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Monthly Recap: Global Cosmetic Regulatory Updates | March 2023

Chinese Mainland

China Implemented Two CSAR Subsidiary Regulations in March

On March 1, 2023, China National Medical Products Administration (NMPA) implemented the Measures for the Management of Cosmetic Sampling Testing and the Regulations on Supervision and Administration of Enterprises in Implementing Entity Responsibility for Cosmetic Quality and Safety. These two regulations are important subsidiary regulations of CSAR in China. The former spells out the detailed requirements on the formulation of sampling testing work plan, sampling, testing and result submission, objection and re-testing, verification and disposal of unqualified products, as well as information disclosure. The latter specifies the entities responsible for cosmetic's quality and safety, the responsibilities of key positions related to cosmetic quality and safety, as well as the scope of personnel subject to penalties when certain misconduct happens, and the situations where penalties can be mitigated or exempted.

China Halts the Use of Nonylphenol Ingredients in Cosmetics

On March 1, 2023, the "List of Key Controlled New Pollutants (2023 Edition)" took effect, which was jointly published by six departments including the Ministry of Ecology and Environment and the State Administration for Market Regulation (SAMR) in December last year. The 2023 Edition lists nonylphenol as a new pollutant and explicitly prohibits using nonylphenol ingredients as cosmetic components and nonylphenol to produce nonylphenoxypoly(ethyleneoxy)ethanol.

China Consults on the First Regulation for Freckle-Removing and Whitening Cosmetic Ingredients

On March 17, 2023, China National Institutes for Food and Drug Control (NIFDC) released the draft Technical Guidelines for Research on Freckle-removing and Whitening Cosmetics and the draft Technical Guidelines for Research on Functional Ingredients of Freckle-removing and Whitening Cosmetics for public consultation. The former draft regulation provides technical guidance for the R&D, safety assessment, efficacy evaluation, manufacturing, quality control and labeling of freckle-removing and whitening cosmetics, while the latter offers scientific suggestions and technical guidance for cosmetic registrants to research and evaluate freckle-removing and whitening ingredients.

China Issues an Enforcement Guidance on the Use of Absolute Terms in Advertising

On March 20, 2023, China SAMR issued Enforcement Guidance on Absolute Terms in Advertising, with immediate effect. The Guidance clarifies the concept and application scenarios of absolute terms, specifies situations where the previous provisions on absolute terms do not apply, and guide market supervision authorities to issue punishment.

China SAMR to Implement the Administrative Measures on Toothpaste

On March 23, 2023, China SAMR issued the finalized Administrative Measures on Toothpaste, which clarifies the responsibilities of all parties, the definition of toothpaste, as well as the requirements for toothpaste products and new ingredients management, toothpaste safety assessment, efficacy claims and labeling, etc. The regulation will come into force on December 1, 2023.

China NMPA Provides Relief for Cosmetic Industry with Eased Ingredient Safety Information Submission Policies

On March 27, 2023, China NMPA issued the adjusted management policies on the submission of cosmetic ingredient safety information. The new rule highlights that for ingredients without an ingredient submission code, cosmetics registrants and notifiers can now fill in and submit the ingredient safety information documents by themselves. The transition period of the cosmetic ingredient safety information submission policies has been extended to January 1, 2024. For all cosmetics registered and notified before 2024, only registrants and notifiers of specific categories of ingredients are required to supplement the safety information.

The 2023 Annual Report Submission Period of General Cosmetics Closed on March 31

On March 31, 2023, the three-month general cosmetics annual report for the current year ended, which targeted general cosmetics notified before December 31, 2021, including Chinese domestic and imported products. The required reporting information includes the general situation of the production and import of products, the suspension of production during the reporting period (if any), as well as self-inspection on the conformity of products with laws and regulations, mandatory national standards, and technical specifications.

China NMPA Approves Three New Cosmetic Ingredients

In March 2023, NMPA updated the notification information of three new cosmetic ingredients (NCIs). The details of these NCIs have yet to be published. Please stay tuned for ChemLinked’s update.

NMPA, Guangzhou AMR and Beijing Municipal MPA Publish FAQs Regarding Cosmetics Notification

In March 2023, Guangzhou Administration for Market Regulation (AMR) and Beijing Municipal MPA released four batches of FAQs surrounding cosmetics notification, such as requirements for enterprises information management, cosmetic labelling, toxicological testing, safety assessment, notification self-testing, etc.

