Monthly Recap: Global Cosmetic Regulatory Updates | September 2024

Guangzhou Releases 2023 Cosmetics Special Sampling Inspection Results

On September 3, 2024, the Guangzhou Administration for Market Supervision (AMR) announced the cosmetic inspection results for 2023. 2,550 batches of cosmetics were inspected during the past year. Out of these, 2,454 batches met regulatory standards, while 96 batches were found to be non-compliant, representing a non-compliance rate of 3.76%. The non-compliant products primarily fell into ten categories, including sunscreens, facial masks, general skincare products, shampoos and conditioners, hair perming and coloring products, freckle-removing and whitening products, cleansing and bathing products, anti-acne products, toothpastes, as well as skincare items for infants and children.

Zhejiang Province Implements Digital Submission for Cosmetic Notification Dossiers

On September 2, 2024, the Zhejiang Medical Products Administration (MPA) announced the full implementation of the electronic submission for cosmetic notification dossiers. Effective from September 1, 2024, Chinese domestic registrants, notifiers, responsible persons, and cosmetics manufacturers in Zhejiang Province are required to submit user information materials and cosmetic notification dossiers exclusively through the Cosmetics Registration and Notification Information Service Platform. The submission of paper documents will no longer be necessary, but these entities are responsible for archiving the relevant paper records.

China NMPA Releases 2023 National Cosmetics Sampling and Inspection Annual Report

On September 10, 2024, the China National Medical Products Administration (NMPA) issued the “2023 National Cosmetics Sampling and Inspection Annual Report”. The report provides an overview of the cosmetic sampling and inspection conducted throughout 2023, covering 12 product categories, including hair dyes, freckle removal and whitening products, makeup, sunscreens, children’s products, and anti-acne products.

In total, 20,936 batches of cosmetics were sampled, with 20,388 batches meeting the regulatory standards, representing a compliance rate of 97.38%. Among the 12 categories, ordinary skin care products, makeup, and children’s cosmetics had the highest compliance rates, achieving 99.5%, 99.4%, and 99.3%, respectively.

China Clarifies Seven Key Risk Monitoring Items for Cosmetics 

On September 14, 2024, the NMPA released the draft of Administrative Measures on Cosmetic Safety Risk Monitoring for public comment until October 8. The draft Measures applies to the safety risk monitoring of cosmetics and toothpaste, excluding special monitoring conducted due to emergencies.

As per the draft, the key monitoring products and items are:

1. Substances commonly added to cosmetics that may pose risks to human health;

2. Substances added or brought into cosmetics that have caused harm to human health abroad;

3. Substances that could affect the health of vulnerable groups, such as children;

4. Substances identified in regulatory practices or specified in literature that may influence cosmetic safety;

5. Risk substances introduced through raw materials or generated during the production and use of cosmetics;

6. Items involved in the standards to be formulated or revised;

7. Other critical monitoring items.

NMPA Suspends the Sale of a Spanish Cosmetic Product

On September 18, 2024, the NMPA announced that a Spanish company was suspected of illegally using the prohibited ingredient "diflurasone propionate" in two cosmetics products labeled as "Blue Cap Spray" and "Blue Cap Foam," respectively. As a result, the NMPA has ordered the suspension of sales for these two products.

China General Administration of Customs (GACC): Six Batches of Cosmetics Rejected in August

On September 20, 2024, the GACC released an update on rejected food and cosmetics in August 2024. Among them, six batches of cosmetics were refused entry. Three batches from France, Thailand, and Taiwan, China were rejected due to the lack of required qualified documentation. Two batches from Australia failed customs inspection because their total bacterial counts exceeded the limits set by the Safety and Technical Standards for Cosmetics 2015 (STSC 2015). Additionally, a batch from Israel was rejected for non-compliance with STSC 2015 due to acrylamide content violations.

Guangdong Provincial MPA Releases Draft Rules for Regulating Discretionary Administrative Penalties

On September 25, 2024, the Guangdong MPA announced a solicitation for opinions on rules for regulating discretionary administrative penalties until October 15. Rules subject to solicitation includes a draft of Implementation Rules for the Discretionary Application of Administrative Penalties and related criteria documents, such as the draft of Discretionary Criteria for Administrative Penalties in the Cosmetics Sector, which all apply exclusively to the discretionary administrative penalties enforced by the medical products administration departments in Guangdong Province. 

