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

Chinese Mainland

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

On Nov. 30, 2021, China NMPA officially issued a notice, announcing that the addition of whitening ingredient SymWhite 377 in general cosmetics is suspected of violating the relevant provisions in the Cosmetic Supervision and Administration Regulation and Administrative Measures on Cosmetics Registration and Notification, and will be investigated and dealt with by the provincial medical products administrations (MPA). All provincial MPA shall report the investigation and handling progress of the general cosmetics added with SymWhite 377 to NMPA by Dec. 20, 2021. [ChemLinked News]

2. China Finalizes the Mandatory Labeled Logo on Children Cosmetics

The finalized Supervision and Administration Provisions on Children Cosmetics stipulated that children cosmetics should be labeled with NMPA designated children cosmetics' logo on the display panel of the sales package. On Dec. 1, 2021, China NMPA revealed the children cosmetics’ logo, as well as its labeling area and color matching information. From May 1, 2022, children cosmetics that apply for registration/notification must be labeled with the logo. For those that have applied for registration/notification before May 1, 2022, the registrant/notifier shall update the label before May 1, 2023. [ChemLinked News]

Children Cosmetics Logo.jpgChildren Cosmetics Logo

3. One Cosmetic National Standards for Cosmetics Came into Effect on Dec. 1

On Dec. 1, 2021, one national standard for cosmetics came into effect, GB/T 40145-2021 Determination of 11 glucocorticoids including desonide in cosmetics—Liquid chromatography-tandem mass spectrometry. This standard applies to the determination of 11 glucocorticoids in water, lotion, cream cosmetics, and essential oils. [Reference Link]

4. China Publicizes the Notification Information of Two New Cosmetic Ingredients

On Dec. 2 and Dec. 8, 2021, China NMPA publicizes the notification information of two new cosmetic ingredients (NCI) from overseas companies. Up to now, the notification information of six NCI has been publicized. The basic information of the two NCI notified in Dec. is as follows:

INCI Name

Tetrafluoropropene

Sodium Lauroyl Methyl Isethionate

CAS Number

29118-24-9

928663-45-0

Use Purpose

Propellant

Cleansing agent

Applicable Scope

1. Leave-on products: skin cosmetics, hair care cosmetics

2. Rinse-off products: skin cosmetics, hair care cosmetics

Shampoo, bath products, facial cleansing products, and other cleansing cosmetics (not to be used in eye products)

The Maximum Concentration

90%

11%

Notifier

Honeywell International Inc.

Innospec (Beijing) Inc.

[ChemLinked News]

810 150.png5. China NMPA Further Clarifies Requirements for Children Cosmetics

On Dec. 3 and Dec. 9, China NMPA respectively issued a reply to the questions related to children makeup’s definition and a popular science article on children cosmetics. The key points include:

  • Cosmetics refer to products applied to the human body surface. Toy products only used for dolls or other finshing purposes should not be managed as cosmetics. They shall be managed in accordance with the toy regulations;

  • If a product is within the scope of cosmetics, whether it is sold separately or together with other products such as toys, the product should be supervised and managed as cosmetics;

  • The permitted efficacy claims for cosmetics used by infants under three years old do not include "beautifying and embellishing" and "makeup removing." Therefore, it is illegal to claim that any makeup is suitable for infants under three years old. [Reference Link 1] [Reference Link 2]

6. China to Release a List of Permitted Cosmetic Whitening Ingredients

In response to the recent industry buzz on the ban of whitening ingredient phenethyl resorcinol (commonly known as SymWhite 377 in the industry) in general cosmetics, China NMPA issued a popular science article on Dec. 16, 2021, expounding the reasons for the ban as well as the definition, judging principles, safety risks, supervision requirements, etc., of whitening cosmetics. It also revealed that relevant departments are preparing to draft a list of cosmetic whitening agents, which will influence the definition of whitening cosmetics in China. [ChemLinked News]

7. China GACC Cancels the Consignee Filing of Imported Cosmetics

In a move to further streamline the administration and simplify the import process, the General Administration of Customs of China (GACC) issued a notice on Dec. 17, 2021, deciding to cancel the filing of Chinese domestic consignees of imported cosmetics from Jan. 1, 2022. [ChemLinked News]

