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Regulatory Affairs Cosmetics Product

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We offer regulatory consultancy for the importation and marketing of cosmetic products. Finding one's way in the new regulation is becoming more and more difficult. This slide includes only the questions asked by our customers.

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Page 1: Regulatory Affairs Cosmetics Product
Page 2: Regulatory Affairs Cosmetics Product

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Control list of permitted substances Not all substances may be used in a cosmetic. EC Regulation 1223/2009 has Annexes that regulate the presence of substances such as preservatives, colorants and UV-filters.Not only that, the legislation provides a long list of substances that may only be permitted in specific product types and concentrations, and others that must be totally absent in a cosmetic product. The verification of compliance with regulations is, above all, from the point of view of the formulation, the first step in having a cosmetic accepted at a European level.

Page 3: Regulatory Affairs Cosmetics Product

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Preparation and control of labelsArticle 19 of EC Regulation 1223/2009 specifies the minimum requirements of the label of a cosmetic product. Each type of product may have to comply in a different manner to meet legal requirements, making it sometimes difficult for new companies or those who are only engaged in a commercial activity to attain the labels according to the law.The supervision of the texts by a technical consultant eases the task for companies and allows them to disentangle themselves from the sometimes delicate legislation on claims and actions vaunted for the product.

Page 4: Regulatory Affairs Cosmetics Product

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Preparation and verification of publicity textsUnlike other product sectors, such as medical devices, the advertising of cosmetic products does not need to be authorized by the Ministry of Health. However, it remains the obligation of the company to comply with cosmetics regulations in force, which impose certain constraints on communication to the public. Failure to comply with the law, even for simple negligence and in good faith by the company, may result in penalties commensurate with the extent of fault ranging from monetary fines, withdrawal of the product from the market or, in more severe cases, may incur criminal liability.An experienced technician can allow the company to recognize the limits within which they may use correct publicity information, avoiding damage, at times serious, to the company.

Page 5: Regulatory Affairs Cosmetics Product

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Notification of import of cosmetics and initiating commercialization

EC Regulation 1223/2009, which will be in force as of 11 July 2013, provides for a precise procedure of notification of cosmetic products, which is necessary in order to place the product on the market. The notification includes a first registration of the company in the European database and the subsequent notification of the cosmetic. This procedure is centralized at the European level and fully electronic. Up to July 2013 it will still be necessary to notify the product in accordance with national regulations, which often differ from country to country and especially with the new procedure. It will be an assured aid for companies to have a consultant who can follow the entire process of notification, right up to its completion.

Page 6: Regulatory Affairs Cosmetics Product

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Preparation and correction package leaflets

Examination of printed materials and documentation: as well as the text of the labels and advertising, the drafting of a package leaflet must also follow very specific rules.This type of communication is to be configured not only as informative on the quality of the product or, in certain cases, an entire line of cosmetics, but for those cosmetics with small packaging, with a sole font, compulsory by law with all essential information that the consumer must receive, according to EC Regulation 1223/2009.Once again the support of a qualified technician to correct the drafting of texts and assist the company is fundamental for compliance.

Page 7: Regulatory Affairs Cosmetics Product

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Evaluation of safety

EC Regulation 1223/2009 places great importance on the safety of the product. Article 10 states that every product must be safe and that safety, within reasonable profiles, must be evaluated and proven by scientific evidence by a Safety Assessor. Thus there is a need to define a new normative figure that in order to fulfil his/her role, must be in possession of particular requirements established by law. Relying on a Safety Assessor with the right training and experience enables the company to ensure that the legal requirements on the safety and quality of the cosmetic product are respected, allowing for a safer marketing of the product itself.

Page 8: Regulatory Affairs Cosmetics Product

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Preparation of the technical dossierA further obligation to which the cosmetic companies must comply in order to market a cosmetic product is the preparation of a Product Information File. This documentation must be conceived as a dossier that contains all possible information on the product, starting from the manufacturing process, the texts present on the label, possible indications for use, together with all data relating to the safety, toxicity and chemical / physical and microbiological characteristics, as well as the stability not only of the finished product, but also of each ingredient used for the production. The Product Information File also includes the Safety Assessment prepared by the Safety Assessor, which take into account all the data in the PIF, processing and verifying the "big picture" which is delineated, thus generating a document to be submitted to the competent authorities if requested by them.

Page 9: Regulatory Affairs Cosmetics Product

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Request for Certificates of Free Sale

Some countries outside the European Union require a Certificate of Free Sale issued by the Ministry of Health, to allow entry of Italian cosmetic products into their territory. It is important for companies to have a consultant who can take care of every aspect of the procedure, from the progress with the Ministry of Health until the completion of the entire procedure.

Page 10: Regulatory Affairs Cosmetics Product

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Preparation of the graphic design of cosmetic packaging

Cosmetic products, more than others, need to combine accurate information on the product with graphics designed in every detail. Having within the team of consultants an experienced graphic designer allows the company to receive a complete consultation that takes into account not only the accuracy of the texts from a regulatory point of view or technical information provided to the consumer, but also the graphic and aesthetic appearance, thus making better use of the available space on the packaging.