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

Chinese Mainland

1. Guangdong Cosmetics Association Approves One Group Standards

On October 29, 2021, Guangdong Cosmetics Association released a group standard, namely T/GDCA 006-2021 Test Method for the Inhibition of Tyrosinase Activity by Cosmetic Ingredients (In-Vitro Method). The standard will take effect on November 27, 2021. (Reference Link)

2. Beijing MPA Consults on the Draft of Practice for Cosmetics Production Licensing in Beijing

On November 1, 2021, Beijing Medical Products Administration (MPA) opened a one-month public consultation on the draft of Practice for Cosmetics Production Licensing in Beijing. The draft stipulates the basic requirements, procedures, required documents, supervision and inspections, etc., for enterprises that intend to engage in cosmetics production in Beijing to apply for production licenses. It is scheduled to come into force on January 1, 2022, in sync with the effective date of Supervision and Administration Measures on Cosmetics Manufacture and Operation. (Reference Link)

3. SAMR Releases the Law Enforcement Guide for Medical Beauty Advertising

On November 2, 2021, China State Administration for Market Regulation (SAMR) released the Law Enforcement Guide for Medical Beauty Advertising Law, to crack down on illegal and false medical beauty advertisements and better regulate the sector. Under the new regulation, medical beauty advertising is categorized as medical advertising. Relevant beauty advertisers are required to acquire special licensing accordingly before placing adverts.

In addition, the Guide also detailedly lists medical beauty advertising chaoses that will be the focus of the crackdown, including the use of spokespersons, doctors, or experts by medical beauty institutions to make recommendations or endorsement for medical beauty. (Reference Link)

4. World’s Largest Trade Deal RCEP to Kick Off in January 2022

On November 2, 2021, the ASEAN Secretariat issued a notice announcing that the threshold for the Regional Comprehensive Economic Partnership (RCEP) Agreement coming into force had been reached. Six ASEAN member states, including Brunei, Cambodia, Laos, Singapore, Thailand, and Vietnam, as well as four non-ASEAN signatory states, including China, Japan, New Zealand, and Australia, have deposited their instrument of ratification/acceptance with the Secretary-General. As a result, the agreement will first come into effect for these ten signatories on January 1, 2022. (ChemLinked News)

5. Zhejiang MPA Launches Rectification to Crack Down on Three Types of Cosmetics

In line with National Medical Products Administration (NMPA)’s notice of a nationwide rectification campaign targeting illegal cosmetics sold online, Zhejiang MPA published its local enforcement scheme on November 4, 2021. Zhejiang’s rectification campaign has the same duration with nationwide rectification, from October 2021 to October 2022. The key regulatory targets are unregistered and unnotified cosmetics, cosmetics with illegal claims, and cosmetics with quality and safety risks. (Reference Link)

6. Henan MPA Launches Rectification to Crack Down on Four Types of Cosmetics

In line with NMPA’s notice of a nationwide rectification campaign targeting illegal cosmetics sold online, Henan MPA also published its local enforcement scheme in November. Henan’s rectification campaign runs from November 2021 to October 2022. The key regulatory targets are unregistered and unnotified cosmetics, cosmetics with illegal claims, cosmetics with quality and safety risks and cosmetic false or illegal advertising. (Reference Link)

7. China Consults on Five Testing Methods for Cosmetics Products and Ingredients, New Animal Testing Alternatives Included

During November 12-28, 2021, China National Institutes for Food and Drug Control (NIFDC) opened a public consultation on five draft testing standards for cosmetic products and ingredients. The five testing methods pertain to the pH determination of cosmetics as well as in-vitro skin sensitization, in-vitro eye irritation/corrosion, and genotoxicity test of cosmetic ingredients. Among them, the drafts of In Chemico Skin Sensitisation: Amino acid Derivative Reactivity Assay (ADRA)Human Cell Line Activation Test, and Fluorescein Leakage In Vitro Test Method are new in vitro alternative methods, which can reduce the industry’s reliance on the use of animal testing. (ChemLinked News)

