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Regulation (EC) No 1223/2009 of the European Parliament and of the CouncilDangos y teitl llawn

Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (Text with EEA relevance)

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Regulation (EC) No 1223/2009 of the European Parliament and of the Council

of 30 November 2009

on cosmetic products

(recast)

(Text with EEA relevance)

THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 95 thereof,

Having regard to the proposal from the Commission,

Having regard to the opinion of the European Economic and Social Committee(1),

Acting in accordance with the procedure laid down in Article 251 of the Treaty(2),

Whereas:

(1) Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products(3) has been significantly amended on several occasions. Since further amendments are to be made, in this particular case it should be recast as one single text in the interests of clarity.

(2) A Regulation is the appropriate legal instrument as it imposes clear and detailed rules which do not give room for diverging transposition by Member States. Moreover, a Regulation ensures that legal requirements are implemented at the same time throughout the Community.

(3) This Regulation aims at simplifying procedures and streamlining terminology, thereby reducing administrative burden and ambiguities. Moreover, it strengthens certain elements of the regulatory framework for cosmetics, such as in-market control, with a view to ensuring a high level of protection of human health.

(4) This Regulation comprehensively harmonises the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health.

(5) The environmental concerns that substances used in cosmetic products may raise are considered through the application of Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency(4), which enables the assessment of environmental safety in a cross-sectoral manner.

(6) This Regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal products. The 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.

(7) The assessment of whether a product is a cosmetic product has to be made on the basis of a case-by-case assessment, taking into account all characteristics of the product. Cosmetic products may include creams, emulsions, lotions, gels and oils for the skin, face masks, tinted bases (liquids, pastes, powders), make-up powders, after-bath powders, hygienic powders, toilet soaps, deodorant soaps, perfumes, toilet waters and eau de Cologne, bath and shower preparations (salts, foams, oils, gels), depilatories, deodorants and anti-perspirants, hair colorants, products for waving, straightening and fixing hair, hair-setting products, hair-cleansing products (lotions, powders, shampoos), hair-conditioning products (lotions, creams, oils), hairdressing products (lotions, lacquers, brilliantines), shaving products (creams, foams, lotions), make-up and products removing make-up, 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 and anti-wrinkle products.

(8) The Commission should define the categories of cosmetic products which are relevant for the application of this Regulation.

(9) Cosmetic products should be safe under normal or reasonably foreseeable conditions of use. In particular, a risk-benefit reasoning should not justify a risk to human health.

(10) The presentation of a cosmetic product and in particular its form, odour, colour, appearance, packaging, labelling, volume or size should not endanger health and safety of consumers due to confusion with foodstuffs, in accordance with Council Directive 87/357/EEC of 25 June 1987 on the approximation of the laws of the Member States concerning products which, appearing to be other than they are, endanger the health or safety of consumers(5).

(11) In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person established within the Community.

(12) Ensuring traceability of a cosmetic product throughout the whole supply chain helps to make market surveillance simpler and more efficient. An efficient traceability system facilitates market surveillance authorities’ task of tracing economic operators.

(13) It is necessary to determine under which conditions a distributor is to be considered as the responsible person.

(14) All legal or natural persons in the wholesale trade as well as retailers selling directly to the consumer are covered by reference to the distributor. The obligations of the distributor should therefore be adapted to the respective role and part of the activity of each of these operators.

(15) The European cosmetics sector is one of the industrial activities affected by counterfeiting, which may increase risks to human health. Member States should pay particular attention to the implementation of horizontal Community legislation and measures regarding counterfeit products in the field of cosmetic products, for example Council Regulation (EC) No 1383/2003 of 22 July 2003 concerning customs action against goods suspected of infringing certain intellectual property rights and the measures to be taken against goods found to have infringed such rights(6) and Directive 2004/48/EC of the European parliament and of the Council of 29 April 2004 on the enforcement of intellectual property rights(7). In-market controls represent a powerful means of identifying products that do not comply with the requirements of this Regulation.

(16) To ensure their safety, cosmetic products placed on the market should be produced according to good manufacturing practice.

(17) For the purpose of effective market surveillance, a product information file should be made readily accessible, at one single address within the Community, to the competent authority of the Member State where the file is located.

(18) In order to be comparable and of high quality, the results of the non-clinical safety studies carried out for the purposes of assessing the safety of a cosmetic product should comply with the relevant Community legislation.

(19) It should be made clear which information is to be made available to the competent authorities. That information should include all the necessary particulars relating to identity, quality, safety for human health and the effects claimed for the cosmetic product. In particular, this product information should include a cosmetic product safety report documenting that a safety assessment has been conducted.

(20) To ensure the uniform application and control of the restrictions for substances, sampling and analysis should be carried out in a reproducible and standardised manner.

(21) The term ‘mixture’ as defined in this Regulation should have the same meaning as the term ‘preparation’ previously used in Community legislation.

(22) For reasons of effective market surveillance, the competent authorities should be notified of certain information about the cosmetic product placed on the market.

(23) In order to allow for rapid and appropriate medical treatment in the event of difficulties, the necessary information about the product formulation should be submitted to poison control centres and assimilated entities, where such centres have been established by Member States to that end.

(24) In order to keep administrative burdens to a minimum, the notified information for competent authorities, poison control centres and assimilated entities should be submitted centrally for the Community by way of an electronic interface.

(25) In order to ensure a smooth transition to the new electronic interface, economic operators should be allowed to notify the information required in accordance with this Regulation before its date of application.

(26) The general principle of the responsibility of the manufacturer or importer for the safety of the product should be supported by restrictions of some substances in Annexes II and III. Moreover, substances which are intended to be used as colorants, preservatives and UV-filters should be listed in the Annexes IV, V and VI respectively in order to be allowed for these uses.

(27) To avoid ambiguities, it should be clarified that the list of allowed colorants contained in Annex IV includes only substances which colour through absorption and reflection and not substances which colour through photoluminescence, interference, or chemical reaction.

(28) To address safety concerns raised, Annex IV, which is currently restricted to skin colorants, should also include hair colorants once the risk assessment of these substances by the Scientific Committee for Consumer Safety (SCCS) set up by Commission Decision 2008/721/EC of 5 September 2008 setting up an advisory structure of Scientific Committees and experts in the field of consumer safety, public health and the environment(8) has been finalised. To this end, the Commission should have the possibility to include hair colorants in the scope of that Annex by the comitology procedure.

(29) The use of nanomaterials in cosmetic products may increase with the further development of technology. In order to ensure a high level of consumer protection, free movement of goods and legal certainty for manufacturers, it is necessary to develop a uniform definition for nanomaterials at international level. The Community should endeavour to reach an agreement on a definition in appropriate international fora. Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly.

(30) At present, there is inadequate information on the risks associated with nanomaterials. In order to better assess their safety the SCCS should provide guidance in cooperation with relevant bodies on test methodologies which take into account specific characteristics of nanomaterials.

(31) The Commission should regularly review the provisions on nanomaterials in the light of scientific progress.

(32) Given the hazardous properties of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A, 1B and 2, pursuant to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures(9), their use in cosmetic products should be prohibited. However, as a hazardous property of a substance does not necessarily always entail a risk, there should be a possibility to allow the use of substances classified as CMR 2 substances where, in view of exposure and concentration, they have been found safe for use in cosmetic products by the SCCS and are regulated by the Commission in the Annexes to this Regulation. With regard to substances which are classified as CMR 1A or 1B substances, there should be a possibility, in the exceptional case that these substances comply with food safety requirements, inter alia as a result of their naturally occurring in food, and that no suitable alternative substances exist, to use such substances in cosmetic products on the condition that such use has been found safe by the SCCS. Where such conditions are met, the Commission should amend the relevant Annexes to this Regulation within 15 months of classification of substances as CMR 1A or 1B substances under Regulation (EC) No 1272/2008. Such substances should be continuously reviewed by the SCCS.

(33) A safety assessment of substances, particularly those classified as CMR 1A or 1B substances, should consider the overall exposure to such substances stemming from all sources. At the same time, for those involved in producing safety assessments, it is essential that there be a harmonised approach to the development and use of such overall exposure estimates. In consequence, the Commission, in close cooperation with the SCCS, the European Chemicals Agency (ECHA), the European Food Safety Authority (EFSA) and other relevant stakeholders, should, as a matter of urgency, carry out a review and develop guidance regarding the production and use of overall exposure estimates for these substances.

(34) The assessment by the SCCS of the use of substances classified as CMR 1A and 1B in cosmetic products should also take into account the exposure to those substances of vulnerable population groups, such as children under three years of age, elderly people, pregnant and breast-feeding women and persons with compromised immune responses.

(35) The SCCS should give opinions where appropriate on the safety of use of nanomaterials in cosmetic products. These opinions should be based on full information being made available by the responsible person.

(36) Action by the Commission and Member States relating to the protection of human health should be based on the precautionary principle.

(37) In order to ensure product safety, prohibited substances should be acceptable at trace levels only if they are technologically inevitable with correct manufacturing processes and provided that the product is safe.

(38) The Protocol on protection and welfare of animals annexed to the Treaty provides that the Community and the Member States are to pay full regard to the welfare requirements of animals in the implementation of Community policies, in particular with regard to the internal market.

(39) 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(10) established common rules for the use of animals for experimental purposes within the Community and laid down the conditions under which such experiments must be carried out in the territory of the Member States. In particular, Article 7 of that Directive requires that animal experiments be replaced by alternative methods, where such methods exist and are scientifically satisfactory.

(40) The safety of cosmetic products and their ingredients may be ensured through the use of alternative methods which are not necessarily applicable to all uses of chemical ingredients. Therefore, the use of such methods by the whole cosmetic industry should be promoted and their adoption at Community level ensured, where such methods offer an equivalent level of protection to consumers.

(41) The safety of finished cosmetic products can already be ensured on the basis of knowledge of the safety of the ingredients that they contain. Provisions prohibiting animal testing of finished cosmetic products should therefore be laid down. The application, in particular by small and medium-sized enterprises, of both test methods and assessment procedures for relevant available data, including the use of read-across and weight-of-evidence approaches, which do not involve the use of animals for assessing the safety of finished cosmetic products could be facilitated by Commission guidelines.

(42) It will gradually become possible to ensure the safety of ingredients used in cosmetic products by using non-animal alternative methods validated at Community level, or approved as being scientifically validated, by the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the Organisation for Economic Cooperation and Development (OECD). After consulting the SCCS as regards the applicability of the validated alternative methods to the field of cosmetic products, the Commission should immediately publish the validated or approved methods recognised as being applicable to such ingredients. In order to achieve the highest possible degree of animal protection, a deadline should be set for the introduction of a definitive prohibition.

(43) The Commission established timetables of deadlines up to 11 March 2009 for prohibiting the marketing of cosmetic products, the final formulation, ingredients or combinations of ingredients which have been tested on animals, and for prohibiting each test currently carried out using animals. In view, however, of tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, it is appropriate for the final deadline for prohibiting the marketing of cosmetic products for which those tests are used to be 11 March 2013. On the basis of annual reports, the Commission should be authorised to adapt the timetables within the abovementioned maximum time limit.

(44) Better coordination of resources at Community level will contribute to increasing the scientific knowledge indispensable for the development of alternative methods. It is essential, for this purpose, that the Community continue and increase its efforts and take the measures necessary for the promotion of research and the development of new non-animal alternative methods, in particular within its Framework Programmes for research.

(45) The recognition by third countries of alternative methods developed in the Community should be encouraged. In order to achieve this objective, the Commission and the Member States should take all appropriate steps to facilitate acceptance of such methods by the OECD. The Commission should also endeavour, within the framework of European Community cooperation agreements, to obtain recognition of the results of safety tests carried out in the Community using alternative methods so as to ensure that the export of cosmetic products for which such methods have been used is not hindered and to prevent or avoid third countries requiring the repetition of such tests using animals.

(46) Transparency is needed regarding the ingredients used in cosmetic products. Such transparency should be achieved by indication of the ingredients used in a cosmetic product on its packaging. Where for practical reasons it is impossible to indicate the ingredients on the packaging, such information should be enclosed so that the consumer has access to this information.

(47) A glossary of common ingredient names should be compiled by the Commission to ensure uniform labelling and to facilitate identification of cosmetics ingredients. This glossary should not be intended to constitute a limitative list of substances used in cosmetic products.

(48) In order to inform consumers, cosmetic products should bear precise and easily understandable indications concerning their durability for use. Given that consumers should be informed of the date until which the cosmetic product will continue to fulfil its initial function and remain safe, it is important to know the date of minimum durability, i.e. the date by which it is best to use the product. Where the minimum durability is more than 30 months, the consumer should be informed of the period of time after opening that the cosmetic product may be used without any harm to the consumer. However, this requirement should not apply where the concept of the durability after opening is not relevant, that is to say for single-use products, products not at risk of deterioration or products which do not open.

(49) A number of substances have been identified by the SCCS as likely to cause allergic reactions and it will be necessary to restrict their use and/or impose certain conditions concerning them. In order to ensure that consumers are adequately informed, the presence of these substances should be mentioned in the list of ingredients and consumers’ attention should be drawn to the presence of these ingredients. This information should improve the diagnosis of contact allergies among consumers and should enable them to avoid the use of cosmetic products which they do not tolerate. For substances which are likely to cause allergy to a significant part of the population, other restrictive measures such as a ban or a restriction of concentration should be considered.

(50) In the safety assessment of a cosmetic product it should be possible to take into account results of risk assessments that have been carried out in other relevant areas. The use of such data should be duly substantiated and justified.

(51) The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products. In particular Directive 2005/29/EC of the European Parliament and of the Council of 11 May 2005 concerning unfair business-to-consumer commercial practices in the internal market(11) is applicable. Furthermore, the Commission, in cooperation with Member States, should define common criteria in relation to specific claims for cosmetic products.

(52) It should be possible to claim on a cosmetic product that no animal testing was carried out in relation to its development. The Commission, in consultation with the Member States, has developed guidelines to ensure that common criteria are applied in the use of claims and that an aligned understanding of the claims is reached, and in particular that such claims do not mislead the consumer. In developing such guidelines, the Commission has also taken into account the views of the many small and medium-sized enterprises which make up the majority of the ‘non-animal testing’ producers, relevant non-governmental organisations, and the need for consumers to be able to make practical distinctions between products on the basis of animal testing criteria.

(53) In addition to the labelled information, consumers should be given the possibility to request certain product-related information from the responsible person in order to make informed product choices.

(54) Effective market surveillance is necessary in order to ensure that the provisions of this Regulation are respected. To this end, serious undesirable effects should be notified and competent authorities should have a possibility to request from the responsible person a list of cosmetic products containing substances which have raised serious doubts in terms of safety.

(55) This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the notification by health professionals or consumers of serious undesirable effects to the competent authorities of Member States.

(56) This Regulation is without prejudice to the possibility for Member States to regulate, in compliance with Community law, the establishment of economic operators in the area of cosmetic products.

(57) In case of non-compliance with this Regulation, a clear and efficient procedure for the withdrawal and recall of products may be necessary. This procedure should, where possible, build upon existing Community rules for unsafe goods.

(58) In order to address cosmetic products which, despite complying with the provisions of this Regulation, might endanger human health, a safeguard procedure should be introduced.

(59) The Commission should provide indications for the uniform interpretation and application of the concept of serious risks in order to facilitate the consistent implementation of this Regulation.

(60) In order to comply with principles of good administrative practices, any decision by a competent authority in the framework of market surveillance should be duly substantiated.

(61) In order to ensure effective in-market control, a high degree of administrative cooperation amongst the competent authorities is necessary. This concerns in particular mutual assistance in the verification of product information files located in another Member State.

(62) The Commission should be assisted by the SCCS, an independent risk assessment body.

(63) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(12).

(64) In particular, power should be conferred on the Commission to adapt the Annexes to this Regulation to technical progress. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC.

(65) When, on imperative grounds of urgency, the normal time-limits for the regulatory procedure with scrutiny cannot be complied with, the Commission should be able to apply the urgency procedure provided for in Article 5a(6) of Decision 1999/468/EC for the adoption of certain measures relating to CMRs, nanomaterials and potential risks to human health.

(66) Member States should lay down provisions on penalties applicable to infringements of the provisions of this Regulation and ensure that they are implemented. Those penalties should be effective, proportionate and dissuasive.

(67) Economic operators as well as Member States and the Commission need sufficient time to adapt to the changes introduced by this Regulation. Therefore it is appropriate to provide for a sufficient transitional period for that adaptation. However, in order to ensure a smooth transition, economic operators should be allowed to place on the market cosmetic products which comply with this Regulation before the expiry of that transitional period.

(68) In order to enhance the safety of cosmetic products and strengthen the market surveillance, cosmetic products placed on the market after the date of application of this Regulation should comply with its obligations regarding safety assessment, the product information file and notification, even if similar obligations have already been fulfilled under Directive 76/768/EEC.

(69) Directive 76/768/EEC should be repealed. However, in order to ensure appropriate medical treatment in the event of difficulties and to ensure market surveillance, the information received pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC concerning cosmetic products should be kept by the competent authorities for a certain period of time and the information kept by the responsible person should remain available for the same period of time.

(70) This Regulation should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex IX.

(71) Since the objective of this Regulation, namely the achievement of the internal market and a high level of protection of human health through the compliance of cosmetic products with the requirements laid down in this Regulation, cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale of the action, be better achieved at Community level, the Community may adopt measures, in accordance with the principle of subsidiarity, as set out in Article 5 of the Treaty. In accordance with the principle of proportionality, as set out in that Article, this Regulation does not go beyond what is necessary in order to achieve that objective,

HAVE ADOPTED THIS REGULATION:

CHAPTER ISCOPE, DEFINITIONS

Article 1Scope and objective

This Regulation establishes rules to be complied with by any cosmetic product made available on the market, in order to ensure the functioning of the internal market and a high level of protection of human health.

Article 2Definitions

1.For the purposes of this Regulation, the following definitions shall apply:

(a)‘cosmetic product’ means any substance or mixture intended to be placed in contact with the 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, protecting them, keeping them in good condition or correcting body odours;

(b)‘substance’ means a chemical element and its compounds in the natural state or obtained by any manufacturing process, including any additive necessary to preserve its stability and any impurity deriving from the process used but excluding any solvent which may be separated without affecting the stability of the substance or changing its composition;

(c)‘mixture’ means a mixture or solution composed of two or more substances;

(d)‘manufacturer’ means any natural or legal person who manufactures a cosmetic product or has such a product designed or manufactured, and markets that cosmetic product under his name or trademark;

(e)‘distributor’ means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a cosmetic product available on the Community market;

(f)‘end user’ means either a consumer or professional using the cosmetic product;

(g)‘making available on the market’ means any supply of a cosmetic product for distribution, consumption or use on the Community market in the course of a commercial activity, whether in return for payment or free of charge;

(h)‘placing on the market’ means the first making available of a cosmetic product on the Community market;

(i)‘importer’ means any natural or legal person established within the Community, who places a cosmetic product from a third country on the Community market;

(j)‘harmonised standard’ means a standard adopted by one of the European standardisation bodies listed in Annex I to Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services(13) on the basis of a request made by the Commission in accordance with Article 6 of that Directive;

(k)‘nanomaterial’ means an insoluble or biopersistant and intentionally manufactured material with one or more external dimensions, or an internal structure, on the scale from 1 to 100 nm;

(l)‘preservatives’ means substances which are exclusively or mainly intended to inhibit the development of micro-organisms in the cosmetic product;

(m)‘colorants’ means substances which are exclusively or mainly intended to colour the cosmetic product, the body as a whole or certain parts thereof, by absorption or reflection of visible light; in addition, precursors of oxidative hair colorants shall be deemed colorants;

(n)‘UV-filters’ means substances which are exclusively or mainly intended to protect the skin against certain UV radiation by absorbing, reflecting or scattering UV radiation;

(o)‘undesirable effect’ means an adverse reaction for human health attributable to the normal or reasonably foreseeable use of a cosmetic product;

(p)‘serious undesirable effect’ means an undesirable effect which results in temporary or permanent functional incapacity, disability, hospitalisation, congenital anomalies or an immediate vital risk or death;

(q)‘withdrawal’ means any measure aimed at preventing the making available on the market of a cosmetic product in the supply chain;

(r)‘recall’ means any measure aimed at achieving the return of a cosmetic product that has already been made available to the end user;

(s)‘frame formulation’ means a formulation which lists the category or function of ingredients and their maximum concentration in the cosmetic product or gives relevant quantitative and qualitative information whenever a cosmetic product is not covered or only partially covered by such a formulation. The Commission shall provide indications for the establishment of the frame formulation and adapt them regularly to technical and scientific progress.

2.For the purposes of point (a) of paragraph 1, a substance or mixture intended to be ingested, inhaled, injected or implanted into the human body shall not be considered to be a cosmetic product.

3.In view of the various definitions of nanomaterials published by different bodies and the constant technical and scientific developments in the field of nanotechnologies, the Commission shall adjust and adapt point (k) of paragraph 1 to technical and scientific progress and to definitions subsequently agreed at international level. That measure, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

CHAPTER IISAFETY, RESPONSIBILITY, FREE MOVEMENT

Article 3Safety

A cosmetic product made available on the market shall be safe for human health when used under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following:

(a)

presentation including conformity with Directive 87/357/EEC;

(b)

labelling;

(c)

instructions for use and disposal;

(d)

any other indication or information provided by the responsible person defined in Article 4.

The provision of warnings shall not exempt persons defined in Articles 2 and 4 from compliance with the other requirements laid down in this Regulation.

Article 4Responsible person

1.Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’ shall be placed on the market.

2.For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation.

3.For a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer established within the Community shall be the responsible person.

The manufacturer may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.

4.Where, for a cosmetic product manufactured within the Community, and not subsequently exported and imported back into the Community, the manufacturer is established outside the Community, he shall designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing.

5.For an imported cosmetic product, each importer shall be the responsible person for the specific cosmetic product he places on the market.

The importer may, by written mandate, designate a person established within the Community as the responsible person who shall accept in writing.

6.The distributor shall be the responsible person where he places a cosmetic product on the market under his name or trademark or modifies a product already placed on the market in such a way that compliance with the applicable requirements may be affected.

The translation of information relating to a cosmetic product already placed on the market shall not be considered as a modification of that product of such a nature that compliance with the applicable requirements of this Regulation may be affected.

Article 5Obligations of responsible persons

1.Responsible persons shall ensure compliance with Articles 3, 8, 10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2) and (5), as well as Articles 20, 21, 23 and 24.

2.Responsible persons who consider or have reason to believe that a cosmetic product which they have placed on the market is not in conformity with this Regulation shall immediately take the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate.

Furthermore, where the cosmetic product presents a risk to human health, responsible persons shall immediately inform the competent national authorities of the Member States in which they made the product available and of the Member State in which the product information file is readily accessible, giving details, in particular, of the non-compliance and of the corrective measures taken.

3.Responsible persons shall cooperate with these authorities, at the request of the latter, on any action to eliminate the risks posed by cosmetic products which they have made available on the market. In particular, responsible persons shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of specific aspects of the product, in a language which can be easily understood by that authority.

Article 6Obligations of distributors

1.In the context of their activities, when making a cosmetic product available on the market, distributors shall act with due care in relation to applicable requirements.

2.Before making a cosmetic product available on the market distributors shall verify that:

  • the labelling information provided for in Article 19(1)(a), (e) and (g) and Article 19(3) and (4) is present,

  • the language requirements provided for in Article 19(5) are fulfilled,

  • the date of minimum durability specified, where applicable under Article 19(1), has not passed.

3.Where distributors consider or have reason to believe that:

  • a cosmetic product is not in conformity with the requirements laid down in this Regulation, they shall not make the product available on the market until it has been brought into conformity with the applicable requirements,

  • a cosmetic product which they have made available on the market is not in conformity with this Regulation, they shall make sure that the corrective measures necessary to bring that product into conformity, withdraw it or recall it, as appropriate, are taken.

Furthermore, where the cosmetic product presents a risk to human health, distributors shall immediately inform the responsible person and the competent national authorities of the Member States in which they made the product available, giving details, in particular, of the non-compliance and of the corrective measures taken.

4.Distributors shall ensure that, while a product is under their responsibility, storage or transport conditions do not jeopardise its compliance with the requirements set out in this Regulation.

5.Distributors shall cooperate with competent authorities, at the request of the latter, on any action to eliminate the risks posed by products which they have made available on the market. In particular, distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of the product with the requirements listed under paragraph 2, in a language which can be easily understood by that authority.

Article 7Identification within the supply chain

At the request of a competent authority:

  • responsible persons shall identify the distributors to whom they supply the cosmetic product,

  • the distributor shall identify the distributor or the responsible person from whom, and the distributors to whom, the cosmetic product was supplied.

This obligation shall apply for a period of three years following the date on which the batch of the cosmetic product was made available to the distributor.

Article 8Good manufacturing practice

1.The manufacture of cosmetic products shall comply with good manufacturing practice with a view to ensuring the objectives of Article 1.

2.Compliance with good manufacturing practice shall be presumed where the manufacture is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.

Article 9Free movement

Member States shall not, for reasons related to the requirements laid down in this Regulation, refuse, prohibit or restrict the making available on the market of cosmetic products which comply with the requirements of this Regulation.

CHAPTER IIISAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION

Article 10Safety assessment

1.In order to demonstrate that a cosmetic product complies with Article 3, the responsible person shall, prior to placing a cosmetic product on the market, ensure that the cosmetic product has undergone a safety assessment on the basis of the relevant information and that a cosmetic product safety report is set up in accordance with Annex I.

The responsible person shall ensure that:

(a)the intended use of the cosmetic product and the anticipated systemic exposure to individual ingredients in a final formulation are taken into account in the safety assessment;

(b)an appropriate weight-of-evidence approach is used in the safety assessment for reviewing data from all existing sources;

(c)the cosmetic product safety report is kept up to date in view of additional relevant information generated subsequent to placing the product on the market.

The first subparagraph shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.

The Commission, in close cooperation with all stakeholders, shall adopt appropriate guidelines to enable undertakings, in particular small and medium-sized enterprises, to comply with the requirements laid down in Annex I. Those guidelines shall be adopted in accordance with the regulatory procedure referred to in Article 32(2).

2.The cosmetic product safety assessment, as set out in Part B of Annex I shall be carried out by a person in possession of a diploma or other evidence of formal qualifications awarded on completion of a university course of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline, or a course recognised as equivalent by a Member State.

3.Non-clinical safety studies referred to in the safety assessment according to paragraph 1 and carried out after 30 June 1988 for the purpose of assessing the safety of a cosmetic product shall comply with Community legislation on the principles of good laboratory practice, as applicable at the time of performance of the study, or with other international standards recognised as being equivalent by the Commission or the ECHA.

Article 11Product information file

1.When a cosmetic product is placed on the market, the responsible person shall keep a product information file for it. The product information file shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market.

2.The product information file shall contain the following information and data which shall be updated as necessary:

(a)a description of the cosmetic product which enables the product information file to be clearly attributed to the cosmetic product;

(b)the cosmetic product safety report referred to in Article 10(1);

(c)a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 8;

(d)where justified by the nature or the effect of the cosmetic product, proof of the effect claimed for the cosmetic product;

(e)data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety assessment of the cosmetic product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of third countries.

3.The responsible person shall make the product information file readily accessible in electronic or other format at his address indicated on the label to the competent authority of the Member State in which the file is kept.

The information contained in the product information file shall be available in a language which can be easily understood by the competent authorities of the Member State.

4.The requirements provided in paragraphs 1 to 3 of this Article shall also apply to cosmetic products that have been notified under Directive 76/768/EEC.

Article 12Sampling and analysis

1.Sampling and analysis of cosmetic products shall be performed in a reliable and reproducible manner.

2.In the absence of any applicable Community legislation, reliability and reproducibility shall be presumed if the method used is in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.

Article 13Notification

1.Prior to placing the cosmetic product on the market the responsible person shall submit, by electronic means, the following information to the Commission:

(a)the category of cosmetic product and its name or names, enabling its specific identification;

(b)the name and address of the responsible person where the product information file is made readily accessible;

(c)the country of origin in the case of import;

(d)the Member State in which the cosmetic product is to be placed on the market;

(e)the contact details of a physical person to contact in the case of necessity;

(f)the presence of substances in the form of nanomaterials and:

(i)

their identification including the chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI to this Regulation;

(ii)

the reasonably foreseeable exposure conditions;

(g)the name and the Chemicals Abstracts Service (CAS) or EC number of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), of category 1A or 1B, under Part 3 of Annex VI to Regulation (EC) No 1272/2008;

(h)the frame formulation allowing for prompt and appropriate medical treatment in the event of difficulties.

The first subparagraph shall also apply to cosmetic products notified under Directive 76/768/EEC.

2.When the cosmetic product is placed on the market, the responsible person shall notify to the Commission the original labelling, and, where reasonably legible, a photograph of the corresponding packaging.

3.As from 11 July 2013, a distributor who makes available in a Member State a cosmetic product already placed on the market in another Member State and translates, on his own initiative, any element of the labelling of that product in order to comply with national law, shall submit, by electronic means, the following information to the Commission:

(a)the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification;

(b)the Member State in which the cosmetic product is made available;

(c)his name and address;

(d)the name and address of the responsible person where the product information file is made readily accessible..

4.Where a cosmetic product has been placed on the market before 11 July 2013 but is no longer placed on the market as from that date, and a distributor introduces that product in a Member State after that date, that distributor shall communicate the following to the responsible person:

(a)the category of cosmetic product, its name in the Member State of dispatch and its name in the Member State in which it is made available, enabling its specific identification;

(b)the Member State in which the cosmetic product is made available;

(c)his name and address.

On the basis of that communication, the responsible person shall submit to the Commission, by electronic means, the information referred to in paragraph 1 of this Article, where notifications according to Article 7(3) and Article 7a (4) of Directive 76/768/EEC have not been carried out in the Member State in which the cosmetic product is made available.

5.The Commission shall, without delay, make the information referred to in points (a) to (g) of paragraph 1, and in paragraphs 2 and 3 available electronically to all competent authorities.

That information may be used by competent authorities only for the purposes of market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.

6.The Commission shall, without delay, make the information referred to in paragraphs 1, 2 and 3 available electronically to poison centres or similar bodies, where such centres or bodies have been established by Member States.

That information may be used by those bodies only for the purposes of medical treatment.

7.Where any of the information set out in paragraphs 1, 3 and 4 changes, the responsible person or the distributor shall provide an update without delay.

8.The Commission may, taking into account technical and scientific progress and specific needs related to market surveillance, amend paragraphs 1 to 7 by adding requirements.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

CHAPTER IVRESTRICTIONS FOR CERTAIN SUBSTANCES

Article 14Restrictions for substances listed in the Annexes

1.Without prejudice to Article 3, cosmetic products shall not contain any of the following:

(a)prohibited substances

  • (a)prohibited substances listed in Annex II;

(b)restricted substances

  • (b)restricted substances which are not used in accordance with the restrictions laid down in Annex III;

(c)colorants

(i)

colorants other than those listed in Annex IV and colorants which are listed there but not used in accordance with the conditions laid down in that Annex, except for hair colouring products referred to in paragraph 2;

(ii)

without prejudice to points (b), (d)(i) and (e)(i), substances which are listed in Annex IV but which are not intended to be used as colorants, and which are not used in accordance with the conditions laid down in that Annex;

(d)preservatives

(i)

preservatives other than those listed in Annex V and preservatives which are listed there but not used in accordance with the conditions laid down in that Annex;

(ii)

without prejudice to points (b), (c)(i) and (e)(i), substances listed in Annex V but which are not intended to be used as preservatives, and which are not used in accordance with the conditions laid down in that Annex;

(e)UV-filters

(i)

UV-filters other than those listed in Annex VI and UV-filters which are listed there but not used in accordance with the conditions laid down in that Annex;

(ii)

without prejudice to points (b), (c)(i) and (d)(i), substances listed in Annex VI but which are not intended to be used as UV-filters and which are not used in accordance with the conditions laid down in that Annex.

2.Subject to a decision of the Commission to extend the scope of Annex IV to hair colouring products, such products shall not contain colorants intended to colour the hair, other than those listed in Annex IV and colorants intended to colour the hair which are listed there but not used in accordance with the conditions laid down in that Annex.

The decision of the Commission referred to in the first subparagraph, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

Article 15Substances classified as CMR substances

1.The use in cosmetic products of substances classified as CMR substances, of category 2, under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited. However, a substance classified in category 2 may be used in cosmetic products where the substance has been evaluated by the SCCS and found safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation.

2.The use in cosmetic products of substances classified as CMR substances, of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008 shall be prohibited.

However, such substances may be used in cosmetic products by way of exception where, subsequent to their classification as CMR substances of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No 1272/2008, all of the following conditions are fulfilled:

(a)they comply with the food safety requirements as defined in Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Authority and laying down procedures in matters of food safety(14);

(b)there are no suitable alternative substances available, as documented in an analysis of alternatives;

(c)the application is made for a particular use of the product category with a known exposure; and

(d)they have been evaluated and found safe by the SCCS for use in cosmetic products, in particular in view of exposure to these products and taking into consideration the overall exposure from other sources, taking particular account of vulnerable population groups.

