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) - Main contents

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22.12.2009

Official Journal of the European Union

L 342/59

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 I

SCOPE, DEFINITIONS

Article 1

Scope 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 2

Definitions

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 II

SAFETY, RESPONSIBILITY, FREE MOVEMENT

Article 3

Safety

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 4

Responsible 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 5

Obligations 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 6

Obligations 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 7

Identification 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 8

Good 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 9

Free 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 III

SAFETY ASSESSMENT, PRODUCT INFORMATION FILE, NOTIFICATION

Article 10

Safety 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 11

Product 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 12

Sampling 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 13

Notification

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 IV

RESTRICTIONS FOR CERTAIN SUBSTANCES

Article 14

Restrictions for substances listed in the Annexes

1.

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

(a)

prohibited substances

—	prohibited substances listed in Annex II;

(b)

restricted substances

—	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 15

Substances 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 16

Nanomaterials

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 17

Traces 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 V

ANIMAL TESTING

Article 18

Animal 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 VI

CONSUMER INFORMATION

Article 19

Labelling

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 20

Product 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 21

Access 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 VII

MARKET SURVEILLANCE

Article 22

In-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 23

Communication 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 24

Information 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 VIII

NON-COMPLIANCE, SAFEGUARD CLAUSE

Article 25

Non-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 26

Non-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 27

Safeguard 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 28

Good 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 IX

ADMINISTRATIVE COOPERATION

Article 29

Cooperation 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 30

Cooperation 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 X

IMPLEMENTING MEASURES, FINAL PROVISIONS

Article 31

Amendment 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 32

Committee 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 33

Glossary 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 34

Competent 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 35

Annual 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 36

Formal 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 37

Penalties

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 38

Repeal

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 39

Transitional 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 40

Entry 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

(1)

OJ C 27, 3.2.2009, p. 34.

(2)

Opinion of the European Parliament of 24 March 2009 (not yet published in the Official Journal) and Council Decision of 20 November 2009.

(3)

OJ L 262, 27.9.1976, p. 169.

(4)

OJ L 396, 30.12.2006, p. 1.

(5)

OJ L 192, 11.7.1987, p. 49.

(6)

OJ L 196, 2.8.2003, p. 7.

(7)

OJ L 157, 30.4.2004, p. 45.

(8)

OJ L 241, 10.9.2008, p. 21.

(9)

OJ L 353, 31.12.2008, p. 1.

(10)

OJ L 358, 18.12.1986, p. 1.

(11)

OJ L 149, 11.6.2005, p. 22.

(12)

OJ L 184, 17.7.1999, p. 23.

(13)

OJ L 204, 21.7.1998, p. 37.

(14)

OJ L 31, 1.2.2002, p. 1.

(15)

OJ L 142, 31.5.2008, p. 1.

(16)

OJ L 11, 15.1.2002, p. 4.

(17)

OJ L 218, 13.8.2008, p. 30.

