52008PC0049R(01)

EN

Brussels, 14.4.2008

COM(2008)49 final/2

2008/0035 (COD)

Corrigendum :

annule et remplace le COM(2008)49 final. Il convient de lire la référence interinstitutionnelle 2008/0035 (COD). Concerne toutes les versions linguistiques

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on cosmetic products

(recast)

(Text with EEA relevance)

(SEC(2008)117)

(SEC(2008)118)

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. Background to the proposal

Simplification of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products [1] (the “Cosmetics Directive”) was announced in the Commission Communication “Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment” [2] and in the Commission’s Annual Policy Strategy for 2007. [3]

This proposal pursues three objectives:

– Objective 1: To remove legal uncertainties and inconsistencies. These inconsistencies can be explained by the high number of amendments (55 to date) and the complete absence of any set of definitions. This objective also includes several measures to facilitate management of the Cosmetics Directive with regard to implementing measures;

– Objective 2: To avoid divergences in national transposition which do not contribute to product safety but instead add to the regulatory burden and administrative costs;

– Objective 3: To ensure that cosmetic products placed on the EU market are safe in the light of innovation in this sector.

2. Public consultation

(...PICT...)

A stakeholder consultation was held from 12 January 2007 to 16 March 2007. The Commission received 72 contributions in response to this public consultation. Of these, 46 were from industry (fine chemicals, cosmetics and others [4]), 18 from national and regional authorities, 4 from academia/health professionals, 3 from consumers and consumer organisations and 1 from an animal welfare organisation. In terms of regions, 7 contributions were received from EU-wide associations, 15 from Germany, 9 from France, 3 each from the UK, Austria and Sweden, 2 each from Lithuania, Belgium/Luxembourg, Denmark, Norway, the Czech Republic, Spain, Poland and Ireland, 1 each from Finland, Malta, Hungary, the Netherlands, Slovenia, Greece, Slovakia, Latvia and Switzerland and 7 from non-European Third Countries.

Generally speaking, the consultation confirmed that the Cosmetics Directive needed to be recast and that many provisions required clarification. The stakeholder consultation also stressed that in order to ensure a high level of protection of human health throughout the EU and to ensure an internal market for cosmetic product, a recast Cosmetics Directive should take the form of a Regulation. In terms of product safety, responses in the stakeholder consultation stressed the need to sharpen the focus on the manufacturer’s responsibility for the safety of cosmetic products placed on the market.

A summary of the responses is contained in Annex 1 to the impact assessment report.

3. Impact assessment

The Commission, based on the results of the stakeholder consultation and three studies assessing various aspects of European cosmetics legislation [5], carried out an impact assessment of the various policy options to achieve the objectives set out above (1.). The impact assessment board of the European Commission [6] assessed a draft version of this impact assessment in August 2007 and approved it subject to some modifications.

Analysis and comparison of the various options and their impact lead to the following conclusions:

With regard to objective 1, the impact assessment supports amendment of the Cosmetics Directive as the only effective means of achieving this aim thereby reducing the regulatory burdens considerably. For example, the impact assessment shows a potential to reduce administrative costs associated with notification to poison control centres by approx. 80%. The clarification and streamlining of various provisions – including those on labelling – facilitates compliance without compromising product safety.

With regard to objective 2, the impact assessment supports a recast into the form of a Regulation. In particular, this is supported by the fact that the Cosmetics Directive is very detailed and frequently amended (approximately three to five times a year in recent years). Albeit minor, the differences in the 27 national transposing laws create additional costs for industry without contributing to product safety.

With regard to objective 3, the impact assessment supports striking a better balance between “manufacturer responsibility” and “prescriptive regulation of individual ingredients”: This is a crucial element, as the Cosmetics Directive is still shaped by the original concept – developed 30 years ago – of regulation of all substances used in cosmetic products “ingredient by ingredient”. Today it is acknowledged that this approach alone is not sufficient to ensure that cosmetic products placed on the market are safe. Instead, manufacturer responsibility and in-market control aspects need to be strengthened to make sure that products from this innovative sector will be safe in the future. This includes:

– clear minimum requirements for the cosmetics safety assessment which is then controlled via in-market surveillance;

– a system of administrative cooperation of competent authorities: this entails a system of coordination of Member States in the assessment of products and their supporting information, including rules for product withdrawal;

– an obligation of industry to actively report serious undesirable effects to competent authorities as part of an early detection mechanism for risks for human health caused by cosmetic products; and

– a notification requirement which provides information to all competent authorities of the internal market through one single notification portal.

The most important element in terms of impact is the introduction of clear minimum requirements for the cosmetics safety assessment. Up until now, the Cosmetics Directive did not contain clear legal prerequisites for the contents of a cosmetics safety assessment. This has contributed to a relatively high degree of non-compliance. Clear minimum requirements increase the costs for companies which so far refrained from establishing a robust cosmetics safety assessment prior to placing the product on the market.

However, the impact assessment shows that there are a number of measures which soften the impact of this requirement. For example, the increased costs can be largely outbalanced by the considerable decrease in administrative costs. Any residual increase can be justified on the strength of the benefits to the consumer in terms of solid safety assessments brought about by this option.

4. Legal Basis and subsidiarity

The Cosmetics Directive is based on Article 95 of the EC Treaty. It aims at establishing an internal market for cosmetic products while ensuring a high level of protection of human health.

Prior to the adoption of the Cosmetics Directive, the provisions laid down by law, regulation or administrative action in force in the Member States differed from one Member State to another. These differences between these laws obliged the cosmetic industry to vary their production according to the Member State for which the products are intended. Consequently, the different national rules hindered trade in these products and, as a result, had a direct effect on the establishment and functioning of the internal market. To respond to this, it was necessary to determine at Community level, the rules which must be observed as regards the composition, labelling and packaging of cosmetic products. This objective could only be achieved with a very limited efficiency at national level.

This rationale is still valid today: Community action is necessary to avoid a fragmentation of the market and to ensure a high and equal level of protection of the European consumer.

The Cosmetics Directive exhaustively harmonises rules on protection of human health for cosmetic products placed on the Community market. Thus, changes to this legal framework can only be achieved by Community action and are in compliance with the principle of subsidiarity as established in Article 5 of the EC Treaty.

5. Codification of the 55 amendments of the Cosmetics Directive and adoption of text as Regulation

The Cosmetics Directive has been amended 55 times. The proposal joins together these 55 amendments in one legal text.

The choice of the legal form is that of a Regulation. This will facilitate a harmonised application and removes the need for transposition of the highly detailed provisions of the Cosmetics Directive.

6. Substantive amendments

According to the interinstitutional agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts [7], substantive amendments have been shaded in grey.

The substantive changes can be summarised as follows:

6.1. Facilitating the management of cosmetics legislation

6.1.1. Introducing a set of definitions

Article 2 as well as the preamble to Annexes II to VI of the proposal introduce a set of definitions. Until now, the Cosmetics Directive contains practically no legal definitions. This increases legal uncertainty and renders compliance more costly and burdensome than necessary. The proposal ensures coherence with existing definitions in the field of free movement of goods – in particular with view to the proposals for a common framework for new approach legislation. [8]

6.1.2. Glossary of ingredient names

Article 28 of the proposal introduces a facilitated system to update a glossary of ingredient names. This glossary takes up essentially the function of the “inventory of ingredient names”, which was already provided for in the Cosmetics Directive. [9] It contains the names of all relevant cosmetic ingredients (approximately 10.000). The names used are independent of any national language and usually much shorter than the chemical name. Thus these names help to avoid the need for translation of the labelled list of ingredients. Moreover, these names are accepted worldwide which greatly facilitates exportation for EU companies and thus enhances external competitiveness.

6.2. Strengthening certain elements to ensure product safety in the future

6.2.1. Cosmetics safety assessment

Annex I of the proposal sets out the requirements for the cosmetic product safety assessment in terms of content.

The concept of a cosmetic product safety assessment is not new. The Cosmetics Directive already contained the requirement to undertake such an assessment prior to placing the product on the market. [10] However, the information to be contained in this safety assessment was never specified, with the practical implication that the safety assessment never took on the important role that it was meant to play within the current legal framework.

A crucial element of the recast is clarification as to what information has to be contained in the cosmetic product safety assessment to provide evidence of the safety of the cosmetic product placed on the market.

6.2.2. Strengthening in-market control

Cosmetics regulation in the EU is based on in-market controls. Therefore, it is crucial that in-market control is effective. The proposal strengthens the role and improves the functioning of in-market control – in particular, in view of ever increasing imports from third countries. This entails the following:

– Article 4 of the proposal defines the responsible person for the relevant legal obligations. This provision also addresses the responsibility in cases of products supplied to the consumer from outside the EU, for example via internet.

– Article 10 of the proposal introduces a simplified, centralised and electronic notification requirement: Notification of certain information concerning the product placed on the market is an important element in a sector based on in-market control. Until now, the Cosmetics Directive contains two notification requirements: one to competent authorities and one to poison control centres. Modalities differ considerably between Member States and multiple registrations are necessary.

– Article 19 of the proposal introduces a communication of information on certain undesirable effects to the competent authority.

– Article 20 of the proposal introduces the possibility for competent authority to investigate on a broader basis the extent of the use of certain substances.

– Articles 21, 23, 24 and 25 of the proposal introduce and strengthen the rules that apply to non-compliant products, including more detailed provisions on administrative cooperation in market surveillance. Presently, the Cosmetics Directive does not provide for any such rules.

6.3. CMR Substances

Article 12(2) introduces a differentiated regime for substances classified as carcinogenic, mutagenic or reprotoxic (“CMR”).

CMR substances are classified based on their intrinsic properties (“hazard”) without taking into account exposure, i.e. future use. The difference between hazard and risk is best explained with an example: A lion is a “hazard” (i.e. a lion as such is dangerous for humans) but a lion is not necessarily a “risk” (e.g. if it is in a guarded zoo, behind a fence, and well-fed).

CMR substances are categorised into 3 categories, “1”, “2” and “3“ based on the degree of evidence of their carcinogenic, mutagenic or reprotoxic properties. [11]

Up until now, CMR 1 and 2 substances were automatically banned in cosmetic products. CMR 3 substances were banned unless the Scientific Committee, on the basis of exposure-data, has found that the substance is safe for use in cosmetics. [12]

The automatic ban without possibility of an exception for CMR 1 and 2 substances made regulation of cosmetics dependent on a hazard-classification without considering exposure and actual use of the substance. This could lead to absurd situations. A recent – but not the only – example is ethanol: Ethanol (i.e. alcohol) is widely used in cosmetic products. It was considered for classification as CMR 1 substance in 2006. The dossier is pending. A classification as CMR 1 substance would have tremendous impact on the EU cosmetics industry, without ever giving the possibility for industry to prove its safe use in cosmetic products based on exposure data. On the other hand, this substance could be used in food with a much higher exposure.

Article 12(2) of the proposal intends to propose a risk management regime for CMR 1 and 2 substances which allows, subject to rigid conditions, the use of these substances if they have been found to be safe by the Scientific Committee for Consumer Products.

6.4. Other substantive changes

Apart from the amendments set out under points 6.1. to 6.3., the following substantive amendments have been made in the proposal:

· Article 7(1) of the proposal clarifies the obligation for the responsible person to keep the cosmetic product safety report up to date.

· In Article 8 of the proposal, the reference to the appropriate level of qualification for the manufacturer and the importer has been deleted. This issue is now addressed by a strengthened role of the cosmetic product safety report as well as the adoption of a harmonised standard for GMP.

· Articles 5(2) and 9 (2) of the proposal provide for clarification of the role of harmonised standards in the field of good manufacturing practices and sampling/analysis of cosmetic products.

· Article 11(1)(d), (f) of the proposal clarifies that the restrictions for substances contained in Annex IV (colorants) and V (preservatives) also apply if the substance is added to the product for another than a colorant/preservative purpose.

· Article 14(2) of the proposal introduces the Comitology procedure with scrutiny for granting a derogation from the animal testing regime.

· Article 15(1)(a) of the proposal introduces the possibility to highlight on the label the relevant address for competent authorities in cases where several addresses indicated.

· Article 15(1)(c) and point 3 under Annex VII of the proposal introduces the possibility to label the date of minimum durability by way of a pictogram.

· In Article 15(1)(g) of the proposal, the possibility to suppress ingredients on the product labelling for reasons of trade secrecy has been deleted. This provision was practically never applied and did not play any role in practice.

· Article 16(1), sub-paragraph (2) of the proposal introduces the possibility to make use of harmonised standards to address issues of claims relating to cosmetic products.

· Article 22 of the proposal introduces a clear procedure for the application of the safeguard clause (cf. Article 12 of the Cosmetics Directive).

· Article 26 of the proposal introduces and clarifies the rules applying to the amendment of the Annexes of the text.

· Article 27(3),(4) of the proposal introduces the Comitology procedure with scrutiny.

· Article 31 of the proposal allows for the formal objection against harmonised standards.

· Article 32 of the proposal introduces the obligation for Member State to adopt provisions on penalties.

· Article 33 and 34 of the proposal establish the rules for the repeal of the Cosmetics Directive, and entry into force and application of the Regulation.

· Article 8a as well as Annex V of the Cosmetics Directive have been deleted. Both provisions contradicted the principle of exhaustiveness of the Cosmetics Directive and did not play a role in praxis.

7. Budgetary implication

The proposal envisages establishing a central electronic interface for the product notification to the competent authorities of the Member States. Budgetary implications are discussed in the legislative financial statement annexed to this proposal.

8. Additional information

8.1. Repeal of legislation

The adoption of the proposal will lead to repeal of one basic legal act, its 55 amendments as well as one implementing Commission Directive.

8.2. European Economic Area

The proposal concerns an EEA matter and should therefore extend to the European Economic Area.

2008/0035 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on cosmetic products

(recast)

(Text with EEA relevance)

76/768/EEC (adapted)

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 [13],

Having regard to the opinion of the European Economic and Social Committee [14],

Having regard to the opinion of the Committee of the Regions [15],

Acting in accordance with the procedure laid down in Article 251 of the Treaty [16],

Whereas:

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(1) Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products [17] has been significantly amended on several occasions. Since further amendments are to be made, it should be recast as one single text in the interests of clarity.

(2) The recast aims at simplifying procedures and streamlining terminology thereby reducing administrative burden and ambiguities. Moreover, the recast 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.

(3) A recast as 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.

76/768/EEC Recital 1

(4) The provisions laid down by law, regulation or administrative action in force in the Member States define the composition characteristics to which cosmetic products must conform and prescribe rules for their labelling and for their packaging. These provisions differ from one Member State to another.

76/768/EEC Recital 2

(5) The differences between these laws oblige Community cosmetic producers to vary their production according to the Member State for which the products are intended. Consequently, they hinder trade in these products and, as a result, have a direct effect on the establishment and functioning of the common market.

76/768/EEC Recital 3

(6) The main objective of these laws is the safeguarding of public health and, as a result, the pursuit of the same objective must inspire Community legislation in this sector. However, this objective must be attained by means which also take account of economic and technological requirements.

76/768/EEC Recital 4

(7) It is necessary to determine at Community level the regulations which must be observed as regards the composition, labelling and packaging of cosmetic products.

03/15/EC Recital 1 (adapted)

(8) Council Directive 76/768/EEC [18] This Regulation has comprehensively harmonised harmonises the national laws rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of relating to cosmetic products and has as its main objective the protection of human public health. To this end, it continues to be indispensable to carry out certain toxicological tests to evaluate the safety of cosmetic products.

76/768/EEC Recital 5 (adapted)

(9) This Directive Regulation relates only to cosmetic products and not to medicinal products, medical devices or biocidal products pharmaceutical specialities and medicinal products. For this purpose it is necessary to define the scope of the Directive by delimiting the field of cosmetics from that of pharmaceuticals. Theis 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. This Directive is not applicable to the products that fall under the definition of cosmetic product but are exclusively intended to protect from disease. Moreover, it is advisable to specify that certain products come under this definition, whilst products containing substances or preparations intended to be ingested, inhaled, injected or implanted in the human body do not come under the field of cosmetics.

76/768/EEC Annex I (adapted)

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(10) The assessment whether a product is a cosmetic product has to be taken on the basis of a case by case assessment, taking into account all characteristics of the product. Typical examples for cosmetic products may include creams, emulsions, lotions, gels and oils for the skin (hands face feet etc.), face masks (with the exception of peeling products), tinted bases (liquids, pastes, powders), make-up powders, after-bath powders, hygienic powders, etc. toilet soaps, deodorant soaps, etc. perfumes, toilet waters and eau de Cologne, bath and shower preparations (salts, foams, oils, gels, etc.), depilatories, deodorants and anti-perspirants, hair care products, hair tints and bleaches 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, etc.), products for making up and removing make-up from the face and the eyes, 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.

76/768/EEC Recital 6 (new)

(11) In the present state of research, it is advisable to exclude cosmetic products containing one of the substances listed in Annex V from the scope of this Directive.

76/768/EEC Recital 7 (adapted)

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(12) Cosmetic products should must not be safe harmful under normal or reasonably foreseeable conditions of use. In particular, a risk-benefit reasoning should not justify a risk to human health. it is necessary to take into account the possibility of danger to zones of the body that are contiguous to the area of application.

(13) In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person who is established within the Community. It is in particular necessary to determine who is the responsible person for cosmetic products which are sold directly to the consumer without recurring to an importer.

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

(15) For the purpose of efficient 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.

(16) 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.

93/35/EEC Recital 4 (adapted)

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(17) Whereas, with regard to the finished cosmetic product, Iit should be made clear which information is to be made available to the monitoring competent authorities. of the place of manufacture or of initial importation into the Community market; whereas Tthat 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.

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

93/35/EEC Recital 5 (adapted)

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(19) Whereas, however, Ffor reasons of monitoring effective market surveillance , the competent authorities should be notified apprised of certain information about the cosmetic product placed on the market. the place of manufacture and of the information needed for rapid and appropriate medical treatment in the event of difficultires.

(20) In order to allow for rapid and appropriate medical treatment in the event of difficulties, the necessary information about the product formula should be submitted to poison control centres and assimilated entities if such centres are established by Member States to that effect.

(21) In order to keep administrative burdens to a minimum, both notifications should be submitted centrally for the Community by way of an electronic interface.

83/574/EEC Recital 2 (adapted)

(22) Whereas, on the basis of the latest scientific and technical research, a list of substances authorized as ultra-violet filters can be established;

(23) 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 have to be listed in the Annexes IV, V and VI respectively in order to be allowed for these uses.

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

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(25) 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 Products (SCCP) has been finalised. To this end, the Commission should have the possibility to include hair colorants in the scope of this Annex by Comitology procedure.

03/15/EC Recital 13 (adapted)

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(26) Given the hazardous properties of special risks that substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR) , category 1, 2 and 3, pursuant to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [19] Directive 67/548/EEC may entail for human health, their use in cosmetic products should be prohibited. A substance classified in category 3 may be used in cosmetics if the substance has been evaluated by the SCCNFP and found acceptable for use in cosmetic products. 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 3 substances if, in view of exposure and concentration, they have been found safe for use in cosmetic products by the SCCP and are regulated by the Commission in the Annexes to this Regulation. With regard to substances which are classified as CMR 1 or 2 substances, there should be a possibility, in the exceptional case where these substances are legally used in food and no suitable alternative substances exist, to use such substances in cosmetic products if such use has been found safe by the SCCP. Such substances should be continuously reviewed by the SCCP.

82/368/EEC Recital 11 (adapted)

(27) Whereas the presence of traces of substances which cosmetic products must not contain according to Annex II to Directive 76/768/EEC In order to ensure product safety, prohibited substances should only be acceptable at trace levels if they are is technologically inevitable with correct manufacturing processes and provided that the product is safe. ; whereas therefore certain provisions should be made in this connection;

03/15/EC Recital 2 (adapted)

(28) The Protocol on protection and welfare of animals annexed by the Treaty of Amsterdam to the Treaty establishing the European Community 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.

03/15/EC Recital 3 (adapted)

(29) 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 [20] has 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, when such methods exist and are scientifically satisfactory. In order to facilitate the development and use of alternative methods in the cosmetic sector which do not use live animals, specific provisions have been introduced by Council Directive 93/35/EEC of 14 June 1993 amending for the sixth time Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products [21].

However, these provisions concern only alternative methods which do not use animals and they do not take account of alternative methods developed in order to reduce the number of animals used for experiments or to reduce their suffering. Therefore, in order to afford optimal protection to animals used for testing cosmetic products pending implementation of the prohibition of animal tests for cosmetic products and the marketing of animal-tested cosmetic products in the Community, these provisions should be amended in order to provide for the systematic use of alternative methods, which reduce the number of animals used or reduce the suffering caused, in those cases where full replacement alternatives are not yet available, as provided by Article 7(2) and (3) of Directive 86/609/EEC, when these methods offer consumers a level of protection equivalent to that of the conventional methods which they are intended to replace.

03/15/EC Recital 5 (adapted)

(30) Currently, only alternative methods which are scientifically validated by the European Centre for the Validation of Alternative Methods (ECVAM) or the Organisation for Economic Cooperation and Development (OECD) and applicable to the whole chemical sector are systematically adopted at Community level. However, Tthe 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, when such methods offer an equivalent level of protection to consumers.

03/15/EC Recital 6 (adapted)

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(31) 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 can should therefore be provided. be incorporated into Directive 76/768/EEC. The Commission should establish guidelines in order to facilitate the The application, in particular by small and medium-sized enterprises, of methods which do not involve the use of animals for assessing the safety of finished cosmetic products could be facilitated by Commission guidelines .

03/15/EC Recital 7 (adapted)

(32) 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) ECVAM and with due regard to the development of validation within the Organisation for Economic Cooperation and Development (OECD) OECD. After consulting the Scientific Committee on Cosmetic Products and Non-Food Products intended for Consumers (SCCNFP) SCCP 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 must be should be set for the introduction of a definitive prohibition.

03/15/EC Recital 8 (adapted)

(33) The Commission should establish has established timetables of deadlines for the prohibition of the marketing of cosmetic products, the final formulation, ingredients or combinations of ingredients which have been tested on animals, and for the prohibition of each test currently carried out using animals, up to 11 March 2009 a maximum of six years from the date of entry into force of this Directive. In view, however, of the fact that there are no alternatives yet under consideration for tests concerning repeated-dose toxicity, reproductive toxicity and toxicokinetics, it is appropriate for the maximum deadline for the prohibition of the marketing of cosmetic products for which those tests are used to be 11 March 2013 10 years from the date of entry into force of this Directive. On the basis of annual reports, the Commission should be authorised to adapt the timetables within the respective abovementioned maximum time limits.

03/15/EC Recital 9 (adapted)

(34) 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 Sixth Framework Programmes for research as set out in Decision No 1513/EC/2002 of the European Parliament and of the Council [22].

03/15/EC Recital 10 (adapted)

(35) The recognition by third non-member 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 non-member countries requiring the repetition of such tests using animals.

93/35/EEC Recital 3 (adapted)

(36) Whereas greater Ttransparency is needed regarding the ingredients employed in cosmetics products. if the latter are to be placed on the market without any prior procedure, if the necessary information on the finished product is to be available solely at the place of manufacture or of initial importation into the Community and if better information is to be provided to the consumer; whereas Ssuch transparency should be achieved by indication of a product's function and of the ingredients used in a cosmetic product on its packaging.; whereas Wwhere for practical reasons it is impossible to indicate the ingredients and any warnings regarding use on the container or the packaging, such particulars should be enclosed so that the consumer may can have access to this all necessary information.;

93/35/EEC Recital 2 (adapted)

(37) Whereas it has become apparent that it is desirable that data on the ingredients employed in cosmetic products be gathered so that all issues relating to their use and the resulting action at Community level may be assessed with a view, in particular, to the establishment of a common nomenclature of ingredients used in cosmetic products; whereas the gathering of that data can be facilitated if the Commission compiles an inventory of the ingredients concerned; A glossary of common ingredient names should be compiled by the Commission to ensure uniform labelling and to facilitate identification of cosmetics ingredients. whereas that inventory This glossary should not be intended to will be indicative and is not intended to constitute a limitative list of substances used in cosmetic products;

03/15/EC Recital 14 (adapted)

(38) In order to inform improve the information provided to consumers, cosmetic products should bear more precise and easily understandable indications concerning their durability for use.

03/15/EC Recital 15 (adapted)

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(39) A number of substances have been identified by the SCCP as likely to cause allergenic reactions and it will be necessary to restrict their use and/or impose certain conditions concerning them. Certain substances have been identified as an important cause of contact-allergy reactions in fragrance-sensitive consumers. In order to ensure that such consumers are adequately informed, it is therefore necessary to amend the provisions of Directive 76/768/EEC to require that the presence of these substances should be mentioned in the list of ingredients. This information should will improve the diagnosis of contact allergies among such consumers and should will enable them to avoid the use of cosmetic products which they do not tolerate.

(40) The consumer should be protected from misleading claims concerning efficacy and other characteristics of cosmetic products. In order to address specific claims concerning the characteristics of cosmetic products, the possibility to make use of harmonised standards should be provided.

03/15/EC Recital 11 (adapted)

(41) 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 should develop 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 must also taken take 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 of consumers to be able to make practical distinctions between products on the basis of animal testing criteria.

(42) 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.

76/768/EEC Recital 8

(43) In particular, the determination of the methods of analysis together with possible modifications or additions which may have to be made to them on the basis of the results of scientific and technical research, are implementing measures of a technical nature. It is advisable to entrust their adoption to the Commission, subject to certain conditions specified in this Directive, for the purpose of simplifying and accelerating the procedure.

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(44) An 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.

(45) 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 build, where possible, upon existing Community rules for unsafe goods.

76/768/EEC Recital 11 (adapted)

(46) In order to address products which, albeit It could happen that although conforming with to the provisions of this Regulation Directive and its Annexes, cosmetic products placed on the market might endanger human public health , a safeguard procedure should be introduced. It is therefore advisable to provide for a procedure intended to remove this danger.

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(47) 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.

(48) In order to ensure an efficient in-market control, a high degree of administrative cooperation amongst the enforcing authorities is necessary. This concerns in particular the mutual assistance in the verification of product informations files located in another Member State.

76/768/EEC Recital 10

(49) It is necessary, on the basis of scientific and technical research, to draw up proposals for lists of authorized substances which could include antioxidants, hair dyes, preservatives and ultraviolet filters, taking into account in particular the problem of sensitization.

76/768/EEC Recital 9 (adapted)

(50) Technical progress necessitates rapid adaptation of the technical provisions defined in this Directive and in subsequent Directives in this field. It is advisable, in order to facilitate implementation of the measures necessary for this purpose, to provide for a procedure establishing close cooperation between the Member States and the Commission within the Committee for adaptation to technical progress of Directives aimed at the removal of technical obstacles to trade in the cosmetic products sector.

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

(52) 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 procedures for the exercise of implementing powers conferred on the Commission [23].

(53) 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.

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

(55) Economic operators as well as Member States and the Commission need sufficient time to adapt to the changes introduced by this Regulation. Therefore, this Regulation should apply 36 months after its publication.

(56) Directive 76/768/EEC should be repealed.

(57) 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.

76/768/EEC (adapted)

HAVE ADOPTED THIS DIRECTIVE REGULATION :

93/35/EEC (adapted)

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 1 2

Definitions

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

(a) ‘cosmetic product’ means A ‘cosmetic product’ shall mean any substance or preparation or mixture intended to be placed in contact with the various 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, and/or correcting body odours and/or protecting them, or keeping them in good condition or correcting body odours .

76/768/EEC (adapted)

2. The products to be considered as cosmetic products within the meaning of this definition are listed in Annex I.

88/667/EEC

3. Cosmetic products containing one of the substances listed in Annex V shall be excluded from the scope of this Directive. Member States may take such measures as they deem necessary with regard to those products.

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

(c) ‘making available on the market’ means any supply by any means, including electronic means, of a 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;

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

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

(f) ‘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 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on information society services [24] in accordance with Article 6 of that Directive;

(g) ‘traces’ means the non-intended presence of a substance stemming from impurities of natural or synthetic ingredients, the manufacturing process, storage, migration from transport facilities or packaging;

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

(i) ‘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;

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

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

(l) ’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;

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

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

76/768/EEC, recital 5 (adapted)

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.

93/35/EEC (adapted)

Chapter II

Safety, responsible person, free movement

Article 23

Safety

A cosmetic product made available on the market put on the market within the Community must shall be safe for not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the following :

(a) the product’s presentation,;

(b) its labelling,;

(c) any instructions for its use and disposal;

(d) as well as any other indication or information provided by the manufacturer or his authorized agent or by any other person responsible for placing the product on the Community market. the person defined in Article 4.

The provision of such warnings shall not, in any event, exempt any person from compliance with the other requirements laid down in this Directive Regulation .

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Article 4

Responsible person

1. For each cosmetic product placed on the market, a legal or natural person shall ensure compliance with the relevant obligations set out in this Regulation (hereinafter ‘responsible person’).

2. 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.

3. 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.

4. For an imported cosmetic product, each importer shall be the responsible person.

The importer may, by written mandate, designate a person established within the Community as the responsible person.

5. For a cosmetic product made available on the market directly to the consumer from outside the Community by any means and in the absence of an importer, the person placing the cosmetic product on the market shall designate, by written mandate, a person established within the Community as the responsible person.

76/768/EEC (adapted)

Article 3

Member States shall take all necessary measures to ensure that only cosmetic products which conform to the provisions of this Directive and its Annexes may be put on the market.

93/35/EEC (adapted)

Article 5

Good manufacturing practice

1. Manufacturing of cosmetic products shall comply with good manufacturing practice with a view to ensure the objectives of Article 1.

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

76/768/EEC (adapted)

Article 6

Free movement

Member States may not, for reasons related to the requirements laid down in this Directive and the Annexes thereto Regulation , refuse, prohibit or restrict the marketing making available on the market of any cosmetic products which comply with the requirements of this Directive and the Annexes thereto Regulation .

93/35/EEC (adapted)

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Chapter III

Safety assessment, product information file, notification

Article 7a 7

Safety assessment

1. 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 in accordance with Annex I is set up.

The responsible person shall ensure that 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.

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, certificate or other evidence of formal qualifications awarded on completion of a university course of study, or a course recognised as equivalent by a Member State, extending over a period of at least three years of theoretical and practical study in pharmacy, toxicology, medicine or a similar discipline.

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 the 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 European Chemicals Agency.

Article 8

Product information file

1. The responsible person manufacturer or his agent or the person to whose order a cosmetic product is manufactured or the person responsible for placing an imported cosmetic product on the Community market shall for control purposes keep a product information file for the cosmetic product for which he is the responsible person. the following information readily accessible to the competent authorities of the Member State concerned at the address specified on the label in accordance with Article 6 (1) (a):

2. The product information file shall contain the following information and data:

(a) a description of the cosmetic product which allows for a clear attribution of the product information file to the cosmetic product;

(b) the cosmetic product safety report referred to in Article 7(1);

(c) a description of the method of manufacturing and a statement on compliance with good manufacturing practice referred to in Article 5;

(a) the qualitative and quantitative composition of the product; in the case of perfume compositions and perfumes, the name and code number of the composition and the identity of the supplier;

(b) the physico-chemical and microbiological specifications of the raw materials and the finished product and the purity and microbiological control criteria of the cosmetic product;

(c) the method of manufacture complying with the good manufacturing practice laid down by Community law or, failing that, laid down by the law of the Member State concerned; the person responsible for manufacture or first importation into the Community must possess an appropriate level of professional qualification or experience in accordance with the legislation and practice of the Member State which is the place of manufacture or first importation;

2003/15/EC Art. 1.6 (adapted)

(d) assessment of the safety for human health of the finished product. To that end the manufacturer shall take into consideration the general toxicological profile of the ingredients, their chemical structure and their level of exposure. It shall take particular account of the specific exposure characteristics of the areas on which the product will be applied or of the population for which it is intended. 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.

Should the same product be manufactured at several places within Community territory, the manufacturer may choose a single place of manufacture where that information will be available. In this connection, and when so requested for monitoring purposes, it shall be obliged to indicate the place so chosen to the monitoring authority or authorities concerned. In this case this information shall be easily accessible;

93/35/EEC (adapted)

(e) the name and address of the qualified person or persons responsible for the assessment referred to in (d). That person must hold a diploma as defined in Article 1 of Directive 89/48/EEC in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline;

(f) existing data on undesirable effects on human health resulting from use of the cosmetic product;

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

2003/15/EC Art. 1.7 (new)

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

Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, Member States shall ensure that the information required under (a) and (f) shall be made easily accessible to the public by any appropriate means, including electronic means. The quantitative information required under (a) to be made publicly accessible shall be limited to dangerous substances covered by Directive 67/548/EEC.

2. The assessment of the safety for human health referred to in paragraph 1 (d) shall be carried out in accordance with the principle of good laboratory practice laid down in Council Directive 87/18/EEC of 18 December 1986 on the harmonization of laws, regulations and administrative provisions relating to the application of the principles of good laboratory practice and the verification of their application for tests on chemical substances ( [25]).

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

The information referred to in paragraph 1 contained in the product information file must shall be available in the national language or languages of the Member State concerned where the product file is made available , or in a language readily understood by the competent authorities of that Member State.

4. The manufacturer or his agent, or the person to whose order a cosmetic product is manufactured, or the person responsible for placing imported cosmetic products on the Community market, shall notify the competent authority of the Member State of the place of manufacture or of the initial importation of the address of the place of manufacture or of initial importation into the Community of the cosmetic products before the latter are placed on the Community market.

5. Member States shall designate the competent authorities referred to in paragraphs 1 and 4 and shall send details thereof to the Commission, which shall publish that information in the Official Journal of the European Communities.

The Member States shall ensure that the abovementioned authorities continue to cooperate in areas where such cooperation is necessary to the smooth application of this Directive.

82/368/EEC (adapted)

Article 9

Sampling and analysis

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

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2. In absence of any applicable Community legislation, compliance with paragraph 1 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.

76/768/EEC (adapted)

Article 710

Notification

93/35/EEC

2. They may, however, require that the particulars provided for in Article 6 (1) (b), (c), (d) and (f) be expressed at least in their own national or official language or languages; they may also require that the particulars provided for in Article 6 (1) (g) be expressed in a language easily understood by the consumer. To that end, the Commission shall adopt a common ingredients nomenclature in accordance with the Article 10 procedure.

3. Furthermore, a Member State may, for purposes of prompt and appropriate medical treatment in the event of difficulties, require that appropriate and adequate information on substances used in cosmetic products be made available to the competent authority, which shall ensure that that information is used only for the purposes of such treatment.

Each Member State shall designate a competent authority and send details thereof to the Commission, which shall publish that information in the Official Journal of the European Communitites.

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1. The responsible person shall submit, prior to placing the cosmetic product on the market, the following information to the Commission:

(a) the category of cosmetic product and its complete commercial name;

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

(c) the Member State where the cosmetic product is placed on the market;

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

(e) the presence of substances in the form of micronised particles other than substances listed in Annexe III to VI to this Regulation;

(f) the presence of substances classified as carcinogenic, mutagenic or toxic for reproduction, of category 1 or 2, under Annex I to Directive 67/548/EEC;

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

2. The frame formulation referred in point (g) of paragraph 1 shall detail the type of ingredients and their maximum concentration in the cosmetic product. If a cosmetic product is partially or not covered by a frame formulation, relevant quantitative and qualitative information shall be provided.

3. The Commission shall transmit electronically the information referred to in points (a) to (f) of paragraph 1 to the competent authorities.

That information may only be used by the competent authorities for the purposes of market surveillance.

4. The Commission shall transmit electronically the information referred to in points (a) to (d) and in points (f) and (g) of paragraph 1 to poison centres or similar bodies, where established to this end by Member States.

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

5. Where any of the information set out in paragraph 1 changes, the responsible person shall provide an update without delay.

93/35/EEC (new)

Each Member State shall designate a competent authority and send details thereof to the Commission, which shall publish that information in the Official Journal of the European Communities.

