Monthly Recap: Global Cosmetic Regulatory Updates | December 2023

China Implements Three Cosmetic Regulations

On December 1, 2023, the China State Administration for Market Regulation (SAMR) enacted Administrative Measures on Toothpaste (the Measures) and GB/T 42763-2023 Guideline for Safety Assessment of Oral Care and Cleansing Products. The Measures provides clear definitions, outlines stakeholder responsibilities, establishes management requirements for toothpaste products and new ingredients, maintains the existing toothpaste production licensing system, and sets forth the criteria for toothpaste safety assessment, efficacy claims, and labeling. The national standard, GB/T 42763-2023, offers guidance on the general principles, procedures, and conditions of the safety assessment on oral care products (toothpaste and mouthwash) and their ingredients.

On the same day, the China National Medical Products Administration (NMPA) implemented the Provisions for Management of Toothpaste Notification Dossiers, refining the responsibilities and obligations of toothpaste notifiers, the requirements for user-information-related dossiers, and the necessary documentation for initial toothpaste notification, etc.

China Details Principles for Determining and Researching New Cosmetic Ingredients (NCIs)

On December 1, 2023, the China National Institutes for Food and Drug Control (NIFDC) unveiled the second draft of the Technical Guidelines for Determination and Research of New Cosmetic Ingredients (NCIs) to establish standardized guiding principles for the identification and research of NCIs. It offers comprehensive information on NCI categorization, as well as the research content of and the naming requirements for NCIs.

China Introduces Operational Framework for Communication and Exchange of New Cosmetic Ingredients (Trial)

On December 1, 2023, China NIFDC issued the Working Mechanism for Communication and Exchange of New Cosmetic Ingredients (Trial). This initiative is designed to encourage and support the research and innovation of NCIs, as well as promote communication and exchange among registrants, notifiers, and cosmetic technical review departments involved with NCIs. Registrants and notifiers of NCIs are encouraged to seek communication on critical technical matters through NMPA's cosmetics registration and notification system before initiating the formal registration and notification process.

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

On December 19, 2023, GACC updated the list of rejected food and cosmetics in November. Three batches of cosmetics imported from France and South Korea failed customs inspection due to the lack of required qualified documentation, while one batch of cosmetics imported from Bulgaria were rejected due to non-compliant labeling.

Zhejiang Province to Implement New Regulation for Cosmetics Enterprises' Annual Self-Inspection Reports

On December 22, 2023, Zhejiang Medical Products Administration (MPA) rolled out the Regulation on the Implementation of Self-Inspection Reports System and Production Suspension and Resumption Reporting System for Cosmetics Registrants, Notifiers, and Entrusted Production Enterprises. The regulation, effective from February 1, 2024, offers detailed instructions to cosmetics enterprises in Zhejiang Province for fulfilling their obligations related to annual self-inspection report and production suspension and resumption reporting, as outlined in the Cosmetic Supervision and Administration Regulations (CSAR) and other relevant regulations.

China NMPA Approves 13 NCIs

In December 2023, NMPA updated the notification status of 13 NCIs. Since detailed technical information about these ingredients has not been disclosed, the provided names below are the English translations based on the Chinese names and may differ from the INCI names supplied by the companies.

1. Pyrroloquinoline quinone disodium (PQQ) salt (CAS No. 122628-50-6), notified on December 4, 2023

2. α-Dextran Hydroxypropyltrimonium Chloride, notified on December 7, 2023

3. Candida Bombicola/Glucose/Prinsepia Utilis Oil Ferment, notified on December 11, 2023

4. Candida Bombicola/Glucose/Coconut Oil/Prinsepia Utilis Oil Ferment, notified on December 11, 2023

5. Gynura Procumbens Leaf/Steam Extract, notified on December 14, 2023

6. Soudium Lauroyl Methyl Isethionate (CAS No. 928663-45-0), notified on December 14, 2023

7. Cellulose Olivate, notified on December 15, 2023

8. Sea Cucumber Peptide, notified on December 15, 2023

9. Polycitronelleth-11, notified on December 19, 2023

10. Lactobacillus Plantarum/Crithmum Maritimum Ferment Filtrate, notified on December 26, 2023

11. β-Nicotinamide Mononucleotide (CAS No. 1094-61-7), notified on December 14, 2023