8. China Further Clarifies the Transitional Measures on the Previous Special Use Cosmetics and Cosmetics Containing Newly Prohibited Ingredients

On Dec. 17, 2021, China NMPA released an announcement to clarify the transitional measures for the previous five types of special use cosmetics (hair growth products, depilating products, breast beauty products, slimming products, and deodorants) and cosmetics containing newly prohibited ingredients, as well as the management measures for the renewal of special cosmetics registration certificate. The key points are as follows:

  • The previous five special use cosmetics can continue to be produced, imported, and sold during the grace period until Dec. 31, 2025, even if their administrative licenses expire during the grace period;

  • It is not mandatory to cancel the registration/notification of cosmetics containing newly prohibited ingredients. The original registration or notification number can be retained after the formula is changed, and the prohibited ingredients are replaced or deleted;

  • Registrant intending to extend the validity of special cosmetics registration certificate shall conduct a product self-inspection six months before the certificate expires. [ChemLinked News]

9. GACC: 13 Batches of Cosmetics Rejected in November

On Dec. 20, 2021, GACC gave an update on rejected food and cosmetics in November. A total of 13 batches of cosmetics imported from 5 countries (Czechoslovakia, Japan, South Korea, Italy, and Germany) failed customs inspection. The reasons for rejections are detection of hemp seed oil, detection of pseudomonas aeruginosa, failing to provide certificates or compliant certification documents, failing to pass sensory inspection, exceeding shelf life, excessive molds and yeasts, and unqualified labels. [Reference Link]

10. Guangdong MPA Clarifies Matters Related to Cosmetics Production License

On Dec. 20, 2021, Guangdong MPA issued a notice on matters related to the cosmetics production license. The key points include:

  • Starting from Dec. 20, 2021, for enterprises that have the production conditions for eye care cosmetics and children's skincare cosmetics, Guangdong MPA would specifically mark the corresponding items on the licenses;

  • On Dec. 20, 2021, Guangdong MPA implemented the notification and commitment system for production license renewal;

  • Starting from Jan. 1, 2022, for the application for new, changing and renewing production licenses, Guangdong MPA will issue the new version of the license;

  • Starting from Jan. 1, 2022, newly established enterprises that only engage in preparing cosmetic content shall apply for a production license. The production can begin only after granted the cosmetic production license. [Reference Link ]

11. China to Further Encourage the Development of CBEC

On Dec. 23, 2021, the State Council executive meeting mentioned that China would further encourage the development of cross-border e-commerce, establish more CBEC comprehensive pilot zones, and optimize the CBEC positive list to expand import categories. [Reference Link]

12. Hei Longjiang MPA Cancels Five General Cosmetics Notification

On Dec. 27, 2021, Hei Longjiang MPA announced to cancel the five Chinese domestic general cosmetics notifications. The reasons are that the notifiers’ business licenses have been cancelled, and the notifiers have been out of contact for a long time. [Reference Link]

13. China Pilots the Electronic Registration Certificate System

On Dec. 30, 2021, China issued an announcement stating that from Jan. 1, 2022, NMPA would issue electronic registration certificate as a trial for special cosmetics and high-risk new cosmetic ingredients. The time for the official implementation will be announced separately.

  • From Jan. 1, 2022, NMPA begins to issue electronic registration certificates for special cosmetics and new cosmetic ingredients which are approved for registration;

  • From May 1, 2022, NMPA will begin to issue electronic registration certificates for special cosmetics which are approved for certificate change or renewal;

  • The electronic registration certificate has the same legal effect as the paper registration certificate;

  • During the trial period, the electronic and the paper registration certificate are issued in parallel. [Reference Link]

14. Guangdong MPA Strengthens Notification Management of General Cosmetics

On Dec. 30, 2021, Guangdong MPA issued an announcement to strengthen the notification management of general cosmetics. The key points are:

