Global Cosmetics Regulatory Updates-Vol. 22 (November-December 2024)

This article compiles the cosmetic regulation updates that took place in November and December, covering regions and countries including Europe (EU, Austria, Russia), the Americas (USA, Canada), and the Asia-Pacific region (China, Thailand, Indonesia, Vietnam, Malaysia).

Europe

November 7, the SCCS Issued Preliminary Opinion on Benzophenone-1.

The Scientific Committee on Consumer Safety (SCCS) of the European Union issued preliminary opinion (SCCS/1672/24) on Benzophenone -1 (CAS No. 131-56-6). The deadline for comments is set for January 13, 2025. Having considered the data provided, and the concerns relating to potential endocrine disrupting properties of Benzophenone-1 (BP-1), the SCCS cannot conclude on the safety of BP-1, because the information provided is insufficient to exclude genotoxicity.

Details: https://www.cirs-group.com/en/cosmetics/sccs-issued-preliminary-opinion-on-benzophenone-1

November 12, the SCCS Issued Preliminary Opinion on Ethylhexyl Methoxycinnamate.

The Scientific Committee on Consumer Safety (SCCS) of the European Union issued preliminary opinion (SCCS/1671/24) on Ethylhexyl Methoxycinnamate (CAS No. 5466-77-3/83834-59-7). The deadline for comments is set for January 17, 2025. Having considered the data provided, and the concerns relating to potential endocrine disrupting properties of EHMC, the SCCS cannot conclude on the safety of EHMC, because the information provided is insufficient to exclude genotoxicity.In addition, the available evidence also shows that EHMC is an endocrine-active substance due to clear demonstration of estrogenic activity and weak anti-androgenic activity both in vitro and in vivo.

Details: https://www.cirs-group.com/en/cosmetics/sccs-issued-preliminary-opinion-on-ethylhexyl-methoxycinnamate

November 18, Austria released the 2024 Monitoring Report on Heavy Metals and UV-Active Substances in Children's Cosmetics.

The Austrian Agency for Health and Food Safety (AGES) published the final report of its 2024 targeted monitoring campaign on heavy metals and UV-active substances in children's cosmetics, with a particular focus on bath additives. A total of 36 samples collected from various regions in Austria were examined, of which 9 samples were found to be non-compliant.

November 29, the Eurasian Economic Union proposed amendments to the Technical Regulation on the Safety of Perfumery and Cosmetic Products.

The Eurasian Economic Commission introduced modifications to the Customs Union Technical Regulation "On the Safety of Perfumery and Cosmetic Products" (TR TS 009/2011). These amendments include adjustments to the scope of application, the addition of new term definitions, an expanded list of prohibited substances, revised labeling and marking requirements, and clarified grounds for consumer property claims. On November 29, the Eurasian Economic Commission Council adopted the amendments to the Technical Regulation on the Safety of Perfumery and Cosmetic Products which clarify the scope of the regulation as it applies to perfumery and cosmetic products affixed to other goods. Additionally, the use of registered pharmaceutical or medical device trade names in the names of perfumery and cosmetic products is prohibited. The procedures and schemes for state registration and declarations of conformity for perfumery and cosmetic products have also been aligned with the approved standardized conformity assessment schemes.

November 30, Russia Published Labeling Rules for Certain Types of Perfumery, Cosmetic Products, and Household Chemicals.

The Government of the Russian Federation issued Resolution No. 1681, which primarily addresses the labeling rules for certain types of perfumery, cosmetic products, and household chemicals packaged for consumer use, as well as the monitoring requirements for the circulation of these goods through the national information system. The main provisions include the scope of application, packaging requirements, labeling methods, labeling content, and product registration procedures. The new rules will come into effect on March 1, 2025.

In December, EU Announced a 2025 Review of the Cosmetics Regulation.

The European Commission announced its intention to review the EU Cosmetics Regulation (EC) No. 1223/2009, with plans to launch a public consultation to gather feedback from the market and stakeholders. The review aims to assess whether the current rules are functioning as intended.

