ◄ |
|
21 |
Bronopol (INN) (*) |
0,1 % |
Avoid formation of 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 |
|
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-dioxoimidazolidin-4-yl)-1,1'-methylenediurea (‘Imidazolidinyl urea’) (*) |
0,6 % |
||
28 |
Poly (1-hexamethylenebiguanide hydrochloride (*) |
0,3 % |
||
29 |
2-Phenoxyethanol (*) |
1,0 % |
||
30 |
Hexamethylenetetramine (*) (methenamine) (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-dimethylimidazolidine-2,4-dione (*) |
0,6 % |
||
34 |
Benzyl alchohol (*) |
1,0 % |
||
35 |
1-Hydroxy-4-methyl-6(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt (*) |
1,0 % 0,5 % |
Products rinsed off For other products |
|
36 |
1,2-Dibromo-2,4-dicyanobutane (methyldibromo glutaronitrile) |
0,1 % |
Rinse-off products only |
|
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 magnesium nitrate |
►M15 0,0015 % ◄ (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'-(hydroxymethyl) urea |
0,5 % |
||
47 |
1,6-Di (4-amidinophenoxy)-n-hexane (Hexamidine) and its salts (including isethionate and p-hydroxybenzoate) (+) |
0,1 % |
||
48 |
Glutaraldehyde (Pentane-1,5-dial) |
0,1 % |
Prohibited in aerosols (sprays) |
Contains glutaraldehyde (where glutaraldehyde concentration in the finished product exceeds 0,05 %) |
49 |
5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane |
0,3 % |
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 dioxide |
0,004 % calculated as AgCl |
20 % AgCl (W/W) on TiO2. Prohibited in products for children under three years of age, in oral hygiene products and in products intended for application around the eyes and on the lips |
|
53 |
Benzethonium Chloride (INCI) |
0,1 % |
(a) Rinse-off products, (b) Leave-on products other than for oral care use |
|
54 |
Belzalkonium chloride, bromide and saccharinate (+) |
0,1% calculated as benzalkonium chloride |
Avoid contact with eyes |
|
55 |
Benzylhemiformal |
0,15 % |
Only for products to be removed by rinsing |
|
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 iodine |
Contains iodine |
|||
57 |
Methylisothiazolinone (INCI) |
0,01 % |
||
(1) Solely for products which might be used for children under three years of age and which remain in prolonged contact with the skin. |
PART 2
LIST OF PRESERVATIVES PROVISIONALLY ALLOWED
Reference number |
Substance |
Maximum authorized concentration |
Limitations and requirements |
Conditions of use and warnings which must be printed on the label |
Allowed until |
a |
b |
c |
d |
e |
f |
►M15 ◄ |
|||||
►M25 ◄ |
|||||
►M15 ◄ |
|||||
►M18 ◄ |
|||||
►M15 ◄ |
|||||
►M18 ◄ |
|||||
►M13 ◄ |
|||||
►M12 ◄ |
|||||
►M13 ◄ |
|||||
►M12 ◄ |
|||||
►M13 ◄ |
|||||
►M24 ◄ |
|||||
►M30 ◄ |
|||||
►M18 ◄ |
|||||
►M13 ◄ |
|||||
►M15 ◄ |
|||||
►M20 ◄ |
|||||
▼M31 ————— |
|||||
►M13 ◄ |
|||||
►M15 ◄ |
|||||
►M23 ◄ |
|||||
▼M31 ————— |
ANNEX VII
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.