ANNEX I

COSMETIC 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 II

LIST OF SUBSTANCES PROHIBITED IN COSMETIC PRODUCTS

Reference number	Substance identification
Reference number	Chemical name/INN	CAS number	EC number
a	b	c	d
1	N-(5-Chlorobenzoxazol-2-yl)acetamide	35783-57-4
2	(2-Acetoxyethyl)trimethylammonium hydroxide (Acetylcholine) and its salts	51-84-3	200-128-9
3	Deanol aceglumate (INN)	3342-61-8	222-085-5
4	Spironolactone (INN)	52-01-7	200-133-6
5	[4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid (Tiratricol (INN)) and its salts	51-24-1	200-086-1
6	Methotrexate (INN)	59-05-2	200-413-8
7	Aminocaproic acid (INN) and its salts	60-32-2	200-469-3
8	Cinchophen (INN), its salts, derivatives and salts of these derivatives	132-60-5	205-067-1
9	Thyropropic acid (INN) and its salts	51-26-3
10	Trichloroacetic acid	76-03-9	200-927-2
11	Aconitum napellus L. (leaves, roots and galenical preparations)	84603-50-9	283-252-6
12	Aconitine (principal alkaloid of Aconitum napellus L.) and its salts	302-27-2	206-121-7
13	Adonis vernalis L. and its preparations	84649-73-0	283-458-6
14	Epinephrine (INN)	51-43-4	200-098-7
15	Rauwolfia serpentina L., alkaloids and their salts	90106-13-1	290-234-1
16	Alkyne alcohols, their esters, ethers and salts
17	Isoprenaline (INN)	7683-59-2	231-687-7
18	Allyl isothiocyanate	57-06-7	200-309-2
19	Alloclamide (INN) and its salts	5486-77-1
20	Nalorphine (INN), its salts and ethers	62-67-9	200-546-1
21	Sympathicomimetic amines acting on the central nervous system: any substance contained in the first list of medicaments which are subject to medical prescription and are referred to in resolution AP (69) 2 of the Council of Europe	300-62-9	206-096-2
22	Aniline, its salts and its halogenated and sulphonated derivatives	62-53-3	200-539-3
23	Betoxycaine (INN) and its salts	3818-62-0
24	Zoxazolamine (INN)	61-80-3	200-519-4
25	Procainamide (INN), its salts and derivatives	51-06-9	200-078-8
26	Benzidine	92-87-5	202-199-1
27	Tuaminoheptane (INN), its isomers and salts	123-82-0	204-655-5
28	Octodrine (INN) and its salts	543-82-8	208-851-1
29	2-Amino-1,2-bis(4-methoxyphenyl)ethanol and its salts	530-34-7
30	1,3-Dimethylpentylamine and its salts	105-41-9	203-296-1
31	4-Aminosalicylic acid and its salts	65-49-6	200-613-5
32	Toluidines, their isomers, salts and halogenated and sulphonated derivatives	26915-12-8	248-105-2
33	Xylidines, their isomers, salts and halogenated and sulphonated derivatives	1300-73-8	215-091-4
34	Imperatorin (9-(3-methylbut-2-enyloxy)furo[3,2-g]chromen-7-one)	482-44-0	207-581-1
35	Ammi majus L. and its galenical preparations	90320-46-0	291-072-4
36	2,3-Dichloro-2-methylbutane	507-45-9
37	Substances with androgenic effect
38	Anthracene oil	120-12-7	204-371-1
39	Antibiotics
40	Antimony and its compounds	7440-36-0	231-146-5
41	Apocynum cannabinum L. and its preparations	84603-51-0	283-253-1
42	Apomorphine ((R) 5,6,6a,7-tetrahydro-6-methyl-4H-dibenzo[de,g]quinoline-10,11-diol) and its salts	58-00-4	200-360-0
43	Arsenic and its compounds	7440-38-2	231-148-6
44	Atropa belladonna L. and its preparations	8007-93-0	232-365-9
45	Atropine, its salts and derivatives	51-55-8	200-104-8
46	Barium 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
47	Benzene	71-43-2	200-753-7
48	Benzimidazol-2(3H)-one	615-16-7	210-412-4
49	Benzazepines and benzodiazepines	12794-10-4
50	1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts	644-26-8	211-411-1
51	2,2,6-Trimethyl-4-piperidyl benzoate (eucaine) and its salts	500-34-5
52	Isocarboxazid (INN)	59-63-2	200-438-4
53	Bendroflumethiazide (INN) and its derivatives	73-48-3	200-800-1
54	Beryllium and its compounds	7440-41-7	231-150-7
55	Bromine, elemental	7726-95-6	231-778-1
56	Bretylium tosilate (INN)	61-75-6	200-516-8
57	Carbromal (INN)	77-65-6	201-046-6
58	Bromisoval (INN)	496-67-3	207-825-7
59	Brompheniramine (INN) and its salts	86-22-6	201-657-8
60	Benzilonium bromide (INN)	1050-48-2	213-885-5
61	Tetrylammonium bromide (INN)	71-91-0	200-769-4
62	Brucine	357-57-3	206-614-7
63	Tetracaine (INN) and its salts	94-24-6	202-316-6
64	Mofebutazone (INN)	2210-63-1	218-641-1
65	Tolbutamide (INN)	64-77-7	200-594-3
66	Carbutamide (INN)	339-43-5	206-424-4
67	Phenylbutazone (INN)	50-33-9	200-029-0
68	Cadmium and its compounds	7440-43-9	231-152-8
69	Cantharides, Cantharis vesicatoria	92457-17-5	296-298-7
70	Cantharidine	56-25-7	200-263-3
71	Phenprobamate (INN)	673-31-4	211-606-1
72	Nitroderivatives of carbazole
73	Carbon disulphide	75-15-0	200-843-6
74	Catalase	9001-05-2	232-577-1
75	Cephaeline and its salts	483-17-0	207-591-6
76	Chenopodium ambrosioides L. (essential oil)	8006-99-3
77	2,2,2-Trichloroethane-1,1-diol	302-17-0	206-117-5
78	Chlorine	7782-50-5	231-959-5
79	Chlorpropamide (INN)	94-20-2	202-314-5
80	Moved or deleted
81	4-Phenylazophenylene-1,3-diamine citrate hydrochloride (chrysoidine citrate hydrochloride)	5909-04-6
82	Chlorzoxazone (INN)	95-25-0	202-403-9
83	2-Chloro-6-methylpyrimidin-4-yldimethylamine (crimidine-ISO)	535-89-7	208-622-6
84	Chlorprothixene (INN) and its salts	113-59-7	204-032-8
85	Clofenamide (INN)	671-95-4	211-588-5
86	N,N-bis(2-chloroethyl)methylamine N-oxide and its salts	126-85-2
87	Chlormethine (INN) and its salts	51-75-2	200-120-5
88	Cyclophosphamide (INN) and its salts	50-18-0	200-015-4
89	Mannomustine (INN) and its salts	576-68-1	209-404-3
90	Butanilicaine (INN) and its salts	3785-21-5
91	Chlormezanone (INN)	80-77-3	201-307-4
92	Triparanol (INN)	78-41-1	201-115-0
93	2-[2(4-Chlorophenyl)-2-phenylacetyl]indane-1,3-dione (chlorophacinone-ISO)	3691-35-8	223-003-0
94	Chlorphenoxamine (INN)	77-38-3
95	Phenaglycodol (INN)	79-93-6	201-235-3
96	Chloroethane	75-00-3	200-830-5
97	Chromium; chromic acid and its salts	7440-47-3	231-157-5
98	Claviceps purpurea Tul., its alkaloids and galenical preparations	84775-56-4	283-885-8
99	Conium maculatum L. (fruit, powder, galenical preparations)	85116-75-2	285-527-6
100	Glycyclamide (INN)	664-95-9	211-557-6
101	Cobalt benzenesulphonate	23384-69-2
102	Colchicine, its salts and derivatives	64-86-8	200-598-5
103	Colchicoside and its derivatives	477-29-2	207-513-0
104	Colchicum autumnale L. and its galenical preparations	84696-03-7	283-623-2
105	Convallatoxin	508-75-8	208-086-3
106	Anamirta cocculus L. (fruit)
107	Croton tiglium L. (oil)	8001-28-3
108	1-Butyl-3-(N-crotonoylsulphanilyl)urea	52964-42-8
109	Curare and curarine	8063-06-7/22260-42-0	232-511-1/244-880-6
110	Synthetic curarizants
111	Hydrogen cyanide and its salts	74-90-8	200-821-6
112	Feclemine (INN); 2-(alpha-Cyclohexylbenzyl)-N,N,N',N'-tetraethyl-1,3-propanediamine	3590-16-7
113	Cyclomenol (INN) and its salts	5591-47-9	227-002-6
114	Sodium hexacyclonate (INN)	7009-49-6
115	Hexapropymate (INN)	358-52-1	206-618-9
116	Moved or deleted
117	O,O'-Diacetyl-N-allyl-N-normorphine	2748-74-5
118	Pipazetate (INN) and its salts	2167-85-3	218-508-8
119	5-(α,β-Dibromophenethyl)-5-methylhydantoin	511-75-1	208-133-8
120	N,N'-Pentamethylenebis(trimethylammonium) salts, e. g. pentamethonium bromide (INN)	541-20-8	208-771-7
121	N,N'-[(Methylimino)diethylene]bis(ethyldimethylammonium) salts, e. g. azamethonium bromide (INN)	306-53-6	206-186-1
122	Cyclarbamate (INN)	5779-54-4	227-302-7
123	Clofenotane (INN); DDT (ISO)	50-29-3	200-024-3
124	N,N'-Hexamethylenebis(trimethylammonium) salts, e. g. hexamethonium bromide (INN)	55-97-0	200-249-7
125	Dichloroethanes (ethylene chlorides) e.g. 1,2-Dichloroethane	107-06-2	203-458-1
126	Dichloroethylenes (acetylene chlorides) e.g. Vinylidene chloride (1,1-Dichloroethylene)	75-35-4	200-864-0
127	Lysergide (INN) (LSD) and its salts	50-37-3	200-033-2
128	2-Diethylaminoethyl 3-hydroxy-4-phenylbenzoate and its salts	3572-52-9	222-686-2
129	Cinchocaine (INN) and its salts	85-79-0	201-632-1
130	3-Diethylaminopropyl cinnamate	538-66-9
131	O,O'-Diethyl-O-4-nitrophenyl phosphorothioate (Parathion - ISO)	56-38-2	200-271-7
132	[Oxalylbis(iminoethylene)]bis[(o-chlorobenzyl)diethylammonium] salts, e. g. ambenonium chloride (INN)	115-79-7	204-107-5
133	Methyprylon (INN) and its salts	125-64-4	204-745-4
134	Digitaline and all heterosides of Digitalis purpurea L.	752-61-4	212-036-6
135	7-[2-Hydroxy-3-(2-hydroxyethyl-N-methylamino)propyl]theophylline (xanthinol)	2530-97-4
136	Dioxethedrin (INN) and its salts	497-75-6	207-849-8
137	Piprocurarium iodide (INN)	3562-55-8	222-627-0
138	Propyphenazone (INN)	479-92-5	207-539-2
139	Tetrabenazine (INN) and its salts	58-46-8	200-383-6
140	Captodiame (INN)	486-17-9	207-629-1
141	Mefeclorazine (INN) and its salts	1243-33-0
142	Dimethylamine	124-40-3	204-697-4
143	1,1-Bis(dimethylaminomethyl)propyl benzoate (amydricaine, alypine) and its salts	963-07-5	213-512-6
144	Methapyrilene (INN) and its salts	91-80-5	202-099-8
145	Metamfepramone (INN) and its salts	15351-09-4	239-384-1
146	Amitriptyline (INN) and its salts	50-48-6	200-041-6
147	Metformin (INN) and its salts	657-24-9	211-517-8
148	Isosorbide dinitrate (INN)	87-33-2	201-740-9
149	Malononitrile	109-77-3	203-703-2
150	Succinonitrile	110-61-2	203-783-9
151	Dinitrophenol isomers	51-28-5/329-71-5/573-56-8/25550-58-7	200-087-7/206-348-1/209-357-9/247-096-2
152	Inproquone (INN)	436-40-8
153	Dimevamide (INN) and its salts	60-46-8	200-479-8
154	Diphenylpyraline (INN) and its salts	147-20-6	205-686-7
155	Sulfinpyrazone (INN)	57-96-5	200-357-4
156	N-(3-Carbamoyl-3,3-diphenylpropyl)-N,N-diisopropylmethyl-ammonium salts, e. g. isopropamide iodide (INN)	71-81-8	200-766-8
157	Benactyzine (INN)	302-40-9	206-123-8
158	Benzatropine (INN) and its salts	86-13-5
159	Cyclizine (INN) and its salts	82-92-8	201-445-5
160	5,5-Diphenyl-4-imidazolidone (Doxenitoin (INN))	3254-93-1	221-851-6
161	Probenecid (INN)	57-66-9	200-344-3
162	Disulfiram (INN); thiram (INN)	97-77-8/137-26-8	202-607-8/205-286-2
163	Emetine, its salts and derivatives	483-18-1	207-592-1
164	Ephedrine and its salts	299-42-3	206-080-5
165	Oxanamide (INN) and its derivatives	126-93-2
166	Eserine or physostigmine and its salts	57-47-6	200-332-8
167	Esters of 4-aminobenzoic acid, with the free amino group, with the exception of that given in Annex VI
168	Choline salts and their esters, e. g. choline chloride (INN)	67-48-1	200-655-4
169	Caramiphen (INN) and its salts	77-22-5	201-013-6
170	Diethyl 4-nitrophenyl phosphate (Paraoxon - ISO)	311-45-5	206-221-0
171	Metethoheptazine (INN) and its salts	509-84-2
172	Oxpheneridine (INN) and its salts	546-32-7
173	Ethoheptazine (INN) and its salts	77-15-6	201-007-3
174	Metheptazine (INN) and its salts	469-78-3
175	Methylphenidate (INN) and its salts	113-45-1	204-028-6
176	Doxylamine (INN) and its salts	469-21-6	207-414-2
177	Tolboxane (INN)	2430-46-8
178	4-Benzyloxyphenol and 4-ethoxyphenol	103-16-2/622-62-8	203-083-3/210-748-1
179	Parethoxycaine (INN) and its salts	94-23-5	205-246-4
180	Fenozolone (INN)	15302-16-6	239-339-6
181	Glutethimide (INN) and its salts	77-21-4	201-012-0
182	Ethylene oxide	75-21-8	200-849-9
183	Bemegride (INN) and its salts	64-65-3	200-588-0
184	Valnoctamide (INN)	4171-13-5	224-033-7
185	Haloperidol (INN)	52-86-8	200-155-6
186	Paramethasone (INN)	53-33-8	200-169-2
187	Fluanisone (INN)	1480-19-9	216-038-8
188	Trifluperidol (INN)	749-13-3
189	Fluoresone (INN)	2924-67-6	220-889-0
190	Fluorouracil (INN)	51-21-8	200-085-6
191	Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III	7664-39-3	231-634-8
192	Furfuryltrimethylammonium salts, e. g. furtrethonium iodide (INN)	541-64-0	208-789-5
193	Galantamine (INN)	357-70-0
194	Progestogens
195	1,2,3,4,5,6-Hexachlorocyclohexane (BHC-ISO)	58-89-9	200-401-2
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)	72-20-8	200-775-7
197	Hexachloroethane	67-72-1	200-666-4
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)	465-73-6	207-366-2
199	Hydrastine, hydrastinine and their salts	118-08-1/6592-85-4	204-233-0/229-533-9
200	Hydrazides and their salts e.g. Isoniazid (INN)	54-85-3	200-214-6
201	Hydrazine, its derivatives and their salts	302-01-2	206-114-9
202	Octamoxin (INN) and its salts	4684-87-1
203	Warfarin (INN) and its salts	81-81-2	201-377-6
204	Ethyl bis(4-hydroxy-2-oxo-1-benzopyran-3-yl)acetate and salts of the acid	548-00-5	208-940-5
205	Methocarbamol (INN)	532-03-6	208-524-3
206	Propatylnitrate (INN)	2921-92-8	220-866-5
207	4,4'-Dihydroxy-3,3'-(3-methylthiopropylidene) dicoumarin
208	Fenadiazole (INN)	1008-65-7
209	Nitroxoline (INN) and its salts	4008-48-4	223-662-4
210	Hyoscyamine, its salts and derivatives	101-31-5	202-933-0
211	Hyoscyamus niger L. (leaves, seeds, powder and galenical preparations)	84603-65-6	283-265-7
212	Pemoline (INN) and its salts	2152-34-3	218-438-8
213	Iodine	7553-56-2	231-442-4
214	Decamethylenebis(trimethylammonium) salts, e. g. decamethonium bromide (INN)	541-22-0	208-772-2
215	Ipecacuanha (Cephaelis ipecacuanha Brot. and related species) (roots, powder and galenical preparations)	8012-96-2	232-385-8
216	(2-Isopropylpent4-enoyl)urea (apronalide)	528-92-7	208-443-3
217	α-Santonin [(3S,5aR,9bS)-3,3a,4,5,5a,9b-hexahydro-3,5a,9-trimethylnaphto [1,2-b] furan-2,8-dione]	481-06-1	207-560-7
218	Lobelia inflata L. and its galenical preparations	84696-23-1	283-642-6
219	Lobeline (INN) and its salts	90-69-7	202-012-3
220	Barbiturates
221	Mercury and its compounds, except those special cases included in Annex V	7439-97-6	231-106-7
222	3,4,5-Trimethoxyphenethylamine (Mescaline) and its salts	54-04-6	200-190-7
223	Metaldehyde	9002-91-9
224	2-(4-Allyl-2-methoxyphenoxy)-N,N-diethylacetamide and its salts	305-13-5
225	Coumetarol (INN)	4366-18-1	224-455-1
226	Dextromethorphan (INN) and its salts	125-71-3	204-752-2
227	2-Methylheptylamine and its salts	540-43-2
228	Isometheptene (INN) and its salts	503-01-5	207-959-6
229	Mecamylamine (INN)	60-40-2	200-476-1
230	Guaifenesin (INN)	93-14-1	202-222-5
231	Dicoumarol (INN)	66-76-2	200-632-9
232	Phenmetrazine (INN), its derivatives and salts	134-49-6	205-143-4
233	Thiamazole (INN)	60-56-0	200-482-4
234	3,4-Dihydro-2-methoxy-2-methyl-4-phenyl-2H,5H-pyrano [3,2-c]-[1] benzopyran-5-one (cyclocoumarol)	518-20-7	208-248-3
235	Carisoprodol (INN)	78-44-4	201-118-7
236	Meprobamate (INN)	57-53-4	200-337-5
237	Tefazoline (INN) and its salts	1082-56-0
238	Arecoline	63-75-2	200-565-5
239	Poldine metilsulfate (INN)	545-80-2	208-894-6
240	Hydroxyzine (INN)	68-88-2	200-693-1
241	2-Naphthol	135-19-3	205-182-7
242	1-and 2-Naphthylamines and their salts	134-32-7/91-59-8	205-138-7/202-080-4
243	3-(1-Naphthyl)-4-hydroxycoumarin	39923-41-6
244	Naphazoline (INN) and its salts	835-31-4	212-641-5
245	Neostigmine and its salts e. g. neostigmine bromide (INN)	114-80-7	204-054-8
246	Nicotine and its salts	54-11-5	200-193-3
247	Amyl nitrites	110-46-3	203-770-8
248	Inorganic nitrites, with the exception of sodium nitrite	14797-65-0
249	Nitrobenzene	98-95-3	202-716-0
250	Nitrocresols and their alkali metal salts	12167-20-3
251	Nitrofurantoin (INN)	67-20-9	200-646-5
252	Furazolidone (INN)	67-45-8	200-653-3
253	Nitroglycerin; Propane-1,2,3-triyl trinitrate	55-63-0	200-240-8
254	Acenocoumarol (INN)	152-72-7	205-807-3
255	Alkali pentacyanonitrosylferrate (2-) e.g.	14402-89-2/13755-38-9	238-373-9 / -
256	Nitrostilbenes, their homologues and their derivatives
257	Noradrenaline and its salts	51-41-2	200-096-6
258	Noscapine (INN) and its salts	128-62-1	204-899-2
259	Guanethidine (INN) and its salts	55-65-2	200-241-3
260	Oestrogens
261	Oleandrin	465-16-7	207-361-5
262	Chlortalidone (INN)	77-36-1	201-022-5
263	Pelletierine and its salts	2858-66-4/4396-01-4	220-673-6/224-523-0
264	Pentachloroethane	76-01-7	200-925-1
265	Pentaerithrityl tetranitrate (INN)	78-11-5	201-084-3
266	Petrichloral (INN)	78-12-6
267	Octamylamine (INN) and its salts	502-59-0	207-947-0
268	Picric acid	88-89-1	201-865-9
269	Phenacemide (INN)	63-98-9	200-570-2
270	Difencloxazine (INN)	5617-26-5
271	2-Phenylindan-1,3-dione (phenindione (INN))	83-12-5	201-454-4
272	Ethylphenacemide (pheneturide (INN))	90-49-3	201-998-2
273	Phenprocoumon (INN)	435-97-2	207-108-9
274	Fenyramidol (INN)	553-69-5	209-044-7
275	Triamterene (INN) and its salts	396-01-0	206-904-3
276	Tetraethyl pyrophosphate (TEPP - ISO)	107-49-3	203-495-3
277	Tritolyl phosphate	1330-78-5	215-548-8
278	Psilocybine (INN)	520-52-5	208-294-4
279	Phosphorus and metal phosphides	7723-14-0	231-768-7
280	Thalidomide (INN) and its salts	50-35-1	200-031-1
281	Physostigma venenosum Balf.	89958-15-6	289-638-0
282	Picrotoxin	124-87-8	204-716-6
283	Pilocarpine and its salts	92-13-7	202-128-4
284	α-Piperidin-2-ylbenzyl acetate, laevorotatory threoform (levofacetoperane (INN)) and its salts	24558-01-8
285	Pipradrol (INN) and its salts	467-60-7	207-394-5
286	Azacyclonol (INN) and its salts	115-46-8	204-092-5
287	Bietamiverine (INN)	479-81-2	207-538-7
288	Butopiprine (INN) and its salts	55837-15-5	259-848-7
289	Lead and its compounds	7439-92-1	231-100-4
290	Coniine	458-88-8	207-282-6
291	Prunus laurocerasus L. (‘cherry laurel water’)	89997-54-6	289-689-9
292	Metyrapone (INN)	54-36-4	200-206-2
293	Radioactive substances, as defined by Directive 96/29/Euratom (1) laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation
294	Juniperus sabina L. (leaves, essential oil and galenical preparations)	90046-04-1	289-971-1
295	Hyoscine, its salts and derivatives	51-34-3	200-090-3
296	Gold salts
297	Selenium and its compounds with the exception of selenium disulphide under the conditions set out under reference No 49 in Annex III	7782-49-2	231-957-4
298	Solanum nigrum L. and its galenical preparations	84929-77-1	284-555-6
299	Sparteine (INN) and its salts	90-39-1	201-988-8
300	Glucocorticoids (Corticosteroids)
301	Datura stramonium L. and its galenical preparations	84696-08-2	283-627-4
302	Strophantines, their aglucones and their respective derivatives	11005-63-3	234-239-9
303	Strophantus species and their galenical preparations
304	Strychnine and its salts	57-24-9	200-319-7
305	Strychnos species and their galenical preparations
306	Narcotics, natural and synthetic: All substances listed in Tables I and II of the single Convention on narcotic drugs signed in New York on 30 March 1961
307	Sulphonamides (sulphanilamide and its derivatives obtained by substitution of one or more H-atoms of the -NH2 groups) and their salts
308	Sultiame (INN)	61-56-3	200-511-0
309	Neodymium and its salts	7440-00-8	231-109-3
310	Thiotepa (INN)	52-24-4	200-135-7
311	Pilocarpus jaborandi Holmes and its galenical preparations	84696-42-4	283-649-4
312	Tellurium and its compounds	13494-80-9	236-813-4
313	Xylometazoline (INN) and its salts	526-36-3	208-390-6
314	Tetrachloroethylene	127-18-4	204-825-9
315	Carbon tetrachloride	56-23-5	200-262-8
316	Hexaethyl tetraphosphate	757-58-4	212-057-0
317	Thallium and its compounds	7440-28-0	231-138-1
318	Thevetia neriifolia Juss., glycoside extract	90147-54-9	290-446-4
319	Ethionamide (INN)	536-33-4	208-628-9
320	Phenothiazine (INN) and its compounds	92-84-2	202-196-5
321	Thiourea and its derivatives, with the exception of the one listed in Annex III	62-56-6	200-543-5
322	Mephenesin (INN) and its esters	59-47-2	200-427-4
323	Vaccines, toxins or serums defined as immunological medicinal products pursuant to Article 1(4) of Directive 2001/83/EC
324	Tranylcypromine (INN) and its salts	155-09-9	205-841-9
325	Trichloronitromethane (chloropicrine)	76-06-2	200-930-9
326	2,2,2-Tribromoethanol (tribromoethyl alcohol)	75-80-9	200-903-1
327	Trichlormethine (INN) and its salts	817-09-4	212-442-3
328	Tretamine (INN)	51-18-3	200-083-5
329	Gallamine triethiodide (INN)	65-29-2	200-605-1
330	Urginea scilla Steinh. and its galenical preparations	84650-62-4	283-520-2
331	Veratrine, its salts and galenical preparations	8051-02-3	613-062-00-4
332	Schoenocaulon officinale Lind (seeds and galenical preparations)	84604-18-2	283-296-6
333	Veratrum spp. and their preparations	90131-91-2	290-407-1
334	Vinyl chloride monomer	75-01-4	200-831-0
335	Ergocalciferol (INN) and cholecalciferol (vitamins D2 and D3)	50-14-6/67-97-0	200-014-9/200-673-2
336	Salts of O-alkyldithiocarbonic acids (xanthates)
337	Yohimbine and its salts	146-48-5	205-672-0
338	Dimethyl sulfoxide (INN)	67-68-5	200-664-3
339	Diphenhydramine (INN) and its salts	58-73-1	200-396-7
340	4-tert-Butylphenol	98-54-4	202-679-0
341	4-tert-Butylpyrocatechol	98-29-3	202-653-9
342	Dihydrotachysterol (INN)	67-96-9	200-672-7
343	Dioxane	123-91-1	204-661-8
344	Morpholine and its salts	110-91-8	203-815-1
345.	Pyrethrum album L. and its galenical preparations
346	2-[4-Methoxybenzyl-N-(2-pyridyl)amino]ethyldimethylamine maleate (Mepyramine maleate; pyrilamine maleate)	59-33-6	200-422-7
347	Tripelennamine (INN)	91-81-6	202-100-1
348	Tetrachlorosalicylanilides	7426-07-5
349	Dichlorosalicylanilides	1147-98-4
350	Tetrabromosalicylanilides
351	Dibromosalicylanilides
352	Bithionol (INN)	97-18-7	202-565-0
353	Thiuram monosulphides	97-74-5	202-605-7
354	Moved or deleted
355	Dimethylformamide (N,N-Dimethylformamide)	68-12-2	200-679-5
356	4-Phenylbut-3-en-2-one (Benzylidene acetone)	122-57-6	204-555-1
357	Benzoates 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	3902-71-4/298-81-7/484-20-8	223-459-0/206-066-9/207-604-5
359	Oil from the seeds of Laurus nobilis L.	84603-73-6	283-272-5
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	94-59-7	202-345-4
361	5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite (thymol iodide)	552-22-7	209-007-5
362	3'-Ethyl-5',6',7',8'-tetrahydro-5',5',8',8'-tetramethyl-2'-acetonaphthone or 7-acetyl-6-ethyl-1,1,4,4-tetramethyl-1,2,3,4-tetrahydronaphtalen (AETT; Versalide)	88-29-9	201-817-7
363	o-Phenylenediamine and its salts	95-54-5	202-430-6
364	4-Methyl-m-phenylenediamine (Toluene-2,4-diamine) and its salts	95-80-7	202-453-1
365	Aristolochic acid and its salts; Aristolochia spp. and their preparations	475-80-9/313-67-7/15918-62-4	202-499-6/206-238-3/-
366	Chloroform	67-66-3	200-663-8
367	2,3,7,8-Tetrachlorodibenzo-p-dioxin (TCDD)	1746-01-6	217-122-7
368	2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane)	828-00-2	212-579-9
369	Pyrithione sodium (INNM) (2)	3811-73-2	223-296-5
370	N-(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (Captan - ISO)	133-06-2	205-087-0
371	2,2'-Dihydroxy-3,3',5,5',6,6'-hexachlorodiphenylmethane (Hexachlorophene (INN))	70-30-4	200-733-8
372	6-(Piperidinyl)-2,4-pyrimidinediamine 3-oxide (Minoxidil (INN)) and its salts	38304-91-5	253-874-2
373	3,4',5-Tribromosalicylanilide (Tribromsalan (INN))	87-10-5	201-723-6
374	Phytolacca spp. and their preparations	65497-07-6/60820-94-2
375	Tretinoin (INN) (retinoic acid and its salts)	302-79-4	206-129-0
376	1-Methoxy-2,4-diaminobenzene (2,4-diaminoanisole - CI 76050) and its salts	615-05-4	210-406-1
377	1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) and its salts	5307-02-8	226-161-9
378	Colouring agent CI 12140	3118-97-6	221-490-4
379	Colouring agent CI 26105 (Solvent Red 24)	85-83-6	201-635-8
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
381	Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN))	14779-78-3	238-849-6
383	2-Amino-4-nitrophenol	99-57-0	202-767-9
384	2-Amino-5-nitrophenol	121-88-0	204-503-8
385	11-α-Hydroxypregn-4-ene-3,20-dione and its esters	80-75-1	201-306-9
386	Colouring 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)	1694-09-3	216-901-9
387	Colouring agent CI 13065	587-98-4	209-608-2
388	Colouring agent CI 42535 (Basic Violet 1)	8004-87-3
389	Colouring agent CI 61554 (Solvent Blue 35)	17354-14-2	241-379-4
390	Anti-androgens of steroidal structure
391	Zirconium and its compounds, with the exception of the substances listed under reference number 50 in Annex III, and the zirconium lakes, pigments or salts of the colouring agents when listed in Annex IV	7440-67-7	231-176-9
392	Moved or deleted
393	Acetonitrile	75-05-8	200-835-2
394	Tetrahydrozoline (Tetryzoline (INN)) and its salts	84-22-0	201-522-3
395	Hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51 in Annex III	148-24-3/134-31-6	205-711-1/205-137-1
396	Dithio-2,2-bispyridine-dioxide 1,1' (additive with trihydrated magnesium sulphate) - (pyrithione disulphide + magnesium sulphate)	43143-11-9	256-115-3
397	Colouring agent CI 12075 (Pigment Orange 5) and its lakes, pigments and salts	3468-63-1	222-429-4
398	Colouring agent CI 45170 and CI 45170:1 (Basic Violet 10)	81-88-9/509-34-2	201-383-9/208-096-8
399	Lidocaine (INN)	137-58-6	205-302-8
400	1,2-Epoxybutane	106-88-7	203-438-2
401	Colouring agent CI 15585	5160-02-1/2092-56-0	225-935-3/218-248-5
402	Strontium lactate	29870-99-3	249-915-9
403	Strontium nitrate	10042-76-9	233-131-9
404	Strontium polycarboxylate
405	Pramocaine (INN)	140-65-8	205-425-7
406	4-Ethoxy-m-phenylenediamine and its salts	5862-77-1
407	2,4-Diaminophenylethanol and its salts	14572-93-1
408	Pyrocatechol (Catechol)	120-80-9	204-427-5
409	Pyrogallol	87-66-1	201-762-9
410	Nitrosamines e.g. Dimethylnitrosoamine; Nitrosodipropylamine; 2,2'-Nitrosoimino)bisethanol	62-75-9/621-64-7/1116-54-7	200-549-8/210-698-0/214-237-4
411	Secondary alkyl- and alkanolamines and their salts
412	4-Amino-2-nitrophenol	119-34-6	204-316-1
413	2-Methyl-m-phenylenediamine (Toluene-2,6-diamine)	823-40-5	212-513-9
414	4-tert.-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette)	83-66-9	201-493-7
415	Moved or deleted
416	Cells, tissues or products of human origin
417	3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein (INN))	77-09-8	201-004-7
418	3-Imidazol-4-ylacrylic acid (Urocanic acid) and its ethyl ester	104-98-3/27538-35-8	203-258-4/248-515-1
419	Category 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 Council (3), and ingredients derived therefrom
420	Crude and refined coal tars	8007-45-2	232-361-7
421	1,1,3,3,5-Pentamethyl-4,6-dinitroindane (Moskene)	116-66-5	204-149-4
422	5-tert.-Butyl-1,2,3-trimethyl-4,6-dinitrobenzene (Musk Tibetene)	145-39-1	205-651-6
423	Alanroot oil (Inula helenium L.), when used as a fragrance ingredient	97676-35-2
424	Benzyl cyanide, when used as a fragrance ingredient	140-29-4	205-410-5
425	Cyclamen alcohol, when used as a fragrance ingredient	4756-19-8	225-289-2
426	Diethyl maleate, when used as a fragrance ingredient	141-05-9	205-451-9
427	3,4-Dihydrocoumarin, when used as a fragrance ingredient	119-84-6	204-354-9
428	2,4-Dihydroxy-3-methylbenzaldehyde, when used as a fragrance ingredient	6248-20-0	228-369-5
429	3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol), when used as a fragrance ingredient	40607-48-5	254-999-5
430	4,6-Dimethyl-8-tert-butylcoumarin, when used as a fragrance ingredient	17874-34-9	241-827-9
431	Dimethyl citraconate, when used as a fragrance ingredient	617-54-9
432	7,11-Dimethyl-4,6,10-dodecatrien-3-one (Pseudomethylionone), when used as a fragrance ingredient	26651-96-7	247-878-3
433	6,10-Dimethyl-3,5,9-undecatrien-2-one (Pseudoionone)(, when used as a fragrance ingredient	141-10-6	205-457-1
434	Diphenylamine, when used as a fragrance ingredient	122-39-4	204-539-4
435	Ethyl acrylate, when used as a fragrance ingredient	140-88-5	205-438-8
436	Fig leaf absolute (Ficus carica L.), when used as a fragrance ingredient	68916-52-9