December 16, the European Council Officially Adopted the Packaging and Packaging Waste Regulation (PPWR).

The European Council formally adopted the Packaging and Packaging Waste Regulation (PPWR), a revision of Directive 94/62/EC on Packaging and Packaging Waste, which was originally established in 1994. This new regulation, proposed as a draft amendment on November 30, 2022, was approved after two years of deliberation. Key provisions include: Reduction-Oriented Design: A requirement to minimize the weight and volume of packaging, eliminating unnecessary packaging waste; Transparency in Labeling and Information: Clear labeling of material composition and recycling rates to help consumers make informed choices and improve waste sorting, etc.

The Americas

November 8, the U.S. Increased Certification Fees for Color Additives.

The U.S. Food and Drug Administration (FDA) announced an increase in certification service fees for color additives. The certification fee for straight colors and lakes has been adjusted to $0.45 per pound (an increase of $0.10), with a minimum certification fee of $288. This adjustment also applies to the repackaging fees for certified color additives and mixtures. The new fees will take effect on December 9, 2024.

November 26, California’s Department of Public Health (CDPH) has Added Nine Substances to its Reportable Ingredients List (RIL) for Cosmetics.

The RIL update incorporates nine substances includes dibutyltin oxide, dimethyl propylphosphonate and so on that were identified as reproductive and/or genetic toxicants under Annex VI of the EU’s CLP regualtion. All nine substances must be reported if they are used as cosmetic fragrance or flavor ingredient in California.

December 7, Canada Adds SNAc Notification Requirements for Cosmetics Containing Phosphoric Acid, Mixed Decyl and Octyl Esters, Potassium Salts.

Published in the Canada Gazette, Canada’s health and environment agencies have applied significant new activity (SNAc) notification requirements. The provision requires companies to notify Environment and Climate Change Canada (ECCC) before manufacturing or importing activity related to cosmetic products containing "phosphoric acid, mixed decyl and octyl esters, potassium salts" above certain thresholds.

December 11, FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products.

the U.S. Food and Drug Administration (FDA) issued updated guidance for industry on registration and listing of cosmetic product facilities and products. The guidance finalizes the frequently asked questions and answers (FAQ) in Appendix B (Q1-19). In addition, three new FAQ in Appendix B of the guidance (Q20-22) are marked as “for comment purposes only” to be open for comment before being finalized. The comment period closes on January 13, 2025.

Details: https://www.cirs-group.com/en/cosmetics/us-fda-updates-guidance-for-industry-on-registration-and-listing-of-cosmetic-product-facilities-and-products

December 19, Washington State Initiates Rulemaking to ‘Potentially’ Raise Lead Limit in Cosmetics.

Washington State’s Department of Ecology (Ecology) has initiated a new rulemaking to "potentially" adjust the 1ppm allowable limit on lead impurities in cosmetic products, set to take effect on 1 January as part of the state’s 2023 Toxic-Free Cosmetics Act (TFCA).

December 26, the FDA Issues Proposed Rule on Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products.

The proposed rule, entitled “Testing Methods for Detecting and Identifying Asbestos in Talc-Containing Cosmetic Products,” if finalized, would require manufacturers of talc-containing cosmetic products to test their products for asbestos using specific testing methods. The proposed rule also contains corresponding adulteration provisions. FDA proposes to require that manufacturers of talc-containing cosmetic products use both Polarized Light Microscopy (PLM) and Transmission Electron Microscopy/Energy Dispersive Spectroscopy/Selected Area Electron Diffraction (TEM/EDS/SAED) to test talc-containing cosmetic products for potential asbestos contamination.

The Asia-Pacific region

November 4, China’s NMPA Approved the Cosmetic New Ingredient Isobutyryl Thiazolyl Resorcinol.