82/368/EEC (adapted)

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Chapter IV

Restrictions for certain substances

Article 411

Restrictions for substances listed in the Annexes

1. Without prejudice to Article 3, their general obligations deriving from Article 2, Member States shall prohibit the marketing of cosmetic products shall not contain containing any of the following :

(a) substances listed in Annex II;

(b) substances listed in the first part of Annex III, beyond the limits and outside the conditions which are not used in accordance with the restrictions laid down in Annex III ;

88/667/EEC (new)

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(c) except for hair colouring products referred to in paragraph 2, colorants colouring agents other than those listed in Annex IV, Part 1, with the exception of cosmetic products containing colouring agents intended solely to colour hair and colorants which are not used in accordance with the conditions laid down in that Annex ;

(d) colouring agents listed in Annex IV, Part 1, used outside the conditions laid down, with the exception of cosmetic products containing colouring agents intended solely to colour hair;

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

82/368/EEC (adapted)

(e) preservatives other than those listed in Annex VI, Part 1, V and preservatives which are not used in accordance with the conditions laid down in that Annex ;

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(f) Without prejudice to points (b) (c) and (g), 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.

82/368/EEC (new)

(f) preservatives listed in Annex VI, Part 1, beyond the limits and outside the conditions laid down, unless other concentrations are used for specific purposes apparent from the presentation of the product;

83/574/EEC (adapted)

(g) UV-filters other than those listed in Part 1 of Annex VII VI and UV-filters which are not used in accordance with the conditions set out in that Annex ;

(h) without prejudice to points (b) (c) and (e), 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.

(h) UV filters listed in Part 1 of Annex VII, beyond the limits and outside the conditions laid down therein.

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2. Subject to a Commission Decision to extend the scope of Annex IV to hair colouring products, these 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 not used in accordance with the conditions laid down in that Annex.

The Commission Decision 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 27(3).

2003/15/EC Art. 1.2 (adapted)

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Article 4b12

Substances classified as carcinogenic, mutagenic or toxic for reproduction

(1) The use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction, of category 1, 2 and3, under Annex I to Directive 67/548/EEC shall be prohibited. To that end the Commission shall adopt the necessary measures in accordance with the procedure referred to in Article 10(2). However, a A substance classified in category 3 may be used in cosmetic products cosmetics if the substance has been evaluated by the SCCP SCCNFP and found acceptable safe for use in cosmetic products. To these ends the Commission shall adopt the necessary measures in accordance with the procedure referred to in Article 27(3) .

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(2) The use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction, of category 1 or 2, under Annex I to Directive 67/548/EEC shall be prohibited.

However, such substances may be used in cosmetic products if, subsequent to their classification as carcinogenic, mutagenic or toxic for reproduction of category 1 or 2 under Directive 67/548/EEC, all of the following conditions are fulfilled:

– they have been evaluated and found safe for use by the SCCP in cosmetic products in particular in view of exposure;

– they are complying 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 [26];

– there are no suitable alternative substances available, as documented in an analysis of alternatives.

Specific labelling in order to avoid misuse of the cosmetic product shall be provided in accordance with Article 3, 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 procedure referred to in Article 27(3) within 15 months at the latest after the inclusion of the substances concerned in Annex I to Council Directive 67/548/EEC.

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 27(4).

The Commission shall mandate the SCCP to re-evaluate those substances as soon as safety concerns arise and at the latest every 5 years after their inclusion in Annexes III to VI.

82/368/EEC (adapted)

Article 13

Traces

2. Without prejudice to Article 3, Tthe presence of traces of the prohibited substances listed in Annex II shall be allowed provided that such presence is technically unavoidable in good manufacturing practice and that it conforms with Article 2.

2003/15/EC Art. 1.2 (adapted)

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Chapter V

Animal testing

Article 4a 14

Animal testing

1. Without prejudice to the general obligations deriving from Article 23, the following shall not be allowed Member States shall prohibit:

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

(d) the performance within the Community on their territory of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Regulation Directive, no later than the date on which such tests are required to be replaced by one or more validated alternative methods listed in Annex V to Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances [27] or in Annex VIIIIX to this Regulation Directive.

No later than 11 September 2004 the Commission shall, in accordance with the procedure referred to in Article 10(2) and after consultation of the Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers (SCCNFP) establish the contents of Annex IX.

2. The Commission, after consultation of the SCCNFP SCCP and of the European Centre for the Validation of Alternative Methods (ECVAM) and with due regard to the development of validation within the OECD, shall establish has established timetables for the implementation of the provisions under paragraph 1(a), (b) and (d), including deadlines for the phasing-out of the various tests. The timetables shall be were made available to the public on 1st October 2004 not later than 11 September 2004 and be sent to the European Parliament and the Council. The period for implementation shall be limited to 11 March 2009 a maximum of six years after the entry into force of Directive 2003/15/EC [28] in relation to paragraph 1(a), (b) and (d).

2.1. 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 a maximum of 10 years after the entry into force of Directive 2003/15/EC.

2.2. 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 should form part of the yearly reports presented pursuant to Article 930.

On the basis of these annual reports, the timetables established in accordance with paragraph 2 , first subparagraph, may be adapted up to 11 March 2009 within a maximum time limit of six years in relation to as referred to in the first subparagraph paragraph 2 or 11 March 2013 10 years in relation to as referred to in the second subparagraph paragraph 2.1 and after consultation of the entities referred to in the first subparagraph paragraph 2.

2.3 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 should form part of the yearly reports presented pursuant to Article 930. If these studies conclude, at the latest two years prior to the end of the maximum period referred to in the second subparagraph paragraph 2.1, that for technical reasons one or more tests referred to in that subparagraph paragraph 2.1 will not be developed and validated before the expiry of the period referred to therein in paragraph 2.1 it shall inform the European Parliament and the Council and shall put forward a legislative proposal in accordance with Article 251 of the Treaty.

2.4 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 consultation of the SCCP SCCNFP and by means of a reasoned decision, authorise the derogation in accordance with the procedure referred to in Article 10(2). This authorisation shall lay down the conditions associated with this derogation in terms of specific objectives, duration and reporting of the results.

The measures 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 27(3).

A derogation shall only be granted if:

(a) the ingredient is in wide use and cannot be replaced by another ingredient able to perform 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 to be presented by the Commission in accordance with Article 930.

3. For the purposes of this Article and Article 16:

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

88/667/EEC (adapted)

Article 5

Member States shall allow the marketing of cosmetic products containing:

(a) the substances listed in Annex III, Part 2, within the limits and under the conditions laid down, up to the dates in column (g) of that Annex;

(b) the colouring agents listed in Annex IV, Part 2, within the limits and under the conditions laid down, until the admission dates given in that Annex;

(c) the preservatives listed in Annex VI, Part 2, within the limits and under the condition laid down, until the dates given in column (f) of that Annex. However, some of these substances may be used in other concentrations for specific purposes apparent from the presentation of the product;

(d) the UV filters listed in Part 2 of Annex VII, within the limits and under the conditions laid down, until the dates given in column (f) of that Annex.

At these dates, these substances, colouring agents, preservatives and UV filters shall be:

– definitively allowed, or

– definitively prohibited (Annex II), or

– maintained for a given period specified in Part 2 of Annexes III, IV, VI and VII, or

– deleted from all the Annexes, on the basis of available scientific information or because they are no longer used.

93/35/EEC

Article 5a

1. No later than 14 December 1994 the Commission shall, under the procedure laid down in Article 10, compile an inventory of ingredients employed in cosmetic products, on the basis in particular of information supplied by the industry concerned.

For the purposes of this Article, ‘cosmetic ingredient’ shall mean any chemical substance or preparation of synthetic or natural origin, except for perfume and aromatic compositions, used in the composition of cosmetic products.

The inventory shall be divided into two sections: one concerning perfume and aromatic raw materials and the second concerning other substances.

2. The inventory shall contain informtion on:

– the identity of each ingredient, in particular its chemical name, the CTFA name, the European Pharmacopoeia name, the international non-proprietary names recommended by the World Health Organization, the Einecs, Iupac, CAS and colour index numbers, and the common name referred to in Article 7 (2),

– the usual function(s) of the ingredient in the final product,

– where appropriate, restrictions and conditions of use and warnings which must be printed on the label by reference to the Annexes.

3. The Commission shall publish the inventory and shall update it periodically under the procedure provided for in Article 10. The inventory shall be indicative and shall not constitute a list of the substances authorized for use in cosmetic products

88/667/EEC (adapted)

Chapter VI

Consumer information

Article 615

Labelling

93/35/EEC (adapted)

1. Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if the Without prejudice to other provisions in this Article, the container and packaging of cosmetic products shall bear the following information in indelible, easily legible and visible lettering; the information mentioned in point (g) may, however, be indicated on the packaging alone:

88/667/EEC (adapted)

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(a) the name or style and the address or registered office of the manufacturer or the responsible person responsible for marketing the cosmetic product who is established within the Community. Such information may be abbreviated in so far as the abbreviation makes it generally possible to identify the undertaking. that person . If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted; Member States may require that the country of origin be specified for goods manufactured outside the Community;

(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;

2003/15/EC Art. 1.3 (adapted)

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(c) the date of minimum durability date until which the cosmetic product, stored under appropriate conditions, continues to fulfil its initial function and, in particular, remains in conformity with Article 3 (hereinafter: “date of minimum durability”);

The date itself or details of where it appears on the packaging shall be preceded by

– the symbol given in point 3 of Annex VII to this Regulation or indicated by

– the words: ‘best used before the end of’. followed by either: the date itself, or

– details of where it appears on the packaging;

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 can be used without any harm to the consumer. This information shall be indicated by the symbol given in Annex VIIIa set out in point 2 of Annex VII to this Regulation followed by the period (in months and/or years);

93/35/EEC (adapted)

(d) particular precautions to be observed in use, and at least especially those listed in the column ‘Conditions of use and warnings which must be printed on the label’ inAnnexes III to VI III, IV, VI and VII, which must appear on the container and packaging, and as well as any special precautionary information on cosmetic products for professional use.., in particular in hairdressing. Where this is impossible for practical reasons, an enclosed leaflet, label, tape or card must contain that information to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII, which must appear on the container and the packaging;

88/667/EEC (adapted)

(e) the batch number of manufacture or the reference for identifying the cosmetic product goods. Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging;

93/35/EEC (adapted)

(f) the function of the cosmetic product, unless it is clear from its the presentation of the product;

2003/15/EC Art. 1.4 (adapted)

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(g) a list of ingredients in descending order of weight at the time they are added. This information may be indicated on the packaging alone. The That list shall be preceded by the term word‘ingredients’. Where that is impossible for practical reasons, an enclosed leaflet, label, tape or card must contain the ingredients to which the consumer is referred either by abbreviated information or the symbol given in Annex VIII, which must appear on the packaging.

The following shall not, however, be regarded as ingredients:

(i) - impurities in the raw materials used,

(ii) - subsidiary technical materials used in the preparation but not present in the final product,

(iii) - materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions.

Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ word ‘perfume’ or ‘aroma’. However, the presence of substances, the mention of which is required under the column ‘other limitations and requirements’ in Annex III, shall be indicated in the list irrespective of their function in the product.

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 %.

Colouring agents Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients, in accordance with the colour index number or denomination adopted in Annex IV. For decorative cosmetic products marketed in several colour shades, all colouring agents 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.

An ingredient must be identified by the common name referred to in Article 7(2) or, failing that, by one of the names referred to in Article 5a(2), first indent.

In accordance with the procedure referred to in Article 10(2), the Commission may adapt the criteria and conditions set out in Commission Directive 95/17/EC of 19 June 1995 laying down detailed rules for the application of Council Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for the labelling of cosmetic products [29] under which a manufacturer may, for reasons of trade secrecy, apply not to include one or more ingredients on the abovementioned list.

93/35/EEC (adapted)

2. When 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.

Where it is impracticable, for reasons of size or shape, for the particulars referred to in points (d) and (g), to appear in an enclosed leaflet, those particulars shall appear on a label, tape or card which is enclosed or attached to the cosmetic product.

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

42. 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 particulars referred to in paragraph 1.

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

6. The person making the product available to the end user is responsible for the respect of paragraphs 3 to 5.

7. 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 28. In the absence of a common ingredient name, a term as contained in a generally accepted nomenclature shall be used.

88/667/EEC (adapted)

1 2003/15/EC Art. 1.5

Article 16

Product claims

3.1. Member States shall take all measures necessary to ensure that, iIn the labelling, putting up for sale making available on the market and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs shall are not be used to imply that these products have characteristics which they do not have. 1 ---

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Compliance with the first subparagraph shall be presumed if the cosmetic products are in accordance with the relevant harmonised standards, the references of which have been published in the Official Journal of the European Union.

2003/15/EC Art. 1.5 (adapted)

2. Furthermore, the manufacturer or The responsible person responsible for placing the product on the Community market may refer take advantage, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the cosmetic product, to of 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. Guidelines shall be adopted in accordance with the procedure referred to in Article 10(2) and published in the Official Journal of the European Union. The European Parliament shall receive copies of the draft measures submitted to the Committee.

2003/15/EC Art. 1.7 (adapted)

Article 17

Access to information for the public

Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, Member States the responsible person shall ensure that the qualitative and quantitative composition of the cosmetic product and, in the case of perfume compositions and perfumes, 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 is information required under (a) and (f) shall be made publicly easily accessible to the public by any appropriate means, including electronic means.

The quantitative information regarding composition of the cosmetic product required under (a) to be made publicly accessible shall be limited to dangerous substances covered by Directive 67/548/EEC [30].

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Chapter VII

Market surveillance

Article 18

In-market control

Member States shall survey compliance with this Regulation via in-market controls of the cosmetic products made available on the market.

Article 19

Communication of serious undesirable effects

1. The responsible person shall without delay notify the following to the competent authority where the product information file is readily accessible:

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

(b) the complete commercial name of the product concerned,

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

2. The competent authority concerned shall transmit the information referred to in paragraph 1 to the competent authorities of the other Member States.

3. Competent authorities may use the information referred to in this Article only for the purposes of in-market surveillance.

Article 20

Information on concentration of substances

In case of serious doubt regarding the safety of any substance contained in cosmetic products, the competent authority of a Member State where 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 only for the purposes of in-market surveillance.

Chapter VIII

Non-compliance, safeguard clause

Article 21

Non compliance

1. Competent authorities shall require the responsible person to take all appropriate measures, including corrective actions bringing the product into compliance, 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 any of the following:

(a) the requirements for the product information file referred to in Article 8;

(b) the notification requirements referred to in Article 10;

(c) the good manufacturing practices referred to in Article 5;

(d) the restrictions for substances referred to in Articles 11 and 12;

(e) the labelling requirements referred to in Article 15(1), (2), and (7);

(f) the requirements related to product claims set out in Article 16;

(g) the animal testing requirements referred to in Article 14.

2. 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.

3. In the case of serious risks for human health, where the competent authority considers that the non-compliance is not limited to the territory of the Member State where the 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.

4. 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 case of serious risk for human health; or

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

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

5. For the purposes of paragraphs 3 and 4 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 [31] shall be used.

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

76/768/EEC (new)

Article 12

1. If a Member State notes, on the basis of a substantiated justification, that a cosmetic product, although complying with the requirements of the Directive, represents a hazard to health, it may provisionally prohibit the marketing of that product in its territory or subject it to special conditions. It shall immediately inform the other Member States and the Commission thereof, stating the grounds for its decision.

88/667/EEC (new)

2. The Commission shall as soon as possible consult the Member States concerned, following which it shall deliver its opinion without delay and take the appropriate steps.

76/768/EEC (new)

3. If the Commission is of the opinion that technical adaptations to the Directive are necessary, such adaptations shall be adopted by either the Commission or the Council in accordance with the procedure laid down in Article 10. In that event, the Member State which has adopted safeguard measures may maintain them until entry into force of the adaptations.

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Article 22

Safeguard clause

1. Where Article 21 does not apply, and a competent authority ascertains that a cosmetic product placed on the market is liable to present a serious risk for human health, it shall take all appropriate provisional measures in order to ensure that a cosmetic product is withdrawn, recalled or its availability otherwise restricted.

2. The competent authority shall immediately communicate to the Commission and the competent authorities of the other Member States of 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 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 SCCP.

4. If the provisional measures are justified, Article 26(1) shall apply.

5. If 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.

76/768/EEC (new)

Article 13

Precise reasons shall be stated for any individual measures placing a restriction or ban on the marketing of cosmetic products taken pursuant to this Directive. It shall be notified to the party concerned together with particulars of the remedies available to him under the laws in force in the Member States and of the time limits allowed for the exercise of such remedies.

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Article 23

Good administrative practices

1. Any decision taken pursuant to Articles 21 and 22 shall state the exact grounds on which it is based. It shall be notified 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 case where immediate action is necessary for reasons of serious risk for human health, the responsible person shall have the opportunity to put forward his viewpoint before any decision is taken.

Chapter IX

Administrative cooperation

Article 24

Cooperation between competent authorities

1. The competent authorities of the Member States shall cooperate with each other and with the Commission and transmit to each other all information necessary in view of 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 25

Cooperation regarding verification of product information file

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 8(2) and whether the information set out therein provide 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, carry out the verification and shall inform the requesting competent authority of its finding.

76/768/EEC (new)

Article 8

1. In accordance with the procedure laid down in Article 10 the following shall be determined:

– the methods of analysis necessary for checking the composition of cosmetic products,

– the criteria of microbiological and chemical purity for cosmetic products and methods for checking compliance with those criteria.

93/35/EEC (new)

1 2003/15/EC Art. 1.8

2. The common nomenclature of ingredients used in cosmetic products and, after consultation of the 1 Scientific Committee for Cosmetic Products and Non-Food Products intended for Consumers , the amendments necessary for the adaptation to technical progress of the Annexes shall be adopted in accordance with the same procedure, as appropriate.

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Chapter X

Implementing measures, final provisions

Article 26

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 consultation of the SCCP, 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 27(3).

On imperative grounds of urgency, the Commission may use the urgency procedure referred to in Article 27(4).

2. The Commission may, after consultation of the SCCP, 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 27(3).

3. Where it appears necessary, in order to ensure the safety of cosmetic products placed on the market, the Commission may, after consultation of the SCCP, 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 27(3).

2003/15/EC Art. 1.9 (adapted)

Article 10 27

Committee

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.

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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.

2003/15/EC Art. 1.9 (new)

3. The Committee shall adopt its rules of procedure

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Article 28

Glossary of common ingredient names

The Commission shall compile and update a glossary of common ingredient names. 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 29

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 bodies referred to in Article 10(4) to the Commission. They shall communicate an update of these details when 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.

82/368/EEC

1 2003/15/EC Art. 1.8

Article 8a

1. Notwithstanding Article 4 and without prejudice to Article 8 (2), a Member State may authorize the use within its territory of other substances not contained in the lists of substances allowed, for certain cosmetic products specified in its national authorization, subject to the following conditions:

(a) the authorization must be limited to a maximum period of three years;

(b) the Member State must carry out an official check on cosmetic products manufactured from the substance or preparation use of which it has authorized;

(c) cosmetic products thus manufactured must bear a distinctive indication which will be defined in the authorization.

2. The Member Stats shall forward to the Commission and to the other Member States the next of any authorization decision taken pursuant to paragraph 1 within two months of the date on which it came into effect.

3. Before expiry of the three-year period provided for in paragraph 1, the Member State may submit to the Commission a request for the inclusion in a list of permitted substances of the substance given national authorization in accordance with paragraph 1. At the same time, it shall supply supporting documents setting out the grounds on which it deems such inclusion justified and shall indicate the uses for which the substance or preparation is intended. Within 18 months of submission of the request, a decision shall be taken on the basis of the latest scientific and technical knowledge, after consultation, at the initiative of the Commission or of a Member State, of the 1 Scientific Committee for Cosmetic Products and Non-Food Products intended for Consumers and in accordance with the procedure laid down in Article 10 as to whether the substance in question may be included in a list of permitted substances or whether the national authorization should be revoked. Notwithstanding paragraph 1 (a), the national authorization shall remain in force until a decision is taken on the request for inclusion in the list.

2003/15/EC Art. 1.9 (adapted)

Article 930

Annual report on animal testing

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

(a1) 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 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 [32]. The Commission shall in particular ensure the development, validation and legal acceptance of alternative test methods which do not use live animals;

(b2) 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 non-member 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;

(c3) the manner in which the specific needs of small and medium-sized enterprises have been taken into account.

76/768/EEC

Article 11

Without prejudice to Article 5 and not later than one year after expiry of the period laid down in Article 14 (1) for implementation of this Directive by the Member States, the Commission shall, on the basis of the results of the latest scientific and technical research, submit to the Council appropriate proposals establishing lists of permitted substances.

Article 14

1. Member States shall bring into force the provisions needed in order to comply with this Directive within 18 months of its notification and shall forthwith inform the Commission thereof.

2. Member States may, however, for a period of 36 months from notification of this Directive, authorize the marketing in their territory of cosmetic products which do not conform to the requirements of the Directive.

3. Member States shall ensure that the texts of such provisions of national law as they adopt in the field governed by this Directive are communicated to the Commission.

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Article 31

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 32

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 on [date to be added: 36 months after publication of this Regulation in the Official Journal of the European Union] at the latest and shall notify it without delay of any subsequent amendment affecting them.

Article 33

Repeal

Directive 76/768/EEC is repealed with effect from [date to be added: 36 months after publication of this Regulation in the Official Journal of the European Union].

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

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.

Article 34

Entry into force

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 [date to be added: 36 months after publication in the Official Journal of the European Union].

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

76/768/EEC

Article 15

This Directive is addressed to the Member States.

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Done at Brussels, […]

For the European Parliament For the Council

The President The President

[…] […]

76/768/EEC (adapted)

ANNEX I

ILLUSTRATIVE LIST BY CATEGORY OF COSMETIC PRODUCTS

– Creams, emulsions, lotions, gels and oils for the skin (hands, face, feet, etc.).

– Face masks (with the exception of peeling products).

– Tinted bases (liquids, pastes, powders).

– Make-up powders, after-bath powders, hygienic powders, etc.

– Toilet soaps, deodorant soaps, etc.

– Perfumes, toilet waters and eau de Cologne.

– Bath and shower preparations (salts, foams, oils, gels, etc.).

– Depilatories.

– Deodorants and anti-perspirants.

– Hair care products:

– hair tints and bleaches,

– products for waving, straightening and fixing,

– setting products,

– cleansing products (lotions, powders, shampoos),

– conditioning products (lotions, creams, oils),

– hairdressing products (lotions, lacquers, brilliantines).

– Shaving products (creams, foams, lotions, etc.).

– Products for making up and removing make-up from the face and the eyes.

– 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.

– Anti-wrinkle products.

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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 product

Description of the qualitative and quantitative composition of the product, including chemical identity of the substances (incl. chemical name, INCI, CAS, EINECS/ELINCS) and their intended function. In the case of essential oils, perfume compositions and perfumes, 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

Description of the physical and chemical characteristics of the substances, the raw-material as well as the cosmetic product.

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

3. Microbiological quality

Description of the microbiological specifications of the raw material 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

Description of purity of the substances and raw material.

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

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

5. Normal and reasonably foreseeable use

Description of 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

Description of 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

Description of 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 14, description of the toxicological profile of 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.

In case of significant percutaneous absorption, systemic effects shall be considered and NOAEL shall be assessed. 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;

– 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

Description of 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. description of existing studies from human volunteers.

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 15(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 calculated 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. If such interaction is not expected, this shall be duly justified.

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 not to stay in prolonged contact with 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,

– in the vicinity 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 European Inventory of Existing Commercial chemical Substances (EINECS) numbers and the European List of Notified Chemical Substances (ELINCS) numbers.

76/768/EEC

ANNEX II

82/368/EEC (adapted)

LIST OF SUBSTANCES PROHIBITED IN WHICH MUST NOT FORM PART OF THE COMPOSITION OF COSMETIC PRODUCTS

76/768/EEC (adapted)

1 82/368/EEC

2 90/121/EEC

Reference number | Substance identification |

| Chemical name/INN | CAS number | EINECS/ELINCS number |

a | b | c | d |

1. | N-5-Chlorobenzoxazol-2-ylacetamide | 35783-57-4 | |

2. | 1 (2-Acetoxyethyl)trimethylammonium hydroxide (acetylcholine) and its salts | 51-84-3 | 200-128-9 |

3. | Deanol aceglumate (INN) ( [33]) | 3342-61-8 | 222-085-5 |

4. | Spironolactone (INN) * | 52-01-7 | 200-133-6 |

5. | 1 [4-(4-Hydroxy-3-iodophenoxy)-3,5-diiodophenyl]acetic acid 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 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. | 1 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. | 1 Imperatorin (9-(3-methoxylbut-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 2 --- | | |

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. | 1 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 |

83/191/EEC (adapted)

46. | Barium salts, with the exception of barium sulphate, barium sulphide under the conditions laid down in Annex III, Part 1], and lakes, salts and pigments prepared from the colouring agents listed with the reference (5) in Annex III , Part 2 and Annex IV, Part 2 | | |

76/768/EEC (adapted)

1 82/368/EEC

2 85/391/EEC

47. | Benzene | 71-43-2 | 200-753-7 |

48. | 1 Benzimidazol-2(3H)-one | 615-16-7 | 210-412-4 |

49. | 1 Benzazepines and benzodiazepines | 12794-10-4 | |

50. | 1 1-Dimethylaminomethyl-1-methylpropyl benzoate (amylocaine) and its salts | 644-26-8 | 211-411-1 |

51. | 1 2,2,6-Trimethyl-4-piperidyl benzoate (benzamine) and its salts | 500-34-5 | |

52. | 1 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. | (1R,2S)-Hexahydro-1,2-dimethyl-3,6-epoxyphthalic anhydride (cantharidin) | 56-25-7 | 200-263-3 |

71. | Phenprobamate (INN) * | 673-31-4 | 211-606-1 |

72. | 1 Nitroderivatives of carbazole | 31438-22-9 | |

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. | 1 Diphenoxylate (INN) * hydrochloride | 3810-80-8 | 223-287-6 |

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. | 1 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. | 1 Chlormezanone (INN) * | 80-77-3 | 201-307-4 |

92. | Triparanol (INN) * | 78-41-1 | 201-115-0 |

93. | 2-[2(4-Chiorophenyl)-2-phenylacetyl]indane-1,3-dione (chlorophacinone-ISO) | 3691-35-8 | 223-003-0 |

94. | Chlorphenoxamine (INN) * | 77-38-3 | |

95. | 1 2-[2-(4-Chlorophenyl)-2-phenylacetyl]indan 1,3-dione (chlorophacinone - ISO) 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. | GColchicum 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 (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. | 1 2-α-Cyclohexylbenzyl(N,N,N',N',-tetraethyl)trimethylenediamine (phenetamine) | | |

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. | Dextropropoxyphene (INN) * | 469-62-5 | 207-420-5 |

117. | 1 O,O'-Diacetyl-N-allyl-N-normorphine | 2748-74-5 | |

118. | Pipazetate (INN) * and its salts | 2167-85-3 | 218-508-8 |

119. | 1 5-(αβ-Dibromophenethyl)-5-methylhydantoin | 511-75-1 | 208-133-8 |

120. | 1 N,N'-Pentamethylenebis (trimethylammonium salts), e. g. pentamethonium bromide (INN) * | 541-20-8 | 208-771-7 |

121. | 1 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. | 1 N,N'-Hexamethylenebis(trimethylammonium) salts, e. g. hexamethonium bromide (INN) * | 55-97-0 | 200-249-7 |

125. | Dichloroethanes (ethylene chlorides) | | |

126. | Dichloroethylenes (acetylene chlorides) | | |

127. | Lysergide (INN) * and its salts | 50-37-3 | 200-033-2 |

128. | 1 2-Diethylaminoethyl-3-hydroxy-4-phenylbenzoate and its salts | | |

129. | Cinchocaine (INN) * and its salts | 85-79-0 | 201-632-1 |

130. | 3-Diethylaminopropyl cinnamate | 538-66-9 | |

131. | 1 O,O'-Diethyl O-4-nitrophenyl phosphorothioate (pParathion-lSO) | 56-38-2 | 200-271-7 |

132. | 1 [Oxalylbisiminoethylene)]bis[(o-chlorobenzyl)diethylammonium salts], e. g. ambenonmium 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 1,1-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 | | |

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. | 1 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. | 1 5,5-Diphenyl-4-imidazolidone | 3254-93-1 | 221-851-6 |

161. | Probenecid (INN) * | 57-66-9 | 200-344-3 |

162. | Disulfiram (INN) *; thiram (ISO) (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 2 Annex VIVII, Part 2 | | |

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 | 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 | |

2003/83/EC Art. 1 and Annex .1(a) amended by Corrigendum, OJ L 058, 26.2.2004, p. 28 (adapted)

178. | 4-Benzyloxyphenol and 4-ethoxyphenol | 103-16-2; 622-62-8 | 203-083-3; 210-748-1 |

76/768/EEC (adapted)

179. | Parethoxycaine (INN) * and its salts | 136-46-9 | 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 |

82/368/EEC (adapted)

191. | Hydrofluoric acid, its normal salts, its complexes and hydrofluorides with the exception of those given in Annex III, Part 1 | 7664-39-3 | 231-634-8 |

76/768/EEC (adapted)

1 82/368/EEC

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. | 1 (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-dimethano-naphthalene (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 | 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. | 1 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. | 1 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. | 1 Decamethylenebis(trimethylammonium) salts, e. g. decamethonium bromide | 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. | 1 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 | | |

86/199/EEC (adapted)

1 91/184/EEC

221. | Mercury and its compounds, except those special cases included 1 in Annex VVI, Part 1 | 7439-97-6 | 231-106-7 |

76/768/EEC (adapted)

1 82/368/EEC

2 89/174/EEC

222. | 3,4,5-Trimethoxyphenethylamine 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. | 1 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. | 1 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. | 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-) | | |

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 2 --- | | |

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 | 220-673-6 |

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 |

82/368/EEC (adapted)

268. | Picric acid | 88-89-1 | 201-865-9 |

76/768/EEC (adapted)

1 82/368/EEC

269. | Phenacemide (INN) * | 63-98-9 | 200-570-2 |

270. | Difencldoxazine (INN) * | 5617-26-5 | |

271. | 1 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. | 1 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. | 1 α-Piperidin-2-ylbenzyl acette (SIC! acetate) , laevorotatory threoform (levofphacetoperane) (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 |

2004/93/EC Art. 1 and Annex .1 (adapted)

289. | Lead and its compounds | 7439-92-1 | 231-100-4 |

76/768/EEC (adapted)

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 |

2002/34/EC Art. 1 and Annex .1(i)

293. | Radioactive substances, as defined by Directive 96/29/Euratom [34] laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionising radiation | | |

76/768/EEC (adapted)

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 | | |

85/391/EEC (adapted)

297. | Selenium and its compounds with the exception of selenium disulphideele under the conditions set out under reference No 49 in Annex III, Part 1 | 7782-49-2 | 231-957-4 |

76/768/EEC (adapted)

1 82/368/EEC

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 | | |

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. | 1 Sulphonamides (sulphanilamide and its derivatives…) and their salts 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. | 1 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 |

82/368/EEC (adapted)

321. | Thiourea and its derivatives, with the exception of the one listed in Annex III, Part 1 | 62-56-6 | 200-543-5 |

76/768/EEC (adapted)

new

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 listed in the Annex to the second Council Directive of 20 May 1975 on the approximation of provisions laid down by law, regulation or administrative action relating to proprietary medicinal products (OJ No L 147, 9. 6. 1975, p. 13) | | |

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. | Trich l iormethine (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 Steinhrn. 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 o f lficinale Lind (seeds and galenical preparations) | 84604-18-2 | 283-296-6 |

84/415/EEC (adapted)

333. | Veratrum Spp and their preparations | 90131-91-2 | 290-407-1 |

76/768/EEC (adapted)

1 82/368/EEC

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 | | |

337. | Yohbimbine 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. | Pyretbhrum album L. and its galenical preparations | | |

346. | 1 2-[4-Methoxybenzyl-N-(2-pyridyl)amino]ethyldimethylamine 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 | |

82/368/EEC (adapted)

350. | Tetrabromosalicylanilides | | |

351. | Dibromosalicylanilides | 24556-64-7 | 246-310-1 |

76/768/EEC (adapted)

352. | Bithionol (INN) * | 97-18-7 | 202-565-0 |

353. | Thiuram monosulphides | 97-74-5 | 202-605-7 |

354. | Thiuram disulphides | 137-26-8 | 205-286-2 |

355. | Dimethylformamide | 68-12-2 | 200-679-5 |

356. | 4-Phenylbut-3-en-2-one | 122-57-6 | 204-555-1 |

357. | Benzoates of 4-hydroxy-3-methoxycinnamyl alcohol except for normal content in natural essences used | | |

95/34/EC (adapted)

358. | Furocoumarines (e. g. trioxyysalean (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 |

76/768/EEC (adapted)

359. | Oil from the seeds of Laurus nobilis L. | 84603-73-6 | 283-272-5 |

82/368/EEC (adapted)

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 |

76/768/EEC (adapted)

361. | 5,5'-Di-isopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite | 552-22-7 | 209-007-5 |

2000/11/EC Art. 1 and Annex .II (adapted)

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 | 88-29-9 | 201-817-7 |

83/341/EEC (adapted)

363. | Oo-phenylenediamine and its salts | 95-54-5 | 202-430-6 |

364. | 4-methyl-m-phenylenediamine and its salts | 95-80-7 | 202-453-1 |

2000/11/EC Art. 1 and Annex .II (adapted)

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; - |

86/179/EEC (adapted)

366. | Chloroform | 67-66-3 | 200-663-8 |

2000/11/EC Art. 1 and Annex .II (adapted)

367. | 2,3,7,8-Tetra chlorodibenzo-p-dioxin | 1746-01-6 | 217-122-7 |

86/179/EEC (adapted)

368. | 2,6-Dimethyl-1,3-dioxan-4-yl acetate (Dimethoxane) | 828-00-2 | 212-579-9 |

369. | Pyrithione sodium (INNM) | 3811-73-2 | 223-296-5 |

87/137/EEC (adapted)

370. | N-(Trichloromethylthio)-4-cyclohexene-1,2-dicarboximide (captan) | 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 |

2000/11/EC Art. 1 and Annex .II (adapted)

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 | |

88/233/EEC (adapted)

1 90/121/EEC

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) 1 and their salts | 615-05-4 | 210-406-1 |

377. | 1-Methoxy-2,5-diaminobenzene (2,5-diaminoanisole) 1 and their salts | 5307-02-8 | 226-161-9 |

378. | Colouring agent CI 12140 | 3118-97-6 | 221-490-4 |

379. | Colouring agent CI 26105 | 85-83-6 | 201-635-8 |

380. | Colouring agent CI 42555Colouring agent CI 42555:1Colouring agent CI 42555:2 | 548-62-9467-63-0 | 208-953-6207-396-6 |

89/174/EEC (adapted)

381. | Amyl 4-dimethylaminobenzoate, mixed isomers (Padimate A (INN)) | 14779-78-3 | 238-849-6 |

89/174/EEC (adapted)

383. | 2-Amino-4-nitrophenol | 99-57-0 | 202-767-9 |

384. | 2-Amino-5-nitrophenol | 121-88-0 | 204-503-8 |

90/121/EEC (adapted)

385. | 11-α-Hydroxypregn-4-ene-3,20-dione and its esters | 80-75-1 | 201-306-9 |

2000/11/EC Art. 1 and Annex .II (adapted)

385. 11α-Hydroxypregn-4-ene-3, 20-dione) and its esters

2000/11/EC Art. 1 and Annex .II (adapted)

386. | Colouring agent CI 42640 | 1694-09-3 | 216-901-9 |

90/121/EEC (adapted)

387. | Colouring agent CI 13065 | 587-98-4 | 209-608-2 |

388. | Colouring agent CI 42535 | 8004-87-3 | |

389. | Colouring agent CI 61554 | 17354-14-2 | 241-379-4 |

2000/11/EC Art. 1 and Annex .II (adapted)

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, Part One, and the zirconium lakes, pigments or salts of the colouring agents listed in Annex IV, Part One, with reference number 3 | 7440-67-7 | 231-176-9 |

393. | Acetonitrile | 75-05-8 | 200-835-2 |

394. | Tetrahydrozoline Tetryzoline (INN) and its salts | 84-22-0 | 201-522-3 |

91/184/EEC (adapted)

