Legal Acts in the EU in the area of technical harmonization: adopted or proposed during the last quarter

Cosmetic products

-  negotiations concluded
-  published in OJ EU L 342 22. 12. 2009
-  Celex No.: 32009R1223

The text is available on the following websites

URL Link 1

OR

URL Link 2

The description of the agenda:
Because the Council Directive 76/768/EEC concerning cosmetic products was amended 55 times it was necessarily to change the basic Directive and to consolidate all of the changes to a new legal regulation.

The legal form was chosen Regulation which leads to harmonized use of regulation thereby there will not be the necessity of transposition to the national legal order of member states.

This Regulation comprehensively harmonises the rules in the Community in order to achieve an internal market for cosmetic products while ensuring a high level of protection of human health.

The main substantive changes can be summarised as follows: facilitating the management of cosmetics legislation, strengthening certain elements to ensure product safety in the future, differential regime for CMR substances.

Aims and benefits:
This proposal pursues three objectives:

• 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;
• to avoid divergences in national transposition which do not contribute to product safety but instead add to the regulatory burden and administrative costs;
• to ensure that cosmetic products placed on the EU market are safe in the light of innovation in this sector.

Difficulties:
Legal origin of the text - the central issue was the question of whether the directive can be converted into a regulation in the context of a recast exercise and some Member States did not want to discuss about technical aspects before clarification of this problem.

The European Parliament and European Commission Legal Services evaluated the legal origin as a “recast”.

This statement was agreed by Committee of permanent representation at the end of December. Disputed points: The most discussed disputed points were:

• nanomaterials – definition and its safety assessment,
• the way of cooperation between market surveillance authorities and responsible persons in single Member states,
• assessment of conditions for extraordinarily use of substances classified as carcinogenic, mutagenic or toxic for reproduction (CMR), category 1A and 1B,
• uniform labelling of cosmetic products,
• counterfeit products

Time sequence:

Entry into force:
Economic operators as well as Member States and the Commission need sufficient time to adapt to the changes introduced by this Regulation. Therefore it is appropriate to provide for a sufficient transitional period for that adaptation. However, in order to ensure a smooth transition, economic operators should be allowed to place on the market cosmetic products which comply with this Regulation before the expiry of that transitional period. In order to strengthen the safety of cosmetic products and the market surveillance, cosmetic products placed on the market after the date of application of this Regulation should comply with its obligations regarding safety assessment, product information file and notification, even if similar obligations have already been performed under Directive 76/768/EEC.

This Regulation shall enter into force on the twentieth day after its publication in the Official Journal of the European Union and it shall apply from 11 July 2013, with the exception of:

• Article 15(1) and (2) – labelling requirements - which shall apply from 1 December 2010, as well as Articles 14, 31 and 32 to the extent that they are necessary to apply Article 15(1) and (2); and
• Article 16(3) – nanomaterials - second subparagraph, which shall apply from11 January 2013

Related documents:
European Parliament – The Legislative Observatory

European Parliament – Texts adopted

PreLex – Monitoring of the decision-making process between institutions

Opinion of the European Economic and Social Committee

Connection with UNECE Regulations:
The Community should endeavour to reach an agreement on a definition in appropriate international fora. Should such an agreement be reached, the definition of nanomaterials in this Regulation should be adapted accordingly.