Annex I, 1223/2009/EC

By the presentation of early 2010, the EU Regulation 1223/2009 presented a big change in the structure in comparison with the old 76/768/EEC Directive: the Annex I that was an indicative list of cosmetic categories was replaced with the new Annex I, that shows the detailed structure of the Cosmetic Product Safety Report, a key-document that is the most important part of the Product Information File. The Cosmetic Product Safety Report contains the Safety Assessment, and its structure is well more articulated than in past. Anyway most of the items were not new: impurities, stability, exposure and margin of safety were well known by Safety Assessors as they were very well explained in the very important SCCS (Scientific Committee for Consumer Safety) “Note of Guidance” Guidelines. So what is new? In truth the whole structure of the 1223/2009 EC shows a new “olistic” and integrated approach. 
So, far from being a “copy and paste” from SCCS Notes of Guidance to the EU Regulation, in fact the regulation 1223/2009 brings to a different “approach”: the “centralized” role and responsibility of the Responsible Person has to coordinate the scientific skills of the Safety Assessor and to apply all the issues in the production that by law has to be led under the GMP.
That new approach is even confirmed and clarified in the Guidelines that were published in 2013: their analysis and practical interpretation are the aim of the session.

References:
1. REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 30 November 2009 on cosmetic products
2. COMMISSION IMPLEMENTING DECISION of 25 November 2013 on Guidelines on Annex I to Regulation (EC) No 1223/2009 of the European Parliament and of the Council on cosmetic products (2013/674/EU) 
3. SCCS/1564/15 The SCCS Notes of Guidance for the testing of cosmetic ingredients and their safety evaluation 9th revision.


Presented by Dr. Matteo Zanotti Russo, Italy