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Monthly Recap: Global Cosmetic Regulatory Updates | April 2023

Chinese Mainland

China to Implement the First Regulation on the Supervision for Cosmetic Online Operation

On April 4, China National Medical Products Administration (NMPA) issued the finalized Supervision and Administration Measures on Online Operation of Cosmetics (Measures) and would implement it on September 1, 2023. The Measures clarifies the regulatory objects and authorities of cosmetics online operation, the management responsibilities of cosmetics e-commerce platforms, and the obligations of cosmetic operators on the e-commerce platforms.

Shanghai Released Guidelines for the Standardized Operation of Cosmetic Samples in Xuhui District (Trial)

On April 6, Xuhui District Administration for Market Regulation (AMR), Shanghai, released Guidelines for the Standardized Operation of Cosmetic Samples in Xuhui District (Trial), unifying the management requirements for cosmetics samples.

Shanghai Releases Regulation for On-site Personalized Service Review of General Cosmetics in Pudong New Area (Trial)

On April 10, Shanghai Municipal MPA released the draft Regulation for On-site Personalized Service Review for General Cosmetics in Pudong New Area of Shanghai (Trial) for public consultation. The regulation focuses on application, personnel and management system requirements for on-site personalized cosmetic services.

China Releases Guidelines for the Registration Review of Radio Frequency Beauty Devices

On April 12, China NMPA issued Guidelines for Review of Registration of Radio Frequency Beauty Devices to assist relevant enterprises in preparing registration application documents, and the technical review department under the supervision authority in reviewing documents.

China Consults on Technical Guidelines for 28-Day/90-Day Repeated Dose Inhalation Toxicity Test

On April 13, China National Institutes for Food and Drug Control (NIFDC) released the draft Technical Guidelines for Toxicity Test for 28-Day/90-Day Repeated Dose Inhalation for public consultation.

Tmall Global Updates Tmall Global Cosmetics Platform Standards

On April 13, Tmall Global updated Tmall Global Cosmetics Platform Standards to strengthen the management of the cosmetics industry, which came into force on April 19. The update focuses on "the release of commodities’ attribute" and "commodities’ detail description on commodity page" specifications in the "product release specification."

Guangzhou Issues Implementation Rules for the Quality Supervision and Spot Inspection for Cosmetics Excessive Packaging

On April 23, Guangzhou AMR issued Implementation Rules for the Quality Supervision and Spot Inspection of Cosmetics Excessive Packaging (Revised in January 2023), which clarified the sampling method, inspection basis and judgment rules for the supervision and random inspection for cosmetics excessive packaging.

China NIFDC Consults on Seven Technical Guidelines for the Testing of Cosmetic Products and New Cosmetic Ingredients

On April 27, China National Institutes for Food and Drug Control (NIFDC) released seven technical testing guidelines for public consultation.

No.

Draft Technical Guideline

1

Technical Guidelines for Dermal Irritation/Corrosion Test

2

Technical Guidelines for Acute Eye Irritation/Corrosion Test

3

Technical Guidelines for Dermal Phototoxicity Test

4

Technical Guidelines for Bacterial Reverse Mutation Test

5

Technical Guidelines for Human Skin Patch Test

6

Technical Guidelines for Cosmetic Safety In-use Test

7

Technical Guidelines for the Determination of Sunscreen Product's Protection Factor of UVA (PFA)

China NMPA Approves Three New Cosmetic Ingredients

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

1) Conopeptide, notified on April 4, 2023

2) Carboxydecyltrisiloxane, notified on April 6, 2023

3) α-glucan polysaccharide, notified on April 7, 2023

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

On April 28, 2023, GACC updated the list of rejected food and cosmetics in March. One batch of cosmetics imported from Switzerland failed customs inspection. The reason for rejection was lack of required qualified documentation.

Guangzhou, Beijing and Shandong Authorities Publish FAQs Regarding Cosmetics and Toothpaste Regulation

In April, Guangzhou AMR, Beijing Municipal MPA, and Shandong Center for Food and Drug Evaluation & Inspection released three batches of FAQs concerning cosmetics and toothpaste regulation, including requirements for cosmetic labelling, transitional measures, toothpaste notification, etc.

