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Monthly Recap: Global Cosmetic Regulatory Updates | August 2024

Chinese Mainland

Shanghai Municipal MPA Drafts Measures for Grading the Quality and Safety Risks of Cosmetic Manufacturers

On August 7, 2024, Shanghai Municipal Medical Products Administration (MPA) released the draft of Administrative Measures on Quality and Safety Risk Grading of Cosmetic Manufacturers in Shanghai (Trial). According to the draft, Shanghai Municipal MPA intends to grade the quality and safety risks of cosmetic manufacturers into four levels based on their regulatory compliance situation and credit risk. The grading results will be used to determine and adjust the supervision and inspection frequency for cosmetic manufacturers by Shanghai Municipal MPA and relevant district market supervision departments.

China NMPA Unveils the 2024 Cosmetics Standards Plan

On August 8, 2024, China National Medical Products Administration (NMPA) released the Notice on the 2024 Cosmetics Standard Project Plan. The notice outlined the revision to 31 cosmetics standards and the formulation of 24 new cosmetics standards, covering prohibited and restricted ingredients, as well as testing methods for cosmetics and toothpaste. 

China NMPA Discloses Findings from an Unannounced Inspection of a South Korean Company

On August 13, 2024, NMPA released the results of an unannounced inspection conducted on a South Korean cosmetic company. The inspection uncovered several regulatory violations, including the failure to implement a compliant product release management system, and the absence of a supervision system for the production activities of its entrusted manufacturers. These issues were in breach of regulations such as the Cosmetic Supervision and Administration Regulation (CSAR) and the Supervision and Administration Measures on Cosmetics Manufacture and Operation.

NMPA Issues the Charter of the Technical Committee for Cosmetics Standardization

On August 14, 2024, NMPA released the Charter of NMPA's Technical Committee on Cosmetics Standardization (the Charter), which took effect upon its release. The Charter outlines eight primary responsibilities of the committee, including:

  1. Developing plans, programs, and policies for cosmetics standardization;

  2. Analyzing and resolving key issues related to cosmetics standardization;

  3. Reviewing and coordinating the implementation of the annual project initiation plan for the formulation and revision of cosmetics standards;

  4. Reviewing projects for formulating and revising cosmetics standards;

  5. Promoting and providing training on cosmetics standards;

  6. Engaging in international exchanges regarding cosmetics standardization;

  7. Offering insights on the interpretation of cosmetics standards;

  8. Carrying out additional standardization tasks assigned by NMPA. 

NMPA Introduces Provisions for Formulating and Revising Cosmetics Standards

On August 15, 2024, NMPA published the Provisions on the Working Procedures for the Formulation and Revision of Cosmetics Standards (Trial) (the Provisions) with immediate effect. The Provisions applies to cosmetics standards including national standards (both mandatory and recommended ones), industry standards, safety and technical standards, supplementary testing items and testing methods, etc. Details include the procedures and corresponding requirements, covering standard establishment, drafting, verification, review, approval, release, revision, and abolition.

Shanghai Municipal MPA Drafts Guidelines for Cosmetic Samples

On August 26, 2024, Shanghai Municipal MPA issued the Guidelines for the Standardized Operation of Cosmetic Samples in Shanghai (Draft) (the Guidelines), which is open for public comment until September 18, 2024. As per the Guidelines, cosmetic samples are defined as cosmetics intended for promotional purposes, including free trials, gifts, and goods redeemed through voucher, and smaller than full-size products. 

In terms of regulatory compliance, cosmetic samples are required to be registered or notified, and meet the specified labeling requirements. Regarding the operation of cosmetic samples, the Guidelines clarifies the obligations that cosmetic sample operators shall fulfill, including establishing and implementing a material purchase inspection record system, assisting relevant departments in monitoring cosmetics adverse reactions, cooperating in the implementation of cosmetics recalls, etc. Notably, the Guidelines also clarifies the compliance responsibilities of cosmetics registrants and notifiers, who are required to establish and implement a product sales record system for products including cosmetic samples. 

