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Report on the APPROXIMATION of the Draft Law on Cosmetic Products

with the relevant EU Legislation

- Chisinau May 2008

A project implemented by European Profiles

 Complementary Measures Supporting the Implementation of the EU - Moldova Action Plan in the Framework of the PCA"

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I. Legal framework of the Republic of Moldova regarding the cosmetic products 1. In the Republic of Moldova the legal act regulating the cosmetic products is the Rules and Sanitary and Epidemiological Norms concerning the labelling of the cosmetic products, that has been elaborated and adopted by the Ministry of Health on 22 December 2004. The Rules establishes the following provisions related to:

- Safety conditions of the cosmetic products commercialised to consumers; - Labelling condition of cosmetic and perfumes’ products; - List of cosmetic products; - Toxicological indexes of inoffensive of cosmetic and perfume products; - Microbiological indexes of inoffensive of cosmetic and perfume products; - Clinical and laboratory indexes of inoffensive of cosmetic and perfume

products; - And other indexes.

The draft law on cosmetic products has been elaborated by the Working Group of the Ministry of Health, namely by the officials of the National Scientific Centre for Preventive Medicine. The main objective of the draft law is to regulate the free circulation of cosmetic products on the Moldovan market, as well as to ensure the safety of cosmetic products placed on it. The draft law establishes the legal framework for the production and marketing of cosmetic products. Furthermore, it regulates the basic conditions for circulation of cosmetic products, including the assurance of their safety for the purpose of safeguarding human health, protecting consumer interests and the environment, and promoting fair practices in trade with cosmetic products. The centralized public authorities responsible for the application of the law will be the Ministry of Health and the Ministry of Economy and Trade of the Republic of Moldova. The draft law has been submitted for consideration to the relevant ministries. While drafting the law, the drafters has worked with the consolidated version of the EU Directive of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, with all its amendments and other regulations in this field. The Working Group has also studied the legislation of Romania related to cosmetic products. 2. Law on general safety of products, No 422-XVI of 22 December 2006, establishes the general legal framework for ensuring safety of the products placed on the market of the Republic of Moldova and is applicable to all products specified as such. The Law establishes the notions of safe product and harmful product, provides the responsibility of manufacturers and distributors as to ensuring the general safety of products. The Law determines the situations in which the products should be revoked or recalled.

Удалено: d

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II. Provisions of the EU – Moldova Action Plan (ENP AP) There are no direct provisions in the EU – Republic of Moldova Action Plan, but there are some indirect priority regarding the market surveillance in paragraph (28) as mentioned below: (28) Move toward EU and international legislative and administrative practices for standards, technical regulations and conformity assessment Reinforce institutional capacity of market surveillance. Revise the institutional arrangements in this area to avoid the concentration of functions within a single institution; Approximate legislation on liability for defective products and general product safety; Simplify procedures to avoid compulsory certification of non-risk products and multiple testing of products; Develop market surveillance capacities based on best practice of EU Member States. a) The specific law that is being discussed in this report Safety of products is a key aspect in EU legislation concerning consumer protection. The main instrument regarding safety of product is the General Product Safety Directive (Directive 2001/95/EC) and this Directive is complementary to specific safety legislation, that is, it applies to consumer products also covered other sectors Directives, e.g. toys etc. In the case of cosmetics, the EU Cosmetics Directive (76/768/EEC) regulates safety aspects of cosmetic products, but also facilitates trade between Member States, by eliminating trade barriers. The drafting of the Law on cosmetic products was conceived necessary in order to promote legal harmonisation of Moldovan legislation with the relevant EU rules, which will have a direct effect on trade relationships between them. In accordance with the Moldovan National Plan of Legal Harmonisation, the draft law, which was elaborated by the Ministry of Health, should be harmonised with the EU Cosmetic Products Directives. III. Approximation process General principles The selection of the appropriate Acquis was undertaken according to the following principles: 1. The organisation and hierarchy of legislation at the EU level 2. The appropriate degree of approximation 3. Specific requirements of the ENP AP

Удалено: law which

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a). The organisation and hierarchy of legislation at the EU level. In the area of cosmetic products Directive 76/768/EEC is the main regulatory framework for a finished cosmetic product as defined therein when placed on the Community market. The Directive 76/768 has been amended by the European legislators seven times in order to reflect new trends and challenges concerning cosmetic products. Apart from the so called amendments, the European Commission has adopted more than thirty “adaptations” in order to adapt to technical process the provisions in the annexes to the Cosmetics Directive to technical progress. In order to provide guidance to Member state authorities, industry, and other stakeholders on the interpretation of various provisions of the cosmetics directive, a number of guidance documents, for example on border-line products, have been adopted. Moreover, the Cosmetics Directive has been the subject to a number of European Court of Justice rulings on the interpretation of the Directive.1 There are also other legislative instruments such as the Council Directive 76/760/EEC relating to restrictions on the marketing and use of certain dangerous substances and preparations, Directive 94/62/EC on packaging and packaging waste, Directives 75/324/EEC and 75/324/EEC relating to aerosol dispensers, Directive 80/232/EEC concerning the ranges of nominal quantities and nominal capacities permitted for certain pre-packaged products, Directive 76/211/EEC concerning metrological requirements and Directive 95/17/EC laying down rules for the application of the Directive 76/768/EEC as regards the non-inclusion of one or more ingredients on the list used for labelling of cosmetic products. These Directives are not specifically referring to cosmetics with the exception of Directive 95/17/EC. All the aforementioned EU legislation is taken into account, but our interest is focussed principally at Directive 76/768/EEC, because of its central importance in the specific area. b). The appropriate degree of approximation The Directive includes very specific provisions, which have to be implemented almost verbatim into national law, in most cases. Particularly as regards the Annexes of the Directive, these have to be included in the law on cosmetic products as they are, since the Directive is an old approach Directive, which does not define essential requirements that cosmetic products have to fulfil, but contain detailed lists of substances, which are allowed, restricted or prohibited. Certainly, organisational issues regarding the surveillance activities have to be implemented by Member States in their own discretion, however, the Directive is still binding on the result expected, i.e., the obligation to maintain an effective market surveillance system for cosmetic products and maintain a system of in-market control for such products.