China NMPA Unveils 2024 Cosmetics Standards Plan

On September 27, 2024, the NMPA issued the finalized version of the “2024 Cosmetics Standards Development Plan” to Provincial Medical Products Administration departments in Jiangsu, Shandong, and Guangdong, as well as the Cosmetic Standardization Technical Committee's secretariat and sub-technical committees. The finalized plan covers 54 standards, including limit values for the total colony count (in eye cosmetics, lip cosmetics, and children’s cosmetics) and limit values for dioxane, etc. 

Guangzhou and Shandong Authorities Publish Two Batches of FAQs

In September 2024, the Guangzhou AMR and the Shandong Center for Food and Drug Evaluation & Inspection released two batches of FAQs. These FAQs address key concerns related to the notifications of cosmetic entrusted production, ingredient restrictions, risk substances, as well as the management of factory facilities and equipment.

China NMPA Approves Six NCIs

In September 2024, NMPA updated the notification status of six NCIs. With these recent notifications, a total of 70 NCIs has 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.

1. Pyrroloquinoline Quinone Disodium (PQQ) Salt, notified on September 2, 2024

2. 3,4-Dihydroxyphenylethyl Alcohol, notified on September 14, 2024

3. Dasiphora Fruticosa Extract, notified on September 19, 2024

4. Nicotinamide Mononucleotide, notified on September 19, 2024

5. L-Homoserine, notified on September 25, 2024

6. Maltobionic Acid, notified on September 26, 2024

China Issues Ten Cosmetics-related Standards in September

In September 2024, China issued nine cosmetics-related standards and released one draft cosmetics standard for public comments. The essential information is as follows:

Market Condition

1. According to the National Bureau of Statistics, the retail sales of cosmetic products from January to August 2024 was CNY 273 billion, with a year-on-year (YoY) decrease of 0.5%. In August, the retail sales decreased by 6.1% YoY to CNY 31.9 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 August 2024 totaled CNY 77.6 billion, declining 8.9% YoY. In August, the import value decreased by 9.4% YoY to CNY 9.0 billion.

South Korea to Update Enforcement Rule of Cosmetic Act

On September 24, 2024, Ministry of Food and Drug Safety (MFDS) published the draft of Enforcement Rule of Cosmetics Act for public feedback, proposing plans to establish exceptions for labeling information on cosmetics’ external packaging, ban labeling and advertising practices beyond cosmetic scope, and optimize the administrative provisions. Stakeholders can send suggestions to MFDS before November 11, 2024. 

South Korea Modifies Labeling Standards for Cosmetic Precautions

On September 24, 2024, MFDS disclosed the latest version of Regulation of Labelling Cosmetics Precautions for Use and Fragrance Allergens. The modifications focus on the precautions for small-packaged cosmetics and eye-lash permanent wave products. 

South Korea Publishes Q&As Related to Labeling Information on the External Packaging of Cosmetics

On September 24, 2024, MFDS issued a guideline named Q&A Related to Labeling Information on the External Packaging of Cosmetics. This guideline explains the requirements on cosmetic labeling information, covering external packaging, labeling requirements for set product, exception situations, etc.

South Korea Updates Two Guidelines of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics

On September 5, MFDS updated two guidelines, namely, Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (Local Lymph Node Assay by using flow cytometry, LLNA: BrdU-FCM), and Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (Local Lymph Node Assay: BrdU-ELISA). The modifications are made to update the maximum dosage for the tests.

South Korea Consults on Quasi-Drug Manufacturing Standard

On September 20, 2024, MFDS published the draft of Quasi-Drug Manufacturing Standard to solicit public feedback until October 10, 2024. The modifications proposed in the draft are as follows:

1. The current formulations of toothpaste (paste, liquid, gel, powder) will be expanded to include the tablet formulation. This provision will provide enterprises and consumers with more choices in product development and consumption.

2. The order of items in the manufacturing standards are standardized.

3. Ingredient names and other terminologies are updated to keep aligned with the Korean Pharmacopoeia.

Please note that quasi-drug is a special part of Korean consumer goods. Different from cosmetics, premarket review is required for quasi-drug products. For more requirements related to Korean quasi-drugs, please refer to ChemLinked CosmePedia.

