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Monthly Recap: Global Cosmetic Regulatory Updates | March 2022

Chinese Mainland

China NMPA Approves One New Cosmetic Ingredient

In March 2022, China National Medical Products Administration (NMPA) updated the notification information of one new cosmetic ingredient (NCI). The basic information of the new NCI is as follows:

INCI Name

Chenopodium formosanum Extract

CAS Number

/

Purpose of Use

Skin protectant

Applicable Scope

All kinds of cosmetics

The Maximum Concentration

≤0.7%

Notifier

Baiyuet Biotechnology (Shanghai) Co., Ltd.

Children Cosmetics Logo is Not a Product Quality Certification Mark

On March 7, NMPA released a popular science article to help consumers correctly understand the meaning of the children cosmetic logo, Little Golden Shield. "Little Golden Shield" is a symbol that distinguishes children cosmetics from adult cosmetics, disinfection products, and toys. From May 1, 2022, children cosmetics that apply for registration/notification must be labeled with the logo. For those that applied for registration/notification before May 1, 2022, the registrant/notifier shall update the label before May 1, 2023. Non-children cosmetics shall not be labeled with this logo.

Labeling "Little Golden Shield" on the cosmetic packaging only indicates that the product belongs to children cosmetics, but does not mean that the product has been approved by the regulatory authorities or certified for quality and safety.

children cosmetic logo.jpg"Little Golden Shield"

ChemLinked will host a webinar on China's new cosmetic labeling requirements on April 26. Welcome to register here.

China NMPA Answers Key Questions on Cosmetic Supervision and Administration

On March 10, China NMPA issued an announcement, answering frequently asked questions about ingredient safety information, efficacy claim evaluation and sample retention. The key points include:

Ingredient Safety Information

  • Cosmetic registrants and notifiers just need to fill in the ingredient submission code provided by the ingredient manufacturers, then the platform will help match the ingredients' safety information documents;

  • If any ingredient currently has no submission code, the cosmetic registration and notification will not be affected. Cosmetic registrants and notifiers can submit relevant ingredient safety information on the cosmetics registration and notification information service platform based on the ingredient's safety information documents provided by its manufacturer.

Efficacy Claim Evaluation

For cosmetics that have been registered and notified before May 1, 2021, cosmetic registrants and notifiers should upload the abstract of the efficacy claim's basis of relevant products in accordance with the transitional policies. After registrants and notifiers evaluate the efficacy claim of the relevant products as required by Standards for Cosmetic Efficacy Claim Evaluation, if the efficacy claim involved in the product name or label cannot be supported by the evaluation result, a change application should be filed before the expiry of the transitional period. In the application, the registrants and notifiers shall adjust the classification code of the product based on its actual properties, and amend the relevant content in the product name or label, to make it comply with regulations.

Sample Retention

  • NMPA compiled a Reference Table for the Quantify of Retained Samples of Cosmetic Registrants and Notifiers. According to the Table, registrants and notifiers are asked to keep at least three packs of samples for products that are subject to samples retention;

  • The entrusted cosmetic registrants and notifiers shall retain samples in their respective domicile or main business premise. They can also retain samples in other business premises where their respective domicile or main business premise is located.

China NIFDC Consults on the Limitation of Benzene in Cosmetics

To strengthen the management of safety risk substances in cosmetics, on March 10, 2022, China National Institutes for Food and Drug Control (NIFDC) released an announcement seeking public comments on the limitation requirements of benzene (CAS No. 71-43-2). According to the risk assessment results, the limit of benzene in cosmetics is proposed to be 2mg/kg.

Shanghai Songjiang District Administration for Market Regulation Issues the First Penalty for General Cosmetics Containing Whitening Ingredient SymWhite 377

On November 30, 2021, China NMPA announced that the addition of whitening ingredient SymWhite 377 in general cosmetics is illegal, and shall be investigated and dealt with by the provincial regulatory authorities. On March 14, 2022, Shanghai Songjiang District Administration for Market Regulation issued an administrative penalty decision. A company was fined 30,000 yuan because the claims of “SymWhite 377” and “whitening” appeared in the advertising of the company's general cosmetics. It claimed the efficacy that the product did not have, which constituted the act of publishing false advertising. This is the first public penalty case related to products containing SymWhite 377. The notification of the above products has been cancelled.

