Product Compliance
filing/registration/consulting/training
Q&A on the Filing of Ordinary Cosmetics by Beijing Food and Drug Administration (Issue 47)
problem1 Can physical and chemical stability testing be submitted in the complete safety evaluation report Preservative Challenge Test Conclusion of compatibility testing and evaluation of packaging materials
answer according to Several measures to optimize the management of cosmetic safety assessment ,Cosmetics companies can comply with national standards technical specifications Industry standards international standard Technical guidelines or enterprise self built methods for product stability Anti corrosion system Conduct relevant research on the compatibility of packaging materials, etc,And submit relevant testing or evaluation conclusions in the security assessment report.
problem2 What are the conditions for exemption from anti-corrosion challenge testing
answer according to Technical Guidelines for Safety Assessment of Cosmetics ,Based on product characteristics,Belongs to products that are not easily contaminated by microorganisms,Non water containing products Products mainly composed of organic solvents Water activity in products containing water
problem3 Technical Guidelines for Children's Cosmetics As stipulated in the regulations,If the essence and aromatic vegetable oil raw materials used in children's cosmetics contain the ingredients of potentially allergenic fragrances issued by domestic and foreign authorities,In principle, the content of potentially allergenic spice components in the product should be calculated,If it is in the category of resident products>0.001%,In rinsing products>0.01%time,The safety of children's use should be fully evaluated,And mark it on the product label.Does the content of allergenic spice components here refer to the content of a single component or the sum of the contents of all components
answer The content of allergenic spice components here refers to the content of a single component.
problem4 Received quality specification certification documents or inspection reports provided by the raw material supplier in the safety assessment report ProvidedXXThere is no correlation between the information and the declared formula How should the review opinions be modified
answer Can be included in the product formula Fill in the safety information of raw materials on your own Fill in the product name of the raw material in the column Consistent with relevant information is required ,Or submit Regulations on the Management of Registration and Filing Materials for Cosmetics attachment14 Information related to raw material safety Information related to raw material safety The relevant information needs to be consistent with the formula .
problem5 Resident children's cosmetics,In the standards for product executionpHThe value range is set to4.0-8.5,Is it reasonable
answer according to Technical Guidelines for Children's Cosmetics ,Children's cosmetics should be set uppHValue Range Unable to determinepHExcluding dosage forms with values ,Resident cosmeticspHThe value range should be within4.5~7.5 contain4.5as well as7.5 Rinse off cosmeticspHThe value range should be within4.5~8.5 contain4.5as well as8.5 If considering the physiological characteristics of specific usage areas Like the diaper area for infants and young children Factors such as product attributes and raw material stability,settingpHWhen the value range belongs to any of the following situations,Scientific and reasonable explanations should be provided,And conduct a thorough security assessment 1 settingpHLower limit of value range≥3.5only
problem6 When the formula contains raw materials carbomer time,How to identify and evaluate the potential risk substances it may contain
answer The National Medical Products Administration has released 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 Add management limits for the banned component benzene in cosmetics,support If it is technically impossible to avoid benzene as an impurity entering cosmetics,Its limit does not exceed2mg/kg bring into Technical specifications for cosmetic safety 2015Year Edition Chapter 2 List of Prohibited Components in Cosmetics1pour 3 ,On the date of self release 2023year8the moon28sun Start implementation.Carbopol is a common substance that may introduce risks benzene The raw materials for cosmetics,Cosmetic registrant When the registrant uses this type of raw material,Risk substances should be identified and evaluated benzene ,just benzene The residual amount in the product should≤2mg/kg.If the provided specifications are for the quality of raw materials,Then conversion is required,Confirm whether the benzene content in the product meets the requirements Technical specifications for cosmetic safety 2015Year Edition require.for example The Carbopol quality specification provided by a certain product shows benzene Limited to5000ppm,The content of Carbopol in the product formula is0.3%,Converted,In the product benzene The maximum content may reach15ppm approach15mg/kg ,outstrips Technical specifications for cosmetic safety 2015Year Edition The limited quantity requirement.
problem7 Regarding the formula essence useIFRAWhat should be noted when conducting security assessments on certificates
answer Attention should be paid to the following content
1 formulation Fill in the safety information of raw materials on your own Fill in the product name andIFRAThe sample names in the certificate should be consistent.for example IFRAIn the certificate,Essence Trade name is grapefruit essence,The product name of the raw material under the product formula should be consistent with it.
2 IFRAThe version of the certificate should be the latest version Currently, it is the51edition .
3 Determine based on the usage site and dosage form of the productIFRAclassification.
for example The evaluation conclusion of a essence is adoptedIFRACategory in the certificate5CBased on the highest usage amount,IFRAIn the category5CSuitable for applying cream products to the hands,The dosage form of this product is liquid,Not applicable to this category.
4 The formula amount of the essence should be lower than that of the essence in theIFRAThe maximum number of additions in the corresponding category of the certificate.