8. CAFFCI Approves One Group Standard

On November 15, 2021, the Association of Fragrance Flavor and Cosmetic Industries (CAFFCI) released a group standard, namely T/CAFFCI 49-2021 Daily Nano-micro Sustained-release Flavor. The standard took effect upon issuance. (Reference Link)

9. GACC: Four Batches of Cosmetics Rejected in October

On November 22, 2021, the General Administration of Customs of China (GACC) gave an update on rejected food and cosmetics in October. A total of four batches of cosmetics imported from two countries (Japan and Switzerland) failed customs inspection. The reason for rejections is failing to provide certificates or compliant certification documents. (Reference Link)

10. China Alerts the Use of Whitening Ingredient Phenylethyl Resorcinol (SymWhite 377) in General Cosmetics

In late November, cosmetic industry insiders revealed that China NMPA is organizing spot check of the notification information on the new notification platform, with the focus placed on general cosmetics that contain whitening ingredients such as phenethyl resorcinol (commonly known as SymWhite 377 in the industry). Such products are suspected of exceeding the scope of general cosmetics and will result in notification failure. All notifiers are required to strictly check the notification dossiers, prohibit the use of restricted or permitted ingredients beyond their scope or limits, and prohibit illegal claims and exaggerated publicity. (ChemLinked News)

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11. China Announces the Second Batch of National Cosmetic Adverse Reaction Monitoring and Evaluation Institutions

On November 25, 2021, China NMPA issued a notice announcing that 17 hospitals have been designated as the second batch of national cosmetics adverse reaction monitoring and evaluation institutions. (Reference Link)

12. Guangdong to Strengthen Post-Notification Inspection on the New Notification Platform

According to Guangdong Cosmetic Quality Management Association’s report on November 25, 2021, Guangdong MPA has announced to strengthen the post-notification inspection on the new notification platform, focusing on dossiers inspection.

There are three key points of inspection:

  • Focus on checking whether the online notification dossiers meet the requirements of related notification regulations, and whether the paper notification dossiers meet the authenticity and consistency requirements.

  • Companies that have poor performance in daily notification management and routine supervision and inspection shall be the key objects of post-notification supervision and inspection.

  • For infant cosmetics, children's cosmetics, and other key categories subject to NMPA's supervision, the inspection shall cover all inspection items in the post-notification supervision and inspection. Notified products found to have quality problems in the inspection shall be investigated and dealt with in accordance with the law. (Reference Link)

13. China Clarifies the Enforcement Rules of Supervision and Administration Measures on Cosmetics Manufacture and Operation

In a move to promote the implementation of China’s Supervision and Administration Measures on Cosmetics Manufacture and Operation and refine enforcement standards, China NMPA issued a notice on November 26, 2021, stipulating the details for cosmetic production license management, cosmetic production management, and cosmetic operation management, which includes the point-in-time for certificate replacement, the retention of samples, the holding of trade fairs, and the labeling requirements for beauty salons. (ChemLinked News)

14. 13 Cosmetic National Standards to Take Effect on June 1, 2022

On November 26, 2021, the Standardization Administration of China released an announcement, approving 185 recommended national standards and a revision list of existing national standards, among which 13 are cosmetic standards:

  1. GB/T 40891-2021 Determination of lyral in cosmetics—Gas chromatography-mass spectrometry

  2. GB/T 40894-2021 Determination of prohibited substances thiamazole in cosmetics—High-performance liquid chromatography

  3. GB/T 40895-2021 Determination of prohibited tetracaine and its salts in cosmetics—Ion chromatography

  4. GB/T 40896-2021 Determination of diethylene glycol monoethyl ether in cosmetics—Gas chromatography mass spectrometry

  5. GB/T 40897-2021 Determination of alkali sulfides and alkaline earth sulfides in cosmetics—Methylene blue spectrophotometric method

  6. GB/T 40898-2021 Determination of prohibited bemegride and its salts in cosmetics—High-performance liquid chromatography

  7. GB/T 40899-2021 Determination of prohibited bromisoval, carbromal and carisoprodol in cosmetics—High-performance liquid chromatography

