Safety Assessment of Cosmetics

Safety is a key issue in the regulation of cosmetics in the EU. It was firstly dealt with in Council Directive 93/35/EEC amending for the sixth time Directive 76/768/EEC. The new provisions of Article 7a §5b(4) introduced the obligation to keep available for every cosmetic product marketed in the EU a technical dossier containing a safety evaluation of the finished product. §5c(2) states that the safety evaluation must be done by a qualified professional, holding a diploma in the field of pharmacy, toxicology, medicine, dermatology, food chemistry, chemistry or a similar discipline after a minimum education period of three years. (Ref. Vrije Universiteit Brussel, http://safetycourse.vub.ac.be/index2.shtml)

NECESSARY DOCUMENTS FOR SAFETY ASSESSMENT AND PIF (*)

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 test (****)
12. Dermatological Test, Patch test (****)
13. Claim Substantiation Studies
14. Product labels