1 So, e.g., cases C-112/89, C-60/89, C-219/91, C-150/88,C-315/92, C-77/97, C-257/06, C-246/91,C-99/01, C-212/91.

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c). Listing and brief description of the EU Cosmetic Products Directive During the review of the Draft law on cosmetic products, the Expert in cooperation with the representatives of the Centre for Legal Approximation and under the leadership of the Ministry of Health analysed and took into consideration the following EU Directive: Council Directive 76/768/EEC on the approximation of the laws of the Member States relating to cosmetic products; The Directive aims at ensuring that only cosmetic products which conform to the provisions of the Directive and its Annexes are placed on the market and that the marketing of such products may not be refused, prohibited or restricted for reasons related to the requirements laid down in this Directive and its Annexes. Under the Directive, a cosmetic product is any substance or preparation 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. An illustrative list of cosmetic products is provided in Annex I of the Directive. Such products must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use. The objectives of the Directive are both to protect human health by establishing harmonized provisions for the placing on the market of cosmetic products and to ensure the proper functioning of the internal market by harmonising the national rules applying to the composition, labelling and packaging of cosmetic products. The Directive is complemented by the General Product Safety Directive (2001/95), which applies to cosmetics for risks not covered by the Cosmetics Directive. In particular, the Directive establishes which substances cannot be included in the composition of cosmetic products (Annex II) and also, which substances cosmetic products may contain under the conditions provided in Annex III , including a list of colouring agents (Annex IV), preservatives (Annex VI) and UV filters (Annex VII). A Member State may, however, authorize the use within its territory of other substances not contained in the lists of substances allowed subject to conditions, such as that the authorisation is limited to a period of three years, an official check will be carried out and the manufactured products bear a distinctive indication. Furthermore, it establishes a prohibition on animal testing by imposing bans on: i) testing of cosmetic products and ingredients on animals and ii) marketing of cosmetic products and ingredients, which have been tested on animals. The testing ban on finished cosmetic products has applied since 2004 and the ban on ingredients will apply progressively as alternative methods are introduced, while the deadline is 11 March 2009. The prohibition of marketing applies also progressively with the deadline being 11 March 2009, whereas for specific risks the deadline is 11 March 2013.

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Under Article 5a of the Directive, an inventory of ingredients employed in cosmetic products was complied, which contains the names of all relevant cosmetic ingredients. It contains information about the identity of each ingredient, its functions and where appropriate, restrictions and conditions of use and warnings. As far as labelling is concerned, container and packaging must bear the following information in indelible , easily legible and visible lettering:

the name or style and the address or registered office of the manufacturer or the person responsible for marketing the cosmetic product within the Community;

the nominal content at the time of packaging, given by weight or by volume; the date of minimum durability shall be indicated by the words: ‘best used

before the end of'; particular precautions for use; the batch number of manufacture or the reference for identifying the goods; the function of the product; a list of ingredients in descending order of weight.

EU Member States may require that some information related to labelling be expressed in their national language The Directive establishes a system of in-market control, excluding pre-market control. It provides for the obligation of the 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, to keep for control purposes certain product and safety information at the disposal of the competent monitoring authorities of the Member State.2 Furthermore, Member States must take all necessary measures to ensure that only cosmetic products are put on the market which comply with the Directive.3 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, must 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. A safeguard clause is also included in the Directive, which provides that 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 2 In Greece, for example, the authority responsible for market surveillance is the National Organization for Medicines, which is public body established under the umbrella of the Ministry of Health, see: http://www.eof.gr/eof_en/enhome.html 3 In Greece, the aforementioned organisation is the one which assumes the responsibility to ensure that cosmetic products which are put on the Greek market are in compliance with the rules transposing the EU Cosmetics Directive, i.e. Ministerial decision Nr. DYG3a/GP.132979 of 7 March 2005, Government Gazette Nr. B/352 of 18 March 2005.

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subject it to special conditions, and should immediately inform the other Member States and the Commission thereof, stating the grounds for its decision. However, for any individual measures placing a restriction or ban on the marketing of cosmetic products precise reasons shall be stated and a notification should be given to the party concerned together with particulars of the remedies available to him . The Commission announced the simplification of the Directive in the Commission Communication “Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment” and in the Commission’s Annual Policy Strategy for 2007, with a view at simplifying the legal framework for economic activities in the EU. The simplification procedure has progressed after a public consultation that took place between 12 January 2007 and 16 March 2007, and an impact assessment report published on 5 February 2008, the Commission submitted a Proposal for a Cosmetics Regulation. The objectives, in particular, followed by the Commission in this proposal are to remove legal uncertainties and inconsistencies, avoid divergences in national transposition which do not contribute to product safety but instead add to the regulatory burden and administrative costs and ensure that cosmetic products placed on the EU market are safe in the light of innovation in this sector. The Draft Cosmetics Regulation 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. It 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 comply with the principle of subsidiary as established in Article 5 of the EC Treaty. The most essential of the amendments being proposed are the following:

Introduction of a set of definitions A glossary of ingredient names is set up The requirements for safety assessment are laid down In-market control is strengthened A differentiated regime for CMR substances is introduced The obligation of the responsible person is established to keep the safety

report updated The role of harmonised standards is clarified etc.