China’s NMPA approved the registration application for the cosmetic new ingredient Isobutyryl Thiazolyl Resorcinol, submitted by Beiersdorf's German headquarters. This ingredient is synthesized through chemical processes and has undergone efficacy and safety validation organized by the registrant. It is approved for use as a whitening agent in leave-on cosmetics, excluding products with potential inhalation exposure. The approval of this new ingredient provides a new option for the development and use of freckle-removal and whitening cosmetics in China.

November 6, Indonesia Proposed Revisions to the Cosmetic Good Manufacturing Practices (GMP) Certification Regulation.

The Indonesian Legal and Organization Bureau (JDIH) has proposed revisions to the regulation on Cosmetic Good Manufacturing Practices (CPKB) Certification. The main changes include:Clarification of Definitions, Methods for Applying for CPKB, Conditions for CPKB Applicants, Manufacturing Compliance, Certificate Validity and Certificate Renewal and Modifications.

November 7, China’s Ministry of Industry and Information Technology Released 761 Industry Standards.

The Ministry of Industry and Information Technology of the People's Republic of China issued Announcement No. 28 of 2024, approving the release of 761 industry standards, including HG/T 6326-2024 “Zinc Sulfate for Cosmetics.” The document specifies the requirements, test methods, inspection rules, markings, accompanying documentation, as well as packaging, transportation, and storage for zinc sulfate used in cosmetics. This standard provides a regulatory basis to ensure the quality and safety of zinc sulfate as a cosmetic ingredient, supporting the industry’s compliance and development.

November 8, Taiwan Revised the “Risk Assessment Guidelines for Cosmetics Containing Nanomaterials”.

The Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare revised the “Risk Assessment Guidelines for Cosmetics Containing Nanomaterials.” The revision aims to strengthen the management of cosmetics containing nanomaterials. The updated guidelines include an annex that outlines the physicochemical properties and safety assessment parameters for nanomaterials, providing a reference framework for product characterization and safety evaluation.

November 8, the National Center for Adverse Drug Reaction Monitoring, China issued a notice soliciting public comments on the draft document titled "Guidelines for the Preparation of Self-Inspection Reports on Cosmetic Adverse Reactions by Cosmetic Registrants and Notifiers (Trial Version)".

These guidelines are applicable to cosmetic registrants and notifiers conducting the preparation of self-inspection reports on cosmetic adverse reactions within the territory of the People's Republic of China. The document aims to assist registrants and notifiers in understanding and mastering the fundamental requirements and content for drafting such reports.

November 12, Taiwan revised the "Scope and Categories of Cosmetics".

The Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare amended the "Scope and Categories of Cosmetics". The category "13. Tooth Whitening Products"was revised to "13. Tooth Whitening Agents", and the item "tooth whitening toothpaste" was removed from its scope. Additionally, within the category "14. Non-Medicated Toothpaste and Mouthwash", the item "non-medicated toothpaste" was updated to "non-medicated toothpaste and tooth powder". This revision will come into effect on July 1, 2026.

November 15, the National Institutes for Food and Drug Control (NIFDC) publicly solicited opinions on the draft revision of the "Information on Ingredients Used in Marketed Products (Revised Draft for Comments)".

Compared to the current version of the "Information on Ingredients Used in Marketed Products", the revised draft expands its scope from special cosmetics to include general cosmetics. The number of recorded ingredients has increased by 1,344, bringing the total to 3,578, while the amount of usage information has grown to 5,240 entries, making the content significantly more comprehensive.

November 18, Thailand’s Food and Drug Administration (FDA) published labelling updates for cosmetics containing titanium dioxide (TiO2).

In the first notice, cosmetic products containing TiO2 used in powder form in the production process, and containing 1% or more of particles with an aerodynamic diameter of less than or equal to 10 micrometres (μm), as separate from products containing all other types of TiO2. The labelling requirements for this specific type of TiO2 would apply to face and dusting powders, and hair products in aerosol spray form used by consumers. The second notice confirms that sunscreen products must include a warning on their labels stating that using the product is just one way to protect from sun damage. Labelling must also advise consumers to read and follow the instructions for use and, if any problems arise after use, to consult a doctor or pharmacist.

