Monthly Recap: Asia-Pacific Cosmetic Regulatory Updates | March 2021

1. Cosmetic Regulations/Standards

China Includes 7 Cosmetic Testing Methods into the Safety and Technical Standards for Cosmetics 2015

On March 2, 2021, China approved seven cosmetic testing methods and included them in the Safety and Technical Standards for Cosmetics 2015 (STSC). Among the seven testing methods, In Vitro Mammalian Cells Micronucleus Test, Test Method for Efficacy Measurement of Skin Whitening Cosmetic Products, and Test Method for Efficacy Measurement of Anti-hair Loss Cosmetic Products are newly introduced testing methods, which took effect on March 2, 2021. The other four testing methods, Determination of Preservatives in Cosmetics, Determination of Boric Acid and Borate in Cosmetics, Determination of P-phenylenediamine and Other 31 Kinds of Components in Cosmetics, and Determination of Tretinoin and Other 7 Kinds of Components in Cosmetics, are revised testing methods and will be effective on May 1, 2021. (ChemLinked News)

China to Exempt Animal Testing for Imported General Cosmetics on May 1

On Mar. 4, 2021, China NMPA released the finalized regulations on cosmetic registration and notification dossiers, which is renamed as Provisions for Management of Cosmetic Registration and Notification Dossiers and set to be effective on May 1. The regulation specifies the animal testing exemption requirements for general cosmetics, and clarifies the information required for annual reports of general cosmetics, the dossiers required for cosmetic registration and notification as well as the dossiers required for imported products that are specifically designed for the Chinese market. (ChemLinked News)

China Finalizes Dossier Requirements for Registration and Notification of New Cosmetic Ingredients

On Mar. 4, 2021, China NMPA released the finalized regulations on new cosmetic ingredient (NCI) registration and notification dossiers, which is renamed as Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers and set to be effective on May 1. Key points of the Provisions include: 1) The detailed documents for NCI registration and notification are finalized. 2) Three additional toxicological tests are required for high-risk, relative high-risk NCI and NCI with high biological activity first used at home and abroad. 3) Animal testing alternative method data for NCI registration/notification can be conditionally accepted. (ChemLinked News)

China Introduces Transitional Measures to Implement the New Provisions on Cosmetic Registration and Notification Dossiers

On March 5, 2021, China NMPA released multiple transitional measures to help enterprises better cope with the new registration and notification regulations. The transitional measures mainly deal with matters on the migration of cosmetics registration and notification information service platform, management of already registered and notified products, submission of cosmetic ingredients safety-related information, efficacy evaluation testing report of special cosmetics, and annual reporting of general cosmetics. (ChemLinked News)

China Releases Two Cosmetic Testing National Standards

On March 9, the Standardization Administration of China released two national standards for the testing of cosmetics. They are “GB/T 39927-2021 Determination of Prohibited Substances Veratrine in Cosmetics-High Performance Liquid Chromatography” and “GB/T 39946-2021 Determination of Prohibited Para Red in Lip Cosmetics-High Performance Liquid Chromatography”. Both standards will take effect on October 1, 2021. (Reference Link)

China Launches the Online Cosmetics Registration and Notification Platform

On March 23, China NMPA announced that a cosmetics registration and notification information service platform (https://zwfw.nmpa.gov.cn/web/index) would be launched on April 1, 2021, along with the release of a User Manual for User Registration and Enterprise Information Management. The company information and document management module was live on April 1, 2021, and general cosmetics notification and special cosmetics registration management module will be live on May 1, 2021. (ChemLinked News)

China to Ban CBD and 3 Other Cannabis Sativa Derived Ingredients in Cosmetics

On March 26, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation, which outlawed the use of Cannabis Sativa Fruit, Cannabis Sativa Seed Oil, Cannabis Sativa Leaf Extract, and Cannabidiol (CBD) in cosmetics. Stakeholders with any comments can send back to the NIFDC by email at hzpbwh@nifdc.org.cn before April 19, 2021. (ChemLinked News)

China CAFFCI Approves One Group Standard

On March 29, China Association of Fragrance Flavor and Cosmetic Industries (CAFFCI) released a group standard, namely “T/CAFFCI 45-2021 Determination of 4-Hydroxybenzoic Acid and its SALTS and Esters in Cosmetics - High Performance Liquid Chromatography-Mass Spectrometry”. The standard will take effect on April 28, 2021. (Reference Link)

China to Strength Supervision on Infant and Children Cosmetics

Cosmetic regulatory authorities in more than 20 regions in China including Beijing and Zhejiang, have issued the Special Inspection Work Plan for Children Cosmetics to strengthen post-market surveillance of children cosmetics. Most of the work plans are similar. The special rectification work on children cosmetics will last for 7 months from Mar. 1 to Sep 30, cover a wide range of inspection targets and impose heavy penalties for non-compliance. (ChemLinked News)

2. CBEC Rules

Tmall Releases Sample Products Posting Specification

On March 1, Tmall released a new standard, i.e., Sample Products Posting Specification, which stipulates that beauty samples sold on Tmall shall indicate the product information such as variety, specification, quantity, price, etc., and the attribute keywords such as "trial," "sample," "tester," "trial packaging" in the title of the product. The standard has taken effect on March 8, 2021. (ChemLinked News)

Tmall Global Increases Qualification Requirements for Imported CBEC Cosmetics

On March 8, Tmall Global issued a notice clarifying that merchants shall ensure conformance to the corresponding product posting guidelines of Tmall Global when releasing beauty, food, and pet products, and provide qualification certificates or third-party authoritative testing reports that meet the specified qualification requirements. In the beauty sector, the CBEC imported cosmetics need to conduct tests and submit qualification certificates of the items including Total bacterial count (CFU/g or CFU/ml), Mercury, Lead. The notice has come into force on March 15, 2021. (ChemLinked News)

