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
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Article 9
Article 35
Article 10
Article 32
Article 11
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Article 12
Article 27
Article 13
Article 28
Article 14
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Article 15
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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
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Annex IX
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Annex X
Safer cosmetics for EU citizens
Safer cosmetics for EU citizens
SUMMARY OF:
Regulation (EC) No 1223/2009 on cosmetic products
WHAT IS THE AIM OF THE REGULATION?
Makes cosmetics products sold in the EU safer by tightening safety requirements.
Simplifies procedures for companies and regulatory authorities in the sector.
Updates the rules to take account of the latest technological developments, including the possible use of nanomaterials.
Maintains the existing ban on animal testing.
KEY POINTS
Extra requirements for manufacturers in compiling the safety report they need to place a product on the market.
New concept of ‘responsible person’ for each product: businesses can only sell cosmetic products in the EU when a natural or legal person is designated as a ‘responsible person’;the responsible person must ensure the product meets all the relevant safety requirements under Regulation (EC) No 1223/2009.
Red tape for manufacturers is reduced as they have to register their products only once, with the EU’s Cosmetic Products Notification Portal.
New requirement to report serious undesirable effects: responsible persons and distributors are required to report such effects to their national authorities;national authorities must then share this information — together with any they receive from other sources (users, health professionals) — with their counterparts in other EU Member States.
Packaging must include a range of information, including the name and the address of the responsible person, the contents, precautions for use and the list of ingredients.
New rules for the use of nanomaterials.
Lists of substances which are prohibited, restricted or authorised for use in cosmetics.
Distributors must check that labelling, including the use-by date, and language requirements are all in order.
The main points of the regulation are summarised in this infographic. The regulation repealed and replaced Directive 76/768/EEC.
The various annexes to the regulation have been amended many times. These changes have been incorporated into the consolidated version of the regulation.
In addition, since in some cases it is difficult to distinguish between medical devices and cosmetic products, Article 119 of Regulation (EU) 2017/745 (see summary) amends Regulation (EC) No 1223/2009 by making it possible to take an EU-wide decision on regulatory status of a product. Since 26 May 2021, the European Commission may, at the request of a Member State or on its own initiative, decide whether or not a specific product or group of products falls within the definition ‘cosmetic product’.
FROM WHEN DOES THE REGULATION APPLY?
              
It has applied since 11 July 2013.
BACKGROUND
              
For more information, see:
Cosmetics (European Commission).
MAIN DOCUMENT
            
Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (recast) (OJ L 342, 22.12.2009, pp. 59-209)
Successive amendments to Regulation (EC) No 1223/2009 have been incorporated into the original text. This consolidated version is of documentary value only.
RELATED DOCUMENTS
            
Report from the Commission to the European Parliament and the Council on the development, validation and legal acceptance of methods alternative to animal testing in the field of cosmetics (2018) (COM(2019) 479 final, 15.10.2019)
Report from the Commission to the European Parliament and the Council — Review of Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products with regard to substances with endocrine-disrupting properties (COM(2018) 739 final, 7.11.2018)
Report from the Commission to the European Parliament and the Council on product claims made based on common criteria in the field of cosmetics (COM(2016) 580 final, 19.9.2016)
Communication from the Commission to the European Parliament and the Council on the animal testing and marketing ban and on the state of play in relation to alternative methods in the field of cosmetics (COM(2013) 135 final, 11.3.2013)
last update 18.05.2021