From January to August 2024, several significant regulatory developments occurred in the APAC region. Notably, China introduced a transition period along with several regulatory documents for safety assessments and amended the Safety and Technical Standards for Cosmetics. Taiwan eliminated the category of specific purpose cosmetics and implemented unified management for all cosmetics. Additionally, updates regarding cosmetic ingredients, particularly the prohibition of specific substances, remain a key focus across various countries. It is crucial for enterprises to stay informed about these changes and adjust their strategies to comply with regulatory requirements.
Here are brief updates on key developments.
1. China
1.1 NMPA Amends the Safety and Technical Standards for Cosmetics 2015
On March 21, 2024, NMPA announced significant amendments to the Safety and Technical Standards for Cosmetics (2015 Edition) (STSC). The updates include:
- Addition of 5 newly prohibited ingredients: Bimatoprost, Tafluprost, Taflupamide, Travoprost, and Latanoprost;
- Revision of 3 existing testing methods, including those for dioxane and other prohibited and restricted ingredients;
- Introduction of 11 new testing methods, covering areas such as acute inhalation toxicity, skin sensitization, and reproductive toxicity.
The updated ingredient list is in effect immediately, while the revised testing methods will take effect on December 1, 2024.
1.2 China Sets Transition Period for Submitting Complete Safety Assessment Reports and Issues Multiple Regulatory Documents to Clarify Safety Assessment Requirements
Under CSAR framework, cosmetics registrants and notifiers are required to submit product safety assessment documents during registration and notification. Until May 1, 2024, they have the option to submit a simplified safety assessment report. However, from May 1, 2024 onwards, the full version of the assessment report must be submitted.
Considering industry challenges, China’s National Medical Products Administration (NMPA) has extended the transition period. Registrants and notifiers can still submit a simplified safety assessment report before May 1, 2025, as long as the assessment was started before May 1, 2024.
To guide companies, in April and July 2024, NMPA issued several new regulatory documents related to safety assessment. This includes guidelines that classify submission requirements based on risk management principles and provide self-examination points for the assessment reports.
ChemLinked Comments
With these supporting policies and optimization measures, the full safety assessment report system can be effectively implemented in China’s cosmetics industry.
Although the NMPA has provided a transition period for companies, it is advisable to proactively prepare for the full version of the report. This includes assembling qualified personnel, reviewing ingredients and addressing data gaps, and seeking expert consultants, etc.
2. Taiwan
2.1 TFDA Amends Cosmetic Ingredient Use Requirements
Taiwan Food and Drug Administration (TFDA) issued several announcements on December 13, 2023, January 4, 2024 and May 30, 2024, regarding the revision of prohibited and restricted ingredients for cosmetics. Please refer to the table below for the specific amendments.
| Source | Main Amendments | Effective Date |
| Announcement issued by TFDA on December 13, 2023 | 1. Adding 9 ingredients to the List of Prohibited Ingredients in Cosmetics, including HICC, Aminocaproic acid and its salts;
2. Revising 2 ingredients in the List of Prohibited Ingredients in Cosmetics: Cells, tissues or products of human origin, Zirconium and its compounds. |
Amendments to cells, tissues, or products of human origin took effect on March 21, 2024, while other amendments are scheduled to come into force on January 1, 2025. |
| Announcements issued by TFDA on January 4, 2024 and May 30, 2024 | 1. Newly establishing the List of UV Filters in Cosmetic Products;
2. Abolishing the previous List of Specific Purpose Ingredients in Cosmetic Products, and the List of Antibacterial Ingredients Allowed in Cosmetic Products, with their ingredients reallocated to the List of Ingredients Restricted in Cosmetic Products and the new List of UV Filters. |
Took effect on July 1, 2024. |
2.2 Taiwan Cancels Specific Purpose Cosmetics Category and Implements Unified Management for All Cosmetics
On July 1, 2019, Taiwan enacted the Cosmetic Hygiene and Safety Act, its primary regulation for cosmetics. According to the Act, the category of specific purpose cosmetics was discontinued as of July 1, 2024. From that date, all cosmetics in Taiwan are regulated under a unified management system, resulting in changes to the scope of application and expressions of Taiwan’s cosmetic regulations, including ingredient lists, pre-market notification, Product Information Files (PIF), Good Manufacturing Practices (GMP), and product labeling.
Beginning July 1, 2024, manufacturers and importers of cosmetics previously classified as specific purpose must complete product notifications, establish product-specific PIFs, ensure GMP compliance, and meet updated labeling requirements before marketing their products in Taiwan.
