Monthly Recap: Global Cosmetic Regulatory Updates | July 2024

China Implements Regulations on Implementation of Consumer Rights Protection Law

On March 15, 2024, Chinese Premier Li Qiang signed a decree of the State Council, unveiling the refined Regulations for the Implementation of the Nation's Law on the Protection of Consumer Rights and Interests. Effective on July 1, 2024, the Regulations made detailed provisions on business operators' obligations, including the protection of consumers' personal and property safety, the handling of defective products, the avoidance of fraudulent advertisement, price transparency, quality guarantee, the protection of consumers' personal information, as well as the safeguard of rights and interests of the elderly and minors as consumers.

China Implements Two Cosmetic Ingredient Standards in July

On July 1, 2024, China implemented two cosmetics ingredient standards.

NMPA Announces 3 Typical Non-compliant Cases

On July 3, 2024, NMPA issued an announcement regarding three typical non-compliant cases in the cosmetics industry. The reasons for these non-compliant cases were falsely changing the expiration date of cosmetics, producing perfumes without production license, and using recycled cosmetics to produce cosmetics. The companies involved have received administrative punishment by the local MPAs.

China Announces Full Digitization of Cosmetics and New Ingredient Registration/Notification Materials

On July 8, 2024, China's National Medical Products Administration (NMPA) announced the full implementation of electronic submission for cosmetic product and new cosmetic ingredient (NCI) registration and notification materials.

China NIFDC Introduces Technical Guidelines for Cosmetics Safety Assessment

On April 10, 2024, China National Institutes for Food and Drug Control (NIFDC) initiated a public consultation on four technical guidelines concerning cosmetics safety assessment. These documents focus on stability testing, preservative challenge testing, packaging compatibility testing, and skin sensitization testing. Following the consultation period, on July 8, 2024, NIFDC released the finalized guidelines along with relevant Q&As, offering more comprehensive guidance on the safety assessment of cosmetics and cosmetic ingredients. Titles of the four technical guidelines are as below:

China General Administration of Customs (GACC): Nine Batches of Cosmetics Rejected in May and June 2024

On July 9 and July 30, 2024, GACC updated the list of rejected food and cosmetics in May and June 2024. Nine batches of cosmetics imported from France, Indonesia, the US and Poland failed customs inspection due to the lack of required certificates or certification documents, non-compliant packaging, hemp seed oil not meeting national standards, and boric acid not meeting national standards.

Guangzhou Administration for Market Regulation (AMR) Consults on Guangzhou Special Support Measures for Promoting High-quality Development of the Cosmetics Industry

On July 12, 2024, Guangzhou Administration for Market Regulation (AMR) released the draft of Guangzhou Special Support Measures for Promoting High-quality Development of the Cosmetics Industry for public opinion until August 19, 2024.

Hangzhou AMR Issues the Implementation Rules for the Pilot Program of Personalized Cosmetics Services (Trial)

On July 16, 2024, Hangzhou AMR issued the Implementation Rules for the Pilot Program of Personalized Cosmetics Services (Trial), which will come into effect on August 17, 2024.

Zhejiang Provincial Medical Products Administration (MPA) Consults on Zhejiang Province Cosmetics Business Credit Management Measures (Trial)

On July 19, 2024, Zhejiang Provincial MPA released the draft of Zhejiang Province Cosmetics Business Credit Management Measures (Trial) for public opinion.

China Convenes a Meeting to Formally Establish the Technical Committee for Cosmetics Standardization

On July 24, 2024, China's National Medical Products Administration (NMPA) convened a meeting in Beijing to formally establish the Technical Committee for Cosmetics Standardization. During the meeting, the following key actions were taken:

• The articles of association for the Cosmetics Standardization Technical Committee were reviewed and approved.

• The management measures for committee members were approved.

• The working procedures for the formulation and revision of cosmetics standards were established.

NIFDC, Beijing, Guangzhou and Shandong Authorities Publishes Eight Batches of FAQs

In July 2024, Beijing Municipal Medical Products Administration (MPA), National Institutes for Food and Drug Control (NIFDC), Guangzhou AMR and Shandong Center for Food and Drug Evaluation & Inspection released eight batches of FAQs, regarding general cosmetic notification, new cosmetic ingredients, aerosol cosmetics, packaging material compatibility testing, and safety assessment, etc.

