DRAFT AOAC Allergen SMPR Version 7; March 31, 2016.
1
2
Detection and Quantitation of Selected Food Allergens
3
4
Intended Use
: Reference method for cGMP compliance.
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
verification at user laboratories.
15
16
2.
Applicability
:
17
Detection and quantitation of egg, milk, peanut, and hazelnut food allergens in finished food
18
products and ingredients. Method(s) shall uniquely identify each allergen.
19
20
3.
Analytical Technique
:
21
Mass spectrometry based methods.
22
23
4.
Definitions
:
24
25
Food Allergens
26
Hazelnut
27
Any of the nuts deriving from species of the genus
Corylus
, especially the nuts of the
28
specie
s Corylus avellana(the common hazel tree).
29
30
Milk
31
For the purposes of this SMPR: “milk” refers to pasteurized whole cow’s (
Bos
32
Taurus)
. milk, and shall contain not less than 8 1/4 percent milk solids not fat and not
33
less than 3 1/4 percent milkfat
. 134
35
Peanut
36
The seed of the
Arachis hypogaea
plant. For the purposes of this SMPR, includes both
37
raw and roasted peanuts.
38
39
1
Code of Federal Regulations; Title 21 - Food and Drugs, § 131.110. Other internationally
recognized definition may be applied.