January 12, 2024
Part 1: Reminder of New Regulations, MoCRA in the United States
On December 29, 2022, the "Modernization of Cosmetics Regulation Act" or MoCRA was enacted through the signature of the integrated spending bill by President Biden. This law introduces new regulations regarding cosmetic facility registration, product registration, record-keeping, adverse event reporting, safety substantiation, Good Manufacturing Practices (GMP), recalls, and more. MOCRA is significant in that it is the first revision of the U.S. Cosmetics Act at the federal level since 1938.
Enactment of MoCRA (Modernization of Cosmetics Regulation Act)
- What MoCRA focuses on is the safety of products for consumers.
- Facility Registered Manufacturer (US agent required)
- Product Registration RP (Responsible Person)
- Safety certification data TRA (Toxicological Risk Assessment)
- Labeling (RP information + allergen)
- GMP (ISO 22716 base revision scheduled)
- Adverse Case Reporting Market Monitoring (US agent Recommendation)
The key amendments brought by MoCRA are as follows:
1. Cosmetic Facility Registration:
A new requirement has been established for manufacturers who manufacture or process cosmetics to register their facilities.
- Manufacturers that mainly manufacture or process cosmetics require registration.
- Any changes in registration information must be submitted within 60 days, with biennial renewals required.
- New facilities must register within 60 days of commencing manufacturing.
- Existing companies producing products already on the market must register their facilities by December 29, 2023.
- Exemption: Label companies, packaging companies, distributors, raw material companies, testing institutes
* Foreign manufacturing facilities require the appointment of a U.S. Agent.
2. Product Registration:
There has been a revision that requires RP(Responsible Persons) to register products. RPs representing the manufacturer, brand, or distributor with their name on the label must register existing products by December 29, 2023, and new products within 120 days. Annual updates are mandatory.
- Variants of the same formula, color, or flavor: Submit a single listing
- Submit product registration: Proceed together with facility registration or separately
- Product registration number: not disclosed
3. Safety Substantiation:
RPs have an obligation to ensure proper substantiation of safety and maintain records supporting the safety of cosmetics and their ingredients.
- Appropriate verification: Data prepared by qualified experts based on scientific research and experience, indicating the validity of cosmetics and their ingredients. Must have tests, studies, analyzes or other safety supporting data prepared to evaluate safety.
- Safety: Must be harmless to users who use the product under the conditions of use specified on the label or under normal conditions of use.
- The FDA can request safety substantiation data at any time.
- Product-specific testing reviews and safety reports are mandatory.
4. Labeling - 3 new requirements
There are three new requirements that require labeling.
- Allergen
It must be included in the INCI list. The FDA will set and announce threshold figures related to this. It's a plan. (Draft: 2024.06, final regulation 2024.12) - RESPONSIBLE PERSON (RP)
According to the current FDA definition, the RP is the entity indicated on the label as a manufacturer or distributor, and the RP's U.S. address, phone number, or electronic address (website, QR code, etc.) must be listed on the label. - PROFESSIONAL PRODUCTS
The fact that the product is for professional use must be clearly and emphatically stated.
Professional = A person permitted by the relevant authorities to practice in fields such as beauty, nail care, hair salons, or esthetics.
5. Adverse Event Reporting:
A new obligation to report adverse events has been established.
- Adverse events:
The RP of a product must maintain reports and records of adverse events related to the use of cosmetics for six years. Small businesses unrelated to the manufacturing or processing of cosmetics must keep records for three years. - Significant adverse events must be reported within 15 days, potentially leading to product recalls due to non-compliance.
6. Good Manufacturing Practices (GMP):
What is GMP?
GMP, or Good Manufacturing Practices, are rules and guidelines that industries like pharmaceuticals follow to make sure their products are safe and of high quality. It involves things like keeping manufacturing facilities clean, training employees, and testing products to ensure they work as they should. GMP is important to make sure the products we use are safe and effective.
The goal of GMP is to protect public health and prevent the entry of substandard cosmetic products into the market.
- Cosmetic manufacturing facilities must adhere to GMP and comply with national/international standards.
- Simplified GMP or grace periods are considered for small businesses.
Collaboration with cosmetic manufacturers, consumer organizations, and other experts is recommended for discussing these requirements.
MoCRA Announcement: Late 2022
GMP Draft (1st proposal before final GMP release): Late 2024
GMP Final (Manufacturing facilities must comply with the final GMP): Late 2025
7. Other Changes:
- PFAS (perfluorinated compounds)
Evaluation of the usability of perfluoroalkyl and polyfluoroalkyl cosmetic raw materials
- The safety evaluation report is scheduled to be posted on the FDA website by December 29, 2025.
- Products containing talc (TALC)
Recommendation on standardized test methods for detection and identification of asbestos in talc-containing cosmetics (before December 29, 2023)
- Establishment of final regulations within 180 days after the end of the public comment period for the first recommendation
- Animal testing
Opinion that animal testing should not be used for safety testing purposes for cosmetics and should be gradually abolished except in special cases.
- The ban on animal testing is not officially regulated.
MoCRA Deadlines:
- December 29, 2022: MoCRA Announcement
- December 29, 2023: MoCRA Effective Date (Safety Substantiation, Adverse Event Reporting)
- June 29, 2024: Draft of Allergen Inducing List (~180 days before final rule by December 29, 2024)
- July 1, 2024: Product and Facility Registration delayed
- December 29, 2024: Labeling Requirements (RP Information, Professional Use, etc.), GMP Draft (~360 days before final rule by December 29, 2025)
- December 29, 2025: PFAS Reports on FDA Website
https://www.fda.gov/cosmetics/registration-listing-cosmetic-product-facilities-and-products
