December 2022: Global Cosmetic Regulatory Updates

Jan. 04th, 2023
1017

This is a collection of global cosmetic regulatory updates, including cosmetic regulations in Chinathe EU etc.

🇨🇳China


China NMPA Approves Three New Cosmetic Ingredients

In December, China NMPA updated the notification information of three new cosmetic ingredients (NCIs). The basic information about these new NCIs is as follows:

1) Donkey milk powder, notified on December 8, 2022

2) Swiftlet nest peptide, notified on December 8, 2022

3) Nicotinoyl Tetrapeptide-30, notified on December 29, 2022 (Read more)

China Issues 12 Cosmetics-related Standards in December

In December, China issued 12 cosmetics-related standards. The basic information is as follows:

Release Date Initiator Standard Name  Effective Date
December 2, 2022 China Anti-aging Promoting Association Efficacy Assessment for Skin Microecology/microbiome-modulating Cosmetics (Draft) /
December 7, 2022 Zhejiang Health Products & Cosmetics Industry Association Cosmetics: General Standards of Plant Juices “Water-free” Formula Skin Care (Draft) /
December 7, 2022 Guangdong Cosmetics Association In Vitro Evaluation Methods for Mild Efficacy of Rinse-off Cosmetics (Draft) /
December 7, 2022 Evaluation Method for Hair Nourishing Efficacy of Hair Products (Draft) /
December 7, 2022 Method for Evaluating the Efficacy of Hair Products Against Hair Breakage (Draft) /
December 22, 2022 Cosmetics: Determination of Antioxidant-Cellular Methods January 22, 2023
December 23, 2022 Determination of Retinol, Retinyl Acetate, Retinyl Palmitate, Hydroxypinacolone Retinoate in Cosmetics by HPLC and HPLC-MS/MS January 22, 2023
December 9, 2022 Shanghai Daily Chemistry Trade Association Cosmetics Moisturizing Efficacy Assessment Based on Consumer Use December 30, 2022
December 15, 2022 Determination of All-trans-retinol and Its Derivatives in Cosmetics and Raw Materials by High-Performance Liquid Chromatography December 30, 2022
December 16, 2022 Testing Method for Repairing and Relieving Efficacies of Cosmetics Based on UV-Induced Skin Erythema Model December 30, 2022
December 20, 2022 The Federation of Consumer Products Trade Center of All China Cities Technical Specification for the Production of Sunscreens for Adults January 3, 2023
December 26, 2022 Guangzhou Huangpu Cosmetic Industry Association Cosmetics: Technical Requirements of Zebrafish Research Laboratory January 1, 2023

China Clarifies Specific Practices of Cosmetic Adverse Reaction Monitoring and Reporting

On November 25, 2022, the Center for Drug Reevaluation and the National Center for ADR Monitoring of China jointly released the draft of Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial) for public comments. The draft is to guide registrants and notifiers to carry out the collection and reporting of cosmetic adverse reactions, covering collection, recording, transmission, verification, report confirmation, analysis and evaluation, submission, quality control, and record management. (Read more)

China Further Refines the Requirements for Enterprises to Perform the Entity Responsibility for Cosmetic Quality and Safety

On November 29, 2022, China National Medical Products Administration (NMPA) launched a public consultation on the draft of Regulations on Supervision and Administration of Enterprises in Implementing Entity Responsibility for Cosmetic Quality and Safety (the Regulations). Consisting of 5 chapters and 33 articles, the draft Regulations specifies the responsible entities of cosmetic’s quality and safety, emphasize the responsibilities of key positions related to cosmetic quality and safety, as well as clarify the personnel subject to penalties when specific misconduct happens, and the situations where penalties can be mitigated or exempted.

On December 29, NMPA released the finalized version of the Regulations, which will take effect from March 1, 2023. (Read more)

China Consults on An Enforcement Guidance on the Use of Absolute Terms in Advertising

On December 7, 2022, China’s State Administration for Market Regulation (SAMR) released Enforcement Guidance on Absolute Terms in Advertising (Guidance) for public consultation. According to the Guidance, if the absolute terms do not implicate the commodity, or the absolute terms that implicate the commodity do not have the objective effect of misleading consumers or disparaging other operators, their use in advertising can be allowed. Besides, market supervision authorities shall, after considering political, social, and legal effects, impose punishments equal to the fault, be fair and adhere to the principle of comprehensive discretion (based on the fact, consequence, etc.). (Read more)

China NMPA Allows Self-Updating of the Notified Ingredient Safety Information by Cosmetic Notifiers

On December 8, 2022, China Cosmetics Notification System announced that a new function of “Ingredient Safety Information Self-updating” had been added to the general cosmetics notification information system. The new function allows companies that meet specified conditions to update and maintain their notified ingredient’s safety information on their own, such as ingredient manufacturers and ingredient submission codes. (Read more)

China General Administration of Customs (GACC): Four Batches of Cosmetics Rejected in November

On December 18, 2022, GACC updated the list of rejected food and cosmetics in November. Four batches of cosmetics respectively imported from Thailand and China’s Taiwan failed customs inspection. For all four batches, the reason for rejection was a lack of required qualified documentation.

China NMPA Issues Two Cosmetics Supplementary Testing Methods

On December 23, 2022, China NMPA released a new supplementary testing method, BJH 202204 Determination of Five Components Including Tetrahydrozoline in Cosmetics, applying to five imidazoline drugs including Tetrahydrozoline, Naphazoline, Oxymetazoline, Antazoline and Xylometazoline. These ingredients are mainly used in the medical field but are not allowed to be used in cosmetics.

On December 26, NMPA released another supplementary testing method, BJH 202205 Determination of Dehydroandrographolide Succinate in Cosmetics, specifying the qualitative and quantitative determination method of Dehydroandrographolide Succinate in cream, lotion, liquid (water), and gel-based cosmetics. With the release of these two methods, China has approved seven cosmetic supplementary testing methods in total.

Four Provincial and Municipal MPAs Cancel the Notification of Non-Compliant General Cosmetics

In December, Henan MPA, Shanghai Municipal MPA, Guizhou MPA and Hunan MPA successively announced to cancel the notification of nearly 16,000 batches of general cosmetics. These cancelled cosmetics are either notified with non-conforming documents or lacking the required annual report. According to CSAR, if cosmetics are still on the market after being cancelled by the regulatory authorities, depending on the severity of the violations, the relevant responsible persons will be subject to fines, administrative penalties or even criminal penalties.

Taiwan Region Releases One Test Method for Cosmetics

On December 30, 2022, Taiwan Food and Drug Administration (FDA) released a new test method, Method of Test for Sunscreen Agents in Cosmetics (3), stipulating the test method for 4 sunscreen agents in cosmetics, including benzophenone-4, benzylidene camphor sulfonic acid, camphor benzalkonium methosulfate and phenyl benzimidazole sulfonic acid.

🇪🇺European Union


EU SCCS Consults on Opinion as to Salicylic Acid

On December 15, 2022, EU Scientific Committee on Consumer Safety (SCCS) released the preliminary opinion on Salicylic Acid (CAS No. 69-72-7). Compared to the restrictions laid in  Regulation (EC) No 1223/2009, SCCS’s opinion allows the use of Salicylic Acid in oral products and alerts its use in the combination with oral and dermal products. The opinion is open for comment until February 17, 2023. (Read more)

[Read more global regulatory updates at ChemLinked]

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