From April to June 2024, the cosmetic industry in the Asia-Pacific region experienced notable cosmetic regulatory developments. The Chinese mainland published several technical guidelines for safety assessments, regulations for adverse reaction collection, administrative measures on cosmetic inspection and other. Taiwan adopted a series of changes to its cosmetic regulations. Moreover, countries including Thailand, the Philippines and Indonesia implemented significant regulatory changes during this period. Following are brief updates.
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From April to June 2024, the cosmetic industry in the Asia-Pacific region experienced notable cosmetic regulatory developments. The Chinese mainland published several technical guidelines for safety assessments, regulations for adverse reaction collection, administrative measures on cosmetic inspection and other. Taiwan adopted a series of changes to its cosmetic regulations. Moreover, countries including Thailand, the Philippines and Indonesia implemented significant regulatory changes during this period. Following are brief updates.
China: 6 Draft Safety Assessment Guidelines
On April 10, 2024, the China National Institutes for Food and Drug Control (NIFDC) published six draft guidelines for public consultation aiming to enhance the overall safety assessment process for cosmetics.1 These six drafts include:
- Technical Guidelines for Stability Evaluation of Cosmetics;2
- Technical Guidelines for Cosmetic Preservative Challenge Testing;3
- Technical Guidelines for Compatibility Evaluation of Cosmetics with Packaging Materials;4
- Technical Guidelines for Integrated Approaches to Testing and Assessment (IATA) of Skin Sensitization;5
- Index of Cosmetics Safety Assessment Data from Authoritative Organizations;6 and
- Ingredient Usage Information of Marketed Products.7
Among these, the final versions of the Index of Cosmetics Safety Assessment Data from Authoritative Organizations8 and Ingredient Usage Information of Marketed Products9 were published on April 30, 2024, including minor changes based on the feedback received.
Highlights of these two documents are as follows.
- The Index encompasses 3,651 ingredients and details their corresponding serial numbers in IECIC, Chinese name, INCI name/English name and previous/current name. These ingredients have been used in cosmetics available in China but are not included in the Safety and Technical Standards for Cosmetics (STSC).10 They have assessment conclusions from agencies such as the SCCS and CIR. The Index serves as a reference for enterprises conducting cosmetic safety assessments.
- The Ingredient Usage Information of Marketed Products includes 2,234 ingredients with their serial numbers in IECIC, Chinese name, INCI name/English name, previous name, application sites, application methods of the products containing the ingredient, and the concentration used in products. These ingredients are used in special cosmetics available in China with valid registration certificates but are not included in the STSC and lack assessment conclusions from authoritative agencies. The specified concentrations serve as a reference for enterprises conducting cosmetic safety assessments.
China: Adverse Reaction Management
On April 19, 2024, the Center for Drug Reevaluation and the National Center for Adverse Drug Reaction (ADR) Monitoring of China revealed the Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial).11 The Guidelines provide detailed instructions for registrants and notifiers12 and outline the following key points.
- Adverse reaction collection
- Registrants and notifiers must establish effective information collection channels with consumers, entrusted production enterprises, cosmetic operators and medical institutions and collect the adverse reaction information actively.
- Registrants and notifiers are responsible for maintaining the authenticity, completeness and accuracy of adverse reaction information.
- Adverse reaction report confirmation
- When submitting reports, it is important to confirm compliance with reporting principles and the validity of adverse reaction reports collected through different channels.
- Upon confirming adverse reactions, registrants and notifiers shall conduct a comprehensive analysis and evaluation of the severity of adverse reactions and their correlation with the products involved. If necessary, they should perform a comprehensive self-inspection of the product’s ingredients, formulation, production processes, production quality management, as well as storage and transportation practices, among other factors that may contribute to adverse reactions.
- Registrants and notifiers shall submit adverse reaction reports within specified time requirements through the National Cosmetic Adverse Reaction Monitoring System and update the information in a timely manner.
- Adverse reaction monitoring records management: The management of adverse reaction records shall include monitoring records and original records. These records must be retained for a minimum of three years from the date of reporting. Both physical records and electronic documents are acceptable.
China: Cosmetics Inspection
On April 29, 2024, the China National Medical Products Administration (NMPA) published the finalized version of the Administrative Measures on Cosmetics Inspection,13 initially opened for public opinion on Oct. 19, 2023. This regulation is the first one specific to cosmetic inspections following the Cosmetic Supervision and Administration Regulation (CSAR)14 and consists of eight chapters and 47 articles. It systematically clarifies requirements for inspection categories, procedures, the link between inspection and audit, and result handling, addressing key issues in cosmetics inspection. The measures will come into effect on Nov. 1, 202415.
