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Chinese Mainland
Beijing Municipal MPA Issues Exemption List for Cosmetics Sector Violations
On October 31, 2024, Beijing Municipal Medical Products Administration (MPA) issued the Penalty Exemption List for Violations in the Cosmetics Sector in Beijing (Trial) (the List) for a one-year trial, which took effect immediately. According to the List, violations eligible for exemption are grouped into three types: minor violations, first-time offenses, and cases with no fault. The related circumstances and management measures for each are outlined below.
Violation Type | Specific Circumstances | Exemption Criteria | Management Measures |
Minor violations |
| The illegal act is minor and rectified in a timely manner, and has not led to any harmful outcomes. | Instead of imposing penalties, the authority will offer persuasive education, issue warnings, and arrange talk to provide guidance. |
| First-time offenses |
| The violation is a first-time offense, with minor harmful consequences that were rectified in a timely manner. | Instead of imposing penalties, the authority will offer persuasive education, issue warnings, and arrange talk to provide guidance. |
Cases with no fault |
| The parties have adequate evidence to establish that there is no subjective fault. | Instead of imposing penalties, the authority will confiscate the cosmetics involved, offer persuasive education, issue warnings, and arrange talk to provide guidance. |
China Approves the First New Whitening Ingredient Under CSAR Framework
On November 4, 2024, the National Medical Products Administration (NMPA) approved the registration of Isobutylamido Thiazolyl Resorcinol (Thiamidol 630), the first new cosmetic ingredient (NCI) registered after the implementation of Cosmetic Supervision and Administration Regulation (CSAR) in 2021. It is approved for use as a whitening agent in leave-on cosmetics, excluding those that may pose inhalation risks.
China Releases Draft Guidelines for Writing Self-Inspection Reports on Cosmetic Adverse Reactions
On November 8, 2024, in a move to implement the Measures for the Management of Cosmetic Adverse Reaction Monitoring and guide cosmetic registrants and notifiers on preparing self-inspection reports on cosmetic adverse reactions, the Center for Drug Reevaluation of the NMPA (the National Center for ADR Monitoring of China) issued the draft of Guidelines for Cosmetic Registrants and Notifiers in Writing Self-inspection Reports on Cosmetic Adverse Reactions (Trial) (the Guidelines). The Guidelines specifies the purpose, application scope, requirements, and content of self-inspection reports on cosmetic adverse reactions. According to it, the self-inspection report includes seven aspects: basic information, information on the cosmetics used, details of adverse reactions, analysis and evaluation, self-inspection conclusions, measures taken, and attachments.
China Consults on Ingredient Usage Information of Marketed Products
On November 15, 2024, the National Institutes for Food and Drug Control (NIFDC) issued the revised draft of Ingredient Usage Information of Marketed Products (Revised Draft for Public Consultation) for public consultation. Compared to the initial version released in April 2024, this revised draft is expanded to include 3,578 ingredients and 5,240 items of ingredient usage information, incorporating information of validly notified general cosmetics.
Shanghai Municipal MPA Cancels the Notification of 607 Batches of Non-compliant General Cosmetics
On November 21, 2024, Shanghai Municipal MPA announced to cancel the notification of 607 batches of general cosmetics. The reason is their notifiers neither submitted the required annual report by March 31, 2024, nor completed the correction within the specified time limit. As a result of the cancellation, these cosmetics shall not be sold or imported from the date of cancellation.
China General Administration of Customs (GACC): Five Batches of Cosmetics Rejected in October
On November 22, 2024, GACC updated the list of rejected food and cosmetics in October 2024. Among these, five batches were cosmetics: two due to the mismatch between the declared goods and the actual shipment, and three for failing to meet the national standard of Acrylamide.
NIFDC, Beijing, and Guangzhou Authorities Publish Five Batches of FAQs
In November 2024, NIFDC, Guangzhou Administration for Market Regulation (AMR), and Beijing Municipal MPA released five batches of FAQs. They cover various topics related to general cosmetics notification, especially the requirements for safety assessment, product executive standard, efficacy claims, etc.