It should be stressed out that the EU Cosmetics Directive is the main regulatory instrument in the specific area which it relates to, whereas also the Directive on General Product Safety (2001/95/EC) may apply in cases not covered by the first Directive. In other words, the General Product Safety Directive is complementary to the EU Cosmetics Directive. In more particular, both Directives establish a safety obligation, but the General Product Safety Directive is more global in scope and applies for risks not covered by the EU Cosmetics Directive. The provisions of the former Directive on information to consumer for risks and on identification of product and producer do not apply, but the information requirement from producers to the competent authorities for dangerous products applies, as well as the obligation of the producer to follow up safety of cosmetic products, in case certain aspects are not

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covered by the latter. The provisions of the General Product Safety Directive relating to co-operation with the competent authorities are applicable when specific aspects are not covered by the Cosmetics Directive. And also, its provisions dealing with distributors' obligations, since these are not covered by the Cosmetics Directive. Furthermore, regarding Member States' obligations and powers with regard to enforcement of the safety requirement, the provisions of the General Product Safety Directive are more precise in many aspects, as it refers explicitly to market surveillance and the attribution of powers to competent authorities. And as far as the procedures for exchange of information in emergency situations is concerned via the RAPEX system and for intervention, the aforementioned Directive applies. IV) Key gaps and contradictions of the draft law with the EU legislation The new draft law shows a high degree of convergence with the EU Directive and implements most provisions of it, but still maintains the traditional approach towards market surveillance, as it provides for pre-market approval of cosmetic products and for mandatory hygienic certificates, which cosmetic products should have. Generally speaking, the system of market surveillance should be reorganised and reinforced to be able to face the risks that arise in global markets. It is notable that the new Draft Regulation on Cosmetics introduces a new concept for producer responsibility, in which in-market surveillance plays an important role. Moreover, the regulation of safety assessment is in line with the provisions of the EU Cosmetics Directive and the only divergence concerns animal testing. Namely, the provisions of the Directive imposing a ban on such testing and providing for alternative methods regarding the testing of cosmetic products are not fully implemented in the draft law, although it is implied in the draft law that only alternative testing methods are permitted, as it is deduced from the reference to Annex IX. One final comment is that the implementation of the provisions of the EU Cosmetics Directive does not take place in a systematic way, as the provisions of its Articles are not transposed in a straight-forward manner. V) Specific Rationale for Approximation and Recommendations The new law on cosmetic products would certainly contribute to ensuring safety of products and to protecting public health. It aims at establishing the legal framework for the production and marketing of cosmetic products. This law is included in the Moldovan National Plan of Legal Harmonization and therefore its adoption is of priority. Its adoption will establish harmonised rules with those of the EU. VI. Recommendations

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It is recommended to proceed to the following amendments of the draft law: − to change the system of pre-market controls and rescind the approval of

cosmetic products prior to their placement of the market and the need to have a hygienic certificate. Instead the manufacture or import of cosmetics has to be notified to the competent authorities;

− furthermore, in-market control should be strengthened; it should be provided that market surveillance authorities have to take all appropriate measures to check for compliance of cosmetics such as taking samples for analysis and laboratory checking in relation to the qualitative and quantitative composition of the products and in relation to safety assessment;

− to provide for the principal of proportionality as regards the imposition of penalties to manufacturers and/or importers of cosmetic products in case of non-compliance with the provisions of the law;

− to transpose the Directive provisions concerning animal testing restrictions; − to repeal any secondary regulation regulating cosmetics, since these could

contravene with the provisions of the Directive, which are transposed in the law; − concerning the rules on labelling and packaging to take also into account the ISO

rules which are to be adopted, as it is pointed out in the Terms of Reference of this project (see, e.g., http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=36436);

− to transpose Art. 4 (2) of the Directive ; − to transpose Art 4b of the Directive; and − to abolish the Annexes X to XIV and the references to them VII. Annex Table of correspondence

TABLE OF CORRESPONDENCE

1. The title of the community act, subject and the field regulated by the act Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products, as amen 2. The title of the national normative act, subject and the field regulated by the act Draft Law on Cosmetic Products 3. The level of compliance Partially Compliant

4. Provisions and requirements of community regulations (article, paragraph)

5. Provisions of the national normative act (chapter, article, sub-paragraph)

6. Level of compatibility between the national a and EU provisions (totally compatible, partially compatible, not compatible, national legislative gap)

7. Reasons that explain that the national law is partially compliant or not compliant

8. Responsible institution

9. Timuntil compamust b

Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products

Draft Law on Cosmetic Products

Art.1: 1. A ‘cosmetic product’ shall mean any substance or preparation intended to be placed in contact with the

Art.3: A cosmetic product intended for human use shall mean any substance or preparation

Compatible

The definition of cosmetic products in the Draft law is similar with the one in 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.

intended to be placed in contact with the various external parts of the human body (epidermis, eyes, nails, lips, external genital organs, head and body hair system, etc.) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly of cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition; - A 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 date of minimum durability shall mean the manufacturer-established date prior to which this product, provided storage under adequate conditions, continues to fulfill its initial function and to comply with the requirements of Article 5. - cosmetic coloring agents (colorants) shall mean the substances which are added to the cosmetic products with a view to color the product and/or a certain part of human body; - preservatives shall mean the substances which are added to the cosmetic products primarily with a view to inhibit the development of microorganisms in such products; - UV filters shall mean the substances which are added to the cosmetic products to filter certain ultra-violet radiation with a view to protect the skin from undesired effects caused by such radiation; - Batch (lot) shall mean a definite quantity of raw material, packaging material or finished product manufactured in hygienic conditions in a process or a set of processes in a way which allows to consider

Directive. The draft law also includes other important definitions. The following definitions from the Draft Cosmetic Products regulation could also be adopted, some of which are not included in the draft law and some are differently defined: (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; (....) (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

it homogenous; - finished cosmetic product shall mean the cosmetic product in its final formulation, as placed on the market and made available to the final consumer, or its prototype; - prototype shall mean a first model or design of the cosmetic product, that has not been produced in batches, and from which the finished cosmetic product is copied or finally developed; - safety of cosmetic products shall mean the reasonable and substantiated assurance that, when applied under normal conditions of use, the cosmetic products do not cause damage and present no threat for the health of the current generation as well as future generations; - circulation of cosmetic products shall mean the elaboration (development), manufacture, procession, pre-packing, packing, labeling, storage, transportation and distribution (including imports and exports) of the cosmetic products and other methods of their transfer; - placement on the market shall mean actions with a view to make the cosmetic products available at the market of Moldova, including their storage for the purposes of their distribution, offer via sale or any other method of their transfer against or with no payment.

regulations and of rules on information society services24 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.

