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Editor's note: This article was originally published on March 25, 2024, and was updated on December 3, 2024, as per the latest developments. The updated contents are marked in red below.
On March 21, 2024, China National Medical Products Administration (NMPA) released an announcement that incorporates 15 new toothpaste testing methods into the Safety and Technical Standards for Cosmetics. 1 Effective from December 1, 2024, these testing methods apply to toothpaste registration, notification, and sampling tests.
No. | Testing Method | Type | Chapters in STSC |
1 | Determination of pH in Toothpastes | New testing method | Chapter 4 Physical and Chemical Test Methods 1 General Principles 1.11 Determination of pH in Toothpastes |
2 | Determination of Mercury in Toothpaste | Chapter 4 Physical and Chemical Test Methods 1 General Principles 1.12 Determination of Mercury in Toothpaste | |
3 | Determination of Lead in Toothpaste | Chapter 4 Physical and Chemical Test Methods 1 General Principles 1.13 Determination of Lead in Toothpaste | |
4 | Determination of Arsenic in Toothpaste | Chapter 4 Physical and Chemical Test Methods 1 General Principles 1.14 Determination of Arsenic in Toothpaste | |
5 | Determination of Cadmium in Toothpaste | Chapter 4 Physical and Chemical Test Methods 1 General Principles 1.15 Determination of Cadmium in Toothpaste | |
6 | Determination of Li and 36 Kinds of Elements in Toothpaste | Chapter 4 Physical and Chemical Test Methods 1 General Principles 1.16 Determination of Li and 36 Kinds of Elements in Toothpaste | |
7 | Determination of Dioxane in Toothpaste | Chapter 4 Physical and Chemical Test Methods 2 Testing Methods of Prohibited Ingredients 2.37 Determination of Dioxane in Toothpaste | |
8 | Determination of Methanol in Toothpaste | Chapter 4 Physical and Chemical Test Methods 2 Testing Methods of Prohibited Ingredients 2.38 Determination of Methanol in Toothpaste | |
9 | Determination of Free Formaldehyde in Toothpaste | Chapter 4 Physical and Chemical Test Methods 4 Testing Methods of Preservatives 4.10 Determination of Free Formaldehyde in Toothpaste | |
10 | General Guidelines in Toothpaste | Chapter 5 Methods of Microbiological Test 7 General Guidelines in Toothpaste | |
11 | Aerobic Plate Count in Toothpaste | Chapter 5 Methods of Microbiological Test 8 Aerobic Plate Count in Toothpaste | |
12 | Detection of Thermotolerant Coliform Bacteria in Toothpaste | Chapter 5 Methods of Microbiological Test 9 Detection of Thermotolerant Coliform Bacteria in Toothpaste | |
13 | Detection of Pseudomonas Aeruginosa in Toothpaste | Chapter 5 Methods of Microbiological Test 10 Detection of Pseudomonas Aeruginosa in Toothpaste | |
14 | Detection of Staphylococcus Aureus in Toothpaste | Chapter 5 Methods of Microbiological Test 11 Detection of Staphylococcus Aureus in Toothpaste | |
15 | Molds and Yeasts Count in Toothpaste | Chapter 5 Methods of Microbiological Test 12 Molds and Yeasts Count in Toothpaste |
The implementation of the Cosmetic Supervision and Administration Regulation (CSAR) has ushered in a more rigorous management framework for toothpastes. Under the new regulations, toothpastes are now subject to comprehensive oversight, covering notification, testing, safety assessment, efficacy evaluation, etc.
Previously, toothpaste testing shall be in line with the national standard GB/T 8372-2017, encompassing microbiological and physicochemical tests. These tests covered aspects such as microbiological testing, detection of heavy metals lead and arsenic, measurement of total fluorine, soluble fluorine, free fluorine, pH value, and identification of hard particles.
Later on December 1, 2023, the Provisions for Management of Toothpaste Notification Dossiersexpanded the scope of testing. This expansion newly includes the tests for heavy metals such as mercury and cadmium, as well as the detection of hazardous substances like methanol, dioxane, free formaldehyde, diethylene glycol, and glycol. To facilitate compliance, the above 15 new testing methods have been introduced, providing guidelines for conducting these tests. The table below outlines the limits for the test items covered by these 15 methods.
Type | Testing Item | Limitation | Source | ||
Physical and chemical test | Routine testing items | pH value | ≤ 10.5 | Annex 3 "Microbiological and Physical and Chemical Testing Items for Toothpaste Notification" of Provisions for Management of Toothpaste Notification Dossiers | |
Lead | ≤ 10 mg/kg | ||||
Arsenic | ≤ 2 mg/kg | ||||
Mercury | ≤ 1 mg/kg | ||||
Cadmium | ≤ 5 mg/kg | ||||
Testing items depending on product formula | Methanol testing is required for product formula with a mass fraction of alcohol and isopropyl alcohol ≥10% | Methanol | ≤ 2,000 mg/kg | ||
Dioxane testing is required for product formula containing ingredients with ethoxy structure | Dioxane | ≤ 30 mg/kg | |||
1. Free formaldehyde testing is required for product formula containing formaldehyde or formaldehyde-releasing ingredients; 2. When the concentration of free formaldehyde in the product is > 0.05%, "containing formaldehyde" must be labeled on the product. | Free formaldehyde | ≤ 0.1% | |||
Microbiological test | Routine testing items | Aerobic plate count | ≤ 500 CFU/g | ||
Molds and yeasts count | ≤ 100 CFU/g | ||||
Thermotolerant coliform bacteria | Negative | ||||
Pseudomonas aeruginosa | Negative | ||||
Staphylococcus aureus | Negative | ||||
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