[pic] | COMMISSION OF THE EUROPEAN COMMUNITIES |

Brussels, 5.2.2008

COM(2008)49 final

2008/0035 (COD)

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

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.

Public consultation

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.

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.

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.

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.

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:

Facilitating the management of cosmetics legislation

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]

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.

Strengthening certain elements to ensure product safety in the future

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.

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.

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.

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.

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.

Additional information

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.

European Economic Area

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

2008/0025 (COD)

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on cosmetic products

(recast)

(Text with EEA relevance)

ê 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 Ö 95 Õ 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:

ò new

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.

ê 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.

ê 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.

ê 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.

ê 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.

ê 03/15/EC Recital 1 (adapted)

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

ê 76/768/EEC Recital 5 (adapted)

9. This Directive Ö Regulation Õ relates only to cosmetic products and not to Ö medicinal products, medical devices or biocidal products Õ 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.

ê 76/768/EEC Annex I (adapted)

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10. ð 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 ï 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 Ö colorants Õ , products for waving, straightening and fixing Ö hair Õ , Ö hair Õ setting products, Ö hair Õ cleansing products (lotions, powders, shampoos), Ö hair Õ 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, Ö make-up and products removing make-up Õ , 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.

ê 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.

ê 76/768/EEC Recital 7 (adapted)

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12. Cosmetic products Ö should Õ must not be Ö safe Õ harmful under normal or Ö reasonably Õ foreseeable conditions of use. In particular, Ö a risk-benefit reasoning should not justify a risk to human health. Õ 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. Ö In order to establish clear responsibilities, each cosmetic product should be linked to a responsible person who is established within the Community. Õ ð 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. ï

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

15. Ö 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. Õ

16. Ö 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. Õ

ê 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 Ö competent Õ 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.; Ö In particular, this product information should include a cosmetic product safety report documenting that a safety assessment has been conducted. Õ

18. Ö 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. Õ

ê 93/35/EEC Recital 5 (adapted)

ð new

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

20. Ö 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. Õ

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

ê 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. Ö 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. Õ

24. Ö 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. Õ

ò new

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.

ê 03/15/EC Recital 13 (adapted)

ð new

26. Given the ð hazardous properties of ï special risks that substances classified as carcinogenic, mutagenic or toxic for reproduction Ö (CMR) Õ , category 1, 2 and 3, pursuant to Ö 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] Õ 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. Ö 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. Õ ð 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. ï

ê 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 Ö In order to ensure product safety, prohibited substances should only be acceptable at trace levels if they are Õ is technologically inevitable with correct manufacturing processes Ö and provided that the product is safe. Õ ; whereas therefore certain provisions should be made in this connection;

ê 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.

ê 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.

ê 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.

ê 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 ð should ï therefore Ö be provided. Õ be incorporated into Directive 76/768/EEC. The Commission should establish guidelines in order to facilitate the Ö The Õ 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 Ö could be facilitated by Commission guidelines Õ .

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

ê 03/15/EC Recital 8 (adapted)

33. The Commission should establish Ö has established Õ 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 Ö 11 March 2009 Õ 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 Ö 11 March 2013 Õ 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.

ê 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 Ö for research Õ as set out in Decision No 1513/EC/2002 of the European Parliament and of the Council[22].

ê 03/15/EC Recital 10 (adapted)

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

ê 93/35/EEC Recital 3 (adapted)

36. Whereas greater Ttransparency is needed regarding the ingredients employed in cosmetics Ö products. Õ 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 Ö can Õ have access to Ö this Õ all necessary information.;

ê 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; Ö A glossary of common ingredient names should be compiled by the Commission to ensure uniform labelling and to facilitate identification of cosmetics ingredients. Õ whereas that inventory Ö This glossary should not be intended to Õ will be indicative and is not intended to constitute a limitative list of substances used in cosmetic products;

ê 03/15/EC Recital 14 (adapted)

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

ê 03/15/EC Recital 15 (adapted)

ð new

39. Ö 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. Õ 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 Ö should Õ be mentioned in the list of ingredients. This information Ö should Õ will improve the diagnosis of contact allergies among such consumers and Ö should Õ will enable them to avoid the use of cosmetic products which they do not tolerate.

