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Regulatory Affairs

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Changes to Cosmetic GMPs

The new cosmetic regulation EC 1223/2009 will enter into force on July 11th 2013. This new European legislation introduces many novelties but they all comes from the legislators will to increase the responsibilities of the trademark owner marketing the cosmetic products.

According to the regulation currently in force, Law 713/86, the marketing of a cosmetic product on the Italian market requires, and will require until July 2013, that a communication is sent to the Ministry of Health on the beginning of the manufacturing and marketing of the product.

Only-trading companies simply notified the marketing, communicating the manufacturing site to the Ministry. The site notified in turn its intention to produce a cosmetic product on behalf of the trademark owner.

Regulation 1223/2009 provides for a European centralized notification by the Cosmetic Products Notification Portal, which must be done by cosmetic trademark owner only (thus becoming the Responsible Person for the technical issues), with no need to indicate the manufacturing site, which paradoxically disappears from the notification.

Moreover the Responsible Person will have to assure and check that the manufacturing site works under the cosmetic standard Good Manufacturing Practice as defined in ISO 22176 and enclose the inspection minutes inside the Product Information File (PIF) of the product. The manufacturing company is not obliged to have an ISO certification, but will have to show the purchaser that they work under a GMP regime. However, any self-declaration by the manufacturer which is not supported by an ISO 22716 certificate will not be considered as sufficient by the authorities.

Since an auditing technical staff is not present in every cosmetic-owning company according to the regulation, this can be carried out by consultants entrusted by the Responsible Person.

REGULATION EC 1223/2009

 

In these slides, Di Renzo Regulatory Affairs will show you some of services offered to cosmetic companies that have to comply with regulationEC 1223/2009. Cosmetic companies should comply with the regulation entered into force on 11th July 2013 and provides for a specific notification procedure of cosmetic products, required for their marketing.

 

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