BS EN 15842:2019 pdf free.Foodstuffs – Detection of food allergens – General considerations and validation of methods.
A major challenge for allergen analysis consists in achieving measurement results which are comparable across different measurement methods and laboratories. The key requirement to ensure such comparability is the metrological traceability of all measurement results to a common reference, which serves as an anchor or benchmark for scaling the data.
For establishing metrological traceability an agreement is needed on the definition of the measurand, i.e., on the quantity intended to be measured (JCGM 200 [161). In order to support current risk assessment and EU legislation, the quantity for reporting the content of an allergen in food should be the mass (rng) of total allergenic ingredient protein per mass (kg) of food. Consequently the International System of Units (SI), namely the kilogramme, is used as one component of the ultimate reference for measurement results on allergens. However, the common reference as defined above can only be realized for each allergen via reference measurement systems, consisting of reference methods and reference materials. In that concept the reference method is forming the highest metrological level of the traceability chain. It needs to be well described and specific enough to ensure that results can be reliably reproduced within a prescribed measurement uncertainty over time and space.
The reference method shall be applied in allergen analysis for characterizing candidate reference materials, intended to be used as primary calibrants, and for establishing conversion factors allowing the transformation of results obtained by different methods to the common measurands scale.
Testing for the presence and amounts of allergens in food may be often performed by using screening methods. At the discretion of the laboratory or on customer request, the measurement results from such screening methods may be checked by using confirmatory methods. The latter should be validated according to standards, such as EN ISO/IEC 17025, before their application.
As the measurand defined above is not directly accessible by any currently available measurement method, the whole measurement process from the laboratory sample to the final result should be appropriately designed for being able to express the measurement results in a uniform manner. Specific consideration for that are listed in the following clauses and subclauses.BS EN 15842 pdf download.