PART 1
List of permitted UV filters which cosmetic products may contain
Reference No |
Substances |
Maximum authorized concentration |
Other limitations and requirements |
Conditions of use and warnings which must be printed on the label |
a |
b |
c |
d |
e |
1 |
4-Aminobenzoic acid |
5 % |
||
2 |
N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulphate |
6 % |
||
3 |
Homosalate (INN) |
10 % |
||
4 |
Oxybenzone (INN) |
10 % |
Contains oxybenzone (1) |
|
►M22 ◄ |
||||
6 |
2-phenylbenzimidazole-5-sulphonic acid and its potassium, sodium and triethanolamine salts |
8 % (expressed as acid) |
||
7 |
3,3'-(1,4-Phenylenedimethylene) bis (7, 7-dimethyl-2-oxobicyclo-[2,2,1]hept-1-yl-methanesulfonic acid) and its salts |
10 % (expressed as acid) |
||
8 |
1-(4-tert-butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione |
5 % |
||
9 |
alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts |
6 % (expressed as acid) |
||
10 |
2-cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester (Octocrylene) |
10 % (expressed as acid) |
||
11 |
Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl}acrylamide |
6 % |
||
12 |
Octyl methoxycinnamate |
10 % |
||
13 |
Ethoxylated Ethyl-4-Aminobenzoate (PEG-25 PABA) |
10 % |
||
14 |
Isopentyl-4-methoxycinnamate (Isoamyl p-Methoxycinnamate) |
10 % |
||
15 |
2,4,6-Trianilino-(p-Carbo-2‘-Ethylhexyl-1‘Oxy)-1,3,5-Triazine (Octyl Triazone) |
5 % |
||
16 |
Phenol,2-(2H-Benzotriazol-2-yl)-4-Methyl-6-(2-Methyl-3-(1,3,3,3-Tetramethyl-I-(Trimethylsilyl)Oxy)-Disiloxanyl)Propyl) (Drometrizole Trisiloxane) |
15 % |
||
17 |
Benzoic acid, 4,4-((6-(((1,1-dimethylethyl)amino)carbonyl)phenyl)amino) 1,3,5-triazine-2,4-diyl)diimino)bis-,bis-(2-ethylhexyl)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 % |
||
22 |
2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid (Benzophenone-5) and its sodium salt |
5 % (of acid) |
||
23 |
2,2'-Methylene-bis-6-(2H-benzotriazol-2yl)-4-(tetramethyl-butyl)-1,1,3,3-phenol |
10 % |
||
24 |
Monosodium salt of 2-2'-bis-(1,4-phenylene)1H-benzimidazole-4,6-disulphonic acid) |
10 % (of acid) |
||
25 |
(1,3,5)-Triazine-2,4-bis((4-(2-ethyl-hexyloxy)-2-hydroxy)-phenyl)-6-(4-methoxyphenyl) |
10 % |
||
26 |
Dimethicodiethylbenzalmalonate (CAS No 207574-74-1) |
10 % |
||
27 |
Titanium dioxide |
25 % |
||
28 |
Benzoic acid, 2-[-4-(diethylamino)-2-hydroxybenzoyl]-, hexylester (INCI name: Diethylamino Hydroxybenzoyl Hexyl Benzoate; CAS No 302776-68-7) |
10 % in sunscreen products |
||
(1) Not requiered if concentration is 0,5 % or less and when it is used only for product protection purposes. |
PART 2
LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MAY PROVISIONALLY CONTAIN
Reference number |
Substances |
Maximum authorized concentration |
Other limitations and requirements |
Conditions of use and warnings which must be printed on the label |
Allowed until |
a |
b |
c |
d |
e |
f |
►M20 ◄ |
|||||
►M30 ◄ |
|||||
►M20 ◄ |
|||||
▼M31 ————— |
|||||
►M30 ◄ |
|||||
►M30 ◄ |
|||||
►M28 ◄ |
|||||
►M20 ◄ |
|||||
▼M31 ————— |
|||||
►M23 ◄ |
|||||
►M30 ◄ |
|||||
►M30 ◄ |
|||||
►M23 ◄ |
|||||
▼M31 ————— |
|||||
►M22 ◄ |
|||||
►M30 ◄ |
|||||
►M25 ◄ |
ANNEX VIII
ANNEX VIIIa
ANNEX IX
LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING
This Annex lists the alternative methods validated by the European Centre on Validation of Alternative Methods (ECVAM) of the Joint Research Centre available to meet the requirements of this Directive and which are not listed in Annex V to Council Directive 67/548/EEC on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances. As animal testing may not be replaced completely by an alternative method, it should be mentioned in Annex IX whether the alternative method fully or partially replaces animal testing.
Reference number |
Validated alternative methods |
Nature of replacement full or partial |
A |
B |
C |
( 1 ) OJ No C 40, 8. 4. 1974, p. 71.
( 2 ) OJ No C 60, 26. 7. 1973, p. 16.
( 3 ) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1).
( 4 ) OJ L 140, 23.6.1995, p. 26.
( 5 ) OJ No L 15, 17. 1. 1987, p. 29.
( 6 ) OJ L 358, 18.12.1986, p. 1.
( 7 ) 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.
( 8 ) OJ L 159, 29.6.1996, p. 1.
( 9 ) OJ L 147, 31.5.2001, p. 1.