Specific labelling in order to avoid misuse of the cosmetic product shall be provided in accordance with Article 3 of this Regulation, taking into account possible risks linked to the presence of hazardous substances and the routes of exposure.

In order to implement this paragraph, the Commission shall amend the Annexes to this Regulation in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation within 15 months of the inclusion of the substances concerned in Part 3 of Annex VI to Regulation (EC) No 1272/2008.

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 32(4) of this Regulation.

The Commission shall mandate the SCCS to re-evaluate those substances as soon as safety concerns arise, and at the latest five years after their inclusion in Annexes III to VI to this Regulation, and at least every subsequent five years.

3.By 11 January 2012, the Commission shall ensure that appropriate guidance is developed with the aim of enabling a harmonised approach to the development and use of overall exposure estimates in assessing the safe use of CMR substances. This guidance shall be developed in consultation with the SCCS, the ECHA, the EFSA and other relevant stakeholders, drawing, as appropriate, on relevant best practice.

4.When Community or internationally agreed criteria for identifying substances with endocrine-disrupting properties are available, or at the latest on 11 January 2015, the Commission shall review this Regulation with regard to substances with endocrine-disrupting properties.

Article 16Nanomaterials

1.For every cosmetic product that contains nanomaterials, a high level of protection of human health shall be ensured.

2.The provisions of this Article do not apply to nanomaterials used as colorants, UV-filters or preservatives regulated under Article 14, unless expressly specified.

3.In addition to the notification under Article 13, cosmetic products containing nanomaterials shall be notified to the Commission by the responsible person by electronic means six months prior to being placed on the market, except where they have already been placed on the market by the same responsible person before 11 January 2013.

In the latter case, cosmetic products containing nanomaterials placed on the market shall be notified to the Commission by the responsible person between 11 January 2013 and 11 July 2013 by electronic means, in addition to the notification in Article 13.

The first and the second subparagraphs shall not apply to cosmetic products containing nanomaterials that are in conformity with the requirements set out in Annex III.

The information notified to the Commission shall contain at least the following:

(a)the identification of the nanomaterial including its chemical name (IUPAC) and other descriptors as specified in point 2 of the Preamble to Annexes II to VI;

(b)the specification of the nanomaterial including size of particles, physical and chemical properties;

(c)an estimate of the quantity of nanomaterial contained in cosmetic products intended to be placed on the market per year;

(d)the toxicological profile of the nanomaterial;

(e)the safety data of the nanomaterial relating to the category of cosmetic product, as used in such products;

(f)the reasonably foreseeable exposure conditions.

The responsible person may designate another legal or natural person by written mandate for the notification of nanomaterials and shall inform the Commission thereof.

The Commission shall provide a reference number for the submission of the toxicological profile, which may substitute the information to be notified under point (d).

4.In the event that the Commission has concerns regarding the safety of a nanomaterial, the Commission shall, without delay, request the SCCS to give its opinion on the safety of such nanomaterial for use in the relevant categories of cosmetic products and on the reasonably foreseeable exposure conditions. The Commission shall make this information public. The SCCS shall deliver its opinion within six months of the Commission's request. Where the SCCS finds that any necessary data is lacking, the Commission shall request the responsible person to provide such data within an explicitly stated reasonable time, which shall not be extended. The SCCS shall deliver its final opinion within six months of submission of additional data. The opinion of the SCCS shall be made publicly available.

5.The Commission may, at any time, invoke the procedure in paragraph 4 where it has any safety concerns, for example due to new information supplied by a third party.

6.Taking into account the opinion of the SCCS, and where there is a potential risk to human health, including when there is insufficient data, the Commission may amend Annexes II and III.

7.The Commission may, taking into account technical and scientific progress, amend paragraph 3 by adding requirements.

8.The measures, referred to in paragraphs 6 and 7, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

9.On imperative grounds of urgency the Commission may use the procedure referred to in Article 32(4).

10.The following information shall be made available by the Commission:

(a)By 11 January 2014, the Commission shall make available a catalogue of all nanomaterials used in cosmetic products placed on the market, including those used as colorants, UV-filters and preservatives in a separate section, indicating the categories of cosmetic products and the reasonably foreseeable exposure conditions. This catalogue shall be regularly updated thereafter and be made publicly available.

(b)The Commission shall submit to the European Parliament and the Council an annual status report, which will give information on developments in the use of nanomaterials in cosmetic products within the Community, including those used as colorants, UV-filters and preservatives in a separate section. The first report shall be presented by 11 July 2014 The report update shall summarise, in particular, the new nanomaterials in new categories of cosmetic products, the number of notifications, the progress made in developing nano-specific assessment methods and safety assessment guides, and information on international cooperation programmes.

11.The Commission shall regularly review the provisions of this Regulation concerning nanomaterials in the light of scientific progress and shall, where necessary, propose suitable amendments to those provisions.

The first review shall be undertaken by 11 July 2018.

Article 17Traces of prohibited substances

The non-intended presence of a small quantity of a prohibited substance, stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from packaging, which is technically unavoidable in good manufacturing practice, shall be permitted provided that such presence is in conformity with Article 3.

CHAPTER VANIMAL TESTING

Article 18Animal testing

1.Without prejudice to the general obligations deriving from Article 3, the following shall be prohibited:

(a)the placing on the market of cosmetic products where the final formulation, in order to meet the requirements of this Regulation, 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 placing on the market of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Regulation, 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 within the Community of animal testing of finished cosmetic products in order to meet the requirements of this Regulation;

(d)the performance within the Community of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Regulation, after the date on which such tests are required to be replaced by one or more validated alternative methods listed in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH)(15) or in Annex VIII to this Regulation.

2.The Commission, after consulting the SCCS and the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the OECD, has established timetables for the implementation of the provisions under points (a), (b) and (d) of paragraph 1, including deadlines for the phasing-out of the various tests. The timetables were made available to the public on 1 October 2004 and sent to the European Parliament and the Council. The period for implementation was limited to 11 March 2009 in relation to points (a), (b) and (d) of paragraph 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 11 March 2013.

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 forms part of the yearly reports presented pursuant to Article 35.

On the basis of these annual reports, the timetables established as referred to in the first subparagraph, could be adapted up to 11 March 2009 in relation to the first subparagraph and may be adapted up to 11 March 2013 in relation to the second subparagraph and after consultation of the entities referred to in the first subparagraph.

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 forms part of the yearly reports presented pursuant to Article 35. If these studies conclude, at the latest two years prior to the end of the maximum period referred to in the second subparagraph, that for technical reasons one or more tests referred to in that subparagraph will not be developed and validated before the expiry of the period referred to therein it shall inform the European Parliament and the Council and shall put forward a legislative proposal in accordance with Article 251 of the Treaty.

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 consulting the SCCS and by means of a reasoned decision, authorise the derogation. That authorisation shall lay down the conditions associated with this derogation in terms of specific objectives, duration and reporting of the results.

A derogation shall be granted only where:

(a)the ingredient is in wide use and cannot be replaced by another ingredient capable of performing 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 presented by the Commission in accordance with Article 35.

The measures referred to in the sixth subparagraph, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

3.For the purposes of this Article and Article 20:

(a)‘finished cosmetic product’ means the cosmetic product in its final formulation, as placed on the market and made available to the end user, 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.

CHAPTER VICONSUMER INFORMATION

Article 19Labelling

1.Without prejudice to other provisions in this Article, cosmetic products shall be made available on the market only where the container and packaging of cosmetic products bear the following information in indelible, easily legible and visible lettering:

(a)the name or registered name and the address of the responsible person. Such information may be abbreviated in so far as the abbreviation makes it possible to identify that person and his address. If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted. The country of origin shall be specified for imported cosmetic products;

(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 until which the cosmetic product, stored under appropriate conditions, will continue to fulfil its initial function and, in particular, will remain in conformity with Article 3 (‘date of minimum durability’).

The date itself or details of where it appears on the packaging shall be preceded by the symbol shown in point 3 of Annex VII or the words: ‘best used before the end of’.

The date of minimum durability 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 minimum 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 is safe and can be used without any harm to the consumer. This information shall be indicated, except where the concept of durability after opening is not relevant, by the symbol shown in point 2 of Annex VII followed by the period (in months and/or years);

(d)particular precautions to be observed in use, and at least those listed in Annexes III to VI and any special precautionary information on cosmetic products for professional use;

(e)the batch number of manufacture or the reference for identifying the cosmetic product. 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 cosmetic product, unless it is clear from its presentation;

(g)a list of ingredients. This information may be indicated on the packaging alone. The list shall be preceded by the term ‘ingredients’.

For the purpose of this Article, an ingredient means any substance or mixture intentionally used in the cosmetic product during the process of manufacturing. The following shall not, however, be regarded as ingredients:

(i)

impurities in the raw materials used;

(ii)

subsidiary technical materials used in the mixture but not present in the final product.

Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ or ‘aroma’. Moreover, the presence of substances, the mention of which is required under the column ‘Other’ in Annex III, shall be indicated in the list of ingredients in addition to the terms parfum or aroma.

The list of ingredients shall be established in descending order of weight of the ingredients at the time they are added to the cosmetic product. Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %.

All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word ‘nano’ in brackets.

Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients. For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol ‘+/-’ are added. The CI (Colour Index) nomenclature shall be used, where applicable.

2.Where it is impossible for practical reasons to label the information mentioned in points (d) and (g) of paragraph 1 as provided, the following applies:

  • the information shall be mentioned on an enclosed or attached leaflet, label, tape, tag or card;

  • unless impracticable, this information shall be referred to by abbreviated information or the symbol given in point 1 of Annex VII, which must appear on the container or packaging for the information referred in point (d) of paragraph 1 and on packaging for the information referred in point (g) of paragraph 1.

3.In the case of soap, bath balls and other small products where it is impossible for practical reasons for the information referred to in point (g) of paragraph 1 to appear on a label, tag, tape or card or in an enclosed leaflet, this information shall appear on a notice in immediate proximity to the container in which the cosmetic product is exposed for sale.

4.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 information referred to in paragraph 1.

5.The language of the information mentioned in points (b), (c), (d) and (f) of paragraph 1 and in paragraphs (2), (3) and (4) shall be determined by the law of the Member States in which the product is made available to the end user.

6.The information mentioned in point (g) of paragraph 1 shall be expressed by using the common ingredient name set out in the glossary provided for in Article 33. In the absence of a common ingredient name, a term as contained in a generally accepted nomenclature shall be used.

Article 20Product claims

1.In the labelling, making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall not be used to imply that these products have characteristics or functions which they do not have.

2.The Commission shall, in cooperation with Member States, establish an action plan regarding claims used and fix priorities for determining common criteria justifying the use of a claim.

After consulting the SCCS or other relevant authorities, the Commission shall adopt a list of common criteria for claims which may be used in respect of cosmetic products, in accordance with the regulatory procedure with scrutiny referred to in Article 32(3) of this Regulation, taking into account the provisions of Directive 2005/29/EC.

By 11 July 2016, the Commission shall submit to the European Parliament and the Council a report regarding the use of claims on the basis of the common criteria adopted under the second subparagraph. If the report concludes that claims used in respect of cosmetic products are not in conformity with the common criteria, the Commission shall take appropriate measures to ensure compliance in cooperation with the Member States.

3.The responsible person may refer, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the cosmetic product, to 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 cosmetic 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.

Article 21Access to information for the public

Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, the responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume and aromatic compositions, the name and code number of the composition and the identity of the supplier, as well as existing data on undesirable effects and serious undesirable effects resulting from use of the cosmetic product are made easily accessible to the public by any appropriate means.

The quantitative information regarding composition of the cosmetic product required to be made publicly accessible shall be limited to hazardous substances in accordance with Article 3 of Regulation (EC) No 1272/2008.

CHAPTER VIIMARKET SURVEILLANCE

Article 22In-market control

Member States shall monitor compliance with this Regulation via in-market controls of the cosmetic products made available on the market. They shall perform appropriate checks of cosmetic products and checks on the economic operators on an adequate scale, through the product information file and, where appropriate, physical and laboratory checks on the basis of adequate samples.

Member States shall also monitor compliance with the principles of good manufacturing practices.

Member States shall entrust to market surveillance authorities the necessary powers, resources and knowledge in order for those authorities to properly perform their tasks.

Member States shall periodically review and assess the functioning of their surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission and be made available to the public, by way of electronic communication and, where appropriate, by other means.

Article 23Communication of serious undesirable effects

1.In the event of serious undesirable effects, the responsible person and distributors shall without delay notify the following to the competent authority of the Member State where the serious undesirable effect occurred:

(a)all serious undesirable effects which are known to him or which may reasonably be expected to be known to him;

(b)the name of the cosmetic product concerned, enabling its specific identification;

(c)the corrective measures taken by him, if any.

2.Where the responsible person reports serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member States.

3.Where distributors report serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information referred to in paragraph 1 to the competent authorities of the other Member States and to the responsible person.

4.Where end users or health professionals report serious undesirable effects to the competent authority of the Member State where the effect occurred, that competent authority shall immediately transmit the information on the cosmetic product concerned to the competent authorities of the other Member States and to the responsible person.

5.Competent authorities may use the information referred to in this Article for the purposes of in-market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.

Article 24Information on substances

In the event of serious doubt regarding the safety of any substance contained in cosmetic products, the competent authority of a Member State in which a product containing such a substance is made available on the market may by reasoned request require the responsible person to submit a list of all cosmetic products for which he is responsible and which contain this substance. The list shall indicate the concentration of this substance in the cosmetic products.

Competent authorities may use the information referred to in this Article for the purposes of in-market surveillance, market analysis, evaluation and consumer information in the context of Articles 25, 26 and 27.

CHAPTER VIIINON-COMPLIANCE, SAFEGUARD CLAUSE

Article 25Non-compliance by the responsible person

1.Without prejudice to paragraph 4, competent authorities shall require the responsible person to take all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market or its recall, within an expressly mentioned time limit, commensurate with the nature of the risk, where there is non-compliance with any of the following:

(a)the good manufacturing practice referred to in Article 8;

(b)the safety assessment referred to in Article 10;

(c)the requirements for the product information file referred to in Article 11;

(d)the provisions on sampling and analysis referred to in Article 12;

(e)the notification requirements referred to in Articles 13 and 16;

(f)the restrictions for substances referred to in Articles 14, 15 and 17;

(g)the animal testing requirements referred to in Article 18;

(h)the labelling requirements referred to in Article 19(1), (2), (5) and (6);

(i)the requirements related to product claims set out in Article 20;

(j)the access to information for the public referred to in Article 21;

(k)the communication of serious undesirable effects referred to in Article 23;

(l)the information requirements on substances referred to in Article 24.

2.Where applicable, a competent authority shall inform the competent authority of the Member State in which the responsible person is established of the measures which it has required the responsible person to take.

3.The responsible person shall ensure that the measures referred to in paragraph 1 are taken in respect of all the products concerned which are made available on the market throughout the Community.

4.In the case of serious risks to human health, where the competent authority considers that the non-compliance is not limited to the territory of the Member State in which the cosmetic product is made available on the market, it shall inform the Commission and the competent authorities of the other Member States of the measures which it has required the responsible person to take.

5.The competent authority shall take all appropriate measures to prohibit or restrict the making available on the market of the cosmetic product or to withdraw the product from the market or to recall it in the following cases:

(a)where an immediate action is necessary in the event of serious risk to human health; or

(b)where the responsible person does not take all appropriate measures within the time limit referred to in paragraph 1.

In the event of serious risks to human health, that competent authority shall inform the Commission and the competent authorities of the other Member States, without delay, of the measures taken.

6.In the absence of a serious risk to human health, in the event that the responsible person does not take all appropriate measures, the competent authority shall without delay inform the competent authority of the Member State in which the responsible person is established of the measures taken.

7.For the purposes of paragraphs 4 and 5 of this Article, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC of the European Parliament and of the Council of 3 December 2001 on general product safety(16) shall be used.

Article 12(2), (3) and (4) of Directive 2001/95/EC and Article 23 of Regulation (EC) No 765/2008 of the European Parliament and of the Council of 9 July 2008 setting out the requirements for accreditation and market surveillance relating to the marketing of products(17) shall also apply.

Article 26Non-compliance by distributors

Competent authorities shall require distributors to take all appropriate measures, including corrective actions bringing the cosmetic product into conformity, the withdrawal of the product from the market or its recall, within a given reasonable time limit, commensurate with the nature of the risk, where there is non-compliance with obligations laid down in Article 6.

Article 27Safeguard clause

1.In the case of products meeting the requirements listed in Article 25(1), where a competent authority ascertains, or has reasonable grounds for concern, that a cosmetic product or products made available on the market present or could present a serious risk to human health, it shall take all appropriate provisional measures in order to ensure that the product or products concerned are withdrawn, recalled or their availability is otherwise restricted.

2.The competent authority shall immediately communicate to the Commission and the competent authorities of the other Member States the measures taken and any supporting data.

For the purposes of the first subparagraph, the information exchange system provided for in Article 12(1) of Directive 2001/95/EC shall be used.

Article 12(2), (3) and (4) of Directive 2001/95/EC shall apply.

3.The Commission shall determine, as soon as possible, whether the provisional measures referred to in paragraph 1 are justified or not. For that purpose it shall, whenever possible, consult the interested parties, the Member States and the SCCS.

4.Where the provisional measures are justified, Article 31(1) shall apply.

5.Where the provisional measures are not justified the Commission shall inform the Member States thereof and the competent authority concerned shall repeal the provisional measures in question.

Article 28Good administrative practices

1.Any decision taken pursuant to Articles 25 and 27 shall state the exact grounds on which it is based. It shall be notified by the competent authority without delay to the responsible person, who shall at the same time be informed of the remedies available to him under the law of the Member State concerned and of the time limits to which remedies are subject.

2.Except in the case where immediate action is necessary for reasons of serious risk to human health, the responsible person shall have the opportunity to put forward his viewpoint before any decision is taken.

3.Where applicable, the provisions mentioned in paragraphs 1 and 2 shall apply with regard to the distributor for any decisions taken pursuant to Articles 26 and 27.

CHAPTER IXADMINISTRATIVE COOPERATION

Article 29Cooperation between competent authorities

1.The competent authorities of the Member States shall cooperate with each other and with the Commission to ensure the proper application and due enforcement of this Regulation and shall transmit to each other all information necessary with a view to applying this Regulation uniformly.

2.The Commission shall provide for the organisation of an exchange of experience between the competent authorities in order to coordinate the uniform application of this Regulation.

3.Cooperation may be part of initiatives developed at international level.

Article 30Cooperation regarding verification of product information files

The competent authority of any Member State where the cosmetic product is made available may request the competent authority of the Member State where the product information file is made readily accessible to verify whether the product information file satisfies the requirements referred to in Article 11(2) and whether the information set out therein provides evidence of the safety of the cosmetic product.

The requesting competent authority shall provide a motivation for the request.

Upon that request, the competent authority requested shall, without undue delay and taking into account the degree of urgency, carry out the verification and shall inform the requesting competent authority of its findings.

CHAPTER XIMPLEMENTING MEASURES, FINAL PROVISIONS

Article 31Amendment of the Annexes

1.Where there is a potential risk to human health, arising from the use of substances in cosmetic products, which needs to be addressed on a Community-wide basis, the Commission may, after consulting the SCCS, amend Annexes II to VI accordingly.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 32(4).

2.The Commission may, after consulting the SCCS, amend Annexes III to VI and VIII for the purposes of adapting them to technical and scientific progress.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

3.Where it appears necessary, in order to ensure the safety of cosmetic products placed on the market, the Commission may, after consulting the SCCS, amend Annex I.

Those measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 32(3).

Article 32Committee procedure

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.Where reference is made to this paragraph, Article 5a(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.

4.Where reference is made to this paragraph, Article 5a(1), (2), (4) and (6) and Article 7 of Decision 1999/468/EC shall apply having regard to the provisions of Article 8 thereof.

Article 33Glossary of common ingredient names

The Commission shall compile and update a glossary of common ingredient names. To this end, the Commission shall take account of internationally recognised nomenclatures including the International Nomenclature of Cosmetic Ingredients (INCI). That glossary shall not constitute a list of the substances authorised for use in cosmetic products.

The common ingredient name shall be applied for the purpose of labelling cosmetic products placed on the market at the latest twelve months after publication of the glossary in the Official Journal of the European Union.

Article 34Competent authorities, poison control centres or assimilated entities

1.Member States shall designate their national competent authorities.

2.Member States shall communicate the details of authorities referred to in paragraph 1 and of the poison centres and similar bodies referred to in Article 13(6) to the Commission. They shall communicate an update of these details as necessary.

3.The Commission shall compile and update a list of the authorities and bodies referred to in paragraph 2 and make it available to the public.

Article 35Annual report on animal testing

Every year the Commission shall present a report to the European Parliament and the Council on:

(1)

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 Directive 86/609/EEC. The Commission shall in particular ensure the development, validation and legal acceptance of alternative test methods which do not use live animals;

(2)

progress made by the Commission in its efforts to obtain acceptance by the OECD of alternative methods validated at Community level and recognition by third 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;

(3)

the manner in which the specific needs of small and medium-sized enterprises have been taken into account.

Article 36Formal objection against harmonised standards

1.When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements set out in the relevant provisions of this Regulation, the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, giving its arguments. The Committee shall deliver its opinion without delay.

2.In the light of the Committee's opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in the Official Journal of the European Union.

3.The Commission shall inform the Member States and the European standardisation body concerned. It shall, if necessary, request the revision of the harmonised standards concerned.

Article 37Penalties

Member States shall lay down the provisions on penalties applicable for infringement of the provisions of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties provided for must be effective, proportionate and dissuasive. The Member States shall notify those provisions to the Commission by 11 July 2013 and shall notify it without delay of any subsequent amendment affecting them.

Article 38Repeal

Directive 76/768/EEC is repealed with effect from 11 July 2013, with the exception of Article 4b which is repealed with effect from 1 December 2010.

References to the repealed Directive shall be understood as references to this Regulation.

This Regulation shall be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Part B of Annex IX.

However, the competent authorities shall continue to keep available the information received pursuant to Article 7(3) and Article 7a(4) of Directive 76/768/EEC and responsible persons shall continue to keep readily accessible the information collected pursuant to Article 7a of that Directive until 11 July 2020.

Article 39Transitional provisions

By way of derogation from Directive 76/768/EEC, cosmetic products which comply with this Regulation may be placed on the market before 11 July 2013.

As from 11 January 2012, by way of derogation from Directive 76/768/EEC, notification carried out in accordance with Article 13 of this Regulation shall be considered to comply with Article 7(3) and Article 7a(4) of that Directive.

Article 40Entry into force and date of application

1.This Regulation shall enter into force on the [twentieth day after its publication in the Official Journal of the European Union

2.It shall apply from 11 July 2013, with the exception of:

  • Article 15(1) and (2) which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and

  • Article 16(3) second subparagraph, which shall apply from 11 January 2013.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels, 30 November 2009.

For the European Parliament

The President

J. Buzek

For the Council

The President

B. Ask

ANNEX ICOSMETIC PRODUCT SAFETY REPORT

The cosmetic product safety report shall, as a minimum, contain the following:

PART A –Cosmetic product safety information

1.Quantitative and qualitative composition of the cosmetic product

The qualitative and quantitative composition of the cosmetic product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS, where possible) and their intended function. In the case of perfume and aromatic compositions, description of the name and code number of the composition and the identity of the supplier.

2.Physical/chemical characteristics and stability of the cosmetic product

The physical and chemical characteristics of the substances or mixtures, as well as the cosmetic product.

The stability of the cosmetics product under reasonably foreseeable storage conditions.

3.Microbiological quality

The microbiological specifications of the substance or mixture and the cosmetic product. Particular attention shall be paid to cosmetics used around the eyes, on mucous membranes in general, on damaged skin, on children under three years of age, on elderly people and persons showing compromised immune responses.

Results of preservation challenge test.

4.Impurities, traces, information about the packaging material

The purity of the substances and mixtures.

In the case of traces of prohibited substances, evidence for their technical unavoidability.

The relevant characteristics of packaging material, in particular purity and stability.

5.Normal and reasonably foreseeable use

The normal and reasonably foreseeable use of the product. The reasoning shall be justified in particular in the light of warnings and other explanations in the product labelling.

6.Exposure to the cosmetic product

Data on the exposure to cosmetic product taking into consideration the findings under Section 5 in relation to

1)

The site(s) of application;

2)

The surface area(s) of application;

3)

The amount of product applied;

4)

The duration and frequency of use;

5)

The normal and reasonably foreseeable exposure route(s);

6)

The targeted (or exposed) population(s). Potential exposure of a specific population shall also be taken into account.

The calculation of the exposure shall also take into consideration the toxicological effects to be considered (e.g. exposure might need to be calculated per unit area of skin or per unit of body weight). The possibility of secondary exposure by routes other than those resulting from direct application should also be considered (e.g. non-intended inhalation of sprays, non-intended ingestion of lip products, etc.).

Particular consideration shall be given to any possible impacts on exposure due to particle sizes.

7.Exposure to the substances

Data on the exposure to the substances contained in the cosmetic product for the relevant toxicological endpoints taking into account the information under Section 6.

8.Toxicological profile of the substances

Without prejudice to Article 18, the toxicological profile of substance contained in the cosmetic product for all relevant toxicological endpoints. A particular focus on local toxicity evaluation (skin and eye irritation), skin sensitisation, and in the case of UV absorption photo-induced toxicity shall be made.

All significant toxicological routes of absorption shall be considered as well as the systemic effects and margin of safety (MoS) based on a no observed adverse effects level (NOAEL) shall be calculated. The absence of these considerations shall be duly justified.

Particular consideration shall be given to any possible impacts on the toxicological profile due to

  • particle sizes, including nanomaterials,

  • impurities of the substances and raw material used, and

  • interaction of substances.

Any read-across shall be duly substantiated and justified.

The source of information shall be clearly identified.

9.Undesirable effects and serious undesirable effects

All available data on the undesirable effects and serious undesirable effects to the cosmetic product or, where relevant, other cosmetic products. This includes statistical data.

10.Information on the cosmetic product

Other relevant information, e.g. existing studies from human volunteers or the duly confirmed and substantiated findings of risk assessments carried out in other relevant areas.

PART B –Cosmetic product safety assessment

1.Assessment conclusion

Statement on the safety of the cosmetic product in relation to Article 3.

2.Labelled warnings and instructions of use

Statement on the need to label any particular warnings and instructions of use in accordance with Article 19(1)(d).

3.Reasoning

Explanation of the scientific reasoning leading to the assessment conclusion set out under Section 1 and the statement set out under Section 2. This explanation shall be based on the descriptions set out under Part A. Where relevant, margins of safety shall be assessed and discussed.

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.

Possible interactions of the substances contained in the cosmetic product shall be assessed.

The consideration and non-consideration of the different toxicological profiles shall be duly justified.

Impacts of the stability on the safety of the cosmetic product shall be duly considered.

4.Assessor's credentials and approval of part B

Name and address of the safety assessor.

Proof of qualification of safety assessor.

Date and signature of safety assessor.

Preamble to Annexes II to VI

(1)

For the purposes of the Annexes II to VI:

(a)

‘Rinse-off product’ means a cosmetic product which is intended to be removed after application on the skin, the hair or the mucous membranes;

(b)

‘Leave-on product’ means a cosmetic product which is intended to stay in prolonged contact with the skin, the hair or the mucous membranes;

(c)

‘Hair product’ means a cosmetic product which is intended to be applied on the hair of head or face, except eye lashes;

(d)

‘Skin product’ means a cosmetic product which is intended to be applied on the skin;

(e)

‘Lip product’ means a cosmetic product which is intended to be applied on the lips;

(f)

‘Face product’ means a cosmetic product which is intended to be applied on the skin of the face;

(g)

‘Nail product’ means a cosmetic product which is intended to be applied on nails;

(h)

‘Oral product’ means a cosmetic product which is intended to be applied on teeth or the mucous membranes of the oral cavity;

(i)

‘Product applied on mucous membranes’ means a cosmetic product which is intended to be applied on the mucous membranes

  • of the oral cavity,

  • on the rim of the eyes,

  • or of the external genital organs;

(j)

‘Eye product’ means a cosmetic product which is intended to be applied in the vicinity of the eyes;

(k)

‘Professional use’ means the application and use of cosmetic products by persons in the exercise of their professional activity.

(2)

In order to facilitate substance identification, the following descriptors are used:

  • The Non-proprietary Names (INN) for pharmaceutical products, WHO, Geneva, August 1975;

  • The Chemical Abstracts Service numbers (CAS);

  • The EC number which correspond to either the European Inventory of Existing Commercial chemical Substances (EINECS) numbers or the European List of Notified Chemical Substances (ELINCS) numbers or the registration number given under Regulation (EC) No 1907/2006;

  • The XAN which is the name approved by specific country (X), e.g. USAN which correspond to the United State approved name;

  • The name in the glossary of common ingredient names referred to in Article 33 of this Regulation.

(3)

Substances listed in Annexes III to VI do not cover nanomaterials, except where specifically mentioned.

ANNEX IILIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS

b

Modified INNM-name.

d

for the individual ingredient see reference number 364 in Annex II.

e

for the individual ingredient see reference number 413 in Annex II.

