Monthly Recap: Global Cosmetic Regulatory Updates | October 2024

On October 9, 2024, the Guangdong Provincial Medical Products Administration (MPA) held a special meeting to strengthen the supervision of general cosmetics with claims of hair dyeing efficacy. The meeting provided a comprehensive analysis of the current issues related to these products and specified the next stage of work, focusing on targeting three primary types of illegal activity.

1. Production and distribution of unregistered hair dyeing cosmetics (Products with claims of hair dyeing efficacy);

2. Manufacturing and sale of general cosmetics with claims of hair dyeing efficacy that do not comply with mandatory national standards, technical specifications, or the requirements outlined in their notification dossiers;

3. Distribution of general cosmetics falsely with claims of hair dyeing efficacy.

China NMPA Reportes Four Typical Non-Compliant Cosmetic Cases

On October 21, the National Medical Products Administration (NMPA) reported four typical non-compliance cases of cosmetics. They are selling counterfeit products, manufacturing and selling cosmetics without a valid production license, producing products that fail to meet technical standards, and failing to establish or implement a purchase examination records system.

China General Administration of Customs (GACC): 18 Batches of Cosmetics Rejected in September

On October 24, 2024, the GACC released a list of rejected food and cosmetics in September 2024. Among them, 18 batches of cosmetics were refused entry. Among them, 12 batches from Indonesia, Thailand, the UK, Japan, Pakistan, France, Italy, and the US were refused entry for the lack of certificates or proof of qualification as requested. Three batches from Thailand were refused due to failing to meet the national standard of Triclosan. One batch from Israel failed customs inspection due to the mismatch between the declared goods and the actual shipment. Additionally, two batches from Japan were rejected due to non-compliant labels.

China Amends the Safety and Technical Standards for Cosmetics 2015 (STSC): Adding 3 Testing Methods and Revising 2 Testing Methods

On October 30, 2024, China NMPA announced amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC), introducing 3 new testing methods and revising 2 existing testing methods. Effective from July 1, 2025, these updated testing methods apply to cosmetic registration, notification, and sampling tests.

Beijing and Guangdong Authorities Publish Four Batches of FAQs

In October 2024, the Beijing Municipal MPA, Guangdong Provincial MPA and Guangzhou AMR released four batches of FAQs. These FAQs address key concerns related to toothpaste notification, general cosmetics notification as well as cosmetic safety assessment.

China NMPA Approves Three NCIs

In October 2024, NMPA updated the notification status of three NCIs. With these recent notifications, a total of 73 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 translations based on these NCIs’ Chinese names, which may differ from the INCI names provided by the notifiers.

1. PHOEBE HUI stem/root oil notified on October 10, 2024

2. Tremella aurantialba body extract, notified on October 16, 2024

3. Pentapeptide-48, notified on October 16, 2024

China Issues 15 Cosmetics-related Standards in October

Market Condition

1. According to the National Bureau of Statistics, the retail sales of cosmetic products from January to September 2024 was CNY 307 billion, with a year-on-year (YoY) decrease of 1%. In September, the retail sales decreased by 4.6% YoY to CNY 32.9 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 September 2024 totaled CNY 87.7 billion, declining 9.0% YoY. In September, the import value decreased by 9.6% YoY to CNY 10.0 billion.

Taiwan Introduces One Test Method for Cosmetics

On October 2, 2024, the Taiwan Food and Drug Administration (TFDA) issued a recommended test method for identifying four perfluoroalkyl substances in cosmetics, including perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), nonadecafluorodecanoic acid (PFDA), and perfluorononan-1-oic acid (PFNA). These substances were added to Taiwan’s List of Prohibited Ingredients in Cosmetics on March 21, 2024. Starting January 1, 2025, their use in cosmetics will be banned.

PMDA: 360 Batches Cosmetics and Quasi-drugs Recalled in September

In October 2024, Japan Pharmaceutical and Medical Devices Agency (PMDA) successively announced and recalled 360 batches of unqualified cosmetics and quasi-drugs. The most commonly disclosed issue was ingredient problems in various mask products, accounting for 75.3% of the non-compliant products. In addition, 37 batches of perfume were found with mistakes in labeling ingredient list and were ordered to be canceled.