China General Administration of Customs (GACC): 18 Batches of Cosmetics Rejected in July

On August 26, 2024, GACC updated the list of rejected food and cosmetics in July 2024. Nine batches of cosmetics imported from China's Taiwan, Thailand, and Italy failed customs inspection due to the lack of required qualified documentation, while another nine batches from the United States, Italy, Belgium, and Canada were rejected due to the failure to pass sensory inspection.

Hainan MPA Launches a Two-Year Pilot for Electronic Labels on Designated Cosmetics

On August 30, 2024, Hainan MPA announced a two-year pilot implementation of electronic Chinese labels for offshore duty-free cosmetics in Hainan, effective from September 1, 2024. Cosmetics registrants and notifiers who intend to use electronic labels are required to submit the Chinese label information online to Hainan MPA. Once the information is confirmed as compliant, Hainan MPA will generate an electronic label, which shall be prominently displayed on the visible panel of the product's sales package. It is important to note that for cosmetics with electronic labels, the following information shall still be labeled on the visible panel of the product's sales package:

  1. The product's Chinese name, and the registration certificate number of special cosmetics

  2. Net content

  3. Durability

  4. Name of the cosmetic registrant/notifier

  5. Precautions

  6. Children cosmetics logo (only for children cosmetics)

Beijing Municipal MPA Publishes FAQs Regarding Cosmetics Safety Assessment

On August 6 and August 19, 2024, Beijing Municipal MPA issued the 35th and 36th batches of FAQs. These FAQs cover various topics related to cosmetics safety assessment, especially the application of the Threshold of Toxicological Concern (TTC) and read-across methods, requirements for adopting assessment conclusions published by international authoritative agencies, the preparation of the full version of the safety assessment report, etc.

China NMPA Approves Nine NCIs

In August 2024, NMPA updated the notification status of nine NCIs. With these recent notifications, a total of 64 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 the notifiers.

  1. Pyrroloquinoline Quinone Disodium Salt, notified on August 1, 2024

  2. Pterostilbene, notified on August 6, 2024

  3. Nicotinamide Mononucleotide, notified on August 13, 2024

  4. Acetyl Zingerone, notified on August 23, 2024

  5. Schizophyllum Commune Ferment Filtrate, notified on August 27, 2024

  6. sr-Mussel Oligopeptide-1, notified on August 27, 2024

  7. Oxyresveratrol, notified on August 29, 2024

  8. Ceratostigma Willmottianum Extract, notified on August 29, 2024

  9. Abelmoschus Manihot Flower Extract, notified on August 29, 2024

China Issues Ten Cosmetics-related Standards in August

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

No.

Release Date

Initiator

Standard Name

Effective Date

1

August 6, 2024

Henan Nonferrous Metals Industry Association

T/HNNMIA XXXX—2024 Aluminum and Aluminum Alloy Sheet and Strip for Cosmetic Containers

/

2

August 13, 2024

China Association of Fragrance Flavour and Cosmetic Industries

T/CAFFCI XXXX—202X Method for Assessment of Cosmetics Firmness Efficacy

/

3

August 13, 2024

China Association of Fragrance Flavour and Cosmetic Industries

T/CAFFCI XX—2024 Test Methods for Anti-dandruff Efficacy of Cosmetic Products

/

4

August 15, 2024

Guangdong Chamber of Daily Used Chemicals

T/GDCDC 041—2024 Test for the Cytotoxicity of Cosmetics and Cosmetic Ingredients

August 15, 2024

5

August 18, 2024

Nanning Cosmetics Industry Association

T/NNHZP XXXX—XXXX Nursing After Spot Repair Tonic (Lotion, Cream)

/

6

August 18, 2024

Nanning Cosmetics Industry Association

T/NNHZP XXXX—XXXX Nursing After Spot Repair Mask

/

7

August 23, 2024

Guangdong Institute of Cosmetics Science and Technology

T/GDICST 004—2024 Test Method for the Microbial Challenge of Cosmetics

August 23, 2024

8

August 23, 2024

Standardization Administration of the P.R.C.

