From July 11, 2013 the new Regulation (EC) No.1223/2009 applies, definitively repealing the previous European Community legislation, Directive 76/768/EEC and all national implementations. The new Regulation introduces several new features including: a redefinition of roles and responsibilities, new requirements concerning the manufacturing of cosmetic products (GMP), new rules about labeling, CMR substances, nanomaterials, notification, vigilance, and reporting of adverse events, packaging, advertising and claims.
It also introduces a new and more comprehensive safety assessment and a new set of documents to be readily accessible to the Competent Authority, now called Product Information File.
The new Regulation (EC) No. 1223/2009 has helped to clarify several aspects of the European cosmetic legislation and has introduced new requirements in order to increase the level of protection of human health.
From July, the Regulation will be the reference for the manufacturing, import and distribution of cosmetic products across the 31 countries of the European Union and European Economic Area.