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Monthly Recap: Global Cosmetic Regulatory Updates | January 2022

Chinese Mainland

China to Implement the Finalized Good Manufacturing Practices for Cosmetics in July 2022

In September 2020 and 2021, China National Medical Products Administration (NMPA) released the first and the second draft of Good Manufacturing Practices for Cosmetics (hereinafter referred to as Practices). After two rounds of public consultation, on January 7, 2022, NMPA released the finalized Practices and will implement it on July 1, 2022. The Practices finalizes the qualification requirements and duties of the person in charge of quality and safety, ensures the traceability of products from production to market, refines the requirements for sample retention, further clarifies the requirements for entrusted production, etc. [ChemLinked News]

China Lays down Practical Guidelines on Special Cosmetics Registration Certificate Renewal

On January 6, 2022, China National Institutes for Food and Drug Control (NIFDC) released the Review Points for the Acceptance of Special Cosmetic Registration Renewal Application (Trial) (hereinafter referred to as Review Points) to roll out the detailed action plan for the renewing of the special cosmetic registration certificate, which came into force upon its release. The Review Points specifies the application requirements and acceptance conditions for special cosmetic registration certificate renewal, and introduces specific policy pertaining to potential force majeure. [ChemLinked News]

China Approves One New Cosmetic Ingredient

On January 17, 2022, China NMPA publicized the notification information of one new cosmetic ingredient (NCI) from the overseas company Dow Chemical. Up to now, the notification information of seven NCI has been publicized. The basic information of the new NCI is as follows:

INCI NameCetyl Diglyceryl Tris (Trimethylsiloxy) Silylethyl Dimethicone
CAS Number1466529-58-7
Purpose of UseEmulsifying agent
Applicable ScopeAll kinds of cosmetics
The Maximum Concentration2%-8%
NotifierDow Chemical (Zhang Jiagang) Investment Co., Ltd.

[ChemLinked News]

China Issues Seven Group Standards in January

China issued seven group standards in January. The basic information is as follows:

Release DateInitiatorGroup StandardImplementation DateSource
January 4, 2022Guangdong Cosmetic AssociationCosmetics: Evaluation Method of Palliation Effect in Zebrafish Embryos (draft)/Reference Link
January 11, 2022Shandong Daily Chemical Industry AssociationCosmetic Ingredients: Paeonia Suffruticosa Seed OilFebruary11, 2022Reference Link
January 26, 2022Zhejiang Health Products & Cosmetics Industry AssociationEvaluation of Anti-Wrinkle Effect of Cosmetics: Detection Method for the Recovery Rate of Caudal Fin Shrinkage of Zebrafish LarvaeMarch 15, 2022Reference Link
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
January 28, 2022Guangdong Daily Chemical Chamber of CommerceMethod for Assessment of Cosmetics Anti-acne Efficacy (draft)/
Reference Link
Method for Assessment of Cosmetics Oil Control Efficacy (draft)

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Shanghai Municipal MPA Clarifies Matters Related to Cosmetics Production License

On December 31, 2021, Shanghai Municipal Medical Products Administration (MPA) issued a notice on matters related to the cosmetics production license. The key points are as follows:

  • Shanghai Municipal MPA will continue to implement the notification and commitment system for cosmetics production license renewal;

  • Starting from January 1, 2022, for the application for new, changing, renewing and canceling production licenses, Shanghai Municipal MPA will process and issue the applications according to the relevant provisions in Supervision and Administration Measures on Cosmetics Manufacture and Operation;

  • Since electronic cosmetics production license has been fully implemented in Shanghai, in principle, Shanghai Municipal MPA will not issue paper certificates. Where it is necessary, stakeholders should submit designated materials to apply for the paper version;

  • Starting from January 1, 2022, newly established enterprise that only engage in preparing cosmetic content cannot begin production until it grants the cosmetic production license.

[Reference Link]

China NMPA Further Clarifies Requirements for Toothpastes

As a response to the public concern for toothpastes, China NMPA issued replies to questions of this topic. In the replies, China NMPA reiterated that toothpastes, including children toothpastes, are not classified as cosmetics. Currently, they are just managed with reference to cosmetic regulations, and only non-compliant toothpastes shall be subject to punishment or taken off from the shelf. [Reference Link]

In addition, NMPA clarified that, with the completion of efficacy verification, toothpastes can claim efficacies such as preventing caries, inhibiting dental plaque, alleviating gum problems, etc. However, in their claims, toothpastes are not allowed to indicate medical effects implicitly or explicitly, or to deliver false or misleading contents. [Reference Link]

Tmall Details Management Specifications for Product Shelf Life

On January 21, 2022, Tmall released detailed management specifications for product shelf life. The key points include:

