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Monthly Recap: Global Cosmetic Regulatory Updates | May 2024

Chinese Mainland

China Sets up Technical Committee for Cosmetics Standardization

On May 6, 2024, the National Medical Products Administration (NMPA) announced to finalize the establishment of the Technical Committee for Cosmetics Standardization. The committee consists of 164 professionals from various sectors, including regulatory departments, industry associations, testing agencies, universities, and hospitals. Compared to the initial candidate list, the final committee list has 26 fewer members, and excludes representatives from cosmetics brand companies. The committee is further divided into eight sub-committees, addressing areas such as general technical requirements, ingredients and packaging materials, human safety and efficacy evaluation, products, inspection and testing, etc.

NMPA Answers Questions About Cosmetics Production and Operation

On May 10, 2024, NMPA released an announcement answering common questions surrounding the production and operation of cosmetic products, covering critical topics such as the repackaging and sales of cosmetics, and cosmetics labeling requirements.

China Issues a New Cosmetic Supplementary Testing Method for Diflorasone 17-Propionate and Diflorasone 21-Propionate

On May 10, 2024, NMPA introduced a new supplementary testing method for cosmetics, BJH 202402 Determination of Diflorasone 17-Propionate and Diflorasone 21-Propionate in Cosmetics, to detect two prohibited ingredients listed below. They are topical synthetic corticosteroids typically used to treat skin conditions, but not allowed to be used in cosmetics. The new method is applicable for the determination of these two ingredients in liquid (water, oil), cream, gel, and wax-based cosmetics.

No.Ingredient Name (CAS No.)Detection Limit (ng)The Lower Quantitative Limit (ng)Detection Concentration (μg/g)Minimum Quantitative Concentration (μg/g)
1Diflorasone 17-Propionate
(CAS No. 924726-89-6)
0.00120.0040.030.1
2

Diflorasone 21-Propionate

(CAS No. 541502-98-1)
0.00120.0040.030.1

SAMR Issues New Rules to Combat Online Unfair Competition

On May 11, 2024, the State Administration for Market Regulation (SAMR) issued the Interim Provisions on Anti-Unfair Competition on the Internet (the Provisions), which will come into force on September 1, 2024. As a supporting regulation to Anti-Unfair Competition Law of the People's Republic of China, the Provisions aims to ensure fair market competition, foster innovation, safeguard the rights of operators and consumers, and promote a standardized, sustainable, and healthy digital economy. Besides, it provides clear guidelines for defining and addressing unfair competition in the online sector.

China NIFDC Consults on Seven Testing Methods for Cosmetic Ingredients, Toothpaste, and Toxicological Test

On May 15, 2024, China National Institutes for Food and Drug Control (NIFDC) released seven testing methods for public consultation. Stakeholders with any comments can mail to hzpbwh@nifdc.org.cn untill June 10, 2024. 

No.Draft Testing Methods
1Determination of Phenacetin in Cosmetics
2Determination of Glucuronic Acid and Other 13 Kinds of Components in Cosmetics
3Determination of Gluconic Acid and Other Two Kinds of Components in Cosmetics
4Determination of Hydroxycapric Acid in Cosmetics
5Determination of Asbestos in Cosmetics
6Determination of Soluble/Free Fluoride in Toothpastes
7The ARE-Nrf2 Luciferase LuSens Test

China Proposes to Amend Administrative Measures on Inspection of Imported and Exported Cosmetics

On May 23, 2024, the General Administration of Customs of the People's Republic of China (GACC) released an amended draft of Supervision and Administration Measures on Inspection of Imported and Exported Cosmetics for public comments until June 22, 2024. The proposed amendments include further clarifying the regulation's applicable scope, strengthening the quality and safety responsibilities of cosmetics manufacturers and operators, and reinforcing penalties for regulatory violations.

China Consults on Two Guidelines for Determining New Cosmetic Ingredients (NCIs)

On May 31, 2024, NIFDC initiated a public consultation on the drafts of Guidelines for Research and Determination of Safe Use History of New Cosmetic Ingredients (Trial) and Guidelines for Research and Determination of Safe Consumption History of New Cosmetic Ingredients (Trial). These draft guidelines are designed to standardize the research and evaluation processes of NCIs, and guide the collection, determination, and application of relevant materials on the safe use history and safe consumption history of NCIs in safety assessment.

