Monthly Recap: Global Cosmetic Regulatory Updates | April 2024

China Implements Two Cosmetic-related National Standards

On April 1, 2024, China implements two cosmetic-related national standards:

1) GB/T 43197-2023 Determination of Prohibited Acid Red 73 and Solvent Red 1 in Cosmetics—Liquid Chromatography–Tandem Mass Spectrometry;

2) GB/T 26513-2023 Lip Moisturizer (Gel, Cream).

NMPA Announces Four Typical Non-complaint Cases

On April 2, 2024, China National Medical Products Administration (NMPA) issued an announcement regarding four typical non-compliant cases in the cosmetics industry. The reasons for these cases were the production of counterfeit cosmetics, the use of prohibited ingredients in cosmetics, failure to compliance with good manufacturing practices, and the provision of false notification dossiers (i.e., the safety assessment report was not completed and issued by the named unit and personnel).

SAMR Announces Ten Typical Cases of “Iron Fist” Operation in 2023

On April 8, 2024, State Administration for Market Regulation (SAMR) announced ten typical cases of the "Iron Fist" Operation in 2023, which included a cosmetics-related case involving false advertising.

China Consults on Cosmetic Ingredient Safety Data Catalogs and Guidelines for Stability, Preservative Challenges, Packaging Compatibility, and Skin Sensitization Testing

On April 10, 2024, China National Institutes for Food and Drug Control (NIFDC) unveiled six draft guidance documents concerning cosmetics safety assessment. These documents are:

1. Technical Guidelines for Stability Evaluation of Cosmetics

2. Technical Guidelines for Cosmetic Preservative Challenge Testing

3. Technical Guidelines for Compatibility Evaluation of Cosmetics with Packaging Materials

4. Technical Guidelines for Integrated Approaches to Testing and Assessment (IATA) of Skin Sensitization

5. Index of Cosmetics Safety Assessment Data from Authoritative Organizations

6. Information on Cosmetic Ingredient Usage

Among these, the finalized versions of the Index of Cosmetics Safety Assessment Data from Authoritative Organizations and Information on Cosmetic Ingredient Usage were officially released on April 30.

After the public comment period’s conclusion on April 17, the official versions of other four technical guidelines are currently awaiting publication.

SAMR Releases the Approved Amendments to JJF 1070—2023 Rules of Metrological Testing for Net Quantity of Products in Prepackages with Fixed Content

On April 10, 2024, SAMR officially announced the approval of Amendment No. 1 to the National Metrology Technical Specification of JJF 1070-2023, titled Rules of Metrological Testing for Net Quantity of Products in Prepackages with Fixed Content. This Amendment came into effect immediately upon announcement.

SAMR Strengthens Advertising Supervision, with Focus on Medical Beauty, Cosmetics, and Other Key Areas

On April 10, 2024, SAMR announced an eight-month special action on advertising supervision in the field of people's livelihood nationwide, including six key tasks for supervising advertising in the field of people's livelihood.

China Specifies Practices of Cosmetic Adverse Reaction Monitoring and Reporting

On April 19, 2024, the Center for Drug Reevaluation and the National Center for Adverse Drug Reaction (ADR) Monitoring of China published Cosmetic Adverse Reaction Collection and Reporting Guidelines for Cosmetic Registrants and Notifiers (Trial). The Guidelines provides instructions for registrants and notifiers on the collection and reporting of cosmetic adverse reactions.

China NMPA Grants One-Year Buffer Period for the Implementation of the Full Version of Cosmetic Safety Assessment

On April 22, 2024, NMPA unveiled the Announcement on Issuing Several Measures to Optimize Cosmetic Safety Assessment Management, pointing out that before May 1, 2025, cosmetics registrants and notifiers can still submit a simplified version of the safety assessment report that meets the requirements of the Technical Guidelines when applying for registration or notification.

China General Administration of Customs (GACC): One Batch of Cosmetics Rejected in March 2024

On April 28, 2024, GACC updated the list of rejected food and cosmetics in March 2024. One batch of cosmetics imported from France failed customs inspection due to the lack of required certificates or certification documents.

China to Implement Administrative Measures on Cosmetics Inspection from November 1, 2024

On October 19, 2023, China NMPA initiated public consultation on the draft of Administrative Measures on Cosmetics Inspection. On April 29, 2024, NMPA released the finalized Measures, and will implement it on November 1, 2024.