China NMPA Approves Nine NCIs in July

In July, NMPA updated the notification status of nine NCIs. After these recent notifications, a total of 55 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 translations based on these NCIs’ Chinese names, which may differ from the INCI names provided by notifiers.

1. Sessile Ganoderma mycelium fermentation product filtrate

2. Isopropylideneglycerol

3. Tectorigenin

4. Pterostilbene

5. Matrine Salicylate

6. 10-Hydroxy-2-decenoic acid

7. ANOECTOCHILUS ROXBURGHII extract

8. METAPANAX DELAVAYI extract

9. Lactobacillus/Coffea arabica seed fermentation filtrate

China Issues Eight Cosmetics-related Standards in July

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

NMPA Announces 113 Batches of Non-Compliant Cosmetics

In July 2024, NMPA issued three announcements regarding the detection of non-compliant cosmetics, with a total of 113 problematic batches identified. In terms of product categories, hair dye products accounted for the highest proportion (34%), followed by sunscreen products (21%). The reasons of disqualification mainly include:

1. Inconsistency between product formula/labeled ingredients and registration/notification dossiers: 60%

2. Microorganisms exceeding the standard: 21.7%

3. Restricted ingredients exceeding the standard: 17.4%

4. Heavy metals exceeding the standard: 0.9%

NMPA Announces 17 Batches of Cosmetics Containing Prohibited Ingredients

In July 2024, NMPA issued an announcement on the detection of prohibited ingredients in 17 batches of cosmetics, with 6 acne-removing products involved. The prohibited ingredients detected were: metronidazole, clindamycin, lincomycin, fusidic acid, ciprofloxacin, enrofloxacin, cimetidine, terbinafine, m-phenylenediamine, o-aminophenol, clobetasol propionate, dexamethasone, flumethasone, etc.

Market Condition

1. According to the National Bureau of Statistics, the retail sales of cosmetic products from January to June 2024 was CNY 216.8 billion, with a year-on-year increase of 1%. In June, the retail sales decreased by 14.6% YoY to CNY 40.5 billion.

2. According to the GACC, the total import value of cosmetics and toiletries from January to June 2024 was CNY 59.32 billion, declining 9.6% YoY. In June, the import value decreased by 4.4% YoY to CNY 8.9 billion.

Hong Kong Consumer Council Releases the Test Results for 50 Hair Styling Product Samples

On July 15, 2024, the Hong Kong Consumer Council released the test results for 50 hair styling product samples. The testing was conducted based on relevant requirements from Safety and Technical Standards for Cosmetics (STSC) in the Chinese Mainland, Air Pollution Control (Volatile Organic Compounds) Regulation in Hongkong SAR, China, and Cosmetics Regulation of the EU. According to the test results, over 90% of the hair styling product samples were found to contain harmful substances, with some exceeding the prescribed limits.

Taiwan Repeals Four Regulations on Specific Purpose Cosmetics

On July 1, 2024, Taiwan Food and Drug Administration (TFDA) approved the immediate repeal of four regulations on specific purpose cosmetics, followed by the discontinuation of specific purpose cosmetics as a product classification. The repealed regulations include:

1) Regulations for Issuance of Permit License of Specific Purpose Cosmetics

2) Regulation for Authorizing the Applications of Import of Non-licensed Specific Purpose Cosmetics

3) Import Limits for Personal Use Specific Purpose Cosmetics Exempted from Inspection and Registration

4) Particulars of Specific Purpose Cosmetics that May Be Voluntarily Modified

Taiwan to Update the Scope and Categories of Cosmetics

The Scope and Categories of Cosmetics defines the scope of cosmetics. It outlines 14 distinct cosmetic categories, such as bath cosmetics, soap, perfume, and lip cosmetics. With an aim to more accurately match cosmetic products with their respective categories, TFDA issued a new draft of this regulation on July 26, 2024, updating two cosmetic categories in the regulation.

South Korea Releases the Alternative Animal Test Guideline for Skin Sensitization

On July 8, 2024, the Ministry of Food and Drug Safety (MFDS) published the Guideline of Alternative Animal Testing Methods [Genomic Allergen Rapid Detection (GARDT) For Assessment of Skinsensitisers (GARDTskin)] for enterprises’ reference.

This guideline is applicable for skin sensitizing test by using GARDT method. Main contents include principle of the test, considerations and limitations, test procedure, recognition standards, result explanation and predictive models, result and report, etc. Please note that this guideline is not a mandatory document.

