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

Chinese Mainland

Zhejiang Health Products & Cosmetics Industry Association Releases Technical Specification for Disinfection of Cosmetic Production Enterprises 

On September 1, 2021, Zhejiang Health Products & Cosmetics Industry Association released one group standard—Technical Specification for Disinfection of Cosmetic Production Enterprises. The standard took effect on Oct. 1, 2021. [Reference Link]

China Association of Fragrance Flavor and Cosmetic Industries (CAFFCI) Consults on One Group Standard

On September 1, 2021, China Association of Fragrance Flavor and Cosmetic Industries (CAFFCI) consulted on one group standard—Daily Nano-micro Sustained-release Flavor. Now the consultation period has ended. [Reference Link]

China to Strengthen Control over Excessive Package for Cosmetics

On September 2, 2021, China’s State Administration of Market Supervision (SAMR) issued the revised mandatory national standard GB 23350-2021 Requirements of Restricting Excessive Package—Food and Cosmetics, to supersede the existing GB 23350-2009. The new standard is scheduled to be effective on September 1, 2023, allowing a two-year grace period for stakeholders. [ChemLinked News]

China NMPA Consults on the Second Draft of Good Manufacturing Practices for Cosmetics

On September 8, 2021, China National Medical Products Administration (NMPA) consulted on the second draft Good Manufacturing Practices for Cosmetics. Compared with the first draft, the second draft of Good Manufacturing Practices for Cosmetics relaxes the qualification requirements for the person in charge of quality and safety, the person in charge of the quality management department and the person in charge of the production management department. The draft also refines the management requirements for brands who entrust factories to produce cosmetics. [ChemLinked News]

The Old General Cosmetics Notification Platform Closed on Sep. 15

On September 15, 2021, the old general cosmetics notification platform was officially closed. General cosmetics that have been notified and passed post-notification review on the old platform can continue to be sold in the Chinese market. The notifier should supplement the product executive standard and label sample, and fill in the product formula of domestic general cosmetics on the new platform before May 1, 2022. [ChemLinked News]

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China Solicits Organizations to Formulate/Revise 29 Testing Methods in STSC 2021 

On September 16, 2020, China National Institutes for Food and Drug Control (NIFDC) released a notice to solicit organizations to undertake the formulation or revision work of 29 testing methods in the Safety and Technical Standards for Cosmetics (STSC) 2021.[Reference Link]

GAC: 7 Batches of Cosmetics Rejected in August 

On September 17, 2021, China General Administration of Customs (GAC) gave an update on rejected food and cosmetics in August. A total of 7 batches of cosmetics imported from 2 countries (Japan and South Korea) failed customs inspection in August. The reason for rejections is “failure to provide certificates or compliant certification documents”. [Reference Link]

China Consults on Five Standards Relating to Cosmetics Supervision Data

On September 24, 2021, China NMPA consulted on five standards relating to cosmetic supervision data, including 1) basic data set of cosmetics production license management, 2) basic data set of ordinary cosmetics products record-keeping system management, 3) basic data set of special cosmetics record-keeping system management, 4) basic data element of cosmetic administration information, and 5) coding for value domain of cosmetic administration information basic data element. [ChemLinked News]

China NMPA Releases Two Supplementary Testing Methods 

In September 2021, China NMPA released two supplementary testing methods, namely, Determination of Benvitimod in Cosmetics and Determination of Bimatoprost and Other 4 Components in Cosmetics. [Reference Link]

China NMPA Releases Cosmetic Registration and Notification Data in 2021H1

In September 2021, NMPA released the cosmetic registration and notification data in 2021H1, including data on initial registration, renewal, modification, re-issuance and cancellation of special cosmetics as well as the notification of imported general cosmetics. [ChemLinked News]

Zhejiang Health Products & Cosmetics Industry Association Consults on Three Group Standards

On September 28, 2021, Zhejiang Health Products & Cosmetics Industry Association (ZHCA) released three group standards for public consultation, including:

  • Evaluation of anti-wrinkle effect of cosmetics—Detection method for the recovery rate of caudal fin shrinkage of zebrafish larvae.