KCA Reminds the End of Grace Period for THB in Cosmetics

As revealed by the Korean Cosmetic Association (KCA), cosmetics containing 1,2,4-trihydroxy benzene (THB) are no longer allowed to be sold in South Korea after October 2, 2024, in accordance with the modifications in the Regulation on Safety Standards, etc. for Cosmetics.

Offenders may face imprisonment for up to three years or a fine of up to 30 million KRW following the Cosmetics Act. As for the responsible cosmetic sellers, a suspension of manufacturing or sales operations for three months will be imposed according to the Enforcement Rules of the Cosmetics Act.

Therefore, KCA suggests enterprises promptly check the cosmetic ingredient compliance to avoid THB-contained cosmetics being sold to consumers.

South Korea Cracks Down False and Exaggerated Advertising for Cosmetics with the Claim of Hair Loss Alleviation

On October 25, 2024, the Ministry of Food and Drug Safety (MFDS) revealed the inspection results of 151 online postings for cosmetics with the claim of hair loss alleviation. In total, 67 cases were identified as false and exaggerated advertising in violation of Article 13 of the Cosmetics Act, which prohibits “improper labeling and advertising practices”. These postings would be blocked from access under MFDS requests. Additionally, among the 67 improper cases, 27 postings directly promoted by the responsible cosmetic sellers were found illegal via on-site inspections, resulting in administrative penalties.

K-Beauty Exports Soar to New Heights in Q3 2024

On October 11, 2024, MFDS revealed the export scale of K-beauty products in the third quarter of this year. The export value reached 7.4 billion USD, marking a 19.3% YoY increase. China was the biggest importer of K-beauty products in Q3 2024. Amongst the exported products, basic cosmetics were sold the most.

South Korea Issues the Analytical Methods for Fragrance Allergens

On October 17, 2024, the Korea Pharmaceutical Traders Association (KPTA) released a document titled Analytical Methods for Fragrance Allergens (Notice No. 488). This document was developed based on the results of research and development projects conducted by MFDS, to provide references for the cosmetic industry. This document outlines 25 fragrance allergens, along with their chemical formulas, CAS numbers, usage controls, etc., test methods, operational procedures, calculation equations, and references.

According to the authority, this document has no legally binding force, and scientifically validated alternative analytical methods may be used if available.

South Korea Modifies Quasi-Drug Manufacturing Standard

On October 21, 2024, MFDS published the Quasi-Drug Manufacturing Standard, which mainly introduced new form of toothpaste and clarified standards of additive usage.

The detailed modifications are as follows:

1. The standards and specifications of toothpaste in tablet formulation is introduced in the new regulation. Compared with the traditional toothpaste, pill-shaped toothpaste is easier to carry and use.  

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

3. Ingredient names and other terminologies are updated in line 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.

KPTA Reminds of Properly Labeling of Cosmetics Containing Harpagophytum Root Extract

According to MFDS inspection results, some products containing “Harpagophytum Root Extract (하르파고피툼근 추출물)” as a cosmetic ingredient are being indiscriminately advertised for their anti-inflammatory and analgesic effects. In response, on October 31, 2024, the Korea Pharmaceutical Traders Association (KPTA) published a notice (No. 489) reminding enterprises to properly advertise cosmetics containing “Harpagophytum Root Extract (하르파고피툼근 추출물)” and to avoid expressions such as “anti-inflammatory and analgesic effects (염증완화, 진통).”

As per Article 2 of the Cosmetics Act, cosmetics are defined as items used for cleansing or beautifying the human body, enhancing attractiveness, or changing appearance through methods such as application, rubbing, or spraying. These items are considered to have a mild effect on the human body and do not include items classified as pharmaceuticals.

