Allergens ERP Book, Sept 17

1. Are the definitions specified in the SMPR used and applied appropriately in the supporting documentation (manuscripts, method studies, etc...)? If not, please explain the differences and if the method is impacted by the difference. 2. Is there information demonstrating that the method meets the SMPR Method Performance Requirements using the Reference Materials stated in the SMPR? If not, then specify what is missing and how this impacts demonstration of performance of the method. method performs within the SMPR Method Performance REquirements table specifications for all analytes in the SMPR applicability statement? If not, please specify what is missing and whether or not the method's applicability should be modified. 3. Is there information demonstrating that the

Yes

The method is calibrated using f the reference materials in case of three of the studied allergens (Whole Egg, Milk, Peanut). The method accuracy not established by analysis of other reference materials, or comparing its results with those obtained by other currently established methods. The method accuracy may be evaluated using available reference materials (CRMs) like IFAAN reference std. for peanut, and from Food Allergen Lab for egg, hazelnut and milk and other reference materials. The use of reference material necessarily don't guarantee the method accuracy because the material has been processed extensively in the method.

Yes, in most parts with the following exceptions.

Allergen Matrix

Egg Yolk No internal std qualifier ion Ey1 available Egg White EW2-J Used as qualifier ion - No internal std in red and white wine matrices Milk M2-1 Used as qualifier ion - No internal std in red and white wine matrices Analytical Range Exceptions include Egg yolk in white wine, peanut and hazelnut in ice cream and milk chocolate Egg Yolk MDL and MQL in all matrices > SMPR requirement MDL and MQL (ppm) Egg white in red and white wines Peanut in ice cream and milk chocolate Hazelnut MQL in ice cream and milk chocolate Hazelnut MDL in ice cream, milk chocolate & breakfast cereals. % Recovery Hazelnut in ice cream, milk chocolate & breakfast cereals. Peanut in milk chocolate. Milk in dark chocolate. Egg yolk in salad dressing.