810 150@1x.pngChina NMPA to Set Up a Cosmetic Technical Specification Committee

On March 15, China NMPA issued a notice to select members of the Cosmetic Technical Specification Committee publicly. In order to implement Cosmetics Supervision and Administration Regulation and further improve the formulation and revision of cosmetic technical specifications, NMPA will establish a Cosmetic Technical Specification Committee, and the selection of the committee members are now open to the public. The selection scope includes cosmetic supervision departments, scientific research institutions, colleges and universities, cosmetic testing institutions, drug testing institutions, toothpaste testing institutions, and hospitals. The target candidates are technical experts who have professional backgrounds in cosmetic science, fine chemicals, analytical chemistry, microbiology, toxicology, medicine, pharmacy, public health, or biotechnology and have worked in the cosmetic or toothpaste industry.

Guangzhou Government Reminds Cosmetic Notifiers to Complete the Annual Report, Product Confirmation and Document Supplement

On March 16, Guangzhou Administration for Market Regulation issued an announcement reminding general cosmetic notifiers to complete the product confirmation and annual report before March 31, and supplement the notification documents (e.g., product classification code, executive standard, label samples, product formula) before May 1.

46 Cosmetic Inspection and Testing Institutions Were Suspended from Using Testing Information System

On March 18, China NMPA issued a notice on the disposal for the inspection and testing institutions for cosmetic registration and notification according to their capacity evaluation results. The capacity assessment results and disposal measures are as follows:

Capacity Evaluation Results

Disposal Measures

6 inspection and testing institutions did not participate in the capacity evaluation without special reasons

Suspend the use permission for the cosmetic registration and notification testing information system, and require them to take corrective and rectification measures.

40 inspection and testing institutions’capacity evaluation results failed to meet the requirements

Some of the capacity evaluation items of 12 inspection and testing institutions have doubtful results

Require them to conduct self-inspection, and take rectification and preventive measures.

The capacity evaluation's unqualified, unsatisfactory or doubtful items are related to "thermotolerant coliforms" and "cadmium." From this evaluation, it can be seen that NMPA is strengthening the supervision for inspection and testing institutions.

China NMPA Releases the 2021 National Cosmetics Supervision and Sampling Annual Report

On March 21, China NMPA released the 2021 National Cosmetics Supervision and Sampling Annual Report. In 2021, NMPA took risk-prone cosmetic types and places as the key sampling objects, and organized sampling testing for 11 cosmetic types including hair dyeing products, hair shampoos and conditioners, make-up products, sunscreens, products claimed to remove acne, facial masks, general skin care products claimed to moisturize & moisten, general skin care products claimed to tighten and anti-wrinkle, children cosmetic products, freckle-removing/whitening products and talcum powders, totaling 20,245 batches. 33 cosmetic inspection and testing institutions tested these products in accordance with Safety and Technical Standards for Cosmetics 2015, of which 19,847 batches of products met the standards, with a pass rate of 98.03%. Among the 11 types of cosmetics involved in the sampling test, the pass rate of 9 types, including talcum powder and freckle/whitening cosmetics, reached more than 98%.

China Customs Cracks Down on Cross-border Ecommerce Tax Evasion

On March 22, Yiwu Customs issued an administrative penalty decision. The reason for the penalty was the omission of the CBEC consumption tax. When the company imported cosmetics through CBEC, it declared the gross weight of the product as the first legal quantity to the customs. In this way, the unit price per gram of this cosmetics was lowered below the cosmetic consumption tax threshold, resulting in the omission of consumption tax. The company was fined 800,000 yuan. Customs departments across China are cracking down on the illegal act of evading tax by concealing the name, quantity, and amount of the imported goods.

A Company Legal Person in Guangdong was Banned from Engaging in Cosmetic Production and Operation Activities for 10 Years

On March 25, Guangdong MPA issued an administrative penalty decision. The reasons for the penalty were:

  • The company's products were found to contain salicylic acid, an ingredient neither marked on the label nor in the notification dossiers;

  • The pH value of the product did not meet the requirements in the executive standard (QB/T2660-2004);

  • In Xinjiang, there were reports of adverse reactions caused by the use of the product;

  • During the investigation of the case, the company's legal person provided false evidence and obstructed the investigation.