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

Art. 1 (2) This law shall apply to the categories of cosmetic products listed in Annex 1. (3) This law shall apply only to cosmetic products and not to pharmaceutical products or medicines. For this purpose, the scope of this Law shall be defined by delimiting the field of cosmetics from that of medicines. Such delimitation shall follow in particular from the detailed definition of the cosmetic products covered by this law, which refers both to their areas of application and to the purposes of their use. The provisions hereof shall not apply to the products that fall under the definition of cosmetic product but are exclusively intended to protect from disease.

Compatible

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.

Art 1 (4) Cosmetic products containing one of the substances listed in Annex V shall be excluded from the scope of this Law.

Compatible

it is notable that this provision is removed from the Draft Regulation. In the draft there is a new provision stating that: '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.'

Art. 2 Art. 4(1) Compatible It is recommended to draft the

A cosmetic product put on the market within the Community must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use, taking account, in particular, of the product's presentation, its labelling, any instructions for its use and disposal 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.

Cosmetic products placed on the market may not present threat to human health and consumers, provided the conditions of their use (labeling, marking, information regarding their preservation, storage, use and disposal) as well as any other indications given by the manufacturer are observed throughout the total durability period. Art. 1 (6) The centralized public authorities responsible for the application of the laws harmonized with the requirements of the EC Directives shall be: the Ministry of Health and the Ministry of Economy and Commerce.

regulation closely to the wording of the Directive.

Art.4 (2) (previous version) The safety of cosmetic products shall be ensured with a set of requirements, including the requirements provided in the annexes which form an integral part hereof. The requirements refer to:

- Product composition; - Microbiological contaminations; - Physical and chemical properties; - Toxicological profile; - Clinical aspects; - Information for consumers and

controlling authorities (marking and labeling requirements);

- Production process for the manufacture of the product;

- Storage conditions.

Compatible Nevertheless, this regulation is not necessary.

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

Art. 4 (3) The provision of such warnings shall not, in any event, exempt any person from compliance with the other requirements laid down in this law.

Compatible

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

Art. 5 (1) The cosmetic products intended for human consumption must satisfy the requirements regarding their purported use, be safe, contain no contaminants, microorganisms or other biological organisms and substances, be manufactured and placed on the market in the adequate hygienic conditions, in conformity with the regulations in the field of cosmetics. (2) As introduction of amendments is possible to the lists in annexes II-VII in view of the findings of scientific research and technical progress, EC Directives and Decisions of special committees, the Ministry of Health shall suggest the respective amendments to this Law. (5) The requirements regarding the quality and safety of cosmetic products shall be laid down in technical regulations, sanitary and epidemiological rules and norms applicable to this chapter, which are developed by the authorities responsible for the respective sphere and duly approved by the Government. (6) The development or adoption of the regulations regarding marketing and distribution of cosmetic products shall be performed with account of the applicable international norms and guidelines which have been enacted or substantially enacted, including in the European Community.

Compatible

It is recommended again to draft the regulation closely to the wording of the Directive.

Art. 5

(7) The manufacture and marketing of cosmetic products shall not be allowed where: a) They are not in compliance with the requirements of the applicable regulations in the field of cosmetics; b) They are dangerous and can present a threat to human life and health or the environment under normal conditions of their use by consumers, with account of the provided information; c) They are not fit for human consumption, because they are contaminated and/or impure, with signs of alteration; d) They are falsified; e) The required information is lacking on the label – contrary to the applicable regulations in the field of cosmetic products; f) The period of durability is not defined or has expired, or has been changed, or differs from the one indicated by the manufacturer; g) They have no hygienic certificates. (8) The cosmetic products specified in Par. 6 shall be considered not complying to the applicable regulations in the field of cosmetic products, dangerous and not allowed for marketing; they must be destroyed in an environmentally safe way and according to the rules established by the Government. Art. 6 (1) The manufacture and marketing of the

Partially compatible

The restriction of manufacture and marketing of cosmetics for the reason that they don't have a hygienic certificate is not complying with the Directive, which provides only for intra-market controls and precludes any pre-market control procedures or other procedure imposing administrative burdens. Furthermore, the corrective measures taken by surveillance authorities must be in conformity with the principle of proportionality. Destroying cosmetic products must be decided in extreme cases.

cosmetic products shall be performed on premises and in the environment, which are in compliance with the applicable sanitary rules and norms and according to the terms and conditions of the sanitary authorizations permitting the operation of the respective entities. (2) The manufacture of the cosmetic products shall be organized in a way that ensures the safety of the production processes for the environment and the health of employees. (3) The manufacturer, the authorized representative of the manufacturer or any other party responsible for the marketing of cosmetic products shall take adequate measures to eliminate the risk of their contamination and alteration to products dangerous for humans.

Art.7 (4) Prior to placement on the market, new types of cosmetic products – whether manufactured domestically or imported - must be checked for safety and approved in due course. In addition the imported cosmetic products must have a hygienic certificate issued prior to their entry in Moldova. (5) The approval must be issued by the national sanitary epidemiological control authority; its goal is to verify the safety of the cosmetic products for human health and to determine their appropriateness for human consumption.

Not compatible The Directive establishes an in-market and not a pre-marketing control as the draft law does with the requirement for approval and certificates. Furthermore, mandatory certificates are incompatible with EU Law, as they are regarded as not-tariff trade barriers. A system of in-market should to adopted. It is recommended to provide for the obligation of manufacturers and importers of cosmetic products to notify the surveillance authorities about their products every year, so that it could be possible for the authorities to organise controls.

Art. 7 (6) The durability term shall be established by the manufacturer and at the manufacturer’s sole responsibility or in collaboration with a research institute, based

Partially compatible

These provisions of the draft seem to impose pre-market control, which is not consistent with the system of the Directive.

on findings of the performed tests, and it must be approved by the national sanitary epidemiological control authority. (7) The quality and safety characteristics of new types of cosmetic products, the requirements for their packaging and labeling, their manufacturing and distribution conditions, production safety assurance programs, and test methods applied to such products must be included in the applicable regulations in the field of cosmetic products. (8) Draft regulations and product compositions must undergo expert sanitary epidemiological examination. Experimental samples of new types of cosmetic products shall be subject to toxicological, sanitary-hygienic, and microbiological tests, as the case may be.

