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Regulatory Updates

Monthly Collection: China and International Cosmetic Regulatory Updates in March 2024
Publication date:2024-04-02

China Cosmetic Regulatory Updates

 

| New Cosmetics Ingredients

 

In March 2024, a total of 7 new cosmetic ingredients were filed with the China National Medical Products Administration (NMPA). They include:

Ingredient Name in CN & EN

Filing No.

Filer in CN

明胶交联聚合物

(Gelatin Crosslinked Polymer)

20240017

华诺生物

南方红豆杉籽油(TAXUSWALLICHIANAMAIREI Seed Oil)

20240018

贝泰妮生物

南方红豆杉嫩枝提取物(TAXUSWALLICHIANAMAIREI Twig Extract)

20240019

贝泰妮生物

补骨脂酚

(Bakuchiol)

20240020

粤微生物

刺云实胶(Caesalpinia Apinosa Gum)/AMPS铵交联聚合(Ammonium Crosslinked Polymer)

20240021

科莱恩

聚丙烯酸酯交联聚合物-11(Polyacrylate crosslinked polymer -11)

20240022

科莱恩

山梨醇聚醚-230 五硬脂酸酯(Polysorbate-230 Pentastearate)

20240023

苹果化学

The technical requirements for the 7 new cosmetic ingredients mentioned above have not been disclosed, and they have not yet entered the monitoring period.

 

| Regulations & Policies

 

On March 7, 2024, the Shanghai Administration for Market Regulation and the Shanghai Food and Drug Administration jointly issued the "Shanghai Cosmetics Industry Advertising Compliance Guidelines" (hereinafter referred to as the "Guidelines"). The "Guidelines" stipulate that the content of cosmetic advertisements should be truthful and legal. Cosmetic advertisements should not explicitly or implicitly imply the medical effects of the products, not contain false or misleading information, nor deceive or mislead consumers. Cosmetic advertisements should not promote effects that cosmetics don’t have, such as anti-hair loss products, with claims of regulating hormonal effects and hair growth, hair growth promotion, and similar terms. 

On March 20, 2024, the Guangzhou Administration for Market Regulation issued the 55th "FAQs on Registration of Ordinary Cosmetics" which provides explanations on questions related to whether there is an expiration period for the registration of ordinary cosmetics and whether deregistered products need to submit annual reports.

On March 21, 2024, the National Medical Products Administration (NMPA) released 15 inspection methods for toothpaste, including "Method for pH Value Inspection of Toothpaste", "Method for Mercury Inspection in Toothpaste", "Method for Lead Inspection in Toothpaste" etc. Starting December 1, 2024, toothpaste registration, filing, and sampling inspection should adopt the inspection methods published in this notice. Read the previous report here

On March 21, 2024, the National Medical Products Administration (NMPA) issued the "Notice on Incorporating 19 Revised Items including the General Rules for Pretreatment of Toxicological Test Methods Samples for Cosmetics into the Safety and Technical Standards for Cosmetics (2015 edition)". Read the previous report here.


On March 22, 2024, the Beijing Cosmetics Evaluation and Inspection Center released the 30th "FAQs on Common Issues in the Filing of Ordinary Cosmetics", providing explanations on matters to be noted when filing cosmetics that use new cosmetic ingredients still under safety monitoring period, and considerations when filling out ingredient purposes in formulations, among other related questions.

On March 27, 2024, the China National Institutes for Food and Drug Control (NIFDC) released the "Interpretation of Classification of Radiofrequency Treatment Devices and Radiofrequency Skin Treatment Devices", stating that radiofrequency beauty products intended for "wrinkle reduction (such as forehead lines, crow's feet, etc.), alleviating fine lines, wrinkle reduction around the eyes, improving sagging and drooping, lifting the cheekbones, facial contour lifting, tightening, firming the skin, lifting and shaping, and shrinking pores" should be classified and managed as Class III medical devices.

On March 29, 2024, the China National Institutes for Food and Drug Control (NIFDC) released two drafts for solicitation of comments on "Guidelines for Submission of Cosmetic Safety Assessment Data" and the "Technical Guidance Principles for Identification and Assessment of Cosmetic Risk Substances" to standardize and guide the preparation and submission of cosmetic safety assessment data. The deadline for public comments was set for April 8, 2024. Read the previous report here.

 

| Industry Environment

 

On March 18, 2024, the National Bureau of Statistics released the data for social consumer goods retail sales for January to February 2024. According to the data, the total retail sales of consumer goods reached 8.1307 trillion yuan from January to February, representing a year-on-year increase of 5.5%. Among them, the retail sales of cosmetics reached 678 billion yuan, with a year-on-year increase of 4.0%.