3. South Korea
3.1 South Korea Bans THB in Cosmetics
On December 7, 2023, South Korean Ministry of Food and Drug Safety (MFDS) proposed an amendment to the Regulation on Safety Standards for Cosmetics. The purpose was to prohibit the use of 1,2,4-trihydroxy benzene (THB) as an ingredient in cosmetics. The decision was based on safety verification results from the Cosmetic Ingredient Safety Evaluation Committee, which indicated that the genotoxicity potential of THB cannot be ruled out.
The amendment was finalized on February 7, 2024, and MFDS officially implemented the ban on THB in cosmetics.
3.2 South Korea Consults on Cosmetic Safety Standard
On August 2, 2024, the Ministry of Food and Drug Safety (MFDS) released a notice to solicit public feedback of the modifications to Cosmetic Safety Standard till October 3, 2024. The authority proposed to designate one new UV filter, delete one UV filter, and enhance the usage limits of six restricted ingredients.
MFDS Consults on Cosmetic Safety Standard: Enhancing Management of UV filters, D4, D5, and Other Ingredients as below;
| Ingredient | Current Requirements | Proposed Requirements |
| Compounds of Lawsone and Dihydroxyacetone | Can be used as UV filter
(Usage limit: Lawsone: 0.25%, Dihydroxyacetone: 3%) |
Cannot be used as UV filter |
| 2,6-Dihydroxyethylaminotoluene | Can be used as hair dye component
(No usage limits specified) |
Can be used as hair dye component
(Usage limit: 1.0%) (Cannot be used along with nitrating agents, and the total amount of Nitrosamine shall be 50 ppb or less) |
| Benzophenone-3 (Oxybenzone) | Can be used as UV filter
(Usage limit: 5%) |
Can be used as UV filter
(Usage limit: 2.4%. For facial, hand, and lip products: 5%) |
| Nonoxynol-9 | Can be used as a cosmetic ingredient
(No usage limits specified) |
Can be used as a cosmetic ingredient
(Usage limit: 17.2%) |
| Butylphenyl methylpropional(Lilial) | Can be used as a cosmetic ingredient
(No usage limits specified) |
Can be used as a cosmetic ingredient
(Usage limit: 0.14%) |
| Cyclosiloxane (D4) | Can be used as a cosmetic ingredient
(No usage limits specified) |
Can be used as a cosmetic ingredient
(Usage limit: 8.7%) |
| Cyclopentasiloxane (D5) | Can be used as a cosmetic ingredient
(No usage limits specified) |
Can be used as a cosmetic ingredient
(Usage limit: 19.7%) |
| Tris-Biphenyl Triazine | Cannot be used as UV filter | Can be used as UV filter
(Usage limit: 10%) |
4. Japan
4.1 Japan Approves a New Ingredient for Rinse-off Hair Styling Products
On March 8, 2024, the Ministry of Health, Labour and Welfare (MHLW) of Japan released a proposal for the Standards for Cosmetics, inviting public consultation. The proposal requests the inclusion of “Cysteamine Hydrochloride” as an ingredient for rinse-off hair styling products. The proposal was finalized on July 12, 2024, and came into force upon issuance.
| Ingredient | Product Type | Limitation |
| Cysteamine Hydrochloride | Hair styling products used exclusively on the hair and rinsed off | 8.63g |
| Other cosmetics excluding hair styling products used exclusively on the hair and rinsed off | Prohibited |
ChemLinked Comments
Cosmetic manufacturers and distributors are required to adhere to the updated guidelines, which may involve modifying product formulations, manufacturing processes, labeling, and quality control measures.
5. ASEAN
5.1 ASEAN Updates ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes
The ASEAN Cosmetic Committee (ACC) and ASEAN Cosmetic Scientific Body (ACSB) hold meetings twice a year to discuss the latest developments in ASEAN cosmetic industry and related regulations, annexes related to ingredients.
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, 1 added
3) Annex VI – List of Permitted Preservatives: 9 revised
4) Annex VII – List of Permitted UV Filters: 2 revised
In addition to the amendments mentioned above, there are also some updates to the CAS No. information for 56 entries in the annexes.
ChemLinked Comments
The amendments to the ingredient annexes of ACD apply to all ASEAN member states. However, the timeline for each member state to formally adopt these amendments may vary. So far, member states such as Malaysia, Singapore, Vietnam, and the Philippines have adopted these amendments.