Art. 7 (9) (9) The applicable regulations in the field of cosmetic products shall lay down, as the case may be:

a) Minimum quality requirements for the identification of the cosmetic product;

b) Safety requirements; c) Specific intended use of the

cosmetic product; d) Organization of the production and

marketing process; e) State control and supervision over

the market circulation of cosmetic products;

f) Conformity assessment procedures, including sampling and risk assessment;

g) Packaging and labeling requirements.

Compatible The exact meaning of this provision is not clear. It is not therefore necessary and can be abolished.

Art. 4: 1. Without prejudice to their general obligations deriving from Article 2, Member States shall prohibit

Art. 5 (3) It shall be prohibited to market the cosmetic products containing:

Compatible

the marketing of cosmetic products containing: (a) substances listed in Annex II; (b) substances listed in the first part of Annex III, beyond the limits and outside the conditions laid down; (c) 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; (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; (e) preservatives other than those listed in Annex VI, Part 1; (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; (g) UV filters other than those listed in Part 1 of Annex VII; (h) UV filters listed in Part 1 of Annex VII, beyond the limits and outside the conditions laid down therein.

a) substances listed in Annex II; b) substances listed in Annex III, Part 1, beyond the limits and outside the conditions laid down; c) coloring agents other than those listed in Annex IV Part 1, with the exception of cosmetic products coloring agents intended solely to color hair; d) coloring agents listed in Annex IV Part 1, used outside the conditions laid down, with the exception of cosmetic products coloring agents intended solely to color hair; e) 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; f) preservatives other than those listed in Annex VI Part 1; g) UV filters listed in Annex VII, Part 1, beyond the limits and outside the conditions laid down therein; h) UV filters other than those listed in Annex VII, Part 1.

2. The presence of traces of the 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.

National legislative gap

Art.4a: 1. Without prejudice to the general obligations deriving from Article 2, Member States shall prohibit: (a) the marketing of cosmetic products where the final formulation, in order to meet the requirements of this 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 marketing of cosmetic products containing ingredients or combinations of ingredients which, in order to meet the requirements of this Directive, have

Art. 7 (10) The Ministry of Health shall approve only such testing methods and the criteria of purity in respect of the cosmetic products, which are specified in Annexes IX- XIV. Art.9 (4) The manufacturer or the person responsible for placing the product on the market may take advantage, on the product packaging or in any document, notice, label,

Partially compatible

This provision of the Directive establishing a ban on animal testing was not implemented. Nevertheless, Art. 7 (10) of the draft law implies that only alternative methods are acceptable and paragraphs 4 and 11 of the same provision provide for information concerning animal testing. It has to be clearly established in the law that animal testing is not permitted.

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 on their territory of animal testing of finished cosmetic products in order to meet the requirements of this Directive; (d) the performance on their territory of animal testing of ingredients or combinations of ingredients in order to meet the requirements of this 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 (1)or in Annex IX to this Directive. No later than 11 September 2004 the Commission shall, in accordance with the procedure referred to in Article 10(2) and after consultation of the Scientific Committee on Cosmetic Products and Non-Food Products intended for consumers (SCCNFP) establish the contents of Annex IX. (2.4) 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 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. 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

ring or collar accompanying or referring to the product, 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 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. Art. 7 (11) The manufacturer or his agent or the person to whose order the cosmetic product is manufactured or person responsible for placing of an imported cosmetic product on the market shall for control purposes keep the following information readily accessible at the address specified on the label: (...) i) Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of countries which are not EU member countries.

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 9. 3. For the purposes of this Article: (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. Art. 4b: The use in cosmetic products of substances classified as carcinogenic, mutagenic or toxic for reproduction, of category 1, 2 and 3, 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). 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.

National legislative gap

This provision was also not taken into account by the draft law.

Art. 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,

Art. 5 (9): It shall be allowed to place on the market the 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 coloring agents listed in Annex IV, Part 1, 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

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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.

2, within the limits and under the conditions laid down, until the admission 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 product presentation; (d) the UV filters listed in Annex VII Part 2, within the limits and under the conditions laid down, until the admission dates given in column (f) of that Annex. At these dates given in the Annex, these substances, coloring agents, preservatives and UV filters shall be: (a) definitively allowed; or; (b) definitively prohibited (Annex II); or (c) maintained for a given period specified in Annexes III, IV, VI and VII; or (d) deleted from all the annexes to this law.

Art. 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 information 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

Art. 5 (10) The Ministry of Health shall review and edit the inventory of ingredients employed in cosmetic products, on the basis in particular of the information supplied by the industry of cosmetic products; such inventory shall be divided into of two sections: one concerning perfume and aromatic raw materials and the second concerning other substances. The inventory shall contain information on:

• The identity of each ingredient, in particular its chemical name, the CTFA name, the European Pharmacopoeia name, the international non-proprietary name (INN) recommended by the World Health Organization, the Einecs, Iupac, CAS and other Color Index numbers, as well as the common name referred to in Article 9 (XX);

• The usual function(s) of the

Compatible It is recommended to provide for a reference to the inventory drafted by the EU, which was published Official Journal of EC (L 132/1.6.1996).

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.

ingredient in the final product; • Where appropriate, restrictions and

conditions of use and warnings which must be printed on the label in conformity with the Annexes.

The inventory shall be indicative and shall not constitute a list of the substances authorized for use in the cosmetic products. (10) The general names of the ingredients used in cosmetic products and – upon consultation with the Scientific Committee for cosmetic products – the modifications with a view to adapt and update the annexes with consideration of the technical progress shall be adopted respectively in conformity with that procedure.