Release Date

Regulatory Authority

Batch

March 14, 2023

Guangzhou AMR

The 33rd Batch

March 17, 2023

Beijing Municipal MPA

The 19th Batch

March 22, 2023

Guangzhou AMR

The 34th Batch

March 30, 2023

NMPA

The 6th Batch

China Issued Ten Cosmetics-related Standards in March

In March, China issued ten cosmetics-related standards. The basic information is as follows:

Type

Initiator

Standard Name

Release Date

Effective Date

Group Standard

China International Association for Promotion of Science and Technology

T/CI 016-2023 Cosmetic Ingredients-Nicotinamide

March 1, 2023

February 23, 2023

China Household Chemicals Industry Association

T/CHCIA 0012-2023 Cosmetic Skin Microbiome Evaluation Guidelines Microbiomics (Amplicon Sequencing)

March 13, 2023

April 15, 2023

Guangdong Chamber of Daily-Used Chemicals

T/XXX XXXX-2023 Method for Exfoliating Effect of Cosmetics (Draft for Comments)

March 14, 2023

/

Zhejiang Health Products & Cosmetics Industry Association

T/ZHCA 022-2023 Cosmetics-General Rules for "Anhydrous Skin Care" Products Based on Plant Liquids

March 21, 2023

April 15, 2023

Zhejiang Product and Engineering Standardization Association

T/ZS 0463-2023 Specifications for Excessive Packaging Inspection of Commodities-

Food and Cosmetics

March 24, 2023

March 31, 2023

National Standard

Standardization Administration of China

GB/T 42424-2023 Determination of 11 Kinds of Restricted Dyestuff such as 5-amino-6-chloro-o-cresol in Hair Dyes—HPLC-MS

March 24, 2023

October 1, 2023

GB/T 42423-2023 Determination of Dichlorobenzyl Alcohol and Chlorophensin in Cosmetics—High-performance Liquid Chromatography

March 24, 2023

GB/T 42425-2023 Determination of Capryloyl Salicylic Acid, Phenyiethyi Resorcinol, Ferulic Acid in Cosmetics―High-performance Liquid Chromatography

March 24, 2023

GB/T 42462-2023 Validation Criteria for Analytical Results of Cosmetics Using Chromatographic Techniques

March 24, 2023

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

March 24, 2023

April 1, 2024

Taiwan, China

Taiwan Releases Two Test Methods for Cosmetics

On March 8, 2023, Taiwan Food and Drug Administration released two test methods for cosmetics. The basic information is as follows:

No.

Test Method

Implementation Date

1

Method of Test for Hair Dyes in Cosmetics

March 8, 2023

3

Method of Test for Hair Dyes in Cosmetics (3)

cosmetic-compliance-service-47.gif

Japan

Japan Revises the Requirements for JSQI 2021

On March 27, 2023, the Ministry of Health, Labour and Welfare (MHLW) issued Notification 0327 No. 1 and Notification 0327 No. 5, making minor adjustments to the Japanese Standards of Quasi-drug Ingredients 2021 (JSQI 2021) and revising the application requirements for manufacturing and sales license. Details are as follows:

  1. The description method of reagent and test solution are unified with those in the Japanese Pharmacopeia, etc.

  2. Application requirements for quasi-drugs are approved with some tiny adjustments.

These amendments came into effect upon its publication on March 27, but the previous provisions can still be applied before September 30, 2024.

South Korea

South Korea Consults on Cosmetics Act

On March 22, 2023, the Ministry of Food and Drug Safety (MFDS) published a notification to solicit public opinions on the Cosmetics Act. The authority proposed to modify the relevant provisions and clarify the obscure terminologies, in order to distinguish the prohibited label scope. Suggestions are welcome before May 2, 2023.

South Korea Requires the Recyclability Data of Products and Packaging Materials before April 15

On March 28, 2023, the Ministry of Environment (MOE) published a notice to require the relevant enterprises to submit the delivery and import data of products and packing materials before April 15, 2023. ChemLinked concluded the critical points of the notice, including the data to submit, and exemption situations. Find out the details at ChemLinked News.

Thailand

Thailand to Ban PFAS in Cosmetic Products

In response to New Zealand Environmental Protection Authority’s draft proposal to ban all PFAS in cosmetics by 2025, the Thai Food and Drug Administration (Thai FDA) announced on March 12, 2023, that it had found no PFAS and their derivatives in cosmetics produced, imported and sold in Thailand after checking the database of registered cosmetics. The Thai FDA also plans to issue an updated list of prohibited cosmetic ingredients, including 13 kinds of PFAS and their derivatives.

