EnterCo’s Newsletter – May 2023
- Scott
- Aug 17, 2023
- 7 min read
Updated: Dec 18, 2023
EnterCo has collected cosmetics regulatory updates in China, with sharing our activities & events.
Official Announcements & Notices
Technical Guidelines for Skin Sensitization Test (Draft for Comments)
Source: China National Institutes for Food and Drug Control (NIFDC)
Publish Date: May 4, 2023
Main Content Involved
1) Selection, quantity, and management of test animals
2) Preparation of subjects
3) Subject dose design
4) Control group setting
5) Induction exposure and challenge exposure
Source: China National Institutes for Food and Drug Control (NIFDC)
Publish Date: May 4, 2023
Main Content Involved
1) Scope
The Guidelines are applicable to situations where cosmetic registrants and filers fill in and submit ingredient safety information on their own, and do not apply to situations where ingredient manufacturers submit ingredient safety information through the Cosmetic Ingredient Safety Information Registration Platform.
2) Basic information of ingredients
The Guidelines provide recommendations on filling in the basic information about ingredients, including ingredient composition, restrictions on the use of ingredients, ingredient properties, etc.
3) Production process
The Guidelines require a brief description of the production process of ingredients based on actual production conditions, with a focus on steps that may be related to ingredient safety risks.
4) Quality control
The Guidelines emphasize that in ingredient safety information, the relevant content of quality control requirements should be truthfully filled in, with a focus on ingredient identification methods, control indicators, and testing methods, as well as other key information closely related to ingredient quality.
Source: China National Institutes for Food and Drug Control (NIFDC)
Publish Date: May 4, 2023
Main Content Involved
1) Scope
The Guidelines apply to guide the filling out of cosmetic product formulas, including the requirements of the formula components, the form of formula filling, the name and content of raw materials, the purpose of use, the filling in of the note column in the formula table and raw material safety information, etc.
2) The form of formula filling
The Guidelines introduce the filling forms of three kinds of formula ingredients, namely: single-component ingredients; non-single-component ingredients; and category ingredients.
3) Formula ingredient name
The name of the formula ingredient should use the standard Chinese name and INCI name/English name specified in the "Ingredient Catalogue".
4) Percentage content of ingredients in the formula
The formula ingredients are arranged in descending order of content, which is calculated as a percentage by mass. The total content of the ingredients should be 100%.
5) Ingredient safety information
Combined with the actual situation of the used ingredient, fill in and upload the safety information file of ingredients, or associated with the ingredient submission code.
Source: China National Institutes for Food and Drug Control (NIFDC)
Publish Date: May 12, 2023
Main Content Involved
1) Scope
The Guidelines apply to guide ingredient manufacturers to regulate the use of the Cosmetic Ingredient Safety Information Registration Platform.
2) Filling in and submitting entity
Cosmetic ingredient manufacturers can submit cosmetic ingredient safety information on their own, or authorize overseas or domestic legal entities to submit and maintain ingredient safety information.
Only one enterprise can be authorized for the ingredient safety information with the same quality specifications.
3) Enterprise information forms
Cosmetic ingredient manufacturers or authorized enterprises should fill in and submit the enterprise information form in accordance with the relevant provisions, and upload a scanned copy of the enterprise information form with a stamp, supporting documents of the enterprise entity, and authorization letters.
4) Ingredient safety information
Cosmetic ingredient safety information mainly includes ingredient quality specifications, control of safety risk substances, safety risk assessment conclusions, etc.
5) Generation and application of ingredient submission code
A submission code is automatically generated after the successful registration of ingredient safety information. The code is only shared between the ingredient manufacturer and the cosmetic registrant or filer without publicity.
Guidelines for Compiling the Simplified Safety Assessment Report of General Cosmetics in Zhejiang (Draft for Comments)
Source: Zhejiang Medical Products Administration
Publish Date: May 15, 2023
Main Content Involved
1) Compiling requirements for different items of the report
2) Cosmetic exposure information sheet
3) IFRA product classification list
4) Common risk substance list
5) Description template of adverse reaction monitoring
Official Q&A
Source: Guangzhou Administration for Market Regulation
Publish Date: May 8, 2023
Main Content Involved
1) Why the management measures for filing inspection of general cosmetics should be optimized?
2) What conditions should the filer or the entrusted production enterprise meet when conducting the filing inspection through self-inspection?
3) How should qualified filers or entrusted production enterprises conduct the filing inspection through self-inspection?
4) How should the filer or entrusted production enterprise issue a statement of inspection capability when conducting filing inspection through self-inspection?