Release Date | Regulatory Authority | Batch |
November 15, 2024 | NIFDC | |
November 19, 2024 | Guangzhou AMR | |
November 19, 2024 | Guangzhou AMR | |
November 22, 2024 | Beijing Municipal MPA | |
November 28, 2024 | Guangzhou AMR |
China NMPA Approves Six NCIs
In November 2024, NMPA updated the notification status of six NCIs. With these recent notifications, a total of 79 NCIs have been notified year to date. Since the detailed technical requirements for newly notified NCIs have not been made public, the English translations below are merely literal translation based on these NCIs' Chinese names, which may differ from the INCI names provided by the notifiers.
Camellia chrysantha leaf extract, notified on November 1, 2024
Dihydromyricetin, notified on November 1, 2024
Cyclocarya paliurus leaf extract, notified on November 1, 2024
Selaginella uncinata extract, notified on November 1, 2024
Phenoxy-di-ethylene glycol, notified on November 6, 2024
Tremella aurantialba fruiting body extract, notified on November 11, 2024
China Issues 15 Cosmetics-related Standards in November
In November 2024, China issued 15 cosmetics-related standards. The essential information is as follows:
No. | Release Date | Initiator | Standard Name | Type | Effective Date |
1 | November 1, 2024 | China Health Care Association | Group standard | November 1, 2024 | |
2 | November 1, 2024 | Guangdong Cosmetics Association | Group standard | November 1, 2024 | |
3 | November 7, 2024 | Ministry of Industry and Information Technology | Industry standard | May 1, 2025 | |
4 | November 7, 2024 | Ministry of Industry and Information Technology | Industry standard | May 1, 2025 | |
5 | November 18, 2024 | Shanghai Daily Chemistry Trade Association | T/SHRH 066—2024 Evaluation Method of Cosmetics Formula with Tear-free Claim | Group standard | December 18, 2024 |
6 | November 19, 2024 | China Association of Fragrance Flavour and Cosmetic Industries | Group standard | / | |
7 | November 19, 2024 | China Association of Fragrance Flavour and Cosmetic Industries | Group standard | / | |
8 | November 19, 2024 | China Association of Fragrance Flavour and Cosmetic Industries | Group standard | / | |
9 | November 20, 2024 | Shanghai Daily Chemistry Trade Association | T/SHRH 072—2024 Guidelines for Cosmetic and Packaging Materials Compatibility Test and Assessment | Group standard | December 20, 2024 |
10 | November 21, 2024 | Zhejiang Health Products & Cosmetics Industry Association | Group standard | / | |
11 | November 26, 2024 | China Association of Fragrance Flavour and Cosmetic Industries | Group standard | / | |
12 | November 26, 2024 | China Association of Fragrance Flavour and Cosmetic Industries | T/CAFFCI XXXX-XXXX Cosmetic Ingredients - Pueraria Lobata Extract (Draft for Comments) | Group standard | / |
13 | November 26, 2024 | China Association of Fragrance Flavour and Cosmetic Industries | T/CAFFCI XXXX-XXXX Cosmetic Ingredients – Gentiana Scabra Extract (Draft for Comments) | Group standard | / |
14 | November 26, 2024 | China Association of Fragrance Flavour and Cosmetic Industries | Group standard | / | |
15 | November 28, 2024 | National Technical Committee for Standardization of Flavors Fragrances and Cosmetics | National standard | June 1, 2025 |
Market Condition
1. According to the National Bureau of Statistics, the retail sales of cosmetic products from January to October 2024 was CNY 356 billion, with a year-on-year (YoY) increase of 3%. In October, the retail sales increased by 40.1% YoY to CNY 46.8 billion.
Notes: To mitigate the effects of non-fixed factors during the Spring Festival and improve data comparability, the National Bureau of Statistics only released combined data for January and February.
2. According to the GACC, the total import value of cosmetics and toiletries from January to October 2024 totaled CNY 98.2 billion, declining 9.0% YoY. In October, the import value decreased by 9.6% YoY to CNY 10.5 billion.
Taiwan, China
Taiwan Updates Risk Assessment Guidelines for Cosmetics Containing Nanomaterials
On November 8, 2024, Taiwan Food and Drug Administration (TFDA) introduced updates to the Guidelines for Risk Assessment of Cosmetics with Nanomaterials (the Guidelines). Compared to its predecessor released in July 2015, the updated Guidelines primarily revises the assessment items for cosmetics containing nanomaterials.