395. | Hydroxy-8-quinoline and its sulphate, except for the uses provided for in No 51 in Annex III, Part 1 | 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 and its lakes, pigments and salts | 3468-63-1 | 222-429-4 |

398. | Colouring agent CI 45170 and CI 45170:1 | 81-88-9; 509-34-2 | 201-383-9; 208-096-8 |

399. | Lidocaine (INN) | 137-58-6 | 205-302-8 |

92/86/EEC (adapted)

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. | Catechol | 120-80-9 | 204-427-5 |

409. | Pyrogallol | 87-66-1 | 201-762-9 |

410. | Nitrosamines | | |

2003/83/EC Art. 1 and Annex .1(c)

411. | Secondary alkyl- and alkanolamines and their salts | | |

93/47/EEC (adapted)

412. | 4-Amino-2-nitrophenol | 119-34-6 | 204-316-1 |

94/32/EC (adapted)

413. | 2-Methyl-m-phenylenediamine | 823-40-5 | 212-513-9 |

95/34/EC (adapted)

414. | 4-tert-Butyl-3-methoxy-2,6-dinitrotoluene (Musk Ambrette) | 83-66-9 | 201-493-7 |

95/34/EC (adapted)

416. | Cells, tissues or products of human origin | | |

417. | 3,3-Bis(4-hydroxyphenyl)phthalide (Phenolphthalein (INN) ) | 77-09-8 | 201-004-7 |

96/41/EC (adapted)

418. | 3-Imidazol-4-ylacrylic acid and its ethyl ester (urocanic acid) | 104-98-3, 27538-35-8 | 203-258-4, 248-515-1 |

2006/78/EC Art. 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 [35], and ingredients derived therefrom | | |

97/45/EC (adapted)

420. | Crude and refined coal tars | 8007-45-2 | 232-361-7 |

98/62/EC (adapted)

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 |

2002/34/EC Art. 1 and Annex .1(ii) (adapted)

1 2002/34/EC Art. 1 and Annex .1(ii) amended by Corrigendum, OJ L 341, 17.12.2002, p. 71

423. | Alanroot oil (Inula helenium) (CAS No 97676-35-2), when used as a fragrance ingredient | 97676-35-2 | |

424. | Benzyl cyanide (CAS No 140-29-4), when used as a fragrance ingredient | 140-29-4 | 205-410-5 |

425. | Cyclamen alcohol (CAS No 4756-19-8), when used as a fragrance ingredient | 4756-19-8 | 225-289-2 |

426. | Diethyl maleate (CAS No 141-05-9), when used as a fragrance ingredient | 141-05-9 | 205-451-9 |

427. | Dihydrocoumarine (CAS No 119-84-6), when used as a fragrance ingredient | 119-84-6 | 204-354-9 |

428. | 2,4-Dihydroxy-3-methylbenzaldehyde (CAS No 6248-20-0), when used as a fragrance ingredient | 6248-20-0 | 228-369-5 |

429. | 3,7-Dimethyl-2-octen-1-ol (6,7-Dihydrogeraniol) (CAS No 40607-48-5), when used as a fragrance ingredient | 40607-48-5 | 254-999-5 |

430. | 4,6-Dimethyl-8-tert-butylcoumarin (CAS No 17874-34-9), when used as a fragrance ingredient | 17874-34-9 | 241-827-9 |

431. | Dimethyl citraconate (CAS No 617-54-9), when used as a fragrance ingredient | 617-54-9 | |

432. | 7,11-Dimethyl-4,6,10-dodecatrien-3-one (CAS No 26651-96-7), when used as a fragrance ingredient | 26651-96-7 | 247-878-3 |

433. | 6,10-Dimethyl-3,5,9-undecatrien-2-one (CAS No 141-10-6), when used as a fragrance ingredient | 141-10-6 | 205-457-1 |

434. | Diphenylamine (CAS No 122-39-4), when used as a fragrance ingredient | 122-39-4 | 204-539-4 |

435. | Ethyl acrylate (CAS No 140-88-5), when used as a fragrance ingredient | 140-88-5 | 205-438-8 |

436. | Fig leaf absolute (Ficus carica) (CAS No 68916-52-9), when used as a fragrance ingredient | 68916-52-9 | |

437. | trans-2-Heptenal (CAS No 18829-55-5), when used as a fragrance ingredient | 18829-55-5 | 242-608-0 |

438. | trans-2-Hexenal diethyl acetal (CAS No 67746-30-9), when used as a fragrance ingredient | 67746-30-9 | 266-989-8 |

439. | trans-2-Hexenal dimethyl acetal (CAS No 18318-83-7), when used as a fragrance ingredient | 18318-83-7 | 242-204-4 |

440. | Hydroabietyl alcohol (CAS No 13393-93-6), when used as a fragrance ingredient | 13393-93-6 | 236-476-3 |

441. | 6-Isopropyl-2-decahydronaphthalenol (CAS No 34131-99-2), when used as a fragrance ingredient | 34131-99-2 | 251-841-7 |

442. | 7-Methoxycoumarin (CAS No 531-59-9), when used as a fragrance ingredient | 531-59-9 | 208-513-3 |

443. | 4-(4-Methoxyphenyl)-3-butene-2-one (CAS No 943-88-4), when used as a fragrance ingredient | 943-88-4 | 213-404-9 |

444. | 1-(4-Methoxyphenyl)-1-penten-3-one (CAS No 104-27-8), when used as a fragrance ingredient | 104-27-8 | 203-190-5 |

445. | Methyl trans-2-butenoate (CAS No 623-43-8), when used as a fragrance ingredient | 623-43-8 | 210-793-7 |

446. | 7-Methylcoumarin (CAS No 2445-83-2), when used as a fragrance ingredient | 2445-83-2 | 219-499-3 |

447. | 5-Methyl-2,3-hexanedione (CAS No 13706-86-0), when used as a fragrance ingredient | 13706-86-0 | 237-241-8 |

448. | 2-Pentylidenecyclohexanone (CAS No 25677-40-1), when used as a fragrance ingredient | 25677-40-1 | 247-178-8 |

449. | 3,6,10-Trimethyl-3,5,9-undecatrien-2-one (CAS No 1117-41-5), when used as a fragrance ingredient | 1117-41-5 | 214-245-8 |

450. | Verbena oil (Lippia citriodora Kunth.) (CAS No 8024-12-2), when used as a fragrance ingredient | 8024-12-2 | |

451. | 1Methyleugenol (CAS No 93-15-2) except for normal content in the natural essences used and provided that the concentration does not exceed:(a) 0,01 % in fine fragrance(b) 0,004 % in eau de toilette(c) 0,002 % in fragrance cream(d) 0,001 % in rinse-off products(e) 0,0002 % in other leave-on products and oral hygiene products | | |

.

2004/93/EC Art. 1 and Annex .2 (adapted)

452. | 6-(2-Chloroethyl)-6-(2-methoxyethoxy)-2,5,7,10-tetraoxa-6-silaundecane (Cas No 37894-46-5) | 37894-46-5 | 253-704-7 |

453. | Cobalt dichloride (Cas No 7646-79-9) | 7646-79-9 | 231-589-4 |

454. | Cobalt sulphate (Cas No 10124-43-3) | 10124-43-3 | 233-334-2 |

455. | Nickel monoxide (Cas No 1313-99-1) | 1313-99-1 | 215-215-7 |

456. | Dinickel trioxide (Cas No 1314-06-3) | 1314-06-3 | 215-217-8 |

457. | Nickel dioxide (Cas No 12035-36-8) | 12035-36-8 | 234-823-3 |

458. | Trinickel disulphide (Cas No 12035-72-2) | 12035-72-2 | 234-829-6 |

459. | Tetracarbonylnickel (Cas No 13463-39-3) | 13463-39-3 | 236-669-2 |

460. | Nickel sulphide (Cas No 16812-54-7) | 16812-54-7 | 240-841-2 |

461. | Potassium bromate (Cas No 7758-01-2) | 7758-01-2 | 231-829-8 |

462. | Carbon monoxide (Cas No 630-08-0) | 630-08-0 | 211-128-3 |

463. | Buta-1,3-diene (Cas No 106-99-0) | 106-99-0 | 203-450-8 |

464. | Isobutane (Cas No 75-28-5), if it contains ≥ 0,1 % w/w Butadiene | 75-28-5 | 200-857-2 |

465. | Butane (Cas No 106-97-8), if it contains ≥ 0,1 % w/w Butadiene | 106-97-8 | 203-448-7 |

466. | Gases (petroleum), C3-4 (Cas No 68131-75-9), 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 (Cas No 68307-98-2), if it contains > 0,1 % w/w Butadiene | 68307-98-2 | 269-617-2 |

468. | Tail gas (petroleum), catalytic polymn. naphtha fractionation stabiliser (Cas No 68307-99-3), 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 (Cas No 68308-00-9), if it contains > 0,1 % w/w Butadiene | 68308-00-9 | 269-619-3 |

470. | Tail gas (petroleum), cracked distillate hydrotreater stripper (Cas No 68308-01-0), if it contains > 0,1 % w/w Butadiene | 68308-01-0 | 269-620-9 |

471. | Tail gas (petroleum), gas oil catalytic cracking absorber (Cas No 68308-03-2), if it contains > 0,1 % w/w Butadiene | 68308-03-2 | 269-623-5 |

472. | Tail gas (petroleum), gas recovery plant (Cas No 68308-04-3), if it contains > 0,1 % w/w Butadiene | 68308-04-3 | 269-624-0 |

473. | Tail gas (petroleum), gas recovery plant deethaniser (Cas No 68308-05-4), 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 (Cas No 68308-06-5), 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 (Cas No 68308-07-6), if it contains > 0,1 % w/w Butadiene | 68308-07-6 | 269-627-7 |

476. | Tail gas (petroleum), isomerised naphtha fractionation stabiliser (Cas No 68308-08-7), 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 (Cas No 68308-09-8), if it contains > 0,1 % w/w Butadiene | 68308-09-8 | 269-629-8 |

478. | Tail gas (petroleum), straight-run distillate hydrodesulferised, hydrogen sulfide-free (Cas No 68308-10-1), if it contains > 0,1 % w/w Butadiene | 68308-10-1 | 269-630-3 |

479. | Tail gas (petroleum), propane-propylene alkylation feed prep deethaniser (Cas No 68308-11-2), if it contains > 0,1 % w/w Butadiene | 68308-11-2 | 269-631-9 |

480. | Tail gas (petroleum), vacuum gas oil hydrodesulferised, hydrogen sulfide-free (Cas No 68308-12-3), if it contains > 0,1 % w/w Butadiene | 68308-12-3 | 269-632-4 |

481. | Gases (petroleum), catalytic cracked overheads (Cas No 68409-99-4), if they contain > 0,1 % w/w Butadiene | 68409-99-4 | 270-071-2 |

482. | Alkanes, C1-2 (Cas No 68475-57-0), if they contain > 0,1 % w/w Butadiene | 68475-57-0 | 270-651-5 |

483. | Alkanes, C2-3 (Cas No 68475-58-1), if they contain > 0,1 % w/w Butadiene | 68475-58-1 | 270-652-0 |

484. | Alkanes, C3-4 (Cas No 68475-59-2), if they contain > 0,1 % w/w Butadiene | 68475-59-2 | 270-653-6 |

485. | Alkanes, C4-5 (Cas No 68475-60-5), if they contain > 0,1 % w/w Butadiene | 68475-60-5 | 270-654-1 |

486. | Fuel-gases (Cas No 68476-26-6), if they contain > 0,1 % w/w Butadiene | 68476-26-6 | 270-667-2 |

487. | Fuel gases, crude oil distillates (Cas No 68476-29-9), if they contain > 0,1 % w/w Butadiene | 68476-29-9 | 270-670-9 |

488. | Hydrocarbons, C3-4 (Cas No 68476-40-4), if they contain > 0,1 % w/w Butadiene | 68476-40-4 | 270-681-9 |

489. | Hydrocarbons, C4-5 (Cas No 68476-42-6), if they contain > 0,1 % w/w Butadiene | 68476-42-6 | 270-682-4 |

490. | Hydrocarbons, C2-4, C3-rich (Cas No 68476-49-3), if they contain > 0,1 % w/w Butadiene | 68476-49-3 | 270-689-2 |

491. | Petroleum gases, liquefied (Cas No 68476-85-7), if they contain > 0,1 % w/w Butadiene | 68476-85-7 | 270-704-2 |

492. | Petroleum gases, liquefied, sweetened (Cas No 68476-86-8), if they contain > 0,1 % w/w Butadiene | 68476-86-8 | 270-705-8 |

493. | Gases (petroleum), C3-4, isobutane-rich (Cas No 68477-33-8), if they contain > 0,1 % w/w Butadiene | 68477-33-8 | 270-724-1 |

494. | Distillates (petroleum), C3-6, piperylene-rich (Cas No 68477-35-0), if they contain > 0,1 % w/w Butadiene | 68477-35-0 | 270-726-2 |

495. | Gases (petroleum), amine system feed (Cas No 68477-65-6), if they contain > 0,1 % w/w Butadiene | 68477-65-6 | 270-746-1 |

496. | Gases (petroleum), benzene unit hydrodesulferised off (Cas No 68477-66-7), if they contain > 0,1 % w/w Butadiene | 68477-66-7 | 270-747-7 |

497. | Gases (petroleum), benzene unit recycle, hydrogen-rich (Cas No 68477-67-8), if they contain > 0,1 % w/w Butadiene | 68477-67-8 | 270-748-2 |

498. | Gases (petroleum), blend oil, hydrogen-nitrogen-rich (Cas No 68477-68-9), ,if they contain > 0,1 % w/w Butadiene | 68477-68-9 | 270-749-8 |

499. | Gases (petroleum), butane splitter overheads (Cas No 68477-69-0), if they contain > 0,1 % w/w Butadiene | 68477-69-0 | 270-750-3 |

500. | Gases (petroleum), C2-3 (Cas No 68477-70-3), 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 (Cas No 68477-71-4), 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 (Cas No 68477-72-5), 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 (Cas No 68477-73-6), if they contain > 0,1 % w/w Butadiene | 68477-73-6 | 270-755-0 |

504. | Gases (petroleum), catalytic cracker (Cas No 68477-74-7), if they contain > 0,1 % w/w Butadiene | 68477-74-7 | 270-756-6 |

505. | Gases (petroleum), catalytic cracker, C1-5-rich (Cas No 68477-75-8), 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 (Cas No 68477-76-9), if they contain > 0,1 % w/w Butadiene | 68477-76-9 | 270-758-7 |

507. | Gases (petroleum), catalytic reformed naphtha stripper overheads (Cas No 68477-77-0), if they contain > 0,1 % w/w Butadiene | 68477-77-0 | 270-759-2 |

508. | Gases (petroleum), catalytic reformer, C1-4-rich (Cas No 68477-79-2), if they contain > 0,1 % w/w Butadiene | 68477-79-2 | 270-760-8 |

509. | Gases (petroleum), C6-8 catalytic reformer recycle (Cas No 68477-80-5), if they contain > 0,1 % w/w Butadiene | 68477-80-5 | 270-761-3 |

510. | Gases (petroleum), C6-8 catalytic reformer (Cas No 68477-81-6), if they contain > 0,1 % w/w Butadiene | 68477-81-6 | 270-762-9 |

511. | Gases (petroleum), C6-8 catalytic reformer recycle, hydrogen-rich (Cas No 68477-82-7), if they contain > 0,1 % w/w Butadiene | 68477-82-7 | 270-763-4 |

512. | Gases (petroleum), C3-5 olefinic-paraffinic alkylation feed, (Cas No 68477-83-8), if they contain > 0,1 % w/w Butadiene | 68477-83-8 | 270-765-5 |

513. | Gases (petroleum), C2-return stream (Cas No 68477-84-9), if they contain > 0,1 % w/w Butadiene | 68477-84-9 | 270-766-0 |

514. | Gases (petroleum), C4-rich (Cas No 68477-85-0), if they contain > 0,1 % w/w Butadiene | 68477-85-0 | 270-767-6 |

515. | Gases (petroleum), deethaniser overheads (Cas No 68477-86-1), if they contain > 0,1 % w/w Butadiene | 68477-86-1 | 270-768-1 |

516. | Gases (petroleum), deisobutaniser tower overheads (Cas No 68477-87-2), if they contain > 0,1 % w/w Butadiene | 68477-87-2 | 270-769-7 |

517. | Gases (petroleum), depropaniser dry, propene-rich (Cas No 68477-90-7), if they contain > 0,1 % w/w Butadiene | 68477-90-7 | 270-772-3 |

518. | Gases (petroleum), depropaniser overheads (Cas No 68477-91-8), if they contain > 0,1 % w/w Butadiene | 68477-91-8 | 270-773-9 |

519. | Gases (petroleum), dry sour, gas-concn. -unit-off (Cas No 68477-92-9), if they contain > 0,1 % w/w Butadiene | 68477-92-9 | 270-774-4 |

520. | Gases (petroleum), gas concn. reabsorber distn. (Cas No 68477-93-0), if they contain > 0,1 % w/w Butadiene | 68477-93-0 | 270-776-5 |

521. | Gases (petroleum), gas recovery plant depropaniser overheads (Cas No 68477-94-1), if they contain > 0,1 % w/w Butadiene | 68477-94-1 | 270-777-0 |

522. | Gases (petroleum), Girbatol unit feed (Cas No 68477-95-2), if they contain > 0,1 % w/w Butadiene | 68477-95-2 | 270-778-6 |

523. | Gases (petroleum), hydrogen absorber off (Cas No 68477-96-3), if they contain > 0,1 % w/w Butadiene | 68477-96-3 | 270-779-1 |

524. | Gases (petroleum), hydrogen-rich (Cas No 68477-97-4), if they contain > 0,1 % w/w Butadiene | 68477-97-4 | 270-780-7 |

525. | Gases (petroleum), hydrotreater blend oil recycle, hydrogen-nitrogen-rich (Cas No 68477-98-5), 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 (Cas No 68477-99-6), if they contain > 0,1 % w/w Butadiene | 68477-99-6 | 270-782-8 |

527. | Gases (petroleum), recycle, hydrogen-rich (Cas No 68478-00-2), if they contain > 0,1 % w/w Butadiene | 68478-00-2 | 270-783-3 |

528. | Gases (petroleum), reformer make-up, hydrogen-rich, (Cas No 68478-01-3), if they contain > 0,1 % w/w Butadiene | 68478-01-3 | 270-784-9 |

529. | Gases (petroleum), reforming hydrotreater (Cas No 68478-02-4), if they contain > 0,1 % w/w Butadiene | 68478-02-4 | 270-785-4 |

530. | Gases (petroleum), reforming hydrotreater, hydrogen-methane-rich (Cas No 68478-03-5), if they contain > 0,1 % w/w Butadiene | 68478-03-5 | 270-787-5 |

531. | Gases (petroleum), reforming hydrotreater make-up, hydrogen-rich (Cas No 68478-04-6), if they contain > 0,1 % w/w Butadiene | 68478-04-6 | 270-788-0 |

532. | Gases (petroleum), thermal cracking distn., (Cas No 68478-05-7), 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 (Cas No 68478-21-7), if it contains > 0,1 % w/w Butadiene | 68478-21-7 | 270-802-5 |

534. | Tail gas (petroleum), catalytic cracked naphtha stabilisation absorber (Cas No 68478-22-8), if it contains > 0,1 % w/w Butadiene | 68478-22-8 | 270-803-0 |

535. | Tail gas (petroleum), catalytic cracker, catalytic reformer and hydrodesulferised combined fractionater (Cas No 68478-24-0), if it contains > 0,1 % w/w Butadiene | 68478-24-0 | 270-804-6 |

536. | Tail gas (petroleum), catalytic cracker refractionation absorber (Cas No 68478-25-1), if it contains > 0,1 % w/w Butadiene | 68478-25-1 | 270-805-1 |

537. | Tail gas (petroleum), catalytic reformed naphtha fractionation stabiliser (Cas No 68478-26-2), if it contains > 0,1 % w/w Butadiene | 68478-26-2 | 270-806-7 |

538. | Tail gas (petroleum), catalytic reformed naphtha separator (Cas No 68478-27-3), if it contains > 0,1 % w/w Butadiene | 68478-27-3 | 270-807-2 |

539. | Tail gas (petroleum), catalytic reformed naphtha stabiliser, (Cas No 68478-28-4), if it contains > 0,1 % w/w Butadiene | 68478-28-4 | 270-808-8 |

540. | Tail gas (petroleum), cracked distillate hydrotreater separator (Cas No 68478-29-5), if it contains > 0,1 % w/w Butadiene | 68478-29-5 | 270-809-3 |

541. | Tail gas (petroleum), hydrodesulfurised straight-run naphtha separator (Cas No 68478-30-8), 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 (Cas No 68478-32-0), 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 (Cas No 68478-33-1), if it contains > 0,1 % w/w Butadiene | 68478-33-1 | 270-814-0 |

544. | Tail gas (petroleum), vacuum residues thermal cracker, (Cas No 68478-34-2), if it contains > 0,1 % w/w Butadiene | 68478-34-2 | 270-815-6 |

545. | Hydrocarbons, C3-4-rich, petroleum distillate (Cas No 68512-91-4), if they contain > 0,1 % w/w Butadiene | 68512-91-4 | 270-990-9 |

546. | Gases (petroleum), catalytic reformed straight-run naphtha stabiliser overheads, (Cas No 68513-14-4), if they contain > 0,1 % w/w Butadiene | 68513-14-4 | 270-999-8 |

547. | Gases (petroleum), full-range straight-run naphtha dehexaniser off (Cas No 68513-15-5), if they contain > 0,1 % w/w Butadiene | 68513-15-5 | 271-000-8 |

548. | Gases (petroleum), hydrocracking depropaniser off, hydrocarbon-rich (Cas No 68513-16-6), if they contain > 0,1 % w/w Butadiene | 68513-16-6 | 271-001-3 |

549. | Gases (petroleum), light straight-run naphtha stabiliser off (Cas No 68513-17-7), if they contain > 0,1 % w/w Butadiene | 68513-17-7 | 271-002-9 |

550. | Gases (petroleum), reformer effluent high-pressure flash drum off (Cas No 68513-18-8), if they contain > 0,1 % w/w Butadiene | 68513-18-8 | 271-003-4 |

551. | Gases (petroleum), reformer effluent low-pressure flash drum off (Cas No 68513-19-9), if they contain > 0,1 % w/w Butadiene | 68513-19-9 | 271-005-5 |

552. | Residues (petroleum), alkylation splitter, C4-rich (Cas No 68513-66-6), if they contain > 0,1 % w/w Butadiene | 68513-66-6 | 271-010-2 |

553. | Hydrocarbons, C1-4 (Cas No 68514-31-8), if they contain > 0,1 % w/w Butadiene | 68514-31-8 | 271-032-2 |

554. | Hydrocarbons, C1-4, sweetened (Cas No 68514-36-3) , if they contain > 0,1 % w/w Butadiene | 68514-36-3 | 271-038-5 |

555. | Gases (petroleum), oil refinery gas distn. off (Cas No 68527-15-1), if they contain > 0,1 % w/w Butadiene | 68527-15-1 | 271-258-1 |

556. | Hydrocarbons, C1-3 (Cas No 68527-16-2), if they contain > 0,1 % w/w Butadiene | 68527-16-2 | 271-259-7 |

557. | Hydrocarbons, C1-4, debutanizer fraction (Cas No 68527-19-5), if they contain > 0,1 % w/w Butadiene | 68527-19-5 | 271-261-8 |

558. | Gases (petroleum), benzene unit hydrotreater depentaniser overheads (Cas No 68602-82-4), if they contain > 0,1 % w/w Butadiene | 68602-82-4 | 271-623-5 |

559. | Gases (petroleum), C1-5, wet (Cas No 68602-83-5), 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 (Cas No 68602-84-6), if they contain > 0,1 % w/w Butadiene | 68602-84-6 | 271-625-6 |

561. | Hydrocarbons, C2-4 (Cas No 68606-25-7), if they contain > 0,1 % w/w Butadiene | 68606-25-7 | 271-734-9 |

562. | Hydrocarbons, C3 (Cas No 68606-26-8), if they contain > 0,1 % w/w Butadiene | 68606-26-8 | 271-735-4 |

563. | Gases (petroleum), alkylation feed (Cas No 68606-27-9), if they contain > 0,1 % w/w Butadiene | 68606-27-9 | 271-737-5 |

564. | Gases (petroleum), depropaniser bottoms fractionation off (Cas No 68606-34-8), if they contain > 0,1 % w/w Butadiene | 68606-34-8 | 271-742-2 |

565. | Petroleum products, refinery gases (Cas No 68607-11-4), if they contain > 0,1 % w/w Butadiene | 68607-11-4 | 271-750-6 |

566. | Gases (petroleum), hydrocracking low-pressure separator (Cas No 68783-06-2), if they contain > 0,1 % w/w Butadiene | 68783-06-2 | 272-182-1 |

567. | Gases (petroleum), refinery blend (Cas No 68783-07-3), if they contain > 0,1 % w/w Butadiene | 68783-07-3 | 272-183-7 |

568. | Gases (petroleum), catalytic cracking (Cas No 68783-64-2), if they contain > 0,1 % w/w Butadiene | 68783-64-2 | 272-203-4 |

569. | Gases (petroleum), C2-4, sweetened (Cas No 68783-65-3), if they contain > 0,1 % w/w Butadiene | 68783-65-3 | 272-205-5 |

570. | Gases (petroleum), refinery (Cas No 68814-67-5), if they contain > 0,1 % w/w Butadiene | 68814-67-5 | 272-338-9 |

571. | Gases (petroleum), platformer products separator off (Cas No 68814-90-4), if they contain > 0,1 % w/w Butadiene | 68814-90-4 | 272-343-6 |

572. | Gases (petroleum), hydrotreated sour kerosine depentaniser stabiliser off (Cas No 68911-58-0), if they contain > 0,1 % w/w Butadiene | 68911-58-0 | 272-775-5 |

573. | Gases (petroleum), hydrotreated sour kerosine flash drum (Cas No 68911-59-1), if they contain > 0,1 % w/w Butadiene | 68911-59-1 | 272-776-0 |

574. | Gases (petroleum), crude oil fractionation off (Cas No 68918-99-0), if they contain > 0,1 % w/w Butadiene | 68918-99-0 | 272-871-7 |

575. | Gases (petroleum), dehexaniser off (Cas No 68919-00-6), if they contain > 0,1 % w/w Butadiene | 68919-00-6 | 272-872-2 |

576. | Gases (petroleum), distillate unifiner desulfurisation tripper off (Cas No 68919-01-7), if they contain > 0,1 % w/w Butadiene | 68919-01-7 | 272-873-8 |

577. | Gases (petroleum), fluidised catalytic cracker fractionation off (Cas No 68919-02-8) if they contain > 0,1 % w/w Butadiene | 68919-02-8 | 272-874-3 |

578. | Gases (petroleum), fluidised catalytic cracker scrubbing secondary absorber off (Cas No 68919-03-9), if they contain > 0,1 % w/w Butadiene | 68919-03-9 | 272-875-9 |

579. | Gases (petroleum), heavy distillate hydrotreater desulfurisation stripper off (Cas No 68919-04-0), if they contain > 0,1 % w/w Butadiene | 68919-04-0 | 272-876-4 |

580. | Gases (petroleum), light straight run gasoline fractionation stabiliser off (Cas No 68919-05-1), if they contain > 0,1 % w/w Butadiene | 68919-05-1 | 272-878-5 |

581. | Gases (petroleum), naphtha unifiner desulfurisation stripper off (Cas No 68919-06-2), if they contain > 0,1 % w/w Butadiene | 68919-06-2 | 272-879-0 |

582. | Gases (petroleum), platformer stabiliser off, light ends fractionation (Cas No 68919-07-3), if they contain > 0,1 % w/w Butadiene | 68919-07-3 | 272-880-6 |

583. | Gases (petroleum), preflash tower off, crude distn. (Cas No 68919-08-4), if they contain > 0,1 % w/w Butadiene | 68919-08-4 | 272-881-1 |

584. | Gases (petroleum), straight-run naphtha catalytic reforming off (Cas No 68919-09-5), if they contain > 0,1 % w/w Butadiene | 68919-09-5 | 272-882-7 |

585. | Gases (petroleum), straight-run stabiliser off (Cas No 68919-10-8), if they contain > 0,1 % w/w Butadiene | 68919-10-8 | 272-883-2 |

586. | Gases (petroleum), tar stripper off (Cas No 68919-11-9), if they contain > 0,1 % w/w Butadiene | 68919-11-9 | 272-884-8 |

587. | Gases (petroleum), unifiner stripper off (Cas No 68919-12-0), if they contain > 0,1 % w/w Butadiene | 68919-12-0 | 272-885-3 |

588. | Gases (petroleum), fluidised catalytic cracker splitter overheads (Cas No 68919-20-0), if they contain > 0,1 % w/w Butadiene | 68919-20-0 | 272-893-7 |

589. | Gases (petroleum), catalytic cracked naphtha debutanizer (Cas No 68952-76-1), if they contain > 0,1 % w/w Butadiene | 68952-76-1 | 273-169-3 |

590. | Tail gas (petroleum), catalytic cracked distillate and naphtha stabiliser (Cas No 68952-77-2), if it contains > 0,1 % w/w Butadiene | 68952-77-2 | 273-170-9 |

591. | Tail gas (petroleum), catalytic hydrodesulfurised naphtha separator (Cas No 68952-79-4), if it contains > 0,1 % w/w Butadiene | 68952-79-4 | 273-173-5 |

592. | Tail gas (petroleum), straight-run naphtha hydrodesulferised (Cas No 68952-80-7), 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 (Cas No 68952-81-8), 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 (Cas No 68952-82-9), if it contains > 0,1 % w/w Butadiene | 68952-82-9 | 273-176-1 |

595. | Gases (petroleum), light steam-cracked, butadiene conc. (Cas No 68955-28-2), 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 (Cas No 68955-33-9), if they contain > 0,1 % w/w Butadiene | 68955-33-9 | 273-269-7 |

597. | Gases (petroleum), straight-run naphtha catalytic reformer stabiliser overhead (Cas No 68955-34-0), if they contain > 0,1 % w/w Butadiene | 68955-34-0 | 273-270-2 |

598. | Gases (petroleum), crude distn. and catalytic cracking (Cas No 68989-88-8), if they contain > 0,1 % w/w Butadiene | 68989-88-8 | 273-563-5 |

599. | Hydrocarbons, C4 (Cas No 87741-01-3), if they contain > 0,1 % w/w Butadiene | 87741-01-3 | 289-339-5 |

600. | Alkanes, C1-4, C3-rich (Cas No 90622-55-2), if they contain > 0,1 % w/w Butadiene | 90622-55-2 | 292-456-4 |

601. | Gases (petroleum), gas oil diethanolamine scrubber off (Cas No 92045-15-3), if they contain > 0,1 % w/w Butadiene | 92045-15-3 | 295-397-2 |

602. | Gases (petroleum), gas oil hydrodesulfurisation effluent (Cas No 92045-16-4), if they contain > 0,1 % w/w Butadiene | 92045-16-4 | 295-398-8 |

603. | Gases (petroleum), gas oil hydrodesulfurisation purge (Cas No 92045-17-5), if they contain > 0,1 % w/w Butadiene | 92045-17-5 | 295-399-3 |

604. | Gases (petroleum), hydrogenator effluent flash drum off (Cas No 92045-18-6), if they contain > 0,1 % w/w Butadiene | 92045-18-6 | 295-400-7 |

605. | Gases (petroleum), naphtha steam cracking high-pressure residual (Cas No 92045-19-7), if they contain > 0,1 % w/w Butadiene | 92045-19-7 | 295-401-2 |

606. | Gases (petroleum), residue visbreaking off (Cas No 92045-20-0), if they contain > 0,1 % w/w Butadiene | 92045-20-0 | 295-402-8 |

607. | Gases (petroleum), steam-cracker C3-rich (Cas No 92045-22-2), if they contain > 0,1 % w/w Butadiene | 92045-22-2 | 295-404-9 |

608. | Hydrocarbons, C4, steam-cracker distillate (Cas No 92045-23-3), if they contain > 0,1 % w/w Butadiene | 92045-23-3 | 295-405-4 |

609. | Petroleum gases, liquefied, sweetened, C4 fraction (Cas No 92045-80-2), if they contain > 0,1 % w/w Butadiene | 92045-80-2 | 295-463-0 |

610. | Hydrocarbons, C4, 1,3-butadiene- and isobutene-free (Cas No 95465-89-7), 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 (Cas No 97722-19-5), if they contain > 0,1 % w/w Butadiene | 97722-19-5 | 307-769-4 |

612. | Benzo[def]chrysene (=benzo[a]pyrene) (Cas No 50-32-8) | 50-32-8 | 200-028-5 |

613. | Pitch, coal tar-petroleum (Cas No 68187-57-5), if it contains > 0,005 % w/w benzo[a]pyrene | 68187-57-5 | 269-109-0 |

614. | Distillates (coal-petroleum), condensed-ring arom. (Cas No 68188-48-7), if they contain > 0,005 % w/w benzo[a]pyrene | 68188-48-7 | 269-159-3 |

617. | Creosote oil, acenaphthene fraction, acenaphthene-free (Cas No 90640-85-0), if it contains > 0,005 % w/w benzo[a]pyrene | 90640-85-0 | 292-606-9 |

618. | Pitch, coal tar, low-temp. (Cas No 90669-57-1), if it contains > 0,005 % w/w benzo[a]pyrene | 90669-57-1 | 292-651-4 |

619. | Pitch, coal tar, low-temp., heat-treated (Cas No 90669-58-2), if it contains > 0,005 % w/w benzo[a]pyrene | 90669-58-2 | 292-653-5 |

620. | Pitch, coal tar, low-temp., oxidised (Cas No 90669-59-3), if it contains > 0,005 % w/w benzo[a]pyrene | 90669-59-3 | 292-654-0 |

621. | Extract residues (coal), brown (Cas No 91697-23-3), 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 (Cas No 92045-71-1), 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 (Cas No 92045-72-2), if they contain > 0,005 % w/w benzo[a]pyrene | 92045-72-2 | 295-455-7 |

624. | Waste solids, coal-tar pitch coking (Cas No 92062-34-5), if they contain > 0,005 % w/w benzo[a]pyrene | 92062-34-5 | 295-549-8 |

625. | Pitch, coal tar, high-temp. , secondary (Cas No 94114-13-3), if it contains > 0,005 % w/w benzo[a]pyrene | 94114-13-3 | 302-650-3 |

626. | Residues (coal), liq. solvent extn. (Cas No 94114-46-2), if they contain > 0,005 % w/w benzo[a]pyrene | 94114-46-2 | 302-681-2 |

627. | Coal liquids, liq. solvent extn. soln. (Cas No 94114-47-3), if they contain > 0,005 % w/w benzo[a]pyrene | 94114-47-3 | 302-682-8 |

628. | Coal liquids, liq. solvent extn. (Cas No 94114-48-4), 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 (Cas No 97926-76-6), 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 (Cas No 97926-77-7), 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 (Cas No 97926-78-8), 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 (Cas No 101316-45-4), 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 (Cas No 101794-74-5), 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 (Cas No 101794-75-6), 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 (Cas No 101794-76-7), if they contain > 0,005 % w/w benzo[a]pyrene | 101794-76-7 | 309-958-7 |

636. | Pitch, coal tar, high-temp. , heat-treated (Cas No 121575-60-8), if it contains > 0,005 % w/w benzo[a]pyrene | 121575-60-8 | 310-162-7 |