  8. GB/T 40900-2021 Determination of fluorescent brightener 367 and fluorescent brightener 393 in cosmetics—Liquid chromatography-tandem mass spectrometry

  9. GB/T 40901-2021 Determination of eleven kinds of prohibited azoles antifungal agents in cosmetics—Liquid chromatography-tandem mass spectrometry

  10. GB/T 40950-2021 Determination of alkyl (C12~C22) trimethyl ammonium salt in cosmetics—High-performance liquid chromatography tandem mass spectrometry

  11. GB/T 40955-2021 Determination of octamethylcyclotetrasiloxane(D4) and decamethylcyclopentasiloxane(D5) in cosmetics—Gas chromatography

  12. GB/T 40970-2021 Determination of ammonia in cosmetics—Titration method

  13. GB/T 14455.1-2021 Essential oils—Principles of nomenclature

All these standards will enter into force on June 1, 2022. (Reference Link)

15. China NMPA and Local Regulatory Authorities Publish Frequently Asked Questions Regarding New Cosmetic Regulations

In November 2021, NMPA and many provincial and municipal regulatory authorities of Guangdong, Beijing, Liaoning, etc., issued seven batches of frequently asked questions, which pertain to the registration and notification of cosmetics and new cosmetic ingredients under China’s new cosmetic regulations. Specifics are as follows: 

Release Date

Regulatory Authority

Contents

November 1

Guangzhou Market Regulation Administration (the 11th Batch)

Five questions about cosmetic ingredients, claim, labeling, and sales packaging.

November 8

NMPA

 Six questions about the person in charge of quality and safety, cosmetic manufacture, and operation.

November 9

Review Centre of Guangdong MPA

Nine questions about the cosmetic notification and the operation of the new notification platform.

November 11

NMPA

Five questions about the registration and notification of new cosmetic ingredients.

November 17

Guangzhou Market Regulation Administration (the 12th Batch)

Five questions about the operation of the new notification platform.

November 22

Review Centre of Beijing MPA

Five questions about product executive standards for cosmetic notification.

November 26

Liaoning Inspection, Examination and Certification Centre

Seven questions about general cosmetic’s annual reporting, testing reports, labeling of ingredients, safety assessment, and efficacy claim.

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Taiwan, China

Taiwan to Expand the Qualification Scope of Safety Assessment Report Signer

Taiwan FDA is now soliciting public consultation on the amended qualification for the signer of the safety assessment report included in the product information file (PIF) until January 11, 2022. According to the amendment, the qualification scope of the signer will be expanded to two types of persons. (ChemLinked News)

South Korea

1. South Korea to Amend the Enforcement Decree of Cosmetic Act

On November 4, 2021, the Ministry of Food and Drug Safety (MFDS) released the draft of the Enforcement Decree of Cosmetic Act to solicit public opinions. The draft mainly added the administrative penalties for prohibited behaviors, including using a similar name of a registered custom cosmetic compounding manager and failing to complete the compulsory education courses. The consultation period is set to end on December 15, 2021. (Reference Link)

2. South Korea to Revise Enforcement Rule of Cosmetics Act (MFDS Notice No. 2021-539)

On November 18, 2021, MFDS issued the draft of the Enforcement Rule of Cosmetics Act. MFDS proposed to designate food-simulating cosmetics as products subject to recall. The requirements for functional cosmetic certificate’s transfer and acquisition are modified. The custom cosmetic business operation standards are clarified as well. Stakeholders can send suggestions to MFDS before December 28, 2021. (ChemLinked News)

3. South Korea Consults on Enforcement Rule of Cosmetics Act (MFDS Notice No. 2021-553)

On November 24, 2021, MFDS published another draft on the Enforcement Rule of Cosmetics Act. This version proposed to modify the application form for the functional cosmetics certificate’s transfer and acquisition. Suggestions can be sent to MFDS before December 9, 2021. (Reference Link)

Japan

1. PMDA: 27 Batches of Cosmetics Were Recalled in November

Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced 27 batches of non-compliant cosmetics in November. They are all imported from South Korea and recalled due to labeling issues. (Reference link)

2. MHLW Notified Five Products Containing THC

Japan Ministry of Health, Labour and Welfare (MHLW) reported on November 8, 2021 that five CBD products were found to contain trace amounts of THC. The five products are now being recalled due to suspected violations of the Cannabis Control Act. (Reference link)

※ A ChemLinked webinar explaining Japan’s quasi-drug regulations will be held on Dec. 16.

