3.2.2009   

EN

Official Journal of the European Union

C 27/34

1.1

The Committee endorses the aims and objectives of the draft regulation as well as the recasting of Directive 76/768/EEC as a regulation.

1.2

The Committee draws attention to the fact that considerable costs are liable to be incurred, particularly by SMEs, in meeting the new requirements for manufacturing practices, safety assessment and product information file preparation, not to mention all the relevant tests.

1.3

The Committee considers it advisable to minimise this negative financial impact on SMEs, for instance by specifying that the product information file and safety assessment be prepared in accordance with the new requirements for products placed on the market for the very first time.

1.3.1

The Committee endorses the 36-month period for the entry into force of the regulation. However, with regard to updating the product information files and safety assessment of cosmetic products already on the market, the Committee recommends a further transition period of 24 months after entry into force.

1.4

The Committee welcomes the introduction of a differentiated regime based on the risk assessment of substances classified as carcinogenic, mutagenic or reprotoxic (‘CMR’). The ban on the use of such substances should be maintained.

2.1

The main aim of the directive (Directive 76/768/EEC) is to protect consumer health while harmonising legal provisions on cosmetic products within the common market. An assessment of the current market situation shows that the amendments to Directive 76/768/EEC and their inconsistent transpositions by Member States have led to numerous legal uncertainties and discrepancies. For this reason, it has resulted in an administrative burden and unnecessary costs for the competent authorities as well as the industry without contributing to the safety of cosmetic products.

2.2

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 (the ‘Cosmetics Directive’) was announced 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 and in the Commission's Legislative and Work Program 2007. The Commission proposed to simplify the Cosmetics Directive in the form of a recast, i.e. a legislative technique which makes it possible to codify a legislative text and its amendments and to introduce substantial improvements.

2.3

On the basis of feedback from a public consultation launched in 2006, as well as several Commission studies, the Commission prepared an extensive impact assessment prior to drafting the proposal for a regulation (recast) (1).

2.4

The EU cosmetics sector is characterised by SMEs. 97 % of all EU cosmetic companies are SMEs and 80 % of them have less than 19 employees. SMEs account for approximately two thirds of all people directly employed in the cosmetics sector in the EU.

2.5

In terms of employment, there are approximately 150 000 people employed in the cosmetics industry in Europe. Since 1999, the European sector has been steadily creating new jobs (an increase of 1.2 % per year).

2.6

Apart from direct employment, the cosmetics sector has a strong indirect impact on employment such as retail, distribution and transport. It can be estimated that approximately 350 000 jobs are created indirectly by the cosmetics industry.

2.7

That is why the interests and views of SMEs in the cosmetic sector in the EU should be taken into consideration when analysing the impact of the present proposal.

2.8

Intra-community cosmetics exports have increased year-on-year since 1999 by an average of 5 % a year in terms of volume, and by 6.5 % a year in terms of value.

2.9

The cosmetics industry is an international business in which Europe is a very important player. The global nature of this sector is particularly relevant to the EU as a net exporter. In 2005, the export of cosmetic products outside the EU stood at EUR 16 billion, with imports at EUR 4.4 billion.

2.10

The situation varies from one Member State to another. Poland is an example of one such a situation. A considerable part of the Polish cosmetics sector is still independent with more than 400 enterprises, mostly SMEs, operating. The Polish cosmetics market, which experienced a growth of 8.2 % in 2006 and 7.2 % in 2007 and which still has strong growth potential, is a good example of steady growth, which is no longer being experienced in the EU's 5 largest developed economies (UK, Germany, France, Italy and Spain).

3.1

The proposed recast of Council Directive 76/768/EEC has the following key objectives:

3.2

The Commission proposal maintains the scope of Directive 76/768/EEC, and the definition of ‘cosmetic product’ remains unchanged. During the public consultation carried out by the European Commission most parties were in favour of recasting Directive 76/768/EEC in the form of a regulation.

3.3

A set of new definitions has been proposed for terms such as: manufacturer, importer, making available on the market, placing on the market, harmonised standards, traces, preservatives, colorants, UV-filters, undesirable effects, serious undesirable effects, withdrawal and recall. However, no definition has been proposed for the actual term ‘cosmetic product’.