Harpagophytum Root Extract is derived from the “Harpagophytum Root,” an ingredient listed in the Korean Pharmacopoeia and the Herbal Medicine Standards. If products containing Harpagophytum Root Extract have the claim of “anti-inflammatory and analgesic effects,” they are not categorized as cosmetics.

Therefore, claims of “anti-inflammatory and analgesic effects” and other pharmaceutical-like expressions are not allowed for cosmetic products. Enterprises in violation will face administrative actions. KPTA advised cosmetic enterprises to conduct proper advertising practices to avoid disadvantages resulting from false and exaggerated claims.

Thailand Approves Eight New TIS Standards for Cosmetics

On October 1, 2024, Thailand’s Ministry of Industry announced in the Official Gazette the approval of eight new voluntary Thai Industrial Standards Institute (TIS) standards for cosmetics. These standards, effective from October 2, 2024, cover a range of areas critical to cosmetic safety and quality, including microbiological testing, analytical methods, sun protection evaluation, as well as natural and organic cosmetic ingredients.

Thailand Implements Updated Fee Structure for Cosmetic Review Process

On October 4, 2024, the Thai Food and Drug Administration (FDA) introduced an updated fee structure for the cosmetic review process, effective retroactively from October 1, 2024. This update replaces the previous fee regulations, introducing revised inspection fees for establishments involved in cosmetic production, import, and contract production under Thailand’s Cosmetics Act, B.E. 2558 (2015). Additionally, inspection fees for cosmetic production facilities following the ASEAN Good Manufacturing Practice (GMP) standards have been adjusted. Fees for other cosmetic-related applications and approvals remain unchanged.

Indonesia’s BPJPH Signs 52 Mutual Recognition Agreements (MRAs) with Foreign Halal Institutions

On October 10, 2024, the Indonesia Halal Product Assurance Agency (BPJPH) released a media article on its website, announcing the conclusion of the 3rd H20 Halal World Forum. In this event, 52 Mutual Recognition Agreements (MRAs) were signed between BPJPH and foreign halal institutions from 24 countries, alongside a joint agreement aimed at strengthening the global halal ecosystem. However, the media article did not specify the foreign institutions involved in the agreements.

Indonesia Launches Two Programs to Support Micro, Small, and Medium Enterprises

On October 15, 2024, the Indonesian Food and Drug Supervisory Agency (BPOM) issued and implemented Decree No. 390 of 2024 Concerning Implementation Guidelines for the Adopting Parent Program for Micro, Small, and Medium Enterprises (MSMEs) for Natural Medicines and Cosmetics and Decree No. 391 of 2024 Concerning Implementation Guidelines for the MSMEs Meet Market Program.

Indonesia Updates Implementation Regulation of Halal Product Assurance

On October 17, 2024, Indonesia released and implemented Government Regulation (GR) No. 42 of 2024 Regarding Implementation of Halal Product Assurance. The key amendments include:

1) Clarifying the required documents for the appointment of the halal supervisor;

2) Slightly adjusting the time limits for certain halal certification steps;

3) Clarifying the obligations of companies with halal certificates;

4) Clarifying requirements for halal certificate renewal;

5) Adding exemption for halal labeling;

6) Clarifying conditions of imported products applying for halal certificate from BPJPH;

7) Adjusting the timeline for renewing foreign halal certificate registration.

Philippines Updates Requirements for Cosmetic Ingredient Use

On October 10, 2024, the Philippines Food and Drug Administration (FDA) introduced revised amendments to the ingredient annexes to ASEAN Cosmetic Directive (ACD). These amendments, which were adopted during the 39th ASEAN Cosmetic Scientific Body (ACSB) meeting, primarily include the following:

1) Annex II: revising the requirements for 1 prohibited ingredient;

2) Annex III: adding 1 restricted ingredient, and revising the requirements for 3 restricted ingredients;

3) Annex VI: revising the identification of 9 permitted preservatives;

4) Annex VII: revising the identification of 2 permitted UV filters.

