EN

EN

COMMISSION OF THE EUROPEAN COMMUNITIES

Brussels, 14.4.2008

COM(2008)49 final/2

2008/0035 (COD)

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

Proposal for a

REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL

on cosmetic products

(recast)

(Text with EEA relevance)

(SEC(2008)117)(SEC(2008)118)

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. Background to the proposal

Simplification of Council Directive 76/768/EEC of 27 July 1976 on the approximation of the laws of the Member States relating to cosmetic products (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 Commissions Annual Policy Strategy for 2007.

This proposal pursues three objectives:

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

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

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

2. Public consultation

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

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

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

3. Impact assessment

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

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

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

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

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

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

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

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

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

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

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

4. Legal Basis and subsidiarity

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

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

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

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

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

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

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

6. Substantive amendments

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

The substantive changes can be summarised as follows:

6.1. Facilitating the management of cosmetics legislation

6.1.1. Introducing a set of definitions

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