GB/T 44366—2024 Determination of Restricted Lauryl Alcohol Polyether-9 in Cosmetics—Liquid Chromatography Tandem Mass Spectrometry

March 1, 2025

9

August 23, 2024

Standardization Administration of the P.R.C.

GB/T 44367—2024 Determination of Restricted 2,4-Diamino-pyrimidine-3-oxide in Cosmetics—High Performance Liquid Chromatography

March 1, 2025

10

August 23, 2024

Standardization Administration of the P.R.C.

GB/T 44428—2024 Determination of Cannabidiol and Tetrahydrocannabinol in Cosmetics—Liquid Chromatography Tandem Mass Spectrometry

March 1, 2025

Market Condition

1. According to the National Bureau of Statistics, the retail sales of cosmetic products from January to July 2024 was CNY 241 billion, with a year-on-year increase of 0.3%. In July, the retail sales decreased by 6.1% YoY to CNY 24.5 billion. 

cosmetic-retail-sales.jpg

Notes: To mitigate the effects of non-fixed factors during the Spring Festival and improve data comparability, the National Bureau of Statistics released combined data for January and February. 

2. According to the GACC, the total import value of cosmetics and toiletries from January to July 2024 totaled CNY 68.6 billion, declining 8.8% YoY. In July, the import value decreased by 3.2% YoY to CNY 9.3 billion.

import-of-cosmetics-and-toiletries.jpg

Hongkong SAR, China

Hong Kong Customs Seizes Three Unsafe Whitening Moisturizers

On August 8, 2024, Hong Kong Customs issued a press release, urging the public to stop using three unsafe whitening moisturizers. Tests showed that one product contained 23,000 ppm of mercury, while two others from the same brand reached 24,000 ppm. Notably, the packaging for all three products bore warnings solely in English, lacking any Chinese warnings or cautions.

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Japan

PMDA: 226 Batches Cosmetics and Quasi-drugs Recalled in August

In August 2024, Japan Pharmaceuticals and Medical Devices Agency (PMDA) notified and recalled a total of 226 batches of cosmetic and quasi-drug products. The most affected products were nail polish with leaking issues, with a total of 162 batches recalled. The next most affected products were perfumes without proper manufacturer information.

South Korea

South Korea Clarifies the Labeling Methods for Salicylic Acid-Contained Cosmetics

On August 1, 2024, the Korean Cosmetic Association (KCA) issued a notice to clarify the proper labeling methods for salicylic acid-related claims for cosmetics.

Following the latest review result, for general cosmetic products, advertising and labeling of salicylic acid for purposes other than preservation is not allowed. However, if extracts containing salicylic acid are used in general cosmetics, the products can be advertised and labeled with efficacies of exfoliation control (각질조절). In this case, the direct advertising and labeling of the salicylic acid component is not permitted.

South Korea Consults on Cosmetic Safety Standard: Enhancing Management of UV filters, D4, D5, and Other Ingredients

On August 2, 2024, the Ministry of Food and Drug Safety (MFDS) released a notice to solicit public feedback on the modifications to Cosmetic Safety Standard till October 3, 2024. The authority proposes to designate one new UV filter, delete one UV filter, and enhance the usage limits of six restricted ingredients. Details are as follows: 

Ingredient

Current Requirements

Proposed Requirements

Compounds of Lawsone and Dihydroxyacetone
로우손·디하이드록시아세톤 혼합물

Can be used as UV filter
(Usage limit: Lawsone: 0.25%, Dihydroxyacetone: 3%)

Cannot be used as UV filter

2,6-Dihydroxyethylaminotoluene
2,6-디하이드록시 에칠아미노톨루엔

Can be used as hair dye component
(No usage limits specified)

