China toothpaste filing information has been released in the form of questions and answers by the Beijing Medical Products Administration.
In this article, we will provide a comprehensive overview of the key questions and answers from the 29th edition of the FAQ (frequent asked questions) series to help manufacturers and regulatory consultants understand the toothpaste filing process in China.
Question 1: Can toothpaste be produced using multiple manufacturing processes?
Answer: Yes, according to the regulations outlined in the “Management Regulations for Toothpaste Filing Documents,” toothpaste can be produced using two or more manufacturing processes simultaneously. Manufacturers should provide a brief description of each production process. If multiple manufacturing processes are used, only one complete product inspection report is required for one of the production processes. Additionally, microbiological and physicochemical test reports for the other production processes should be submitted.
Question 2: Can toothpaste with multiple types of packaging provide label images for just one type of packaging?
Answer: Toothpaste with multiple types of packaging should submit label images for all packaging variations. However, in certain cases, you may only need to upload label images for one type of packaging if the following situations areise:
- There are differences in net weight only
- The uploaded packaging has been labelled additionally with information for sales channels, promotions, holiday specials and free gifts only
- There are difference in colour only
- Already notified products are being sold in sets, gift boxes and other forms of combination which do not affect the product’s content
- The text description clearly reflects the difference with the uploaded packaging, and has been noted.
Question 3: What are the toxicity testing requirements for toothpaste?
Answer: According to “Toothpaste Filing Document Management Regulations”, some toothpaste product inspection reports must include oral mucosal irritation test items with preference given to the test methods listed in the “Cosmetic Safety & Technical Standards” or reference to the relevant oral medical device test methods.
Toothpaste manufacturers who have:
- government-issued GMP certificates (and if produced by a number of different manufacturers and all manufacturers have obtained the relevant qualifications), AND
- product safety risk assessment results that fully confirm the safety of the product
can be exempted from the submission of oral mucosal irritation test report, except for the following circumstances:
- any product that targets use by children aged 12 or under;
- any product that makes anti-caries, plaque inhibition, anti-dentin sensitivity, reduces gum problems claims;
- any product which is still under safety monitoring of new ingredients.
Question 4: Which toothpaste products need efficacy evaluations, and which are exempt?
Answer: Toothpaste efficacy evaluations can include human testing or other methods. Toothpaste claiming to prevent cavities, inhibit plaque, relieve tooth sensitivity, or address gum issues must undergo human efficacy evaluations and provide summaries of these evaluations. However, products achieving cavity prevention through fluoride, meeting specified requirements, are exempt from efficacy evaluations. Similarly, toothpaste with identical active ingredients and concentrations as previously registered products can be exempted from human efficacy evaluations.
Toothpastes that claim “cleaning efficacy” only are exempt from efficacy evaluation.
Question 5: What are the requirements for safety warning labels on toothpaste?
Answer: Safety warning labels on toothpaste must comply with relevant laws, regulations, mandatory national standards, and technical specifications. These labels may include:
- warnings and safety instructions regarding restricted or conditional ingredients
- precautions for children or special populations
- statements for non-child toothpaste containing fluoride.
Question 6: What defines children’s toothpaste, and what are the requirements for it?
Answer: Children’s toothpaste refers to toothpaste marketed for children aged 12 and below. Any 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 will be managed as children’s toothpaste.
Children’s toothpaste can only claim to have cleansing and cavity-preventing properties. Labels should include:
- warnings such as “use under adult supervision,” “do not swallow,”
- limits on fluoride content for products with fluoride.
Manufacturers must consider children’s physiology during safety assessments.
Children’s toothpaste should feature a specific logo on the packaging, replacing the previous “Children’s Cosmetic” label with “Children’s Toothpaste.”
Reminder for Annual Report Submission:
All companies with notified general cosmetics in China are reminded to submit their relevant annual reports via the online platform. The time window to do so is January 1, 2024 until March 31, 2024 for the previous calendar year.
Read the original China toothpaste filing information update.
Read our previous article on China Toothpaste Filing Requirements.
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