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Requirements and Q&A of China Academy of Food and Drug Control on “Toothpaste Inspection Report” and “Ointment Safety Assessment Report” of Toothpaste

First. Requirements for Product Inspection Report

The same filer for the record aroma, color, and appearance of different toothpastes only needs to submit one of the product samples of the complete inspection report. At the same time, the need to submit other product samples of microbiological and physical and chemical test reports can be.

Second, toxicology tests and human efficacy evaluation test requirements

Claims to have anti-caries, plaque inhibition, dentin sensitivity, reduced gum problems, and other efficacy of toothpaste need to carry out toxicology and human efficacy evaluation tests. In addition, the four primary effects of the product, such as whitening, anti-calculus, and other non-four significant effects, can be exempted from human efficacy evaluation and can not be used to borrow the way.

Third, microbiological physical and chemical test requirements

Microbiological physical and chemical tests require the same batch number to be sent for inspection. Microbiological physical and chemical parts can also be separated from the test but must be the same batch of products.

Fourth, on the four major efficacy test requirements

Oral mucosal irritation cannot be observed when conducting the four major efficacy tests, unlike toxicology tests. Although it does not claim an anti-caries effect, fluoride toothpaste can not be exempted from toxicology tests.

Fifth. Safety Assessment Data Requirements

Regarding the safety assessment data of toothpaste, we have to wait for the subsequent release of the “Safety Assessment Technical Guidelines.”

Cosmetics and toothpaste, the full version of the safety assessment is more difficult; the transition period should not be extended but will be rereleased to help companies transition safety assessment guidelines.

Sixth, the adequacy of the arguments to explain

CIQ has detailed requirements and guidelines for the test report and safety assessment of toothpaste, formulated based on scientific principles and practical experience and have sufficient scientific basis and feasibility.

Enterprises must submit relevant information and data according to the requirements, including product inspection reports, toxicology tests, human efficacy evaluation test data, microbial physical and chemical test data, etc. These data must be true, reliable, and aligned with the relevant standards and norms.

CIQ will strictly audit and evaluate the data submitted by the enterprises to ensure the safety and effectiveness of the products. If the data submitted by the enterprise does not meet the requirements or there is fraudulent behavior, it will be punished and sanctioned accordingly.

In conclusion, the CIQ has detailed requirements and guidelines for the test reports and safety assessment of toothpaste, and enterprises need to seriously comply with and implement these requirements and guidelines to ensure the safety and effectiveness of their products. At the same time, CIQ will also strictly audit and evaluate the data submitted by enterprises to ensure the authenticity and reliability of the data.

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