Regulatory Roundup December

EU NEWS

New EU Restrictions on Triclocarban and Triclosan in Cosmetics

Effective?31 December 2024, Regulation (EU) 2024/996 introduces new restrictions on the preservatives?Triclocarban and?Triclosan?for new products placed on the market. Products already on the market must comply by?31 October 2025.

Key Updates:

• Triclocarban:
• Limit:?0.2%?(except mouthwash).
• Warning: Toothpaste labels must state:?“Not to be used for children under 6 years of age.”
• Purity: Tetrachloroazobenzene and Tetrachloroazoxybenzene ≤ 1 ppm.

• Triclosan:
• Limit:?0.3%?in toothpaste, soaps, deodorants, and nail cleaning products.
• Warning: Toothpaste labels must state:?“Not to be used for children under 3 years of age.”

?ECHA Identifies Climbazole as an Environmental Endocrine Disruptor

On?4 December 2024, the ECHA published Belgium’s evaluation of?Climbazole?(INCI: Climbazole) under the?Community Rolling Action Plan (CoRAP). The substance was found to meet the criteria for?endocrine disruption (environment)?and is recommended for?harmonized classification and labeling.

Key Findings:

• Endocrine Disruption: Classified as?ED ENV 1?(environmental endocrine disruptor).
• Toxicity:
• Aquatic Acute 1 (H400): Very toxic to?aquatic?life.
• Aquatic Chronic 1 (H410): Long-lasting aquatic toxicity.
• Acute Toxicity (H302): Harmful if swallowed.

• Consumer Use: Widely used in cosmetics (e.g., anti-dandruff shampoos), but no immediate regulatory action is needed.

• Belgium removed concerns about?skin sensitization?and?reproductive toxicity?but recommended further study on?mutagenicity. Regulatory updates under the CLP Regulation are expected.

UK NEWS

UK Bans 64 CMR Substances and Restricts Kojic Acid in Cosmetics

On?17 December 2024, the UK published?Statutory Instrument 2024 No. 1334, introducing a ban on 64 substances classified as CMR (Carcinogenic, Mutagenic, or Reprotoxic) and placing new restrictions on?kojic acid?in cosmetics.

Banned Substances

Eight of the banned substances have INCI names and are already prohibited in the EU.

These include:

• Methylene di-t-Butylcresol?(CAS 119-47-1)
• MIBK?(CAS 108-10-1)
• Benzophenone?(CAS 119-61-9)
• Theophylline?(CAS 58-55-9)
• Trimethylolpropane Triacrylate?(CAS 15625-89-5)
• Azadirachta Indica Seed Extract?(CAS 84696-25-3)
• Melamine?(CAS 108-78-1)
• Dimethyltolylamine?(CAS 99-97-8)

In the UK, the ban will apply to?new products from 20 April 2025?and all products on the market by?20 October 2025.

Kojic Acid Restriction

Kojic acid, commonly used in face and hand products, will be limited to?a 1%?concentration. This restriction will apply to?new products from 20 June 2025?and to all products on the market by?1 November 2025. Manufacturers and Responsible Persons must ensure compliance with these regulations by the specified dates to avoid penalties.

USA NEWS

FDA Proposes Rule on Asbestos Testing for Talc-Containing Cosmetics

The FDA has proposed a new rule under the?Modernization of Cosmetics Regulation Act (MoCRA)?to require standardized testing for asbestos in talc-based cosmetics.

Key Highlights of the Proposed Rule

• Standardized Testing Methods: Manufacturers must use?Polarized Light Microscopy (PLM)?and?Transmission Electron Microscopy (TEM/EDS/SAED)?to test for asbestos in talc-containing cosmetics.
• Batch Testing Requirements: Manufacturers must test representative samples of each batch or lot of talc-containing products or talc ingredients used in production.
• Supplier Verification: Reliance on supplier certificates is allowed, provided manufacturers ensure their reliability through verification testing.
• Adulteration Provisions: Products found to contain asbestos or that do not comply with the rule’s testing and recordkeeping requirements will be considered adulterated?under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

This rule aims to reduce asbestos-related risks and enhance consumer safety.

?“Safer Products for Washington” Targets Harmful Chemicals in Beauty Products

Under the?Toxic Pollution Law,?Washington’s?“Safer Products for Washington”?program is working to reduce harmful chemicals in consumer products, including cosmetics, through a structured five-year plan.

What’s Happening?

• Phase 1: Identified harmful chemicals based on their toxicity and potential exposure risks.
• Phase 2: Currently analyzing consumer products to determine the impact of these chemicals.

Why It Matters for the Beauty Industry

The recently published?Draft Identification of Priority Products Report?(November 1, 2024) highlights key chemicals used in cosmetics:

• Cyclic volatile methylsiloxanes (cVMS): Commonly used for smooth texture and sensory appeal in products.
• BTEX chemicals: Frequently found in nail care products.

????Next Steps:

The?final report?will be released by?June 1, 2025. Stay updated to ensure compliance and safer formulations for your products.

Washington’s Interim Policy on Lead in Cosmetics Begins January 2025

As part of the?Toxic-Free Cosmetics Act, Washington State has introduced an?Interim Policy on Lead in Cosmetics. This policy offers flexibility for manufacturers struggling to meet the strict 1 ppm lead limit.

Key Points:

• Effective Date: January 1, 2025.
• Safe Harbour Options for Manufacturers:
• Option 1: Lead limit of?2 ppm?for general cosmetics and?5?ppm?for color cosmetics/clay masks, with a plan submitted to the Department of Ecology.

• Option 2: For color cosmetics/clay masks with lead between?5–10 ppm, manufacturers must:

• Notify the Department of Ecology.
• Monitor lead levels in every batch.
• Maintain records and documentation.

• Small Business Support: Alternative testing methods like calculations or composite testing are allowed with demonstrated good-faith efforts to reduce lead levels.

Next Steps:

The Department of Ecology will continue data collection to assess the feasibility of the?1?ppm limit and explore regulatory adjustments.

?FDA Updates Guidance on Cosmetic Facility Registration and Product Listing

In?December 2024, the FDA released an updated?Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products, providing essential compliance details for the?Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

Key Updates:

• Finalized 19 FAQs from the 2023 version.
• Introduced three new draft FAQs (open for comments until?13 January 2025), addressing:
• U.S. Agent Responsibilities: Role clarification under MoCRA.
• FEI Numbers: Managing multiple buildings in a facility.
• Free Samples: Registration specifics for promotional products.

The guidance outlines who must register, the required information, and submission processes while detailing exemptions.