Indonesia Amends Limitations for Chemical Contamination in Cosmetics

On November 9, 2023, Indonesia released an amended draft of the Regulation Concerning Limitations for Contamination in Cosmetics for public consultation. Subsequently, on September 18, 2024, the finalized version was published, set to take effect on September 18, 2025. 

The amended Regulation further clarifies its application scope, expands the scope of institutions authorized to conduct cosmetic contaminant testing, and updates standards for chemical contamination.

Indonesia Signs Halal Product Assurance MRA with Italy

On September 19, 2024, Indonesia announced that the Minister of Religious Affairs signed a Mutual Recognition Agreement (MRA) for Halal Product Assurance (JPH) with Halal Italia, an Italian halal certification agency. This MRA establishes the basis for mutual recognition of halal certificates between the Indonesian Ministry of Religious Affairs and Halal Italia.

Vietnam Plans to Improve the Cosmetic Notification System

The Drug Administration of Vietnam (DAV) sent two letters to the General Administration of Customs and the National Health Information Center, requesting the two departments to improve the Cosmetic Notification System due to problems found in August 2024.

However, system errors remain in the following days. In response, on September 4, 2024, DAV sent another letter to the National Health Information Center, requesting the Center to coordinate with relevant agencies and units to review the system, promptly fix technical problems, and provide timely feedback. 

Vietnam Publishes the Consolidated Decree of the Law on Advertising

On November 14, 2013, Vietnam issued Decree No. 181/2013/ND-CP, providing detailed guidelines for implementing certain articles of the Law on Advertising. From 2017 to 2021, several amendments and supplements have been made to this decree.

On September 18, 2024, the Minister of Culture, Sports and Tourism signed Decree No. 3977/VBHN-BVHTTDL, consolidating Decree No. 181/2013/ND-CP and a series of previous amendments and supplements into one document for better public accessibility.

Vietnam Aims to Strengthen Cosmetic Management

Currently, a significant number of non-compliant cosmetics present in the Vietnamese market. On September 19, 2024, DAV issued a letter to the Health Departments of Provinces and Municipalities, urging them to enhance the enforcement of cosmetic regulations to ensure consumer safety. Specifically, DAV outlines three key actions for the departments: 1) Strengthening cosmetic inspection; 2) Coordinating with local authorities; 3) Imposing strict penalties.

Vietnam Releases Guidelines for the 2024 Inspection and Evaluation of Pharmaceutical and Cosmetics Management

On September 30, 2024, DAV issued guidelines to organize local Health Departments to conduct inspections and evaluations on the implementation of pharmaceutical and cosmetics regulations in 2024 in accordance with the requirements of Decision No. 4369/QĐ-BYT The Content and Time of Inspection and Evaluation of the Implementation of State Management Regulations on Pharmaceuticals and Cosmetics. The guidelines include a clear scoring system, a series of evaluation criteria, and encouragement of cross-departmental collaboration. The inspections should be completed by December 25, 2024.

Thailand Further Revises Notification Standard for Products Used in Intimate Areas 

On September 24, 2024, the Thai Food and Drug Administration (FDA) released the Guidelines for Evaluating the Notification of Products Used in Intimate Areas (Revised Edition July 2024). Built upon the previous April 2024 version, the revised standard introduces new provisions related to physical characteristics, product formulations, and naming regulations for products used in intimate areas. 

Thailand Updates Advertising Manual for Cosmetics

On September 25, 2024, the Thai FDA issued a revised version of its Cosmetic Advertising Manual, aimed at enhancing the regulation and compliance of cosmetic advertisements under the Cosmetics Act 2015. The manual mainly outlines general principles for cosmetic advertising, prohibited claims, examples of acceptable and unacceptable marketing messages across 23 categories, and details on penalties for non-compliance.

Thailand Reports Non-Compliant Cosmetics in September 2024

On September 16, 2024, the Thai FDA disclosed that a batch of alcohol-based hand sanitizer, sold on an online marketplace, failed regulatory inspection. The product was found to contain methanol, a prohibited ingredient, at an alarming concentration of 51.25%, posing serious health risks to consumers.

HSA Alerts 4 Batches of Non-compliant Cosmetics Containing Potent Ingredients Found Overseas

On September 17, 2024, Singapore's Health Sciences Authority (HSA) released a list of products found overseas in August 2024 that contain potent ingredients, including 4 batches of cosmetics. The potent ingredients detected in these cosmetics include Tretinoin, Mercury, Betamethasone (Corticosteroid), and Hydroquinone. These ingredients are prohibited for general use in cosmetics in accordance with ASEAN Cosmetic Directive (ACD).

