Explanatory Memorandum to COM(2008)49 - Cosmetic products (recast) (SEC(2008)117) (SEC(2008)118) - Main contents
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| dossier | COM(2008)49 - Cosmetic products (recast) (SEC(2008)117) (SEC(2008)118). |
|---|---|
| source | COM(2008)49  |
| date | 05-02-2008 |
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 i (the “ Cosmetics Directive ”) was announced in the Commission Communication “Implementing the Community Lisbon programme: A strategy for the simplification of the regulatory environment”[2] and in the Commission’s Annual Policy Strategy for 2007.[3]
This proposal pursues three objectives :
- Objective 1: To remove legal uncertainties and inconsistencies. These inconsistencies can be explained by the high number of amendments (55 to date) and the complete absence of any set of definitions. This objective also includes several measures to facilitate management of the Cosmetics Directive with regard to implementing measures;
- Objective 2: To avoid divergences in national transposition which do not contribute to product safety but instead add to the regulatory burden and administrative costs;
- Objective 3: To ensure that cosmetic products placed on the EU market are safe in the light of innovation in this sector.
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 i), 18 from national and regional authorities, 4 from academia/health professionals, 3 from consumers and consumer organisations and 1 from an animal welfare organisation. In terms of regions, 7 contributions were received from EU-wide associations, 15 from Germany, 9 from France, 3 each from the UK, Austria and Sweden, 2 each from Lithuania, Belgium/Luxembourg, Denmark, Norway, the Czech Republic, Spain, Poland and Ireland, 1 each from Finland, Malta, Hungary, the Netherlands, Slovenia, Greece, Slovakia, Latvia and Switzerland and 7 from non-European Third Countries.
Generally speaking, the consultation confirmed that the Cosmetics Directive needed to be recast and that many provisions required clarification. The stakeholder consultation also stressed that in order to ensure a high level of protection of human health throughout the EU and to ensure an internal market for cosmetic product, a recast Cosmetics Directive should take the form of a Regulation. In terms of product safety, responses in the stakeholder consultation stressed the need to sharpen the focus on the manufacturer’s responsibility for the safety of cosmetic products placed on the market.
A summary of the responses is contained in Annex 1 to the impact assessment report.
The Commission, based on the results of the stakeholder consultation and three studies assessing various aspects of European cosmetics legislation i, 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 i 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.
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.
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.
According to the interinstitutional agreement of 28 November 2001 on a more structured use of the recasting technique for legal acts i, substantive amendments have been shaded in grey.
The substantive changes can be summarised as follows:
Introducing a set of definitions
Article 2 as well as the preamble to Annexes II to VI of the proposal introduce a set of definitions. Until now, the Cosmetics Directive contains practically no legal definitions. This increases legal uncertainty and renders compliance more costly and burdensome than necessary. The proposal ensures coherence with existing definitions in the field of free movement of goods – in particular with view to the proposals for a common framework for new approach legislation.[8]
Article 28 of the proposal introduces a facilitated system to update a glossary of ingredient names. This glossary takes up essentially the function of the “inventory of ingredient names”, which was already provided for in the Cosmetics Directive.[9] It contains the names of all relevant cosmetic ingredients (approximately 10.000). The names used are independent of any national language and usually much shorter than the chemical name. Thus these names help to avoid the need for translation of the labelled list of ingredients. Moreover, these names are accepted worldwide which greatly facilitates exportation for EU companies and thus enhances external competitiveness.
Cosmetics safety assessment
Annex I of the proposal sets out the requirements for the cosmetic product safety assessment in terms of content.
The concept of a cosmetic product safety assessment is not new. The Cosmetics Directive already contained the requirement to undertake such an assessment prior to placing the product on the market.[10] However, the information to be contained in this safety assessment was never specified, with the practical implication that the safety assessment never took on the important role that it was meant to play within the current legal framework.
A crucial element of the recast is clarification as to what information has to be contained in the cosmetic product safety assessment to provide evidence of the safety of the cosmetic product placed on the market.
Cosmetics regulation in the EU is based on in-market controls. Therefore, it is crucial that in-market control is effective. The proposal strengthens the role and improves the functioning of in-market control – in particular, in view of ever increasing imports from third countries. This entails the following:
- Article 4 of the proposal defines the responsible person for the relevant legal obligations. This provision also addresses the responsibility in cases of products supplied to the consumer from outside the EU, for example via internet.
- Article 10 of the proposal introduces a simplified, centralised and electronic notification requirement: Notification of certain information concerning the product placed on the market is an important element in a sector based on in-market control. Until now, the Cosmetics Directive contains two notification requirements: one to competent authorities and one to poison control centres. Modalities differ considerably between Member States and multiple registrations are necessary.
- Article 19 of the proposal introduces a communication of information on certain undesirable effects to the competent authority.
- Article 20 of the proposal introduces the possibility for competent authority to investigate on a broader basis the extent of the use of certain substances.
