NEWSLETTER no. 02/2015 MINISTERIAL CIRCULAR DGFDM.VII/P 38518 ISSUED ON DATE 07.08.2015, PUBLISHED ON 24.08.2015 – MARKET SUPERVISION OF COSMETIC PRODUCTS ACCORDING TO THE PROVISIONS OF EC LAW 1223/2009. INDICATION OF THE RESPONSIBLE PERSON FOR NAIL CARE PRODUCTS. The Ministerial Circular in question pays specific attention to the level of conformity established by law of some nail products, advising the Liable Part to comply with legal obligations in order to grant the safety of these products. Because of toxic materials used in some formulations of this cosmetic category, we must consider the following two aspects: • a right toxicological evaluation to verify the safety of the product • a responsible management of the risk associated to the usage of the product, including warnings and instructions (both mandatory and supplementary, evaluated one by one) In order to comply with the above-mentioned points, the Liable Person must consider the conclusions of the Safety Report, as required by the Enclosure I of EC Regulation n. 1223/2009. BIO BASIC EUROPE is already complying with the requests of the Department of Health. The products destined to be personally and/or professionally used on nails undergo to a Safety Assessment that evaluates the toxicological profile of all raw materials employed, both at a dermal and inhalation level. The conclusions of the Report are used by the Safety Assessor in order to complete the label with special reference to the warnings and instructions for the final consumers. To complete and confirm the preliminary results, BIO BASIC EUROPE realizes focused tests, in vitro and/or in vivo. The results have the dual purpose of supporting the Responsible Person, who must comply with law obligations, and of assuring the safety to the final consumer. We are pleased to thank you for your kind attention and we make ourselves available for a fruitful business collaboration. Best regards, BIO BASIC EUROPE s.r.l. Managing Director Dr. Umberto Pianca Technical Manager Safety Assessor Claudio Angelinetta research@biobasiceurope.it Responsible of the Toxicology Department Francesca Vallotto lab@biobasiceurope.it