美国对过敏源的规定

1、FDA Perspectives on Food Allergens and Method Validation ProgramsDouglas L. Park, Ph.D.Division of Natural ProductsCenter for Food Safety and Applied NutritionFood and Drug AdministrationFood allergies affect an estimated 6% of children younger than 3 years old and 1.5% of adults in the U.S.Sources

2、of Food Allergens of Primary ConcernPeanutsSoybeanTree nutsCrustaceansMilkFishEggWheat 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 allergens do not

3、meet the requirements for incidental allergen exemptionCurrent Regulations and PoliciesRationale 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, the food la

4、bel 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 Standard Referen

5、ce Material Proficiency Testing Laboratory Quality ControlMethod Validation Single Laboratory Validation Multiple Laboratory Validation Harmonized Collaborative ValidationSingle Laboratory Validation Research Purposes Limited Number of Samples or Applications Quality Control Modification to Existing

6、 Methodology Performance Tested MethodsMultiple 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 Reference Method Dispute

7、 Situations “Gold Standard” Harmonized Protocol AOAC, IUPAC, ISO, CodexMethod 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 materials Comparati

8、ve evaluation of test kits with food matrices and challenge proteins Method Validation Program for Peanut Allergens in FoodsCollaboration:- AOAC International- Test Kit manufacturers- FDA/CFSANPeanut Protein Test Kit Validation StudyTest KitsBiokits Peanut Assay (Tepnel Biosystems Ltd, Flintshire, U

9、K)RIDASCREENFAST Peanut(R-Biopharm AG, Darmstadt, Germany)Veratox for Peanut Allergen (Neogen Corp., Lansing, MI, USA)Peanut Protein Test Kit Validation StudyCommodities tested:- Breakfast cereal, cookies, ice cream, milk chocolatePeanut Protein Concentrations1 & 5 ppmTest Criteria- Pass/Fail (Y

10、es/No)Peanut Protein Test Kit Validation Study32 Challenge ProteinsBarleyCornWheatWheat glutenRiceRyeOatsBuck wheatSoy beanPistachio Lima beans Sunflower seedChick peas SesameAlmondPumpkin seedBrazil nutCashewChestnutPoppy seedCoconutHazelnutMacadamia Bovine gelatinPecan nutPine nutWalnutSkim milk p

11、owderCocoaLecithinPeasPorcine gelatin 60 Test portions: commodity concentration kit Sample preparation & distribution (FDA/CFSAN)Peanut Protein Test Kit Validation StudyParticipating Analytical Laboratories:Allergen Method Development Group, Health Canada, OttawaNational Food Processors Associat

12、ion, Washington DCFDA Northeast Regional Laboratory, Jamaica, NYPeanut Protein Test Kit Validation Study RESULTS Biokits RidascreenVeratoxSensitivity(%)10099.6 100Specificity(%)10098.8 99.6X-reaction* None Somea None*Cross-reaction with challenge proteinsaCross-reacted with legume proteins at high c

13、onc.Peanut Protein Test Kit Validation StudyConclusions 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 chocolateConclusions (cont.) Users can decide which method to use based on va

14、lidated 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 completedWhere do we go from here? Conduct collaborative validation studies (harmonized protocols AOAC/IUPAC/