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Regulatory Updates

Monthly Collection: China & International Cosmetic Regulatory Updates in December 2025
Publication date:2026-01-06

The global cosmetics regulatory environment continues to evolve. To help businesses stay updated with regulatory changes, ZMUni Compliance Center regularly releases a monthly recap of global cosmetics regulations. This article covers the regulatory developments related to cosmetics in China and globally in December 2025, with an emphasis on updates in cosmetic ingredients and cosmetic management, among other areas.

 

 

China Cosmetic Regulatory Updates

New Cosmetics Ingredients (NCI)

In December 2025, 20 new cosmetic ingredients were notified with the China National Medical Products Administration (NMPA). They include:

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To learn more about these NCIs and their respective companies, check out the following episodes:

 

 

Regulatory Updates

 

🔘 China Proposes Draft Toothpaste Classification Catalogue

On December 1, 2025, China's National Medical Products Administration (NMPA) issued the Draft Catalogue for Toothpaste Classification for public consultation.According to the draft, toothpaste notifier will be required to assign a product classification code when submitting a notification, based on the product's efficacy category and target user group. Efficacy categories are detailed in Annex 1, while user groups are outlined in Annex 2. See previous news.

 

 

🔘 Chinese Society of Toxicology Releases Two Key Group Standards

On December 3, 2025, the Chinese Society of Toxicology approved and released two group standards: Guidance of the Approach on Threshold of Toxicological Concern (T/CST 001-2025) and Guiding Principles for Integrated Approaches to Testing and Assessment (T/CST 002-2025), effective from November 28, 2025. Developed through expert review, the standards fill key gaps in China's toxicological assessment framework and establish harmonized approaches for the safety evaluation of cosmetics, chemicals, and pharmaceuticals, accelerating the adoption and application of alternative testing methods.

 

Source: https://www.chntox.org/home/shfw/shfw_detail/id/984.html; https://www.chntox.org/home/shfw/shfw_detail/id/985.html. 

 

 

🔘 China Issues Two Draft Technical Guidelines for Naming New Cosmetic Ingredients

On December 11, 2025, China's National Institutes for Food and Drug Control (NIFDC) released two draft technical guidance documents on the naming of new cosmetic ingredients for public consultation, namely the Technical Guidelines for the Naming of Plant-Derived New Cosmetic Ingredients (Draft for Comments) and the Technical Guidelines for the Naming of Fermentation-Derived New Cosmetic Ingredients (Draft for Comments). See previous news.

 

 

🔘 China Launches Three-Year Action Plan to Strengthen Cosmetics Quality Management

On December 12, 2025, China NMPA issued a three-year action plan (2026–2028) to enhance the quality management systems of cosmetics enterprises. The initiative aims to improve product safety, boost industry competitiveness, and promote high-quality development in China's cosmetics sector. See previous news.

 

 

🔘 China Publishes Technical Guidelines for Updating New Cosmetic Ingredient Notification Information

On December 15, 2025, China NIFDC released the Technical Guidelines for Updating New Cosmetic Ingredient Notification Information. The document was initially opened for public consultation in March 2025. Alongside the guidelines, NIFDC also published a set of Q&A to clarify key points and assist industry stakeholders in implementing the updated notification requirements. See previous news.

 

 

🔘 China Releases Trial Technical Guidelines for Anti-Hair Loss Cosmetics

On December 16, 2025, China NIFDC released two cosmetic technical guidance documents, including the Technical Guidelines for Anti-Hair Loss Products (Trial) and Technical Guidelines for Research on Efficacy-Related Ingredients in Anti-Hair Loss Cosmetics (Trial), together with the corresponding Q&A. See previous news.

 

 

🔘 China Issues Trial Guidelines on Cosmetic Ingredient Intended Uses

On December 19, 2025, China NIFDC released Technical Guidelines for Cosmetic Ingredient Intended Uses(Trial), the Guidelines will come into effect on June 19, 2026. The NIFDC also provided responses to several key questions regarding the Guidelines. See previous news.

 

 

🔘 China Allows Safety Use History to Replace Toxicology Tests for Toothpaste Notification

On December 23, 2025, China NMPA issued Announcement No. 124 of 2025, simplifying toothpaste notification requirements. For toothpastes eligible for simplified version of notification, applicants may use documented safety use history in place of toxicological test reports. 

For products first marketed after January 1, 2021, when submitting supplementary notification materials, applicants may, based on a compliant safety assessment report, demonstrate safety use history through information on production and sales, quality or safety incidents, and adverse reaction monitoring, thereby waiving the oral mucosal irritation test.

 

Source: https://www.nmpa.gov.cn/xxgk/ggtg/hzhpggtg/jmhzhptg/20251223114130129.html

 

 

🔘 China Customs Rejects 20 Batches of Cosmetic Imports in October 2025

On December 25, 2025, China's General Administration of Customs (GACC) published the list of non-compliant cosmetic imports for November. A total of 3 batches were rejected, one was found to exceed the lead limit, one contained ethylhexyl salicylate in non-compliance with regulatory requirements, and one failed to meet the specifications stated in its registration/notification documents.

 

Source: http://jckspj.customs.gov.cn/spj/2025-12/25/article_2025122816141441159.html

 

 

🔘 China Proposes to Revise Key New Cosmetic Ingredient Regulation

On December 26, 2025, China NMPA released the draft revision of the Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers for public consultation. The consultation period runs from December 26, 2025, to January 25, 2026, and feedback can be submitted via email to hzpjgyc@nmpa.gov.cn. See previous news.

