Certification and Registration
Oral Hygiene and Care Test
Category:
Oral Hygiene and Care Test
Oral Hygiene Testing and Assessment
With the continuous implementation of regulations such as the Regulations on the Supervision and Administration of Cosmetics and the Draft Measures for the Supervision and Administration of Toothpaste, oral hygiene and care products are increasingly being incorporated into a more comprehensive and stringent regulatory framework. Products such as toothpaste, mouthwash, and oral sprays are required to provide scientific evidence supporting their efficacy claims, while also submitting comprehensive testing and evaluation data to demonstrate product safety, ingredient compliance, and microbial control.
In recent years, national drug regulatory authorities have repeatedly emphasized that “efficacy claims must be supported by scientific evidence.” This means that the market launch and registration of oral care products can no longer rely solely on manufacturers’ internal assessments or empirical judgments. Instead, products must be supported by objective, traceable, and scientifically validated data from qualified third-party testing laboratories.
Oral Hygiene Products
Applicable products include:Toothpaste, tooth powder, mouthwash, oral sprays, dental strips, chewing gum, antibacterial oral pastes, desensitizing oral pastes, and other oral care products.
Oral Hygiene Testing and Assessment Services
(1) Safety Assessment
Conducted in accordance with the Technical Guidelines for Cosmetic Safety Assessment and the Guidance on Safety Assessment of Oral Cleaning and Care Products:
⬤ Safety assessment of raw materials used in oral hygiene products
⬤ Safety assessment of oral hygiene and care products
(2) Safety Testing
Safety testing mainly consists of three categories: physicochemical testing, microbiological testing, and in vitro testing.
|
Test Category |
Specific Test Items |
|
Microbiological Testing |
Total aerobic microbial count, molds and yeasts, thermotolerant coliform bacteria, Pseudomonas aeruginosa, Staphylococcus aureus, and other microorganisms |
|
Physicochemical Testing |
Heavy metals, pH value, oral mucosal tissue safety evaluation, hard particles, total fluoride, soluble fluoride, free fluoride, diethylene glycol and ethylene glycol, methanol, dioxane, free formaldehyde, lead, cadmium, total bacterial count, furanone, dihexyl adipate, chlorine, ammonia, chloramine, chloramine T, hydroxyethylpiperazine ethanesulfonic acid, thioglycolic acid, hydrogen peroxide (peroxide), melanin-related substances, hydroxyethyl urea, and other substances |
|
In Vitro Testing |
Evaluation of tooth abrasion degree and other related tests |
(3) Clinical Efficacy Testing
Anti-Caries Efficacy Test (According to toothpaste efficacy standard WS/T 326.3-2010)
Stain Removal and Whitening Efficacy Test (According to China Oral Care Products Association group standard T/COCIA 8-2020)
Plaque Inhibition Test (According to toothpaste efficacy standard WS/T 326.3-2010)
Gingival Inflammation Reduction Test (According to toothpaste efficacy standard WS/T 326.3-2010)
Anti-Dentin Hypersensitivity Test (According to China Oral Care Products Association group standard T/COCIA 10-2020)
Anti-Tartar Test (According to China Oral Care Products Association group standard T/COCIA 9-2020)
Halitosis Reduction Test (According to China Oral Care Products Association group standard T/COCIA 9-2020)
As one of the most complex microbial ecosystems in the human body, oral health is closely associated with the daily use of oral care products. Scientific and systematic testing not only supports regulatory compliance but also provides essential technical support for product development, quality control, and consumer confidence.
SATISFY has long been dedicated to cosmetic testing, regulatory research, and compliance services. Our expertise covers major global markets, including the United States, Canada, the European Union, Australia, ASEAN countries, and China. We provide customized efficacy assessments, regulatory consulting, safety evaluations, and testing solutions tailored to the requirements of different countries and regions. For more information, please contact SATISFY customer service.
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SATISFY TECH AND SERVICE LLC
SATISFY TECH AND SERVICE LLC delivers full-lifecycle technical solutions for children’s products, hygiene care, protective equipment, furniture, and building materials. Our framework spans compliance pre-assessment, standard upgrading, and risk control. We empower manufacturers and exporters through expert testing, certification, consulting, and standards interpretation.
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