What is MoCRA  Registration

FDA MoCRA registration is the new requirement as per the Cosmetic Modernization Act. As per  MoCRA the manufacturer of the cosmetic products must register their facility and list the product manufacturer at their facility.  These facilities must also renew their registration every two years.

The MoCRA registration and product listing requirements apply to every facility engaged in manufacturing or processing a cosmetic product for sale in the United States .

What type of Facilities are Exempted from the FDA MoCRA Registration? 

Under the Modernization of Cosmetics Regulation Act (MoCRA), small businesses are exempt from the registration and listing requirements if they meet the following criteria:

• Average gross annual sales in the United States of cosmetic products for the previous 3-year period is less than $1,000,000, adjusted for inflation.
• Do not manufacture or process certain cosmetic products described in section 612(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The cosmetic products that are not exempt from the registration and listing requirements, regardless of the company’s size, are:

• Cosmetic products that regularly come into contact with the mucous membrane of the eye under customary or usual conditions.
• Cosmetic products that are injected.
• Cosmetic products that are intended for internal use.
• Cosmetic products that are intended to alter appearance for more than 24 hours under customary or usual conditions and removal by the consumer is not part of such conditions of use.

Examples of Non-Exempt Cosmetic Products

• Contact lens solution
• Eyeliner
• Mascara
• Lipstick
• Lip gloss
• Foundation
• Concealer
• Blush
• Bronzer
• Self-tanner
• Hair dye
• Nail polish

Also, cosmetic products, which are also regulated as Devices or Drugs such as sunscreen, are exempted from the FDA’s MoCRA registration requirements.

What information is required for MoCRA Facility Registration

To register a cosmetic product facility, the owner or operator must provide the following information:

• Name of the owner and operator of the facility
• Facility name, address, email address, and telephone number
• Contact details of the United States agent of the facility (if foreign facility), including name, phone number, and email address.
• Facility registration number (if previously assigned)
• All brand names under which cosmetic products manufactured or processed in the facility are sold
• Product category or categories (refer to Appendix A of the FDA’s draft guidance document) and responsible person for each cosmetic product manufactured or processed at the facility

What information is required for MoCRA Facility Registration

1. FDA registration number of the facility
2. Name of the cosmetic product as it appears on the product label
3. Name and telephone number of the responsible person
4. List of ingredients in the product, including any fragrances, flavors, or colors
5. Product category
6. Product listing number, if any, previously assigned by the FDA.

FDAbasics shall assist you with facility registration product listing and act as a US agent for foreign companies. Please click contact us for more information.

You can find more information regarding FDA cosmetic compliance requirements on the below link.

What you should know about FDA’s cosmetics new MoCRA requirements.

Cosmetic Labeling Requirements FDA