South Korea Modifies the Cosmetic Labeling Requirements

On January 31, MFDS announced a legislative proposal for amendments to the Enforcement Rule of the Cosmetics Act, to strengthen the labeling requirements to ensure consumer’s safety of using special cosmetics. After six months, the revised Enforcement Rule of the Cosmetics Act, was officially published. Key amendments are as follows:

(1) Intensification of cosmetic labeling standards

Previously, for small-volume cosmetics with insufficient labeling space on the container, enterprises can only indicate the essential information such as product name, business name, and expiry date. However, for special cosmetics such as external genital cleansers and eyelash perm wave products, MFDS deemed it necessary to disclose information about ingredient list and precautions to ensure the safety use. Therefore, the new version mandates the ingredients list and precautions for external genital cleansers and eyelash perm wave products, regardless of the product volume.

(2) Utilization of certification results from private institutions in cosmetic advertising

According to the previous regulation, only certification results from institutions delegated by the MFDS can be used in cosmetic advertisements. To utilize resources from wider parties, the certification results provided by private institutions are allowed for advertising once the act is implemented.

(3) Optimization of administrative measures

The regulation introduces a procedure to directly report resignation to the competent local food and drug administration when a responsible sales manager or custom cosmetic manufacturing manager intends to quit his/her job. This enables smoother registration of the responsible sales manager when he/she works in a new company.

Additionally, the responsible government official is authorized to directly verify the necessary family relationship documents for business inheritance in the business’ administrative information and changes in its cosmetic businesses. 

Despite the regulation’s implementation on July 9, 2024, the modifications related to the labeling requirements for small-volume cosmetics will be effective one year later. In addition, with this revision of allowing using the certification results provided by private institutions, the subordinate Regulation on the Authentication of Liability of Certification Assurance Institutions for Cosmetic Labelling and Advertisements got abolished on July 9, 2024.

MFDS Issues the Examination Results of Tris-Biphenyl Triazine

On July 11, 2024, MFDS published the examination result of a restricted material. As per the result, the substance Tris-Biphenyl Triazine (트리스-바이페닐트라이아진) is compliant with Korean cosmetic material designation standards when meeting the following conditions. The usage of this substance in cosmetic should be 10% or less. Moreover, it cannot be used in aerosol products (including pump sprays). In the case of nanoparticles, the uncoated particles shall have a median particle size exceeding 80 nm, and a purity of 98% or higher. According to MFDS, Tris-Biphenyl Triazine is to be included in the restricted material list under the Cosmetic Safety Standards in the near future.

South Korea Consults on the GMP Regulations for Cosmetic

On July 16, 2024, MFDS released a notification to solicit public feedback on the modifications of the Regulations on Cosmetic Good Manufacturing and Quality Control Practices. By modifying the regulation, MFDS intends to harmonize the Korean Cosmetic Good Manufacturing Practices (CGMP) with the international standard ISO 22716 (hereinafter referred to as "the international standard") in order to improve the efficiency of cosmetic industries and strengthen international competitiveness. Details are proposed as below:

• Deleting the definition of semi-finished products that is difficult to be clearly distinguished from raw materials.

• Modifying the terminology related to organizational structure, employee responsibilities, education and training, etc. of human resources, by referring to the international standard.

• Aligning the facility standards with the international standard, such as deleting the example of air conditioning facilities which may be misunderstood as a mandatory requirement.

• Improving the standards to allow manufacturers to set and implement criteria for rework, similar to the international standard.

Japan Approves a New Ingredient for Rinse-off Hair Styling Products

On July 12, 2024, the Ministry of Health, Labour and Welfare of Japan approval Proposal No.495230435, planning to add "Cysteamine Hydrochloride" as an ingredient for hair styling products that are exclusively intended for hair application and rinsing off. The Maximum Allowable Concentration is 8.63g per 100g.

PMDA: 118 Batches Cosmetics and Quasi-drugs Recalled in July

In July 2024, Japan Pharmaceuticals and Medical Devices Agency (PMDA) notified and recalled a total of 118 batches of cosmetic and quasi-drug products. Among them, 37% batches were recalled because trace amounts of methanol were detected. According to Standards for Cosmetics, methanol is prohibited in all cosmetic products. Additionally, the second most significant factor leading to the recalls was improper labeling, accounting for 22% of the batches.