Reference numberSubstance identification
Chemical name/INNCAS numberEC number
abcd
1N-(5-Chlorobenzoxazol-2-yl)acetamide35783-57-4
2(2-Acetoxyethyl)trimethylammonium hydroxide (Acetylcholine) and its salts51-84-3200-128-9
3Deanol aceglumate (INN)3342-61-8222-085-5
4Spironolactone (INN)52-01-7200-133-6
5[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid (Tiratricol (INN)) and its salts51-24-1200-086-1
6Methotrexate (INN)59-05-2200-413-8
7Aminocaproic acid (INN) and its salts60-32-2200-469-3
8Cinchophen (INN), its salts, derivatives and salts of these derivatives132-60-5205-067-1
9Thyropropic acid (INN) and its salts51-26-3
10Trichloroacetic acid76-03-9200-927-2
11 Aconitum napellus L. (leaves, roots and galenical preparations)84603-50-9283-252-6
12Aconitine (principal alkaloid of Aconitum napellus L.) and its salts302-27-2206-121-7
13 Adonis vernalis L. and its preparations84649-73-0283-458-6
14Epinephrine (INN)51-43-4200-098-7
15 Rauwolfia serpentina L., alkaloids and their salts90106-13-1290-234-1
16Alkyne alcohols, their esters, ethers and salts
17Isoprenaline (INN)7683-59-2231-687-7
18Allyl isothiocyanate57-06-7200-309-2
19Alloclamide (INN) and its salts5486-77-1
20Nalorphine (INN), its salts and ethers62-67-9200-546-1
21Sympathicomimetic 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 Europe300-62-9206-096-2
22Aniline, its salts and its halogenated and sulphonated derivatives62-53-3200-539-3
23Betoxycaine (INN) and its salts3818-62-0
24Zoxazolamine (INN)61-80-3200-519-4
25Procainamide (INN), its salts and derivatives51-06-9200-078-8
26Benzidine92-87-5202-199-1
27Tuaminoheptane (INN), its isomers and salts123-82-0204-655-5
28Octodrine (INN) and its salts543-82-8208-851-1
292-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts530-34-7
301,3-Dimethylpentylamine and its salts105-41-9203-296-1
314-Aminosalicylic acid and its salts65-49-6200-613-5
32Toluidines, their isomers, salts and halogenated and sulphonated derivatives26915-12-8248-105-2
33Xylidines, their isomers, salts and halogenated and sulphonated derivatives1300-73-8215-091-4
34Imperatorin (9-(3-methylbut-2-enyloxy)furo[3,2-g]chromen-7-one)482-44-0207-581-1
35 Ammi majus L. and its galenical preparations90320-46-0291-072-4
362,3-Dichloro-2-methylbutane507-45-9
37Substances with androgenic effect
38Anthracene oil120-12-7204-371-1
39Antibiotics
40Antimony and its compounds7440-36-0231-146-5
41 Apocynum cannabinum L. and its preparations84603-51-0283-253-1
42Apomorphine ((R) 5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol) and its salts58-00-4200-360-0
43Arsenic and its compounds7440-38-2231-148-6
44 Atropa belladonna L. and its preparations8007-93-0232-365-9
45Atropine, its salts and derivatives51-55-8200-104-8
46Barium salts, with the exception of barium sulphide under the conditions laid down in Annex III, and of barium sulfate, lakes, salts and pigments prepared from colouring agents when listed in Annex IV
47Benzene71-43-2200-753-7
48Benzimidazol-2(3H)-one615-16-7210-412-4
49Benzazepines and benzodiazepines12794-10-4
501-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts644-26-8211-411-1
512,2,6-Trimethyl-4-piperidyl benzoate (eucaine) and its salts500-34-5
52Isocarboxazid (INN)59-63-2200-438-4
53Bendroflumethiazide (INN) and its derivatives73-48-3200-800-1
54Beryllium and its compounds7440-41-7231-150-7
55Bromine, elemental7726-95-6231-778-1
56Bretylium tosilate (INN)61-75-6200-516-8
57Carbromal (INN)77-65-6201-046-6
58Bromisoval (INN)496-67-3207-825-7
59Brompheniramine (INN) and its salts86-22-6201-657-8
60Benzilonium bromide (INN)1050-48-2213-885-5
61Tetrylammonium bromide (INN)71-91-0200-769-4
62Brucine357-57-3206-614-7
63Tetracaine (INN) and its salts94-24-6202-316-6
64Mofebutazone (INN)2210-63-1218-641-1
65Tolbutamide (INN)64-77-7200-594-3
66Carbutamide (INN)339-43-5206-424-4
67Phenylbutazone (INN)50-33-9200-029-0
68Cadmium and its compounds7440-43-9231-152-8
69Cantharides, Cantharis vesicatoria92457-17-5296-298-7
70Cantharidine56-25-7200-263-3
71Phenprobamate (INN)673-31-4211-606-1
72Nitroderivatives of carbazole
73Carbon disulphide75-15-0200-843-6
74Catalase9001-05-2232-577-1
75Cephaeline and its salts483-17-0207-591-6
76 Chenopodium ambrosioides L. (essential oil)8006-99-3
772,2,2-Trichloroethane-1,1-diol302-17-0206-117-5
78Chlorine7782-50-5231-959-5
79Chlorpropamide (INN)94-20-2202-314-5
80Moved or deleted
814-Phenylazophenylene-1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride)5909-04-6
82Chlorzoxazone (INN)95-25-0202-403-9
832-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO)535-89-7208-622-6
84Chlorprothixene (INN) and its salts113-59-7204-032-8
85Clofenamide (INN)671-95-4211-588-5
86 N,N-bis(2-chloroethyl)methylamine N-oxide and its salts126-85-2
87Chlormethine (INN) and its salts51-75-2200-120-5
88Cyclophosphamide (INN) and its salts50-18-0200-015-4
89Mannomustine (INN) and its salts576-68-1209-404-3
90Butanilicaine (INN) and its salts3785-21-5
91Chlormezanone (INN)80-77-3201-307-4
92Triparanol (INN)78-41-1201-115-0
932-[2(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione (chlorophacinone-ISO)3691-35-8223-003-0
94Chlorphenoxamine (INN)77-38-3
95Phenaglycodol (INN)79-93-6201-235-3
96Chloroethane75-00-3200-830-5
97Chromium; chromic acid and its salts7440-47-3231-157-5
98 Claviceps purpurea Tul., its alkaloids and galenical preparations84775-56-4283-885-8
99 Conium maculatum L. (fruit, powder, galenical preparations)85116-75-2285-527-6
100Glycyclamide (INN)664-95-9211-557-6
101Cobalt benzenesulphonate23384-69-2
102Colchicine, its salts and derivatives64-86-8200-598-5
103Colchicoside and its derivatives477-29-2207-513-0
104 Colchicum autumnale L. and its galenical preparations84696-03-7283-623-2
105Convallatoxin508-75-8208-086-3
106 Anamirta cocculus L. (fruit)
107 Croton tiglium L. (oil)8001-28-3
1081-Butyl-3-(N-crotonoylsulphanilyl)urea52964-42-8
109Curare and curarine8063-06-7/22260-42-0232-511-1/244-880-6
110Synthetic curarizants
111Hydrogen cyanide and its salts74-90-8200-821-6
112Feclemine (INN); 2-(alpha-Cyclohexylbenzyl)-N,N,N',N'-tetraethyl-1,3-propanediamine3590-16-7
113Cyclomenol (INN) and its salts5591-47-9227-002-6
114Sodium hexacyclonate (INN)7009-49-6
115Hexapropymate (INN)358-52-1206-618-9
116Moved or deleted
117 O,O'-Diacetyl-N-allyl-N-normorphine2748-74-5
118Pipazetate (INN) and its salts2167-85-3218-508-8
119 5-(α,β-Dibromophenethyl)-5-methylhydantoin511-75-1208-133-8
120 N,N'-Pentamethylenebis(trimethylammonium) salts, e. g. pentamethonium bromide (INN)541-20-8208-771-7
121 N,N'-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, e. g. azamethonium bromide (INN)306-53-6206-186-1
122Cyclarbamate (INN)5779-54-4227-302-7
123Clofenotane (INN); DDT (ISO)50-29-3200-024-3
124 N,N'-Hexamethylenebis(trimethylammonium) salts, e. g. hexamethonium bromide (INN)55-97-0200-249-7
125Dichloroethanes (ethylene chlorides) e.g. 1,2-Dichloroethane107-06-2203-458-1
126Dichloroethylenes (acetylene chlorides) e.g. Vinylidene chloride (1,1-Dichloroethylene)75-35-4200-864-0
127Lysergide (INN) (LSD) and its salts50-37-3200-033-2
1282-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts3572-52-9222-686-2
129Cinchocaine (INN) and its salts85-79-0201-632-1
1303-Diethylaminopropyl cinnamate538-66-9
131 O,O'-Diethyl-O-4-nitrophenyl phosphorothioate (Parathion - ISO)56-38-2200-271-7
132[Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts, e. g. ambenonium chloride (INN)115-79-7204-107-5
133Methyprylon (INN) and its salts125-64-4204-745-4
134Digitaline and all heterosides of Digitalis purpurea L.752-61-4212-036-6
1357-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline (xanthinol)2530-97-4
136Dioxethedrin (INN) and its salts497-75-6207-849-8
137Piprocurarium iodide (INN)3562-55-8222-627-0
138Propyphenazone (INN)479-92-5207-539-2
139Tetrabenazine (INN) and its salts58-46-8200-383-6
140Captodiame (INN)486-17-9207-629-1
141Mefeclorazine (INN) and its salts1243-33-0
142Dimethylamine124-40-3204-697-4
1431,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine, alypine) and its salts963-07-5213-512-6
144Methapyrilene (INN) and its salts91-80-5202-099-8
145Metamfepramone (INN) and its salts15351-09-4239-384-1
146Amitriptyline (INN) and its salts50-48-6200-041-6
147Metformin (INN) and its salts657-24-9211-517-8
148Isosorbide dinitrate (INN)87-33-2201-740-9
149Malononitrile109-77-3203-703-2
150Succinonitrile110-61-2203-783-9
151Dinitrophenol isomers51-28-5/329-71-5/573-56-8/25550-58-7200-087-7/206-348-1/209-357-9/247-096-2
152Inproquone (INN)436-40-8
153Dimevamide (INN) and its salts60-46-8200-479-8
154Diphenylpyraline (INN) and its salts147-20-6205-686-7
155Sulfinpyrazone (INN)57-96-5200-357-4
156 N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethyl-ammonium salts, e. g. isopropamide iodide (INN)71-81-8200-766-8
157Benactyzine (INN)302-40-9206-123-8
158Benzatropine (INN) and its salts86-13-5
159Cyclizine (INN) and its salts82-92-8201-445-5
1605,5-Diphenyl-4-imidazolidone (Doxenitoin (INN))3254-93-1221-851-6
161Probenecid (INN)57-66-9200-344-3
162Disulfiram (INN); thiram (INN)97-77-8/137-26-8202-607-8/205-286-2
163Emetine, its salts and derivatives483-18-1207-592-1
164Ephedrine and its salts299-42-3206-080-5
165Oxanamide (INN) and its derivatives126-93-2
166Eserine or physostigmine and its salts57-47-6200-332-8
167Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in Annex VI
168Choline salts and their esters, e. g. choline chloride (INN)67-48-1200-655-4
169Caramiphen (INN) and its salts77-22-5201-013-6
170Diethyl 4-nitrophenyl phosphate (Paraoxon - ISO)311-45-5206-221-0
171Metethoheptazine (INN) and its salts509-84-2
172Oxpheneridine (INN) and its salts546-32-7
173Ethoheptazine (INN) and its salts77-15-6201-007-3
174Metheptazine (INN) and its salts469-78-3
175Methylphenidate (INN) and its salts113-45-1204-028-6
176Doxylamine (INN) and its salts469-21-6207-414-2
177Tolboxane (INN)2430-46-8
1784-Benzyloxyphenol and 4-ethoxyphenol103-16-2/622-62-8203-083-3/210-748-1
179Parethoxycaine (INN) and its salts94-23-5205-246-4
180Fenozolone (INN)15302-16-6239-339-6
181Glutethimide (INN) and its salts77-21-4201-012-0
182Ethylene oxide75-21-8200-849-9
183Bemegride (INN) and its salts64-65-3200-588-0
184Valnoctamide (INN)4171-13-5224-033-7
185Haloperidol (INN)52-86-8200-155-6
186Paramethasone (INN)53-33-8200-169-2
187Fluanisone (INN)1480-19-9216-038-8
188Trifluperidol (INN)749-13-3
189Fluoresone (INN)2924-67-6220-889-0
190Fluorouracil (INN)51-21-8200-085-6
191Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III7664-39-3231-634-8
192Furfuryltrimethylammonium salts, e. g. furtrethonium iodide (INN)541-64-0208-789-5
193Galantamine (INN)357-70-0
194Progestogens
1951,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)58-89-9200-401-2
196(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)72-20-8200-775-7
197Hexachloroethane67-72-1200-666-4
198(1R,4S,5R,8S)-1,2,3,4,10,10-Hexachloro-1,4,4a,5,8,8a-hexahydro-1,4:5,8-dimethanonaphthalene (isodrin-ISO)465-73-6207-366-2
199Hydrastine, hydrastinine and their salts118-08-1/6592-85-4204-233-0/229-533-9
200Hydrazides and their salts e.g. Isoniazid (INN)54-85-3200-214-6
201Hydrazine, its derivatives and their salts302-01-2206-114-9
202Octamoxin (INN) and its salts4684-87-1
203Warfarin (INN) and its salts81-81-2201-377-6
204Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid548-00-5208-940-5
205Methocarbamol (INN)532-03-6208-524-3
206Propatylnitrate (INN)2921-92-8220-866-5
2074,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin
208Fenadiazole (INN)1008-65-7
209Nitroxoline (INN) and its salts4008-48-4223-662-4
210Hyoscyamine, its salts and derivatives101-31-5202-933-0
211 Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)84603-65-6283-265-7
212Pemoline (INN) and its salts2152-34-3218-438-8
213Iodine7553-56-2231-442-4
214Decamethylenebis(trimethylammonium) salts, e. g. decamethonium bromide (INN)541-22-0208-772-2
215Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)8012-96-2232-385-8
216(2-Isopropylpent4-enoyl)urea (apronalide)528-92-7208-443-3
217α-Santonin [(3S,5aR,9bS)-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethylnaphto [1,2-b] furan-2,8-dione]481-06-1207-560-7
218 Lobelia inflata L. and its galenical preparations84696-23-1283-642-6
219Lobeline (INN) and its salts90-69-7202-012-3
220Barbiturates
221Mercury and its compounds, except those special cases included in Annex V7439-97-6231-106-7
2223,4,5-Trimethoxyphenethylamine (Mescaline) and its salts54-04-6200-190-7
223Metaldehyde9002-91-9
2242-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts305-13-5
225Coumetarol (INN)4366-18-1224-455-1
226Dextromethorphan (INN) and its salts125-71-3204-752-2
2272-Methylheptylamine and its salts540-43-2
228Isometheptene (INN) and its salts503-01-5207-959-6
229Mecamylamine (INN)60-40-2200-476-1
230Guaifenesin (INN)93-14-1202-222-5
231Dicoumarol (INN)66-76-2200-632-9
232Phenmetrazine (INN), its derivatives and salts134-49-6205-143-4
233Thiamazole (INN)60-56-0200-482-4
2343,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano [3,2-c]-[1] benzopyran-5-one (cyclocoumarol)518-20-7208-248-3
235Carisoprodol (INN)78-44-4201-118-7
236Meprobamate (INN)57-53-4200-337-5
237Tefazoline (INN) and its salts1082-56-0
238Arecoline63-75-2200-565-5
239Poldine metilsulfate (INN)545-80-2208-894-6
240Hydroxyzine (INN)68-88-2200-693-1
2412-Naphthol135-19-3205-182-7
2421-and 2-Naphthylamines and their salts134-32-7/91-59-8205-138-7/202-080-4
2433-(1-Naphthyl)-4-hydroxycoumarin39923-41-6
244Naphazoline (INN) and its salts835-31-4212-641-5
245Neostigmine and its salts e. g. neostigmine bromide (INN)114-80-7204-054-8
246Nicotine and its salts54-11-5200-193-3
247Amyl nitrites110-46-3203-770-8
248Inorganic nitrites, with the exception of sodium nitrite14797-65-0
249Nitrobenzene98-95-3202-716-0
250Nitrocresols and their alkali metal salts12167-20-3
251Nitrofurantoin (INN)67-20-9200-646-5
252Furazolidone (INN)67-45-8200-653-3
253Nitroglycerin; Propane-1,2,3-triyl trinitrate55-63-0200-240-8
254Acenocoumarol (INN)152-72-7205-807-3
255Alkali pentacyanonitrosylferrate (2-) e.g.14402-89-2/13755-38-9238-373-9 / -
256Nitrostilbenes, their homologues and their derivatives
257Noradrenaline and its salts51-41-2200-096-6
258Noscapine (INN) and its salts128-62-1204-899-2
259Guanethidine (INN) and its salts55-65-2200-241-3
260Oestrogens
261Oleandrin465-16-7207-361-5
262Chlortalidone (INN)77-36-1201-022-5
263Pelletierine and its salts2858-66-4/4396-01-4220-673-6/224-523-0
264Pentachloroethane76-01-7200-925-1
265Pentaerithrityl tetranitrate (INN)78-11-5201-084-3
266Petrichloral (INN)78-12-6
267Octamylamine (INN) and its salts502-59-0207-947-0
268Picric acid88-89-1201-865-9
269Phenacemide (INN)63-98-9200-570-2
270Difencloxazine (INN)5617-26-5
2712-Phenylindan-1,3-dione (phenindione (INN))83-12-5201-454-4
272Ethylphenacemide (pheneturide (INN))90-49-3201-998-2
273Phenprocoumon (INN)435-97-2207-108-9
274Fenyramidol (INN)553-69-5209-044-7
275Triamterene (INN) and its salts396-01-0206-904-3
276Tetraethyl pyrophosphate (TEPP - ISO)107-49-3203-495-3
277Tritolyl phosphate1330-78-5215-548-8
278Psilocybine (INN)520-52-5208-294-4
279Phosphorus and metal phosphides7723-14-0231-768-7
280Thalidomide (INN) and its salts50-35-1200-031-1
281 Physostigma venenosum Balf.89958-15-6289-638-0
282Picrotoxin124-87-8204-716-6
283Pilocarpine and its salts92-13-7202-128-4
284α-Piperidin-2-ylbenzyl acetate, laevorotatory threoform (levofacetoperane (INN)) and its salts24558-01-8
285Pipradrol (INN) and its salts467-60-7207-394-5
286Azacyclonol (INN) and its salts115-46-8204-092-5
287Bietamiverine (INN)479-81-2207-538-7
288Butopiprine (INN) and its salts55837-15-5259-848-7
289Lead and its compounds7439-92-1231-100-4
290Coniine458-88-8207-282-6
291 Prunus laurocerasus L. (‘cherry laurel water’)89997-54-6289-689-9
292Metyrapone (INN)54-36-4200-206-2
293Radioactive substances, as defined by Directive 96/29/Euratoma 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)90046-04-1289-971-1
295Hyoscine, its salts and derivatives51-34-3200-090-3
296Gold salts
297Selenium and its compounds with the exception of selenium disulphide under the conditions set out under reference No 49 in Annex III7782-49-2231-957-4
298 Solanum nigrum L. and its galenical preparations84929-77-1284-555-6
299Sparteine (INN) and its salts90-39-1201-988-8
300Glucocorticoids (Corticosteroids)
301 Datura stramonium L. and its galenical preparations84696-08-2283-627-4
302Strophantines, their aglucones and their respective derivatives11005-63-3234-239-9
303 Strophantus species and their galenical preparations
304Strychnine and its salts57-24-9200-319-7
305 Strychnos species and their galenical preparations
306Narcotics, 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
307Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts
308Sultiame (INN)61-56-3200-511-0
309Neodymium and its salts7440-00-8231-109-3
310Thiotepa (INN)52-24-4200-135-7
311 Pilocarpus jaborandi Holmes and its galenical preparations84696-42-4283-649-4
312Tellurium and its compounds13494-80-9236-813-4
313Xylometazoline (INN) and its salts526-36-3208-390-6
314Tetrachloroethylene127-18-4204-825-9
315Carbon tetrachloride56-23-5200-262-8
316Hexaethyl tetraphosphate757-58-4212-057-0
317Thallium and its compounds7440-28-0231-138-1
318 Thevetia neriifolia Juss., glycoside extract90147-54-9290-446-4
319Ethionamide (INN)536-33-4208-628-9
320Phenothiazine (INN) and its compounds92-84-2202-196-5
321Thiourea and its derivatives, with the exception of the one listed in Annex III62-56-6200-543-5
322Mephenesin (INN) and its esters59-47-2200-427-4
323Vaccines, toxins or serums defined as immunological medicinal products pursuant to Article 1(4) of Directive 2001/83/EC
324Tranylcypromine (INN) and its salts155-09-9205-841-9
325Trichloronitromethane (chloropicrine)76-06-2200-930-9
3262,2,2-Tribromoethanol (tribromoethyl alcohol)75-80-9200-903-1
327Trichlormethine (INN) and its salts817-09-4212-442-3
328Tretamine (INN)51-18-3200-083-5
329Gallamine triethiodide (INN)65-29-2200-605-1
330 Urginea scilla Steinh. and its galenical preparations84650-62-4283-520-2
331Veratrine, its salts and galenical preparations8051-02-3613-062-00-4
332 Schoenocaulon officinale Lind (seeds and galenical preparations)84604-18-2283-296-6
333 Veratrum spp. and their preparations90131-91-2290-407-1
334Vinyl chloride monomer75-01-4200-831-0
335Ergocalciferol (INN) and cholecalciferol (vitamins D2 and D3)50-14-6/67-97-0200-014-9/200-673-2
336Salts of O-alkyldithiocarbonic acids (xanthates)
337Yohimbine and its salts146-48-5205-672-0
338Dimethyl sulfoxide (INN)67-68-5200-664-3
339Diphenhydramine (INN) and its salts58-73-1200-396-7
3404-tert-Butylphenol98-54-4202-679-0
3414-tert-Butylpyrocatechol98-29-3202-653-9
342Dihydrotachysterol (INN)67-96-9200-672-7
343Dioxane123-91-1204-661-8
344Morpholine and its salts110-91-8203-815-1
345. Pyrethrum album L. and its galenical preparations
3462-[4-Methoxybenzyl-N-(2-pyridyl)amino]ethyldimethylamine maleate (Mepyramine maleate; pyrilamine maleate)59-33-6200-422-7
347Tripelennamine (INN)91-81-6202-100-1
348Tetrachlorosalicylanilides7426-07-5
349Dichlorosalicylanilides1147-98-4
350Tetrabromosalicylanilides
351Dibromosalicylanilides
352Bithionol (INN)97-18-7202-565-0
353Thiuram monosulphides97-74-5202-605-7
354Moved or deleted
355Dimethylformamide (N,N-Dimethylformamide)68-12-2200-679-5
3564-Phenylbut-3-en-2-one (Benzylidene acetone)122-57-6204-555-1
357Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol (coniferyl alcohol) except for normal content in natural essences used
358

Furocoumarines (e. g. trioxysalen (INN), 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

3902-71-4/298-81-7/484-20-8223-459-0/206-066-9/207-604-5
359Oil from the seeds of Laurus nobilis L.84603-73-6283-272-5
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

94-59-7202-345-4
3615,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite (thymol iodide)552-22-7209-007-5
3623'-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 (AETT; Versalide)88-29-9201-817-7
363 o-Phenylenediamine and its salts95-54-5202-430-6
3644-Methyl-m-phenylenediamine (Toluene-2,4-diamine) and its salts95-80-7202-453-1
365Aristolochic acid and its salts; Aristolochia spp. and their preparations475-80-9/313-67-7/15918-62-4202-499-6/206-238-3/-
366Chloroform67-66-3200-663-8
3672,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD)1746-01-6217-122-7
3682,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane)828-00-2212-579-9
369Pyrithione sodium (INNM)b3811-73-2223-296-5
370 N-(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (Captan - ISO)133-06-2205-087-0
3712,2'-Dihydroxy-3,3',5,5',6,6'-hexachlorodiphenylmethane (Hexachlorophene (INN))70-30-4200-733-8
3726-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide (Minoxidil (INN)) and its salts38304-91-5253-874-2
3733,4',5-Tribromosalicylanilide (Tribromsalan (INN))87-10-5201-723-6
374 Phytolacca spp. and their preparations65497-07-6/60820-94-2
375Tretinoin (INN) (retinoic acid and its salts)302-79-4206-129-0
3761-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole - CI 76050) and its salts615-05-4210-406-1
3771-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) and its salts5307-02-8226-161-9
378Colouring agent CI 121403118-97-6221-490-4
379Colouring agent CI 26105 (Solvent Red 24)85-83-6201-635-8
380

Colouring agent CI 42555 (Basic Violet 3)