637. | Dibenz[a,h]anthracene (Cas No 53-70-3) | 53-70-3 | 200-181-8 |

638. | Benz[a]anthracene (Cas No 56-55-3) | 56-55-3 | 200-280-6 |

639. | Benzo[e]pyrene (Cas No 192-97-2) | 192-97-2 | 205-892-7 |

640. | Benzo[j]fluoranthene (Cas No 205-82-3) | 205-82-3 | 205-910-3 |

641. | Benz(e)acephenanthrylene (Cas No 205-99-2) | 205-99-2 | 205-911-9 |

642. | Benzo(k)fluoranthene (Cas No 207-08-9) | 207-08-9 | 205-916-6 |

643. | Chrysene (Cas No 218-01-9) | 218-01-9 | 205-923-4 |

644. | 2-Bromopropane (Cas No 75-26-3) | 75-26-3 | 200-855-1 |

645. | Trichloroethylene (Cas No 79-01-6) | 79-01-6 | 201-167-4 |

646. | 1,2-Dibromo-3-chloropropane (Cas No 96-12-8) | 96-12-8 | 202-479-3 |

647. | 2,3-Dibromopropan-1-ol (Cas No 96-13-9) | 96-13-9 | 202-480-9 |

648. | 1,3-Dichloropropan-2-ol (Cas No 96-23-1) | 96-23-1 | 202-491-9 |

649. | α,α,α-Trichlorotoluene (Cas No 98-07-7) | 98-07-7 | 202-634-5 |

650. | α-Chlorotoluene (Cas No 100-44-7) | 100-44-7 | 202-853-6 |

651. | 1,2-Dibromoethane (Cas No 106-93-4) | 106-93-4 | 203-444-5 |

652. | Hexachlorobenzene (Cas No 118-74-1) | 118-74-1 | 204-273-9 |

653. | Bromoethylene (Cas No 593-60-2) | 593-60-2 | 209-800-6 |

654. | 1,4-Dichlorobut-2-ene (Cas No 764-41-0) | 764-41-0 | 212-121-8 |

655. | Methyloxirane (Cas No 75-56-9) | 75-56-9 | 200-879-2 |

656. | (Epoxyethyl)benzene (Cas No 96-09-3) | 96-09-3 | 202-476-7 |

657. | 1-Chloro-2,3-epoxypropane (Cas No 106-89-8) | 106-89-8 | 203-439-8 |

658. | R-1-Chloro-2,3-epoxypropane (Cas No 51594-55-9) | 51594-55-9 | 603-166-00-8 |

659. | 1,2-Epoxy-3-phenoxypropane (Cas No 122-60-1) | 122-60-1 | 204-557-2 |

660. | 2,3-Epoxypropan-1-ol (Cas No 556-52-5) | 556-52-5 | 209-128-3 |

661. | R-2,3-Epoxy-1-propanol (Cas No 57044-25-4) | 57044-25-4 | 603-143-00-2 |

662. | 2,2′-Bioxirane (Cas No 1464-53-5) | 1464-53-5 | 215-979-1 |

2007/1/EC Art. 1 and Annex pt. 3 (adapted)

663. | (2RS,3RS)-3-(2-Chlorophenyl)-2-(4-fluorophenyl)-[1H-1,2,4-triazol-1-yl)methyl]oxirane; Eepoxiconazole (CAS No 133855-98-8) | 133855-98-8 | 613-175-00-9 |

2004/93/EC Art. 1 and Annex .2 (adapted)

664. | Chloromethyl methyl ether (Cas No 107-30-2) | 107-30-2 | 203-480-1 |

665. | 2-Methoxyethanol (Cas No 109-86-4) | 109-86-4 | 203-713-7 |

666. | 2-Ethoxyethanol (Cas No 110-80-5) | 110-80-5 | 203-804-1 |

667. | Oxybis[chloromethane], bis (Chloromethyl) ether (Cas No 542-88-1) | 542-88-1 | 208-832-8 |

668. | 2-Methoxypropanol (Cas No 1589-47-5) | 1589-47-5 | 216-455-5 |

669. | Propiolactone (Cas No 57-57-8) | 57-57-8 | 200-340-1 |

670. | Dimethylcarbamoyl chloride (Cas No 79-44-7) | 79-44-7 | 201-208-6 |

671. | Urethane (Cas No 51-79-6) | 51-79-6 | 200-123-1 |

672. | 2-Methoxyethyl acetate (Cas No 110-49-6) | 110-49-6 | 203-772-9 |

673. | 2-Ethoxyethyl acetate (Cas No 111-15-9) | 111-15-9 | 203-839-2 |

674. | Methoxyacetic acid (Cas No 625-45-6) | 625-45-6 | 210-894-6 |

675. | Dibutyl phthalate (Cas No 84-74-2) | 84-74-2 | 201-557-4 |

676. | bis(2-Methyoxyethyl) ether (Cas No 111-96-6) | 111-96-6 | 203-924-4 |

677. | bis(2-Ethylhexyl) phthalate (Cas No 117-81-7) | 117-81-7 | 204-211-0 |

678. | bis(2-Methoxyethyl) phthalate (Cas No 117-82-8) | 117-82-8 | 204-212-6 |

679. | 2-Methoxypropyl acetate (Cas No 70657-70-4) | 70657-70-4 | 274-724-2 |

680. | 2-Ethylhexyl[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]-methyl]thio]acetate (Cas No 80387-97-9) | 80387-97-9 | 279-452-8 |

681. | Acrylamide, unless regulated elsewhere in this Regulation Directive (Cas No 79-06-1) | 79-06-1 | 201-173-7 |

682. | Acrylonitrile (Cas No 107-13-1) | 107-13-1 | 203-466-5 |

683. | 2-Nitropropane (Cas No 79-46-9) | 79-46-9 | 201-209-1 |

684. | Dinoseb (Cas No 88-85-7), its salts and esters with the exception of those specified elsewhere in this list | 88-85-7 | 201-861-7 |

685. | 2-Nitroanisole (Cas No 91-23-6) | 91-23-6 | 202-052-1 |

686. | 4-Nitrobiphenyl (Cas No 92-93-3) | 92-93-3 | 202-204-7 |

2005/80/EC Art. 1 and Annex .1(b) (adapted)

687. | dinitrotoluene, technical grade (Cas No 121-14-2) | 121-14-2 | 204-450-0 |

2004/93/EC Art. 1 and Annex .2 (adapted)

1 2004/93/EC Art. 1 and Annex .2 amended by Corrigendum, OJ L 097, 15.4.2005, p. 63

688. | Binapacryl (Cas No 485-31-4) | 485-31-4 | 207-612-9 |

689. | 2-Nitronaphthalene (Cas No 581-89-5) | 581-89-5 | 209-474-5 |

690. | 2,3-Dinitrotoluene (Cas No 602-01-7) | 602-01-7 | 210-013-5 |

691. | 5-Nitroacenaphthene (Cas No 602-87-9) | 602-87-9 | 210-025-0 |

692. | 2,6-Dinitrotoluene (Cas No 606-20-2) | 606-20-2 | 210-106-0 |

693. | 3,4-Dinitrotoluene (Cas No 610-39-9) | 610-39-9 | 210-222-1 |

694. | 3,5-Dinitrotoluene (Cas No 618-85-9) | 618-85-9 | 210-566-2 |

695. | 2,5-Dinitrotoluene (Cas No 619-15-8) | 619-15-8 | 210-581-4 |

696. | Dinoterb (Cas No 1420-07-1), its salts and esters | 1420-07-1 | 215-813-8 |

697. | Nitrofen (Cas No 1836-75-5) | 1836-75-5 | 217-406-0 |

698. | Dinitrotoluene (Cas No 25321-14-6) | 25321-14-6 | 246-836-1 |

699. | Diazomethane (Cas No 334-88-3) | 334-88-3 | 206-382-7 |

700. | 1,4,5,8-Tetraaminoanthraquinone (Disperse Blue 1) (Cas No 2475-45-8) | 2475-45-8 | 219-603-7 |

701. | Dimethylnitrosoamine (Cas No 62-75-9) | 62-75-9 | 200-549-8 |

702. | 1-Methyl-3-nitro-1-nitrosoguanidine (Cas No 70-25-7) | 70-25-7 | 200-730-1 |

703. | Nitrosodipropylamine (Cas No 621-64-7) | 621-64-7 | 210-698-0 |

704. | 2,2′-(Nitrosoimino)bisethanol (Cas No 1116-54-7) | 1116-54-7 | 214-237-4 |

705. | 4,4′-Methylenedianiline (Cas No 101-77-9) | 101-77-9 | 202-974-4 |

706. | 4,4′-(4-Iminocyclohexa-2,5-dienylidenemethylene) dianiline hydrochloride (Cas No 569-61-9) | 569-61-9 | 209-321-2 |

707. | 4,4′-Methylenedi-o-toluidine (Cas No 838-88-0) | 838-88-0 | 212-658-8 |

708. | o-Anisidine (Cas No 90-04-0) | 90-04-0 | 201-963-1 |

709. | 3,3′-Dimethoxybenzidine (Cas No 119-90-4) | 119-90-4 | 204-355-4 |

710. | Salts of o-dianisidine | | |

711. | o-Dianisidine based azo dyes | | |

712. | 3,3′-Dichlorobenzidine (Cas No 91-94-1) | 91-94-1 | 202-109-0 |

713. | Benzidine dihydrochloride (Cas No 531-85-1) | 531-85-1 | 208-519-6 |

714. | [[1,1′-Biphenyl]-4,4′-diyl]diammonium sulphate (Cas No 531-86-2) | 531-86-2 | 208-520-1 |

715. | 3,3′-Dichlorobenzidine dihydrochloride (Cas No 612-83-9) | 612-83-9 | 210-323-0 |

716. | Benzidine sulphate (Cas No 21136-70-9) | 21136-70-9 | 244-236-4 |

717. | Benzidine acetate (Cas No 36341-27-2) | 36341-27-2 | 252-984-8 |

718. | 3,3′-Dichlorobenzidine dihydrogen bis(sulphate) (Cas No 64969-34-2) | 64969-34-2 | 265-293-1 |

719. | 3,3′-Dichlorobenzidine sulphate (Cas No 74332-73-3) | 74332-73-3 | 277-822-3 |

720. | Benzidine based azo dyes | | |

721. | 4,4′-Bi-o-toluidine (Cas No 119-93-7) | 119-93-7 | 204-358-0 |

722. | 4,4′-Bi-o-toluidine dihydrochloride (Cas No 612-82-8) | 612-82-8 | 210-322-5 |

723. | [3,3′-Dimethyl[1,1′-biphenyl]-4,4′-diyl]diammonium bis(hydrogen sulphate) (Cas No 64969-36-4) | 64969-36-4 | 265-294-7 |

724. | 4,4′-Bi-o-toluidine sulphate (Cas No 74753-18-7) | 74753-18-7 | 277-985-0 |

725. | o-Toluidine based dyes | | |

726. | Biphenyl-4-ylamine (Cas No 92-67-1) and its salts | 92-67-1 | 202-177-1 |

727. | Azobenzene (Cas No 103-33-3) | 103-33-3 | 203-102-5 |

728. | (Methyl-ONN-azoxy)methyl acetate (Cas No 592-62-1) | 592-62-1 | 209-765-7 |

729. | Cycloheximide (Cas No 66-81-9) | 66-81-9 | 200-636-0 |

730. | 2-Methylaziridine (Cas No 75-55-8) | 75-55-8 | 200-878-7 |

731. | Imidazolidine-2-thione (Cas No 96-45-7) | 96-45-7 | 202-506-9 |

732. | Furan (Cas No 110-00-9) | 110-00-9 | 203-727-3 |

733. | Aziridine (Cas No 151-56-4) | 151-56-4 | 205-793-9 |

734. | Captafol (2425-06-1) | 2425-06-1 | 219-363-3 |

735. | Carbadox (Cas No 6804-07-5) | 6804-07-5 | 229-879-0 |

736. | Flumioxazin (Cas No 103361-09-7) | 103361-09-7 | 613-166-00-X |

737. | Tridemorph (Cas No 24602-86-6) | 24602-86-6 | 246-347-3 |

738. | Vinclozolin (Cas No 50471-44-8) | 50471-44-8 | 256-599-6 |

739. | Fluazifop-butyl (Cas No 69806-50-4) | 69806-50-4 | 274-125-6 |

740. | Flusilazole (Cas No 85509-19-9) | 85509-19-9 | 014-017-00-6 |

741. | 1,3,5-Tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione (Cas No 2451-62-9) | 2451-62-9 | 219-514-3 |

742. | Thioacetamide (Cas No 62-55-5) | 62-55-5 | 200-541-4 |

743. | N,N-Dimethylformamide (Cas No 68-12-2) | 68-12-2 | 200-679-5 |

744. | Formamide (Cas No 75-12-7) | 75-12-7 | 200-842-0 |

745. | N-Methylacetamide (Cas No 79-16-3) | 79-16-3 | 201-182-6 |

746. | N-Methylformamide (Cas No 123-39-7) | 123-39-7 | 204-624-6 |

747. | N,N-Dimethylacetamide (Cas No 127-19-5) | 127-19-5 | 204-826-4 |

748. | Hexamethylphosphoric-triamide (Cas No 680-31-9) | 680-31-9 | 211-653-8 |

749. | Diethyl sulphate (Cas No 64-67-5) | 64-67-5 | 200-589-6 |

750. | Dimethyl sulphate (Cas No 77-78-1) | 77-78-1 | 201-058-1 |

751. | 1,3-Propanesultone (Cas No 1120-71-4) | 1120-71-4 | 214-317-9 |

752. | Dimethylsulphamoyl-chloride (Cas No 13360-57-1) | 13360-57-1 | 236-412-4 |

753. | Sulfallate (Cas No 95-06-7) | 95-06-7 | 202-388-9 |

754. | A mixture of: 4-[[bis-(4-Fluorophenyl)methylsilyl]methyl]-4H-1,2,4-triazole and 1-[[bis-(4-fluorophenyl)methylsilyl]methyl]-1H-1,2,4-triazole (EC No 403-250-2) | | 403-250-2 |

755. | (+/–)-Tetrahydrofurfuryl –(R)-2-[4-(6-chloroquinoxalin-2-yloxy)phenyloxy]propionate (Cas No 119738-06-6) | 119738-06-6 | 607-373-00-4 |

756. | 6-Hydroxy-1-(3-Isopropoxypropyl)-4-methyl-2-oxo-5-[4-(phenylazo)phenylazo]-1,2-dihydro-3-pyridinecarbonitrile (Cas No 85136-74-9) | 85136-74-9 | 611-057-00-1 |

757. | (6-(4-Hydroxy-3-(2-methoxyphenylazo)-2-sulfonato-7-naphthylamino)-1,3,5-triazine-2,4-diyl)bis[(amino-1-methylethyl)ammonium] formate (Cas No 108225-03-2) | 108225-03-2 | 611-058-00-7 |

758. | Trisodium [4′-(8-acetylamino-3,6-disulfonato-2-naphthylazo)-4″-(6-benzoylamino-3-Sulfonato-2-naphthylazo)-biphenyl-1,3′,3″,1″′-tetraolato-O,O′,O″,O″′]copper(II) (EC No 413-590-3) | | 413-590-3 |

759. | A mixture of: N-[3-Hydroxy-2-(2-methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide and N-[2,3-bis-(2-Methylacryloylaminomethoxy)propoxymethyl]-2-methylacrylamide and methacrylamide and 2-methyl-N-(2-methylacryloylaminomethoxymethyl)-acrylamide and N-(2,3-dihydroxypropoxymethyl)-2-methylacrylamide (EC No 412-790-8) | | 412-790-8 |

760. | 1,3,5-tris-[(2S and 2R)-2,3-Epoxypropyl]-1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (Cas No 59653-74-6) | 59653-74-6 | 616-091-00-0 |

761. | Erionite (Cas No 12510-42-8) | 12510-42-8 | 650-012-00-0 |

762. | Asbestos (Cas No 12001-28-4) | 12001-28-4 | 650-013-00-6 |

763. | Petroleum (Cas No 8002-05-9) | 8002-05-9 | 232-298-5 |

764. | Distillates (petroleum), heavy hydrocracked (Cas No 64741-76-0), if they contain > 3 % w/w DMSO extract | 64741-76-0 | 265-077-7 |

765. | Distillates (petroleum), solvent-refined heavy paraffinic (Cas No 64741-88-4), if they contain > 3 % w/w DMSO extract | 64741-88-4 | 265-090-8 |

766. | Distillates (petroleum), solvent-refined light paraffinic (Cas No 64741-89-5), if they contain > 3 % w/w DMSO extract | 64741-89-5 | 265-091-3 |

767. | Residual oils (petroleum), solvent deasphalted (Cas No 64741-95-3), if they contain > 3 % w/w DMSO extract | 64741-95-3 | 265-096-0 |

768. | Distillates (petroleum), solvent-refined heavy naphthenic (Cas No 64741-96-4), if they contain > 3 % w/w DMSO extract | 64741-96-4 | 265-097-6 |

769. | Distillates (petroleum), solvent-refined light naphthenic (Cas No 64741-97-5), if they contain > 3 % w/w DMSO extract | 64741-97-5 | 265-098-1 |

770. | Residual oils (petroleum), solvent-refined (Cas No 64742-01-4), if they contain > 3 % w/w DMSO extract | 64742-01-4 | 265-101-6 |

771. | Distillates (petroleum), clay-treated heavy paraffinic (Cas No 64742-36-5), if they contain > 3 % w/w DMSO extract | 64742-36-5 | 265-137-2 |

772. | Distillates (petroleum), clay-treated light paraffinic (Cas No 64742-37-6), if they contain > 3 % w/w DMSO extract | 64742-37-6 | 265-138-8 |

773. | Residual oils (petroleum), clay-treated (Cas No 64742-41-2), if they contain > 3 % w/w DMSO extract | 64742-41-2 | 265-143-5 |

774. | Distillates (petroleum), clay-treated heavy naphthenic (Cas No 64742-44-5), if they contain > 3 % w/w DMSO extract | 64742-44-5 | 265-146-1 |

775. | Distillates (petroleum), clay-treated light naphthenic (Cas No 64742-45-6), if they contain > 3 % w/w DMSO extract | 64742-45-6 | 265-147-7 |

776. | Distillates (petroleum), hydrotreated heavy naphthenic (Cas No 64742-52-5), if they contain > 3% w/w DMSO extract | 64742-52-5 | 265-155-0 |

777. | Distillates (petroleum), hydrotreated light naphthenic (Cas No 64742-53-6), if they contain > 3 % w/w DMSO extract | 64742-53-6 | 265-156-6 |

778. | Distillates (petroleum), hydrotreated heavy paraffinic (Cas No 64742-54-7), if they contain > 3 % w/w DMSO extract | 64742-54-7 | 265-157-1 |

779. | Distillates (petroleum), hydrotreated light paraffinic (Cas No 64742-55-8), if they contain > 3 % w/w DMSO extract | 64742-55-8 | 265-158-7 |

780. | Distillates (petroleum), solvent-dewaxed light paraffinic (Cas No 64742-56-9), if they contain > 3 % w/w DMSO extract | 64742-56-9 | 265-159-2 |

781. | Residual oils (petroleum), hydrotreated (Cas No 64742-57-0), if they contain > 3 % w/w DMSO extract | 64742-57-0 | 265-160-8 |

782. | Residual oils (petroleum), solvent-dewaxed, (Cas No 64742-62-7), if they contain > 3 % w/w DMSO extract | 64742-62-7 | 265-166-0 |

783. | Distillates (petroleum), solvent-dewaxed heavy naphthenic (Cas No 64742-63-8), if they contain > 3 % w/w DMSO extract | 64742-63-8 | 265-167-6 |

784. | Distillates (petroleum), solvent-dewaxed light naphthenic (Cas No 64742-64-9), if they contain > 3 % w/w DMSO extract | 64742-64-9 | 265-168-1 |

785. | Distillates (petroleum), solvent-dewaxed heavy paraffinic (Cas No 64742-65-0), if they contain > 3 % w/w DMSO extract | 64742-65-0 | 265-169-7 |

786. | Foots oil (petroleum) (Cas No 64742-67-2), if it contains > 3 % w/w DMSO extract | 64742-67-2 | 265-171-8 |

787. | Naphthenic oils (petroleum), catalytic dewaxed heavy (Cas No 64742-68-3), if they contain > 3 % w/w DMSO extract | 64742-68-3 | 265-172-3 |

788. | Naphthenic oils (petroleum), catalytic dewaxed light (Cas No 64742-69-4), if they contain > 3 % w/w DMSO extract | 64742-69-4 | 265-173-9 |

789. | Paraffin oils (petroleum), catalytic dewaxed heavy (Cas No 64742-70-7), if they contain > 3 % w/w DMSO extract | 64742-70-7 | 265-174-4 |

790. | Paraffin oils (petroleum), catalytic dewaxed light (Cas No 64742-71-8), if they contain > 3 % w/w DMSO extract | 64742-71-8 | 265-176-5 |

791. | Naphthenic oils (petroleum), complex dewaxed heavy, (Cas No 64742-75-2), if they contain > 3 % w/w DMSO extract | 64742-75-2 | 265-179-1 |

792. | Naphthenic oils (petroleum), complex dewaxed light (Cas No 64742-76-3), if they contain > 3 % w/w DMSO extract | 64742-76-3 | 265-180-7 |

793. | Extracts (petroleum), heavy naphthenic distillate solvent, arom. Conc. (Cas No 68783-00-6), if they contain > 3 % w/w DMSO extract | 68783-00-6 | 272-175-3 |

794. | Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent (Cas No 68783-04-0), if they contain > 3 % w/w DMSO extract | 68783-04-0 | 272-180-0 |

795. | Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted (Cas No 68814-89-1), if they contain > 3 % w/w DMSO extract | 68814-89-1 | 272-342-0 |

796. | Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity (Cas No 72623-85-9), if they contain > 3 % w/w DMSO extract | 72623-85-9 | 276-736-3 |

797. | Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based (Cas No 72623- 86-0), if they contain > 3 % w/w DMSO extract | 72623- 86-0 | 276-737-9 |

798. | Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based (Cas No 72623- 87-1), if they contain > 3 % w/w DMSO extract | 72623- 87-1 | 276-738-4 |

799. | Lubricating oils, (Cas No 74869-22-0), if they contain > 3 % w/w DMSO extract | 74869-22-0 | 278-012-2 |

800. | Distillates (petroleum), complex dewaxed heavy paraffinic (Cas No 90640-91-8), if they contain > 3 % w/w DMSO extract | 90640-91-8 | 292-613-7 |

801. | Distillates (petroleum), complex dewaxed light paraffinic (Cas No 90640-92-9), if they contain > 3 % w/w DMSO extract | 90640-92-9 | 292-614-2 |

802. | Distillates (petroleum), solvent dewaxed heavy paraffinic, clay-treated (Cas No 90640-94-1), if they contain > 3 % w/w DMSO extract | 90640-94-1 | 292-616-3 |

803. | Hydrocarbons, C20-50, solvent dewaxed heavy paraffinic, hydrotreated (Cas No 90640-95-2), if they contain > 3 % w/w DMSO extract | 90640-95-2 | 292-617-9 |

804. | Distillates (petroleum), solvent dewaxed light paraffinic, clay-treated (Cas No 90640-96-3), if they contain > 3 % w/w DMSO extract | 90640-96-3 | 292-618-4 |

805. | Distillates (petroleum), solvent dewaxed light paraffinic, hydrotreated (Cas No 90640-97-4), if they contain > 3 % w/w DMSO extract | 90640-97-4 | 292-620-5 |

806. | Extracts (petroleum), heavy naphthenic distillate solvent, hydrotreated (Cas No 90641-07-9), if they contain > 3 % w/w DMSO extract | 90641-07-9 | 292-631-5 |

807. | Extracts (petroleum), heavy paraffinic distillate solvent, hydrotreated (Cas No 90641-08-0), if they contain > 3 % w/w DMSO extract | 90641-08-0 | 292-632-0 |

808. | Extracts (petroleum), light paraffinic distillate solvent, hydrotreated (Cas No 90641-09-1), if they contain > 3 % w/w DMSO extract | 90641-09-1 | 292-633-6 |

809. | Residual oils (petroleum), hydrotreated solvent dewaxed (Cas No 90669-74-2), if they contain > 3 % w/w DMSO extract | 90669-74-2 | 292-656-1 |

810. | Residual oils (petroleum), catalytic dewaxed (Cas No 91770-57-9), if they contain > 3 % w/w DMSO extract | 91770-57-9 | 294-843-3 |

811. | Distillates (petroleum), dewaxed heavy paraffinic, hydrotreated, (Cas No 91995-39-0) if they contain > 3 % w/w DMSO extract | 91995-39-0 | 295-300-3 |

812. | Distillates (petroleum), dewaxed light paraffinic, hydrotreated (Cas No 91995-40-3), if they contain > 3 % w/w DMSO extract | 91995-40-3 | 295-301-9 |

813. | Distillates (petroleum), hydrocracked solvent-refined, dewaxed (Cas No 91995-45-8), if they contain > 3 % w/w DMSO extract | 91995-45-8 | 295-306-6 |

814. | Distillates (petroleum), solvent-refined light naphthenic, hydrotreated (Cas No 91995-54-9), if they contain > 3 % w/w DMSO extract | 91995-54-9 | 295-316-0 |

815. | Extracts (petroleum), hydrotreated light paraffinic distillate solvent (Cas No 91995- 73-2), if they contain > 3 % w/w DMSO extract | 91995- 73-2 | 295-335-4 |

816. | Extracts (petroleum), light naphthenic distillate solvent, hydrodesulfurised (Cas No 91995-75-4), if they contain > 3 % w/w DMSO extract | 91995-75-4 | 295-338-0 |

817. | Extracts (petroleum), light paraffinic distillate solvent, acid-treated (Cas No 91995-76-5), if they contain > 3 % w/w DMSO extract | 91995-76-5 | 295-339-6 |

818. | Extracts (petroleum), light paraffinic distillate solvent, hydrodesulfurised (Cas No 91995-77-6), if they contain > 3 % w/w DMSO extract | 91995-77-6 | 295-340-1 |

819. | Extracts (petroleum), light vacuum gas oil solvent, hydrotreated (Cas No 91995-79-8), if they contain > 3 % w/w DMSO extract | 91995-79-8 | 295-342-2 |

820. | Foots oil (petroleum), hydrotreated (Cas No 92045-12-0), if it contains > 3 % w/w DMSO extract | 92045-12-0 | 295-394-6 |

821. | Lubricating oils (petroleum), C17-35, solvent-extd. , dewaxed, hydrotreated (Cas No 92045-42-6), if they contain > 3 % w/w DMSO extract | 92045-42-6 | 295-423-2 |

822. | Lubricating oils (petroleum), hydrocracked nonarom solvent-deparaffined (Cas No 92045-43-7), if they contain > 3 % w/w DMSO extract | 92045-43-7 | 295-424-8 |

823. | Residual oils (petroleum), hydrocracked acid-treated solvent-dewaxed (Cas No 92061-86-4), if they contain > 3 % w/w DMSO extract | 92061-86-4 | 295-499-7 |

824. | Paraffin oils (petroleum), solvent-refined dewaxed heavy (Cas No 92129-09-4), if they contain > 3 % w/w DMSO extract | 92129-09-4 | 295-810-6 |

825. | Extracts (petroleum), heavy paraffinic distillate solvent, clay-treated (Cas No 92704- 08-0), if they contain > 3 % w/w DMSO extract | 92704- 08-0 | 296-437-1 |

826. | Lubricating oils (petroleum), base oils, paraffinic (Cas No 93572-43-1), if they contain > 3 % w/w DMSO extract | 93572-42-1 | 297-474-6 |

827. | Extracts (petroleum), heavy naphthenic distillate solvent, hydrodesulfurised (Cas No 93763-10-1), if they contain > 3 % w/w DMSO extract | 93763-10-1 | 297-827-4 |

828. | Extracts (petroleum), solvent-dewaxed heavy paraffinic distillate solvent, hydrodesulfurised (Cas No 93763-11-2), if they contain > 3 % w/w DMSO extract | 93763-11-2 | 297-829-5 |

829. | Hydrocarbons, hydrocracked paraffinic distn. residues, solvent-dewaxed (Cas No 93763-38-3), if they contain > 3 % w/w DMSO extract | 93763-38-3 | 297-857-8 |

830. | Foots oil (petroleum), acid-treated (Cas No 93924-31-3), if it contains > 3 % w/w DMSO extract | 93924-31-3 | 300-225-7 |

831. | Foots oil (petroleum), clay-treated (Cas No 93924-32-4), if it contains > 3 % w/w DMSO extract | 93924-32-4 | 300-226-2 |

832. | Hydrocarbons, C20-50, residual oil hydrogenation vacuum distillate (Cas No 93924-61-9), if they contain > 3 % w/w DMSO extract | 93924-61-9 | 300-257-1 |

833. | Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated (Cas No 94733-08-1), if they contain > 3 % w/w DMSO extract | 94733-08-1 | 305-588-5 |

834. | Distillates (petroleum), solvent-refined hydrocracked light (Cas No 94733-09-2), if they contain > 3 % w/w DMSO extract | 94733-09-2 | 305-589-0 |

835. | Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based (Cas No 94733-15-0), if they contain > 3 % w/w DMSO extract | 94733-15-0 | 305-594-8 |

836. | Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrogenated raffinate-based (Cas No 94733-16-1), if they contain > 3 % w/w DMSO extract | 94733-16-1 | 305-595-3 |

837. | Hydrocarbons, C13-30, arom. -rich, solvent-extd. naphthenic distillate (Cas No 95371-04-3), if they contain > 3 % w/w DMSO extract | 95371-04-3 | 305-971-7 |

838. | Hydrocarbons, C16-32, arom. rich, solvent-extd. naphthenic distillate (Cas No 95371-05-4), if they contain > 3 % w/w DMSO extract | 95371-05-4 | 305-972-2 |

839. | Hydrocarbons, C37-68, dewaxed deasphalted hydrotreated vacuum distn. Residues (Cas No 95371-07-6), if they contain > 3 % w/w DMSO extract | 95371-07-6 | 305-974-3 |

840. | Hydrocarbons, C37-65, hydrotreated deasphalted vacuum distn. Residues (Cas No 95371-08-7), if they contain > 3 % w/w DMSO extract | 95371-08-7 | 305-975-9 |

841. | Distillates (petroleum), hydrocracked solvent-refined light (Cas No 97488-73-8), if they contain > 3 % w/w DMSO extract | 97488-73-8 | 307-010-7 |

842. | Distillates (petroleum), solvent-refined hydrogenated heavy (Cas No 97488-74-9), if they contain > 3 % w/w DMSO extract | 97488-74-9 | 307-011-2 |

843. | Lubricating oils (petroleum), C18-27, hydrocracked solvent-dewaxed (Cas No 97488-95-4), if they contain > 3 % w/w DMSO extract | 97488-95-4 | 307-034-8 |

844. | Hydrocarbons, C17-30, hydrotreated solvent-deasphalted atm. distn. residue, distn. lights (Cas No 97675-87-1), if they contain > 3 % w/w DMSO extract | 97675-87-1 | 307-661-7 |

845. | Hydrocarbons, C17-40, hydrotreated solvent-deasphalted distn. residue, vacuum distn. lights (Cas No 97722-06-0), if they contain > 3 % w/w DMSO extract | 97722-06-0 | 307-755-8 |

846. | Hydrocarbons, C13-27, solvent-extd. light naphthenic (Cas No 97722-09-3), if they contain > 3 % w/w DMSO extract | 97722-09-3 | 307-758-4 |

847. | Hydrocarbons, C14-29, solvent-extd. light naphthenic (Cas No 97722-10-6), if they contain > 3 % w/w DMSO extract | 97722-10-6 | 307-760-5 |

848. | Foots oil (petroleum), carbon-treated (Cas No 97862-76-5), if it contains > 3 % w/w DMSO extract | 97862-76-5 | 308-126-0 |

849. | Foots oil (petroleum), silicic acid-treated (Cas No 97862-77-6), if it contains > 3 % w/w DMSO extract | 97862-77-6 | 308-127-6 |

850. | Hydrocarbons, C27-42, dearomatised (Cas No 97862-81-2), if they contain > 3 % w/w DMSO extract | 97862-81-2 | 308-131-8 |

851. | Hydrocarbons, C17-30, hydrotreated distillates, distn. Lights (Cas No 97862-82-3), if they contain > 3 % w/w DMSO extract | 97862-82-3 | 308-132-3 |

852. | Hydrocarbons, C27-45, naphthenic vacuum distn. (Cas No 97862-83-4), if they contain > 3 % w/w DMSO extract | 97862-83-4 | 308-133-9 |

853. | Hydrocarbons, C27-45, dearomatised (Cas No 97926-68-6), if they contain > 3 % w/w DMSO extract | 97926-68-6 | 308-287-7 |

854. | Hydrocarbons, C20-58, hydrotreated (Cas No 97926-70-0), if they contain > 3 % w/w DMSO extract | 97926-70-0 | 308-289-8 |

855. | Hydrocarbons, C27-42, naphthenic (Cas No 97926-71-1), if they contain > 3 % w/w DMSO extract | 97926-71-1 | 308-290-3 |

856. | Extracts (petroleum), light paraffinic distillate solvent, carbon-treated (Cas No 100684-02-4), if they contain > 3 % w/w DMSO extract | 100684-02-4 | 309-672-2 |

857. | Extracts (petroleum), light paraffinic distillate solvent, clay-treated (Cas No 100684- 03-5), if they contain > 3 % w/w DMSO extract | 100684- 03-5 | 309-673-8 |

858. | Extracts (petroleum), light vacuum, gas oil solvent, carbon-treated (Cas No 100684-04-6), if they contain > 3 % w/w DMSO extract | 100684-04-6 | 309-674-3 |

859. | Extracts (petroleum), light vacuum gas oil solvent, clay-treated (Cas No 100684-05-7), if they contain > 3 % w/w DMSO extract | 100684-05-7 | 309-675-9 |

860. | Residual oils (petroleum), carbon-treated solvent-dewaxed (Cas No 100684-37-5), if they contain > 3 % w/w DMSO extract | 100684-37-5 | 309-710-8 |

861. | Residual oils (petroleum), clay-treated solvent-dewaxed (Cas No 100684-38-6), if they contain > 3 % w/w DMSO extract | 100684-38-6 | 309-711-3 |

862. | Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated (Cas No 101316-69-2), if they contain > 3 % w/w DMSO extract | 101316-69-2 | 309-874-0 |

863. | Lubricating oils (petroleum), C17-32, solvent-extd. , dewaxed, hydrogenated (Cas No 101316-70-5), if they contain > 3 % w/w DMSO extract | 101316-70-5 | 309-875-6 |

864. | Lubricating oils (petroleum), C20-35, solvent-extd. , dewaxed, hydrogenated (Cas No 101316-71-6), if they contain > 3 % w/w DMSO extract | 101316-71-6 | 309-876-1 |

865. | Lubricating oils (petroleum), C24-50, solvent-extd. , dewaxed, hydrogenated (Cas No 101316-72-7), if they contain > 3 % w/w DMSO extract | 101316-72-7 | 309-877-7 |

866. | Distillates (petroleum), sweetened middle (Cas No 64741-86-2), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64741-86-2 | 265-088-7 |

867. | Gas oils (petroleum), solvent-refined (Cas No 64741-90-8), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64741-90-8 | 265-092-9 |

868. | Distillates (petroleum), solvent-refined middle (Cas No 64741-91-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64741-91-9 | 265-093-4 |

869. | Gas oils (petroleum), acid-treated (Cas No 64742-12-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64742-12-7 | 265-112-6 |

870. | Distillates (petroleum), acid-treated middle (Cas No 64742-13-8), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64742-13-8 | 265-113-1 |

871. | Distillates (petroleum), acid-treated light (Cas No 64742-14-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64742-14-9 | 265-114-7 |

872. | Gas oils (petroleum), chemically neutralised (Cas No 64742-29-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64742-29-6 | 265-129-9 |

873. | Distillates (petroleum), chemically neutralised middle (Cas No 64742-30-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64742-30-9 | 265-130-4 |

874. | Distillates (petroleum), clay-treated middle (Cas No 64742-38-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64742-38-7 | 265-139-3 |

875. | Distillates (petroleum), hydrotreated middle (Cas No 64742-46-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64742-46-7 | 265-148-2 |

876. | Gas oils (petroleum), hydrodesulfurised (Cas No 64742-79-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64742-79-6 | 265-182-8 |

877. | Distillates (petroleum), hydrodesulfurised middle (Cas No 64742-80-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64742-80-9 | 265-183-3 |

878. | Distillates (petroleum), catalytic reformer fractionator residue, high-boiling (Cas No 68477-29-2), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 68477-29-2 | 270-719-4 |

879. | Distillates (petroleum), catalytic reformer fractionator residue, intermediate-boiling (Cas No 68477-30-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 68477-30-5 | 270-721-5 |

