US FDA Grants Extension for MoCRA Compliance
Cosmetics manufacturers in the United States have received a respite as the U.S. Food and Drug Administration (FDA) extends the deadline for compliance with the Modernisation of Cosmetics Regulation Act of 2022 (MoCRA). In a strategic move, the FDA has granted a six-month delay, shifting the compliance date from December 29 to July 2024. This extension provides companies with additional time to register their cosmetic facilities and product listings in accordance with the new obligations outlined in MoCRA.
Notably, the FDA will not enforce the registration requirement for cosmetics manufacturing and processing facilities that commenced operations after December 29, 2022.Once officially registered after MoCRA enactment in July 2024, businesses must update content within 60 days and renew their registration every two years. The FDA has also delayed the enforcement of registering cosmetic products marketed after December 29, 2022, until July 1, 2024.
The FDA encourages stakeholders to leverage this additional time to ensure a smooth transition into compliance with MoCRA. As part of this effort, the FDA has published a compliance policy, providing guidance to assist cosmetic product facility owners or operators in meeting the Federal Food, Drug, and Cosmetic Act requirements for registration and responsible persons.
MoCRA exempts certain small businesses from facility registration and product listing requirements. Specific cosmetic products and facilities are also subject to exemptions. These products include those that are regularly in contact with the mucus membrane of the eye, injected products, those intended for internal use and products altering appearance for more than 24 hours. Notably, exemptions do not apply to facilities or responsible persons for products subject to drug and device requirements
UK Sets Limits on BHT and Kojic Acid in Cosmetics
The UK’s Office for Product Safety and Standards (OPSS) has heightened its focus on two common ingredients in beauty products: kojic acid and butylated hydroxytoluene (BHT). The government agency’s Scientific Advisory Group on Chemical Safety of Non-Food and Non-Medicinal Consumer Products (SAG-CS) has issued final opinions on these substances in cosmetics.
Kojic acid, derived from rice fermentation, has been a traditional ingredient in Japanese cosmetics for centuries, known for its skin-lightening and antioxidant properties. However, the SAG-CS has raised concerns about its potential health impacts, prompting UK regulators to propose specific restrictions.
The SAG-CS members consider kojic acid safe at a maximum concentration of up to 1% in face cream and hand cream, disputing claims of it being an endocrine-disrupting chemical.
BHT, commonly used as a preservative in personal care products, has faced scrutiny due to its link to health concerns like endocrine disruption and organ-system toxicity. UK regulators have introduced restrictions on BHT usage in various products, including toothpaste, mouthwash, and other leave-on and rinse-off cosmetics.
UK regulators have set specific limits on BHT concentration in different products:
- Toothpaste: Maximum 0.1% BHT concentration
- Mouthwash and leave-on oral care products: Maximum 0.001% BHT concentration
- Other leave-on and rinse-off products: Maximum 0.8% BHT concentration
These proposed restrictions align with the SAG-CS opinions and EU Cosmetic Products Regulation, with the UK imposing a more stringent limit on leave-on oral care products.
The proposed deadlines for implementing these regulations are 6 October 2024, for placing on the market and 6 February 2025, for making products available off-shelf.
To ensure transparency, the notification of these regulations is open for public comments, industry feedback, and input from relevant organisations for a 60-day period from the date of notification.
SCCS Issues Final Opinion on Benzyl Salicylate: Safety Endorsed
The Scientific Committee on Consumer Safety (SCCS) has issued a final decision on benzyl salicylate, stating its safety when used within specified concentrations.
The SCCS have stated benzyl salicylate is safe when used at the specified concentration in the following products:
- Hydroalcoholic-based fragrances (spray and non-spray) 4%
- Rinse-off skin & hair products (except rinse off body products) 0.5 %
- Rinse off body products 1.3 %
- Leave on skin & hair products (non-spray/non-aerosol)(except body lotion) 0.5 %
- Leave on hair products (spray/aerosol) 0.5 %
- Leave on body products (non-spray/spray/aerosol) 0.7 %
- Face make-up products and make-up remover 0.2 %
- Oral care 0.004 %
- Deodorant products (spray/aerosol) 0.91%
The full opinion may be read here.
