EU NEWS
Styralyl Alcohol Evaluation Results Released: Potential Health Impacts for Cosmetic Use
On October 16, 2024, the European Chemicals Agency (ECHA) announced Italy’s conclusions on the evaluation of Styralyl Alcohol (1-phenylethanol), completed as part of the Community Rolling Action Plan (CoRAP). This assessment raises significant health concerns about this widely used fragrance ingredient.
📋 Key Findings:
- Classifications Proposed: Italy has recommended classifying Styralyl Alcohol as follows:
- Acute Toxicity (Oral): Category 4
- Eye Irritation: Category 2
- Specific Target Organ Toxicity (Liver): Repeated Exposure, Category 2
- Carcinogenicity: Category 2
- Concerns Confirmed: Initial evaluations pointed to potential carcinogenicity, acute toxicity, eye irritation, and liver toxicity, with mutagenicity concerns unconfirmed.
🗂️ Regulatory Implications:
Though not currently regulated under European Cosmetics Regulation 1223/2009 or CLP Regulation 1272/2008, this evaluation could lead to future regulatory actions for products containing Styralyl Alcohol.
EU Deforestation Regulation Update: Extra Time and New Guidance for Smooth Implementation
The European Commission has proposed an additional 12-month phase-in for the EU Deforestation Regulation (EUDR), setting compliance for large companies on December 30, 2025, and for small businesses on June 30, 2026. This extension, awaiting approval, addresses global readiness concerns.
New guidance documents provide critical details on compliance, including the Information System setup, traceability obligations, and updated country risk classifications, enabling targeted compliance efforts. The Commission has also strengthened international cooperation, prioritizing support for smallholders and ensuring a fair, inclusive shift to deforestation-free supply chains.
These measures reinforce the EU’s commitment to combating deforestation and protecting biodiversity, offering clarity and support to stakeholders worldwide.
New EU Restrictions on Arbutin in Skincare
EU Cosmetics Regulation 2024/996 imposes restrictions on the concentrations of arbutin and alpha-arbutin, effective February 1, 2025, due to concerns over potential endocrine disruption.
Key Compliance Points:
- Concentration Limits:
- Alpha Arbutin: Max 2% for face products; 0.5% for body products
- Arbutin: Max 7% for face products
- Phased Implementation: Non-compliant products cannot enter the market after February 2025, and by November 1, 2025, they will be entirely removed from the EU market.
Manufacturers must reformulate products to meet these new safety standards.
UK NEWS
SAG-CS Final Verdict on Cosmetic Ingredients: New Recommendations for Dihydroxyacetone, Benzophenone-3, and Octocrylene
The British Scientific Advisory Group on Chemical Safety (SAG-CS) has released its final opinions on the safety of three key cosmetic ingredients: Dihydroxyacetone, Benzophenone-3, and Octocrylene. Their findings differ significantly from current EU regulations and SCCS opinions. Here’s a summary of the new guidance:
📝 Ingredient-Specific Opinions
1. Dihydroxyacetone (DHA):
- Safe for adults in self-tan products at:
- 14% for lotions/non-aerosol sprays and weekly spray booth applications
- 22.5% for rinse-off lotions
- Safe for adolescents aged 14-18 based on body weight calculations.
- In contrast, the EU limits DHA at 10% for self-tanning products and 6.25% for hair dyes.
2. Benzophenone-3:
- Approved as a UV filter in the face, hand, and lip products up to 6%.
- Limited to 2.2% for full body use due to safety concerns.
- Notably stricter than the EU, which limits Benzophenone-3 to 2.2% in body products.
3. Octocrylene:
- Deemed safe at a maximum of 10% as a UV filter in cosmetic products.
- The EU restricts Octocrylene in propellant sprays to 9%, with other products capped at 10%.
⚠️ Additional Safety Notes
- SAG-CS advises risk assessments for children and adolescents once comprehensive data is available.
- Data on endocrine disruption remains inconclusive, though potential interactions with medications like ketoprofen were noted.
💡 Implications
The UK and the EU, with potential future impacts on product formulations.
UK Expands CMR Bans: 13 New Chemicals Added to Cosmetics Restrictions
On October 3, 2024, the United Kingdom notified the World Trade Organization (WTO) of a proposed amendment to the Great Britain (GB) Cosmetics Regulations, expanding its list of banned CMR (carcinogenic, mutagenic, or toxic to reproduction) chemicals. This addition of 13 new substances reinforces the UK’s commitment to cosmetic safety, diverging further from EU regulations and presenting unique brand compliance requirements.
