ANNELIE STRUESSMANN
CONUSBAT, Kruppstr. 18, D-52072 Aachen Germany

Abstract

The EU implemented a new regulatory framework for cosmetics, which clarified and extended a modular approach taken from the earlier directive and at the same time changed the legal procedure to direct validity over all Member States. Regulatory modules, including the safety assessment, notification, GMP, substance regulation, cosmetovigilance, etc., can be easily transferred into other countries’ legislation, which is wanted in view of more harmonized international requirements. It has successfully happened with the highest acceptance worldwide accounting to the element of substance regulation.

INTRODUCTION
By 11 July 2013, the new European cosmetics legislation, Regulation (EC) 1223/2009 (1) on cosmetic products (CPR) was fully implemented with all its provisions. On that day, the old Cosmetics Directive 76/768/EEC (2) was repealed. The new regulation meant no fundamental change to the earlier framework; however, it brought general clarifications, amendments and updates to state of the art of science. The paramount amendment was a change in legal tool, from ‘directive’ to ‘regulation’ and, as a consequence, the legislation for cosmetics is now directly applicable in all EU Member States plus three countries of the European Economic Area (EEA), Norway, Liechtenstein and Iceland.

THE REGULATION’S ELEMENTS
As a consequence of the legal framework’s direct applicability over all EU Member States, a new central notification system was required and was implemented at EU Commission level, the Cosmetics Product Notification Portal (CPNP). Other regulatory modules either revised or newly implemented with the CPR include the following:

• clear definitions and assignments of roles and responsibili ...
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