OMB First to Final Action Recommendation Checklist 11-12-18

ERP - GLUTEN ASSAYS: AOAC 2015.05 FAR

3.4. Precision data from QC testing  To check if the reproducibility standard deviation is still comparable to the values that led to OMA First  Action status, regular QC testing at R‐Biopharm was assessed. QC testing is performed according to a  predefined scheme. Measurements take place every 3 or 4 months during the guaranteed shelf life of  the product which is normally about 18 months. As can be seen from table 5, the CVs for the beer  samples were between 21 and 30% which is comparable to the collaborative test in which –depending  on the concentration‐ CVs (or RSD R ) between 26% to 37% were observed. A gluten‐free beer was  always part of the measurement. This sample was never tested above LoQ (5 mg/kg).  Table 5. QC data for 4 different lots tested by 14 different persons using spiked beer samples,  naturally contaminated beer samples and one gluten‐free beer; values are given as mg/kg prolamins;  an estimate for the reproducibility standard deviation is given at the end of the table.  lot months person 5 mg/kg 15 mg/kg 45 mg/kg 135 mg/kg Krusovice Lammsbräu Becks Gold 1 0 1 5.2 18.1 53.1 124.7 21.9 < S2 11.3 1 0 2 4.7 14.2 47.5 126.7 20.3 < S2 9.5 1 0 2 4.8 12.5 40.7 121.7 21.0 < S2 9.7 1 4 3 10.5 30.6 42.7 23.2 < S2 12.3 1 8 4 5.4 9.9 31.2 94.3 18.2 < S2 10.1 2 0 1 6.9 16.5 51.6 129.7 21.8 < S2 11.1 2 0 2 8.7 17.4 61.2 144.2 29.7 < S2 13.6 2 0 2 10.6 21.7 54.8 153.2 30.9 < S2 21.1 2 4 7 11.8 27.9 72.3 163.5 34.1 < S2 16.1 2 4 7 9.7 25.0 72.8 167.0 27.5 < S2 10.7 2 8 8 7.4 31.7 76.8 206.6 20.0 < S2 8.2 2 8 8 7.7 29.1 75.6 211.6 22.3 < S2 16.7 2 12 7 4.4 14.9 44.2 125.7 18.4 < S2 9.7 2 12 7 7.3 18.5 54.7 143.4 23.8 < S2 12.0 3 0 9 5.7 15.6 45.0 110.8 21.7 < S2 12.1 3 0 2 8.7 13.6 43.0 110.3 21.4 < S2 9.8 3 0 2 8.5 20.4 44.9 121.0 27.4 < S2 9.8 3 4 10 8.8 14.7 43.5 107.7 24.1 < S2 13.3 3 8 6 8.8 17.6 44.7 164.9 21.9 < S2 11.0 3 12 10 5.9 16.8 46.6 120.8 40.6 < S2 17.7 3 16 11 10.5 14.7 48.9 156.5 20.2 < S2 6.8 4 0 12 6.6 16.0 43.3 153.2 27.2 < S2 11.2 4 0 12 5.4 13.5 52.3 135.4 22.7 < S2 11.0 4 0 13 8.2 19.3 53.7 163.3 34.0 < S2 14.6 4 0 13 4.2 12.7 48.6 156.8 25.7 < S2 9.9 4 3 14 7.2 21.6 60.8 181.0 43.5 < S2 12.6 4 3 10 6.4 18.1 53.1 133.9 26.5 < S2 11.6 4 6 2 4.5 11.1 47.2 112.8 18.1 < S2 8.9 4 9 10 8.8 16.1 47.7 138.1 32.6 < S2 16.6 4 12 6 4.9 22.0 52.4 158.1 30.3 < S2 10.4 4 15 6 7.9 15.1 47.2 151.8 38.2 < S2 13.1 4 18 10 6.2 20.0 47.6 116.1 37.3 < S2 8.5 4 21 14 3.1 16.5 76.6 240.5 49.1 < S2 14.9 4 24 8 6.3 15.6 45.9 118.4 27.4 < S2 11.5 mean 7.1 18.2 52.1 144.4 27.1 12.0 SD 2.14 5.40 11.13 32.13 7.71 3.03 CV (%) 30.1 29.7 21.4 22.3 28.4 25.3 Beer (Lammsbräu, spiked with prolamins) Beer Beer Beer

< S2 = concentration below concentration of standard 2 (5 mg/kg) 

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