Q&A on the Filing of Ordinary Cosmetics by Beijing Food and Drug Administration Thirty eight issues
Special Issue on Cosmetics Safety Assessment
Guidelines for the Use of Cosmetic Raw Material Data It contains seven main types of raw material data,Is there a weight order relationship between various types of evidence
The raw materials are Technical specifications for cosmetic safety Restricted components in Approved preservatives Approved sunscreen Approved colorants and hair dyes,Should meet Technical specifications for cosmetic safety Related requirements,The types of evidence among the seven types of evidence one ,Other raw materials can be combined with their characteristics and actual situations,Using any one of the other six types of evidence,And there is no hierarchical relationship between the six types of evidence mentioned above.
A certain product formula contains a plant extract,If the plant is Chinese Food Ingredient List in,Is it only necessary to provide evidence to prove that the plant is Chinese Food Ingredient List ,Exemption from systemic toxicity of the plant extract
If only the plant is provided Chinese Food Ingredient List Evidence within,It cannot be proven whether the plant extract has been mixed with other hazardous substances in the production process,For example, risky extraction solvents,The systemic toxicity of the plant extract cannot be exempted.according to Guidelines for the Use of Cosmetic Raw Material Data Related requirements,Raw materials with a history of safe consumption,Also deal with its consumption history Conduct comprehensive and thorough research on production processes, etc,Ensure that the raw materials or the raw materials used to prepare the raw materials have safe edible properties.
The complete version of the security assessment uses raw materials3When using historical evidence as a type of evidence, it differs from the evidence type in the simplified security assessment3What are the differences
The biggest difference between the two is the complete version of the raw materials3The annual usage history can be adopted from non local enterprises3year contain3year The above historical raw materials are used as evaluation criteria,It should be noted that an authorization letter issued by the raw material production enterprise or the cosmetics production enterprise using the same raw material should also be provided.secondly,Complete version of raw materials3The annual usage history further clarifies the criteria for determining the same raw material,That is, in List of Used Cosmetics Ingredients 2021Year Edition Same middle number,And proof materials proving that they are the same raw material need to be submitted,At the same time, it is explicitly required to provide proof of listed sales data,The cosmetics registrant should analyze the sales situation,The results can reflect the safety of the use of raw materials in the population.
When the cosmetics registrant conducts compatibility assessment between cosmetics and packaging materials,Is it necessary to follow Technical Guidelines for Compatibility Testing and Evaluation of Cosmetics and Packaging Materials Conduct research
The method for evaluating the compatibility between cosmetics and packaging materials by the cosmetics registrant includes, but is not limited to, selecting appropriate simulated liquids to conduct leaching research reports on packaging materials,Historical safety data or reports of cosmetic products,According to the food Compatibility research report on packaging materials of cosmetics using drugs or self built methods,Based on data, statements, or quality control reports provided by suppliers,Comprehensive evaluation of cosmetic stability test results and cosmetic safety report, etc.The registrant of cosmetics can use one or more of these methods,Evaluate the compatibility between cosmetics and packaging materials.If the cosmetics registrant is unable to provide the above safety assessment information or discovers that the cosmetics interact with their packaging materials and affect the quality of the cosmetics When safety is affected,Reference should be made Technical Guidelines for Compatibility between Cosmetics and Packaging Materials Conduct relevant research.
When the cosmetics registrant conducts compatibility assessment between cosmetics and packaging materials,Reference drugs What are the food related standards
Drug related standards mainly include Guidelines for compatibility testing of drug packaging materials and drugs YBB00142002-2015 Technical guidance principles for compatibility research between chemical drug injections and plastic packaging materials Trial implementation Technical guidance principles for compatibility research of chemical drugs and elastomeric seals Trial implementation and Technical guidance principles for compatibility research between chemical drug injections and pharmaceutical glass packaging containers Trial implementation etc..
Food related standards mainly include GB31604.1-2023 National Food Safety Standards General rules for migration testing of food contact materials and products GB4806.1-2016 National Food Safety Standards General safety requirements for food contact materials and products andGB5009.156-2016 National Food Safety Standards General rules for pretreatment methods of migration test for food contact materials and products etc..in addition,GB31604The series standards also include heavy metals The determination of harmful substances such as phthalates can be used as a reference.