China NIFDC Finalizes Seven Technical Documents for Cosmetic Safety Assessment

On April 30, 2024, NIFDC released seven finalized technical documents on cosmetics safety assessment. They are:

1) Guidelines for Submission of Cosmetics Safety Assessment Dossiers

2) Guidelines for Cosmetic Ingredient Data Usage

3) Index of Cosmetics Safety Assessment Data from Authoritative Organizations

4) Ingredient Usage Information of Marketed Cosmetic Products

5) Technical Guidelines for Identification and Assessment of Cosmetic Risk Substances

6) Technical Guidelines for Application of Threshold of Toxicological Concern (TTC) Method

7) Technical Guidelines for Application of Read-across

The supporting documents needed for cosmetics safety assessment during the transition period from May 1, 2024 to May 1, 2025, have all been finalized and released.

Shanghai Municipal Medical Products Administration Releases the Inspection Plan of Cosmetics Quality and Safety Administrative Law Enforcement for 2024

On April 30, Shanghai Municipal Medical Products Administration (MPA) released the Inspection Plan of Cosmetics Quality and Safety Administrative Law Enforcement for 2024. This plan establishes clear guidelines for inspection, inspection methods, and inspection ratios, etc.

China NMPA Approves Six NCIs

In April 2024, NMPA updated the notification status of six new cosmetic ingredients (NCIs). With these recent notifications, a total of 29 NCIs have been notified as of April. 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. HORDEUM VULGARE VAR. COELESTE Seed Extract, notified on April 7, 2024

2. Ledum Palustre Leaf Oil, notified on April 7, 2024

3. Cyclohexapeptide-9, notified on April 7, 2024

4. Methylbenzothiazole azotoluidine bis-(triethoxysilylpropylcarbamoylPEG-5/PPG-5 ethanol), notified on April 16, 2024

5. Bis-(phenylazotoluidine) bis-(triethoxysilylpropylcarbamoylPEG-5/PPG-5ethanol)sulfone, notified on April 16, 2024

6. Donkey milk powder, notified on April 26, 2024

NIFDC and Guangzhou Administration for Market Regulation Publishes FAQs Regarding General Cosmetics Notification

In April 2024, NIFDC and Guangzhou Administration for Market Regulation (AMR) published six batches of Frequently Asked Questions (FAQs). These FAQs cover topics such as special cosmetics registration, cosmetic safety assessment, cosmetic samples and product name.

China Issued/Implemented 13 Cosmetics-related Standards in April 2024

In April 2024, China issued/implemented 13 cosmetics-related standards. The essential information is as follows:

Market Condition

1. According to the National Bureau of Statistics, the retail sales of cosmetic products from January to March 2024 was CNY 108.6 billion, with a year-on-year increase of 3.4%. In March, the retail sales increased by 2.2% YoY to CNY 41.1 billion. 

2. According to the GACC, the total import value of cosmetics and toiletries from January to March 2024 totaled CNY 28.59 billion, declining 17.2% YoY. In March, the import value decreased by 17.8% YoY to CNY 11.82 billion.

Taiwan to Update the Applicable Products Subject to PIF Requirements

On April 11, 2024, Taiwan Food and Drug Administration (TFDA) released the draft of Cosmetic Categories Subject to Product Information File and Effective Dates (2024), aiming to replace the 2019 version. In line with the discontinuation of the specific purpose cosmetics category from July 1, 2024, the draft proposes to revise the expressions used in the regulation, and expand its applicable scope.

PMDA: 88 Batches Cosmetics Recalled in April

In April 2024, Japan Pharmaceuticals and Medical Devices Agency (PMDA) released a series of notifications regarding a total of 88 batches of cosmetics and quasi-drugs. These products included items such as anti-wrinkle serums, hair dyes, eyeshadows, and scrubs. According to the notifications, the most significant issue was related to ingredient specifications, accounting for 33% of the cases. Labeling problems followed closely behind at 32%, and the lack of relevant permits accounted for 16% of the cases.

JCIA Tracks Plastic Usage in Cosmetic Container Packaging

On April 17, 2024, JCIA released an announcement on The Use of Plastic in Cosmetic Container Packaging (2022). According to the announcement, the waste reduction rate resulted from supplementation and replacement efforts reached 57%, marking a 5% improvement compared to the previous year.

JCIA is committed to resolving long-term environmental concerns in cosmetic container packaging and promoting sustainable development within the cosmetics industry. In addition to monitoring plastic usage on an annual basis, JCIA has also developed the Environmental Design Guidelines for Cosmetic Container Packaging, which holds significant influence and enforceability within the industry.

South Korea Extends the Grace Period for Labeling the Extract Component

On April 1, 2024, the Korean Cosmetic Association (KCA) released a notice regarding the labeling of extract components in the Guideline for the Labeling of Cosmetic Products, an industrial guidance giving examples of prohibited claims and claims subject to substantiation.

