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p. 14-17 / REGULATORY ISSUES
How European cosmetics legislation influences regulatory frameworks world-wide
ANNELIE STRUESSMANN
CONUSBAT, Kruppstr. 18, D-52072 Aachen Germany

KEYWORDS: Worldwide Cosmetics Legislation
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 On that day, the old Cosmetics Directive 76/768/EEC (2) was repealed.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 responsibilities were formulated, the role of Responsible Person was introduced;
  • ‘Criteria for Claims’ were requested in the CPR and published with Regulation (EU) No 655/2013 (3);
  • a system of cosmetovigilance was implemented, including reporting of serious undesirable effects;
  • more detailed requirements for the safety assessment were given in Annex I (CPR);
  • new substance specific requirements for nanomaterials, colorants and CMRs were introduced in order to meet state of the art of science.

Both, the old Cosmetics Directive and the CPR, regulate cosmetic products as one single product category and with a wide definition for the relevant products, which is given in Article 2a (CPR). The responsibility for the products’ safety lies with manufacturers, respectively with the importers when products are manufactured outside of the Union. Further regulatory modules, which were unchanged with the new regulation, include:

  • a system of in-market control by EU Member States – no pre-market approval applies;
  • the responsibility for the products’ safety lies with the manufacturers, respectively, with the importers when products are manufactured outside of the Union;
  • the majority of the ingredients are free to use while ingredients with restrictions and conditions for their use are listed in the Annexes II-VI;
  • the key...In order to continue reading this article please register to our website – registration is for free and no fees will be applied afterwards to download contents.

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