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

Chinese Mainland

China Launches the Online Cosmetics Registration and Notification Platform

On April 1, 2021, China NMPA launched the cosmetics registration and notification information service platform (https://zwfw.nmpa.gov.cn), which provides company information and document management module. Starting from the date, companies can apply for user permission on the platform, which is a precondition of submitting registration and notification application. [ChemLinked News]

China SAMR Unveils the 2021 Legislation Scheme

On April 1, 2021, China State Administration for Market Regulation unveiled its 2021 legislation scheme. The scheme includes 61 regulations, among which 2 regulations are relating to cosmetics, namely Supervision and Administration Measures on Cosmetics Manufacture and Operation and Administrative Measures on Toothpaste. [Reference Link]

China NMPA Answers FAQs about Cosmetics Registration and Notification

Starting from May 1, 2021, cosmetics registration and notification in China shall comply with the new regulations, which are Administrative Measures on Cosmetics Registration and Notification, and Provisions for Management of Cosmetic Registration and Notification Dossiers. On Apr. 2, 2021, China NMPA issued an announcement answering the frequently asked questions about cosmetics registration and notification. [ChemLinked News]

China SAMR to Abolish the Regulations Concerning the Hygiene Supervision over Cosmetics

On Apr. 2, 2021, China State Administration for Market Regulation release a notice, stipulating that the Regulations concerning the Hygiene Supervision over Cosmetics will be abolished starting from Jun 1, 2021. Cosmetic Supervision and Administration Regulation will replace it as the new overarching cosmetic regulation in China. [Reference Link]

China SAMR Releases the Results of National-level Testing Institutions Proficiency Test

On Apr. 2, 2021, China State Administration for Market Regulation release the results of national-level testing institutions proficiency test in 2020. There were 146 testing institutions participating in the proficiency test for the determination of lead and mercury content in cosmetics, among which eight institutions failed the proficiency test. [Reference Link]

China Details Cosmetic Safety Assessment Requirements

On Apr. 9, 2021, the finalized Technical Guidelines for Cosmetic Safety Assessment was officially published and will take effect on May 1, 2021. Starting from Jan. 1, 2022, cosmetic registrants and notifiers shall conduct cosmetic safety assessments in accordance with the Technical Guidelines and submit product safety assessment documents when applying for special cosmetics registration or general cosmetics notification. [ChemLinked News]

China Finalizes Standards for Cosmetic Efficacy Claim Evaluation

On April 9, 2021, China NMPA officially released the finalized Standards for Cosmetic Efficacy Claim Evaluation, which will take effect on May 1, 2021. The Standards stipulates that 20 kinds of efficacy claims require efficacy evaluation. Cosmetic registrants and notifiers shall complete the efficacy evaluation and disclose the abstract of efficacy evaluation basis on the website specified by the NMPA for public view at the time of registration and notification. [ChemLinked News]

China Unveils the Cosmetic Classification Rules and Catalogs

On April 9, 2021, the finalized Cosmetic Classification Rules and Catalogs was officially released and will come into force on May 1, 2021. Starting from the Catalogs' effective date, cosmetic registrants or notifiers shall fill in the product classification code in accordance with the Catalogs when applying for special cosmetics registration and general cosmetics notification. [ChemLinked News]

Zhejiang Health Products & Cosmetics Industry Association Consults on A Group Standard

On Apr. 15, 2021, Zhejiang Health Products & Cosmetics Industry Association (ZHCA) released one group standard for public consultation, namely, Method of eye irritation test in vitro for facial cleanser cosmetic products- In vitro eye irritation test with human cornea-like epithelial tissue model. Any suggestions can be mailed to zjcos2015@163.com before May 14, 2021. [Reference Link]

China NMPA Publishes Cosmetic Supervisory Statistics of 2020

On Apr. 20, 2021, China National Medical Products Administration released the 2020 annual report on drug supervisory statistics, including statistics on 1) cosmetic registration and notification, 2) investigation and handling of non-compliant cosmetics, as well as 3) licensing for and routine inspection on cosmetic manufacturers. [ChemLinked News]

GAC: 11 Batches of Cosmetics Rejected in March

On Apr. 20, 2021, China General Administration of Customs (GAC) gave an update on rejected food and cosmetics. A total of 11 batches of cosmetics imported from 2 regions (Ghana and Taiwan, China) failed customs inspection in March. Reasons for rejections were unqualified labels and non-compliant certificates. [Reference Link]

China Clarifies Transitional Measures on the Existing NCI Applications

On Apr. 23, 2021, China introduced transitional processing measures on the existing registration applications of new cosmetic ingredients (NCI). NCI applicants can apply for withdrawing the existing registration applications by two methods before May 1, 2021. If NCI applicants fail to apply for withdrawing the registration applications before May 1, 2021, NIFDC will continue to complete the document review in accordance with Provisions for Management of New Cosmetic Ingredient Registration and Notification Dossiers. [ChemLinked News]

China Clarifies Submission Requirements for Cosmetics Registration and Notification Dossiers

On Apr. 25, 2021, China released the Technical Guidance for Submission of Cosmetics Registration and Notification Dossiers (Trial). The Guidance specifies detailed requirements relating to registration and notification of cosmetics and new cosmetic ingredients (NCI), such as obtaining the user account, opening user permission, submitting paper and electronic documents, the format of documents, etc. [ChemLinked News]

