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Monthly Recap: Global Cosmetic Regulatory Updates | January 2024

Chinese Mainland

China Requires the Submission of Safety Information on All Ingredients

Starting from January 1, 2024, when applying for registration of special cosmetics and notification of general cosmetics, the cosmetic registrant and notifier must provide ingredient safety information documents for all ingredients used in the product formula.

Cosmetics Notifiers Are Required to Submit Annual Reports for Notified General Cosmetics

According to Provisions for Management of Cosmetic Registration and Notification Dossiers, cosmetic notifiers are required to submit annual reports for general cosmetics that have been notified for at least one year through the Cosmetics (Toothpaste) Information Service Platform. The submission period for these reports is from January 1 to March 31 each year.

For the specific year 2024, relevant notifiers and Chinese domestic responsible persons should submit their annual reports between January 1, 2024, and March 31, 2024, which cover general cosmetics notified before January 1, 2023.

China Solicits Public Opinions on Several Industry Standards

On January 8, 2024, the Ministry of Industry and Information Technology (MIIT) released an announcement seeking public feedback on 371 industry standards, 1 industry standard modification form, and 6 foreign language versions of industry standards. The public comment period is from January 8, 2024, to February 8, 2024. The table below shows the standards specifically related to cosmetics and oral hygiene products.

Standard Number

Standard Name

Standards to be Replaced

QB/T 2660-2024

Lotion

QB/T 2660-2004

QB/T 4079-2024

Massage Base Oil, Massage Oil

QB/T 4079-2010

QB/T 8003-2024

Cosmetic Ingredient - Salicylic Acid

/

QB/T 8004-2024

Cosmetics Ingredient - Squalane

/

QB/T 8005-2024

Cosmetic Ingredient - Palmitoyl Pentapeptide-4

/

QB/T 2317-2024

Oral Hygiene Products - Natural Calcium   Carbonate for Toothpaste

QB/T 2317-2012

QB/T 8039-2024

Oral Hygiene Products - Cocamidopropyl Betaine for Toothpaste

/

China Releases One Supplementary Testing Method for Ten Prohibited Ingredients

On January 9, 2024, China National Medical Products Administration (NMPA) released a supplementary testing method titled "Determination of 10 Ingredients in Cosmetics, Including Finasteride." This method is applicable to the quanlitative and quantitative determination of 10 prohibited ingredients in various cosmetic forms such as creams, liquids (water, oil), gels, wax-based products, and powder cosmetics.

The Ten Prohibited Cosmetic Ingredients

Chinese Name

English Name

CAS No.

羟基氟他胺

Hydroxyflutamide

52806-53-8

非那雄胺

Finasteride

98319-26-7

尼鲁米特

Nilutamide

63612-50-0

比卡鲁胺

Bicalutamide

90357-06-5

氟罗地尔

Fluridil

260980-89-0

氟他胺

Flutamide

13311-84-7

环丙孕酮

Cyproterone

2098-66-0

醋酸环丙孕酮

Cyproterone acetate

427-51-0

度他雄胺

Dutasteride

164656-23-9

依立雄胺

Epristeride

119169-78-7

China Releases the Inventory of Existing Toothpaste Ingredients

On January 12, 2024, China Oral Care Products Industry Association (COCIA) released the initial version of Inventory of Existing Toothpaste Ingredients in China, comprising 1,026 ingredients. The Inventory includes information such as the Chinese name, INCI/English name, the highest historical use concentration, and notes.

China General Administration of Customs (GACC): 22 Batches of Cosmetics Rejected in December 2023

On January 24, 2024, GACC updated the list of rejected food and cosmetics in December 2023. 22 batches of cosmetics imported from Germany, the United States, Italy, France, and South Korea were found to fail customs inspection. These failures were primarily attributed to the lack of required qualified documentation, non-compliant labeling, excessive bacterial colonies, and failed sensory inspection.

China Further Optimizes the Requirements for Exporting Cosmetics Containing Triethanolamine (TEA) to China

On January 25, 2024, China's MIIT, Ministry of Commerce (MOFCOM), and GACC jointly announced the removal of the import license requirement for products containing low-concentration Triethanolamine (CAS No. 102-71-6), including cosmetics. This adjustment became effective on February 1, 2024.

