Monthly Recap: Global Cosmetic Regulatory Updates | August 2023

China

China NIFDC to Formulate Toothpaste Efficacy Evaluation Standards

On August 8, 2023, China National Institutes for Food and Drug Control (NIFDC) issued an announcement to seek project undertaking units to formulate five toothpaste efficacy evaluation standards.

NIFDC Calls for Project Undertaking Units to Revise Safety and Technical Standards for Cosmetics

On August 18, 2023, NIFDC initiated a ten-day public call for project undertaking units to revise Safety and Technical Standards for Cosmetics (STSC). This revision aims to expand the application scope of the existing cosmetics testing methods to include toothpaste, as well as to develop new toxicological, physical and chemical testing methods specifically for toothpastes. 

China General Administration of Customs (GACC): One Batch of Cosmetics Rejected in July

On August 19, 2023, GACC updated the list of rejected food and cosmetics in July. One batch of cosmetics imported from Singapore failed customs inspection due to the lack of required qualified documentation.

Fujian MPA Outlines the Responsibilities for Cosmetics E-commerce Platform Operators and Merchants on the Platforms

On August 21, 2023, Fujian Medical Products Administration (MPA) released two separate lists, specifying the responsibilities of cosmetics e-commerce platform operators, and merchants on the platforms, especially in areas such as product labels, purchase inspections, and advertising. These lists were developed in accordance with Supervision and Administration Measures on Online Operation of Cosmetics that came into effect on September 1, 2023. 

Douyin Requires Merchants to Implement Stricter Monitoring of Cosmetic Quality and Safety

On August 24, 2023, Douyin announced to revise its platform rules on cosmetic quality and safety. As per the revision, cosmetic merchants on the platform are obligated to closely monitor the publicly available regulatory information regarding the quality and safety of cosmetics they operate. If specific batches of cosmetics are found to be non-compliant during the sampling testing conducted by medical products administration departments, merchants should cease the operations immediately.

China Revises the Safety and Technical Standards for Cosmetics 2015

On August 28, 2023, China National Medical Products Administration (NMPA) announced significant amendments to STSC. The key amendments include the addition of a new prohibited ingredient, the clarification of benzene limit in cosmetics, the revision of 5 testing methods, and the introduction of 14 additional testing methods. While the revised methods are scheduled to come into force on March 1, 2024, all other new contents will take immediate effect upon release. 

China NMPA Approves Two New Cosmetic Ingredients

In August, NMPA updated the notification status of two new cosmetic ingredients (NCIs), namely Pyrroloquinoline quinone disodium salt (CAS No. 122628-50-6), and Nicotinamide Mononucleotide (CAS No. 1094-61-7). With these latest notifications, a total of 31 NCIs have been notified year to date.

Two Provincial MPAs Cancel the Notification of 2,100 batches of Non-compliant General Cosmetics

In August, both Shandong MPA and Fujian MPA announced to cancel the notification of over 2,100 batches of general cosmetics. The reason is their notifiers' failure to submit the required annual report by March 31, 2023, and to complete the correction within the specified time limit. As a result of the cancellation, these cosmetics shall not be sold or imported from the date of cancellation. 

Huzhou and Guangzhou AMRs Publish FAQs Regarding Cosmetics Notification

In August, Huzhou Administration for Market Regulation (AMR) and Guangzhou AMR released three batches of FAQs. They cover various topics related to general cosmetics notification, including the requirements for notification dossiers, product executive standard, the filling and submission of ingredient's safety information, the labelling of children cosmetics, etc. 

China Issues Seven Cosmetics-related Standards in August

South Korea

South Korea Functional Cosmetic Evaluation Situation

The Ministry of Food and Drug Safety (MFDS) released the Statistics on Functional Cosmetics Evaluation in the First Half of 2023, aiming to provide insights into Korean functional cosmetics development trends for research and development.

Reminder! South Korea Officially Bans Five Genotoxic Substances in Cosmetic

O-Aminophenol and other four hair dye substances are prohibited in cosmetics after August 22, 2023 for they are genotoxic.

South Korea Consults on Cosmetic Colorant Requirement

On August 24, 2023, MFDS published an exposure draft of Types, Standards, and Testing Methods for Cosmetic Colorants for public opinion. The authority mainly proposes deleting the specified testing methods in the regulation, to allow companies to autonomously establish the testing methods for their product characteristics. The consultation period is set to end on September 13, 2023.

Updated | Innovation in Korean Cosmetics: From Refilling to AI Robot

Korean beauty industry is introducing cosmetics in easy-to-use stick products such as sunblock sticks, which have gained popularity as a hot item during the summer for their portability and convenience. Besides, as most sick-formed cosmetics are made as per solid formulations, sunblock sticks contain less water than regular cream and serum formulations, making it easier to control microorganisms' contamination.