Taiwan Adopts the Updated Scope and Categories of Cosmetics
On July 26, 2024, TFDA released an updated draft of the Scope and Categories of Cosmetics, aiming to more accurately align cosmetic products with their respective categories. The draft proposed revisions to two categories: "Tooth-whitening products", and "Non-medicated toothpastes and mouthwashes". Following the comment period, TFDA adopted the final version on November 12, 2024, with no changes made to the draft. The updated regulation will take effect on July 1, 2026.
Japan
PMDA: 81 Batches Cosmetics and Quasi-drugs Recalled in November
In November 2024, the Japan Pharmaceutical and Medical Devices Agency (PMDA) successively announced and recalled 81 batches of unqualified cosmetics and quasi-drugs. According to PMDA, the most commonly disclosed noncompliance issue was labeling, accounting for 95%. For example, 53 batches of moisturizers were found to be labeled with wrong product names. Enterprises are advised to check the product information carefully before labeling and update the label information in time if any item is changed.
South Korea
South Korea to Modify the Guideline for the Labeling of Cosmetic Products
As revealed by the Korean Cosmetic Industry Association (KCA) on November 27, 2024, the Guideline for the Labeling of Cosmetic Products is to be modified.
This guideline provides examples of prohibited expressions used in the labeling and advertising of cosmetics, as well as defines the products subject to substantiating the cosmetic labeling and advertising. It is also expected to encourage more appropriate cosmetic labeling and advertisement by cosmetic manufacturers, responsible sellers, custom cosmetic sellers, and retailers.
According to the authority, the draft newly specifies that when reviewing whether an online advertisement constitutes unfair advertising, the phrases in the advertisement's title are also considered in the judgment.
It also details the methods to correctly indicate the extracts. The content of extracted substances, excluding the amounts of extraction and dilution solvents, should be indicated on the finished product. However, if it is difficult to determine the ratio of the solvent, the truth that the extract contains the solvent should be stated. For example, "XX extract (contains extraction solvent A)".
Besides, some prohibited expressions are added, including human-derived ingredient "exosome", misrepresented expressions for cosmetic usage methods such as "microneedle", "inner care", etc.
South Korea Updates Guidelines for Testing Methods for the Substantiation of Cosmetic Labeling and Advertising
The Guidelines for Testing Methods for the Substantiation of Cosmetic Labeling and Advertising, modified by the Ministry of Food and Drug Safety, entered into effect on November 29, 2024.
The document introduces general provisions, testing methods, result reporting, and other issues related to the substantiation of "skin moisturizing", "improving skin elasticity", "sebum control", "temporarily reducing cellulite", "suitable for acne-prone skin", "alleviating dark circles", "improving blood circulation of skin", "puffiness reduction", "paraben-free", and "hazy blocking".
The new version introduces the contents related to "temporarily shrinking pores".
South Korea Issues the Guideline for Evaluating the Effectiveness of Quasi-drug Toothpastes
On November 26, 2024, the Ministry of Food and Drug Safety (MFDS) published the Guideline for Evaluating the Effectiveness of Quasi-drug Toothpastes (의약외품 치약제 효력평가법 가이드라인).
In South Korea, toothpaste is defined as a product used in the oral cavity, aimed at keeping teeth white and strong, maintaining oral hygiene, and preventing diseases of the teeth, gums, and oral cavity. It contains formulations with fluoride or hydrogen peroxide, or compounds and/or mixtures that release hydrogen peroxide. However, please note that toothpaste is classified as a quasi-drug in South Korea, not a cosmetic.
This guideline presents efficacy evaluation methods for the effectiveness of toothpaste products. It includes general test standards, criteria for selecting and excluding test subjects, efficacy evaluation variables, and testing methods. MFDS expects to help relevant companies and researchers conduct product effectiveness evaluation easily by providing this guideline.
Thailand
Thailand Updates Notification Guidelines for Ampoule, Vial, and Syringe Cosmetics
In November 2024, the Thai Food and Drug Administration (Thai FDA) released the Guidelines for Consideration of Notification of Cosmetics in Ampoule, Vial, or Syringe Forms (Revised Edition September 2024). This updated guideline introduces new provisions specifying the types of cosmetics that can be notified in these forms, improves the physical characteristics of such containers, and refines the documentation requirements for product notification.