  • Municipal medical products administration departments should supervise and urge the notifier to carry out self-inspection and self-correction, and rectify the cosmetics on the original notification platform. Where rectification has been completed before Sep. 15, 2021 and meets the requirements, the notifier shall promptly claim the product on the new notification platform; for those that have not been corrected after Sep. 15, 2021 or still do not meet the requirements after rectification, the notifier shall cancel the notification through the new notification platform. The cosmetics that have been marketed before notification cancellation can be sold until the end of the shelf life. On Mar. 31, 2022, the notification of unclaimed product on the original notification platform will be cancelled;

  • The notifier shall submit the annual report of general cosmetics from Jan. 1 to Mar. 31, 2022;

  • For general cosmetics that have been notified on the original notification platform, the notifier shall supplement product executive standard and label samples, and fill in the product formula (for Chinese domestic general cosmetics) before May 1, 2022;

  • Registrant, notifier, and domestic responsible person who have opened temporary user account of the new notification platform must supplement the quality management system overview, adverse reaction monitoring and evaluation system overview before Jan. 1, 2022. If the supplementary submission is not completed within the time limit, the temporary user account will be automatically inaccessible;

  • Starting from Jan. 1, 2022, the notifier is required to evaluate the efficacy claims of cosmetics and upload a summary of efficacy evaluation on the website designated by NMPA;

  • Starting from Jan. 1, 2022, the registrant/notifier shall provide safety information of preservative, sunscreen, colorant, hair dyeing, freckle-removing and whitening ingredients when applying for product registration/notification. [Reference Link]

15. China Launches Cosmetics Ingredient Safety Information Submission Platform

On Dec. 31, 2021, China launched a Cosmetics Ingredient Safety Information Submission Platform. Cosmetic ingredient manufacturers or their authorized companies can log in to the platform to submit ingredient safety information. Chinese domestic company can directly log in the submission platform. Overseas company shall log in after opening an account on the “Cosmetic Ingredient Safety Information Submission Platform”.

When registering or notifying a cosmetic product, the cosmetic registrant, notifier, and domestic responsible person can submit the ingredient safety information documents issued by the ingredient manufacturer, or fill in the ingredient submission code generated by the Cosmetics Ingredient Safety Information Submission Platform. [ChemLinked News]

16. Guangdong and Beijing Regulatory Authorities Publish Frequently Asked Questions Regarding New Cosmetic Regulations

In December 2021, Guangzhou Administration for Market Regulation, Beijing Municipal and Guangdong MPAs 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. [ChemLinked News]

Release Date

Regulatory Authority

Batch

Dec. 2

Guangzhou Administration for Market Regulation

The 15th Batch

Dec. 10

The 16th Batch

Dec. 24

The 17th Batch

Dec. 13

Review Centre of Beijing Municipal MPA

The 2nd Batch

Dec. 22

The 3rd Batch

Dec, 28

The 4th Batch

Dec. 29

Review Centre of Guangdong MPA

The 3rd Batch

17. Tmall Updates the Requirements for the Display of Cosmetics Label Information

Tmall released a Notice on Updates to Requirements for the Display of Cosmetics Label Information. According to the notice, e-commerce operators in Tmall should

  • Display the picture of the labels on the front and back display panel of the cosmetics on the product main page or product details page;

  • For product set, display the pictures of the labels on the front and back display panel of all cosmetic products sold in the set;

  • When releasing cosmetic products, operators should truthfully fill in the "registrant/notifier’s name," "registrant/notifier’s address," "manufacturer’s name," "product executive standard number," etc., based on the actual situation. [Reference Link]

18. China Issues 8 Group Standards in December

China issued eight group standards in December. Four have come into effect, and four are still drafts.