3.4

The concept of a responsible person who is established within the Community has been introduced. Responsibility in cases of products supplied to the consumer from outside the EU, for example via internet was described.

3.5

‘New approach’ principles have been introduced: the reference to the harmonised standards in legal acts in the field of good manufacturing practices, sampling and analysis as well as claims relating to cosmetic products.

3.6

The minimum requirements for the safety assessment and the product information file (a product dossier) have been established. The Cosmetic Product Safety Report has been proposed as Annex I to the draft regulation. The safety assessment of the cosmetic product is based on the toxicological profile of its ingredients.

3.7

A differentiated regime based on a risk (but not a hazard) assessment of substances classified as carcinogenic, mutagenic or reprotoxic (‘CMR’) has been proposed instead of the recent regime based on hazard. In general, the ban of CMR categories 1 and 2 has been maintained. However, the new approach allows, subject to rigid conditions, the use of CMR 1 and 2 substances if they have been found to be safe to use in cosmetics.

3.8

The overall strategy to ban the animal testing of finished products as well as timetables of deadlines for the prohibition of the marketing of cosmetic products containing ingredients or combinations of ingredients which have been tested on animals has been maintained.

3.9

The uniform approach to the management of undesirable effects and serious undesirable effects has been established. Data on undesirable effects and serious undesirable effects shall become a part of the Cosmetics Product Safety Report and will be communicated to the public. Additionally, serious undesirable effects shall be actively reported to the competent authorities.

3.10

The simplified, centralised, electronic notification in a ‘one-stop-shop’ has been proposed. Until now, prior to placing a cosmetic product on the market, notification had to be made separately in each Member State. The scope of information differs from one Member State to another. Moreover, the separate notification to poison control centres is currently required in several Member States.

3.11

The administrative collaboration between competent authorities and the application of good administrative practices have been strengthened.

4.1

The Committee endorses the aims and objectives of the draft regulation — the simplification and unification of certain administrative procedures — while ensuring a high level of consumer safety. The proposed regulation is undoubtedly transparent. The legal provisions it sets out clarify previous legal ambiguities that had led to divergent interpretations and applications.

4.2

Recasting Directive 76/768/EEC as a regulation will ensure the uniform application of legal provisions enhancing the free movement of products within the common market and simplify administrative procedures on EU markets.

4.3

While the simplification of administrative procedures could reduce certain costs (i.e. notification of products and notification to the poison control centres), considerable costs are liable to be incurred by SMEs in meeting the new requirements on the content of the product information file and compliance with harmonised standard EN ISO 22716 (GMP). It should be emphasised that current legal provisions do not require as high a level of detailed toxicological data as the proposed regulation.

4.4

It is to be expected that the additional costs incurred by the requirements set out in the regulation will depend heavily on the size of the enterprise. The costs pertaining to the preparation of the product information files and safety assessment will be borne, first and foremost, by small and medium-sized enterprises, which formerly used to prepare rudimentary data as specified in existing legal provisions.

In the case of large international corporations, one should not expect a considerable increase in costs due to their longstanding experience, expertise, human resources, technical background and access to third-party know-how. In the case of large enterprises manufacturing products on several EU markets, the centralised European notification system will definitely simplify former administrative procedures. This will partly reduce notification costs. Moreover, international enterprises have already implemented notification systems for their frame formulations (formulas).

4.5

In the case of SMEs, one can expect a considerable increase in costs relating to good manufacturing practices, safety assessment and product information file preparation, not to mention all relevant tests.

For research and the dossier and safety assessment alone, the costs of SMEs may increase by as much as 100 % for every new formula placed on the market. This will considerably increase production costs for SMEs and affect the retail price of products, thus impacting on consumer interests.

One should bear in mind that in the case of SMEs, product series are manufactured in considerably smaller volumes than those of large international concerns selling large quantities of products. As a result, the costs of research and the dossier and safety assessment per product are much higher for SMEs.