Thailand Updates Titanium Dioxide Regulations for Cosmetics
On November 18, 2024, the Thai FDA officially approved amendments to regulations for the use of titanium dioxide in cosmetics. These changes address this substance as a restricted ingredient, permitted colorant, and sunscreen, aligning Thailand's regulations with the latest updates to the ASEAN Cosmetic Directive (ACD).
Thailand Expands Rules on Unacceptable Cosmetic Advertising Claims
On November 22, 2024, the Thai Minister of Public Health (MOPH) issued a new ministerial regulation under the Cosmetic Act B.E. 2558 (2015), expanding the list of prohibited cosmetic advertising claims. To be specific, this regulation introduces two additional types of claims deemed misleading: those suggesting internal body use and those involving invasive devices or procedures.
Indonesia
Indonesia Unveils Guidelines for Cosmetic Clinical Trials
On November 4, 2024, Indonesia released a draft amendment to BPOM Regulation No. 8 of 2024 concerning Procedures for Approving Clinical Trials. The draft proposes the addition of Appendix IIIa, which contains Cosmetic Clinical Trial Guidelines.
Indonesia Proposes to Update Cosmetic GMP Certification Application and Renewal Requirements
On November 5, 2024, the Indonesia Food and Drug Supervisory Agency (BPOM) released a draft of Technical Requirements for Cosmetic Good Manufacturing Practices (GMP) Certification. The key proposed amendments include:
Changes to required documents and the verification period for application submissions;
Revised requirements for GMP certificate renewal.
On November 5, 2024, Indonesia issued Presidential Regulation No. 153 of 2024 concerning the Halal Product Assurance Organizing Agency (BPJPH). This regulation establishes BPJPH as a non-ministerial government institution operating under the President and accountable through the minister overseeing religious affairs. Led by a head, BPJPH's primary role is to implement government responsibilities related to halal product certification in accordance with applicable laws and regulations.
On November 11, 2024, BPOM released a draft Regulation concerning Risk Assessment for Ingredients Used in Certain Natural Medicines, Health Supplements, Quasi-Drugs, and Cosmetics for public consultation. This regulation requires that ingredients used in certain natural medicines, health supplements, quasi-drugs, and cosmetic preparations meet the standards and quality requirements as pharmaceutical ingredients.
Indonesia Reveals Non-Compliant Products Identified During Supervision and Inspection
From September 2023 to October 2024, BPOM conducted an intensive supervision of cosmetics circulation. As a result of this oversight, the Directorate of Standardization of Traditional Medicines, Health Supplements, and Cosmetics issued an announcement on November 21, 2024, revealing that 16 cosmetic products were being used or applied like medicines through needles or microneedles.
Indonesia Amends Cosmetic Labeling, Promotion and Advertising Requirements
On August 29, 2024, Indonesia released a draft amendment to the Regulation Concerning Cosmetic Labeling, Promotion, and Advertising for public consultation. This was followed by the finalized BPOM Regulation No. 18 of 2024 Concerning Cosmetic Labeling, Promotion, and Advertising, which was released and implemented on November 28, 2024.
BPOM Regulation No. 18 of 2024 replaces BPOM Regulation No. 30 of 2020 Concerning Technical Requirements for Cosmetic Labeling, BPOM Regulation No. 32 of 2021 Concerning Technical Guidelines for Cosmetics Advertising, and the supervision requirements for cosmetic (including refillable cosmetics) labeling and advertising outlined in BPOM Regulation No. 12 of 2023 Concerning Supervision on Manufacture and Circulation of Cosmetics.
Vietnam
Vietnam Ministry of Health Publishes the Inspection Plan of 2025
On November 25, the Vietnam Ministry of Health issued Decision No. 3552/QĐ-BYT on Promulgating the 2025 Inspection Plan. The Ministry aims to conduct 30 inspections, including six focusing on the cosmetics industry, to evaluate the implementation of healthcare laws and regulations, identify weaknesses and gaps in the health management system, and ensure timely corrective actions.
