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Standard Group

Industry Solution
Oral Care Product Evaluation

Brief Introduction

Functional oral care products are oral care products that add active ingredients to the products, which have both preventive or auxiliary therapeutic effects, and its main efficacies include: whitening/ stain removal, stain prevention, anti-dentin hypersensitivity, anti-halitosis, anti-inflammatory, anti-bacterial, etc. However, these drugs or chemicals with special active ingredients should be safe and have no obvious side effects.

National Medical Products Administration issued a notice on the Measures for the Supervision and Administration of Toothpaste (Draft for Comment) for public comment on November 13, 2020. In order to implement the Cosmetics Supervision and Administration Regulations, it is proposed to implement positive list management on the efficacy claims of toothpaste through the mode of efficacy classification catalog, so as to curb the occurrence of illegal claims of toothpaste.

The Measures for the Supervision and Administration of Toothpaste (Draft for Comment) article 16 points out that the efficacies of toothpaste claims should have sufficient scientific basis. In addition to the basic cleaning type, other efficacies of toothpastes should be carried out in accordance with the requirements of efficacy evaluation. Toothpaste can be claimed to have anti-caries, anti- dental plaque, anti-dentin hypersensitivity, reduce gum problems and other efficacies once its efficacy has been evaluated in accordance with national standards, industry standards.

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Details
S.N.ItemsTest basis
1Breath fresheningLaboratory method: In vitro evaluation of breath freshening efficacy of oral products (methyl mercaptan)
2Anti-dental plaqueLaboratory method: In vitro evaluation of anti-dental plaque efficacy of oral products by biofilm inhibition method
3Teeth whitening/stain removalLaboratory method: Evaluate the teeth whitening efficacy by hydroxyapatite method
Teeth whitening/stain removalLaboratory method: Evaluate the teeth whitening efficacy by bovine teeth method (toothbrush)
4Gingiva protectionLaboratory method: Gingival protection efficacy of oral products - Gingival anti-aging cell model(Coll)
5Anti-inflammatoryLaboratory method: Anti-inflammatory efficacy of oral products - Cell model inflammatory factor
Anti-inflammatoryLaboratory method - Guidelines for the Ear Edema Method in Mice
6Hemostatic testLaboratory method - Guidelines for Rabbit Liver Hemostatic Test
7Anti-dentin hypersensitivity (Occlude dentinal tubules test)Laboratory method: Evaluate the effect of toothpaste occluding dentinal tubules
8Safety (demineralization)Refer to YY/T0825-2011 Dentistry - Products for External Tooth Bleaching, ISO28399:2011 Dentistry - Products for External Tooth Bleaching
9Oral mucosa membrane irritation testRefer to YY/T 0127.13-2009 Biological Evaluation of Medical Devices Used in Dentistry - Part 2: Test Method - Oral Mucosa Membrane Irritation Test, GB/T16886.10-2017 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization Appendix B.3
10Acute oral toxicity testRefer to Safety and Technical Standards for Cosmetics 2015, GB151933-2014 National Food Safety Standards Acute Oral Toxicity Test (in mice)

Safety test

1Oral mucosa membrane irritation testRefer to YY/T 0127.13-2009 Biological Evaluation of Medical Devices Used in Dentistry - Part 2: Test Method - Oral Mucosa Membrane Irritation Test, GB/T16886.10-2017 Biological Evaluation of Medical Devices – Part 10: Tests for Irritation and Skin Sensitization Appendix B.3
2Acute oral toxicity testRefer to Safety and Technical Standards for Cosmetics 2015, GB151933-2014 National Food Safety Standards Acute Oral Toxicity Test (in mice)


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Qualification Certificate

Standard Group has built a comprehensive service system with primary focuses on biomedical and life sciences. We are solid developing in ecological environment, comprehensive trade, innovative services and other micron sectors. We have CMA, CNAS qualifications, import and export commodity inspection and appraisal, engineering design, building construction, water conservancy project quality inspection and other qualifications.

Standard Group Service Network

Standard Group laboratories have deployed cross all geographic of China, with 16 branch offices to respond our customers’ inquiries quickly at any time. We determinate to provide close-range and localized professional services at our customers’ conveniences.