Efficacy Evaluation of Oral Products-NOA Testing & Certification Group

Efficacy Evaluation of Oral Products

On January 3, 2020, the "Regulations on the Supervision and Administration of Cosmetics" (hereinafter referred to as the "Regulations") were reviewed and approved by the 77th executive meeting of the State Council. On June 16, Premier Li Keqiang signed a State Council decree, promulgating the "Regulations", which will come into force on January 1, 2021. According to the latest "Cosmetics Supervision and Administration Regulations", toothpaste is managed with reference to the regulations on ordinary cosmetics. Toothpaste filers can claim that toothpaste has anti-caries, anti-plaque, anti-dentin sensitivity, and alleviating gingival effects after evaluating the efficacy in accordance with national standards and industry standards. The specific management measures for toothpaste shall be formulated by the drug regulatory department of the State Council and reported to the market regulatory department of the State Council for review and publication.

A series of policies such as various management measures, work norms, and technical guidelines to be implemented in 2021. Will there be any unclear test items during the product filing process? Not sure about the filing process? Frequent filing audit problems?

NOA has built a first-class testing platform around cosmetics, providing customers with product filing testing, formula design draft regulations review, product safety evaluation, efficacy evaluation project testing, system operation guidance, legal knowledge answers, etc. Customer assistance. Our one-stop solution can assist companies to produce satisfactory, safe and effective cosmetics, and provide customers with professional analysis, testing, testing, research and development, regulatory consultation and other technical services at any stage of product development and production.

Service Content

Toothpaste efficacy test items

• Teeth Whitening	• Maintain oral health	• Anti-dentin sensitive
• Reduce plaque and teeth whitening	• Reduce tooth stains	• Remove stains and add white
• Fresh breath	• Reduce soft debris	• Anti-dental stones
• Maintain the teeth and periodontal tissue (including gingival) health	• Inhibit dental plaque	• Reduce gingival inflammation

Service Process

Q&A

Can toothpaste claim to be a medical effect?

Toothpaste refers to the semi-solid preparation that acts on the surface of human teeth in the auxiliary cleaning effect. Toothpaste can beautify and protect the teeth and surrounding tissues. According to the Regulations on Supervision and Administration of Cosmetics implemented on January 1,2021, toothpaste is managed according to the regulations of general cosmetics; after efficacy evaluation according to national standards and industry standards, toothpaste can be declared to have caries prevention, plaque suppression, dentine sensitivity, gum problem reduction and other effects. It is worth noting that toothpaste can not express or imply a medical effect, and can not claim a false or misleading effect. At present, the State Food and Drug Administration is promptly formulating a special department regulation for toothpaste management "toothpaste supervision and management measures", and will promote the introduction of the regulations as soon as possible.

Can toothpaste claim itself as "anti-Helicobacter pylori"?

Helicobacter pylori is mainly found in the human stomach, and there is no evidence that brushing your teeth with toothpaste can have an impact on the Helicobacter pylori present in the stomach. Moreover, the oral cavity is a complex environment in which multiple microorganisms such as bacteria coexist. Studies have shown that the possible presence of Helicobacter pylori in the mouth is mainly concentrated in saliva and plaque. The correlation of H. pylori in the oral cavity with digestive diseases such as periodontal disease, halitosis, and gastric cancer is not supported by evidence-based medical evidence. Toothpastes that claim to be "anti-H. pylori" products may have added broad-spectrum bacteriostasis. If a large number of broad spectrum bacteriostasis is used for a long time, it may lead to oral flora disorder, which is not conducive to oral health.

What content should be filled in for the summary of cosmetics efficacy claims?

According to article 19 of the "Cosmetics efficacy Declaration Evaluation Code": the summary of the cosmetics efficacy declaration basis should briefly list the content of the product efficacy declaration basis, including at least the following information:

(1) Basic product information;

(2) Efficacy claims evaluation projects and evaluation institutions;

(3) A brief description of the evaluation methods and results;

(4) The conclusion of the efficacy claim evaluation shall clarify the relationship between the efficacy claim of the product and the evaluation method and results.

At what time point should the old system product complete the supplement record? What does the supplementary record content include?

According to the state food and drug administration on implementing relevant matters announcement (no. 35,2021) and the requirements of the state food and drug administration about release announcement (no. 49), domestic ordinary cosmetics record shall through the new registration platform, in May 1,2022 supplement, record content including product classification code, execution standards and product label sample, fill in product formula.

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