美国对过敏源的规定.ppt

1、FDA Perspectives on Food Allergens and Method Validation Programs Douglas L. Park, Ph.D. Division of Natural Products Center for Food Safety and Applied Nutrition Food and Drug Administration,Food allergies affect an estimated 6% of children younger than 3 years old and 1.5% of adults in the U.S.,So

2、urces of Food Allergens of Primary Concern,PeanutsSoybean Tree nutsCrustaceans MilkFish EggWheat,The Food, Drug and Cosmetic Act requires a complete listing of all food ingredients on the label FDA recommends that food manufacturers voluntarily declare potentially allergenic ingredients Food allerge

3、ns do not meet the requirements for incidental allergen exemption,Current Regulations and Policies,Rationale for Method Validation,Accurate, reliable analytical results are crucial to monitoring and enforcement programs focusing on the safety of food and labeling. In the event of incorrect labeling,

4、 the food label is corrected and a recall of the product may occur.,FDA relies on the validation programs administered by AOAC INTERNATIONAL in its enforcement programs (21 CFR 2.19),Strengthening the Reliability of Analytical Results,Method Validation Qualified Analyst Analyte Reference Standard St

5、andard Reference Material Proficiency Testing Laboratory Quality Control,Method Validation,Single Laboratory Validation Multiple Laboratory Validation Harmonized Collaborative Validation,Single Laboratory Validation,Research Purposes Limited Number of Samples or Applications Quality Control Modifica

6、tion to Existing Methodology Performance Tested Methods,Multiple Laboratory Validation,2 8 Laboratories Peer-Verified MethodsSM Full Collaborative Study not Justified Economic reasons Need for rapid validation Regulatory Surveillance Activities,Harmonized Collaborative Validation,Official or Referen

7、ce Method Dispute Situations “Gold Standard” Harmonized Protocol AOAC, IUPAC, ISO, Codex,Method Evaluation Program for Food Allergens,Search for test kit availability Evaluation and characterization of standards & reference materials Comparative evaluation of test kits with standards/reference mater

8、ials Comparative evaluation of test kits with food matrices and challenge proteins,Method Validation Program for Peanut Allergens in Foods,Collaboration: - AOAC International - Test Kit manufacturers - FDA/CFSAN,Peanut Protein Test Kit Validation Study,Test Kits Biokits Peanut Assay (Tepnel Biosyste

9、ms Ltd, Flintshire, UK) RIDASCREENFAST Peanut (R-Biopharm AG, Darmstadt, Germany) Veratox for Peanut Allergen (Neogen Corp., Lansing, MI, USA),Peanut Protein Test Kit Validation Study,Commodities tested: - Breakfast cereal, cookies, ice cream, milk chocolate Peanut Protein Concentrations 1 & 5 ppm T

10、est Criteria - Pass/Fail (Yes/No),Peanut Protein Test Kit Validation Study,32 Challenge Proteins,BarleyCornWheatWheat gluten RiceRyeOatsBuck wheat Soy beanPistachio Lima beansSunflower seed Chick peasSesameAlmondPumpkin seed Brazil nutCashewChestnutPoppy seed CoconutHazelnutMacadamiaBovine gelatin P

11、ecan nutPine nutWalnutSkim milk powder CocoaLecithinPeasPorcine gelatin,60 Test portions: commodity concentration kit Sample preparation & distribution (FDA/CFSAN),Peanut Protein Test Kit Validation Study,Participating Analytical Laboratories: Allergen Method Development Group, Health Canada, Ottawa

12、 National Food Processors Association, Washington DC FDA Northeast Regional Laboratory, Jamaica, NY,Peanut Protein Test Kit Validation Study,RESULTS,Biokits RidascreenVeratox Sensitivity(%)10099.6 100 Specificity(%)10098.8 99.6 X-reaction* None Somea None *Cross-reaction with challenge proteins aCro

13、ss-reacted with legume proteins at high conc.,Peanut Protein Test Kit Validation Study,Conclusions,All three test kit methods were approved as Performance Tested Methods Reliable for the detection of peanut proteins in breakfast cereals, cookies, ice cream and milk chocolate,Conclusions (cont.),User

14、s can decide which method to use based on validated performance results, cost, time, and ease of use. FDA intends to use these kit methods for detection of peanut proteins in various food matrices until collaborative validation studies are completed,Where do we go from here?,Conduct collaborative validation studies (harmonized protocols AOAC/IUPAC/