Singapore
HSA Alerts 9 Batches of Non-compliant Cosmetics Containing Potent Ingredients Found Overseas
On November 6, 2024, Singapore's Health Sciences Authority (HSA) released a list of products found overseas in October 2024 that contain potent ingredients, including 9 batches of cosmetics. The potent ingredients detected in these cosmetics are prohibited for general use in cosmetics following the ASEAN Cosmetic Directive (ACD), including Hydroquinone, Tretinoin, Betamethasone, Mercury, Lead, Rhodamine B, Clindamycin, and Metronidazole.
As revealed by HSA on November 27, 2024, from 23 September to 23 October 2024, 3,336 illegal health product listings were removed in a first-of-its-kind large-scale collaboration with online platform administrators. Among all these products, aesthetic enhancement products held the largest share at 48% (1,611). These products included do-it-yourself beauty injectable kits, dermal fillers, Botulinum toxin, sutures, placenta injectables, and skin products marketed for facial lifting, skin whitening, and treating conditions like acne and eczema.
According to HSA, selling unregistered aesthetic enhancement products on local e-commerce and social media platforms is illegal. Anyone who supplies such products is liable to prosecution and if convicted, may be imprisoned for up to 3 years and/or fined up to 100,000 USD.
The Philippines
Philippines FDA Finalizes Revisions to LTO Guidelines
On November 27, 2024, Philippines Food and Drug Administration (FDA) issued the Administrative Order (AO) No. 2024-0015, titled Prescribing the Rules, Requirements and Procedures in the Application for License to Operate of Covered Health Product Establishments with the Food and Drug Administration Repealing for the Purpose Administrative Order No. 2020-0017. Compared to its predecessor, the newly released AO No. 2024-0015 refines LTO application procedures, modifies the requirements and validities for LTO applications, strengthens the requirements for the Qualified Person, and details FDA's decision grounds for LTO applications and issued LTOs.
The European Union
ECHA Reveals Hazardous Substances in 285 Non-compliant Cosmetics
On October 30, 2024, the European Chemicals Agency (ECHA) published findings from the Pilot Project Report on: Enforcement of Restrictions of PFCAs and Related Substances Focusing on Cosmetics, revealing that 285 cosmetic products were found to contain six hazardous substances. Perfluorononyl dimethicone and cyclopentasiloxane (D5) were the most frequently detected.
United States
Washington Identifies Priority Consumer Products for Second Safer Products Program Cycle
On November 1, 2024, Washington State's Department of Ecology released the Draft Identification of Priority Products Report to the Legislature, along with a technical supporting documentation. These documents are open for public consultation until December 31, 2024. This legislative report identifies priority consumer products for Cycle 2 of the Safer Products for Washington program.
The priority chemicals and their corresponding consumer products in the cosmetic sector include:
Cyclic volatile methylsiloxanes (cVMS): Cosmetics
Benzene, ethyl benzene, toluene, and xylene substances (BTEX) substances: Nail products
The draft documents were also notified to the WTO on November 4, 2024.
U.S. FDA to Increase Color Additive Certification Fees
On November 8, 2024, the U.S. Food and Drug Administration (FDA) amended the color additive regulations to raise fees for certification services. The updated fees include a $0.10 per pound increase for straight colors, including lakes, along with similar increases for repacks of certified color additives and color additive mixtures. The new fee structure has been effective since December 9, 2024.
U.S. FDA Issues Warning Letter to Tom's of Maine for CGMP Violations
On November 19, 2024, the U.S. FDA publicly released a warning letter revealing serious manufacturing concerns with Tom's of Maine's toothpaste. During an FDA inspection, it was discovered that the toothpaste was produced using water contaminated with bacteria. Additionally, a "black mold-like substance" was identified in the facility where the product was manufactured. The warning letter was sent earlier to the parent company, Colgate-Palmolive, on November 5, 2024.
California Proposes Listing Nail Products Containing Methyl Methacrylate as a Priority Product
On November 20, 2024, California's Department of Toxic Substances Control (DTSC) notified the WTO of a draft amendment, proposing to designate nail products containing methyl methacrylate (MMA)—including nail coatings and artificial nails—as a priority product under the state's Safer Consumer Products Program.
The proposed listing would cover any nail product containing MMA as an added ingredient, residual, or contaminant. Additionally, DTSC proposes setting an Alternatives Analysis Threshold (AAT) of 1,000 parts per million (ppm) for MMA in such products. The draft amendment is open for public comments from November 1, 2024, to December 16, 2024.
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