On November 23, 2023, KCA added the methods to label extract components on cosmetic packaging and gave enterprises a one-year grace period to change the packaging. However, considering the industry's limitations in changing packaging materials, KCA recently decided to extend the grace period for cosmetics’ packaging from 1 year to 2 years after the guideline's implementation, till November 23, 2025.

South Korea Publishes CGMP Guidelines to Support Korean Cosmetic Industry

On April 16, 2024, the Ministry of Food and Drug Safety (MFDS) published a booklet titled Common Improvement Cases in the Evaluation of Cosmetic Good Manufacturing Practice (CGMP). Although CGMP is a voluntary application, as more companies are engaged in producing CGMP product, the authority released the booklet, introducing the overview of major improvement cases in CGMP evaluations in the past five years (2019-2023).

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Philippines Introduces Updated Cosmetic Ingredient Use Requirements

On April 8, 2024, the Philippines Food and Drug Administration (FDA) announced the updated amendments to the ingredient annexes to the ASEAN Cosmetic Directive (ACD). These amendments were adopted during the 38th ASEAN Cosmetic Scientific Body (ACSB) meeting, mainly including the following:

1) Annex II: 15 prohibited ingredients added, and the requirements for 4 prohibited ingredients revised;

2) Annex III: the requirements for 5 restricted ingredients revised;

3) Annex IV: the requirements for 1 permitted colorant revised;

4) Annex VI: 1 permitted preservative deleted;

5) Annex VII: 2 permitted UV-filters added, and the requirements for 1 permitted UV-filter revised.

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Vietnam Releases the List of Notification Numbers with Processing Issues Due to System Errors

On April 8, 2024, the Drug Administration of Vietnam (DAV) issued Official Dispatch No. 1059/QLD-MP, publishing a list of notification numbers of documents that cannot be processed in the notification system due to errors. However, the list may not be comprehensive. Companies are recommended to review their notification application and report any errors encountered during the notification process.

Vietnam’s Ministry of Health has assigned the National Health Information Center to develop a software named "Comprehensive Management and Origin Traceability Information System for Cosmetics", which will replace the current notification system. This software aims to comprehensively address existing errors and facilitate the connection and resolution of public services from the central to local levels.

HSA Alerts 15 Batches of Non-compliant Cosmetics Containing Potent Ingredients Found Overseas

On April 2, 2024, Singapore's Health Sciences Authority (HSA) released a list of products found overseas in March 2024 that contained potent ingredients, including 15 batches of cosmetics. The potent ingredients detected in these cosmetics include Mercury, Betamethasone, Clobetasol, Hydroquinone, and Retinoic Acid, all prohibited for general use in cosmetics in accordance with ASEAN Cosmetic Directive (ACD).

HSA Updates Cosmetic Ingredient Use Requirements

On April 5, 2024, Singapore's Health Sciences Authority (HSA) updated the Annexes of the ASEAN Cosmetic Directive regarding the use requirements for cosmetic ingredients. These updates are in line with the amendments made to the ASEAN Cosmetics Directive (ACD) during the 38th ASEAN Cosmetic Scientific Body (ACSB) Meeting.

EU Adopts 11 Changes to the Use Requirements for Cosmetic Ingredients

On June 8, 2023, EU notified WTO of a draft regulation, aiming at revising the ingredient lists in Regulation (EC) No 1223/2009 (Cosmetics Regulation). On April 4, 2024, EU released the Commission Regulation (EU) 2024/996 to introduce the finalized changes with corresponding transitional periods. These changes include:

1) Adding one prohibited ingredient, and eight restricted ingredients;

2) Amending the use requirements for two permitted preservatives;

3) Deleting one permitted UV filter.

EU SCCS Finalizes the Opinion on Benzophenone-4

On December 15, 2023, EU Scientific Committee on Consumer Safety (SCCS) issued a preliminary opinion on the use of Benzophenone-4 (CAS No. 4065-45-6) in cosmetics. Considering the comments received, SCCS released the final opinion on April 4, 2024, with some modifications made to the initial conclusion.

EU SCCS Consults on the Opinion About Silver

On April 4, 2024, EU SCCS published the preliminary opinion on the use of Silver (CAS No. 7440-22-4) in cosmetic products. Based on the provided information, SCCS concluded the safe concentration for the use of micron-sized particulate Silver in shampoo, eye shadow, and oral exposure products.

EU SCCS Refines the Opinion on Aluminium

On April 4, 2024, EU SCCS published the finalized opinion on the safety of Aluminium (Al). Compared to the preliminary opinion released in December 2023, the final version includes additional non-spray product categories where the use of Al compounds is considered safe.

