May regulatory roundup

EU

New Safety Measures for Titanium Dioxide in Cosmetics

According to the European Cosmetics Regulation, Titanium Dioxide (TiO2) is approved as a colorant and UV filter. However, the SCCS re-assessed its safety after classifying it as a Carcinogen Category 2 by inhalation.

Key Updates:

• Revised Use: Further restrictions on cosmetic products, including inhalation and oral routes, are needed.
• Genotoxicity Concerns: EFSA has raised concerns about potential genotoxicity, prompting a re-evaluation.
• Regulatory Changes: New provisions have been added to Annexes III, IV, and VI.
• SCCS Recommendations: More data on TiO2 nano grades in oral products is requested.

EU Implements New Restrictions on D4, D5, and D6 in Cosmetics

D4, D5, and D6 Ban:

• Effective Date: From June 6, 2026, banned in concentrations ≥ 0.1% by weight.
• Leave-on Products: Restriction applies from June 6, 2027.

Background:

• Previous Restrictions: D4 and D5 have already restricted wash-off products since January 31, 2020.
• Environmental Risks: Identified as substances of very high concern (SVHC) due to persistent, bioaccumulative, and toxic properties.

Implementation:

• Union-Wide Measure: Aimed to minimize emissions and environmental impact.
• Derogations: Specific exemptions for certain uses and more extended deferral periods for medical devices and other specific applications.

New Regulation for Beauty Accessories in the EU: GPSR

Effective Date: December 13, 2024

The European Union has introduced the General Product Safety Regulation (GPSR) to replace the General Product Safety Directive (GPSD). The GPSR aims to enhance consumer safety for products, including beauty accessories like combs, sponges, and make-up brushes.

Critical obligations for manufacturers include:

• conducting risk analyses
  • maintaining technical documentation
  • providing safety information.

Importers must ensure product compliance before entering the EU market. Additionally, non-EU manufacturers must appoint an EU economic operator to manage product safety responsibilities.

CANADA

Health Canada Updates Cosmetic Ingredient Hotlist: Key Changes for 2024

Health Canada has recently made significant updates to the Cosmetic Ingredient Hotlist, incorporating crucial modifications proposed earlier this year. These changes are of utmost importance for all cosmetic manufacturers, regulatory compliance officers, and industry professionals to be aware of. Here are some key highlights:

 New Additions:

• Basic Green 4: Now prohibited due to potential developmental effects.
• Benzophenone: Allowed at ≤3% concentration due to adverse maternal effects.
• p-Chloro-m-cresol: Not permitted near mucosal membranes; allowed at ≤0.1% in other cosmetics with specific label warnings.
• Violet Solvent 13: Added to the list of restricted substances due to health concerns. Maximum authorized concentration: 0.3% in cosmetics other than nail products.

 Amendments:

• Amended to include secondary alkyl– and alkanolamines and their salts due to potential as carcinogenic nitrosamine precursors.
• Hydroquinone & p-Hydroxyanisole: Expanded use in nail products with new concentration limits.
• Alpha-hydroxy acids (AHAs): Increased permitted concentration for consumer use from 10% to 18%; updated warnings and usage directions.
• Talc: Amended to reduce chronic inhalation exposure risks and ovarian cancer risks. Prohibited genital area products for those with ovaries, limited to 51% in loose powder products for diapering and 77% in other loose powder products and updated cautionary statements.

USA

Important Update: Proposition 65 and Cosmetic Products

Overview: Proposition 65 is a California law addressing consumer exposure to toxic chemicals. The list, updated on December 29, 2023, includes around 900 substances, many of which are used in cosmetics.

Warning Requirements:

• Full Version: Must state, “WARNING: This product can expose you to chemicals including [substance], known to the State of California to cause [cancer or congenital disabilities or other reproductive harm]. For more information, go to www.P65Warnings.ca.gov.”
• Abbreviated Version: “WARNING: [cancer or congenital disabilities or other reproductive harm] – www.P65Warnings.ca.gov.”

Recent Changes: Prop 65 is being revised to limit the use of the abbreviated warning and require listing at least one substance.

UK

Critical Updates on GB CLP Regulation: Post-Brexit Divergences and Implications

Background: Following Brexit, the GB CLP (UK CLP Regulation) retained the classifications from the European CLP Regulation up to December 31, 2020. However, two distinct processes for classifying substances have since emerged:

1. European Origin Classification: Based on the ECHA’s ERC Opinion, with HSE validating the decision for Great Britain.
2. GB-Specific Classification: Proposed by HSE with a consultation for companies.

Divergences and Consequences:

• Safety Data Sheets: Must align with GB classifications, potentially differing from European ones.
• CMR Classifications: Some substances banned in Europe, like Pentetic acid, may not be prohibited in GB.
• Regulatory Opinions: Divergences between SAG-CS (GB) and SCCS (Europe), e.g., differing opinions on Methyl salicylate.
• REACH Regulation: Ongoing revisions in GB may lead to registration changes and further discrepancies.

Implementation Delays:

• Deadlines and application dates may differ, requiring companies to stay informed and adaptable.