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

ê 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, Ö has developed Õ 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 Ö has Õ must also Ö taken Õ 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. Ö 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. Õ

ê 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.

ò new

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.

ê 76/768/EEC Recital 11 (adapted)

46. Ö In order to address products which, albeit Õ It could happen that although conforming Ö with Õ to the provisions of this Ö Regulation Õ Directive and its Annexes, cosmetic products placed on the market might endanger Ö human Õ public health Ö , a safeguard procedure should be introduced. Õ 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.

ê 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.

ê 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.

ê 76/768/EEC (adapted)

HAVE ADOPTED THIS DIRECTIVE Ö REGULATION Õ :

ê 93/35/EEC (adapted)

Ö Chapter I Scope, definitions Õ

Ö Article 1 Scope and objective Õ

Ö 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. Õ

Article 1 2 Ö Definitions Õ

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

(a) Ö ‘cosmetic product’ means Õ A ‘cosmetic product’ shall mean any substance or preparation Ö or mixture Õ 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 Ö or correcting body odours Õ.

ê 76/768/EEC (adapted)

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

ê 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.

ò new

(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.

ê 76/768/EEC, recital 5 (adapted)

Ö 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. Õ

ê 93/35/EEC (adapted)

Ö Chapter II Safety, responsible person, free movement Õ

Article 23 Ö Safety Õ

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

(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. Ö the person defined in Article 4. Õ

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

ò new

Article 4Responsible 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.

ê 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.

ê 93/35/EEC (adapted)

Ö Article 5 Good manufacturing practice Õ

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

ò new

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 .

ê 76/768/EEC (adapted)

Ö Article 6 Free movement Õ

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

ê 93/35/EEC (adapted)

ð new

Ö Chapter III Safety assessment, product information file, notification Õ

Article 7a 7 Ö Safety assessment Õ

Ö 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. Õ

ð 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. ï

Ö 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. Õ

Ö 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. Õ

Ö Article 8 Product information file Õ

1. The Ö responsible person Õ 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 Ö a product information file for the cosmetic product for which he is the responsible person. Õ 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):

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

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

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

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

(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;

ê 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;

ê 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)Ö where justified by the nature or the effect of the cosmetic product, Õ proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product;

ê 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 Ö assessment Õ of the Ö cosmetic Õ product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of Ö third Õ 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. Ö 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. Õ

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

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.

ê 82/368/EEC (adapted)

Ö Article 9 Sampling and analysis Õ

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

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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 .

ê 76/768/EEC (adapted)

Article 710 Ö Notification Õ

ê 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 .

ò new

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.

ê 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 .

ê 82/368/EEC (adapted)

ð new

Ö Chapter IV Restrictions for certain substances Õ

Article 411 Ö Restrictions for substances listed in the Annexes Õ

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

(a) substances listed in Annex II;

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

ê 88/667/EEC (new)

ð new

(c) Ö except for hair colouring products referred to in paragraph 2, colorants Õ 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 Ö and colorants which are not used in accordance with the conditions laid down in that Annex Õ ;

(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;

ð (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. ï

ê 82/368/EEC (adapted)

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

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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.

ê 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;

ê 83/574/EEC (adapted)

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

Ö (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. Õ

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

ò new

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).

ê 2003/15/EC Art. 1.2 (adapted)

ð new

Article 4b12 Ö Substances classified as carcinogenic, mutagenic or toxic for reproduction Õ

( 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). Ö However, a Õ A substance classified in category 3 may be used in Ö cosmetic products Õ cosmetics if the substance has been evaluated by the Ö SCCP Õ SCCNFP and found acceptable ð safe ï for use in cosmetic products. Ö To these ends the Commission shall adopt the necessary measures in accordance with the procedure referred to in Article 27(3) Õ .

ò new

(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.

ê 82/368/EEC (adapted)

Ö Article 13 Traces Õ

2. Ö Without prejudice to Article 3, Õ Tthe presence of traces of the Ö prohibited Õ 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.

ê 2003/15/EC Art. 1.2 (adapted)

ð new

Ö Chapter V Animal testing Õ

Article 4a 14 Ö Animal testing Õ

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

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

(d) the performance Ö within the Community Õ on their territory of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this Ö Regulation Õ 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 Ö Regulation Õ 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.