437	trans-2-Heptenal, when used as a fragrance ingredient	18829-55-5	242-608-0
438	trans-2-Hexenal diethyl acetal, when used as a fragrance ingredient	67746-30-9	266-989-8
439	trans-2-Hexenal dimethyl acetal, when used as a fragrance ingredient	18318-83-7	242-204-4
440	Hydroabietyl alcohol, when used as a fragrance ingredient	13393-93-6	236-476-3
441	6-Isopropyl-2-decahydronaphthalenol, when used as a fragrance ingredient	34131-99-2	251-841-7
442	7-Methoxycoumarin, when used as a fragrance ingredient	531-59-9	208-513-3
443	4-(4-Methoxyphenyl)-3-butene-2-one (Anisylidene acetone), when used as a fragrance ingredient	943-88-4	213-404-9
444	1-(4-Methoxyphenyl)-1-penten-3-one (alpha-Methylanisylideneacetone), when used as a fragrance ingredient	104-27-8	203-190-5
445	Methyl trans-2-butenoate, when used as a fragrance ingredient	623-43-8	210-793-7
446	7-Methylcoumarin, when used as a fragrance ingredient	2445-83-2	219-499-3
447	5-Methyl-2,3-hexanedione (Acetyl isovaleryl), when used as a fragrance ingredient	13706-86-0	237-241-8
448	2-Pentylidenecyclohexanone, when used as a fragrance ingredient	25677-40-1	247-178-8
449	3,6,10-Trimethyl-3,5,9-undecatrien-2-one (Pseudo-Isomethyl ionone), when used as a fragrance ingredient	1117-41-5	214-245-8
450	Verbena oil (Lippia citriodora Kunth.), when used as a fragrance ingredient	8024-12-2
451	Moved or deleted
452	6-(2-Chloroethyl)-6-(2-methoxyethoxy)-2,5,7,10-tetraoxa-6-silaundecane	37894-46-5	253-704-7
453	Cobalt dichloride	7646-79-9	231-589-4
454	Cobalt sulphate	10124-43-3	233-334-2
455	Nickel monoxide	1313-99-1	215-215-7
456	Dinickel trioxide	1314-06-3	215-217-8
457	Nickel dioxide	12035-36-8	234-823-3
458	Trinickel disulphide	12035-72-2	234-829-6
459	Tetracarbonylnickel	13463-39-3	236-669-2
460	Nickel sulphide	16812-54-7	240-841-2
461	Potassium bromate	7758-01-2	231-829-8
462	Carbon monoxide	630-08-0	211-128-3
463	Buta-1,3-diene, see also entries 464-611	106-99-0	203-450-8
464	Isobutane, if it contains ≥ 0,1 % w/w Butadiene	75-28-5	200-857-2
465	Butane, if it contains ≥ 0,1 % w/w Butadiene	106-97-8	203-448-7
466	Gases (petroleum), C3-4, if they contain > 0,1 % w/w Butadiene	68131-75-9	268-629-5
467	Tail gas (petroleum), catalytic cracked distillate and catalytic cracked naphtha fractionation absorber, if it contains > 0,1 % w/w Butadiene	68307-98-2	269-617-2
468	Tail gas (petroleum), catalytic polymn. naphtha fractionation stabiliser, if it contains > 0,1 % w/w Butadiene	68307-99-3	269-618-8
469	Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene	68308-00-9	269-619-3
470	Tail gas (petroleum), cracked distillate hydrotreater stripper, if it contains > 0,1 % w/w Butadiene	68308-01-0	269-620-9
471	Tail gas (petroleum), gas oil catalytic cracking absorber, if it contains > 0,1 % w/w Butadiene	68308-03-2	269-623-5
472	Tail gas (petroleum), gas recovery plant, if it contains > 0,1 % w/w Butadiene	68308-04-3	269-624-0
473	Tail gas (petroleum), gas recovery plant deethaniser, if it contains > 0,1 % w/w Butadiene	68308-05-4	269-625-6
474	Tail gas (petroleum), hydrodesulfurised distillate and hydrodesulfurised naphtha fractionator, acid-free, if it contains > 0,1 % w/w Butadiene	68308-06-5	269-626-1
475	Tail gas (petroleum), hydrodesulfurised vacuum gas oil stripper, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene	68308-07-6	269-627-7
476	Tail gas (petroleum), isomerised naphtha fractionation stabiliser, if it contains > 0,1 % w/w Butadiene	68308-08-7	269-628-2
477	Tail gas (petroleum), light straight-run naphtha stabiliser, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene	68308-09-8	269-629-8
478	Tail gas (petroleum), straight-run distillate hydrodesulfurised, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene	68308-10-1	269-630-3
479	Tail gas (petroleum), propane-propylene alkylation feed prep deethaniser, if it contains > 0,1 % w/w Butadiene	68308-11-2	269-631-9
480	Tail gas (petroleum), vacuum gas oil hydrodesulfurised, hydrogen sulfide-free, if it contains > 0,1 % w/w Butadiene	68308-12-3	269-632-4
481	Gases (petroleum), catalytic cracked overheads, if they contain > 0,1 % w/w Butadiene	68409-99-4	270-071-2
482	Alkanes, C1-2, if they contain > 0,1 % w/w Butadiene	68475-57-0	270-651-5
483	Alkanes, C2-3, if they contain > 0,1 % w/w Butadiene	68475-58-1	270-652-0
484	Alkanes, C3-4, if they contain > 0,1 % w/w Butadiene	68475-59-2	270-653-6
485	Alkanes, C4-5, if they contain > 0,1 % w/w Butadiene	68475-60-5	270-654-1
486	Fuel-gases, if they contain > 0,1 % w/w Butadiene	68476-26-6	270-667-2
487	Fuel gases, crude oil distillates, if they contain > 0,1 % w/w Butadiene	68476-29-9	270-670-9
488	Hydrocarbons, C3-4, if they contain > 0,1 % w/w Butadiene	68476-40-4	270-681-9
489	Hydrocarbons, C4-5, if they contain > 0,1 % w/w Butadiene	68476-42-6	270-682-4
490	Hydrocarbons, C2-4, C3-rich, if they contain > 0,1 % w/w Butadiene	68476-49-3	270-689-2
491	Petroleum gases, liquefied, if they contain > 0,1 % w/w Butadiene	68476-85-7	270-704-2
492	Petroleum gases, liquefied, sweetened, if they contain > 0,1 % w/w Butadiene	68476-86-8	270-705-8
493	Gases (petroleum), C3-4, isobutane-rich if they contain > 0,1 % w/w Butadiene	68477-33-8	270-724-1
494	Distillates (petroleum), C3-6, piperylene-rich, if they contain > 0,1 % w/w Butadiene	68477-35-0	270-726-2
495	Gases (petroleum), amine system feed, if they contain > 0,1 % w/w Butadiene	68477-65-6	270-746-1
496	Gases (petroleum), benzene unit hydrodesulfurised off, if they contain > 0,1 % w/w Butadiene	68477-66-7	270-747-7
497	Gases (petroleum), benzene unit recycle, hydrogen-rich, if they contain > 0,1 % w/w Butadiene	68477-67-8	270-748-2
498	Gases (petroleum), blend oil, hydrogen-nitrogen-rich, if they contain > 0,1 % w/w Butadiene	68477-68-9	270-749-8
499	Gases (petroleum), butane splitter overheads, if they contain > 0,1 % w/w Butadiene	68477-69-0	270-750-3
500	Gases (petroleum), C2-3, if they contain > 0,1 % w/w Butadiene	68477-70-3	270-751-9
501	Gases (petroleum), catalytic-cracked gas oil depropaniser bottoms, C4-rich acid-free, if they contain > 0,1 % w/w Butadiene	68477-71-4	270-752-4
502	Gases (petroleum), catalytic-cracked naphtha debutaniser bottoms, C3-5-rich, if they contain > 0,1 % w/w Butadiene	68477-72-5	270-754-5
503	Gases (petroleum), catalytic cracked naphtha depropaniser overhead, C3-rich acid-free, if they contain > 0,1 % w/w Butadiene	68477-73-6	270-755-0
504	Gases (petroleum), catalytic cracker, if they contain > 0,1 % w/w Butadiene	68477-74-7	270-756-6
505	Gases (petroleum), catalytic cracker, C1-5-rich, if they contain > 0,1 % w/w Butadiene	68477-75-8	270-757-1
506	Gases (petroleum), catalytic polymd. naphtha stabiliser overhead, C2-4-rich, if they contain > 0,1 % w/w Butadiene	68477-76-9	270-758-7
507	Gases (petroleum), catalytic reformed naphtha stripper overheads, if they contain > 0,1 % w/w Butadiene	68477-77-0	270-759-2
508	Gases (petroleum), catalytic reformer, C1-4-rich, if they contain > 0,1 % w/w Butadiene	68477-79-2	270-760-8
509	Gases (petroleum), C6-8 catalytic reformer recycle, if they contain > 0,1 % w/w Butadiene	68477-80-5	270-761-3
510	Gases (petroleum), C6-8 catalytic reformer, if they contain > 0,1 % w/w Butadiene	68477-81-6	270-762-9
511	Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich, if they contain > 0,1 % w/w Butadiene	68477-82-7	270-763-4
512	Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed, if they contain > 0,1 % w/w Butadiene	68477-83-8	270-765-5
513	Gases (petroleum), C2-return stream, if they contain > 0,1 % w/w Butadiene	68477-84-9	270-766-0
514	Gases (petroleum), C4-rich, if they contain > 0,1 % w/w Butadiene	68477-85-0	270-767-6
515	Gases (petroleum), deethaniser overheads, if they contain > 0,1 % w/w Butadiene	68477-86-1	270-768-1
516	Gases (petroleum), deisobutaniser tower overheads, if they contain > 0,1 % w/w Butadiene	68477-87-2	270-769-7
517	Gases (petroleum), depropaniser dry, propene-rich, if they contain > 0,1 % w/w Butadiene	68477-90-7	270-772-3
518	Gases (petroleum), depropaniser overheads, if they contain > 0,1 % w/w Butadiene	68477-91-8	270-773-9
519	Gases (petroleum), dry sour, gas-concn. -unit-off, if they contain > 0,1 % w/w Butadiene	68477-92-9	270-774-4
520	Gases (petroleum), gas concn. reabsorber distn., if they contain > 0,1 % w/w Butadiene	68477-93-0	270-776-5
521	Gases (petroleum), gas recovery plant depropaniser overheads, if they contain > 0,1 % w/w Butadiene	68477-94-1	270-777-0
522	Gases (petroleum), Girbatol unit feed, if they contain > 0,1 % w/w Butadiene	68477-95-2	270-778-6
523	Gases (petroleum), hydrogen absorber off, if they contain > 0,1 % w/w Butadiene	68477-96-3	270-779-1
524	Gases (petroleum), hydrogen-rich, if they contain > 0,1 % w/w Butadiene	68477-97-4	270-780-7
525	Gases (petroleum), hydrotreater blend oil recycle, hydrogen-nitrogen-rich, if they contain > 0,1 % w/w Butadiene	68477-98-5	270-781-2
526	Gases (petroleum), isomerised naphtha fractionator, C4-rich, hydrogen sulfide-free, if they contain > 0,1 % w/w Butadiene	68477-99-6	270-782-8
527	Gases (petroleum), recycle, hydrogen-rich, if they contain > 0,1 % w/w Butadiene	68478-00-2	270-783-3
528	Gases (petroleum), reformer make-up, hydrogen-rich, if they contain > 0,1 % w/w Butadiene	68478-01-3	270-784-9
529	Gases (petroleum), reforming hydrotreater, if they contain > 0,1 % w/w Butadiene	68478-02-4	270-785-4
530	Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich, if they contain > 0,1 % w/w Butadiene	68478-03-5	270-787-5
531	Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich, if they contain > 0,1 % w/w Butadiene	68478-04-6	270-788-0
532	Gases (petroleum), thermal cracking distn., if they contain > 0,1 % w/w Butadiene	68478-05-7	270-789-6
533	Tail gas (petroleum), catalytic cracked clarified oil and thermal cracked vacuum residue fractionation reflux drum, if it contains > 0,1 % w/w Butadiene	68478-21-7	270-802-5
534	Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber, if it contains > 0,1 % w/w Butadiene	68478-22-8	270-803-0
535	Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulfurised combined fractionater, if it contains > 0,1 % w/w Butadiene	68478-24-0	270-804-6
536	Tail gas (petroleum), catalytic cracker refractionation absorber, if it contains > 0,1 % w/w Butadiene	68478-25-1	270-805-1
537	Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser, if it contains > 0,1 % w/w Butadiene	68478-26-2	270-806-7
538	Tail gas (petroleum), catalytic reformed naphtha separator, if it contains > 0,1 % w/w Butadiene	68478-27-3	270-807-2
539	Tail gas (petroleum), catalytic reformed naphtha stabiliser, if it contains > 0,1 % w/w Butadiene	68478-28-4	270-808-8
540	Tail gas (petroleum), cracked distillate hydrotreater separator, if it contains > 0,1 % w/w Butadiene	68478-29-5	270-809-3
541	Tail gas (petroleum), hydrodesulfurised straight-run naphtha separator, if it contains > 0,1 % w/w Butadiene	68478-30-8	270-810-9
542	Tail gas (petroleum), saturate gas plant mixed stream, C4-rich, if it contains > 0,1 % w/w Butadiene	68478-32-0	270-813-5
543	Tail gas (petroleum), saturate gas recovery plant, C1-2-rich, if it contains > 0,1 % w/w Butadiene	68478-33-1	270-814-0
544	Tail gas (petroleum), vacuum residues thermal cracker, if it contains > 0,1 % w/w Butadiene	68478-34-2	270-815-6
545	Hydrocarbons, C3-4-rich, petroleum distillate, if they contain > 0,1 % w/w Butadiene	68512-91-4	270-990-9
546	Gases (petroleum), catalytic reformed straight-run naphtha stabiliser overheads, if they contain > 0,1 % w/w Butadiene	68513-14-4	270-999-8
547	Gases (petroleum), full-range straight-run naphtha dehexaniser off, if they contain > 0,1 % w/w Butadiene	68513-15-5	271-000-8
548	Gases (petroleum), hydrocracking depropaniser off, hydrocarbon-rich, if they contain > 0,1 % w/w Butadiene	68513-16-6	271-001-3
549	Gases (petroleum), light straight-run naphtha stabiliser off, if they contain > 0,1 % w/w Butadiene	68513-17-7	271-002-9
550	Gases (petroleum), reformer effluent high-pressure flash drum off, if they contain > 0,1 % w/w Butadiene	68513-18-8	271-003-4
551	Gases (petroleum), reformer effluent low-pressure flash drum off, if they contain > 0,1 % w/w Butadiene	68513-19-9	271-005-5
552	Residues (petroleum), alkylation splitter, C4-rich, if they contain > 0,1 % w/w Butadiene	68513-66-6	271-010-2
553	Hydrocarbons, C1-4, if they contain > 0,1 % w/w Butadiene	68514-31-8	271-032-2
554	Hydrocarbons, C1-4, sweetened, if they contain > 0,1 % w/w Butadiene	68514-36-3	271-038-5
555	Gases (petroleum), oil refinery gas distn. off, if they contain > 0,1 % w/w Butadiene	68527-15-1	271-258-1
556	Hydrocarbons, C1-3, if they contain > 0,1 % w/w Butadiene	68527-16-2	271-259-7
557	Hydrocarbons, C1-4, debutaniser fraction, if they contain > 0,1 % w/w Butadiene	68527-19-5	271-261-8
558	Gases (petroleum), benzene unit hydrotreater depentaniser overheads, if they contain > 0,1 % w/w Butadiene	68602-82-4	271-623-5
559	Gases (petroleum), C1-5, wet, if they contain > 0,1 % w/w Butadiene	68602-83-5	271-624-0
560	Gases (petroleum), secondary absorber off, fluidised catalytic cracker overheads fractionator, if they contain > 0,1 % w/w Butadiene	68602-84-6	271-625-6
561	Hydrocarbons, C2-4, if they contain > 0,1 % w/w Butadiene	68606-25-7	271-734-9
562	Hydrocarbons, C3, if they contain > 0,1 % w/w Butadiene	68606-26-8	271-735-4
563	Gases (petroleum), alkylation feed, if they contain > 0,1 % w/w Butadiene	68606-27-9	271-737-5
564	Gases (petroleum), depropaniser bottoms fractionation off, if they contain > 0,1 % w/w Butadiene	68606-34-8	271-742-2
565	Petroleum products, refinery gases, if they contain > 0,1 % w/w Butadiene	68607-11-4	271-750-6
566	Gases (petroleum), hydrocracking low-pressure separator, if they contain > 0,1 % w/w Butadiene	68783-06-2	272-182-1
567	Gases (petroleum), refinery blend, if they contain > 0,1 % w/w Butadiene	68783-07-3	272-183-7
568	Gases (petroleum), catalytic cracking, if they contain > 0,1 % w/w Butadiene	68783-64-2	272-203-4
569	Gases (petroleum), C2-4, sweetened, if they contain > 0,1 % w/w Butadiene	68783-65-3	272-205-5
570	Gases (petroleum), refinery, if they contain > 0,1 % w/w Butadiene	68814-67-5	272-338-9
571	Gases (petroleum), platformer products separator off, if they contain > 0,1 % w/w Butadiene	68814-90-4	272-343-6
572	Gases (petroleum), hydrotreated sour kerosine depentaniser stabiliser off, if they contain > 0,1 % w/w Butadiene	68911-58-0	272-775-5
573	Gases (petroleum), hydrotreated sour kerosine flash drum, if they contain > 0,1 % w/w Butadiene	68911-59-1	272-776-0
574	Gases (petroleum), crude oil fractionation off, if they contain > 0,1 % w/w Butadiene	68918-99-0	272-871-7
575	Gases (petroleum), dehexaniser off, if they contain > 0,1 % w/w Butadiene	68919-00-6	272-872-2
576	Gases (petroleum), distillate unifiner desulfurisation stripper off, if they contain > 0,1 % w/w Butadiene	68919-01-7	272-873-8
577	Gases (petroleum), fluidised catalytic cracker fractionation off if they contain > 0,1 % w/w Butadiene	68919-02-8	272-874-3
578	Gases (petroleum), fluidised catalytic cracker scrubbing secondary absorber off, if they contain > 0,1 % w/w Butadiene	68919-03-9	272-875-9
579	Gases (petroleum), heavy distillate hydrotreater desulfurisation stripper off, if they contain > 0,1 % w/w Butadiene	68919-04-0	272-876-4
580	Gases (petroleum), light straight run gasoline fractionation stabiliser off, if they contain > 0,1 % w/w Butadiene	68919-05-1	272-878-5
581	Gases (petroleum), naphtha unifiner desulfurisation stripper off, if they contain > 0,1 % w/w Butadiene	68919-06-2	272-879-0
582	Gases (petroleum), platformer stabiliser off, light ends fractionation, if they contain > 0,1 % w/w Butadiene	68919-07-3	272-880-6
583	Gases (petroleum), preflash tower off, crude distn., if they contain > 0,1 % w/w Butadiene	68919-08-4	272-881-1
584	Gases (petroleum), straight-run naphtha catalytic reforming off, if they contain > 0,1 % w/w Butadiene	68919-09-5	272-882-7
585	Gases (petroleum), straight-run stabiliser off, if they contain > 0,1 % w/w Butadiene	68919-10-8	272-883-2
586	Gases (petroleum), tar stripper off, if they contain > 0,1 % w/w Butadiene	68919-11-9	272-884-8
587	Gases (petroleum), unifiner stripper off, if they contain > 0,1 % w/w Butadiene	68919-12-0	272-885-3
588	Gases (petroleum), fluidised catalytic cracker splitter overheads, if they contain > 0,1 % w/w Butadiene	68919-20-0	272-893-7
589	Gases (petroleum), catalytic cracked naphtha debutaniser, if they contain > 0,1 % w/w Butadiene	68952-76-1	273-169-3
590	Tail gas (petroleum), catalytic cracked distillate and naphtha stabiliser, if it contains > 0,1 % w/w Butadiene	68952-77-2	273-170-9
591	Tail gas (petroleum), catalytic hydrodesulfurised naphtha separator, if it contains > 0,1 % w/w Butadiene	68952-79-4	273-173-5
592	Tail gas (petroleum), straight-run naphtha hydrodesulfurised, if it contains > 0,1 % w/w Butadiene	68952-80-7	273-174-0
593	Tail gas (petroleum), thermal-cracked distillate, gas oil and naphtha absorber, if it contains > 0,1 % w/w Butadiene	68952-81-8	273-175-6
594	Tail gas (petroleum), thermal cracked hydrocarbon fractionation stabiliser, petroleum coking, if it contains > 0,1 % w/w Butadiene	68952-82-9	273-176-1
595	Gases (petroleum), light steam-cracked, butadiene conc., if they contain > 0,1 % w/w Butadiene	68955-28-2	273-265-5
596	Gases (petroleum), sponge absorber off, fluidised catalytic cracker and gas oil desulfuriser overhead fractionation, if they contain > 0,1 % w/w Butadiene	68955-33-9	273-269-7
597	Gases (petroleum), straight-run naphtha catalytic reformer stabiliser overhead, if they contain > 0,1 % w/w Butadiene	68955-34-0	273-270-2
598	Gases (petroleum), crude distn. and catalytic cracking, if they contain > 0,1 % w/w Butadiene	68989-88-8	273-563-5
599	Hydrocarbons, C4, if they contain > 0,1 % w/w Butadiene	87741-01-3	289-339-5
600	Alkanes, C1-4, C3-rich, if they contain > 0,1 % w/w Butadiene	90622-55-2	292-456-4
601	Gases (petroleum), gas oil diethanolamine scrubber off, if they contain > 0,1 % w/w Butadiene	92045-15-3	295-397-2
602	Gases (petroleum), gas oil hydrodesulfurisation effluent, if they contain > 0,1 % w/w Butadiene	92045-16-4	295-398-8
603	Gases (petroleum), gas oil hydrodesulfurisation purge, if they contain > 0,1 % w/w Butadiene	92045-17-5	295-399-3
604	Gases (petroleum), hydrogenator effluent flash drum off, if they contain > 0,1 % w/w Butadiene	92045-18-6	295-400-7
605	Gases (petroleum), naphtha steam cracking high-pressure residual, if they contain > 0,1 % w/w Butadiene	92045-19-7	295-401-2
606	Gases (petroleum), residue visbreaking off, if they contain > 0,1 % w/w Butadiene	92045-20-0	295-402-8
607	Gases (petroleum), steam-cracker C3-rich, if they contain > 0,1 % w/w Butadiene	92045-22-2	295-404-9
608	Hydrocarbons, C4, steam-cracker distillate, if they contain > 0,1 % w/w Butadiene	92045-23-3	295-405-4
609	Petroleum gases, liquefied, sweetened, C4 fraction, if they contain > 0,1 % w/w Butadiene	92045-80-2	295-463-0
610	Hydrocarbons, C4, 1,3-butadiene- and isobutene-free, if they contain > 0,1 % w/w Butadiene	95465-89-7	306-004-1
611	Raffinates (petroleum), steam-cracked C4 fraction cuprous ammonium acetate extn., C3-5 and C3-5 unsatd., butadiene-free, if they contain > 0,1 % w/w Butadiene	97722-19-5	307-769-4
612	Benzo[def]chrysene (benzo[a]pyrene)	50-32-8	200-028-5
613	Pitch, coal tar-petroleum, if it contains > 0,005 % w/w benzo[a]pyrene	68187-57-5	269-109-0
614	Distillates (coal-petroleum), condensed-ring arom., if they contain > 0,005 % w/w benzo[a]pyrene	68188-48-7	269-159-3
615	Moved or deleted
616	Moved or deleted
617	Creosote oil, acenaphthene fraction, acenaphthene-free, if it contains > 0,005 % w/w benzo[a]pyrene	90640-85-0	292-606-9
618	Pitch, coal tar, low-temp., if it contains > 0,005 % w/w benzo[a]pyrene	90669-57-1	292-651-4
619	Pitch, coal tar, low-temp., heat-treated, if it contains > 0,005 % w/w benzo[a]pyrene	90669-58-2	292-653-5
620	Pitch, coal tar, low-temp., oxidised, if it contains > 0,005 % w/w benzo[a]pyrene	90669-59-3	292-654-0
621	Extract residues (coal), brown, if they contain > 0,005 % w/w benzo[a]pyrene	91697-23-3	294-285-0
622	Paraffin waxes (coal), brown-coal high-temp. tar, if they contain > 0,005 % w/w benzo[a]pyrene	92045-71-1	295-454-1
623	Paraffin waxes (coal), brown-coal high-temp. tar, hydrotreated, if they contain > 0,005 % w/w benzo[a]pyrene	92045-72-2	295-455-7
624	Waste solids, coal-tar pitch coking, if they contain > 0,005 % w/w benzo[a]pyrene	92062-34-5	295-549-8
625	Pitch, coal tar, high-temp., secondary, if it contains > 0,005 % w/w benzo[a]pyrene	94114-13-3	302-650-3
626	Residues (coal), liq. solvent extn., if they contain > 0,005 % w/w benzo[a]pyrene	94114-46-2	302-681-2
627	Coal liquids, liq. solvent extn. soln., if they contain > 0,005 % w/w benzo[a]pyrene	94114-47-3	302-682-8
628	Coal liquids, liq. solvent extn., if they contain > 0,005 % w/w benzo[a]pyrene	94114-48-4	302-683-3
629	Paraffin waxes (coal), brown-coal high-temp. tar, carbon-treated, if they contain > 0,005 % w/w benzo[a]pyrene	97926-76-6	308-296-6
630	Paraffin waxes (coal), brown-coal high-temp tar, clay-treated, if they contain > 0,005 % w/w benzo[a]pyrene	97926-77-7	308-297-1
631	Paraffin waxes (coal), brown-coal high-temp tar, silicic acid-treated, if they contain > 0,005 % w/w benzo[a]pyrene	97926-78-8	308-298-7
632	Absorption oils, bicyclo arom. and heterocylic hydrocarbon fraction, if they contain > 0,005 % w/w benzo[a]pyrene	101316-45-4	309-851-5
633	Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene polypropylene pyrolysis-derived, if they contain > 0,005 % w/w benzo[a]pyrene	101794-74-5	309-956-6
634	Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polyethylene pyrolysis-derived, if they contain > 0,005 % w/w benzo[a]pyrene	101794-75-6	309-957-1
635	Aromatic hydrocarbons, C20-28, polycyclic, mixed coal-tar pitch-polystyrene pyrolysis-derived, if they contain > 0,005 % w/w benzo[a]pyrene	101794-76-7	309-958-7
636	Pitch, coal tar, high-temp., heat-treated, if it contains > 0,005 % w/w benzo[a]pyrene	121575-60-8	310-162-7
637	Dibenz[a,h]anthracene	53-70-3	200-181-8
638	Benz[a]anthracene	56-55-3	200-280-6
639	Benzo[e]pyrene	192-97-2	205-892-7
640	Benzo[j]fluoranthene	205-82-3	205-910-3
641	Benz(e)acephenanthrylene	205-99-2	205-911-9
642	Benzo(k)fluoranthene	207-08-9	205-916-6
643	Chrysene	218-01-9	205-923-4
644	2-Bromopropane	75-26-3	200-855-1
645	Trichloroethylene	79-01-6	201-167-4
646	1,2-Dibromo-3-chloropropane	96-12-8	202-479-3
647	2,3-Dibromopropan-1-ol	96-13-9	202-480-9
648	1,3-Dichloropropan-2-ol	96-23-1	202-491-9
649	α,α,α-Trichlorotoluene	98-07-7	202-634-5
650	α-Chlorotoluene (Benzyl chloride)	100-44-7	202-853-6
651	1,2-Dibromoethane	106-93-4	203-444-5
652	Hexachlorobenzene	118-74-1	204-273-9
653	Bromoethylene (Vinyl bromide)	593-60-2	209-800-6
654	1,4-Dichlorobut-2-ene	764-41-0	212-121-8
655	Methyloxirane (Propylene oxide)	75-56-9	200-879-2
656	(Epoxyethyl)benzene (Styrene oxide)	96-09-3	202-476-7
657	1-Chloro-2,3-epoxypropane (Epichlorohydrin)	106-89-8	203-439-8
658	R-1-Chloro-2,3-epoxypropane	51594-55-9	424-280-2
659	1,2-Epoxy-3-phenoxypropane (Phenylglycidyl ether)	122-60-1	204-557-2
660	2,3-Epoxypropan-1-ol (Glycidol)	556-52-5	209-128-3
661	R-2,3-Epoxy-1-propanol	57044-25-4	404-660-4
662	2,2′-Bioxirane (1,2:3,4-Diepoxybutane)	1464-53-5	215-979-1
663	(2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophenyl)-[1H-1,2,4-triazol-1-yl)methyl]oxirane; Epoxiconazole	133855-98-8	406-850-2
664	Chloromethyl methyl ether	107-30-2	203-480-1
665	2-Methoxyethanol and its acetate (2-Methoxyethyl acetate)	109-86-4/110-49-6	203-713-7/203-772-9
666	2-Ethoxyethanol and its acetate (2-Ethoxyethyl acetate)	110-80-5/111-15-9	203-804-1/203-839-2
667	Oxybis[chloromethane], bis (Chloromethyl) ether	542-88-1	208-832-8
668	2-Methoxypropanol	1589-47-5	216-455-5
669	Propiolactone	57-57-8	200-340-1
670	Dimethylcarbamoyl chloride	79-44-7	201-208-6
671	Urethane (Ethyl carbamate)	51-79-6	200-123-1
672	Moved or deleted
673	Moved or deleted
674	Methoxyacetic acid	625-45-6	210-894-6
675	Dibutyl phthalate	84-74-2	201-557-4
676	bis(2-Methoxyethyl) ether (Dimethoxydiglycol)	111-96-6	203-924-4
677	bis(2-Ethylhexyl) phthalate (Diethylhexyl phthalate)	117-81-7	204-211-0
678	bis(2-Methoxyethyl) phthalate	117-82-8	204-212-6
679	2-Methoxypropyl acetate	70657-70-4	274-724-2
680	2-Ethylhexyl[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]-methyl]thio]acetate	80387-97-9	279-452-8
681	Acrylamide, unless regulated elsewhere in this Regulation	79-06-1	201-173-7
682	Acrylonitrile	107-13-1	203-466-5
683	2-Nitropropane	79-46-9	201-209-1
684	Dinoseb, its salts and esters with the exception of those specified elsewhere in this list	88-85-7	201-861-7
685	2-Nitroanisole	91-23-6	202-052-1
686	4-Nitrobiphenyl	92-93-3	202-204-7
687	2,4-Dinitrotoluene; Dinitrotoluene, technical grade	121-14-2/25321-14-6	204-450-0/246-836-1
688	Binapacryl	485-31-4	207-612-9
689	2-Nitronaphthalene	581-89-5	209-474-5
690	2,3-Dinitrotoluene	602-01-7	210-013-5
691	5-Nitroacenaphthene	602-87-9	210-025-0
692	2,6-Dinitrotoluene	606-20-2	210-106-0
693	3,4-Dinitrotoluene	610-39-9	210-222-1
694	3,5-Dinitrotoluene	618-85-9	210-566-2
695	2,5-Dinitrotoluene	619-15-8	210-581-4
696	Dinoterb, its salts and esters	1420-07-1	215-813-8
697	Nitrofen	1836-75-5	217-406-0
698	Moved or deleted
699	Diazomethane	334-88-3	206-382-7
700	1,4,5,8-Tetraaminoanthraquinone (Disperse Blue 1)	2475-45-8	219-603-7
701	Moved or deleted
702	1-Methyl-3-nitro-1-nitrosoguanidine	70-25-7	200-730-1
703	Moved or deleted
704	Moved or deleted
705	4,4′-Methylenedianiline	101-77-9	202-974-4
706	4,4′-(4-Iminocyclohexa-2,5-dienylidenemethylene) dianiline hydrochloride	569-61-9	209-321-2
707	4,4′-Methylenedi-o-toluidine	838-88-0	212-658-8
708	o-Anisidine	90-04-0	201-963-1
709	3,3′-Dimethoxybenzidine (ortho-Dianisidine) and its salts	119-90-4	204-355-4
710	Moved or deleted
711	o-Dianisidine based azo dyes
712	3,3′-Dichlorobenzidine	91-94-1	202-109-0
713	Benzidine dihydrochloride	531-85-1	208-519-6
714	[[1,1′-Biphenyl]-4,4′-diyl]diammonium sulphate	531-86-2	208-520-1
715	3,3′-Dichlorobenzidine dihydrochloride	612-83-9	210-323-0
716	Benzidine sulphate	21136-70-9	244-236-4
717	Benzidine acetate	36341-27-2	252-984-8
718	3,3′-Dichlorobenzidine dihydrogen bis(sulphate)	64969-34-2	265-293-1
719	3,3′-Dichlorobenzidine sulphate	74332-73-3	277-822-3
720	Benzidine based azo dyes
721	4,4′-Bi-o-toluidine (ortho-Tolidine)	119-93-7	204-358-0
722	4,4′-Bi-o-toluidine dihydrochloride	612-82-8	210-322-5
723	[3,3′-Dimethyl[1,1′-biphenyl]-4,4′-diyl]diammonium bis(hydrogen sulphate)	64969-36-4	265-294-7
724	4,4′-Bi-o-toluidine sulphate	74753-18-7	277-985-0
725	o-Tolidine based dyes		611-030-00-4
726	Biphenyl-4-ylamine (4-Aminobiphenyl) and its salts	92-67-1	202-177-1
727	Azobenzene	103-33-3	203-102-5
728	(Methyl-ONN-azoxy)methyl acetate	592-62-1	209-765-7