Thailand Revises Cosmetic Ingredient Use Requirements: 2 Ingredients Added and 1 Revised

On July 3, 2024, the Thai Food and Drug Administration (Thai FDA) officially approved amendments to its cosmetic ingredient lists. The changes include the addition of a prohibited ingredient, the addition of a permitted sunscreen, and the revision of a permitted colorant in cosmetics. These amendments took effect immediately.

Thailand Proposes to Update Cosmetic Ingredient Regulations: 57 New Additions, and 1 Revision

On July 11, 2024, the Thai FDA launched a 15-day public consultation on the newly proposed amendments to its cosmetic ingredient lists. The proposal includes the addition of 56 prohibited ingredients and one restricted ingredient, along with the revision to another restricted ingredient. Once adopted, the changes will take effect upon publication in the Government Gazette. Cosmetic stakeholders who have already manufactured, imported, or sold products containing the 56 prohibited ingredients and the revised restricted ingredient prior to the official announcement will be granted a grace period of 180 days to comply with the new regulations.

Thailand Reports Non-Compliant Cosmetics in July 2024

On July 26, 2024, the Thai FDA announced that a batch of hair dye product imported from India failed inspection. The non-compliance was due to the presence of Clostridium spp., a disease-causing microorganism, as well as excessive bacterial counts. The total bacterial counts in the affected batch were 520,000 colonies per gram, significantly exceeding the legal limit of 1,000 colonies per gram.

Indonesia BPJPH Opens Channel of Foreign Halal Certificate Registration

On July 15, 2024, the Indonesia Halal Product Guarantee Agency (BPJPH) announced the opening of the Foreign Halal Certificate Registration (RSHLN) channel on the Halal Information System (Sihalal).

Malaysia NPRA Releases Cosmetics GMP Inspection Deficiency Report

On July 24, 2024, Malaysia's National Pharmaceutical Regulatory Agency (NPRA) released a Deficiency Analysis Report on Good Manufacturing Practice (GMP) inspections of cosmetics manufacturers conducted in 2023. The report covers on-site routine inspections of manufacturing facilities for various products, including cosmetics, carried out between January to December 2023.

Vietnam Updates the Ingredient Annexes Approved During the 39th ACSB Meeting

On July 9, 2024, the Drug Administration of Vietnam (DAV) issued Official Letter No. 2365/QLD-MP to announce the updated ingredient annexes approved during the 39th ASEAN Cosmetic Scientific Body (ACSB) meeting. All the amendments came into immediate effect on July 9, 2024, while the amendments in Annex III will be effective on different dates.

The Key amendments include:

1) Annex II - List of Prohibited Ingredients: 1 revised

2) Annex III - List of Restricted Ingredients: 3 revised, 1 added

3) Annex VI - List of Permitted Preservatives: 9 revised

4) Annex VII - List of Permitted UV Filters: 2 revised

Singapore Updates ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes

On July 1, 2024, the Singapore Health Sciences Authority (HSA) issued the updated ingredient annexes approved during the 39th ACSB meeting. The key amendments include:

1) Annex II - List of Prohibited Ingredients: 1 revised

2) Annex III - List of Restricted Ingredients: 3 revised, 1added

3) Annex VI - List of Permitted Preservatives: 9 revised

4) Annex VII - List of Permitted UV Filters: 2 revised

India Proposes Draft Rules for Compounding of Offences Under the Drugs & Cosmetics Act

On July 10, 2024, the Ministry of Health and Family Welfare issued the draft of the Drugs and Cosmetics (Compounding of Offences) Rules, 2023 for public comment over the next 45 days. The proposed Rules introduces a mechanism for compounding offenses, allowing companies and individuals to settle violations by paying a fine instead of undergoing legal proceedings.

U.S. FDA’s Enforcement for Facility Registration and Product Listing Began on July 1, 2024

Starting July 1, 2024, all cosmetic companies wishing to enter the U.S. market must complete the mandatory FDA registration, which includes facility registration and product listing. Cosmetic stakeholders are urged to complete the necessary procedures promptly.

U.S. FDA Delays Rulemaking on Fragrance Allergens and Asbestos Testing Methods Under MoCRA

On July 5, 2024, the Office of Information and Regulatory Affairs (OIRA) released the "Spring 2024 Unified Agenda of Regulatory and Deregulatory Actions" (the Unified Agenda). The Unified Agenda reveals that the proposed rulemaking on fragrance allergens and asbestos testing methods under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) have been delayed from their original timelines, with further delays possible.

