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Monthly Recap: Global Cosmetic Regulatory Updates | October 2022

China

China Launches Cosmetic Adverse Reaction Monitoring System on October 1

On October 1, 2022, China National Medical Products Administration (NMPA) implemented the Measures for the Management of Cosmetic Adverse Reaction Monitoring, proposing systematic requirements for cosmetic adverse reaction monitoring.

On the same day, the upgraded National Cosmetic Adverse Reaction Monitoring System was put into service. Where cosmetic registrants, notifiers, entrusted production enterprises, operators, or medical institutions find or learn any cosmetic adverse reaction, they shall submit a report through the system.

Fujian Medical Products Administration Publishes a Popular Science Article on "Anti-glycation" Cosmetics

On October 13, the Fujian Medical Products Administration (MPA) republished a popular science article “Can 'anti-glycation' cosmetics really fight ageing?" on its official website, which originally appeared on CNPHARM.COM. The article points out that "anti-glycation" and “anti-ageing” are not exactly the same concept, and whether ingredients and cosmetics have "anti-glycation" efficacy on the skin needs further research.

Guangzhou Municipal Administration for Market Regulation (AMR) Implements the First Local Live E-Commerce Specification

On October 14, 2022, a local standard of Guangzhou City, Guangdong Province, DB4401/T 171-2022 Specification for live e-commerce marketing and after-sales service, was officially implemented. Combined with the actual situation in Guangzhou, this local standard clarifies the qualifications, responsibilities and obligations of relevant parties involved in online live-streaming marketing activities, such as live streamers, live-streaming staffs, multi-channel network (MCN) organizations, live-stream marketing platforms, live-streaming room operators, and merchants. In particular, virtual live streamers are subject to the standard as well, with its definition specified in the standard virtual.

Alibaba International Station Publishes Compliance Rules for Cosmetics Products

On October 17, 2022, Alibaba International, China's leading cross-border trade platform, added a new product rule entitled "Compliance Rules for Cosmetic Products on Alibaba.com" in view of the strict regulatory requirements and industry standards for cosmetics at home and abroad. The new rule stipulates that merchants who list cosmetic products on the platform shall comply with the importing countries/regions' regulatory requirements and compliance standards. The new rule took effect on October 24, 2022.

China General Administration of Customs (GACC): A Batch of Cosmetics Rejected in September

On October 24, 2022, GACC updated the list of rejected food and cosmetics in September. A batch of cosmetics imported from South Korea failed the customs inspection due to excessive bacterial counts.

China Finalizes Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices

On October 25, 2022, China NMPA issued the finalized Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices, which will come into force on December 1, 2022. The new regulation will replace the current Inspection Points for Cosmetics Production License (commonly known as "105 Articles") and become a new standard for unannounced inspections on cosmetic production.

The Cosmetic Ingredient Submission Code Does Not Represent the Endorsement of the Regulatory Authority

On October 27, 2022, China National Institutes for Food and Drug Control (NIFDC) answered a question related to the generation of cosmetic ingredient submission codes. It emphasizes that using terms such as "ingredient submission codes obtained" to falsely claim that the ingredients have been approved or recognized by regulatory authorities is suspected of false or exaggerated publicity, and will be investigated and punished by relevant regulatory authorities.

Guangzhou Government Cancels the Notification of over 220,000 Batches of Non-compliant General Cosmetics

On October 31, 2022, Guangzhou Municipal AMR announced that it had cancelled the notification of over 220,000 batches of general cosmetics. These non-compliant general cosmetics include unconfirmed cosmetics on the new Cosmetics Registration and Notification Platform, and cosmetics lacking the required annual report. Cosmetics included in the cancellation scope shall not be sold or imported from the date of cancellation.

China Further Regulates Celebrity Endorsements

On October 31, 2022, the State Administration for Market Regulation (SAMR) and six other departments jointly issued the Guiding Opinions on Further Regulating Celebrity Endorsements, which entered into force upon its issuance. Consisting of six parts, the Guiding Opinions makes comprehensive and systematic regulations on the behaviour of each subject engaged in star endorsements, including celebrities, enterprises, and media.

