In order to regulate the field of cosmetic products in a coordinated manner in all Member States, the European Community has, over the past few years, been working on a project to codify the numerous regulatory amendments of the Directive 76/768/EEC, adopted in Italy by the Law 713/86.
The Regulation (EC) No. 1223/2009 came into force in July 2013 and introduced a number of clarifications and definitions, as well as important new features such as a single centralized notification procedure across the EU, a system of in-market monitoring by the Member States and a central “cosmetovigilance” system, a new procedure for a rapid update of the inventory of ingredients in cosmetic products and technical details regarding the contents of the report on the safety of cosmetics.
It also specifies the rules for the importation of cosmetics from non-EU countries and the responsibilities of the various parties involved (manufacturer, importer, distributor).
Di Renzo Regulatory Affairs caters to all companies that manufacture, market or intend to import cosmetics and enables them to respond to the new regulations issued by the European Community by offering the following services:
- European Central Notification
- Consultancy for manufacturers of cosmetic products in order to comply with new provisions of Regulation (EC) no. 1223/2009
- Preliminary examination of printed material and verification of compliance with applicable regulations
- Review, revision and possible integration of the documentation provided by the company
- Preparation and signature of the safety assessment of the cosmetic product
- Coordination of activities for the preparation of Product Information File (dossier)
- Verification of documents that accompany imported cosmetics such as certificates of analysis, batch records, lists of ingredients
- Request for Certificates of Free Sale (CLV)
- Supplier evaluations and audits conducted by specialized technicians at manufacturingcompanies to verify the quality and compliance with GMP
- Graphic design for cosmetic packaging
- Supervision service of for those companies who are in possession of a PIF prepared in accordance with regulations outside Europe