729	Cycloheximide	66-81-9	200-636-0
730	2-Methylaziridine	75-55-8	200-878-7
731	Imidazolidine-2-thione (Ethylene thiourea)	96-45-7	202-506-9
732	Furan	110-00-9	203-727-3
733	Aziridine	151-56-4	205-793-9
734	Captafol	2425-06-1	219-363-3
735	Carbadox	6804-07-5	229-879-0
736	Flumioxazin	103361-09-7	613-166-00-X
737	Tridemorph	24602-86-6	246-347-3
738	Vinclozolin	50471-44-8	256-599-6
739	Fluazifop-butyl	69806-50-4	274-125-6
740	Flusilazole	85509-19-9	014-017-00-6
741	1,3,5-Tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (TGIC)	2451-62-9	219-514-3
742	Thioacetamide	62-55-5	200-541-4
743	Moved or deleted
744	Formamide	75-12-7	200-842-0
745	N-Methylacetamide	79-16-3	201-182-6
746	N-Methylformamide	123-39-7	204-624-6
747	N,N-Dimethylacetamide	127-19-5	204-826-4
748	Hexamethylphosphoric-triamide	680-31-9	211-653-8
749	Diethyl sulphate	64-67-5	200-589-6
750	Dimethyl sulphate	77-78-1	201-058-1
751	1,3-Propanesultone	1120-71-4	214-317-9
752	Dimethylsulphamoyl-chloride	13360-57-1	236-412-4
753	Sulfallate	95-06-7	202-388-9
754	A mixture of: 4-[[bis-(4-Fluorophenyl)methylsilyl]methyl]-4H-1,2,4-triazole and 1-[[bis-(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole		403-250-2
755	(+/–)-Tetrahydrofurfuryl –(R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate	119738-06-6	607-373-00-4
756	6-Hydroxy-1-(3-Isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrile	85136-74-9-	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] formate	108225-03-2	402-060-7
758	Trisodium [4′-(8-acetylamino-3,6-disulfonato-2-naphthylazo)-4″-(6-benzoylamino-3-Sulfonato-2-naphthylazo)-biphenyl-1,3′,3″,1‴-tetraolato-O,O′,O″,O‴]copper(II)		413-590-3
759	A 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-methylacrylamide		412-790-8
760	1,3,5-tris-[(2S and 2R)-2,3-Epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (Teroxirone)	59653-74-6	616-091-00-0
761	Erionite	12510-42-8	650-012-00-0
762	Asbestos	12001-28-4	650-013-00-6
763	Petroleum	8002-05-9	232-298-5
764	Distillates (petroleum), heavy hydrocracked, if they contain > 3 % w/w DMSO extract	64741-76-0	265-077-7
765	Distillates (petroleum), solvent-refined heavy paraffinic, if they contain > 3 % w/w DMSO extract	64741-88-4	265-090-8
766	Distillates (petroleum), solvent-refined light paraffinic, if they contain > 3 % w/w DMSO extract	64741-89-5	265-091-3
767	Residual oils (petroleum), solvent deasphalted, if they contain > 3 % w/w DMSO extract	64741-95-3	265-096-0
768	Distillates (petroleum), solvent-refined heavy naphthenic, if they contain > 3 % w/w DMSO extract	64741-96-4	265-097-6
769	Distillates (petroleum), solvent-refined light naphthenic, if they contain > 3 % w/w DMSO extract	64741-97-5	265-098-1
770	Residual oils (petroleum), solvent-refined, if they contain > 3 % w/w DMSO extract	64742-01-4	265-101-6
771	Distillates (petroleum), clay-treated heavy paraffinic, if they contain > 3 % w/w DMSO extract	64742-36-5	265-137-2
772	Distillates (petroleum), clay-treated light paraffinic, if they contain > 3 % w/w DMSO extract	64742-37-6	265-138-8
773	Residual oils (petroleum), clay-treated, if they contain > 3 % w/w DMSO extract	64742-41-2	265-143-5
774	Distillates (petroleum), clay-treated heavy naphthenic, if they contain > 3 % w/w DMSO extract	64742-44-5	265-146-1
775	Distillates (petroleum), clay-treated light naphthenic, if they contain > 3 % w/w DMSO extract	64742-45-6	265-147-7
776	Distillates (petroleum), hydrotreated heavy naphthenic, if they contain > 3 % w/w DMSO extract	64742-52-5	265-155-0
777	Distillates (petroleum), hydrotreated light naphthenic, if they contain > 3 % w/w DMSO extract	64742-53-6	265-156-6
778	Distillates (petroleum), hydrotreated heavy paraffinic, if they contain > 3 % w/w DMSO extract	64742-54-7	265-157-1
779	Distillates (petroleum), hydrotreated light paraffinic, if they contain > 3 % w/w DMSO extract	64742-55-8	265-158-7
780	Distillates (petroleum), solvent-dewaxed light paraffinic, if they contain > 3 % w/w DMSO extract	64742-56-9	265-159-2
781	Residual oils (petroleum), hydrotreated, if they contain > 3 % w/w DMSO extract	64742-57-0	265-160-8
782	Residual oils (petroleum), solvent-dewaxed, if they contain > 3 % w/w DMSO extract	64742-62-7	265-166-0
783	Distillates (petroleum), solvent-dewaxed heavy naphthenic, if they contain > 3 % w/w DMSO extract	64742-63-8	265-167-6
784	Distillates (petroleum), solvent-dewaxed light naphthenic, if they contain > 3 % w/w DMSO extract	64742-64-9	265-168-1
785	Distillates (petroleum), solvent-dewaxed heavy paraffinic, if they contain > 3 % w/w DMSO extract	64742-65-0	265-169-7
786	Foots oil (petroleum), if it contains > 3 % w/w DMSO extract	64742-67-2	265-171-8
787	Naphthenic oils (petroleum), catalytic dewaxed heavy, if they contain > 3 % w/w DMSO extract	64742-68-3	265-172-3
788	Naphthenic oils (petroleum), catalytic dewaxed light, if they contain > 3 % w/w DMSO extract	64742-69-4	265-173-9
789	Paraffin oils (petroleum), catalytic dewaxed heavy, if they contain > 3 % w/w DMSO extract	64742-70-7	265-174-4
790	Paraffin oils (petroleum), catalytic dewaxed light, if they contain > 3 % w/w DMSO extract	64742-71-8	265-176-5
791	Naphthenic oils (petroleum), complex dewaxed heavy, if they contain > 3 % w/w DMSO extract	64742-75-2	265-179-1
792	Naphthenic oils (petroleum), complex dewaxed light, if they contain > 3 % w/w DMSO extract	64742-76-3	265-180-7
793	Extracts (petroleum), heavy naphthenic distillate solvent, arom. Conc., if they contain > 3 % w/w DMSO extract	68783-00-6	272-175-3
794	Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent, if they contain > 3 % w/w DMSO extract	68783-04-0	272-180-0
795	Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted, if they contain > 3 % w/w DMSO extract	68814-89-1	272-342-0
796	Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity, if they contain > 3 % w/w DMSO extract	72623-85-9	276-736-3
797	Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based, if they contain > 3 % w/w DMSO extract	72623- 86-0	276-737-9
798	Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, if they contain > 3 % w/w DMSO extract	72623- 87-1	276-738-4
799	Lubricating oils, if they contain > 3 % w/w DMSO extract	74869-22-0	278-012-2
800	Distillates (petroleum), complex dewaxed heavy paraffinic, if they contain > 3 % w/w DMSO extract	90640-91-8	292-613-7
801	Distillates (petroleum), complex dewaxed light paraffinic, if they contain > 3 % w/w DMSO extract	90640-92-9	292-614-2
802	Distillates (petroleum), solvent dewaxed heavy paraffinic, clay-treated, if they contain > 3 % w/w DMSO extract	90640-94-1	292-616-3
803	Hydrocarbons, C20-50, solvent dewaxed heavy paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract	90640-95-2	292-617-9
804	Distillates (petroleum), solvent dewaxed light paraffinic, clay-treated, if they contain > 3 % w/w DMSO extract	90640-96-3	292-618-4
805	Distillates (petroleum), solvent dewaxed light paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract	90640-97-4	292-620-5
806	Extracts (petroleum), heavy naphthenic distillate solvent, hydrotreated, if they contain > 3 % w/w DMSO extract	90641-07-9	292-631-5
807	Extracts (petroleum), heavy paraffinic distillate solvent, hydrotreated, if they contain > 3 % w/w DMSO extract	90641-08-0	292-632-0
808	Extracts (petroleum), light paraffinic distillate solvent, hydrotreated, if they contain > 3 % w/w DMSO extract	90641-09-1	292-633-6
809	Residual oils (petroleum), hydrotreated solvent dewaxed, if they contain > 3 % w/w DMSO extract	90669-74-2	292-656-1
810	Residual oils (petroleum), catalytic dewaxed, if they contain > 3 % w/w DMSO extract	91770-57-9	294-843-3
811	Distillates (petroleum), dewaxed heavy paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract	91995-39-0	295-300-3
812	Distillates (petroleum), dewaxed light paraffinic, hydrotreated, if they contain > 3 % w/w DMSO extract	91995-40-3	295-301-9
813	Distillates (petroleum), hydrocracked solvent-refined, dewaxed, if they contain > 3 % w/w DMSO extract	91995-45-8	295-306-6
814	Distillates (petroleum), solvent-refined light naphthenic, hydrotreated, if they contain > 3 % w/w DMSO extract	91995-54-9	295-316-0
815	Extracts (petroleum), hydrotreated light paraffinic distillate solvent, if they contain > 3 % w/w DMSO extract	91995- 73-2	295-335-4
816	Extracts (petroleum), light naphthenic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract	91995-75-4	295-338-0
817	Extracts (petroleum), light paraffinic distillate solvent, acid-treated, if they contain > 3 % w/w DMSO extract	91995-76-5	295-339-6
818	Extracts (petroleum), light paraffinic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract	91995-77-6	295-340-1
819	Extracts (petroleum), light vacuum gas oil solvent, hydrotreated, if they contain > 3 % w/w DMSO extract	91995-79-8	295-342-2
820	Foots oil (petroleum), hydrotreated, if it contains > 3 % w/w DMSO extract	92045-12-0	295-394-6
821	Lubricating oils (petroleum), C17-35, solvent-extd., dewaxed, hydrotreated, if they contain > 3 % w/w DMSO extract	92045-42-6	295-423-2
822	Lubricating oils (petroleum), hydrocracked nonarom solvent-deparaffined, if they contain > 3 % w/w DMSO extract	92045-43-7	295-424-8
823	Residual oils (petroleum), hydrocracked acid-treated solvent-dewaxed, if they contain > 3 % w/w DMSO extract	92061-86-4	295-499-7
824	Paraffin oils (petroleum), solvent-refined dewaxed heavy, if they contain > 3 % w/w DMSO extract	92129-09-4	295-810-6
825	Extracts (petroleum), heavy paraffinic distillate solvent, clay-treated, if they contain > 3 % w/w DMSO extract	92704-08-0	296-437-1
826	Lubricating oils (petroleum), base oils, paraffinic, if they contain > 3 % w/w DMSO extract	93572-43-1	297-474-6
827	Extracts (petroleum), heavy naphthenic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract	93763-10-1	297-827-4
828	Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent, hydrodesulfurised, if they contain > 3 % w/w DMSO extract	93763-11-2	297-829-5
829	Hydrocarbons, hydrocracked paraffinic distn. residues, solvent-dewaxed, if they contain > 3 % w/w DMSO extract	93763-38-3	297-857-8
830	Foots oil (petroleum), acid-treated, if it contains > 3 % w/w DMSO extract	93924-31-3	300-225-7
831	Foots oil (petroleum), clay-treated, if it contains > 3 % w/w DMSO extract	93924-32-4	300-226-2
832	Hydrocarbons, C20-50, residual oil hydrogenation vacuum distillate, if they contain > 3 % w/w DMSO extract	93924-61-9	300-257-1
833	Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated, if they contain > 3 % w/w DMSO extract	94733-08-1	305-588-5
834	Distillates (petroleum), solvent-refined hydrocracked light, if they contain > 3 % w/w DMSO extract	94733-09-2	305-589-0
835	Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based, if they contain > 3 % w/w DMSO extract	94733-15-0	305-594-8
836	Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrogenated raffinate-based, if they contain > 3 % w/w DMSO extract	94733-16-1	305-595-3
837	Hydrocarbons, C13-30, arom. -rich, solvent-extd. naphthenic distillate, if they contain > 3 % w/w DMSO extract	95371-04-3	305-971-7
838	Hydrocarbons, C16-32, arom. rich, solvent-extd. naphthenic distillate, if they contain > 3 % w/w DMSO extract	95371-05-4	305-972-2
839	Hydrocarbons, C37-68, dewaxed deasphalted hydrotreated vacuum distn. Residues, if they contain > 3 % w/w DMSO extract	95371-07-6	305-974-3
840	Hydrocarbons, C37-65, hydrotreated deasphalted vacuum distn. Residues, if they contain > 3 % w/w DMSO extract	95371-08-7	305-975-9
841	Distillates (petroleum), hydrocracked solvent-refined light, if they contain > 3 % w/w DMSO extract	97488-73-8	307-010-7
842	Distillates (petroleum), solvent-refined hydrogenated heavy, if they contain > 3 % w/w DMSO extract	97488-74-9	307-011-2
843	Lubricating oils (petroleum), C18-27, hydrocracked solvent-dewaxed, if they contain > 3 % w/w DMSO extract	97488-95-4	307-034-8
844	Hydrocarbons, C17-30, hydrotreated solvent-deasphalted atm. distn. residue, distn. lights, if they contain > 3 % w/w DMSO extract	97675-87-1	307-661-7
845	Hydrocarbons, C17-40, hydrotreated solvent-deasphalted distn. residue, vacuum distn. lights, if they contain > 3 % w/w DMSO extract	97722-06-0	307-755-8
846	Hydrocarbons, C13-27, solvent-extd. light naphthenic, if they contain > 3 % w/w DMSO extract	97722-09-3	307-758-4
847	Hydrocarbons, C14-29, solvent-extd. light naphthenic, if they contain > 3 % w/w DMSO extract	97722-10-6	307-760-5
848	Foots oil (petroleum), carbon-treated, if it contains > 3 % w/w DMSO extract	97862-76-5	308-126-0
849	Foots oil (petroleum), silicic acid-treated, if it contains > 3 % w/w DMSO extract	97862-77-6	308-127-6
850	Hydrocarbons, C27-42, dearomatised, if they contain > 3 % w/w DMSO extract	97862-81-2	308-131-8
851	Hydrocarbons, C17-30, hydrotreated distillates, distn. Lights, if they contain > 3 % w/w DMSO extract	97862-82-3	308-132-3
852	Hydrocarbons, C27-45, naphthenic vacuum distn., if they contain > 3 % w/w DMSO extract	97862-83-4	308-133-9
853	Hydrocarbons, C27-45, dearomatised, if they contain > 3 % w/w DMSO extract	97926-68-6	308-287-7
854	Hydrocarbons, C20-58, hydrotreated, if they contain > 3 % w/w DMSO extract	97926-70-0	308-289-8
855	Hydrocarbons, C27-42, naphthenic, if they contain > 3 % w/w DMSO extract	97926-71-1	308-290-3
856	Extracts (petroleum), light paraffinic distillate solvent, carbon-treated, if they contain > 3 % w/w DMSO extract	100684-02-4	309-672-2
857	Extracts (petroleum), light paraffinic distillate solvent, clay-treated, if they contain > 3 % w/w DMSO extract	100684- 03-5	309-673-8
858	Extracts (petroleum), light vacuum, gas oil solvent, carbon-treated, if they contain > 3 % w/w DMSO extract	100684-04-6	309-674-3
859	Extracts (petroleum), light vacuum gas oil solvent, clay-treated, if they contain > 3 % w/w DMSO extract	100684-05-7	309-675-9
860	Residual oils (petroleum), carbon-treated solvent-dewaxed, if they contain > 3 % w/w DMSO extract	100684-37-5	309-710-8
861	Residual oils (petroleum), clay-treated solvent-dewaxed, if they contain > 3 % w/w DMSO extract	100684-38-6	309-711-3
862	Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract	101316-69-2	309-874-0
863	Lubricating oils (petroleum), C17-32, solvent-extd., dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract	101316-70-5	309-875-6
864	Lubricating oils (petroleum), C20-35, solvent-extd., dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract	101316-71-6	309-876-1
865	Lubricating oils (petroleum), C24-50, solvent-extd., dewaxed, hydrogenated, if they contain > 3 % w/w DMSO extract	101316-72-7	309-877-7
866	Distillates (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 carcinogen	64741-86-2	265-088-7
867	Gas 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 carcinogen	64741-90-8	265-092-9
868	Distillates (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 carcinogen	64741-91-9	265-093-4
869	Gas 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 carcinogen	64742-12-7	265-112-6
870	Distillates (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 carcinogen	64742-13-8	265-113-1
871	Distillates (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 carcinogen	64742-14-9	265-114-7
872	Gas 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 carcinogen	64742-29-6	265-129-9
873	Distillates (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 carcinogen	64742-30-9	265-130-4
874	Distillates (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 carcinogen	64742-38-7	265-139-3
875	Distillates (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 carcinogen	64742-46-7	265-148-2
876	Gas 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 carcinogen	64742-79-6	265-182-8
877	Distillates (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 carcinogen	64742-80-9	265-183-3
878	Distillates (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 carcinogen	68477-29-2	270-719-4
879	Distillates (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 carcinogen	68477-30-5	270-721-5
880	Distillates (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 carcinogen	68477-31-6	270-722-0
881	Alkanes, 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 carcinogen	90622-53-0	292-454-3
882	Distillates (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 carcinogen	90640-93-0	292-615-8
883	Distillates (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 carcinogen	91995-34-5	295-294-2
884	Gas 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 carcinogen	93924-33-5	300-227-8
885	Naphtha (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 carcinogen	97488-96-5	307-035-3
886	Hydrocarbons, 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 carcinogen	97675- 85-9	307-659-6
887	Hydrocarbons, 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 carcinogen	97675-86-0	307-660-1
888	Hydrocarbons, 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 carcinogen	97722-08-2	307-757-9
889	Gas 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 carcinogen	97862-78-7	308-128-1
890	Distillates (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 carcinogen	100683-97-4	309-667-5
891	Distillates (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 carcinogen	100683-98-5	309-668-0
892	Distillates (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 carcinogen	100683-99-6	309-669-6
893	Lubricating 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 carcinogen	74869-21-9	278-011-7
894	Slack 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 carcinogen	64742-61-6	265-165-5
895	Slack 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 carcinogen	90669-77-5	292-659-8
896	Slack 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 carcinogen	90669-78-6	292-660-3
897	Slack 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 carcinogen	92062-09-4	295-523-6
898	Slack 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 carcinogen	92062-10-7	295-524-1
899	Slack 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 carcinogen	92062-11-8	295-525-7
900	Slack 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 carcinogen	97863-04-2	308-155-9
901	Slack 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 carcinogen	97863-05-3	308-156-4
902	Slack 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 carcinogen	97863-06-4	308-158-5
903	Slack 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 carcinogen	100684-49-9	309-723-9
904	Petrolatum, except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen	8009-03-8	232-373-2
905	Petrolatum (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 carcinogen	64743-01-7	265-206-7
906	Petrolatum (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 carcinogen	85029-74-9	285-098-5
907	Petrolatum (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 carcinogen	92045-77-7	295-459-9
908	Petrolatum (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 carcinogen	97862-97-0	308-149-6
909	Petrolatum (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 carcinogen	97862-98-1	308-150-1
910	Petrolatum (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 carcinogen	100684-33-1	309-706-6
911	Distillates (petroleum), light catalytic cracked	64741-59-9	265-060-4
912	Distillates (petroleum), intermediate catalytic cracked	64741-60-2	265-062-5
913	Distillates (petroleum), light thermal cracked	64741-82-8	265-084-5
914	Distillates (petroleum), hydrodesulfurised light catalytic cracked	68333-25-5	269-781-5
915	Distillates (petroleum), light steam-cracked naphtha	68475-80-9	270-662-5
916	Distillates (petroleum), cracked steam-cracked petroleum distillates	68477-38-3	270-727-8
917	Gas oils (petroleum), steam-cracked	68527-18-4	271-260-2
918	Distillates (petroleum), hydrodesulfurised thermal cracked middle	85116-53-6	285-505-6
919	Gas oils (petroleum), thermal-cracked, hydrodesulfurised	92045-29-9	295-411-7
920	Residues (petroleum), hydrogenated steam-cracked naphtha	92062-00-5	295-514-7
921	Residues (petroleum), steam-cracked naphtha distn.	92062-04-9	295-517-3
922	Distillates (petroleum), light catalytic cracked, thermally degraded	92201-60-0	295-991-1
923	Residues (petroleum), steam-cracked heat-soaked naphtha	93763-85-0	297-905-8
924	Gas oils (petroleum), light vacuum, thermal-cracked hydrodesulfurised	97926-59-5	308-278-8
925	Distillates (petroleum), hydrodesulfurised middle coker	101316-59-0	309-865-1
926	Distillates (petroleum), heavy steam-cracked	101631-14-5	309-939-3
927	Residues (petroleum), atm. Tower	64741-45-3	265-045-2
928	Gas oils (petroleum), heavy vacuum	64741-57-7	265-058-3
929	Distillates (petroleum), heavy catalytic cracked	64741-61-3	265-063-0
930	Clarified oils (petroleum), catalytic cracked	64741-62-4	265-064-6
931	Residues (petroleum), catalytic reformer fractionator	64741-67-9	265-069-3
932	Residues (petroleum), hydrocracked	64741-75-9	265-076-1
933	Residues (petroleum), thermal cracked	64741-80-6	265-081-9
934	Distillates (petroleum), heavy thermal cracked	64741-81-7	265-082-4
935	Gas oils (petroleum), hydrotreated vacuum	64742-59-2	265-162-9
936	Residues (petroleum), hydrodesulfurised atmospheric tower	64742-78-5	265-181-2
937	Gas oils (petroleum), hydrodesulfurised heavy vacuum	64742-86-5	265-189-6
938	Residues (petroleum), steam-cracked	64742-90-1	265-193-8
939	Residues (petroleum), atmospheric	68333-22-2	269-777-3
940	Clarified oils (petroleum), hydrodesulfurised catalytic cracked	68333-26-6	269-782-0
941	Distillates (petroleum), hydrodesulfurised intermediate catalytic cracked	68333-27-7	269-783-6
942	Distillates (petroleum), hydrodesulfurised heavy catalytic cracked	68333-28-8	269-784-1
943	Fuel oil, residues-straight-run gas oils, high-sulfur	68476-32-4	270-674-0
944	Fuel oil, residual	68476-33-5	270-675-6
945	Residues (petroleum), catalytic reformer fractionator residue distn.	68478-13-7	270-792-2
946	Residues (petroleum), heavy coker gas oil and vacuum gas oil	68478-17-1	270-796-4
947	Residues (petroleum), heavy coker and light vacuum	68512-61-8	270-983-0
948	Residues (petroleum), light vacuum	68512-62-9	270-984-6
949	Residues (petroleum), steam-cracked light	68513-69-9	271-013-9
950	Fuel oil, No 6	68553-00-4	271-384-7
951	Residues (petroleum), topping plant, low-sulfur	68607-30-7	271-763-7
952	Gas oils (petroleum), heavy atmospheric	68783-08-4	272-184-2
953	Residues (petroleum), coker scrubber, condensed-ring-arom. -contg	68783-13-1	272-187-9
954	Distillates (petroleum), petroleum residues vacuum	68955-27-1	273-263-4
955	Residues (petroleum), steam-cracked, resinous	68955-36-2	273-272-3
956	Distillates (petroleum), intermediate vacuum	70592-76-6	274-683-0
957	Distillates (petroleum), light vacuum	70592-77-7	274-684-6
958	Distillates (petroleum), vacuum	70592-78-8	274-685-1
959	Gas oils (petroleum), hydrodesulfurised coker heavy vacuum	85117-03-9	285-555-9
960	Residues (petroleum), steam-cracked, distillates	90669-75-3	292-657-7
961	Residues (petroleum), vacuum, light	90669-76-4	292-658-2
962	Fuel oil, heavy, high-sulfur	92045-14-2	295-396-7
963	Residues (petroleum), catalytic cracking	92061-97-7	295-511-0
964	Distillates (petroleum), intermediate catalytic cracked, thermally degraded	92201-59-7	295-990-6
965	Residual oils (petroleum)	93821-66-0	298-754-0
966	Residues, steam cracked, thermally treated	98219-64-8	308-733-0
967	Distillates (petroleum), hydrodesulfurised full-range middle	101316-57-8	309-863-0
968	Distillates (petroleum), light paraffinic	64741-50-0	265-051-5
969	Distillates (petroleum), heavy paraffinic	64741-51-1	265-052-0
970	Distillates (petroleum), light naphthenic	64741-52-2	265-053-6
971	Distillates (petroleum), heavy naphthenic	64741-53-3	265-054-1
972	Distillates (petroleum), acid-treated heavy naphthenic	64742-18-3	265-117-3
973	Distillates (petroleum), acid-treated light naphthenic	64742-19-4	265-118-9
974	Distillates (petroleum), acid-treated heavy paraffinic	64742-20-7	265-119-4
975	Distillates (petroleum), acid-treated light paraffinic	64742-21-8	265-121-5
976	Distillates (petroleum), chemically neutralised heavy paraffinic	64742-27-4	265-127-8
977	Distillates (petroleum), chemically neutralised light paraffinic	64742-28-5	265-128-3
978	Distillates (petroleum), chemically neutralised heavy naphthenic	64742-34-3	265-135-1
979	Distillates (petroleum), chemically neutralised light naphthenic	64742-35-4	265-136-7
980	Extracts (petroleum), light naphthenic distillate solvent	64742-03-6	265-102-1
981	Extracts (petroleum), heavy paraffinic distillate solvent	64742-04-7	265-103-7
982	Extracts (petroleum), light paraffinic distillate solvent	64742-05-8	265-104-2
983	Extracts (petroleum), heavy naphthenic distillate solvent	64742-11-6	265-111-0
984	Extracts (petroleum), light vacuum gas oil solvent	91995-78-7	295-341-7
985	Hydrocarbons, C26-55, arom. rich	97722-04-8	307-753-7
986	Disodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis(4-aminonaphthalene-1-sulphonate)	573-58-0	209-358-4
987	Disodium 4-amino-3-[[4′-[(2,4-diaminophenyl)azo] [1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate	1937-37-7	217-710-3
988	Tetrasodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonate]	2602-46-2	220-012-1
989	4-o-Tolylazo-o-toluidine	97-56-3	202-591-2
990	4-Aminoazobenzene	60-09-3	200-453-6
991	Disodium[5-[[4′-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulphophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]salicylato(4-)]cuprate(2-)	16071-86-6	240-221-1
992	Resorcinol diglycidyl ether	101-90-6	202-987-5
993	1,3-Diphenylguanidine	102-06-7	203-002-1
994	Heptachlor-epoxide	1024-57-3	213-831-0
995	4-Nitrosophenol	104-91-6	203-251-6
996	Carbendazim	10605-21-7	234-232-0
997	Allyl glycidyl ether	106-92-3	203-442-4
998	Chloroacetaldehyde	107-20-0	203-472-8
999	Hexane	110-54-3	203-777-6
1000	2-(2-Methoxyethoxy)ethanol (Diethylene glycol monomethyl ether; DEGME)	111-77-3	203-906-6
1001	(+/–)-2-(2,4-Dichlorophenyl)-3-(1H-1,2,4-triazol-1-yl)propyl-1,1,2,2-tetrafluoroethylether (Tetraconazole - ISO)	112281-77-3	407-760-6
1002	4-[4-(1,3-Dihydroxyprop-2-yl)phenylamino]-1,8-dihydroxy-5-nitroanthraquinone	114565-66-1	406-057-1
1003	5,6,12,13-Tetrachloroanthra(2,1,9-def:6,5,10-d'e'f')diisoquinoline-1,3,8,10(2H,9H)-tetrone	115662-06-1	405-100-1
1004	tris(2-Chloroethyl) phosphate	115-96-8	204-118-5
1005	4′-Ethoxy-2-benzimidazoleanilide	120187-29-3	407-600-5
1006	Nickel dihydroxide	12054-48-7	235-008-5
1007	N,N-Dimethylaniline	121-69-7	204-493-5
1008	Simazine	122-34-9	204-535-2
1009	bis(Cyclopentadienyl)-bis(2,6-difluoro-3-(pyrrol-1-yl)-phenyl)titanium	125051-32-3	412-000-1
1010	N,N,N′,N′-Tetraglycidyl-4,4′-diamino-3,3′-diethyldiphenylmethane	130728-76-6	410-060-3
1011	Divanadium pentaoxide	1314-62-1	215-239-8
1012	Pentachlorophenol and its alkali salts	87-86-5/131-52-2/7778-73-6	201-778-6/205-025-2/231-911-3
1013	Phosphamidon	13171-21-6	236-116-5
1014	N-(Trichloromethylthio)phthalimide (Folpet - ISO)	133-07-3	205-088-6
1015	N-2-Naphthylaniline	135-88-6	205-223-9
1016	Ziram	137-30-4	205-288-3
1017	1-Bromo-3,4,5-trifluorobenzene	138526-69-9	418-480-9
