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)
Date: 2009-11-30
Institutions: Council of the European Union, European Parliament
Subjects: approximation of laws, chemical product, consumer information, cosmetic product, health risk, product safety




L_2009342EN.01005901.xml










22.12.2009   


EN


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




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




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




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




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




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




a


b


c


d


e


f


g


h


i




1a


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








1b


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








2a


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




2b


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








3


Oxalic acid, its esters and alkaline salts


Oxalic acid


144-62-7


205-634-3


Hair products


5 %


Professional use


For professional use only




4


Ammonia


Ammonia


7664-41-7/1336-21-6


231-635-3/215-647-6


 


6 % (as NH3)


 


Above 2 %: Contains ammonia




5


Tosylchloramide sodium (INN)


Chloramine-T


127-65-1


204-854-7


 


0,2 %


 


 




6


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


 


 


 


 




7


Dichloromethane


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


 




8


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








9


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








10


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








11


Dichlorophen


Dichlorophen


97-23-4


202-567-1


 


0,5 %


 


Contains Dichlorophen




12


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


 


 




13


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)





14


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


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


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






 




16


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




17


Sodium nitrite


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


 




18


Nitromethane


Nitromethane


75-52-5


200-876-6


Rust inhibitor


0,3 %


 


 




19


Moved or deleted




20


Moved or deleted




21


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)






 


 




22


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




23








(a)


Alkali sulphides






 


 


 








(a)


Depilatories












(a)


2 % (as sulphur)






pH ≤ 12,7








(a) (b)


Keep out of reach of children
Avoid contact with eyes














(b)


Alkaline earth sulphides






 


 


 








(b)


Depilatories












(b)


6 % (as sulphur)








24


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)


 


 




25


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




26


Ammonium monofluorophosphate


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’




27


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’




28


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’




29


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’




30


Calcium fluoride


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’




31


Sodium fluoride


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’




32


Potassium fluoride


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’




33


Ammonium fluoride


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’




34


Aluminium fluoride


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’




35


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’




36


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’




37


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’




38



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’




39


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’




40


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’




41


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’




42


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’




43


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’




44


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








45


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


 




46


6-Methylcoumarin


6-Methylcoumarin


92-48-8


202-158-8


Oral products


0,003 %


 


 




47


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’




48


Silver nitrate


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




49


Selenium sulfide


Selenium disulphide


7488-56-4


231-303-8


Antidandruff shampoos


1 %


 


Contains selenium disulphide
Avoid contact with eyes or damaged skin




50


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


 


 


 


Anti-perspirants


20 % (as anhydrous aluminium zirconium chloride hydroxide)
5,4 % (as zirconium)








1.


The ratio of the number of aluminium atoms to that of zirconium atoms must be between 2 and 10










2.


The ratio of the number of (Al + Zr) atoms to that of chlorine atoms must be between 0,9 and 2,1










3.


Not to be used in aerosol dispensers (sprays)






Do not apply to irritated or damaged skin




51


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)


 


 




52


Methanol


Methyl alcohol


67-56-1


200-659-6


Denaturant for ethanol and isopropyl alcohol


5 % (as a % ethanol and isopropyl alcohol)


 


 




53


(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)


 


 




54


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


 




55


Moved or deleted




56


Magnesium fluoride


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’




57


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 %


 


 




58


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




59


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








60


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






 




61


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






 




62


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






 




63


Strontium hydroxide


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




64


Strontium peroxide


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




65


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




66


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






 




67


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






 




68


Benzyl alcohol


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






 




69


Cinnamyl alcohol


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






 




70


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






 




71


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






 




72


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






 




73


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






 




74


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






 




75


Benzyl salicylate


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






 




76


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






 




77


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






 




78


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






 




79


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






 




80


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






 




81


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






 




82


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






 




83


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






 




84


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






 




85


Benzyl benzoate


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






 




86


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






 




87


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






 




88


(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






 




89


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






 




90


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






 




91


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






 




92


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






 




93


2,4-Pyrimidinediamine, 3-oxide


Diaminopyrimidine oxide


74638-76-9


—


Hair products


1,5 %


 


 




94


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




95


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




96


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






 


 




97


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






 