Beijing Municipal MPA and Guangzhou AMR Publish FAQs Regarding Cosmetics Notification

In May 2024, Beijing Municipal Medical Products Administration (MPA) and Guangzhou Administration for Market Regulation (AMR) released four batches of FAQs. They cover various topics related to general cosmetics notification, especially the requirements for safety assessment, entrusted production, the person in charge of quality and safety, etc. 

Release DateRegulatory AuthorityBatch
May 9, 2024Beijing Municipal MPAThe 32nd Batch
May 15, 2024Guangzhou AMR
The 59th Batch
May 21, 2024The 60th Batch
May 28, 2024The 61st Batch

China NMPA Approves Eight NCIs

In May, NMPA updated the notification status of eight NCIs. With these recent notifications, a total of 37 NCIs have been notified year to date. Since the detailed technical requirements for newly notified NCIs have not been made public, the English translations below are merely literal translation based on these NCIs’ Chinese names, which may differ from the INCI names provided by notifiers.

  1. Acetyl Dipeptide-1, notified on May 7, 2024

  2. Anoectochilus Roxburghii Extract, notified on May 9, 2024

  3. Maleated Soybean Oil Glyceryl / Octyldodecanol Esters, notified on May 10, 2024

  4. RGD Amidated Hyaluronic Acid, notified on May 14, 2024

  5. Calixarenes 8A-12C, notified on May 14, 2024

  6. AMPS/HEMA Crosspolymer, notified on May 17, 2024

  7. Idesia Polycarpa Fruit/Seed Oil, notified on May 17, 2024

  8. Glycine Tomentella Root Extract, notified on May 24, 2024

China Issues Ten Cosmetics-related Standards in May

In May 2024, China issued ten cosmetics-related standards. The essential information is as follows:

Release DateInitiatorStandard Name Effective Date
May 10, 2024The National Federation of City Industrial Products Trading CenterMetal Bottle Caps for CosmeticsMay 22, 2024
May 10, 2024Guangdong Cosmetics AssociationCosmetics—Detailed Rules and Regulations of Clean Make-up (Draft)/
May 10, 2024Guangdong Cosmetics AssociationEvaluation Method of Sunscreen Cosmetics Wash-off TestMay 10, 2024
May 10, 2024China Association for Promoting International Economic & Technical CooperationQuality Requirements for Compound Acid Anti-acne CosmeticsMay 26, 2024
May 10, 2024Guangdong Cosmetic Quality Management AssociationGuidelines for Cosmetic Production Process Validation (Draft)/
May 14,   2024Guangdong Cosmetics AssociationThe Skincare Cosmetics for LED Beauty DeviceMay 20, 2024
May 17, 2024Guangdong Cosmetics AssociationCosmetic Ingredient—Bionic Sebum Compositions From Fruit OilMay 17, 2024
May 21, 2024Zhejiang Drug Administration & Industrial Development Research SocietyCosmetics Ingredients—Citrus Aurantium Dulcis (Citrus Aurantium Changshan-Huyou) Peel ExtractsJune 21, 2024
May 21, 2024Guangdong Chamber of Daily-used ChemicalsKeratinocyte Test for Toxicity of Cosmetics and Raw Materials (Draft)/
May 22, 2024Guangdong Cosmetics AssociationCosmetic Ingrendients—Hydroxypropyl Tetrahydropyrantriol (β,S)May 23, 2024

Market Condition

1. According to the National Bureau of Statistics, the retail sales of cosmetic products from January to April 2024 was CNY 135.7 billion, with a year-on-year increase of 2.1%. In April, the retail sales decreased by 2.7% YoY to CNY 27.8 billion. 

retail.jpeg

2. According to the GACC, the total import value of cosmetics and toiletries from January to April 2024 totaled CNY 39.76 billion, declining 12.6% YoY. In April, the import value increased by 2.3% YoY to CNY 11.2 billion.

import.jpeg

Taiwan, China

Taiwan to Update the Applicable Products for GMP Requirements

On May 10, 2024, Taiwan Food and Drug Administration (TFDA) announced the draft of Cosmetic Categories for Which Manufacturing Premises Shall Comply with Cosmetics Good Manufacturing Practice Regulations. The draft aims to replace the existing regulation titled Cosmetic Categories That Shall Comply with Cosmetics Good Manufacturing Practice Regulations. In line with the upcoming discontinuation of the specific purpose cosmetics category from July 1, 2024, the draft revises the expressions used in the regulation, and further clarifies its applicable scope.

