Working Group Chair Presentation Book

DRAFTAOACAllergenSMPRVersion5;March10,2016. 1 2 DetectionandQuantitationofSelected Food Allergens 3 4 IntendedUse : Referencemethod for cGMP compliance.

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5 6 1. Purpose: AOAC SMPRs describe the minimum recommended performance characteristics 7 to be used during the evaluation of a method. The evaluation may be an on-site 8 verification, a single-laboratory validation, or a multi-site collaborative study. SMPRs are 9 written and adopted by AOAC Stakeholder Panels composed of representatives from the 10 industry, regulatory organizations, contract laboratories, test kit manufacturers, and 11 academic institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their 12 evaluation of validation study data for method being considered for Performance Tested 13 Methods or AOAC Official Methods of Analysis , and can be used as acceptance criteria for 14 verificationatuser laboratories.

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2. Applicability :

Detectionandquantitationofegg,milk,peanut,andhazelnut foodallergens in finished food

productsand ingredients. Method(s) shalluniquely identifyeachallergen.

3. AnalyticalTechnique :

Mass spectrometrybasedmethods.

4. Definitions :

FoodAllergens

Hazelnut

Anyof thenutsderiving from speciesof thegenus Corylus ,especially thenutsof the species Corylusavellana (the commonhazel tree). It isalsoknownas cobnutor filbert nutaccording to species. For thepurposesof thisSMPR, includesboth rawand

processednuts.

Milk

For thepurposesof thisSMPR : “milk” refers topasteurized whole cow’s ( Bos Taurus) . milk .,and shall containnot less than81/4percentmilk solidsnot fat andnot

less than31/4percentmilkfat. 1

Peanut

The seedof the Arachishypogaea plant. For thepurposesof thisSMPR, includesboth

rawand roastedpeanuts.

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1 CodeofFederalRegulations;Title21 -FoodandDrugs,§131.110. Other internationally recognizeddefinitionmaybeapplied.

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WholeEgg

A combinationofpasteurized [ chicken ] ( Gallusgallusdomesticus ) eggwhitesandegg yolks from the sameproductionbatchblended together in theirentirety, innatural

proportions. 2

LimitofQuantitation (LOQ)

Theminimum concentrationormassofanalyte inagivenmatrix that canbe reportedasa

quantitative result. LOQ=average (blank)+10* s0 (blank).*

Methoddetection limit (MDL)

Methoddetection limit (MDL) is theminimum concentrationofa substance than canbe measuredand reportedwith99% confidence that theanalyte concentration isgreater than zero. It isdetermined fromanalysisofa sample inagivenmatrix containing theanalyte. 3 Theminimum concentrationofa substance that canbemeasured (detected)and reported with99%confidence that theanalyte concentration isgreater than zeroand isdetermined fromanalysisofa sample inagivenmatrix containing theanalyteusingat least two ion MS/MS transitions. See4 (a)of40CFRPart136,AppendixB toPart136 -Definitionand Procedure for theDeterminationof theMethodDetection Limit-Revision. 4

Repeatability

Variationarisingwhenalleffortsaremade tokeep conditions constantbyusing the same instrumentandoperatorand repeatingduringa short timeperiod.Expressedas the

repeatability standarddeviation (SD r

);or% repeatability relative standarddeviation

(%RSD r

). *

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Reproducibility

The standarddeviationor relative standarddeviation calculated fromamong-laboratory

data.Expressedas the reproducibility standarddeviation (SD R

);or% reproducibility relative

standarddeviation (%RSD R

). *

Recovery

The fractionorpercentageof spikedanalyte that is recoveredwhen the test sample is

analyzedusing theentiremethod. **

5. MethodPerformanceRequirements :

See table1.

2 Introduction toEggProducts,USDAFoodSafetyand InspectionService,website:http://www.fsis.usda. gov/wps/wcm/connect/c5c85914-5055-4f09-8098-1a179a1c6e14/EPT_Introduction.pdf?MOD=AJPERES, accessed12/15/2015. * SeeTableA3 inAppendixF: Guidelines forStandardMethodPerformanceRequirements for additionalguidance. **See Spiking method in AppendixM in theOfficialMethodsofAnalysis. 3 Volume II -Methods,MethodVerificationandValidationORA-LAB.5.4.5; DOCUMENTNO.: IV-02; VERSIONNO.:1.7; Section2–Microbiology;EFFECTIVEDATE:10-01-03;REVISED:08-25-14;WEBSITE: http://www.fda.gov/ScienceResearch/FieldScience/ucm171877.htm,ACCESSED:Feb.22,16. 4 40CFRPart136,AppendixB toPart136 -DefinitionandProcedure for theDeterminationof theMethod Detection Limit-Revision (link)

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