Asia-Pacific Regulatory Update: Safety Report Buffer, Tox Threshold, New Zealand’s Overhaul and More

From late January to March 2024, the cosmetic industry in the Asia-Pacific region has witnessed significant regulatory developments revolving around cosmetic safety assessment, testing methods, sampling standards, ingredient management, etc. Following are brief updates.

China: Temporary Safety Assessment Buffer

As per the “Technical Guidelines for Cosmetic Safety Assessment,”¹ cosmetic registrants and notifiers were to submit a full safety assessment report from May 1, 2024. However, this presented challenges for the industry due to difficulties such as inadequate safety assessment capabilities and the lack of certain ingredient safety information.

In response to such challenges, on April 22, 2024, China’s National Medical Products Administration (NMPA) officially granted a one-year buffer period for registrants to submit the full version of the cosmetic safety assessment report. During this time, cosmetic registrants and notifiers may submit a simplified version of the safety assessment report.

In addition, as reported on Mar. 15, 2024, by the official newspaper of the NMPA, the administration is developing measures to optimize cosmetic safety assessment administration. The proposed measures include advancing the development of safety assessment systems, strengthening technical guidance, integrating ingredient data resources, innovating assessment report management mechanisms, etc.² These efforts will help to ensure that enterprises can conduct safety assessments in a standardized and efficient manner.

China: Toxicology Threshold and Read-across Guidelines

On Mar. 20, 2024, the China National Institutes for Food and Drug Control (NIFDC) launched an 18-day public consultation on two technical guidances related to cosmetic safety assessment: the “Technical Guidelines for Application of Threshold of Toxicological Concern (TTC) Method,”³ and the “Technical Guidelines for Application of Read-across.”⁴

These guidelines are designed to improve the applicability of technical methods such as read-across and TTC in cosmetic safety assessment. They provide detailed information on the application scope, terminology and definition, substances classification, evaluation procedures, etc.⁵

The TTC Guidelines apply to the assessment of cosmetic ingredients and risk substances with specific criteria, including clear chemical structures, the absence of highly mutagenic alert structures, low content and lack of systematic toxicology research data. However, they do not apply to substances such as metal or metal compounds, strong carcinogens, proteins, steroids, high molecular weight substances, substances with significant bioaccumulation potential, radioactive chemicals, ingredients with high-risk functions (e.g., preservatives, sunscreens, colorants, hair dyes), substances with high biological activity, nano ingredients and inorganic substances with inhalation risk.

The Read-across Guidelines are applicable to non-functional ingredients and risk substances but do not apply to ingredients with high-risk functions like preservation, sun protection, coloring,

China: STSC Updates

On Mar. 21, 2024, China NMPA issued two announcements regarding amendments to the “Safety and Technical Standards for Cosmetics (2015 Edition) (STSC).”⁶ These updates focus on prohibited ingredients and testing methods for cosmetics,⁷ as well as specific changes related to toothpaste.⁸ Notably, the ingredient updates took immediate effect upon release, while the updates to testing methods will be implemented from Dec. 1, 2024.

Key highlights include:

• Prohibited ingredients: Five ingredients, namely bimatoprost, latanoprost, tafluprost, tafluprost ethyl amide and travoprost, have been newly designated as prohibited ingredients in cosmetics.
• Revised test methods: Three test methods have been revised and updated to replace the corresponding original methods mentioned in the STSC. These revised test methods include the "Determination of Dioxane in Cosmetics;" "Determination of Dimetridazole and Other 119 Kinds of Components in Cosmetics;" and "Determination of Selenium Disulfide."
• New cosmetic testing methods: Eleven new cosmetic testing methods have been incorporated into the STSC, including the “General Rule for Pretreatment of Cosmetic in Toxicological Experiments;” “Acute Inhalation Toxicity Study;” and “U937 Cell Line Activation Test,” among others.
• New toothpaste testing methods: Fifteen new toothpaste testing methods have been included in the STSC. These methods cover the determination of pH value, heavy metal content (e.g., mercury, lead and arsenic), risk substances (e.g., dioxane) and microbial content (e.g., Pseudomonas aeruginosa) in toothpaste.

China: Classified Management for Safety Assessment Report

On Mar. 29, 2024, China NIFDC issued two more significant safety assessment guides for public comments until April 8, 2024.⁹ They are the “Guidelines for Submission of Cosmetics Safety Assessment Dossiers (Draft for Comments);”¹⁰ and the “Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances (Draft for Comments).”¹¹

The Submission Guidelines categorize cosmetics into three tiers depending on their risk levels:

• Category 1 cosmetics: This category includes children's cosmetics, cosmetics containing NCIs within the monitoring period and those posing high safety risks to human health.
• Category 2 cosmetics: This category includes cosmetics with higher-risk ingredients, such as nano ingredients and exfoliating functional ingredients.
• Category 3 cosmetics: This category refers to general cosmetics that do not fall under Category 1 or Category 2.