Release Date

Regulatory Authority

Batch

April 3, 2023

Guangzhou AMR

The 35th Batch

April 18, 2023

Beijing Municipal MPA

The 20th Batch

April 25, 2023

Shandong Center for Food and Drug Evaluation & Inspection

The 1st Batch

China Issues Nine Cosmetics-related Standards in April

In April, China issued nine cosmetics-related standards. The essential information is as follows:

Type

Release Date

Initiator

Standard Name

Effective Status and Date

National Standard

April 20, 2023

Shanghai Research Institute of Fragrance & Flavour Industry

Determination of Restricted Components Lauryl Alcohol Polyether-9 in Cosmetics—HPLC-MS/MS

Draft

Determination of Restricted 2,4-Diamino-Pyrimidine-3-Oxide in Cosmetics—High Performance Liquid Chromatography

Provincial Standard

April 25, 2023

Guangzhou AMR

DB 4401/T 211-2023 Quality Management Specification of Cosmetics Business

Effective since May 25, 2023

Group Standard

April 6, 2023

Zhejiang Brand Construction Federation

T/ZZB 2942—2022 Highly Resistant Ultraviolet (UV) Curing Coatings for Cosmetic Packaging Materials

Effective since Dec. 31, 2022

April 7, 2023

China Daily Chemical Industry Association

T/CHCIA 010—2023 Guidelines for Evaluating the Effects of Cosmetics on Skin Microbiota Microbiome   (Amplicon Sequencing)

Effective since April 15, 2023

April 13, 2023

China Association of Fragrance Flavour and Cosmetic Industries

Human Body Test Method for Cosmetic Anti-acne Efficacy

Draft

April 13, 2023

China Association of Fragrance Flavour and Cosmetic Industries

Test Method for Cosmetic Repairing Efficacy

Draft

April 23, 2023

Guangdong Cosmetics Quality Management   Association

T/GDCQMA 001—2023 General Rules for Production Quality of Disposable Cosmetics

Effective since April 25, 2023

April 28, 2023

China Anti-aging Promoting Association

T/ZGKSL 004—2023 Recombinant Collagen for Cosmetics

Effective since April 28, 2023

Taiwan, China

Taiwan Releases One Test Method for Cosmetics

On April 18, 2023, Taiwan Food and Drug Administration (TFDA) released one test method for determining 29 aromatic amines in hair dyes, including three specific purpose ingredients and 26 prohibited ingredients. The method’s details and the complete list of involved ingredients can be found here

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South Korea

FAQs for South Korea Cosmetic Requirements

Earlier this year, the Ministry of Food and Drug Safety (MFDS) published the Frequently Asked Questions (FAQs) for the biotech industry in 2022. ChemLinked compiles the FAQs for cosmetic parts for enterprises' references, covering the ingredient, labeling, and functional cosmetic, etc. Check the details on ChemLinked website.

South Korea Issues the List of Designated Test and Inspection Institutions for Cosmetics

MFDS disclosed the list of designated test and inspection agencies for cosmetics on April 24, 2023. As per Article 20 of the Cosmetics Act, the authority can order a business operator to undergo an inspection on cosmetics handled by the business operator, if deemed necessary. The qualified cosmetics testing and inspection institutions are prescribed in Article 6 (2) 5 of the Act on Testing and Inspection in the Food and Drug Industry.

Japan

PMDA: 68 Batches Cosmetics and Quasi-drugs Recalled in April

In April 2023, Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued four recall notices. 65 batches of cosmetics and three batches of quasi-drugs were required to be recalled. Among them, 58 batches of cosmetics were recalled because containing pharmaceutical ingredients. Others were rejected due to label non-compliance.

Thailand

Thailand Unveils April 2023 Non-Compliant Cosmetics

On April 3, 2023, the Thai Food and Drug Administration (Thai FDA) reported that that three batches of hair coloring products imported from South Korea and distributed by Thai companies failed cosmetics inspection and analysis, as they were found to contain prohibited ingredients o-Aminophenol or m-Phenylenediamine.

Thai FDA Establishes Criteria for FDA Quality Award Logo Usage in Advertising and Public Relations

The Thai FDA has recently released guidelines for the appropriate use of the FDA Quality Award logo in advertising and public relations. Winners of the award from 2022 onwards may use the logo on product labels and in different media, provided the type and year of the award are specified. The logo can be either blue or gold, and can be resized proportionally to the prototype proportionally.