China NMPA Approves 12 NCIs

In January 2024, NMPA updated the notification status of 12 NCIs. 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. Pyridoxine tris-hexyldecanoate, notified on January 4, 2024

2. OPLOPANAX ELATUS adventitious root extract, notified on January 11, 2024

3. Dihydroxyphenylethyl alcohol, notified on January 12, 2024

4. β-Nicotinamide mononucleotide, notified on January 16, 2024

5. β-Alanyl Hydroxyprolydiaminobutyroyl Benzylamide, notified on January 16, 2024

6. 2'-fucosyllactose, notified on January 16, 2024

7. Polyglyceryl-3 stearate/sebacate crosspolymer, notified on January 16, 2024

8. Bis-(isostearoyl/oleoyl isopropyl)dimethylammonium methyl sulfate, notified on January 16, 2024

9. CARYODENDRON ORINOCENSE seed oil, notified on January 23, 2024

10. ERIGERON BREVISCAPUS Extract, notified on January 23, 2024

11. SALVIA PLEBEIA Extract, notified on January 23, 2024

12. Bishydroxyethyl PPG/PEG-7/4 dicyanomethylthiophene azotoluidine triethoxysilyl propyl carbamate, notified on January 25, 2024

Beijing and Guangzhou Authorities Publish FAQs Regarding Cosmetics and Toothpaste Notification

In January 2024, Guangzhou Administration for Market Regulation (AMR) and Beijing MPA published four batches of Frequently Asked Questions (FAQs). These FAQs cover a range of topics, emphasizing enterprise responsibility, toothpaste notification and general cosmetics notification, as well as essential oil regulatory requirements.

Release Date

Regulatory Authority

Batch

January 3, 2024

Beijing MPA

The 28th Batch

January 11, 2024

The 29th Batch

January 12, 2024

Guangzhou AMR

The 52nd Batch

January 18, 2024

The 53rd Batch

China Issues 13 Cosmetic Group Standards in January

In January 2024, China issued 13 cosmetic group standards. The essential information is as follows:

Release Date

Initiator

Standard Name

Effective Date

January 5, 2024

Guangdong Cosmetics Science and Technology Research Association

T/GDICST 003—2023 Soothing efficacy evaluation of cosmetics Test method for interleukin-6 (IL-6) with macrophage induced by lipopolysaccharide

January 5, 2024

T/GDICST 002—2023 Determination of SPF Value of Sunscreen Powder in vitro

China Association of Fragrance Flavour and Cosmetic Industries

T/CAFFCI 71—2024 Cosmetic ingredients—Hexapeptide-11

T/CAFFCI 72—2024 Cosmetic ingredients—Acetyl Dipeptide-1 Cetyl Ester

T/CAFFCI 73—2024 Cosmetic ingredients - Dendrobium Officinale Stem Extract

January 6, 2024

Shaoguan Forestry Industry Development Association

T/SGLYCYX 001—2024 Raw Materials for Cosmetics-camellia Oil

January 6, 2024

January 12, 2024

China Small and Medium Business   Enterprises Association

T/CASME 1248—2024 Cosmetic ingredients—Fibronectin

January 25, 2024

January 16, 2024

Guangdong Cosmetics Science and Technology Research Association

T/GDICST 001—2023 Guidelines for the Verification of Cosmetic Stability Tests

January 17, 2024

January 17, 2024

Zhejiang Health Products and Cosmetics Industry Association

T/ZHCA 029-2024 Cosmetic Soothing Efficacy Test: Keratinocyte Interleukin-8 Production Inhibition Method

April 15, 2024

T/ZHCA 030-2024 Cosmetic Soothing Efficacy Test: Reconstructed Epidermis Model Interleukin-8 Production Inhibition Method

T/ZHCA 031-2024 Tissue Vitality Method of Reconstructed Epidermal Model for Evaluation of Mildness of Rinse-off Cosmetics

T/ZHCA 032-2024 Tissue Vitality Method of Reconstructed Epidermal Model for Evaluation of Mildness of Leave-on Cosmetics

January 23, 2024

Guangdong Cosmetics Society

T/GDCA 035—2024 General Principles of Minimalist Formula Cosmetics

January 23, 2024

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Taiwan, China

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

On January 4, 2024, Taiwan Food and Drug Administration (TFDA) revealed its plans to adjust the current cosmetic ingredient lists. The proposed adjustments 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.

