FAQs Vol. 7 | What Are the Industry’s Latest Concerns over Cosmetic Registration and Notification

Ingredient's Safety Information

Q1. What does the ingredient's safety-related information include?

A1: The ingredient's safety-related information shall include the trade name and the basic information of ingredient, the brief descriptions of ingredient's production process, necessary quality control requirements, the assessment conclusions from international authority, the limit requirements for risk substances, etc. 

Q2. How to define an ingredient manufacturer? Can the ingredient distributor submit the safety-related information of cosmetic ingredients through the submission platform? 

A2: Ingredient manufacturer refers to the enterprise responsible for the safety of ingredients. It can be: 

• the production enterprise of the ingredient; or

• the affiliated enterprise belonging to the same group company as the production enterprise of the ingredients; or

• the entrusting enterprise which entrusts the ingredient production to another party. 

If the ingredient distributor is also the ingredient manufacturer, it can submit the cosmetics ingredient's safety information by itself. Otherwise, after submitting an authorization letter issued by the cosmetic ingredient manufacturers, it can gain permission to submit cosmetics ingredient's safety information as an authorized enterprise. 

Efficacy Claims 

Q1. What shall the abstract of cosmetic efficacy claim's basis include?

A1: Article 19 of Standards for Cosmetic Efficacy Claim Evaluation (Standards) stipulates that, the contents of product efficacy claim's basis shall be concisely listed in the abstract of cosmetic efficacy claim's basis, including at least the following information:

1. The product's basic information;

2. The evaluation items and evaluation institution of the efficacy claim;

3. A brief description of evaluation methods and results;

4. Evaluation conclusions of the efficacy claim, in which the relevance between the product's efficacy claim and the evaluation method as well as the results shall be clarified. 

Q2. If the abstract of the efficacy claim is wrongly submitted, is it possible to withdraw and correct it?

A2: The abstract of efficacy claim cannot be withdrawn after submission. The notifier can edit the abstract and submit it again, and the publicity system will publicize the latest submitted abstract. All the abstracts of the efficacy claim submitted by the notifier will be retained in the system for future reference. 

Formula Filling

Q1. How to fill in the formula of aerosol products containing propellant?

A1: As stated by Article 29 of Provisions for Management of Cosmetic Registration and Notification Dossiers (Provisions), if the product contains propellant in direct contact with the contents of the product, the type and addition amount of the propellant shall be indicated in the remarks of the formula form. 

Q2. How to fill in colorants in the cosmetic notification management system? How to mark them on labels?

A2: If colorants are used, the colorant index number (CI No.) specified in Safety and Technical Standards for Cosmetics 2015 shall be indicated under "ingredient name" of the product formula form. In addition, the CI No. shall be marked on the product label, except for those without a CI No. For ingredients that can be used as both colorants and other purposes, such as titanium dioxide, mica, zinc oxide, etc., when they are used for other purposes, the corresponding ingredient names in the product formula and marked on the labels shall be their standard Chinese names. 

Others

Q1. What are the new requirements for notifying imported general cosmetics since January 1, 2022?

A1: (1) The submission of cosmetic ingredient's safety-related information: as required by Provisions, when applying for registration or notification, registrants and notifiers shall provide safety-related information of preservative, sunscreen, colorant, hair dye, freckle-removing and whitening ingredients since January 1, 2022. 

(2) The annual report of general cosmetics: since January 1, 2022, the annual report system has been implemented uniformly for general cosmetics notified through the previous and the new registration and notification systems. From January 1 to March 31 of each year, notifiers shall submit the annual report of general cosmetics notified over one year ago through the new system. For products that fail to complete the annual report in time, their notification will be forcibly cancelled. 

(3) Efficacy claim evaluation: starting from January 1, 2022, when applying for special cosmetics registration or general cosmetics notification, cosmetic registrants and notifiers shall evaluate the efficacy claims of cosmetics in accordance with the Standards, and upload the evaluation abstracts on the website specified by NMPA. 

(4) The safety assessment report of product: starting from January 1, 2022, cosmetic registrants and notifiers shall conduct cosmetic safety assessments according to the Technical Guidelines for Cosmetic Safety Assessment 2021 (Technical Guidelines), and submit the safety assessment documents of the product when applying for special cosmetics registration or general cosmetics notification. Before May 1, 2024, cosmetic registrants and notifiers can submit a simplified version of the product safety assessment report according to the relevant requirements in Technical Guidelines. 

Q2. How to change the domestic responsible person for notified imported general cosmetics?

A2: (1) If the address of the domestic responsible person for general cosmetics changes to a different province, the responsible notification department changes accordingly. Since this further leads to the change of general cosmetics' notification number as well as notification supervision responsibility, the product shall be re-notified. The documents used for the previous notification can be used again when applying for re-notification. 

(2) If the domestic responsible person changes within the same province, the information of domestic responsible person shall be updated in accordance with the User Manual for User Registration and Enterprise Information Management. Relevant documents required for the change shall be submitted according to Provisions. 

Q3. If a product has various sales packagings, under what circumstances can the label pictures of only one of the sales packagings be submitted?

A3: If the product meets one or more of the following conditions, the label pictures of only one of the sales packagings can be submitted, and the label pictures of other sales packaging are allowed to be exempted from uploading: 

1. Only the net content specifications are different;

2. Comparing to the uploaded sales packaging, only extra information of sales channels, promotions, holiday styles, gifts, etc., are planned to attach to the original sales packaging;

3. Only the colors of sales packagings are different;

4. Registered or notified products are sold in combination in the form of set boxes, gift boxes, etc. The contents of the products are not contacted during the combination process, except for adding the name of the combined packaging products, no other information is added comparing to the original label of each products;

5. The differences with the uploaded sales packagings can be clearly reflected through text description, and the explanations have been noted. 

Q4. If the original notification is cancelled and the product is to be re-notified after a name change, is it allowed to use the previous testing report?

A4: It depends. If there is a change in the product formula, production process, manufacturer, etc., of the originally notified product, the previous testing report shall not be used.