  • Firmness efficacy test of cosmetics—Test method for relative expression of elastin gene in zebrafish larvae

  • Evaluation of soothing effect of cosmetics—Detection method of neutrophil migration in zebrafish larvae

Any suggestions can be mailed to hyfg@121jk.cn before Oct. 27, 2021. [Reference Link]

China Starts a New Round of Consultation on Regulations for Cosmetic Adverse Reaction Monitoring

On September 29, 2021, China consulted on the second draft of Measures for the Management of Cosmetic Adverse Reaction Monitoring. Compared to the first draft, the second draft clarifies the reporting content of cosmetic adverse reactions, revises the reporting time limit and monitoring records retention period of cosmetic adverse reactions, and adds new provisions on the disposal of and punishment for cosmetic adverse reactions. [ChemLinked News]

Taiwan, China

Taiwan Revises the List of Micro-organisms Limits in Cosmetics

On September 7, 2021, Taiwan Food and Drug Administration (TFDA) released the finalized list of micro-organisms limits in cosmetic products, which revises the requirements of the micro-organisms limits for two product categories. The finalized list is scheduled to come into effect from Jan. 1, 2022. Cosmetics manufactured after the date should comply with the new requirements. [ChemLinked News]

Taiwan Releases a Test Method for Camphor, Menthol and Methyl Salicylate in Cosmetics

On September 17, 2021, TFDA released the Test Method for Camphor, Menthol and Methyl Salicylate in Cosmetics. [Reference Link]

South Korea

South Korea Amends Six Guidelines Concerning Alternative Animal Testing

On September 7, 2021, the Ministry of Food and Drug Safety (MFDS) released six notifications to announce the amendments of alternative animal testing guidelines. The modified guidelines are: Guideline of Alternative Animal Testing Methods for Cosmetics(In Vitro 3T3 NRU Phototoxicity Test); Guideline of Alternative Animal Testing Methods of Eye Test for Cosmetics (Isolated Chicken Eye Test Methods, ICE); Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (Local Lymph Node Assay); Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (Local Lymph Node Assay: DA); Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (Local Lymph Node Assay: BrdU-ELISA); and Guideline of Alternative Animal Testing Methods for Cosmetic Skin Irritation (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method). All these guidelines are added with an English translation of the OECD guideline.

South Korea Outlines the Guideline for Quality, Safety, and Retailer Store Sanitation Management of Custom Cosmetics (Division and Refilling)

On September 15, 2021, MFDS issued the Guideline for Quality, Safety, and Retailer Store Sanitation Management of Custom Cosmetics (Division and Refilling). This Guideline interprets the provisions regarding the division of cosmetics into smaller units or refilling the cosmetics, as stipulated in Article 5 of Cosmetic Act and Article 12-2 of Enforcement Rule of Cosmetic Act.

This guideline includes the quality and safety management for cosmetics' division and refilling, retailer store sanitation control, labeling methods of divided/refilled cosmetics, and consumer guide. [Reference Link]

South Korea Establishes Two Guidelines of Alternative Animal Test for Cosmetics

On September 27, 2021, MFDS issued two guidelines regarding cosmetic alternative tests: nterleukin-8 luciferase test method for skin sensitive, and In vitro Macromolecular Test Method for eye irritation. Both guidelines include the test principle, considerations and limitations, method of the test, judgment standard, and test result report, etc. 

