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DRAFT AOAC Allergen SMPR Version 5; March 10, 2016.
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Detection and Quantitation of Selected Food Allergens
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Intended Use
: Reference method for cGMP compliance.
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1.
Purpose:
AOAC SMPRs describe the minimum recommended performance characteristics
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to be used during the evaluation of a method. The evaluation may be an on-site
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verification, a single-laboratory validation, or a multi-site collaborative study. SMPRs are
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written and adopted by AOAC Stakeholder Panels composed of representatives from the
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industry, regulatory organizations, contract laboratories, test kit manufacturers, and
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academic institutions. AOAC SMPRs are used by AOAC Expert Review Panels in their
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evaluation of validation study data for method being considered for
Performance Tested
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Methods
or AOAC
Official Methods of Analysis
, and can be used as acceptance criteria for
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verification at user laboratories.
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2.
Applicability
:
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Detection and quantitation of egg, milk, peanut, and hazelnut food allergens in finished food
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products and ingredients. Method(s) shall uniquely identify each allergen.
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3.
Analytical Technique
:
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Mass spectrometry based methods.
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4.
Definitions
:
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Food Allergens
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Hazelnut
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Any of the nuts deriving from species of the genus
Corylus
, especially the nuts of the
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specie
s Corylus avellana(the common hazel tree).
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Milk
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For the purposes of this SMPR: “milk” refers to pasteurized whole cow’s (
Bos
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Taurus)
. milk, and shall contain not less than 8 1/4 percent milk solids not fat and not
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less than 31/4 percent milkfat.
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Peanut
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The seed of the
Arachis hypogaea
plant. For the purposes of this SMPR, includes both
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raw and roasted peanuts.
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Code of Federal Regulations; Title 21 - Food and Drugs, § 131.110. Other internationally
recognized definition may be applied.