Taiwan Releases One Test Method for Cosmetics

On January 11, 2024, TFDA issued and implemented a test method for determining two hair waving agents, Thioglycolic Acid and Cysteine. Currently, products containing them are classified as specific purpose cosmetics, and subject to pre-market registration with TFDA. However, effective July 1, 2024, these products will be regulated as general cosmetics, whose pre-market obligation will be changed to notification and the establishment of a product information file (PIF).

Japan

PMDA: 86 Cosmetics and Quasi-drugs Products Recalled in January

In January 2024, Japan Pharmaceuticals and Medical Devices Agency (PMDA) issued 10 batches of non-compliant cosmetics and 76 batches of non-compliant quasi-drugs. Among the cosmetics, the main issue identified was the incorrect listing of ingredients on the product labels, including the listing of those not actually present in the products. As for quasi-drugs, the primary issue detected was the presence of foreign substances in the products, followed by multiple cases where the actual ingredient content was lower than the approved levels.

South Korea

South Korea Introduces the Electronic Document Service for Cosmetics Industry

On January 26, 2024, the Ministry of Food and Drug Safety (MFDS) announced the implementation of an electronic document service for the cosmetics industry, allowing for the issuance and management of registration certificates and other documents in electronic form. According to MFDS, the electronic document service is available for cosmetic manufacturing registration certificates, sales certificates, and other related documents on January 29, 2024. The service will be expanded to include CGMP compliance certificates and English certificates from February 19 this year.

South Korea to Modify the Cosmetic Labeling Requirements

On January 31, MFDS announced a legislative proposal for amendments to the Enforcement Rule of the Cosmetics Act, to strengthen the labeling requirements to ensure consumer’s safety of using special cosmetics. On the same day, the draft of Regulation of Labelling Cosmetics Precautions for Use and Fragrance Allergens is also published with corresponding modifications.

Key proposed amendments include:

(1) Intensification of cosmetic labeling standards by requiring mandatory ingredient list and precautions for "external genital cleansers" and "eyelash perm wave products," regardless of the product volume.

(2) Permission of the usage of certification results from private institutions in cosmetic advertising

(3) Optimization of administrative measures related to responsible sales manager resignation and business information changes.

India

India Consults on the Revised Standard for Petroleum Jelly Used in the Cosmetic Industry

On December 3, 2023, the Bureau of Indian Standards (BIS) released a revised draft of the petroleum jelly standard, IS 4887 Specification for Petroleum Jelly for Cosmetic Industry (Second Revision), for public consultation until March 12, 2024. The proposed changes primarily focus on adjusting the specifications of petroleum jelly and revising the marking requirements for ingredient containers.

Indonesia

Indonesia Proposes to Abolish Regulation No. 26 of 2018 Concerning Integration of Electronic Business Licensing Services in the Drug and Food Sector

On January 4, 2024, the Indonesian Food and Drug Supervisory Agency (BPOM) issued a draft proposal to invalidate Regulation No. 26 of 2018, which pertains to the integration of electronic business licensing services in the drug and food sector. This regulation, implemented on August 23, 2018, outlined the types of licenses required for the drug (including cosmetics) and food industries, along with corresponding requirements, application procedures, validity periods, and supervision measures. Specifically, it included provisions related to cosmetics licensing, such as the requirements for cosmetic notification certificates, GMP certificates, and import certificates.

BPOM's proposal to abolish Regulation No. 26 of 2018 stems from the release of Regulation No. 10 of 2021, which focuses on the Standards for Business Activities and Products in the Implementation of Risk-Based Business Licensing in the Drug and Food Sector. This subsequent regulation offers more comprehensive and explicit guidelines for obtaining cosmetics licenses. Consequently, the requirements specified in Regulation No. 26 of 2018 are no longer in line with current developments and must be invalidated.

Indonesia Proposes to Revise Cosmetic Types Prohibited from Online Sales

On January 22, 2024, Indonesia released the second draft amended Regulation Concerning the Control of Drug and Food Online Distribution. This regulation primarily focuses on regulating the criteria for online sales of drugs (including cosmetics) and food.