Key highlights include:
- Scope of application: The regulation applies to inspections of registrations and notifications of cosmetic products and new cosmetic ingredients (NCIs); and notification of toothpastes and new toothpaste ingredients, production and operation of toothpastes. It also extends to comprehensive inspections conducted by medical product administration departments on suppliers and manufacturers of cosmetic ingredients and primary packaging materials.
- Inspection classification: The regulation introduces a nuanced classification system with four categories — licensing inspection, routine inspection, cause-based inspection, and other inspection. Each category delineates specific requirements for inspection initiation, focus, and methods.
China: Cosmetic Safety Assessment Guidelines
On April 30, 2024, the China NIFDC released the finalized version of another seven significant technical documents on cosmetics safety assessment. These seven documents include:
- Index of Cosmetics Safety Assessment Data from Authoritative Organizations;16
- Ingredient Usage Information of Marketed Cosmetic Products;17
- Guidelines for Submission of Cosmetics Safety Assessment Dossiers;18
- Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances;19
- Guidelines for Use of Cosmetic Ingredient Data;20
- Technical Guidelines for Application of Threshold of Toxicological Concern (TTC) Method;21 and
- Technical Guidelines for Application of Read-across.22
China: Recognized Ingredient Safety Data
On April 30, 2024, the China NIFDC released the Guidelines for Use of Cosmetic Ingredient Data.23 The guidelines broaden the scope of recognized ingredient data in the full version of the safety assessment report and provide specific requirements for ingredient data adoption and corresponding documents.
The guidelines are structured in three parts and not only clarify the data types that can be used to prove ingredient safety in the cosmetic safety assessment report, but also outline the requirements and supporting documents necessary for using ingredient data during the safety assessment.
The Technical Guidelines for Cosmetic Safety Assessment24 and Guidelines for Use of Cosmetic Ingredient Data expand recognized ingredient data for cosmetic safety assessments. The previous three types of data have been broadened to encompass seven types, which is a major positive development for the cosmetics industry.
The seven data types now recognized include:
- Restricted ingredients and permitted preservatives, sunscreens, colorants and hair dyes listed in STSC;
- Assessment conclusions published by international authoritative agencies specializing in cosmetics safety assessment;
- Safety limits or conclusions published by authoritative organizations such as the WHO and FAO;
- Ingredient usage information of marketed products published by regulatory authorities;
- The three-year usage history of ingredients;
- Safe consumption history; and
- High molecular polymers with stable structure and properties (excluding ingredients with high biological activity).
China: Safety Assessment Dossiers Submission
On April 30, 2024, the China NIFDC published the final version of the Guidelines for Submission of Cosmetics Safety Assessment Dossiers25 after public consultation on March 29, 2024.
The guideline highlights the following key points:
- Cosmetics are categorized into two main groups, Category I (special cosmetics, infant and children’s cosmetics, and those with new cosmetic ingredients under safety monitoring period) and Category II (all other cosmetics).
- The requirements for submitting cosmetic safety assessment dossiers differ based on the product classification system. For Category I Cosmetics, enterprises shall submit the full version of the safety assessment report. For Category II Cosmetics, enterprises have the option to submit safety assessment reports or safety assessment conclusions with relevant supporting materials and may archive the safety assessment reports for future reference.
- The guideline introduces the Self-Inspection Points for Cosmetics Safety Assessment Reports as an annex, covering the technical points required in the safety assessment report. This assists companies in self-inspecting their product safety assessment reports and forming safety assessment conclusions.
- The guideline distinguishes the differences between safety assessment conclusions and safety assessment reports.
China: Cosmetic Risk Substances
On April 30, 2024, the China NIFDC revealed the finalized version of the Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances26 after a public consultation on March 29, 2024. The identification and assessment of cosmetic risk substances is one of the important aspects of the product safety assessment report.
The Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances summarizes 21 common risk substances and their usage restrictions in cosmetics, and clarifies the dossier requirements for assessing these risk substances.
For example:
- When harmful substances like mercury, lead, arsenic, cadmium, dioxane, etc., could potentially be present in the product, a testing report must be provided.
- For ingredients listed in the STSC that have restrictions on risk substances, said substances can be assessed through ingredient quality specifications or ingredient safety information documents; or through the testing report of the risk substance content in the ingredients in combination with corresponding quality management measures to ensure that the relevant control indicators of the ingredients meet the requirements of the STSC.