According to this impact assessment prepared by the Commission, this could be inadequate in the case of Member States with a high number of small and medium-sized enterprises, such as Spain, Italy, Poland and Bulgaria.

4.6

It seems advisable to minimise the negative financial impact on SMEs, for instance by specifying that the product information file and safety assessment are to be prepared in accordance with the new requirements for products that are being placed on the market for the very first time. It would appear necessary to extend the transition period for updating the product information files and safety assessment for products already on the market.

4.6.1

The Committee endorses the 36-month period for the entry into force of the regulation. However, with regard to updating the product information files and safety assessment of cosmetic products already on the market, the Committee recommends a further transition period of 24 months after entry into force.

4.7

The Committee welcomes the introduction of a set of definitions. This will facilitate the interpretation of the provisions of the regulation and help to remove legal uncertainties and inconsistencies. However, a new definition for cosmetic products has not been proposed. The cosmetics industry is highly innovative and new efficacies and product categories are introduced to the market each year. This may generate problems concerning product qualification (cosmetics, pharmaceutical products etc.) and ‘borderline products’. It is therefore necessary to undertake educational and information campaigns as well as strengthen market surveillance in this field.

4.8

The Committee welcomes the introduction of the concept of ‘a responsible person’. Establishing a responsible person — who may be an entrepreneur other than the manufacturer — is useful and consistent with existing market practices such as outsourcing and private labelling. Provisions concerning the responsible person establish responsibility in cases where products are made available on the market from outside the EU, for example via internet.

4.9

Furthermore, the Committee considers that other concepts should also be defined, so as to ensure legal certainty, especially since the instrument is in the form of a regulation. This applies in particular to the concepts of ‘fragrance’ and ‘active ingredient’.

4.10

The Committee welcomes the introduction of the electronic notification of cosmetics and frame formulas to poison control centres. It will certainly unify administrative procedures on the EU market.

4.11

The Committee endorses the introduction of new approach principles to legislation on cosmetic products. The application of harmonised standards, which can be voluntarily applied by the manufacturers and competent authorities, enables the unification of applied methodologies. Harmonised standards are a good example of self-regulation tools that are both useful and willingly used by the cosmetics industry. However, the Committee has reservations about the uncritical application of new approach principles. Consumer health and safety issues must be regulated by the relevant regulations.

4.12

The Committee welcomes the reference to harmonised standards for product claims. However, harmonised standards should address methods of efficacy assessment applied to prove the claims, not to the claims themselves. Claimed effects can be measured by reliable and reproducible methods. Moreover, harmonised standards should take into consideration scientific and technological progress and the vastness of the subject.

4.13

The Committee welcomes the introduction of a differentiated regime based on the risk assessment of substances classified as carcinogenic, mutagenic or reprotoxic (‘CMR’) referred to in Directive 67/548/EEC (Article 12(2)). The ban on the use of such substances should be maintained. However, the current system is based on hazard (i.e. intrinsic properties of the substance) and does not take into consideration the dose and route of exposure. It could lead to the automatic ban of ethanol (i.e. alcohol) in case of its re-classification in CMR categories 1 or 2, despite the fact that the use of the substance in cosmetics is safe. The draft regulation provides that substances in CMR categories 1 and 2 may be used as compounds in cosmetics only subject to the simultaneous fulfilment of three conditions (Article 12(2)). However, one of these conditions assumes that the substance has to be legally used in food and nutritional products. But there may very well be cases where CMR 1 or 2 substances are considered safe for use in cosmetics but are not allowed for food (i.e. formaldehyde, boric acid etc.). The drafted provisions exclude any application of such substances in the cosmetics industry.

4.14

The Committee is aware of the transition periods for adapting the products dossier and safety assessment for products already on the market (Article 34). The draft does not specify whether the transitional period is only applicable to products being placed on the market, or also to products already on the market. Specifying the same transitional period (36 months) for all products — including those already on the market — may lead to a situation where products already legally on the market will have to be withdrawn because their labelling or their product information files has not been updated. The Committee endorses the 36 month-period for the entry into force of the regulation. However, with regard to updating the product information files and safety assessment of cosmetic products already on the market, the Committee recommends a further transition period of 24 months after entry into force.