Malaysia

Malaysia Amends Cosmetic Ingredient Use Requirements: 17 Ingredients Added and 12 Ingredients Revised

On January 19, 2024, Malaysia National Pharmaceutical Regulatory Agency (NPRA) released Circular No. 1/2024 Information on the Updated Status of Ingredients in the Annex of the Guidelines for Control of Cosmetic Products in Malaysia. According to the Circular, the amendments are:

1) Annex II: List of Prohibited Ingredients - 15 added and 4 revised

2) Annex III: List of Restricted Ingredients - 5 revised

3) Annex IV: List of Permitted Colorants - 1 revised

4) Annex VI: List of Permitted Preservatives - 1 deleted

5) Annex VII: List of Permitted UV Filters - 2 added and 1 revised

The United States

U.S. FDA Unveils Additional Submission Tools for Cosmetic Facility Registration and Product Listing

On January 8, 2024, the U.S. Food and Drug Administration (FDA) officially launched several additional submission tools beyond the existing electronic submission portal, Cosmetic Direct. These tools are Structured Product Labeling (SPL) Xforms, and Form FDA 5066 and Form FDA 5067.

Oregon Implements Two Regulations Which Impacts Cosmetics

On January 1, 2024, the state of Oregon in the United States enacted two significant measures related to cosmetics. Firstly, House Bill 3043, approved on July 27, 2023 and involving revisions to the Toxic Free Kids Act, officially came into effect. Additionally, on the same day, the state enforced the cosmetic animal testing ban outlined in House Bill 3213, which was signed into law on August 4, 2023. As per the regulation, as of January 1, 2024, the sale of cosmetics developed through animal testing is prohibited in the state.

Australia

Australia Adds One Cosmetic Ingredient to the Australian Inventory of Industrial Chemicals (AIIC)

On January 4, 2024, the Australian Government added the cosmetic chemical 2H-Pyran, 3-heptyltetrahydro- (CAS No. 854737-09-0) to the AIIC under Section 83 of the Industrial Chemicals Act 2019. This ingredient has undergone assessment as a fragrance component intended for use in cosmetics and household products within Australia. The permitted maximum annual import volume of this chemical is one tonne.

Australia TGA Consults on Amendments to the Poisons Standard

On January 5, 2024, the Therapeutic Goods Administration (TGA) of Australia launched a month-long consultation on the proposed amendments to eight substances in the Poisons Standard. Among these, changes relevant to cosmetics include the scheduling adjustments of ethyl lactyl retinoate (CAS No. 74534-80-8) and tranexamic acid (CAS No. 1197-18-8).

Australia Consults on Proposed Amendments to Industrial Chemicals Categorization Guidelines

On January 25, 2024, the Australian Government initiated a public consultation regarding the proposed amendments to the “List of Chemicals with High Hazards for Categorization” and minor textual revisions to the Industrial Chemicals Categorization Guidelines. Stakeholders are invited to provide feedback before February 22, 2024.

New Zealand

New Zealand Bans PFAS in Cosmetics

The Environmental Protection Authority (EPA) of New Zealand implemented a ban on the use of PFAS in cosmetics on January 30, 2024.

In addition to the PFAS ban, the Cosmetic Products Group Standard has undergone some other updates to ensure the safety of cosmetic products and align with the rules in Europe, such as "non-hazardous cosmetic products" introduction, nanomaterials record-keeping requirements, precautions and labels, etc.

Sri Lanka

Sri Lanka Consults on Amendments to Three Cosmetic Standards

On January 9, 2024, the Sri Lanka Standards Institution (SLSI) opened a public consultation on the proposed amendments to three cosmetic standards, namely SLS 589: 2018 Sri Lanka Standard—Specification for Baby CologneSLS 742: 2021 Sri Lanka Standard—Specification for Skin Creams and Lotions for Babies, and SLS 743: 2021 Sri Lanka Standard—Specification for Skin Creams and Lotions. Stakeholders can provide feedback no later than March 10, 2023. The proposed changes aim to improve the clarity of warning statements and address practical challenges in the testing procedures.

Others

IFRA Releases the Updated Version of the IFRA Standards

On January 8, 2024, the International Fragrance Association (IFRA) published the updated version of the IFRA Standards. This revised edition incorporates the 51st Amendment to the previous version, ensuring a comprehensive and integrated set of standards.

Further Reading

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