 

 

International Cosmetic Regulatory Updates

 

🔘 IFRA Opens Public Consultation on the 52nd Amendment to IFRA Standards

On December 12, 2025, the International Fragrance Association (IFRA) officially launched a public consultation on the 52nd Amendment to the IFRA Standards. The consultation period runs through 12 June 2026.

The proposed amendment is based on the latest safety assessments from the Research Institute for Fragrance Materials (RIFM) and IFRA’s Expert Panel, and includes 51 new restriction standards and 18 revisions to existing standards.

 

Source: https://ifrafragrance.org/zh/latest-updates/press-releases/ifra-launches-consultation-on-latest-update-to-its-safe-use-program

 

 

Asia

 

🔘 Indonesia Issues New Regulation on Cosmetics Import Permits

On December 8, 2025, the Indonesian BPOM published a regulation specifying mandatory testing parameters for Certificates of Analysis (CoA) required to apply for cosmetics import permits (Surat Keterangan Impor, SKI). The regulation is scheduled to take effect on 8 January 2026; the draft was previously open for public comment on 3 June 2025.

 

Source: https://jdih.pom.go.id/view/slide/1719/627/2025/c92a10324374fac681719d63979d00fe

 

 

🔘 South Korea Updates Key Functional Cosmetics Regulations

On December 16, 2025, the Ministry of Food and Drug Safety (MFDS) published two regulatory updates for functional cosmetics:

Notice of Partial Revision to the Regulations on the Evaluation of Functional Cosmetics

  • Introduces pre-market sales authorization: products meeting GMP and reporting review results are considered approved.

  • Expands data exemptions to include solid formulations for whitening, anti-wrinkle, and acne-control products.

  • Adjusts hair dye safety standards, removing prohibited ingredients and revising some concentration limits.

Notice on Partial Revision of Functional Cosmetics Standards and Testing Methods

  • Adds definition of solid formulations and sets standards/test methods for nine new whitening and anti-wrinkle actives in solid forms.

  • Updates quantitative test methods for certain whitening, anti-wrinkle, and sunscreen ingredients, including sunscreen validation tests.

  • The revisions are effective upon publication and apply to applications submitted after the announcement; products approved under the previous rules do not require resubmission.

 

Source: 1. Ministry of Food and Drug Safety Notice No. 2025-88; 2. Ministry of Food and Drug Safety Notice No. 2025-89

 

 

Europe

 

🔘 EU SCCS Releases Preliminary Opinion on the Use of Silver in Cosmetic Products

On December 18, 2025, the European Commission's Scientific Committee on Consumer Safety (SCCS) published a preliminary scientific opinion (SCCS/1687/25) on the use of silver (CAS/EC No. 7440-22-4/231-131-3) in cosmetic products, with a public consultation open until 23 February 2026.

In light of newly submitted data indicating that micron-sized particulate silver (100 nm < particle diameter < 1 mm) does not penetrate the skin, the SCCS considers it safe for use at concentrations up to 0.2 % in rinse-off products and 0.3 % in leave-on products under the assessed exposure conditions. This assessment supports the safety of silver in categories including creams, toners, sprays, hand and body lotions, eye shadows, lip balms, deodorants, shampoos, toothpaste and mouthwash.

The preliminary opinion does not cover propellant-based spray products, as such uses were not included in the safety assessment.

 

Source: https://health.ec.europa.eu/publications/sccs-scientific-advice-silver-used-cosmetic-products-casec-no-7440-22-4231-131-3_en 

 

 

North America

 

🔘 U.S. FDA Proposes Addition of Bemotrizinol to OTC Sunscreen Monograph

On December 15, 2025, the U.S. FDA issued Proposed Order OTC000039 to amend OTC Monograph M020, following a submission by DSM Nutritional Products, adding bemotrizinol as a sunscreen active ingredient at concentrations up to 6%. Permitted forms include lotion, cream, gel, ointment, stick, and spray (propellant-free or isolated). Public comments are open until 26 January 2026. If finalized, this change would allow manufacturers to market bemotrizinol-containing sunscreens under the OTC monograph without individual New Drug Applications.

 

Source: https://www.federalregister.gov/documents/2025/12/12/2025-22649/amending-over-the-counter-monograph-m020-sunscreen-drug-products-for-over-the-counter-human-use.com

 

 

🔘 U.S. FDA Issues Draft Guidance on Mandatory Cosmetics Recalls

On December 18, 2025, the U.S. FDA released a Draft Guidance for Industry: Questions and Answers Regarding Mandatory Cosmetics Recalls. The guidance clarifies FDA's authority under Section 611 of the FD&C Act and the 2022 Modernization of Cosmetics Regulation Act (MoCRA) to mandate recalls. It explains circumstances that may trigger a mandatory recall, FDA's recall procedures, and the compliance obligations of companies. The draft guidance is currently open for public comment for 60 days from its Federal Register publication.

 

Source: https://www.fda.gov/cosmetics/cosmetics-news-events/fda-issues-draft-guidance-industry-questions-and-answers-regarding-mandatory-cosmetics-recalls

 

 

 

Note: This article is compiled by ZMUni Compliance Centre, drawing from the latest updates from official regulatory authorities in various countries and regions. For any questions regarding interpretations or expressions, please consult the official real-time announcements.

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