61 / 228
6. System suitability testsand/oranalyticalquality control:
80
Suitablemethodswill includeblank check samples,and check standards at the lowestpoint
81
andmidrangepointof theanalytical range.
82
83
7.
Potential
ReferenceMaterial(s):
84
85
WholeEgg
86
x
NIST8445
87
x
LGCSAL-RSM-5 (Check for characterization level)
88
89
NonfatMilkPowder
90
x
NISTSRM1549 (nonfatmilkpowder)
91
x
NISTSRM1549a (wholemilkpowder)
92
93
Peanut
94
x
NISTSRM2387 (peanutbutter)
95
x
LGC FAL-RFM1017-XXX
96
97
Hazelnut
98
x
Noknown referencematerialavailable.
99
x
LGC FAL-RFM1015-50orFAL-RFM1015-50ÂorFAL-RFM1015-5
100
101
Additionalmaterials canbe foundat the LGCandFAPASwebsites
102
LGC=
http://www.lgcstandards.com/HK/en/search/?q=allergen:relevance:category:CEFP_77243
103
FAPAS=
http://fapas.com/quality-control-materials/Available-quality-control-materials.cfm104
105
Refer toAnnexF:
DevelopmentandUseof In-HouseReferenceMaterials
inAppendixF:
106
Guidelines forStandardMethodPerformanceRequirements
,19
th
Editionof theAOAC
107
INTERNATIONALOfficialMethodsofAnalysis (2012). Availableat:
108
http://www.eoma.aoac.org/app_f.pdf109
110
NIST=National Institute forStandardsandTechnology.
111
LGC= formerly theUK
Laboratoryof theGovernmentChemist
,now simply “LGCStandards”.
112
FAPAS= formerly the
FoodAnalysis PerformanceAssessmentScheme
in theUK, now simply
113
“FAPAS”.
114
115
116
8. ValidationGuidance
:
117
118
Methoddevelopers shall submit
LOQ,MDL, recoveryandprecision
data
evaluating for
the
119
matrices inTable2.
120
121
AppendixD:Guidelines forCollaborativeStudyProceduresToValidateCharacteristicsofa
122
MethodofAnalysis;19
th
Editionof theAOAC INTERNATIONALOfficialMethodsofAnalysis
123
(2012). Availableat:
http://www.eoma.aoac.org/app_d.pdf124
125
AppendixF: Guidelines forStandardMethodPerformanceRequirements;19
th
Editionof the
126
AOAC INTERNATIONALOfficialMethodsofAnalysis (2012).Availableat:
127
http://www.eoma.aoac.org/app_f.pdf128
129
9. MaximumTime-To-Result:
None
130
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
Formatted
...
13
131
Table1:Methodperformance requirements.
132
133
Parameter
Targetallergen
wholeegg
milk
peanut
hazelnut
Analytical
Range (ppm)
10-1000
10-1000
10-1000
10-1000
LOQ (ppm*)
5
10
10
10
MDL (ppm*)
101.65
103
103
103
Recovery (%)
60-120%
60-120%
60-120%
60-120%
%RSD
r
чϮϬй
чϮϬй
чϮϬй
чϮϬй
%RSD
R
чϯϬй
чϯϬй
чϯϬй
чϯϬй
*Reportedasppmof the targetallergen in food commodity, i.e.,25ppmof
“wholeegg” in cookies.
Definitions for LOQandMDLprovided in section4.
134
135
136
137
138
139
140
141
142
143
144
145
146
147
148
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
Formatted:
No underline,Font color:Auto
14