The Regulation (EC) no. 1223/2009 of the European Parliament and of the Council on cosmetic products will be effective on 11th July 2013. For each cosmetic product placed on the market as of 11th July 2013 a P.I.F. will be required in a language which can be easily understood by the competent authorities of the Member State in which the P.I.F. will be kept. The P.I.F. shall contain the following information: 1. description of the cosmetic product 2. cosmetic safety report A. PART A – Cosmetic product safety information B. PART B – Cosmetic product safety assessment 3. method of manufacturing 4. proof of effect for the product 5. data on animal testing The P.I.F. shall be kept for a period of ten years following the date on which the last batch of the cosmetic product was placed on the market. It shall be made readily accessible to the competent authority within 72 hours from the request. At present Council Directive 76/768/EEC is in force. During this transition period companies can decide either to comply from now on with the new Regulation or to comply with the current Directive. The following cases must be considered: A. For products placed on the market before 11th July 2013 and complying with the Directive: • If the product continues to be placed on the market as of 11th July 2013, the P.I.F. must be adapted to the new requirements of the Regulation. • If the product is no longer placed on the market as of 11th July 2013, the P.I.F. needs no adaption to the new requirements of the Regulation. Nevertheless all the information collected in the P.I.F. in compliance with the Directive must be retained until 11th July 2020. B. For products placed on the market before 11th July 2013 and complying with the Regulation: • If the product continues to be placed on the market as of 11th July 2013, P.I.F. complies. No further action is required except when updates to information in the P.I.F. occur. Further information: A. If products are sold in a multi-product pack (e.g. gift-set) but each of them is also sold individually, a P.I.F.is required for each individual product. B. A single P.I.F. is required for packs (such as make up kits) which comprise products that are not sold individually. The P.I.F. must include the information about each component of the kit. C. Each company can choose a Member State of the EU in which the P.I.F. can be kept and can notify its choice to the Ministry. Bio Basic Europe can write the P.I.F. in compliance with the above mentioned Regulation in the following languages: English, Italian and Spanish. Our toxicological database and the exposure models applied, in compliance with the Guidelines available at present, are being updated in order to meet your requirements. Moreover we are studying a proper model to assess the inhalatory risk for the application of spray products and of products formulated with volatile solvents (i.e. nail polishes). It is be important for cosmetic companies to be already in compliance with the above mentioned Regulation for those products which the company intends to continue selling even after 11th July 2013. BIO BASIC EUROPE S.r.l. Technical Department Manager Claudio Angelinetta research@biobasiceurope.it Toxicology and Regulatory Department Francesca Vallotto lab@biobasiceurope.it Toxicology and Regulatory Department Domenico Marchesini labtox@biobasiceurope.it