 




98


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)





99


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




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




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




a


b


c


d


e


f


g


h


i




1


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)




1a


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)


 


 




2


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)


 


 




3


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)





4


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)


 


 




5


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)




6


Moved or deleted




7


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)


 


 




8


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 %




9


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)


 


 




10


Moved or deleted




11


Chlorobutanol


Chlorobutanol


57-15-8


200-317-6


 


0,5 %


Not to be used in aerosol dispensers (sprays)


Contains Chlorobutanol




12


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


 


 




13


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)


 




14


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)


 


 




15


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


Dibromohexamidine Isethionate


93856-83-8


299-116-4


 


0,1 %


 


 




16


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




17


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




18


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)


 


 




19


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


Hexetidine


141-94-6


205-513-5


 


0,1 %


 


 




20


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


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


30007-47-7


250-001-7


Rinse-off products


0,1 %


Avoid formation of nitrosamines


 




21


Bronopol


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


52-51-7


200-143-0


 


0,1 %


Avoid formation of nitrosamines


 




22


2,4-Dichlorobenzyl alcohol


Dichlorobenzyl Alcohol


1777-82-8


217-210-5


 


0,15 %


 


 




23


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


 




24


Chlorocresol


p-Chloro-m-Cresol


59-50-7


200-431-6


Not to be used in products applied on mucuous membranes


0,2 %


 


 




25


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


Triclosan


3380-34-5


222-182-2


 


0,3 %


 


 




26


Chloro-xylenol


Chloroxylenol


88-04-0


201-793-8


 


0,5 %


 


 




27


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


Imidazolidinyl urea


39236-46-9


254-372-6


 


0,6 %


 


 




28


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


Polyaminopropyl biguanide


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


 


 


0,3 %


 


 




29


2-Phenoxyethanol


Phenoxyethanol


122-99-6


204-589-7


 


1,0 %


 


 




30


Methenamine


Methenamine


100-97-0


202-905-8


 


0,15 %


 


 




31


Methenamine 3-chloroallylochloride


Quaternium-15


4080-31-3


223-805-0


 


0,2 %


 


 




32


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


Climbazole


38083-17-9


253-775-4


 


0,5 %


 


 




33


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


DMDM Hydantoin


6440-58-0


229-222-8


 


0,6 %


 


 




34


Benzyl alcohol (7)



Benzyl alcohol


100-51-6


202-859-9


 


1,0 %


 


 




35


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 %




36


Moved or deleted




37


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


Bromochlorophene


15435-29-7


239-446-8


 


0,1 %


 


 




38


4-Isopropyl-m-cresol


o-Cymen-5-ol


3228-02-2


221-761-7


 


0,1 %


 


 




39


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


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


 


 




40


2-Benzyl-4-chlorophenol


Chlorophene


120-32-1


204-385-8


 


0,2 %


 


 




41


2-Chloroacetamide


Chloroacetamide


79-07-2


201-174-2


 


0,3 %


 


Contains chloroacetamide




42


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)


 


 




43


1-Phenoxypropan-2-ol (8)



Phenoxyisopropanol


770-35-4


212-222-7


Only for rinse-off products


1,0 %


 


 




44


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 %


 


 




45


4,4-Dimethyl-1,3-oxazolidine


Dimethyl Oxazolidine


51200-87-4


257-048-2


 


0,1 %


pH > 6


 




46


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


Diazolidinyl Urea


78491-02-8


278-928-2


 


0,5 %


 


 




47


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 %


 


 




48


Glutaraldehyde (Pentane-1,5-dial)


Glutaral


111-30-8


203-856-5


 


0,1 %


Not to be used in aerosols (sprays)


Contains glutaral (9)





49


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


 




50


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


Chlorphenesin


104-29-0


203-192-6


 


0,3 %


 


 




51


Sodium hydroxymethylamino acetate


Sodium Hydroxymethylglycinate


70161-44-3


274-357-8


 


0,5 %


 


 




52


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


 




53


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 %


 


 




54


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




55


Methanol, (phenylmethoxy-)


Benzylhemiformal


14548-60-8


238-588-8


Rinse-off products


0,15 %


 


 




56


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)









57


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




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




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