ERP Sulfite Methods-Meeting Materials_4-2020

ERP for Sulfites in Seafood Methods Materials

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and published validation study will specify the validated matrices. The Biofish ‐ 300 SUL method will be validated for raw head ‐ on, raw head ‐ off and cooked shrimp matrices.

The method will be validated according to the AOAC Research Institute policies and procedures. The validation has two main parts: Method Developer Studies and the Independent Laboratory Study. Method Developer Studies include linearity, a matrix study for the 3 claimed matrices, lot ‐ to ‐ lot and stability studies, and robustness testing. The Independent Laboratory Study includes a matrix study for 1 of the 3 claimed matrices to verify method performance in a second lab. Regulations in the US, Canada, and EU for crustaceans require sulfites to be declared on the labeling if the sulfite concentration is 10 ppm or more. US and Canada limit the allowable sulfite concentration to 100 ppm. In the EU, sulfite is limited to the range 150 ‐ 300 ppm in unprocessed shrimp, or 135 ‐ 180 ppm in cooked shrimp. The actual upper limit depends on the size of the shrimp. In the US and Canada, sulfite is measured as H 2 SO 4 using the modified Monier ‐ Williams method (OMA 990.28, which is also FSIS CLG SFT1.00 and NOAA NSIL C022 v2).

OMA 990.28

SO 3 2 ‐  SO 2  H 2 SO 4 (by titration) HCl H 2 O 2

The yellow highlight indicates the moiety determined by the method.

The Biofish method, therefore, is not intended for regulatory purposes since it does not quantitate down to 10 ppm. Instead, it is intended for producers to ensure that added sulfite is below the upper allowable limit. The validation will include spiked and incurred shrimp covering the concentration range of the method. The Biofish ‐ 300 SUL method will be compared to OMA 990.28.

2.0

METHOD DEVELOPER STUDIES

2.1

Overview

The method developer studies will generate method performance data for selectivity, linearity, LOD, LOQ, recovery, and precision and will include product quality assurance data for lot ‐ to ‐ lot consistency, kit stability and method robustness.

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04/16/2020