Can be used as hair dye component
(Usage limit: 1.0%)
(Cannot be used along with nitrating agents, and the total amount of Nitrosamine shall be 50 ppb or less)

Benzophenone-3 (Oxybenzone)
벤조페논-3

Can be used as UV filter
(Usage limit: 5%)

Can be used as UV filter
(Usage limit: 2.4%. For facial, hand, and lip products: 5%)

Nonoxynol-9
노녹시놀-9

Can be used as a cosmetic ingredient
(No usage limits specified)

Can be used as a cosmetic ingredient
(Usage limit: 17.2%)

Butylphenyl methylpropional
부틸페닐메칠프로피오날 (릴리알)

Can be used as a cosmetic ingredient
(No usage limits specified)

Can be used as a cosmetic ingredient
(Usage limit: 0.14%)

Cyclosiloxane (D4)
사이클로테트라실록세인 (D4)

Can be used as a cosmetic ingredient
(No usage limits specified)

Can be used as a cosmetic ingredient
(Usage limit: 8.7%)

Cyclopentasiloxane (D5)
사이클로펜타실록세인 (D5)

Can be used as a cosmetic ingredient
(No usage limits specified)

Can be used as a cosmetic ingredient
(Usage limit: 19.7%)

Tris-Biphenyl Triazine
트리스-바이페닐트라이아진

Cannot be used as UV filter

Can be used as UV filter
(Usage limit: 10%)

Thailand

Thailand to Revise the Labeling Requirements for Cosmetics Containing Climbazole

On August 5, 2024, the Thai Food and Drug Administration (Thai FDA) released a draft notification for public consultation until August 19, 2024, proposing revisions to the warning statements on the labels of cosmetics containing climbazole as a preservative. To be specific,the warning statements are proposed to be updated to align with those for climbazole as a restricted ingredient.

Indonesia

Indonesia Revises Cosmetic Types Prohibited from Online Sales

On August 5, 2024, the finalized Regulation Concerning the Control of Drug and Food Online Distribution was released and implemented. This regulation primarily focuses on regulating the criteria for online sales of drugs (including cosmetics) and foods.

Indonesia Signs MoUs on Cooperation regarding Halal Product Quality Assurance with Singapore and Uruguay

Indonesia’s Halal Product Assurance Agency (BPJPH) issued two media statements on August 9 and August 12, 2024, announcing that BPJPH signed memorandums of understanding on cooperation regarding halal product quality assurance with the Singapore Islamic Religious Council (MUIS) and the Ambassador Extraordinary and Plenipotentiary of Uruguay to Indonesia.

Indonesia Proposes to Amend Cosmetic Labeling and Advertising Requirements

On August 29, 2024, Indonesia released an amended draft of the Regulation Concerning Cosmetic Labeling, Promotion, and Advertising for public consultation. This revised draft incorporates corporate obligations and supervision requirements for labeling, promotion and advertising outlined in the Technical Requirements for Cosmetic Labeling, Technical Guidelines for Cosmetics Advertising, as well as Regulation for Supervision on Manufacture and Circulation of Cosmetics.

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Vietnam

Vietnam Plans to Improve the Cosmetic Notification System

On August 6, 2024, issues arose in Vietnam's cosmetic notification system, preventing notifiers from uploading document files, digitally signing and submitting notification dossiers, or downloading payment receipts for appraisal fees. To ensure the smooth operation of the system, on August 26 and August 28, the Drug Administration of Vietnam (DAV) sent two letters to the General Administration of Customs and the National Health Information Center, requesting them to review and optimize the imported cosmetics notification system and urging them to resolve technical issues to facilitate the notification application process for cosmetic enterprises.

Singapore

HSA Alerts 3 Batches of Non-compliant Cosmetics Containing Potent Ingredients Found Overseas

On August 2, 2024, Singapore's Health Sciences Authority (HSA) released a list of products found overseas in July 2024 that contain potent ingredients, including 3 batches of cosmetics. The potent ingredients detected in these cosmetics include Bimatoprost, Mercury, and Tretinoin. These ingredients are prohibited for general use in cosmetics in accordance with ASEAN Cosmetic Directive (ACD).