880. | Distillates (petroleum), catalytic reformer fractionator residue, low-boiling (Cas No 68477-31-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 68477-31-6 | 270-722-0 |

881. | Alkanes, C12-26-branched and linear (Cas No 90622-53-0), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 90622-53-0 | 292-454-3 |

882. | Distillates (petroleum), highly refined middle (Cas No 90640-93-0), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 90640-93-0 | 292-615-8 |

883. | Distillates (petroleum), catalytic reformer, heavy arom. conc. Cas No 91995-34-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 91995-34-5 | 295-294-2 |

884. | Gas oils, paraffinic (Cas No 93924-33-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 93924-33-5 | 300-227-8 |

885. | Naphtha (petroleum), solvent-refined hydrodesulfurised heavy (Cas No 97488-96-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 97488-96-5 | 307-035-3 |

886. | Hydrocarbons, C16-20, hydrotreated middle distillate, distn. Lights (Cas No 97675- 85-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 97675- 85-9 | 307-659-6 |

887. | Hydrocarbons, C12-20, hydrotreated paraffinic, distn. lights (Cas No 97675-86-0), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 97675-86-0 | 307-660-1 |

888. | Hydrocarbons, C11-17, solvent-extd. light naphthenic (Cas No 97722-08-2), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 97722-08-2 | 307-757-9 |

889. | Gas oils, hydrotreated (Cas No 97862-78-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 97862-78-7 | 308-128-1 |

890. | Distillates (petroleum), carbon-treated light paraffinic (Cas No 100683-97-4), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 100683-97-4 | 309-667-5 |

891. | Distillates (petroleum), intermediate paraffinic, carbon-treated (Cas No 100683-98-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 100683-98-5 | 309-668-0 |

892. | Distillates (petroleum), intermediate paraffinic, clay-treated (Cas No 100683-99-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 100683-99-6 | 309-669-6 |

893. | Lubricating greases (Cas No 74869-21-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 74869-21-9 | 278-011-7 |

894. | Slack wax (petroleum) (Cas No 64742-61-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64742-61-6 | 265-165-5 |

895. | Slack wax (petroleum), acid-treated (Cas No 90669-77-5), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 90669-77-5 | 292-659-8 |

896. | Slack wax (petroleum), clay-treated (Cas No 90669-78-6), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 90669-78-6 | 292-660-3 |

897. | Slack wax (petroleum), hydrotreated (Cas No 92062-09-4), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 92062-09-4 | 295-523-6 |

898. | Slack wax (petroleum), low-melting (Cas No 92062-10-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 92062-10-7 | 295-524-1 |

899. | Slack wax (petroleum), low-melting, hydrotreated (Cas No 92062-11-8), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 92062-11-8 | 295-525-7 |

900. | Slack wax (petroleum), low-melting, carbon-treated (Cas No 97863-04-2), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 97863-04-2 | 308-155-9 |

901. | Slack wax (petroleum), low-melting, clay-treated (Cas No 97863-05-3), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 97863-05-3 | 308-156-4 |

902. | Slack wax (petroleum), low-melting, silicic acid-treated (Cas No 97863-06-4), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 97863-06-4 | 308-158-5 |

903. | Slack wax (petroleum), carbon-treated (Cas No 100684-49-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 100684-49-9 | 309-723-9 |

904. | Petrolatum (Cas No 8009-03-8), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 8009-03-8 | 232-373-2 |

905. | Petrolatum (petroleum), oxidised (Cas No 64743-01-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 64743-01-7 | 265-206-7 |

906. | Petrolatum (petroleum), alumina-treated (Cas No 85029-74-9), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 85029-74-9 | 285-098-5 |

907. | Petrolatum (petroleum), hydrotreated (Cas No 92045-77-7), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 92045-77-7 | 295-459-9 |

908. | Petrolatum (petroleum), carbon-treated (Cas No 97862-97-0), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 97862-97-0 | 308-149-6 |

909. | Petrolatum (petroleum), silicic acid-treated (Cas No 97862-98-1), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 97862-98-1 | 308-150-1 |

910. | Petrolatum (petroleum), clay-treated (Cas No 100684-33-1), except if the full refining history is known and it can be shown that the substance from which it is produced is not a carcinogen | 100684-33-1 | 309-706-6 |

911. | Distillates (petroleum), light catalytic cracked (Cas No 64741-59-9) | 64741-59-9 | 265-060-4 |

912. | Distillates (petroleum), intermediate catalytic cracked (Cas No 64741-60-2) | 64741-60-2 | 265-062-5 |

913. | Distillates (petroleum), light thermal cracked (Cas No 64741-82-8) | 64741-82-8 | 265-084-5 |

914. | Distillates (petroleum), hydrodesulfurised light catalytic cracked (Cas No 68333-25-5) | 68333-25-5 | 269-781-5 |

915. | Distillates (petroleum), light steam-cracked naphtha (Cas No 68475-80-9) | 68475-80-9 | 270-662-5 |

916. | Distillates (petroleum), cracked steam-cracked petroleum distillates (Cas No 68477-38-3) | 68477-38-3 | 270-727-8 |

917. | Gas oils (petroleum), steam-cracked (Cas No 68527-18-4) | 68527-18-4 | 271-260-2 |

918. | Distillates (petroleum), hydrodesulfurised thermal cracked middle (Cas No 85116-53-6) | 85116-53-6 | 285-505-6 |

919. | Gas oils (petroleum), thermal-cracked, hydrodesulfurised (Cas No 92045-29-9) | 92045-29-9 | 295-411-7 |

920. | Residues (petroleum), hydrogenated steam-cracked naphtha (Cas No 92062-00-5) | 92062-00-5 | 295-514-7 |

921. | Residues (petroleum), steam-cracked naphtha distn. (Cas No 92062-04-9) | 92062-04-9 | 295-517-3 |

922. | Distillates (petroleum), light catalytic cracked, thermally degraded (Cas No 92201-60-0) | 92201-60-0 | 295-991-1 |

923. | Residues (petroleum), steam-cracked heat-soaked naphtha (Cas No 93763-85-0) | 93763-85-0 | 297-905-8 |

924. | Gas oils (petroleum), light vacuum, thermal-cracked hydrodesulfurised (Cas No 97926-59-5) | 97926-59-5 | 308-278-8 |

925. | Distillates (petroleum), hydrodesulfurised middle coker (Cas No 101316-59-0) | 101316-59-0 | 309-865-1 |

926. | Distillates (petroleum), heavy steam-cracked (Cas No 101631-14-5) | 101631-14-5 | 309-939-3 |

927. | Residues (petroleum), atm. Tower (Cas No 64741-45-3) | 64741-45-3 | 265-045-2 |

928. | Gas oils (petroleum), heavy vacuum (Cas No 64741-57-7) | 64741-57-7 | 265-058-3 |

929. | Distillates (petroleum), heavy catalytic cracked (Cas No 64741-61-3) | 64741-61-3 | 265-063-0 |

930. | Clarified oils (petroleum), catalytic cracked (Cas No 64741-62-4) | 64741-62-4 | 265-064-6 |

931. | Residues (petroleum), catalytic reformer fractionator (Cas No 64741-67-9) | 64741-67-9 | 265-069-3 |

932. | Residues (petroleum), hydrocracked (Cas No 64741-75-9) | 64741-75-9 | 265-076-1 |

933. | Residues (petroleum), thermal cracked (Cas No 64741-80-6) | 64741-80-6 | 265-081-9 |

934. | Distillates (petroleum), heavy thermal cracked (Cas No 64741-81-7) | 64741-81-7 | 265-082-4 |

935. | Gas oils (petroleum), hydrotreated vacuum (Cas No 64742-59-2) | 64742-59-2 | 265-162-9 |

936. | Residues (petroleum), hydrodesulfurised atmospheric tower (Cas No 64742-78-5) | 64742-78-5 | 265-181-2 |

937. | Gas oils (petroleum), hydrodesulfurised heavy vacuum (Cas No 64742-86-5) | 64742-86-5 | 265-189-6 |

938. | Residues (petroleum), steam-cracked (Cas No 64742-90-1) | 64742-90-1 | 265-193-8 |

939. | Residues (petroleum), atmospheric (Cas No 68333-22-2) | 68333-22-2 | 269-777-3 |

940. | Clarified oils (petroleum), hydrodesulfurised catalytic cracked (Cas No 68333-26-6) | 68333-26-6 | 269-782-0 |

941. | Distillates (petroleum), hydrodesulfurised intermediate catalytic cracked (Cas No 68333-27-7) | 68333-27-7 | 269-783-6 |

942. | Distillates (petroleum), hydrodesulfurised heavy catalytic cracked (Cas No 68333-28-8) | 68333-28-8 | 269-784-1 |

943. | Fuel oil, residues-straight-run gas oils, high-sulfur (Cas No 68476-32-4) | 68476-32-4 | 270-674-0 |

944. | Fuel oil, residual (Cas No 68476-33-5) | 68476-33-5 | 270-675-6 |

945. | Residues (petroleum), catalytic reformer fractionator residue distn. (Cas No 68478-13-7) | 68478-13-7 | 270-792-2 |

946. | Residues (petroleum), heavy coker gas oil and vacuum gas oil (Cas No 68478-17-1) | 68478-17-1 | 270-796-4 |

947. | Residues (petroleum), heavy coker and light vacuum (Cas No 68512-61-8) | 68512-61-8 | 270-983-0 |

948. | Residues (petroleum), light vacuum (Cas No 68512-62-9) | 68512-62-9 | 270-984-6 |

949. | Residues (petroleum), steam-cracked light (Cas No 68513-69-9) | 68513-69-9 | 271-013-9 |

950. | Fuel oil, No 6 (Cas No 68553-00-4) | 68553-00-4 | 271-384-7 |

951. | Residues (petroleum), topping plant, low-sulfur (Cas No 68607-30-7) | 68607-30-7 | 271-763-7 |

952. | Gas oils (petroleum), heavy atmospheric (Cas No 68783-08-4) | 68783-08-4 | 272-184-2 |

953. | Residues (petroleum), coker scrubber, condensed-ring-arom. -contg (Cas No 68783-13-1) | 68783-13-1 | 272-187-9 |

954. | Distillates (petroleum), petroleum residues vacuum (Cas No 68955-27-1) | 68955-27-1 | 273-263-4 |

955. | Residues (petroleum), steam-cracked, resinous (Cas No 68955-36-2) | 68955-36-2 | 273-272-3 |

956. | Distillates (petroleum), intermediate vacuum (Cas No 70592-76-6) | 70592-76-6 | 274-683-0 |

957. | Distillates (petroleum), light vacuum (Cas No 70592-77-7) | 70592-77-7 | 274-684-6 |

958. | Distillates (petroleum), vacuum (Cas No 70592-78-8) | 70592-78-8 | 274-685-1 |

959. | Gas oils (petroleum), hydrodesulfurised coker heavy vacuum (Cas No 85117-03-9) | 85117-03-9 | 285-555-9 |

960. | Residues (petroleum), steam-cracked, distillates (Cas No 90669-75-3) | 90669-75-3 | 292-657-7 |

961. | Residues (petroleum), vacuum, light (Cas No 90669-76-4) | 90669-76-4 | 292-658-2 |

962. | Fuel oil, heavy, high-sulfur (Cas No 92045-14-2) | 92045-14-2 | 295-396-7 |

963. | Residues (petroleum), catalytic cracking (Cas No 92061-97-7) | 92061-97-7 | 295-511-0 |

964. | Distillates (petroleum), intermediate catalytic cracked, thermally degraded (Cas No 92201-59-7) | 92201-59-7 | 295-990-6 |

965. | Residual oils (petroleum) (Cas No 93821-66-0) | 93821-66-0 | 298-754-0 |

966. | Residues, steam cracked, thermally treated (Cas No 98219-64-8) | 98219-64-8 | 308-733-0 |

967. | Distillates (petroleum), hydrodesulfurised full-range middle (Cas No 101316-57-8) | 101316-57-8 | 309-863-0 |

968. | Distillates (petroleum), light paraffinic (Cas No 64741-50-0) | 64741-50-0 | 265-051-5 |

969. | Distillates (petroleum), heavy paraffinic (Cas No 64741-51-1) | 64741-51-1 | 265-052-0 |

970. | Distillates (petroleum), light naphthenic (Cas No 64741-52-2) | 64741-52-2 | 265-053-6 |

971. | Distillates (petroleum), heavy naphthenic (Cas No 64741-53-3) | 64741-53-3 | 265-054-1 |

972. | Distillates (petroleum), acid-treated heavy naphthenic (Cas No 64742-18-3) | 64742-18-3 | 265-117-3 |

973. | Distillates (petroleum), acid-treated light naphthenic (Cas No 64742-19-4) | 64742-19-4 | 265-118-9 |

974. | Distillates (petroleum), acid-treated heavy paraffinic (Cas No 64742-20-7) | 64742-20-7 | 265-119-4 |

975. | Distillates (petroleum), acid-treated light paraffinic (Cas No 64742-21-8) | 64742-21-8 | 265-121-5 |

976. | Distillates (petroleum), chemically neutralised heavy paraffinic (Cas No 64742-27-4) | 64742-27-4 | 265-127-8 |

977. | Distillates (petroleum), chemically neutralised light paraffinic (Cas No 64742-28-5) | 64742-28-5 | 265-128-3 |

978. | Distillates (petroleum), chemically neutralised heavy naphthenic (Cas No 64742-34-3) | 64742-34-3 | 265-135-1 |

979. | Distillates (petroleum), chemically neutralised light naphthenic (Cas No 64742-35-4) | 64742-35-4 | 265-136-7 |

980. | Extracts (petroleum), light naphthenic distillate solvent (Cas No 64742-03-6) | 64742-03-6 | 265-102-1 |

981. | Extracts (petroleum), heavy paraffinic distillate solvent (Cas No 64742-04-7) | 64742-04-7 | 265-103-7 |

982. | Extracts (petroleum), light paraffinic distillate solvent (Cas No 64742-05-8) | 64742-05-8 | 265-104-2 |

983. | Extracts (petroleum), heavy naphthenic distillate solvent (Cas No 64742-11-6) | 64742-11-6 | 265-111-0 |

984. | Extracts (petroleum), light vacuum gas oil solvent (Cas No 91995-78-7) | 91995-78-7 | 295-341-7 |

985. | Hydrocarbons, C26-55, arom. rich (Cas No 97722-04-8) | 97722-04-8 | 307-753-7 |

986. | Disodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)] bis(4-aminonaphthalene-1- sulphonate) (Cas No 573-58-0) | 573-58-0 | 209-358-4 |

987. | Disodium 4-amino-3-[[4′-[(2,4-diaminophenyl)azo] [1,1′-biphenyl]-4-yl]azo]-5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate (Cas No 1937-37-7) | 1937-37-7 | 217-710-3 |

988. | Tetrasodium 3,3′-[[1,1′-biphenyl]-4,4′-diylbis(azo)]bis[5-amino-4- hydroxynaphthalene-2,7-disulphonate] (Cas No 2602-46-2) | 2602-46-2 | 220-012-1 |

989. | 4-o-Tolylazo-o-toluidine (Cas No 97-56-3) | 97-56-3 | 202-591-2 |

990. | 4-Aminoazobenzene (Cas No 60-09-3) | 60-09-3 | 200-453-6 |

991. | Disodium[5-[[4′-[[2,6-dihydroxy-3-[(2-hydroxy-5-sulphophenyl)azo]phenyl]azo][1,1′-biphenyl]-4-yl]azo]salicylato(4-)]cuprate(2-) (Cas No 16071-86-6) | 16071-86-6 | 240-221-1ue se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 74 | 2-pentil-3-fenilprop-2-en-1-ol 27 Alcohol amilcinamílico | Amylcin namyl alcohol | 101-85-9 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 75 | 27 Salicilato de bencilo bencílico | Benzyl salicylate | 118-58-1 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 76 | Cinamaldehído | 27 Cinamal | 104-55-2 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 77 | 27 Cumarina | Coumarin | 91-64-5 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 78 | 2,6-octadien-1-ol, 3,7-dimetil-, (2E) | 27 Geraniol | 106-24-1 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 79 | 27 Hidroximetil-pentilciclohex-enocarbaldehído | Hydroxyisohexyl 3-cyclohexene carboxaldehyde | 31906-04-4 , 51414-25-6 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 80 | 27 Alcohol 4-metoxibencílico | Anisyl alcohol, anise alcohol alcohol | 105-13-5 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 81 | Ácido 2-propenoico, 3-fenil-, éster fenilmetílico 27 Cinamato bencílico | Benzyl cinnamate | 103-41-3 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 82 | 2,6,10-dodecatrien-1-ol, 3,7,11-trimetil- | 27 Farnesol | 4602-84-0 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 83 | 27 2-(4-terc-butilbencil) propionaldehído | Butylphenyl methylpropional | 80-54-6 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 84 | 1,6-octadien-3-ol, 3,7-dimetil- 27 Linalol | Linalool | 78-70-6 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 85 | 27 Benzoato de bencilo | Benzyl benzoate | 120-51-4 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 86 | 27 Citronelol | Citronellol | 106-22-9 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 87 | | Hexyl cinnamal | 101-86-0 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 88 | 27 d-Llimoneno | | 5989-27-5 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 89 | 27 Oct-2-inoato heptino carbonato de metilo | Methyl 2-octynoate | 111-12-6 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 90 | 27 3-metil-4-(2,6,6-trimetil-2-ciclohexen-1-il)-3-buten-2-ona | alpha-Isomethyl ionone | 127-51-5 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 91 | 27 Evernia prunastri, extracto | Evernia prunastri extract | 90028-68-5 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

27 92 | 27 Evernia furfuracea, extracto | Evernia furfuracea extract | 90028-67-4 | | | | 27 La presencia de la sustancia deberá indicarse en la lista de ingredientes a que se hace referencia en el artículo 14, apartado 1, letra g), la letra g) del apartado 1 del artículo 6 cuando su concentración supere:el 0,01 % en productos que no se aclaran los productos que no deben enjuagarseel 0,01 % en productos que se aclaran los productos que deben enjuagarse | |

28 93 | 28 2,4-diaminopirimidina-3-óxido | Diaminopyrimidine oxide | 74638-76-9 | | 28 Productos para el pelo tratamiento del cabello | 28 1,5 % | | |

28 94 | 29 Peróxido de dibenzoilo benzoilo | Benzoyl peroxide | | | 28 Sistemas de uñas artificiales | 28 0,7 % (después de la mezcla) | 28 Uso profesional Reservado a los profesionales | 28 – Sólo para uso profesional Reservado a los profesionales- Evítese el contacto con la piel- Léanse las instrucciones de uso |

28 95 | 28 Hidroquinona dimetiléter | Mequinol | | | 28 Sistemas de uñas artificiales | 28 0,02 % (después de la mezcla para su utilización) | 28 Uso profesional Reservado a los profesionales | 28 – Sólo para uso profesional Reservado a los profesionales- Evítese el contacto con la piel- Léanse las instrucciones de uso |

29 96 | 5-terc-butil-2,4,6-trinitro-m-xileno 29 Almizcle de xileno | Musk xylene | 81-15-2 | | 29 Todos los productos cosméticos, excepto los productos bucales para higiene bucal | 29 a) 1,0 % en perfumes b) 0,4 % en agua de colonia c) 0,03 % en los demás productos | | |

29 97 | 4'-terc-butil-2',6'-dimetil-3',5'-dinitroacetofenona 29 Almizcle de cetona | Musk ketone | 81-14-1 | | 29 Todos los productos cosméticos, excepto los productos bucales para higiene bucal | 29 a) 1,4 % en perfumes b) 0,56 % en agua de colonia c) 0,042 % en los demás productos | | |

30 98 [51] | 30 Ácido salicílico | Salicylic acid | 69-72-7 | | 30 a) Productos para el cabello que se aclaranb) Otros productos | 30 a) 3,0 %b) 2,0 % | 30 No utilizar en productos destinados a niños menores de 3 tres años, excepto en champús.Con otros fines que no sean la inhibición del crecimiento de microorganismos en el producto. La presentación del producto debe poner en evidencia estos otros fines. | 30 No emplear para los cuidados de los niños menores de 3 tres años [52] |

30 99 [53] | 30 Sulfitos y bisulfitos inorgánicos | Ammonium bisulfite, ammonium sulfite, potassium metabisulfite, potassium sulfite, sodium bisulfite, sodium hydrosulfite, sodium metabisulfite, sodium sulfite | | | 30 a) Tintes para el cabello oxidantesb) Productos alisadores del cabelloc) Autobronceadores facialesd) Otros autobronceadores | 30 a) 0,67 % (de expresado en SO2 libre ) b) 6,7 % (de expresado en SO2 libre ) c) 0,45 % (de expresado en SO2 libre ) d) 0,40 % (de expresado en SO2 libre ) | 30 Con otros fines que no sean la inhibición del crecimiento de microorganismos en el producto. La presentación del producto debe poner en evidencia estos otros fines. | 30 |

30 100 [54] | 1-(4-clorofenil)-3-(3,4-diclorofenil)urea | 30 Triclocarban | 101-20-2 | | 30 Productos que se aclaran | 30 1,5 % | 30 Criterios de pureza:3,3',4,4'-Tetracloroazobenczeno ≤ 1 ppm3,3',4,4'-Tetracloroazoxibenczeno ≤ 1 ppmCon otros fines que no sean la inhibición del crecimiento de microorganismos en el producto. La presentación del producto debe poner en evidencia estos otros fines. | 30 |

30 101 [55] | 30 Piritiona de zcinc | Zinc pyrithione | 13463-41-7 | | 30 Productos para el pelo cabello que no se aclaran | 30 0,1 % | 30 Con otros fines que no sean la inhibición del crecimiento de microorganismos en el producto. La presentación del producto debe poner en evidencia estos otros fines. | 30 |

102 | 4-Alilveratrol | Methyl eugenol | 93-15-2 | 202-223-0 | Perfumes Agua de colonia Crema de fragancia Otros productos que no se aclaran y productos bucales Productos que se aclaran salvo contenidos normales en los aceites naturales utilizados y siempre que la concentración no exceda de: | 0,01 %0,004 %0,002 %0,0002 % 0,001 % : | | |

86/199/CEE (adaptado)

1 88/667/CEE

2 2002/34/CE art. 1 y anexo, pt. 3

3 2007/67/CE art. 1

4 2002/34/CE art. 1 y anexo, pt. 3 mod. por Rectificación, DO L 151 de 19.6.2003, p. 44

1 SEGUNDA PARTE

LISTA DE SUSTANCIAS PROVISIONALMENTE ADMITIDAS

Número de orden | Substancias | Restricciones | Condiciones de empleo y advertencias que se consignarán obligatoriamente en la etiqueta | Fecha límite de admisión |

| | Campo de aplicación y/o uso | Concentración máxima autorizada en el producto cosmético acabado | Otras limitaciones y exigencias | | |

| | | | | | | | | |

| | | | | | | | | |

| | | | | | | | | |

2 1053 | 2 4-Amino-3-nitrofphenol y sus sales | 4-Amino-3-nitrophenol | 610-81-1 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 3,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,5 % No usar después del 3 31.12.2009 | 2 a) b) Puede provocar una reacción alérgica | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 3,0 % | | | |

2 1064 | 2 Naftaleno-2,7-diol 2,7-Naphthalenediol y sus sales | Naphthalene-2,7-diol (CI 76645). | 582-17-2 | | 2 Colorantes de oxidación para el teñido del cabello | 2 1,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 0,5 % No usar después del 3 31.12.2009 | | |

2 1075 | 2 3-aminofenol m-Aminophenol y sus sales | 3-Aminophenol (CI 76545). | 591-27-5 | | 2 Colorantes de oxidación para el teñido del cabello | 2 2,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,0 % No usar después del 3 31.12.2009 | 2 Puede provocar una reacción alérgica | |

2 1086 | 2 6-hidroxi-3,4-dimetil-2-piridona 2,6-Dihydroxy-3,4-dimethylpyridine y sus sales | 2,6-Dihydroxy-3,4-dimethylpyridine | 84540-47-6 | | 2 Colorantes de oxidación para el teñido del cabello | 2 2,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,0 % No usar después del 3 31.12.2009 | | |

2 1097 | 2 1-hidroxi-3-nitro-4-(3-hidroxipropilamino)-benceno 4-Hydroxypropylamino-3-nitrophenol y sus sales | 2 4-Hydroxypropylamino-3-nitrophenol | 92952-81-3 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 5,2 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 2,6 % No usar después del 3 31.12.2009 | 2 a) b) Puede provocar una reacción alérgica | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 2,6 % | | | |

| | | | | | | | | |

2 1119 | 2 1-[(2'-metoxietil)amino]-2-nitro-4-[di-(2'-hidroxietil)amino] benceno HC Blue no 11 y sus sales | 2 HC Blue No 11 | 23920-15-2 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 3,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,5 % No usar después del 3 31.12.2009 | 2 a) b) Puede provocar una reacción alérgica | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 2,0 % | | | |

2 1120 | 2 1-metil-3-nitro-4-(β-hidroxietil)aminobenceno Hydroxyethyl-2-nitro-p-toluidine y sus sales | 2 Hydroxyethyl-2-nitro-p-toluidine | 100418-33-5 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 2,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,0 % No usar después del 3 31.12.2009 | 2 a) b) Puede provocar una reacción alérgica | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 1,0 % | | | |

2 113 | 2 1-hidroxi-2-β-hidroxietilamino-4,6-dinitrobenceno 2-Hydroxyethyl picramic acid y sus sales | 2 2-Hydroxyethylpicramic acid | 99610-72-7 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 3,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,5 % No usar después del 3 31.12.2009 | 2 a) b) Puede provocar una reacción alérgica | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 2,0 % | | | |

2 1142 | 2 4-metilaminofenol p-Methylaminophenol y sus sales | 2 p-Methylaminophenol | 150-75-4 | | 2 Colorantes de oxidación para el teñido del cabello | 2 3,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,5 % No usar después del 3 31.12.2009 | 2 Puede provocar una reacción alérgica | |

| | | | | | | | | |

2 1164 | 2 1-(3-hidroxipropilamino)-2-nitro-4-bis(2-hidroxietilamino) benceno HC Violet no 2 y sus sales | 2 HC Violet No 2 | 104226-19-9 | | 2 Colorantes no de oxidación para el teñido del cabello | 2 2,0 % | No usar después del 3 31.12.2009 | | |

| | | | | | | | | |

2 1186 | 2 1-(β-hidroxietil)amino-2-nitro-4,N-etil-N-(β-hidroxietil)aminobenceno HC Blue no 12 y sus sales | 2 HC Blue No 12 | 104516-93-0 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 1,5 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 0,75 % No usar después del 3 31.12.2009 | 2 a) b) Puede provocar una reacción alérgica | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 1,5 % | | | |

2 1198 | 2 4,4'-[1,3-propanodiilbis(oxi)]bis(benceno-1,3-diamina) 1,3-Bis-(2,4-diaminophenoxy)propane y sus sales | 2 1,3-Bis-(2,4-diaminophenoxy)propane | 81892-72-0 | | 2 Colorantes de oxidación para el teñido del cabello | 2 2,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,0 % No usar después del 3 31.12.2009 | 2 Puede provocar una reacción alérgica | |

2 1209 | 4 3-Amino-2,4-dichlorophenol y sus sales | 3-Amino-2,4-dichlorophenol | 61693-43-4 | | 2 Colorantes de oxidación para el teñido del cabello | 2 2,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,0 % No usar después del 3 31.12.2009 | 2 Puede provocar una reacción alérgica | |

2 1210 | 2 3-metil-1-fenil-5-pirazolona Phenyl methyl pyrazolone y sus sales | 2 Phenyl methyl pyrazolone | 89-25-8 | | 2 Colorantes de oxidación para el teñido del cabello | 2 0,5 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 0,25 % No usar después del 3 31.12.2009 | | |

2 1221 | 2 5-[(2-hidroxietil)amino]-o-cresol 2-Methyl-5-hydroxyethylaminophenol y sus sales | 2 2-Methyl-5-hydroxyethylaminophenol | 55302-96-0 | | 2 Colorantes de oxidación para el teñido del cabello | 2 2,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,0 % No usar después del 3 31.12.2009 | 2 Puede provocar una reacción alérgica | |

2 1232 | 2 3,4-dihidro-2H-1,4-benzoxazin-6-ol Hydroxybenzomorpholine y sus sales | 2 Hydroxybenzomorpholine | 26021-57-8 | | 2 Colorantes de oxidación para el teñido del cabello | 2 2,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,0 % No usar después del 3 31.12.2009 | 2 Puede provocar una reacción alérgica | |

2 124 | 2 1,5-bis(β-hidroxietil)amino-2-nitro-4-clorobenceno HC Yellow no 10 y sus sales | 2 HC Yellow No 10 | 109023-83-8 | | 2 Colorantes no de oxidación para el teñido del cabello | 2 0,2 % | No usar después del 3 31.12.2009 | | |

2 125 | 2 3,5-diamino-2,6-dimetoxipiridina, diclorhidrato 2,6-Dimethoxy-3,5-pyridinediamine y sus sales | 2 2,6-Dimethoxy-3,5-pyridinediamine | 85679-78-3 | | 2 Colorantes de oxidación para el teñido del cabello | 2 0,5 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 0,25 % No usar después del 3 31.12.2009 | 2 Puede provocar una reacción alérgica | |

2 126 | 2 1-(2-aminoetil)amino-4-(2-hidroxietil)oxi-2-nitrobenceno HC Orange no 2 y sus sales | 2 HC Orange No 2 | 85765-48-6 | | 2 Colorantes no de oxidación para el teñido del cabello | 2 1,0 % | No usar después del 3 31.12.2009 | | |

2 127 | 2 Etanol, 2-[(4-amino-2-metil-5-nitrofenil)amino]- HC Violet no 1 y sus sales | 2 HC Violet No 1 | 82576-75-8 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 0,5 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 0,25 % No usar después del 3 31.12.2009 | | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 0,5 % | | | |

2 128 | 2 2-[3-(metilamino)-4-nitrofenoxi]etanol 3-Methylamino-4-nitrophenoxyethanol y sus sales | 2 3-Methylamino-4-nitro-phenoxyethanol | 59820-63-2 | | 2 Colorantes no de oxidación para el teñido del cabello | 2 1,0 % | No usar después del 3 31.12.2009 | | |

2 129 | 2 2-[(2-metoxi-4-nitrofenil)amino]etanol 2-Hydroxyethylamino-5-nitro-anisole y sus sales | 2 2-Hydroxy-ethylamino-5-nitro-anisole | 66095-81-6 | | 2 Colorantes no de oxidación para el teñido del cabello | 2 1,0 % | No usar después del 3 31.12.2009 | | |

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2 131 | 2 clorhidrato de 2,2'-[(4-amino-3-nitrofenil)imino]bisetanol y sus sales | 4 HC Red No 13 | 94158-13-1 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 2,5 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,25 % No usar después del 3 31.12.2009 | | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 2,5 % | | | |

2 132 | 2 Naftaleno-1,5-diol (CI 76625) 1,5-Naphhthalenediol y sus sales | 2 1,5-Naphthalenediol | 83-56-7 | | 2 Colorantes de oxidación para el teñido del cabello | 2 1,0 % | No usar después del 3 31.12.2009 | | |

2 133 | Hidroxipropil bis (N-hidroxietil-p-fenilendiamina) 2 Hydroxypropyl bis (N-hydroxyethyl-p-phenylenediamine) y sus sales | | 128729-30-6 | | 2 Colorantes de oxidación para el teñido del cabello | 2 3,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,5 % No usar después del 3 31.12.2009 | 2 Puede provocar una reacción alérgica | |

2 134 | o-Aminofenol 2 o-Aminophenol y sus sales | o-Aminophenol | 95-55-6 | | 2 Colorantes de oxidación para el teñido del cabello | 2 2,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,0 % No usar después del 3 31.12.2009 | | |

2 135 | 2 5-amino-o-cresol y sus sales | 2 4-Amino-2-hydroxytoluene | 2835-95-2 | | 2 Colorantes de oxidación para el teñido del cabello | 2 3,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,5 % No usar después del 3 31.12.2009 | | |

2 136 | 2 Diclorhidrato de 2-(2,4-diaminofenoxi)etanol y sus sales | 4 2,4-Diaminophenoxyethanol | 66422-95-5 | | 2 Colorantes de oxidación para el teñido del cabello | 2 4,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 2,0 % No usar después del 3 31.12.2009 | | |

2 137 | 2 1,3-bencenodiol,2-metil- y sus sales | 2 2-Methylresorcinol | 608-25-3 | | 2 Colorantes de oxidación para el teñido del cabello | 2 2,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,0 % No usar después del 3 31.12.2009 | | |

2 138 | 2 4-Amino-m-cresol y sus sales | 2 4-Amino-m-cresol | 2835-99-6 | | 2 Colorantes de oxidación para el teñido del cabello | 2 3,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,5 % No usar después del 3 31.12.2009 | | |

2 139 | 2 2-[(3-amino-4-metoxifenil)amino]etanol y sus sales | 2 2-Amino-4-hydroxyethylaminoanisole | 83763-47-7 | | 2 Colorantes de oxidación para el teñido del cabello | 2 3,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,5 % No usar después del 3 31.12.2009 | | |

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2 1424 | 2 2-(1,3-benzodioxol-5-ilamino)etanol, clorhidrato Hydroxyethyl-3,4-methylenedioxyaniline y sus sales | HCI | 81329-90-0 | | 2 Colorantes de oxidación para el teñido del cabello | 2 3,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,5 % No usar después del 3 31.12.2009 | | |

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2 1457 | 2 2,2'-[[4-[(2-hidroxietil)amino]-3-nitrofenil]imino]bisetanol y sus sales | 2 HC Blue No 2 | 33229-34-4 | | 2 Colorantes no de oxidación para el teñido del cabello | 2 2,8 % | No usar después del 3 31.12.2009 | | |

2 1468 | 2 4-[(2-hidroxietil)amino]-3-nitrofenol y sus sales | 2 3-Nitro-p-hydroxyethylaminophenol | 65235-31-6 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 6,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 3,0 % No usar después del 3 31.12.2009 | | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 6,0 % | | | |

2 1479 | 2 1-(β-ureidoetil)amino-4-nitrobenceno y sus sales | 2 4-Nitrophenyl aminoethylurea | 27080-42-8 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 0,5 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 0,25 % No usar después del 3 31.12.2009 | | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 0,5 % | | | |

2 14850 | 2 1-amino-2-nitro-4-(2',3'-dihidroxipropil)amino-5-clorobencenoy1,4-bis-(2',3'-dihidroxipropil)amino-2-nitro-5-clorobenceno y sus sales | 2 HC Red No 10 + HC Red No 11 | 95576-89-9 and 95576-92-4 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 2,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,0 % No usar después del 3 31.12.2009 | | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 1,0 % | | | |

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2 15355 | 2 Fenol, 2-cloro-6-(etilamino)-4-nitro- y sus sales | 2 2-Chloro-6-ethylamino-4-nitrophenol | 131657-78-8 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 3,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,5 % No usar después del 3 31.12.2009 | | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 3,0 % | | | |

2 15456 | 2 2-Amino-6-chloro-4-nitrofphenol y sus sales | 2-Amino-6-chloro-4-nitrophenol | 6358-09-4 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 2,0 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 1,0 % No usar después del 3 31.12.2009 | | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 2,0 % | | | |

2 1557 | Cloruro de [4-[[4-anilino-1-naftil][4-(dimetilamino)fenil]metilen]ciclohexa-2,5-dien-1-iliden]dimetilamonio 2 y sus sales | 2 Basic Blue 26 (CI 44045) | 2580-56-5 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 0,5 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 0,25 % No usar después del 3 31.12.2009 | | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 0,5 % | | | |

2 15658 | 5-amino-4-hidroxi-3-(fenilazo)naftaleno-2,7-disulfonato de disodio 2 y sus sales | 2 Acid Red 33 (CI 17200) | 3567-66-6 | | 2 Colorantes no de oxidación para el teñido del cabello | 2 2,0 % | No usar después del 3 31.12.2009 | | |

2 15759 | 3-[(2,4-dimetil-5-sulfonatofenil)azo]-4-hidroxinaftaleno-1-sulfonato de disodio (CI 14700) 2 y sus sales | 2 Ponceau SX (CI 14700) | 4548-53-2 | | 2 Colorantes no de oxidación para el teñido del cabello | 2 2,0 % | No usar después del 3 31.12.2009 | | |

2 15860 | Clorhidrato de (4-(4-aminofenil)(4-iminociclohexa-2,5-dieniliden)metil)-2-metilanilina 2 y sus sales | 2 Basic Violet 14 (CI 42510) | 632-99-5 | | 2 a) Colorantes de oxidación para el teñido del cabello | 2 a) 0,3 % | 2 En combinación con peróxido de hidrógeno, la concentración máxima para su uso es de 0,15 % No usar después del 3 31.12.2009 | | |

| | | | | 2 b) Colorantes no de oxidación para el teñido del cabello | 2 b) 0,3 % | | | |

76/768/CEE

ANEXO IV

86/179/CEE (adaptado)

1 88/667/CEE

2 90/121/CEE

1 PRIMERA PARTE

LISTA DE COLORANTES ADMITIDOS EN QUE PODRÁN CONTENER LOS PRODUCTOS COSMÉTICOS [56]

PREÁMBULO

Sin perjuicio de otras disposiciones de la presente Directiva, un colorante expresado como sal incluirá las lacas y sus otras sales.

