Chinese Mainland
China Implements Three National Standards
In October, China implemented three national standards. The essential information is as follows:
Release Date | Initiator | Standard Name | Effective Date |
March 17, 2023 | National Technical Committee for Standardization of China Association of Fragrance, Flavour and Cosmetic Industries | October 1, 2023 | |
Validation criteria for analytical results of cosmetics using chromatographic techniques |
On October 12, Zhejiang Medical Products Administration (MPA) revised and issued Regulations on Self-Inspection Reports and Production Suspension and Resumption Reporting Systems for Cosmetic Registrants, Notifiers and Entrusted Production Enterprises in Zhejiang Province. Zhejiang MPA is seeking public opinions on the Regulations until November 12, 2023. Suggestions can be sent to zjfdabhc@163.com.
China Consults on Administrative Measures on Cosmetics Inspection
On October 19, China National Medical Products Administration (NMPA) started the solicitation opinions on Administrative Measures on Cosmetics Inspection. The Measures systematically clarifies the requirements about cosmetic inspection categories, inspection procedures, link between inspection and audit, and result handling.
NMPA to Publicize the Images of Special Cosmetics Labels
On October 27, NMPA's cosmetics registration and notification system issued a reminder. As per the reminder, it will publicize the label images of special cosmetics for sale that have been uploaded by registrants on the NMPA website. This new measure addresses the previous challenge faced by consumers and regulators in screening and supervising products due to the lack of label picture’s publicity. The publicity requirement aims to combat the non-compliant behavior by companies that use different labels during the sales process.
China NMPA Approves Eight New Cosmetic Ingredients
In October, NMPA updated the notification status of eight NCIs. The basic information about these new NCIs is as follows:
1. Urolithin A, notified on October 12, 2023
2. Cestrum Latifolium Leaf Extract, notified on October 12, 2023
3. Bakuchiol, notified on October 13, 2023
4. ASINI CORII COLLA POWDER, notified on October 17, 2023
5. Acetyl Octapeptide-1, notified on October 18, 2023
6. Vitamin K2(35), notified on October 25, 2023
7. BLACK GINSENG EXTRACT, notified on October 25, 2023
8. Hydroxy-α-sanshool, notified on October 30, 2023
Guangzhou and Beijing Authorities Publish FAQs Regarding Cosmetics Notification
In October, Beijing Municipal MPA and Guangzhou Administration for Market Regulation (AMR) released four batches of FAQs concerning general cosmetics notification, including requirements for toothpaste, children cosmetics, and product formula, etc.
Release Date | Regulatory Authority | Batch |
October 8, 2023 | Guangzhou AMR | |
October 9, 2023 | ||
October 26, 2023 | ||
October 16, 2023 | Beijing Municipal MPA |
China Issues 10 Cosmetics-related Standards in October
In October, China issued 10 cosmetics-related group standards. The essential information is as follows:
Release Date | Initiator | Standard Name | Effective Date |
October 12, 2023 | China Standardization Association | October 12, 2023 | |
October 18, 2023 | Foshan Biomedical Engineering Society | October 19, 2023 | |
October 20, 2023 | Shanghai Daily Chemicals Industry Association | November 20, 2023 | |
October 25, 2023 | Shanghai Beauty and Health Industry Association | T/SHBA 002—2023 Method for skin penetration test in vitro for cosmetics products | November 1, 2023 |
October 26, 2023 | Beijing Daily Chemicals Industry Association | T/BDCA 0004—2023 Guideline for the development and quality operation of lip cosmetics | November 1, 2023 |
October 31, 2023 | China Association of Fragrance Flavour and Cosmetic Industries | Draft | |
TCAFFCI 68-2023 Test methods for nourishing efficacy of cosmetic products | October 31, 2023 | ||
TCAFFCI 67-2023 Test methods for anti-acne efficacy of cosmetic products | October 31, 2023 | ||
TCAFFCI 66-2023 Test methods for repairing efficacy of cosmetic products | October 31, 2023 |
Taiwan, China
Taiwan Updates Guidance Documents for Establishing the Product Information File (PIF)
On October 2, Taiwan Food and Drug Administration (TFDA) released the updated guidance documents for establishing the product information file (PIF) for cosmetics. The main revisions made in these documents are related to the terminology of and references for documents, PIF templates, and the alternatives to animal testing, which entered into force upon their release.