- If risk substances not listed in the technical guidelines are found, an assessment must be carried out in accordance with the requirements of the Technical Guidelines for Cosmetic Safety Assessment.27 Only ingredients deemed to be safe can be used.
China: 7 Draft Testing Methods
On May 15, 2024, the China NIFDC issued seven testing methods regarding cosmetic ingredients, toothpaste and toxicological tests for public consultation until June 10, 2024.28 The seven draft testing methods include:
- Determination of Phenacetin in Cosmetics;
- Determination of Glucuronic Acid and Other 13 Kinds of Components in Cosmetics;
- Determination of Gluconic Acid and Other Two Kinds of Components in Cosmetics;
- Determination of Hydroxycapric Acid in Cosmetics;
- Determination of Asbestos in Cosmetics;
- Determination of Soluble/Free Fluoride in Toothpastes; and
- The ARE-Nrf2 Luciferase LuSens Test.
China: NCIs Determination Guides
On May 31, 2024, the China NIFDC proposed a public consultation29 on the drafts of the Guidelines for Research and Determination of Safe Use History of New Cosmetic Ingredients (Trial)30 and the Guidelines for Research and Determination of Safe Consumption History of New Cosmetic Ingredients (Trial).31
The Safe Use History Guidelines draft is applicable to the research and determination of the safe use history of NCIs in Situation 3 and Situation 4 (i.e., NCIs with safe usage history exceeding three years in cosmetics marketed overseas). It mainly outlines the overview, application scope, general principles, basic requirements for safe use history proof materials, proof material format requirements and safety assessment requirements.
The Safe Consumption History Guidelines draft applies to the research and determination of the safe consumption history for NCIs in Situation 5 (i.e., NCIs with safe consumption history). Its main text consists of six parts, including the overview, application scope, general principles, basic requirements for safe consumption history proof materials, common certification sources and key points, as well as safety assessment requirements.
Taiwan: Cosmetic Reclassifications
On July 1, 2019, Taiwan enacted the Cosmetic Hygiene and Safety Act,32 its overarching cosmetic regulation. This regulation reclassified cosmetics from general and medicated to general and specific-purpose categories. However, as of July 1, 2024, the specific-purpose cosmetics category will be discontinued, and all specific-purpose cosmetics will be regulated as general cosmetics. To align with this change, the TFDA plans to adjust relevant cosmetic regulations.
Key amendments are as follows.
- Ingredient lists reconstruction: From July 1, 2024, Taiwan’s cosmetic ingredient structure will align with those of the EU and ASEAN countries. The List of Specific Purpose Ingredients in Cosmetic Products33 and the List of Antibacterial Ingredients Allowed in Cosmetic Products34 will be abolished, with ingredients reallocated to other lists. A new List of UV Filters in Cosmetic Products35 will also be established.
- PIF requirements: Effective July 1, 2024, the Cosmetic Categories Required to Establish the Product Information File and Effective Dates (2024)36 will remove the terms specific purpose cosmetics and general cosmetics, and extend its scope to include certain products managed differently in other regions and countries.37
- GMP requirements: On May 10, 2024, the TFDA released a draft of Cosmetic Categories for Which Manufacturing Premises Shall Comply with Cosmetics Good Manufacturing Practice Regulations.38 This draft plans to remove the terms specific purpose cosmetics and general cosmetics from the regulation, further clarifying its scope to prevent potential confusion from the change in cosmetic product categories.39
ASEAN: Ingredient Updates
The 38th ASEAN Cosmetic Scientific Body (ACSB) meeting commenced from Nov. 15 – Nov. 21, 2023, during which the ingredient annexes of the ASEAN Cosmetic Directive (ACD) were updated.40 The main amendments including the following.
- Annex II list of prohibited ingredients: Fifteen prohibited ingredients have been added, for example: N,N-diethyl-mtoluamide/diethyltoluamide (DEET), tetrafluoroethylene, 3-methylpyrazole and 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol [DBMC], etc. Also, the names of four prohibited ingredientsa have been amended to ensure clarity. For example, the mercury listing was updated as follows: Mercury and its compounds
except those special cases included in Annex VI.(Editor's note: the stricken text was the amendment.) - Annex III list of restricted ingredients: The use requirements of five restricted ingredientsa have been amended to clarify: 1) that the CAS numbers provided are not exhaustive and do not cover all intended substances; and 2) to clarify in which cases restrictions do not apply to products with secondary UV protection claims, such as moisturizing and skin lightening products. Notified cosmetic products failing to comply with the updated conditions are permitted to be sold on the market until Jan. 19, 2024.
