Global Cosmetics Regulatory Updates – Vol.23 (January 2025)

This article compiles and summarizes the latest updates on cosmetics regulations globally as of January 2025, covering newly issued regulations, relevant policy adjustments, and regulatory requirements. It aims to assist enterprises in ensuring compliance and keeping up with global cosmetics regulatory trends.

China

Shanghai Municipal Drug Administration Issues the Measures for the Classification Management of Quality and Safety Risks of Cosmetics Manufacturers in Shanghai

On January 16, 2025, the Shanghai Municipal Drug Administration (SMDA) issued this regulation to strengthen the supervision of cosmetics manufacturers, enhance their awareness of quality and safety risks, and optimize the allocation of regulatory resources to improve supervision efficiency. This regulation will take effect on February 13, 2025, and will remain valid for five years, until February 12, 2030.

https://yjj.sh.gov.cn/zx-hzp/20250116/a42294ac2cd3400e9e001b875f8f75c0.html

Zhejiang Provincial Drug Administration Releases the First Lesson on Filing and Marketing of General Cosmetics in Zhejiang Province and the Submission Guide for General Cosmetics Filing Materials in Zhejiang Province

On January 21, 2025, the Zhejiang Provincial Drug Administration issued two new guidelines to further regulate the filing management of general cosmetics in the province. These documents were developed by the Zhejiang Drug and Cosmetics Evaluation Center in accordance with the Regulations on the Supervision and Administration of Cosmetics and other relevant regulations.

https://mpa.zj.gov.cn/art/2025/1/21/art_1228989285_58939339.html

Taiwan Proposes Draft Regulations on Specific Fragrance or Perfume Ingredients Labeling and Amendment to Labeling Requirements

On January 21, 2025, the Taiwan Food and Drug Administration (TFDA) under the Ministry of Health and Welfare issued two draft regulations for public consultation: Regulations on the Labeling of Outer Packaging, Containers, Labels, or Package Inserts of Cosmetics and Specific Fragrance or Perfume Ingredients Required for Labeling in Cosmetics. The public consultation period is 60 days from the date of the draft release, during which feedback from stakeholders will be collected. According to the draft, 24 specific fragrance or perfume ingredients must be explicitly labeled if they are present in a cosmetic product at concentrations exceeding the specified limits. These ingredients cannot be replaced by general terms such as "Fragrance," "Flavor," "Parfum," "Perfume," or "Aroma."

https://www.fda.gov.tw/tc/includes/GetFile.ashx?id=f638729861144442115

https://www.fda.gov.tw/TC/newsContent.aspx?cid=5072&id=30920

China National Institutes for Food and Drug Control (NIFDC) Seeks Public Comments on Nine Draft Testing Methods, Including the "In Vitro Skin Absorption Test"

On January 22, 2025, the National Institutes for Food and Drug Control (NIFDC) issued a notice inviting public comments on nine draft testing methods, including the In Vitro Skin Absorption Test (Draft for Comments). This initiative aims to further refine technical standards for cosmetics (including toothpaste). The NIFDC has organized the drafting of these testing methods, which are now open for public consultation. Stakeholders are encouraged to submit their feedback through the Cosmetics Standards Development and Revision Management System by February 21, 2025.

https://www.nifdc.org.cn/nifdc/bshff/hzhpbzh/hzhpbzhxt/index.html

https://www.nifdc.org.cn//nifdc/xxgk/ggtzh/tongzhi/202501221347011412290.html

Europe

SCCS's Preliminary Opinion on Butylparaben and Its Exposure in Children

On January 13, 2025, the Scientific Committee on Consumer Safety (SCCS) of the European Union issued a preliminary opinion (SCCS/1674/25) on Butylparaben (CAS No. 94-26-8). The deadline for comments is set for March 10, 2025. Based on the safety assessment carried out in consideration of all available information, including the potential endocrine effects, the SCCS is of the opinion that the use of Butylparaben as a preservative at a maximum concentration of 0.14 % (as acid) in all cosmetic products included in this exposure assessment is not safe for children between 0.5-1 years, 1-3 years, 3-6 years and 6-10 years when used in combination. With the exception of body lotion, it is safe in single dermal and oral product categories, when used only in the respective product category.