On October 18, the Ministry of Food and Drug Safety (MFDS) issued a new Guideline of alternative animal testing for cosmetics using Reconstructed human Cornea-like Epithelium (RhCE). This Guideline is established based on the latest OECD-approved alternative testing methods. So far the Korean authority has published 29 guidelines on alternative animal testing methods. Find all the guidelines and more requirements for alternative animal testing here.
South Korea Revises Prohibited Ingredients Analysis Guideline
The Ministry of Food and Drug Safety (MFDS) revised the Guideline of Analysis Method of Prohibited Ingredients in Cosmetics on October 25. In the revised guideline, the number of phthalate ingredients that can be detected increases from three to seven. The guideline also provides the latest analysis methods for 23 prohibited ingredients, such as atranol and chloroatranol.
In October 2023, Japan Pharmaceuticals and Medical Devices Agency (PMDA) has announced three batches of recall notices for hair care products, involving 5,192 products. Among the recalled products, 98% were voluntarily recalled due to bacterial contamination.
Thailand
Thailand Consults on Amendments to Cosmetic Ingredient Lists
From October 4 to October 27, the Thai Food and Drug Administration (Thai FDA) launched a public consultation on four draft notifications, planning to revise the requirements for permitted preservatives, as well as restricted and prohibited ingredients in cosmetics.
Thailand Consults on Labeling Regulations for Ampoule, Vial, and Syringe Cosmetics
From October 11 to October 27, the Thai FDA opened a public consultation on a newly-drafted regulation for the labeling of ampoule, vial, and syringe cosmetics. The draft outlines essential requirements, including the necessary content, position, language, and other pertinent details of labeling.
On September 26, Indonesia signed Regulation No. 31 of 2023 concerning Business Licensing, Advertising, Guidance, and Supervision of Business Actors in Trading via Electronic Systems, introducing new restrictions on e-commerce activities involving imported goods.
The new Regulation No. 31 of 2023 makes several key revisions, impacting businesses operating in the e-commerce sector:
Social media platforms, such as TikTok, are now prohibited from serving as sales platforms for goods;
The minimum Free on Board (FOB) price for imported goods sold on e-commerce platforms is set at US$100 per piece;
E-commerce platforms are no longer permitted to sell products produced by the platform itself;
Imported products sold online must meet Indonesian regulatory requirements, including product notification and halal certification, before being available for sale.
On October 12, Indonesia enacted Decision No. 397 of 2023, outlining the checklist for the inspection on technical documents and facilities by the local UPT BPOM. The inspection serves as the basis of recommendation letter for cosmetic notification applicants, including importers and contract manufacturers, which is a mandatory document for cosmetics notification application.
Indonesia Plans to Adjust Cosmetics Import Requirements
On October 13, Indonesia Food and Drug Administration (BPOM) released draft amendments to Regulation for Supervision on the Entry of Drugs and Food into the Territory of Indonesia. The proposed changes for cosmetics include replacing the required certificate for importing cosmetics from SKI Post Border to SKI Border. Additionally, if the Certificate of Analysis (CoA) required for the SKI Border application is not issued by the manufacturer, it must be issued by an accredited laboratory.
Indonesia and Saudi Arabia Sign a Memorandum of Understanding (MoU) on Halal Product Assurance
On October 19, Indonesia and Saudi Arabia signed a MoU on Halal Product Quality Assurance. The scope of the cooperation includes the development of assessment procedures, standard specifications, and technical regulations for issuing Halal certificates. It also involves mutual recognition of Halal certificates issued by the Indonesian Halal Product Assurance Organizing Body (BPJPH) and Saudi Food and Drug Authority (SFDA) for exported products, the exchange of experience and knowledge in training, research, and halal product laboratory analysis. The MoU is valid for two years and can be extended by mutual agreement.
