Fragrance Focus: RIFM's Deadline Extension
In a crucial update for fragrance creators and consumer product companies, the Research Institute for Fragrance Materials (RIFM) has extended the deadline for two significant surveys. The new deadline, set for December 29th, 2023, applies to both RIFM Survey 042 and the RIFM Consumer Product Survey 2023.
RIFM Survey 042 specifically requests concentration data on 244 fragrance ingredients, essential for safety assessments. The extension aims to provide ample time for fragrance creators and product companies to submit this critical information, recognising the importance of exposure data in safety evaluations across various health endpoints.
Workshop Alert: Dermal Absorption and EFSA 2017 Guidance
Scheduled for January 10-11, 2024, the Health and Safety Executive (HSE) is organising a live online workshop on dermal absorption. Focused on presenting and explaining the European Food Safety Authority (EFSA) 2017 guidance, this workshop addresses dermal absorption issues for both plant protection and biocidal products.
Targeted at technical and registration specialists involved in study design and preparation for product applications, the workshop covers critical aspects of the 2017 guidance, key differences from the 2012 guidance, and practical examples. Interested professionals can register by January 2, 2024.
UK REACH: Navigating the Alternative Transitional Registration Model (ATRm)
Following the UK's departure from the EU, the establishment of the UK REACH framework brought forth an independent regulatory approach. Recognising concerns within the chemicals industry about accessing EU data packages for UK REACH transitional registrations, Defra, the Health and Safety Executive (HSE), and the Environment Agency have explored an alternative transitional registration model (ATRm).
Designed to mitigate significant costs for businesses while upholding high levels of protection for human health and the environment, the ATRm reflects a comprehensive review of UK REACH implementation. This approach ensures a targeted focus on intrinsic properties, hazards, and risk assessment, ultimately aligning with the project's objectives.
GB Review Programme: Upcoming Active Substance Dossier Deadline
As part of the GB Review Programme, the Health and Safety Executive (HSE) reminds stakeholders of the approaching deadline for active substance dossiers. Specifically, for active chlorine generated from sodium chloride by electrolysis (CAS 7782-50-5 EC n/a) in product types 2, 3, 4, 5, and 11, the submission deadline is April 17, 2025.
Only entities successfully notifying the active substance/product type combinations can submit a dossier. Failure to meet the deadline may result in a GB non-approval decision, requiring the removal of biocidal products containing the active substance from the GB market.
SCCS Safety Assessments: Insights into Cosmetic Ingredients
In a comprehensive safety review, the European Commission's Scientific Committee on Consumer Safety (SCCS) evaluated various cosmetic ingredients. The SCCS have confirmed the safety of water-soluble zinc salts in toothpaste and mouthwash. The SCCS has also addressed concerns about benzyl salicylate's potential endocrine-disrupting properties and provided safety assessments for hydroxypropyl p-phenylenediamine, butylparaben, and fullerenes in personal care products.
These assessments reflect the ongoing commitment to consumer safety and regulatory transparency. Further, the SCCS calls for additional scientific assessments to identify potential risks associated with fullerenes in cosmetic products.
FDA's SPL Guidelines: Modernising Cosmetic Product Registrations
On November 11, 2023, the U.S. Food and Drug Administration (FDA) released an updated Structured Product Labelling (SPL) Implementation Guide with Validation Procedures. This guide encompasses modifications to cosmetic product facility registrations and product listings, aligning with the Modernisation of Cosmetics Regulation Act of 2022 (MoCRA).
The Implementation Guide serves as a comprehensive resource for SPL authoring tools, facilitating the submission of SPL-formatted data through the FDA's Electronic Submission Gateway (ESG) or SPL authoring software. With the impending launch of Cosmetics Direct, a dedicated portal for cosmetic products, this initiative streamlines the registration process and enhances regulatory compliance.
South Korea Consults on Cosmetic Safety Standard Amendments
The Ministry of Food and Drug Safety (MFDS) in South Korea is inviting public opinions on proposed amendments to the Cosmetic Safety Standard. Issued on November 7, 2023, the notification aims to make key updates, including the designation of a new UV-Filter ingredient and the inclusion of CAS No. and chemical names for prohibited and restricted ingredients.
Proposed Changes:
New UV-Filter: A UV-filter ingredient, meeting the standards set by the Regulation on the Examination of Designation and Changes of Cosmetics Ingredient Standards, is slated to join the Restricted Ingredient List. The new addition, Methoxypropylamino Cyclohexenylidene Ethoxyethylcyanoacetate (CAS No. 1419401-88-9), comes with a maximum concentration limit of 3% and specific usage guidelines. It is particularly restricted in applications that may expose users' lungs via inhalation and is prohibited in cosmetics containing nitrosating agents.
CAS No. and Chemical Names: To enhance accessibility and understanding, MFDS plans to introduce CAS No. and general chemical names for prohibited and restricted ingredients.
Stakeholders are invited to submit comments until November 27, 2023.
Australia Adjusts Import Conditions for Cosmetics and Soaps
Australia's Department of Agriculture, Fisheries, and Forestry recently implemented a minor revision to import conditions for retail packaged cosmetics and soaps intended for non-personal human use (commercial purposes). Effective from October 18, 2023, the update streamlines import processes, primarily concerning products with less than 20% animal-derived material by mass.
Revised Import Conditions:
For cosmetics and soaps with less than 20% animal-derived material:
a) A statement confirming commercial preparation and packaging.
b) A statement affirming readiness for retail sale without further processing.
c) A statement indicating less than 20% animal-derived material, excluding approved materials. These declarations must be presented through Manufacturer's or Supplier's declaration.
Imported goods are solely for human use, and no import permit from the Department of Agriculture, Fisheries, and Forestry is required.
EU SCCS Preliminary Opinion on Hexyl Salicylate
On November 9, 2023, the EU Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion on the use of Hexyl Salicylate (CAS No. 6259-76-3) in cosmetics. Open for comments until January 12, 2024, the opinion addresses recent recommendations by the Risk Assessment Committee (RAC) of the European Chemicals Agency (ECHA).
Key Points:
Following the RAC's suggestion to classify Hexyl Salicylate as "Toxic for Reproduction Category 2" and "Skin Sensitizer Category 1," the SCCS conducted a safety assessment. The industry submitted a dossier proposing concentration limits, leading to SCCS's conclusion that Hexyl Salicylate is safe within specified concentrations for various product categories.
Concentration Limits:
Hydroalcoholic-based fragrances: 2%
All rinse-off products: 0.5%
All leave-on products: 0.3%
Oral care products (toothpaste and mouthwash): 0.001%