Australia

Australia Consults on Proposed Amendments to Sunscreens Regulation

On April 24, 2023, Australia's Therapeutic Goods Administration (TGA) launched a public consultation seeking public feedback on proposed updates and clarifications to sunscreen regulations. The proposed changes include adopting the Australian/New Zealand Standard Sunscreen Products-Evaluation and Classification AS/NZS 2604:2021 Amd 1: 2022 as the current sunscreen standard, eliminating exemptions for sunscreens with SPF less than 4, and seeking clarification on clarifying the indications (therapeutic uses) that sunscreens can make. The consultation period will run until May 31, 2023.

Australia Releases Guidance for Submitting Pre-Introduction Reports for Chemicals Internationally Assessed for Human Health Only

On April 26, 2023, the Australian Government released a new guidance to help businesses submit Pre-Introduction Reports (PIRs) for chemicals that are classified as “internationally-assessed for human health but not the environment” under the reported introduction category. This guide includes a detailed checklist to ensure businesses have all the necessary information before commencing the submission process, and provides instructions for completing the PIR form in the AICIS Business Services platform.

The European Union

EU SCCS Consults on Opinion as to Silver Zinc Zeolite

On April 4, 2023, EU Scientific Committee on Consumer Safety (SCCS) released the opinion on Silver Zinc Zeolite for public consultation. Based on all available information, SCCS concludes in the opinion that when functioning as a preservative in spray deodorant and powder foundation, Silver Zinc Zeolite (incorporating a maximum silver content of 2.5%) is safe at the proposed concentration of 1%.

EU SCCS Consults on Opinion About Fullerenes, Hydroxylated Fullerenes and Hydrated Forms of 19 Hydroxylated Fullerenes (nano)

On April 24, 2023, EU SCCS published the preliminary opinion on using Fullerenes, Hydroxylated Fullerenes, and hydrated forms of 19 Hydroxylated Fullerenes (nano) in cosmetics. Due to the uncertainties and data gaps regarding physicochemical, toxicokinetic and toxicological aspects, SCCS cannot conclude the safety of these ingredients. However, SCCS expresses concerns overusing hydrated forms of 19 Hydroxylated Fullerenes and Hydroxylated Fullerenes in cosmetics due to their potential genotoxicity.

The UK

UK Introduces Notification Archive Function to Cosmetic Notification System

On April 4, the Office for Product Safety and Standards (OPSS), the UK competent authority for cosmetic products, informed Submit Cosmetic Products Notifications (SCPN) portal users about a new archive function for outdated product notifications. Users can select a reason from a drop-down list, and move notifications to the "archived notifications" list, which can also be reversed if needed.

UK to Amend Permitted Levels of Certain Chemicals in the Cosmetics Regulations

On April 28, World Trade Organization released G/TBT/N/GBR/61. According to the notice, UK will permit the use of methyl-N.Methylanthranilate up to 0.1% for leave-on and 0.2% for rinse-off cosmetic products, and the use of HAA299 and HAA299 (nano) up to a level of 10%, excluding the use in spray and/or aerosol products.

Canada

Canada Introduces Legislation to Ban Cosmetic Animal Testing and Trade

On April 20, the Government of Canada introduced the Budget Implementation Act, Bill C-47. This important legislation aims to implement the key commitments outlined in 2023 Federal Budget, which includes the prohibition of cosmetic animal testing. The Bill has been officially tabled in the Canadian Parliament.

Brazil

Brazil Formulates List of Permitted Ingredients for Hair Straightening or Perming Cosmetics

On April 14, the Brazilian Government Gazette published Instruction IN N° 220, outlining a list of permitted ingredients for hair straightening and perming cosmetics. The instruction came into force on May 2.

Argentina

Argentina Proposes to Revise the List of Prohibited Ingredients for Cosmetics

On April 12, the Argentine National Administration on Drugs, Food and Medical Devices (ANMAT) issued Consultation Circular ANMAT-COS-PCO 001-00 to revise the list of prohibited ingredients for cosmetics. The Circular adds 6-amino-p-phenol (CAS No. 2835-98-5), 1,2,4-glucinol (CAS No. 533-73-3), 4-2-[(4-amino-2 -Nitrophenyl)-amino]-benzoic acid (CAS No. 117907-43-4) to the list, with a 90-day transition period for production, import, and sales companies to adjust product formulations and labels.

Argentina Enacts Biobased Content Requirements for Some Cosmetic Products

On April 21, the Argentine Ministry of Economy issued Resolution No. 150/2023, outlining biobased content requirements for specific cosmetic products.

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