U.S. FDA Launches New Features in Cosmetics Direct for Improved Product Management

On July 29, 2024, the U.S. Food and Drug Administration (FDA) announced the addition of two new features to Cosmetics Direct, the electronic submission portal for cosmetic facility registration and product listing under the MoCRA. These new features enable users to discontinue and relist cosmetic product listings, enhancing the overall management of product information.

U.S. FDA Reports Rejection of 72 Batches of Cosmetics in July 2024

In July 2024, the U.S. FDA revealed that a total of 72 batches of imported cosmetics had been refused entry. These rejections spanned various categories, including hair preparations, oral hygiene products, makeup preparations, skin care preparations, personal cleanliness items, manicuring preparations, and fragrance preparations. Thailand was the leading country of origin with 21 batches rejected, followed by India with 9 batches and Korea with 8 batches. The primary reasons for these rejections were the misdeclaration of drugs as cosmetics and labeling issues.

Canada Requires Companies to Provide PFAS Information

On July 27, 2024, the Government of Canada published a notice in the Canada Gazette, Part I, Volume 158, Number 30, requiring relevant companies to provide information on certain per- and polyfluoroalkyl substances (PFAS). The purpose of this information gathering is to assess whether the PFAS substances listed in Schedule 1 of the notice are toxic or have the potential to become toxic. Additionally, the government aims to evaluate the necessary control measures for the risks posed by these substances.

Australia Consults on a Proposed Exposure Model for Assessing the Safety of Sunscreen Ingredients

On July 2, 2024, the Therapeutic Goods Administration (TGA) initiated a public consultation on developing a standardized model to assess exposure to sunscreen ingredients. It will enable the TGA to calculate safe concentrations of sunscreen ingredients based on Australian conditions and the latest scientific information. Three options are given to the public to consider.

Australia Recalls a Batch of Non-compliant Cosmetics

On July 16, 2024, the Australian Competition and Consumer Commission (ACCC) issued a notice regarding the recall of an exfoliating gel cleanser. The recall was initiated due to the error in the product’s ingredient list, which is a non-compliance with the mandatory standard, Consumer Goods (Cosmetics) Information Standard 2020.

Australia Adds Two Ingredients to the Australian Inventory of Industrial Chemicals (AIIC)

On July 19, 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) announced the addition of four industrial chemicals to the Australian Inventory of Industrial Chemicals (AIIC) under Section 82 of the Industrial Chemicals Act 2019. This update follows five years since the issuance of assessment certificates for these chemicals. Notably, two of the newly listed chemicals can be utilized in cosmetic formulations:

1) Siloxanes and Silicones, di-Me, Me hydrogen, polymers with vinyl group-terminated di-Me, Me vinyl siloxanes (CAS No. 869736-22-1);

2) Poly (oxy-1,2-ethanediyl),. alpha.-sulfo-.omega.-hydroxy-, C12-16-alkyl ethers, zinc salts (CAS No. 224175-26-2).

Reminder: Australia Opens AICIS Business Registration Renewal for Year 2024-2025

On July 24, the AICIS issued a notice to remind introducers intending to continue importing or manufacturing products in Australia to renew their registration for the upcoming registration year (September 1, 2024, to August 31, 2025) by August 31, and pay registration fees on its Business Services platform. Notably, the registration level thresholds and fees will change for the next registration year. . Failure to renew by the deadline may result in penalties.

Australia Proposes Amendments to the Poisons Standard

On January 5, 2024, the TGA launched a public consultation regarding proposed amendments to the Poisons Standard. Two cosmetic-related amendments have been made in Schedule 4 – Prescription-only medicines and prescription animal remedies. On July 26, 2024, the TGA released the interim decisions of these proposals and launched a public consultation on these decisions. Stakeholders are encouraged to participate in the consultation by August 23, 2024.

IARC Declares Talc as a Class 2A Carcinogen

On July 5, 2024, the International Agency for Research on Cancer (IARC), an affiliate of the World Health Organization (WHO), announced that IARC had declared that talc had been classified as a Class 2A carcinogen. The decision was made during the meeting at the IARC headquarters in Lyon, France, participated by a working group of 29 scientists from 13 countries.