1018	Propazine	139-40-2	205-359-9
1019	3-(4-Chlorophenyl)-1,1-dimethyluronium trichloroacetate; monuron-TCA	140-41-0	006-043-00-1
1020	Isoxaflutole	141112-29-0	606-054-00-7
1021	Kresoxim-methyl	143390-89-0	607-310-00-0
1022	Chlordecone	143-50-0	205-601-3
1023	9-Vinylcarbazole	1484-13-5	216-055-0
1024	2-Ethylhexanoic acid	149-57-5	205-743-6
1025	Monuron	150-68-5	205-766-1
1026	Morpholine-4-carbonyl chloride	15159-40-7	239-213-0
1027	Daminozide	1596-84-5	216-485-9
1028	Alachlor (ISO)	15972-60-8	240-110-8
1029	UVCB condensation product of: tetrakis-hydroxymethylphosphonium chloride, urea and distilled hydrogenated C16-18 tallow alkylamine	166242-53-1	422-720-8
1030	Ioxynil and Ioxynil octanoate (ISO)	1689-83-4/3861-47-0	216-881-1/223-375-4
1031	Bromoxynil (ISO) (3,5-Dibromo-4-hydroxybenzonitrile) and Bromoxynil heptanoate (ISO)	1689-84-5/56634-95-8	216-882-7/260-300-4
1032	2,6-Dibromo-4-cyanophenyl octanoate	1689-99-2	216-885-3
1033	Moved or deleted
1034	5-Chloro-1,3-dihydro-2H-indol-2-one	17630-75-0	412-200-9
1035	Benomyl	17804-35-2	241-775-7
1036	Chlorothalonil	1897-45-6	217-588-1
1037	N′-(4-Chloro-o-tolyl)-N,N-dimethylformamidine monohydrochloride	19750-95-9	243-269-1
1038	4,4′-Methylenebis(2-ethylaniline)	19900-65-3	243-420-1
1039	Valinamide	20108-78-5	402-840-7
1040	[(p-Tolyloxy)methyl]oxirane	2186-24-5	218-574-8
1041	[(m-Tolyloxy)methyl]oxirane	2186-25-6	218-575-3
1042	2,3-Epoxypropyl o-tolyl ether	2210-79-9	218-645-3
1043	[(Tolyloxy)methyl]oxirane, cresyl glycidyl ether	26447-14-3	247-711-4
1044	Di-allate	2303-16-4	218-961-1
1045	Benzyl 2,4-dibromobutanoate	23085-60-1	420-710-8
1046	Trifluoroiodomethane	2314-97-8	219-014-5
1047	Thiophanate-methyl	23564-05-8	245-740-7
1048	Dodecachloropentacyclo[5.2.1.02,6.03,905,8]decane (Mirex)	2385-85-5	219-196-6
1049	Propyzamide	23950-58-5	245-951-4
1050	Butyl glycidyl ether	2426-08-6	219-376-4
1051	2,3,4-Trichlorobut-1-ene	2431-50-7	219-397-9
1052	Chinomethionate	2439-01-2	219-455-3
1053	(R)-α-Phenylethylammonium (-)-(1R,2S)-(1,2-epoxypropyl)phosphonate monohydrate	25383-07-7	418-570-8
1054	5-Ethoxy-3-trichloromethyl-1,2,4-thiadiazole (Etridiazole - ISO)	2593-15-9	219-991-8
1055	Disperse Yellow 3	2832-40-8	220-600-8
1056	1,2,4-Triazole	288-88-0	206-022-9
1057	Aldrin (ISO)	309-00-2	206-215-8
1058	Diuron (ISO)	330-54-1	206-354-4
1059	Linuron (ISO)	330-55-2	206-356-5
1060	Nickel carbonate	3333-67-3	222-068-2
1061	3-(4-Isopropylphenyl)-1,1-dimethylurea (Isoproturon - ISO)	34123-59-6	251-835-4
1062	Iprodione	36734-19-7	253-178-9
1063	Moved or deleted
1064	5-(2,4-Dioxo-1,2,3,4-tetrahydropyrimidine)-3-fluoro-2-hydroxymethyltetrahydrofuran	41107-56-6	415-360-8
1065	Crotonaldehyde	4170-30-3	224-030-0
1066	Hexahydrocyclopenta(c)pyrrole-1-(1H)-ammonium N-ethoxycarbonyl-N-(p-tolylsulfonyl)azanide		418-350-1
1067	4,4′-Carbonimidoylbis[N,N-dimethylaniline] and its salts	492-80-8	207-762-5
1068	DNOC (ISO)	534-52-1	208-601-1
1069	Toluidinium chloride	540-23-8	208-740-8
1070	Toluidine sulphate (1:1)	540-25-0	208-741-3
1071	2-(4-tert.-Butylphenyl)ethanol	5406-86-0	410-020-5
1072	Fenthion	55-38-9	200-231-9
1073	Chlordane, pur	57-74-9	200-349-0
1074	Hexan-2-one (Methyl butyl ketone)	591-78-6	209-731-1
1075	Fenarimol	60168-88-9	262-095-7
1076	Acetamide	60-35-5	200-473-5
1077	N-Cyclohexyl-N-methoxy-2,5-dimethyl-3-furamide (Furmecyclox - ISO)	60568-05-0	262-302-0
1078	Dieldrin	60-57-1	200-484-5
1079	4,4′-Isobutylethylidenediphenol	6807-17-6	401-720-1
1080	Chlordimeform	6164-98-3	228-200-5
1081	Amitrole	61-82-5	200-521-5
1082	Carbaryl	63-25-2	200-555-0
1083	Distillates (petroleum), light hydrocracked	64741-77-1	265-078-2
1084	1-Ethyl-1-methylmorpholinium bromide	65756-41-4	612-182-00-4
1085	(3-Chlorophenyl)-(4-methoxy-3-nitrophenyl)methanone	66938-41-8	423-290-4
1086	Fuels, 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 carcinogen	68334-30-5	269-822-7
1087	Fuel oil, no. 2	68476-30-2	270-671-4
1088	Fuel oil, no. 4	68476-31-3	270-673-5
1089	Fuels, diesel, no. 2	68476-34-6	270-676-1
1090	2,2-Dibromo-2-nitroethanol	69094-18-4	412-380-9
1091	1-Ethyl-1-methylpyrrolidinium bromide	69227-51-6	612-183-00-X
1092	Monocrotophos	6923-22-4	230-042-7
1093	Nickel	7440-02-0	231-111-4
1094	Bromomethane (Methyl bromide - ISO)	74-83-9	200-813-2
1095	Chloromethane (Methyl chloride)	74-87-3	200-817-4
1096	Iodomethane (Methyl iodide)	74-88-4	200-819-5
1097	Bromoethane (Ethyl bromide)	74-96-4	200-825-8
1098	Heptachlor	76-44-8	200-962-3
1099	Fentin hydroxide	76-87-9	200-990-6
1100	Nickel sulphate	7786-81-4	232-104-9
1101	3,5,5-Trimethylcyclohex-2-enone (Isophorone)	78-59-1	201-126-0
1102	2,3-Dichloropropene	78-88-6	201-153-8
1103	Fluazifop-P-butyl (ISO)	79241-46-6	607-305-00-3
1104	(S)-2,3-Dihydro-1H-indole-carboxylic acid	79815-20-6	410-860-2
1105	Toxaphene	8001-35-2	232-283-3
1106	(4-Hydrazinophenyl)-N-methylmethanesulfonamide hydrochloride	81880-96-8	406-090-1
1107	CI Solvent Yellow 14	842-07-9	212-668-2
1108	Chlozolinate	84332-86-5	282-714-4
1109	Alkanes, C10-13, monochloro	85535-84-8	287-476-5
1110	Moved or deleted
1111	2,4,6-Trichlorophenol	88-06-2	201-795-9
1112	Diethylcarbamoyl-chloride	88-10-8	201-798-5
1113	1-Vinyl-2-pyrrolidone	88-12-0	201-800-4
1114	Myclobutanil (ISO) (2-(4-chlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)hexanenitrile)	88671-89-0	410-400-0
1115	Fentin acetate	900-95-8	212-984-0
1116	Biphenyl-2-ylamine	90-41-5	201-990-9
1117	Trans-4-cyclohexyl-L-proline monohydro-chloride	90657-55-9	419-160-1
1118	2-Methyl-m-phenylene diisocyanate (Toluene 2,6-diisocyanate)	91-08-7	202-039-0
1119	4-Methyl-m-phenylene diisocyanate (Toluene 2,4-diisocyanate)	584-84-9	209-544-5
1120	m-Tolylidene diisocyanate (Toluene diisocyanate)	26471-62-5	247-722-4
1121	Fuels, jet aircraft, coal solvent extn., hydrocracked hydrogenated	94114-58-6	302-694-3
1122	Fuels, diesel, coal solvent extn., hydrocracked hydrogenated	94114-59-7	302-695-9
1123	Pitch, if it contains > 0,005 % w/w benzo[a]pyrene	61789-60-4	263-072-4
1124	2-Butanone oxime	96-29-7	202-496-6
1125	Hydrocarbons, C16-20, solvent-dewaxed hydrocracked paraffinic distn. Residue	97675-88-2	307-662-2
1126	α,α-Dichlorotoluene	98-87-3	202-709-2
1127	Mineral wool, with the exception of those specified elsewhere in this Annex; [Man-made vitreous (silicate)fibres with random orientation with alkaline oxide and alkali earth oxide (Na2O + K2O + CaO + MgO + BaO) content greater than 18 % by weight]
1128	Reaction product of acetophenone, formaldehyde, cyclohexylamine, methanol and acetic acid		406-230-1
1129	Moved or deleted
1130	Moved or deleted
1131	Trisodium bis(7-acetamido-2-(4-nitro-2-oxidophenylazo)-3-sulfonato-1-naphtholato)chromate(1-)		400-810-8
1132	A mixture of: 4-allyl-2,6-bis(2,3-epoxypropyl)phenol, 4-allyl-6-(3-(6-(3-(6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)-phenoxy)2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)phenoxy)-2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)-phenoxy-2-hydroxypropyl-2-(2,3-epoxypropyl)phenol, 4-allyl-6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)phenoxy)-2- hydroxypropyl)-2-(2,3-epoxypropyl)phenoxy)phenol and 4-allyl-6-(3-(6-(3-(4-allyl-2,6-bis(2,3-epoxypropyl)-phenoxy)-2-hydroxypropyl)-4-allyl-2-(2,3-epoxypropyl)phenoxy)2-hydroxypropyl)-2-(2,3-epoxypropyl)phenol		417-470-1
1133	Costus root oil (Saussurea lappa Clarke), when used as a fragrance ingredient	8023-88-9
1134	7-Ethoxy-4-methylcoumarin, when used as a fragrance ingredient	87-05-8	201-721-5
1135	Hexahydrocoumarin, when used as a fragrance ingredient	700-82-3	211-851-4
1136	Peru balsam (INCI name: Myroxylon pereirae), when used as a fragrance ingredient	8007-00-9	232-352-8
1137	Isobutyl nitrite	542-56-2	208-819-7
1138	Isoprene (stabilized); (2-methyl-1,3-butadiene)	78-79-5	201-143-3
1139	1-Bromopropane; n-Propyl bromide	106-94-5	203-445-0
1140	Chloroprene (stabilized); (2-Chlorobuta-1,3-diene)	126-99-8	204-818-0
1141	1,2,3-Trichloropropane	96-18-4	202-486-1
1142	Ethylene glycol dimethyl ether (EGDME)	110-71-4	203-794-9
1143	Dinocap (ISO)	39300-45-3	254-408-0
1144	Diaminotoluene, technical product -mixture of [4-methyl-m-phenylenediamine] (4) and [2-methyl-m-phenylenediamine] (5) Methyl-phenylenediamine	25376-45-8	246-910-3
1145	p-Chlorobenzotrichloride	5216-25-1	226-009-1
1146	Diphenylether; octabromo derivate	32536-52-0	251-087-9
1147	1,2-bis(2-Methoxyethoxy)ethane; Triethylene glycol dimethyl ether (TEGDME)	112-49-2	203-977-3
1148	Tetrahydrothiopyran-3-carboxaldehyde	61571-06-0	407-330-8
1149	4,4′-bis(Dimethylamino)benzophenone (Michler's ketone)	90-94-8	202-027-5
1150	Oxiranemethanol, 4-methylbenzene-sulfonate, (S)-	70987-78-9	417-210-7
1151	1,2-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
1152	Benzyl butyl phthalate (BBP)	85-68-7	201-622-7
1153	1,2-Benzenedicarboxylic acid, di-C7-11, branched and linear alkyl esters	68515-42-4	271-084-6
1154	A 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)benzenesulfonate		402-660-9
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 dihydrochloride		401-500-5
1156	2-[2-Hydroxy-3-(2-chlorophenyl)carbamoyl-1-naphthylazo]-7-[2-hydroxy-3-(3-methylphenyl)carbamoyl-1-naphthylazo]fluoren-9-one		420-580-2
1157	Azafenidin	68049-83-2
1158	2,4,5-Trimethylaniline [1]	137-17-7 [1]	205-282-0
1158	2,4,5-Trimethylaniline hydrochloride [2]	21436-97-5 [2]
1159	4,4′-Thiodianiline and its salts	139-65-1	205-370-9
1160	4,4′-Oxydianiline (p-Aminophenyl ether) and its salts	101-80-4	202-977-0
1161	N,N,N′,N′-Tetramethyl-4,4′-methylenedianiline	101-61-1	202-959-2
1162	6-Methoxy-m-toluidine; (p-Cresidine)	120-71-8	204-419-1
1163	3-Ethyl-2-methyl-2-(3-methylbutyl)-1,3-oxazolidine	143860-04-2	421-150-7
1164	A 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-trione		421-550-1
1165	2-Nitrotoluene	88-72-2	201-853-3
1166	Tributyl phosphate	126-73-8	204-800-2
1167	Naphthalene	91-20-3	202-049-5
1168	Nonylphenol [1]	25154-52-3 [1]	246-672-0
1168	4-Nonylphenol, branched [2]	84852-15-3 [2]	284-325-5
1169	1,1,2-Trichloroethane	79-00-5	201-166-9
1170	Moved or deleted
1171	Moved or deleted
1172	allyl chloride; (3-Chloropropene)	107-05-1	203-457-6
1173	1,4-Dichlorobenzene; (p-Dichlorobenzene)	106-46-7	203-400-5
1174	bis(2-Chloroethyl) ether	111-44-4	203-870-1
1175	Phenol	108-95-2	203-632-7
1176	Bisphenol A (4,4′-Isopropylidenediphenol)	80-05-7	201-245-8
1177	Trioxymethylene (1,3,5-Trioxan)	110-88-3	203-812-5
1178	Propargite (ISO)	2312-35-8	219-006-1
1179	1-Chloro-4-nitrobenzene	100-00-5	202-809-6
1180	Molinate (ISO)	2212-67-1	218-661-0
1181	Fenpropimorph (ISO)	67564-91-4	266-719-9
1182	Moved or deleted
1183	Methyl isocyanate	624-83-9	210-866-3
1184	N,N-Dimethylanilinium tetrakis(pentafluorophenyl)borate	118612-00-3	422-050-6
1185	O,O′-(Ethenylmethylsilylene) di[(4-methylpentan-2-one) oxime]		421-870-1
1186	A 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)	140698-96-0	414-770-4
1187	A 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
1188	Malachite green hydrochloride [1]	569-64-2 [1]	209-322-8
1188	Malachite green oxalate [2]	18015-76-4 [2]	241-922-5
1189	1-(4-Chlorophenyl)-4,4-dimethyl-3-(1,2,4-triazol-1-ylmethyl)pentan-3-ol	107534-96-3	403-640-2
1190	5-(3-Butyryl-2,4,6-trimethylphenyl)-2-[1-(ethoxyimino)propyl]-3-hydroxycyclohex-2-en-1-one	138164-12-2	414-790-3
1191	trans-4-Phenyl-L-proline	96314-26-0	416-020-1
1192	Moved or deleted
1193	A 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 acid	163879-69-4	418-230-9
1194	2-{]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 formate		424-260-3
1195	5-Nitro-o-toluidine [1]	99-55-8 [1]	202-765-8
1195	5-Nitro-o-toluidine hydrochloride [2]	51085-52-0 [2]	256-960-8
1196	1-(1-Naphthylmethyl)quinolinium chloride	65322-65-8	406-220-7
1197	(R)-5-Bromo-3-(1-methyl-2-pyrrolidinylmethyl)-1H-indole	143322-57-0	422-390-5
1198	Pymetrozine (ISO)	123312-89-0	613-202-00-4
1199	Oxadiargyl (ISO)	39807-15-3	254-637-6
1200	Chlorotoluron (3-(3-chloro-p-tolyl)-1,1-dimethylurea)	15545-48-9	239-592-2
1201	N-[2-(3-Acetyl-5-nitrothiophen-2-ylazo)-5-diethylaminophenyl]acetamide		416-860-9
1202	1,3-bis(Vinylsulfonylacetamido)propane	93629-90-4	428-350-3
1203	p-Phenetidine (4-Ethoxyaniline)	156-43-4	205-855-5
1204	m-Phenylenediamine and its salts	108-45-2	203-584-7
1205	Residues (coal tar), creosote oil distn., if it contains > 0,005 % w/w benzo[a]pyrene	92061-93-3	295-506-3
1206	Creosote oil, acenaphthene fraction, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene	90640-84-9	292-605-3
1207	Creosote oil, if it contains > 0,005 % w/w benzo[a]pyrene	61789-28-4	263-047-8
1208	Creosote, if it contains > 0,005 % w/w benzo[a]pyrene	8001-58-9	232-287-5
1209	Creosote oil, high-boiling distillate, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene	70321-79-8	274-565-9
1210	Extract residues (coal), creosote oil acid, wash oil extract residue, if it contains > 0,005 % w/w benzo[a]pyrene	122384-77-4	310-189-4
1211	Creosote oil, low-boiling distillate, wash oil, if it contains > 0,005 % w/w benzo[a]pyrene	70321-80-1	274-566-4
1212	6-Methoxy-2,3-Pyridinediamine and its HCl salt, when used as a substance in hair dye products	94166-62-8	303-358-9
1213	2,3-Naphthalenediol, when used as a substance in hair dye products	92-44-4	202-156-7
1214	2,4-Diaminodiphenylamine, when used as a substance in hair dye products	136-17-4
1215	2,6-Bis(2-Hydroxyethoxy)-3,5-Pyridinediamine and its HCl salt, when used as a substance in hair dye products	117907-42-3
1216	2-Methoxymethyl-p-Aminophenol and its HCl salt, when used as a substance in hair dye products	135043-65-1/29785-47-5
1217	4,5-Diamino-1-Methylpyrazole and its HCl salt, when used as a substance in hair dye products	20055-01-0/21616-59-1
1218	4,5-Diamino-1-((4-Chlorophenyl)Methyl)-1H-Pyrazole Sulfate, when used as a substance in hair dye products	163183-00-4
1219	4-Chloro-2-Aminophenol, when used as a substance in hair dye products	95-85-2	202-458-9
1220	4-Hydroxyindole, when used as a substance in hair dye products	2380-94-1	219-177-2
1221	4-Methoxytoluene-2,5-Diamine and its HCl salt, when used as a substance in hair dye products	56496-88-9
1222	5-Amino-4-Fluoro-2-Methylphenol Sulfate, when used as a substance in hair dye products	163183-01-5
1223	N,N-Diethyl-m-Aminophenol, when used as a substance in hair dye products	91-68-9/68239-84-9	202-090-9/269-478-8
1224	N,N-Dimethyl-2,6-Pyridinediamine and its HCl salt, when used as a substance in hair dye products	—
1225	N-Cyclopentyl-m-Aminophenol, when used as a substance in hair dye products	104903-49-3
1226	N-(2-Methoxyethyl)-p-phenylenediamine and its HCl salt, when used as a substance in hair dye products	72584-59-9/66566-48-1	276-723-2
1227	2,4-Diamino-5-methylphenetol and its HCl salt, when used as a substance in hair dye products	113715-25-6
1228	1,7-Naphthalenediol, when used as a substance in hair dye products	575-38-2	209-383-0
1229	3,4-Diaminobenzoic acid, when used as a substance in hair dye products	619-05-6	210-577-2
1230	2-Aminomethyl-p-aminophenol and its HCl salt, when used as a substance in hair dye products	79352-72-0
1231	Solvent Red 1 (CI 12150), when used as a substance in hair dye products	1229-55-6	214-968-9
1232	Acid Orange 24 (CI 20170), when used as a substance in hair dye products	1320-07-6	215-296-9
1233	Acid Red 73 (CI 27290), when used as a substance in hair dye products	5413-75-2	226-502-1
1234	PEG-3,2′,2′-di-p-Phenylenediamine	144644-13-3
1235	6-Nitro-o-Toluidine	570-24-1	209-329-6
1236	HC Yellow No 11	73388-54-2
1237	HC Orange No 3	81612-54-6
1238	HC Green No 1	52136-25-1	257-687-7
1239	HC Red No 8 and its salts	13556-29-1/97404-14-3	- / 306-778-0
1240	Tetrahydro-6-nitroquinoxaline and its salts	158006-54-3/41959-35-7/73855-45-5
1241	Disperse Red 15, except as impurity in Disperse Violet 1	116-85-8	204-163-0
1242	4-Amino-3-fluorophenol	399-95-1	402-230-0
1243	N,N′-dihexadecyl-N,N′-bis(2-hydroxyethyl)propanediamide Bishydroxyethyl Biscetyl Malonamide	149591-38-8	422-560-9
1244	1-Methyl-2,4,5-trihydroxybenzene and its salts, when used as a substance in hair dye products	1124-09-0	214-390-7
1245	2,6-Dihydroxy-4-methylpyridine and its salts, when used as a substance in hair dye products	4664-16-8	225-108-7
1246	5-Hydroxy-1,4-benzodioxane and its salts, when used as a substance in hair dye products	10288-36-5	233-639-0
1247	3,4-Methylenedioxyphenol and its salts, when used as a substance in hair dye products	533-31-3	208-561-5
1248	3,4-Methylenedioxyaniline and its salts, when used as a substance in hair dye products	14268-66-7	238-161-6
1249	Hydroxypyridinone and its salts, when used as a substance in hair dye products	822-89-9	212-506-0
1250	3-Nitro-4-aminophenoxyethanol and its salts, when used as a substance in hair dye products	50982-74-6
1251	2-methoxy-4-nitrophenol (4-Nitroguaiacol) and its salts, when used as a substance in hair dye products	3251-56-7	221-839-0
1252	CI Acid Black 131 and its salts, when used as a substance in hair dye products	12219-01-1
1253	1,3,5-Trihydroxybenzene (Phloroglucinol) and its salts, when used as a substance in hair dye products	108-73-6	203-611-2
1254	1,2,4-Benzenetriacetate and its salts, when used as a substance in hair dye products	613-03-6	210-327-2
1255	Ethanol, 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 products	68478-64-8/158571-58-5
1256	N-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 products	158571-57-4
1257	4-Aminobenzenesulfonic acid (Sulfanilic acid) and its salts, when used as a substance in hair dye products	121-57-3/515-74-2	204-482-5/208-208-5
1258	3,3'-(Sulfonylbis(2-nitro-4,1-phenylene)imino)bis(6-(phenylamino)) benzenesulfonic acid and its salts, when used as a substance in hair dye products	6373-79-1	228-922-0
1259	3(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 products	89959-98-8/12221-69-1	289-660-0
1260	2,2'-((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 products	23355-64-8	245-604-7
1261	Benzothiazolium, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methyl-, and its salts, when used as a substance in hair dye products	12270-13-2	235-546-0
1262	2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutanamide (Pigment Yellow 73) and its salts, when used as a substance in hair dye products	13515-40-7	236-852-7
1263	2,2'-[(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 products	6358-85-6	228-787-8
1264	2,2'-(1,2-Ethenediyl)bis[5-((4-ethoxyphenyl)azo]benzenesulfonic acid) and its salts, when used as a substance in hair dye products	2870-32-8	220-698-2
1265	2,3-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 products	4197-25-5	224-087-1
1266	3(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 products	3442-21-5/34977-63-4	222-351-0/252-305-5
1267	2-Naphthalenesulfonic acid, 7-(benzoylamino)-4-hydroxy-3-[[4-[(4-sulfophenyl)azo]phenyl]azo]-, and its salts, when used as a substance in hair dye products	2610-11-9	220-028-9
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 products	37279-54-2	253-441-8
1269	3-[(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 products	3441-14-3	222-348-4
1270	2-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 products	2610-10-8/25188-41-4	220-027-3
1271	Ethanaminium, 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 products	2390-59-2	219-231-5
1272	3H-Indolium, 2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-, and its salts, when used as a substance in hair dye products	54060-92-3	258-946-7
1273	3H-Indolium, 2-(2-((2,4-dimethoxyphenyl)amino)ethenyl)-1,3,3-trimethyl-, and its salts, when used as a substance in hair dye products	4208-80-4	224-132-5
1274	Nigrosine spirit soluble (Solvent Black 5), when used as a substance in hair dye products	11099-03-9
1275	Phenoxazin-5-ium, 3,7-bis(diethylamino)-, and its salts, when used as a substance in hair dye products	47367-75-9/33203-82-6	251-403-5
1276	Benzo[a]phenoxazin-7-ium, 9-(dimethylamino)-, and its salts, when used as a substance in hair dye products	7057-57-0/966-62-1	230-338-6/213-524-1
1277	6-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 products	2478-20-8	219-607-9
1278	1-Amino-4-[[4-[(dimethylamino)methyl]phenyl]amino]anthraquinone and its salts, when used as a substance in hair dye products	67905-56-0/12217-43-5	267-677-4/235-398-7
1279	Laccaic Acid (CI Natural Red 25) and its salts, when used as a substance in hair dye products	60687-93-6
1280	Benzenesulfonic acid, 5-[(2,4-dinitrophenyl)amino]-2-(phenylamino)-, and its salts, when used as a substance in hair dye products	6373-74-6/15347-52-1	228-921-5/239-377-3
1281	4-[(4-Nitrophenyl)azo]aniline (Disperse Orange 3) and its salts, when used as a substance in hair dye products	730-40-5/70170-61-5	211-984-8
1282	4-Nitro-m-phenylenediamine and its salts, when used as a substance in hair dye products	5131-58-8	225-876-3
1283	1-Amino-4-(methylamino)-9,10-anthracenedione (Disperse Violet 4) and its salts, when used as a substance in hair dye products	1220-94-6	214-944-8
1284	N-Methyl-3-nitro-p-phenylenediamine and its salts, when used as a substance in hair dye products	2973-21-9	221-014-5
1285	N1-(2-Hydroxyethyl)-4-nitro-o-phenylenediamine (HC Yellow No. 5) and its salts, when used as a substance in hair dye products	56932-44-6	260-450-0
1286	N1-(Tris(hydroxymethyl))methyl-4-nitro-1,2-phenylenediamine (HC Yellow No. 3) and its salts, when used as a substance in hair dye products	56932-45-7	260-451-6
1287	2-Nitro-N-hydroxyethyl-p-anisidine and its salts, when used as a substance in hair dye products	57524-53-5
1288	N,N'-Dimethyl-N-Hydroxyethyl-3-nitro-p-phenylenediamine and its salts, when used as a substance in hair dye products	10228-03-2	233-549-1
1289	3-(N-Methyl-N-(4-methylamino-3-nitrophenyl)amino)propane-1,2-diol and its salts, when used as a substance in hair dye products	93633-79-5	403-440-5
1290	4-Ethylamino-3-nitrobenzoic acid (N-Ethyl-3-Nitro PABA) and its salts, when used as a substance in hair dye products	2788-74-1	412-090-2
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 products	71134-97-9	275-216-3
1292	5-((4-(Dimethylamino)phenyl)azo)-1,4-dimethyl-1H-1,2,4-triazolium and its salts, when used as a substance in hair dye products	12221-52-2
1293	m-Phenylenediamine, 4-(phenylazo)-, and its salts, when used as a substance in hair dye products	495-54-5	207-803-7
1294	1,3-Benzenediamine, 4-methyl-6-(phenylazo)- and its salts, when used as a substance in hair dye products	4438-16-8	224-654-3
1295	2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-4-hydroxy-3-((2-methylphenyl)azo)-, and its salts, when used as a substance in hair dye products	6441-93-6	229-231-7
1296	4,4'-[(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 products	4482-25-1	224-764-1
1297	Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-2-methylphenyl]azo]-N,N,N-trimethyl-, and its salts, when used as a substance in hair dye products	83803-99-0	280-920-9
1298	Benzenaminium, 3-[[4-[[diamino(phenylazo)phenyl]azo]-1-naphthalenyl]azo]-N,N,N-trimethyl-, and its salts, when used as a substance in hair dye products	83803-98-9	280-919-3
1299	Ethanaminium, N-[4-[(4-(diethylamino)phenyl)phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl- and its salts, when used as a substance in hair dye products	633-03-4	211-190-1
1300	9,10-Anthracenedione, 1-[(2-hydroxyethyl)amino]-4-(methylamino)-, and its derivatives and salts, when used as a substance in hair dye products	2475-46-9/86722-66-9	219-604-2/289-276-3
1301	1,4-Diamino-2-methoxy-9,10-anthracenedione (Disperse Red 11) and its salts, when used as a substance in hair dye products	2872-48-2	220-703-8
1302	1,4-Dihydroxy-5,8-bis[(2-hydroxyethyl)amino]anthraquinone (Disperse Blue 7) and its salts, when used as a substance in hair dye products	3179-90-6	221-666-0
1303	1-[(3-Aminopropyl)amino]-4-(methylamino)anthraquinone and its salts, when used as a substance in hair dye products	22366-99-0	244-938-0
1304	N-[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 products	66612-11-1	266-424-5
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 products	56330-88-2	260-116-4
1306	Phenothiazin-5-ium, 3,7-bis(dimethylamino)-, and its salts, when used as a substance in hair dye products	61-73-4	200-515-2
1307	4,6-Bis(2-Hydroxyethoxy)-m-Phenylenediamine and its salts, when used as a substance in hair dye products	94082-85-6
1308	5-Amino-2,6-Dimethoxy-3-Hydroxypyridine and its salts, when used as a substance in hair dye products	104333-03-1
1309	4,4'-Diaminodiphenylamine and its salts, when used as a substance in hair dye products	537-65-5	208-673-4
1310	4-Diethylamino-o-toluidine and its salts, when used as a substance in hair dye products	148-71-0/24828-38-4/2051-79-8	205-722-1/246-484-9/218-130-3
1311	N,N-Diethyl-p-phenylenediamine and its salts, when used as a substance in hair dye products	93-05-0/6065-27-6/6283-63-2	202-214-1/227-995-6/228-500-6
1312	N,N-Dimethyl-p-phenylenediamine and its salts, when used as a substance in hair dye products	99-98-9/6219-73-4	202-807-5/228-292-7
1313	Toluene-3,4-Diamine and its salts, when used as a substance in hair dye products	496-72-0	207-826-2
1314	2,4-Diamino-5-methylphenoxyethanol and its salts, when used as a substance in hair dye products	141614-05-3/113715-27-8
1315	6-Amino-o-cresol and its salts, when used as a substance in hair dye products	17672-22-9
1316	Hydroxyethylaminomethyl-p-aminophenol and its salts, when used as a substance in hair dye products	110952-46-0/135043-63-9
1317	2-Amino-3-nitrophenol and its salts, when used as a substance in hair dye products	603-85-0	210-060-1
1318	2-Chloro-5-nitro-N-hydroxyethyl-p-phenylenediamine and its salts, when used as a substance in hair dye products	50610-28-1	256-652-3
1319	2-Nitro-p-phenylenediamine and its salts, when used as a substance in hair dye products	5307-14-2/18266-52-9	226-164-5/242-144-9
1320	Hydroxyethyl-2,6-dinitro-p-anisidine and its salts, when used as a substance in hair dye products	122252-11-3
1321	6-Nitro-2,5-pyridinediamine and its salts, when used as a substance in hair dye products	69825-83-8
1322	Phenazinium, 3,7-diamino-2,8-dimethyl-5-phenyl-, and its salts, when used as a substance in hair dye products	477-73-6	207-518-8
1323	3-Hydroxy-4-[(2-hydroxynaphthyl)azo]-7-nitronaphthalene-1-sulphonic acid and its salts, when used as a substance in hair dye products	16279-54-2/5610-64-0	240-379-1/227-029-3
1324	3-[(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 products	104333-00-8
1325	2-[(4-chloro-2-nitrophenyl)amino]ethanol (HC Yellow No. 12) and its salts, when used as a substance in hair dye products	59320-13-7
1326	3-[[4-[(2-Hydroxyethyl)Methylamino]-2-Nitrophenyl]Amino]-1,2-Propanediol and its salts, when used as a substance in hair dye products	173994-75-7/102767-27-1
1327	3-[[4-[Ethyl(2-Hydroxyethyl)Amino]-2-Nitrophenyl]Amino]-1,2-Propanediol and its salts, when used as a substance in hair dye products	114087-41-1/114087-42-2
1328	Ethanaminium, 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 products	2390-60-5	219-232-0

