Regulatory Affairs Directorate
Market Surveillance Directorate
On 11 July 2013 a new EU Regulation 1223/2009 ('Cosmetics Regulation') came into force strengthening the safety of cosmetic products and streamlining the framework for all operators in the sector. The Regulation simplifies procedures to the extent that the internal market of cosmetic products is now a reality. The Cosmetics Regulation, adopted in 2009, replaces Directive 76/768/EC that was adopted in 1976 and has been substantially revised on no less than 7 occasions.
The Cosmetics Regulation provides a robust, internationally recognised regime, which reinforces product safety taking into consideration the latest technological developments, including the possible use of nanomaterials. Previous ban and the strict regime aiming at phasing out animal testing were not modified.
The most significant changes introduced by the Cosmetics Regulation include:
- Strengthened safety requirements for cosmetic products
Manufacturers need to follow specific requirements in the preparation of a product safety report prior to placing a product on the market.
- Introduction of the notion of 'responsible person'
Only cosmetic products for which a legal or natural person is designated within the EU as "responsible person" can be placed on the market. The new Cosmetics Regulation allows the precise identification of who the responsible person is and clearly outlines the obligations.
- Centralized notification of all cosmetic products placed on the EU market
Manufacturer will need to notify its product only once - via the EU Cosmetic Products Notification Portal (CPNP).
- Introduction of reporting of serious undesirable effects
A responsible person will have an obligation to notify serious undesirable effects to competent national authorities. The authorities will also collect information coming from e.g. users and health professionals, and will be obliged to share the information with other EU Member States.
- New rules for the use of nanomaterials in cosmetic products
Colorants, preservatives and UV-filters, including those that are nanomaterials, must be explicitly authorized. Products containing other nanomaterials not otherwise restricted by the Cosmetics Regulation will be the object of a full safety assessment at the EU level, if the Commission has concerns. Nanomaterials must be labelled in the list of ingredients with the word 'nano' in brackets following the name of the substance, e.g. "titanium dioxide (nano)".
The Cosmetics Regulations were implemented into national legislation by the Cosmetic Products (Implementation)Regulations of 2011, Legal Notice 323 of 2011.