Product Compliance
filing/registration/consulting/training
Q&A on the Filing of Ordinary Cosmetics by Beijing Food and Drug Administration Forty second issue
Problem1 What are the special circumstances of product safety assessment included in the self-examination of cosmetics safety assessment reports by enterprises?
answer According to the report released by the National People's Procuratorate Guidelines for Submitting Cosmetic Safety Assessment Data attachment1Regulations on the Key Points of Self Inspection for Cosmetics Safety Assessment Reports,The safety assessment of products in special circumstances includes the safety assessment of aerosol cosmetics Safety assessment of products that require the use of two or more doses in combination Safety assessment of products that must be used in conjunction with instruments or tools Safety assessment of children's cosmetics.
Problem2 What are the precautions for safety assessment of aerosol cosmetics?
answer Due to the strong volatility of propellants,When using aerosol products containing propellants in practice,Only trace amounts of propellant residue remain on the surface of the human body,therefore,The exposure level of formula raw materials other than propellants in the human body is the concentration of the raw materials after removing propellants,Propellants should be evaluated separately from other raw materials,The evaluation concentration of other raw materials should be the formula after deducting the propellant use100%count The concentration of each component in the middle And propellants can be evaluated separately or based on their usage concentration in the formula.in addition,For propellants with inhalation toxicity risks, a safety assessment of their inhalation toxicity is also required.
Problem3 What are the precautions for safety assessment of products that require the use of two or more doses in combination?
answer Products that require two or more doses to be used in combination,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,The actual usage of raw materials should also be evaluated for 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.
Problem4 What are the precautions for safety assessment of products that must be used in conjunction with instruments or tools?
answer 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.
Products used in conjunction with instruments,If the instrument affects transdermal absorption,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.
Problem5 What are the precautions for safety assessment of children's cosmetics?
answer When evaluating children's cosmetics,The principles of product formula design should be clearly defined,Formula design should prioritize safety Essential efficacy The principle of minimalist formula,Should ensure the safety of raw materials stability function Compatibility and other aspects,Combining the physiological characteristics of children and possible application scenarios,Evaluate the scientificity and necessity of the raw materials used,Especially spice essence colorant preservative Sunscreen and surfactants and other raw materials.The specific evaluation principles should comply with Regulations on Supervision and Management of Children's Cosmetics and Technical Guidelines for Children's Cosmetics The requirements.
Thoughtful reminder according to Management Measures for Registration and Filing of Cosmetics Article 37,according to The National Medical Products Administration's Implementation