China NMPA Approves Four New Cosmetic Ingredients

In October 2022, China NMPA updated the notification information of four new cosmetic ingredients (NCIs). The basic information about these new NCIs is as follows:

  1. Lauroyl/Myristoyl Methyl Glucamide (CAS No: 287735-50-6), notified on October 9, 2022

  2. Sodium Hydrolyzed Potato Starch Dodecenylsuccinate (CAS No: 1218992-20-1), notified on October 13, 2022

  3. Hibiscus taiwanensis root/stem extract, notified on October 17, 2022

  4. Perfluorobutylethyl Stearyl Dimethicone, notified on October 28, 2022

Hainan MPA and Beijing Municipal MPA Publish FAQs Regarding Cosmetics Notification

In October 2022, Hainan MPA and Beijing Municipal MPA issued two batches of FAQs pertaining to the general cosmetics notification and cosmetic efficacy claim.

Release Date

Regulatory Authority

Batch

October 17, 2022

Hainan MPA

The 2nd batch

October 19, 2022

Beijing Municipal MPA

The 13th batch

China Issues Six Group Standards in October

In October 2022, Zhejiang Health Products and Cosmetics Industry Association, Guangdong Cosmetics Association and some other industry associations issued six group standards. These standards are all about cosmetic ingredients, whose basic information is as follows:

Release Date

Initiator

Group Standard

Implementation Date

October 14, 2022

Zhejiang Health Products and Cosmetics Industry Association

T/ZHCA 018-2022 Cosmetic Ingredients—Birch Sap

November 15, 2022

October 21, 2022

Guangdong Cosmetics Association

T/GDCA 013-2022 Cosmetics—Evaluation of Antioxidant Activity—Caenorhabditis Elegans Assay

November 21, 2022

October 28, 2022

Shandong Society of Biomedical Engineering

T/SDSBME 001-2022 Cosmetic Ingrendients—Hydroxypropyl Tetrahydropyrantriol

October 28, 2022

T/SDSBME 002-2022 Cosmetic Ingredients—Hydroxypropyl Tetrahydropyrantriol (The ratio of β,S configuration to β,R configuration is 5:5)

T/SDSBME 003—2022 Cosmetic Ingredients—Hydroxypropyl Tetrahydropyrantriol (The ratio of β,S configuration to β,R configuration is 7:3)

October 31, 2022

Zhejiang Daily Chemical Industry Association

T/ZJRHXH 0007-2022 Cosmetics Fragrance

November 15, 2022

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Taiwan, China

Taiwan Releases Three Test Methods for Cosmetics

On October 27, 2022, Taiwan Food and Drug Administration (FDA) released three test methods for cosmetics. The basic information is as follows:

No.

Test Method

Implementation Date

1

Method of Test for Colorants in Cosmetics

October 27, 2022

2

Method of Test for Preservatives in Cosmetics (4)

3

Method of Test for Preservatives in Cosmetics (5)

Japan

PMDA: 181 Batches of Cosmetics and Quasi-drugs Recalled in October

In October 2022, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced the recall of 181 batches of non-compliant cosmetics and quasi-drugs. Among them, 96% were recalled for labelling issues. Stakeholders need to be aware that cosmetic products with an outer box on the Japanese market must carry a Japanese display label on both the container and the outer box.

South Korea

South Korea Issues the Guideline of Alternative Animal Testing Methods of Skin Sensitizing for Cosmetics (In Chemico, kDPRA)

On October 14, 2022, the Ministry of Food and Drug Safety (MFDS) published a new cosmetic alternative animal test guideline, which is for skin-sensitizing testing by using kDPRA method. It outlines the general provisions, test principles, limits and matters to concern, test methods, data preparation and report, recognition standards, as well as test results and report.

South Korea Issues the Guideline for Preservation Ability Testing of Cosmetics

On October 25, 2022, MFDS disclosed the Guideline for Preservation Ability Testing of Cosmetics. The preservation ability test is to control the quality and sanitation of cosmetics. Cosmetic’s preservation ability can be confirmed by studying the growth, survival, and death of the microorganisms introduced into the cosmetics in the test. This guideline contains the basic concepts, introduction of the preservation test, matters to be concerned during the test, test methods, and references.

South Korea Amends the Guideline for Restricted Cosmetic Ingredient Analysis

On October 31, 2022, MFDS modified the Guideline for Restricted Cosmetic Ingredient Analysis. The analysis methods of ten colourants are newly added.

Philippines

Philippines Released the Second Draft Amendment to the Requirements for Licensing and Inspection of Health Products

On October 3, 2022, Philippine FDA launched the second round of consultation on the draft amendment to Administrative Order No. 2020-0017. Compared with the first draft, supplements are added to further clarify the requirements for the Qualified Person (QP) and the License to Operate (LTO) application. To ensure a smooth transition, FDA also sets transitional provisions for concerned establishments.

