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Beijing MPA FAQs on Toothpaste Filing on January 11

Toothpaste Filing

1. Can two or more paste-making processes be used in the production of toothpaste at the same time?

Certainly. According to Article 27 (3) of the Provisions for Notification Dossiers of Toothpastes, if two or more paste-making processes are used simultaneously, their respective production processes shall be briefly described. In addition, according to Article 29 (1), if multiple paste-making processes are used to produce toothpaste, only the complete product inspection report of one process production sample needs to be submitted, while the microbiological and physicochemical inspection reports of other process production samples need to be submitted.

2. For toothpaste with multiple sales packages, is it permissible to provide the label image for only one of the sales packages?

According to Article 28 (2) of the Provisions for Notification Dossiers of Toothpastes, for toothpaste with multiple sales packages, all label images of the sales packages should be submitted. If one or more of the following situations are met, submit a label image of one of the sales packages:

(1) Only the net content specifications are different;

(2) Only the uploaded sales package is additionally labeled with information on sales channels, promotions, holiday specials, and giveaways;

(3) Only the colors of sales packages are different;

(4) The filed products are sold in the form of set products, and gift boxes, without touching the product content during the combination process. Except for adding the name of the combined packaging product, other marked contents do not exceed the content of each product label;

(5) The text description clearly reflects the differences with the uploaded sales packaging and has been noted and explained.

3. What are the requirements for toxicological testing of toothpaste?

If the production enterprise of toothpaste has obtained the relevant qualification certification of the production quality management system issued by the competent government department of the country (region) where it is located (if it is produced by multiple production enterprises, all production enterprises have obtained the relevant qualification certification), and the product safety risk assessment results can fully confirm the product safety, it is exempt from submitting the oral mucosal irritation test report of the product, except for the following situations:

(1) The product claims to be used by children;

(2) The product claims to have such efficacy as anti-caries, inhibition of dental plaque, anti-dentin sensitivity, gum problem reduction;

(3) The use of new raw materials in the product is still under safety monitoring.

4. Which toothpaste needs to undergo efficacy evaluation, and which are exempt from efficacy evaluation?

Toothpaste that only claims cleansing efficacy is exempt from efficacy evaluation. Toothpaste that claims to have anti-caries, inhibition of dental plaque, anti-dentin sensitivity, and gum problem reduction efficacy should conduct a human efficacy evaluation.

5. What are the requirements for the safety warning words in toothpaste?

The safety warning phrases in toothpaste should comply with relevant requirements, such as labeling requirements for the restricted and approved components of toothpaste; labeling requirements for toothpaste suitable for special groups such as children; for non-children's toothpaste with fluoride, "This product is not suitable for children (本产品不适用于儿童)" should be marked; Other needed situations. The safety warning words should be labeled with "attention (注意)" or "warning (警告)" as a guide.

6. What is children's toothpaste? What are the requirements for children's toothpaste?

Children's toothpaste refers to toothpaste claimed to be suitable for children under the age of 12 (including 12 years old). The claimed efficacy categories of children's toothpaste are limited to cleansing and anti-caries. Products that indicate the use of words such as "applicable to the whole people" and "for family use", or use trademarks, patterns, homophones, letters, Chinese Pinyin, numbers, symbols, packaging forms, etc. to imply that the product user group includes children, shall be managed according to children's toothpaste.

Children's toothpaste should be labeled with relevant warning words such as "should be used under adult supervision (应当在成人监护下使用)", "cannot be consumed (不能食用)", and "be cautious of swallowing (谨防吞咽)" on the visible surface of the sales packaging; Children's toothpaste with added fluoride should be labeled with a single use limit.

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