USA: MoCRA

USA: MoCRA

  • 16 Jan 2023

!! Last information !!

-> The November 8, 2023, FDA announced a delayed of 6 months for the registration of cosmetic products and establishments, after the December 29, 2023 ; until July 1, 2024. FDA announced also to delay until July 1, 2024, the registration requirement of new establishments and cosmetic products marketed after enactement of MocRA.


The December 29, 2022, the Modernization of Cosmetics Regulation Act (MoCRA) has adopted. It's the first major amendment of the regulation of cosmetic products in USA since 1938.

What are the news?

1/ Definition of the Responsible Person - It's the manufacturer, the packager or the distributor which is indicated on the label of the cosmetic product - She will have to ensure the following items are respected. Please note, it's not mandatory to be located in USA.

2/ Mandatory to register the cosmetic products and the establishments (Section 607) - Will be effective no later than 12/29/2023 -> 07/01/2024.

- Registration of establishemnts - Are concerned: the companies which manufacture or process cosmetic products for US distribution (are excluded: the compaies which solely performs labeling, relabeling, packaging, repackaging, holding and/or distributing of cosmetic products, the manufacturing of raw materials,...).

  • Existing establishments (before the December 29, 2022): they must register within 1 year after the date of enactement of MoCRA (December 29, 2023 -> July 1, 2024).
  • New establishments (after the December 29, 2022): they must register within 60 days after beginning to manufacture cosmetic products or before the February 27, 2024 -> July 1, 2024) (the later date will be chosen).

Be careful, all registrations must be renewed biennially - FDA could suspend the registration of a establishment if a cosmetic product manufactures in this establishment may be dangerous for the user health and others products are also manufactured by the establishment which could be concerned.

- Registration of cosmetic products - The Responsible Person must list each cosmetic product distributed in US with the FDA (included its ingredients, the registration number of establishment,...).

  • For the cosmetic products marketed before the enactment of MoCRA (12/29/2022), the Responsible Person must submit product listings no later than 1 year after enactement of MoCRA (December 29, 2023 -> July 1, 2024).
  • For the cosmetic products marketed after enactment of MoCRA (12/29/2022), the Responsible Person must submit product listings within 120 days of marketing or before the April 28, 2024 -> July 1, 2024.

Be careful, the Responsible Person must update product listings annually.

Please note, a single listing submission for a cosmetic product may include multiple cosmetic products with formulations which differ only by the color, the fragrance, the aroma or the quantity of content.

The small companies according MoCRA wouldn't be subject to these registrations - Be careful for exceptions!

3/ Labeling (Section 609) - It must include:

  • Contact information (addresse in US or phone number US or email) through which the Responsible Person can receive adverse event reports - Please note, it's not mandatory this contact is the Responsible Person; she may be designated by the Responsible Person who will be responsible of her cosmetics marketed in US - Takes effect 2 years after the date of enactment of MoCRA (December 29, 2024).
  • For the professional cosmetic products, the label must include the same information than the cosmetic products for sale and it must be indicated that only licensed professionals may use the product - Takes effect 1 year after the date of enactment of MoCRA (December 29, 2023).
  • The fragrance allergens must be identified once FDA will have published the fragrance allergen rule (cf. item 6).

4/ Justification of the safety of cosmetic products (Section 608) - The Responsible Person must ensure and maintain records supporting "adequate substantiation" to justify that a cosmetic product is "safe" for the user under normal and reasonably foreseeable conditions of use.

5/ Animal Testing - They shouldn't be used for the purposes of safety testing on cosmetic products and they should be phased out with the exception of justified and appropriate permissions.

6/ Ingredients:

  • Talc (with asbestos) - FDA must submit regulations/methids which will allow to detect and identify the asbestos in the cosmetic products with talc - The regulation proposal must be published no later than 1 year after the date of enactment of MoCRA (December 29, 2023) - The definitive publication is waited in 180 days after the publication of the regulation proposal.
  • PFAS (=per- and polyfluoroalkyl substances) - FDA must evaluate their usage and safety in the cosmetic products - A report with the results must be published in 3 years after the date of enactment of MoCRA (December 29, 2025).
  • The fragrance allergens - The regulation proposal must be published in 18 months after the date of enactment of MoCRA (June 29, 2024) - The definitive publication of the regulation is waited in 180 days after the publication of the regulation proposal.

7/ Good Manufacturing Practice (GMP) (Section 606) - It will be mandatory to follow and respect the GMP which should be simialr with the existing standards (national and international) - They must be pusblished by FDA within 3 years with a law project within 2 years. (The small companies according MoCRA wouldn't be subject to GMP - Be careful for exceoptions!)

8/ Adverse Event recordkeeping and Serious Adverse Event reporting (Section 605):

  • The Responsible Person must maintain records of any Adverse Events associated with the use of cosmetic products for 6 years (or 3 years for some small companies).
  • The serious Adverse Events must be reported to FDA no later than 15 days after learning about the issue. The Responsible Person must also provide any new related to the Serious Adverse Event for 1 year following the initial submission.

(Serious Adverse Event = event resulting in death, endangerment, hospitalization, disability or persistent or serious inability, disfigurement (including serious and persistent skin rashes), second- or third- degree burns, significant hair los or persistent or significant alteration of appearance, other than as intended under normal and reasonably foreseeable conditions of use; and requires a medical/surgical intervention).

9/ Products recall (Section 611) - FDA could mandatory recall if the product is adulterated, misbranded or its usage may cause Serious Adverse Events - Before, FDA could request to the Responsible Person to do a voluntary recall - In case of refusal and it's justified, FDA could recall immediately the marketed products (when a reall is required, a public notification must be done) - Will be effective no later than 12/29/2023.