China Allows the Application for Submission Codes for Compound Ingredients
In a recent update to the Cosmetic Ingredients Safety Information Submission Platform, China has now allowed compound ingredients to obtain new submission codes through the platform. This marks a significant development in the regulatory landscape, streamlining the process for obtaining submission codes, particularly for complex formulations.
Background:
In line with the Provisions for Management of Cosmetic Registration and Notification Dossiers, the submission of ingredient safety information is a prerequisite for cosmetic registration and notification in China. On March 27, 2023, the National Medical Products Administration (NMPA) extended the transition period for cosmetic ingredient safety information submission policies until January 1, 2024. From this date onwards, cosmetic registrants and notifiers are required to submit ingredient safety information for all ingredients used in product formulas according to relevant regulations and technical specifications.
In September 2023, the China National Institutes for Food and Drug Control (NIFDC) introduced three guidelines related to the submission of cosmetic ingredient safety information. However, after these updates, the Cosmetic Ingredients Safety Information Submission Platform only allowed ingredients with single independent serial numbers from the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC) to apply for ingredient submission codes. Compound ingredients, typically comprising multiple serial numbers, faced challenges in obtaining new submission codes through the platform.
This month the Cosmetic Ingredients Safety Information Submission Platform underwent another update, reinstating the ability of applying for ingredient submission codes for compound ingredients. This means that during the cosmetic product registration and notification process, registrants and notifiers can now use both existing submission codes and newly obtained submission codes for compound ingredients.
This development is expected to simplify and expedite the regulatory process for businesses dealing with compound ingredients, aligning with China's ongoing efforts to enhance the efficiency of its regulatory framework in the cosmetics industry.
ECHA Calls for Public Comments on Chemical Classification
The European Chemicals Agency (ECHA) has initiated targeted public consultations on the harmonised classification and labelling (CLH) of certain chemicals under the Great Britain Mandatory Classification and Labelling (GB MCL) process.
The chemicals subject to this consultation include:
- lithium carbonate [1] lithium chloride [2] lithium hydroxide [3] (EC 209-062-5 [1]; 231-212-3 [2]; 215-183-4 [3]); CAS 554-13-2[1] 7447-41-8 [2] 1310-65-2 [3]), chemicals registered under REACH
- methyl methacrylate; methyl 2-methylprop-2-enoate; methyl 2-methylpropenoate (EC 201-297-1; CAS 80-62-6), a chemical registered under REACH
These ad-hoc consultations specifically focus on health hazard classes. The original ECHA public consultation on the lithium substances ended on 2 October 2020, and for methyl methacrylate on 5 July 2019.
Interested parties, especially UK-based businesses, are encouraged to submit relevant information to the proposal. For those wishing to provide scientific and technical input, submissions should be made directly to ECHA using their commenting webform by the deadline of 21 November 2023.
All comments received will be made publicly available on ECHA's website.
East African Countries Notifies Alkaline thioglycolic based hair removers to WTO
Five East African countries—Burundi, Kenya, Rwanda, Tanzania, and Uganda—have notified the World Trade Organization (WTO) regarding a Draft East African Standard for alkaline thioglycolic based hair removers. The draft is open for public comments for a duration of 60 days from the date of notification.
The standard outlines sampling and test methods for alkaline thioglycolic based hair removers, excluding epilator-type removers and those containing metallic sulfides or stannite composition.
Products must comply with the East African Standard for Cosmetics and cosmetic products (EAS 337) and meet additional criteria:
- It should convert human hair into a soft plastic mass which can be easily removed from the skin by rinsing or wiping.
- It should be non-toxic and non-irritating to the skin even after prolonged contact with the skin.
- It must not stick to clothes and be stain free
The products must meet specifications for pH, calcium thioglycollate content, thermal stability, and free alkali, as well as adhere to limits for heavy metals (lead, arsenic, mercury) and microbiological standards.
Packing and Labelling Requirements:
The final formulation should be securely packed in containers that prevent leakage and do not react with the product. Labelling must adhere to the East African Standard for Labelling of Cosmetics (EAS 346) and include:
- Product name: "Alkaline thioglycolic based hair remover" or "Hair remover X" (where "X" denotes the form/presentation).
- Contact time permitted for complete hair removal.
- Instructions for use, cautioning against use beyond specified times, on inflamed or broken skin, or near the eyes.
- Instruction to conduct a patch test for first-time users.
- A statement that the product contains thioglycolate and any other cautionary information.
The full standard may be read here.