Columna 1 | = | Colorantes admitidos en todos los productos cosméticos. |

Columna 2 | = | Colorantes admitidos en todos los productos cosméticos excepto en los que se aplican cerca de los ojos y, más concretamente, en los productos para maquillar y desmaquillar los ojos. |

Columna 3 | = | Colorantes admitidos únicamente en los productos cosméticos que no se destinen a entrar en contacto con las mucosas. |

Columna 4 | = | Colorantes admitidos únicamente en los productos cosméticos destinados a entrar en breve contacto con la piel. |

Número de referencia | Identificación de las sustancias | Condiciones Campo de aplicación | Texto de las condiciones de uso y advertencias |

| Nombre químico | Número de índice color contenido en el glosario o denominación | Número CAS | Número EINECS / ELINCS | Coloración | Tipo de producto, partes del cuerpo Campo de aplicación1234 | Concentración máxima | Otras condiciones limitaciones y exigencias [57] | |

a | B | c | d | e | f | g | h | i | j |

1 | Tris(1,2-naftoquinona-1-oximato-O, O')ferrato(1-) de sodio | 10006 | | | Vverde | X Productos que se aclaran | | | |

2 | Tris[5,6-dihidro-5-(hidroxiimino)-6-oxonaftaleno-2-sulfonato(2-)-N5,O6]ferrato(3-) de trisodio | 10020 | | | Vverde | X No usar en productos aplicados en las mucosas | | | |

3 | 5,7-dinitro-8-óxidonaftaleno-2-sulfonato de disodio y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 10316 [58] | | | Aamarilla | X No usar en productos oculares | | | |

4 | 2-[(4-metil-2-nitrofenil)azo]-3-oxo-N-fenilbutiramida | 11680 | | | Aamarilla | X No usar en productos aplicados en las mucosas | | | |

5 | 2-[(4-cloro-2-nitrofenil)azo]-N-(2-clorofenil)-3-oxobutiramida | 11710 | | | Aamarilla | X No usar en productos aplicados en las mucosas | | | |

6 | 2-[(4-metoxi-2-nitrofenil)azo]-3-oxo-N-(o-tolil)butiramida | 11725 | | | Nnaranja | X Productos que se aclaran | | | |

7 | 4-(fenilazo)resorcinol | 11920 | | | Nnaranja | X | | | |

8 | 4-[(4-etoxifenil)azo]naftol | 12010 | | | Rroja | X No usar en productos aplicados en las mucosas | | | |

9 | 1-[(2-cloro-4-nitrofenil)azo]-2-naftol y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 12085 [59] | | | Rroja | X | 3 % máx. en el producto acabado | | |

10 | 1-(4-metil-2-nitrofenilazo)-2-naftol | 12120 | | | Rroja | X Productos que se aclaran | | | |

11 | 3-hidroxi-N-(o-tolil)-4-[(2,4,5-triclorofenil)azo]naftaleno-2- carboxamida | 12370 | | | Rroja | X Productos que se aclaran | | | |

12 | N-(4-cloro-2-metilfenil)-4-[(4-cloro-2-metilfenil)azo]-3-hidroxinaftaleno-2-carboxamida | 12420 | | | Rroja | X Productos que se aclaran | | | |

13 | 4-[(2,5-diclorofenil)azo]-N-(2,5-dimetoxifenil)-3-hidroxinaftaleno-2-carboxamida | 12480 | | | Mmarrón | X Productos que se aclaran | | | |

14 | N-(5-cloro-2,4-dimetoxifenil)-4-[[5-[(dietilamino)sulfonil]-2-metoxifenil]azo]-3-hidroxinaftaleno-2-carboxamida | 12490 | | | Rroja | X | | | |

15 | 2,4-dihidro-5-metil-2-fenil-4-(fenilazo)-3H-pirazol-3-ona | 12700 | | | Aamarilla | X Productos que se aclaran | | | |

16 | 2-amino-5-[(4-sulfonatofenil)azo]bencenosulfonato de disodio | 13015 | | | Aamarilla | X | | E 105 | |

17 | 4-(2,4-dihidroxifenilazo)bencenosulfonato de sodio | 14270 | | | Nnaranja | X | | E 103 | |

18 | 3-[(2,4-dimetil-5-sulfonatofenil)azo]-4-hidroxinaftaleno-1-sulfonato de disodio | 14700 | | | Rroja | X | | | |

19 | 4-hidroxi-3-[(4-sulfonatonaftil)azo]naftalenosulfonato de disodio | 14720 | | | Rroja | X | | E 122 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 122) | |

20 | 6-[(2,4-dimetil-6-sulfonatofenil)azo]-5-hidroxinaftaleno-1-sulfonato de disodio | 14815 | | | Rroja | X | | E 125 | |

21 | 4-[(2-hidroxi-1-naftil)azo]bencenosulfonato de sodio y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 15510 [60] | | | Nnaranja | X No usar en productos oculares | | | |

22 | Bis[2-cloro-5-[(2-hidroxi-1-naftil)azo]-4-sulfonatobenzoato] de calcio | 15525 | | | Rroja | X | | | |

23 | Bis[4-[(2-hidroxi-1-naftil)azo]-2-metilbencenosulfonato] de bario | 15580 | | | Rroja | X | | | |

24 | 4(-2-hidroxi-1-naftilazo)naftalenosulfonato de sodio | 15620 | | | Rroja | X Productos que se aclaran | | | |

25 | 2-[(2-hidroxinaftil)azo]naftalenosulfonato de sodio y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 15630 [61] | | | Rroja | X | 3 % máx. en el producto acabado | | |

26 | Bis[4-(fenilazo)-3-hidroxi-2-naftoato] de calcio | 15800 | | | Red | X No usar en productos aplicados en las mucosas | | | |

27 | 3-hidroxi-4-[(4-metil-2-sulfonatofenil)azo]-2-naftoato de disodio y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 15850 [62] | | | Rroja | X | | Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 180) | |

28 | 4-[(5-cloro-4-metil-2-sulfonatofenil)azo]-3-hidroxi-2-naftoato de disodio y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 15865 [63] | | | Rroja | X | | | |

29 | 3-hidroxi-4-[(1-sulfonato-2-naftil)azo]-2-naftoato de calcio | 15880 | | | Rroja | X | | | |

30 | 6-hidroxi-5-[(3-sulfonatofenil)azo]naftaleno-2-sulfonato de disodio | 15980 | | | Nnaranja | X | | E 111 | |

31 | 6-hidroxi-5-[(4-sulfonatofenil)azo]naftaleno-2-sulfonato de disodio y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 15985 [64] | | | Aamarilla | X | | E 110 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 110) | |

32 | 6-hidroxi-5-[(2-metoxi-4-sulfonato-m-tolil)azo]naftaleno-2- sulfonato de disodio | 16035 | | | Rroja | X | | Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 129) | |

33 | 3-hidroxi-4-(4'-sulfonatonaftilazo)naftaleno-2,7-disulfonato de trisodio | 16185 | | | Rroja | X | | E 123 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 123) | |

34 | 7-hidroxi-8-fenilazonaftaleno-1,3-disulfonato de disodio | 16230 | | | Nnaranja | X No usar en productos aplicados en las mucosas | | | |

35 | 1-(1-naftilazo)-2-hidroxinaftaleno-4',6,8-trisulfonato de trisodio y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 16255 [65] | | | Rroja | X | | E 124 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 124) | |

36 | 7-hidroxi-8-[(4-sulfonato-1-naftil)azo]naftaleno-1,3,6-trisulfonato de tetrasodio | 16290 | | | Rroja | X | | E 126 | |

37 | 5-amino-4-hidroxi-3-(fenilazo)naftaleno-2,7-disulfonato de disodio y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 172002 [66] | | | Rroja | X | | | |

38 | 5-acetilamino-4-hidroxi-3-(fenilazo)naftaleno-2,7-disulfonato de disodio | 18050 | | | Rroja | X No usar en productos aplicados en las mucosas | | Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 128) | |

39 | Ácido 2,7-naftalenodisulfónico, 3-((4-ciclohexil-2-metilfenil)azo)-4-hidroxi-5-(((4-metilfenil)sulfonil)amino)-, sal disódica | 18130 | | | Rroja | X Productos que se aclaran | | | |

40 | Bis[2-[(4,5-dihidro-3-metil-5-oxo-1-fenil-1H-pirazol-4-il)azo]benzoato(2-)]cromato(1-) de hidrógeno | 18690 | | | Aamarilla | X Productos que se aclaran | | | |

41 | Bis[5-cloro-3-[(4,5-dihidro-3-metil-5-oxo-1-fenil-1H-pirazol-4-il)azo]-2-hidroxibencenosulfonato(3-)]cromato(3-) de disodio e hidrógeno | 18736 | | | Rroja | X Productos que se aclaran | | | |

42 | 4-(3-hidroxi-5-metil-4-fenilazopirazol-2-il)bencenosulfonato de sodio | 18820 | | | Aamarilla | X Productos que se aclaran | | | |

43 | 2,5-dicloro-4-(5-hidroxi-3-metil-4-(sulfofenilazo)pirazol-1-il)bencenosulfonato de disodio | 18965 | | | Aamarilla | X | | | |

44 | 5-hidroxi-1-(4-sulfofenil)-4-(4-sulfofenilazo)pirazol-3-carboxilato de trisodio y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 19140 [67] | | | Aamarilla | X | | E 102 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 102) | |

45 | N, N'-(3,3'-dimetil[1,1'-bifenil]-4,4'-diil)bis[2-[(2,4-diclorofenil)azo]-3-oxobutiramida] | 20040 | | | Aamarilla | X Productos que se aclaran | | Ccontenido máx. de 5 ppm de 3,3'-dimetilbencidina en el colorante | |

46 | 4-amino-5-hidroxi-3-(4-nitrofenilazo)-6-(fenilazo)naftaleno-2,7-disulfonato de sodio | 20470 | | | Nnegra | X Productos que se aclaran | | | |

47 | 2,2'-[(3,3'-dicloro[1,1'-bifenil]-4,4'-diil)bis(azo)]bis[N-(2,4-dimetilfenil)-3-oxobutiramida] | 21100 | | | Aamarilla | X Productos que se aclaran | | Ccontenido máx. de 5 ppm de 3,3'-dimetilbencidina en el colorante | |

48 | 2,2'-[(3,3'-dicloro[1,1'-bifenil]-4,4'-diil)bis(azo)]bis[N-(4-cloro-2,5-dimetoxifenil)-3-oxobutiramida] | 21108 | | | Aamarilla | X Productos que se aclaran | idem | Ccontenido máx. de 5 ppm de 3,3'-dimetilbencidina en el colorante | |

49 | 2,2'-[ciclohexiliden-bis[(2-metil-4,1-fenilen)azo]]bis[4-ciclohexilfenol] | 21230 | | | Aamarilla | X No usar en productos aplicados en las mucosas | | | |

50 | 4,6-dihidroxi-3-[[4-[1-[4-[[1-hidroxi-7-[(fenilsulfonil)oxi]-3-sulfonato-2-naftil]azo]fenil]ciclohexil]fenil]azo]naftaleno-2-sulfonato de disodio | 24790 | | | Rroja | X Productos que se aclaran | | | |

76/768/CEE (adaptado)

1 92/86/CEE

2 86/179/CEE

3 90/121/CEE

4 87/137/CEE

5 88/233/CEE

51 | 1-(4-(fenilazo)fenilazo)-2-naftol | 1 26100 | | | 1 Rroja | 1 X No usar en productos aplicados en las mucosas | | 1 Criterios de pureza:anilina ≤ 0,2 %2-naftol ≤ 0,2 %4-aminoazobenceno ≤ 0,1 %1-(fenilazo)-2-naftol ≤ 3 %1-[[2-(fenilazo)fenil]azo]-2-naftalenol ≤ 2 % | |

52 | 6-amino-4-hidroxi-3-[[7-sulfonato-4-[(4-sulfonatofenil)azo]-1-naftil]azo]naftaleno-2,7-disulfonato de tetrasodio | 2 27755 | | | 2 Nnegra | 2 X | | 2 E 152 | |

53 | 1-acetamido-2-hidroxi-3-(4-((4-sulfonatofenilazo)-7-sulfonato-1-naftilazo))naftaleno-4,6-disulfonato de tetrasodio | 2 28440 | | | 2 Nnegra | 2 X | | 2 E 151 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 151) | |

54 | Ácido bencenosulfónico, 2,2'-(1,2-etenodiil)bis[5-nitro-, sal disódica, productos de reacción con ácido 4-[(4-aminofenil)azo] bencenosulfónico, sales sódicas | 2 40215 | | | 2 Nnaranja | 2 X Productos que se aclaran | | | |

55 | β, β-caroteno | 2 40800 | | | 2 Nnaranja | 2 X | | Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 160a) | |

56 | 8'-apo-β-caroten-8'-al | 2 40820 | | | 2 Nnaranja | 2 X | | 2 E 160 e Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 160c) | |

57 | 8'-apo-β-caroten-8'-oato de etilo | 2 40825 | | | 2 Nnaranja | 2 X | | 2 E 160 f Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 160f) | |

58 | Cantaxantina | 2 40850 | | | 2 Nnaranja | 2 X | | 2 E 161 g Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 161g) | |

59 | [4-[4-(dietilamino)-2',4'-disulfonatobencidriliden]ciclohexa-2,5-dien-1-iliden]dietilamonio de hidrógeno, sal sódica | 2 42045 | | | 2 Aazul | 3 X No usar en productos aplicados en las mucosas | | | |

60 | Bis[[4-[4-(dietilamino)-5'-hidroxi-2',4'-disulfonatobencidriliden]ciclohexa-2,5-dien-1-iliden]dietilamonio de hidrógeno], sal cálcica y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 2 42051 [68] | | | 2 Aazul | 2 X | | 2 E 131 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 131) | |

61 | (Etil)[4-[4-[etil(3-sulfonatobencil)amino](4-hidroxi-2-sulfonatobencidriliden]ciclohexa-2,5-dien-1-iliden](3-sulfonatobencil)amonio de dihidrógeno, sal disódica | 2 42053 | | | 2 Vverde | 2 X | | | |

62 | (Bencil)[4-[[4-[benciletilamino]fenil](2,4-disulfonatofenil)metilen]ciclohexa-2,5-dien-1-iliden](etil)amonio de hidrógeno, sal sódica | 2 42080 | | | 2 Aazul | 2 X Productos que se aclaran | | | |

63 | (Etil)[4-[4-[etil(3-sulfonatobencil)]amino]-2'-sulfonatobencidriliden]ciclohexa-2,5-dien-1-iliden](3-sulfonatobencil)amonio de dihidrógeno, sal disódica | 2 42090 | | | 2 Aazul | 2 X | | Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 133) | |

64 | [4-[(2-clorofenil)[4-[etil(3-sulfonatobencil)amino]fenil]metilen]ciclohexa-2,5-dien-1-iliden](etil)(3-sulfonatobencil)amonio de hidrógeno, sal sódica | 2 42100 | | | 2 Vverde | 2 X Productos que se aclaran | | | |

65 | [4-[(2-clorofenil)[4-[etil(3-sulfonatobencil)amino]-o-tolil]metilen]-3-metilciclohexa-2,5-dien-1-iliden](etil)(3-sulfonatobencil)amonio de hidrógeno, sal sódica | 2 42170 | | | 2 Vverde | 2 X Productos que se aclaran | | | |

66 | Clorhidrato de (4-(4-aminofenil)(4-iminociclohexa-2,5-dieniliden)metil)-2-metilanilina | 2 42510 | | | 2 Violeta | 2 X No usar en productos aplicados en las mucosas | | | |

67 | Monoclorhidrato de 4-[(4-amino-m-tolil)(4-imino-3-metilciclohexa-2,5-dien-1-iliden)metil]-o-toluidina | 2 42520 | | | 2 Violeta | 2 X Productos que se aclaran | | 2 5 ppm máx. en el producto acabado | |

68 | [4-[[4-(dietilamino)fenil][4-[etil[(3-sulfonatobencil)amino]-o-tolil]metilen]-3-metilciclohexa-2,5-dien-1-iliden](etil)(3-sulfonatobencil)amonio de hidrógeno, sal sódica | 2 42735 | | | 2 Aazul | 2 X No usar en productos aplicados en las mucosas | | | |

69 | Cloruro de [4-[[4-anilino-1-naftil][4-(dimetilamino)fenil]metilen]ciclohexa-2,5-dien-1-iliden]dimetilamonio | 2 44045 | | | 2 Aazul | 3 X No usar en productos aplicados en las mucosas | | | |

70 | [4-[4-(dimetilamino)-α-(2-hidroxi-3,6-disulfonato-1-naftil)benciliden]ciclohexa-2,5-dien-1-iliden]dimetilamonio de hidrógeno, sal monosódica | 2 44090 | | | 2 Vverde | 2 X | | 2 E 142 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 142) | |

71 | 3,6-bis(dietilamino)-9-(2,4-disulfonatofenil)xantilio de hidrógeno, sal sódica | 2 45100 | | | 2 Rroja | 2 X Productos que se aclaran | | | |

72 | 9-(2-carboxilatofenil)-3-(2-metilanilino)-6-(2-metil-4-sulfoanilino)xantilio de hidrógeno, sal monosódica | 2 45190 | | | 2 Vvioleta | 2 X Productos que se aclaran | | | |

73 | 9-(2,4-disulfonatofenil)-3,6-bis(etilamino)-2,7-dimetilxantilio de hidrógeno, sal monosódica | 2 45220 | | | 2 Rroja | 2 X Productos que se aclaran | | | |

74 | 2-(3-oxo-6-óxidoxanten-9-il)benzoato de disodio | 2 45350 | | | 2 Aamarilla | 2 X | 2 6 % máx. en el producto acabado | | |

75 | 4',5'-dibromo-3',6'-dihidroxiespiro[isobenzofuran-1(3H),9'-[9H]xanten]-3-ona y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 2 45370 [69] | | | 2 Nnaranja | 2 X | | 2 Contenido máximo del 1 % máx. de fluoresceína 1 % y del 2 % de monobromofluoresceína demonobromofluoresceina 2 % | |

76 | 2-(2,4,5,7-tetrabromo-6-óxido-3-oxoxanten-9-il)benzoato de disodio y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 2 45380 [70] | | | 2 Rroja | 2 X | 2 idem | 2 Contenido máximo del 1 % máx. de fluoresceína 1 % y del 2 % de monobromofluoresceína demonobromofluoresceina 2 % | |

77 | 3',6'-dihidroxi-4',5'-dinitroespiro[isobenzofuran-1(3H),9'-[9H]xanten]-3-ona | 2 45396 | | | 2 Nnaranja | 2 X | 2 1 %, cuando Cuando se emplee en productos labiales para los labios sólo se admitirá en forma de ácido libre con una concentración máxima del 1 % | Sólo en forma de ácido libre, cuando se emplee en productos labiales | |

78 | 3,6 dicloro-2-(2,4,5,7-tetrabromo-6-óxido-3-oxoxanten-9-il)benzoato de dipotasio | 2 45405 | | | 2 Rroja | 2X No usar en productos oculares | | 2 Contenido máximo del 1 % máx. de fluoresceína 1 % y del 2 % de monobromofluoresceína demonobromofluoresceina 2 % | |

79 | Ácido 3,4,5,6-tetracloro-2-(1,4,5,8-tetrabromo-6-hidroxi-3-oxoxanten-9-il)benzoico y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 2 45410 [71] | | | 2 Rroja | 2 X | 2 idem | 2 Contenido máximo del 1 % máx. de fluoresceína 1 % y del 2 % de monobromofluoresceína demonobromofluoresceina 2 % | |

80 | 2-(2,4,5,7-tetrayodo-6-óxido-3-oxoxanten-9-il)benzoato de disodio y sus lacas, sales y pigmentos insolubles de bario, estroncio y circonio | 2 45430 [72] | | | 2 Rroja | 2 X | | 2 E 127 idem Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 127) Contenido máximo del 1% de fluoresceína y del 3% de monoyodofluoresceína | |

81 | 1,3-isobenzofuranodiona, productos de reacción con metilquinolina y quinolina. | 2 47000 | | | 2 Aamarilla | 2 X No usar en productos aplicados en las mucosas | | | |

82 | 1H-indeno-1,3(2H)-diona, 2-(2-quinolinil)-, sulfonada, sales sódicas | 2 47005 | | | 2 Aamarilla | 2 X | | 2 E 104 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 104) | |

83 | 9-[(3-metoxifenil)amino]-7-fenil-5-(fenilamino)-4,10-disulfonatobenzo[a]fenazinio de hidrógeno, sal sódica | 2 50325 | | | 2 Vvioleta | 2 X Productos que se aclaran | | | |

84 | Nigrosina sulfonada soluble | 2 50420 | | | 2 Nnegra | 2 X No usar en productos aplicados en las mucosas | | | |

85 | 8,18-dicloro-5,15-dietil-5,15-dihidrodiindolo[3,2-b:3',2'-m]trifenodioxazina | 2 51319 | | | 2 Vvioleta | 2 X Productos que se aclaran | | | |

86 | 1,2-dihidroxiantraquinona | 2 58000 | | | 2 Rroja | 2 X | | | |

87 | 8-hidroxipireno-1,3,6-trisulfonato de trisodio | 2 59040 | | | 2 Vverde | 2 X No usar en productos aplicados en las mucosas | | | |

88 | 1-anilino-4-hidroxiantraquinona | 2 60724 | | | 2 Vvioleta | 2 X Productos que se aclaran | | | |

89 | 1-hidroxi-4-(p-toluidino)antraquinona | 2 60725 | | | 2 Vvioleta | 2 X | | | |

90 | 4-[(9,10-dihidro-4-hidroxi-9,10-dioxo-1-antril)amino]tolueno-3-sulfonato de sodio | 2 60730 | | | 2 Vvioleta | 2 X No usar en productos aplicados en las mucosas | | | |

91 | 1,4-bis(p-tolilamino)antraquinona | 2 61565 | | | 2 Vverde | 2 X | | | |

92 | 2,2'-(9,10-dioxoantraceno-1,4-diildiimino)bis(5-metilsulfonato de disodio | 2 61570 | | | 2 Vverde | 2 X | | | |

93 | 3,3'-(9,10-dioxoantraceno-1,4-diildiimino)bis(2,4,6-trimetilbencenosulfonato) de sodio | 2 61585 | | | 2 Aazul | 2 X Productos que se aclaran | | | |

94 | 1-amino-4-(ciclohexilamino)-9,10-dihidro-9,10-dioxoantraceno-2-sulfonato de sodio | 2 62045 | | | 2 Aazul | 2 X Productos que se aclaran | | | |

95 | 6,15-dihidroantrazina-5,9,14,18-tetrona | 2 69800 | | | 2 Aazul | 2 X | | 2 E 130 | |

96 | 7,16-dicloro-6,15-dihidroantrazina-5,9,14,18-tetrona | 2 69825 | | | 2 Aazul | 2 X | | | |

97 | Bisbencimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]fenantrolina-8,17-diona | 2 71105 | | | 2 Nnaranja | 2 X No usar en productos aplicados en las mucosas | | | |

98 | 2-(1,3-dihidro-3-oxo-2H-indazol-2-iliden)-1,2-dihidro-3Hindol-3-ona | 2 73000 | | | 2 Aazul | 2 X | | | |

99 | 5,5'-(2-(1,3-dihidro-3-oxo-2H-indazol-2-iliden)-1,2-dihidro-3H-indol-3-ona)disulfonato de disodio | 2 73015 | | | 2 Aazul | 2 X | | 2 E 132 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 132) | |

100 | 6-cloro-2-(6-cloro-4-metil-3-oxobenzo[b]tien-2(3H)-iliden)-4-metilbenzo[b]tiofen-3(2H)-ona | 2 73360 | | | 2 Rroja | 2 X | | | |

101 | 5-cloro-2-(5-cloro-7-metil-3-oxobenzo[b]tien-2(3H)-iliden)-7-metilbenzo[b]tiofen-3(2H)-ona | 2 73385 | | | 2 Vvioleta | 2 X | | | |

102 | 5,12-dihidroquino[2,3-b]acridina-7,14-diona | 2 73900 | | | 2 Vvioleta | 2 X Productos que se aclaran | | | |

103 | 5,12-dihidro-2,9-dimetilquino[2,3-b]acridina-7,14-diona | 2 73915 | | | 2 Rroja | 2 X Productos que se aclaran | | | |

104 | 29H,31H-ftalocianina | 2 74100 | | | 2 Aazul | 2 X Productos que se aclaran | | | |

105 | [29H,31H-ftalocianinato(2-)N29,N30,N31,N32] cobre | 2 74160 | | | 2 Aazul | 2 X | | | |

106 | [29H,31H-ftalocianinadisulfonato(4-)-N29,N30,N31,N32]cuprato(2-) de disodio | 2 74180 | | | 2 Aazul | 2 X Productos que se aclaran | | | |

107 | Policloro ftalocianina de cobre | 2 74260 | | | 2 Vverde | 2X No usar en productos oculares | | | |

108 | Ácido 8,8'-diapo-ψ,ψ-carotenodioico | 2 75100 | | | 2 Aamarilla | 2 X | | | |

109 | Bija | 2 75120 | | | 2 Nnaranja | 2 X | | 2 E 160 b Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 160b) | |

110 | ψ,ψ-caroteno | 2 75125 | | | 2 Aamarilla | 2 X | | 2 E 160 d Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 160d) | |

111 | --caroteno | 2 75130 | | | 2 Nnaranja | 2 X | | 2 E 160 a Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 160e) | |

112 | β, τ-caroten-3-ol | 2 75135 | | | 2 Aamarilla | 2 X | | 2 E 161 d | |

113 | 2-amino-1,7-dihidro-6H-purin-6-ona; guanina | 2 75170 | | | 2 Bblanca | 2 X | | | |

114 | 1,7-bis(4-hidroxi-3-metoxifenil)hepta-1,6-dien-3,5-diona | 2 75300 | | | 2 Aamarilla | 2 X | | 2 E 100 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 100) | |

115 | Carmín | 2 75470 | | | 2 Rroja | 2 X | | 2 E 120 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 120) | |

116 | (2S-trans)-[18-carboxi-20-(carboximetil)-13-etil-2,3-dihidro-3,7,12,17-tetrametil-8-vinil-21H,23H-porfina-2-propionato(5-)-N21,N22,N23,N24]cuprato(3-) de trisodio | 2 75810 | | | 2 Vverde | 2 X | | 2 E 140 and E 141 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 140, E 141) | |

117 | Aluminio | 2 77000 | | | 2 Bblanca | 2 X | | 2 E 173 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 173) | |

118 | Hidroxisulfato de aluminio | 2 77002 | | | 2 Bblanca | 2 X | | | |

119 | Silicato de aluminio hidratado natural, Al2O3.2SiO2.2H2O, con impurezas de carbonatos de calcio, magnesio o hierro, hidróxido férrico, arena de cuarzo, mica, etc. | 2 77004 | | | 2 Bblanca | 2 X | | | |

120 | Lazurita | 2 77007 | | | 2 Aazul | 2 X | | | |

121 | Silicato de aluminio coloreado con óxido férrico | 2 77015 | | | 2 Rroja | 2 X | | | |

122 | Sulfato de bario | 2 77120 | | | 2 Bblanca | 2 X | | | |

123 | Oxicloruro de bismuto | 2 77163 | | | 2 Bblanca | 2 X | | | |

124 | Carbonato cálcico | 2 77220 | | | 2 Bblanca | 2 X | | 2 E 170 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 170) | |

125 | Sulfato cálcico | 2 77231 | | | 2 Bblanca | 2 X | | | |

126 | Negro de carbón | 2 77266 | | | 2 Nnegra | 2 X | | Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 153) | |

127 | Carbón, hueso. Polvo negro fino obtenido quemando huesos de animales en un recipiente cerrado. Compuesto principalmente de fosfato de calcio y carbono | 2 77267 | | | 2 Nnegra | 2 X | | | |

128 | Negro de coque | 2 77268:1 | | | 2 Nnegra | 2 X | | 2 E 153 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión | |

129 | Óxido de cromo (III) | 4 77288 | | | 4 Vverde | 4 X | | 4 Eexento de ión cromato | |

130 | Hidróxido de cromo (III) | 4 77289 | | | 4 Vverde | 4 X | | 4 Eexento de ión cromato | |

131 | Espinela azul de cobalto aluminato | 2 77346 | | | 2 Vverde | 2 X | | | |

132 | Cobre | 2 77400 | | | 2 Mmarrón | 2 X | | | |

133 | Oro | 2 77480 | | | 2 Mmarrón | 2 X | | Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión | |

134 | Óxido de hierro | 2 77489 | | | 2 Nnaranja | 2 X | | 2 E 172 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 172) | |

135 | Trióxido de dihierro | 2 77491 | | | 2 Rroja | 2 X | | 2 E 172 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 172) | |

136 | Amarillo de óxido e hidróxido de hierro | 2 77492 | 51274-00-1 | 257-098-5 | 2 Aamarilla | 2 X | | 2 E 172 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 173) | |

137 | Tetraóxido de trihierro | 2 77499 | | | 2 Nnegra | 2 X | | 2 E 172 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 172) | |

138 | Azul de Prusia | 2 77510 | | | 2 Aazul | 2 X | | 2 Eexento de ión cianuro | |

139 | Carbonato de magnesio | 2 77713 | | | 2 Bblanca | 2 X | | | |

140 | Difosfato de amonio y manganeso(3+) | 2 77742 | | | 2 Vvioleta | 2 X | | | |

141 | Bis(ortofosfato) de trimanganeso | 2 77745 | | | 2 Rroja | 2 X | | | |

142 | Plata | 2 77820 | | | 2 Bblanca | 2 X | | 2 E 174 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 174) | |

143 [73] | Dióxido de titanio | 2 77891 | | | 2 Bblanca | 2 X | | 2 E 171 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 171) | |

144 | Óxido de zinc | 2 77947 | | | 2 Bblanca | 2 X | | | |

145 | Riboflavina | 2 Lactoflavine | | | 2 Aamarilla | 2 X | | 2 E 101 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 101) | |

146 | 2 Caramelo | Caramel | | | 2 Mmarrón | 2 X | | 2 E 150 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 150) | |

147 | 2 Capsanteína, capsorubina (3R,3'S,5'R)-3,3'-dihidroxi-β,κ-caroten-6'-ona | Capsanthin / capsorubin | | | 2 Nnaranja | 2 X | | 2 E 160 c Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 160c) | |

148 | 2 Rojo de remolacha, betanina | Beetroot red | | | 2 Rroja | 2 X | | 2 E 162 Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 162) | |

149 | 2 Antocianos | Anthocyanins | | | 2 Rroja | 2 X | | 2 E 163 Obtenidos por tratamiento físico de frutas u hortalizas comestibles. Criterios de pureza establecidos en la Directiva 95/45/CE de la Comisión (E 163) | |

150 | 2 Estereatos de aluminio, de zcinc, de magnesio y de calcio | Aluminium stearate, zinc stearate, magnesium stearate and calcium stearate | | | 2 Bblanca | 2 X | | | |

151 | 2 Azul de bromotimol Fenol, 4,4'-(3H-2,1-benzoxatiol-3-iliden)bis[2-bromo-3-metil-6-(1-metiletil)-], S, S-dióxido | Bromothymol blue | | | 2 Aazul | 2 X Productos que se aclaran | | | |

152 | 2 Verde de bromocresol Fenol, 4,4'-(3H-2,1-benzoxatiol-3-iliden)bis[2,6-dibromo-3-metil-], S, S-dióxido | Bromocresol green | | | 2 Vverde | 2 X Productos que se aclaran | | | |

153 | 4-[(1-fenil-4,5-dihidro-3-metil-5-oxo-1H-pirazol-4-il)azo]-3-hidroxinaftaleno-1-sulfonato de sodio | 5 Acid red 195 | | | 5 Rroja | 5 X No usar en productos aplicados en las mucosas | | | |

86/179/CEE (adaptado)

SEGUNDA PARTE

LISTA DE LOS COLORANTES ADMITIDOS PROVISIONALMENTE Y QUE PODRÁN CONTENER LOS PRODUCTOS COSMÉTICOS [74] |

Campo de aplicación |

Nº índice Color o denominación | Coloración | Campo de aplicación | Otras limitaciones y exigencias [75] | Fecha limite (SIC! límite) de admisión |

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Columna 1 | = | Colorantes admitidos en todos los productos cosméticos. |

Columna 2 | = | Colorantes admitidos en todos los productos cosméticos excepto en los que se aplican cerca de los ojos y, más concretamente, en los productos para maquillar y desmaquillar los ojos. |

Columna 3 | = | Colorantes admitidos únicamente en los productos cosméticos que no se destinen a entrar en contacto con las mucosas. |

Columna 4 | = | Colorantes admitidos únicamente en los productos cosméticos destinados a entrar en breve contacto con la piel. |

76/768/CEE

ANEXO V

LISTA DE LAS SUSTANCIAS EXCLUIDAS DEL ÁMBITO DE APLICACIÓN DE LA DIRECTIVA

94/32/CE

5. Estroncio y sus compuestos, con excepción del lactato de estroncio, del nitrato de estroncio y del policarboxilato de estroncio inscritos en el Anexo II, del sulfuro de estroncio, del cloruro de estroncio, del acetato de estroncio, del hidróxido de estroncio y del peróxido de estroncio en las condiciones previstas en la primera parte del Anexo III, y de las lacas, pigmentos o sales de estroncio de los colorantes que figuran con la referencia (3) de la primera parte del Anexo IV.

86/199/CEE (adaptado)

1 2007/17/CE art. 1 y anexo, pt. 2.b)

2 2007/17/CE art. 1 y anexo, pt. 2.c)

3 2007/17/CE art. 1 y anexo, pt. 2.d)

ANEXO VVI

LISTA DE LOS CONSERVANTES ADMITIDOS EN QUE PUEDEN CONTENER LOS PRODUCTOS COSMÉTICOS

PREÁMBULO

1. Se entiende por conservantes las sustancias que se añaden como ingrediente a los productos cosméticos principalmente para inhibir el desarrollo de micro-organismos en tales productos.

2. Las substancias que van acompañadas del signo (*) pueden añadirse también, en concentraciones diferentes a las previstas en el presente Anexo, a productos cosméticos con otros fines específicos precisados en la presentación del producto, tales como desodorante en los jabones o agentes en los champúes.

3. Otras sustancias empleadas en la fórmula de los productos cosméticos pueden tener adicionalmente propiedades antimicrobianas y contribuir, por tanto, a la conservación de los productos, como es el caso de muchos aceites esenciales y algunos alcoholes. Tales sustancias no figuran en el presente Anexo.

14. A los efectos de En la presente lista , se entenderá por:

– sales: las sales de cationes sodio, potasio, calcio, magnesio, amonio y etanolaminas; de aniones cloruro, bromuro, sulfatos y acetato;

– ésteres: los ésteres de metilo, etilo, propilo, isopropilo, butilo, isobutilo y fenilo.

25. Todos los productos acabados que contengan formaldehído o sustancias que figuran en el presente Aanexo y liberen formaldehído deberán consignar en la etiqueta la mención «contiene formaldehído» siempre que la concentración de formaldehído en el producto acabado supere el 0,05 %.

