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China Cosmetic and Toothpaste Regulation Updates in 2023

As 2023 draws to a close, cosmetics and toothpaste compliance is on track with a series of regulatory updates. EnterCo has picked out some significant regulation updates in 2023 and listed the main challenges in 2024.


Source: National Medical Products Administration (NMPA)

Publish Date: January 12, 2023

Implementation Date: March 1, 2023

Keywords: Sampling, Inspection, Post-Marketing


It has 8 chapters and 61 articles, which define the procedures, time limits, and requirements for the whole process of sampling inspection, and strive to reduce the burden of enterprises and protect their legitimate rights and interests from multiple aspects such as sampling inspection, disposal, and information disclosure.


Source: National Medical Products Administration (NMPA)

Publish Date: January 18, 2023

Implementation Date: January 18, 2023

Keywords: General Cosmetics, Filing Inspection


It has relaxed the requirements for filing inspection of general cosmetics. As long as the product safety risk assessment results can fully confirm the product's safety, the filing can conduct self-inspection and issue inspection reports during the product filing (except for special circumstances).


The Technical Guidelines for the Determination of New Cosmetic Raw Materials (Draft for Comments)

Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: January 19, 2023

Expiry Date: February 10, 2023

Keywords: New Cosmetic Raw Materials, Technical Guidelines, Draft


The draft summarizes the principles of determining, classifying, and naming new cosmetic raw materials.


Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: March 17, 2023

Expiry Date: April 2, 2023

Keywords: Anti-freckle, Whitening, Cosmetics, Ingredients, Technical Guidelines, Draft


Two drafts stipulate anti-freckle and whitening cosmetics requirements covering the scope of application, general principles, product properties, formula design, product safety assessment, production process and quality control, efficacy evaluation and product label, as well as the use and research of raw materials for anti-freckle and whitening cosmetics.


Source: State Administration for Market Regulation (SAMR)

Publish Date: March 23, 2023

Implementation Date: December 1, 2023

Keyword: Toothpaste


The Measures have 25 Articles, covering the definition of toothpaste and regulatory departments, the management requirements for toothpaste and toothpaste raw materials, toothpaste efficacy management, and labeling requirements, etc.


Publish Date: March 27, 2023

Implementation Date: March 27, 2023

Keywords: Cosmetic Ingredients, Safety Information


As of March 27, 2023, cosmetic registrants and filers can choose the following three ways to submit cosmetic ingredient safety information:1) Fill in the ingredient submission code; 2) Fill out and submit the ingredient safety information by yourself; 3) Combination of filling in the ingredient submission code and filling out and submitting the ingredient safety information by oneself. The starting time for submitting ingredient safety information for all ingredients is postponed from January 1, 2023, to January 1, 2024.


Source: National Medical Products Administration (NMPA)

Publish Date: April 4, 2023

Implementation Date: September 1, 2023

Keywords: Cosmetics Online Operation


It consists of 5 Chapters and 35 Articles, which clarify the regulatory targets and departments for cosmetic online operation, the Platform's responsibility for the management of operators within the Platform, the legal obligations of cosmetic operators within the Platform, and the regulatory requirements for cosmetic online operation.


The Technical Guidelines for 28-Day Inhalation Toxicity Study and 90-Day Inhalation Toxicity Study (Draft for Comments)

Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: April 13, 2023

Expiry Date: May 6, 2023

Keywords: Inhalation Toxicity Study


The draft provides the basic principles, requirements, and methods for the 28/90 days inhalation toxicity study on rodents, which applies to the detection of 28/90 days inhalation toxicity of cosmetic raw materials.


The Technical Guidelines for Dermal Irritation and Corrosion Test and Other 6 Tests (Draft for Comments)

Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: April 27, 2023

Expiry Date: May 20, 2023

Keywords: Dermal Irritation, Dermal Corrosion, Technical Guidelines


The draft technical guidelines cover the following tests: Dermal Irritation/Corrosion Test, Acute Eye Irritation/Corrosion Test, Dermal Phototoxicity Test, Bacterial Reverse Mutation Test, Human Skin Patch Test, Safety Evaluation of Using Tests of Cosmetics on Human Body, In vivo Determination of Sunscreen UVA Protection.


The Technical Guidelines for Skin Sensitisation Test (Draft for Comments)

Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: May 4, 2023

Expiry Date: May 20, 2023

Keywords: Skin Sensitisation Test, Technical Guidelines


The draft stipulates the general principles, basic contents, and result evaluation of the skin sensitization test.


Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: May 4, 2023

Expiry Date: May 20, 2023

Keywords: Cosmetic Ingredients, Safety Information, Technical Guidelines


The draft summarizes the technical points and principles that need to be considered in the process of filling out the raw material safety information, focusing on basic information on raw materials, a brief description of production processes, quality control requirements, and limit requirements for hazardous substances.


Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: May 4, 2023

Expiry Date: May 20, 2023

Keywords: Cosmetic Formula, Technical Guidelines


The draft is used to guide and refine the specific requirements for filling in formula ingredients, ingredient name, ingredient content, purpose of use, formula remarks column, and ingredient safety information.


Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: May 12, 2023

Expiry Date: May 31, 2023

Keywords: Cosmetic Ingredient Safety Information, Registration Platform, Technical Guidelines


The draft is intended to guide raw material producers to standardize the use of the Cosmetic Ingredient Safety Information Registration Platform. Raw materials with independent serial numbers in the Inventory of Existing Cosmetic Ingredients in China (IECIC 2021) are suitable for registering safety information on the Platform.


Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: June 5, 2023

Keywords: Cosmetics, New Cosmetic Ingredients, Guidelines


Nine guidelines for registration and approval of cosmetics and new cosmetic ingredients provide a detailed introduction to the registration and approval of high-risk new cosmetic ingredients. They also provide detailed explanations and answers on the registration change, initial registration, registration renewal, and registration cancellation of domestic and imported special cosmetics.


Publish Date: June 12, 2023

Expiry Date: July 15, 2023

Keywords: Prohibited Cosmetic Ingredient, Toxicity Study


It covers seven test method drafts, including 28-day Inhalation Toxicity Study, 90-day Inhalation Toxicity Study, Extended One-generation Reproductive Toxicity Study, Two-generation Reproductive Toxicity, Skin Absorption-In Vivo Method, Acute Inhalation Toxicity and Acute Toxic Class Method, U937 Cell Line Activation Test, and five cosmetic raw materials proposed to be added to the Catalogue of Raw Materials Banned for Cosmetics, namely Bimatoprost, Latanoprost, Tafluprost ethyl amide, and Travoprost.


Publish Date: July 7, 2023

Keywords: Tacrolimus, Pimecrolimus, Test Method


The method applies to multiple cosmetic products, including liquids, creams & lotions, for qualitative and quantitative analysis of Tacrolimus and Pimecrolimus.


Publish Date: July 12, 2023

Expiry Date: August 13, 2023

Keywords: Azelaic Acid, Photoreactivity, Reactive Oxygen Species, Selenium Sulfide, Test Method


It includes the test method for Azelaic Acid and Potassium Azeloyl Diglycinate in cosmetics, the determination of reactive oxygen species (ROS) for photoreactivity, and the determination of Selenium Sulfide in cosmetics.


NMPA Announcement on Matters Related to the Implementation of Toothpaste Regulation and Simplified Filing Requirements for Marketed Toothpaste

Publish Date: September 25, 2023

Expiry Date: November 30, 2023

Keywords: Toothpaste, Simplified Filing


From October 1, 2023, to November 30, 2023, the toothpaste filer can submit the simplified filing materials through the filing platform for the filing of marketed toothpaste products.


Source: National Medical Products Administration (NMPA)

Publish Date: August 28, 2023

Keywords: Cosmetic Safety, Test Method, Banned Ingredient


Five revised test methods will replace the original test methods in the Technical Specification for the Safety of Cosmetics(Edition 2015), which shall be effective as of March 1, 2024.

14 new test methods were added in the Specification, which shall come into force upon release.

The addition of a new banned ingredient (Tapinarof) in the Specification, shall come into force upon release.

The addition of a new regulatory limit for benzene (2mg/kg) in the Specification, shall take effect upon release.


Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: August 31, 2023

Keywords: Children's Cosmetics, Technical Guidelines

 

The Guidelines stipulate the definition and efficacy of children's cosmetics, requirements for the use of ingredients, product implementation standards, cosmetic inspection reports, cosmetic product safety assessment, etc.


Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: September 4, 2023

Implementation Date: September 4, 2023

Keywords: Cosmetic Formula, Technical Guidelines

 

It applies to guide the filling in of cosmetic product formulas, including the requirements for formula components, the form of formula filling, the name and content of ingredients, the main purpose of use, and the filling out of the remarks column in the formula table, as well as the filling in of ingredient safety information, etc.


Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: September 4, 2023

Implementation Date: September 4, 2023

Keywords: Cosmetic Ingredient Safety Information, Technical Guidelines


It applies to situations where cosmetic registrants, filers (and their domestic responsible persons) fill in and submit ingredient safety information on their own in the cosmetic registration and filing materials, but does not apply to situations where ingredient manufacturers submit ingredient safety information through the Cosmetic Ingredient Safety Information Registration Platform.


Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: September 4, 2023

Keywords: Cosmetic Ingredient Safety Information, Registration Platform, Guidelines

 

It is used to guide ingredient manufacturers to standardize the use of the Cosmetic Ingredient Safety Information Registration Platform. Ingredients that have a separate serial number in the IECIC (2021) are suitable for registering safety information in the Cosmetic Ingredient Safety Information Registration Platform.


Publish Date: September 25, 2023

Expiry Date: November 30, 2023

Keywords: Toothpaste, Simplified Filing


From October 1, 2023, to November 30, 2023, the toothpaste filer can submit the simplified filing materials through the filing platform for the filing of marketed toothpaste products.


Source: National Medical Products Administration (NMPA)

Publish Date: September 25, 2023

Expiry Date: October 18, 2023

Keywords: Toothpaste Filing, Draft


It consists of 3 chapters and 33 articles, including general provisions, requirements for related materials of user information, and requirements for toothpaste filing materials. What’s more, it provides detailed explanations of product name information, product formula, product execution standards, product labels, product inspection reports, children's toothpaste, etc.


Source: National Medical Products Administration (NMPA)

Publish Date: October 19, 2023

Expiry Date: November 10, 2023

Keywords: Cosmetic Inspection, Management Measures, Draft


The draft consists of 8 chapters and 46 articles, which provide detailed regulations for cosmetic inspection work, including inspection classification, inspection methods, and inspection focus.


NMPA Announcement on the Test Method for Determination of Clobetasol Acetate in Cosmetics

Publish Date: November 2, 2023

Keywords: Clobetasol Acetate, Test Method


The method is applicable to multiple cosmetic products, including liquids, creams & lotions, gels, mud masks, and films, for qualitative and quantitative analysis of Clobetasol Acetate.


NMPA Announcement on Encouraging Innovation and Standardizing Management of New

Cosmetic Raw Materials

Publish Date: November 10, 2023

Keyword: New Cosmetic Raw Materials


The announcement has important guiding significance for the standardized development of new cosmetic raw materials, and the long-standing problem of the illegal addition of cosmetic raw materials in the industry may be resolved. It stated that if the applicant for the filing of new cosmetic raw materials discovers problems during their self-inspection, they can proactively cancel the filing of new raw materials. Moreover, it encourages the development of new cosmetic raw materials by combining traditional advantageous projects and characteristic plant resources in China. It supports the use of modern science and technology for cosmetic raw materials research and innovation.

 

Source: National Medical Products Administration (NMPA)

Publish Date: November 22, 2023

Implementation Date: December 1, 2023

Keyword: Toothpaste Filing Materials


There are three chapters and thirty-two articles in the Provisions, which provide detailed descriptions of toothpaste filers, user information, toothpaste filing information, children's toothpaste, efficacy evaluation, etc.


Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: December 1, 2023

Expiry Date: December 18, 2023

Keywords: New Cosmetic Ingredients, Definition, Classification


The draft is applicable to registrants and filers of new cosmetic raw materials to define and conduct related research on new cosmetic raw materials. It clarifies the new cosmetic raw materials definition, the categories of new cosmetic raw materials, and raw materials that do not belong to new cosmetic raw materials. It emphasizes the general requirements for conducting research on new cosmetic raw materials.


Source: National Institutes for Food and Drug Control (NIFDC)

Publish Date: December 1, 2023

Keywords: Working Mechanism, Communication and Exchange, New Cosmetic Ingredients


It aims to encourage and support the research and innovation of new cosmetic raw materials, standardize communication and exchange between the registrants and filers of new cosmetic raw materials, and the department for cosmetic evaluation. The registrants and filers of new cosmetic raw materials can apply for communication and exchange on important technical issues before application and during the evaluation process.


Challenges in 2024

In 2024, the industry will face a series of new challenges with tighter regulations. The following aspects need to be focused on:


Cosmetic Ingredient Safety Information

Starting from January 1, 2024, when applying for cosmetic registration and filing, the registrant and filer shall fill in and submit the safety information of all ingredients used in the product formula in accordance with relevant regulations and technical specifications.


Cosmetic Safety Assessment

Before May 1, 2024, cosmetic registrants and filers can submit a simplified version of the product safety assessment report in accordance with the relevant requirements; after May 1, 2024, a full version of the product safety assessment report is required.


Toothpaste Label

The simplified filing toothpaste requires the completion of product label updates as required by July 1, 2024.


EnterCo, as a professional cosmetic and toothpaste compliance service provider, can help you solve the above problems. For a detailed compliance solution, contact us via info@enter-co.com.

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