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Document 32009R1223

    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)

    OJ L 342, 22.12.2009, p. 59–209 (BG, ES, CS, DA, DE, ET, EL, EN, FR, GA, IT, LV, LT, HU, MT, NL, PL, PT, RO, SK, SL, FI, SV)

    ⏵This document has been published in a special edition(s) (HR)

    Legal status of the document In force: This act has been changed. Current consolidated version: 24/04/2024

    ELI: http://data.europa.eu/eli/reg/2009/1223/oj

    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