MoCRA Update: Registration Delay and Key Requirements

**MoCRA Update: Registration Delay and Key Requirements**

The FDA has just announced a delay in MoCRA registration, moving the deadline from December 29, 2023, to July 1, 2024. Despite the extension, the FDA strongly encourages businesses to commence facility and product listing registrations by the original deadline of December 29, 2023.

This concise update is extracted from the FDA's guidelines; for more in-depth information, refer to their comprehensive MoCRA guide [here](https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022). In December 2022, the Modernization of Cosmetics Regulation Act (MoCRA) expanded the FDA's regulatory authority over most cosmetics, introducing significant changes that may impact your cosmetics business. Effective July 1, 2024, MoCRA grants the FDA increased authority to regulate cosmetics, ensuring consumer and industry worker safety and health.

MoCRA applies to every cosmetics company responsible for a finished cosmetic product sold in the United States. However, certain small businesses are exempt from registration (businesses with average gross annual sales for the previous three-year period of less than US$1,000,000.00).

These exemptions do not apply to companies or facilities manufacturing specific cosmetic products, such as those regularly coming into contact with the mucus membrane of the eye, injected products, products intended for internal use, and products intended to alter appearance for more than 24 hours under customary conditions of use.

1. Evaluate if your brand produces over $1 million per year in the last three consecutive years.

2. Assess if your brand produces products for the mucus membrane (eyes), alters appearance for more than 24 hours, etc.

3. If the answers to the above are yes, register your cosmetics facility with the FDA and renew every two years, obtaining a registration number for each facility. Establish a system for adverse events (e.g., skin reactions, hair loss, eye issues).

4. A responsible person must register your products by July 1, 2024, and provide annual updates [details here](https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022).

A "Responsible person" is the manufacturer, packer, or distributor whose name appears on the label of the cosmetic product.

5. Include adverse event contact details on all product packaging (e.g., manufactured by, address, phone number, website information, or email).

6. Maintain up-to-date and complete safety substantiation records for all products on sale in the United States.

7. List known fragrance allergens on labels (available on the FDA website).

If your skin/hair/cosmetics line is just starting or has less than $1 million in sales, and you don't produce products for the mucus membrane, eyes, injection, internal use, or changes in appearance for 24 hours, you don't need to register your facility or products with the FDA. However, following guidelines for proper labeling and recording is encouraged.

1. Create a system for adverse events, reviewing, reporting, and investigating any feedback from customers.

2. Maintain records of safety substantiation, assessing formulations and ingredients.

3. Ensure label compliance, including adverse event contact information on packaging.

This information provides insight into upcoming MoCRA requirements. Additional details can be found in the provided links. Keep in mind that some details, such as the registration portal and safety requirements, are still being decided by regulators, and more information is in development.

**General Info:**

-https://direct.fda.gov/apex/f?p=100:LOGIN_DESKTOP

- [FDA MoCRA Overview](https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022)

- [Cosmetics and Toiletries MoCRA Compliance Checklist](https://www.cosmeticsandtoiletries.com/regulations/regional/article/22876564/a-modernization-of-cosmetics-regulation-act-mocra-compliance-checklist)

**Registration Info:**

- [FDA MoCRA Registration](https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022)

**Draft Guidance:**

- [FDA Draft Guidance on Registration and Listing](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/draft-guidance-industry-registration-and-listing-cosmetic-product-facilities-and-products?utm_medium=email&utm_source=govdelivery)

**IBA:**

- [Personal Care Council - MoCRA](https://www.personalcarecouncil.org/public-policy/mocra/)