Product Compliance
filing/registration/consulting/training
Q&A on the Filing of Ordinary Cosmetics by Beijing Food and Drug Administration 43rd issue
problem1 Can accelerated testing in stability testing provide a basis for confirming product shelf life answer Technical Guidelines for Stability Testing and Evaluation of Cosmetics Medium term testing is required to provide a basis for confirming storage conditions and shelf life.The cosmetics registrant may submit a filing application after the accelerated testing is completed,Long term test report enterprise archive. problem2 Some raw materials areCIRThere are limitations in the evaluation conclusion When the formula is non irritating ,The evaluation conclusion should be adopted under the condition that the limiting conditions are met.How to provide proof that meets the restrictive conditions answer We need to provide proof that the product using this raw material does not cause skin irritation.Product toxicology test reports can be used,If through acute/Multiple skin irritation tests have proven that the product has no skin irritation. problem3 currently, Technical specifications for cosmetic safety What are the alternative methods for detecting skin sensitization in China answer currently, Technical specifications for cosmetic safety Alternative methods for detecting skin sensitization in China include Skin allergy Local lymph node test LLNA:DAandLLNA: BrdU-ELISA ,In vitro skin allergy test Direct peptide reaction test DPRA Test method for amino acid derivatization reaction ADRA Human cell line activation assay h-CLAT U937Cell activation assay method U-SENS Fluorescein reporter gene testing for keratinocytesLuSensmethod LuSens . problem4 How to conduct safety assessment for essence and fragrance in the formula answer 1 Product formula table Standard Chinese name Only fill in the column essence Raw Material,Should be in accordance with Guidelines Evaluate essence according to the principles and requirements of,Or specify that the essence used in the product conforms to the International Daily Flavor Association IFRA Practice regulatory requirements or comply with relevant regulations in China essence national standard. 2 Product formula table Standard Chinese name Fill in both columns simultaneously essence And specific flavor components in essence,Conduct safety assessments for each spice component. 3 Children's cosmetics formula contains essence When it comes to plant essential oils or spice ingredients,It is necessary to identify and evaluate the allergenic components involved. problem5 Do ingredients that have not been filled in the formula need to undergo safety assessment answer When evaluating raw materials,Simultaneously deal with extremely trace components that are not reported as ingredients in the formula For example, extremely trace amounts of ingredients added to cosmetic raw materials to ensure their quality Explain one by one and conduct a thorough security assessment,Ensure that such ingredients do not affect the quality and safety of the raw materials.