(1)

OJ L 159, 29.6.1996, p. 1

(2)

Modified INNM-name.

(3)

OJ L 273, 10.10.2002, p. 1.

(4)

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

(5)

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

ANNEX III

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

Reference number

Substance identification

Restrictions

Wording of conditions of use and warnings

Chemical name/INN

Name of Common Ingredients Glossary

CAS number

EC number

Product type, body parts

Maximum concentration in ready for use preparation

Other

Boric acid, borates and tetraborates with the exception of substance No 1184 in Annex II

Boric acid

10043-35-3/11113-50-1

233-139-2/234-343-4

(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

Tetraborates, 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

Thioglycolic acid and its salts

Thioglycolic acid

68-11-1

200-677-4

(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

Thioglycolic acid esters

Hair 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

Oxalic acid, its esters and alkaline salts

Oxalic acid

144-62-7

205-634-3

Hair products

5 %

Professional use

For professional use only

Ammonia

7664-41-7/1336-21-6

231-635-3/215-647-6

6 % (as NH3)

Above 2 %: Contains ammonia

Tosylchloramide sodium (INN)

Chloramine-T

127-65-1

204-854-7

0,2 %

Chlorates of alkali metals

Sodium chlorate

7775-09-9

231-887-4

(a)	Toothpaste

(b)	Other products

(a)

5 %

(b)

3 %

Potassium chlorate

3811-04-9

223-289-7

Dichloromethane

75-09-2

200-838-9

35 % (when mixed with 1,1,1-trichloro-ethane, total concentration must not exceed 35 %)

0,2 % as maximum impurity content

p-Phenylenediamine, its N-substituted derivatives and its salts; N-substituted derivatives of o-Phenylenediamine (1), with the exception of those derivatives listed elsewhere in this Annex and under reference numbers 1309, 1311, and 1312 in Annex II

p-Phenylenediamine

106-50-3

203-404-7

Oxidising colouring agents for hair dyeing

6 % (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

Methylphenylenediamines, their N-substituted derivatives (1) and their salts with the exception of substances under reference numbers 364, 413, 1144, 1310 and 1313 in Annex II

Toluene-2,5-diamine

95-70-5

202-442-1

Oxidising colouring agents for hair dyeing

10 % (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

Diaminophenols (1)

Oxidising colouring agents for hair dyeing

10 % (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

Dichlorophen

97-23-4

202-567-1

0,5 %

Contains Dichlorophen

Hydrogen peroxide, and other compounds or mixtures that release hydrogen peroxide, including carbamide peroxide and zinc peroxide

Hydrogen peroxide

7722-84-1

231-765-0

(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

Formaldehyde (2)

Formaldehyde

50-00-0

200-001-8

Nail hardening products

5 % (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 formaldehyde (3)

Hydroquinone (4)

Hydroquinone

123-31-9

204-617-8

(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

15a

Potassium or sodium hydroxide

Potassium hydroxide/sodium hydroxide

1310-58-3/1310-73-2

215-181-3/215-185-5

(a)	Nail cuticle solvent

(a)

5 % (5)

(a)	Contains alkali Avoid contact with eyes Can cause blindness Keep out of reach of children

(b)	Hair straightener

2 % (5)

General use

Contains alkali

Avoid contact with eyes

Can cause blindness

Keep out of reach of children

4,5 % (5)

Professional 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

15b

Lithium hydroxide

1310-65-2

215-183-4

(a)	Hair straighteners

2 % (6)

General use

(a)	Contains alkali Avoid contact with eyes Can cause blindness Keep out of reach of children

4,5 % (6)

Professional 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

15c

Calcium hydroxide

1305-62-0

215-137-3

(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

1-Naphthol and its salts

1-Naphtol

90-15-3

201-969-4

Oxidising colouring agents for hair dyeing

2,0 %

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

Can cause an allergic reaction

Sodium nitrite

7632-00-0

231-555-9

Rust inhibitor

0,2 %

Not to be used with secondary and/or tertiary amines or other substances forming nitrosamines

Nitromethane

75-52-5

200-876-6

Rust inhibitor

0,3 %

Moved or deleted

Cinchonan-9-ol, 6'-methoxy-, (8.alpha., 9R)- and its salts

Quinine

130-95-0

205-003-2

(a)	Hair rinse-off products

(a)	0,5 % (as quinine base)

(b)	Hair leave-on products

(b)	0,2 % (as quinine base)

Resorcinol (4)

Resorcinol

108-46-3

203-585-2

(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

(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)

Water-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 glutamate

1 % (as zinc)

Zinc 4-hydroxybenzene sulphonate

Zinc phenolsulfonate

127-82-2

204-867-8

Deodorants, antiperspirants and astringent lotions

6 % (as % anhydrous substance)

Avoid contact with eyes

Ammonium monofluorophosphate

20859-38-5/66115-19-3

Oral products

0,15 % (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’

Disodium fluorophosphate

Sodium monofluorophosphate

10163-15-2/7631-97-2

233-433-0/231-552-2

Oral products

0,15 % (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’

Dipotassium fluorophosphate

Potassium monofluorophosphate

14104-28-0

237-957-0

Oral products

0,15 % (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’

Calcium fluorophosphate

Calcium monofluorophosphate

7789-74-4

232-187-1

Oral products

0,15 % (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’

Calcium fluoride

7789-75-5

232-188-7

Oral products

0,15 % (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’

Sodium fluoride

7681-49-4

231-667-8

Oral products

0,15 % (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’

Potassium fluoride

7789-23-3

232-151-5

Oral products

0,15 % (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’

Ammonium fluoride

12125-01-8

235-185-9

Oral products

0,15 % (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’

Aluminium fluoride

7784-18-1

232-051-1

Oral products

0,15 % (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’

Tin difluoride

Stannous fluoride

7783-47-3

231-999-3

Oral products

0,15 % (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’

Hexadecyl ammonium fluoride

Cetylamine hydrofluoride

3151-59-5

221-588-7

Oral products

0,15 % (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’

3-(N-Hexadecyl-N-2-hydroxy-ethylammonio) propylbis (2-hydroxyethyl) ammonium difluoride

—

Oral products

0,15 % (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’

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

—

Oral products

0,15 % (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’

9-Octadecenamine, hydrofluoride

Octadecenyl-ammonium fluoride

2782-81-2

—

Oral products

0,15 % (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’

Disodium hexafluorosilicate

Sodium fluorosilicate

16893-85-9

240-934-8

Oral products

0,15 % (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’

Dipotassium hexafluorosilicate

Potassium fluorosilicate

16871-90-2

240-896-2

Oral products

0,15 % (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’

Ammonium hexafluorosilicate

Ammonium fluorosilicate

16919-19-0

240-968-3

Oral products

0,15 % (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’

Magnesium hexafluorosilicate

Magnesium fluorosilicate

16949-65-8

241-022-2

Oral products

0,15 % (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’

1,3-Bis (hydroxymethyl)imidazolidine-2-thione

Dimethylol ethylene thiourea

15534-95-9

239-579-1

(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

Benzyl alcohol (7)

Benzyl alcohol

100-51-6

202-859-9

Solvents, perfumes and flavourings

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

6-Methylcoumarin

92-48-8

202-158-8

Oral products

0,003 %

3-Pyridinemethanol, hydrofluoride

Nicomethanol hydrofluoride

62756-44-9

—

Oral products

0,15 % (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’

Silver nitrate

7761-88-8

231-853-9

Only for colouring eyelashes and eyebrows

4 %

Contains silver nitrate

Rinse eyes immediately if product comes into contact with them

Selenium sulfide

Selenium disulphide

7488-56-4

231-303-8

Antidandruff shampoos

1 %

Contains selenium disulphide

Avoid contact with eyes or damaged skin

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

Quinolin-8-ol and bis (8-hydroxy-quinolium) sulphate

Oxyquinoline and oxyquinoline sulfate

148-24-3/134-31-6

205-711-1/205-137-1

Stabilizer for hydrogen peroxide in rinse-off hair- products

0,3 % (as base)

Stabilizer for hydrogen peroxide in leave-on hair products

0,03 % (as base)

Methanol

Methyl alcohol

67-56-1

200-659-6

Denaturant for ethanol and isopropyl alcohol

5 % (as a % ethanol and isopropyl alcohol)

(1-Hydroxyethylidene-diphosphonic acid) and its salts

Etidronic acid

2809-21-4

220-552-8

(a)	Hair- product

1,5 % (as etidronic acid)

(b)

Soap

0,2 % (as etidronic acid)

1-Phenoxypropan-2-ol (8)

Phenoxyisopropanol

770-35-4

212-222-7

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

Moved or deleted

Magnesium fluoride

7783-40-6

231-995-1

Oral products

0,15 % (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’

Strontium chloride hexahydrate

Strontium chloride

10476-85-4

233-971-6

(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 %

Strontium acetate hemihydrate

Strontium acetate

543-94-2

208-854-8

Oral products

3,5 % (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

Talc: Hydrated magnesium silicate

Talc

14807-96-6

238-877-9

(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

Fatty acid dialkylamides and dialkanolamides

Maximum 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

Monoalkylamines, monoalkanolamines and their salts

Maximum 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

Trialkylamines, 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

Strontium hydroxide

18480-07-4

242-367-1

pH adjuster for depilatories

3,5 % (as strontium)

pH ≤ 12,7

Keep out of reach of children

Avoid contact with eyes

Strontium peroxide

1314-18-7

215-224-6

Rinse-off hair products

4,5 % (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

Benzalkonium chloride, bromide and saccharinate (9)

Benzalkonium bromide

91080-29-4

293-522-5

Rinse-off hair (head) products

3 % (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 chloride

63449-41-2/68391-01-5/68424-85-1/85409-22-9

264-151-6/269-919-4/270-325-2/287-089-1

Benzalkonium saccharinate

68989-01-5

273-545-7

Polyacrylamides

(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

2-Benzylideneheptanal

Amyl cinnamal

122-40-7

204-541-5

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

Benzyl alcohol

100-51-6

202-859-9

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

Cinnamyl alcohol

104-54-1

203-212-3

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

3,7-Dimethyl-2,6-octadienal

Citral

5392-40-5

226-394-6

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

Phenol, 2-methoxy-4-(2-propenyl)

Eugenol

97-53-0

202-589-1

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

7-Hydroxycitronellal

Hydroxycitronellal

107-75-5

203-518-7

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

Phenol, 2-methoxy-4-(1-propenyl)-

Isoeugenol

97-54-1

202-590-7

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

2-Pentyl-3-phenylprop-2-en-1-ol

Amylcinnamyl alcohol

101-85-9

202-982-8

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

Benzyl salicylate

118-58-1

204-262-9

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

2-Propenal, 3-phenyl-

Cinnamal

104-55-2

203-213-9

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

2H-1-Benzopyran-2-one

Coumarin

91-64-5

202-086-7

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

2,6-Octadien-1-ol, 3,7-dimethyl-, (2E)-

Geraniol

106-24-1

203-377-1

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

3 and 4-(4-Hydroxy-4-methylpentyl)cyclohex-3-ene-1-carbaldehyde

Hydroxyisohexyl 3-cyclohexene carboxaldehyde

51414-25-6/31906-04-4

257-187-9/250-863-4

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

4-Methoxybenzyl alcohol

Anise alcohol

105-13-5

203-273-6

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

2-Propenoic acid, 3-phenyl-, phenylmethyl ester

Benzyl cinnamate

103-41-3

203-109-3

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

2,6,10-Dodecatrien-1-ol, 3,7,11-trimethyl-

Farnesol

4602-84-0

225-004-1

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

2-(4-tert-Butylbenzyl)propionaldehyde

Butylphenyl methylpropional

80-54-6

201-289-8

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

1,6-Octadien-3-ol, 3,7-dimethyl-

Linalool

78-70-6

201-134-4

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

Benzyl benzoate

120-51-4

204-402-9

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

Citronellol/(±) -3,7-dimethyloct-6-en-1-ol

Citronellol

106-22-9/26489-01-0

203-375-0/247-737-6

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

2-Benzylideneoctanal

Hexyl cinnamal

101-86-0

202-983-3

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

(4R)-1-Methyl-4-(1-methylethenyl)cyclohexene

Limonene

5989-27-5

227-813-5

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

Methyl heptin carbonate

Methyl 2-octynoate

111-12-6

203-836-6

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

3-Methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one

alpha-Isomethyl ionone

127-51-5

204-846-3

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

Oak moss extract

Evernia prunastri extract

90028-68-5

289-861-3

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

Treemoss extract

Evernia furfuracea extract

90028-67-4

289-860-8

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

2,4-Pyrimidinediamine, 3-oxide

Diaminopyrimidine oxide

74638-76-9

—

Hair products

1,5 %

Dibenzoyl peroxide

Benzoyl peroxide

94-36-0

202-327-6

Artificial nail systems

0,7 % (after mixing for use)

Professional use

For professional use only

Avoid skin contact

Read directions for use carefully

Hydroquinone methylether/Mequinol

p-Hydroxyanisol

150-76-5

205-769-8

Artificial nail systems

0,02 % (after mixing for use)

Professional use

For professional use only

Avoid skin contact

Read directions for use carefully

5-tert-Butyl-2,4,6-trinitro-m-xylene

Musk xylene

81-15-2

201-329-4

All 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

4'-tert-Butyl-2',6'-dimethyl-3',5'-dinitroacetophenone

Musk ketone

81-14-1

201-328-9

All 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

Benzoic acid, 2-hydroxy- (10)

Salicylic acid

69-72-7

200-712-3

(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 age (11)

Inorganic sulfites and bisulfites (12)

(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)

100

1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl)urea (13)

Triclocarban

101-20-2

202-924-1

Rinse-off products

1,5 %

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

101

Pyrithione zinc (14)

Zinc pyrithione

13463-41-7

236-671-3

Leave-on hair products

0,1 %

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

102

1,2-Dimethoxy-4-(2-propenyl)-benzene

Methyl eugenol

93-15-2

202-223-0

Fine fragrance

0,01 %

Eau de toilette

0,004 %

Fragrance cream

0,002 %

Other leave-on products and oral products

0,0002 %

Rinse-off products

0,001 %

215

4-Amino-3-nitrophenol and its salts

4-Amino-3-nitrophenol

610-81-1

210-236-8

(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 %

216

2,7-Naphthalenediol and its salts

Naphthalene-2,7-diol

582-17-2

209-478-7

Oxidising colouring agents for hair dyeing

1,0 %

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

Not to be used after 31.12.2009

217

m-Aminophenol and its salts

3-Aminophenol

591-27-5

209-711-2

Oxidising colouring agents for hair dyeing

2,0 %

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

218

2,6-Dihydroxy-3,4-dimethylpyridine and its salts

2,6-Dihydroxy-3,4-dimethylpyridine

84540-47-6

283-141-2

Oxidising colouring agents for hair dyeing

2,0 %

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

Not to be used after 31.12.2009

219

1-Hydroxy-3-nitro-4-(3-hydroxypropylamino)benzene and its salts

4-Hydroxypropylamino-3-nitrophenol

92952-81-3

406-305-9

(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 %

220

1-[(2'-Methoxyethyl)amino]-2-nitro-4-[di-(2'-hydroxyethyl)amino]benzene and its salts