Taiwan to Restructure Cosmetic Ingredient Lists, Effective July 1, 2024

On May 30, 2024, TFDA finalized the plan to establish a new ingredient list and adjust the current ingredient lists, which will take effect on July 1, 2024. The adopted amendments mainly include:

  1. Abolishing the current List of Specific Purpose Ingredients in Cosmetic Products, and the List of Antibacterial Ingredients Allowed in Cosmetic Products;

  2. Newly establishing the List of UV Filters in Cosmetic Products;

  3. Adding 122 ingredients to, revising 31 ingredients in, and deleting 2 ingredients from the List of Ingredients Restricted in Cosmetic Products.

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Japan

PMDA: 16 Batches Cosmetics and Quasi-drugs Recalled in May

In May 2024, Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued recalls for a total of 16 batches of cosmetic and quasi-drug products. According to the notifications, the largest category of non-compliant products was shampoo that had deteriorated, accounting for over 80% of the recalls. Other reasons include unqualified product quality or mislabeling.

PMDA Updates Certification List of Foreign Manufacturers

On May 16, 2024, PMDA updated its List of Certified and Registered Foreign Manufacturers. The current list shows that the registration information of foreign manufacturers of seven categories of quasi-drugs will soon expire, involving companies from South Korea, Malaysia, the UK, France, Turkey, etc.

Japan Enhances Supervision of Cannabis-related Controlled Products

On May 30, 2024, the Ministry of Health, Labour and Welfare (MHLW) of Japan issued the Standard Analytical Method for Δ9-THC Content in Cannabis-Derived Products (Draft), seeking for public comment till June 29, 2024. This draft covers the requirements for samples, preparation and determination. It stipulates techniques such as LC-MS/MS or LC-QTOF MS to measure trace levels of Δ9-THC in compliance with regulatory limits.

South Korea

South Korea Publishes Cosmetic Industry Performance in 2023

On May 20, 2024, the Ministry of Food and Drug Safety (MFDS) published the Korean cosmetic production, import, and export performance in 2023. The key contents are as follows:

  1. Cosmetics exports reached 8.5 billion USD, the second highest on record.

  2. Exports to China decreased. However, exports to the United States, Japan, and other countries increased.

  3. Cosmetics import amount was similar to 2022.

  4. The greatest production increase happened on for color cosmetics and lip products.

  5. The number of companies with gross output over 100 billion KWR (80 million USD) increased from 7 in 2022 to 12 in 2023.

South Korea Modifies the Guideline of Analysis Method of Prohibited Ingredients in Cosmetics

On May 23, 2024, MFDS released the latest version of the Guideline of Analysis Method of Prohibited Ingredients in Cosmetics. The authority newly inserted the analysis methods of 12 per- and polyfluoroalkyl substances (PFAS) following the amendments in the Cosmetics Act. The relevant substances are:

  1. Perfluorooctanoic acid (PFOA)

  2. Ammonium pentadecafluorooctanoate Pentadecafluorooctanoic acid ammonium salt

  3. Tetraconazole

  4. Perfluorononanoic acid (PFNA)

  5. Ammonium perfluorononanoate

  6. Sodium heptadecafluorononanoate

  7. Perfluorooctanesulfonic acid (PFOS)

  8. Potassium perfluorooctanesulfonate

  9. Lithium perfluorooctanesulfonate

  10. Nonadecafluorodecanoic acid

  11. Ammonium nonadecafluorodecanoate

  12. Sodium nonadecafluorodecanoate

To help enterprises better acknowledge the phthalates requirements in global markets. ChemLinked compiles the requirements for phthalates in South Korea, Japan, E.U., U.S., and Canada. Find more at Control on Phthalates: Usage Limits in South Korea, Japan, E.U., U.S., and Canada

Thailand

Thailand Implements Revisions to Hand Sanitizer Regulations

On May 31, 2024, Thailand officially adopted two finalized documents concerning the amendments to its regulations governing alcohol-based hand sanitizer cosmetics. The two documents are:

The draft versions of these documents were previously notified to the WTO on February 2, 2024. With immediate effect, these amendments aim to ease access restrictions on alcohol-based hand sanitizers and refine the current regulatory framework.

