Low Lactose ERP - Review Book

III. Review of Supporting Information 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. IV. General Submission Package 1. Based on the supporting information, were there any additional steps in the evaluation of the method that indicated the need for any additional precautionary statements in the method? 3. Is there information demonstrating that the

Yes, the definitions are used.

There is quite some information demonstrating the good performance of the method, however only two certified reference materials are included. The two reference materials used were not mentioned in the SMPR. It could be helpful to also demonstrate applicability of the method with some of the other reference materials in the SMPR.

There is information for milk, milk products and products containing dairy ingredients, not for infant formula and adult nutritionals. Selectivity studies were extensively performed and all ascribed were not interfering. Nothing is said about potential enzymatic activity interference, this needs to be checked. Many spiked matrices were analyzed and repeatability and recovery values are given. Different sample preparation is needed for samples with various fat content. The value needs to be corrected based on the fat content. It is unclear whether the results presented in Table 5 represent these corrected values. Next to that it is not very clear whether fat contents need to be determined or can be used from the label? (which will result in an error inclusion). Some samples were slightly out of the SMPR criterion (1 for low concentration, 4 in total for high concentration). It is not known whether these values are statistical outliers, since that information is not given. The only information given is that they were just outside of the criterion. The fat content of the sample influences the result. Information is given on how to treat these samples. The use of the biosensor requires specific and quick handling.