5) What are the requirements for the format and content of product inspection reports issued through self-inspection?
Source: Guangzhou Administration for Market Regulation
Publish Date: May 11, 2023
Main Content Involved
1) How should general cosmetic filers collect cosmetic ingredient safety information?
2) Do we need to verify and confirm the cosmetic ingredient safety information provided by raw material manufacturers?
3) If the raw material manufacturer has not yet registered and obtained the cosmetic ingredient submission code on the Cosmetic Ingredient Safety Information Registration Platform, how can the cosmetic filer submit cosmetic ingredient safety information?
4) According to Announcement No. 34 of 2023, what are the requirements for the submission of cosmetic ingredient safety information documents in the transition period?
5) How to fill in the recommended dosage of ingredients in cosmetics?
Source: Guangzhou Administration for Market Regulation
Publish Date: May 18, 2023
Main Content Involved
1) How to mark net content on the cosmetic labels?
2) How to mark the net content of set packaging products?
3) How to mark the legal units of measurement?
4) What is the minimum height requirement for the net content labeling characters of quantitatively packaged goods?
Source: Guangzhou Administration for Market Regulation
Publish Date: May 29, 2023
Main Content Involved
1) What is the definition of cosmetics?
2) Are anti-mosquito and mosquito repellent products cosmetics?
3) Do colored drawing products belong to cosmetics?
4) Do nail enhancement products that are only used for bonding artificial nails and solid decorative objects belong to cosmetics?
5) Do color lotion products (色乳产品) for embroidery (纹绣) belong to cosmetics?
Source: Beijing Medical Products Administration
Publish Date: May 29, 2023
Main Content Involved
1) What is the scope of the application and regulatory department of the Measures for the Supervision and Management of Toothpastes?
2) What are the basic requirements for toothpaste management?
3) What are the management requirements for toothpaste raw materials?
4) What is the product labeling requirement for children's toothpaste?
5) What is the requirement for the filing of overseas toothpaste products?
6) How to handle illegal activities of toothpaste filers, entrusted production enterprises, operators, and domestic responsible persons according to the Measures?
7) What is the basis for the management of the content not clearly specified in the Measures?
Company News (Activities & Events)
Date: May 12, 2023
The 27th China Beauty Expo (CBE) was held from May 12th to 14th, 2023 at the Shanghai Pudong New International Expo Center. The exhibition covers the whole hall of the New International Expo Center, with a total scale of 280,000 square meters, covering skincare, make-up, perfume, beauty tools, cosmetic ingredients, oral care, pregnancy and infant care, efficacy, inspection, beauty instruments, packaging, labels, ODM/OEM, imported products and many other categories. Almost 3,800 companies from over 40 countries and regions have participated, with over 500,000 professional buyers from over 90 countries and regions.
EnterCo and Innoderm attended the CBE, and about 300 companies, partners, and potential customers came to the booth to inquire about cosmetic compliance issues, covering cosmetic registration and filing, cosmetic product safety assessment, efficacy evaluation, etc.
Vian Fang, BD director of EnterCo, invited by the organizer (CBE) and SGS, shared the speech on Cosmetic Registration and Filing Data and Intelligent Compliance Solution, which has induced great responses.
Date: April 20-21, 2023
EnterCo, together with the Hangzhou Cosmetics Industry Association and SGS, has organized a Cosmetic High-Quality Development Forum from April 20 to April 21. The forum has invited relevant regulatory agency officials from Zhejiang Medical Products Administration, Hangzhou Administration for Market Regulation, cosmetic industry experts from Air Force General Hospital, Shanghai Daily Chemistry Trade Association, and top cosmetic enterprises such as Proya to share hot topics such as cosmetic quality and safety, regulatory affairs, efficacy research, and intelligent cosmetic compliance system, etc., which has triggered lively discussions among more than 400 participants.
Director Wu of the Division of Cosmetics Regulation of Zhejiang MPA, gave a speech on Cosmetic Regulation Development and Industry Status, sharing a detailed interpretation of the newly released 18 Measures to Optimize and Improve the Business Environment of the Cosmetics Industry in Zhejiang.
Lemon Zhang, the regulatory director of EnterCo, gave a complete and detailed introduction of hazard identification, dose-response relationship assessment, exposure assessment, and risk characterization involved in the cosmetic safety assessment, as well as a brief explanation of review points of safety assessment reports.
Dr. Wei, the chief scientist of Proya, introduced the testing strategy throughout the entire product lifecycle, aiming to help enterprises promote their consumer loyalty and affection.
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