Philippines

Philippines Develops Guidelines on Cosmetics Refilling Licensing

On May 21, 2024, Philippines Food and Drug Administration (FDA) published the Guidelines on the Licensing of Establishments Engaged in Refilling Activity of Certain Cosmetics and Household/Urban Hazardous Substances (HUHS) Products (the Guidelines). Through the Guidelines, the Philippines FDA introduces general requirements for cosmetics refilling, and primary obligations for cosmetic refillers.

Indonesia

Indonesia Cancels PI Import Approval Requirement for Cosmetics

On October 6, 2023, the President of Indonesia issued Minister of Trade Regulation No. 36 of 2023 to tighten the importation of certain commodity groups, including cosmetics. By May 2024, a backlog of approximately 26,000 containers had stranded at the ports. To address this issue, the Indonesian President instructed an immediate revision of Regulation No. 36 of 2023. This led to the issuance of Minister of Trade Regulation No. 8 of 2024,  which introduced a primary change to the cosmetics and household goods sectors, i.e., the cancellation of the requirement for Import Approval (PI) applications. This change, effective from May 17, 2024, applies to 38 HS codes within the cosmetics and household goods product categories.

Indonesia Implements Regulation Concerning Procedure for Approval of Clinical Trials

On May 21, 2024, Indonesia issued and implemented BPOM Regulation No. 8 of 2024 Concerning Procedure for Approval of Clinical Trials. The regulation clarified the approval requirements for clinical trial applications for various products, such as cosmetics, health supplements, medicines, and processed foods.

Indonesia BPJPH Emphasizes Not All Ingredients Need to be Halal Certified

The Halal Product Assurance Organizing Body (BPJPH) of the Ministry of Religious Affairs stated that not all products or materials circulating in Indonesia must be certified halal. The Indonesian government has issued the Minister of Religion Decree Number 1360 of 2021 concerning Materials Excluded from the Obligation of Halal Certification, stipulating that three categories of materials are exempt from the obligation to be certified halal.

Singapore

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

On May 10, 2024, Singapore's Health Sciences Authority (HSA) released a list of products found overseas in April 2024 that contain potent ingredients, including two batches of cosmetics. The potent ingredients detected include Mercury and Betamethasone, which are prohibited for general use in cosmetics in accordance with ASEAN Cosmetic Directive (ACD).

Australia

Australia Proposes Amendments to the Poisons Standard

Between April 22 and May 22, 2024, the Therapeutic Goods Administration (TGA) of Australia initiated a public consultation on proposed amendments to the Poisons Standard. These amendments primarily target five substances: sildenafil, allyl esters, glyoxylic acid, intravenous potassium salts, and sulfonamides. Among these, the suggested new addition of glyoxylic acid to the Poisons Standard, holds particular significance for the cosmetic industry.

Australia Adds Three Fragrance Ingredients to the Australian Inventory of Industrial Chemicals (AIIC)

On May 1, 2024, the Australian Government announced the addition of two industrial chemical to the AIIC under Section 83 of the Industrial Chemicals Act 2019. Following this, on May 24, 2024, another chemical was added to the inventory. All three chemicals have undergone assessments and are identified as fragrance ingredients permitted for import into Australia, each capped at a maximum of 1 tonne per annum. The basic information of these chemicals is as follows: 

No.Chemical NameCAS No.
15-Cyclotetradecen-1-one, 3-methyl-1117765-92-0
24H-1,3-Benzodioxin, hexahydro-4-methyl-2-(phenylmethyl)-1373821-23-8
3Phenol, 2-ethoxy-4-(ethoxymethyl)-71119-07-8

Australia Introduces an Innovative Online Tool for Human Health Categorization Volume Calculation

On May 29, 2024, the Australian Government launched a new online tool on the AICIS website, making it easier for chemical importers and manufacturers to calculate the human health categorization volume (HHCV). Accurate HHCV calculation is vital for determining the appropriate human health exposure band (ranging from 1 to 4) applicable to their chemical introductions.

