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. After reviewing the ten points in Annex I of Cosmetics Regulation 1223/2009, the inspectors dealt with Part B and the particular case of cosmetic products to be personalized.
Second part of article Safety assessment report: ANSM expectations (1/2)
Due to the considerable number of operators placing this type of products on the market, with many different concepts, ANSM launched a campaign of inspections focused on cosmetic products to be personalized in 2016, and prolonged it in 2017. Manuela Boutillier and Vanessa Picot decided to target this type of products, because they have raised new issues.
Particular case: cosmetic products to be personalized
• Non-conformity
No safety reports to provide a framework for the placing on the market of all possible combinations, so that the products can be guaranteed as safe for consumers, used as such.
• ANSM comment
The idea is not to draft one safety report for each combination, but at least one for all of them.
• Non-conformity
Absence of any strategy to assess the cosmetic products to be personalized.
• ANSM comment
The assessment strategy should be based on specific data:
• Regulatory data (maximum percentages of regulated substances, interactions of certain raw materials)
• Stability and compatibility tests, physico-chemical and microbiological specifications on the mixtures, and challenge test on the most sensitive formula
• Toxicological data (safety of the mixtures)
• Risk of misuse …