On March 27, 2024, the General Administration of Customs published the list of non-compliant imported cosmetics in February 2024. The list included 9 batches of cosmetics, such as Beraru, Dove, and Johnson's, that were not allowed entry. For instance, the "Beraru Moisturizing Spray" and "Beraru Moisturizing Cream" were not permitted due to non-compliant labeling. At the same time, the "Elizabeth Arden Prevage Anti-Aging Capsule Essence" was prohibited due to expiration. In addition, 6 batches of cosmetics such as Dove shampoo, Johnson's shower gel, and NATURA BISSÉ facial cream were not allowed for import due to failure to provide required certificates or qualification documents.

International Cosmetic Regulatory Updates

 

Europe

 

On March 5, 2024, the European Union Scientific Committee on Consumer Safety (SCCS) released its preliminary opinion (SCCS/1663/24) on the inhalation toxicity of the fragrance ingredient Acetylated Vetiver Oil (AVO) (CAS No 84082-84-8, EC No 282-031-1) in spray-type cosmetics. The deadline for public comments was set for May 3, 2024.

On March 11, 2024, the European Union Scientific Committee on Consumer Safety (SCCS) released its final opinion (SCCS/1658/23) on Hexyl Salicylate (CAS/EC No. 6259-76-3/228-408-6). SCCS, considering the potential endocrine-disrupting properties, confirmed the safe concentrations of Hexyl Salicylate for use in certain types of cosmetics. The specific cosmetic types and their corresponding safe concentrations are listed in the table below.

However, this opinion does not include an assessment of environmental safety. While SCCS acknowledged the lack of specific scenarios for exposure to children's dermal cosmetics and the differences in exposure factors among different age groups (such as weight, amount of product used, body surface area, etc.), it noted that the Margin of Safety (MoS) for products used by adults is far above 100. This implies that the MoS for children aged 3 to 10 would also exceed 100.

Table 1: Cosmetic Types and Corresponding Safe Concentrations of Hexyl Salicylate]

Product type, Body parts

Maximum concentration (% w/w)

Hydroalcoholic-based fragrances

2

All Rinse-off products

0.5

All Leave on products

0.3

Oral care (toothpaste and mouthwash)

0.001

On March 14, 2024, the European Union revised the list of prohibited substances (Appendix II) and restricted substances (Appendix III) for cosmetics in the EU Cosmetics Regulation (EC) No 1223/2009 by issuing Regulation (EU) 2024/858. Cosmetics with prohibited nanomaterials like "Styrene/Acrylates Copolymer (Nano)" and "Sodium Styrene/Acrylates Copolymer (Nano)" are banned from the EU market from February 1, 2024 and cannot be sold in the EU market from November 1, 2025. Additionally, cosmetics containing the restricted substance Hydroxyapatite (Nano) must comply with restrictions from February 1, 2025, and cannot be sold from November 1, 2025.

On March 8, 2024, the UK Scientific Advisory Group on Chemicals in Consumer Products (SAG-CS) released its final opinion on the use of Methyl Salicylate (CAS number: 119-36-8) in cosmetic products. The opinion sets specific concentration limits for different product types and age groups.

 

Asia

 

On March 1, 2024, the Indonesian Food and Drug Supervisory Agency (BPOM) released the 2024 Legislative Plan, including cosmetic notification, labeling requirements, ingredient requirements, adverse reaction monitoring, and restrictions on contaminants.

On March 4, 2024, the Drug Administration of Vietnam (DAV) issued Announcement No. 589/QLD-MP, amending regulations on cosmetic ingredient requirements. The main revisions include: (1) adding 14 substances including Tetrafluoroethylene to the list of prohibited ingredients in cosmetics; (2) revising the list of restricted substances for cosmetics and sunscreen agents, specifying newly approved substances and their usage requirements.

On March 21, 2024, the Ministry of Health and Welfare in Taiwan, amended the "List of Ingredients Prohibited in Cosmetic Products" by issuing a regulation titled "Requirements for the Submission of Documents for Review of Cases Applying Human Cell-Derived Exosomes for Use in Cosmetics". This regulation modifies the number 11 ingredient [cells, tissues, or products of human origin] to [Cells, tissues, or products of human origin. For cases approved through review, they are no longer subject to this restriction]. The regulation is effective immediately.

 

Sources: Official regulatory authorities in respective countries/regions.

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