The company was fined 40,000 yuan, and the legal person was imposed a 10-year ban on cosmetic production and operation activities. This is the second case of a ban on the legal person to engage in the cosmetic industry after CSAR implementation.

China NMPA Starts Using the Special Seal for Cosmetics Inspection and Sampling

On March 24, 2022, China NMPA issued an announcement stating that from April 1, 2022, NMPA started using the “Special Seal of National Medical Products Administration for Cosmetic Inspection and Sampling."

Special Seal of National Medical Products Administration for Cosmetic Inspection and Sampling.pngSpecial Seal of National Medical Products Administration for Cosmetic Inspection and Sampling

China NMPA Consults on the Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices

On January 7, 2022, China NMPA issued the finalized Good Manufacturing Practices for Cosmeticsand will implement it on July 1, 2022. Cosmetics registrants, notifiers, and entrusted production enterprises shall organize the cosmetic production in accordance with the Practices. Following that, on March 30, 2022, NMPA released the draft of Inspection Points and Judgment Principles of Cosmetic Good Manufacturing Practices for public consultation. Regulatory authorities across China will use the Points as a basis to determine whether the enterprise complies with GMP. Any suggestions about the Points can be mailed to NMPA (hzpjgc@nmpa.gov.cn) before April 20, 2022. 

China NIFDC Consults on Safety and Technical Standards for Cosmetics 2022

On March 31, 2022, China NIFDC released a draft of the Safety and Technical Standard for Cosmetics 2022 (STSC 2022) for public consultation. The consultation will end on April 30, 2022. Stakeholders with any suggestions can fill out the feedback form and send it back by email at hzpbwh@nifdc.org.cn before that.

Compared with the 2015 version, the framework of the 2022 version remains basically unchanged. The draft STSC 2022 revises the content that is not suitable for the current supervision practice, retains the content that still applies, incorporates the previous approved revisions for STSC 2015 (they were issued as notifications), as well as standardizes and improves some terms and expressions.

Guangdong MPA Issues a Notice on Matters Related to General Cosmetics Annual Report

Notifiers shall submit the annual report of general cosmetics notified over one year through the new platform. The annual report's submission period lasts from January 1 to March 31 of each year. Recently, Guangdong MPA issued a notice stating that for general cosmetics failed to submit the annual report before March 31, 2022, the local municipal MPA will issue a rectification opinion and urge the notifier to submit the annual report before June 30, 2022. If the rectification is not completed as required within the time limit, the notification of the product will be forcibly cancelled.

A Beauty Collection Store was Fined and Confiscated 887,000 Yuan for Operating Cosmetic Samples with Non-compliant Labels

Recently, a well-known beauty collection store was fined and confiscated 887,000 yuan for selling cosmetic samples with non-compliant labels. The labels of these small samples lack the full ingredient list, production batch number, or notification number of imported cosmetics, which violates paragraph 1 of Article 35 of CSAR, “The minimum sales unit of cosmetics shall be labeled, which shall comply with relevant laws, administrative regulations and mandatory national standards, and the content therein shall be authentic, complete and correct.”

The fine is a huge amount in the industry. It can be seen that the cosmetics sample business has aroused the attention of the regulatory authorities, and the supervision for the sample sales will be gradually tightened.

化妆品合规BANNER 810 150  gif.gifChina Issues Eleven Group Standards in March

China issued eleven group standards in March. The basic information is as follows:

Type

Release Date

Initiator

Group Standard

Implementation Date / Deadline for Comments

To be effective

March 25, 2022

Zhejiang Provincial Brand Construction Association

T/ZZB 2632—2022 Cosmetic Grade White Oil

April 25, 2022

March 28, 2022

T/ZZB 2708—2022 Glass Bottles for Cosmetic Packaging

April 28, 2022

March 28, 2022

T/ZZB 2717—2022 Soothing and Moisturizing Lotion

April 28, 2022

Draft

March 23, 2022

Shanghai Daily Chemistry Trade Association

T/SHRH041-2022 Guidelines on Technical Definitions and Calculation of Natural Ingredients in Cosmetics

April 10, 2022

March 25, 2022

Guangdong Cosmetics Association

Test Method for Efficacy Measurement of Anti-dandruff Cosmetic Products

April 22, 2022

March 28, 2022

China Association of Fragrance Flavour and Cosmetic Industries

Linalool Compound Spice

April 27, 2022

Tetrahydrogeraniol Compound Spice

Ionone Compound Spice

Citral Compound Spice

Methyl Dihydrojasmonate Compound Spice

Citronella Compound Spice

Beijing, Guangzhou and Zhejiang Regulatory Authorities Publish Frequently Asked Questions Regarding General Cosmetics Notification

In March, Beijing Municipal and Zhejiang Medical Products Administration (MPA), and Guangzhou Administration for Market Regulation issued four batches of frequently asked questions, which pertain to the general cosmetics notification under China’s new cosmetic regulations.

