Cosmetic products must obey to strict legislation wherever they are marketed. In the European Union a common Regulation is applicable to all member states, together with several Amendments, as well as other international guidelines that may not be mandatory, but are nevertheless useful for the cosmetic industry. To help its clients keep up with the European Regulation inovapotek provides a full range of regulatory affairs services:

Formula Review – Review of the product formulation, counselling in case of forbidden and/or subject to restrictions substances and elaboration of the INCI list of the cosmetic product.

Cosmetic Product Safety Report – Elaboration of both part A (Cosmetic product safety information) and part B (Cosmetic product safety assessment) according to Annex I of the Regulation (EC) No 1223/2009 and respective Guidelines (Commission Implementing Decision of 25 November 2013). The report can be elaborated exclusively based on the data provided by the client and toxicological review of the ingredients or further testing might be needed.

Claim substantiation – Elaboration of a claim substantiation report according to Commission Regulation (EU) No 655/2013 and respective guidelines, including bibliographic review of the active ingredients’ support data and analysis of tests performed with the final product and/or tests needed to support the claims.

Product Information File (PIF) – Elaboration of the product information file according to Regulation (EC) No 1223/2009.

Label Review – Elaboration of the labelling texts for cosmetic products or verification and correction of labels according to EU legislation.

Notification to EU authorities – Electronic notification of cosmetic products to EU authorities at the Cosmetic Products Notification Portal (CPNP) – single notification for all EU countries.