HC Blue No 11

23920-15-2

459-980-7

(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 %

221

1-Methyl-3-nitro-4-(.beta.-hydroxyethyl)aminobenzene and its salts

Hydroxyethyl-2-nitro-p-toluidine

100418-33-5

408-090-7

(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 %

222

1-Hydroxy-2-.beta.-hydroxyethylamino-4,6-dinitrobenzene and its salts

2-Hydroxyethylpicramic acid

99610-72-7

412-520-9

(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 %

223

4-Methylaminophenol and its salts

p-Methylaminophenol

150-75-4

205-768-2

Oxidising colouring agent for hair dyeing

3,0 %

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

224

1-(3-Hydroxypropylamino)-2-nitro-4-bis(2-hydroxyethylamino)benzene and its salts

HC Violet No 2

104226-19-9

410-910-3

Non-oxidising colouring agent for hair dyeing

2,0 %

Not to be used after 31.12.2009

225

1-(.beta.-Hydroxyethyl)amino-2-nitro-4-N-ethyl-N-(.beta.-hydroxyethyl)aminobenzene and its salts

HC Blue No 12

104516-93-0

407-020-2

(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 %

226

4,4'-[1,3-Propanediylbis(oxy)]bis-, benzene-1,3-diamine and its salts

1,3-Bis-(2,4-diaminophenoxy)propane

81892-72-0

279-845-4

Oxidising colouring agents for hair dyeing

2,0 %

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

227

3-Amino-2,4-dichlorophenol and its salts

3-Amino-2,4-dichlorophenol

61693-43-4

262-909-0

Oxidising colouring agents for hair dyeing

2,0 %

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

228

3-Methyl-1-phenyl-5-pyrazolone and its salts

Phenyl methyl pyrazolone

89-25-8

201-891-0

Oxidising colouring agents for hair dyeing

0,5 %

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

Not to be used after 31.12.2009

229

5-[(2-Hydroxyethyl)amino]-o-cresol and its salts

2-Methyl-5-hydroxyethylaminophenol

55302-96-0

259-583-7

Oxidising colouring agents for hair dyeing

2,0 %

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

230

3,4-Dihydro-2H-1,4-benzoxazin-6-ol and its salts

Hydroxybenzomorpholine

26021-57-8

247-415-5

Oxidising colouring agents for hair dyeing

2,0 %

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

231

1,5-bis(.beta.-Hydroxyethyl)amino-2-nitro-4-chlorobenzene and its salts

HC Yellow No 10

109023-83-8

416-940-3

Non-oxidising colouring agents for hair dyeing

0,2 %

Not to be used after 31.12.2009

232

3,5-Diamino-2,6-dimethoxypyridine and its salts

2,6-Dimethoxy-3,5-pyridinediamine HCl

85679-78-3/56216-28-5

-

/ 260-062-1

Oxidising colouring agents for hair dyeing

0,5 %

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

233

1-(2-Aminoethyl)amino-4-(2-hydroxyethyl)oxy-2-nitrobenzene and its salts

HC Orange No 2

85765-48-6

416-410-1

Non-oxidising colouring agents for hair dyeing

1,0 %

Not to be used after 31.12.2009

234

Ethanol, 2-[(4-amino-2-methyl-5-nitrophenyl)amino]-and its salts

HC Violet No 1

82576-75-8

417-600-7

(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 %

235

2-[3-(Methylamino)-4-nitrophenoxy]ethanol and its salts

3-Methylamino-4-nitro-phenoxyethanol

59820-63-2

261-940-7

Non-oxidising colouring agents for hair dyeing

1,0 %

Not to be used after 31.12.2009

236

2-[(2-Methoxy-4-nitrophenyl)amino]ethanol and its salts

2-Hydroxy-ethylamino-5-nitro-anisole

66095-81-6

266-138-0

Non-oxidising colouring agents for hair dyeing

1,0 %

Not to be used after 31.12.2009

237

2,2'-[(4-Amino-3-nitrophenyl)imino]bisethanol hydrochloride and other salts

HC Red No 13

94158-13-1

303-083-4

(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 %

238

Naphthalene-1,5-diol and its salts

1,5-Naphthalenediol

83-56-7

201-487-4

Oxidising colouring agents for hair dyeing

1,0 %

Not to be used after 31.12.2009

239

Hydroxypropyl bis(N-hydroxyethyl-p-phenylenediamine) and its salts

Hydroxypropyl bis(N-hydroxyethyl-p-phenyldiamine) HCl

128729-30-6

416-320-2

Oxidising colouring agents for hair dyeing

3,0 %

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

240

o-Aminophenol and its salts

o-Aminophenol

95-55-6

202-431-1

Oxidising colouring agents for hair dyeing

2,0 %

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

Not to be used after 31.12.2009

241

5-Amino-o-cresol and its salts

4-Amino-2-hydroxytoluene

2835-95-2

220-618-6

Oxidising colouring agents for hair dyeing

3,0 %

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

Not to be used after 31.12.2009

242

2,4-Diaminophenoxyethanol and its salts

2,4-Diaminophenoxyethanol HCl

66422-95-5

266-357-1

Oxidising colouring agents for hair dyeing

4,0 %

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

Not to be used after 31.12.2009

243

1,3-Benzenediol, 2-methyl-, and its salts -

2-Methylresorcinol

608-25-3

210-155-8

Oxidising colouring agents for hair dyeing

2,0 %

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

Not to be used after 31.12.2009

244

4-Amino-m-cresol and its salts

4-Amino-m-cresol

2835-99-6

220-621-2

Oxidising colouring agents for hair dyeing

3,0 %

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

Not to be used after 31.12.2009

245

2-[(3-amino-4-methoxyphenyl)amino]ethanol and its salts

2-Amino-4-hydroxyethylaminoanisole

83763-47-7

280-733-2

Oxidising colouring agents for hair dyeing

3,0 %

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

Not to be used after 31.12.2009

246

Hydroxyethyl-3,4-methylenedioxyaniline 2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride and other salts

Hydroxyethyl-3,4-methylenedioxyaniline HCI

81329-90-0

303-085-5

Oxidising colouring agents for hair dyeing

3,0 %

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

Not to be used after 31.12.2009

247

2,2'-[[4-[(2-Hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol. and its salts

HC Blue No 2

33229-34-4

251-410-3

Non-oxidising colouring agents for hair dyeing

2,8 %

Not to be used after 31.12.2009

248

4-[(2-Hydroxyethyl)amino]-3-nitrophenol and its salts

3-Nitro-p-hydroxyethylaminophenol

65235-31-6

265-648-0

(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 %

249

1-(.beta.-Ureidoethyl)amino-4-nitrobenzene and its salts

4-Nitrophenyl aminoethylurea

27080-42-8

410-700-1

(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 %

250

1-amino-2-nitro-4-(2',3'-dihydroxypropyl)amino-5-chlorobenzene and 1,4-bis-(2',3'-dihydroxypropyl)amino-2-nitro-5-chlorobenzene and its salts

HC Red No 10 and HC Red No 11

95576-89-9 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 %

251

Phenol, 2-chloro-6-(ethylamino)-4-nitro- and its salts

2-Chloro-6-ethylamino-4-nitrophenol

131657-78-8

411-440-1

(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 %

252

2-Amino-6-chloro-4-nitrophenol and its salts

2-Amino-6-chloro-4-nitrophenol

6358-09-4

228-762-1

(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 salts

Basic Blue 26 (CI 44045)

2580-56-5

219-943-6

(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 %

254

Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CI 17200) and other salts

Acid Red 33 (CI 17200)

3567-66-6

222-656-9

Non-oxidising colouring agents for hair dyeing

2,0 %

Not to be used after 31.12.2009

255

Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (CI 14700) and other salts

Ponceau SX (CI 14700)

4548-53-2

224-909-9

Non-oxidising colouring agents for hair dyeing

2,0 %

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 salts

Basic Violet 14 (CI 42510)

632-99-5

211-189-6

(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 %

(1)

These substances may be used singly or in combination provided that the sum of the ratios of the levels of each of them in the cosmetic product expressed with reference to the maximum level authorised for each of them does not exceed 1.

(2)

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

(3)

Only if the concentration exceeds 0,05 %.

(4)

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.

(5)

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.

(6)

The concentration of sodium, potassium or lithium hydroxide is expressed as weight of sodium hydroxide. In case of mixtures, the sum should not exceed the limits given in column g.

(7)

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

(8)

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

(9)

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

(10)

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

(11)

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

(12)

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

(13)

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

(14)

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

ANNEX IV

LIST 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.

Reference number	Substance identification					Conditions			Wording of conditions of use and warnings
Reference number	Chemical Name	Colour index Number/Name of Common Ingredients Glossary	CAS number	EC number	Colour	Product type, Body parts	Maximum concentration in ready for use preparation	Other	Wording of conditions of use and warnings
a	b	c	d	e	f	g	h	i	j
1	Sodium tris(1,2-naphthoquinone 1-oximato-O,O')ferrate(1-)	10006			Green	Rinse-off products
2	Trisodium tris[5,6-dihydro-5-(hydroxyimino)-6-oxonaphthalene-2-sulphonato(2-)-N5,O6]ferrate(3-)	10020			Green	Not to be used in products applied on mucous membranes
3	Disodium 5,7-dinitro-8-oxidonaphthalene-2-sulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments	10316			Yellow	Not to be used in eye products
4	2-[(4-Methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide	11680			Yellow	Not to be used in products applied on mucous membranes
5	2-[(4-Chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide	11710			Yellow	Not to be used in products applied on mucous membranes
6	2-[(4-Methoxy-2-nitrophenyl)azo]-3-oxo-N-(o-tolyl)butyramide	11725			Orange	Rinse-off products
7	4-(Phenylazo)resorcinol	11920			Orange
8	4-[(4-Ethoxyphenyl)azo]naphthol	12010			Red	Not to be used in products applied on mucous membranes
9	1-[(2-Chloro-4-nitrophenyl)azo]-2-naphthol and its insoluble barium, strontium and zirconium lakes, salts and pigments	12085			Red		3 %
10	1-[(4-Methyl-2-nitrophenyl)azo]-2-naphthol	12120			Red	Rinse-off products
11	3-Hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide	12370			Red	Rinse-off products
12	N-(4-Chloro-2-methylphenyl)-4-[(4-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide	12420			Red	Rinse-off products
13	4-[(2,5-Dichlorophenyl)azo]-N-(2,5-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide	12480			Brown	Rinse-off products
14	N-(5-Chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide	12490			Red
15	2,4-Dihydro-5-methyl-2-phenyl-4-(phenylazo)-3H-pyrazol-3-one	12700			Yellow	Rinse-off products
16	Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate	13015			Yellow
17	Sodium 4-(2,4-dihydroxyphenylazo)benzenesulphonate	14270			Orange
18	Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate	14700			Red
19	Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate	14720		222-657-4	Red			Purity criteria as set out in Commission Directive 95/45/EC (E 122)
20	Disodium 6-[(2,4-dimethyl-6-sulphonatophenyl)azo]-5-hydroxynaphthalene-1-sulphonate	14815			Red
21	Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments	15510			Orange	Not to be used in eye products
22	Calcium disodium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]-4-sulphonatobenzoate]	15525			Red
23	Barium bis[4-[(2-hydroxy-1-naphthyl)azo]-2-methylbenzenesul-phonate]	15580			Red
24	Sodium 4-[(2-Hydroxy-1-naphthyl)azo]naphthalenesulphonate	15620			Red	Rinse-off products
25	Sodium 2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments	15630			Red		3 %
26	Calcium bis[3-hydroxy-4-(phenylazo)-2-naphthoate]	15800			Red	Not to be used in products applied on mucous membranes
27	Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate and its insoluble barium, strontium and zirconium lakes, salts and pigments	15850		226-109-5	Red			Purity criteria as set out in Commission Directive 95/45/EC (E 180)
28	Disodium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate and its insoluble barium, strontium and zirconium lakes, salts and pigments	15865			Red
29	Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate	15880			Red
30	Disodium 6-hydroxy-5-[(3-sulphonatophenyl)azo]naphthalene-2-sulphonate	15980			Orange
31	Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments	15985		220-491-7	Yellow			Purity criteria as set out in Commission Directive 95/45/EC (E 110)
32	Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate	16035		247-368-0	Red			Purity criteria as set out in Commission Directive 95/45/EC (E 129)
33	Trisodium 3-hydroxy-4-[(4'-sulphonatonaphthyl)azo]naphthalene-2,7-disulphonate	16185		213-022-2	Red			Purity criteria as set out in Commission Directive 95/45/EC (E 123)
34	Disodium 7-hydroxy-8-(phenylazo)naphthalene-1,3-disulphonate	16230			Orange	Not to be used in products applied on mucous membranes
35	Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments	16255		220-036-2	Red			Purity criteria as set out in Commission Directive 95/45/EC (E 124)
36	Tetrasodium 7-hydroxy-8-[(4-sulphonato-1-naphthyl)azo]naphthalene-1,3,6-trisulphonate	16290			Red
37	Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate and its insoluble barium, strontium and zirconium lakes, salts and pigments	17200			Red
38	Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate	18050		223-098-9	Red	Not to be used in products applied on mucous membranes		Purity criteria as set out in Commission Directive 95/45/EC (E 128)
39	2,7-Naphthalenedisulfonic acid, 3-((4-cyclohexyl-2-methylphenyl)azo)-4-hydroxy-5-(((4-methylphenyl)sulfonyl)amino)-, disodium salt	18130			Red	Rinse-off products
40	Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)	18690			Yellow	Rinse-off products
41	Disodium hydrogen bis[5-chloro-3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxybenzenesulphonato(3-)]chromate(3-)	18736			Red	Rinse-off products
42	Sodium 4-(3-hydroxy-5-methyl-4-(phenylazo)pyrazol-2-yl)benzenesulphonate	18820			Yellow	Rinse-off products
43	Disodium 2,5-dichloro-4-(5-hydroxy-3-methyl-4-((sulphophenyl)azo)pyrazol-1-yl)benzenesulphonate	18965			Yellow
44	Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-((4-sulphophenyl)azo)pyrazole-3-carboxylate and its insoluble barium, strontium and zirconium lakes, salts and pigments	19140		217-699-5	Yellow			Purity criteria as set out in Commission Directive 95/45/EC (E 102)
45	N,N'-(3,3'-Dimethyl[1,1'-biphenyl]-4,4'-diyl)bis[2-[(2,4-dichlorophenyl)azo]-3-oxobutyramide]	20040			Yellow	Rinse-off products		Maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
46	Sodium 4-amino-5-hydroxy-3-((4-nitrophenyl)azo)-6-(phenylazo)naphthalene-2,7-disulphonate	20470			Black	Rinse-off products
47	2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]	21100			Yellow	Rinse-off products		Maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
48	2,2'-[(3,3'-Dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]	21108			Yellow	Rinse-off products		Maximum 3,3'-dimethylbenzidine concentration in the colouring agent: 5 ppm
49	2,2'-[Cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis[4-cyclohexylphenol]	21230			Yellow	Not to be used in products applied on mucous membranes
50	Disodium 4,6-dihydroxy-3-[[4-[1-[4-[[1-hydroxy-7-[(phenylsulphonyl)oxy]-3-sulphonato-2-naphthyl]azo]phenyl]cyclohexyl]phenyl]azo]naphthalene-2-sulphonate	24790			Red	Rinse-off products
51	1-(4-(Phenylazo)phenylazo)-2-naphthol	26100			Red	Not 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 %
52	Tetrasodium 6-amino-4-hydroxy-3-[[7-sulphonato-4-[(4-sulphonatophenyl)azo]-1-naphthyl]azo]naphthalene-2,7-disulphonate	27755			Black
53	Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate	28440		219-746-5	Black			Purity criteria as set out in Commission Directive 95/45/EC (E 151)
54	Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo] benzenesulfonic acid, sodium salts	40215			Orange	Rinse-off products
55	beta Carotene	40800		230-636-6	Orange			Purity criteria as set out in Commission Directive 95/45/EC (E160a)
56	8'-apo-.beta.-Caroten-8'-al	40820			Orange			Purity criteria as set out in Commission Directive 95/45/EC (E 160e)
57	Ethyl 8'-apo-.beta.-caroten-8'-oate	40825		214-173-7	Orange			Purity criteria as set out in Commission Directive 95/45/EC (E 160f)
58	Canthaxanthin	40850		208-187-2	Orange			Purity criteria as set out in Commission Directive 95/45/EC (E 161g)
59	Ammonium, (4-(alpha-(p-(diethylamino)phenyl)-2,4-disulfobenzylidene)-2,5-cyclohexadien-1-ylidene)diethyl-, hydroxide, monosodium salt	42045			Blue	Not to be used in products applied on mucous membranes
60	Ethanaminium, 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 pigments	42051		222-573-8	Blue			Purity criteria as set out in Commission Directive 95/45/EC (E 131)
61	Benzene-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 salt	42053			Green
62	Hydrogen (benzyl)[4-[[4-[benzylethylamino]phenyl](2,4-disulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)ammonium, sodium salt	42080			Blue	Rinse-off products
63	Benzene-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 salt	42090		223-339-8	Blue			Purity criteria as set out in Commission Directive 95/45/EC (E 133)
64	Hydrogen [4-[(2-chlorophenyl)[4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt	42100			Green	Rinse-off products
65	Hydrogen [4-[(2-chlorophenyl)[4-[ethyl(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt	42170			Green	Rinse-off products
66	(4-(4-Aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride	42510			Violet	Not to be used in products applied on mucous membranes
67	4-[(4-Amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride	42520			Violet	Rinse-off products	5ppm
68	Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt	42735			Blue	Not 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 chloride	44045			Blue	Not to be used in products applied on mucous membranes
70	Hydrogen [4-[4-(dimethylamino)-.alpha.-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt	44090		221-409-2	Green			Purity criteria as set out in Commission Directive 95/45/EC (E 142)
71	Hydrogen 3,6-bis(diethylamino)-9-(2,4-disulphonatophenyl)xanthylium, sodium salt	45100			Red	Rinse-off products
72	Hydrogen 9-(2-carboxylatophenyl)-3-(2-methylanilino)-6-(2-methyl-4-sulphoanilino)xanthylium, monosodium salt	45190			Violet	Rinse-off products
73	Hydrogen 9-(2,4-disulphonatophenyl)-3,6-bis(ethylamino)-2,7-dimethylxanthylium, monosodium salt	45220			Red	Rinse-off products
74	Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate	45350			Yellow		6 %
75	4',5'-Dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one and its insoluble barium, strontium and zirconium lakes, salts and pigments	45370			Orange			Not 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
76	Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate and its insoluble barium, strontium and zirconium lakes, salts and pigments	45380			Red			Not 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
77	3',6'-Dihydroxy-4',5'-dinitrospiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one	45396			Orange		1 %, when used in lip products	Only in free acid form, when used in lip products
78	Dipotassium 3,6-dichloro-2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate	45405			Red	Not to be used in eye products		Not more than 1 % 2-(6-hydroxy-3-oxo-3Η xanthen-9-yl) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
79	3,4,5,6-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 pigments	45410			Red			Not more than 1 % 2-(6-hydroxy-3-oxo-3Η xanthen-9-yl) benzoic acid and 2 % 2-(bromo-6-hydroxy-3-oxo-3H-xanthen-9-yl) benzoic acid
80	Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate and its insoluble barium, strontium and zirconium lakes, salts and pigments	45430		240-474-8	Red			Purity criteria as set out in Commission Directive 95/45/EC (E 127)
81	1,3-Isobenzofurandione, reaction products with methylquinoline and quinoline	47000			Yellow	Not to be used in products applied on mucous membranes
82	1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts	47005		305-897-5	Yellow			Purity criteria as set out in Commission Directive 95/45/EC (E 104)
83	Hydrogen 9-[(3-methoxyphenyl)amino]-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, sodium salt	50325			Violet	Rinse-off products
84	Sulfonated nigrosine color	50420			Black	Not to be used in products applied on mucous membranes
85	8,18-Dichloro-5,15-diethyl-5,15-dihydrodiindolo[3,2-b:3',2'-m]triphenodioxazine	51319			Violet	Rinse-off products
86	1,2-Dihydroxyanthraquinone	58000			Red
87	Trisodium 8-hydroxypyrene-1,3,6-trisulphonate	59040			Green	Not to be used in products applied on mucous membranes
88	1-Anilino-4-hydroxyanthraquinone	60724			Violet	Rinse-off products
89	1-Hydroxy-4-(p-toluidino)anthraquinone	60725			Violet
90	Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate	60730			Violet	Not to be used in products applied on mucous membranes
91	1,4-bis(p-Tolylamino)anthraquinone	61565			Green
92	Disodium 2,2'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate)	61570			Green
93	Sodium 3,3'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(2,4,6-trimethylbenzenesulphonate)	61585			Blue	Rinse-off products
94	Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate	62045			Blue	Rinse-off products
95	6,15-Dihydroanthrazine-5,9,14,18-tetrone	69800			Blue
96	7,16-dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone	69825			Blue
97	Bisbenzimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione	71105			Orange	Not to be used in products applied on mucous membranes
98	2-(1,3-Dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one	73000			Blue
99	Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate	73015		212-728-8	Blue			Purity criteria as set out in Commission Directive 95/45/EC (E 132)
100	6-Chloro-2-(6-chloro-4-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-4-methylbenzo[b]thiophene-3(2H)-one	73360			Red
101	5-Chloro-2-(5-chloro-7-methyl-3-oxobenzo[b]thien-2(3H)-ylidene)-7-methylbenzo[b]thiophene-3(2H)-one	73385			Violet
102	5,12-Dihydroquino[2,3-b]acridine-7,14-dione	73900			Violet	Rinse-off products
103	5,12-Dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione	73915			Red	Rinse-off products
104	29H,31H-Phthalocyanine	74100			Blue	Rinse-off products
105	29H,31H-Phthalocyaninato(2-)-N29,N30,N31,N32 copper	74160			Blue
106	Disodium [29H,31H-phthalocyaninedisulphonato (4-)-N29,N30,N31,N32] cuprate (2-)	74180			Blue	Rinse-off products
107	Polychloro copper phthalocyanine	74260			Green	Not to be used in eye products
108	8,8'-diapo-.psi.,.psi.-Carotenedioic acid	75100			Yellow
109	Annatto	75120		215-735-4/289-561-2/230-248-7	Orange			Purity criteria as set out in Commission Directive 95/45/EC (E 160b)
110	Lycopene	75125		—	Yellow			Purity criteria as set out in Commission Directive 95/45/EC (E 160d)
111	CI Food Orange 5	75130		214-171-6	Orange			Purity criteria as set out in Commission Directive 95/45/EC (E 160a)
112	(3R)-beta-4-Caroten-3-ol	75135			Yellow
113	2-Amino-1,7-dihydro-6H-purin-6-one	75170			White
114	Curcumins	75300		207-280-5	Yellow			Purity criteria as set out in Commission Directive 95/45/EC (E 100)
115	Carmines	75470		215-680-6/215-023-3/215-724-4	Red			Purity criteria as set out in Commission Directive 95/45/EC (E 120)
116	Trisodium (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)	75810		215-800-7/207-536-6/208-272-4/287-483-3/239-830-5/246-020-5	Green			Purity criteria as set out in Commission Directive 95/45/EC (E 140, E 141)
117	Aluminium	77000		231-072-3	White			Purity criteria as set out in Commission Directive 95/45/EC (E 173)
118	Aluminium hydroxide sulphate	77002			White
119	Natural hydrated aluminium silicate, Al2O3.2SiO2.2H2O, containing calcium, magnesium or iron carbonates, ferric hydroxide, quartz-sand, mica, etc. as impurities	77004			White
120	Lazurite	77007			Blue
121	Aluminum silicate coloured with ferric oxide	77015			Red
122	Barium sulfate	77120			White
123	Bismuth chloride oxide	77163			White
124	Calcium carbonate	77220		207-439-9/215-279-6	White			Purity criteria as set out in Commission Directive 95/45/EC (E 170)
125	Calcium sulfate	77231			White
126	Carbon black	77266		215-609-9	Black			Purity criteria as set out in Commission Directive 95/45/EC (E 153)
127	Charcoal, bone. A fine black powder obtained by burning animal bones in a closed container. It consists primarily of calcium phosphate and carbon	77267			Black
128	Coke black	77268:1			Black
129	Chromium (III) oxide	77288			Green			free from chromate ion
130	Chromium (III) hydroxide	77289			Green			free from chromate ion
131	Cobalt Aluminum Oxide	77346			Green
132	Copper	77400			Brown
133	Gold	77480		231-165-9	Brown			Purity criteria as set out in Commission Directive 95/45/EC (E 175)
134	Iron oxide	77489			Orange
135	Iron Oxide Red	77491		215-168-2	Red			Purity criteria as set out in Commission Directive 95/45/EC (E 172)
136	Iron Oxide Yellow	77492	51274-00-1	257-098-5	Yellow			Purity criteria as set out in Commission Directive 95/45/EC (E 172)
137	Iron Oxide Black	77499		235-442-5	Black			Purity criteria as set out in Commission Directive 95/45/EC (E 172)
138	Ferric Ammonium Ferrocyanide	77510			Blue			free from cyanide ions
139	Magnesium carbonate	77713			White
140	Ammonium manganese(3+) diphosphate	77742			Violet
141	Trimanganese bis (orthophosphate)	77745			Red
142	Silver	77820		231-131-3	White			Purity criteria as set out in Commission Directive 95/45/EC (E 174)
143	Titanium dioxide (1)	77891		236-675-5	White			Purity criteria as set out in Commission Directive 95/45/EC (E 171)
144	Zinc oxide	77947			White
145	Riboflavin	Lactoflavin		201-507-1/204-988-6	Yellow			Purity criteria as set out in Commission Directive 95/45/EC (E 101)
146	Caramel	Caramel		232-435-9	Brown			Purity criteria as set out in Commission Directive 95/45/EC (E 150a-d)
147	Paprika extract, Capsanthin, capsorubin	Capsanthin, capsorubin		207-364-1/207-425-2	Orange			Purity criteria as set out in Commission Directive 95/45/EC (E 160c)
148	Beetroot red	Beetroot Red	7659-95-2	231-628-5	Red			Purity 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	Red			Purity criteria as set out in Commission Directive 95/45/EC (E 163)
150	Aluminium, 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
151	Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2-bromo-3-methyl-6-(1-methylethyl)-, S,S-dioxide	Bromothymol blue	76-59-5	200-971-2	Blue	Rinse-off products
152	Phenol, 4,4'-(3H-2,1-benzoxathiol-3-ylidene)bis[2,6-dibromo-3-methyl-,S,S-dioxide	Bromocresol green	76-60-8	200-972-8	Green	Rinse-off products
153	Sodium 4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonate	Acid red 195	12220-24-5	—	Red	Not to be used in products applied on mucous membranes

(1)

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

ANNEX V

LIST 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 %.

