Working Group Chair Presentation Book
DRAFTAOACAllergenSMPRVersion5;March10,2016. 1 2 DetectionandQuantitationofSelected Food Allergens 3 4 IntendedUse : Referencemethod for cGMP compliance.
Formatted: Font:Calibri, 11 pt Formatted: Font:Calibri, 11 pt Formatted: Font:Calibri, 11 pt
Formatted: Font:11 pt Formatted: Font:11 pt
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.
Formatted: Font color:Auto Formatted: No underline,Font color:Auto Formatted: No underline,Font color:Auto Formatted: Font color:Auto Formatted: Indent: Left: 0.5",First line: 0" Formatted: Font:Calibri, 11 pt,NotBold, Font color:Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font color:Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font color:Auto,Not Superscript/ Subscript Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font color:Auto Formatted: Font:NotItalic Formatted: Font:NotItalic, Font color:Auto
15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41
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.
Formatted: Font color:Auto Formatted: Font:Calibri, 11 pt
1 CodeofFederalRegulations;Title21 -FoodandDrugs,§131.110. Other internationally recognizeddefinitionmaybeapplied.
Formatted: Not Superscript/ Subscript Formatted: Font:Calibri, 11 pt,NotBold, Font color:Auto,Not Superscript/ Subscript
11
42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79
Formatted: Font:NotItalic, Font color:Auto Formatted: Font color:Auto Formatted: Font:NotItalic Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font:Calibri, 11 pt,NotItalic, Font color:Auto Formatted: Font:NotItalic Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted: Font:Calibri, 11 pt, Font color: Auto Formatted ... Formatted ... Formatted ... Formatted ... Formatted: Not Superscript/ Subscript Formatted ... Formatted: Not Superscript/ Subscript Formatted ...
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
). *
Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Not Superscript/ Subscript Formatted: Font:11 pt Formatted
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)
...
Formatted: Font:11 pt Formatted
...
Formatted: Font:11 pt Formatted: Not Superscript/ Subscript Formatted: Font:10 pt Formatted
... ... ... ...
Formatted Formatted Formatted
12
Made with FlippingBook - Online catalogs