Indonesia

Indonesia Implements the Amended Criteria and Procedure for Submission of Cosmetics Notification

On October 5, 2022, Indonesia Food and Drug Supervisory Agency (BPOM) issued and implemented the amended Procedure for Submission of Cosmetics Notification, replacing the previous Criteria and Procedure for Submission of Cosmetics Notification (2020).

The regulation is divided into 7 chapters, 56 articles, and 5 appendices, which stipulates the scope of notification applicants, the documents required for notification, notification procedures, cosmetic product categories, etc.

Indonesia Implements the Amended Application of 2D Barcode in the Control of Drugs and Food

On October 5, 2022, Indonesia BPOM issued and implemented the amended Application of 2D Barcode in the Control of Drugs and Food, replacing the previous Application of 2D Barcode in the Control of Drugs and Food (2018).

The regulation is divided into 7 chapters, 31 articles, and 1 appendix, which stipulates the 2D barcode’s definition, category, labeling requirements, and information that should appear after scanning, etc.

Indonesia Releases the Draft of Guidelines for Product Information File

On October 31, 2022, Indonesia BPOM released the draft of the Guidelines for Product Information File (PIF) for public consultation.

The draft is divided into 3 chapters, 16 articles, and 1 appendix, which stipulates the documents requirements, language requirements, retention time, retention form, PIF review, etc.

Thailand

Thailand Releases Two Guides for Cosmetic Efficacy Testing

On October 4, 2022, Thai FDA released two guides for cosmetic efficacy testing: the Efficacy Testing Guide for Rinse-Off Skin Cleansing Cosmetics and the Efficacy Testing Guide for Alcohol-Based Hand Hygiene Products. The two guides are applicable to the testing of the anti-bacterial efficacy of rinse-off skin cleansing cosmetics and alcohol-based hand hygiene products, respectively.

Thailand Issues Amendment to Cosmetics Act

On October 12, 2022, Thai FDA issued the Cosmetics Act (No. 2) 2022, which revised some Articles in the current Cosmetics Act 2015. The amendment took effect from the date of publication. The remaining unamended provisions of the Cosmetics Act 2015 still apply. A detailed analysis article will be published later.

Australia

Australia Adds a Cosmetic Ingredient to the Australian Inventory of Industrial Chemicals

On October 28, 2022, Australia AICIS announced the addition of the industrial chemical 1-Decen-4-yne (CAS No. 24948-66-1) to the Australian Inventory of Industrial Chemicals under Section 83 of the Industrial Chemicals Act 2019.

The chemical has been assessed as a fragrance component in finished consumer products 

  • at less than or equal to 1% concentration in continuous action air fresheners; or

  • at less than or equal to 0.2% concentration in fine fragrances, cosmetics, or other household products.

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Saudi Arabia

Saudi Arabia Issues Cosmetics Registration Regulation

On October 10, 2022, the Saudi Food and Drug Authority issued the Cosmetics Registration Regulation, which sets out the definition and scope of cosmetics, pre-market registration requirements, required registration dossiers, as well as the review, change, cancellation, and revocation procedures of cosmetic licenses. The regulation took effect from the date of publication. Existing products on the market can be sold until the end of their shelf life.

The European Union

EU SCCS Releases the Revised Opinion on Vitamin A

In 2016, EU Scientific Committee on Consumer Safety (SCCS) published its opinion on the use of Vitamin A in cosmetics. On October 26, 2022, SCCS released a revised version of this opinion, re-confirming that Vitamin A in cosmetics at the concentrations specified in its original opinion is safe. As a supplementary, SCCS reminds that the contribution of vitamin A from cosmetics will add to the overall consumer exposure, which may be of concern for consumers with the highest exposure to vitamin A (5% of the total population) from food and food supplements.

Webinar Recommendation

How to Comply with Cosmetics Advertising Regulations in Japan

Complying with the laws and regulations related to cosmetics advertising in Japan, such as the Pharmaceutical and Medical Devices Law, the Guidelines for Cosmetic Advertisements 2020, etc. is of significant importance for companies to conduct cosmetics business in Japan.

ChemLinked will host a webinar on Nov. 16 to introduce the current advertising regulations, supervision, essential advertising claim requirements, etc. and analyze some advertising cases, offering a preliminary overview for stakeholders that want to advertise cosmetics in Japan.

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