What risks do I incur if I do not comply with the regulations?

Articles L. 5431-2 through 5431-9 of the French Public Health Code (CSP) provide for criminal penalties for any person(s) in the cosmetic supply chain in the event of non-compliance to the Cosmetics Regulation.
Let’s look at the types of sanctions provided for according to the offences committed.

Two years in prison and €30,000 fine

This sanction can be applied in the following cases:

• Non declaration of establishment provided for in Article L. CSP L.5131-2
• Failure to communicate any modifications made to the constituent elements of this declaration.
• Non-compliance with the European Commission notification obligations, in accordance with articles 13 and 16 of the Cosmetics Regulation.
• Launch of a cosmetic product that does not comply with the rules on substances provided for in Article 14 and Article 15 (paragraphs 1 and 2) of the Cosmetics Regulation.
• Not reporting to the ANSM all serious adverse reactions to a cosmetic product, without delay and by any means.

One year in prison and €15,000 fine

This sanction can be applied in the following cases:

• Not making the Product Information File (PIF), provided for in Article 11 of the Cosmetics Regulation, available to the supervisory authorities, at the address indicated on the label.
• Providing the supervisory authorities with a PIF lacking the mandatory information required in Article 11, paragraph 2 of the Cosmetics Regulation.
• Failure to communicate to the ANSM any of the information mentioned in Article 24 of the Cosmetics Regulation, despite the formal notice.

€45,000 fine

This penalty applies if you do not submit the declaration of establishment, provided for in Article L. 5131-2 of the CSP, to the ANSM, on or before March 31 of the year underway.

€25,000 fine

This penalty applies if the declaration of establishment, to be submitted to the ANSM by March 31 of the year underway at the latest, is incomplete or inaccurate.

€15,000 fine

This sanction applies in the event that a cosmetic product placed on the market does not bear (on the container or packaging) one of the indications provided for in Article 19 of the Cosmetics Regulation.

Suspension or prohibition of activity

Under the provisions of Article L 5312-1 of the CSP, the ANSM may decide:

• To suspend all production activity in connection with a cosmetic product (such as its manufacture, import, distribution or launch), in the event of danger or suspected danger to human health
  • Either for a maximum of one year,
  • Or, until the product concerned is brought into compliance with the Cosmetics Regulation
• To prohibit all activity in connection with a cosmetic product (such as its manufacture, import, distribution or launch), in the event of serious danger or suspected serious danger to human health.