- Articles 21, 23, 24 and 25 of the proposal introduce and strengthen the rules that apply to non-compliant products, including more detailed provisions on administrative cooperation in market surveillance. Presently, the Cosmetics Directive does not provide for any such rules.
Article 12 i introduces a differentiated regime for substances classified as carcinogenic, mutagenic or reprotoxic (“ CMR ”).
CMR substances are classified based on their intrinsic properties (“hazard”) without taking into account exposure, i.e. future use. The difference between hazard and risk is best explained with an example: A lion is a “hazard” (i.e. a lion as such is dangerous for humans) but a lion is not necessarily a “risk” (e.g. if it is in a guarded zoo, behind a fence, and well-fed).
CMR substances are categorised into 3 categories, “1”, “2” and “3“ based on the degree of evidence of their carcinogenic, mutagenic or reprotoxic properties.[11]
Up until now, CMR 1 and 2 substances were automatically banned in cosmetic products. CMR 3 substances were banned unless the Scientific Committee, on the basis of exposure-data, has found that the substance is safe for use in cosmetics.[12]
The automatic ban without possibility of an exception for CMR 1 and 2 substances made regulation of cosmetics dependent on a hazard-classification without considering exposure and actual use of the substance. This could lead to absurd situations. A recent – but not the only – example is ethanol: Ethanol (i.e. alcohol) is widely used in cosmetic products. It was considered for classification as CMR 1 substance in 2006. The dossier is pending. A classification as CMR 1 substance would have tremendous impact on the EU cosmetics industry, without ever giving the possibility for industry to prove its safe use in cosmetic products based on exposure data. On the other hand, this substance could be used in food with a much higher exposure.
Article 12 i of the proposal intends to propose a risk management regime for CMR 1 and 2 substances which allows, subject to rigid conditions, the use of these substances if they have been found to be safe by the Scientific Committee for Consumer Products.
Apart from the amendments set out under points 6.1. to 6.3., the following substantive amendments have been made in the proposal:
- Article 7 i of the proposal clarifies the obligation for the responsible person to keep the cosmetic product safety report up to date.
- In Article 8 of the proposal, the reference to the appropriate level of qualification for the manufacturer and the importer has been deleted. This issue is now addressed by a strengthened role of the cosmetic product safety report as well as the adoption of a harmonised standard for GMP.
- Articles 5 i and 9 i of the proposal provide for clarification of the role of harmonised standards in the field of good manufacturing practices and sampling/analysis of cosmetic products.
- Article 11(1)(d), (f) of the proposal clarifies that the restrictions for substances contained in Annex IV (colorants) and V (preservatives) also apply if the substance is added to the product for another than a colorant/preservative purpose.
- Article 14 i of the proposal introduces the Comitology procedure with scrutiny for granting a derogation from the animal testing regime.
- Article 15(1)(a) of the proposal introduces the possibility to highlight on the label the relevant address for competent authorities in cases where several addresses indicated.
- Article 15(1)(c) and point 3 under Annex VII of the proposal introduces the possibility to label the date of minimum durability by way of a pictogram.
- In Article 15(1)(g) of the proposal, the possibility to suppress ingredients on the product labelling for reasons of trade secrecy has been deleted. This provision was practically never applied and did not play any role in practice.
- Article 16 i, sub-paragraph i of the proposal introduces the possibility to make use of harmonised standards to address issues of claims relating to cosmetic products.
- Article 22 of the proposal introduces a clear procedure for the application of the safeguard clause (cf. Article 12 of the Cosmetics Directive).
- Article 26 of the proposal introduces and clarifies the rules applying to the amendment of the Annexes of the text.
- Article 27 i,(4) of the proposal introduces the Comitology procedure with scrutiny.
- Article 31 of the proposal allows for the formal objection against harmonised standards.
- Article 32 of the proposal introduces the obligation for Member State to adopt provisions on penalties.
- Article 33 and 34 of the proposal establish the rules for the repeal of the Cosmetics Directive, and entry into force and application of the Regulation.
- Article 8a as well as Annex V of the Cosmetics Directive have been deleted. Both provisions contradicted the principle of exhaustiveness of the Cosmetics Directive and did not play a role in praxis.
Contents
- Budgetary implication
- Public consultation
- Impact assessment
- LEGAL BASIS AND SUBSIDIARITY
- CODIFICATION OF THE 55 AMENDMENTS OF THE COSMETICS DIRECTIVE AND ADOPTION OF TEXT AS REGULATION
- Substantive amendments
- Facilitating the management of cosmetics legislation
- Glossary of ingredient names
- Strengthening certain elements to ensure product safety in the future
- Strengthening in-market control
- CMR Substances
- Other substantive changes
- Additional information
- European Economic Area
The proposal envisages establishing a central electronic interface for the product notification to the competent authorities of the Member States. Budgetary implications are discussed in the legislative financial statement annexed to this proposal.
Repeal of legislation
The adoption of the proposal will lead to repeal of one basic legal act, its 55 amendments as well as one implementing Commission Directive.
The proposal concerns an EEA matter and should therefore extend to the European Economic Area.