- Annex IV list of permitted colorants: The usage requirements of one permitted colorant (CI 45430) have been amended.
- Annex VI list of permitted preservatives: One permitted preservative (methenamine 3-chloroallylochloride) has been deleted, and the preamble to Annex VI has been amended for clarity.
- Annex VII list of permitted UV filters: Two permitted UV filters have been added, and the use requirements of one permitted UV filter (benzophenone-3) have been modified.
On April 5, 2024, and April 8, 2024, Singapore41 and the Philippines42 adopted the updated ingredient annexes to align with the ASEAN Cosmetic Directive (ACD).
Thailand: Proposed Titanium Dioxide Revisions
On April 19, 2024, the Thai Food and Drug Administration (Thai FDA) launched a public consultation on proposed amendments regarding the use of titanium dioxide in cosmetics as a restricted ingredient, permitted colorant and approved sunscreen agent.43 These changes will be implemented upon approval and their publication in the government gazette.
A 180-day grace period will be provided to cosmetic enterprises that have already manufactured, imported or marketed products containing affected titanium dioxide ingredients before the official announcement.
Thailand: Intimate Product Standards
On April 23, 2024, the Thai FDA released the updated version of the Criteria for Reviewing Notification of Products Used in Intimate Areas,44 aiming to improve and clarify the regulations related to the definition, formulation, efficacy claims, naming rules, container characteristics and notification documentation requirements for products used in intimate areas.45
Thailand: Ingredient Updates
On April 23, 2024, the Thai Food and Drug Administration (Thai FDA) officially announced the amendments to its cosmetic ingredient lists after a public consultation from Oct. 4 – Oct. 27, 2023. This revision aims to align with the updated ACD. The key amendments include:
- Revising the prohibited condition of dioxane, which is now prohibited except as a contaminant in finished products at a maximum of 10 parts per million (10 ppm or 10 mg/kg), and introducing one prohibited ingredient of deoxyarbutin, tetrahydropyranyloxy phenol, to the prohibited list;46
- Deleting silver nitrate from the restricted list; revising the use condition of climbazole; introducing eight restricted ingredients including dimethylpiperazinium aminopyrazolopyridine HCl, methylimidazolium propyl pphenylenediamine HCl, HC Orange No. 6, Acid Orange 7, Tetrabromophenol Blue, trimethylbenzoyl diphenylphosphine oxide, furfural and dihydroxyacetone;47 and updating the labeling requirement of above restricted ingredients accordingly;48 and
- Revising the use conditions of one permitted preservative, climbazole.49
Cosmetic stakeholders who had already manufactured, imported or sold products containing the revised and newly prohibited ingredients (excluding dioxane and silver nitrate) before April 23, 2024, are granted a grace period of 180 days to ensure compliance with the new regulation.
Thailand: Hand Sanitizer Regulations
On May 31, 2024, Thailand officially approved two documents on amendments to its regulations for alcohol-based hand sanitizer cosmetics. The amendments mainly focus on refining the concentration thresholds and deviation limits for alcohol in these products. The two amendments are:
- Announcement of the Ministry of Public Health Regarding the Determination of Important Substances and Specifying the Characteristics of Cosmetics Containing Alcohol for Hand Hygiene that are Prohibited from Being Produced, Imported or Sold, B.E. 2024;50 and
- Announcement of the Ministry of Public Health Regarding the Determination of Criteria for Deviation Limits of Main Substances in Cosmetics Containing Alcohol for Hand Hygiene, B.E. 2024.51
Indonesia: PI Import Requirement Cancelled
To reduce the trade barrier imposed by the Minister of Trade Regulation No. 36 of 2023,52 which tightens the importation of certain commodity groups including cosmetics, Indonesia released the Minister of Trade Regulation No. 8 of 2024.53 The most significant change in the cosmetics and household goods sectors is the cancellation of import approval (PI) applications.
Effective from May 17, 2024, this change applies to 38 HS codes within cosmetic and household products requiring enterprises to submit a surveyor report (LS) and import declaration letter (SKI) for customs clearance, while as noted, a PI is no longer required.
Conclusion
Recent regulatory updates across the Asia-Pacific region demonstrate a consistent trend toward stricter and more comprehensive cosmetic safety and quality standards. The focus on safety assessment, ingredient usage, adverse reaction management and alignment with international standards is evident. Companies should proactively adapt to these changes by enhancing their compliance mechanisms, staying updated with evolving regulations, and investing in robust safety and quality assurance practices to ensure market access and consumer safety.
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