Release Date

Regulatory Authority

Batch

March 14, 2022

Beijing Municipal Medical Products Administration

The 6th Batch

March 18, 2022

Guangzhou Administration for Market Regulation

The 21st Batch

March 25, 2022

The 22nd Batch

March 29, 2022

Zhejiang Medical Products Administration

The 1st Batch

South Korea

MOE discloses the Notice on Submitting the Delivery and Import Records of Recycled Package

On March 29, 2022, the Ministry of Environment (MOE) published the notice on submitting the delivery and import records of recycled packages and products. Enterprises whose products and packaging are subject to recycling shall submit the delivery and import records of 2021 via the EPR online system before April 15, 2022. The notice also specifies the key points for the online submission, including the required documents, exceptions, etc.

KCA issues the Guideline on Functional Cosmetic Business Transfer

On March 29, 2022, the Korea Cosmetic Association (KCA) released the Guideline on Functional Cosmetic Business Transfer. The Guideline mainly outlines the online application method for the business transfer, covering the legal ground, application submission steps via MFDS website, and documents uploading methods, etc.

Japan

PMDA: 143 Batches Cosmetics were Recalled in March

In March 2022, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced 143 batches of non-compliant cosmetics were recalled. The recalls were primarily associated with non-compliant labeling, including inconsistent ingredient labels and not labeled in Japanese.

Thailand

Thailand Updated Cosmetic Ingredient Lists

Thailand’s Ministry of Public Health announced revisions to the cosmetic ingredient lists in Cosmetic Act B.E. 2015 on February 28, 2022, which have been effective from March 1, 2022. The key revisions include:

  • Adding seven prohibited ingredients and two restricted ingredients;

  • Changing two prohibited ingredients and one restricted ingredient;

  • Deleting two restricted ingredients and three permitted preservatives.

Notably, these revisions further align the Thai regulations with the updated ASEAN Cosmetic Directive adopted by the past ASEAN Cosmetic Committee Meetings.

Indonesia

Indonesia Unveils New Halal Label Logo

On March 13, Indonesia Halal Product Guarantee Agency (BPJPH) announced a new halal label logo stipulated in BPJPH Number 40 of 2022 regarding the Determination of Halal Labels. The new halal logo has been applied nationally and must be shown on the product packaging as a sign of product halalness from March 1, 2022. Halal-certificated products in stock manufactured and packaged with the former halal logo before implementing the new logo are allowed to be sold first. After that, they shall immediately adjust the halal label on the products. Halal certification started voluntarily for cosmetic products on October 17, 2021 and will become mandatory since October 17, 2026.

Indonesia Releases Draft Amendments to Cosmetic Ingredient Use Requirements

On March 29, Indonesia BPOM released the draft amendments to Technical Requirements for Cosmetics Ingredients for public consultation. The main amendments include:

1) revising the general requirements for prohibited cosmetic ingredients;

2) revising the use requirements for other ingredients and natural ingredients;

3) adding 5 restricted ingredients and deleting 1 restricted ingredient;

4) adding 2 permitted sunscreens;

5) adding 230 prohibited ingredients.

The European Union

EU’s Ban on Zinc Pyrithione (ZPT) Officially Takes Effect

In November 2021, the EU added 23 CMR substances (substances classified as carcinogenic, mutagenic or toxic for reproduction) to the list of prohibited ingredients in Regulation (EC) No 1223/2009, including the anti-dandruff agent ZPT (CAS No. 13463-41-7). The amendment officially came into force on March 1, 2022. Cosmetics containing ZPT cannot be made available on the European Union market after this date.

