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The unmissable event of the year!
Monday, January 7, 2013Authorities

ANSM 2012 inspections report

©L'Observatoire des Cosmétiques

Monitoring the market and its practices is one of the duties of the French ANSM. Sometimes working in cooperation with the DGCCRF, it commands inspections of cosmetic products and companies. Vanessa Picot and Jean-Christophe Born, both inspectors in the Agency, have presented the result of these inspections, during the 10th Perfumes and Cosmetics Convention of the Cosmetic Valley, on November 28, 2012.

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Inspections related to cosmetic products performed by the National Agency for the Safety of Medicines and Health Products (ANSM) come after three axis:
So-called "campaign" regulatory inspections: in 2010, the target was the products for pregnant women, in 2011, the products for men, and, in 2012, it was the anti-spots products;
• Inspections after alerts (thanks to the cosmetovigilance network, or to reporting) and follow-up re-inspections (for instance, to check the implementation of corrective actions, in case of formal notice after a previous inspection);
GMP inspections, which, currently, are only yet an evaluation of the level of compliance with the ISO 22716 standard.
All in all, 55 inspections have been performed in 2011, while 48 were planned for 2012.

Regulatory inspections

They are performed after a precise methodology, which allows the inspectors for the controlling of:
The process of placing cosmetics products on the market, from development to design: formalization of the process, approval of the raw materials, evaluation of the safety beforehand, blackspots …,
The level of anticipation about the regulatory changes in 2013: Responsible Person, PIF, notification, evaluation of the "enhanced" safety, GMP, distributors, nano-materials …
Regulatory files and labelling dealing with the surveyed files, …

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