Based on this categorization, a classified management system will be introduced for safety assessment reports. Specifically, Category 1 cosmetics are mandated to the submission of complete safety assessment reports, whereas Category 2 and Category 3 cosmetics are only subject to safety assessment conclusions. The safety assessment reports for Category 2 and Category 3 cosmetics can be retained by enterprises for future reference.

The Technical Guidelines for Risk Substances outline common risk substances and their usage restrictions in cosmetics and establishes standardized procedures for identifying and evaluating such risk substances in cosmetics.

Taiwan: Prohibited Ingredients

On Mar. 21, 2024, the Taiwan Food and Drug Administration (TFDA) officially approved the proposed amendments to the “List of Prohibited Ingredients in Cosmetics,” which was originally launched for public comments on Dec. 13, 2023.¹²

The key modifications include:

• Addition of nine ingredients: The amended list now includes nine additional ingredients that are prohibited in cosmetics, including aminocaproic acid (INN) and its salts, hydroxyisohexyl 3-cyclohexene carboxaldehyde (HICC), atranol, chloroatranol and certain PFAS substances. This move aligns Taiwan's regulations with international practices observed in regions such as ASEAN and the EU, where bans are already imposed on these ingredients.
• Revised use conditions: The use conditions for two existing ingredients were revised. The collective ingredients: 1) "cells, tissues or products of human origin" are amended to "cells, tissues or products of human origin, except for specific exosomes-related cases^a that have been reviewed and approved by the competent authority." Additionally, the ingredient 2) "zirconium and its compounds" is altered to "cells, tissues or products of human origin, except for specific exosomes-related cases that have been reviewed and approved by the competent authority."

The effective date for these revisions is set for Jan. 1, 2025, except for changes related to the substance "cells, tissues or products of human origin," which became effective upon release.

Japan: New Hair Styling Ingredient

On Mar. 8, 2024, the Ministry of Health, Labor and Welfare of Japan released proposed revisions to the “Standards for Cosmetics,”¹³ planning to add cysteamine hydrochloride as an ingredient for hair styling products that are exclusively intended for hair application and rinsing off.¹⁴ Hair styling products used exclusively on the hair and rinsed off will be allowed to contain a maximum allowable concentration of 8.63 g of cysteamine hydrochloride per 100 g of the product. Other cosmetics excluding hair styling products used exclusively on the hair and rinsed off will be prohibited from using cysteamine hydrochloride.

Currently, the proposed revisions are open for public consultation until April 8, 2024. If approved, the revised standards are expected to come into effect in late June 2024.

South Korea: THB Ban

On Feb. 7, 2024, the Ministry of Food and Drug Safety (MFDS) of South Korea approved the amendments to the “Regulation on Safety Standards, etc. for Cosmetics.” As a result, the use of 1,2,4-trihydroxy benzene (THB) in cosmetics is officially banned.¹⁵ This ban follows safety verification results conducted by the Cosmetic Ingredient Safety Evaluation Committee, which indicated that THB poses potential genotoxicity risks.

South Korea: Cosmetic Policy Plan 2024

On Mar. 21, 2024, MFDS published the cosmetic policy plan for 2024. The plan focuses on three main initiatives:¹⁶

• Implementation of a proactive safety network based on science: This initiative aims to establish a cosmetics safety assessment system, promote ingredient evaluation based on domestic and international research data and regulatory trends, etc.
• Implementation of safety and welfare that allows everyone to enjoy at any time: Specific actions include implementing the cosmetics e-label pilot project, optimizing the labeling items on the external packaging of cosmetics to provide clear information to consumers, enhancing the management of customized cosmetics for safety consumption, etc.
• Innovation of regulation: Specific actions include the promotion of regulatory improvement tasks, the allowance of hair dye products applied through automated devices, the establishment of a new application process for lifting the ban on prohibited ingredients, etc.

Thailand: Proposed Ingredient Updates

On Feb. 22, 2024, the Thai Food and Drug Administration released a draft proposal on amendments to the country's cosmetic ingredient lists. These proposed changes involve the addition of prohibited ingredient diethyltoluamide (DEET)¹⁷ and a new permitted sunscreen bis-(diethylaminohydroxybenzoyl benzoyl) piperazine, including its nano form,¹⁸ and the removal of the use limitations for the existing permitted colorant CI 45430.¹⁹

Indonesia: Proposed Ingredient Updates

On Mar. 1, 2024, the Indonesian Agency for Food and Drug Control (BPOM) released the amended draft of the “Technical Requirements for Cosmetic Ingredients,” inviting public consultation until Mar. 19, 2024. The proposed amendments include:²⁰

• Deleting requirements specifically related to cosmetics containing alpha arbutin or beta arbutin;
• Making slight adjustments to the wording in the usage requirements for the restricted ingredient salicylic acid. Specifically, the entry number in the usage requirements has been adjusted to align with the serial number in Indonesia’s latest ingredient lists. This adjustment was made due to the removal of two preservatives from Appendix III. The usage limit and conditions for salicylic acid remain unchanged.
• Deleting two permitted preservatives (quaternium-15 and chlorophene);
• Amending the use requirements for the existing permitted sunscreen benzophenone-3;
• Adding 75 newly prohibited ingredients^b, including 2-chloracetamide, octamethylcyclotetrasiloxane, acetaldehyde, sodium perborate, etc.