12. Fucoxanthin, notified on December 27, 2023

13. Kluyveromyces Lactis/GANODERMA SINENSIS Ferment Filtrate, notified on December 28, 2023

Guangzhou and Jiangsu Authorities Publish FAQs Regarding Cosmetics Notification

In December 2023, Guangzhou Administration for Market Regulation (AMR) and Jiangsu MPA released three batches of FAQs. These FAQs address various aspects of general cosmetics notification, with a focus on requirements related to user registration dossiers, notification dossiers, pre-notification numbers, labeling for children's cosmetics, and more. 

China Issues 14 Cosmetics-related Standards in December

In December 2023, China issued 14 cosmetics-related standards. The essential information is as follows:

Taiwan Proposes Amendments to the List of Prohibited Ingredients in Cosmetics

On December 13, 2023, Taiwan Food and Drug Administration (TFDA) released a new draft of List of Prohibited Ingredients in Cosmetics for comments until February 15, 2024. Compared to the current list, the draft proposes newly including nine ingredients, and revising the use conditions of two existing ingredients.

PMDA: 88 Cosmetics and Quasi-drugs Products Recalled in December

In December 2023, Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued a total of 88 batches of non-compliant cosmetics and quasi-drugs. Among them, 59 batches were cosmetics, and 29 batches were quasi-drugs. The main non-compliance factor was "incorrect or missing labeling" on the products, accounting for 94% of the recalled products.

Japan Proposes to Revise Japanese Standards of Quasi-drug Ingredients (JSQI 2021)

On December 4, 2023, Japan Ministry of Health, Labor and Welfare (MHLW) unveiled a public consultation notice, to seek public input and suggestions on a more efficient and labor-saving approval process for manufacturing and selling quasi-drugs through modifications to Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021). To be more specific, MHLW plans to include more new ingredients and revise various specification requirements in JSQI 2021.

South Korea Updates the Guideline for Cosmetics Risk Assessment

On December 1, 2023, MFDS revised the Guideline for Cosmetics Risk Assessment to scientifically assess cosmetic ingredients. The amendments mainly include: (1) Adding the evaluation subjects, methods, and examples for inhalation exposure evaluation; (2) Clearly stating the method for selecting toxicity reference values and determining the considerations for genetic toxicity assessment; and (3) Updating the method for collecting toxicity data.

South Korea to Ban THB in Cosmetics

On December 7, 2023, MFDS proposed the amendments to the Regulation on Safety Standards, etc. for Cosmetics, in order to designate 1,2,4-trihydroxy benzene (THB) as a prohibited ingredient in cosmetics.

Philippines Drafts Procedural Guidelines on LTO Applications

On November 30, 2023, the Philippines Food and Drug Administration (FDA) published the draft guidelines for cosmetic companies applying for the License to Operate (LTO) through the FDA’s eServices portal. These draft guidelines details dossier requirements for different types of LTO applications, and outlines corresponding application procedures.

Philippines Consults on Cosmetics Recall Guidelines

On December 22, 2023, the Philippines FDA released a draft of Guidelines on the Recall of Health Products Regulated by the Food and Drug Administration (the Guidelines), aiming at developing an updated framework for health product recalls. Comprising 11 sections, the Guidelines details precise procedures for product recalls, and specifies the responsibilities of the marketing authorization holder (MAH) in this process.