Reference number

Substance identification

Conditions

Wording of conditions of use and warnings

Chemical name/INN

Name of Common Ingredients Glossary

CAS number

EC number

Product type, Body parts

Maximum concentration in ready for use preparation

Other

Benzoic 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 products

2,5 % (acid)

Oral products

1,7 % (acid)

Leave-on products

0,5 % (acid)

Salts of benzoic acid other than that listed under reference number 1 and esters of benzoic acid

Ammonium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, MEA-benzoate, methyl benzoate, ethyl benzoate, propyl benzoate, butyl benzoate, isobutyl benzoate, isopropyl benzoate, phenyl benzoate

1863-63-4, 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, 93-99-2

217-468-9, 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, 202-293-2

0,5 % (acid)

Propionic acid and its salts

Propionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate

79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6

201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-4

2 % (acid)

Salicylic acid (1) and its salts

Salicylic acid, calcium salicylate, magnesium salicylate, MEA-salicylate, sodium salicylate, potassium salicylate, TEA-salicylate

69-72-7, 824-35-1, 18917-89-0, 59866-70-5, 54-21-7, 578-36-9, 2174-16-5

200-712-3, 212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-3

0,5 % (acid)

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

Not to be used for children under 3 years of age (2)

Hexa-2,4-dienoic acid and its salts

Sorbic acid, calcium sorbate, sodium sorbate, potassium sorbate

110-44-1, 7492-55-9, 7757-81-5, 24634-61-5

203-768-7, 231-321-6, 231-819-3, 246-376-1

0,6 % (acid)

Formal-dehyde, paraformaldehyde (3)

Formaldehyde

Paraformaldehyde

50-00-0, 30525-89-4

200-001-8

Oral products

0,1 % (free formaldehyde)

Not to be used in aerosol dispensers (sprays)

Other products

0,2 % (free formaldehyde)

Moved or deleted

Biphenyl-2-ol, and its salts

o-Phenylphenol, sodium o-phenylphenate, potassium o-phenylphenate, MEA o-phenylphenate

90-43-7, 132-27-4, 13707-65-8, 84145-04-0

201-993-5, 205-055-6, 237-243-9, 282-227-7

0,2 % (as phenol)

Pyrithione zinc (4)

Zinc pyrithione

13463-41-7

236-671-3

Hair products

1,0 %

Only in rinse-off products

Not to be used in oral products

Other products

0,5 %

Inorganic sulphites and hydrogen- sulphites (5)

Sodium sulfite, ammonium bisulfite, ammonium sulfite, potassium sulfite, potassium hydrogen sulfite, sodium bisulfite, sodium metabisulfite, potassium metabisulfite

7757-83-7, 10192-30-0, 10196-04-0, 10117-38-1, 7773-03-7, 7631-90-5, 7681-57-4, 16731-55-8

231-821-4, 233-469-7, 233-484-9, 233-321-1, 231-870-1, 231-548-0, 231-673-0, 240-795-3

0,2 % (as free SO2)

Moved or deleted

Chlorobutanol

57-15-8

200-317-6

0,5 %

Not to be used in aerosol dispensers (sprays)

Contains Chlorobutanol

4-Hydroxybenzoic acid and its salts and esters

4-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, phenylparaben

99-96-7, 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, 17696-62-7

202-804-9, 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

3-Acetyl-6-methylpyran-2,4 (3H)-dione and its salts

Dehydroacetic acid, sodium dehydroacetate

520-45-6, 4418-26-2, 16807-48-0

208-293-9, 224-580-1

0,6 % (as acid)

Not to be used in aerosol dispensers (sprays)

Formic acid and its sodium salt

Formic acid, sodium formate

64-18-6, 141-53-7

200-579-1, 205-488-0

0,5 % (as acid)

3,3'-Dibromo-4,4'-hexamethylenedioxydi-benzamidine and its salts (including isethionate)

Dibromohexamidine Isethionate

93856-83-8

299-116-4

0,1 %

Thiomersal

Thimerosal

54-64-8

200-210-4

Eye 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

Phenylmercuric salts (including borate)

Phenyl Mercuric Acetate, Phenyl Mercuric Benzoate

62-38-4, 94-43-9

200-532-5, 202-331-8

Eye 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

Undec-10-enoic acid and its salts

Undecylenic acid, potassium undecylenate, sodium undecylenate, calcium undecylenate, TEA-undecylenate, MEA-undecylenate

112-38-9, 6159-41-7, 3398-33-2, 1322-14-1, 84471-25-0, 56532-40-2

203-965-8, 222-264-8, 215-331-8, 282-908-9, 260-247-7

0,2 % (as acid)

5- Pyrimidinamine, 1,3-bis (2-ethylhexyl) hexahydro-5-methyl-

Hexetidine

141-94-6

205-513-5

0,1 %

5-Bromo-5-nitro-1,3-dioxane

30007-47-7

250-001-7

Rinse-off products

0,1 %

Avoid formation of nitrosamines

Bronopol

2-Bromo-2-nitropropane-1,3-diol

52-51-7

200-143-0

0,1 %

Avoid formation of nitrosamines

2,4-Dichlorobenzyl alcohol

Dichlorobenzyl Alcohol

1777-82-8

217-210-5

0,15 %

1-(4-Chlorophenyl)-3-(3,4-dichlorophenyl) urea (6)

Triclocarban

101-20-2

202-924-1

0,2 %

Purity criteria:

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

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

Chlorocresol

p-Chloro-m-Cresol

59-50-7

200-431-6

Not to be used in products applied on mucuous membranes

0,2 %

5-Chloro-2- (2,4- dichlorophenoxy) phenol

Triclosan

3380-34-5

222-182-2

0,3 %

Chloro-xylenol

Chloroxylenol

88-04-0

201-793-8

0,5 %

N,N″-methylenebis[N′-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]

Imidazolidinyl urea

39236-46-9

254-372-6

0,6 %

Poly(methylene),.alpha.,.omega.-bis[[[(aminoiminomethyl)amino]iminomethyl] amino]-, dihydrochloride

Polyaminopropyl biguanide

70170-61-5, 28757-47-3, 133029-32-0

0,3 %

2-Phenoxyethanol

Phenoxyethanol

122-99-6

204-589-7

1,0 %

Methenamine

100-97-0

202-905-8

0,15 %

Methenamine 3-chloroallylochloride

Quaternium-15

4080-31-3

223-805-0

0,2 %

1-(4-Chlorophenoxy)-1-(imidazol-1-yl)-3,3-dimethylbutan-2-one

Climbazole

38083-17-9

253-775-4

0,5 %

1,3-Bis (hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione

DMDM Hydantoin

6440-58-0

229-222-8

0,6 %

Benzyl alcohol (7)

Benzyl alcohol

100-51-6

202-859-9

1,0 %

1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon and its monoethanolamine salt

1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine

50650-76-5, 68890-66-4

272-574-2

Rinse-off products

1,0 %

Other products

0,5 %

Moved or deleted

2,2'-methylenebis(6-bromo-4-chlorophenol)

Bromochlorophene

15435-29-7

239-446-8

0,1 %

4-Isopropyl-m-cresol

o-Cymen-5-ol

3228-02-2

221-761-7

0,1 %

Mixture of 5-Chloro-2-methyl-isothiazol-3(2H)-one and 2-methylisothiazol-3(2H)-one with magnesium chloride and magnesium nitrate

Methylchloroisothiazolinone and Methylisothiazolinone

26172-55-4, 2682-20-4, 55965-84-9

247-500-7, 220-239-6

0,0015 % (of a mixture in the ratio 3:1 of 5-chloro-2-methylisothiazol 3(2H)-one and 2-methylisothiazol-3 (2H)-one

2-Benzyl-4-chlorophenol

Chlorophene

120-32-1

204-385-8

0,2 %

2-Chloroacetamide

Chloroacetamide

79-07-2

201-174-2

0,3 %

Contains chloroacetamide

N,N″-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine and its digluconate, diacetate and dihydrochloride

Chlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Digluconate, Chlorhexidine Dihydrochloride

55-56-1, 56-95-1, 18472-51-0, 3697-42-5

200-238-7, 200-302-4, 242-354-0, 223-026-6

0,3 % (as chlorhexidine)

1-Phenoxypropan-2-ol (8)

Phenoxyisopropanol

770-35-4

212-222-7

Only for rinse-off products

1,0 %

Alkyl (C 12-22) trimethyl ammonium bromide and chloride

Behentrimonium chloride, cetrimonium bromide, cetrimonium chloride, laurtrimonium bromide, laurtrimonium chloride, steartrimonium bromide, steartrimonium chloride

17301-53-0, 57-09-0, 112-02-7, 1119-94-4, 112-00-5, 1120-02-1, 112-03-8

241-327-0, 200-311-3, 203-928-6, 214-290-3, 203-927-0, 214-294-5, 203-929-1

0,1 %

4,4-Dimethyl-1,3-oxazolidine

Dimethyl Oxazolidine

51200-87-4

257-048-2

0,1 %

pH > 6

N-(Hydroxymethyl)-N-(dihydroxymethyl-1,3-dioxo-2,5-imidazolidinyl-4)-N'-(hydroxymethyl) urea

Diazolidinyl Urea

78491-02-8

278-928-2

0,5 %

Benzenecarboximidamide, 4,4'-(1,6-hexanediylbis (oxy))bis- and its salts (including isethionate and p-hydroxybenzoate)

Hexamidine, Hexamidine diisethionate, Hexamidine paraben

3811-75-4, 659-40-5, 93841-83-9

211-533-5, 299-055-3

0,1 %

Glutaraldehyde (Pentane-1,5-dial)

Glutaral

111-30-8

203-856-5

0,1 %

Not to be used in aerosols (sprays)

Contains glutaral (9)

5-Ethyl-3,7-dioxa-1-azabicyclo [3.3.0] octane

7-Ethylbicyclooxazolidine

7747-35-5

231-810-4

0,3 %

Not to be used in oral products and in products applied on mucous membranes

3-(p-Chlorophenoxy)-propane-1,2 diol

Chlorphenesin

104-29-0

203-192-6

0,3 %

Sodium hydroxymethylamino acetate

Sodium Hydroxymethylglycinate

70161-44-3

274-357-8

0,5 %

Silver chloride deposited on titanium dioxide

Silver chloride

7783-90-6

232-033-3

0,004 % (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

Benzenemethanaminium, N,N-dimethyl-N-[2-[2-[4-(1,1,3,3,-tetramethylbutyl)phenoxy]ethoxy] ethyl]-, chloride

Benzethonium Chloride

121-54-0

204-479-9

(a)	Rinse-off products

(b)	Leave-on products other than oral products

0,1 %

Benzalkonium chloride, bromide and saccharinate (10)

Benzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate

8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9

264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-1

0,1 % (as benzalkonium chloride)

Avoid contact with eyes

Methanol, (phenylmethoxy-)

Benzylhemiformal

14548-60-8

238-588-8

Rinse-off products

0,15 %

3-Iodo-2-propynylbutylcarbamate

Iodopropynyl butylcarbamate

55406-53-6

259-627-5

(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 cream (13)

(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 age (11)

(b) and (c)

Not to be used for children under 3 years of age (12)

2-Methyl-2H-isothiazol-3-one

Methylisothiazolinone

2682-20-4

220-239-6

0,01 %

(1)

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

(2)

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

(3)

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

(4)

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

(5)

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

(6)

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

(7)

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

(8)

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

(9)

Only if the concentration exceeds 0,05 %.

(10)

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

(11)

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

(12)

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

(13)

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

ANNEX VI

LIST OF UV FILTERS ALLOWED IN COSMETIC PRODUCTS

Reference number	Substance identification				Conditions			Wording of conditions of use and warnings
Reference number	Chemical name/INN/XAN	Name of Common Ingredients Glossary	CAS number	EC number	Product type, body parts	Maximum concentration in ready for use preparation	Other	Wording of conditions of use and warnings
a	b	c	d	e	f	g	h	i
1	4-Aminobenzoic acid	PABA	150-13-0	205-753-0		5 %
2	N,N,N-Trimethyl-4-(2-oxoborn-3-ylidenemethyl) anilinium methyl sulfate	Camphor Benzalkonium Methosulfate	52793-97-2	258-190-8		6 %
3	Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester/Homosalate	Homosalate	118-56-9	204-260-8		10 %
4	2-Hydroxy-4-methoxybenzophenone/Oxybenzone	Benzophenone-3	131-57-7	205-031-5		10 %		Contains Benzophenone-3 (1)
5	Moved or deleted
6	2-Phenylbenzimidazole-5-sulfonic acid and its potassium, sodium and triethanolamine salts/Ensulizole	Phenylbenzimidazole Sulfonic Acid	27503-81-7	248-502-0		8 %(as acid)
7	3,3'-(1,4-Phenylenedimethylene) bis(7, 7-dimethyl-2-oxobicyclo-[2.2.1]hept-1-yl-methanesulfonic acid) and its salts/Ecamsule	Terephthalylidene Dicamphor Sulfonic Acid	92761-26-7, 90457-82-2	410-960-6		10 %(as acid)
8	1-(4-tert-Butylphenyl)-3-(4-methoxyphenyl)propane-1,3-dione/Avobenzone	Butyl Methoxydibenzoylmethane	70356-09-1	274-581-6		5 %
9	alpha-(2-Oxoborn-3-ylidene)-toluene-4-sulphonic acid and its salts	Benzylidene Camphor Sulfonic Acid	56039-58-8			6 % (as acid)
10	2-Cyano-3,3-diphenyl acrylic acid, 2-ethylhexyl ester/Octocrilene	Octocrylene	6197-30-4	228-250-8		10 % (as acid)
11	Polymer of N-{(2 and 4)-[(2-oxoborn-3-ylidene)methyl]benzyl} acrylamide	Polyacrylamidomethyl Benzylidene Camphor	113783-61-2			6 %
12	2-Ethylhexyl 4-methoxycinnamate/Octinoxate	Ethylhexyl Methoxycinnamate	5466-77-3	226-775-7		10 %
13	Ethoxylated ethyl-4-aminobenzoate	PEG-25 PABA	116242-27-4			10 %
14	Isopentyl-4-methoxycinnamate/Amiloxate	Isoamyl p-Methoxycinnamate	71617-10-2	275-702-5		10 %
15	2,4,6-Trianilino-(p-carbo-2'-ethylhexyl-1'-oxy)-1,3,5-triazine	Ethylhexyl Triazone	88122-99-0	402-070-1		5 %
16	Phenol,2-(2H-benzotriazol-2-yl)-4-methyl-6-(2-methyl-3-(1,3,3,3-tetramethyl-1-(trimethylsilyl)oxy)-disiloxanyl)propyl)	Drometrizole Trisiloxane	155633-54-8			15 %
17	Benzoic 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 Triazone	154702-15-5			10 %
18	3-(4-Methylbenzylidene)-d1 camphor/Enzacamene	4-Methylbenzylidene Camphor	38102-62-4/36861-47-9	- / 253-242-6		4 %
19	3-Benzylidene camphor	3-Benzylidene Camphor	15087-24-8	239-139-9		2 %
20	2-Ethylhexyl salicylate/Octisalate	Ethylhexyl Salicylate	118-60-5	204-263-4		5 %
21	2-Ethylhexyl 4-(dimethylamino)benzoate/Padimate O (USAN:BAN)	Ethylhexyl Dimethyl PABA	21245-02-3	244-289-3		8 %
22	2-Hydroxy-4-methoxybenzophenone-5-sulfonic acid and its sodium salt/Sulisobenzone	Benzophenone-4, Benzophenone-5	4065-45-6/6628-37-1	223-772-2 / -		5 % (as acid)
23	2,2'-Methylene-bis(6-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethyl-butyl)phenol) / Bisoctrizole	Methylene Bis-Benzotriazolyl Tetramethylbutylphenol	103597-45-1	403-800-1		10 %
24	Sodium salt of 2,2'-bis(1,4-phenylene)-1H-benzimidazole-4,6-disulfonic acid) / Bisdisulizole disodium (USAN)	Disodium Phenyl Dibenzimidazole Tetrasulfonate	180898-37-7	429-750-0		10 % (as acid)
25	2,2'-(6-(4-Methoxyphenyl)-1,3,5-triazine-2,4-diyl)bis(5-((2-ethylhexyl)oxy)phenol) / Bemotrizinol	Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine	187393-00-6			10 %
26	Dimethicodiethylbenzalmalonate	Polysilicone-15	207574-74-1	426-000-4		10 %
27	Titanium dioxide (2)	Titanium Dioxide	13463-67-7/1317-70-0/1317-80-2	236-675-5/205-280-1/215-282-2		25 %
28	Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexylester	Diethylamino Hydroxybenzoyl Hexyl Benzoate	302776-68-7	443-860-6		10 % in sunscreen products

(1)

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

(2)

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

ANNEX VII

SYMBOLS USED ON PACKAGING/CONTAINER

1.

Reference to enclosed or attached information

2.

Period-after-opening

3.

Date of minimum durability

ANNEX VIII

LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING

This Annex lists the alternative methods validated by the European Centre on Validation of Alternative Methods (ECVAM) of the Joint Research Centre available to meet the requirements of this 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 number	Validated alternative methods	Nature of replacement full or partial
A	B	C

ANNEX IX

PART A

Repealed 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 B

List of time-limits for transposition into national law and application

(referred to in Article 33)

Directive	Time-limit for transposition
Council Directive 76/768/EEC of 27 July 1976	30.1.1978
Council Directive 79/661/EEC of 24 July 1979	30.7.1979
Commission Directive 82/147/EEC of 11 February 1982	31.12.1982
Council Directive 82/368/EEC of 17 May 1982	31.12.1983
Commission Directive 83/191/EEC of 30 March 1983	31.12.1984
Commission Directive 83/341/EEC of 29 June 1983	31.12.1984
Commission Directive 83/496/EEC of 22 September 1983	31.12.1984
Council Directive 83/574/EEC of 26 October 1983	31.12.1984
Commission Directive 84/415/EEC of 18 July 1984	31.12.1985
Commission Directive 85/391/EEC of 16 July 1985	31.12.1986
Commission Directive 86/179/EEC of 28 February 1986	31.12.1986
Commission Directive 86/199/EEC of 26 March 1986	31.12.1986
Commission Directive 87/137/EEC of 2 February 1987	31.12.1987
Commission Directive 88/233/EEC of 2 March 1988	30.9.1988
Council Directive 88/667/EEC of 21 December 1988	31.12.1993
Commission Directive 89/174/EEC of 21 February 1989	31.12.1989
Council Directive 89/679/EEC of 21 December 1989	3.1.1990
Commission Directive 90/121/EEC of 20 February 1990	31.12.1990
Commission Directive 91/184/EEC of 12 March 1991	31.12.1991
Commission Directive 92/8/EEC of 18 February 1992	31.12.1992
Commission Directive 92/86/EEC of 21 October 1992	30.6.1993
Council Directive 93/35/EEC of 14 June 1993	14.6.1995
Commission Directive 93/47/EEC of 22 June 1993	30.6.1994
Commission Directive 94/32/EC of 29 June 1994	30.6.1995
Commission Directive 95/17/EC of 19 June 1995	30.11.1995
Commission Directive 95/34/EC of 10 July 1995	30.6.1996
Commission Directive 96/41/EC of 25 June 1996	30.6.1997
Commission Directive 97/1/EC of 10 January 1997	30.6.1997
Commission Directive 97/18/EC of 17 April 1997	31.12.1997
Commission Directive 97/45/EC of 14 July 1997	30.6.1998
Commission Directive 98/16/EC of 5 March 1998	1.4.1998
Commission Directive 98/62/EC of 3 September 1998	30.6.1999
Commission Directive 2000/6/EC of 29 February 2000	1.7.2000
Commission Directive 2000/11/EC of 10 March 2000	1.6.2000
Commission Directive 2000/41/EC of 19 June 2000	29.6.2000
Commission Directive 2002/34/EC of 15 April 2002	15.4.2003
Commission Directive 2003/1/EC of 6 January 2003	15.4.2003
Commission Directive 2003/16/EC of 19 February 2003	28.2.2003
Directive 2003/15/EC of the European Parliament and of the Council of 27 February 2003	10.9.2004
Commission Directive 2003/80/EC of 5 September 2003	11.9.2004
Commission Directive 2003/83/EC of 24 September 2003	23.9.2004
Commission Directive 2004/87/EC of 7 September 2004	1.10.2004
Commission Directive 2004/88/EC of 7 September 2004	1.10.2004
Commission Directive 2004/94/EC of 15 September 2004	21.9.2004
Commission Directive 2004/93/EC of 21 September 2004	30.9.2004
Commission Directive 2005/9/EC of 28 January 2005	16.2.2006
Commission Directive 2005/42/EC of 20 June 2005	31.12.2005
Commission Directive 2005/52/EC of 9 September 2005	1.1.2006
Commission Directive 2005/80/EC of 21 November 2005	22.5.2006
Commission Directive 2006/65/EC of 19 July 2006	1.9.2006
Commission Directive 2006/78/EC of 29 September 2006	30.3.2007
Commission Directive 2007/1/EC of 29 January 2007	21.8.2007
Commission Directive 2007/17/EC of 22 March 2007	23.9.2007
Commission Directive 2007/22/EC of 17 April 2007	18.1.2008
Commission Directive 2007/53/EC of 29 August 2007	19.4.2008
Commission Directive 2007/54/EC of 29 August 2007	18.3.2008
Commission Directive 2007/67/EC of 22 November 2007	31.12.2007
Commission Directive 2008/14/EC of 15 February 2008	16.8.2008
Commission Directive 2008/42/EC of 3 April 2008	4.10.2008
Commission Directive 2008/88/EC of 23 September 2008	14.2.2009
Commission Directive 2008/123/EC of 18 December 2008	8.7.2009
Commission Directive 2009/6/EC of 4 February 2009	5.8.2009
Commission Directive 2009/36/EC of 16 April 2009	15.11.2009

ANNEX X

CORRELATION TABLE

Directive 76/768/EEC	This Regulation
Article 1	Article 2(1)(a)
Article 2	Article 3
Article 3	—
Article 4(1)	Article 14(1)
Article 4(2)	Article 17
Article 4a	Article 18
Article 4b	Article 15(1)
Article 5	—
Article 5a	Article 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 9	Article 35
Article 10	Article 32
Article 11	—
Article 12	Article 27
Article 13	Article 28
Article 14	—
Article 15	—
Annex I	Preamble, No. 7
Annex II	Annex II
Annex III	Annex III
Annex IV	Annex IV
Annex V	—
Annex VI	Annex V
Annex VII	Annex VI
Annex VIII	Annex VII
Annex VIIIa	Annex VII
Annex IX	Annex VIII
—	Annex IX
—	Annex X

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