Question 1: Can the toothpaste production process use two or more paste-making processes at the same time?

Answer: Yes. According to Article 27 (3) of the "Regulations on the Management of Toothpaste Filing Information", if two or more paste-making processes are used at the same time, the respective production processes should be briefly described. In addition, according to Article 29 (1), if multiple paste-making processes are used to produce toothpaste, only a complete product inspection report of samples produced by one of the processes must be submitted, and microbiological and physical and chemical inspection reports of samples produced by other processes must be submitted at the same time.

Question 2: For a toothpaste that has multiple sales packages, is it possible to only provide the label picture of one of the sales packages?

Answer: According to Article 28 (2) of the "Regulations on the Management of Toothpaste Filing Information", if there are multiple sales packages, the label pictures of all sales packages must be submitted. If one or more of the following conditions are met, submit the label image of one of the sales packages, and the label images of other sales packages do not need to be uploaded repeatedly:

(1) Only the net content specifications are different;

(2) Only add information such as sales channels, promotions, holiday funds, gifts, etc. to the uploaded sales package;

(3) Only the color of the sales packaging is different;

(4) Registered products are sold together in sets, gift boxes, etc. The combination process does not touch the product contents. Except for adding the name of the combined package product, other marked contents do not exceed the content of each product label;

(5) The text description can clearly reflect the differences from the uploaded sales packaging, and notes have been made.

Question 3: What are the requirements for toxicology testing of toothpaste?

Answer: According to Article 29 (3) of the "Regulations on the Management of Toothpaste Filing Information", in order to further confirm the safety of the product, the product inspection report of some toothpastes must include oral mucosal irritation test items, and the "Cosmetic Safety Technical Specifications" will be given priority. Test methods, or refer to relevant oral medical device test methods.

The toothpaste manufacturer has obtained the relevant qualification certification for the production quality management system issued by the competent government department of the country (region) where it is located (it is produced by multiple manufacturers, all of which have obtained relevant qualification certification), and the product safety risk assessment results can If the safety of the product is fully confirmed, submission of the oral mucosal irritation test report of the product is exempted, except in the following circumstances:

(1) The product is declared to be used by children;

(2) The product claims to have the effects of preventing caries, inhibiting dental plaque, fighting dentin sensitivity, and alleviating gum problems;

(3) Products using new raw materials that are still under safety monitoring.

Question 4: Which toothpastes require efficacy evaluation and which ones are exempt from efficacy evaluation?

Answer: According to Article 29 (4) of the "Regulations on the Management of Toothpaste Filing Information", toothpaste product efficacy evaluation methods are generally divided into human evaluation methods and other evaluation methods. Toothpaste that claims to have the effects of preventing caries, inhibiting dental plaque, fighting dentin sensitivity, and alleviating gum problems needs to conduct a human efficacy evaluation, submit efficacy evaluation data when filing, and prepare and publish an efficacy claim evaluation summary based on the efficacy evaluation results. If the anti-caries effect is achieved by adding fluoride, and the fluoride content meets the "Inspection Item Requirements", the evaluation of the anti-caries effect is exempted. Toothpaste products registered by the same filer use the same functional raw materials that have been proven to be effective, and the formula concentration is not lower than that of the registered products. They claim to have the functions of preventing caries, inhibiting dental plaque, fighting dentin sensitivity, and alleviating gum problems, etc. Products with the same efficacy are exempt from human efficacy evaluation.

If claims of other efficacy than cleaning are required, a human body efficacy evaluation or other efficacy evaluation must be conducted, and the filing party shall prepare and publish a summary of the efficacy claim evaluation based on the efficacy evaluation results.

Toothpastes that only claim cleaning efficacy are exempt from efficacy evaluation.

Question 5: What are the requirements for safety warning words for toothpaste?

Answer: According to Article 27 (7) of the "Regulations on the Management of Toothpaste Filing Information", safety warning words should comply with the requirements of laws, administrative regulations, departmental rules, mandatory national standards, and technical specifications. For example, there are warning words and safety matters related labeling requirements for toothpaste restricted and permitted components; relevant precautions are required for toothpaste suitable for children and other special groups; non-children's toothpaste with added fluoride should be labeled "This product does not "Applicable to children"; and other safety warnings and precautions that should be marked. Safety warning words should be marked with "attention" or "warning" as the guiding words.

Question 6: What is children’s toothpaste? What are the requirements for children's toothpaste?

Answer: According to Article 32 of the "Regulations on the Management of Toothpaste Filing Information", children's toothpaste refers to toothpaste claimed to be suitable for children under the age of 12 (including 12 years old). The efficacy categories that children's toothpaste can claim are limited to cleaning and preventing caries. Products that use words such as "applicable to all people" or "family use" or use trademarks, patterns, homophones, letters, Chinese pinyin, numbers, symbols, packaging forms, etc. to imply that the product user group includes children are managed as children's toothpaste.

Children's toothpaste should use "Caution" or "Warning" as the guide, and the visible side of the sales package should be marked with "should be used under adult supervision", "not edible", "beware of swallowing" and other relevant warnings; children's toothpaste with added fluoride should be marked on the visible side of the sales package. Mark the single use limit.

The filer should design children's toothpaste based on the physiological characteristics of children, follow the principles of safety priority, efficacy must, and formula simplicity, submit the formula design principles in the safety assessment materials, and explain the necessity of using raw materials in the formula. When conducting safety assessments of children's toothpaste, children's physiological characteristics should be considered in terms of hazard identification and exposure calculation.

In addition, according to the "Announcement on Implementing Toothpaste Supervision Regulations and Simplifying the Registration Information Requirements for Marketed Toothpaste and Other Relevant Matters" (2023 No. 124), children's toothpaste should be marked with the children's toothpaste logo and the pattern of the children's toothpaste logo on the sales package display surface. It should comply with the requirements of the "Announcement of the State Food and Drug Administration on the Issuance of Children's Cosmetics Labels" (2021 No. 143), in which the text part of the label is replaced from "children's cosmetics" to "children's toothpaste".