Indonesia Amends Cosmetic Ingredient Use Requirements

On August 24, 2023, Indonesia’s Food and Drug Supervisory Agency (BPOM) proposed draft amendments to the Appendices in the Technical Requirements for Cosmetic Ingredients. Three months later, on December 7, the finalized amendments were released and implemented. The main amendments include:

1. Appendix I: List of Restricted Ingredients – 1 added and 7 revised

2. Appendix II: List of Permitted Colorants – 1 revised

3. Appendix III: List of Permitted Preservatives – 2 revised

4. Appendix IV: List of Permitted Sunscreens – 2 revised

Indonesia Punishes Non-compliant Cosmetics

On December 12, 2023, BPOM announced the discovery of 181 cosmetic items containing prohibited/hazardous ingredients during inspections from September 2022 to October 2023. These items amounted to 1.2 million pieces valued at 42 billion Indonesian Rupiah.

Malaysia to Strengthen Supervision of Manufacturers that Do not Meet GMP Requirements

Since 2014, an increasing number of manufacturers have been found non-compliant during GMP inspections. Some manufacturers even have repeatedly failed to comply with the regulations. To ensure the safety and quality of cosmetic products, the National Pharmaceutical Regulatory Agency (NPRA) has reviewed its regulatory actions and will enforce stricter measures for non-compliant manufacturers. NPRA determines the appropriate regulatory actions based on the records of the previous five GMP inspections. The implementation and effective date for the regulatory actions is July 1, 2024.

Vietnam Plans for Substantial Revision of Cosmetics Overarching Regulation

On December 13, 2023, the Vietnam Ministry of Health (MoH) announced the proposed development of a new Decree on cosmetics management. It has already submitted relevant documents to the Government, requesting consideration, comments, and approval for the proposal.

The proposed revisions in the new Decree primarily target three key areas: cosmetic notification, post-market surveillance, and quality enhancement for Vietnam’s domestically produced cosmetics. These revisions encompass changes to the required notification documents, notification validity period, notification processing time, labeling information, the abolition of advertising registration, and other regulations closely relevant to enterprises. 

Vietnam Plans to Optimize the Imported Cosmetics Notification System

The Drug Administration of Vietnam (DAV) has written multiple letters to the National Health Information Center of Vietnam, proposing to improve the notification system for imported cosmetics and establish a comprehensive information system for traceability. After DAV proposed improvements, the system still experience frequent malfunctions, rendering it nearly unusable and preventing DAV from operating it. DAV has also received feedback from notifiers regarding system errors, such as the inability to upload documents, which has impacted their product launch plans.

To ensure the stable operation of the system and minimize disruptions to businesses, DAV recently sent another letter on December 28, 2023, requesting the National Health Information Center to coordinate with the General Administration of Customs and other relevant units to review and optimize the imported cosmetics notification system and resolve technical issues, to facilitate the cosmetics notification application process for enterprises.

Thailand Revises Notification Review Standard for Ampoule, Vial, and Syringe Cosmetics

On December 1, 2023, the Thai Food and Drug Administration (Thai FDA) released a revised version of the Criteria for Reviewing the Notification of Ampoule, Vial, and Syringe Cosmetics. This updated standard primarily adjusts the notification documentation requirements for these cosmetics.

Australia Adds Four Cosmetic Ingredients to the Australian Inventory of Industrial Chemicals (AIIC)

On September 19, 2023, the Australian Government added the following four cosmetic chemicals to the AIIC under Section 83 of the Industrial Chemicals Act 2019. These components, when combined at specified concentrations, have been assessed as fragrance ingredients for use in various cosmetics and household products. 

