November regulatory roundup

EU NEWS

Key Updates on EU Regulation 2024/2865 for the Cosmetics Industry

The European Union recently published Regulation 2024/2865, introducing significant updates to the Classification, Labelling, and Packaging (CLP) of chemical substances and mixtures. This regulation aims to enhance consumer safety and transparency in product formulations and presents opportunities and responsibilities for stakeholders in the cosmetics sector.

Key Highlights of the Regulation

1. Expanded Hazard Classifications:
2. New categories have been introduced for endocrine disruptors (EDCs) and persistent, bioaccumulative substances.
3. Several chemicals have now been reclassified as Endocrine disruptors hazardous to human health or the environment.
4. Updated Labeling Requirements:
5. Labels must now reflect revised hazard classifications and comply with Annex II guidelines.
6. Precise and accurate labeling is mandatory to meet regulatory standards.
7. Industry Implications:
8. Cosmetic manufacturers will need to reassess formulations and raw material sourcing.
9. Safety evaluations and product documentation must be updated to align with the revised classifications.
10. Compliance Deadlines:
11. Adherence to the updated requirements is mandatory to ensure continued market access. The regulation enters into force on 10th December 2024, with a grace period as outlined below to comply with these changes.

For new ’substances’ on the market, companies need to comply with the new rules from 1 May 2025, whereas substances that have ‘alreadybeen ‘on the EU market, companies have until November 1^st 2026 to comply.

4. Different transition times apply for ’mixtures’. New hazard classes apply from ’1 May 2026’to new ’mixtures’, whereas companies have until 1 May 2028 to update the classification and labelling forexisting mixtures

Steps for Compliance

• Supplier Collaboration: Companies are encouraged to request updated Safety Data Sheets (SDS) from suppliers and verify raw material compliance.
• Documentation Updates: The new regulations require revisions to Product Information Files (PIF) and safety evaluations.
• Team Training: Internal teams should be educated on the implications of the new classifications and labeling requirements.

By adhering to these updates, companies can ensure compliance while maintaining consumer confidence in their products.

GPSR Transforming Consumer Safety

The European Union is introducing transformative changes to consumer product safety with the General Product Safety Regulation (GPSR), which will replace the General Product Safety Directive (GPSD) by December 2024. These updates ensure product safety throughout their lifecycle and address the challenges of globalization and digital markets.

Key Highlights of GPSR

• Lifecycle Safety: Ensures all consumer products, including cosmetics, meet safety standards at every stage.
• Enhanced Traceability: Strengthens supply chain transparency for faster and more effective risk management.
• Digital Compliance: Requires online platforms to prevent unsafe products from reaching consumers.

Impact on Cosmetics

The GPSR explicitly reinforces the need for clear labeling for safe product use, robust documentation, particularly those consumer products offered for sale online. Cosmetic companies can maintain consumer trust while staying competitive in global markets by aligning with these requirements.

Steps for Compliance

• Manufacturer Identification: Include the name, postal, and electronic contact details of the manufacturer or Responsible Person (RP).
• Responsible Person: The RP, often the brand owner or importer, must ensure compliance for all products placed on the EU market.
• Address Requirements: Postal addresses can be abbreviated, but transparency for both postal and electronic details is essential.

For more information, explore the GPSR’s influence on cosmetics here. These updates mark a pivotal shift toward safer, more transparent products in the cosmetics industry.

SCCS Final Opinion on Sodium Myristoyl Sarcosinate Coating for Titanium Dioxide (Nano)

The Scientific Committee on Consumer Safety (SCCS) has released its final Opinion on using Sodium Myristoyl Sarcosinate as a coating for titanium dioxide (nano) as a UV filter in dermally applied cosmetic products. This follows the initial mandate issued in November 2023 and a preliminary opinion published in May 2024.

Key Findings:

• The SCCS assessed Eclipse 70, a nano-form of titanium dioxide coated with:
• 6% Aluminium Hydroxide
• 14% Sodium Myristoyl Sarcosinate
• 10% Dimethicone

• While Aluminium Hydroxide and Dimethicone coatings were previously evaluated (2014), Sodium Myristoyl Sarcosinate (CAS No. 30364-51-3) has just been assessed.
• Conclusion: The SCCS determined that uncertainties and data gaps prevent it from concluding the safety of this nano-form titanium dioxide coating.

Scientific Concerns:

• There is insufficient evidence to demonstrate a similarity between Eclipse 70 and other previously assessed TiO2 nanomaterials.
• Data gaps in:
• Physicochemical characterization
• Coating stability
• Dermal absorption of nanoparticles
• Additional data on toxicology, exposure, and physicochemical properties specific to Eclipse 70 are required for a conclusive safety assessment.