Release/Implementation Date

Release Department

Group Standard

Source

Dec. 1, 2021

Guangdong Daily Chemical Chamber of Commerce

Test method for efficacy measurement of skin soothing cosmetic products (draft)

Reference Link

Dec. 1, 2021

Test method for efficacy measurement of skin firming cosmetics products (draft)

Reference Link

Dec. 2, 2021

T/GDCDC 019-2021 Test method for efficacy measurement of anti-wrinkle cosmetics products

Reference Link

Dec. 4, 2021

National Technical Committee for Fragrances, Flavors and Cosmetics Standardization

Method for Assessment of Cosmetics Anti-wrinkle Efficacy (Draft)

Reference Link

Dec. 4, 2021

Method for Assessment of Cosmetics on Transepidermal Water Loss (Draft)

Reference Link

Dec. 20, 2021

National Association of Health Industry and Enterprise Management

T/NAHIEM 45—2021 Jellyfish Extract for Cosmetics

Reference Link

Dec. 28, 2021

China Association of Fragrance Flavor and Cosmetic Industries

T/CAFFCI 50-2021 N-hexyl Acetate

Reference Link

Dec. 28, 2021

T/CAFFCI 51-2021 Neryl Acetate

Reference Link

South Korea

South Korea Consults on Types, Standards, and Test Methods of Cosmetic Color Additives

On Dec. 21, 2021, the Ministry of Food and Drug Safety (MFDS) proposed to update the re-evaluation time of the Types, Standards and Test Methods of Cosmetic Color Additives.

MFDS will make reasonable re-review and improvement on the content of the clauses every three years. The base date is changed from July 1, 2016 to “July 1, 2022”. (Reference Link)

South Korea Consults on Cosmetic Safety Standards

On Dec. 27, 2021, MFDS issued a notification to solicit public opinions on the draft of Regulation on Safety Standards, etc. for Cosmetics. The draft proposed prohibited ingredients, including eight perfluorinated compounds, persistent pollutants, and 1,2,4-Trihydroxybenzene. Eleven restricted ingredients are drafted out as well. Additionally, the management of unintentionally added ingredients is clarified. The consultation period is set to end on January 17, 2022. (ChemLinked News)

South Korea Revises the Enforcement Rule of Cosmetics Act

On Dec. 28, 2021, MFDS modified the Enforcement Rule of Cosmetics Act. The new regulation simplified the business transfer of functional cosmetics. The safety and efficacy evaluation of functional cosmetics is replaced by a simple transfer review when transferring the functional cosmetic business from one entity to another. (Reference Link

Japan

1. PMDA: 18 Quasi-drugs were Recalled in December

On Dec. 8, 2021, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced 18 non-compliant quasi-drugs. Among them, 13 products were recalled because they did not carry out the purity test and confirmation test specified in the approval certificate, and the other 5 quasi-drugs were recalled for possible allergic reactions. (Reference Link-1) (Reference Link-2)

2. Japan Prohibits the Use of Methylrosanilinium Chloride in Quasi-drugs and Cosmetics

On Dec. 28, 2021, PMDA issued a notice with immediate effect, stating the Methylrosanilinium Chloride shall not be used in quasi-drugs and cosmetics due to the possibility of genetic toxicity and carcinogenicity. (Reference Link)

ASEAN

1. ASEAN Adopts Significant Changes to the Annexes of ASEAN Cosmetic Directive

The 34th ASEAN Cosmetic Scientific Body (ACSB) meeting was held in November 2021. During the meeting, significant changes to cosmetic ingredients in the Annexes of the ASEAN Cosmetic Directive (ACD) were introduced, which include:

  • Adding 223 prohibited ingredients

  • Adding 8 restricted ingredients

  • Adding 1 permitted preservative

  • Adding 1 permitted UV Filter

  • Amending requirements of 3 restricted ingredients [ChemLinked News]

Indonesia

1. Indonesia Releases the Draft of the Criteria and Procedure for Submission of Cosmetics Notification

On Dec. 6, 2021, Indonesia released a revised draft of the Criteria and Procedure for Submission of Cosmetics Notification for public consultation. The draft clarifies the scope of notification applicants, necessary documents, notification procedures, notification template, cosmetics categories, etc. The main amendments include

  • Slightly modifying the documents required for cosmetic notification in Indonesia;

  • Clarifying the requirements for importers and commissioning manufacturers;

  • Allowing the use of previously notified cosmetic product names in one more situation;

  • Adding notification requirements for the cosmetic product set;

