The former Cosmetics Directive 76/768/EG has been replaced by the Cosmetic Regulation (EC) No. 1223/2009 in 2013. The requirements on safety of cosmetic products have been revised, as well as the responsibilities within manufacturing and marketing of cosmetic products.
Consumer safety is the main focus: the normal and reasonable foreseeable use of cosmetic products has to be safe.
Product Information File
For every cosmetic product placed on the market a product information file (PIF) needs to be prepared and kept up to date. The PIF contains the cosmetic safety assessment along with a description of the manufacturing process, a declaration that Good Manufacturing Practice (GMP) is followed, and in case of product claims a substantiation of those.
A safety assessment – performed by specially qualified experts –, needs to be prepared for each cosmetic product placed on the market. The requirements for the safety assessment are described in much more detail than in the Directive 76/768. Thus, it may be necessary to update the evaluation of cosmetic products already assessed according to the Directive 76/768 in order to conform to the Cosmetics Regulation 1223/2009.
Moreover, each safety assessment should be re-evaluated by a qualified safety assessor from time to time as regulations may change and make a safety assessment invalid (e.g. new regulation of substances, like changes in maximum authorised concentrations, reduction of levels for contaminants, prohibition of substances for certain uses, etc.)
If such changes of the regulations are not known at the time the safety assessment has been prepared, they have not been taken into consideration. But after enforcement of the respective amendments they may lead to invalid safety assessments.
Simplified EU notification
A simplified EU wide notification system has been implemented with the Cosmetics Regulation 1223/2009 replacing the notification to national authorities.
The cosmetic products are notified before placing them on the market. The following details are notified: information on the product (name, category), country of origin in case of import from outside the EU, the presence of nanomaterials or CMR substances, if applicable. The EU commission then informs all competent authorities (poison control centers, national authorities, etc.).
The responsible person and distributors are obliged to notify any serious undesirable effects to the competent authority of the Member State where the effect occurred.
Natural or organic cosmetics are not exempted from these regulations. The same requirements for safety do apply.
To date, there are no standardised criteria for natural cosmetics. An ISO standard is currently under development.
There is consensus amongst several guidelines that all raw materials shall be of plant, animal or mineral origin. Nature-identical preservatives may be used, as well as emulsifyers produced by hydrolysis, esterification or transesterification of natural materials.