6. Indonesia
6.1 Indonesia Proposes to Amend Cosmetic Ingredient Use Requirements
On March 1, 2024, the Indonesian Agency for Food and Drug Control (BPOM) released the amended draft of the Technical Requirements for Cosmetic Ingredients for public consultation until March 19, 2024. The proposed amendments include:
1) Deleting requirements specifically related to cosmetics containing alpha arbutin or beta arbutin;
2) Appendix I: List of Restricted Ingredients – 1 revised;
3) Appendix III: List of Permitted Preservatives – 2 deleted;
4) Appendix IV: List of Permitted Sunscreens – 1 revised;
5) Appendix V: List of Prohibited Ingredients – 75 added.
ChemLinked Comments
The proposed amendments to Indonesian cosmetic ingredients align with the amendments made to the ingredient annexes of the ASEAN Cosmetic Directive (ACD) during the 36th, 37th, and 38th ACSB meetings.
For salicylic acid in Appendix I List of Restricted Ingredients, the only adjustment is the serial number in the usage requirements, which is a result of the removal of two preservatives from Appendix III. The usage limit and conditions for salicylic acid remain unchanged.
7. Thailand
7.1 Thailand Amends Cosmetic Ingredient Use Requirements
From January to August 2024, Thailand issued several announcements regarding revisions to the requirements for cosmetic ingredients. Some of these announcements were formal revisions, while others were drafts. The updates are as follows:
1) List of Prohibited Ingredients: 2 added, 1 revised, and 56 proposed for addition.
2) List of Restricted Ingredients: 8 added, 1 revised, 1 deleted, 3 proposed for addition, and 1 proposed for revision.
3) List of Permitted Colorants: 1 revised and 1 proposed for revision.
4) List of Permitted Preservatives: 1 revised.
5) List of Permitted Sunscreens: 1 added and 1 proposed for revision.
ChemLinked Comments
As a member of ASEAN, Thailand has been somewhat delayed in adopting the revisions to the ingredient use requirements outlined in the ACD. The above adjustments aim to align with previous updates from the ACD.
8. New Zealand
8.1 New Zealand EPA Bans PFAS in Cosmetics
On January 30, 2024, the New Zealand Environmental Protection Authority (EPA) announced a ban on PFAS in cosmetics. The ban, outlined in the updated “Cosmetic Products Group Standard,” reflects New Zealand’s precautionary approach to managing the potential risks associated with these chemicals.
To ensure compliance, the ban on PFAS in cosmetics includes the following transitional provisions:
- Manufacture Ban: Starting from December 31, 2026, the manufacture and import of cosmetic products containing PFAS will be prohibited;
- Sale Ban: As of December 31, 2027, the sale of cosmetic products containing PFAS will be banned;
- Product Disposal: All remaining cosmetic products containing PFAS must be disposed of by June 30, 2028. This ensures the complete removal of these products from the market and minimizes potential PFAS exposure.
9. Australia
9.1 Australia Adopts Updated Sunscreen Standards
On April 11, 2024, the TGA announced the adoption of the Australian/New Zealand Standard: Sunscreen products – Evaluation and Classification (AS/NZS 2604:2021) (amended) into therapeutic goods legislation framework. This updated standard enhances testing and labeling requirements for sunscreens available in the Australian market. Notable changes compared to its predecessor include:
- Incorporation of the latest ISO Standards for sunscreen testing, including “ISO 24444:2019 Cosmetics—Sun Protection Test Methods—In Vivo Determination of the Sun Protection Factor (SPF),” “ISO Standard 24443:2021 Determination of Sunscreen UVA Photoprotection in Vitro,” and “ISO 16217:2020 Cosmetics—Water Immersion Procedure for the Determination of Water Resistance.”
- Introduction of a new flow chart to guide sponsors (product owners) in determining the applicable sections of the standard for primary and secondary sunscreens.
- Addition of labeling instructions for aerosol and spray pump pack sunscreens, advising consumers on the appropriate amount for effective protection against UV radiation, and cautioning against spraying these products on the face or in windy conditions to avoid product inhalation.
Further Reading
- China Expands Recognized Ingredient Safety Data for Safety Assessment Report
- Taiwan Restructures Cosmetic Ingredient Lists, Effective July 1, 2024
- Updates to ASEAN Cosmetic Directive (ACD)’s Ingredient Annexes: 15 Revised and 1 Added
- Australia Adopts Updated Sunscreen Standards
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