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Indonesia

1. Indonesia Allows Cosmetics Packaged by Different Companies to Apply for One Notification Number

In view of the impact of COVID-19 and for the convenience of companies, Indonesia issued a notice on October 29, 2021, allowing the same cosmetics packaged by different packaging companies (a maximum of three) to apply for one notification number. The notification applicant shall have a GMP certificate and packaging cooperation contracts with each packaging company. (ChemLinked News)

2. Indonesia Released the Draft of Regulation for Supervision on the Entry of Drugs and Food into the Territory of Indonesia and Regulation for Supervision on the Entry of Drugs and Food Ingredients into the Territory of Indonesia

On November 12, 2021, National Agency of Drug and Food Control of Indonesia (BPOM) released the draft of Regulation for Supervision on the Entry of Drugs and Food into the Territory of Indonesia and draft of Regulation for Supervision on the Entry of Drugs and Food Ingredients into the Territory of Indonesia for public consultation. The two drafts stipulate the entry requirements for imported drugs, food, and ingredients (including cosmetics). Imported cosmetic products and ingredients are required to obtain import approval letters called SKI Post Border prior to entering Indonesia. The main amendments related to cosmetics in the drafts are as follows:

  • Modify the requirements for the remaining shelf life of imported cosmetic products, from the current one-third to two-thirds of the original shelf life;

  • Modify the application documents for SKI Post Border. Newly required documents include the original identity card of the person in charge, and photos of the front and back view of the company's warehouse and office;

  • Delete the lists of drugs, food, and ingredients restricted from entering Indonesia. Drugs, food, and ingredients (including cosmetics) restricted from entering Indonesia will be determined separately by the head of BPOM. (ChemLinked News)

Thailand

Thailand Simplifies the License Renewal Application Procedures for Hazardous Substances and Cosmetics

On November 19, 2021, Thailand Food and Drug Administration (FDA) issued a notice stating that starting from November 22, the business licenses for hazardous substances and cosmetics can be automatically renewed through FDA's e-submission system upon payment of renewal fees. There is no need to submit renewal applications or to wait for approval from the relevant authority. The renewed cosmetic licenses are valid for another three years and can be used instead of or attached to the old licenses, and the FDA number will be remained unchanged. License holders can download the new license from the system by themselves. (Reference Link)

Australia

1. Australia Specifies the Effective Dates for the Regulatory Amendments to the Industrial Chemicals Rules 2019

The Australian government opened a consultation on the proposed amendments to the Industrial Chemicals (General Rules) 2019, and the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019 on August 23, 2021, aiming to clarify the operation of the rules under the existing Australian Industrial Chemicals Introduction Scheme (AICIS)’s policy.

After considering stakeholders’ feedback, AICIS finalized the amendments to the General and Transitional Rules and designated two effective dates (November 23 and December 10 of 2021) for the regulatory changes on November 22, 2021. (Reference Link)

2. Australia Release the Categorization Guide Version 1.3

To align with the amendment to the Industrial Chemicals (General) Rules 2019, Australia AICIS updated the Guide to categorizing chemical importation and manufacture (Categorization Guide) and made it public on November 26, 2021. The detailed updates include:

  • Adding two exceptions to the category of “introductions that cannot be exempted or reported”;

  • Making more precise explanation of some chemicals that belongs to the category of “introductions that are automatically categorized as exempted”;

  • Making more precise explanation of the nanoscale criteria for research and development in the category of “introductions that are automatically categorized as reported”;

  • Adding a statement to clarify that a chemical with an end-use in an air freshener is not a “designated kind or release into the environment." (Reference Link)

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