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China National Medical Products Administration releases Q&A on cosmetic technology review9be,Standards related to product execution label Raw materials and other related content

Common Q&A on Cosmetics Technical Review

How to understand the relationship between product label claims and classification coding efficacy claims

The claimed efficacy content on the product label should be Application Form for Registration and Filing of Cosmetics The classification code filled in is within the claimed scope of efficacy,Cannot exceed the scope of efficacy covered by the classification code,The claimed efficacy of filling in classification codes is only Moisture ,Content related to moisturizing function that can be claimed in the product label sample,for example Moisture  Reduce water loss  Relieve dry skin condition etc.,It is not allowed to claim that the moisturizing effect is outside the scope compact  Soothing Waiting for related content.


In the report on the determination of sun protection index for sunscreen cosmetics,The mean95%The confidence interval exceeds the mean17%,How to handle it

In the report on the determination of sun protection index for sunscreen cosmetics,The mean95%The confidence interval exceeds the mean17%When,Should be in accordance with Technical specifications for cosmetic safety Request to increase the number of subjects on the basis of the original population for the experiment,The increase in the number of subjects should comply with Technical specifications for cosmetic safety requirement,And for all subjects(Including original subjects)Merge the measurement data for statistical analysis.


How long does it take to observe the skin allergy test section of oxidative hair dye products

Technical specifications for cosmetic safety Clearly stipulate,Oxidative hair dye products must be labeled on the product label Hair dye may cause severe allergic reactions Waiting for safety warnings,Therefore, for products labeled with skin allergy testing methods or skin allergy observation time,The observation time for skin reactions should be at least observed48hour,To ensure the observation of all types of skin adverse reactions.


How to set up children's cosmeticspHvalue

Regulations on Supervision and Management of Children's Cosmetics Encourage the development of stricter than mandatory national standards for children's cosmetics Product execution standards for technical specifications.Children's cosmetics should be made according to Technical Guidelines for Children's Cosmetics The requirements,According to the product formula Production process Scientifically and reasonably set up research materials such as usage methodspHValue project Scope of indicators Quality management measures and brief explanation. Guidelines for Registration and Filing Inspection of Cosmetics Regulations do not require testingpHExcluding products with value,Like pure oil Waxy base The product.


How to standardize the control range of components that need to be controlled in the standards for product execution

In the standards for product execution, it is necessary to set the control range of ingredients based on the declared amount of the formula,For example, the amount of Okelin added in the product formula is5%,If it is proposed to set the upper limit of its indicator control range as6%,The lower limit is set to4%,The control range of indicators can be expressed as4%~6%  4~6 %  0.8~1.2 ×Formula quantity, etc.Avoid using non-standard or ambiguous expressions,as5±20% 5%±20%etc..


How to fill in the production process description in the standards for product execution

1.The main steps of the actual production process should be briefly described,Including feeding blend Filling, etc.If there is pre mixing The filling and other production steps are completed in cooperation with different production enterprises,It should be noted in the remarks section.

2.Should reflect the range of main production process parameters,Like temperature, etc,Should be related to the basic properties of the raw materials The product dosage form is consistent.

3.All ingredients in the formula should be included,The name or serial number of the raw material should be consistent with the formula table If the same raw material is used in different stages of the process,Should be distinguished If water needs to be used during the production process but removed in subsequent production steps Volatile solvents and other additives,Should be noted.


crystallite or Micro needle Does the product category belong to the definition of cosmetics

declare crystallite or Micro needle Class products,If according to its formula Production process usage method The comprehensive judgment of product content, form, etc. is that it is not applied to the surface of the skin,This type of product exceeds Regulations on the Supervision and Administration of Cosmetics The scope of the definition of cosmetics in China.


The formula uses raw materials directly derived from plants,How to label specific usage areas

according to Regulations on the Management of Registration and Filing Materials for Cosmetics ,The formula uses raw materials directly derived from plants,The usage site of the original plant should be explained.If the raw materials are filled in the formula as peach PRUNUS PERSICA juice ,The usage location should be noted in the remarks column of the formula table based on its source,as flesh .


Plant materials obtained through steam distillation are used in the formula,Its standard Chinese nameHow to call itFill in

The formula uses plant raw materials obtained by steam distillation,The standard Chinese name should be based on the actual product obtained from the preparation process,according to List of Used Cosmetics Ingredients 2021Year Edition  Standardize the filling of the names of the raw materials already included in the report.for example,rose ROSA RUGOSA Oil like liquid obtained by steam distillation of flowers,Should be filled in as rose ROSA RUGOSA Flower oil  Obtained aqueous solution,Should be filled in as rose ROSA RUGOSA Flower water .

If List of Used Cosmetics Ingredients 2021Year Edition  Raw materials obtained by steam distillation without corresponding names in China,But the corresponding plant extract names have been included in the above directory,Can be filled in by the name of the plant extract,At the same time, explain in the remarks column of the formula table.for example,tuberose POLIANTHES TUBEROSA Flowers through water vapor

Oil like liquid obtained by distillation,Can be filled in as evening jasmine POLIANTHESTUBEROSA extractive,And explain in the remarks column of the formula table The usage area is flower,Actually, it is evening jasmine POLIANTHESTUBEROSA Flower oil .