India Rejects Proposal to Mandate INCI Names on Cosmetic Labels

On June 19, 2024, India's Drugs Consultative Committee (DCC) reviewed a proposal that aimed to mandate the inclusion of International Nomenclature of Cosmetic Ingredients (INCI) names in the ingredient lists on cosmetic product labels. After discussions, the DCC concluded that adding INCI names on labels would be impractical due to space limitations. Instead, it recommended that the cosmetics industry continue to adhere to the existing Bureau of Indian Standards (BIS) for ingredient labeling.

Sri Lanka Updates Labeling Requirements for Borderline Products

On October 22, 2024, Sri Lanka’s National Medicines Regulatory Authority (NMRA) announced revised labeling requirements for borderline products—items with combined characteristics of medicines, foods, medical devices, or cosmetics. Under the new rules, each commercial pack must have a non-peelable or printed sticker displaying “NMRA approved,” along with details of the market authorization holder and the product’s retail price.

These requirements will apply to all batches released on and after November 1, 2024, with products in the market produced prior to November 1 exempted. A three-month grace period is provided for compliance for both local and imported products, after which adherence to the new labeling standards will be mandatory.

Australia Launches a New Decision Tool for Soap Introducers to Determine Whether They Need to Register with AICIS

On October 2, 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) launched a decision tool designed to assist Australian soap introducers. By answering a series of questions online, users can determine whether they need to register their business with AICIS before introducing soaps into Australia.

Australia Consults on Proposed Revisions to Industrial Chemicals Categorization Guidelines in 2025

On October 24, 2024, AICIS proposed a public consultation to revise the Industrial Chemicals Categorization Guidelines that will come into force in September 2025. The main change is the addition of 120 chemicals to the List of chemicals with high hazards for categorization. Stakeholders are encouraged to submit their feedback by December 5, 2024.

Australia Adds an Information Notice for Cosmetics for Human Use

On October 10, 2024, the Australian Department of Agriculture, Fisheries and Forestry added an information notice to the BICON (Biosecurity Import Conditions) case “Cosmetics and soaps” for cosmetics for human use. While there are no changes to the existing import conditions, the notice highlights that for certain cosmetics that are considered to be therapeutic goods, importers are required to comply with the relevant regulations set by the Therapeutic Goods Administration (TGA).

Australia Consults on Draft Assessment Statements of Industrial Chemicals

In October 2024, AICIS released a series of draft assessment statements of industrial chemicals for public consultation. Among the eight draft evaluation statements, four of them are related to cosmetic use.

1. 1H-Benzotriazole and its mono-substituted derivatives

2. Phenolic benzotriazoles

3. Extracts and essential oils primarily composed of methyl salicylate

4. Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester (Homosalate)

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

On September 27 and October 18, 2024, AICIS announced the addition of two industrial chemicals to the Australian Inventory of Industrial Chemicals (AIIC) under Section 83 of the Industrial Chemicals Act 2019.

1. 4-Pentenal, 2,4-dimethyl-5-(4-methylphenyl)-, (4E)-, (CAS No. 1226911-73-4)

2. 2(3H)-Furanone, 3-ethyldihydro-5,5-dimethyl-, (CAS No. 66094-79-9)

EU SCCS Releases Final Opinion About Acetylated Vetiver Oil

On March 5, 2024, EU Scientific Committee on Consumer Safety (SCCS) released the preliminary opinion on the inhalation toxicity of acetylated vetiver oil in sprayable cosmetics. Following an extensive consultation, SCCS released the final opinion on October 25, 2024, upholding the same conclusion as the preliminary version.

EU SCCS Finalizes Addendum to Opinion on Hexyl Salicylate, Addressing Children’s Exposure

On July 29, 2024, EU SCCS initiated a public consultation on an addendum to its previous opinion on hexyl salicylate, which highlights concerns about children's exposure. After a thorough consultation phase, SCCS published the final opinion on October 25, 2024, incorporating modifications to the initial conclusions.