Colouring agent CI 42555:1

Colouring agent CI 42555:2

548-62-9

467-63-0

208-953-6

207-396-6

381Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN))14779-78-3238-849-6
3832-Amino-4-nitrophenol99-57-0202-767-9
3842-Amino-5-nitrophenol121-88-0204-503-8
38511-α-Hydroxypregn-4-ene-3,20-dione and its esters80-75-1201-306-9
386Colouring agent CI 42640 ([4-[[4-(Dimethylamino)phenyl][4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt)1694-09-3216-901-9
387Colouring agent CI 13065587-98-4209-608-2
388Colouring agent CI 42535 (Basic Violet 1)8004-87-3
389Colouring agent CI 61554 (Solvent Blue 35)17354-14-2241-379-4
390Anti-androgens of steroidal structure
391Zirconium and its compounds, with the exception of the substances listed under reference number 50 in Annex III, and the zirconium lakes, pigments or salts of the colouring agents when listed in Annex IV7440-67-7231-176-9
392Moved or deleted
393Acetonitrile75-05-8200-835-2
394Tetrahydrozoline (Tetryzoline (INN)) and its salts84-22-0201-522-3
395Hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51 in Annex III148-24-3/134-31-6205-711-1/205-137-1
396Dithio-2,2-bispyridine-dioxide 1,1' (additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate)43143-11-9256-115-3
397Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts3468-63-1222-429-4
398Colouring agent CI 45170 and CI 45170:1 (Basic Violet 10)81-88-9/509-34-2201-383-9/208-096-8
399Lidocaine (INN)137-58-6205-302-8
4001,2-Epoxybutane106-88-7203-438-2
401Colouring agent CI 155855160-02-1/2092-56-0225-935-3/218-248-5
402Strontium lactate29870-99-3249-915-9
403Strontium nitrate10042-76-9233-131-9
404Strontium polycarboxylate
405Pramocaine (INN)140-65-8205-425-7
4064-Ethoxy-m-phenylenediamine and its salts5862-77-1
4072,4-Diaminophenylethanol and its salts14572-93-1
408Pyrocatechol (Catechol)120-80-9204-427-5
409Pyrogallol87-66-1201-762-9
410Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-Nitrosoimino)bisethanol62-75-9/621-64-7/1116-54-7200-549-8/210-698-0/214-237-4
411Secondary alkyl- and alkanolamines and their salts
4124-Amino-2-nitrophenol119-34-6204-316-1
4132-Methyl-m-phenylenediamine (Toluene-2,6-diamine)823-40-5212-513-9
4144-tert.-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette)83-66-9201-493-7
415Moved or deleted
416Cells, tissues or products of human origin
4173,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein (INN))77-09-8201-004-7
4183-Imidazol-4-ylacrylic acid (Urocanic acid) and its ethyl ester104-98-3/27538-35-8203-258-4/248-515-1
419Category 1 material and Category 2 material as defined in Articles 4 and 5 respectively of Regulation (EC) No 1774/2002 of the European Parliament and of the Councilc, and ingredients derived therefrom
420Crude and refined coal tars8007-45-2232-361-7
4211,1,3,3,5-Pentamethyl-4,6-dinitroindane (Moskene)116-66-5204-149-4
4225-tert.-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (Musk Tibetene)145-39-1205-651-6
423Alanroot oil (Inula helenium L.), when used as a fragrance ingredient97676-35-2
424Benzyl cyanide, when used as a fragrance ingredient140-29-4205-410-5
425Cyclamen alcohol, when used as a fragrance ingredient4756-19-8225-289-2
426Diethyl maleate, when used as a fragrance ingredient141-05-9205-451-9
4273,4-Dihydrocoumarin, when used as a fragrance ingredient119-84-6204-354-9
4282,4-Dihydroxy-3-methylbenzaldehyde, when used as a fragrance ingredient6248-20-0228-369-5
4293,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol), when used as a fragrance ingredient40607-48-5254-999-5
4304,6-Dimethyl-8-tert-butylcoumarin, when used as a fragrance ingredient17874-34-9241-827-9
431Dimethyl citraconate, when used as a fragrance ingredient617-54-9
4327,11-Dimethyl-4,6,10-dodecatrien-3-one (Pseudomethylionone), when used as a fragrance ingredient26651-96-7247-878-3
4336,10-Dimethyl-3,5,9-undecatrien-2-one (Pseudoionone)(, when used as a fragrance ingredient141-10-6205-457-1
434Diphenylamine, when used as a fragrance ingredient122-39-4204-539-4
435Ethyl acrylate, when used as a fragrance ingredient140-88-5205-438-8
436Fig leaf absolute (Ficus carica L.), when used as a fragrance ingredient68916-52-9
437 trans-2-Heptenal, when used as a fragrance ingredient18829-55-5242-608-0
438 trans-2-Hexenal diethyl acetal, when used as a fragrance ingredient67746-30-9266-989-8
439 trans-2-Hexenal dimethyl acetal, when used as a fragrance ingredient18318-83-7242-204-4
440Hydroabietyl alcohol, when used as a fragrance ingredient13393-93-6236-476-3
4416-Isopropyl-2-decahydronaphthalenol, when used as a fragrance ingredient34131-99-2251-841-7
4427-Methoxycoumarin, when used as a fragrance ingredient531-59-9208-513-3
4434-(4-Methoxyphenyl)-3-butene-2-one (Anisylidene acetone), when used as a fragrance ingredient943-88-4213-404-9
4441-(4-Methoxyphenyl)-1-penten-3-one (alpha-Methylanisylideneacetone), when used as a fragrance ingredient104-27-8203-190-5
445Methyl trans-2-butenoate, when used as a fragrance ingredient623-43-8210-793-7
4467-Methylcoumarin, when used as a fragrance ingredient2445-83-2219-499-3
4475-Methyl-2,3-hexanedione (Acetyl isovaleryl), when used as a fragrance ingredient13706-86-0237-241-8
4482-Pentylidenecyclohexanone, when used as a fragrance ingredient25677-40-1247-178-8
4493,6,10-Trimethyl-3,5,9-undecatrien-2-one (Pseudo-Isomethyl ionone), when used as a fragrance ingredient1117-41-5214-245-8
450Verbena oil (Lippia citriodora Kunth.), when used as a fragrance ingredient8024-12-2
451Moved or deleted
4526-(2-Chloroethyl)-6-(2-methoxyethoxy)-2,5,7,10-tetraoxa-6-silaundecane37894-46-5253-704-7
453Cobalt dichloride7646-79-9231-589-4
454Cobalt sulphate10124-43-3233-334-2
455Nickel monoxide1313-99-1215-215-7
456Dinickel trioxide1314-06-3215-217-8
457Nickel dioxide12035-36-8234-823-3
458Trinickel disulphide12035-72-2234-829-6
459Tetracarbonylnickel13463-39-3236-669-2
460Nickel sulphide16812-54-7240-841-2
461Potassium bromate7758-01-2231-829-8
462Carbon monoxide630-08-0211-128-3
463Buta-1,3-diene, see also entries 464-611106-99-0203-450-8
464Isobutane, if it contains ≥ 0,1 % w/w Butadiene75-28-5200-857-2
465Butane, if it contains ≥ 0,1 % w/w Butadiene106-97-8203-448-7
466Gases (petroleum), C3-4, if they contain > 0,1 % w/w Butadiene68131-75-9268-629-5
467Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber, if it contains > 0,1 % w/w Butadiene68307-98-2269-617-2
468Tail gas (petroleum), catalytic polymn. naphtha fractionation stabiliser, if it contains > 0,1 % w/w Butadiene68307-99-3269-618-8
469Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene68308-00-9269-619-3
470Tail gas (petroleum), cracked distillate hydrotreater stripper, if it contains > 0,1 % w/w Butadiene68308-01-0269-620-9
471Tail gas (petroleum), gas oil catalytic cracking absorber, if it contains > 0,1 % w/w Butadiene68308-03-2269-623-5
472Tail gas (petroleum), gas recovery plant, if it contains > 0,1 % w/w Butadiene68308-04-3269-624-0
473Tail gas (petroleum), gas recovery plant deethaniser, if it contains > 0,1 % w/w Butadiene68308-05-4269-625-6
474Tail gas (petroleum), hydrodesulfurised distillate and hydrodesulfurised naphtha fractionator, acid-free, if it contains > 0,1 % w/w Butadiene68308-06-5269-626-1
475Tail gas (petroleum), hydrodesulfurised vacuum gas oil stripper, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene68308-07-6269-627-7
476Tail gas (petroleum), isomerised naphtha fractionation stabiliser, if it contains > 0,1 % w/w Butadiene68308-08-7269-628-2
477Tail gas (petroleum), light straight-run naphtha stabiliser, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene68308-09-8269-629-8
478Tail gas (petroleum), straight-run distillate hydrodesulfurised, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene68308-10-1269-630-3
479Tail gas (petroleum), propane-propylene alkylation feed prep deethaniser, if it contains > 0,1 % w/w Butadiene68308-11-2269-631-9
480Tail gas (petroleum), vacuum gas oil hydrodesulfurised, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene68308-12-3269-632-4
481Gases (petroleum), catalytic cracked overheads, if they contain > 0,1 % w/w Butadiene68409-99-4270-071-2
482Alkanes, C1-2, if they contain > 0,1 % w/w Butadiene68475-57-0270-651-5
483Alkanes, C2-3, if they contain > 0,1 % w/w Butadiene68475-58-1270-652-0
484Alkanes, C3-4, if they contain > 0,1 % w/w Butadiene68475-59-2270-653-6
485Alkanes, C4-5, if they contain > 0,1 % w/w Butadiene68475-60-5270-654-1
486Fuel-gases, if they contain > 0,1 % w/w Butadiene68476-26-6270-667-2
487Fuel gases, crude oil distillates, if they contain > 0,1 % w/w Butadiene68476-29-9270-670-9
488Hydrocarbons, C3-4, if they contain > 0,1 % w/w Butadiene68476-40-4270-681-9
489Hydrocarbons, C4-5, if they contain > 0,1 % w/w Butadiene68476-42-6270-682-4
490Hydrocarbons, C2-4, C3-rich, if they contain > 0,1 % w/w Butadiene68476-49-3270-689-2
491Petroleum gases, liquefied, if they contain > 0,1 % w/w Butadiene68476-85-7270-704-2
492Petroleum gases, liquefied, sweetened, if they contain > 0,1 % w/w Butadiene68476-86-8270-705-8
493Gases (petroleum), C3-4, isobutane-rich if they contain > 0,1 % w/w Butadiene68477-33-8270-724-1
494Distillates (petroleum), C3-6, piperylene-rich, if they contain > 0,1 % w/w Butadiene68477-35-0270-726-2
495Gases (petroleum), amine system feed, if they contain > 0,1 % w/w Butadiene68477-65-6270-746-1
496Gases (petroleum), benzene unit hydrodesulfurised off, if they contain > 0,1 % w/w Butadiene68477-66-7270-747-7
497Gases (petroleum), benzene unit recycle, hydrogen-rich, if they contain > 0,1 % w/w Butadiene68477-67-8270-748-2
498Gases (petroleum), blend oil, hydrogen-nitrogen-rich, if they contain > 0,1 % w/w Butadiene68477-68-9270-749-8
499Gases (petroleum), butane splitter overheads, if they contain > 0,1 % w/w Butadiene68477-69-0270-750-3
500Gases (petroleum), C2-3, if they contain > 0,1 % w/w Butadiene68477-70-3270-751-9
501Gases (petroleum), catalytic-cracked gas oil depropaniser bottoms, C4-rich acid-free, if they contain > 0,1 % w/w Butadiene68477-71-4270-752-4
502Gases (petroleum), catalytic-cracked naphtha debutaniser bottoms, C3-5-rich, if they contain > 0,1 % w/w Butadiene68477-72-5270-754-5
503Gases (petroleum), catalytic cracked naphtha depropaniser overhead, C3-rich acid-free, if they contain > 0,1 % w/w Butadiene68477-73-6270-755-0
504Gases (petroleum), catalytic cracker, if they contain > 0,1 % w/w Butadiene68477-74-7270-756-6
505Gases (petroleum), catalytic cracker, C1-5-rich, if they contain > 0,1 % w/w Butadiene68477-75-8270-757-1
506Gases (petroleum), catalytic polymd. naphtha stabiliser overhead, C2-4-rich, if they contain > 0,1 % w/w Butadiene68477-76-9270-758-7
507Gases (petroleum), catalytic reformed naphtha stripper overheads, if they contain > 0,1 % w/w Butadiene68477-77-0270-759-2
508Gases (petroleum), catalytic reformer, C1-4-rich, if they contain > 0,1 % w/w Butadiene68477-79-2270-760-8
509Gases (petroleum), C6-8 catalytic reformer recycle, if they contain > 0,1 % w/w Butadiene68477-80-5270-761-3
510Gases (petroleum), C6-8 catalytic reformer, if they contain > 0,1 % w/w Butadiene68477-81-6270-762-9
511Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich, if they contain > 0,1 % w/w Butadiene68477-82-7270-763-4
512Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed, if they contain > 0,1 % w/w Butadiene68477-83-8270-765-5
513Gases (petroleum), C2-return stream, if they contain > 0,1 % w/w Butadiene68477-84-9270-766-0
514Gases (petroleum), C4-rich, if they contain > 0,1 % w/w Butadiene68477-85-0270-767-6
515Gases (petroleum), deethaniser overheads, if they contain > 0,1 % w/w Butadiene68477-86-1270-768-1
516Gases (petroleum), deisobutaniser tower overheads, if they contain > 0,1 % w/w Butadiene68477-87-2270-769-7
517Gases (petroleum), depropaniser dry, propene-rich, if they contain > 0,1 % w/w Butadiene68477-90-7270-772-3
518Gases (petroleum), depropaniser overheads, if they contain > 0,1 % w/w Butadiene68477-91-8270-773-9
519Gases (petroleum), dry sour, gas-concn. -unit-off, if they contain > 0,1 % w/w Butadiene68477-92-9270-774-4
520Gases (petroleum), gas concn. reabsorber distn., if they contain > 0,1 % w/w Butadiene68477-93-0270-776-5
521Gases (petroleum), gas recovery plant depropaniser overheads, if they contain > 0,1 % w/w Butadiene68477-94-1270-777-0
522Gases (petroleum), Girbatol unit feed, if they contain > 0,1 % w/w Butadiene68477-95-2270-778-6
523Gases (petroleum), hydrogen absorber off, if they contain > 0,1 % w/w Butadiene68477-96-3270-779-1
524Gases (petroleum), hydrogen-rich, if they contain > 0,1 % w/w Butadiene68477-97-4270-780-7
525Gases (petroleum), hydrotreater blend oil recycle, hydrogen-nitrogen-rich, if they contain > 0,1 % w/w Butadiene68477-98-5270-781-2
526Gases (petroleum), isomerised naphtha fractionator, C4-rich, hydrogen sulfide-free, if they contain > 0,1 % w/w Butadiene68477-99-6270-782-8
527Gases (petroleum), recycle, hydrogen-rich, if they contain > 0,1 % w/w Butadiene68478-00-2270-783-3
528Gases (petroleum), reformer make-up, hydrogen-rich, if they contain > 0,1 % w/w Butadiene68478-01-3270-784-9
529Gases (petroleum), reforming hydrotreater, if they contain > 0,1 % w/w Butadiene68478-02-4270-785-4
530Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich, if they contain > 0,1 % w/w Butadiene68478-03-5270-787-5
531Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich, if they contain > 0,1 % w/w Butadiene68478-04-6270-788-0
532Gases (petroleum), thermal cracking distn., if they contain > 0,1 % w/w Butadiene68478-05-7270-789-6
533Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked vacuum residue fractionation reflux drum, if it contains > 0,1 % w/w Butadiene68478-21-7270-802-5
534Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber, if it contains > 0,1 % w/w Butadiene68478-22-8270-803-0
535Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulfurised combined fractionater, if it contains > 0,1 % w/w Butadiene68478-24-0270-804-6
536Tail gas (petroleum), catalytic cracker refractionation absorber, if it contains > 0,1 % w/w Butadiene68478-25-1270-805-1
537Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser, if it contains > 0,1 % w/w Butadiene68478-26-2270-806-7
538Tail gas (petroleum), catalytic reformed naphtha separator, if it contains > 0,1 % w/w Butadiene68478-27-3270-807-2
539Tail gas (petroleum), catalytic reformed naphtha stabiliser, if it contains > 0,1 % w/w Butadiene68478-28-4270-808-8
540Tail gas (petroleum), cracked distillate hydrotreater separator, if it contains > 0,1 % w/w Butadiene68478-29-5270-809-3
541Tail gas (petroleum), hydrodesulfurised straight-run naphtha separator, if it contains > 0,1 % w/w Butadiene68478-30-8270-810-9
542Tail gas (petroleum), saturate gas plant mixed stream, C4-rich, if it contains > 0,1 % w/w Butadiene68478-32-0270-813-5
543Tail gas (petroleum), saturate gas recovery plant, C1-2-rich, if it contains > 0,1 % w/w Butadiene68478-33-1270-814-0
544Tail gas (petroleum), vacuum residues thermal cracker, if it contains > 0,1 % w/w Butadiene68478-34-2270-815-6
545Hydrocarbons, C3-4-rich, petroleum distillate, if they contain > 0,1 % w/w Butadiene68512-91-4270-990-9
546Gases (petroleum), catalytic reformed straight-run naphtha stabiliser overheads, if they contain > 0,1 % w/w Butadiene68513-14-4270-999-8
547Gases (petroleum), full-range straight-run naphtha dehexaniser off, if they contain > 0,1 % w/w Butadiene68513-15-5271-000-8
548Gases (petroleum), hydrocracking depropaniser off, hydrocarbon-rich, if they contain > 0,1 % w/w Butadiene68513-16-6271-001-3
549Gases (petroleum), light straight-run naphtha stabiliser off, if they contain > 0,1 % w/w Butadiene68513-17-7271-002-9
550Gases (petroleum), reformer effluent high-pressure flash drum off, if they contain > 0,1 % w/w Butadiene68513-18-8271-003-4
551Gases (petroleum), reformer effluent low-pressure flash drum off, if they contain > 0,1 % w/w Butadiene68513-19-9271-005-5
552Residues (petroleum), alkylation splitter, C4-rich, if they contain > 0,1 % w/w Butadiene68513-66-6271-010-2
553Hydrocarbons, C1-4, if they contain > 0,1 % w/w Butadiene68514-31-8271-032-2
554Hydrocarbons, C1-4, sweetened, if they contain > 0,1 % w/w Butadiene68514-36-3271-038-5
555Gases (petroleum), oil refinery gas distn. off, if they contain > 0,1 % w/w Butadiene68527-15-1271-258-1
556Hydrocarbons, C1-3, if they contain > 0,1 % w/w Butadiene68527-16-2271-259-7
557Hydrocarbons, C1-4, debutaniser fraction, if they contain > 0,1 % w/w Butadiene68527-19-5271-261-8
558Gases (petroleum), benzene unit hydrotreater depentaniser overheads, if they contain > 0,1 % w/w Butadiene68602-82-4271-623-5
559Gases (petroleum), C1-5, wet, if they contain > 0,1 % w/w Butadiene68602-83-5271-624-0
560Gases (petroleum), secondary absorber off, fluidised catalytic cracker overheads fractionator, if they contain > 0,1 % w/w Butadiene68602-84-6271-625-6
561Hydrocarbons, C2-4, if they contain > 0,1 % w/w Butadiene68606-25-7271-734-9
562Hydrocarbons, C3, if they contain > 0,1 % w/w Butadiene68606-26-8271-735-4
563Gases (petroleum), alkylation feed, if they contain > 0,1 % w/w Butadiene68606-27-9271-737-5
564Gases (petroleum), depropaniser bottoms fractionation off, if they contain > 0,1 % w/w Butadiene68606-34-8271-742-2
565Petroleum products, refinery gases, if they contain > 0,1 % w/w Butadiene68607-11-4271-750-6
566Gases (petroleum), hydrocracking low-pressure separator, if they contain > 0,1 % w/w Butadiene68783-06-2272-182-1
567Gases (petroleum), refinery blend, if they contain > 0,1 % w/w Butadiene68783-07-3272-183-7
568Gases (petroleum), catalytic cracking, if they contain > 0,1 % w/w Butadiene68783-64-2272-203-4
569Gases (petroleum), C2-4, sweetened, if they contain > 0,1 % w/w Butadiene68783-65-3272-205-5
570Gases (petroleum), refinery, if they contain > 0,1 % w/w Butadiene68814-67-5272-338-9
571Gases (petroleum), platformer products separator off, if they contain > 0,1 % w/w Butadiene68814-90-4272-343-6
572Gases (petroleum), hydrotreated sour kerosine depentaniser stabiliser off, if they contain > 0,1 % w/w Butadiene68911-58-0272-775-5
573Gases (petroleum), hydrotreated sour kerosine flash drum, if they contain > 0,1 % w/w Butadiene68911-59-1272-776-0
574Gases (petroleum), crude oil fractionation off, if they contain > 0,1 % w/w Butadiene68918-99-0272-871-7
575Gases (petroleum), dehexaniser off, if they contain > 0,1 % w/w Butadiene68919-00-6272-872-2
576Gases (petroleum), distillate unifiner desulfurisation stripper off, if they contain > 0,1 % w/w Butadiene68919-01-7272-873-8
577Gases (petroleum), fluidised catalytic cracker fractionation off if they contain > 0,1 % w/w Butadiene68919-02-8272-874-3
578Gases (petroleum), fluidised catalytic cracker scrubbing secondary absorber off, if they contain > 0,1 % w/w Butadiene68919-03-9272-875-9
579Gases (petroleum), heavy distillate hydrotreater desulfurisation stripper off, if they contain > 0,1 % w/w Butadiene68919-04-0272-876-4
580Gases (petroleum), light straight run gasoline fractionation stabiliser off, if they contain > 0,1 % w/w Butadiene68919-05-1272-878-5
581Gases (petroleum), naphtha unifiner desulfurisation stripper off, if they contain > 0,1 % w/w Butadiene68919-06-2272-879-0
582Gases (petroleum), platformer stabiliser off, light ends fractionation, if they contain > 0,1 % w/w Butadiene68919-07-3272-880-6
583Gases (petroleum), preflash tower off, crude distn., if they contain > 0,1 % w/w Butadiene68919-08-4272-881-1
584Gases (petroleum), straight-run naphtha catalytic reforming off, if they contain > 0,1 % w/w Butadiene68919-09-5272-882-7
585Gases (petroleum), straight-run stabiliser off, if they contain > 0,1 % w/w Butadiene68919-10-8272-883-2
586Gases (petroleum), tar stripper off, if they contain > 0,1 % w/w Butadiene68919-11-9272-884-8
587Gases (petroleum), unifiner stripper off, if they contain > 0,1 % w/w Butadiene68919-12-0272-885-3
588Gases (petroleum), fluidised catalytic cracker splitter overheads, if they contain > 0,1 % w/w Butadiene68919-20-0272-893-7
589Gases (petroleum), catalytic cracked naphtha debutaniser, if they contain > 0,1 % w/w Butadiene68952-76-1273-169-3
590Tail gas (petroleum), catalytic cracked distillate and naphtha stabiliser, if it contains > 0,1 % w/w Butadiene68952-77-2273-170-9
591Tail gas (petroleum), catalytic hydrodesulfurised naphtha separator, if it contains > 0,1 % w/w Butadiene68952-79-4273-173-5
592Tail gas (petroleum), straight-run naphtha hydrodesulfurised, if it contains > 0,1 % w/w Butadiene68952-80-7273-174-0
593Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber, if it contains > 0,1 % w/w Butadiene68952-81-8273-175-6
594Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabiliser, petroleum coking, if it contains > 0,1 % w/w Butadiene68952-82-9273-176-1
595Gases (petroleum), light steam-cracked, butadiene conc., if they contain > 0,1 % w/w Butadiene68955-28-2273-265-5
596Gases (petroleum), sponge absorber off, fluidised catalytic cracker and gas oil desulfuriser overhead fractionation, if they contain > 0,1 % w/w Butadiene68955-33-9273-269-7
597Gases (petroleum), straight-run naphtha catalytic reformer stabiliser overhead, if they contain > 0,1 % w/w Butadiene68955-34-0273-270-2
598Gases (petroleum), crude distn. and catalytic cracking, if they contain > 0,1 % w/w Butadiene68989-88-8273-563-5
599Hydrocarbons, C4, if they contain > 0,1 % w/w Butadiene87741-01-3289-339-5
600Alkanes, C1-4, C3-rich, if they contain > 0,1 % w/w Butadiene90622-55-2292-456-4
601Gases (petroleum), gas oil diethanolamine scrubber off, if they contain > 0,1 % w/w Butadiene92045-15-3295-397-2
602Gases (petroleum), gas oil hydrodesulfurisation effluent, if they contain > 0,1 % w/w Butadiene92045-16-4295-398-8
603Gases (petroleum), gas oil hydrodesulfurisation purge, if they contain > 0,1 % w/w Butadiene92045-17-5295-399-3
604Gases (petroleum), hydrogenator effluent flash drum off, if they contain > 0,1 % w/w Butadiene92045-18-6295-400-7
605Gases (petroleum), naphtha steam cracking high-pressure residual, if they contain > 0,1 % w/w Butadiene92045-19-7295-401-2
606Gases (petroleum), residue visbreaking off, if they contain > 0,1 % w/w Butadiene92045-20-0295-402-8
607Gases (petroleum), steam-cracker C3-rich, if they contain > 0,1 % w/w Butadiene92045-22-2295-404-9
608Hydrocarbons, C4, steam-cracker distillate, if they contain > 0,1 % w/w Butadiene92045-23-3295-405-4
609Petroleum gases, liquefied, sweetened, C4 fraction, if they contain > 0,1 % w/w Butadiene92045-80-2295-463-0
610Hydrocarbons, C4, 1,3-butadiene- and isobutene-free, if they contain > 0,1 % w/w Butadiene95465-89-7306-004-1
611Raffinates (petroleum), steam-cracked C4 fraction cuprous ammonium acetate extn., C3-5 and C3-5 unsatd., butadiene-free, if they contain > 0,1 % w/w Butadiene97722-19-5307-769-4
612Benzo[def]chrysene (benzo[a]pyrene)50-32-8200-028-5
613Pitch, coal tar-petroleum, if it contains > 0,005 % w/w benzo[a]pyrene68187-57-5269-109-0
614Distillates (coal-petroleum), condensed-ring arom., if they contain > 0,005 % w/w benzo[a]pyrene68188-48-7269-159-3
615Moved or deleted
616Moved or deleted
617Creosote oil, acenaphthene fraction, acenaphthene-free, if it contains > 0,005 % w/w benzo[a]pyrene90640-85-0292-606-9
618Pitch, coal tar, low-temp., if it contains > 0,005 % w/w benzo[a]pyrene90669-57-1292-651-4
619Pitch, coal tar, low-temp., heat-treated, if it contains > 0,005 % w/w benzo[a]pyrene90669-58-2292-653-5
620Pitch, coal tar, low-temp., oxidised, if it contains > 0,005 % w/w benzo[a]pyrene90669-59-3292-654-0
621Extract residues (coal), brown, if they contain > 0,005 % w/w benzo[a]pyrene91697-23-3294-285-0
622Paraffin waxes (coal), brown-coal high-temp. tar, if they contain > 0,005 % w/w benzo[a]pyrene92045-71-1295-454-1
623Paraffin waxes (coal), brown-coal high-temp. tar, hydrotreated, if they contain > 0,005 % w/w benzo[a]pyrene92045-72-2295-455-7
624Waste solids, coal-tar pitch coking, if they contain > 0,005 % w/w benzo[a]pyrene92062-34-5295-549-8
625Pitch, coal tar, high-temp., secondary, if it contains > 0,005 % w/w benzo[a]pyrene94114-13-3302-650-3
626Residues (coal), liq. solvent extn., if they contain > 0,005 % w/w benzo[a]pyrene94114-46-2302-681-2
627Coal liquids, liq. solvent extn. soln., if they contain > 0,005 % w/w benzo[a]pyrene94114-47-3302-682-8
628Coal liquids, liq. solvent extn., if they contain > 0,005 % w/w benzo[a]pyrene94114-48-4302-683-3
629Paraffin waxes (coal), brown-coal high-temp. tar, carbon-treated, if they contain > 0,005 % w/w benzo[a]pyrene97926-76-6308-296-6
630Paraffin waxes (coal), brown-coal high-temp tar, clay-treated, if they contain > 0,005 % w/w benzo[a]pyrene97926-77-7308-297-1
631Paraffin waxes (coal), brown-coal high-temp tar, silicic acid-treated, if they contain > 0,005 % w/w benzo[a]pyrene97926-78-8308-298-7
632Absorption oils, bicyclo arom. and heterocylic hydrocarbon fraction, if they contain > 0,005 % w/w benzo[a]pyrene101316-45-4309-851-5
633Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene polypropylene pyrolysis-derived, if they contain > 0,005 % w/w benzo[a]pyrene101794-74-5309-956-6
634Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene pyrolysis-derived, if they contain > 0,005 % w/w benzo[a]pyrene101794-75-6309-957-1
635Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polystyrene pyrolysis-derived, if they contain > 0,005 % w/w benzo[a]pyrene101794-76-7309-958-7
636Pitch, coal tar, high-temp., heat-treated, if it contains > 0,005 % w/w benzo[a]pyrene121575-60-8310-162-7
637Dibenz[a,h]anthracene53-70-3200-181-8
638Benz[a]anthracene56-55-3200-280-6
639Benzo[e]pyrene192-97-2205-892-7
640Benzo[j]fluoranthene205-82-3205-910-3
641Benz(e)acephenanthrylene205-99-2205-911-9
642Benzo(k)fluoranthene207-08-9205-916-6
643Chrysene218-01-9205-923-4
6442-Bromopropane75-26-3200-855-1
645Trichloroethylene79-01-6201-167-4
6461,2-Dibromo-3-chloropropane96-12-8202-479-3
6472,3-Dibromopropan-1-ol96-13-9202-480-9
6481,3-Dichloropropan-2-ol96-23-1202-491-9
649α,α,α-Trichlorotoluene98-07-7202-634-5
650α-Chlorotoluene (Benzyl chloride)100-44-7202-853-6
6511,2-Dibromoethane106-93-4203-444-5
652Hexachlorobenzene118-74-1204-273-9
653Bromoethylene (Vinyl bromide)593-60-2209-800-6
6541,4-Dichlorobut-2-ene764-41-0212-121-8
655Methyloxirane (Propylene oxide)75-56-9200-879-2
656(Epoxyethyl)benzene (Styrene oxide)96-09-3202-476-7
6571-Chloro-2,3-epoxypropane (Epichlorohydrin)106-89-8203-439-8
658 R-1-Chloro-2,3-epoxypropane51594-55-9424-280-2
6591,2-Epoxy-3-phenoxypropane (Phenylglycidyl ether)122-60-1204-557-2
6602,3-Epoxypropan-1-ol (Glycidol)556-52-5209-128-3
661 R-2,3-Epoxy-1-propanol57044-25-4404-660-4
6622,2′-Bioxirane (1,2:3,4-Diepoxybutane)1464-53-5215-979-1
663(2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophenyl)-[1H-1,2,4-triazol-1-yl)methyl]oxirane; Epoxiconazole133855-98-8406-850-2
664Chloromethyl methyl ether107-30-2203-480-1
6652-Methoxyethanol and its acetate (2-Methoxyethyl acetate)109-86-4/110-49-6203-713-7/203-772-9
6662-Ethoxyethanol and its acetate (2-Ethoxyethyl acetate)110-80-5/111-15-9203-804-1/203-839-2
667Oxybis[chloromethane], bis (Chloromethyl) ether542-88-1208-832-8
6682-Methoxypropanol1589-47-5216-455-5
669Propiolactone57-57-8200-340-1
670Dimethylcarbamoyl chloride79-44-7201-208-6
671Urethane (Ethyl carbamate)51-79-6200-123-1
672Moved or deleted
673Moved or deleted
674Methoxyacetic acid625-45-6210-894-6
675Dibutyl phthalate84-74-2201-557-4
676bis(2-Methoxyethyl) ether (Dimethoxydiglycol)111-96-6203-924-4
677bis(2-Ethylhexyl) phthalate (Diethylhexyl phthalate)117-81-7204-211-0
678bis(2-Methoxyethyl) phthalate117-82-8204-212-6
6792-Methoxypropyl acetate70657-70-4274-724-2
6802-Ethylhexyl[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]-methyl]thio]acetate80387-97-9279-452-8
681Acrylamide, unless regulated elsewhere in this Regulation79-06-1201-173-7
682Acrylonitrile107-13-1203-466-5
6832-Nitropropane79-46-9201-209-1
684Dinoseb, its salts and esters with the exception of those specified elsewhere in this list88-85-7201-861-7
6852-Nitroanisole91-23-6202-052-1
6864-Nitrobiphenyl92-93-3202-204-7
687

2,4-Dinitrotoluene;