PRIMERA PARTE

LISTA DE CONSERVANTES ADMITIDOS

Número de referencia orden | Sustancia Identificación de las sustancias | Condiciones | Texto de las Ccondiciones de empleo y advertencias que se consignarán obligatoriamente en la etiqueta |

| Nombre químico / DCI | Nombre común del ingrediente recogido en el glosario | Número CAS | Número EINECS / ELINCS | Tipo de producto, partes del cuerpo | Concentración máxima autorizada | Otras condiciones Limitaciones y exigencias | |

a | b | c | d | e | f | cg | dh | ei |

2 1 | 2 Ácido benzoico y su sal de sodio | Benzoic acid, Sodium Benzoate | 65-85-0532-32-1 | 200-618-2 208-534-8 | 2 Productos que se aclaran, excepto los productos bucales para la higiene bucal: | 2 2,5 % (ácido) | 2 | 2 |

| | | | | Productos bucales para la higiene bucal: | 2 1,7 % (ácido) | | |

| | | | | Productos que no se aclaran: | 2 0,5 % (ácido) | | |

2 1a | 2 Sales del ácido benzoico distintas de las incluidas en el número de orden 1 y ésteres del ácido benzoico | Ammonium benzoate, calcium benzoate, potassium benzoate, magnesium benzoate, MEA-benzoate, methyl benzoate, ethyl benzoate, propyl benzoate, butyl benzoate, isobutyl benzoate, isopropyl benzoate, phenyl benzoate | 1863-63-4, 2090-05-3, 582-25-2, 553-70-8, 4337-66-0, 93-58-3, 93-89-0, 2315-68-6, 136-60-7, 120-50-3, 939-48-0, 93-99-2 | 217-468-9, 218-235-4, 209-481-3, 209-045-2, 224-387-2, 202-259-7, 202-284-3, 219-020-8, 205-252-7, 204-401-3, 213-361-6, 202-293-2 | | 2 0,5 % (ácido) | 2 | 2 |

2 | Ácido propiónico y sus sales | Propionic acid, ammonium propionate, calcium propionate, magnesium propionate, potassium propionate, sodium propionate | 79-09-4, 17496-08-1, 4075-81-4, 557-27-7, 327-62-8, 137-40-6 | 201-176-3, 241-503-7, 223-795-8, 209-166-0, 206-323-5, 205-290-4 | | 2 % (ácido) | | |

3 [76] | Ácido salicílico y sus sales * | Salicylic acid, calcium salicylate, magnesium salicylate, MEA-salicylate, sodium salicylate, potassium salicylate, TEA-salicylate | 69-72-7, 824-35-1, 18917-89-0, 59866-70-5, 54-21-7, 578-36-9, 2174-16-5 | 200-712-3, 212-525-4, 242-669-3, 261-963-2, 200-198-0, 209-421-6, 218-531-3 | | 0,5 % (ácido) | No utilizar en los productos destinados a niños menores de 3 años, excepto en los champúes | No emplear para los cuidados de los niños menores de 3 años [77] |

4 | Ácido sórbico y sus sales | Sorbic acid calcium sorbate, sodium sorbate, potassium sorbate | 110-44-1, 7492-55-9, 7757-81-5, 24634-61-5 | 203-768-7, 231-321-6, 231-819-3, 246-376-1 | | 0,6 % (ácido) | | |

5 [78] | Formaldehído y Pparaformaldehído 1 (*) | Formaldehyde | 50-00-0, 30525-89-4 | 200-001-8 | Productos (para cuidados bucales) | 0,1 % Concentraciones expresadas en (de formaldehído libre ) | No usar Prohibido en aerosoles | |

| | | | | Otros productos (excepto para cuidados bucales) | 0,2 % Concentraciones expresadas en (de formaldehído libre ) | | |

7 | Bifenil-2-ol O-fenilfenol y sus sales | o-Phenylphenol, sodium o-phenylphenate, potassium o-phenylphenate, MEA o-phenylphenate | 90-43-7, 132-27-4, 13707-65-8, 84145-04-0 | 201-993-5, 205-055-6, 237-243-9, 282-227-7 | | 0,2 % expresado en (de fenol ) | | |

3 8 [79] | 3 Piritiona de zcinc (*) | Zinc pyrithione | 3 13463-41-7 | 236-671-3 | 3 Productos para el pelo cabello | 3 1,0 % | 3 Solo productos que se aclaran.No utilizar en productos bucales para la higiene bucal. | 3 |

| | | | | Otros productos | 3 0,5 % | | |

9 [80] | Sulfitos y bisultitos inorgánicos * | Sodium sulfite, ammonium bisulfite, ammonium sulfite, potassium sulfite, potassium hydrogen sulfite, sodium bisulfite, sodium metabisulfite, potassium metabisulfite | 7757-83-7, 10192-30-0, 10196-04-0, 10117-38-1, 7773-03-7, 7631-90-5, 7681-57-4, 16731-55-8 | 231-821-4, 233-469-7, 233-484-9, 233-321-1, 231-870-1, 231-548-0, 231-673-0, 240-795-3 | | 0,2 % expresado en (de SO2 libre ) | | |

11 | 1,1,1-Tricloro-2-metilpropanol 2 (Clorobutanol) | Chlorobutanol | 57-15-8 | 200-317-6 | | 0,5 % | Prohibido No usar en los aerosoles | Contiene chlorobutanol |

12 | Ácido p-hidroxibenzoico, sus sales y sus ésteres | 4-Hydroxybenzoic acid, methylparaben, butylparaben, potassium ethylparaben, potassium paraben, propylparaben, isobutylparaben, sodium methylparaben, sodium ethylparaben, sodium propylparaben, sodium butylparaben, sodium isobutylparaben, ethylparaben, sodium paraben, isopropylparaben, passiummethylparaben, potassium butylparaben, potassium propylparaben, sodium propylparaben, calcium paraben, phenylparaben | 99-96-7, 99-76-3, 94-26-8, 36457-19-9,16782-08-4, 94-13-3, 4247-02-3, 5026-62-0, 35285-68-8, 35285-69-9, 36457-20-2, 84930-15-4, 120-47-8, 114-63-6, 4191-73-5, 2611-07-2, 38566-94-8, 84930-17-4, 35285-69-9, 69959-44-0, 17696-62-7 | 202-804-9, 202-785-7, 202-318-7, 253-048-1, 240-830-2, 202-307-7, 224-208-8, 225-714-1, 252-487-6, 252-488-1, 253-049-7, 284-595-4, 204-399-4, 204-051-1, 224-069-3, 247-464-2, 254-009-1, 284-597-5, 252-488-1, 274-235-4241-698-9 | | 0,4 % ( de ácido) para un solo éster0,8 % ( de ácido) para las mezclas de ésteres | | |

13 | 3-acetil-6-metil-2H-pirano-2,4(3H)-diona / Ácido dehidroacético y sus sales | Dehydroacetic acid, sodium dehydroacetate | 520-45-6, 4418-26-2, 16807-48-0 | 208-293-9, 224-580-1 | | 0,6 % ( de ácido) | Prohibido No usar en los aerosoles | |

76/768/CEE (adaptado)

1 94/32/CE

2 86/199/CEE

3 89/174/CEE

4 87/137/CEE

5 88/233/CEE

6 2007/17/CE art. 1 y anexo, pt. 2.b)

7 91/184/CEE

8 92/86/CEE

9 96/41/CE

10 2005/42/CE art. 1 y anexo, pt. 3.a)

11 98/62/CE

12 2000/6/CE art. 1 y anexo, pt. 3.i)

13 2007/22/CE art. 1 y anexo, pt. 2.b)

14 2005/42/CE art. 1 y anexo, pt. 3.b)

1 14 | 1 Ácido fórmico y su sal de sodio | Formic acid, sodium formate | 64-18-6, 141-53-7 | 200-579-1, 205-488-0 | | 1 0,5 % expresado en (de ácido ) | | |

2 15 | 2 1,6-di-n-(amidino-2-bromofenoxi) hexano 1,6-Di(4-amidino-2-bromofenoxi)-n-nexano (Dibromohexamidina) y sus sales (incluido el isetionato) | Dibromohexamidine, Isethionate | 93856-83-8 | 299-116-4 | | 2 0,1 % | | |

2 16 | 2 Tiosalicilato de etilmercuro sódico (tiomersal) | Thimerosal | 54-64-8 | 200-210-4 | Productos oculares | 2 0,007 % (en de Hg)Cuando se encuentre mezclado con otros compuestos mercuriales autorizados por el presente Reglamento la presente Directiva, la concentración máxima en Hg seguirá siendo de 0,007 % | 2 Únicamente en productos de maquillaje y desmaquillaje de los ojos | 2 Contiene tiosalicilato de etilmercuro sódico tiomersal |

2 17 | 2 Fenilmercurio y sus sales (incluido el borato) | Phenyl Mercuric Acetate, Phenyl Mercuric Benzoate | 62-38-4, 94-43-9 | 200-532-5, 202-331-8 | Productos oculares | 2 ídem 0,007 % (de Hg)Cuando se encuentre mezclado con otros compuestos mercuriales autorizados por el presente Reglamento la presente Directiva, la concentración máxima en Hg seguirá siendo de 0,007 % | 2 ídem | 2 Contiene componentes fenilmercúricos |

2 18 | 2 Ácido undecilénico y sus sales | Undecylenic acid, potassium undecylenate, sodium undecylenate, calcium undecylenate, TEA-undecylenate, MEA-undecylenate | 112-38-9, 6159-41-7, 3398-33-2, 1322-14-1, 84471-25-0, 56532-40-2 | 203-965-8, 222-264-8, 215-331-8, 282-908-9, 260-247-7 | | 2 0,2 % ( de ácido) | 2 Véase nº 8 de la segunda parte del Anexo VI | |

2 19 | 5-pirimidinamina, 1,3-bis(2-etilhexil)hexahidro-5-metil- / 2 Amino-5-bis (etil-2-hexil)-1,3 metil 1-5-peridropirimidina (Hexetidina) | Hexetidine | 141-94-6 | 205-513-5 | | 2 0,1 % | | |

2 20 | 5-bromo-5-nitro-1,3-dioxano 2 Bromo-5-nitro-5-dioxano 1,3 | 5-Bromo-5-nitro-1,3-dioxane | 30007-47-7 | 250-001-7 | Productos que se aclaran | 2 0,1 % | 2 Únicamente para los productos que se enjuagan.Se debe evitar la formación de nitrosaminas.3 --- | |

2 21 | 2-Bromo-2-nitro-1,3 propanodiol / 2 Bromo-2 nitro-2 propanodiol 1,3 (Bronopol) | 2-Bromo-2-nitropropane-1,3-diol | 52-51-7 | 200-143-0 | | 2 0,1 % | 2 Se debe evitar la formación de nitrosaminas. | |

2 22 | 2 Alcohol 2,4-diclorobencílico dicloro-2, 4-benzílico | Dichlorobenzyl Alcohol | 1777-82-8 | 217-210-5 | | 2 0,15 % | | |

2 23 [81] | 3,4,4'-Triclorocarbanilida / 2 Tricloro-3,4,4' carbanilida (*) (Triclocarbáan) | Triclocarban | 101-20-2 | 202-924-1 | | 2 0,2 % | 2 Criterios de pureza:3,3',4,4'-Tetracloronitrobenczeno <1 ppm3,3',4,4'-Tetracloroni-troxibenczeno <1 ppm | |

2 24 | 2 Paraclorometacresol Clorocresol | p-Chloro-m-Cresol | 59-50-7 | 200-431-6 | 2 Prohibido No usar en los productos aplicados en destinados a entrar en contacto con las mucosas | 2 0,2 % | 2 Prohibido en los productos destinados a entrar en contacto con las mucosas | |

2 25 | 5-cloro-2-(2,4-diclorofenoxi)fenol / 2 Tricloro-2,4,4' hidroxi-2' difenil-éter (Triclosáan) | Triclosan | 3380-34-5 | 222-182-2 | | 2 0,3 % | | |

2 26 | Fenol, 4-cloro-3,5-dimetil- / Cloroxilenol 2 Paraclorometaxilenol | Chloroxylenol | 88-04-0 | 201-793-8 | | 2 0,5 % | | |

2 27 | N, N''-metilen-bis[N'-[3-(hidroximetil)-2,5-dioxoimidazolidin-4-il]urea] 2 Imidazolidinil urea | 2 Imidazolidinyl urea | 39236-46-9 | 254-372-6 | | 2 0,6 % | | |

2 28 | Poli(metileno), α,ω-bis[[[(aminoiminometil)amino]iminometil]amino]-, diclorhidrato 2 Polihexametileno biguanida (chorhidrato de) | Polyaminopropyl biguanide | 70170-61-5, 28757-47-3, 133029-32-0 | | | 2 0,3 % | | |

2 29 | 2-Fenoxietanol 2 Fenoxi-2-etanol | Phenoxyethanol | 122-99-6 | 204-589-7 | | 2 1,0 % | | |

2 30 | 2 Hexametileno tetramina (Metenamina) | Methenamine | 100-97-0 | 202-905-8 | | 2 0,15 % | | |

2 31 | 3-Cloroalilocloruro de metenamina 2 Cloruro de 1-(3-cloroalil)-3,5,7-triza-1-azonio adamantano | Quaternium-15 | 4080-31-3 | 223-805-0 | | 2 0,2 % | | |

2 32 | 2-butanona, 1-(4-clorofenoxi)-1-(1H-imidazol-1-il)-3,3-dimetil- / Climbazol 2 1-Imidazolil-1 (4-clorofenoxi)3,3-dimetil-butano-2-ona | Climbazole | 38083-17-9 | 253-775-4 | | 2 0,5 % | | |

2 33 | 1,3-bis(hidroximetil)-5,5-dimetilimidazolidina-2,4-diona 2 Dimetilol, dimetihidantoína | DMDM Hydantoin | 6440-58-0 | 229-222-8 | | 2 0,6 % | | |

2 34 [82] | 2 Alcohol benczílico * | Benzyl alcohol | 100-51-6 | 202-859-9 | | 2 1,0 % | | |

2 35 | 2 1-Hidroxi-4-metil-6 (2,4,4-trimetil-pentil)2-piridón y su sal de monoetanol amina | 1-Hydroxy-4-methyl-6-(2,4,4-trimethylpentyl) 2-pyridon, Piroctone Olamine | 50650-76-5, 68890-66-4 | 272-574-2 | Productos que se aclaran | 2 1,0 % | En productos que se enjuaganEn los demás productos | |

| | | | | Otros productos | 0,5 % | | |

2 37 | 2,2'-metilen-bis(6-bromo-4-clorofenol) 2 Dibromo 3,3'-dicloro 5,5'-dihidrosi-2,2'difenil metano | Bromochlorophene | 15435-29-7 | 239-446-8 | | 2 0,1 % | | |

2 38 | 2 Isopropil-metacresol | Isopropyl Cresols | 3228-02-2 | 221-761-7 | | 2 0,1 % | | |

2 39 | 5-Cloro-2-metil-3,4-isotiazolona- +2-metil-3,4-isotiazolona 2 Cloro-5-metil-2-isotiazolín-4-ona-3 + metil-2-isotiazolín-4-ona-3 + cloruro de magnesio y nitrato de magnesio | Methylchloroisothiazolinone and Methylisothiazolinone | 26172-55-4, 2682-20-4, 55965-84-9 | 247-500-7, 220-239-6 | | 2 3 0,0015 % (de una mezcla en la proporción 3:1 de 5-cloro-2-metil-3,4-isotiazolona y 2-metil-3,4-isotiazolona con una proporción de 3:1 de cloro-5-metil-2-isotiazolín-4-ona-3 y metil-2 isotiazolín-4-ona-3) | | |

4 40 | 4 2-Benczil-4-clorofenol / (clorofeno) | Chlorophene | 120-32-1 | 204-385-8 | | 4 0.,2 % | | |

5 41 | 2-cloroacetamida 5 Cloracetamida | Chloroacetamide | 79-07-2 | 201-174-2 | | 5 0,3 % | | 5 Contiene chloroacetamide cloracetamida |

5 42 | N, N''-bis(4-clorofenil)-3,12-diimino-2,4,11,13-tetraazatetradecanodiamidina / Clorhexidina y sus 5 Bis-(p-clorofenildiguanida)-1,6 hexano acetato, gluconato y clorhidrato (Clorhexidina) | Chlorhexidine, Chlorhexidine Diacetate, Chlorhexidine Digluconate, Chlorhexidine Dihydrochloride | 55-56-1, 56-95-1, 18472-51-0, 3697-42-5 | 200-238-7, 200-302-4, 242-354-0, 223-026-6 | | 5 0,3 % expresados en (de clorhexidina ) | | |

5 43 [83] | 1-fenoxipropan-2-ol 5 Fenoxipropanol 6 (*) | Phenoxyisopropanol | 770-35-4 | 212-222-7 | | 5 1,0 % | Solo para productos que se aclaran 5 Únicamente en productos que se eliminan con agua. | |

7 44 | 7 Alquil (C12-C22) trimetil amonio, bromuro de, cloruro de * | Behentrimonium chloride, cetrimonium bromide, cetrimonium chloride, laurtrimonium bromide, laurtrimonium chloride, steartrimonium bromide, steartrimonium chloride | 17301-53-0, 57-09-0, 112-02-7, 1119-94-4, 112-00-5, 1120-02-1, 112-03-8 | 241-327-0, 200-311-3, 203-928-6, 214-290-3, 203-927-0, 214-294-5, 203-929-1 | | 7 0,1 % | | |

7 45 | 7 4,4-Dimetil-1,3-oxazolidina | Dimethyl Oxazolidine | 51200-87-4 | 257-048-2 | | 7 0,1 % | 7 pH of the finished product > 6 | |

7 46 | 7 N-(Hidroximetil)-N-(1,3-dihidroximetil-2,5-dioxo-4-imidazolidinil) N' (hidroximetil) urea | Diazolidinyl Urea | 78491-02-8 | 278-928-2 | | 7 0,5 % | | |

8 47 | 8 1,6-Di (4-amidinofenoxi)-n-hexano Bencenocarboxamidina, 4,4'-(1,6-hexanodiilbis(oxi))bis- / (Hexamidina)y sus sales (incluido el isetionato y el p-hidroxibenzoato) | Hexamidine, Hexamidine diisethionate, Hexamidine paraben | 3811-75-4, 659-40-5, 93841-83-9 | 211-533-5, 299-055-3 | | 8 0,1 % | | |

1 48 | 1 Glutaraldehído (1,5-pentanodial) / Glutaral | Glutaral | 111-30-8 | 203-856-5 | | 1 0,1 % | 1 No usar Prohibido en los aerosoles (sprays) | 1 Contiene glutaraldehído glutaral (en la medida en que la concentración de glutaraldehído en el producto acabado sobrepase el 0,05 %) |

1 49 | 1 5-etil-3,7-dioxa-1-azabiciclo [3.3.0] octano 7a-etildihidro-1H,3H,5H-oxazolo[3,4-c]oxazol | 7- ethylbicyclooxazolidine | 7747-35-5 | 231-810-4 | | 1 0,3 % | 1 Prohibido en los productos de higiene bucal y en los productos destinados a las mucosas No usar en productos bucales ni aplicados en las mucosas | |

9 50 | 9 3-(p-clorofenoxi)-propan-1,2 diol / (clorfenesina) | Chlorphenesin | 104-29-0 | 203-192-6 | | 9 0,3 % | | |

9 51 | 9 Hidroximetilaminacetato de sodio (Hidroximetilglicinato de sodio) | Sodium Hydroxymethylglycinate | 70161-44-3 | 274-357-8 | | 9 0,5 % | | |

9 52 | 9 Cloruro de plata depositado sobre dióxido de titanio | Silver chloride | 7783-90-6 | 232-033-3 | | 9 0,004 % calculado como (de AgCl ) | 9 20 % AgCl (p/p) sobre TiO2. Prohibido en los No usar en productos para niños menores de 3 años ni en productos bucales, labiales u oculares , en los productos de higiene bucal y en los productos destinados a ser aplicados alrededor de los ojos o en los labios | |

10 53 | Cloruro de bencenometaminio, N,N-dimetil-N-[2-[2-[4-(1,1,3,3,-tetrametilbutil)fenoxi]etoxi]etil]- / Cloruro de bencetonio | 10 Benzethonium Chloride (INCI) | 121-54-0 | 204-479-9 | | 10 0,1 % | 10 a) Para Pproductos que se aclaran aclaradosb) Para Pproductos que no se aclaran no aclarados salvo los productos bucales de higiene bucal | |

11 54 [84] | 11 Cloruro, bromuro y sacarinato de benzalconio (+) | Benzalkonium chloride, benzalkonium bromide, benzalkonium saccharinate | 8001-54-5, 63449-41-2, 91080-29-4, 68989-01-5, 68424-85-1, 68391-01-5, 61789-71-7, 85409-22-9 | 264-151-6, 293-522-5, 273-545-7, 270-325-2, 269-919-4, 263-080-8, 287-089-1 | | 11 0,1% expresado en (de cloruro de benzalconio ) | | 11 Evitar el contacto con los ojos |

12 55 | Metanol, (fenilmetoxi)- 12 Bencilhemiformal | Benzylhemiformal | 14548-60-8 | 238-588-8 | 12 Solamente en los productos que se aclaran eliminan por aclarado | 12 0,15 % | | |

13 56 | 13 yodopropinil butilcarbamato (IPBC) Butilcarbamato de 3-yodo-2-propinilo | Iodopropynyl butylcarbamate | 55406-53-6 | 259-627-5 | | 13 a) Productos que se aclaran: 0,02 %b) Productos que no se aclaran: 0,01 %, excepto en desodorantes y antitranspirantes: 0,0075 % | 13 No debe utilizarse en productos bucales ni labiales para la higiene oral y el cuidado de los labiosa) No debe utilizarse en productos preparados para niños menores de 3 años, excepto en productos de baño, gel de ducha y champúb)- No debe utilizarse en lociones y cremas corporales [85]- No debe utilizarse en productos preparados para niños menores de 3 años | 13 a) «No debe utilizarse en productos destinados a niños menores de 3 años» [86]b) «No debe utilizarse en productos destinados a niños menores de 3 años» [87] |

14 57 | 14 (INCI) 2-metil-2H-isotiazol-3-ona | 14 Methylisothiazolinone | 2682-20-4 | 220-239-6 | | 14 0,01 % | | |

86/199/CEE (adaptado)

SEGUNDA PARTE

LISTA DE CONSERVANTES PROVISIONALMENTE ADMITIDOS

Número de orden | Substancias | Concentración máxima autorizada | Limitaciones y exigencias | Condiciones de empleo y advertencias que se consignarán obligatoriamente en la etiqueta | Fecha límite de admisión |

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83/574/CEE (adaptado)

ANEXO VIVII

LISTA DE LOS FILTROS ULTRAVIOLETAS ADMITIDOS EN QUE PODRÁN CONTENER LOS PRODUCTOS COSMÉTICOS

Los filtros ultravioletas, con arreglo a la presente Directiva, son sustancias que, contenidas en los productos cosméticos de protección solar, están destinadas específicamente a filtrar determinadas radiaciones para proteger la piel contra determinados efectos nocivos de dichas radiaciones.

Dichos filtros podrán añadirse a otros productos cosméticos, dentro de los límites y condiciones fijados en el presente Anexo.

Otros filtros ultravioletas utilizados en los productos cosméticos únicamente para la protección de los productos contra las radiaciones ultravioletas no figuran en la presente lista.

PRIMERA PARTE

Lista de los filtros ultravioletas admitidos que podrán contener los productos cosméticos

Número de referencia orden | Identificación de las Ssustancias | Requisitos | Texto de las Ccondiciones de uso empleo y advertencias que se consignarán obligatoriamente en la etiqueta |

| | Tipo de producto, partes del cuerpo | Concentración máxima autorizada | Otras condiciones limitaciones y exigencias | |

| Nombre químico / DCI | Nombre común del ingrediente recogido en el glosario | Número CAS | Número EINECS / ELINCS | | | | |

a | b | c | d | e | f | cg | dh | ei |

1 | Ácido 4-aminobenzoico | PABA | 150-13-0 | 205-753-0 | | 5 % | | |

2 | Sulfato de metilo y de n,n,n-trimetil-4-[(2-oxo-3 borniliden)-metil]-anilina de N,N,N-trimetil [(oxo-2 bornilideno-3) metil] - 4 anilinio | Camphor Benzalkonium Methosulfate | 52793-97-2 | 258-190-8 | | 6 % | | |

3 | Ácido benzoico, 2-hidroxi-, éster 3,3,5-trimetilciclohexílico / Homosalato (DCI) | Homosalate | 118-56-9 | 204-260-8 | | 10 % | | |

4 | 2-hidroxi-4-metoxibenzofenona / Oxibenzona (DCI) | Benzophenone-3 | 131-57-7 | 205-031-5 | | 10 % | | Contiene benzophenone-3 oxibenzona [88] |

6 | Ácido 2-fenil-5-bencimidazol 2-fenil-bencimidozol 5 sulfónico y sus sales de potasio, de sodio y de trietanolamina / Ensulizol | Phenylbenzimidazole Sulfonic Acid | 27503-81-7 | 248-502-0 | | 8 %(expressado en de ácido) | | |

76/768/CEE (adaptado)

1 94/32/CE

2 93/47/CEE

3 95/34/CE

4 96/41/CE

5 97/45/CE

6 98/62/CE

7 2000/6/CE art. 1 y anexo, pt. 4.i)

8 2002/34/CE art. 1 y anexo, pt. 4

9 2005/9/CE art. 1 y anexo

1 7 | 3,3'-(1,4-Fenileno dimetilidina) bis [acido 7,7 dimetil-2-oxobiciclo(2,2,1)heptano 1-metano sulfónico] y sus sales / Ecamsul 1 3,3'-(1,4-fenilendimetilen) bis [7,7-dimetil-2-oxo-biciclo(2,2,1)hept-1-ilmetanosulfónico ácido] y sus sales | Terephthalylidene Dicamphor Sulfonic Acid | 92761-26-7, 90457-82-2 | 410-960-6 | | 1 10 %(expresado en de ácido) | | |

2 8 | 2 I1-(4-tert-butil-fenil)-3-(4-metoxifenil) propano-1,3-diona | Butyl Methoxydibenzoylmethane | 70356-09-1 | 274-581-6 | | 2 5 % | | |

1 9 | 1 Ácido (2-oxo-3-bornilideno)-4-toluensulfónico alfa-(oxo-2-borniliden-3)-toluen-4-sulfónico y sus sales / Avobenzona | Benzylidene Camphor Sulfonic Acid | 56039-58-8 | | | 1 6 %(expresado en de ácido) | | |

3 10 | 3 Ester 2-etilhexílico del ácido 2-ciano-3,3-difenilacrílico / O(octocrileno) | Octocrylene | 6197-30-4 | 228-250-8 | | 3 10 %(expresado como de ácido) | | |

4 11 | 4 Polímero de N-[{}{(2 y 4)-[(2-oxoborn-3-iliden)metil]bencil]}}acrilamida | Polyacrylamidomethyl Benzylidene Camphor | 113783-61-2 | | | 4 6 % | | |

5 12 | 5 Metoxicinamato de octilo | Ethylhexyl Methoxycinnamate | 5466-77-3 | 226-775-7 | | 5 10 % | | |

6 13 | 6 Etil-4-aminobenzoato etoxilado | 6 PEG-25 PABA | 116242-27-4 | | | 6 10 % | | |

6 14 | 6 Isopentil-4-metoxicinamato | 6 Isoamyl p-mMethoxycinnamate | 71617-10-2 | 275-702-5 | | 6 10 % | | |

6 15 | 6 2,4,6-Trianilino-p-carbo-2'-etilhexil-1'oxi)-1,3,5-triazina (Octyl Triazone) | Ethylhexyl Triazone | 88122-99-0 | 402-070-1 | | 6 5 % | | |

6 16 | 6 Fenol, 2-(2H-benzotriazol-2-il)-4-metil-6-(2-metil-3-(1,3,3,3-tetrametil-1-(trimetilsilil)oxi)-disiloxani)propilo) | 6 Drometrizole Trisiloxane | 155633-54-8 | | | 6 15 % | | |

6 17 | Ácido benzoico, 4,4'-[[6-[[4-[[(1,1-dimetil-etil)amino]carbonil]fenil]amino]-1,3,5-triazina-2,4-diil]diimino]bis-, éster bis(2-etilhexílico) 6 Benzoato de 4,4-((6-(((1,1-dimetileti)amino)carbonil)fenil)amino)1,3,5-triazina-2,4-dii)diimino)bis-,bis (2-etilhexilo) | Diethylhexyl Butamido Triazone | 154702-15-5 | | | 6 10 % | | |

6 18 | 6 3-(4'-Metilbencilideno)-d-1 alcanfor / Enzacameno | 6 4-Methylbenzylidene Camphor | 38102-62-4, 36861-47-9 | 253-242-6 | | 6 4 % | | |

6 19 | 6 3-Bencilideno alcanfor | 6 3-Benzylidene Camphor | 15087-24-8 | 239-139-9 | | 6 2 % | | |

6 20 | 6 Salicilato de 2-etilhexilo (octyl-salicylate)) | Ethylhexyl Salicylate | 118-60-5 | 204-263-4 | | 6 5 % | | |

7 21 | 4-(dimetilamino)benzoato de 2-etilhexilo 7 4-dimetil-amino-benzoato de etil-2-hexilo (octil dimetil PABA) | Ethylhexyl dimethyl PABA | 21245-02-3 | 244-289-3 | | 7 8 % | | |

7 22 | 7 Ácido 2-hidroxi-4-metoxibenzofenona-5-sulfónico (Benzofenona-5) y su sal de sodio / Sulisobenzona, Sulisobenzona sódica | Benzophenone-4, Benzophen one-5 | 4065-45-6, 6628-37-1 | 223-772-2 | | 7 5 % (expresado en de ácido) | | |

7 23 | 7 2,2'-metilen-bis-6-(2H-benzotriazol-2-il)-4-(tetrametil-butil)-1,1,3,3-fenol / Bisoctrizol | Methylene Bis-Benzotriazolyl Tetramethylbutylphenol | 103597-45-1 | 604-052-00-0, 403-800-1 | | 7 10 % | | |

7 24 | 7 Sal sódica monosódica del ácido 2-2'-bis-(1,4-fenilen)1H-benczimidazol-4,6-disulfónico / Bisdisulizol disódico | Disodium Phenyl Dibenzimidazole Tetrasulfonate | 180898-37-7 | 429-750-0 | | 7 10 % (expresado en de ácido) | | |

7 25 | 7 (1,3,5)-triazina-2,4-bis{}{(4-(2etil-hexiloxi)-2-hydroxi)-fenilo}}-6-(4-metoxifenilo) | Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine | 187393-00-6 | | | 7 10 % | | |

8 26 | 8 Dimethicodiethylbenzalmalonate | Polysilicone-15 | 207574-74-1 | | | 8 10 % | | |

8 27 [89] | Dióxido de titanio 8 Titanium dioxide | Titanium Dioxide | 13463-67-7, 1317-70-0, 1317-80-2 | 236-675-5205-280-1, 215-282-2 | | 8 25 % | | |

9 28 | 9 Ácido benzoico, 2-[-4-(dietilamino)-2-hidroxibenzoil]-, hexilester (nombre INCI | 9 Diethylamino Hydroxybenzoyl Hexyl Benzoate | 9 302776-68-7 | 443-860-6 | | 9 10 % en productos de protección solar | | |

89/174/CEE (adaptado)

SEGUNDA PARTE

LISTA DE FILTROS ULTRAVIOLETA QUE PUEDEN CONTENER, PROVISIONALMENTE, LOS PRODUCTOS COSMÉTICOS

Número de referencia | Sustancias | Concentración máxima autorizada | Otras limitaciones y exigencias | Condiciones de empleo y advertencias que se consignarán obligatoriamente en la etiqueta | Fecha límite de admisión |

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93/35/CEE (adaptado)

ANEXO VIII VII

Símbolos usados en el embalaje o recipiente

1. Referencia a información adjunta o unida

(...PICT...)

2003/15/CE art. 1.11 (adaptado)

ANEXO VIII bis

2. Período tras la apertura

(...PICT...)

.

nuevo

3. Fecha de duración mínima

(...PICT...)

2003/15/CE art. 1.11

2004/94/CE art. 1 y anexo (adaptado)

ANEXO IX VIII

LISTA DE MÉTODOS VALIDADOS ALTERNATIVOS A LOS ENSAYOS EN ANIMALES

En este anexo se ofrece la lista de métodos alternativos validados por el Centro Europeo para la Validación de Métodos Alternativos (CEVMA) del Centro Común de Investigación disponibles para cumplir los requisitos del presente Reglamento de la presente Directiva y que no figuran en el anexo V de la Directiva 67/548/CEE, relativa a la aproximación de las disposiciones legales, reglamentarias y administrativas en materia de clasificación, embalaje y etiquetado de las sustancias peligrosas. Dado que los ensayos en animales no pueden ser sustituidos completamente por un método alternativo, en el anexo IXVIII debe mencionarse si el método alternativo sustituye en su totalidad o parcialmente a los ensayos en animales.

