Official Q&A | Analysis of the Five Key Points of Cosmetic Safety Evaluation and Inspection Methods by the China National Medical Products Administration
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How to conduct safety assessments on cosmetics that must be used in conjunction with instruments or tools
Must be compatible with instruments or tools Brush for auxiliary wiping only air cushion Excluding perm tools, etc Cosmetics used,The mechanism by which the instruments or tools used in conjunction work should be clearly defined,Evaluate the safety of products under the conditions of using instruments or tools in conjunction with them.The instruments or tools used in conjunction should not have cosmetic functions,Should not participate in the reproduction process of cosmetics,Cannot change the way and mechanism of action between cosmetics and skin.
Cosmetics used in conjunction with instruments,If the instrument affects the transdermal absorption of the product,When evaluating, it is necessary to adjust the skin absorption rate of the raw materials,Generally, a more conservative transdermal absorption rate should be chosen.
How to conduct a safety assessment of cosmetics that require two or more doses to be used in combination
Cosmetics that require two or more doses to be used in combination For example, hair dye cosmetics Cosmetics used together with freeze-dried powder and essence ,The content of mixed raw materials should be evaluated based on the usage method of the product.When there may be multiple usage ratios when the product is actually used,It is also necessary to evaluate the actual usage of raw materials under each ratio situation.At the same time, relevant literature research materials or experimental research data of products should be combined,Is there a chemical relationship between the raw materials/Assess potential safety risks arising from biological interactions.
How to execute Technical specifications for cosmetic safety Revised testing method for dioxane in cosmetics
According to the National Medical Products Administration General rules for sample pretreatment of toxicology testing methods for cosmetics19The revised project has been included in the safety technical specifications for cosmetics 2015Year Edition The announcement 2024Year's Day12name ,For cosmetics that require submission of a dioxane inspection report during registration and filing,self2024year12the moon1Starting from,The inspection report should use the inspection method announced in the notice to detect dioxane Standards for product execution Quality control measures of brief centre,If adopted Technical specifications for cosmetic safety Method for determination of dioxane,The revised inspection method name should be filled in.
When conducting safety assessments on cosmetics,What characteristics of products can be exempted from anti-corrosion performance evaluation
Based on product characteristics,For products that are not easily contaminated by microorganisms,Non water containing products Products mainly composed of organic solvents Water activity in products containing water<0.7 Ethanol content>20％ volume tall/lowpHprice 10≤pH<11.5perhaps2<pH≤3 Filling temperature higher than65℃a product Products that are disposable or cannot be opened in packaging, etc,No anti-corrosion performance evaluation is required,But relevant information should be explained.
Cosmetics registration and filing need to be submittedpHWhen checking the value report,how to choosepHValue determination method
According to the National Medical Products Administration Regarding the use of oil in water cosmeticspHValue determination methods, etc21The revised project has been included in the safety technical specifications for cosmetics 2015Year Edition The announcement 2023Year's Day41name ,self2023year8the moon28Starting from, Technical specifications for cosmetic safety 2015Year Edition hereinafter referred to as technical specifications include2A cosmetic productpHValue determination method,approach 1.1 pHprice and 1.10Oil in water cosmeticspHValue determination method .
Submission is required for registration and filingpHCosmetics with value inspection report,The first step is to determine whether the product is a water in oil type based on the formula W/O ,If confirmed as water in oil type,Should be in accordance with 1.10 Oil in water cosmeticspHValue determination method determinepH price If it does not belong to the water in oil type,Should be adopted 1.1 pHprice Measurement method,And it should be clarified whether it is the direct measurement method or the dilution method.
Standards for product execution Quality control measures of brief centre,If adopted Technical specifications for cosmetic safety ofpHValue determination method,Should be filled in Technical specifications for cosmetic safety The name of the inspection method.