Art.6: 1. Member States shall take all measures necessary to ensure that cosmetic products may be marketed only if the container and packaging 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: (a) the name or style and the address or registered office of the manufacturer or the 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. Member States may require that the country of origin be specified for goods manufactured outside the Community; b) the nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than five grams or five millilitres, free samples and single-application packs; for pre-packages normally sold as a number of items, for which details of weight or volume are not significant, the content need not be given provided the

Art. 9(1)

The cosmetic products must be marketed only if the container and/or the packaging bear the following information in indelible, easily legible and visible lettering:

a) The name of the manufacturer, its agent or any other party responsible for the marketing of the product and the address or location. Such information may be abbreviated in so far as the abbreviation makes it possible to identify the undertaking;

b) The country of origin (for imported products), using its UN-accepted name. It must be indicated on local products: Made in Moldova (“Fabricat in Moldova”);

c) The nominal content at the time of packaging, given by weight or by volume, except in the case of packaging containing less than 5 grams or 5 milliliters, free samples

Compatible The Draft Regulation proposes the following amendment in paragraph 1, which could be taken into acount: 1. Without prejudice to other provisions in this Article, the container and packaging of cosmetic products shall bear the following information in indelible, easily legible and visible lettering: a) the name or style and the address of the responsible person. Such information may be abbreviated in so far as the abbreviation makes it possible to identify that person. If several addresses are indicated, the one where the responsible person makes readily available the product information file shall be highlighted; b) the nominal content at the time

number of items appears on the packaging. This information need not be given if the number of items is easy to see from the outside or if the product is normally only sold individually; (c) the date of minimum durability shall be 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 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 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 can be used without any harm to the consumer. This information shall be indicated by the symbol given in Annex VIIIa followed by the period (in months and/or years); (d) particular precautions to be observed in use, especially those listed in the column ‘Conditions of use and warnings which must be printed on the label’ in Annexes III, IV, VI and VII, which must appear on the container and packaging, 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; (e) the batch number of manufacture or the reference for identifying the goods. Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging; (f) the function of the product, unless it is clear from the presentation of the product;

and single application packs for pre-packages normally sold as a number of items, for which the content may not be indicated, 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;

d) Particular precautions to be observed in use, especially those listed in the column “Conditions of use and warnings which must be printed on the label” in Annexes III, IV, VI and VII, which must appear on the container and packaging, 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;

e) The date of minimum durability indicated with the words “Best used before the end of” followed by either the date itself or details of where it appears on the packaging. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability. The date shall be clearly expressed and shall consist of the month and year in that order.

of packaging, given by weight or by volume, except in the case of packaging containing less than five grams or five millilitres, free samples and single-application packs; for pre-packages normally sold as a number of items, for which details of weight or volume are not significant, the content need not be given provided the number of items appears on the packaging. This information need not be given if the number of items is easy to see from the outside or if the product is normally only sold individually; c) the date until which the cosmetic product, stored under appropriate conditions, continues to fulfil its initial function and, in particular, remains in conformity with Article 3 (hereinafter: “date of minimum durability”); The date itself or details of where it appears on the packaging shall be preceded by the symbol given in point 3 of Annex VII to this Regulation the words: 'best used before the end of' The date of of minimum durability shall be clearly expressed and shall consist of either the month and year or the day, month and year, in that order. If necessary, this information shall be supplemented by an indication of the conditions which must be satisfied to guarantee the stated durability.

(g) a list of ingredients in descending order of weight at the time they are added. That list shall be preceded by the 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: — impurities in the raw materials used, — subsidiary technical materials used in the preparation but not present in the final product, — 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 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. Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %. Colouring agents may be listed in any order after the other 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 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

Indication of the date of 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 can be used without any harm to the consumer. This information shall be indicated by the symbol given in Annex VIII(a) followed by the period (in months and/or years);

f) The name under which the cosmetic product is marketed, where applicable – together with indication of the product category and function, unless it is clear from the presentation of the product;

g) A list of ingredients in descending order of weight at the time they are added. That list shall be preceded by the 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:

• impurities in the raw materials

Indication of the date of minimum durability shall not be mandatory for cosmetic products with a minimum durability of more than 30 months. For such products, there shall be an indication of the period of time after opening for which the product is safe. This information shall be indicated by the symbol given in Annex VIIIa set out in point 2 of Annex VII to this Regulation followed by the period (in months and/or years); d) particular precautions to be observed in use, and at least those listed in Annexes III to VI and any special precautionary information on cosmetic products for professional use. e) the batch number of manufacture or the reference for identifying the cosmetic product. Where this is impossible for practical reasons because the cosmetic products are too small, such information need appear only on the packaging; f) the function of the cosmetic product, unless it is clear from its presentation. g) a list of ingredients. This information may be indicated on the packaging alone. The list shall be preceded by the term ‘ingredients’. The following shall not, however, be regarded as ingredients: (i) - impurities in the raw materials used, (ii) - subsidiary technical

for the labelling of cosmetic products (1) under which a manufacturer may, for reasons of trade secrecy, apply not to include one or more ingredients on the above mentioned list. 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. In the case of soap, bath balls and other small products where it is impracticable, for reasons of size or shape, for the particulars referred to in 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. 2. 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. 3. Member States shall take all measures necessary to ensure that, in the labelling, putting up for sale and advertising of cosmetic products, text, names, trade marks, pictures and figurative or other signs are not used to imply that these products have characteristics which they do not have. Furthermore, the manufacturer or the person responsible for placing the product on the Community market may take advantage, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the product, 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 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

used; • subsidiary technical materials used

in the preparation but not present in the final product;

• 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 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. Ingredients in concentrations of less than 1% may be listed in any order after those in concentrations of more than 1%. Coloring agents may be listed in any order after the other ingredients, in accordance with the color index number or denomination adopted in Annex IV. For decorative cosmetic products marketed in several color shades, all coloring agents used in the range may be listed, provided that the words “may contain” or the symbol “+/-“ are added.

h) The batch number of the product; i) Instructions for conservation, use

and disposal, including professional

materials used in the preparation but not present in the final product, (iii) - materials used in strictly necessary quantities as solvents or as carriers for perfume and aromatic compositions. Perfume and aromatic compositions and their raw materials shall be referred to by the terms ‘parfum’ or ‘aroma’. However, the presence of substances, the mention of which is required under the column ‘other’ in Annex III, shall be indicated in the list. The list of ingredients shall be established in descending order of weight of the ingredients at the time they are added to the cosmetic product. Ingredients in concentrations of less than 1 % may be listed in any order after those in concentrations of more than 1 %. Colorants other than colorants intended to colour the hair may be listed in any order after the other cosmetic ingredients. For decorative cosmetic products marketed in several colour shades, all colorants other than colorants intended to colour the hair used in the range may be listed, provided that the words ‘may contain’ or the symbol ‘+/-’ are added.

