MoCRA Public Comment Request: Cosmetic Labelling, Facility Registration and Product Listing Program
The FDA has issued a notice soliciting comments on information about the new statutory provisions for cosmetic labelling, facility registration and products listing.
The Modernisation of Cosmetics Regulation Act (MoCRA) is the most significant expansion of the FDA’s authority to regulate cosmetics since the Federal Food, Drug and Cosmetic (FD&C) act was passed in 1938. MoCRA provides new authorities to the FDA including record access and mandatory recall authority. MoCRA requires actors in the industry to submit adverse event reports, register manufacturing facilities, list each marketed product with the FDA and appoint a responsible person to maintain records supporting adequate substantiation on the product.
MoCRA requires the cosmetic industry comply with regulations that will be established by the FDA for:
- Good Manufacturing Practice (GMP) requirements for cosmetic manufacturing facilities
- Fragrance allergen labelling requirements
- Standardised testing methods for detecting and identifying asbestos in talc-containing cosmetic products
This is an opportunity for the industry to provide input to the FDA on cosmetic labelling, facility registration and product listing.
Either electronic or written comments must be submitted by 30 June 2023.
Submissions will be made public, contributors are responsible for ensuring submissions do not include any confidential information.
FDA MoCRA GMP Meeting - Extended Time
The FDA is hosting a virtual listening session on 1 June 2023.
The purpose of the listening session is to consult cosmetic manufacturers, businesses and consumer organisations to inform FDA’s efforts in developing regulations to establish good manufacturing practices (GMPS) for manufacturing facilities manufacturing and processing cosmetic products distributed in the US.
The agenda is as followed:
- Identify any national or international standard (e.g ISO standard 22716:2007) and the extent to which it would be practical for GMP regulations to be consistent with such standard.
- Describe what constitutes sufficient flexibility within GMP for cosmetic products to ensure regulations are practicable for all sizes and types of facilities
- Describe what constitutes simplified GMP requirements for smaller cosmetic businesses.
- Describe appropriate compliance times for GMP regulations.
- Discuss the extent to which cosmetic product manufacturers are already following a national or international standard.
- Discuss how implementing GMP regulations would impact the likelihood of a recall of cosmetic products.
Deadline to register to attend the listening is 1 June 20203.
You may submit written/electronic comments on https://www.regulations.gov/ to Docket No. FDA-2023-N-1466
Ireland Implements SDS Compliance Checks
The Health and Safety Authority (HSA) Ireland has implemented checks to ensure the compliance of Safety Data Sheets as part of the EU-wide enforcement project.
Member State national enforcement authorities are now inspecting the compliance of safety data sheets (SDSs) for chemicals sold on the EU market.The main objective of these checks is to assess whether duty holders have updated and provided SDS in accordance with the new requirements of Annex II of REACH Regulation.. The results of the checks are expected to be reported in 2024.
The HSA will be checking to ensure the format and content of the SDS aligns with the sixth and seventh editions of the United Nations Globally Harmonised System (GHS) of Classification and Labelling of Chemicals.
New Inspection Protocol for Hazardous Chemicals in China
China’s General Administration of Customs have further strengthened the inspection and supervision of imported hazardous chemicals.
Under the new inspection method the following is required for every batch of imported hazardous chemicals:
- Document verification
- Port inspection
- Destination inspection
The following items must be inspected and verified for import and export:
- The main ingredients or components of the products, including physical and chemical properties
- GHS labels in line with Chinese GHS requirements for imported products
- Safety Data Sheets (SDSs)
Washington Signs Toxic Free Cosmetic Act
This week Governor Jay Inslee signed The Toxic-Free Cosmetics Act (HB 1047) into law. The act bans more chemicals of concern than any other state or deferral law including PFAS, leads, phthalates, and formaldehyde-releasing agents.
The act requires an assessment of chemicals that can impact vulnerable populations. The purpose of this provision is to create incentives for ‘safer’ products for small businesses and independent cosmetologists.
The ban will take effect in 2025 however the formaldehyde releasers ban will have a phased-in approach beginning 2026.
