At the regulatory congress organized by the Cosmetic Valley in Chartres, France, in November 2016, Sophie Roques-Violin and Vanessa Picot, both from the ANSM (French National Agency for Medicines and Health Products Safety), made a presentation of their action and provided the results of the controls carried out on the cosmetics market over the year 2016. They focused in particular on an emerging product category: personalized cosmetics.
After presenting the procedures of the inspection campaign on personalized cosmetics carried out in 2016 (see our article on this issue ), Vanessa Picot, Cosmetic Product Inspector at the ANSM, provided its results and gave examples, with concrete cases, of the issues raised by personalized cosmetics in terms of regulatory requirements or GMPs.
Regulatory aspects of a few concrete cases
1. Personalized cosmetic product prepared in a jar with a determined cream and actives whose quantity is always the same
The principle is that consumers have a cream jar (neutral base) to which they must add various components (A, B, C).
In this case, the ANSM expects a PIF providing a framework for all combinations, including:
• The various formulas
• The compatibility and stability studies
• The microbiological specifications and challenge tests
• A safety report to sum it all up
The label should display:
• Expiry indications
• Batch numbers
• Lists of ingredients
If the A, B, and C quantities to be added to the neutral base are defined (and consumers only have the right dose to be incorporated), the absence of misuse is guaranteed.
But beware, if one of the A, B, or C elements may …
