EU NEWS
Reminder: New Labelling Rules for Cosmetics Containing Certain Preservatives Come into Force
Starting July 31, 2024, regulatory authorities will enforce new labeling regulations for cosmetics containing formaldehyde-releasing preservatives. Here’s what you need to know:
What’s Changing?
- Current Rule: Cosmetic products containing formaldehyde-releasing agents must include the warning “Contains formaldehyde” if the concentration exceeds 0.05%.
- New Rule: Following the SCCS opinion (SCCS/1632/21) and Regulation (EU) 2022/1181, the threshold for this labeling obligation is reduced to 0.001% (10ppm) of total formaldehyde released.
Key Dates:
- July 31, 2024: All new cosmetic products containing these preservatives must comply with the new labeling threshold of 0.001% (10 ppm).
- July 31, 2026: All existing products must comply with the new labeling rules.
Important Note:
- The addition of formaldehyde (CAS RN: 50-00-0; EC RN: 200-001-8) remains prohibited in cosmetic products due to its classification as a category 1B carcinogen.
Action Required:
Ensure your product labels are updated to reflect this new threshold by the specified dates to stay compliant with the European Cosmetics Regulation (EC) No. 1223/2009.
Stay informed and compliant to avoid regulatory issues!
Final Opinion on Triphenyl Phosphate
The Scientific Committee on Consumer Safety (SCCS) has released its final opinion on Triphenyl Phosphate (TPP), a commonly used plasticizer in nail products.
Key Highlights:
- Potential Safety Concerns: The SCCS concludes that, based on available data, the safety of TPP in nail products at concentrations up to 5% cannot be confirmed due to potential genotoxicity concerns. The evidence does not rule out the potential for TPP to cause genetic mutations, highlighting the need for further investigation.
- Endocrine Disruption: Additional concerns are related to TPP’s potential endocrine-disrupting properties. Studies indicate some estrogenic and androgenic activity, though the overall risk remains unclear.
- Carcinogenicity and Obesogenic Effects: The SCCS identified studies suggesting possible carcinogenic and obesogenic effects, particularly related to metabolic disruptions. However, these studies were not conclusive enough to draw firm conclusions.
- Environmental Impact: The current assessment did not cover TPP’s ecological safety, focusing solely on human health risks.
Staying Updated is Key: Manufacturers need to conduct further research to determine the safety of TPP in cosmetic products conclusively. Equally important is staying updated with the latest regulatory requirements and ensuring compliance to maintain consumer safety.
For a detailed read, access the full SCCS opinion here.
REMINDER: IFRA 51 Prohibition Standards for Fragrance Compositions
The IFRA (International Fragrance Association) 51st amendment, effective from July 30, 2024, introduces:
- 48 new standards, including a ban on 3-Acetyl-2,5-dimethylfuran (CAS: 10599-70-9) due to genotoxic potential.
- 11 revised standards.
- 2 minor updates to existing standards and format changes.
Action Required: Ensure your existing fragrance compositions, defined as those on the market or in development before January 30, 2024, comply with these new regulations.
Check your products now to avoid using prohibited ingredients!
Reminder: The Cosmetic Products (Restriction of Chemical Substances) Regulations 2023
Important Update for Cosmetic Manufacturers
The Cosmetic Products (Restriction of Chemical Substances) Regulations 2023 are now in effect. Here’s what you need to know:
- Effective Dates:
- General provisions take effect 21 days after being made.
- Specific provisions, such as regulation 2(2), come into force on July 6, 2024.
- Key Amendments:
- Annex 3: New restrictions on Methyl-N-methylanthranilate in both leave-on and rinse-off products. Leave-on products are not to be used in sunscreens or products marketed for UV exposure.
- Annex 6: Introduction of Bis-(Diethylaminohydroxybenzoyl Benzoyl) Piperazine and its nano form, with specific conditions for use.
- Transitional Provisions: Products placed on the market before July 6, 2024, can continue to be sold until July 6, 2026.
To avoid disruptions, ensure your products comply with these new regulations. The full document is available here.
Safety and Regulation of Silver in Cosmetics
Silver (CAS/EC No. 7440-22-4/231-131-3), widely used for its shimmery effect, is scrutinized. Recognized as colorant CI 77820, it is commonly found in eyeshadows, highlighters, nail polishes, and body powders.
Regulatory Concerns:
- February 2023: The European Risk Assessment Committee (RAC) recommended classifying Silver as ‘Toxic for Reproduction Category 2’.
- Classification Impact: If adopted under the CLP Regulation Annex VI, its use in cosmetics could be restricted unless the SCCS deems it safe.
SCCS Final Opinion:
- Unsafe Uses: Micron-sized particulate Silver is unsafe at concentrations up to 0.2% in rinse-off and 0.3% in leave-on products.
- Safe Uses and Concentrations:
- Eye shadow: 0.2%
- Lip balm: 0.2%
- Toothpaste (adult and children): 0.05%
- Mouthwash: 0.05%
- Shampoo: 0.2%
- Deodorant: 0.3%
Implications: Manufacturers must adjust silver concentrations in their products to comply with these safety thresholds.
Stay informed and ensure your products meet regulatory standards!
Ecodesign for Sustainable Products Regulation
The Ecodesign Sustainable Product Regulation (ESPR) entered into force on 18 July 2024. This regulation will promote sustainability in product design and manufacturing.
Key Points:
- Scope: It will apply to a wide range of products to improve their environmental performance throughout their lifecycle.
- Requirements: Manufacturers must ensure products meet specific sustainability criteria, such as energy efficiency, material use, and recyclability.
- Impact: It will aim to reduce the environmental impact of products and promote circular economy principles.
Action Required:
- Manufacturers will review product designs to ensure compliance with the new requirements.
- Manufacturing processes will be updated to meet sustainability standards.
USA NEWS
FDA Proposes New Rules Implementing MoCRA
The FDA has proposed new rules under the Modernization of Cosmetics Regulation Act (MoCRA). Here are the key highlights:
- Fragrance Allergen Disclosure: A new rule will require labeling certain fragrance allergens in cosmetic products.
- Asbestos in Talc: Standardized testing methods will be required to detect and identify asbestos in talc-containing cosmetics.
- Formaldehyde Ban: Formaldehyde and formaldehyde-releasing chemicals will be banned in hair smoothing and straightening products.
Important Dates:
- Fragrance Allergen Disclosure Rule: Expected in October 2024.
- Asbestos in Talc Rule: Expected in July 2024.
- Formaldehyde Ban Rule: Expected in September 2024.
CANADA NEWS
Embracing Quebec’s French Language Regulations
On June 26, Quebec published new regulations under the Charter of the French Language affecting signage, publicity, trademarks, and product labels. These take effect on June 1, 2025, with a transition period for compliance.
Key Points:
- French Prominence: Public signs, ads, and promotional materials must feature French prominently.
- Packaging and Labeling: All cosmetic products must have French packaging and labels, including product names, descriptions, and instructions.
- Digital Communications: Websites and social media must comply with French language requirements.
- Support for SMEs: Resources and financial assistance are available for small and medium enterprises.
- Trademarks: Descriptive or generic trademarks in other languages must be translated, with French signage more prominent.
Action Steps:
- Update Marketing Materials: Ensure all materials comply with new French language requirements.
- Collaborate with Experts: Work with local linguists and marketing experts.
- Train Your Team: Educate your team on the importance of linguistic inclusivity.
- Leverage Bilingual Opportunities: Provide information in French and another language, with French prominently displayed.
Adapting to these regulations enhances brand presence in Quebec. Stay tuned for updates, and follow our LinkedIn page for the latest insights.
