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Monthly Recap: Global Cosmetic Regulatory Updates | May 2022

Chinese Mainland

China's E-Commerce Giant JD.com Launches Quality Certification Label for Cosmetics

On April 29, 2022, China's leading e-commerce platform JD.com issued two new platform rules: the Quality Standards for Quality Certification of Lotion and Cream Cosmetics and the Quality Standards for Quality Certification of Essence Cosmetics. The two standards specify the terms and definitions, determination criterion, and quality certification rules for the quality certification of essence products as well as lotion and cream products, respectively. Both standards came into force on May 6, 2022.

CBEC Focus: Tmall Global Urges Merchants to Rectify Non-compliant Cosmetic Claims

According to Chinese beauty industry media, Ju Meili, Tmall Global held a training session for cosmetic merchants on the platform in April. The theme is to require merchants to check and rectify non-compliant efficacy claims of cosmetics. Specifically, for cosmetics sold on Tmall Global, the promotion and claims on the product page should:

  • comply with the Chinese Advertising Law and related regulations;

  • not contain prohibited claims for cosmetics;

  • be consistent with the information on the product packaging and leaflet. If any claims on the product page are beyond the information on the packaging and leaflet, the merchant must provide corresponding certification.

If the rectification is not completed within the time limit, Tmall Global will give the merchant two more chances. If the rectification still fails, Tmall Global will remove the product and delete the product link.

China's Provincial Medical Products Administration Clarifies Key Points for Cosmetic Labeling

On May 1, 2022, China implemented the finalized Administrative Measures on Cosmetics Labeling, which unifies the contents of the previously released labeling regulations and further standardizes the requirements for cosmetics labeling. On May 17, 2022, Hunan Provincial Medical Products Administration (MPA) issued an announcement, sorting out the main changes and key points for labeling the ten required items, including Chinese product name, registrant, notifier and Chinese domestic responsible person, production enterprise, executive standard, full ingredients, net content, durability, use method, necessary safety warnings, and other contents prescribed by laws, administrative regulations or mandatory national standards.

China NMPA Extends the Submission Deadline of Certain Cosmetic Documents due to COVID-19 Lockdown

Affected by the lockdowns and restrictions due to the COVID-19 resurgence in several areas, some cosmetic companies are unable to complete the submission of supplementary documents of registered and notified cosmetics as well as the summary of efficacy claim basis as required. In view of this, China NMPA issued a notice on April 27, 2022, approving Shanghai Municipal MPA's request to relax the requirements for cosmetic registration and notification documents and postpone the submission of certain documents.

After Shanghai was allowed to delay the document submission deadline by eight months, the MPA of Guangdong, Jiangsu, and Zhejiang provinces, as well as Beijing and Chongqing municipalities, which have also been affected by the pandemic, adopted similar postponement measures on April 29. So far, there are more than 10 MPAs have joined the rank.

China Customs Rejected Imported Cosmetics Containing Cannabis Sativa Seed Oil

From 2021 to April 2022, China Customs rejected a total of four batches of cosmetics containing cannabis sativa seed oil from entering China, and seized three bottles of cannabidiol (CBD) essential oil containing tetrahydrocannabinol. The suspects were arrested.

As the finalized Inventory of Prohibited Ingredients for Cosmetics and Inventory of Prohibited Plant (Animal) Ingredients for Cosmetics came into effect on May 28, 2021, cosmetic registrants and notifiers are not allowed to produce or import cannabis cosmetics through the general trade channel since the effective date. Besides, CBD oil is not on the positive list of import goods through cross border e-commerce (CBEC), so it is not allowed to enter China through CBEC as well.

China NMPA Approves Two New Cosmetic Ingredients

In late April and May, China NMPA updated the notification information of two new cosmetic ingredients (NCIs). The basic information of the new NCIs is as follows: 

INCI NameNicotinamide MononucleotideDendrobium Officinale Protocorm
CAS Number1094-61-7/
Purpose of UseAnti-wrinkle agent, skin protectant, antioxidantAnti-wrinkle agent, moisturizer
Applicable ScopeAll kinds of skin-applicable cosmeticsAll kinds of cosmetics
The Maximum Concentration< 3%≤ 4%
Notified DateApril 29, 2022May 18, 2022
NotifierShenzhen Winkey Pharmaceutical R&D Co., Ltd.Dalian Practical Biotechnology Co., Ltd.

