Safety Assessment according the EC/1223/2009 Cosmetics Regulation, Annex I, part A and part B. Safety is a key issue in the regulation of cosmetics in the EU. Part A of the Cosmetic Product Safety Report is intended to gather the data necessary to prove that the cosmetic product is safe. PART B is the cosmetic product safety assessment.
Necessary documents for the Safety Assessment and the PIF compilation (*)
1. Producer's and Distributor's address
2. GMP certification of the producer (**)
3. Formula and INCI names of the ingredients (***)
4. Specifications of raw materials.
5. Specifications of the packaging materials
6. Material Safety Data Sheet of raw materials.
7. Specially for perfumes,
All allergens contained must be declared in MSDS §2 Certificate of Allergens
8. Production method, descriptive, not detailed
9. Specification of final product
10. Stability data of the final product (****)
11. Preservation Efficacy Test, Challenge Testing(****)
12. Dermatological Test, Patch test (****)
13. Claim Substantiation Studies
14. Product labels
(*) PIF Product Information File, according to Regulation (EC) 1223/2009.
(**) GMP Good Manufacturing Practice.
(***) Detailed at least on preservatives, filters, perfumes or ingredients under limitation of use.
(****) Can be performed by our laboratory.
In case products are 100% different to each other, every product is a "main" formula.
Same formulations with minor changes, like color, perfume, will generate "variants".
On demand we will be pleased to send our price list. Contact us.