Zhejiang Health Products & Cosmetics Industry Association Releases One Group Standard

On Apr. 28, 2021, Zhejiang Health Products & Cosmetics Industry Association (ZHCA) released one group standard, namely, Whitening Efficacy Test of Cosmetics- Zebrafish Embryos Test Method of Melanin Inhibition. The standard will be implemented on June 1, 2021. [Reference Link]

China NMPA Released Two Regulations on Cosmetic Supplementary Testing Methods

On Apr. 28, 2021, China NMPA released two regulations on cosmetic supplementary testing methods: Working Rules for Management of Cosmetic Supplementary Testing Methods and Technical Guidance for Studying and Drafting Cosmetics Supplementary Testing Methods. The implementation date for the Working Rules is July 1, 2021, while no implementation date is set for the Technical Guidance as it only serves as a reference. [ChemLinked News]

China Releases the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021)

On Apr. 30, 2021, China National Medical Products Administration (NMPA) finalized the Inventory of Existing Cosmetic Ingredients in China 2021 (IECIC 2021). The IECIC 2021 increases the total number of existing cosmetic ingredients in China to 8972. [ChemLinked News]

China Taiwan

Taiwan Releases a Test Method for Nitrosamines in Cosmetics

On April 6, 2021, Taiwan released the Test Method for Nitrosamines in Cosmetics, stipulating the test method of Nitrosamines in cosmetics, such as N-Nitrosodiethanolamine, NDELA, N-Nitrosodiethylamine, NDEA, etc. [Reference Link]

South Korea

South Korea Accepts Online Submission of Imported Cosmetic Certificates

On April 9, 2021, KPTA (Korea Pharmaceutical Traders Association) officially announced to accept online submission of the imported cosmetics certificates. Except for the "TSE (BSE) related documents”, all documents necessary for "entry notice of imported products (표준통관예정보고서)" can be sent to KPTA online. [ChemLinked News]

South Korea Updates the Enforcement Decree of Cosmetic Act

On April 27, 2021, Ministry of Food and Drug Safety (MFDS) released the amended Enforcement Decree of Cosmetic Act. The new version permits the payment prolonging and the installment payment of a penalty. Under certain circumstances where the obligor has difficulty paying the penalty at once, he/she could apply to extend the payment due date or pay by installments. This provision is aimed to ease the industry’s burden under COVID-19. It was praised as a humanitarian policy ever since its draft was released last year. [Reference Link][Latest English Translation]

Japan

Japan Unveils the Guidance on Skin Irritation Assessment System for Quasi-drugs and Cosmetics Safety Assessment

On April 22, 2021, Japan MHLW issued a technical guidance on skin irritation assessment system for quasi-drugs and cosmetics safety assessment. The guidance records the precautions of multiple test methods that replace animal testing in evaluating skin irritation. Notably, the skin irritation test includes primary skin irritation test and cumulative skin irritation test. For cumulative skin irritation test, the alternative method for animal testing using cells and the like has not been developed. [Reference Link]

Japan Unveils the Guidance on Multiple Safety Data Combination Assessment System for Single Dose Toxicity Assessment of Quasi-drugs and Cosmetics

On April 22, 2021, Japan MHLW issued a technical guidance for single dose toxicity assessment of quasi-drugs and cosmetics. In this document, MHLW summarizes the process of evaluating single dose toxicity evaluation by Weight of Evidence (normally abbreviated as WoE) combining safety data including data from 3T3-NRU cytotoxic test. [Reference link]

JCIA is Responsible for Cosmetic GMP Certificates Applications

On April 23, 2021, Japan Cosmetic Industry Association (JCIA) announced in response to China’s new regulation on animal testing exemption for imported general cosmetics that China NMPA required the submission of GMP certificates granted by the government. The announcement specifies that JCIA will be responsible for handling applications for GMP certificates from cosmetic companies which look to circumvent China's animal testing and reviewing the application documents. Ministry of Health, Labour and Welfare (MHLW) will grant official GMP certificates for the compliant applications. For quasi drugs, companies may refer to the requirements of PMDA. [Reference Link]

Indonesia

Indonesia Repeals Technical Guidelines for Supervision of Alpha Hydroxy Acid (AHA) in Cosmetics

On Mar. 5, 2021, Indonesia released an announcement repealing Technical Guidelines for Supervision of Alpha Hydroxy Acid (AHA) in Cosmetics 2006. The regulatory requirements for cosmetics containing AHA have been included and updated in Technical Requirements for Cosmetic Labeling, which came into effect on Dec. 28, 2020. Technical Requirements for Cosmetic Labeling clarified:

  • Grouping of cosmetics containing AHA;

  • Warning requirements;

  • Notification Number Owner's obligations and the format for reporting product distribution

[Reference Link]

India

India Allows Submission of Self Attested Regulatory Documents for Cosmetics Import and Registration amid the COVID-19 Outbreak

Given the worsening COVID-19 lockdown situation, India’s Central Drugs Standard Control Organization (CDSCO) issued a notice on April 13, 2021, to further extend the deadline for submitting notarized, apostilled, and embassy-attested documents for cosmetic import and registration by an extra four months. During the transitional period, cosmetic stakeholders can submit self-attestation of regulatory documents to support the application for import registration. [Reference Link]

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