Journal of the European Union. The European Parliament shall receive copies of the draft measures submitted to the Committee.

use cosmetic products.

(2) Where it is impossible for practical reasons to indicate the information required by Par. (1) Letters (d) and (g), due to small size or shape of the container or packaging, such information must appear on a label, leaflet, tape or card enclosed with or attached to the cosmetic product.

In the case of soap, bath balls and other small products where it is impracticable, for reasons of size or shape, for the particulars referred to in 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. (3) The manufacturer, its agent or any other party responsible for the marketing of the product shall ensure that no text, name, registered trademark, picture, logo or any other symbol appears on the label, in promo materials or in the advertisement of the cosmetic product which indicates the presence in it of any characteristics which are actually not there. (4) The manufacturer or the person responsible for placing the product on the market may take advantage, on the product packaging or in any document, notice, label, ring or collar accompanying or referring to the product, 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 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. (5) 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, the Ministry of Health States shall adopt detailed rules for indication of the particulars referred to in paragraph (1).

Art. 7 (1): 1. Member States may not, for reasons related to the requirements laid down in this Directive and the Annexes thereto, refuse, prohibit or restrict the marketing of any cosmetic products which comply with the requirements of this Directive and the Annexes thereto.

Art. 7 (1):

The Ministry of Health may not refuse, prohibit or restrict the marketing of any cosmetic products which are comply with the requirements of this law.

Compatible

Art. 7 (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.

Art. 9 (6):

The particulars referred to in Article 9 must be provided accurately and clearly in Moldavian or both in Moldavian and Russian, excepting the list of ingredients, which must be indicated using their common names from the International Nomenclature of Cosmetic Ingredients (INCI), and coloring

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agents shall be indicated by their numbers in the Color Index published in “Computer print-out 1975, International Non-proprietary Names (INN) for pharmaceutical products, Lists of proposed INN” WHO, Geneva, 1975.

(7) The information appearing on the label in the case of domestic cosmetic products must be coordinated with the State Sanitary Epidemiologic Service and the Standardization and Metrology Service.

(8) The information must be presented clearly and in a way that does not mislead the customer regarding the nature, identity, origin, intended use and characteristics of the cosmetic product.

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.

Art.7 (2) For purposes of prompt and appropriate medical treatment in situations, the Ministry of Health may require that in the event of risk for human health the manufacturer, importer or person responsible for placement on the market make available the appropriate and adequate information on substances used in cosmetic products to the ministry, which shall ensure that this information is used only for the purposes of such treatment.

Compatible

Art. 7(3), para.2 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.

Art. 7 (3) The Ministry of Health shall be the competent national authority ensuring the transfer of the information provided for in Paragraph (2) above to any of the EU Member States upon the respective request, taking the necessary steps to transfer the information solely for the purposes of ensuring proper medical treatment.

Compatible

Art. 7a: 1. The 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

Art. 7 (11) The manufacturer or his agent or the person to whose order the cosmetic product is manufactured or person responsible for placing of an imported cosmetic product on

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purposes keep 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): (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; (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

the market shall for control purposes keep the following information readily accessible at the address specified on the label: a) The qualitative and quantitative composition of the product; in the case of the 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 god manufacturing practice laid down by the law; the person responsible for manufacture or importation must possess an appropriate level of professional qualification or experience in accordance with the applicable legislation on cosmetics; d)The name of the person responsible for manufacture or first importation of the cosmetic product into the European Community; such responsible person must possess an appropriate level of professional qualification or experience in accordance with the applicable legislation; e) Assessment of the risk for human health of the cosmetic 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 de 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 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

shall be easily accessible; (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; (g) proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product; (h) data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of 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 (1). 3. The information referred to in paragraph 1 must be available in the national language or languages of the Member State concerned, or in a language readily understood by the competent authorities.

hygiene. Should the same product be manufactured at several places within Moldova or within the territory of the EU Member States, the manufacturer may choose a single place of manufacture where that information on the product will be available. In this connection, and when so requested by the competent authority 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; f) The name and address of the qualified person or persons responsible for the assessment of the product safety for human health. That person must hold a university diploma in the field of pharmacy, toxicology, dermatology, medicine or a similar discipline; g) Existing data on undesirable effects on human health resulting from use of the cosmetic product; h) Proof of the effect claimed for the cosmetic product, where justified by the nature of the effect or product; i) Data on any animal testing performed by the manufacturer, his agents or suppliers, relating to the development or safety evaluation of the product or its ingredients, including any animal testing performed to meet the legislative or regulatory requirements of countries which are not EU member countries. (12) The information as per Paragraph (11) must be readily accessible in the national language or in a language easily understood by the competent authority.

Art. 7 (1) Compatible

The manufacturer, its agent or any other party responsible for the marketing of the product must provide customers, consumers and state control and supervision authorities with complete, true and accurate information on the cosmetic products and resulting waste, and on the compliance with the applicable regulations in the field of cosmetic products.

Art. 7a (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.

Art.7 (4): Prior to placement on the market, new types of cosmetic products – whether manufactured domestically or imported - must be checked for safety and approved in due course. In addition the imported cosmetic products must have a hygienic certificate issued prior to their entry in Moldova.

Compatible The Directive provides for the notification of competent authorities with the information concerning the place of manufacture or initial importation into the EU Commission. Instead, the draft law provides for a pre-market control.

Art. 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. 2. The common nomenclature of ingredients used in cosmetic products and, after consultation of the Scientific Committee for Cosmetic Products and Non-Food Products intended for Consumers , the

Art. 7 (10) The Ministry of Health shall approve only such testing methods and the criteria of purity in respect of the cosmetic products, which are specified in Annexes IX- XIV:

• 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

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amendments necessary for the adaptation to technical progress of the Annexes shall be adopted in accordance with the same procedure, as appropriate.

compliance with those criteria.

