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Under MoCRA, a responsible person (RP) is defined as the manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label, in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. The RP has various responsibilities, including:

• Product Listing

• Adverse event reporting

• Safety substantiation

• Disclosure of fragrance allergens

• Fragrance records access

• Labelling

• Contact information on the label

• Record-keeping

• Product recall in case of non-compliance (and upon request by the FDA)

Product listing is applicable to all products introduced into the US market by both US and foreign brands.

The responsible person is responsible for submitting the product listing. The product listing process will be carried out via electronic submission portal Cosmetics Direct.

The following information must be included in the product listing:

• Facility registration number of each facility where the cosmetic product is manufactured.

• Name and contact number of the responsible person

• Name of the cosmetic product

• Cosmetic category of the product

• List of ingredients, including fragrances, flavors, or colors

• Product listing number (if previously assigned)

• Type of submission (initial, update to content (annual), abbreviated renewal)

Each product will be assigned a listing number.

Yes. MoCRA allows flexible listings, which means that multiple cosmetic products with identical formulations, or formulations that differ only in colour, fragrance or flavour, or quantity of contents, may be grouped under the same listing.

Mandatory product listings must be completed by July 1, 2024. These listings must be updated annually.

New products must be registered within 120 days of their introduction into interstate commerce.

The mandatory facility registration affects all existing facilities, both domestic and foreign. Foreign facilities require a US agent who will handle the facility registration. It is important to note that a physical address in the US must be provided, and P.O. boxes are not accepted.

The term ‘facility’ includes any establishment, including importers, involved in the manufacturing or processing of cosmetic products distributed in the United States. Certain establishments such as beauty shops/salons, retailers, pharmacies, hospitals, hotels, etc., are excluded from this term. It does not affect facilities that solely label or re-label, package or repackage or hold or distribute products.

The following information must be included:

• Facility’s name, physical address, email address, and telephone number

• The name of the owner and/or operator of the facility

• Contact information of the US agent (for foreign entities)

• Facility registration number (if previously assigned)

• All brand names produced at the facility

• Product category and the RP for each product manufactured at the facility

• Type of submission (initial, amended, biennial renewal, or abbreviated renewal)

To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration.

Mandatory facility registration must be completed by July 1, 2024. Registrations must be renewed every two years.

Following the deadline, new businesses will have 60 days after beginning manufacturing to register with the FDA.

FEI is an FDA Establishment Identifier or Firm Establishment Identifier that is assigned by the FDA to identify a firm. FDA intends to use FEI as the required facility registration number.

To facilitate the registration process, the owner or operator of a facility will need to obtain an FEI number before submitting the facility registration. To determine if an entity already has an FEI number, please refer to FEI Search Portal. If your firm doesn’t have FEI, you can request it at feiportal@fda.hhs.gov.

MoCRA exempts certain small businesses from GMP, facility registration and product listing. Small businesses are defined as businesses with average gross annual sales in the USA for the previous 3-year period of less than $1,000,000 (adjusted for inflation). However, this exemption does not apply to facilities producing products that:

• Come into contact with the mucous membrane of the eyes.

• Are injected (e.g., tattoos).

• Are intended for internal use (e.g., mouthwash).

• Alter appearance for more than 24 hours under the usual conditions of use.

Exemptions also apply to certain facilities that are subject to requirements for devices and drugs.

Product labels must include:

• A US address.

• A US phone number or

• Electronic contact information (e.g. a website), which is required as a means to contact the Responsible Person (RP) in case of any adverse events.

• Fragrance allergens, if present in the cosmetic product (the FDA will determine which substances are considered allergens).

Labels for professional-use products must comply with the general labelling requirements for cosmetic products and must include a statement indicating that the product should be used only by professionals.

The labelling for professional-use products must be updated by December 29, 2024.

The responsible contact information and fragrance allergens must be listed on product labels by December 29, 2024.