Tmall Global Adds New Management Requirements for Imported Cosmetics Containing CBD

On March 22, Tmall Global announced to update the Tmall Global Cosmetics Platform Standard with the addition of new management requirements of imported CBD cosmetics. Specifically, imported CBD cosmetics sold on Tmall Global shall provide a THC testing report, and the THC content shall not exceed 0.3%. The revised standard will take effect on April 6, 2021. (ChemLinked News)

China Expands the CBEC Pilot Cities

On Mar. 22, 2021, China Ministry of Commerce and other 5 departments jointly announced to expand the CBEC pilots to all cities where pilot free trade zones, CBEC comprehensive zones, comprehensive bonded zones, import trade promotion innovation demonstration zones and bonded logistics center (B type) are located. This announcement comes into effect since the date of promulgation. (ChemLinked News)

Taiwan Revises the List of Micro-organisms Limits in Cosmetics

On Mar. 2, 2021, Taiwan Food and Drug Administration (TFDA) released a draft list of micro-organisms limits in cosmetic products for public consultation. The list revised the requirements of product category and detection result related to micro-organisms limits in cosmetics. (ChemLinked News)

Taiwan Adjusts the Fee of Cosmetic Testing Items

On Mar. 26, 2021, Taiwan Food and Drug Administration announced to adjust the fee of cosmetic testing items, which include the testing of heavy metals, purity, dissolution, PH, etc. (Reference Link)

KBEAUTY Safety Issue: South Korea Arrested the Company Owner for Using Prohibited Colorants in Cosmetics

The competent authority arrested the company owner for illegally using colorants in cosmetic products. The company was accused of adding prohibited colorants in over 1.26 million products worth more than 1.3 billion KRW. The prohibited colorants are Basic Yellow 28, Basic Red 2, Basic Blue 26, Basic Violet 13, and HC Red 13. (Reference Link)

South Korea Drafts the Enforcement Rule of the Cosmetics Act

On March 25, 2021, South Korea disclosed the draft of Enforcement Rule of the Cosmetics Act. It proposed to simplify the application procedure for conducting custom cosmetic business outside of the registered premises. (Reference Link)

Japan Revises the Japanese Standards of Quasi-drug Ingredients

On March 25, the Japan Ministry of Health, Labour and Welfare (MHLW) released the Japanese Standards of Quasi-drug Ingredients 2021, which amend the ingredients and experimental methods in the Japanese Standards of Quasi-drug Ingredients 2006. The revisions were effective on March 25, 2021, and a grace period is given to September 30, 2022. 

Japan Revises the List of Permitted Additives in Quasi-drugs

On March 25, the Japan Ministry of Health, Labour and Welfare (MHLW) unveiled an amendment of the List of Permitted Additives in Quasi-drugs. According to the amendment, No. 255 "Ethanol (96-96.5 degrees)" was deleted, and 13 additives’ English names were modified. (Reference Link)

Japan Revises the Requirements for the Applications of Quasi-Drugs

Along with the revision of JSQI, the Japan Ministry of Health, Labour and Welfare (MHLW) revealed the requirements for quasi-drugs applications on March 25. Applications for products manufactured under old specifications are still acceptable prior to September 30, 2022. But starting from October 1, 2022, stakeholders shall comply with new rules and apply for new manufacturing and marketing licenses. (Reference Link)

Indonesia Adds Prohibited and Permitted Cosmetic Types for Manufacturers with Class B Production Licenses

On Feb. 26, 2021, Indonesia implemented the amended List of Forms and Types of Cosmetics Allowed for Production by Manufacturers with Class B Production Licenses. Several types of cosmetics that are prohibited or permitted to be manufactured by manufacturers with class B production licenses are newly added. (ChemLinked News)

Indonesia Clarifies Requirements for Issuance of Recommendations as Cosmetics Notification Applicants

Before conducting cosmetic notification in Indonesia, an importer or business individual/business entity that undertakes a production contract must obtain a recommendation as a notification applicant from the Head of the local UPT BPOM. On Mar. 4, 2021, Indonesia released and implemented Technical Requirements for Issuance of Recommendations as Cosmetics Notification Applicants. The regulation provides a legal basis for the competent authority to issue a recommendation and includes the requirements for the enterprises, application process, time required, necessary documents and templates, etc. 

Vietnam Details CFS Exemption Requirements for Imported Cosmetics from the CPTPP and the ASEAN Member States

On Dec. 31, 2020, the Vietnam Ministry of Health issued Circular 29/2020/TT-BYT, amending and supplementing the articles of several regulations, including Circular 06/2011/TT-BYT Providing Cosmetic Management. The amendments and supplements took effect on Feb. 15, 2021. On Mar. 16, 2021, Vietnam issued Consolidated Document 07/2021/VBHN-BYT Consolidating the Circular on Cosmetic Management, integrating the amended and newly added articles. The main amendments include the clarification of CFS exemption requirements and the necessary information on the CFS, and slight adjustment on the cosmetic notification report template. (ChemLinked News)

Thailand Solicits Public Feedback on the Use and Labeling of Cosmetics Containing CBD

On March 18, Thailand FDA opened a public consultation on the use and labeling of cosmetics containing CBD.Stakeholders with advice or suggestions were welcome to provide feedback online before March 22, 2020. (Reference Link)

Australia Updates Instructions for Pre-Introduction Reports of Low-Risk Chemicals in Flavour or Fragrance Blends

On March 26, the AICIS released an updated guide, which includes separate sections that describe the process to follow when an introducer knows - or doesn't know - the proper name for the chemicals in the blend, to help introducers complete a pre-introduction report for industrial chemicals that meet the criteria for “low-risk flavour or fragrance blends.” (Reference Link)