India

India CDSCO Introduces New Restrictions on Cosmetics Applications

On August 9, 2024, the Central Drugs Standard Control Organization (CDSCO) of India announced a significant update to the cosmetics registration and import process. Under the new directive, companies submitting applications through the Sugam online portal will be limited to a maximum of 50 products per single application. They are also allowed to submit multiple applications. This change has been in effect since August 16, 2024.

Sri Lanka

Sri Lanka Seeks Public Input on Proposed Amendments to Cosmetic Standard

On August 26, 2024, the Sri Lanka Standards Institution (SLSI) initiated a public consultation regarding proposed revisions to the cosmetic standard SLS 34: 2009 Sri Lanka Standard—Specification for Toilet Soap. The proposed changes primarily focus on revising the "Table 1: Requirements for Toilet Soap" within the standard. Interested stakeholders are encouraged to submit their feedback via the SLSI webpage by October 23, 2024.

Australia

Australia Updates a Batch of Assessment Statements of Industrial Chemicals

On August 9, 2024, the Australia Industrial Chemicals Introduction Scheme (AICIS) released a series of assessment statements of industrial chemicals under application for assessment certificates. Among them, five chemicals are related to cosmetic use.

Australia Opens AICIS Annual Declaration for Year 2023-2024

On August 22, 2024, AICIS issued a notice to remind introducers to submit their annual declaration for the previous registration year by November 30, 2024, on its AICIS Business Services platform. Failure to submit by the deadline may result in penalties.

Australia Recalls a Batch of Non-compliant Cosmetics

On August 23, 2024, the Australian Competition and Consumer Commission (ACCC) issued a notice regarding a recall of a batch of Australian-themed temporary tattoos. The products were recalled because they failed to meet the mandatory labeling requirements in Consumer Goods (Cosmetics) Information Standard 2020.

United States

California Updates Cosmetic Reportable Ingredient List

In July 2024, the California Department of Public Health (CDPH) released the latest version of the Cosmetic Reportable Ingredient List (RIL). The new list adds 29 ingredients, removes 22, and revises 81 existing ingredients.

Under the California Safe Cosmetics Act (CSCA), manufacturers are required to report products containing carcinogenic ingredients to the CDPH. Additionally, the Cosmetic Fragrance and Flavor Ingredient Right to Know Act of 2020 (CFFIRKA) has mandated the reporting of certain fragrance allergens, effective from January 1, 2022. The California Safe Cosmetics Program (CSCP) has developed a comprehensive list of chemicals, consolidating all reportable ingredients under both the CSCA and CFFIRKA.

New Hampshire to Ban PFAS in Cosmetics

On August 2, 2024, the governor of New Hampshire signed House Bill 1649 into law, establishing a ban on the intentional use of PFAS in cosmetics sold within the state. This prohibition will take effect on January 1, 2027.

U.S. FDA Reports Rejection of 72 Batches of Cosmetics in July 2024

In July 2024, the U.S. FDA revealed that a total of 72 batches of imported cosmetics had been refused entry. These rejections spanned various categories, including hair preparations, oral hygiene products, makeup preparations, skin care preparations, personal cleanliness items, manicuring preparations, and fragrance preparations. Thailand was the major country of origin with 21 batches rejected, followed by India with 9 batches and Korea with 8 batches. The primary reasons for these rejections were the misdeclaration of drugs as cosmetics and labeling issues.

Canada

Canada Publishes Inspection Results of Eyelash Extension Adhesives and Pressurized Cosmetics

On August 16, 2024, Health Canada published seven new Consumer Product Safety Enforcement Summary reports of the 2023-2024 fiscal year, including one for cyanoacrylate-based eyelash extension adhesives and another for cosmetics in pressurized containers.

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