Low Lactose ERP - Review Book

4. Does the method, as written, contain all appropriate precautions and warnings related to the method's reagents, components, instrumentation, or method steps that may be hazardous? If no, please suggest wording or option(s). 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. 3. Is there information demonstrating that the

In general, the method contains appropriate precautions and warnings. I would suggest to mention AOAC Official Methods of Analysis (2005), Appendix B: Laboratory Safety.

Yes, the definitions specified in the SMPR are used and applied appropriately in the supporting documentation.

Reference materials stated in the SMPR are: MUVA ML-2308 (UHT-Milk, low in lactose) and ML-2309 (UHT-Milk, lactose-free, frozen), and MUVA CA-0904. The candidate approach mentions correctly available MUVA Kempten materials: MUVA ML-2310 and ML-2011, and ML-2309.

Yes, there are specific information demonstrating that the method performs within the SMPR Method Performance Requirements table specifications. Actually, the method concerns six sugars, while AOAC SMPR 2018.009 concerns only lactose. In addition, it has to be noted that:

a) Reproducibility tests have been performed for lactose with relation to the following samples: Cheese Spread only (repeatability is not mentioned)

b) Precision tests have been performed for lactose with relation to the following samples: dry pet food only

c) A specific extraction robustness study has been performed for lactose with reference to : lactose-free vanilla yogurt

d) Finally, the following reference standards have been considered for lactose and with reference to AOAC SMPR 2018.009: MUVA ML-2310 and ML-2311, and ML-2309.