EU Publishes the Preliminary Opinion on Citral

On April 4, 2024, EU SCCS released the preliminary opinion regarding the sensitisation endpoint of Citral (CAS No. 5392-40-5). Based on the new quantitative risk assessment (QRA2) methodology, SCCS considers the use of Citral safe in sensitization induction at the proposed concentrations in cosmetic products. Additionally, SCCS emphasizes that additional case studies are needed for further confirmation of the applicability of QRA2 to other fragrances and cosmetic ingredients.

UK Imposes Restrictions on the Use of Butylated Hydroxytoluene

On October 27, 2023, UK notified WTO of a draft regulation, proposing to restrict the use of Butylated Hydroxytoluene (CAS No. 128-37-0) in cosmetics, following the opinion of Scientific Advisory Group on Chemical Safety in Consumer Products (SAG-CS). This draft was finalized on April 3, 2024, and came into effect on April 22, 2024.

UK to Revise Cosmetic Ingredient Lists

On April 10, 2024, UK notified a draft regulation to the WTO, aiming to revise the ingredient lists in UK Regulation (EC) 1223/2009 (UK Cosmetics Regulation). The proposed revisions include the addition of 52 prohibited ingredients and 1 restricted ingredient. Notwithstanding these revisions, the draft stipulates that cosmetic products placed on the market on or before April 20, 2025, can continue to be on the market until August 20, 2025.

UK Proposes to Ban the Supply and Sale of Plastic-contained Wet Wipes

On April 24, 2024, UK notified WTO of a draft regulation titled The Environmental Protection (Wet Wipes Containing Plastic) (England) Regulations 2024. Once the draft is approved, the supply and sale of wet wipes containing plastic in England will face strict prohibition, with only three specified exemptions.

US Reopens the Consultation Period on Proposed Increase in Color Additive Certification Fees

On April 25, 2024, the US Food and Drug Administration (FDA) issued a notice, reopening the consultation period for 30 days for the proposed rule titled Color Additive Certification; Increase in Fees for Certification Services, which was initially released on November 2, 2022.

Australia Seeks Public Input on AICIS Fees and Charges for Chemicals Introduction in 2024-25

On April 2, 2024, the Australia government commenced a public consultation regarding its Fees and Charges Proposal 2024-25. This proposal covers the revised fees and charges in relation to the introduction (importation and manufacture) of industrial chemicals in Australia.

Australia Consults on Interim Decisions to Amend the Poisons Standard

On April 3, 2024, the Therapeutic Goods Administration (TGA) of Australia launched a public consultation on interim decisions concerning 14 substances listed in the Poisons Standard. Among these substances, methenamine, adrenaline, and benzoic acid are relevant to cosmetics.

Australia Adds a Fragrance Ingredient to the Australian Inventory of Industrial Chemicals (AIIC)

On April 4, 2024, the Australian Government included one industrial chemical to the AIIC under Section 83 of the Industrial Chemicals Act 2019. The chemical is Ethanone, 1-(2,3-dimethylbicyclo[2.2.1]hept-2-yl)- (CAS No. 854737-10-3), identified as a fragrance component imported into Australia at a maximum of 1 tonne per year.

Australia Updates Sunscreen Standards

On April 11, 2024, the TGA announced the adoption of the Australian/New Zealand Standard: Sunscreen products – Evaluation and Classification (AS/NZS 2604:2021) (amended) into therapeutic goods legislation framework. This updated standard enhances testing and labeling requirements for sunscreens available in the Australian market.

Australia Consults on 14 Draft Evaluations Covering 2,116 Industrial Chemicals

On April 15, 2024, the Australian Government issued a notice, inviting public feedback on 14 draft evaluation statements covering 2,116 industrial chemicals. The comments period will end on May 27, 2024.

Australia Fined Fragrance Distributor $37,560 for Unlawful Imports

On April 19, 2024, the Australian Government announced the issuance of two infringement notices totaling $37,560 (a total of 120 penalty points) to an Australian importer of fragrances, toiletries, and cleaning products. Allegedly, the enterprise unlawfully imported industrial chemicals from the US without AICIS registration and failed to submit the required annual declaration.

Australia AICIS Amends Categorization, Reporting, and Record-keeping Requirements for Industrial Chemicals

On April 24, 2024, the Australian Industrial Chemicals Introduction Scheme (AICIS) began implementing amendments to the Industrial Chemicals (General) Rules 2019 and the Industrial Chemical Categorization Guidelines. The amendments are expected to make compliance easier for introducers, and enhance protection against hazardous chemicals. 

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