Dinitrotoluene, technical grade

121-14-2/25321-14-6204-450-0/246-836-1
688Binapacryl485-31-4207-612-9
6892-Nitronaphthalene581-89-5209-474-5
6902,3-Dinitrotoluene602-01-7210-013-5
6915-Nitroacenaphthene602-87-9210-025-0
6922,6-Dinitrotoluene606-20-2210-106-0
6933,4-Dinitrotoluene610-39-9210-222-1
6943,5-Dinitrotoluene618-85-9210-566-2
6952,5-Dinitrotoluene619-15-8210-581-4
696Dinoterb, its salts and esters1420-07-1215-813-8
697Nitrofen1836-75-5217-406-0
698Moved or deleted
699Diazomethane334-88-3206-382-7
7001,4,5,8-Tetraaminoanthraquinone (Disperse Blue 1)2475-45-8219-603-7
701Moved or deleted
7021-Methyl-3-nitro-1-nitrosoguanidine70-25-7200-730-1
703Moved or deleted
704Moved or deleted
7054,4′-Methylenedianiline101-77-9202-974-4
7064,4′-(4-Iminocyclohexa-2,5-dienylidenemethylene) dianiline hydrochloride569-61-9209-321-2
7074,4′-Methylenedi-o-toluidine838-88-0212-658-8
708o-Anisidine90-04-0201-963-1
7093,3′-Dimethoxybenzidine (ortho-Dianisidine) and its salts119-90-4204-355-4
710Moved or deleted
711o-Dianisidine based azo dyes
7123,3′-Dichlorobenzidine91-94-1202-109-0
713Benzidine dihydrochloride531-85-1208-519-6
714[[1,1′-Biphenyl]-4,4′-diyl]diammonium sulphate531-86-2208-520-1
7153,3′-Dichlorobenzidine dihydrochloride612-83-9210-323-0
716Benzidine sulphate21136-70-9244-236-4
717Benzidine acetate36341-27-2252-984-8
7183,3′-Dichlorobenzidine dihydrogen bis(sulphate)64969-34-2265-293-1
7193,3′-Dichlorobenzidine sulphate74332-73-3277-822-3
720Benzidine based azo dyes
7214,4′-Bi-o-toluidine (ortho-Tolidine)119-93-7204-358-0
7224,4′-Bi-o-toluidine dihydrochloride612-82-8210-322-5
723[3,3′-Dimethyl[1,1′-biphenyl]-4,4′-diyl]diammonium bis(hydrogen sulphate)64969-36-4265-294-7
7244,4′-Bi-o-toluidine sulphate74753-18-7277-985-0
725o-Tolidine based dyes611-030-00-4
726Biphenyl-4-ylamine (4-Aminobiphenyl) and its salts92-67-1202-177-1
727Azobenzene103-33-3203-102-5
728(Methyl-ONN-azoxy)methyl acetate592-62-1209-765-7
729Cycloheximide66-81-9200-636-0
7302-Methylaziridine75-55-8200-878-7
731Imidazolidine-2-thione (Ethylene thiourea)96-45-7202-506-9
732Furan110-00-9203-727-3
733Aziridine151-56-4205-793-9
734Captafol2425-06-1219-363-3
735Carbadox6804-07-5229-879-0
736Flumioxazin103361-09-7613-166-00-X
737Tridemorph24602-86-6246-347-3
738Vinclozolin50471-44-8256-599-6
739Fluazifop-butyl69806-50-4274-125-6
740Flusilazole85509-19-9014-017-00-6
7411,3,5-Tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (TGIC)2451-62-9219-514-3
742Thioacetamide62-55-5200-541-4
743Moved or deleted
744Formamide75-12-7200-842-0
745 N-Methylacetamide79-16-3201-182-6
746 N-Methylformamide123-39-7204-624-6
747N,N-Dimethylacetamide127-19-5204-826-4
748Hexamethylphosphoric-triamide680-31-9211-653-8
749Diethyl sulphate64-67-5200-589-6
750Dimethyl sulphate77-78-1201-058-1
7511,3-Propanesultone1120-71-4214-317-9
752Dimethylsulphamoyl-chloride13360-57-1236-412-4
753Sulfallate95-06-7202-388-9
754A mixture of: 4-[[bis-(4-Fluorophenyl)methylsilyl]methyl]-4H-1,2,4-triazole and 1-[[bis-(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole403-250-2
755(+/–)-Tetrahydrofurfuryl –(R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate119738-06-6607-373-00-4
7566-Hydroxy-1-(3-Isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrile85136-74-9-400-340-3
757(6-(4-Hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazine-2,4-diyl)bis[(amino-1-methylethyl)ammonium] formate108225-03-2402-060-7
758Trisodium [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)413-590-3
759A mixture of: N-[3-Hydroxy-2-(2-methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide and N-[2,3-bis-(2-Methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide and methacrylamide and 2-methyl-N-(2-methylacryloylaminomethoxymethyl)-acrylamide and N-(2,3-dihydroxypropoxymethyl)-2-methylacrylamide412-790-8
7601,3,5-tris-[(2S and 2R)-2,3-Epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (Teroxirone)59653-74-6616-091-00-0
761Erionite12510-42-8650-012-00-0
762Asbestos12001-28-4650-013-00-6
763Petroleum8002-05-9232-298-5
764Distillates (petroleum), heavy hydrocracked, if they contain > 3 % w/w DMSO extract64741-76-0265-077-7
765Distillates (petroleum), solvent-refined heavy paraffinic, if they contain > 3 % w/w DMSO extract64741-88-4265-090-8
766Distillates (petroleum), solvent-refined light paraffinic, if they contain > 3 % w/w DMSO extract64741-89-5265-091-3
767Residual oils (petroleum), solvent deasphalted, if they contain > 3 % w/w DMSO extract64741-95-3265-096-0
768Distillates (petroleum), solvent-refined heavy naphthenic, if they contain > 3 % w/w DMSO extract64741-96-4265-097-6
769Distillates (petroleum), solvent-refined light naphthenic, if they contain > 3 % w/w DMSO extract64741-97-5265-098-1
770Residual oils (petroleum), solvent-refined, if they contain > 3 % w/w DMSO extract64742-01-4265-101-6
771Distillates (petroleum), clay-treated heavy paraffinic, if they contain > 3 % w/w DMSO extract64742-36-5265-137-2
772Distillates (petroleum), clay-treated light paraffinic, if they contain > 3 % w/w DMSO extract64742-37-6265-138-8
773Residual oils (petroleum), clay-treated, if they contain > 3 % w/w DMSO extract64742-41-2265-143-5
774Distillates (petroleum), clay-treated heavy naphthenic, if they contain > 3 % w/w DMSO extract64742-44-5265-146-1
775Distillates (petroleum), clay-treated light naphthenic, if they contain > 3 % w/w DMSO extract64742-45-6265-147-7
776Distillates (petroleum), hydrotreated heavy naphthenic, if they contain > 3 % w/w DMSO extract64742-52-5265-155-0
777Distillates (petroleum), hydrotreated light naphthenic, if they contain > 3 % w/w DMSO extract64742-53-6265-156-6
778Distillates (petroleum), hydrotreated heavy paraffinic, if they contain > 3 % w/w DMSO extract64742-54-7265-157-1
779Distillates (petroleum), hydrotreated light paraffinic, if they contain > 3 % w/w DMSO extract64742-55-8265-158-7
780Distillates (petroleum), solvent-dewaxed light paraffinic, if they contain > 3 % w/w DMSO extract64742-56-9265-159-2
781Residual oils (petroleum), hydrotreated, if they contain > 3 % w/w DMSO extract64742-57-0265-160-8
782Residual oils (petroleum), solvent-dewaxed, if they contain > 3 % w/w DMSO extract64742-62-7265-166-0
783Distillates (petroleum), solvent-dewaxed heavy naphthenic, if they contain > 3 % w/w DMSO extract64742-63-8265-167-6
784Distillates (petroleum), solvent-dewaxed light naphthenic, if they contain > 3 % w/w DMSO extract64742-64-9265-168-1
785Distillates (petroleum), solvent-dewaxed heavy paraffinic, if they contain > 3 % w/w DMSO extract64742-65-0265-169-7
786Foots oil (petroleum), if it contains > 3 % w/w DMSO extract64742-67-2265-171-8
787Naphthenic oils (petroleum), catalytic dewaxed heavy, if they contain > 3 % w/w DMSO extract64742-68-3265-172-3
788Naphthenic oils (petroleum), catalytic dewaxed light, if they contain > 3 % w/w DMSO extract64742-69-4265-173-9
789Paraffin oils (petroleum), catalytic dewaxed heavy, if they contain > 3 % w/w DMSO extract64742-70-7265-174-4
790Paraffin oils (petroleum), catalytic dewaxed light, if they contain > 3 % w/w DMSO extract64742-71-8265-176-5
791Naphthenic oils (petroleum), complex dewaxed heavy, if they contain > 3 % w/w DMSO extract64742-75-2265-179-1
792Naphthenic oils (petroleum), complex dewaxed light, if they contain > 3 % w/w DMSO extract64742-76-3265-180-7
793Extracts (petroleum), heavy naphthenic distillate solvent, arom. Conc., if they contain > 3 % w/w DMSO extract68783-00-6272-175-3
794Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent, if they contain > 3 % w/w DMSO extract68783-04-0272-180-0
795Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted, if they contain > 3 % w/w DMSO extract68814-89-1272-342-0
796Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity, if they contain > 3 % w/w DMSO extract72623-85-9276-736-3
797Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based, if they contain > 3 % w/w DMSO extract72623- 86-0276-737-9
798Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, if they contain > 3 % w/w DMSO extract72623- 87-1276-738-4
799Lubricating oils, if they contain > 3 % w/w DMSO extract74869-22-0278-012-2
800Distillates (petroleum), complex dewaxed heavy paraffinic, if they contain > 3 % w/w DMSO extract90640-91-8292-613-7
801Distillates (petroleum), complex dewaxed light paraffinic, if they contain > 3 % w/w DMSO extract90640-92-9292-614-2
802Distillates (petroleum), solvent dewaxed heavy paraffinic, clay-treated, if they contain > 3 % w/w DMSO extract90640-94-1292-616-3
803Hydrocarbons, C20-50, solvent dewaxed heavy paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract90640-95-2292-617-9
804Distillates (petroleum), solvent dewaxed light paraffinic, clay-treated, if they contain > 3 % w/w DMSO extract90640-96-3292-618-4
805Distillates (petroleum), solvent dewaxed light paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract90640-97-4292-620-5
806Extracts (petroleum), heavy naphthenic distillate solvent, hydrotreated, if they contain > 3 % w/w DMSO extract90641-07-9292-631-5
807Extracts (petroleum), heavy paraffinic distillate solvent, hydrotreated, if they contain > 3 % w/w DMSO extract90641-08-0292-632-0
808Extracts (petroleum), light paraffinic distillate solvent, hydrotreated, if they contain > 3 % w/w DMSO extract90641-09-1292-633-6
809Residual oils (petroleum), hydrotreated solvent dewaxed, if they contain > 3 % w/w DMSO extract90669-74-2292-656-1
810Residual oils (petroleum), catalytic dewaxed, if they contain > 3 % w/w DMSO extract91770-57-9294-843-3
811Distillates (petroleum), dewaxed heavy paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract91995-39-0295-300-3
812Distillates (petroleum), dewaxed light paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract91995-40-3295-301-9
813Distillates (petroleum), hydrocracked solvent-refined, dewaxed, if they contain > 3 % w/w DMSO extract91995-45-8295-306-6
814Distillates (petroleum), solvent-refined light naphthenic, hydrotreated, if they contain > 3 % w/w DMSO extract91995-54-9295-316-0
815Extracts (petroleum), hydrotreated light paraffinic distillate solvent, if they contain > 3 % w/w DMSO extract91995- 73-2295-335-4
816Extracts (petroleum), light naphthenic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract91995-75-4295-338-0
817Extracts (petroleum), light paraffinic distillate solvent, acid-treated, if they contain > 3 % w/w DMSO extract91995-76-5295-339-6
818Extracts (petroleum), light paraffinic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract91995-77-6295-340-1
819Extracts (petroleum), light vacuum gas oil solvent, hydrotreated, if they contain > 3 % w/w DMSO extract91995-79-8295-342-2
820Foots oil (petroleum), hydrotreated, if it contains > 3 % w/w DMSO extract92045-12-0295-394-6
821Lubricating oils (petroleum), C17-35, solvent-extd., dewaxed, hydrotreated, if they contain > 3 % w/w DMSO extract92045-42-6295-423-2
822Lubricating oils (petroleum), hydrocracked nonarom solvent-deparaffined, if they contain > 3 % w/w DMSO extract92045-43-7295-424-8
823Residual oils (petroleum), hydrocracked acid-treated solvent-dewaxed, if they contain > 3 % w/w DMSO extract92061-86-4295-499-7
824Paraffin oils (petroleum), solvent-refined dewaxed heavy, if they contain > 3 % w/w DMSO extract92129-09-4295-810-6
825Extracts (petroleum), heavy paraffinic distillate solvent, clay-treated, if they contain > 3 % w/w DMSO extract92704-08-0296-437-1
826Lubricating oils (petroleum), base oils, paraffinic, if they contain > 3 % w/w DMSO extract93572-43-1297-474-6
827Extracts (petroleum), heavy naphthenic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract93763-10-1297-827-4
828Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract93763-11-2297-829-5
829Hydrocarbons, hydrocracked paraffinic distn. residues, solvent-dewaxed, if they contain > 3 % w/w DMSO extract93763-38-3297-857-8
830Foots oil (petroleum), acid-treated, if it contains > 3 % w/w DMSO extract93924-31-3300-225-7
831Foots oil (petroleum), clay-treated, if it contains > 3 % w/w DMSO extract93924-32-4300-226-2
832Hydrocarbons, C20-50, residual oil hydrogenation vacuum distillate, if they contain > 3 % w/w DMSO extract93924-61-9300-257-1
833Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated, if they contain > 3 % w/w DMSO extract94733-08-1305-588-5
834Distillates (petroleum), solvent-refined hydrocracked light, if they contain > 3 % w/w DMSO extract94733-09-2305-589-0
835Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based, if they contain > 3 % w/w DMSO extract94733-15-0305-594-8
836Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrogenated raffinate-based, if they contain > 3 % w/w DMSO extract94733-16-1305-595-3
837Hydrocarbons, C13-30, arom. -rich, solvent-extd. naphthenic distillate, if they contain > 3 % w/w DMSO extract95371-04-3305-971-7
838Hydrocarbons, C16-32, arom. rich, solvent-extd. naphthenic distillate, if they contain > 3 % w/w DMSO extract95371-05-4305-972-2
839Hydrocarbons, C37-68, dewaxed deasphalted hydrotreated vacuum distn. Residues, if they contain > 3 % w/w DMSO extract95371-07-6305-974-3
840Hydrocarbons, C37-65, hydrotreated deasphalted vacuum distn. Residues, if they contain > 3 % w/w DMSO extract95371-08-7305-975-9
841Distillates (petroleum), hydrocracked solvent-refined light, if they contain > 3 % w/w DMSO extract97488-73-8307-010-7
842Distillates (petroleum), solvent-refined hydrogenated heavy, if they contain > 3 % w/w DMSO extract97488-74-9307-011-2
843Lubricating oils (petroleum), C18-27, hydrocracked solvent-dewaxed, if they contain > 3 % w/w DMSO extract97488-95-4307-034-8
844Hydrocarbons, C17-30, hydrotreated solvent-deasphalted atm. distn. residue, distn. lights, if they contain > 3 % w/w DMSO extract97675-87-1307-661-7
845Hydrocarbons, C17-40, hydrotreated solvent-deasphalted distn. residue, vacuum distn. lights, if they contain > 3 % w/w DMSO extract97722-06-0307-755-8
846Hydrocarbons, C13-27, solvent-extd. light naphthenic, if they contain > 3 % w/w DMSO extract97722-09-3307-758-4
847Hydrocarbons, C14-29, solvent-extd. light naphthenic, if they contain > 3 % w/w DMSO extract97722-10-6307-760-5
848Foots oil (petroleum), carbon-treated, if it contains > 3 % w/w DMSO extract97862-76-5308-126-0
849Foots oil (petroleum), silicic acid-treated, if it contains > 3 % w/w DMSO extract97862-77-6308-127-6
850Hydrocarbons, C27-42, dearomatised, if they contain > 3 % w/w DMSO extract97862-81-2308-131-8
851Hydrocarbons, C17-30, hydrotreated distillates, distn. Lights, if they contain > 3 % w/w DMSO extract97862-82-3308-132-3
852Hydrocarbons, C27-45, naphthenic vacuum distn., if they contain > 3 % w/w DMSO extract97862-83-4308-133-9
853Hydrocarbons, C27-45, dearomatised, if they contain > 3 % w/w DMSO extract97926-68-6308-287-7
854Hydrocarbons, C20-58, hydrotreated, if they contain > 3 % w/w DMSO extract97926-70-0308-289-8
855Hydrocarbons, C27-42, naphthenic, if they contain > 3 % w/w DMSO extract97926-71-1308-290-3
856Extracts (petroleum), light paraffinic distillate solvent, carbon-treated, if they contain > 3 % w/w DMSO extract100684-02-4309-672-2
857Extracts (petroleum), light paraffinic distillate solvent, clay-treated, if they contain > 3 % w/w DMSO extract100684- 03-5309-673-8
858Extracts (petroleum), light vacuum, gas oil solvent, carbon-treated, if they contain > 3 % w/w DMSO extract100684-04-6309-674-3
859Extracts (petroleum), light vacuum gas oil solvent, clay-treated, if they contain > 3 % w/w DMSO extract100684-05-7309-675-9
860Residual oils (petroleum), carbon-treated solvent-dewaxed, if they contain > 3 % w/w DMSO extract100684-37-5309-710-8
861Residual oils (petroleum), clay-treated solvent-dewaxed, if they contain > 3 % w/w DMSO extract100684-38-6309-711-3
862Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract101316-69-2309-874-0
863Lubricating oils (petroleum), C17-32, solvent-extd., dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract101316-70-5309-875-6
864Lubricating oils (petroleum), C20-35, solvent-extd., dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract101316-71-6309-876-1
865Lubricating oils (petroleum), C24-50, solvent-extd., dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract101316-72-7309-877-7
866Distillates (petroleum), sweetened middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64741-86-2265-088-7
867Gas oils (petroleum), solvent-refined, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64741-90-8265-092-9
868Distillates (petroleum), solvent-refined middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64741-91-9265-093-4
869Gas oils (petroleum), acid-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64742-12-7265-112-6
870Distillates (petroleum), acid-treated middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64742-13-8265-113-1
871Distillates (petroleum), acid-treated light, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64742-14-9265-114-7
872Gas oils (petroleum), chemically neutralised, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64742-29-6265-129-9
873Distillates (petroleum), chemically neutralised middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64742-30-9265-130-4
874Distillates (petroleum), clay-treated middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64742-38-7265-139-3
875Distillates (petroleum), hydrotreated middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64742-46-7265-148-2
876Gas oils (petroleum), hydrodesulfurised, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64742-79-6265-182-8
877Distillates (petroleum), hydrodesulfurised middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64742-80-9265-183-3
878Distillates (petroleum), catalytic reformer fractionator residue, high-boiling, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen68477-29-2270-719-4
879Distillates (petroleum), catalytic reformer fractionator residue, intermediate-boiling, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen68477-30-5270-721-5
880Distillates (petroleum), catalytic reformer fractionator residue, low-boiling, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen68477-31-6270-722-0
881Alkanes, C12-26, branched and linear, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen90622-53-0292-454-3
882Distillates (petroleum), highly refined middle, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen90640-93-0292-615-8
883Distillates (petroleum), catalytic reformer, heavy arom. conc., except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen91995-34-5295-294-2
884Gas oils, paraffinic, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen93924-33-5300-227-8
885Naphtha (petroleum), solvent-refined hydrodesulfurised heavy, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen97488-96-5307-035-3
886Hydrocarbons, C16-20, hydrotreated middle distillate, distn. Lights, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen97675- 85-9307-659-6
887Hydrocarbons, C12-20, hydrotreated paraffinic, distn. lights, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen97675-86-0307-660-1
888Hydrocarbons, C11-17, solvent-extd. light naphthenic, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen97722-08-2307-757-9
889Gas oils, hydrotreated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen97862-78-7308-128-1
890Distillates (petroleum), carbon-treated light paraffinic, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen100683-97-4309-667-5
891Distillates (petroleum), intermediate paraffinic, carbon-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen100683-98-5309-668-0
892Distillates (petroleum), intermediate paraffinic, clay-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen100683-99-6309-669-6
893Lubricating greases, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen74869-21-9278-011-7
894Slack wax (petroleum), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64742-61-6265-165-5
895Slack wax (petroleum), acid-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen90669-77-5292-659-8
896Slack wax (petroleum), clay-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen90669-78-6292-660-3
897Slack wax (petroleum), hydrotreated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen92062-09-4295-523-6
898Slack wax (petroleum), low-melting, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen92062-10-7295-524-1
899Slack wax (petroleum), low-melting, hydrotreated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen92062-11-8295-525-7
900Slack wax (petroleum), low-melting, carbon-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen97863-04-2308-155-9
901Slack wax (petroleum), low-melting, clay-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen97863-05-3308-156-4
902Slack wax (petroleum), low-melting, silicic acid-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen97863-06-4308-158-5
903Slack wax (petroleum), carbon-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen100684-49-9309-723-9
904Petrolatum, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen8009-03-8232-373-2
905Petrolatum (petroleum), oxidised, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen64743-01-7265-206-7
906Petrolatum (petroleum), alumina-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen85029-74-9285-098-5
907Petrolatum (petroleum), hydrotreated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen92045-77-7295-459-9
908Petrolatum (petroleum), carbon-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen97862-97-0308-149-6
909Petrolatum (petroleum), silicic acid-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen97862-98-1308-150-1
910Petrolatum (petroleum), clay-treated, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen100684-33-1309-706-6
911Distillates (petroleum), light catalytic cracked64741-59-9265-060-4
912Distillates (petroleum), intermediate catalytic cracked64741-60-2265-062-5
913Distillates (petroleum), light thermal cracked64741-82-8265-084-5
914Distillates (petroleum), hydrodesulfurised light catalytic cracked68333-25-5269-781-5
915Distillates (petroleum), light steam-cracked naphtha68475-80-9270-662-5
916Distillates (petroleum), cracked steam-cracked petroleum distillates68477-38-3270-727-8
917Gas oils (petroleum), steam-cracked68527-18-4271-260-2
918Distillates (petroleum), hydrodesulfurised thermal cracked middle85116-53-6285-505-6
919Gas oils (petroleum), thermal-cracked, hydrodesulfurised92045-29-9295-411-7
920Residues (petroleum), hydrogenated steam-cracked naphtha92062-00-5295-514-7
921Residues (petroleum), steam-cracked naphtha distn.92062-04-9295-517-3
922Distillates (petroleum), light catalytic cracked, thermally degraded92201-60-0295-991-1
923Residues (petroleum), steam-cracked heat-soaked naphtha93763-85-0297-905-8
924Gas oils (petroleum), light vacuum, thermal-cracked hydrodesulfurised97926-59-5308-278-8
925Distillates (petroleum), hydrodesulfurised middle coker101316-59-0309-865-1
926Distillates (petroleum), heavy steam-cracked101631-14-5309-939-3
927Residues (petroleum), atm. Tower64741-45-3265-045-2
928Gas oils (petroleum), heavy vacuum64741-57-7265-058-3
929Distillates (petroleum), heavy catalytic cracked64741-61-3265-063-0
930Clarified oils (petroleum), catalytic cracked64741-62-4265-064-6
931Residues (petroleum), catalytic reformer fractionator64741-67-9265-069-3
932Residues (petroleum), hydrocracked64741-75-9265-076-1
933Residues (petroleum), thermal cracked64741-80-6265-081-9
934Distillates (petroleum), heavy thermal cracked64741-81-7265-082-4
935Gas oils (petroleum), hydrotreated vacuum64742-59-2265-162-9
936Residues (petroleum), hydrodesulfurised atmospheric tower64742-78-5265-181-2
937Gas oils (petroleum), hydrodesulfurised heavy vacuum64742-86-5265-189-6
938Residues (petroleum), steam-cracked64742-90-1265-193-8
939Residues (petroleum), atmospheric68333-22-2269-777-3
940Clarified oils (petroleum), hydrodesulfurised catalytic cracked68333-26-6269-782-0
941Distillates (petroleum), hydrodesulfurised intermediate catalytic cracked68333-27-7269-783-6
942Distillates (petroleum), hydrodesulfurised heavy catalytic cracked68333-28-8269-784-1
943Fuel oil, residues-straight-run gas oils, high-sulfur68476-32-4270-674-0
944Fuel oil, residual68476-33-5270-675-6
945Residues (petroleum), catalytic reformer fractionator residue distn.68478-13-7270-792-2
946Residues (petroleum), heavy coker gas oil and vacuum gas oil68478-17-1270-796-4
947Residues (petroleum), heavy coker and light vacuum68512-61-8270-983-0
948Residues (petroleum), light vacuum68512-62-9270-984-6
949Residues (petroleum), steam-cracked light68513-69-9271-013-9
950Fuel oil, No 668553-00-4271-384-7
951Residues (petroleum), topping plant, low-sulfur68607-30-7271-763-7
952Gas oils (petroleum), heavy atmospheric68783-08-4272-184-2
953Residues (petroleum), coker scrubber, condensed-ring-arom. -contg68783-13-1272-187-9
954Distillates (petroleum), petroleum residues vacuum68955-27-1273-263-4
955Residues (petroleum), steam-cracked, resinous68955-36-2273-272-3
956Distillates (petroleum), intermediate vacuum70592-76-6274-683-0
957Distillates (petroleum), light vacuum70592-77-7274-684-6
958Distillates (petroleum), vacuum70592-78-8274-685-1
959Gas oils (petroleum), hydrodesulfurised coker heavy vacuum85117-03-9285-555-9
960Residues (petroleum), steam-cracked, distillates90669-75-3292-657-7
961Residues (petroleum), vacuum, light90669-76-4292-658-2
962Fuel oil, heavy, high-sulfur92045-14-2295-396-7
963Residues (petroleum), catalytic cracking92061-97-7295-511-0
964Distillates (petroleum), intermediate catalytic cracked, thermally degraded92201-59-7295-990-6
965Residual oils (petroleum)93821-66-0298-754-0
966Residues, steam cracked, thermally treated98219-64-8308-733-0
967Distillates (petroleum), hydrodesulfurised full-range middle101316-57-8309-863-0
968Distillates (petroleum), light paraffinic64741-50-0265-051-5
969Distillates (petroleum), heavy paraffinic64741-51-1265-052-0
970Distillates (petroleum), light naphthenic64741-52-2265-053-6
971Distillates (petroleum), heavy naphthenic64741-53-3265-054-1
972Distillates (petroleum), acid-treated heavy naphthenic64742-18-3265-117-3
973Distillates (petroleum), acid-treated light naphthenic64742-19-4265-118-9
974Distillates (petroleum), acid-treated heavy paraffinic64742-20-7265-119-4
975Distillates (petroleum), acid-treated light paraffinic64742-21-8265-121-5
976Distillates (petroleum), chemically neutralised heavy paraffinic64742-27-4265-127-8
977Distillates (petroleum), chemically neutralised light paraffinic64742-28-5265-128-3
978Distillates (petroleum), chemically neutralised heavy naphthenic64742-34-3265-135-1
979Distillates (petroleum), chemically neutralised light naphthenic64742-35-4265-136-7
980Extracts (petroleum), light naphthenic distillate solvent64742-03-6265-102-1
981Extracts (petroleum), heavy paraffinic distillate solvent64742-04-7265-103-7
982Extracts (petroleum), light paraffinic distillate solvent64742-05-8265-104-2
983Extracts (petroleum), heavy naphthenic distillate solvent64742-11-6265-111-0
984Extracts (petroleum), light vacuum gas oil solvent91995-78-7295-341-7
985Hydrocarbons, C26-55, arom. rich97722-04-8307-753-7
986Disodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate)573-58-0209-358-4
987Disodium 4-amino-3-[[4′-[(2,4-diaminophenyl)azo] [1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate1937-37-7217-710-3
988Tetrasodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]2602-46-2220-012-1
9894-o-Tolylazo-o-toluidine97-56-3202-591-2
9904-Aminoazobenzene60-09-3200-453-6
991Disodium[5-[[4′-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulphophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]salicylato(4-)]cuprate(2-)16071-86-6240-221-1
992Resorcinol diglycidyl ether101-90-6202-987-5
9931,3-Diphenylguanidine102-06-7203-002-1
994Heptachlor-epoxide1024-57-3213-831-0
9954-Nitrosophenol104-91-6203-251-6
996Carbendazim10605-21-7234-232-0
997Allyl glycidyl ether106-92-3203-442-4
998Chloroacetaldehyde107-20-0203-472-8
999Hexane110-54-3203-777-6
10002-(2-Methoxyethoxy)ethanol (Diethylene glycol monomethyl ether; DEGME)111-77-3203-906-6
1001(+/–)-2-(2,4-Dichlorophenyl)-3-(1H-1,2,4-triazol-1-yl)propyl-1,1,2,2-tetrafluoroethylether (Tetraconazole - ISO)112281-77-3407-760-6
10024-[4-(1,3-Dihydroxyprop-2-yl)phenylamino]-1,8-dihydroxy-5-nitroanthraquinone114565-66-1406-057-1
10035,6,12,13-Tetrachloroanthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone115662-06-1405-100-1
1004tris(2-Chloroethyl) phosphate115-96-8204-118-5
10054′-Ethoxy-2-benzimidazoleanilide120187-29-3407-600-5
1006Nickel dihydroxide12054-48-7235-008-5
1007N,N-Dimethylaniline121-69-7204-493-5
1008Simazine122-34-9204-535-2
1009bis(Cyclopentadienyl)-bis(2,6-difluoro-3-(pyrrol-1-yl)-phenyl)titanium125051-32-3412-000-1
1010N,N,N′,N′-Tetraglycidyl-4,4′-diamino-3,3′-diethyldiphenylmethane130728-76-6410-060-3
1011Divanadium pentaoxide1314-62-1215-239-8
1012Pentachlorophenol and its alkali salts87-86-5/131-52-2/7778-73-6201-778-6/205-025-2/231-911-3
1013Phosphamidon13171-21-6236-116-5
1014 N-(Trichloromethylthio)phthalimide (Folpet - ISO)133-07-3205-088-6
1015N-2-Naphthylaniline135-88-6205-223-9
1016Ziram137-30-4205-288-3
10171-Bromo-3,4,5-trifluorobenzene138526-69-9418-480-9
1018Propazine139-40-2205-359-9
10193-(4-Chlorophenyl)-1,1-dimethyluronium trichloroacetate; monuron-TCA140-41-0006-043-00-1
1020Isoxaflutole141112-29-0606-054-00-7
1021Kresoxim-methyl143390-89-0607-310-00-0
1022Chlordecone143-50-0205-601-3
10239-Vinylcarbazole1484-13-5216-055-0
10242-Ethylhexanoic acid149-57-5205-743-6
1025Monuron150-68-5205-766-1
1026Morpholine-4-carbonyl chloride15159-40-7239-213-0
1027Daminozide1596-84-5216-485-9
1028Alachlor (ISO)15972-60-8240-110-8
1029UVCB condensation product of: tetrakis-hydroxymethylphosphonium chloride, urea and distilled hydrogenated C16-18 tallow alkylamine166242-53-1422-720-8
1030Ioxynil and Ioxynil octanoate (ISO)1689-83-4/3861-47-0216-881-1/223-375-4
1031Bromoxynil (ISO) (3,5-Dibromo-4-hydroxybenzonitrile) and Bromoxynil heptanoate (ISO)1689-84-5/56634-95-8216-882-7/260-300-4
10322,6-Dibromo-4-cyanophenyl octanoate1689-99-2216-885-3
1033Moved or deleted
10345-Chloro-1,3-dihydro-2H-indol-2-one17630-75-0412-200-9
1035Benomyl17804-35-2241-775-7
1036Chlorothalonil1897-45-6217-588-1
1037N′-(4-Chloro-o-tolyl)-N,N-dimethylformamidine monohydrochloride19750-95-9243-269-1
10384,4′-Methylenebis(2-ethylaniline)19900-65-3243-420-1
1039Valinamide20108-78-5402-840-7
1040[(p-Tolyloxy)methyl]oxirane2186-24-5218-574-8
1041[(m-Tolyloxy)methyl]oxirane2186-25-6218-575-3
10422,3-Epoxypropyl o-tolyl ether2210-79-9218-645-3
1043[(Tolyloxy)methyl]oxirane, cresyl glycidyl ether26447-14-3247-711-4
1044Di-allate2303-16-4218-961-1
1045Benzyl 2,4-dibromobutanoate23085-60-1420-710-8
1046Trifluoroiodomethane2314-97-8219-014-5
1047Thiophanate-methyl23564-05-8245-740-7
1048Dodecachloropentacyclo[5.2.1.02,6.03,905,8]decane (Mirex)2385-85-5219-196-6
1049Propyzamide23950-58-5245-951-4
1050Butyl glycidyl ether2426-08-6219-376-4
10512,3,4-Trichlorobut-1-ene2431-50-7219-397-9
1052Chinomethionate2439-01-2219-455-3
1053(R)-α-Phenylethylammonium (-)-(1R,2S)-(1,2-epoxypropyl)phosphonate monohydrate25383-07-7418-570-8
10545-Ethoxy-3-trichloromethyl-1,2,4-thiadiazole (Etridiazole - ISO)2593-15-9219-991-8
1055Disperse Yellow 32832-40-8220-600-8
10561,2,4-Triazole288-88-0206-022-9
1057Aldrin (ISO)309-00-2206-215-8
1058Diuron (ISO)330-54-1206-354-4
1059Linuron (ISO)330-55-2206-356-5
1060Nickel carbonate3333-67-3222-068-2
10613-(4-Isopropylphenyl)-1,1-dimethylurea (Isoproturon - ISO)34123-59-6251-835-4
1062Iprodione36734-19-7253-178-9
1063Moved or deleted
10645-(2,4-Dioxo-1,2,3,4-tetrahydropyrimidine)-3-fluoro-2-hydroxymethyltetrahydrofuran41107-56-6415-360-8
1065Crotonaldehyde4170-30-3224-030-0
1066Hexahydrocyclopenta(c)pyrrole-1-(1H)-ammonium N-ethoxycarbonyl-N-(p-tolylsulfonyl)azanide418-350-1
10674,4′-Carbonimidoylbis[N,N-dimethylaniline] and its salts492-80-8207-762-5
1068DNOC (ISO)534-52-1208-601-1
1069Toluidinium chloride540-23-8208-740-8
1070Toluidine sulphate (1:1)540-25-0208-741-3
10712-(4-tert.-Butylphenyl)ethanol5406-86-0410-020-5
1072Fenthion55-38-9200-231-9
1073Chlordane, pur57-74-9200-349-0
1074Hexan-2-one (Methyl butyl ketone)591-78-6209-731-1
1075Fenarimol60168-88-9262-095-7
1076Acetamide60-35-5200-473-5
1077 N-Cyclohexyl-N-methoxy-2,5-dimethyl-3-furamide (Furmecyclox - ISO)60568-05-0262-302-0
1078Dieldrin60-57-1200-484-5
10794,4′-Isobutylethylidenediphenol6807-17-6401-720-1
1080Chlordimeform6164-98-3228-200-5
1081Amitrole61-82-5200-521-5
1082Carbaryl63-25-2200-555-0
1083Distillates (petroleum), light hydrocracked64741-77-1265-078-2
10841-Ethyl-1-methylmorpholinium bromide65756-41-4612-182-00-4
1085(3-Chlorophenyl)-(4-methoxy-3-nitrophenyl)methanone66938-41-8423-290-4
1086Fuels, diesel, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen68334-30-5269-822-7
1087Fuel oil, no. 268476-30-2270-671-4
1088Fuel oil, no. 468476-31-3270-673-5
1089Fuels, diesel, no. 268476-34-6270-676-1
10902,2-Dibromo-2-nitroethanol69094-18-4412-380-9
10911-Ethyl-1-methylpyrrolidinium bromide69227-51-6612-183-00-X
1092Monocrotophos6923-22-4230-042-7
1093Nickel7440-02-0231-111-4
1094Bromomethane (Methyl bromide - ISO)74-83-9200-813-2
1095Chloromethane (Methyl chloride)74-87-3200-817-4
1096Iodomethane (Methyl iodide)74-88-4200-819-5
1097Bromoethane (Ethyl bromide)74-96-4200-825-8
1098Heptachlor76-44-8200-962-3
1099Fentin hydroxide76-87-9200-990-6
1100Nickel sulphate7786-81-4232-104-9
11013,5,5-Trimethylcyclohex-2-enone (Isophorone)78-59-1201-126-0
11022,3-Dichloropropene78-88-6201-153-8
1103Fluazifop-P-butyl (ISO)79241-46-6607-305-00-3
1104(S)-2,3-Dihydro-1H-indole-carboxylic acid79815-20-6410-860-2
1105Toxaphene8001-35-2232-283-3
1106(4-Hydrazinophenyl)-N-methylmethanesulfonamide hydrochloride81880-96-8406-090-1
1107CI Solvent Yellow 14842-07-9212-668-2
1108Chlozolinate84332-86-5282-714-4
1109Alkanes, C10-13, monochloro85535-84-8287-476-5
1110Moved or deleted
11112,4,6-Trichlorophenol88-06-2201-795-9
1112Diethylcarbamoyl-chloride88-10-8201-798-5
11131-Vinyl-2-pyrrolidone88-12-0201-800-4
1114Myclobutanil (ISO) (2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile)88671-89-0410-400-0
1115Fentin acetate900-95-8212-984-0
1116Biphenyl-2-ylamine90-41-5201-990-9
1117 Trans-4-cyclohexyl-L-proline monohydro-chloride90657-55-9419-160-1
11182-Methyl-m-phenylene diisocyanate (Toluene 2,6-diisocyanate)91-08-7202-039-0
11194-Methyl-m-phenylene diisocyanate (Toluene 2,4-diisocyanate)584-84-9209-544-5
1120m-Tolylidene diisocyanate (Toluene diisocyanate)26471-62-5247-722-4
1121Fuels, jet aircraft, coal solvent extn., hydrocracked hydrogenated94114-58-6302-694-3
1122Fuels, diesel, coal solvent extn., hydrocracked hydrogenated94114-59-7302-695-9
1123Pitch, if it contains > 0,005 % w/w benzo[a]pyrene61789-60-4263-072-4
11242-Butanone oxime96-29-7202-496-6
1125Hydrocarbons, C16-20, solvent-dewaxed hydrocracked paraffinic distn. Residue97675-88-2307-662-2
1126α,α-Dichlorotoluene98-87-3202-709-2
1127Mineral 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]
1128Reaction product of acetophenone, formaldehyde, cyclohexylamine, methanol and acetic acid406-230-1
1129Moved or deleted
1130Moved or deleted
1131Trisodium bis(7-acetamido-2-(4-nitro-2-oxidophenylazo)-3-sulfonato-1-naphtholato)chromate(1-)400-810-8
1132A 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)phenol417-470-1
1133Costus root oil (Saussurea lappa Clarke), when used as a fragrance ingredient8023-88-9
11347-Ethoxy-4-methylcoumarin, when used as a fragrance ingredient87-05-8201-721-5
1135Hexahydrocoumarin, when used as a fragrance ingredient700-82-3211-851-4
1136Peru balsam (INCI name: Myroxylon pereirae), when used as a fragrance ingredient8007-00-9232-352-8
1137Isobutyl nitrite542-56-2208-819-7
1138Isoprene (stabilized); (2-methyl-1,3-butadiene)78-79-5201-143-3
11391-Bromopropane; n-Propyl bromide106-94-5203-445-0
1140Chloroprene (stabilized); (2-Chlorobuta-1,3-diene)126-99-8204-818-0
11411,2,3-Trichloropropane96-18-4202-486-1
1142Ethylene glycol dimethyl ether (EGDME)110-71-4203-794-9
1143Dinocap (ISO)39300-45-3254-408-0
1144

Diaminotoluene, technical product -mixture of [4-methyl-m-phenylenediamine]d and [2-methyl-m-phenylenediamine]e