EU SCCS Issues Final Opinions on Three Cosmetic Ingredients

On August 1, 2024, EU SCCS released two preliminary opinions regarding three cosmetic ingredients. One opinion focuses on biphenyl-2-ol and sodium 2-biphenylolate, while the other addresses HC yellow No. 16. Following the commenting period, SCCS issued final opinions on these ingredients on October 25, 2024, which included a clarification to the preliminary opinions.

New UK Regulation Grants Flexibility in Conformity Marking for Aerosols

In May 2024, the UK issued the Product Safety and Metrology etc. (Amendment) Regulations 2024, affirming the continued recognition of EU compliance requirements for 21 product categories, including aerosols. With the regulation taking effect on October 1, 2024, aerosol companies now have the flexibility to use either the inverted epsilon or the UKCA (UK Conformity Assessed) marking to sell aerosols in GB beyond the deadline of December 31, 2024.

UK to Revise Cosmetic Ingredient Lists: 65 Prohibited and 1 Restricted Ingredients Added

On October 3, 2024, UK submitted an addendum to WTO regarding the draft regulation previously notified in April 2024. This addendum proposes a ban on 13 additional CMR substances (carcinogenic, mutagenic, or toxic for reproduction), and revises the transitional policies for impacted cosmetic products. The addendum is open for comments for 60 days, and is set to take effect on January 31, 2025, alongside the regulation.

UK Revokes Proposed Recycling Labelling Requirements for Packaging Producers

On October 28, 2024, UK submitted an addendum to the WTO concerning its notification in May 2024. This addendum revokes the recycling labelling requirements proposed in the earlier notification, which were included in the draft regulation of Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024. With this change, the labelling requirements will no longer be mandatory when the regulation takes effect.

UK SAG-CS Issues Opinions on Dihydroxyacetone, Benzophenone-3, and Octocrylene

In October 2024, the Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS) of UK published its final opinions on Dihydroxyacetone, Benzophenone-3, and Octocrylene, outlining concentration limits for each ingredient in cosmetics for adults. Risk assessments for these ingredients for children and adolescents will follow once sufficient data is obtained.

California Proposes Listing Vinyl Acetate Under Proposition 65 as a Carcinogen

On October 4, 2024, the Office of Environmental Health Hazard Assessment (OEHHA) under the California Environmental Protection Agency announced plans to hold a Carcinogen Identification Committee (CIC) meeting on December 12, 2024. During this meeting, the committee will consider whether to list vinyl acetate as a carcinogen under Proposition 65. This potential listing would signal a determination that vinyl acetate poses a cancer risk to Californians.

As part of the process, OEHHA has opened a 45-day public comment period on the hazard identification document related to vinyl acetate. Stakeholders and the public are invited to submit written comments by November 18, 2024. Comments can be submitted electronically, by mail, or through hand delivery.

FDA Issues Final Guidance on Tattoo Ink Safety

On October 24, 2024, the U.S. Food and Drug Administration (FDA) released final guidance titled Insanitary Conditions in the Preparation, Packing, and Holding of Tattoo Inks and the Risk of Microbial Contamination. This document helps tattoo ink manufacturers and distributors identify conditions that may lead to microbial contamination. It also provides recommendations on measures to prevent contamination and address unsanitary conditions in the manufacturing and distribution processes.

Canada Amends Cosmetic Regulations

On February 11, 2023, the Government of Canada proposed amendments to the Cosmetic Regulations, which were published in the Canada Gazette, Part I, Volume 157, Number 6. The finalized amendments were published on April 24, 2024, in the Canada Gazette, Part II, Volume 158, Number 9.

These amendments include requirements for cosmetics to be labeled with fragrance allergens, allowing the full ingredient list of cosmetics sold in small packages to be disclosed on websites, and modifying cosmetic supervision requirements.

On October 9, 2024, these amendments took effect. The enhanced detail requirements for cosmetic notifications apply only to submissions made on or after October 9, 2024.

Correspondingly, the Industry Guide for Cosmetic Labeling, Industry Guide for Cosmetic Notification, and the Cosmetic Notification Form have been updated to reflect these changes.