Indonesia

Indonesia Releases the Finalized Regulation for Supervision on Manufacture and Circulation of Cosmetics

On March 28, 2023, Indonesia released and implemented the finalized Regulation for Supervision on Manufacture and Circulation of Cosmetics. The main amendments include slight adjustment of the onsite inspection items, standardizing the qualification and document requirements for the technical responsible person of importers and entrusted manufacturers, as well as the addition of supervision requirements for refillable cosmetics.

Australia

Australia Introduces a New Guidance on Submitting Pre-Introduction Report

On March 29, 2023, the Australian Government issued a practical guidance to help businesses avoid common errors when submitting pre-introduction report (PIR) for chemicals categorized as “internationally assessed for human health and the environment” under the reported introduction category. This guide applies to industrial chemical importers and manufacturers whose chemical introductions comply with the reported introduction criteria for the aforementioned classification and are required to the submission of a PIR.

Australia Adds a Cosmetic Ingredient to the Australian Inventory of Industrial Chemicals

On March 30, 2023, the Australian Government announced the addition of the industrial chemical Benzene, 1-(2-methylpropyl)-4-(propoxymethyl)- (CAS No. 1631962-93-0) to the Australian Inventory of Industrial Chemicals (AIIC) under Section 83 of the Industrial Chemicals Act 2019.

The chemical has undergone assessment for the following uses:

  1. Imported as a fragrance component into Australia at a maximum of 1 tonne per year;

  2. Imported as a component of liquid fragrance formulations at a concentration of up to 10% for local reformulation into finished cosmetic and household products;

  3. Imported or formulated as a component of finished cosmetic and household products at the following concentrations:

  • Up to 0.03% concentration in non-spray deodorants

  • Up to 0.1% concentration in leave-on cosmetic products

  • Up to 0.2% concentration in fine fragrances

  • Up to 0.4% concentration in hair care products

  • Up to 0.6% concentration in rinse-off cosmetic and household products

  • Up to 5% concentration in air care products

New Zealand

New Zealand Consults on the Revised Cosmetic Products Group Standard 2020

On March 2, 2023, New Zealand's Environmental Protection Authority (EPA) released a new draft of Cosmetic Products Group Standard 2020 (the Standard) for public consultation. Compared with the current Standard currently in force, the new draft expands its applicable scope to non-hazardous products containing hazardous ingredients, updates the ingredient lists to align with the latest amendments adopted by the EU, modifies labelling requirements, and requires the record keeping of nanomaterial.

The United States

US FDA Stops the VCRP System and Will Launch a New System for Facility Registrations and Product Listings

On March 27, 2023, the U.S. Food and Drug Administration (FDA) announced two major cosmetic regulatory changes, namely, the discontinuation of the Voluntary Cosmetic Registration Program (VCRP) and the launch of a new webpage dedicated to the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), which is the country’s new overarching cosmetic regulation.

Canada

Canadian Government Commits to End Cosmetic Animal Testing

On March 28, 2023, the Government of Canada introduced its 2023 Federal Budget. In the Budget, the government proposes to amend the Food and Drugs Act to ban cosmetic testing on animals. The proposed amendments would prohibit testing cosmetics on animals in Canada, selling cosmetics that rely on animal testing data to prove the product’s safety, and false or misleading labelling related to cosmetic animal testing.

Brazil

Brazil Bans Animal Testing for Cosmetics

Resolution No. 58 adopted on February 24, 2023 by Brazil’s National Council for the Control of Animal Experimentation (CONCEA) officially entered into force on March 1, 2023, which prohibits the use of vertebrates (other than human beings) in R&D and quality control of personal hygiene products, cosmetics, and perfumes. This ban applies to the said products formulated with ingredients and/or compounds that have already been proven to be safe and effective.

Brazil Revises the Labeling Requirements for Cosmetics

On March 9, 2023, Brazil notified WTO of its Resolution RDC No. 773, which updated the labeling requirements for personal hygiene products, cosmetics, and perfumes. Specifically, the chemical composition must be presented in a digital format, accessible through mobile device by scanning the code on the label. Besides, the chemical composition must be in Portuguese, preceded by the phrase "Composition" (in English) or "Ingredients" (in English), and be presented either in parentheses, after a slash, or in a separate list. The resolution takes effect on November 1, 2023.

The European Union

EU SCCS Finalizes the Opinion as to Hydroxyapatite (nano)

On January 11, 2023, EU Scientific Committee on Consumer Safety (SCCS) released the preliminary opinion SCCS/1648/22 on Hydroxyapatite in nano form. In light of the information received during the commenting period, SCCS released the final opinion on March 23, 2023. In the opinion, SCCS concludes that it is safe when Hydroxyapatite (nano) is used at concentrations up to 10% in toothpaste, and up to 0.465% in mouthwash.

Further Reading

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