Methyl-phenylenediamine

25376-45-8246-910-3
1145 p-Chlorobenzotrichloride5216-25-1226-009-1
1146Diphenylether; octabromo derivate32536-52-0251-087-9
11471,2-bis(2-Methoxyethoxy)ethane; Triethylene glycol dimethyl ether (TEGDME)112-49-2203-977-3
1148Tetrahydrothiopyran-3-carboxaldehyde61571-06-0407-330-8
11494,4′-bis(Dimethylamino)benzophenone (Michler's ketone)90-94-8202-027-5
1150Oxiranemethanol, 4-methylbenzene-sulfonate, (S)-70987-78-9417-210-7
11511,2-Benzenedicarboxylic acid, dipentylester, branched and linear [1]84777-06-0 [1]284-032-2
n-Pentyl-isopentylphthalate [2]-[2]
di-n-Pentyl phthalate [3]131-18-0 [3]205-017-9
Diisopentylphthalate [4]605-50-5 [4]210-088-4
1152Benzyl butyl phthalate (BBP)85-68-7201-622-7
11531,2-Benzenedicarboxylic acid, di-C7-11, branched and linear alkyl esters68515-42-4271-084-6
1154A mixture of: disodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-hydroxy-1-(4-sulfonatophenyl) pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate and trisodium 4-(3-ethoxycarbonyl-4-(5-(3-ethoxycarbonyl-5-oxido-1-(4-sulfonatophenyl)pyrazol-4-yl)penta-2,4-dienylidene)-4,5-dihydro-5-oxopyrazol-1-yl)benzenesulfonate402-660-9
1155(Methylenebis(4,1-phenylenazo(1-(3-(dimethylamino)propyl)-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-5,3-diyl)))-1,1′-dipyridinium dichloride dihydrochloride401-500-5
11562-[2-Hydroxy-3-(2-chlorophenyl)carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)carbamoyl-1-naphthylazo]fluoren-9-one420-580-2
1157Azafenidin68049-83-2
11582,4,5-Trimethylaniline [1]137-17-7 [1]205-282-0
2,4,5-Trimethylaniline hydrochloride [2]21436-97-5 [2]
11594,4′-Thiodianiline and its salts139-65-1205-370-9
11604,4′-Oxydianiline (p-Aminophenyl ether) and its salts101-80-4202-977-0
1161 N,N,N′,N′-Tetramethyl-4,4′-methylenedianiline101-61-1202-959-2
11626-Methoxy-m-toluidine; (p-Cresidine)120-71-8204-419-1
11633-Ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine143860-04-2421-150-7
1164A mixture of: 1,3,5-tris(3-aminomethylphenyl)-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione and a mixture of oligomers of 3,5-bis(3-aminomethylphenyl)-1-poly[3,5-bis(3-aminomethylphenyl)-2,4,6-trioxo-1,3,5-(1H,3H,5H)-triazin-1-yl]-1,3,5-(1H,3H,5H)-triazine-2,4,6-trione421-550-1
11652-Nitrotoluene88-72-2201-853-3
1166Tributyl phosphate126-73-8204-800-2
1167Naphthalene91-20-3202-049-5
1168Nonylphenol [1]25154-52-3 [1]246-672-0
4-Nonylphenol, branched [2]84852-15-3 [2]284-325-5
11691,1,2-Trichloroethane79-00-5201-166-9
1170Moved or deleted
1171Moved or deleted
1172allyl chloride; (3-Chloropropene)107-05-1203-457-6
11731,4-Dichlorobenzene; (p-Dichlorobenzene)106-46-7203-400-5
1174bis(2-Chloroethyl) ether111-44-4203-870-1
1175Phenol108-95-2203-632-7
1176Bisphenol A (4,4′-Isopropylidenediphenol)80-05-7201-245-8
1177Trioxymethylene (1,3,5-Trioxan)110-88-3203-812-5
1178Propargite (ISO)2312-35-8219-006-1
11791-Chloro-4-nitrobenzene100-00-5202-809-6
1180Molinate (ISO)2212-67-1218-661-0
1181Fenpropimorph (ISO)67564-91-4266-719-9
1182Moved or deleted
1183Methyl isocyanate624-83-9210-866-3
1184N,N-Dimethylanilinium tetrakis(pentafluorophenyl)borate118612-00-3422-050-6
1185O,O′-(Ethenylmethylsilylene) di[(4-methylpentan-2-one) oxime]421-870-1
1186A 2:1 mixture of: 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinol-4-yl-tris(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate) and 4-(7-hydroxy-2,4,4-trimethyl-2-chromanyl)resorcinolbis(6-diazo-5,6-dihydro-5-oxonaphthalen-1-sulfonate)140698-96-0414-770-4
1187A mixture of: reaction product of 4,4′-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxo-naphthalenesulfonate (1:2) and reaction product of 4,4′-methylenebis[2-(4-hydroxybenzyl)-3,6-dimethylphenol] and 6-diazo-5,6-dihydro-5-oxonaphthalenesulfonate (1:3)417-980-4
1188Malachite green hydrochloride [1]569-64-2 [1]209-322-8
Malachite green oxalate [2]18015-76-4 [2]241-922-5
11891-(4-Chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol107534-96-3403-640-2
11905-(3-Butyryl-2,4,6-trimethylphenyl)-2-[1-(ethoxyimino)propyl]-3-hydroxycyclohex-2-en-1-one138164-12-2414-790-3
1191 trans-4-Phenyl-L-proline96314-26-0416-020-1
1192Moved or deleted
1193A mixture of: 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-2-[(3-phosphonophenyl)azo]benzoic acid and 5-[(4-[(7-amino-1-hydroxy-3-sulfo-2-naphthyl)azo]-2,5-diethoxyphenyl)azo]-3-[(3-phosphonophenyl)azo]benzoic acid163879-69-4418-230-9
11942-{]4-(2-Ammoniopropylamino)-6-[}4-hydroxy-3-(5-methyl-2-methoxy-4-sulfamoylphenylazo)-2-sulfonatonaphth-7-ylamino{]-1,3,5-triazin-2-ylamino[}-2-aminopropyl formate424-260-3
11955-Nitro-o-toluidine [1]99-55-8 [1]202-765-8
5-Nitro-o-toluidine hydrochloride [2]51085-52-0 [2]256-960-8
11961-(1-Naphthylmethyl)quinolinium chloride65322-65-8406-220-7
1197(R)-5-Bromo-3-(1-methyl-2-pyrrolidinylmethyl)-1H-indole143322-57-0422-390-5
1198Pymetrozine (ISO)123312-89-0613-202-00-4
1199Oxadiargyl (ISO)39807-15-3254-637-6
1200Chlorotoluron (3-(3-chloro-p-tolyl)-1,1-dimethylurea)15545-48-9239-592-2
1201N-[2-(3-Acetyl-5-nitrothiophen-2-ylazo)-5-diethylaminophenyl]acetamide416-860-9
12021,3-bis(Vinylsulfonylacetamido)propane93629-90-4428-350-3
1203 p-Phenetidine (4-Ethoxyaniline)156-43-4205-855-5
1204 m-Phenylenediamine and its salts108-45-2203-584-7
1205Residues (coal tar), creosote oil distn., if it contains > 0,005 % w/w benzo[a]pyrene92061-93-3295-506-3
1206Creosote oil, acenaphthene fraction, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene90640-84-9292-605-3
1207Creosote oil, if it contains > 0,005 % w/w benzo[a]pyrene61789-28-4263-047-8
1208Creosote, if it contains > 0,005 % w/w benzo[a]pyrene8001-58-9232-287-5
1209Creosote oil, high-boiling distillate, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene70321-79-8274-565-9
1210Extract residues (coal), creosote oil acid, wash oil extract residue, if it contains > 0,005 % w/w benzo[a]pyrene122384-77-4310-189-4
1211Creosote oil, low-boiling distillate, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene70321-80-1274-566-4
12126-Methoxy-2,3-Pyridinediamine and its HCl salt, when used as a substance in hair dye products94166-62-8303-358-9
12132,3-Naphthalenediol, when used as a substance in hair dye products92-44-4202-156-7
12142,4-Diaminodiphenylamine, when used as a substance in hair dye products136-17-4
12152,6-Bis(2-Hydroxyethoxy)-3,5-Pyridinediamine and its HCl salt, when used as a substance in hair dye products117907-42-3
12162-Methoxymethyl-p-Aminophenol and its HCl salt, when used as a substance in hair dye products135043-65-1/29785-47-5
12174,5-Diamino-1-Methylpyrazole and its HCl salt, when used as a substance in hair dye products20055-01-0/21616-59-1
12184,5-Diamino-1-((4-Chlorophenyl)Methyl)-1H-Pyrazole Sulfate, when used as a substance in hair dye products163183-00-4
12194-Chloro-2-Aminophenol, when used as a substance in hair dye products95-85-2202-458-9
12204-Hydroxyindole, when used as a substance in hair dye products2380-94-1219-177-2
12214-Methoxytoluene-2,5-Diamine and its HCl salt, when used as a substance in hair dye products56496-88-9
12225-Amino-4-Fluoro-2-Methylphenol Sulfate, when used as a substance in hair dye products163183-01-5
1223N,N-Diethyl-m-Aminophenol, when used as a substance in hair dye products91-68-9/68239-84-9202-090-9/269-478-8
1224N,N-Dimethyl-2,6-Pyridinediamine and its HCl salt, when used as a substance in hair dye products
1225N-Cyclopentyl-m-Aminophenol, when used as a substance in hair dye products104903-49-3
1226N-(2-Methoxyethyl)-p-phenylenediamine and its HCl salt, when used as a substance in hair dye products72584-59-9/66566-48-1276-723-2
12272,4-Diamino-5-methylphenetol and its HCl salt, when used as a substance in hair dye products113715-25-6
12281,7-Naphthalenediol, when used as a substance in hair dye products575-38-2209-383-0
12293,4-Diaminobenzoic acid, when used as a substance in hair dye products619-05-6210-577-2
12302-Aminomethyl-p-aminophenol and its HCl salt, when used as a substance in hair dye products79352-72-0
1231Solvent Red 1 (CI 12150), when used as a substance in hair dye products1229-55-6214-968-9
1232Acid Orange 24 (CI 20170), when used as a substance in hair dye products1320-07-6215-296-9
1233Acid Red 73 (CI 27290), when used as a substance in hair dye products5413-75-2226-502-1
1234PEG-3,2′,2′-di-p-Phenylenediamine144644-13-3
12356-Nitro-o-Toluidine570-24-1209-329-6
1236HC Yellow No 1173388-54-2
1237HC Orange No 381612-54-6
1238HC Green No 152136-25-1257-687-7
1239HC Red No 8 and its salts13556-29-1/97404-14-3- / 306-778-0
1240Tetrahydro-6-nitroquinoxaline and its salts158006-54-3/41959-35-7/73855-45-5
1241Disperse Red 15, except as impurity in Disperse Violet 1116-85-8204-163-0
12424-Amino-3-fluorophenol399-95-1402-230-0
1243

N,N′-dihexadecyl-N,N′-bis(2-hydroxyethyl)propanediamide

Bishydroxyethyl Biscetyl Malonamide

149591-38-8422-560-9
12441-Methyl-2,4,5-trihydroxybenzene and its salts, when used as a substance in hair dye products1124-09-0214-390-7
12452,6-Dihydroxy-4-methylpyridine and its salts, when used as a substance in hair dye products4664-16-8225-108-7
12465-Hydroxy-1,4-benzodioxane and its salts, when used as a substance in hair dye products10288-36-5233-639-0
12473,4-Methylenedioxyphenol and its salts, when used as a substance in hair dye products533-31-3208-561-5
12483,4-Methylenedioxyaniline and its salts, when used as a substance in hair dye products14268-66-7238-161-6
1249Hydroxypyridinone and its salts, when used as a substance in hair dye products822-89-9212-506-0
12503-Nitro-4-aminophenoxyethanol and its salts, when used as a substance in hair dye products50982-74-6
12512-methoxy-4-nitrophenol (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products3251-56-7221-839-0
1252CI Acid Black 131 and its salts, when used as a substance in hair dye products12219-01-1
12531,3,5-Trihydroxybenzene (Phloroglucinol) and its salts, when used as a substance in hair dye products108-73-6203-611-2
12541,2,4-Benzenetriacetate and its salts, when used as a substance in hair dye products613-03-6210-327-2
1255Ethanol, 2,2'-iminobis-, reaction products with epichlorohydrin and 2-nitro-1,4-benzenediamine (HC Blue No. 5) and its salts, when used as a substance in hair dye products68478-64-8/158571-58-5
1256N-Methyl-1,4-diaminoanthraquinone, reaction products with epichlorohydrin and monoethanolamine (HC Blue No. 4) and its salts, when used as a substance in hair dye products158571-57-4
12574-Aminobenzenesulfonic acid (Sulfanilic acid) and its salts, when used as a substance in hair dye products121-57-3/515-74-2204-482-5/208-208-5
12583,3'-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products6373-79-1228-922-0
12593(or5)-((4-(Benzylmethylamino)phenyl)azo)-1,2-(or1,4)-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products89959-98-8/12221-69-1289-660-0
12602,2'-((3-Chloro-4-((2,6-dichloro-4-nitrophenyl)azo)phenyl)imino)bisethanol (Disperse Brown 1) and its salts, when used as a substance in hair dye products23355-64-8245-604-7
1261Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl-, and its salts, when used as a substance in hair dye products12270-13-2235-546-0
12622-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (Pigment Yellow 73) and its salts, when used as a substance in hair dye products13515-40-7236-852-7
12632,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutanamide] (Pigment Yellow 12) and its salts, when used as a substance in hair dye products6358-85-6228-787-8
12642,2'-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in hair dye products2870-32-8220-698-2
12652,3-Dihydro-2,2-dimethyl-6-[(4-(phenylazo)-1-naphthalenyl)azo]-1H-pyrimidine (Solvent Black 3) and its salts, when used as a substance in hair dye products4197-25-5224-087-1
12663(or5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylic acid and its salts, when used as a substance in hair dye products3442-21-5/34977-63-4222-351-0/252-305-5
12672-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]-, and its salts, when used as a substance in hair dye products2610-11-9220-028-9
1268(μ-((7,7'-Iminobis(4-hydroxy-3-((2-hydroxy-5-(N-methylsulphamoyl)phenyl)azo)naphthalene-2-sulphonato))(6-)))dicuprate(2-) and its salts, when used as a substance in hair dye products37279-54-2253-441-8
12693-[(4-(Acetylamino)phenyl)azo]-4-hydroxy-7-[[[[5-hydroxy-6-(phenylazo)-7-sulfo-2-naphthalenyl]amino]carbonyl]amino]-2-naphthalenesulfonic acid and its salts, when used as a substance in hair dye products3441-14-3222-348-4
12702-Naphthalenesulfonic acid, 7,7'-(carbonyldiimino)bis(4-hydroxy-3-[[2-sulfo-4-[(4-sulfophenyl)azo]phenyl]azo]-, and its salts, when used as a substance in hair dye products2610-10-8/25188-41-4220-027-3
1271Ethanaminium, N-(4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene)-N-ethyl-, and its salts, when used as a substance in hair dye products2390-59-2219-231-5
12723H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-, and its salts, when used as a substance in hair dye products54060-92-3258-946-7
12733H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl-, and its salts, when used as a substance in hair dye products4208-80-4224-132-5
1274Nigrosine spirit soluble (Solvent Black 5), when used as a substance in hair dye products11099-03-9
1275Phenoxazin-5-ium, 3,7-bis(diethylamino)-, and its salts, when used as a substance in hair dye products47367-75-9/33203-82-6251-403-5
1276Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair dye products7057-57-0/966-62-1230-338-6/213-524-1
12776-Amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione (Solvent Yellow 44) and its salts, when used as a substance in hair dye products2478-20-8219-607-9
12781-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone and its salts, when used as a substance in hair dye products67905-56-0/12217-43-5267-677-4/235-398-7
1279Laccaic Acid (CI Natural Red 25) and its salts, when used as a substance in hair dye products60687-93-6
1280Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, and its salts, when used as a substance in hair dye products6373-74-6/15347-52-1228-921-5/239-377-3
12814-[(4-Nitrophenyl)azo]aniline (Disperse Orange 3) and its salts, when used as a substance in hair dye products730-40-5/70170-61-5211-984-8
12824-Nitro-m-phenylenediamine and its salts, when used as a substance in hair dye products5131-58-8225-876-3
12831-Amino-4-(methylamino)-9,10-anthracenedione (Disperse Violet 4) and its salts, when used as a substance in hair dye products1220-94-6214-944-8
1284N-Methyl-3-nitro-p-phenylenediamine and its salts, when used as a substance in hair dye products2973-21-9221-014-5
1285N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (HC Yellow No. 5) and its salts, when used as a substance in hair dye products56932-44-6260-450-0
1286N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (HC Yellow No. 3) and its salts, when used as a substance in hair dye products56932-45-7260-451-6
12872-Nitro-N-hydroxyethyl-p-anisidine and its salts, when used as a substance in hair dye products57524-53-5
1288N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine and its salts, when used as a substance in hair dye products10228-03-2233-549-1
12893-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol and its salts, when used as a substance in hair dye products93633-79-5403-440-5
12904-Ethylamino-3-nitrobenzoic acid (N-Ethyl-3-Nitro PABA) and its salts, when used as a substance in hair dye products2788-74-1412-090-2
1291(8-[(4-Amino-2-nitrophenyl)azo]-7-hydroxy-2-naphthyl)trimethylammonium and its salts, except Basic Red 118 (CAS 71134-97-9) as impurity in Basic Brown 17, when used as a substance in hair dye products71134-97-9275-216-3
12925-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products12221-52-2
1293m-Phenylenediamine, 4-(phenylazo)-, and its salts, when used as a substance in hair dye products495-54-5207-803-7
12941,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye products4438-16-8224-654-3
12952,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)-, and its salts, when used as a substance in hair dye products6441-93-6229-231-7
12964,4'-[(4-Methyl-1,3-phenylene)bis(azo)]bis[6-methyl-1,3-benzenediamine] (Basic Brown 4) and its salts, when used as a substance in hair dye products4482-25-1224-764-1
1297Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl-, and its salts, when used as a substance in hair dye products83803-99-0280-920-9
1298Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl-, and its salts, when used as a substance in hair dye products83803-98-9280-919-3
1299Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products633-03-4211-190-1
13009,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)-, and its derivatives and salts, when used as a substance in hair dye products2475-46-9/86722-66-9219-604-2/289-276-3
13011,4-Diamino-2-methoxy-9,10-anthracenedione (Disperse Red 11) and its salts, when used as a substance in hair dye products2872-48-2220-703-8
13021,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (Disperse Blue 7) and its salts, when used as a substance in hair dye products3179-90-6221-666-0
13031-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance in hair dye products22366-99-0244-938-0
1304N-[6-[(2-Chloro-4-hydroxyphenyl)imino]-4-methoxy-3-oxo-1,4-cyclohexadien-1-yl]acetamide (HC Yellow No. 8) and its salts, when used as a substance in hair dye products66612-11-1266-424-5
1305[6-[[3-Chloro-4-(methylamino)phenyl]imino]-4-methyl-3-oxocyclohexa-1,4-dien-1-yl]urea (HC Red No. 9) and its salts, when used as a substance in hair dye products56330-88-2260-116-4
1306Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, and its salts, when used as a substance in hair dye products61-73-4200-515-2
13074,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair dye products94082-85-6
13085-Amino-2,6-Dimethoxy-3-Hydroxypyridine and its salts, when used as a substance in hair dye products104333-03-1
13094,4'-Diaminodiphenylamine and its salts, when used as a substance in hair dye products537-65-5208-673-4
13104-Diethylamino-o-toluidine and its salts, when used as a substance in hair dye products148-71-0/24828-38-4/2051-79-8205-722-1/246-484-9/218-130-3
1311N,N-Diethyl-p-phenylenediamine and its salts, when used as a substance in hair dye products93-05-0/6065-27-6/6283-63-2202-214-1/227-995-6/228-500-6
1312N,N-Dimethyl-p-phenylenediamine and its salts, when used as a substance in hair dye products99-98-9/6219-73-4202-807-5/228-292-7
1313Toluene-3,4-Diamine and its salts, when used as a substance in hair dye products496-72-0207-826-2
13142,4-Diamino-5-methylphenoxyethanol and its salts, when used as a substance in hair dye products141614-05-3/113715-27-8
13156-Amino-o-cresol and its salts, when used as a substance in hair dye products17672-22-9
1316Hydroxyethylaminomethyl-p-aminophenol and its salts, when used as a substance in hair dye products110952-46-0/135043-63-9
13172-Amino-3-nitrophenol and its salts, when used as a substance in hair dye products603-85-0210-060-1
13182-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine and its salts, when used as a substance in hair dye products50610-28-1256-652-3
13192-Nitro-p-phenylenediamine and its salts, when used as a substance in hair dye products5307-14-2/18266-52-9226-164-5/242-144-9
1320Hydroxyethyl-2,6-dinitro-p-anisidine and its salts, when used as a substance in hair dye products122252-11-3
13216-Nitro-2,5-pyridinediamine and its salts, when used as a substance in hair dye products69825-83-8
1322Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl-, and its salts, when used as a substance in hair dye products477-73-6207-518-8
13233-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid and its salts, when used as a substance in hair dye products16279-54-2/5610-64-0240-379-1/227-029-3
13243-[(2-nitro-4-(trifluoromethyl)phenyl)amino]propane-1,2-diol (HC Yellow No. 6) and its salts, when used as a substance in hair dye products104333-00-8
13252-[(4-chloro-2-nitrophenyl)amino]ethanol (HC Yellow No. 12) and its salts, when used as a substance in hair dye products59320-13-7
13263-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol and its salts, when used as a substance in hair dye products173994-75-7/102767-27-1
13273-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol and its salts, when used as a substance in hair dye products114087-41-1/114087-42-2
1328Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, and its salts, when used as a substance in hair dye products2390-60-5219-232-0

ANNEX IIILIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJECT TO THE RESTRICTIONS LAID DOWN

a

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.

b

For use as a preservative, see Annex V, No. 5.

c

Only if the concentration exceeds 0,05 %.

d

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 2.

e

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 g.

f

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 g.

g

For use as a preservative, see Annex V, No. 34.

h

For use as a preservative, see Annex V, No 43.

i

For use as a preservative, see Annex V, No. 54.

j

For use as a preservative, see Annex V, No 3.

l

Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.

k

For use as a preservative, see Annex V, No 9.

m

For use as a preservative, see AnnexV, No 23.

n

For use as a preservative, see Annex V, No 8.

Reference numberSubstance identificationRestrictionsWording of conditions of use and warnings
Chemical name/INNName of Common Ingredients GlossaryCAS numberEC numberProduct type, body partsMaximum concentration in ready for use preparationOther
abcdefghi
1aBoric acid, borates and tetraborates with the exception of substance No 1184 in Annex IIBoric acid10043-35-3/11113-50-1233-139-2/234-343-4

(a)Talc

(a)5 % (as boric acid)

(a)Not to be used in products for children under 3 years of age

Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (as boric acid)

(a)Not to be used for children under 3 years of age

Not to be used on peeling or irritated skin

(b)Oral products

(b)0,1 % (as boric acid)

(b)Not to be used in products for children under 3 years of age

(b)Not to be swallowed

Not to be used for children under 3 years of age

(c)Other products (excluding bath products and hair waving products)

(c)3 % (as boric acid)

(c)Not to be used in products for children under 3 years of age

Not to be used on peeling or irritated skin if the concentration of free soluble borates exceeds 1,5 % (as boric acid)

(c)Not to be used for children under 3 years of age

Not to be used on peeling or irritated skin

1bTetraborates, see also 1a)

(a)Bath products

(a)18 % (as boric acid)

(a)Not to be used in products for children under 3 years of age

(a)Not to be used for children under 3 years of age

(b)Hair products

(b)8 % (as boric acid)

(b)Rinse well

2aThioglycolic acid and its saltsThioglycolic acid68-11-1200-677-4

(a)Hair products

8 %

General use

ready for use pH 7 to 9,5

Conditions of use:

(a) (b) (c)

Avoid contact with eyes

In the event of contact with eyes, rinse immediately with plenty of water and seek medical advice

(a) (c)

Wear suitable gloves

Warnings:

(a) (b) (c)

Contains thioglycolate

Follow the instructions

Keep out of reach of children

(a) For professional use only

11 %

Professional use

ready for use pH 7 to 9,5

(b)Depilatories

5 %ready for use pH 7 to 12,7

(c)Hair rinse-off products

2 %

The abovementioned percentages are calculated as thioglycolic acid

ready for use pH 7 to 9,5
2bThioglycolic acid estersHair waving or straightening products

(a)8 %

General use

ready for use pH 6 to 9,5

Conditions of use:

(a) (b)

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

Warnings:

Contains thioglycolate

Follow the instructions

Keep out of reach of children

(b)11 %

The abovementioned percentages are calculated as thioglycolic acid

Professional use

ready for use pH 6 to 9,5

(b)For professional use only

3Oxalic acid, its esters and alkaline saltsOxalic acid144-62-7205-634-3Hair products5 %Professional useFor professional use only
4AmmoniaAmmonia7664-41-7/1336-21-6231-635-3/215-647-66 % (as NH3)Above 2 %: Contains ammonia
5Tosylchloramide sodium (INN)Chloramine-T127-65-1204-854-70,2 %
6Chlorates of alkali metalsSodium chlorate7775-09-9231-887-4

(a)Toothpaste

(b)Other products

(a)5 %

(b)3 %

Potassium chlorate3811-04-9223-289-7
7DichloromethaneDichloromethane75-09-2200-838-935 % (when mixed with 1,1,1-trichloro-ethane, total concentration must not exceed 35 %)0,2 % as maximum impurity content
8p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediaminea, with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex IIp-Phenylenediamine106-50-3203-404-7Oxidising colouring agents for hair dyeing6 % (as free base)

(a)General use

Not to be used on eyebrows

(a)Can cause an allergic reaction

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

Wear suitable gloves

9Methylphenylenediamines, their N-substituted derivativesa and their salts with the exception of substances under reference numbers 364, 413, 1144, 1310 and 1313 in Annex IIToluene-2,5-diamine95-70-5202-442-1Oxidising colouring agents for hair dyeing10 % (as free base)

(a)General use

Not to be used on eyebrows

(a)Can cause an allergic reaction

Contains phenylene-diamines

Do not use to dye eyelashes or eyebrows

(b)Professional use

(b)For professional use only

Contains phenylene-diamines

Can cause an allergic reaction

Wear suitable gloves

10DiaminophenolsaOxidising colouring agents for hair dyeing10 % (as free base)

(a)General use

Not to be used on eyebrows

(a)Can cause an allergic reaction

Do not use to dye eyelashes or eyebrows

(b)Professional use

(b)For professional use only

Can cause an allergic reaction

Wear suitable gloves

11DichlorophenDichlorophen97-23-4202-567-10,5 %Contains Dichlorophen
12Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxideHydrogen peroxide7722-84-1231-765-0

(a)Hair- products

12 % H2O2 (40 volumes), present or released

(a)Wear suitable gloves

(a) (b) (c):

Contains hydrogen peroxide

Avoid contact with eyes

Rinse eyes immediately if product comes into contact with them

(b)Skin- products

4 % H2O2, present or released

(c)Nail hardening products

2 % of H2O2, present or released

(d)Oral products

0,1 % of H2O2, present or released
13FormaldehydebFormaldehyde50-00-0200-001-8Nail hardening products5 % (as formaldehyde)For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product

Protect cuticles with grease or oil

Contains formaldehydec

14HydroquinonedHydroquinone123-31-9204-617-8

(a)Oxidising colouring agent for hair dyeing

0,3 %

General use

Not to be used on eyebrows

Do not use to dye eyelashes or eyebrows

Rinse eyes immediately if the product comes into contact with them

Contains Hydroquinone

Professional use

For professional use only

Contains hydroquinone

Rinse eyes immediately if product comes into contact with them

(b)Artificial nail systems

0,02 % (after mixing for use)Professional use

(b)For professional use only

Avoid skin contact

Read directions for use carefully

15aPotassium or sodium hydroxidePotassium hydroxide/sodium hydroxide1310-58-3/1310-73-2215-181-3/215-185-5

(a)Nail cuticle solvent

(a)5 %e

(a)Contains alkali

Avoid contact with eyes

Can cause blindness

Keep out of reach of children

(b)Hair straightener

2 %eGeneral use

Contains alkali

Avoid contact with eyes

Can cause blindness

Keep out of reach of children

4,5 %eProfessional use

For professional use only

Avoid contact with eyes

Can cause blindness

(c)pH adjuster for depilatories

(c)pH < 12,7

(c)Keep out of reach of children

Avoid contact with eyes

(d)Other uses as pH adjuster

(d)pH < 11

15bLithium hydroxideLithium hydroxide1310-65-2215-183-4

(a)Hair straighteners

2 %fGeneral use

(a)Contains alkali

Avoid contact with eyes

Can cause blindness

Keep out of reach of children

4,5 %fProfessional use

Avoid contact with eyes

Can cause blindness

(b)pH adjuster for depilatories

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)

pH < 11
15cCalcium hydroxideCalcium hydroxide1305-62-0215-137-3

(a)Hair straighteners containing two components: calcium hydroxide and a guanidine salt

(a)7 % (as calcium hydroxide)

(a)Contains alkali

Avoid contact with eyes

Keep out of reach of children

Can cause blindness

(b)pH adjuster for depilatories

(b)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 < 11

161-Naphthol and its salts1-Naphtol90-15-3201-969-4Oxidising colouring agents for hair dyeing2,0 %In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %Can cause an allergic reaction
17Sodium nitriteSodium nitrite7632-00-0231-555-9Rust inhibitor0,2 %Not to be used with secondary and/or tertiary amines or other substances forming nitrosamines
18NitromethaneNitromethane75-52-5200-876-6Rust inhibitor0,3 %
19Moved or deleted
20Moved or deleted
21Cinchonan-9-ol, 6'-methoxy-, (8.alpha., 9R)- and its saltsQuinine130-95-0205-003-2

(a)Hair rinse-off products

(a)0,5 % (as quinine base)

(b)Hair leave-on products

(b)0,2 % (as quinine base)

22ResorcinoldResorcinol108-46-3203-585-2

(a)Oxidising colouring agent for hair dyeing

5 %

General use

Not to be used on eyebrows

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

Professional use

For professional use only

Contains resorcinol

Rinse eyes immediately if product comes into contact with them

(b)Hair lotions and shampoos

0,5 %Contains resorcinol
23

(a)Alkali sulphides

(a)Depilatories

(a)2 % (as sulphur)

pH ≤ 12,7

(a) (b)Keep out of reach of children

Avoid contact with eyes

(b)Alkaline earth sulphides

(b)Depilatories

(b)6 % (as sulphur)

24Water-soluble zinc salts with the exception of zinc 4-hydroxy-benzenesulphonate (entry 25) and zinc pyrithione (entry 101 and Annex V, entry 8)Zinc acetate, zinc chloride, zinc gluconate, zinc glutamate1 % (as zinc)
25Zinc 4-hydroxybenzene sulphonateZinc phenolsulfonate127-82-2204-867-8Deodorants, antiperspirants and astringent lotions6 % (as % anhydrous substance)Avoid contact with eyes
26Ammonium monofluorophosphateAmmonium monofluorophosphate20859-38-5/66115-19-3Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains ammonium monofluorophosphate

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

27Disodium fluorophosphateSodium monofluorophosphate10163-15-2/7631-97-2233-433-0/231-552-2Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains sodium monofluorophosphate

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

28Dipotassium fluorophosphatePotassium monofluorophosphate14104-28-0237-957-0Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains potassium monofluorophosphate

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

29Calcium fluorophosphateCalcium monofluorophosphate7789-74-4232-187-1Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains calcium monofluorophosphate

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

30Calcium fluorideCalcium fluoride7789-75-5232-188-7Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains calcium fluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

31Sodium fluorideSodium fluoride7681-49-4231-667-8Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains sodium fluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

32Potassium fluoridePotassium fluoride7789-23-3232-151-5Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains potassium fluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

33Ammonium fluorideAmmonium fluoride12125-01-8235-185-9Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains ammonium fluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

34Aluminium fluorideAluminium fluoride7784-18-1232-051-1Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains aluminium-fluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

35Tin difluorideStannous fluoride7783-47-3231-999-3Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains stannous fluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

36Hexadecyl ammonium fluorideCetylamine hydrofluoride3151-59-5221-588-7Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains Cetylamine hydrofluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

373-(N-Hexadecyl-N-2-hydroxy-ethylammonio) propylbis (2-hydroxyethyl) ammonium difluorideOral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains 3-(N-Hexadecyl-N-2-hydroxyethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

38 N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluorideOral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains N,N',N'-Tris(polyoxyethylene)-N-hexadecylpropylenediamine dihydrofluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

399-Octadecenamine, hydrofluorideOctadecenyl-ammonium fluoride2782-81-2Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains octadecenyl-ammonium fluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

40Disodium hexafluorosilicateSodium fluorosilicate16893-85-9240-934-8Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains sodium fluorosilicate

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

41Dipotassium hexafluorosilicatePotassium fluorosilicate16871-90-2240-896-2Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains potassium fluorosilicate

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

42Ammonium hexafluorosilicateAmmonium fluorosilicate16919-19-0240-968-3Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains ammonium fluorosilicate

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

43Magnesium hexafluorosilicateMagnesium fluorosilicate16949-65-8241-022-2Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains magnesium fluorosilicate

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

441,3-Bis (hydroxymethyl)imidazolidine-2-thioneDimethylol ethylene thiourea15534-95-9239-579-1

(a)Hair- products

(a)2 %

(a)Not to be used in aerosol dispensers (sprays)

Contains Dimethylol ethylene thiourea

(b)Nail- products

(b)2 %

(b)pH < 4

45Benzyl alcoholgBenzyl alcohol100-51-6202-859-9Solvents, perfumes and flavouringsFor purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
466-Methylcoumarin6-Methylcoumarin92-48-8202-158-8Oral products0,003 %
473-Pyridinemethanol, hydrofluorideNicomethanol hydrofluoride62756-44-9Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains nicomethanol hydrofluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

48Silver nitrateSilver nitrate7761-88-8231-853-9Only for colouring eyelashes and eyebrows4 %

Contains silver nitrate

Rinse eyes immediately if product comes into contact with them

49Selenium sulfideSelenium disulphide7488-56-4231-303-8Antidandruff shampoos1 %

Contains selenium disulphide

Avoid contact with eyes or damaged skin

50

Aluminium zirconium chloride hydroxide complexes

AlxZr(OH)yClz and the aluminium zirconium chloride hydroxide glycine complexes

Anti-perspirants

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 2 and 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.Not to be used in aerosol dispensers (sprays)

Do not apply to irritated or damaged skin
51Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphateOxyquinoline and oxyquinoline sulfate148-24-3/134-31-6205-711-1/205-137-1Stabilizer for hydrogen peroxide in rinse-off hair- products0,3 % (as base)
Stabilizer for hydrogen peroxide in leave-on hair products0,03 % (as base)
52MethanolMethyl alcohol67-56-1200-659-6Denaturant for ethanol and isopropyl alcohol5 % (as a % ethanol and isopropyl alcohol)
53(1-Hydroxyethylidene-diphosphonic acid) and its saltsEtidronic acid2809-21-4220-552-8

(a)Hair- product

1,5 % (as etidronic acid)

(b)Soap

0,2 % (as etidronic acid)
541-Phenoxypropan-2-olhPhenoxyisopropanol770-35-4212-222-7

Use only in rinse-off products

Not to be used in oral products

2 %For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
55Moved or deleted
56Magnesium fluorideMagnesium fluoride7783-40-6231-995-1Oral products0,15 % (as F). When mixed with other fluorine compounds permitted under this Annex, total F concentration must not exceed 0,15 %

Contains magnesium fluoride

For any toothpaste containing 0,1 to 0,15 % fluoride unless it is already labelled as contra-indicated for children (e.g. ‘for adult use only’) the following labelling is obligatory:

‘Children of 6 years and younger: Use a pea sized amount for supervised brushing to minimize swallowing. In case of intake of fluoride from other sources consult a dentist or doctor’

57Strontium chloride hexahydrateStrontium chloride10476-85-4233-971-6

(a)Oral products

3,5 % (as strontium). When mixed with other permitted strontium compounds the total strontium content must not exceed 3,5 %

Contains strontium chloride

Frequent use by children is not advisable

(b)Shampoo and face products

2,1 % (as strontium). When mixed with other permitted strontium compounds the total strontium content must not exceed 2,1 %
58Strontium acetate hemihydrateStrontium acetate543-94-2208-854-8Oral products3,5 % (as strontium). When mixed with other permitted strontium compounds the total strontium content must not exceed 3,5 %

Contains strontium acetate

Frequent use by children is not advisable

59Talc: Hydrated magnesium silicateTalc14807-96-6238-877-9

(a)Powdery products intended to be used for children under 3 years of age

(b)Other products

(a)Keep powder away from children's nose and mouth

60Fatty acid dialkylamides and dialkanolamidesMaximum secondary amine content: 0,5 %
  • Not to be used with nitrosating systems

  • Maximum secondary amine content: 5 % (applies to raw materials)

