Dear Mr/Mrs, Since the Regulation (EC) no. 1223/2009 of the European Parliament and of the Council on cosmetic products has entered into force, cosmetic companies must meet some obligations which were not provided for by Directive 713/86/EEC. The responsible person is obliged to write the Product Information File (P.I.F.), i.e. the ‘identity card’ of each product placed on the cosmetic market. In comparison to the dossier the P.I.F. must contain more information and, above all, it must contain a toxicological assessment about the safety of the cosmetic product itself. Please find hereinafter our answer to some of the questions we are frequently asked about the Product Information File (P.I.F). Q.: Who meets the obligations of the Regulation (EC) no. 1223/2009? A.: The responsible person (company or natural person) placing a cosmetic product on the EU Market (article 11 (1). Q.: In which language shall the P.I.F. be written? A.: The information contained in the documentation about the product must be available in a language which can be easily understood by the competent authorities of the Member State in which the P.I.F. is kept. The Italian Ministry of Health accepts that a P.I.F kept in Italy is written either in Italian or in English (as it was communicated by the Ministry of Health during the ‘Cosmetic Products Day’ held on 20th June 2013 in Rome and organized by the Istituto Superiore della Sanità). Q: Is a P.I.F required even for free samples, promotional products and gifts? A: Yes, a P.I.F is required for all cosmetic products – be them free samples or products to be sold. This is to ensure the traceability and the safety of the product for the consumer. Q: Is the P.I.F required also for existing cosmetic products already on the market before the date of application of the Regulation (i.e. 11th July 2013)? A: Yes, the P.I.F is required for all existing cosmetic products still placed on the market from 11th July 2013 and for all the new products subsequently placed on the market (article11(1) and 11(4)]. Q.: If commercializing a product in several EU Member States is it necessary to keep the P.I.F. in every one of these Member States? A.: No, the information must be accessible only in one of the Member States and at one single place. The choice of the location of the P.I.F. is at the discretion of the responsible person. Q.: Should the P.I.F. be physically kept at the address indicated in the product label? A.: No, not necessarily but the information must be readily accessible at the address written on the packaging. ‘Readily accessible’ means to be available within 72 hours. Q: Where should the P.I.F. be accessible when there is more than one address on the packaging? A.: The information has to be accessible at one of the addresses. That address has to be highlighted. If no address is highlighted, the authorities may expect to have access to the information at each of the addresses. Q.: Can somebody else than the manufacturer or the importer be responsible for the P.I.F. requirement? A.: Yes, the responsible person may designate, by written mandate, a person established within the Community as the responsible person who shall accept in writing. Furthermore, the responsible person can outsource tasks for collecting and storing the P.I.F., but the overall responsibility always lies with the responsible person placing the product on the market. Q.: Is it necessary to prepare a P.I.F. for a multi-product pack (i.e. a gift-set)? A.: A P.I.F. is required for each individual product contained in the multi-product pack, namely whose components are sold individually. Q.: Is it necessary to prepare different P.I.F.s for different pack variations (e.g. tube, pump) and different pack sizes? A.: No, it is not necessary if the pack with different sizes is the same (i.e. if the material and the spray pump are the same). In all the other cases it is compulsory to write a new P.I.F. Q.: Is it compulsory to write the name of the manufacturer and of the one who packs? A.: No, it is not compulsory but it is an additional possibility to check and to ensure that the product is manufactured and packed in compliance with the Good Manufacturing Practices (GMP). Q.: Is it compulsory to enclose the label to the P.I.F.? A.: Yes, the safety assessor must ensure that the labelling is in compliance with the law (article 19 Regulation (EC) No 1223/2009 of the European Parliament and of the Council). Q.: Is it necessary to perform the stability tests of the formula and the content/container compatibility tests? A.: Yes, it is. One of the biggest problems relating to the formulation of cosmetic products is the evaluation of the stability of the formulas and of their compatibility with the chosen pack. If there are no regulations and no guidelines relating to the cosmetic product, and considering the many types of formulation which this category of products includes, it is important for companies to have their own protocols of preliminary and long-term evaluation which will then be applied to each cosmetic product. The assessor will check both the stability test and the compatibility test to ensure that the cosmetic product is safe, stable and compatible with the sales pack. Q.: Which claims can be used for cosmetic products? A.: There are some common principles as to the declaration of a cosmetic product. (See our newsletter no. 02/2014 dated 17th February 2014). Do not hesitate to contact us for any information you need. Yours sincerely, BIO BASIC EUROPE S.r.l. Managing Director Dr. Umberto Pianca Technical Director Safety Assessor Claudio Angelinetta research@biobasiceurope.it Responsible of the Toxicology Department Francesca Vallotto lab@biobasiceurope.it Assistant of the Toxicology Department Ugo Ricci labdoc2@biobasiceurope.it Assistant of the Toxicology Department Marianna Stumpo labtox@biobasiceurope.it Assistant of the Toxicology Department Alessandro Merisio labdoc@biobasiceurope.it Assistant of the Toxicology Department Corrado Muzzarelli tox@biobasiceurope.it