  • Adding notification requirements for applicants with multiple manufacturing sites;

  • Clarifying that applicants can apply for notification information changes instead of reapplication if they intend to add packaging manufacturers or manufacturing sites. [ChemLinked News]

2. Indonesia Releases Draft Amendments to Cosmetic Ingredient Use Requirements

On Dec. 6, 2021, Indonesia released the draft amendments to Technical Requirements for Cosmetics Ingredients for public consultation. The main amendments include

  • Revising the use requirements for other ingredients (ingredients not listed in Appendix I) and natural ingredients. If business actors intend to use other ingredients or natural ingredients in cosmetics, in addition to scientific or empirical evidence, they are required to submit a policy recommendation on ingredient safety/efficacy/quality issued by the Directorate of Standardization of Traditional Medicines, Health Supplements and Cosmetics;

  • Adding 5 restricted ingredients and deleting 1 restricted ingredient;

  • Adding 2 permitted UV filters;

  • Adding 239 prohibited ingredients. [ChemLinked News]

3. Indonesia Implements New Technical Guidelines for Cosmetics Advertising

On Dec. 13, 2021, Indonesia released and implemented the finalized Technical Guidelines for Cosmetics Advertising, replacing the previous 2016 version. Business actors (including those companies that published advertisements before Dec. 13) must update the advertisements to comply with the finalized Guidelines before Jun. 13, 2022. The finalized Guidelines adds three permitted advertising media and new requirements for advertising content, clarifies supervision methods, and modifies administrative sanctions for non-compliant advertisements. [ChemLinked News]

Malaysia

1. Malaysia to Amend Cosmetic Ingredient Use Requirements

On Dec. 13, 2021, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released and implemented Circular No. 3/2021 Information on the Updated Status of Ingredients in the Annex of the Guidelines for Control of Cosmetic Products in Malaysia. According to the Circular, 223 prohibited ingredients, 8 restricted ingredients, 1 permitted preservative, and 1 permitted UV filter are added. [ChemLinked News]

Vietnam

1. Vietnam Revises Regulations on Origin Information Shown on Product Labels

On Dec. 9, 2021, Vietnam issued the Decree No. 111/2021/ND-CP amending the Decree No. 43/2017/ND-CP regarding product labels, slightly revising labeling requirements for product origin. The Decree will come into force on Feb. 15, 2022. The main amendments are as follows:

  • Products (including cosmetics) circulating in Vietnam must be labeled with the product origin. Products of unknown origin can be labeled with the final processing country or region;

  • Product origin marked on the labels can be one of the following expressions: "made in," "manufactured in," "manufacturing country," "origin," "produced by…" or "product of…”;

  • Product’s final processing country or region marked on labels can be one of the following expressions: “assembled in…”; "bottled in…”; “mixed in…”; “finished in…"; “packed in…”; “labeled in…”. [Reference Link]

2. Vietnam Updates Cosmetic Ingredient Use Requirements

On Dec. 22, 2021, Vietnam released and implemented Official Letter No. 14993/QLD-MP on amending cosmetic ingredient use requirements. The amendments are based on the results of the 33rd-34th ASEAN Cosmetic Council Meeting (ACC) and the 33rd-34th ASEAN Cosmetic Scientific Body (ACSB). The main amendments are:

  • Adding 227 prohibited ingredients (Ref. 1385, 1390, 1392, 1394, 1401-1644, A1143);

  • Adding 10 restricted ingredients (Ref. 328-337);

  • Adding 1 permitted UV filter (Ref. 31);

  • Amending the use requirements for a permitted preservative (Ref. 28).

Click here to find the list of newly added ingredients and the effective date of each amendment. [Reference Link]

Australia

1. Australia Reminds Stakeholders of the Regulatory Changes Effective from Dec. 10, 2021

According to AICIS's notice on Nov. 22, 2021, the finalized amendments to the Industrial Chemicals (General Rules) 2019 and the Industrial Chemicals (Consequential Amendments and Transitional Provisions) Rules 2019 were scheduled to take effect on Nov. 23 and Dec. 10, 2021, respectively.