Art. 8a: 1. Notwithstanding Article 4 and without prejudice to Article 8 (2), a Member State may authorize the use within its territory of other substances not contained in the lists of substances allowed, for certain cosmetic products specified in its national authorization, subject to the following conditions: (a) the authorization must be limited to a maximum period of three years; (b) the Member State must carry out an official check on cosmetic products manufactured from the substance or preparation use of which it has authorized; (c) cosmetic products thus manufactured must bear a distinctive indication which will be defined in the authorization. 2. The Member States shall forward to the Commission and to the other Member States the next of any authorization decision taken pursuant to paragraph 1 within two months of the date on which it came into effect. 3. Before expiry of the three-year period provided for in paragraph 1, the Member State may submit to the Commission a request for the inclusion in a list of permitted substances of the substance given national authorization in accordance with paragraph 1. At the same time, it shall supply supporting documents setting out the grounds on which it deems such inclusion justified and shall indicate the uses for which the substance or preparation is intended. Within 18 months of submission of the request, a decision shall be taken on the basis of the latest scientific and technical knowledge, after consultation, at the initiative of the Commission or of a Member State, of the Scientific Committee for Cosmetic Products and Non-Food Products intended for Consumers and in accordance with the procedure laid down in Article 10 as to whether the substance in question may be

Art. 8 (2) Notwithstanding Article 5 (2), the Ministry of Health may authorize the use within the territory of Moldova of other substances not contained in the lists of substances allowed, for certain cosmetic products specified in its national authorization, subject to the following conditions:

a) The authorization must be limited to a maximum period of 3 years;

b) An official check must be carried out on cosmetic products manufactured from the substance or preparation use of which the national authority has authorized;

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

Before expiry of the 3-year period provided for in the above the Ministry of Health may submit to the Commission a request for the inclusion in a list of permitted substances of the substance given national authorization in Moldova. At the same time it shall supply supporting documents setting out the grounds for such inclusion and shall indicate the uses for which the substance or the preparation is intended. Within 18 months of submission of the request, a decision shall be taken on the basis latest scientific and technical knowledge as to whether the substance in question may be included in a list of permitted substances or whether the national authorization shall be revoked (rejected).

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included in a list of permitted substances or whether the national authorization should be revoked. Notwithstanding paragraph 1 (a), the national authorization shall remain in force until a decision is taken on the request for inclusion in the list. Art.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.

Art. 8(4): If it is noted that a cosmetic product, although complying with the requirements of this law, represents a hazard to human health, the Ministry of Health may provisionally prohibit the marketing of that product in Moldova or subject it to special conditions and it shall inform immediately the EU member states, stating the grounds for its decision.

Compatible It is recommended to make the notification using the RAPEX system.

Art.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.

Art.8 (5): Any measures taken according to this law to restrict or prohibit the marketing of cosmetic products must have very serious reasons under it. The reasons shall be notified to the party concerned together with particulars of the remedies available to it under the applicable law

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ANNEX I ILLUSTRATIVE LIST BY CATEGORY OF COSMETIC PRODUCTS

ANNEX I ILLUSTRATIVE LIST BY CATEGORY OF COSMETIC PRODUCTS

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ANNEX II LIST OF SUBSTANCES WHICH MUST NOT FORM PART OF THE COMPOSITION OF COSMETIC PRODUCTS

ANNEX II LIST OF SUBSTANCES WHICH MUST NOT FORM PART OF THE COMPOSITION OF COSMETIC PRODUCTS

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ANNEX III Part 1 - LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJRCT TO THE RESTRICTIONS AND CONDITIONS LAID DOWN Part 2 - LIST OF SUBSTANCES PROVISIONALY ALLOWED

ANNEX III Part 1 - LIST OF SUBSTANCES WHICH COSMETIC PRODUCTS MUST NOT CONTAIN EXCEPT SUBJRCT TO THE RESTRICTIONS AND CONDITIONS LAID DOWN Part 2 - LIST OF SUBSTANCES PROVISIONALY ALLOWED

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ANNEX IV Part 1 - LIST OF COLOURING AGENTS ALLOWED FOR USE IN COSMETIC PRODUCTS Part 2 - LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR USE IN COSMETIC PRODUCTS

ANNEX IV Part 1 - LIST OF COLOURING AGENTS ALLOWED FOR USE IN COSMETIC PRODUCTS Part 2 - LIST OF COLOURING AGENTS PROVISIONALLY ALLOWED FOR USE IN COSMETIC PRODUCTS

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ANNEX V LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE DIRECTIVE

ANNEX V LIST OF SUBSTANCES EXCLUDED FROM THE SCOPE OF THE DIRECTIVE

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ANNEX VI LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN

ANNEX VI LIST OF PRESERVATIVES WHICH COSMETIC PRODUCTS MAY CONTAIN

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ANNEX VII LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MAY CONTAIN

ANNEX VII LIST OF UV FILTERS WHICH COSMETIC PRODUCTS MAY CONTAIN

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ANNEX IX LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING

ANNEX IX LIST OF VALIDATED ALTERNATIVE METHODS TO ANIMAL TESTING

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ANNEX X METHODS FOR ANALYSIS NECESSARY FOR CHECKING THE COMPOSITION OF COSMETIC PRODUCTS

Not compatible Annexes X to XIV of the draft law were taken from the old version of the Directive. These have been repealed.

ANNEX XI HARMLESS TOXICOLOGICAL INDEXES OF COSMETIC PRODUCTS AND PERFUMERY

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ANNEX XII HARMLESS MICROBIOLOGICAL INDEXES OF COSMETIC AND PERFUMERY PRODUCTS

Not compatible

ANNEX XIII THE CLINICAL AND LABORATORY HARMLESS INDEXES OF COSMETIC AND PERFUMERY PRODUCTS

Not compatible

ANNEX XIV THE PHYSICO-CHEMICAL AND ORGANOLEPTIC INDEXES OF COSMETICS AND PERFUMERY PRODUCTS

Not compatible