The European Union

EU Finalizes Amendments to Use Restrictions on D4, D5, D6 in Cosmetics

On June 22, 2023, EU introduced draft amendments to Regulation (EC) No 1907/2006 Concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), proposing to further restrict the use of Octamethylcyclotetrasiloxane (D4), Decamethylcyclopentasiloxane (D5), and Dodecamethylcyclohexasiloxane (D6) in cosmetics as well as other consumer and professional products. On May 17, 2024, EU published the finalized regulation titled Commission Regulation (EU) 2024/1328 in its Official Journal, which became effective on June 6, 2024.

The United Kingdom

UK Introduces Recycling Labelling Requirements for Packaging Producers

On May 1, 2024, UK notified WTO of a draft regulation titled The Producer Responsibility Obligations (Packaging and Packaging Waste) Regulations 2024. Once the draft is approved, designated producers shall conduct recyclability assessment for all primary packaging and shipment packaging they supply. Starting from April 1, 2027, designated producers shall additionally ensure that such packaging complies with the recycling labelling requirements stipulated in the draft. 

United States

US Extends 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. Subsequently, on May 28, 2024, the US FDA announced a further extension of the comment period until June 27, 2024.

Sri Lanka

Sri Lanka Strengthens Quality Controls on Imported Goods

On May 17, 2024, the Ministry of Finance, Economic Stabilization and National Policies of Sri Lanka introduced the Standardization and Quality Control Regulations under the Imports and Exports (Control) Act, No.1 of 1969, in a move to enhance quality control and standardization of imported goods, including cosmetics. Consisting of 13 articles and 2 schedules, this new regulation principally outlines the applicable Sri Lanka Standards for imported goods, and mandates the submission of requisite supporting documentation demonstrating adherence to these standards.

Sri Lanka Implements ISO 22716 Certification for Cosmetics Manufacturers

On May 29, 2024, the National Medicines Regulatory Authority (NMRA) of Sri Lanka issued a notice, necessitating cosmetic manufacturing sites to acquire ISO 22716 certification from the Sri Lanka Standards Institute (SLSI), effective May 1, 2024. Under this directive, Good Manufacturing Practice (GMP) Inspections for cosmetics plants by NMRA will cease. Instead, ISO 22716 GMP certification by SLSI will prevail in the future.

Canada

Canada Amends Cosmetic Ingredient Use Requirements

On July 13, 2023, Health Canada released a notice concerning the review of several amendments to the Cosmetic Ingredient Hotlist. In May 2024, Canada adopted changes to the use requirements for 9 cosmetic ingredients.

Webinar Recommendation

1. Decoding the Full Version of Safety Assessment in China: Regulatory Updates and Changes

Under the CSAR framework, cosmetics registrants and notifiers must submit product safety assessment documents during registration and notification. Until May 1, 2024, they had the option to submit a simplified safety assessment report. However, from that date onwards, the full version of the assessment report became mandatory.

Considering industry challenges, China's National Medical Products Administration (NMPA) has extended the transition period. Registrants and notifiers can still submit a simplified safety assessment report before May 1, 2025, as long as the assessment was started before May 1, 2024. To guide companies, ChemLinked invited an experienced regulatory specialist, Inna Fu from REACH24H, to explain the requirements for cosmetic safety assessment in China and highlight important regulatory updates and changes. Click here for registration now!

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2. Effective in July: Get Ready for Changes to Taiwan's Cosmetic Regulations

On July 1, 2019, Taiwan brought the Cosmetic Hygiene and Safety Act, its overarching cosmetic regulation, into force. This regulation changed cosmetic categories from general and medicated cosmetics to general and specific purpose cosmetics, and introduced a new administrative system with compliance requirements for these two categories of cosmetics.

As per the Cosmetic Hygiene and Safety Act, the category of specific purpose cosmetics will be discontinued as of July 1, 2024. Consequently, Taiwan's cosmetic regulations will undergo changes pertaining to ingredient lists, pre-market notification, PIF, GMP, and product labelling. To help global stakeholders navigate the forthcoming changes, ChemLinked has organized this webinar. It will provide an overview of Taiwan's cosmetics regulatory landscape, followed by a detailed examination of the modifications set to take effect in July 2024.

taiwan.jpgFurther Reading

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