Implications for the Cosmetic Industry:

• The SCCS emphasizes the need for robust data to support the safe use of new nanomaterials in cosmetics.
• Stakeholders using Titanium Dioxide (nano) in products should ensure comprehensive documentation to meet regulatory standards.

Final SCCS Opinion on Hexyl Salicylate in Cosmetics for Children Under 3 Years

The Scientific Committee on Consumer Safety (SCCS) has published its final Opinion on the safety of Hexyl Salicylate for children under 3 years of age. This assessment comes after the industry submitted new data to address previous concerns raised by the Committee.

Key Findings

1. Safe Concentration Levels:
2. Shower gels, hand soaps, shampoos, hair conditioners, body lotions, face creams, hand creams, lipsticks/lip balms, and fragrance products: up to 0.1% (w/w).
3. Toothpaste: up to 0.001% (w/w).

2. Areas of Concern:
3. Enhanced uptake of chemicals through damaged skin, particularly in children with skin issues.
4. The potential presence of Salicylic Acid as an impurity or breakdown product of Hexyl Salicylate, which is prohibited in cosmetics for children under 3 years.
5. Increased ingestion of toothpaste by children raises potential safety concerns when combined with exposure to other salicylates.

3. Exclusions:
4. The Opinion does not apply to sprayable products that might expose users to inhalation risks.
5. Environmental safety aspects are outside the scope of this assessment.

Background

• Hexyl Salicylate is commonly used in fragrance formulations across various consumer goods, including cosmetics.

• Classified as a Toxic for Reproduction (Category 2) and Skin Sensitizer (Category 1), it is not yet listed in the Annexes of the Cosmetic Regulation (EC) No. 1223/2009.
• Following concerns over children’s exposure, additional data was submitted and reviewed, leading to this updated assessment.

Implications for the Cosmetic Industry

Manufacturers must ensure compliance with these safety limits and address concerns related to impurities and product usage on damaged skin. The SCCS highlights the importance of robust safety measures for products for children under 3 years old.

Preliminary SCCS Opinion on Ethylhexyl Methoxycinnamate

The Scientific Committee on Consumer Safety (SCCS) has published its preliminary Opinion on the UV filter Ethylhexyl methoxycinnamate (EHMC), commonly used in sunscreen products. The assessment addresses concerns related to its potential endocrine-disrupting properties, and comments are open until 17 January 2025.

Key Findings

1. Current Use and Safety Concerns:

1. EHMC is authorized as a UV filter in sunscreen products at concentrations of up to 10% (Annex VI/12 of the Cosmetics Regulation).
2. The SCCS cannot conclude on the safety of EHMC due to insufficient data to exclude genotoxicity risks.

2. Endocrine Activity:
3. Evidence indicates EHMC exhibits estrogenic and weak anti-androgenic activity in both in vitro and in vivo studies.
4. These findings classify EHMC as an endocrine-active substance, raising concerns about its long-term safety.

3. Environmental Aspects:
4. The SCCS assessment does not include environmental safety, as it falls outside its current mandate.

Implications for the Industry

The preliminary findings underscore the importance of rigorous safety evaluations for ingredients with potential endocrine activity. Brands formulating with EHMC should closely monitor developments and consider alternative UV filters if necessary.

UK NEWS

UK Takes Bold Steps to Ban Plastic-Containing Wet Wipes

The UK is leading a phased initiative to ban the sale of plastic-containing wet wipes, addressing the environmental damage caused by single-use products like baby wipes, facial wipes, and sheet masks.

Key Updates:

• Northern Ireland and Scotland are leading the way:
• Northern Ireland notified the WTO of its ban on November 1, 2024.
• Scotland introduced draft regulations in July 2024.

• England and Wales are preparing similar bans by the end of 2024, with enforcement expected within 18 months.
• Manufacturing for export will still be allowed, but governments encourage transitioning to plastic-free materials, like cellulose-based alternatives.

Exemptions to the Ban:

• Registered pharmacies can supply plastic-based wipes under strict conditions (e.g., out of public view and only upon request).
• Medical use: Permitted for healthcare purposes or when dispensed by professionals.
• Business supply: Businesses may still access plastic-containing wipes.

This initiative is part of a UK-wide commitment to eliminating plastic in wet wipes, with 95% of public consultation respondents supporting the ban.

If these regulations impact your business, CE.way is here to help you:

• Ensure compliance with new legislation.
• Reformulate products to adopt eco-friendly alternatives.
• Stay ahead of the regulatory timeline across the UK nations.