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EnterCo’s Newsletter – September 2023

EnterCo has collected China cosmetics regulatory updates in August, with sharing our activities & events.


Official Announcements & Notices

NIFDC Notice on the Technical Guidelines for Filling in the Cosmetic Formula


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

Publish Date: September 4, 2023


Main Content Involved

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.


NIFDC Notice on the Technical Guidelines for Filling in the Cosmetic Ingredient Safety Information


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

Publish Date: September 4, 2023


Main Content Involved

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.


NIFDC Notice on the Guidelines for Filling in the Cosmetic Ingredient Safety Information Registration Platform


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

Publish Date: September 4, 2023


Main Content Involved

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.


NIFDC Announcement on the Technical Guidelines for Test Method of Immunotoxicity (Draft for Comments) and Other Two Technical Guidelines


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

Publish Date: September 7, 2023


Main Content Involved

1) Technical Guidelines for Test Method of Immunotoxicity (Draft for Comments) and Its Drafting Instructions

2) Technical Guidelines for Test Method of Toxicokinetics (Draft for Comments) and Its Drafting Instructions

3) Technical Guidelines for Test Method of Reproductive and Developmental Toxicity (Draft for Comments) and Its Drafting Instructions


Hangzhou Notice on Several Measures to Support the High-Quality Development of Synthetic Biology Industry


Source: Hangzhou Municipal Government

Publish Date: September 7, 2023


Main Content Involved

A maximum subsidy of 300,000 yuan will be given for new cosmetic ingredients that have been registered or filed with the National Medical Products Administration (NMPA) and successfully included in the Catalogue of Used Cosmetic Raw Materials (Edition 2021).


For enterprises engaged in cosmetics R&D and production, a maximum reward of 100,000 yuan will be given for each item that obtained special cosmetic registration certificates (excluding cosmetics with the efficacy of hair dye or hair perm).


The maximum annual subsidy (reward) amount for a single enterprise shall not exceed 1 million yuan.


The measure will come into force on October 9, 2023, and be valid until December 31, 2028.



Source: National Medical Products Administration (NMPA)

Publish Date: September 25, 2023


Main Content Involved

As of December 1, 2023, domestic toothpaste shall be filed with the provincial drug regulatory department where the filer is located before being put on the market for sale; Imported toothpaste shall be filed with the National Medical Products Administration (NMPA) before importing.


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


For toothpaste products with simplified filing, toothpaste filers shall collect and complete the corresponding product filing materials in accordance with relevant regulations and requirements before December 1, 2025. If the first batch of products are launched and sold before January 1, 2021, the product filing materials can be kept by the filer for future reference; If the first batch of products are launched and sold after that, the filer shall submit complete filing materials through the filing platform.


For toothpaste products with simplified filing, product label updates should be completed as required before July 1, 2024. Except for toothpaste products that only claim to have cleansing effects, toothpaste products with simplified filing should also upload and publish a summary of the basis of the product efficacy claims through the filing platform before December 1, 2025.



Source: National Medical Products Administration (NMPA)

Publish Date: September 25, 2023


Main Content Involved

It consists of three chapters and thirty-three articles, including general provisions, requirements for user information related materials, 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. Enterprises can prepare filing materials according to this draft in advance.



Source: Zhejiang Medical Products Administration

Publish Date: September 28, 2023


Main Content Involved

As of December 1, 2023, the filing person of domestic toothpaste within Zhejiang Province shall before placing on the market of toothpaste products, complete toothpaste filing through the Toothpaste Filing Information Service Platform and with the Zhejiang MPA, and submit the following complete materials:

1). Name, address, contact information of the filing person;

2). Name, address, contact information of the production enterprise;

3). Product name;

4). Product formula;

5). Product implementation standard;

6). Product label template;

7). Product inspection report;

8). Product safety assessment materials.


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



Source: Guangdong Medical Products Administration

Publish Date: September 28, 2023


Main Content Involved

As of December 1, 2023, the filing person of domestic toothpaste within Guangdong Province shall before the placing on the market of toothpaste products, complete toothpaste filing through the Toothpaste Filing Information Service Platform and with the Guangdong MPA.


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



Official Q&A


Source: Beijing Medical Products Administration

Publish Date: September 5, 2023


Main Content Involved

1) What is the children’s cosmetic?

2) What are the requirements for formula design principles in the safety assessment report of children's cosmetics?

3) What are the requirements for children's cosmetics in the Technical Specification for the Safety of Cosmetics?

4) What are the requirements for children's cosmetic labels?

5) What are the requirements for the inspection report of children's cosmetics?

6) What are the requirements for ingredients used in children's cosmetics?



Source: Guangzhou Administration for Market Regulation

Publish Date: September 20, 2023


Main Content Involved

1) What is the production process of soap?

2) Does soap meet the definition of cosmetics? Does soap implement registration and filing management refer to cosmetics?

3) Do "liquid soap" and "soap liquid" are cosmetics?

4) Do you need to obtain a production license to produce soap?

5) How to conduct filing for cosmetics that must be used in conjunction with the instrument?



Source: Beijing Medical Products Administration

Publish Date: September 28, 2023


Main Content Involved

1) How to choose the category of efficacy claims under the classification code in the application form for general cosmetic filing?

2) What are efficacy claims corresponding to general cosmetics?

3) Whether the "specific claims (ingredient efficacy)" should be checked under the product label item?

4) Is "reducing the occurrence of blackheads" a "cleansing" efficacy?


Activities & Events


Date: September 25, 2023


In order to help cosmetic enterprises enhance competitiveness, the Hangzhou Cosmetics Industry Association, EnterCo, and KingTest organized the Seminar on Cosmetics Industry-University-Research Development—Policy Interpretation of New Cosmetic Ingredients, which invited relevant regulatory agencies, industry experts, and leading enterprises to share the analysis of the requirements of the registration of new cosmetic ingredients, policy analysis, analysis of the registration of the special cosmetics and other hot topics.


Ms. Zhu, deputy director of Hangzhou Administration for Market Regulation Cosmetics Division gave a comprehensive and specific interpretation of recent cosmetic policies and introduced the industry data related to new cosmetic ingredients.


Ms. He, a certified toxicologist by the Chinese Society of Toxicology, and regulatory director of new cosmetic ingredients in EnterCo, introduced the requirements for registration and filing of new cosmetic ingredients and shared some case studies.


Lemon Zhang, a certified toxicologist by the Chinese Society of Toxicology, and regulatory director of EnterCo, sorted out the registration difficulties of special cosmetics and introduced the requirements for full-version safety assessment reports.

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