EU SCCS Releases Final Opinion on Kojic Acid

After a commenting period of eight weeks, EU Scientific Committee on Consumer Safety (SCCS) released the final opinion on Kojic Acid (CAS No. 501-30-4) on March 17, 2022. According to SCCS, the use of Kojic Acid as a skin lightening agent with a maximum concentration of 0.7% in the final cosmetic product is safe for consumers.

EU SCCS Consults on Opinion as to Triclocarban and Triclosan

On March 25, 2022, EU SCCS provided preliminary advice on Triclocarban (CAS No. 101-20-2) and Triclosan (CAS No. 3380-34-5). Based on the safety assessment carried out, the SCCS offered scientific advice on the use of Triclocarban and Triclosan in different product types. The advice is open for comments until May 27, 2022.

European Commission Launches Public Consultation on EU Rules about Cosmetics

With an aim to align with the objectives of the EU's Chemical Strategy for Sustainability, on March 28, 2022, the Commission issued an announcement to seek feedback on the existing cosmetic provisions from all interested parties. The Commission will further improve the rules on cosmetics with reference to the results of this consultation and the previous consultation on the inception impact assessment published in October 2021. The consultation is open until June 20, 2022. 

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Brazil

Brazil Publishes the List of Permitted Colorants in Cosmetics, Sunscreen Regulations and Microbiological Requirements

On March 16, Brazil issued Resolution 628, 629 and 630, publishing the list of permitted colorants in cosmetics, regulations on sunscreens and regulations on microbiological requirements in cosmetics. The Resolutions came into force on April 1, 2022. The main contents are as follows:

Resolution

Main Contents

Resolution No. 628

Provides a list of permitted colorants in personal hygiene products, cosmetics and perfumes.

Resolution No. 629

  • Definitions for sunscreens and multifunctional products;

  • Determination method of sun protection factor (SPF):

  • Labeling requirements. On the main label of sunscreen products, the sun protection number must be prominently marked, preceded by the acronym   "FPS" or "Fator de Proteção Solar";

  • Main indicators of sunscreen, including sun protection factor, minimum critical wavelength, etc.;

  • Items that  sunscreens must not contain in claims and on the label.

Resolution No. 630

  • Cosmetic classification: children cosmetics, eye cosmetics, and cosmetics in contact with mucous membranes are type I; other products are type II;

  • Microbiological control parameters for product type I: the maximum total number of colonies is 5x102CFU/g or mL; shall not contain Pseudomonas aeruginosa, Staphylococcus aureus, total coliforms and fecal coliforms, and Clostridium sulfite reducing;

  • Microbiological control parameters for product type II: the maximum total number of colonies is 5x103CFU/g or mL; shall not contain Pseudomonas aeruginosa, Staphylococcus aureus, total coliforms and fecal coliforms, and Clostridium sulfite reducing.

Webinar Recommendation

1. All You Need to Know about Cosmetic Laws and Regulations in South Korea

South Korea has the most unique and wholesome cosmetic regulation scheme globally, which guides product safety and encourages product innovation. Fully understanding Korea's cosmetic regulation definitely can help enterprises in developing their products no matter whether you are targeting the Korean market or not. However, the complex regulations and the language barrier stop many overseas companies from learning the compliance requirements of Korea and entering the Korean market. ChemLinked will host webinars on April 21 (English Session) and April 22 (Chinese Session) to give you an overarching understanding of the cosmetic laws and regulations in South Korea, including the product standard, ingredient requirements, and the import procedure, etc. Welcome to register here.

korean-cosmetic-regulation-webinar.jpg

2. CSAR Series: Decoding China’s New Cosmetic Labeling Regulation

On June 3, 2021, China NMPA issued the finalized Administrative Measures on Cosmetics Labeling, spelling out the requirements for the labeling and prohibited claims of cosmetics (including cosmetics provided to consumers in the form of trial, gift, exchange, etc.) under China's new cosmetic regulations. The Measures will be implemented on May 1, 2022. Compared with the previous labeling regulations, the Measures has stricter requirements in terms of labeling definition, consistency with registration/notification documents, Chinese labels, product naming, guiding words, etc. Labels of many registered/notified cosmetic products need to be redesigned and updated. ChemLinked will host a webinar on April 26 to explain the required contents and noteworthy points in labeling imported cosmetics, analyze common non-compliance causes, and give insightful regulatory compliance recommendations to enterprises. Welcome to register here.

640-4261x-3.pngFurther Reading

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