60. The Commission, after consultation of the SCCNFP Ö SCCP Õ 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 Ö has established Õ 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 Ö were Õ made available to the public Ö on 1st October 2004 Õ not later than 11 September 2004 and be sent to the European Parliament and the Council. The period for implementation shall be limited to Ö 11 March 2009 Õ 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 Ö 11 March 2013 Õ 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 Ö , first subparagraph, Õ may be adapted Ö up to 11 March 2009 Õ within a maximum time limit of six years Ö in relation to Õ as referred to in the first subparagraph paragraph 2 or Ö 11 March 2013 Õ 10 years Ö in relation to Õ 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 Ö SCCP Õ 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.

ð 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). ï

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.

61. For the purposes of this Article Ö and Article 16: Õ

(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.

ê 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.

ê 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

ê 88/667/EEC (adapted)

Ö Chapter VI Consumer information Õ

Article 615 Ö Labelling Õ

ê 93/35/EEC (adapted)

1. Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if theÖ Without prejudice to other provisions in this Article, the Õ container and packaging Ö of cosmetic products shall Õ 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:

ê 88/667/EEC (adapted)

ð new

(a) the name or style and the address or registered office of the manufacturer or the Ö responsible Õ 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.Ö that person Õ. ð If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted; ïMember 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;

ê 2003/15/EC Art. 1.3 (adapted)

ð new

(c) the date of minimum durability ð 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”); ï

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

- ð the symbol given in point 3 of Annex VII to this Regulation ï Ö or Õ 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 Ö of minimum durability Õ 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 Ö minimum Õ 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 Ö is safe Õ can be used without any harm to the consumer. This information shall be indicated by the symbol given in Annex VIIIa Ö set out in point 2 of Annex VII to this Regulation Õ followed by the period (in months and/or years);

ê 93/35/EEC (adapted)

(d) particular precautions to be observed in use, Ö and at least Õ 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, Ö and Õ 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;

ê 88/667/EEC (adapted)

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

ê 93/35/EEC (adapted)

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

ê 2003/15/EC Art. 1.4 (adapted)

ð new

(g) a list of ingredients in descending order of weight at the time they are added. Ö This information may be indicated on the packaging alone. The Õ That list shall be preceded by the Ö term Õ 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 Ö terms ‘parfum’ Õ 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.

Ö 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. Õ Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %.

Colouring agents Ö Colorants other than colorants intended to colour the hair Õ may be listed in any order after the other Ö cosmetic Õ 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 Ö colorants other than colorants intended to colour the hair Õ 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.

ê 93/35/EEC (adapted)

Ö 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: Õ

- Ö The information shall be mentioned on an enclosed or attached leaflet, label, tape, tag or card; Õ

- Ö 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. Õ

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 Ö where it is impossible for practical reasons Õ impracticable, for reasons of size or shape, for the particulars referred to in Ö point (g) of Õ 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.

Ö 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. Õ

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

Ö 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. Õ

ê 88/667/EEC (adapted)

è1 2003/15/EC Art. 1.5

Ö Article 16 Product claims Õ

3.1. Member States shall take all measures necessary to ensure that, iIn the labelling, putting up for sale Ö making available on the market Õ and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs Ö shall Õ are not Ö be Õ used to imply that these products have characteristics which they do not have. è1 --- ç

ò new

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 .

ê 2003/15/EC Art. 1.5 (adapted)

2. Furthermore, the manufacturer or The Ö responsible Õ person responsible for placing the product on the Community market may Ö refer Õ take advantage, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the Ö cosmetic Õ product, Ö to Õ 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 Ö cosmetic Õ 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.

ê 2003/15/EC Art. 1.7 (adapted)

Ö Article 17 Access to information for the public Õ

Without prejudice to the protection, in particular, of commercial secrecy and of intellectual property rights, Member States Ö the responsible person Õ shall ensure that the Ö 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 Õ information required under (a) and (f) shall be made Ö publicly Õ easily accessible to the public by any appropriate means, including electronic means.

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

ò new

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.

ê 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.

ê 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.

ê 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.

ò new

Article 2 2 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.

ê 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.

ò new

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.

ê 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.

ê 93/35/EEC (new)

è1 2003/15/EC Art. 1.8

2. The common nomenclature of ingredients used in cosmetic products and, after consultati