Número de referencia | Métodos alternativos validados | Naturaleza de la sustitución total o parcial |

A | B | C |

ANEXO IX

Parte A

Directiva derogada, con sus sucesivas modificaciones

(contempladas en el artículo 33)

Directiva 76/768/CEE del Consejo, de 27 de julio de 1976 | (DO L 262 de 27.9.1976, p. 169) |

Directiva 79/661/CEE del Consejo, de 24 de julio de 1979 | (DO L 192 de 31.7.1979, p. 35) |

Directiva 82/147/CEE de la Comisión, de 11 de febrero de 1982 | (DO L 63 de 6.3.1982, p. 26) |

Directiva 82/368/CEE del Consejo, de 17 de mayo de 1982 | (DO L 167 de 15.6.1982, p. 1) |

Directiva 83/191/CEE de la Comisión, de 30 de marzo de 1983 | (DO L 109 de 26.4.1983, p. 25) |

Directiva 83/341/CEE de la Comisión, de 29 de junio de 1983 | (DO L 188 de 13.7.1983, p. 15) |

Directiva 83/496/CEE de la Comisión, de 22 de septiembre de 1983 | (DO L 275 de 8.10.1983, p. 20) |

Directiva 83/574/CEE del Consejo, de 26 de octubre de 1983 | (DO L 332 de 28.11.1983, p. 38) |

Directiva 84/415/CEE de la Comisión, de 18 de julio de 1984 | (DO L 228 de 25.8.1984, p. 31) |

Directiva 85/391/CEE de la Comisión, de 16 de julio de 1985 | (DO L 224 de 22.8.1985, p. 40) |

Directiva 86/179/CEE de la Comisión, de 28 de febrero de 1986 | (DO L 138 de 24.5.1986, p. 40) |

Directiva 86/199/CEE de la Comisión, de 26 de marzo de 1986 | (DO L 149 de 3.6.1986, p. 38) |

Directiva 87/137/CEE de la Comisión, de 2 de febrero de 1987 | (DO L 56 de 26.2.1987, p. 20) |

Directiva 88/233/CEE de la Comisión, de 2 de marzo de 1988 | (DO L 105 de 26.4.1988, p. 11) |

Directiva 88/667/CEE del Consejo, de 21 de diciembre de 1988 | (DO L 382 de 31.12.1988, p. 46) |

Directiva 89/174/CEE de la Comisión, de 21 de febrero de 1989 | (DO L 64 de 8.3.1989, p. 10) |

Directiva 89/679/CEE del Consejo, de 21 de diciembre de 1989 | (DO L 398 de 30.12.1989, p. 25) |

Directiva 90/121/CEE de la Comisión, de 20 de febrero de 1990 | (DO L 71 de 17.3.1990, p. 40) |

Directiva 91/184/CEE de la Comisión, de 12 de marzo de 1991 | (DO L 91 de 12.4.1991, p. 59) |

Directiva 92/8/CEE de la Comisión, de 18 de febrero de 1992 | (DO L 70 de 17.3.1992, p. 23) |

Directiva 92/86/CEE de la Comisión, de 21 de octubre de 1992 | (DO L 325 de 11.11.1992, p. 18) |

Directiva 93/35/CEE del Consejo, de 14 de junio de 1993 | (DO L 151 de 23.6.1993, p. 32) |

Directiva 93/47/CE de la Comisión, de 22 de junio de 1993 | (DO L 203 de 13.8.1993, p. 24) |

Directiva 94/32/CE de la Comisión, de 29 de junio de 1994 | (DO L 181 de 15.7.1994, p. 31) |

Directiva 95/34/CE de la Comisión, de 10 de julio de 1995 | (DO L 167 de 18.7.1995, p. 19) |

Directiva 96/41/CE de la Comisión, de 25 de junio de 1996 | (DO L 198 de 8.8.1996, p. 36) |

Directiva 97/1/CE de la Comisión, de 10 de enero de 1997 | (DO L 16 de 18.1.1997, p. 85) |

Directiva 97/18/CE de la Comisión, de 17 de abril de 1997 | (DO L 114 de 1.5.1997, p. 43) |

Directiva 97/45/CE de la Comisión, de 14 de julio de 1997 | (DO L 196 de 24.7.1997, p. 77) |

Directiva 98/16/CE de la Comisión, de 5 de marzo de 1998 | (DO L 77 de 14.3.1998, p. 44) |

Directiva 98/62/CE de la Comisión, de 3 de septiembre de 1998 | (DO L 253 de 15.9.1998, p. 20) |

Directiva 2000/6/CE de la Comisión, de 29 de febrero de 2000 | (DO L 56 de 1.3.2000, p. 42) |

Directiva 2000/11/CE de la Comisión, de 10 de marzo de 2000 | (DO L 65 de 14.3.2000, p. 22) |

Directiva 2000/41/CE de la Comisión, de 19 de junio de 2000 | (DO L 145 de 20.6.2000, p. 25) |

Directiva 2002/34/CE de la Comisión, de 15 de abril de 2002 | (DO L 102 de 18.4.2002, p. 19) |

Directiva 2003/1/CE de la Comisión, de 6 de enero de 2003 | (DO L 5 de 10.1.2003, p. 14) |

Directiva 2003/16/CE de la Comisión, de 19 de febrero de 2003 | (DO L 46 de 20.2.2003, p. 24) |

Directiva 2003/15/CE, del Parlamento Europeo y del Consejo, de 27 de febrero de 2003 | (DO L 66 de 11.3.2003, p. 26) |

Directiva 2003/80/CE de la Comisión, de 5 de septiembre de 2003 | (DO L 224 de 6.9.2003, p. 27) |

Directiva 2003/83/CE de la Comisión, de 24 de septiembre de 2003 | (DO L 238 de 25.9.2003, p. 23) |

Directiva 2004/87/CE de la Comisión, de 7 de septiembre de 2004 | (DO L 287 de 8.9.2004, p. 4) |

Directiva 2004/88/CE de la Comisión, de 7 de septiembre de 2004 | (DO L 287 de 8.9.2004, p. 5) |

Directiva 2004/94/CE de la Comisión, de 15 de septiembre de 2004 | (DO L 294 de 17.9.2004, p. 28) |

Directiva 2004/93/CE de la Comisión, de 21 de septiembre de 2004 | (DO L 300 de 25.9.2004, p. 13) |

Directiva 2005/9/CE de la Comisión, de 28 de enero de 2005 | (DO L 27 de 29.1.2005, p. 46) |

Directiva 2005/42/CEE de la Comisión, de 20 de junio de 2005 | (DO L 158 de 21.6.2005, p. 17) |

Directiva 2005/52/CE de la Comisión, de 9 de septiembre de 2005 | (DO L 234 de 10.9.2005, p. 9) |

Directiva 2005/80/CE de la Comisión, de 21 de noviembre de 2005 | (DO L 303 de 22.11.2005, p. 32) |

Directiva 2006/65/CE de la Comisión, de 19 de julio de 2006 | (DO L 198 de 20.7.2006, p. 11) |

Directiva 2006/78/CE de la Comisión, de 29 de septiembre de 2006 | (DO L 271 de 30.9.2006, p. 56) |

Directiva 2007/1/CE de la Comisión, de 29 de enero de 2007 | (DO L 25 de 1.2.2007, p. 9) |

Directiva 2007/17/CE de la Comisión, de 22 de marzo de 2007 | (DO L 82 de 23.3.2007, p. 27) |

Directiva 2007/22/CE de la Comisión, de 17 de abril de 2007 | (DO L 101 de 18.4.2007, p. 11) |

Directiva 2007/53/CE de la Comisión, de 29 de agosto de 2007 | (DO L 226 de 30.8.2007, p. 19) |

Directiva 2007/54/CE de la Comisión, de 29 de agosto de 2007 | (DO L 226 de 30.8.2007, p. 21) |

Directiva 2007/67/CE de la Comisión, de 22 de noviembre de 2007 | (DO L 305 de 23.11.2007, p. 22) |

Directiva 95/17/CE de la Comisión, de 19 de junio de 1995 | (DO L 140 de 23.6.1995, p. 26) |

Parte B

Lista de plazos de transposición al Derecho nacional y fechas de aplicación

(contemplados en el artículo 33)

Directiva | Plazos de transposición |

Directiva 76/768/CEE del Consejo, de 27 de julio de 1976 | 30.1.1978 |

Directiva 79/661/CEE del Consejo, de 24 de julio de 1979 | 30.7.1979 |

Directiva 82/147/CEE de la Comisión, de 11 de febrero de 1982 | 31.12.1982 |

Directiva 82/368/CEE del Consejo, de 17 de mayo de 1982 | 31.12.1983 |

Directiva 83/191/CEE de la Comisión, de 30 de marzo de 1983 | 31.12.1984 |

Directiva 83/341/CEE de la Comisión, de 29 de junio de 1983 | 31.12.1984 |

Directiva 83/496/CEE de la Comisión, de 22 de septiembre de 1983 | 31.12.1984 |

Directiva 83/574/CEE del Consejo, de 26 de octubre de 1983 | 31.12.1984 |

Directiva 84/415/CEE de la Comisión, de 18 de julio de 1984 | 31.12.1985 |

Directiva 85/391/CEE de la Comisión, de 16 de julio de 1985 | 31.12.1986 |

Directiva 86/179/CEE de la Comisión, de 28 de febrero de 1986 | 31.12.1986 |

Directiva 86/199/CEE de la Comisión, de 26 de marzo de 1986 | 31.12.1986 |

Directiva 87/137/CEE de la Comisión, de 2 de febrero de 1987 | 31.12.1987 |

Directiva 88/233/CEE de la Comisión, de 2 de marzo de 1988 | 30.9.1988 |

Directiva 88/667/CEE del Consejo, de 21 de diciembre de 1988 | 31.12.1993 |

Directiva 89/174/CEE de la Comisión, de 21 de febrero de 1989 | 31.12.1989 |

Directiva 89/679/CEE del Consejo, de 21 de diciembre de 1989 | 3.1.1990 |

Directiva 90/121/CEE de la Comisión, de 20 de febrero de 1990 | 31.12.1990 |

Directiva 91/184/CEE de la Comisión, de 12 de marzo de 1991 | 31.12.1991 |

Directiva 92/8/CEE de la Comisión, de 18 de febrero de 1992 | 31.12.1992 |

Directiva 92/86/CEE de la Comisión, de 21 de octubre de 1992 | 30.6.1993 |

Directiva 93/35/CEE del Consejo, de 14 de junio de 1993 | 14.6.1995 |

Directiva 93/47/CE de la Comisión, de 22 de junio de 1993 | 30.6.1994 |

Directiva 94/32/CE de la Comisión, de 29 de junio de 1994 | 30.6.1995 |

Directiva 95/34/CE de la Comisión, de 10 de julio de 1995 | 30.6.1996 |

Directiva 96/41/CE de la Comisión, de 25 de junio de 1996 | 30.6.1997 |

Directiva 97/1/CE de la Comisión, de 10 de enero de 1997 | 30.6.1997 |

Directiva 97/18/CE de la Comisión, de 17 de abril de 1997 | 31.12.1997 |

Directiva 97/45/CE de la Comisión, de 14 de julio de 1997 | 30.6.1998 |

Directiva 98/16/CE de la Comisión, de 5 de marzo de 1998 | 1.4.1998 |

Directiva 98/62/CE de la Comisión, de 3 de septiembre de 1998 | 30.6.1999 |

Directiva 2000/6/CE de la Comisión, de 29 de febrero de 2000 | 1.7.2000 |

Directiva 2000/11/CE de la Comisión, de 10 de marzo de 2000 | 1.6.2000 |

Directiva 2000/41/CE de la Comisión, de 19 de junio de 2000 | 29.6.2000 |

Directiva 2002/34/CE de la Comisión, de 15 de abril de 2002 | 15.4.2003 |

Directiva 2003/1/CE de la Comisión, de 6 de enero de 2003 | 15.4.2003 |

Directiva 2003/16/CE de la Comisión, de 19 de febrero de 2003 | 28.2.2003 |

Directiva 2003/15/CE, del Parlamento Europeo y del Consejo, de 27 de febrero de 2003 | 10.9.2004 |

Directiva 2003/80/CE de la Comisión, de 5 de septiembre de 2003 | 11.9.2004 |

Directiva 2003/83/CE de la Comisión, de 24 de septiembre de 2003 | 23.9.2004 |

Directiva 2004/87/CE de la Comisión, de 7 de septiembre de 2004 | 1.10.2004 |

Directiva 2004/88/CE de la Comisión, de 7 de septiembre de 2004 | 1.10.2004 |

Directiva 2004/94/CE de la Comisión, de 15 de septiembre de 2004 | 21.9.2004 |

Directiva 2004/93/CE de la Comisión, de 21 de septiembre de 2004 | 30.9.2004 |

Directiva 2005/9/CE de la Comisión, de 28 de enero de 2005 | 16.2.2006 |

Directiva 2005/42/CEE de la Comisión, de 20 de junio de 2005 | 31.12.2005 |

Directiva 2005/52/CE de la Comisión, de 9 de septiembre de 2005 | 1.1.2006 |

Directiva 2005/80/CE de la Comisión, de 21 de noviembre de 2005 | 22.5.2006 |

Directiva 2006/65/CE de la Comisión, de 19 de julio de 2006 | 1.9.2006 |

Directiva 2006/78/CE de la Comisión, de 29 de septiembre de 2006 | 30.3.2007 |

Directiva 2007/1/CE de la Comisión, de 29 de enero de 2007 | 21.8.2007 |

Directiva 2007/17/CE de la Comisión, de 22 de marzo de 2007 | 23.9.2007 |

Directiva 2007/22/CE de la Comisión, de 17 de abril de 2007 | 18.1.2008 |

Directiva 2007/53/CE de la Comisión, de 29 de agosto de 2007 | 19.4.2008 |

Directiva 2007/54/CE de la Comisión, de 29 de agosto de 2007 | 18.3.2008 |

Directiva 2007/67/CE de la Comisión, de 22 de noviembre de 2007 | 31.12.2007 |

Directiva 95/17/CE de la Comisión, de 19 de junio de 1995 | 30.11.1995 |

____

ANEXO X

Tabla de correspondencias

Directiva 76/768/CEE | El presente Reglamento |

Artículo 1 | Artículo 2, apartado 1, letra a) |

Artículo 2 | Artículo 3 |

Artículo 3 | - |

Artículo 4, apartado 1 | Artículo 11, apartado 1 |

Artículo 4, apartado 2 | Artículo 13 |

Artículo 4 bis | Artículo 14 |

Artículo 4 ter | Artículo 12, punto 1 |

Artículo 5 | - |

Artículo 5 bis | Artículo 28 |

Artículo 6, apartados 1 y 2 | Artículo 15, apartados 1, 2, 3 y 4 |

Artículo 6, apartado 3 | Artículo 16 |

Artículo 7, apartado 1 | Artículo 6 |

Artículo 7, apartado 2 | Artículo 15, apartados 5 y 7 |

Artículo 7, apartado 3 | Artículo 10 |

Artículo 7 bis, apartado 1, letra h) | Artículo 17 |

Artículo 7 bis, apartados 1, 2 y 3 | Artículos 7 y 8, anexo I |

Artículo 7 bis, apartado 4 | Artículo 10 |

Artículo 7 bis, apartado 5 | Artículo 24, 29 |

Artículo 8, apartado 1 | Artículo 9 |

Artículo 8, apartado 2 | Artículo 26 |

Artículo 8 bis | - |

Artículo 9 | Artículo 30 |

Artículo 10 | Artículo 27 |

Artículo 11 | - |

Artículo 12 | Artículo 22 |

Artículo 13 | Artículo 23 |

Artículo 14 | - |

Artículo 15 | - |

Anexo I | Considerando 10 |

Anexo II | Anexo II |

Anexo III | Anexo III |

Anexo IV | Anexo IV |

Anexo V | - |

Anexo VI | Anexo V |

Anexo VII | Anexo VI |

Anexo VIII | Anexo VII |

Anexo VIII bis | Anexo VII |

Anexo IX | Anexo VIII |

- | Anexo IX |

- | Anexo X |

FICHA FINANCIERA LEGISLATIVA

1. DENOMINACIÓN DE LA PROPUESTA:

Propuesta de Reglamento del Parlamento Europeo y del Consejo sobre los productos cosméticos (refundición)

2. MARCO GPA/PPA (gestión/presupuestación por actividades)

Ámbito(s) político(s) afectado(s) y actividad(es) asociada(s): Empresa, mercado interior, seguridad de los productos

3. LÍNEAS PRESUPUESTARIAS

3.1. Líneas presupuestarias [líneas operativas y líneas correspondientes de asistencia técnica y administrativa (antiguas líneas BA)], incluidas sus denominaciones:

02 01 04 01 (mercado interior)

3.2. Duración de la acción y de la incidencia financiera:

La acción comenzará en 2009. Mientras que el presupuesto decrecerá progresivamente (véase más abajo), la acción avanzará de manera continua, a menos que las subsiguientes modificaciones del presente Reglamento dispongan otra cosa.

3.3. Características presupuestarias:

Línea presupuestaria | Tipo de gasto | Nuevo | Contribución de la AELC | Contribución de los países candidatos | Rúbrica de las perspectivas financieras |

02.010401 | GNO | CND [90] | No | Sí | No | Nº 1a |

4. SÍNTESIS DE LOS RECURSOS

4.1. Recursos financieros

4.1.1. Síntesis de los créditos de compromiso (CC) y de los créditos de pago (CP)

millones de euros (al tercer decimal)

Tipo de gasto | Sección nº | | Año n | n + 1 | n + 2 | n + 3 | n + 4 | n + 5 y ss. | Total |

Gastos operativos [91] | | | | | | | | |

Créditos de compromiso (CC) | 8.1. | a | | | | | | | |

Créditos de pago (CP) | | b | | | | | | | |

Gastos administrativos incluidos en el importe de referencia [92] | | | | |

Asistencia técnica y administrativa (CND) | 8.2.4. | c | 0,11 | 0,05 | 0,015 | 0,01 | 0,01 | 0,01 | 0,205 |

IMPORTE DE REFERENCIA TOTAL | | | | | | | |

Créditos de compromiso | | a+c | 0,11 | 0,05 | 0,015 | 0,01 | 0,01 | 0,01 | 0,205 |

Créditos de pago | | b+c | 0,11 | 0,05 | 0,015 | 0,01 | 0,01 | 0,01 | 0,205 |

Gastos administrativos no incluidos en el importe de referencia [93] | | |

Recursos humanos y gastos afines (CND) | 8.2.5. | d | 0,02 | 0,005 | 0,005 | 0,005 | 0,005 | 0,005 | 0,045 |

Costes administrativos, excepto recursos humanos y costes afines, no incluidos en el importe de referencia (CND) | 8.2.6. | e | | | | | | | |

Coste financiero indicativo total de la intervención |

TOTAL CC, incluido el coste de los recursos humanos | | a+c+d+e | 0,13 | 0,055 | 0,002 | 0,015 | 0,015 | 0,015 | 0,25 |

TOTAL CP, incluido el coste de los recursos humanos | | b+c+d+e | 0,13 | 0,055 | 0,002 | 0,015 | 0,015 | 0,015 | 0,25 |

Desglose de la cofinanciación

n.d.

4.1.2. Compatibilidad con la programación financiera

La propuesta es compatible con la programación financiera vigente.

4.1.3. Incidencia financiera en los ingresos

La propuesta no tiene incidencia financiera en los ingresos

4.2. Recursos humanos equivalentes a tiempo completo (ETC) (incluidos funcionarios, personal temporal y externo) – véase el desglose en el punto 8.2.1.

Necesidades anuales | Año n | n + 1 | n + 2 | n + 3 | n + 4 | n + 5 y ss. |

Cantidad total de recursos humanos | 0,2 | 0,05 | 0,05 | 0,05 | 0,05 | 0,05 |

5. CARACTERÍSTICAS Y OBJETIVOS

5.1. Realización necesaria a corto o largo plazo

El Reglamento propuesto tiene por objeto facilitar la aplicación de las normas que rigen la introducción de los productos cosméticos en el mercado de la UE. Hasta ahora, antes de introducir un producto cosmético en el mercado era necesario efectuar varias notificaciones a diversas autoridades nacionales competentes. Esto implicaba la presentación multiplicada de idéntica información.

Para reducir las cargas administrativas, el Reglamento propuesto dispone la presentación centralizada de estos datos a todas las autoridades competentes interesadas mediante una «ventanilla única».

Esta consistiría en un portal informático: las empresas notificantes presentarían la información pertinente una sola vez a través de ese portal, y este transmitiría la información a las autoridades competentes interesadas.

A fin de crear este portal, la Comisión utilizaría un contrato (marco) para la prestación de las tareas técnicas informáticas.

5.2. Valor añadido de la implicación comunitaria, coherencia de la propuesta con otros instrumentos financieros y posibles sinergias

El valor añadido de esta medida ha sido evaluado a fondo en la evaluación de impacto aneja a la propuesta de la Comisión. Según ella, esta medida reduciría las cargas administrativas considerablemente: para las empresas de la UE, supondría un ahorro anual de alrededor de 45 millones de EUR. Como tal, esta medida es una importante contribución a la política de la Comisión encaminada a reducir los costes administrativos para las empresas comunitarias a fin de aprovechar mejor las ventajas del mercado interior.

Esta evaluación de impacto fue aprobada por el Comité de evaluación de impacto.

5.3. Objetivos de la propuesta, resultados esperados e indicadores correspondientes en el contexto de la gestión por actividades

Crear y mantener un portal electrónico que permita presentar, en una sola operación, información sobre productos cosméticos introducidos en el mercado de la UE.

5.4. Método de ejecución (indicativo)

Gestión centralizada

directa, por la Comisión

indirecta, por delegación en:

agencias ejecutivas

organismos creados por las Comunidades, como los previstos en el artículo 185 del Reglamento financiero

organismos nacionales del sector público / organismos con misión de servicio público

Gestión compartida o descentralizada

con los Estados miembros

con terceros países

Gestión conjunta con organizaciones internacionales (especifíquese)

Comentarios:

6. SUPERVISIÓN Y EVALUACIÓN

6.1. Sistema de seguimiento

Puede realizarse un seguimiento de la eficacia del portal electrónico evaluando su manejabilidad. Son foros importantes para intercambiar información a este respecto el Grupo de Trabajo sobre Productos Cosméticos (que reúne, 4 o 5 veces al año, a responsables de reglamentación y partes interesadas) y la Plataforma de Autoridades de Vigilancia del Mercado de los Productos Cosméticos (PEMSAC, formada por las autoridades de los Estados miembros encargadas de la aplicación).

6.2. Evaluación

6.2.1. Evaluación ex ante

La evaluación de impacto presentada junto con la propuesta de la Comisión para la consulta interservicios contiene una evaluación ex ante que analiza los impactos de estas medidas y las posibles alternativas. La conclusión es que la notificación centralizada contribuye en gran medida a una eficaz vigilancia del mercado por parte de las autoridades competentes de los Estados miembros. Además, en comparación con el sistema actual de múltiples notificaciones nacionales, reduce los costes administrativos para las empresas en alrededor de un 50 % (aproximadamente 45 millones EUR). De hecho, la introducción de un procedimiento centralizado de notificación es un buen ejemplo de las ventajas que presenta una refundición para reducir los costes del cumplimiento de la normativa (en este caso, de los costes administrativos) sin comprometer la seguridad de los productos.

El Comité de evaluación de impacto aprobó esta evaluación de impacto. Su dictamen final puede consultarse en: http://ec.europa.eu/governance/impact/cia_2007_en.htm.

6.2.2. Medidas adoptadas sobre la base de una evaluación intermedia / ex post (enseñanzas extraídas de anteriores experiencias similares)

6.2.3. Condiciones y frecuencia de evaluaciones futuras

Estas evaluaciones se efectuarán de forma permanente, dado el uso continuo del portal electrónico por los actores económicos.

7. Medidas antifraude

8. DESGLOSE DE LOS RECURSOS

8.1. Objetivos de la propuesta en términos de coste financiero

Créditos de compromiso en millones de euros (al tercer decimal)

(Indique las denominaciones de los objetivos, de las acciones y de los resultados) | Tipo de resultados | Coste medio | Año n | Año n+1 | Año n+2 | Año n+3 | Año n+4 | Año n+5 y ss. | Total |

| | | Nº de resultados | Coste total | Nº de resultados | Coste total | Nº de resultados | Coste total | Nº de resultados | Coste total | Nº de resultados | Coste total | Nº de resultados | Coste total | Nº de resultados | Coste total |

OBJETIVO OPERATIVO nº 1 [94] | n.d. | | | | | | | | | | | | | | | |

Acción 1………………. | | | | | | | | | | | | | | | | |

- Resultado 1 | | | | | | | | | | | | | | | | |

- Resultado 2 | | | | | | | | | | | | | | | | |

Acción 2………………. | | | | | | | | | | | | | | | | |

- Resultado 1 | | | | | | | | | | | | | | | | |

Subtotal objetivo 1 | | | | | | | | | | | | | | | | |

OBJETIVO OPERATIVO nº 21……… | | | | | | | | | | | | | | | | |

Acción 1………………. | | | | | | | | | | | | | | | | |

- Resultado 1 | | | | | | | | | | | | | | | | |

Subtotal objetivo 2 | | | | | | | | | | | | | | | | |

OBJETIVO OPERATIVO nº n 1 | | | | | | | | | | | | | | | | |

Subtotal objetivo n | | | | | | | | | | | | | | | | |

Coste total | | | | | | | | | | | | | | | | |

8.2. Gastos administrativos

8.2.1. Cantidad y tipo de recursos humanos

Tipos de puestos | | Personal que se asignará a la gestión de la acción utilizando recursos existentes y/o adicionales (número de puestos/ETC) |

| | Año n | Año n+1 | Año n+2 | Año n+3 | Año n+4 | Año n+5 |

Funcionarios o agentes temporales [95] (XX 01 01) | A*/AD | 0,2 | 0,05 | 0,05 | 0,05 | 0,05 | 0,05 |

| B*, C*/AST | | | | | | |

Personal financiado [96] con cargo al artículo XX 01 02 | | | | | | |

Personal financiado [97] con cargo al artículo XX 01 04/05 | | | | | | |

Total | 0,2 | 0,05 | 0,05 | 0,05 | 0,05 | 0,05 |

8.2.2. Descripción de las tareas derivadas de la acción

Inicio de los trabajos para un portal o una interfaz electrónicos, dentro de un contrato marco abierto por DIGIT o, en caso necesario, mediante un concurso convocado por esta Dirección General.

8.2.3. Origen de los recursos humanos (estatutarios)

Puestos que se reasignan utilizando recursos existentes en el servicio gestor (reasignación interna)

8.2.4. Otros gastos administrativos incluidos en el importe de referencia (XX 01 04/05 - Gastos de gestión administrativa)

millones de euros (al tercer decimal)

Línea presupuestaria(nº y denominación) | Año n | Año n+1 | Año n+2 | Año n+3 | Año n+4 | Año n+5 y ss. | Total |

Asistencia técnica y administrativa (incluidos los costes de personal) | | | | | | | |

Agencias ejecutivas [98] | | | | | | | |

Otros tipos de asistencia técnica y administrativa | | | | | | | |

- intramuros | | | | | | | |

- extramuros | 0,11 | 0,05 | 0,015 | 0,01 | 0,01 | 0,01 | 0,205 |

Total asistencia técnica y administrativa | 0,11 | 0,05 | 0,015 | 0,01 | 0,01 | 0,01 | 0,205 |

8.2.5. Coste financiero de los recursos humanos y costes asociados no incluidos en el importe de referencia

millones de euros (al tercer decimal)

Tipo de recursos humanos | Año n | Año n+1 | Año n+2 | Año n+3 | Año n+4 | Año n+5y ss. |

Funcionarios y agentes temporales (XX 01 01) | 0,02 | 0,005 | 0,005 | 0,005 | 0,005 | 0,005 |

Personal financiado con cargo al artículo XX 01 02 (auxiliares, END, contratados, etc.)(indique la línea presupuestaria) | | | | | | |

Coste total de los recursos humanos y costes afines (NO incluidos en el importe de referencia) | 0,02 | 0,005 | 0,005 | 0,005 | 0,005 | 0,005 |

Cálculo – Funcionarios y agentes temporales |

|

|

Cálculo – Personal financiado con cargo al artículo XX 01 02 |

|

|

8.2.6. Otros gastos administrativos no incluidos en el importe de referencia

n.d.

millones de euros (al tercer decimal) |

| Año n | Año n+1 | Año n+2 | Año n+3 | Año n+4 | Año n+5y ss. | Total |

XX 01 02 11 01 - Misiones | | | | | | | |

XX 01 02 11 02 - Reuniones y conferencias | | | | | | | |

XX 01 02 11 03 - Comités [99] | | | | | | | |

XX 01 02 11 04 - Estudios y consultoría | | | | | | | |

XX 01 02 11 05 - Sistemas de información | | | | | | | |

Total otros gastos de gestión (XX 01 02 11) | | | | | | | |

3 Otros gastos de naturaleza administrativa (especifique e indique la línea presupuestaria) | | | | | | | |

Total gastos administrativos, excepto recursos humanos y costes afines (NO incluidos en el importe de referencia) | | | | | | | |

Cálculo – Otros gastos administrativos no incluidos en el importe de referencia |

|

[1] DO L 262 de 27.9.1976, p. 169, modificada.

[2] COM(2005) 535 de 25.10.2005.

[3] COM(2006) 122 de 14.3.2006.

[4] Incluidos minoristas, fabricantes de máquinas y equipos, químicos, peluqueros y empresas de diseño de marcas.

[5] Estos estudios analizan las características de la industria cosmética de la UE, el impacto de la legislación comunitaria para la seguridad de los consumidores y la incidencia de esta legislación en la competitividad de la industria.

[6] http://ec.europa.eu/governance/impact/iab_en.htm

[7] DO C 77 de 28.3.2002, p. 1.

[8] COM(2007) 53.

[9] Artículo 5 bis, artículo 6, apartado 1, letra g), y artículo 7, apartado 2, de la Directiva sobre cosméticos.

[10] Artículo 7 bis, apartado 1, de la Directiva sobre cosméticos.

[11] Categoría 1: «Sustancias que, se sabe, son carcinogénicas (o mutágenas o tóxicas para la reproducción) para el hombre». Categoría 2: «Sustancias que pueden considerarse como carcinogénicas (o mutágenas o tóxicas para la reproducción) para el hombre». Categoría 3: «Sustancias cuyos posibles efectos carcinogénicos (o mutágenos o tóxicos para la reproducción) en el hombre son preocupantes, pero de las que no se dispone de información suficiente para realizar una evaluación satisfactoria».

[12] Artículo 4 ter de la Directiva sobre cosméticos.

[13] DO C de , p. .

[14] DO C de , p. .

[15] DO C de , p. .

[16] DO C de , p. .

[17] DO L 262 de 27.9.1976, p. 169. Directiva modificada en último lugar por […].

[18] DO L 262 de 27.7.1976. Directiva cuya última modificación la constituye la Directiva 2002/34/CE de la Comisión (DO L 102 de 18.4.2002, p. 19).

[19] DO 196 de 16.8.1967, p. 1. Directiva modificada en último lugar por […].

[20] DO L 358 de 18.12.1986, p. 1.

[21] DO L 151 de 23.6.1993, p. 32.

[22] DO L 232 de 29.8.2002, p. 1.

[23] DO L 184 de 17.7.1999, p. 23. Decisión modificada por la Decisión 2006/512/CE (DO L 200 de 22.7.2006, p. 11).

[24] DO L 24 de 21.7.1998, p. 37. Directiva modificada en último lugar por […].

[25] DO nº L 15 de 17.1.1987, p. 29.

[26] DO L 31 de 1.2.2002, p. 1. Reglamento modificado en último lugar por […].

[27] DO 196 de 16.8.1967, p. 1. Directiva cuya última modificación la constituye la Directiva 2001/59/CE de la Comisión (DO L 225 de 21.8.2001, p. 1) modificada en último lugar por .

[28] DO L 66 de 11.3.2003, p. 26.

[29] DO L 140 de 23.6.1995, p. 26.

[30] DO 196 de 16.8.1967, p. 1. Directiva modificada en último lugar por […].

[31] DO L 11 de 15.1.2002, p. 4.

[32] DO L 358 de 18.12.1986, p. 1.

[33] En la presente Directiva, se indican con un asterisco las denominaciones conformes con «computer printout, 1975, International Nonproprietary Names (INN) for pharmaceutical products. Lists 1-33 of proposed INN» publicado por la Organización Mundial de la Salud, Ginebra, agosto de 1975.

[34] DO L 159 de 29.6.1996, p. 1.

[35] DO L 273 de 10.10.2002, p. 1.

[36] Para cada ingrediente véase el número de referencia 364 del anexo II.

[37] Para cada ingrediente véase el número de referencia 413 del anexo II.

[38] Estas sustancias podrán emplearse por separado o mezcladas en cantidades tales que la suma de las proporciones de los contenidos de del producto cosmético en cada una de ellas en el producto cosmético estas sustancias respecto al contenido máximo autorizado para respecto a cada una de ellas no exceda de 1 la unidad.

[39] Como conservante, véase el anexo V, nº 5.

[40] Sólo cuando la concentración sea superior al 0,05 %.

[41] Estas sustancias podrán emplearse por separado o mezcladas en cantidades tales que la suma de las proporciones de los contenidos de del producto cosmético en cada una de ellas en el producto cosmético estas sustancias respecto al contenido máximo autorizado para respecto a cada una de ellas no exceda de 2.

[42] 1 La cantidad de hidróxido de sodio, potasio potasio, sodio o litio se expresa en peso de hidróxido de sodio. En caso de mezclas, la suma no debería sobrepasar los límites indicados establecidos en la columna d.

[43] 1 La cantidad de hidróxido de sodio, potasio potasio, sodio o litio se expresa en peso de hidróxido de sodio. En caso de mezclas, la suma no debería sobrepasar los límites indicados establecidos en la columna d.

[44] 1 La cantidad de hidróxido de sodio, potasio potasio, sodio o litio se expresa en peso de hidróxido de sodio. En caso de mezclas, la suma no debería sobrepasar los límites indicados establecidos en la columna d.

[45] 3 La concentración cantidad de hidróxido de sodio, potasio o litio se expresa en peso de hidróxido de sodio. En caso Si se trata de mezclas, la suma no debería sobrepasar superará los límites indicados en la columna d.

[46] 3 La concentración cantidad de hidróxido de sodio, potasio o litio se expresa en peso de hidróxido de sodio. En caso Si se trata de mezclas, la suma no debería sobrepasar superará los límites indicados en la columna d.

[47] Estas sustancias podrán emplearse por separado o mezcladas en cantidades tales que la suma de las proporciones de los contenidos de del producto cosmético en cada una de ellas en el producto cosmético estas sustancias respecto al contenido máximo autorizado para respecto a cada una de ellas no exceda de 2.

[48] Como conservante, véase el anexo V, nº 34.

[49] Como conservante, véase el anexo V, nº 43.

[50] Como conservante, véase el anexo V, nº 54.

[51] Como conservante, véase el anexo V, nº VI, primera parte, número 3.

[52] Únicamente cuando se trate de productos que pudieran emplearse para los cuidados de los niños menores de tres años y que permanezcan en contacto prolongado con la piel.

[53] Como conservante, véase el anexo V, nº VI, primera parte, número 9.

[54] Como conservante, véase el anexo V, nº VI, primera parte, número 23.

[55] Como conservante, véase el anexo V, nº VI, primera parte, número 8.

[56] Se admitirán también las lacas o sales de estos colorantes que contengan sustancias cuyo empleo no quede prohibido en el Anexo II o que no estén excluídas del campo de aplicación de la presente Directiva con arreglo al Anexo V.

[57] Los colorantes cuyo número va acompañado de la letra E, de conformidad con lo dispuesto en las Directivas CEE de 1962 referentes a los productos alimentarios y a los colorantes, habrán de cumplir las normas de pureza que se estipulan en tales Directivas. Dichos colorantes siguen estando sometidos a los criterios generales del Anexo III de la Directiva de 1962 relativa a los colorantes aun cuando el número E haya sido suprimido de tal Directiva.

[58] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[59] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[60] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[61] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[62] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[63] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[64] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[65] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[66] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[67] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[68] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[69] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[70] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[71] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[72] Se admitirán también las lacas, pigmentos o sales de bario, estroncio y circonio, insolubles, de estos colorantes. Deberán superar la prueba de insolubilidad que se determinará por el procedimiento previsto en el artículo 8.

[73] Como filtro ultravioleta, véase el anexo VI, nº 27.

[74] Se admitirán también las lacas o sales de estos colorantes que contengan sustancias cuyo empleo no quede prohibido en el Anexo II o que no estén excluídas del campo de aplicación de la presente Directiva con arreglo al Anexo V.

[75] Los colorantes cuyo número va acompañado de la letra E, de conformidad con lo dispuesto en las Directivas CEE de 1962 referentes a los productos alimentarios y a los colorantes, habrán de cumplir las normas de pureza que se estipulan en tales Directivas. Dichos colorantes siguen estando sometidos a los criterios generales del Anexo III de la Directiva de 1962 relativa a los colorantes aun cuando el número E haya sido suprimido de tal Directiva.

[76] Con usos distintos del uso como conservante, véase el anexo III, nº 98.

[77] Únicamente cuando se trate de productos que pudieran emplearse para los cuidados de los niños menores de tres años y que permanezcan en contacto prolongado con la piel.

[78] Con usos distintos del uso como conservante, véase el anexo III, nº 13.

[79] Con usos distintos del uso como conservante, véase el anexo III, nº 101.

[80] Con usos distintos del uso como conservante, véase el anexo III, nº 99.

[81] Con usos distintos del uso como conservante, véase el anexo III, nº 100.

[82] Con usos distintos del uso como conservante, véase el anexo III, nos 45 y 68.

[83] Con usos distintos del uso como conservante, véase el anexo III, nº 54.

[84] Con usos distintos del uso como conservante, véase el anexo III, nº 65.

[85] Se refiere a cualquier producto destinado a ser aplicado en grandes extensiones corporales.

[86] Únicamente en caso de productos (distintos de los productos de baño, gel de ducha y champú) que podrían utilizarse con niños menores de 3 años.

[87] Únicamente en caso de productos que podrían utilizarse con niños menores de 3 años.

[88] No se exigirá esta mención cuando la concentración sea igual o inferior al 0,5 % y cuando la sustancia soólo se utilice para proteger el producto.

[89] Como colorante, véase el anexo IV, nº 143.

[90] Créditos no disociados.

[91] Gastos no cubiertos por el capítulo xx 01 del título xx correspondiente.

[92] Gastos correspondientes al artículo xx 01 04 del título xx.

[93] Gastos correspondientes al capítulo xx 01, excepto los artículos xx 01 04 y xx 01 05.

[94] Según se describe en el punto 5.3.

[95] Coste NO cubierto por el importe de referencia.

[96] Coste NO cubierto por el importe de referencia.

[97] Coste incluido en el importe de referencia.

[98] Indique la ficha financiera legislativa correspondiente a la agencia o agencias ejecutivas de que se trate.

[99] Especifique el tipo de comité y el grupo al que pertenece.

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