  • Maximum nitrosamine content: 50 μg/kg

  • Keep in nitrite-free containers

61Monoalkylamines, monoalkanolamines and their saltsMaximum secondary amine content: 0,5 %
  • Not to be used 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

62Trialkylamines, trialkanolamines and their salts

(a)Leave-on products

(b)Rinse-off products

(a)2,5 %

(a) (b)

  • Not to be used 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

63Strontium hydroxideStrontium hydroxide18480-07-4242-367-1pH adjuster for depilatories3,5 % (as strontium)pH ≤ 12,7

Keep out of reach of children

Avoid contact with eyes

64Strontium peroxideStrontium peroxide1314-18-7215-224-6Rinse-off hair products4,5 % (as strontium)

All products must meet the hydrogen peroxide release requirements

Professional use

Avoid contact with eyes

Rinse eyes immediately if product comes into contact with them

For professional use only

Wear suitable gloves

65Benzalkonium chloride, bromide and saccharinateiBenzalkonium bromide91080-29-4293-522-5Rinse-off hair (head) products3 % (as benzalkonium chloride)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)Avoid contact with eyes
For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
Benzalkonium chloride63449-41-2/68391-01-5/68424-85-1/85409-22-9264-151-6/269-919-4/270-325-2/287-089-1
Benzalkonium saccharinate68989-01-5273-545-7
66Polyacrylamides

(a)Body- leave-on products

(a)Maximum residual acrylamide content 0,1 mg/kg

(b)Other products

(b)Maximum residual acrylamide content 0,5 mg/kg

672-BenzylideneheptanalAmyl cinnamal122-40-7204-541-5

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

68Benzyl alcoholBenzyl alcohol100-51-6202-859-9

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

69Cinnamyl alcoholCinnamyl alcohol104-54-1203-212-3

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

703,7-Dimethyl-2,6-octadienalCitral5392-40-5226-394-6

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

71Phenol, 2-methoxy-4-(2-propenyl)Eugenol97-53-0202-589-1

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

727-HydroxycitronellalHydroxycitronellal107-75-5203-518-7

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

73Phenol, 2-methoxy-4-(1-propenyl)-Isoeugenol97-54-1202-590-7

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

742-Pentyl-3-phenylprop-2-en-1-olAmylcinnamyl alcohol101-85-9202-982-8

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

75Benzyl salicylateBenzyl salicylate118-58-1204-262-9

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

762-Propenal, 3-phenyl-Cinnamal104-55-2203-213-9

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

772H-1-Benzopyran-2-oneCoumarin91-64-5202-086-7

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

782,6-Octadien-1-ol, 3,7-dimethyl-, (2E)-Geraniol106-24-1203-377-1

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

793 and 4-(4-Hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehydeHydroxyisohexyl 3-cyclohexene carboxaldehyde51414-25-6/31906-04-4257-187-9/250-863-4

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

804-Methoxybenzyl alcoholAnise alcohol105-13-5203-273-6

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

812-Propenoic acid, 3-phenyl-, phenylmethyl esterBenzyl cinnamate103-41-3203-109-3

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

822,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl-Farnesol4602-84-0225-004-1

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

832-(4-tert-Butylbenzyl)propionaldehydeButylphenyl methylpropional80-54-6201-289-8

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

841,6-Octadien-3-ol, 3,7-dimethyl-Linalool78-70-6201-134-4

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

85Benzyl benzoateBenzyl benzoate120-51-4204-402-9

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

86Citronellol/(±) -3,7-dimethyloct-6-en-1-olCitronellol106-22-9/26489-01-0203-375-0/247-737-6

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

872-BenzylideneoctanalHexyl cinnamal101-86-0202-983-3

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

88(4R)-1-Methyl-4-(1-methylethenyl)cyclohexeneLimonene5989-27-5227-813-5

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

89Methyl heptin carbonateMethyl 2-octynoate111-12-6203-836-6

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

903-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-onealpha-Isomethyl ionone127-51-5204-846-3

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

91Oak moss extractEvernia prunastri extract90028-68-5289-861-3

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

92Treemoss extractEvernia furfuracea extract90028-67-4289-860-8

The presence of the substance must be indicated in the list of ingredients referred to in Article 19(1)(g) when its concentration exceeds:

  • 0,001 % in leave-on products

  • 0,01 % in rinse-off products

932,4-Pyrimidinediamine, 3-oxideDiaminopyrimidine oxide74638-76-9Hair products1,5 %
94Dibenzoyl peroxideBenzoyl peroxide94-36-0202-327-6Artificial nail systems0,7 % (after mixing for use)Professional use

For professional use only

Avoid skin contact

Read directions for use carefully

95Hydroquinone methylether/Mequinolp-Hydroxyanisol150-76-5205-769-8Artificial nail systems0,02 % (after mixing for use)Professional use

For professional use only

Avoid skin contact

Read directions for use carefully

965-tert-Butyl-2,4,6-trinitro-m-xyleneMusk xylene81-15-2201-329-4All cosmetic products, with the exception of oral products

(a)1,0 % in fine fragrance

(b)0,4 % in eau de toilette

(c)0,03 % in other products

974'-tert-Butyl-2',6'-dimethyl-3',5'-dinitroacetophenoneMusk ketone81-14-1201-328-9All cosmetic products, with the exception of oral products

(a)1,4 % in fine fragrance

(b)0,56 % in eau de toilette

(c)0,042 % in other products

98Benzoic acid, 2-hydroxy-jSalicylic acid69-72-7200-712-3

(a)Rinse-off hair products

(b)Other products

(a)3,0 %

(b)2,0 %

Not to be used in preparations for children under 3 years of age, except for shampoos

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product

Not to be used for children under 3 years of agel
99Inorganic sulfites and bisulfitesk

(a)Oxidative hair dye products

(a)0,67 % (as free SO2)

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product

(b)Hair straightening products

(b)6,7 % (as free SO2)

(c)Self-tanning products for the face

(c)0,45 % (as free SO2)

(d)Other self-tanning products

(d)0,40 % (as free SO2)

1001-(4-Chlorophenyl)-3-(3,4-dichlorophenyl)ureamTriclocarban101-20-2202-924-1Rinse-off products1,5 %

Purity criteria:

3,3',4,4'-Tetrachloroazobenzene ≤ 1 ppm

3,3',4,4'-Tetrachloroazoxybenzene ≤ 1 ppm

For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product

101Pyrithione zincnZinc pyrithione13463-41-7236-671-3Leave-on hair products0,1 %For purposes other than inhibiting the development of micro-organisms in the product. This purpose has to be apparent from the presentation of the product
1021,2-Dimethoxy-4-(2-propenyl)-benzeneMethyl eugenol93-15-2202-223-0Fine fragrance0,01 %
Eau de toilette0,004 %
Fragrance cream0,002 %
Other leave-on products and oral products0,0002 %
Rinse-off products0,001 %
2154-Amino-3-nitrophenol and its salts4-Amino-3-nitrophenol610-81-1210-236-8

(a)Oxidising colouring agents for hair dyeing

(a)3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Not to be used after 31.12.2009

(a) (b)Can cause allergic reaction

(b)Non-oxidising colouring agents for hair dyeing

(b)3,0 %

2162,7-Naphthalenediol and its saltsNaphthalene-2,7-diol582-17-2209-478-7Oxidising colouring agents for hair dyeing1,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,5 %

Not to be used after 31.12.2009

217m-Aminophenol and its salts3-Aminophenol591-27-5209-711-2Oxidising colouring agents for hair dyeing2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Not to be used after 31.12.2009

Can cause allergic reaction
2182,6-Dihydroxy-3,4-dimethylpyridine and its salts2,6-Dihydroxy-3,4-dimethylpyridine84540-47-6283-141-2Oxidising colouring agents for hair dyeing2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Not to be used after 31.12.2009

2191-Hydroxy-3-nitro-4-(3-hydroxypropylamino)benzene and its salts4-Hydroxypropylamino-3-nitrophenol92952-81-3406-305-9

(a)Oxidising colouring agents for hair dyeing

(a)5,2 %

In combination with hydrogen peroxide the maximum use concentration upon application is 2,6 %

Not to be used after 31.12.2009

(a) (b)Can cause allergic reaction

(b)Non-oxidising colouring agents for hair dyeing

(b)2,6 %

2201-[(2'-Methoxyethyl)amino]-2-nitro-4-[di-(2'-hydroxyethyl)amino]benzene and its saltsHC Blue No 1123920-15-2459-980-7

(a)Oxidising colouring agents for hair dyeing

(a)3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Not to be used after 31.12.2009

(a) (b)Can cause allergic reaction

(b)Non-oxidising colouring agents for hair dyeing

(b)2,0 %

2211-Methyl-3-nitro-4-(.beta.-hydroxyethyl)aminobenzene and its saltsHydroxyethyl-2-nitro-p-toluidine100418-33-5408-090-7

(a)Oxidising colouring agents for hair dyeing

(a)2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Not to be used after 31.12.2009

(a) (b)Can cause allergic reaction

(b)Non-oxidising colouring agents for hair dyeing

(b)1,0 %

2221-Hydroxy-2-.beta.-hydroxyethylamino-4,6-dinitrobenzene and its salts2-Hydroxyethylpicramic acid99610-72-7412-520-9

(a)Oxidising colouring agents for hair dyeing

(a)3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Not to be used after 31.12.2009

(a) (b)Can cause allergic reaction

(b)Non-oxidising colouring agents for hair dyeing

(b)2,0 %

2234-Methylaminophenol and its saltsp-Methylaminophenol150-75-4205-768-2Oxidising colouring agent for hair dyeing3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Not to be used after 31.12.2009

Can cause allergic reaction
2241-(3-Hydroxypropylamino)-2-nitro-4-bis(2-hydroxyethylamino)benzene and its saltsHC Violet No 2104226-19-9410-910-3Non-oxidising colouring agent for hair dyeing2,0 %Not to be used after 31.12.2009
2251-(.beta.-Hydroxyethyl)amino-2-nitro-4-N-ethyl-N-(.beta.-hydroxyethyl)aminobenzene and its saltsHC Blue No 12104516-93-0407-020-2

(a)Oxidising colouring agents for hair dyeing

(a)1,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,75 %

Not to be used after 31.12.2009

(a) (b)Can cause allergic reaction

(b)Non-oxidising colouring agents for hair dyeing

(b)1,5 %

2264,4'-[1,3-Propanediylbis(oxy)]bis-, benzene-1,3-diamine and its salts1,3-Bis-(2,4-diaminophenoxy)propane81892-72-0279-845-4Oxidising colouring agents for hair dyeing2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Not to be used after 31.12.2009

Can cause allergic reaction
2273-Amino-2,4-dichlorophenol and its salts3-Amino-2,4-dichlorophenol61693-43-4262-909-0Oxidising colouring agents for hair dyeing2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Not to be used after 31.12.2009

Can cause allergic reaction
2283-Methyl-1-phenyl-5-pyrazolone and its saltsPhenyl methyl pyrazolone89-25-8201-891-0Oxidising colouring agents for hair dyeing0,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %

Not to be used after 31.12.2009

2295-[(2-Hydroxyethyl)amino]-o-cresol and its salts2-Methyl-5-hydroxyethylaminophenol55302-96-0259-583-7Oxidising colouring agents for hair dyeing2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Not to be used after 31.12.2009

Can cause allergic reaction
2303,4-Dihydro-2H-1,4-benzoxazin-6-ol and its saltsHydroxybenzomorpholine26021-57-8247-415-5Oxidising colouring agents for hair dyeing2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Not to be used after 31.12.2009

Can cause allergic reaction
2311,5-bis(.beta.-Hydroxyethyl)amino-2-nitro-4-chlorobenzene and its saltsHC Yellow No 10109023-83-8416-940-3Non-oxidising colouring agents for hair dyeing0,2 %Not to be used after 31.12.2009
2323,5-Diamino-2,6-dimethoxypyridine and its salts2,6-Dimethoxy-3,5-pyridinediamine HCl85679-78-3/56216-28-5- / 260-062-1Oxidising colouring agents for hair dyeing0,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %

Not to be used after 31.12.2009

Can cause allergic reaction
2331-(2-Aminoethyl)amino-4-(2-hydroxyethyl)oxy-2-nitrobenzene and its saltsHC Orange No 285765-48-6416-410-1Non-oxidising colouring agents for hair dyeing1,0 %Not to be used after 31.12.2009
234Ethanol, 2-[(4-amino-2-methyl-5-nitrophenyl)amino]-and its saltsHC Violet No 182576-75-8417-600-7

(a)Oxidising colouring agents for hair dyeing

(a)0,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %

Not to be used after 31.12.2009

(b)Non-oxidising colouring agents for hair dyeing

(b)0,5 %

2352-[3-(Methylamino)-4-nitrophenoxy]ethanol and its salts3-Methylamino-4-nitro-phenoxyethanol59820-63-2261-940-7Non-oxidising colouring agents for hair dyeing1,0 %Not to be used after 31.12.2009
2362-[(2-Methoxy-4-nitrophenyl)amino]ethanol and its salts2-Hydroxy-ethylamino-5-nitro-anisole66095-81-6266-138-0Non-oxidising colouring agents for hair dyeing1,0 %Not to be used after 31.12.2009
2372,2'-[(4-Amino-3-nitrophenyl)imino]bisethanol hydrochloride and other saltsHC Red No 1394158-13-1303-083-4

(a)Oxidising colouring agents for hair dyeing

(a)2,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,25 %

Not to be used after 31.12.2009

(b)Non-oxidising colouring agents for hair dyeing

(b)2,5 %

238Naphthalene-1,5-diol and its salts1,5-Naphthalenediol83-56-7201-487-4Oxidising colouring agents for hair dyeing1,0 %Not to be used after 31.12.2009
239Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) and its saltsHydroxypropyl bis(N-hydroxyethyl-p-phenyldiamine) HCl128729-30-6416-320-2Oxidising colouring agents for hair dyeing3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Not to be used after 31.12.2009

Can cause allergic reaction
240o-Aminophenol and its saltso-Aminophenol95-55-6202-431-1Oxidising colouring agents for hair dyeing2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Not to be used after 31.12.2009

2415-Amino-o-cresol and its salts4-Amino-2-hydroxytoluene2835-95-2220-618-6Oxidising colouring agents for hair dyeing3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Not to be used after 31.12.2009

2422,4-Diaminophenoxyethanol and its salts2,4-Diaminophenoxyethanol HCl66422-95-5266-357-1Oxidising colouring agents for hair dyeing4,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 2,0 %

Not to be used after 31.12.2009

2431,3-Benzenediol, 2-methyl-, and its salts -2-Methylresorcinol608-25-3210-155-8Oxidising colouring agents for hair dyeing2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Not to be used after 31.12.2009

2444-Amino-m-cresol and its salts4-Amino-m-cresol2835-99-6220-621-2Oxidising colouring agents for hair dyeing3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Not to be used after 31.12.2009

2452-[(3-amino-4-methoxyphenyl)amino]ethanol and its salts2-Amino-4-hydroxyethylaminoanisole83763-47-7280-733-2Oxidising colouring agents for hair dyeing3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Not to be used after 31.12.2009

246Hydroxyethyl-3,4-methylenedioxyaniline 2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride and other saltsHydroxyethyl-3,4-methylenedioxyaniline HCI81329-90-0303-085-5Oxidising colouring agents for hair dyeing3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Not to be used after 31.12.2009

2472,2'-[[4-[(2-Hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol. and its saltsHC Blue No 233229-34-4251-410-3Non-oxidising colouring agents for hair dyeing2,8 %Not to be used after 31.12.2009
2484-[(2-Hydroxyethyl)amino]-3-nitrophenol and its salts3-Nitro-p-hydroxyethylaminophenol65235-31-6265-648-0

(a)Oxidising colouring agents for hair dyeing

(a)6,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 3,0 %

Not to be used after 31.12.2009

(b)Non-oxidising colouring agents for hair dyeing

(b)6,0 %

2491-(.beta.-Ureidoethyl)amino-4-nitrobenzene and its salts4-Nitrophenyl aminoethylurea27080-42-8410-700-1

(a)Oxidising colouring agents for hair dyeing

(a)0,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %

Not to be used after 31.12.2009

(b)Non-oxidising colouring agents for hair dyeing

(b)0,5 %

2501-amino-2-nitro-4-(2',3'-dihydroxypropyl)amino-5-chlorobenzene and 1,4-bis-(2',3'-dihydroxypropyl)amino-2-nitro-5-chlorobenzene and its saltsHC Red No 10 and HC Red No 1195576-89-9 and 95576-92-4

(a)Oxidising colouring agents for hair dyeing

(a)2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Not to be used after 31.12.2009

(b)Non-oxidising colouring agents for hair dyeing

(b)1,0 %

251Phenol, 2-chloro-6-(ethylamino)-4-nitro- and its salts2-Chloro-6-ethylamino-4-nitrophenol131657-78-8411-440-1

(a)Oxidising colouring agents for hair dyeing

(a)3,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,5 %

Not to be used after 31.12.2009

(b)Non-oxidising colouring agents for hair dyeing

(b)3,0 %

2522-Amino-6-chloro-4-nitrophenol and its salts2-Amino-6-chloro-4-nitrophenol6358-09-4228-762-1

(a)Oxidising colouring agents for hair dyeing

(a)2,0 %

In combination with hydrogen peroxide the maximum use concentration upon application is 1,0 %

Not to be used after 31.12.2009

(b)Non-oxidising colouring agents for hair dyeing

(b)2,0 %

253[4-[[4-Anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride (CI 44045) and other saltsBasic Blue 26 (CI 44045)2580-56-5219-943-6

(a)Oxidising colouring agents for hair dyeing

(a)0,5 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,25 %

Not to be used after 31.12.2009

(b)Non-oxidising colouring agents for hair dyeing

(b)0,5 %

254Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CI 17200) and other saltsAcid Red 33 (CI 17200)3567-66-6222-656-9Non-oxidising colouring agents for hair dyeing2,0 %Not to be used after 31.12.2009
255Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (CI 14700) and other saltsPonceau SX (CI 14700)4548-53-2224-909-9Non-oxidising colouring agents for hair dyeing2,0 %Not to be used after 31.12.2009
256(4-(4-Aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride (CI 42510) and other saltsBasic Violet 14 (CI 42510)632-99-5211-189-6

(a)Oxidising colouring agents for hair dyeing

(a)0,3 %

In combination with hydrogen peroxide the maximum use concentration upon application is 0,15 %

Not to be used after 31.12.2009

(b)Non-oxidising colouring agents for hair dyeing

(b)0,3 %

ANNEX IVLIST OF COLORANTS ALLOWED IN COSMETIC PRODUCTS

Preamble

Without prejudice to other provisions in this Regulation, a colorant shall include its salts and lakes and when a colorant is expressed as a specific salt, its other salts and lakes shall also be included.

a

For use as a UV-Filter, see Annex VI, No. 27.

Reference numberSubstance identificationConditionsWording of conditions of use and warnings
Chemical NameColour index Number/Name of Common Ingredients GlossaryCAS numberEC numberColourProduct type, Body partsMaximum concentration in ready for use preparationOther
abcdefghij
1Sodium tris(1,2-naphthoquinone 1-oximato-O,O')ferrate(1-)10006GreenRinse-off products
2Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-)10020GreenNot to be used in products applied on mucous membranes
3Disodium 5,7-dinitro-8-oxidonaphthalene-2-sulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments10316YellowNot to be used in eye products
42-[(4-Methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide11680YellowNot to be used in products applied on mucous membranes
52-[(4-Chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide11710YellowNot to be used in products applied on mucous membranes
62-[(4-Methoxy-2-nitrophenyl)azo]-3-oxo-N-(o-tolyl)butyramide11725OrangeRinse-off products
74-(Phenylazo)resorcinol11920Orange
84-[(4-Ethoxyphenyl)azo]naphthol12010RedNot to be used in products applied on mucous membranes
91-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol and its insoluble barium, strontium and zirconium lakes, salts and pigments12085Red3 %
101-[(4-Methyl-2-nitrophenyl)azo]-2-naphthol12120RedRinse-off products
113-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide12370RedRinse-off products
12N-(4-Chloro-2-methylphenyl)-4-[(4-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide12420RedRinse-off products
134-[(2,5-Dichlorophenyl)azo]-N-(2,5-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide12480BrownRinse-off products
14N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide12490Red
152,4-Dihydro-5-methyl-2-phenyl-4-(phenylazo)-3H-pyrazol-3-one12700YellowRinse-off products
16Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate13015Yellow
17Sodium 4-(2,4-dihydroxyphenylazo)benzenesulphonate14270Orange
18Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate14700Red
19Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate14720222-657-4RedPurity criteria as set out in Commission Directive 95/45/EC (E 122)
20Disodium 6-[(2,4-dimethyl-6-sulphonatophenyl)azo]-5-hydroxynaphthalene-1-sulphonate14815Red
21Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments15510OrangeNot to be used in eye products
22Calcium disodium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]-4-sulphonatobenzoate]15525Red
23Barium bis[4-[(2-hydroxy-1-naphthyl)azo]-2-methylbenzenesul-phonate]15580Red
24Sodium 4-[(2-Hydroxy-1-naphthyl)azo]naphthalenesulphonate15620RedRinse-off products
25Sodium 2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments15630Red3 %
26Calcium bis[3-hydroxy-4-(phenylazo)-2-naphthoate]15800RedNot to be used in products applied on mucous membranes
27Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate and its insoluble barium, strontium and zirconium lakes, salts and pigments15850226-109-5RedPurity criteria as set out in Commission Directive 95/45/EC (E 180)
28Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate and its insoluble barium, strontium and zirconium lakes, salts and pigments15865Red
29Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate15880Red
30Disodium 6-hydroxy-5-[(3-sulphonatophenyl)azo]naphthalene-2-sulphonate15980Orange
31Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments15985220-491-7YellowPurity criteria as set out in Commission Directive 95/45/EC (E 110)
32Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate16035247-368-0RedPurity criteria as set out in Commission Directive 95/45/EC (E 129)
33Trisodium 3-hydroxy-4-[(4'-sulphonatonaphthyl)azo]naphthalene-2,7-disulphonate16185213-022-2RedPurity criteria as set out in Commission Directive 95/45/EC (E 123)
34Disodium 7-hydroxy-8-(phenylazo)naphthalene-1,3-disulphonate16230OrangeNot to be used in products applied on mucous membranes
35Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments16255220-036-2RedPurity criteria as set out in Commission Directive 95/45/EC (E 124)
36Tetrasodium 7-hydroxy-8-[(4-sulphonato-1-naphthyl)azo]naphthalene-1,3,6-trisulphonate16290Red
37Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments17200Red
38Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate18050223-098-9RedNot to be used in products applied on mucous membranesPurity criteria as set out in Commission Directive 95/45/EC (E 128)
392,7-Naphthalenedisulfonic acid, 3-((4-cyclohexyl-2-methylphenyl)azo)-4-hydroxy-5-(((4-methylphenyl)sulfonyl)amino)-, disodium salt18130RedRinse-off products
40Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)18690YellowRinse-off products
41Disodium hydrogen bis[5-chloro-3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxybenzenesulphonato(3-)]chromate(3-)18736RedRinse-off products
42Sodium 4-(3-hydroxy-5-methyl-4-(phenylazo)pyrazol-2-yl)benzenesulphonate18820YellowRinse-off products
43Disodium 2,5-dichloro-4-(5-hydroxy-3-methyl-4-((sulphophenyl)azo)pyrazol-1-yl)benzenesulphonate18965Yellow
44Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-((4-sulphophenyl)azo)pyrazole-3-carboxylate and its insoluble barium, strontium and zirconium lakes, salts and pigments19140217-699-5YellowPurity criteria as set out in Commission Directive 95/45/EC (E 102)
45N,N'-(3,3'-Dimethyl[1,1'-biphenyl]-4,4'-diyl)bis[2-[(2,4-dichlorophenyl)azo]-3-oxobutyramide]20040YellowRinse-off productsMaximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
46Sodium 4-amino-5-hydroxy-3-((4-nitrophenyl)azo)-6-(phenylazo)naphthalene-2,7-disulphonate20470BlackRinse-off products
472,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]21100YellowRinse-off productsMaximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
482,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]21108YellowRinse-off productsMaximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
492,2'-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol]21230YellowNot to be used in products applied on mucous membranes
50Disodium 4,6-dihydroxy-3-[[4-[1-[4-[[1-hydroxy-7-[(phenylsulphonyl)oxy]-3-sulphonato-2-naphthyl]azo]phenyl]cyclohexyl]phenyl]azo]naphthalene-2-sulphonate24790RedRinse-off products
511-(4-(Phenylazo)phenylazo)-2-naphthol26100RedNot to be used in products applied on mucous membranes

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 %

52Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate27755Black
53Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate28440219-746-5BlackPurity criteria as set out in Commission Directive 95/45/EC (E 151)
54Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo] benzenesulfonic acid, sodium salts40215OrangeRinse-off products
55beta Carotene40800230-636-6OrangePurity criteria as set out in Commission Directive 95/45/EC (E160a)
568'-apo-.beta.-Caroten-8'-al40820OrangePurity criteria as set out in Commission Directive 95/45/EC (E 160e)
57Ethyl 8'-apo-.beta.-caroten-8'-oate40825214-173-7OrangePurity criteria as set out in Commission Directive 95/45/EC (E 160f)
58Canthaxanthin40850208-187-2OrangePurity criteria as set out in Commission Directive 95/45/EC (E 161g)
59Ammonium, (4-(alpha-(p-(diethylamino)phenyl)-2,4-disulfobenzylidene)-2,5-cyclohexadien-1-ylidene)diethyl-, hydroxide, monosodium salt42045BlueNot to be used in products applied on mucous membranes
60Ethanaminium, N-(4-((4-(diethylamino)phenyl)(5-hydroxy-2,4-disulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-N-ethyl-, hydroxide, inner salt, calcium salt (2:1) and its insoluble barium, strontium and zirconium lakes, salts and pigments42051222-573-8BluePurity criteria as set out in Commission Directive 95/45/EC (E 131)
61Benzene-methanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino) phenyl)(4-hydroxy-2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt42053Green
62Hydrogen (benzyl)[4-[[4-[benzylethylamino]phenyl](2,4-disulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)ammonium, sodium salt42080BlueRinse-off products
63Benzene-methanaminium, N-ethyl-N-(4-((4-(ethyl((3-sulfophenyl)methyl)amino) phenyl)(2-sulfophenyl)methylene)-2,5-cyclohexadien-1-ylidene)-3-sulfo-, hydroxide, inner salt, disodium salt42090223-339-8BluePurity criteria as set out in Commission Directive 95/45/EC (E 133)
64Hydrogen [4-[(2-chlorophenyl)[4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt42100GreenRinse-off products
65Hydrogen [4-[(2-chlorophenyl)[4-[ethyl(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt42170GreenRinse-off products
66(4-(4-Aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride42510VioletNot to be used in products applied on mucous membranes
674-[(4-Amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride42520VioletRinse-off products5ppm
68Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt42735BlueNot to be used in products applied on mucous membranes
69[4-[[4-Anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride44045BlueNot to be used in products applied on mucous membranes
70Hydrogen [4-[4-(dimethylamino)-.alpha.-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt44090221-409-2GreenPurity criteria as set out in Commission Directive 95/45/EC (E 142)
71Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt45100RedRinse-off products
72Hydrogen 9-(2-carboxylatophenyl)-3-(2-methylanilino)-6-(2-methyl-4-sulphoanilino)xanthylium, monosodium salt45190VioletRinse-off products
73Hydrogen 9-(2,4-disulphonatophenyl)-3,6-bis(ethylamino)-2,7-dimethylxanthylium, monosodium salt45220RedRinse-off products
74Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate45350Yellow6 %
754',5'-Dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one and its insoluble barium, strontium and zirconium lakes, salts and pigments45370OrangeNot more than 1 % 2-(6-hydroxy-3-oxo-3H-xanthen-9-y1) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
76Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate and its insoluble barium, strontium and zirconium lakes, salts and pigments45380RedNot more than 1 % 2-(6-hydroxy-3-oxo-3H-xanthen-9-y1) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
773',6'-Dihydroxy-4',5'-dinitrospiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one45396Orange1 %, when used in lip productsOnly in free acid form, when used in lip products
78Dipotassium 3,6-dichloro-2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate45405RedNot to be used in eye productsNot 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
793,4,5,6-Tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid and its insoluble barium, strontium and zirconium lakes, salts and pigments45410RedNot 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
80Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate and its insoluble barium, strontium and zirconium lakes, salts and pigments45430240-474-8RedPurity criteria as set out in Commission Directive 95/45/EC (E 127)
811,3-Isobenzofurandione, reaction products with methylquinoline and quinoline47000YellowNot to be used in products applied on mucous membranes
821H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts47005305-897-5YellowPurity criteria as set out in Commission Directive 95/45/EC (E 104)
83Hydrogen 9-[(3-methoxyphenyl)amino]-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, sodium salt50325VioletRinse-off products
84Sulfonated nigrosine color50420BlackNot to be used in products applied on mucous membranes
858,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3',2'-m]triphenodioxazine51319VioletRinse-off products
861,2-Dihydroxyanthraquinone58000Red
87Trisodium 8-hydroxypyrene-1,3,6-trisulphonate59040GreenNot to be used in products applied on mucous membranes
881-Anilino-4-hydroxyanthraquinone60724VioletRinse-off products
891-Hydroxy-4-(p-toluidino)anthraquinone60725Violet
90Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate60730VioletNot to be used in products applied on mucous membranes
911,4-bis(p-Tolylamino)anthraquinone61565Green
92Disodium 2,2'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate)61570Green
93Sodium 3,3'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(2,4,6-trimethylbenzenesulphonate)61585BlueRinse-off products
94Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate62045BlueRinse-off products
956,15-Dihydroanthrazine-5,9,14,18-tetrone69800Blue
967,16-dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone69825Blue
97Bisbenzimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione71105OrangeNot to be used in products applied on mucous membranes
982-(1,3-Dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one73000Blue
99Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate73015212-728-8BluePurity criteria as set out in Commission Directive 95/45/EC (E 132)
1006-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one73360Red
1015-Chloro-2-(5-chloro-7-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-7-methylbenzo[b]thiophene-3(2H)-one73385Violet
1025,12-Dihydroquino[2,3-b]acridine-7,14-dione73900VioletRinse-off products
1035,12-Dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione73915RedRinse-off products
10429H,31H-Phthalocyanine74100BlueRinse-off products
10529H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32 copper74160Blue
106Disodium [29H,31H-phthalocyaninedisulphonato (4-)-N29,N30,N31,N32] cuprate (2-)74180BlueRinse-off products
107Polychloro copper phthalocyanine74260GreenNot to be used in eye products
1088,8'-diapo-.psi.,.psi.-Carotenedioic acid75100Yellow
109Annatto75120215-735-4/289-561-2/230-248-7OrangePurity criteria as set out in Commission Directive 95/45/EC (E 160b)
110Lycopene75125YellowPurity criteria as set out in Commission Directive 95/45/EC (E 160d)
111CI Food Orange 575130214-171-6OrangePurity criteria as set out in Commission Directive 95/45/EC (E 160a)
112(3R)-beta-4-Caroten-3-ol75135Yellow
1132-Amino-1,7-dihydro-6H-purin-6-one75170White
114Curcumins75300207-280-5YellowPurity criteria as set out in Commission Directive 95/45/EC (E 100)
115Carmines75470215-680-6/215-023-3/215-724-4RedPurity criteria as set out in Commission Directive 95/45/EC (E 120)
116Trisodium (2S-trans)-[18-carboxy-20-(carboxymethyl)-13-ethyl-2,3-dihydro-3,7,12,17-tetramethyl-8-vinyl-21H,23H-porphine-2-propionato(5-)-N21,N22,N23,N24]cuprate(3-) (Chlorophylls)75810215-800-7/207-536-6/208-272-4/287-483-3/239-830-5/246-020-5GreenPurity criteria as set out in Commission Directive 95/45/EC (E 140, E 141)
117Aluminium77000231-072-3WhitePurity criteria as set out in Commission Directive 95/45/EC (E 173)
118Aluminium hydroxide sulphate77002White
119Natural hydrated aluminium silicate, Al2O3.2SiO2.2H2O, containing calcium, magnesium or iron carbonates, ferric hydroxide, quartz-sand, mica, etc. as impurities77004White
120Lazurite77007Blue
121Aluminum silicate coloured with ferric oxide77015Red
122Barium sulfate77120White
123Bismuth chloride oxide77163White
124Calcium carbonate77220207-439-9/215-279-6WhitePurity criteria as set out in Commission Directive 95/45/EC (E 170)
125Calcium sulfate77231White
126Carbon black77266215-609-9BlackPurity criteria as set out in Commission Directive 95/45/EC (E 153)
127Charcoal, bone. A fine black powder obtained by burning animal bones in a closed container. It consists primarily of calcium phosphate and carbon77267Black
128Coke black77268:1Black
129Chromium (III) oxide77288Greenfree from chromate ion
130Chromium (III) hydroxide77289Greenfree from chromate ion
131Cobalt Aluminum Oxide77346Green
132Copper77400Brown
133Gold77480231-165-9BrownPurity criteria as set out in Commission Directive 95/45/EC (E 175)
134Iron oxide77489Orange
135Iron Oxide Red77491215-168-2RedPurity criteria as set out in Commission Directive 95/45/EC (E 172)
136Iron Oxide Yellow7749251274-00-1257-098-5YellowPurity criteria as set out in Commission Directive 95/45/EC (E 172)
137Iron Oxide Black77499235-442-5BlackPurity criteria as set out in Commission Directive 95/45/EC (E 172)
138Ferric Ammonium Ferrocyanide77510Bluefree from cyanide ions
139Magnesium carbonate77713White
140Ammonium manganese(3+) diphosphate77742Violet
141Trimanganese bis (orthophosphate)77745Red
142Silver77820231-131-3WhitePurity criteria as set out in Commission Directive 95/45/EC (E 174)
143Titanium dioxidea77891236-675-5WhitePurity criteria as set out in Commission Directive 95/45/EC (E 171)
144Zinc oxide77947White
145RiboflavinLactoflavin201-507-1/204-988-6YellowPurity criteria as set out in Commission Directive 95/45/EC (E 101)
146CaramelCaramel232-435-9BrownPurity criteria as set out in Commission Directive 95/45/EC (E 150a-d)
147Paprika extract, Capsanthin, capsorubinCapsanthin, capsorubin207-364-1/207-425-2OrangePurity criteria as set out in Commission Directive 95/45/EC (E 160c)
148Beetroot redBeetroot Red7659-95-2231-628-5RedPurity criteria as set out in Commission Directive 95/45/EC (E 162)
149

Anthocyanins

(Cyanidin,

Peonidin

Malvidin

Delphinidin

Petunidin

Pelargonidin)

Anthocyanins

528-58-5

134-01-0

528-53-0

643-84-5

134-04-3

208-438-6

205-125-6

211-403-8

208-437-0

205-127-7

RedPurity criteria as set out in Commission Directive 95/45/EC (E 163)
150Aluminium, zinc, magnesium and calcium stearates

Aluminum stearate

Zinc stearate

Magnesium stearate

Calcium stearate

7047-84-9

557-05-1

557-04-0

216-472-8

230-325-5

209-151-9

209-150-3

216-472-8

White
151Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2-bromo-3-methyl-6-(1-methylethyl)-, S,S-dioxideBromothymol blue76-59-5200-971-2BlueRinse-off products
152Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo-3-methyl-,S,S-dioxideBromocresol green76-60-8200-972-8GreenRinse-off products
153Sodium 4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonateAcid red 19512220-24-5RedNot to be used in products applied on mucous membranes

ANNEX VLIST OF PRESERVATIVES ALLOWED IN COSMETIC PRODUCTS

Preamble

1.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.