  • Merchants shall ensure that the products of the smallest sales unit are labeled with information related to production date or shelf life;

  • On the packaging of imported products, the shelf life information in Chinese shall be consistent with the original information;

  • If there are multiple products marked with shelf life information in the same package, the requirements are as follows:

    a. If the shelf life information of all products in the package is exactly the same, and the shelf life information can be clearly viewed through the outer package without unpacking, it is not mandatory to mark the shelf life information on the outer package. However, if it is marked, the information inside and outside shall be completely consistent;

    b. If the shelf life information of all products in the package varies, the shelf life indicated on the outer package shall be the one of the first expired product in the package;

  • If the product shelf life is expressed as a secret code, merchants shall introduce the corresponding interpretation rules to the warehouse when storing the products;

  • Merchants can only sell products whose remaining shelf life falls within the scope of the specifications. If merchants sell products that are close to the expiry date, the words “Close to Expiry Date” shall be marked in the title of the product, and the words “Expiring Product” shall be clearly displayed at the top of the product details page.

[Reference Link]

Guangdong and Beijing Regulatory Authorities Publish Frequently Asked Questions Regarding General Cosmetics Notification

In January 2022, Beijing Municipal 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 DateRegulatory AuthorityBatch
January 5, 2022Review Centre of Beijing Municipal MPAThe 5th Batch
January 11, 2022Guangzhou Administration for Market RegulationThe 18th Batch
January 28, 2022The 19th Batch
January 29, 2022The 20th Batch

China General Administration of Customs (GACC): 34 Batches of Cosmetics Rejected in December

On January 21, 2022, GACC gave an update on rejected food and cosmetics in December. A total of 34 batches of cosmetics imported from 2 countries (Germany and France) failed customs inspection. The reasons for rejections are failing to provide certificates or compliant certification documents and unqualified labels. [Reference Link]

China to lower Tariffs on Specified Korean Cosmetics

On January 13, 2022, the Tariff Commission of the State Council released an announcement on implementing Regional Comprehensive Economic Partnership (RCEP) on specified Korean cosmetics. Starting from February 1, 2022, the tariffs on facial cleanser, soap (except laundry soap), toothpaste, and mouthwash imported from South Korea will drop by 1-1.5%, and the tariff will be gradually cleared by 2031. [Reference Link]

Taiwan, China

Taiwan Consults on a Draft List of Prohibited Ingredients in Cosmetics

On January 4, 2022, Taiwan Food and Drug Administration (TFDA) released a new a draft of List of Prohibited Ingredients in Cosmetics, which adds four ingredients and deletes two ingredients. The list is scheduled to come into effect from July 1, 2022. From that date, it is prohibited to manufacture, import, sell, supply or display cosmetics containing the ingredients in the list. TFDA is now soliciting public comments on the new draft until March 7, 2022. [ChemLinked News]

The United States

New York’s Ban on 1,4-Dioxane in Cosmetics Takes Effect in January 2022

On December 9, 2019, New York adopted a law limiting the acceptable amount of 1,4-dioxane in cosmetics, personal care products, and household cleansing products sold or offered for sale in the state, which has entered into force on January 1, 2022. Under the law, cosmetics should be limited to 10 ppm of 1,4-dioxane in their products by December 31, 2022. Personal care products such as body soaps have stricter regulations, with the limits for 1,4-dioxane not exceeding 2 ppm by December 31, 2022, and 1 ppm by December 31, 2023. Manufacturers who violate the law will face penalties up to $1,000 for each day of violation and $2,500 each day for the violation of the second time. [Reference Link]

California’s Senate Bill 312 Ingredient List Takes Effect in January 2022

On January 1, 2022, California’s Senate Bill 312 (SB 312), also known as the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (hereinafter referred to as Act), officially took effect. It was signed into law on September 30, 2020, requiring the manufacturers who distribute cosmetics in the state to report to California Department of Public Health (CDPH) if their products contain fragrance or flavor ingredients listed in any of the 23 designated lists in the California Health and Safety Code Section 111792.6. CDPH has compiled a list of reportable ingredients cited in the Act based on the lists and reports available from the authoritative scientific bodies to assist companies with reporting. On June 30, 2021, CDPH updated the SB 312 Reportable Ingredient List, which now contains 3,096 chemicals. [Reference Link]

The European Union

EU SCCS Consults on Opinion as to Genistein

On January 13, 2022, EU Scientific Committee on Consumer Safety (SCCS) consulted on public opinion for comments on Genistein (CAS No 446-72-0, EC No 207-174-9). The deadline for comments is March 14, 2022. According to the safety assessment based on the available data, and in consideration of the potential endocrine disrupting properties of phytoestrogens, SCCS is of the opinion that the use of Genistein in cosmetic products up to a maximum concentration of 0.007% is safe. [ChemLinked News]