Japan

PMDA: 11 Batches of Cosmetics Recalled in September

Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced 11 batches of non-compliant cosmetics in September. They are all imported from South Korea, and recalled due to labeling issue. [Reference link]

Malaysia

Malaysia Updates Cosmetic Ingredient Use Requirements

On Sep. 29, 2021, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 2/2021 Information on the Updated Status of Ingredients in Annex in the Guidelines for Control of Cosmetic Products in Malaysia. NPRA conducts periodic reviews on the Guidelines, and amend the Guidelines’ contents to make it in line with the amendments made to the ASEAN Cosmetic Directive (ACD). The amendments include:

Annex

Ingredient

Effective Date

Annex II (List of Prohibited Substances)

1,2,4-Trihydroxybenzene when used as a substance in hair and eyelash dye products

Notified cosmetic products containing the ingredient are only allowed to be sold on the market until May 28, 2022.

4-Amino-3-hydroxytoluene when used as a substance in hair and eyelash dye products

2-[(4-Amino-2-nitrophenyl)-amino]-benzoic acid when used as a substance in hair and eyelash dye products

Annex III (List of Restricted Substances)

2-Hydroxyethyl   Methacrylate (HEMA) is included in Annex III with specified conditions.

Notified cosmetic products that do not comply with the new conditions are only allowed to be sold on the market until Nov. 28, 2022.

11, 14-Dioxa-2,9- diazaheptadec-16-enoic Acid, 4,4,6,16-tetramethy-10, 15- dioxo, 2-[(2-methyl- 1-oxo-2-propenyl) oxy] ethyl ester (DI-HEMA TRIMETHYLHEXYL   DICARBAMATE) is included in Annex Ill with the specified conditions.

Annex IV (List of Coloring Agents)

Errors in the Cl 77266 and Cl 77266 (Nano) ingredient conditions were corrected from total Hg≤10 ppm to total Hg≤1 ppm

/

Annex VI (List of Preservatives)

Update on the preamble

News detailing the amendments will be released soon. [Reference Link]

Vietnam

Vietnam Releases Draft Decree Regulating Import and Export Goods Transacted via E-commerce

On Aug. 31, 2021, Vietnam Ministry of Finance released the draft of Decree Regulating Import and Export Goods Transacted via E-commerce (The Decree). The Decree is expected to affect e-commerce platforms, logistics businesses, payment intermediaries, customs clearance agents, organizations and businesses related to e-commerce. The Decree includes requirements for:

  • Customs electronic data processing system;

  • Procedures for providing information on the transactions of import and export goods (information about orders, payment methods, and transportation);

  • Policies on specialized management and tax;

  • Customs procedures for import and export goods (documentation, implementation time limit, records examination, physical inspection of goods, customs clearance);

  • Supervision of cleared goods and imported goods;

  • Responsibilities of agencies, organizations and individuals.

[Reference Link]

A ChemLinked webinar explaining Vietnam cosmetics regulations will be held on Oct. 28.

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Australia

Australia AICIS Clarifies the Rules on Using New Animal Test Data

Since July 1, 2020, Australia has prohibited the reliance on new animal testing data for supporting the introduction of chemicals that only use as cosmetic ingredients. To help businesses better cope with the rules, the Australian Industrial Chemicals Introduction Scheme (AICIS) issued an information sheet on September 2, 2021, which explains the key points about using new animal test data and includes the situations the restrictions do and don't apply to.

*New animal test data are the data obtained from tests conducted on a cephalopod or any live vertebrate animal (other than a human being) on or after July 1, 2020.

[Reference Link]

Australia Adds Two Chemicals to the Australian Inventory of Industrial Chemicals 

According to Australia AICIS' notice issued on September 10 and 27, 2021two chemicals were added to the Australian Inventory of Industrial Chemicals, which are 13-Oxabicyclo[10.1.0]trideca-4,8-diene, (1R,4E,8Z,12R)-rel- (CAS No. 55722-64-0) and 4-Pentenal, 5-cyclohexyl-2,4-dimethyl-, (4E)- (CAS No. 1449104-34-0). Both chemicals can be used in fine fragrances, cosmetics, and household products. [Reference Link]

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