scope:

This document specifies minimum performance requirements for methods that quantify the food allergens milk, egg, peanut, hazelnut, almond, brazil nut, macadamia nut, cashew, pistachio nut, walnut, pecan nut, lupine, sesame, mustard, soy, celery, fish, molluscs, crustaceans, and wheat in raw and processed foodstuffs. Within the scope of this document, minimum requirements for an LOQ (Limit of Quantification) will be derived from threshold data of allergic consumers. For quantitative antibody-based methods, a normative annex will describe what specific information the method developer needs to deliver and how performance characteristics shall be validated. Regarding PCR and LC-MS/MS, information on performance characteristics are in parts covered by EN 15634-1 and EN 17644¹. This document does not apply to fragmented or hydrolysed food allergens, such as casein hydrolysates or soy sauce. It also does not apply to methods that deliver qualitative results only. Methods that cover gluten-containing cereals (wheat, rye, and barley) with regard to coeliac disease are covered by EN 17254.

¹ Under preparation. Stage at the time of publication: FprEN 17644:2022.