UK New Restrictions on the Use of Methyl Salicylate in Cosmetics

On January 16, 2025, the UK notified the World Trade Organization (WTO) of the draft Cosmetic Products (Restriction of Chemical Substances) Regulations 2025, proposing amendments to Annex III of Regulation (EC) No. 1223/2009 on cosmetic products to restrict the use of Methyl Salicylate in certain cosmetic formulations. The regulation is scheduled to be adopted on April 30, 2025, and will officially come into effect on September 30, 2025.

Asia Pacific 

Indonesia Launched Notifkos 3.0, the New Cosmetic Notification System

On January 2, 2025, Indonesia officially launched Notifkos 3.0, the latest version of its cosmetic notification system, which is now fully operational for businesses. The system integrates an embedded submission link for Product Information Files (PIFs), streamlining regulatory compliance. Key new features of Notifkos 3.0 include:

• simplification of Window A (Enterprise Verification) and Window B (Enterprise Data Updates);
• expanded integration with the Online Single Submission (OSS) system for cosmetic notification services; and
• simplified procedures for company and manufacturing facility modifications.
  
  South Korea New Safety Testing Regulations for Overseas Direct-Purchase Cosmetics in 2025

On January 13, 2025, the Ministry of Food and Drug Safety (MFDS) of South Korea announced new safety testing regulations for overseas direct-purchase cosmetics. The updated policy significantly expands product testing and enhances transparency in safety information.

Key updates include:

• Increased Testing Scope: The number of cosmetics tested from overseas online platforms will increase from 110 samples in 2024 to 1,080 samples in 2025. Priority testing will focus on color cosmetics and eye makeup products containing potentially harmful substances such as heavy metals (lead, nickel, antimony).
• Stricter Regulatory Actions: If a product is found to pose safety risks, authorities will block sales websites and prohibit customs clearance. Testing results will be publicly disclosed on the "Drug Safety Nation" platform.
• Budget and Compliance Data: The 2025 budget allocates 280 million KRW (approx €185,814/ £154,223) for purchasing and testing overseas cosmetics. Recent testing results indicate: 9 out of 40 color cosmetics failed safety standards; 32 out of 175 color cosmetics were non-compliant; 7 out of 97 eye makeup products failed testing; 2 out of 13 nail and foot cosmetics were found to be non-compliant. To enhance consumer safety, MFDS will strengthen collaboration with customs authorities, the Korea Consumer Agency, and local governments. The agency will leverage ingredient analysis results and the Consumer Injury Surveillance System (CISS) to monitor and regulate potentially hazardous overseas direct-purchase cosmetics.

CIRS Global Cosmetic Compliance Services

CIRS can provide a professional one-stop service covering the whole life-cycle of a personal care product, which includes cosmetic ingredient development, physical/chemical tests, toxicological tests (in vivo & in-vitro), efficacy studies (in vivo & in-vitro), ingredient registration, and product registration.

The services items cover:

Regulatory Compliance Services

• China: Compliance Consulting for Cosmetics and Ingredients;
• Globally: Compliance Consulting for Cosmetics (EU, UK, US, Japan, South Korea, Australia & New Zealand, ASEAN, Middle East, Mexico, Brazil, and Africa); and
• Compliance Consulting for Disinfectants and Household Products.

Data Services

• China: Cosmetics and Ingredients Data Services (China CosIng); and
• Globally: Cosmetics and Ingredients Data Services covering China, EU, UK, North America, ASEAN, Japan, and South Korea (Global CosIng).

Product Testing Services

• Cosmetic Safety and Human Efficacy Testing; 
• Toxicological Safety Assessment for Cosmetic Ingredients; and
• In Vitro Efficacy Testing for Cosmetics and Ingredients

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