• 2-Pentanol, 1-[[(2S,5R)-4,4,8-trimethyltricyclo[6.3.1.02,5]dodec-1-yl]oxy]-, (2R)- (CAS No. 2411391-25-6)

• 2-Pentanol, 1-[[(2S,5R)-4,4,8-trimethyltricyclo[6.3.1.02,5]dodec-1-yl]oxy]-, (2S)- (CAS No. 2411391-27-8)

• 2-Pentanol, 1-[[(2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-yl]oxy]-, (2R)- (CAS No. 2952782-14-6)

• 2-Pentanol, 1-[[(2S,5R)-1,4,4-trimethyltricyclo[6.3.1.02,5]dodec-8-yl]oxy]-, (2S)- (CAS No. 2952782-15-7)

Australia Modifies Information Requirements for Three Cosmetic Ingredients Listed on AIIC

On December 15 and 18, 2023, the Australian Government published three notices, updating the requirements for the terms of Inventory listing of three existing cosmetic ingredients on the AIIC, as per Section 93 of the Industrial Chemicals Act 2019. These ingredients are:

• 6,10-Dodecadien-1-ol, 3,7,11-trimethyl-, (3S,6E)- (CAS No. 27745-36-4)

• 6,10-Dodecadienal, 3,7,11-trimethyl-, (3S,6E)- (CAS No. 194934-66-2)

• Santalum austrocaledonicum, ext. (CAS No. 91845-48-6)

EU SCCS to Refine the Opinion on Aluminium

On December 15, 2023, EU Scientific Committee on Consumer Safety (SCCS) released a new opinion on the safety of Aluminium (Al). In comparison to the previous opinion issued in February 2023, SCCS updates the concentration limits for Al compounds in cosmetics based on additional information received.

EU SCCS Releases the Preliminary Opinion on Benzophenone-4

On December 15, 2023, SCCS issued a preliminary opinion on the use of Benzophenone-4 (CAS No. 4065-45-6) in cosmetics. In light of assessment results, SCCS concludes that Benzophenone-4 is safe when used as a UV filter up to a concentration of 5% in sunscreen, face and hand creams, lipstick, as well as sunscreen propellant spray and pump spray, either used separately or in combination.

EU SCCS Finalizes Opinions on Two Cosmetic Ingredients

In December, SCCS issued the final opinions respectively on Silver Zinc Zeolite (CAS No. 130328-20-0) and Methylparaben (CAS No. 99-76-3). The final opinion on Silver Zinc Zeolite upholds all preliminary conclusions, while the final opinion on Methylparaben only retains the safe-use concentration for its individual use in cosmetics.

France to Change the Competent Authority for Cosmetics

On October 27, 2023, France notified WTO of a draft Ordinance on the change of cosmetic competent authority. The proposed Ordinance aims to shift the responsibilities over cosmetics and tattooing products from the French National Agency for Medicines and Health Products Safety (ANSM) to the National Agency for Food, Environmental and Occupational Health and Safety (ANSES) and the French Directorate General for Consumer Affairs, Competition and Fraud Prevention (DGCCRF). After the transition, ANSES will handle regulatory and enforcement responsibilities, while DGCCRF will be in charge of GMP review.

U.S. FDA Updates Instructions for Filing out Serious Adverse Event Reports for Cosmetics

On December 14, 2023, the U.S. Food and Drug Administration (FDA) issued updated instructions for MedWatch Form 3500A, providing comprehensive guidance on filling out the MedWatch Form 3500A, thereby streamlining the process of reporting serious adverse events of cosmetic products.

U.S. FDA Releases the Final Guidance on Cosmetic Facility Registration and Product Listing for MoCRA 

on December 18, 2023, the U.S. FDA officially released the finalized Guidance on Registration and Listing of Cosmetic Product Facilities and Products. The Guidance covers term explanations, responsible entities for application submission, necessary dossiers, submission methods, submission deadlines, etc.

U.S. FDA Launches Cosmetic Direct Electronic Portal for MoCRA

On December 18, 2023, the U.S. FDA officially announced the launch of the electronic submission portal, Cosmetic Direct, for cosmetic facility registration and product listing, accompanied by the release of a comprehensive User’s Guide.

New York State’s Minimum Limits for 1, 4-Dioxane Takes effect

As of December 31, 2023, New York State's minimum limit of 1 ppm for 1,4-dioxane in commercially available personal care products, including facial or body cleansing products, officially took effect. Eligible manufacturers can apply for a 1-year exemption from compliance up to two times.