EnterCo has collected China cosmetics regulatory updates in August, with sharing our activities & events.
Official Announcements & Notices
1.中检院关于发布《化妆品配方填报技术指导原则》的通告（2023年第2号）（2023-09-04）
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.
2.中检院关于发布《化妆品原料安全信息填报技术指导原则》的通告（2023年第3号）（2023-09-04）
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.
3.中检院关于发布《化妆品原料安全信息登记平台填报指南》的通知（2023-09-04）
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.
4.中检院关于公开征求《免疫毒性试验技术指导原则（征求意见稿）》等意见的通知（2023-09-07）
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
5.杭州市人民政府办公厅关于印发支持合成生物产业高质量发展若干措施的通知（2023-09-07）
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.
6.关于贯彻落实牙膏监管法规和简化已上市牙膏备案资料要求等有关事宜的公告（2023年第124号）（2023-09-25）
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.
7.国家药监局综合司公开征求《牙膏备案资料管理规定（征求意见稿）》意见（2023-09-25）
NMPA Notice on Issuing the Provisions for the Filing Dossier of Toothpastes (Draft for Comments)
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.
8.浙江省药品监督管理局关于国产牙膏备案管理有关事项的公告（2023-09-28）
Zhejiang MPA Announcement on Matters Related to the Filing Management of Domestic Toothpastes
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.
9.广东省药品监督管理局关于开展国产牙膏备案工作的通告（2023-09-28）
Guangdong MPA Notice on Carrying out the Filing Work of Domestic Toothpastes
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.
Annex 1: Guidelines for enterprise login and account registration
Annex 2: Toothpaste filing management system (enterprise side) operation manual
Official Q&A
10.北京市化妆品审评检查中心关于普通化妆品备案常见问题一问一答（第二十四期）(2023-09-05)
Beijing MPA Issued FAQs on Children’s Cosmetic Filing (24th Issue)
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?
11.广州市市场监督管理局普通化妆品备案问答（四十五期）(2023-09-20)
Guangzhou Administration for Market Regulation Issued FAQs on General Cosmetic Filing (45th Issue)
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?
12.北京市化妆品审评检查中心关于普通化妆品备案常见问题一问一答（第二十五期）(2023-09-28)
Beijing MPA Issued FAQs on Efficacy Claims of General Cosmetic Filing (25th Issue)
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.