China Issues 16 Group Standards in Late April and May

China issued 16 group standards in late April and May. The basic information is as follows:

Release   DateInitiatorGroup StandardImplementation Date / Deadline   for Comments
May 5, 2022Huangpu Cosmetics AssociationCosmetics: Determination of Acute Toxicity by Zebrafish Embryo Assay (Revised)May 5, 2022
Cosmetics: Determination of Relieving Allergy Efficacy by Zebrafish Embryo Assay (Revised)  
Cosmetics: Determination of Mild Irritation by Zebrafish Embryo Assay (Revised)
Cosmetics: Determination of Whitening Efficacy by Zebrafish Embryo Assay (Revised)
May 7, 2022Guangdong Chamber of Commerce of Daily ChemicalsTest Method for Efficacy of Skin Firming Cosmetic ProductsMay 7, 2022
Test Method for Efficacy of Skin Soothing Cosmetic Products
Testing Method for Hair Combability Efficacy
Method for Assessment of Cosmetics Anti-acne Efficacy
Method for Assessment of Cosmetics Oil Control Efficacy
April 30, 2022Zhejiang Health Products & Cosmetics Industry AssociationMethod for Assessment on the Anagen/Telogen RatioMay 31, 2022
May 17, 2022Method for Assessment of Cosmetics Anti-dandruff Efficacy (Draft)June 11, 2022
April 26, 2022Guangdong Cosmetics AssociationCosmetics: Determination of Antioxidant – Caenorhabditis Elegans (Draft)May 27, 2022
April 29, 2022Evaluation Method for Fragrance Retention for Hair Products (Draft) May 29, 2022
April 30, 2022Evaluation Method for Repairing Efficacy of CosmeticsMay 5, 2022
May 26, 2022Determination of Retinol, Retinyl Acetate Retinyl, Palmitatehydroxypinacolone Retinoate in Cosmetics by HPLC- and HPLC-MSMS (Draft)June 26, 2022
May 30, 2022Shanghai Daily Chemistry Trade AssociationGuidelines on Technical Definitions and Calculation of Natural Ingredients in CosmeticsJune 30, 2022

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COCIA Further Clarifies the Supervision of Children Toothpaste

On May 12, 2022, China Oral Care Industry Association (COCIA) issued a notice to clarify the supervision on children toothpaste. According to COCIA, toothpaste does not fall into the category of cosmetics, while it is regulated with reference to general cosmetics. The draft Administrative Measures on Toothpaste (Measures), which is currently under review by State Administration for Market Regulation, will detail the specific administrative provisions of toothpaste. In addition, the Measures as well as its supporting regulations will define the administrative provisions of children toothpaste. Before the implementation of the corresponding regulations, children toothpaste can be supervised in accordance with the current toothpaste regulations and continue to be sold as usual.

China NMPA Releases the 14th Five-Year Plan on Cosmetics

On May 11, 2022, NMPA issued the "14th Five-Year Plan for Network Security and Information Construction on Medical Product's Supervision" (the "Plan"), which put forward requirements for provincial MPAs on the supervision for medical products, cosmetics and medical devices. For cosmetics, the "Plan" requires provincial MPAs to further tighten the supervision on cosmetics, build a nationally integrated monitoring system for cosmetic's adverse reaction, and improve the archive management of cosmetics.

Person in Charge of Cosmetic Quality and Safety to Have New Requirement to Meet

On April 27, 2022, China NMPA stated in its reply to Jilin MPA and Chongqing MPA that, within their respective administrative regions, provincial MPAs shall strengthen the supervision and training for cosmetic registrant, notifier, as well as the person in charge of quality and safety (the person) of entrusted enterprises. As a response to NMPA's reply, Administration for Market Regulation of Zhengzhou City plans to assess the person's knowledge about his/her liabilities prescribed by relevant regulations before July 1, 2022. The assessment will be a closed-book exam with a passing score of 80%. The person who fails the assessment is allowed to take one makeup exam. If failing again, the cosmetic company is recommended to change the person.

China General Administration of Customs (GACC): 4 Batches of Cosmetics Rejected in April

On May 18, 2022, GACC updated the list of rejected food and cosmetics in April. Four batches of cosmetics respectively imported from Japan, Syria and South Korea failed customs inspection. The reason for rejection were lack of required qualified documentation, failing to pass sensory inspection, and the detection of cannabis sativa seed oil.

Taiwan, China

Taiwan Releases One Test Method for Cosmetics

On May 20, 2022, Taiwan Food and Drug Administration released a new test method for cosmetics, "Method of Test for Sunscreen Agents in Cosmetics". This test is applicable to test eight sunscreen agents in cosmetics, including Benzophenone-3, Diethylamino Hydroxybenzoyl Hexyl Benzoate, Octocrylene, Ethylhexyl Dimethyl PABA, Ethylhexyl Methoxycinnamate, Butyl Methoxydibenzoylmethane, Ethylhexyl Salicylate, and Homosalate.

