1. Certification Overview
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) was included in the 2022 Consolidated Appropriations Act of 2023, and new U.S. cosmetic regulations were implemented under this MoCRA Act.
With the enforcement of this law, the previously voluntary registration of cosmetic products has become mandatory, and products to be marketed in the United States must be registered within 120 days prior to market launch. Facility registration for cosmetic manufacturers and processors has also become mandatory, and manufacturing facilities located outside the United States must designate a U.S. Agent.
2. Regulatory agencies & Basic information
| 규제 기관 | FDA |
| 시험 기관 | 별도의 시험 기관 제시 X |
| 평균 인증 소요 기간/비용 | 제품에 따라 상이 |
| 언어 | Englisg |
| 대리인 | 미국 내 U.S Agent |
Cosmetic Product Classification and Code
3. Registration Process
- Mail / Email Submission
1. Facility Registration
You must mail the completed FDA Form 5066 to the FDA Cosmetic Product Facilities and Products Registration and Listing Program (Address: Food and Drug Administration, Office of Cosmetics and Colors, Registration and Listing of Cosmetic Product Facilities and Products Program, 5001 Campus Drive, CPK1, Room 1B-046, College Park, MD 20740-3835) or submit it via email to RLC-PaperSubmissions@fda.hhs.gov.
2. Product Registration
You must mail the completed FDA Form 5067 to the FDA Cosmetic Product Facilities and Products Registration and Listing Program (Address: Food and Drug Administration, Office of Cosmetics and Colors, Registration and Listing of Cosmetic Product Facilities and Products Program, 5001 Campus Drive, CPK1, Room 1B-046, College Park, MD 20740-3835) or submit it via email to RLC-PaperSubmissions@fda.hhs.gov.
- E-Submission – Cosmetic Direct
1. Facility Registration
1) Access the Cosmetic Direct website (Registration of Cosmetic Product Facility) – Cosmetic Direct Portal
2) New registration Create or Upload existing files
[New registration]
① Determining document type
② Register details
③ Cosmetics Brand Information Registration
④ Confirmation Registration
⑤ Register additional information for authorized agent
[Upload existing files]
① Upload Zip file containing SPL (Structured Product Labeling) file드
2. Product Registration
1) Access the Cosmetic Direct website (Cosmetic Product Listing) – Cosmetic Direct Porral
2) New registration Create or Upload existing files
[New registration]
① Determining document type
② Enter list of cosmetic products, materials, and facilities
- Enter cosmetics category code
- Cosmetic ingredient input
- Selecting a list of facilities for cosmetic manufacturers and processors
③ Product Photo Registration
④ Confirmation Registration
⑤ Register additional information for authorized agent
[Upload existing files]
① Upload a Zip file containing the SPL (Structured Product Labeling) file (the Zip file must include XML and JPG files)
4. Required Documents
1. Facility Registration – Form FDA 5066
1) Document Type (Select one of the types below)
- First registration
- Modification (Change registration or cancel registration)
- Registration renewal (if there are changes)
- Simplified registration renewal (if no changes)
2) Registration (Provide the following required information)
- Facility Name
- Facility FEI (FDA Facility Identification Number)
- Road name address
- city
- State or local
- Zip code
- Country (excluding the United States)
- Facility Email
- Facility phone number (including country/area code)
- Name of the facility owner and/or operator
- Brand name of cosmetics manufactured or processed at this facility (i.e., all brand names of cosmetics manufactured or processed at this facility that are sold)
- Name of the person in charge for each cosmetics brand
- Product Category Code (Cosmetic Product Category and Code Reference)
3) U.S. Agent Information (in the case of overseas manufacturers)
- US agent name
- Email address of the U.S. contact person (If no email address is available, please enter “N/A”)
- US contact number (including country/area code)
4) Confirmation
5) Additional Information on Authorized Agents
- Additional contact name
- Additional contact email
- Additional contact phone number (including country/area code)
- Additional contact phone extension
2. Cosmetic Product Registration
1) Document Type (Select one of the types below)
- First registration
- Update (Annual) – Changes to product information or deletion of listings
- Simplified birthday (if no changes)
2) Product List
- Name of the person in charge
- Contact person’s contact information (including country/area code)
- Product Category Code
- Product Name
- Check if the product contains flavorings and/or flavorings
3) List of cosmetic manufacturing or processing facilities
- FDA Facility Identifier (FEI) for each facility where products are manufactured or processed
4) List of cosmetic ingredients
- In accordance with 21 CFR section 701.3, identify each ingredient or create a list of cosmetic ingredients using the common or ordinary names of the ingredients.
- Indicate which ingredients are applied to which products
5) Confirmation
6) Additional Information on Authorized Agents
- Additional contact name
- Additional contact email
- Additional contact phone number (including country/area code)
- Additional contact phone extension
5. SBD(Small Business Determination)
The U.S. FDA MoCRA Small Business Exemption Program is a system that exempts or relaxes key regulatory obligations for cosmetic manufacturing facilities and responsible persons whose sales revenue is below a certain threshold.
- Exemption Benefits: Exemption from Facility Registration and Product Listing obligations upon meeting eligibility requirements, and application of relaxed GMP (Good Manufacturing Practice) regulations to be introduced in the future.
- Eligibility Requirements: Companies with an average annual gross sales of cosmetics in the U.S. of less than $1 million over the past three years.
- Relaxed record-keeping period: General businesses are required to retain Adverse Event Records for six years, but small businesses are allowed to shorten the retention period to three years.
- Exceptions (Non-exempt): If any of the following items are manufactured or handled, standard MoCRA regulations (mandatory facility registration and product listing) apply unconditionally, regardless of sales revenue conditions.
- Products that come into continuous contact with the mucous membrane of the eye (e.g., mascara, eyeliner, eyelash adhesive, etc.)
- Injectable products
- Internal use products
- Products that alter appearance for more than 24 hours without the consumer typically removing them (e.g., tattoos, semi-permanent makeup, nail gel, etc.)
6. Validity Period and Maintenance
- Certification Validity Period: Not specified
- Facility Registration: Renewable every 2 years
- Product Listing: Annual Change Updates
- Adverse Event Record Management: General Companies 6 years / Small Businesses 3 years