On June 29, 2017, at the meeting organized by ANSM (French National Agency of Medicine and Health Products Safety), which gathered cosmetics safety assessors, the inspection Agency presented the non-conformities found in safety reports during their latest inspections, and explained which points are to be improved and which deviations are to be corrected, referring, point by point, to Annex I of Cosmetics Regulation 1223/2009.
Manuela Boutillier and Vanessa Picot are both cosmetics inspectors at the ANSM market surveillance division. They presented the results of the Agency’s inspections and the non-conformities found in cosmetics safety reports.
As an introduction to their presentation, they made an update on the 2014-2016 inspections, which had consequences as regards Product Information Files (PIF):
• 2014: 25 manufacturers/Responsible Persons inspected, 10 injunctions, 2 reminders of the law
• 2015: 20 manufacturers, 2 DPS (health authority decisions), 2 injunctions, 7 reminders of the law
• 2016: 17 manufacturers, 1 DPS, 8 injunctions
‘These figures vary from one year to another, due to the different inspection themes,’ Manuela Boutillier declared, ‘and most often, they are due to the Product Information File or safety report missing, and to very incomplete safety assessments.’
Given this context, ANSM decided to gather safety assessors in their premises, in order to pass on a few messages and improve practices to better guarantee consumer safety… which would also ensure a more peaceful media environment (read our article on this issue, Safety assessment: 0 deviation for 0 controversy?).
Safety report
The content of the cosmetic product safety report is detailed in Annex I of Cosmetics Regulation 1223/2009. It …