The European Union

EU Finalizes the Updated Glossary of Common Ingredient Names

After a public consultation of 60 days, the EU released the updated "Glossary of Common Ingredient Names" on April 29, 2022. Compared to the glossary currently in force, the updated version corrected the existing ingredient names that were erroneously reported or omitted, and newly included 3,579 ingredient names. The updated glossary will officially take effect on April 29, 2023, while the stakeholders can start to use the ingredient names in it from the glossary's release date.

EU SCCS Consults on the Revised Opinion about Aluminium

On May 30, 2022, EU Scientific Committee on Consumer Safety (SCCS) released the preliminary revised opinion on the safety of Aluminium (Al) in cosmetic products. The opinion is open for comments until July 25, 2022.

In light of the data provided, SCCS considers that Al compounds are safe when used in sprayable antiperspirant products, provided that the percentage of particles with 10 μm diameter does not exceed 20% of the total aerosolized particles. For cases where Al compounds used in non-sprayable products, SCCS sets different concentration limits based on product types.

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South Korea

South Korea Packaging Requirement: Control on Rate of Packaging Space, Package Layers, and Re-packaging

Cosmetics, food, and other commodities shall comply with the requirements of the rate of packaging space, number of package layer, and re-packaging limits. Otherwise, enterprises of these products will face an administrative penalty ranging from 1 to 3 million won.

On May 31, 2022, ChemLinked elaborates the requirements for packaging space rate, packaging layer, and re-packaging for enterprises' reference. Get up to speed here.

South Korea Reminds of the Modification of Product Code for Entry Notice

On May 30, 2022, the Korea Pharmaceutical Traders Association (KPTA) released a notice to remind enterprises of the modification in the entry notice of imported products. As per the changing of cosmetic categorizing in the Enforcement Rule of Cosmetics Act, parts of the cosmetic category codes for entry notice are modified.

Japan

PMDA: 17 Batches of Cosmetics and Quasi-drugs Were Recalled in May

In May 2022, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced that 4 batches of quasi-drugs and 13 batches of non-compliant cosmetics were recalled. The quasi-drugs were recalled for using the inconsistent ingredients. The cosmetics were rejected because of the wrong labels of the origin, and the change of product property.

Thailand

Thailand Launches an Accelerated Approval System for Cosmetics

On May 19, 2022, the Thai FDA issued a notice to launch an accelerated approval system for cosmetics. Low-risk cosmetics such as facial cleansing, body care, hair care, shampoo, and fragrance products will be subject to auto-permission. The system will automatically evaluate the products' notification results immediately after the submission. For higher-risk cosmetics, such as alcohol-based hand sanitizers, SPF50+ sunscreen products, ampoules, etc., the authorities will manually assess the results within 3 working days.

Webinar Recommendation

Regulatory Compliance Strategy for Cosmetic Ingredients Entering China Market

China is the world's largest market and factory for cosmetic products, which makes China the most active country for cosmetic ingredients trading. 2021 witnessed several big changes in cosmetic-related regulations in China. In particular, the Measures for the Environmental Management Registration of New Chemical Substances (MEE Order No. 12) became effective from January 1, 2021, and on the same day the overarching cosmetics regulation, the Cosmetic Supervision and Administration Regulation (CSAR) entered into force. ChemLinked will host a webinar on June 16 to introduce the compliance strategies for cosmetic ingredients entering China under these two regulations, e.g., new chemical registration, new cosmetic ingredients (NCI) registration and notification, existing ingredient code application on the CFDA portal, etc. Welcome to register here.

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Efficacy Claim Evaluation Focus: New Cosmetic Compliance Requirements under China's CSAR

Before the CSAR was released in China, except for sunscreen efficacy and the waterproof efficacy of sunscreens, there is no mandatory requirement and limited testing methods for other efficacies of cosmetics. Under this background, consumers have no access to the supporting materials of cosmetic's claimed efficacy, while cosmetic enterprises lack methods to convince consumers. Responding to this situation, in CSAR, NMPA released a detailed plan to standardize and guide the evaluation of cosmetic efficacy claims. To help cosmetic stakeholders better understand this new compliance requirement, ChemLinked will hold a webinar on June 28 to detail key regulatory points focusing on efficacy claim evaluation, and also introduce the current industry status under the new requirement. Welcome to register here.

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How to Comply with the Cosmetic Regulations in the Middle East

The Middle East has long been a relative patchwork of chemical substance regulations, from some countries implementing significant restrictions and requirements on the management of such items to others that appear to employ little-to-no regulation. The landscape for cosmetic products is similarly fragmented, although several countries in the region have taken significant steps to implement regulatory controls on these types of products within their borders. To help stakeholders to have a much stronger understanding of how cosmetic products are regulated in the Middle Eastern market, ChemLinked will team up with m4 Global Consulting LLC to host a webinar on July 14 to detail all these knowledge. Welcome to register here

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Further Reading

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