📋 New CMR Chemicals Banned in the UK:
The 13 newly prohibited chemicals include:
- thiophanate-methyl (CAS: 23564-05-8)
- Mancozeb (CAS: 8018-01-7)
- Carbendazim (CAS: 10605-21-7)
- Trinickel disulfide / Nickel subsulfide (CAS: 12035-72-2 / 12035-71-1)
- 4-vinylcyclohexene diepoxide (CAS: 106-87-6)
- 1,2,4-triazole (CAS: 288-88-0)
- Flumioxazine (CAS: 103361-09-7)
- Tellurium (CAS: 13494-80-9)
- Daminozide (CAS: 1596-84-5)
- Dimoxystrobin (CAS: 149961-52-4)
- 2-(2-methoxy ethoxy)ethanol (CAS: 111-77-3)
- Divanadium pentoxide (CAS: 1314-62-1)
- 2-ethyl hexanoic acid salts
🇬🇧 Compliance Deadlines:
- April 20, 2025: Final date to stop marketing products containing these restricted substances.
- October 20, 2025: The last date for these products to be available on the UK market.
- Kojic Acid Compliance: Products with Kojic Acid, added to the restricted list in April, must comply by June 20, 2025, for marketing and November 1, 2025, for market availability.
🇪🇺 UK vs. EU Regulations
This latest amendment highlights post-Brexit regulatory divergence. Some of these substances remain permitted in the EU, while other CMR chemicals banned in the EU are still allowed in the UK. Brands active in both regions must now navigate these distinct regulatory landscapes.
🛡️ Implications for Cosmetic Brands
The UK’s expanded restrictions underscore a solid commitment to consumer safety, though rapid adaptation to these regulations will be critical for continued market access in Great Britain.
CANADA NEWS
From Allergens to Labeling: Canada’s Latest Steps in Cosmetic Regulation
Effective October 9, 2024, Canada has introduced significant updates to its cosmetic regulations under SOR/2024-63, prioritizing ingredient transparency and aligning with European standards to ensure consumer safety.
📋 Key Regulatory Changes:
Allergen Disclosure and Contact Information:
- Cosmetic labels must now clearly list fragrance allergens, helping consumers identify potential irritants.
- Manufacturers and importers must provide updated contact information directly on the product label to ensure accountability and consumer support.
Standardized Ingredient Names and Flexibility for Small Packages:
- All ingredients must be listed by their International Nomenclature of Cosmetic Ingredients (INCI) names, creating consistency in ingredient identification.
- Small packaging products now have flexible labeling options to provide essential information without compromising readability.
Updated Product Notifications and Safety Testing:
- Manufacturers must notify Health Canada within 10 days of launching new products, providing a complete ingredient list, product purpose, and updated contact details.
- In cases where ingredient safety is questioned, companies must conduct additional safety tests, strengthening accountability and consumer protection.
🗓️ Key Compliance Dates:
October 9, 2024: Most regulations take effect.
April 12, 2026: Mandatory allergen labeling for fragrances becomes effective, requiring concentration details based on product type (rinse-off or leave-on).
August 1, 2028: Deadline for all existing products to adopt the expanded EU allergen list in their ingredient labeling.
📑 Updated Documentation:
To help the industry transition smoothly, Health Canada has released updated resources on its website, including:
- Cosmetic Labeling Guide
- Cosmetic Notification Form
- Cosmetic Notification Guidance Document
These changes underscore Health Canada’s commitment to enhancing transparency in the cosmetic industry and ensuring products meet consumers’ demand for high safety and clarity standards.
USA NEWS
FDA Issues Guidance to Prevent Microbial Contamination in Tattoo Inks
The U.S. Food and Drug Administration (FDA) has released new guidance aimed at helping tattoo ink manufacturers and distributors identify and prevent microbial contamination. Titled “Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination,” the guidance outlines critical recommendations to ensure safety in tattoo ink production:
- Testing inks and components for microbial contamination
- Implementing sterile manufacturing processes
- Using sterilization methods where applicable
- Taking corrective actions to prevent the release of contaminated products
Following numerous reports of illness and 18 recalls of contaminated inks, the FDA aims to support industry efforts to prevent contamination and safeguard consumers.
