The National Medical Products Administration has included 5 toothpaste inspection methods in the safety technical specifications
2025-05-08
On May 7th, the National Medical Products Administration (NMPA) issued a notice that drafted seven methods, including the "Inspection Method for Hard Particles in Toothpaste". After being reviewed and approved by the Director's Meeting of the National Medical Products Administration's Cosmetics Standardization Technical Committee, they are now released and included in the corresponding chapters of the "Cosmetics Safety Technical Specifications (2015 Edition)". The new regulations will be implemented from March 1, 2026. The 7 new methods include "Testing Method for Hard Particles in Toothpaste", "Testing Method for Diethylene Glycol and Ethylene Glycol in Toothpaste", "Testing Method for Soluble and Free Fluoride in Toothpaste", "Testing Method for Total Fluoride in Toothpaste", and "In vitro Skin Allergic Reaction ARE-Nrf2 Fluorescent Enzyme LuSens Test Method". The "Methods for Testing 43 Elements including Lithium in Cosmetics" and "Methods for Testing 43 Elements including Lithium in Toothpaste" are revised testing methods that replace the original testing methods in the "Technical Specifications for Safety of Cosmetics (2015 Edition)". Among the above methods, 5 are closely related to toothpaste. According to the "Inspection Method for Hard Particles in Toothpaste", a hard particle analyzer should be used as the testing instrument, and a glass slide should be used as a substitute for teeth for hard particle inspection. The toothpaste sample should be rubbed back and forth under a certain pressure and friction frequency to observe whether there are scratches on the glass slide. According to the "Test Method for Diethylene Glycol and Ethylene Glycol in Toothpaste", after sample extraction, it is separated by gas chromatography, detected by hydrogen flame ionization detector, qualitatively determined by retention time, quantified by peak area, and the content is calculated by standard curve method. The detection limits of diethylene glycol and ethylene glycol in this method are both 1.5ng, and the quantification limits are both 5ng. When the sample size is 1g, the detection concentration is 37.5 mg/kg, and the minimum quantification concentration is 125 mg/kg. According to the "Methods for Testing Soluble and Free Fluoride in Toothpaste", after the fluoride in toothpaste is dissolved and extracted in water, sodium fluoride, ammonium fluoride, stannous fluoride, and Olaf are released as fluoride ions; After acid treatment, sodium monofluorophosphate can also release free fluoride ions. The potential value of the solution is measured using a fluoride ion selective electrode, and the content of soluble fluoride or free fluoride in toothpaste is calculated through a standard curve. Toothpaste containing sodium monofluorophosphate in the product formula is suitable for soluble fluoride detection methods; The product formula does not contain sodium monofluorophosphate, and fluoride toothpaste with sodium fluoride (or stannous fluoride, ammonium fluoride, Olaf) as the fluoride source is suitable for free fluoride detection methods. If the fluoride used exceeds the above-mentioned fluoride, explore the applicability of the detection method. In the "Method for Testing Total Fluoride in Toothpaste", it is mentioned that after derivatization extraction, the sample is separated by gas chromatography, detected by hydrogen flame ionization detector, qualitatively determined by retention time, and quantitatively determined by the peak area ratio of fluoride to internal standard. The detection limit of total fluoride in this method is 0.001 mg, and the lower limit of quantification is 0.002 mg. When the sampling amount is 0.2 g, the detection concentration of this method is 5 mg/kg, and the minimum quantification concentration is 10 mg/kg. According to the "Method for Testing 43 Elements including Lithium in Toothpaste", the sample is dissolved into a solution by acid digestion, and then enters a high-temperature radio frequency plasma based on argon gas in the form of an aerosol through a pneumatic atomizer. After evaporation, dissociation, atomization, ionization and other processes, it is converted into positively charged positive ions, which are collected by an ion acquisition system and enter a mass spectrometer. The mass spectrometer separates them according to the mass to charge ratio, and the mass spectrometry integration area is proportional to the number of ions entering the mass spectrometer. The concentration of the element to be tested is directly proportional to the signal intensity CPS generated by each element, and is quantitatively compared with the standard series. If 0.2g of sample is taken and the volume is adjusted to 50mL, this method will detect the concentration and the lowest quantitative concentration. (New Society)
Edit:Yao jue Responsible editor:Xie Tunan
Source:XinhuaNet
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