In document SEC(2008) 117, the impact assessment report, the European Commission states: ‘All available statistics suggest that the number of adverse reactions to cosmetic products is very low. (…) Moreover, since the Cosmetics Directive entered into force the cosmetics industry has had no major safety crisis, unlike, for example, the feed sector’.

5.1

The Committee is aware of certain provisions included in the proposal of the Commission which could be difficult to fulfil. The most crucial ones include the scope of data required for the product information files and safety assessment (Article 7 and Annex I).

5.2

The safety assessment under Article 7 must be carried out by an independent third party, i.e. from outside the company in question.

5.3

In Article 7(3), the term ‘non-clinical safety studies’ is unclear. Available information reveals that this term is interpreted differently by various EU Member States. According to the interpretation of the competent authorities in Poland, clinical tests are tests for medicinal products. Research studies on volunteers used in the assessment of cosmetics (dermatological tests, compatibility tests, instrumental tests) cannot therefore be understood as clinical tests. However, they could not be regarded as non-clinical studies within the meaning of Article 7(3) of the drafted Regulation, either. According to Directive 2004/10/EC, the provisions on good laboratory practices are not applicable to the tests involving the participation of humans.

5.4

Moreover, a requirement that all toxicological tests and analysis necessary for safety assessment be performed in accordance with the principles of good laboratory practice prevents the use of most data included in toxicological databases and scientific publications, which are a valuable source of information. Even in recent scientific publications, one can very rarely find a declaration of compliance (or non-compliance) with good laboratory practice by the laboratories carrying out the relevant tests.

5.5

The provisions of paragraphs 2 and 4 of Annex I concerning the assessment of the purity and stability of packaging material, the evaluation of interactions between the compounds and the evaluation of the influence of product stability on its safety, and the specification of the ‘period-after-opening’ may be difficult to fulfil because there is no commonly available and recognised methodology, for instance in the form of international or European standards, or scientific publications. Hence, this data is not readily available.

5.5.1

The Committee welcomes the content of Annex I (Cosmetic Product Safety Report) with regards to minimum requirements for data and tests to be performed when preparing a product dossier. It will improve the quality of the dossier, facilitate market surveillance and therefore contribute to consumer safety.

5.6

The NOAEL value (No Observed Adverse Effect Level) which is necessary for calculating the MoS (Margin of Safety) is not available for many substances. The obligation to determine the NOAEL value will result in animal tests that violate the EU policy to promote alternative methods. It also contravenes the provisions of Article 14 (Animal testing).

5.6.1

New legislation should therefore clearly specify which tests manufacturers are to carry out on substances used in cosmetics in order to identify potential hazards for consumers.

5.7

The Committee does not accept that the list of ingredients may be indicated on the packaging alone (Article 15(g)); rather, if possible, it should be indicated on the product (container).

5.8

The Committee considers that cosmetic products must carry special warnings regarding their use by children, clearly and very visibly stating a minimum age and that they must be kept out of the reach of children.

5.9

The Committee is also of the view that the regulation should clearly stipulate that, in the case of distance-selling of cosmetic products, exactly the same type of information that must be displayed on labels and packaging when sold in shops must be clearly set out in distance sales offers.

5.10

The Committee endorses the increased pressure for administrative collaboration between the competent authorities and the application of the good administrative practices.

5.11

The Committee endorses rectifying the former Annexes containing lists of prohibited and allowed substances with restrictions to be used in cosmetic products, by adding the CAS and EINECS numbers and INCI names as well as establishing an electronic inventory of cosmetic ingredients.

5.12

Withdrawing former Annex I of Directive 76/768/EEC seems appropriate. The division of categories in the former list was rather arbitrary, and there were numerous repetitions of category groups, for example: ‘make-up powders’ and ‘products for making up and removing make-up’. Moreover, the former list is already out of date — there are new product categories available on the market, such as anti-cellulite adhesives, and make-up remover cleanser tissues with active substances.