India Releases Draft Amendments to Standards for Fragrance and Flavor Ingredients

On September 19, 2024, the Bureau of Indian Standards (BIS) issued two draft amendments concerning the standards for fragrance and flavor ingredients. These drafts, now open for public comment until December 9, 2024, propose revisions to the specifications of two essential oils. The drafts are as follows:

• PCD 18(26598) AC Draft Amendment No.1 to IS 15068: 2001 Oil of Cardamom (Elettaria Cardamomum Maton) — Specification

• PCD 18 (26599) AC Draft Amendment No.1 to IS 16583: 2017 Oil of Peppermint, Mentha Piperita (Indian Type) — Specification

Sri Lanka Updates Labeling Requirements for Cosmetics

On September 6, 2024, the Sri Lanka National Medicines Regulatory Authority (NMRA) announced the revised labeling requirements for cosmetics, which aims at strengthening regulatory control over falsified products, set to be effective from September 1, 2024. The NMRA recommends all marketing authorization holders to place printed or non-peelable stickers on each commercial pack of their cosmetic products, which shall clearly display the wordings “NMRA approved”, along with the details of the market authorization holder and the retail price of the product.

Australia Reminds Introducers to Submit the Post-introduction Declaration (PID)

On September 18, 2024, the Australia Industrial Chemicals Introduction Scheme (AICIS) issued a notice to remind manufacturers and importers who introduced industrial chemicals under exempted introduction during the last registration year (September 1, 2023 to August 31, 2024) to submit the PID through the AICIS platform by November 30, 2024.

Australia Updates the Industrial Chemical Categorization Guide

On September 24, 2024, Australian Industrial Chemicals Introduction Scheme (AICIS) published version 3 of the Industrial Chemicals Categorization Guidelines and revised the online categorization guide accordingly. Additionally, AICIS revised the “Step 0: Introductions that are categorized as listed” page to make the online categorization guide clearer and easier to follow.

Australia Consults to Amend the Poisons Standard

In September 2024, Australia released two public consultations regarding the amendments to the Poisons Standard. One is about the interim decision on the amendments of the Poisons Standard. The other is the proposed changes to the Poisons Standard.

Australia Proposes Amendments to the IChEMS

In September 2024, the Australian Department of Climate Change, Energy, the Environment and Water (DCCEEW) released a public consultation to seek feedback on the proposed decisions and variations to the Industrial Chemicals Environmental Management Standard (IChEMS). Lauryl (dodecyl) sulfates, relating to cosmetic use, are proposed to be included in IChEMS Register Schedule 3 – Relevant industrial chemicals that have the potential to cause harm to the environment.

EU to Implement a Union-wide Ban on PFHxA in Cosmetics

On September 20, 2024, EU released the Commission Regulation (EU) 2024/2462, finalizing the prohibition of undecafluorohexanoic acid (PFHxA), its salts, and related substances in various applications. This regulation is in effect since October 10, 2024, but grants the cosmetics industry a 24-month transitional period until October 10, 2026.

California Proposes Listing Bisphenol S (BPS) as a Male Reproductive Toxicant Under Proposition 65

On September 27, 2024, the California Environmental Protection Agency's Office of Environmental Health Hazard Assessment (OEHHA) released a hazard identification document titled Evidence on the Male Reproductive Toxicity of Bisphenol S, which is open for public consultation until November 12, 2024. BPS, which is currently listed under Proposition 65 for female reproductive toxicity, is now being evaluated for its potential listing as a male reproductive toxicant. OEHHA will consider this proposal during a public meeting scheduled on December 12, 2024. If approved, BPS would be officially recognized for its male reproductive toxicity under Proposition 65, which would expand the scope of regulatory action on this chemical. 

U.S. FDA Rejects 88 Batches of Cosmetics in September 2024

In September 2024, the U.S. FDA reported that 88 batches of cosmetics imported from 12 countries were denied entry into the U.S. These rejections encompassed a wide range of products, including oral hygiene items, makeup, skincare preparations, personal cleanliness products, and items for children. India was the country of origin with the most non-compliant products, followed closely by the UK and South Korea. The primary reason for these rejections was the misdeclaration of drugs as cosmetics.