Japan

PMDA: 74 Batches Cosmetics and Quasi-drugs Recalled in August

In August 2023, Japan Pharmaceuticals and Medical Devices Agency (PMDA) announced the recall of 74 batches of cosmetics and quasi-drugs. Among them, over 30 batches of cosmetics were recalled due to incorrect labeling information, making it the most common non-compliance reason. The second most common recall reason was the use of non-compliant ingredients. In addition to these, there were some other reasons such as incorrect product packaging and non-compliant packaging standards.

PMDA Updates the Foreign Manufacturer Accreditation List

On August 16, 2023, PMDA updated the Foreign Manufacturer Accreditation List, which involves five manufacturers from three countries. 

Malaysia

Department of Islamic Development Malaysia (JAKIM) Holds Pre-Launch Ceremony of Halal Certification System (MyHMS)

On August 30, 2023, the Department of Islamic Development Malaysia (JAKIM) organized a Pre-Launch Ceremony for the Malaysia Halal Management System (MyHMS). The event aims to introduce and promote the products and services available for the Malaysian halal certification industry. MyHMS is an integrated system developed to streamline and facilitate the halal certification process. The ceremony included speeches, a soft launch presentation, and a Q&A session, with Minister of Religious Affairs and industry representatives attended.

Vietnam

Vietnam Plans to Optimize the Online System for Issuing Cosmetic Import Permits

On August 10, 2023, the Drug Administration of Vietnam (DAV) addressed a letter to the National Health Information Center concerning the online system for issuing cosmetic import permits. The system has encountered technical difficulties, resulting in disruptions and delays in import application processing. On the basis of acknowledging these issues, DAV proposes collaboration with the National Health Information Center and the General Department of Customs to resolve the problems, thus to ensure seamless operations for businesses.

Thailand

Thailand Introduces New Regulations for Refilled Cosmetics

On August 23, 2023, the Thai Food and Drug Administration (Thai FDA) approved the refilling of cosmetics through two notifications: the Notification of the Ministry of Public Health Re: Characteristics of Cosmetics, Criteria, Methods and Conditions for Repacking Cosmetics for Sale at Service Points (Refill Stations) and the Notification of the Cosmetics Committee on the Labeling of Cosmetics Repackaged for Sale at Service Points (Refill Stations). These regulations will take effect 90 days after their publication in the Government Gazette, providing comprehensive guidance on the repackaging of certain types of cosmetics at refill stations and the labeling requirements for refilled cosmetic products.

Indonesia

Indonesia Plans to Restrict Online Sales of Imported Goods Priced Below $100

On July 28, 2023, Indonesian Trade Minister Zulkifli Hasan told reporters in Jakarta that Indonesia would impose restrictions on the online sale of imported goods priced below US$100. This measure is expected to have a direct impact on companies planning to enter the Indonesian online market through cross-border e-commerce (CBEC). On the other side, it presents an opportunity for local Indonesian companies to gain larger market share.

Indonesia Amends Required Documents for Product Information File (PIF)

On August 2, 2023, BPOM finalized and implemented the Guidelines for Product Information File (PIF). The updated Guidelines clarifies the standards for documents included in PIF, and amends the required documents in PIF. For products that received the notification number before August 2, 2023, the notification number owner must update the PIF within six months.

Indonesia Proposes to Revise Requirements for Cosmetic Online Sales

On August 21, 2023, Indonesia introduced a draft, amending Regulation Concerning the Control of Drug and Food Online Distribution. This regulation primarily focuses on regulating the requirements for online sales of drugs (including cosmetics) and food. Notably, cosmetics sold online are required to have a notification number.

Indonesia Proposes to Amend Cosmetic Ingredient Use Requirements

On August 24, 2023, Indonesia introduced draft amendments to the Appendices in the Technical Requirements for Cosmetic Ingredients. The main amendments include:

1. Appendix I: List of Restricted Ingredients – 1 added and 6 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

The European Union

EU Amends the Ecolabel Criteria for Cosmetic Products

On July 26, 2023, EU released the Commission Decision (EU) 2023/1540 to amend the Ecolabel criteria for cosmetic products with immediate effect. They primarily pertain to the wording of provisions within the criteria, aiming at avoiding inconsistencies in the practice of the Commission Decision (EU) 2021/1870. 

The United Kingdom

UK Seeks Data on the Safety Assessment of Certain Cosmetic Ingredients

On August 14, 2023, the Office for Product Safety and Standards (OPSS) issued two announcements requesting scientific information relevant to the safety assessment of listed cosmetic ingredients. As required by OPSS, the submission of scientific data should adhere to two guidelines established by EU Scientific Committee on Consumer Safety (SCCS), i.e., The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation and Guidance on the Safety Assessment of Nanomaterials in Cosmetics. Interested parties can submit relevant data to OPSS within the specified deadlines. 

The United States

US FDA Unveils the Draft Guidance for Cosmetic Facility Registration and Product Listing

On August 7, 2023, the U.S. Food and Drug Administration released a draft guidance on cosmetic facility registration and product listing for public consultation until September 7, 2023. The draft guidance provides comprehensive direction on facility registration and product listing, covering entities responsible for application submission, necessary dossiers, submission methods, submission deadlines, etc.