December 14, 2023
On January1, 2024, cosmetics and tattooing products will be removed from the list of health products drawn up under article L. 5311-1 of the French Public Health Code (CSP), and will therefore no longer fall within the remit of the ANSM.
The market surveillance and control authority will therefore no longer be the ANSM, but the DGCCRF.
The ANSM will retain its authority to draw up and take decisions on Good Laboratory Practice (GLP) and Good Practice for non-clinical safety studies designed to assess the safety of cosmetic products, as provided for in article L. 5131-4 of the CSP, which remain applicable to the cosmetics industry.
It also retains responsibility for issuing clinical trial authorizations for cosmetic products.
On this point, see the ANSM press release dated 2/01/2024.
Declarations of establishments manufacturing or packaging cosmetics and tattoo products will henceforth be sent to the DGCCRF: article L. 5131-2 CSP in the version applicable from January1, 2024 stipulates that the DGCCRF will receive the necessary declarations for " the opening and operation of any establishment manufacturing or packaging, even on an ancillary basis, cosmetic products, as well as the extension of the activity of an establishment to such operations (...)". In addition, he must be informed of any change in the elements making up the declaration.
Decree no. 2023-1113 of November 28, 2023, concerning the authorities responsible for monitoring and vigilance of cosmetics and tattoo products, specifies the application of this decree in article R. 5131-1 of the CSP. A decree issued by the Minister for Consumer Affairs will set out the procedures for submitting the declaration and the list of documents to be transmitted.
Note that the same provisions have been adopted in article R. 513-10-2 of the CSP concerning tattooing products.
Responsibilities for cosmetovigilance and market surveillance were previously shared between the ANSM and the DGCCRF: the DGCCRF forwarded to the ANSM any reports of serious adverse reactions (SARs) of which it was aware, and carried out market surveillance in collaboration with the ANSM under a cooperation protocol drawn up in December 2006. From now on, these responsibilities will be shared between the DGCCRF and ANSES.
On the other hand, Article 205 of the Finance Act for 2023 has not yet clarified the exact missions that will be devolved to the DGCCRF and ANSES, which is why this same provision empowers the Government to take measures by ordinance, within one year of the law's promulgation, to bring non-codified codes and laws into line with the provisions that have removed cosmetics and tattoo products from the scope of health products. We note, moreover, that no implementing decree has yet been presented for the implementation of this new legislative framework.
However, relations between these 2 authorities are already organized in terms of the framework applicable to the surveillance of food, food supplements and plant health products. It is likely that a similar scheme will be proposed, with surveillance, investigation and control powers entrusted to the DGCCRF, and decision-making and health police powers entrusted to ANSES.
To this end, the text already provides for :
It should be noted that these same provisions also maintain the powers of all health safety inspectorates. The following are competent to investigate and record infringements of articles L. 5431-2 et seq. of the CSP (e.g. failure to declare, to make appropriate modifications, to notify the European Commission):
Decree no. 2023-1113 of November 28, 2023 on the authorities responsible for monitoring and vigilance of cosmetics and tattoo products clarifies the role of all players involved in the vigilance of cosmetics and tattoo products.
Under the terms of the new article R. 5131-8 of the CSP, the national cosmetovigilance system now includes :
The same players also join the national tattoo product vigilance system, as described in the new article R. 513-10-8 of the CSP.
From January 1, 2024, ANSES and DGCCRF will be responsible for monitoring cosmetics and tattoo products.
As a result, vigilance operators must immediately report all SAEs linked to these products to the Director General of ANSES (article L. 513-10-11 CSP).
It should also be noted that a new article R. 5131-13 of the CSP provides for the transmission of information concerning cosmetovigilance gathered by the DGCCRF as part of its mission to monitor the cosmetics market, to ANSES.
As part of these new responsibilities, these authorities will now be empowered to take preventive and corrective measures ranging from the dissemination of safety information to the suspension of product marketing (animal health measures).
Finally, it should be noted that the decree of November 28, 2023 also simplifies the procedures for requesting information from manufacturers on product composition, the presence of hazardous substances and adverse effects (new article R. 513-10-14 of the CSP). These requests must be kept on file by manufacturers.