2.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 %.

a

For use other than as a preservative, see Annex III, No. 98.

b

Solely for products which might be used for children under 3 years of age and which remain in prolonged contact with the skin.

c

For use other than as a preservative, see Annex III, No. 13.

d

For use other than as a preservative, see Annex III. No. 101.

e

For use other than as a preservative, see Annex III, No. 99.

f

For use other than as a preservative, see Annex III, No. 100.

g

For use other than as a preservative, see Annex III, No. 45, 68.

h

For use other than as a preservative, see Annex III, No. 54.

i

Only if the concentration exceeds 0,05 %.

j

For use other than as a preservative, see Annex III, No. 65.

l

Solely for products, other than bath products/shower gels and shampoo, which might be used for children under 3 years of age.

k

Solely for products which might be used for children under 3 years of age.

m

Concerns any products aimed to be applied on a large part of the body.

Reference numberSubstance identificationConditionsWording of conditions of use and warnings
Chemical name/INNName of Common Ingredients GlossaryCAS numberEC numberProduct type, Body partsMaximum concentration in ready for use preparationOther
abcdefghi
1Benzoic acid and its sodium salt

Benzoic acid

Sodium Benzoate

65-85-0

532-32-1

200-618-2

208-534-8

Rinse-off products, except oral products2,5 % (acid)
Oral products1,7 % (acid)
Leave-on products0,5 % (acid)
1aSalts of benzoic acid other than that listed under reference number 1 and esters of benzoic acidAmmonium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, MEA-benzoate, methyl benzoate, ethyl benzoate, propyl benzoate, butyl benzoate, isobutyl benzoate, isopropyl benzoate, phenyl benzoate1863-63-4, 2090-05-3, 582-25-2, 553-70-8, 4337-66-0, 93-58-3, 93-89-0, 2315-68-6, 136-60-7, 120-50-3, 939-48-0, 93-99-2217-468-9, 218-235-4, 209-481-3, 209-045-2, 224-387-2, 202-259-7, 202-284-3, 219-020-8, 205-252-7, 204-401-3, 213-361-6, 202-293-20,5 % (acid)
2Propionic acid and its saltsPropionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-42 % (acid)
3Salicylic acida and its saltsSalicylic acid, calcium salicylate, magnesium salicylate, MEA-salicylate, sodium salicylate, potassium salicylate, TEA-salicylate69-72-7, 824-35-1, 18917-89-0, 59866-70-5, 54-21-7, 578-36-9, 2174-16-5200-712-3, 212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-30,5 % (acid)Not to be used in products for children under 3 years of age, except for shampoosNot to be used for children under 3 years of ageb
4Hexa-2,4-dienoic acid and its saltsSorbic acid, calcium sorbate, sodium sorbate, potassium sorbate110-44-1, 7492-55-9, 7757-81-5, 24634-61-5203-768-7, 231-321-6, 231-819-3, 246-376-10,6 % (acid)
5Formal-dehyde, paraformaldehydec

Formaldehyde

Paraformaldehyde

50-00-0, 30525-89-4200-001-8Oral products0,1 % (free formaldehyde)Not to be used in aerosol dispensers (sprays)
Other products0,2 % (free formaldehyde)
6Moved or deleted
7Biphenyl-2-ol, and its saltso-Phenylphenol, sodium o-phenylphenate, potassium o-phenylphenate, MEA o-phenylphenate90-43-7, 132-27-4, 13707-65-8, 84145-04-0201-993-5, 205-055-6, 237-243-9, 282-227-70,2 % (as phenol)
8Pyrithione zincdZinc pyrithione13463-41-7236-671-3Hair products1,0 %

Only in rinse-off products

Not to be used in oral products

Other products0,5 %
9Inorganic sulphites and hydrogen- sulphiteseSodium sulfite, ammonium bisulfite, ammonium sulfite, potassium sulfite, potassium hydrogen sulfite, sodium bisulfite, sodium metabisulfite, potassium metabisulfite7757-83-7, 10192-30-0, 10196-04-0, 10117-38-1, 7773-03-7, 7631-90-5, 7681-57-4, 16731-55-8231-821-4, 233-469-7, 233-484-9, 233-321-1, 231-870-1, 231-548-0, 231-673-0, 240-795-30,2 % (as free SO2)
10Moved or deleted
11ChlorobutanolChlorobutanol57-15-8200-317-60,5 %Not to be used in aerosol dispensers (sprays)Contains Chlorobutanol
124-Hydroxybenzoic acid and its salts and esters4-Hydroxybenzoic acid, methylparaben, butylparaben, potassium ethylparaben, potassium paraben, propylparaben, isobutylparaben, sodium methylparaben, sodium ethylparaben, sodium propylparaben, sodium butylparaben, sodium isobutylparaben, ethylparaben, sodium paraben, isopropylparaben, potassium methylparaben, potassium butylparaben, potassium propylparaben, sodium propylparaben, calcium paraben, phenylparaben99-96-7, 99-76-3, 94-26-8, 36457-19–9,16782-08-4, 94-13-3, 4247-02-3, 5026-62-0, 35285-68-8, 35285-69-9, 36457-20-2, 84930-15-4, 120-47-8, 114-63-6, 4191-73-5, 2611-07-2, 38566-94-8, 84930-17-4, 35285-69-9, 69959-44-0, 17696-62-7202-804-9, 202-785-7, 202-318-7, 253-048-1, 240-830-2, 202-307-7, 224-208-8, 225-714-1, 252-487-6, 252-488-1, 253-049-7, 284-595-4, 204-399-4, 204-051-1, 224-069-3, 247-464-2, 254-009-1, 284-597-5, 252-488-1, 274-235-4, 241-698-9

0,4 % (as acid) for single ester,

0,8 % (as acid) for mixtures of esters

133-Acetyl-6-methylpyran-2,4 (3H)-dione and its saltsDehydroacetic acid, sodium dehydroacetate520-45-6, 4418-26-2, 16807-48-0208-293-9, 224-580-10,6 % (as acid)Not to be used in aerosol dispensers (sprays)
14Formic acid and its sodium saltFormic acid, sodium formate64-18-6, 141-53-7200-579-1, 205-488-00,5 % (as acid)
153,3'-Dibromo-4,4'-hexamethylenedioxydi-benzamidine and its salts (including isethionate)Dibromohexamidine Isethionate93856-83-8299-116-40,1 %
16ThiomersalThimerosal54-64-8200-210-4Eye products

0,007 % (of Hg)

If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0,007 %

Contains Thiomersal
17Phenylmercuric salts (including borate)Phenyl Mercuric Acetate, Phenyl Mercuric Benzoate62-38-4, 94-43-9200-532-5, 202-331-8Eye products

0,007 % (of Hg)

If mixed with other mercurial compounds authorised by this Regulation, the maximum concentration of Hg remains fixed at 0,007 %

Contains Phenylmercuric compounds
18Undec-10-enoic acid and its saltsUndecylenic acid, potassium undecylenate, sodium undecylenate, calcium undecylenate, TEA-undecylenate, MEA-undecylenate112-38-9, 6159-41-7, 3398-33-2, 1322-14-1, 84471-25-0, 56532-40-2203-965-8, 222-264-8, 215-331-8, 282-908-9, 260-247-70,2 % (as acid)
195- Pyrimidinamine, 1,3-bis (2-ethylhexyl) hexahydro-5-methyl-Hexetidine141-94-6205-513-50,1 %
205-Bromo-5-nitro-1,3-dioxane5-Bromo-5-nitro-1,3-dioxane30007-47-7250-001-7Rinse-off products0,1 %Avoid formation of nitrosamines
21Bronopol2-Bromo-2-nitropropane-1,3-diol52-51-7200-143-00,1 %Avoid formation of nitrosamines
222,4-Dichlorobenzyl alcoholDichlorobenzyl Alcohol1777-82-8217-210-50,15 %
231-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) ureafTriclocarban101-20-2202-924-10,2 %

Purity criteria:

3,3',4,4'-Tetrachloroazobenzene <1 ppm

3,3',4,4'-Tetrachloroazoxybenzene <1 ppm

24Chlorocresolp-Chloro-m-Cresol59-50-7200-431-6Not to be used in products applied on mucuous membranes0,2 %
255-Chloro-2- (2,4- dichlorophenoxy) phenolTriclosan3380-34-5222-182-20,3 %
26Chloro-xylenolChloroxylenol88-04-0201-793-80,5 %
27N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]Imidazolidinyl urea39236-46-9254-372-60,6 %
28Poly(methylene),.alpha.,.omega.-bis[[[(aminoiminomethyl)amino]iminomethyl] amino]-, dihydrochloridePolyaminopropyl biguanide70170-61-5, 28757-47-3, 133029-32-00,3 %
292-PhenoxyethanolPhenoxyethanol122-99-6204-589-71,0 %
30MethenamineMethenamine100-97-0202-905-80,15 %
31Methenamine 3-chloroallylochlorideQuaternium-154080-31-3223-805-00,2 %
321-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-oneClimbazole38083-17-9253-775-40,5 %
331,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dioneDMDM Hydantoin6440-58-0229-222-80,6 %
34Benzyl alcoholgBenzyl alcohol100-51-6202-859-91,0 %
351-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine50650-76-5, 68890-66-4272-574-2Rinse-off products1,0 %
Other products0,5 %
36Moved or deleted
372,2'-methylenebis(6-bromo-4-chlorophenol)Bromochlorophene15435-29-7239-446-80,1 %
384-Isopropyl-m-cresolo-Cymen-5-ol3228-02-2221-761-70,1 %
39Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrateMethylchloroisothiazolinone and Methylisothiazolinone26172-55-4, 2682-20-4, 55965-84-9247-500-7, 220-239-60,0015 % (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one
402-Benzyl-4-chlorophenolChlorophene120-32-1204-385-80,2 %
412-ChloroacetamideChloroacetamide79-07-2201-174-20,3 %Contains chloroacetamide
42N,N″-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochlorideChlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Digluconate, Chlorhexidine Dihydrochloride55-56-1, 56-95-1, 18472-51-0, 3697-42-5200-238-7, 200-302-4, 242-354-0, 223-026-60,3 % (as chlorhexidine)
431-Phenoxypropan-2-olhPhenoxyisopropanol770-35-4212-222-7Only for rinse-off products1,0 %
44Alkyl (C 12-22) trimethyl ammonium bromide and chlorideBehentrimonium chloride, cetrimonium bromide, cetrimonium chloride, laurtrimonium bromide, laurtrimonium chloride, steartrimonium bromide, steartrimonium chloride17301-53-0, 57-09-0, 112-02-7, 1119-94-4, 112-00-5, 1120-02-1, 112-03-8241-327-0, 200-311-3, 203-928-6, 214-290-3, 203-927-0, 214-294-5, 203-929-10,1 %
454,4-Dimethyl-1,3-oxazolidineDimethyl Oxazolidine51200-87-4257-048-20,1 %pH > 6
46N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl) ureaDiazolidinyl Urea78491-02-8278-928-20,5 %
47Benzenecarboximidamide, 4,4'-(1,6-hexanediylbis (oxy))bis- and its salts (including isethionate and p-hydroxybenzoate)Hexamidine, Hexamidine diisethionate, Hexamidine paraben3811-75-4, 659-40-5, 93841-83-9211-533-5, 299-055-30,1 %
48Glutaraldehyde (Pentane-1,5-dial)Glutaral111-30-8203-856-50,1 %Not to be used in aerosols (sprays)Contains glutarali
495-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane7-Ethylbicyclooxazolidine7747-35-5231-810-40,3 %Not to be used in oral products and in products applied on mucous membranes
503-(p-Chlorophenoxy)-propane-1,2 diolChlorphenesin104-29-0203-192-60,3 %
51Sodium hydroxymethylamino acetateSodium Hydroxymethylglycinate70161-44-3274-357-80,5 %
52Silver chloride deposited on titanium dioxideSilver chloride7783-90-6232-033-30,004 % (as AgCl)20 % AgCl (w/w) on TiO2. Not to be used in products for children under 3 years of age, in oral products and in eye and lip products
53Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chlorideBenzethonium Chloride121-54-0204-479-9
(a)

Rinse-off products

(b)

Leave-on products other than oral products

0,1 %
54Benzalkonium chloride, bromide and saccharinatejBenzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-10,1 % (as benzalkonium chloride)Avoid contact with eyes
55Methanol, (phenylmethoxy-)Benzylhemiformal14548-60-8238-588-8Rinse-off products0,15 %
563-Iodo-2-propynylbutylcarbamateIodopropynyl butylcarbamate55406-53-6259-627-5
(a)

Rinse-off products

(b)

Leave-on products

(c)

Deo-dorants/anti-perspirants

(a)

0,02 %

(b)

0,01 %,

(c)

0,0075 %

Not to be used in oral and lip products

(a)

Not to be used in products for children under 3 years of age, except in bath products/shower gels and shampoo

(b)

Not to be used in body lotion and body creamm

(b) and (c)

Not to be used in products for children under 3 years of age

(a)

Not to be used for children under 3 years of agel

(b) and (c)

Not to be used for children under 3 years of agek

572-Methyl-2H-isothiazol-3-oneMethylisothiazolinone2682-20-4220-239-60,01 %

ANNEX VILIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS

a

Not required if concentration is 0,5 % or less and when it is used only for product protection purposes.

b

For use other than as a colorant, see Annex IV, No. 143.

Reference numberSubstance identificationConditionsWording of conditions of use and warnings
Chemical name/INN/XANName of Common Ingredients GlossaryCAS numberEC numberProduct type, body partsMaximum concentration in ready for use preparationOther
abcdefghi
14-Aminobenzoic acidPABA150-13-0205-753-05 %
2 N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulfateCamphor Benzalkonium Methosulfate52793-97-2258-190-86 %
3Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester/HomosalateHomosalate118-56-9204-260-810 %
42-Hydroxy-4-methoxybenzophenone/OxybenzoneBenzophenone-3131-57-7205-031-510 %Contains Benzophenone-3a
5Moved or deleted
62-Phenylbenzimidazole-5-sulfonic acid and its potassium, sodium and triethanolamine salts/EnsulizolePhenylbenzimidazole Sulfonic Acid27503-81-7248-502-08 %(as acid)
73,3'-(1,4-Phenylenedimethylene) bis(7, 7-dimethyl-2-oxobicyclo-[2.2.1]hept-1-yl-methanesulfonic acid) and its salts/EcamsuleTerephthalylidene Dicamphor Sulfonic Acid92761-26-7, 90457-82-2410-960-610 %(as acid)
81-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione/AvobenzoneButyl Methoxydibenzoylmethane70356-09-1274-581-65 %
9alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its saltsBenzylidene Camphor Sulfonic Acid56039-58-86 % (as acid)
102-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester/OctocrileneOctocrylene6197-30-4228-250-810 % (as acid)
11Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl} acrylamidePolyacrylamidomethyl Benzylidene Camphor113783-61-26 %
122-Ethylhexyl 4-methoxycinnamate/OctinoxateEthylhexyl Methoxycinnamate5466-77-3226-775-710 %
13Ethoxylated ethyl-4-aminobenzoatePEG-25 PABA116242-27-410 %
14Isopentyl-4-methoxycinnamate/AmiloxateIsoamyl p-Methoxycinnamate71617-10-2275-702-510 %
152,4,6-Trianilino-(p-carbo-2'-ethylhexyl-1'-oxy)-1,3,5-triazineEthylhexyl Triazone88122-99-0402-070-15 %
16Phenol,2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl)Drometrizole Trisiloxane155633-54-815 %
17Benzoic acid, 4,4-((6-((4-(((1,1-dimethylethyl)amino)carbonyl)phenyl)amino)-1,3,5-triazine-2,4-diyl)diimino)bis-, bis (2-ethylhexyl) ester/Iscotrizinol (USAN)Diethylhexyl Butamido Triazone154702-15-510 %
183-(4-Methylbenzylidene)-d1 camphor/Enzacamene4-Methylbenzylidene Camphor38102-62-4/36861-47-9- / 253-242-64 %
193-Benzylidene camphor3-Benzylidene Camphor15087-24-8239-139-92 %
202-Ethylhexyl salicylate/OctisalateEthylhexyl Salicylate118-60-5204-263-45 %
212-Ethylhexyl 4-(dimethylamino)benzoate/Padimate O (USAN:BAN)Ethylhexyl Dimethyl PABA21245-02-3244-289-38 %
222-Hydroxy-4-methoxybenzophenone-5-sulfonic acid and its sodium salt/SulisobenzoneBenzophenone-4, Benzophenone-54065-45-6/6628-37-1223-772-2 / -5 % (as acid)
232,2'-Methylene-bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethyl-butyl)phenol) / BisoctrizoleMethylene Bis-Benzotriazolyl Tetramethylbutylphenol103597-45-1403-800-110 %
24Sodium salt of 2,2'-bis(1,4-phenylene)-1H-benzimidazole-4,6-disulfonic acid) / Bisdisulizole disodium (USAN)Disodium Phenyl Dibenzimidazole Tetrasulfonate180898-37-7429-750-010 % (as acid)
252,2'-(6-(4-Methoxyphenyl)-1,3,5-triazine-2,4-diyl)bis(5-((2-ethylhexyl)oxy)phenol) / BemotrizinolBis-Ethylhexyloxyphenol Methoxyphenyl Triazine187393-00-610 %
26DimethicodiethylbenzalmalonatePolysilicone-15207574-74-1426-000-410 %
27Titanium dioxidebTitanium Dioxide13463-67-7/1317-70-0/1317-80-2236-675-5/205-280-1/215-282-225 %
28Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylesterDiethylamino Hydroxybenzoyl Hexyl Benzoate302776-68-7443-860-610 % in sunscreen products

ANNEX VIISYMBOLS USED ON PACKAGING/CONTAINER

1.Reference to enclosed or attached information

2.Period-after-opening

3.Date of minimum durability

ANNEX VIIILIST 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 Regulation and which are not listed in Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). As animal testing may not be replaced completely by an alternative method, it should be mentioned in Annex VIII whether the alternative method fully or partially replaces animal testing.

Reference numberValidated alternative methodsNature of replacement full or partial
ABC

ANNEX IX

PART ARepealed Directive with its successive amendments(referred to in Article 33)

Council Directive 76/768/EEC of 27 July 1976(OJ L 262, 27.9.1976, p. 169)
Council Directive 79/661/EEC of 24 July 1979(OJ L 192, 31.7.1979, p. 35)
Commission Directive 82/147/EEC of 11 February 1982(OJ L 63, 6.3.1982, p. 26)
Council Directive 82/368/EEC of 17 May 1982(OJ L 167, 15.6.1982, p. 1)
Commission Directive 83/191/EEC of 30 March 1983(OJ L 109, 26.4.1983, p. 25)
Commission Directive 83/341/EEC of 29 June 1983(OJ L 188, 13.7.1983, p. 15)
Commission Directive 83/496/EEC of 22 September 1983(OJ L 275, 8.10.1983, p. 20)
Council Directive 83/574/EEC of 26 October 1983(OJ L 332, 28.11.1983, p. 38)
Commission Directive 84/415/EEC of 18 July 1984(OJ L 228, 25.8.1984, p. 31)
Commission Directive 85/391/EEC of 16 July 1985(OJ L 224, 22.8.1985, p. 40)
Commission Directive 86/179/EEC of 28 February 1986(OJ L 138, 24.5.1986, p. 40)
Commission Directive 86/199/EEC of 26 March 1986(OJ L 149, 3.6.1986, p. 38)
Commission Directive 87/137/EEC of 2 February 1987(OJ L 56, 26.2.1987, p. 20)
Commission Directive 88/233/EEC of 2 March 1988(OJ L 105, 26.4.1988, p. 11)
Council Directive 88/667/EEC of 21 December 1988(OJ L 382, 31.12.1988, p. 46)
Commission Directive 89/174/EEC of 21 February 1989(OJ L 64, 8.3.1989, p. 10)
Council Directive 89/679/EEC of 21 December 1989(OJ L 398, 30.12.1989, p. 25)
Commission Directive 90/121/EEC of 20 February 1990(OJ L 71, 17.3.1990, p. 40)
Commission Directive 91/184/EEC of 12 March 1991(OJ L 91, 12.4.1991, p. 59)
Commission Directive 92/8/EEC of 18 February 1992(OJ L 70, 17.3.1992, p. 23)
Commission Directive 92/86/EEC of 21 October 1992(OJ L 325, 11.11.1992, p. 18)
Council Directive 93/35/EEC of 14 June 1993(OJ L 151, 23.6.1993, p. 32)
Commission Directive 93/47/EEC of 22 June 1993(OJ L 203, 13.8.1993, p. 24)
Commission Directive 94/32/EC of 29 June 1994(OJ L 181, 15.7.1994, p. 31)
Commission Directive 95/17/EC of 19 June 1995(OJ L 140, 23.6.1995, p. 26)
Commission Directive 95/34/EC of 10 July 1995(OJ L 167, 18.7.1995, p. 19)
Commission Directive 96/41/EC of 25 June 1996(OJ L 198, 8.8.1996, p. 36)
Commission Directive 97/1/EC of 10 January 1997(OJ L 16, 18.1.1997, p. 85)
Commission Directive 97/18/EC of 17 April 1997(OJ L 114, 1.5.1997, p. 43)
Commission Directive 97/45/EC of 14 July 1997(OJ L 196, 24.7.1997, p. 77)
Commission Directive 98/16/EC of 5 March 1998(OJ L 77, 14.3.1998, p. 44)
Commission Directive 98/62/EC of 3 September 1998(OJ L 253, 15.9.1998, p. 20)
Commission Directive 2000/6/EC of 29 February 2000(OJ L 56, 1.3.2000, p. 42)
Commission Directive 2000/11/EC of 10 March 2000(OJ L 65, 14.3.2000, p. 22)
Commission Directive 2000/41/EC of 19 June 2000(OJ L 145, 20.6.2000, p. 25)
Commission Directive 2002/34/EC of 15 April 2002(OJ L 102, 18.4.2002, p. 19)
Commission Directive 2003/1/EC of 6 January 2003(OJ L 5, 10.1.2003, p. 14)
Commission Directive 2003/16/EC of 19 February 2003(OJ L 46, 20.2.2003, p. 24)
Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003(OJ L 66, 11.3.2003, p. 26)
Commission Directive 2003/80/EC of 5 September 2003(OJ L 224, 6.9.2003, p. 27)
Commission Directive 2003/83/EC of 24 September 2003(OJ L 238, 25.9.2003, p. 23)
Commission Directive 2004/87/EC of 7 September 2004(OJ L 287, 8.9.2004, p. 4)
Commission Directive 2004/88/EC of 7 September 2004(OJ L 287, 8.9.2004, p. 5)
Commission Directive 2004/94/EC of 15 September 2004(OJ L 294, 17.9.2004, p. 28)
Commission Directive 2004/93/EC of 21 September 2004(OJ L 300, 25.9.2004, p. 13)
Commission Directive 2005/9/EC of 28 January 2005(OJ L 27, 29.1.2005, p. 46)
Commission Directive 2005/42/EC of 20 June 2005(OJ L 158, 21.6.2005, p. 17)
Commission Directive 2005/52/EC of 9 September 2005(OJ L 234, 10.9.2005, p. 9)
Commission Directive 2005/80/EC of 21 November 2005(OJ L 303, 22.11.2005, p. 32)
Commission Directive 2006/65/EC of 19 July 2006(OJ L 198, 20.7.2006, p. 11)
Commission Directive 2006/78/EC of 29 September 2006(OJ L 271, 30.9.2006, p. 56)
Commission Directive 2007/1/EC of 29 January 2007(OJ L 25, 1.2.2007, p. 9)
Commission Directive 2007/17/EC of 22 March 2007(OJ L 82, 23.3.2007, p. 27)
Commission Directive 2007/22/EC of 17 April 2007(OJ L 101, 18.4.2007, p. 11)
Commission Directive 2007/53/EC of 29 August 2007(OJ L 226, 30.8.2007, p. 19)
Commission Directive 2007/54/EC of 29 August 2007(OJ L 226, 30.8.2007, p. 21)
Commission Directive 2007/67/EC of 22 November 2007(OJ L 305, 23.11.2007, p. 22)
Commission Directive 2008/14/EC of 15 February 2008 OJ L 42, 16.2.2008, p. 43
Commission Directive 2008/42/EC of 3 April 2008 OJ L 93, 4.4.2008, p. 13
Commission Directive 2008/88/EC of 23 September 2008 OJ L 256, 24.9.2008, p. 12
Commission Directive 2008/123/EC of 18 December 2008 OJ L 340, 19.12.2008, p. 71
Commission Directive 2009/6/EC of 4 February 2009 OJ L 36, 5.2.2009, p. 15
Commission Directive 2009/36/EC of 16 April 2009 OJ L 98, 17.4.2009, p. 31

PART BList of time-limits for transposition into national law and application(referred to in Article 33)

DirectiveTime-limit for transposition
Council Directive 76/768/EEC of 27 July 197630.1.1978
Council Directive 79/661/EEC of 24 July 197930.7.1979
Commission Directive 82/147/EEC of 11 February 198231.12.1982
Council Directive 82/368/EEC of 17 May 198231.12.1983
Commission Directive 83/191/EEC of 30 March 198331.12.1984
Commission Directive 83/341/EEC of 29 June 198331.12.1984
Commission Directive 83/496/EEC of 22 September 198331.12.1984
Council Directive 83/574/EEC of 26 October 198331.12.1984
Commission Directive 84/415/EEC of 18 July 198431.12.1985
Commission Directive 85/391/EEC of 16 July 198531.12.1986
Commission Directive 86/179/EEC of 28 February 198631.12.1986
Commission Directive 86/199/EEC of 26 March 198631.12.1986
Commission Directive 87/137/EEC of 2 February 198731.12.1987
Commission Directive 88/233/EEC of 2 March 198830.9.1988
Council Directive 88/667/EEC of 21 December 198831.12.1993
Commission Directive 89/174/EEC of 21 February 198931.12.1989
Council Directive 89/679/EEC of 21 December 19893.1.1990
Commission Directive 90/121/EEC of 20 February 199031.12.1990
Commission Directive 91/184/EEC of 12 March 199131.12.1991
Commission Directive 92/8/EEC of 18 February 199231.12.1992
Commission Directive 92/86/EEC of 21 October 199230.6.1993
Council Directive 93/35/EEC of 14 June 199314.6.1995
Commission Directive 93/47/EEC of 22 June 199330.6.1994
Commission Directive 94/32/EC of 29 June 199430.6.1995
Commission Directive 95/17/EC of 19 June 199530.11.1995
Commission Directive 95/34/EC of 10 July 199530.6.1996
Commission Directive 96/41/EC of 25 June 199630.6.1997
Commission Directive 97/1/EC of 10 January 199730.6.1997
Commission Directive 97/18/EC of 17 April 199731.12.1997
Commission Directive 97/45/EC of 14 July 199730.6.1998
Commission Directive 98/16/EC of 5 March 19981.4.1998
Commission Directive 98/62/EC of 3 September 199830.6.1999
Commission Directive 2000/6/EC of 29 February 20001.7.2000
Commission Directive 2000/11/EC of 10 March 20001.6.2000
Commission Directive 2000/41/EC of 19 June 200029.6.2000
Commission Directive 2002/34/EC of 15 April 200215.4.2003
Commission Directive 2003/1/EC of 6 January 200315.4.2003
Commission Directive 2003/16/EC of 19 February 200328.2.2003
Directive 2003/15/EC of the European Parliament and of the Council of 27 February 200310.9.2004
Commission Directive 2003/80/EC of 5 September 200311.9.2004
Commission Directive 2003/83/EC of 24 September 200323.9.2004
Commission Directive 2004/87/EC of 7 September 20041.10.2004
Commission Directive 2004/88/EC of 7 September 20041.10.2004
Commission Directive 2004/94/EC of 15 September 200421.9.2004
Commission Directive 2004/93/EC of 21 September 200430.9.2004
Commission Directive 2005/9/EC of 28 January 200516.2.2006
Commission Directive 2005/42/EC of 20 June 200531.12.2005
Commission Directive 2005/52/EC of 9 September 20051.1.2006
Commission Directive 2005/80/EC of 21 November 200522.5.2006
Commission Directive 2006/65/EC of 19 July 20061.9.2006
Commission Directive 2006/78/EC of 29 September 200630.3.2007
Commission Directive 2007/1/EC of 29 January 200721.8.2007
Commission Directive 2007/17/EC of 22 March 200723.9.2007
Commission Directive 2007/22/EC of 17 April 200718.1.2008
Commission Directive 2007/53/EC of 29 August 200719.4.2008
Commission Directive 2007/54/EC of 29 August 200718.3.2008
Commission Directive 2007/67/EC of 22 November 200731.12.2007
Commission Directive 2008/14/EC of 15 February 200816.8.2008
Commission Directive 2008/42/EC of 3 April 20084.10.2008
Commission Directive 2008/88/EC of 23 September 200814.2.2009
Commission Directive 2008/123/EC of 18 December 20088.7.2009
Commission Directive 2009/6/EC of 4 February 20095.8.2009
Commission Directive 2009/36/EC of 16 April 200915.11.2009

ANNEX XCORRELATION TABLE

Directive 76/768/EECThis Regulation
Article 1Article 2(1)(a)
Article 2Article 3
Article 3
Article 4(1)Article 14(1)
Article 4(2)Article 17
Article 4aArticle 18
Article 4bArticle 15(1)
Article 5
Article 5aArticle 33
Article 6(1),(2)Article 19(1),(2),(3),(4)
Article 6(3)Article 20
Article 7(1)Article 9
Article 7(2)Article 19(5), (6)
Article 7(3)Article 13
Article 7a (1) (h)Article 21
Article 7a(1),(2),(3)Article 10, 11, Annex I
Article 7a(4)Article 13
Article 7a(5)Article 29, 34
Article 8(1)Article 12
Article 8(2)Article 31
Article 8a
Article 9Article 35
Article 10Article 32
Article 11
Article 12Article 27
Article 13Article 28
Article 14
Article 15
Annex IPreamble, No. 7
Annex IIAnnex II
Annex IIIAnnex III
Annex IVAnnex IV
Annex V
Annex VIAnnex V
Annex VIIAnnex VI
Annex VIIIAnnex VII
Annex VIIIaAnnex VII
Annex IXAnnex VIII
Annex IX
Annex X

Yn ôl i’r brig

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