Vietnam: Ingredient Updates

On Mar. 4, 2024, the Drug Administration of Vietnam (DAV) issued an announcement regarding amendments to the annexes of the “ASEAN Cosmetic Directive (ACD).” The key amendments highlighted in the announcement are as follows:²¹

• Annex II — List of prohibited ingredients: Fifteen prohibited ingredients have been added to the list. These include DEET, tetrafluoroethylene, DBMC, pyriofenone, tolpyralate, azamethiphos, 3-methylpyrazole, pydiflumetofen, sedaxane, isobutyl methyl ketone, dimethomorph, imazamox, thiamethoxam, triticonazole and desmedipham. Except for DEET, which will become effective on Nov. 15, 2025, the other 14 substances are scheduled to take effect on Nov. 15, 2024.
• Annex VII — List of permitted UV filters: Two permitted UV filters (bis-diethylaminohydroxybenzoyl benzoyl) piperazine and its nano form) have been added. Additionally, the use requirements for one permitted existing UV filter, benzophenone-3, have been modified. The two newly added UV filters took immediate effect, while the revised use requirements for benzophenone-3 will be effective from Nov. 15, 2026.

India: Sampling Guideline

On Feb. 9, 2024, the Central Drugs Standard Control Organization (CDSCO) of India released the finalized “Regulatory Guidelines for Sampling of Drugs, Cosmetics and Medical Devices.”²² This guideline covers various aspects, including sampling plans, sample selection, sampling location selection, sampling batch quantity and sample quantity, timelines, testing laboratories, etc.²³

Under the guideline, drug inspectors will prepare monthly and annual sampling plans, ensuring comprehensive coverage across their jurisdiction, including rural and tribal areas and disease-endemic regions. The annual plan will be reviewed to avoid repetitive sampling and ensure a wide range of brands and categories. Each month, a minimum of 10 samples will be collected, with nine for drugs and one for cosmetics or medical devices.

India: Annual Import Details

On Feb. 23, 2024, India CDSCO issued a circular mandating importer of already registered cosmetics in the country to submit annual import details to the competent authority. This requirement is in accordance with Form COS-4A under the “Cosmetics Rules 2020.”²⁴

The annual import details shall include the number of consignments or bill of entries of each consignment, the quantity and total cost of imported cosmetics per consignment and warehouse details where the products are stored for further distribution and sale, etc.²⁵

New Zealand: Regulation Overhaul

On Jan. 25, 2024, the Environmental Protection Authority (EPA) of New Zealand approved significant amendments to the “Cosmetic Products Group Standard 2020,” aiming to enhance the management of cosmetics within the country.²⁶

Notable key amendments include:

• Expanding the scope of the standard to include non-hazardous cosmetic products that contain a hazardous substance;
• Banning the use of per- and polyfluoroalkyl substances (PFAS) in cosmetic products;
• Increasing nanomaterial record-keeping requirements;
• Updating ingredient lists in line with the EU cosmetic regulation, with one exemption of zinc pyrithione; and
• Amending clauses and conditions for label exemptions, including the 24-hr contact label exemption, adding the UK to the alternative international regulators list and updating the outdated Australian Government Therapeutic Goods Order (TGO) reference.

Transitional provisions are in place for all amendments (except PFAS). For pre-amendment compliant products, the import and manufacture ban will be effective from Dec. 31, 2025, the sales ban from Dec. 31, 2026, and proper disposal of these products must be completed by June 30, 2027.

Regarding PFAS, the manufacture ban in cosmetics will take effect on Dec. 31, 2026, the sales ban on Dec. 31, 2027, and any remaining cosmetic products containing PFAS ingredients must be disposed of by Jun. 30, 2028.

Conclusion

The recent regulatory updates in China primarily aim to facilitate the implementation of the cosmetics safety assessment system and assist enterprises in meeting the May 1 deadline for safety assessments. Stakeholders in the cosmetics industry should carefully review the released guidelines, as they contain important details and provide feedback to the regulatory authority if necessary. It is expected that China will introduce further measures to guide companies in conducting effective safety assessments and businesses should also stay updated on any follow-up actions taken by the authority and make necessary preparations accordingly.

In the remaining Asia-Pacific region, there is a focus on developing stricter ingredient restrictions to foster safer practices, ensure product safety and align with international standards. As companies navigate these evolving regulatory landscapes, it is essential for them to stay informed, adapt their formulations and ensure compliance to succeed in the target market.

^a Effective from Mar. 21, 2023, for case review, the applicant should submit relevant documents or information, including the qualifications of the exosome donor, preparation processes and inspection reports, stability tests, safety tests, as well as absorption, distribution, metabolism and excretion tests.

^b The full list of 75 newly prohibited ingredients is available at: https://cosmetic.chemlinked.com/news/cosmetic-news/indonesia-proposes-to-amend-cosmetic-ingredient-use-requirements-75-newly-prohibited-ingredients-2-amended-restricted-ingredients-and-2-deleted-preservatives

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