French ANSM: the results of the 2018 inspections
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At the Regulatory Meeting organised by Cosmed on 21 March 2019, Vanessa Picot, Cosmetics Inspector of the French ANSM, presented the results of the Agency’s inspections during 2018 and detailed its expectations regarding the non-conformities noted. On the agenda: cosmetics to be personalised, products used by beauty professionals, GMP non-conformities… and at the end of the session, some reminders and information, in particular concerning the Health Police Decision recently taken on phenoxyethanol.
The ANSM has 70 inspectors in charge of health products. They carry out daily inspections, and 10% of them are unannounced as soon as the Agency suspects that there may be a risk to consumers. As a preamble to her talk, Vanessa Picot focused on a few new work tools adopted by the Agency:
• Documentary inspections: as part of the follow-up of injunctions, it is the operators who now go to the Agency for it to check that all the corrections requested have been made
• The improvement of reports: a whistleblower procedure with a dedicated mailbox has been set up on the ANSM website
• An inspection management tool: it allows all the data to be shared between the Agency’s various divisions… In 2018, 1/3 of the inspections concerned administrative follow-up, 1/3 GMP and 1/3 the campaign of products used by professionals. A total of 16 injunctions have been published for cosmetic products.
The cosmetics to personalize campaign
The inspection campaign on cosmetic products to be personalised ran from 2016 to 2018, covering different types of establishments and distribution channels.
Two concepts were distinguished.
• The “Personalized formula” concept: based on a skin diagnosis, one or more active ingredients are introduced into an existing base cream. The product may be prepared ...