China
China Releases Five Technical Guidelines for Toxicological Tests
On February 5, 2024, China National Institutes for Food and Drug Control (NIFDC) published five technical guidelines for the toxicological tests of cosmetics and cosmetic ingredients. Specifics of these guidelines are as follows:
No. | Technical Guidelines | Introduction |
1 | Technical Guidelines for Acute Inhalation Toxicity Test of Cosmetic Ingredients | This Guidelines applies to the research and evaluation of the acute inhalation toxicity of cosmetic ingredients. The selection of specific test methods should align with the relevant cosmetic regulations in China. |
2 | This Guidelines is designed for the toxicity classification, research, and safety evaluation of single-component cosmetic ingredients. However, it excludes the acute inhalation toxicity test of certain materials, such as insoluble isometric and fibrous materials, and manufactured nanomaterials. | |
3 | This Guidelines is suitable for studying and evaluating the repeated dose inhalation toxicity of cosmetic ingredients with potential inhalation exposure risks. | |
4 | Technical Guidelines for Reproduction/Development Toxicity Test of Cosmetics | This Guidelines applies to the evaluation of reproduction and developmental toxicity of cosmetics and cosmetic ingredients, which may have adverse effects on the parental reproductive system and offspring development. |
5 | Technical Guidelines for Immunotoxicity Test of Cosmetic Ingredients | This Guidelines is applicable to the immunotoxicity evaluation of cosmetic ingredients that may have adverse effects on the immune system. |
China Solicits Public Opinions on the Review Conclusions of 18,696 Industry Standards
On February 6, 2024, the Ministry of Industry and Information Technology (MIIT) circulated an announcement seeking public feedback on the review conclusions of a total of 18,696 industry standards in 17 industries, including the cosmetics industry. Among all the standards, 12,794 standards will continue to be valid, 4,655 standards will be revised, and 1,247 standards will be abolished. Stakeholders are invited to provide feedback before March 14, 2024.
Guangzhou AMR Answers Questions About Cosmetic Notification
On February 20, 2024, Guangzhou Administration for Market Regulation (AMR) released the 54th batch of FAQs. They cover various topics related to general cosmetics notification, especially the requirements for aspects such as safety assessment, the submission and update on notification dossiers, etc.
China to Enforce New Rules for Penalties in Cosmetics Administration
On February 23, 2024, China National Medical Products Administration (NMPA) issued the Application Rules for Administrative Penalties in Medical Products Administration (the Application Rules), which was set to take effect on August 1, 2024. The Application Rules further clarifies how regulatory authorities can impose administrative penalties on enterprises involved in illegal activities. Regarding cosmetics, the provisions on penalty discretion are mainly based on the Cosmetic Supervision and Administration Regulation and its supporting documents, with a particular emphasis on the supervision of children cosmetics and ingredients.
Guangzhou AMR Introduces Re-testing Process for Cosmetics
On February 26, 2024, Guangzhou AMR announced the Cosmetics Re-testing Process of Guangzhou Administration for Market Regulation. It is designed to address situations where cosmetic manufacturers and operators have objections to the sampling testing conclusion, and intend to apply for re-testing. Consisting of seven parts, this announcement outlines the dossier requirements and procedures for cosmetics re-testing, and defines the conditions where re-testing application will not be approved.
China NMPA Approves Four New Cosmetic Ingredients
In February 2024, NMPA updated the notification status of four new cosmetic ingredients (NCIs), while the technical requirements for these ingredients have not been made public. With these recent notifications, a total of 16 NCIs have been notified year to date.
China Issues 11 Cosmetics-related Standards in February
In February 2024, China issued 11 cosmetics-related standards. The essential information is as follows:
Release Date | Initiator | Standard Name | Effective Date |
February 1, 2024 | Guangdong Cosmetics Association | February 29, 2024 | |
February 4, 2024 | Hubei Cosmetic Chamber of Commerce | February 20, 2024 | |
Determination of the Cosmetic Efficacy in Alleviating Under-eye Puffiness | February 20, 2024 | ||
February 6, 2024 | Zhejiang Products and Engineering Standardization Association | Requirements for Restricting Excessive Packaging of Food and Cosmetics—Distribuction | January 31, 2024 |
Requirements for Restricting Excessive Packaging of Food and Cosmetics—Production and Processing | January 31, 2024 | ||
Design Requirements for Restricting Excessive Packaging of Commidities—Food and Cosmetics | January 31, 2024 | ||
February 19, 2024 | Guangdong Cosmetics Association | Cosmetics Eye Irritation—Chorioallantoic Membrane Vascular Assay | March 19, 2024 |
February 20, 2024 | China Association of Fragrance Flavour and Cosmetic Industries | / | |
February 21, 2024 | Guangdong Cosmetics Association | Method for Evaluating the Repair Efficacy of Hair Products (In Vitro Method) | March 21, 2024 |
February 26, 2024 | Hangzhou Cosmetics Industry Association | / | |
February 28, 2024 | Guangdong Cosmetics Association | Human Evaluation Method for Assessing the Skin Irritation Relieving Effects of Cosmetics | March 28, 2024 |
Japan
PMDA: 39 Batches Cosmetics Recalled in February
In February 2024, Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued notifications regarding 39 batches of 7 different types of recalled cosmetic products, including facial cleansers and face masks totaling 21 batches. The primary reason for the recall of these 21 batches was the use of ingredients that exceeded the specified limits. Followed by labeling issues, represented by some products lacking essential information and some failing to adhere Japanese labeling as required.