December 6, the National Institutes for Food and Drug Control (NIFDC) issued a notice regarding the optimization of the submission module for cosmetic safety assessment data.

NIFDC has optimized the existing product safety assessment data submission module within the Intelligent Cosmetic Registration and Review System and the upgraded module was officially launched on December 6, 2024, at 5:00 PM. Cosmetic registrants can use this module to submit complete safety assessment data in compliance with relevant cosmetic laws and regulations, as well as normative documents such as the Technical Guidelines for Cosmetic Safety Assessment (2021 Edition).

December 6, the ASEAN announced a ban on the use of 26 chemical substances in cosmetics.

The latest version of the ASEAN Cosmetic Directive (ACD), Version 2024-2, has added at least 26 substances to Annex II, as detailed in the table below. These newly added substances supplement the list of banned ingredients introduced in the previous version of the directive (Version 2024-1), which was released on June 7.

December 13, Thailand Proposes Amendments and Revisions to Multiple Cosmetic Regulations.

The Thai Food and Drug Administration (Thai FDA) has released two consultation documents proposing amendments and revisions to several cosmetic regulations. The specific proposals include: (1) Formulation of regulations for the importation of cosmetics intended for display, research and development, or analytical testing. (2) Development of methods for assessing cosmetic safety data and academic documentation.(3) Revisions to three regulations concerning the list of prohibited and restricted substances in cosmetics and warning label requirements. The consultation period for feedback on these documents is open until December 27, 2024.

December 17, China’s National Institutes for Food and Drug Control (NIFDC) Issued a Notice Soliciting Proposals for the Formulation and Revision of Cosmetic Standards for 2025.

To further strengthen the technical support for the safety supervision of cosmetics (including toothpaste, hereinafter the same), and to continuously improve the formulation and revision of cosmetic standards, the NIFDC is now publicly soliciting proposals for the formulation and revision of cosmetic standards for 2025. Proposals should be submitted through the "Cosmetic Standards Formulation and Revision Management System" in accordance with the specified requirements. The deadline for proposal submission is January 17, 2025.

December 17, the Ministry of Industry and Information Technology (MIIT), the Ministry of Commerce (MOFCOM), and the General Administration of Customs (GAC) Issued a Joint Notice on Optimizing Import and Export Regulatory Measures for Low-Concentration Triethanolamine Mixtures (2024 Edition).

In accordance with the relevant provisions of the Regulations of the People’s Republic of China on the Administration of Controlled Chemicals, the Regulations of the People’s Republic of China on Export Control of Dual-Use Items, and the Implementation Rules of the Regulations on the Administration of Controlled Chemicals, it has been decided to further optimize the import and export regulatory measures for certain low-concentration triethanolamine mixtures starting from January 1, 2025, to continuously enhance the efficiency of controlled chemical management in import and export activities.

December 24, Vietnam Revised Its Cosmetic Ingredient Regulations.

The Vietnam Drug Administration (DAV) issued Notice No. 4086/QLD-MP, revising the regulations on cosmetic ingredients. The main updates in this revision include: (1) Addition of 24 Substances to the List of Prohibited Ingredients in Cosmetics, including Ammonium Bromide. The transition period for compliance is set until November 19, 2025. (2) Revisions to the List of Restricted Substances and the List of Approved UV Filters. This notice came into effect immediately upon its publication.

December 30, Malaysia Revised Its Cosmetic Regulatory Framework.

The Malaysian National Pharmaceutical Regulatory Agency (NPRA) issued Announcement No. 3/2024, revising the Cosmetic Regulatory Framework. The announcement took effect immediately upon publication. The key updates include: (1) Addition of 28 Substances to the List of Prohibited Ingredients in Cosmetics, including Theophylline. The compliance transition period is set until November 19, 2026. (2) Revisions to the List of Restricted Substances and the List of Approved UV Filters: Newly approved substances for use in cosmetics have been added. Specific usage requirements for these substances are detailed in the accompanying table.

If you need any assistance or have any questions, please get in touch with us via service@cirs-group.com.