As of November 4, 2015 (and amended on November 7), this decree adapts the Public Health Code to certain provisions of European Cosmetic Regulation 1223/2009. On the agenda: the creation of a national cosmetovigilance system or the modification of the labelling rules, with the possibility of 5th class fines applicable to distributors. In passing, it also introduces the new declaration of establishment to be sent to the ANSM.
Declaration of establishment
It is detailed in the article R. 5131-1 and now includes the following information: 1. The name or corporate name and address of the undertaking to which the establishment belongs and the address of the establishment which carries on the activity of manufacturing or packaging cosmetic products. 2. The name and function of the declarant. 3. The name, function and qualifications of the person(s) responsible for the safety assessment. 4. Administrative information relating to the establishment where the manufacturing or packaging of cosmetic products is carried out. 5. Technical information relating to the manufacturing and packaging activities of cosmetic products, as well as the existence, where applicable, of other activities carried out on the site.
The list of information mentioned in points 4 and 5 must be specified by order of the Minister in charge of health after advice from the ANSM. The cessation of the establishment's activity must be communicated without delay to the ANSM by any means making it possible to acknowledge receipt.
Labelling of cosmetic products
L' article R. 5131-4 is amended to fully incorporate the provisions of Article 19 of Cosmetics Regulation 1223/2009. This concerns all the particulars which must be marked'in indelible, …