South Korea
South Korea Bans THB in Cosmetics
As released by Ministry of Food and Drug Safety (MFDS), the Regulation on Safety Standards, etc. for Cosmetics was finalized on February 7, 2024. The authority officially designates the 1,2,4-trihydroxy benzene (1,2,4-트리하이드록시벤젠) (Cas No. 533-73-3) as a prohibited ingredient in cosmetics for genotoxicity potential, which means THB cannot be used in cosmetics afterwards. Nevertheless, products manufactured prior to the amendment can be sold until October 1, 2024.
South Korea Modifies the Cosmetics Act
On February 6, 2024, MFDS updated the Cosmetics Act. The legal ground for cosmetics manufacturers to apply for the relief or change of the prohibited ingredients in cosmetics is inserted in the new version. The amendments will be effective on February 7, 2025.
Philippines
Philippines FDA Proposes New Requirements for LTO Application
On February 27, 2024, Philippines Food and Drug Administration (FDA) initiated a consultation on newly proposed amendments to the application requirements for License to Operate (LTO). Compared to previous draft amendments, the new draft primarily updates the requirements and validities for LTO applications, and further clarifies FDA’s decision grounds for these applications.
Singapore
HSA Alerts 43 Batches of Non-compliant Cosmetics Containing Potent Ingredients Found Overseas
On February 2, 2024, Singapore's Health Sciences Authority (HSA) released a list of products found overseas in January 2024 that contain potent ingredients, including 43 batches of cosmetics. The potent ingredients detected in these cosmetics include Mercury, Betamethasone, Hydroquinone, and Retinoic Acid. These ingredients are prohibited for general use in cosmetics in accordance with ASEAN Cosmetic Directive (ACD).
Thailand
Thailand Proposes Amendments to the Regulations for Hand Sanitizers
On February 2, 2024, Thailand notified WTO of two draft notifications, proposing to amend the existing hand sanitizer regulations and clarify the criteria for the deviation limits of key ingredients in such cosmetics. The two drafts are:
Thailand Initiates Cosmetic Ingredient Lists Amendments: Two Ingredients Added and One Revised
The Thai Food and Drug Administration (Thai FDA) has just closed the public consultation on the newly proposed amendments to the country's cosmetic ingredient lists, which lasted from February 22 to March 7, 2024. The key amendments include the addition of a prohibited ingredient and a permitted sunscreen, and the revision of a permitted colorant.
India
India Introduces Regulatory Guidelines for the Sampling of Cosmetics
On February 9, 2024, the Central Drugs Standard Control Organization (CDSCO) of India unveiled the finalized version of the Regulatory Guidelines for Sampling of Drugs, Cosmetics & Medical Devices. This Guidelines covers various aspects of sampling, including sampling plans, sample selection, sampling location selection, sampling batch quantity and sample quantity, timelines, testing laboratories, etc.
India Mandates Annual Import Details from Registered Cosmetics Importers
On February 23, 2024, India CDSCO issued a Circular, requiring importers of already registered cosmetics in the country to provide an annual statement with import details to the competent authority.
Australia
Australia TGA Updates the Poisons Standard
On February 1, 2024, the Therapeutic Goods Administration (TGA) released the Therapeutic Goods (Poisons Standard – February 2024) Instrument 2024, replacing the 2023 version. The updated version incorporates amendments to certain existing entries, such as revisions to the entry of lead compounds about their permissible limits in preparations for cosmetic use and graphic materials in Schedule 6.
Australia AICIS Adds Three Cosmetic Ingredients to AIIC
On February 13, 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) included three cosmetic ingredients in the Australian Inventory of Industrial Chemicals (AIIC) in accordance with Section 83 of the Industrial Chemicals Act 2019. The three chemicals have undergone a collective assessment together as a multi-component introduction. They are required to be manufactured together at the concentration indicated in the table below, and should not be separated during introduction or use.
Chemical Name | Molecular Formula | CAS Number | Concentration |
2H-Pyran, 3,6-dihydro-4-methyl-2-[(2,2,3-trimethyl-3-cyclopenten-1-yl)methyl]- | C15H24O | 947237-75-4 | ≤ 45% |
2H-Pyran, 5,6-dihydro-4-methyl-2-[(2,2,3-trimethyl-3-cyclopenten-1-yl)methyl]- | C15H24O | 947237-84-5 | ≤ 27% |
2H-Pyran, tetrahydro-4-methylene-2-[(2,2,3-trimethyl-3-cyclopenten-1-yl)methyl]- | C15H24O | 947237-93-6 | ≤ 52% |
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