South Korea

South Korea Permits Online Education Course for Cosmetic Sellers

On January 14, 2022, the Ministry of Food and Drug Safety (MFDS) updated the Regulation on Designation and Education of Educational Institution of Cosmetics Laws and Ordinances. The regulation permits the responsible sellers of cosmetics and compounding managers of custom cosmetics to take the primary education online, which was required to take on-site previously. [Reference Link]

South Korea Consults on Cosmetics Precautions Regulation

On December 25, 2022, MFDS unveiled the draft of Regulation of Labelling Cosmetics Precautions for Use and Fragrance Allergens. The authority proposed to add vulva cleaning product under the body cleansing product category. Its precautions for use are drafted, too. In addition, the Attached Table “Precautions for Use” is re-organized. [ChemLinked News

South Korea to ban 1,2,4-THB in Cosmetics

On January 26, 2022, MFDS indicated that the authority is pushing ahead with the regulation of banning 1,2,4-trihydroxybenzene (1,2,4-THB) in hair dyes. The risk evaluation results are released. MFDS intended to finish the legislation by the first half of this year and set a grace period of six months. [Reference Link]

South Korea Issues Products Risk Assessment Act

The Act of Risk Assessment of Products for Human Body came into effect on January 28, 2022. This Act was rolled out on July 27, 2021, to comprehensively manage the risks of the products directly applied to human body. The competent authority introduced that in the past, they individually conducted the risk assessment on food, cosmetics, drugs, and sanitation supplies, etc., which resulted in potential danger of consumer exposure to health risk when using multiple products at once. Therefore, MFDS established the new risk assessment mechanism to control the safety of Fast Moving Consumer Goods (FMCG). It specifies the products subject to risk assessment and the risk assessment processures. [ChemLinked News]

Japan

PMDA: 18 Quasi-drugs Were Recalled in December

On December 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. The other 5 quasi-drugs were recalled for possible allergic reactions. [Reference link 1] [Reference link 2

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

On December 28, 2021, PMDA issued a notice stating the Methylrosanilinium Chloride shall not be used in quasi-drugs and cosmetics due to the possibility of genetic toxicity and carcinogenicity. This instructions came into force upon issuance. [Reference link]

PMDA: 201 Batches Quasi-drugs and Cosmetics Were Recalled in January

In January 2022, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced 201 batches of non-compliant quasi-drugs and cosmetics. Among them, 111 batches of quasi-drugs were recalled because they did not carry out the purity test and quantitative test specified in the approval certificate. 11 batches of quasi-drugs were recalled due to ingredient limits. The rest batches of quasi-drugs and cosmetics were recalled due to labeling issues. [Reference Link]

Indonesia

Indonesia Implements Technical Requirements for Cosmetic Good Manufacturing Practices Certification

On December 31, 2021, Indonesia released and implementedTechnical Requirements for Cosmetic Good Manufacturing Practices Certification (hereinafter referred to as Technical Requirements) Cosmetics manufacturers in Indonesia must comply with GMP Guidelines and prove the GMP compliance status with a GMP Certificate or a Fulfillment Certificate for GMP Aspects. The Technical Requirements clarifies the requirements and procedures for application, renewal and change of GMP Certificate and Fulfillment Certificate for GMP Aspects, as well as the validity period of the certificates. It also attaches the templates of application documents, GMP Certificate, and Fulfillment Certificate for GMP Aspects.

The GMP Certificate, Certificate of GMP Application, Fulfillment Certificate for GMP Aspects, and the approval letter for the use of cosmetics production facilities together with household health supplies that have been issued prior to December 31, 2021, are still valid until its expiry date. [Reference Link]

Indonesia Implements New Technical Requirements for Cosmetics Claims

On January 7, 2022, Indonesia released and implemented the finalized Technical Requirements for Cosmetics Claims, replacing the previous 2015 version. The regulation clarifies requirements for cosmetic claims and attaches two lists of prohibited and permitted claim examples. Claims that have been labeled or published prior to January 7, 2022, must comply with the finalized regulation before January 8, 2023. [ChemLinked News]

Australia

AICIS Publishes Guidance on the Withdrawal of Pre-Introduction Reports

On January 22, 2022, Australia AICIS issued a notice publishing a guidance on withdrawing pre-introduction reports (PIRs). PIRs are once-off mandatory reports only for introductions under the reported category in Australia and can be submitted online through AICIS Business Services. The guidance clarified the subject, time, and procedures for withdrawing PIRs. [Reference Link]

Further Reading

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