Malaysia
Malaysia Plans to Reduce the Processing Time for Halal Certification from 51 to 30 Days
Malaysia plans to reduce the processing time for halal certification from 51 to 30 days, as announced by the YAB Dato' Seri Anwar Ibrahim Prime Minister during the presentation of the 2024 Budget. The Halal Development Corporation (HDC) and the Department of Islamic Development Malaysia (JAKIM) will collaborate to streamline the halal certification process.
Singapore
Singapore Amends Cosmetic Ingredient Use Requirements
On October 25, 2023, Singapore issued the Health Products (Cosmetic Products — ASEAN Cosmetic Directive) (Amendment No. 2) Regulations 2023, announcing the updated use requirements for cosmetic ingredients. These updates are in line with the amendments made to the ASEAN Cosmetics Directive (ACD) during the 34th and 35th ASEAN Cosmetic Scientific Body (ACSB) meetings, and came into effect on November 1, 2023.
Australia
Australia Updates Poisons Standard
On October 3, Australia’s Therapeutic Goods Administration (TGA) released the latest edition of the Therapeutic Goods (Poisons Standard - October 2023) Instrument 2023, superseding the previous version issued in July 2023. The updated Poisons Standard includes a number of modifications to the previous entries and the addition of several new specified substances for the first time.
Australia Adds Seven Cosmetic Ingredients to the Australian Inventory of Industrial Chemicals (AIIC)
On October 17, the Australian Government announced the addition of seven industrial chemicals to the AIIC under Section 83 of the Industrial Chemicals Act 2019. These chemicals are 1-Propanaminium, 2-hydroxy-N,N-dimethyl-N-[3-[(1-oxododecyl)amino]propyl]-3-sulfo-, inner salt (CAS No. 19223-55-3), 2H-Pyran, tetrahydro-3-(phenylmethyl)- (CAS No. 60466-73-1), 7-Nonenal, 6,8-dimethyl- (CAS No. 899810-84-5), 9-Decen-2-one (CAS No. 35194-30-0), Hexanal, 6-cyclopentylidene- (CAS No. 111998-18-6), 2H-Pyran-2-one, tetrahydro-5-propyl- (CAS No. 214335-70-3), 1,3-Dioxane, 2-(3,3-dimethyl-1-cyclohexen-1-yl)-2,5,5-trimethyl- (CAS No. 1853175-99-1).
Australia Updates Import Conditions for Retail Packaged Cosmetics and Soaps
On October 18, the Department of Agriculture, Fisheries, and Forestry of Australia implemented a minor change to the import conditions of retail packaged cosmetics and soaps for non-personal human use. The adjustment specifically targets products with less than 20% animal-derived material by mass.
Australia Publishes FAQs Regarding 2022-23 Annual Declarations
On October 30, the Australian Government released several FAQs concerning the introducers’ annual declaration obligations for chemicals introduced (including those manufactured and imported) between September 1, 2022 and August 31, 2023. The annual declarations will be due by November 30, 2023.
The United States
California to Ban the Use of 26 Ingredients in CosmeticsOn October 8, California's governor signed off on Assembly Bill No. 496, to ban the production and sale of cosmetics containing 26 toxic chemicals known to pose potential health risks within the state.
On October 13, the U.S. Food and Drug Administration (FDA) rolled out a comprehensive Structured Product Labeling (SPL) Implementation Guide with Validation Procedures. Cosmetics product facility registrations and product listings are now included within the SPL framework.
The United Kingdom
UK SAG-CS Publishes Opinions on Butylated Hydroxytoluene and Kojic Acid
Recently, the UK’s Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS) has published opinions on the use of Butylated Hydroxytoluene (BHT) and Kojic Acid in cosmetic products. These opinions partially differ from those released by EU’s Scientific Committee on Consumer Safety (SCCS).
UK Issues Guidelines on Managing CMR Substances Under the Cosmetics Regulation
On October 5, UK released a guidance introducing the management of CMR substances (those classified as carcinogenic, mutagenic or toxic for reproduction) within the cosmetics regulatory framework. This guidance outlines the regulatory requirements for CMR substances, and describes the exemption application process for their continued use.
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