On Dec. 4, 2021, AICIS issued a reminder of the regulatory requirements and obligations that will start on Dec. 10, 2021. The key contents include:

1. Adding a requirement for pre-introduction reports related to nanoscale chemicals for research and development, which requires introducers to report whether their chemical is at the nanoscale.

2. Requiring introducers to declare that they have permission to use the international assessment report from the report's owner.

3. Clarifying that the introduction of a chemical with an end-use in air fresheners is no longer a “designated kind of release into the environment.” (Reference Link)

2. TGA Publishes the Final Decisions of Proposed Amendments to the Current Poisons Standard

On Dec. 20, 2021, the Therapeutic Goods Administration (TGA) issued a notice, publishing the final decisions of the proposed amendments to the Current Poisons Standard presented at the 34th Advisory Committee on Medicines Scheduling (ACMS), the 31st Advisory Committee on Chemicals Scheduling (ACCS), and the 28th Joint ACMS-ACCS meetings in June 2021, as well as the reasons for and the effective date of those decisions.

Regarding proposed amendments related to cosmetics, the final decisions are as follows:

  • Not amending the scheduling for ethanol and isopropanol in hand sanitizers.

  • Amending the scheduling for methanol and creating a new definition for hand sanitizers. The amendments will take effect on Feb. 1, 2022.

  • Not amending the scheduling for eugenol. The authority previously proposed to amend the Schedule 6 entry for eugenol by reducing concentration cut-offs for cosmetic preparations for skin contact.

  • Creating a new Schedule 7 entry and a new Schedule 10 entry for 2-amino-5-methylphenol. The amendments will take effect on Feb. 1, 2022.

  • Adding new entries for 6-methoxy-N2-methyl-2,3-pyridinediamine, which specify the use requirements of this ingredient in hair dyes. The amendments will take effect on Jun. 1, 2022.

  • Amending the scheduling for lead acetates, which deletes the entry of lead compounds in hair cosmetics preparations. The amendments will take effect on Jun. 1, 2022. (Reference Link)

3. TGA Consulted on the Proposed Amendments to the Poisons Standard

On Dec. 20, 2021, TGA opened a public consultation on the proposals to amend the current Poisons Standard, which will close on Jan. 31, 2022. Submissions should be provided through the consultation hub. They will be considered at meetings in Mar. 2022.

The proposed amendments related to cosmetics include removing the entries for lead and lead compounds in Schedules 4, 5, and 6, including preparations including medicines and cosmetics that contain lead in an expanded Schedule 10 entry, etc. (Reference Link)

4. TGA Specifies the Focus of Supervisions and Inspections on Sunscreens

TGA regulates sunscreen products to ensure they meet the high standards for quality, safety, and effectiveness set by the Australian regulatory guidelines for sunscreens. This includes actively monitoring products on the market through both laboratory testing and compliance reviews.

On Dec. 22, 2021, TGA issued a notice stating that it will focus on the supervision over the following aspects to ensure the safety and effectiveness of sunscreen products for the 2021-22 summer.

  • Checking the effectiveness of aerosol sunscreens, particularly when they are applied in real situations, such as at a windy beach.

  • Testing for benzene contamination of sunscreens, in particular in aerosol products.

  • Evaluating benzophenone impurities in sunscreens containing the active ingredient octocrylene. (Reference Link)

Webinar Recommendation

2021 was a year of significant events and progress in Asia-Pacific’s cosmetic industry. China officially implemented the long-awaited new cosmetic regulation CSAR and its supporting rules. Japan launched a new version of the overarching technical standards for quasi-drugs—Japanese Standards of Quasi-drug Ingredients (JSQI 2021). South Korea introduced the natural and organic cosmetic raw material certification mechanism. Taiwan province of China, ASEAN countries (Indonesia, Malaysia, Vietnam, Thailand), India, and Australia have also undergone several regulatory updates. ChemLinked will host webinars on Jan. 12 and Jan. 13 to overview the revised and emerging cosmetic regulations in the Asia-Pacific region over 2021. Welcome to register here.

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Further Reading

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