Low Lactose ERP - Review Book

2. Does the method contain system suitability tests or controls as specified by the SMPR? If not, please indicate if there is a need for such tests or controls and which ones. 3. Is there information demonstrating that the method system suitability tests and controls as specified in the SMPR worked appropriately and as expected? If no, please specify. 4. Based on the supporting information, is the method written clearly and concisely? If no, please specify the needed revisions. 5. Based on the supporting information, what are the pros/strengths of the method?

The system is calibrated with an artificial milk solution. Preparation of these samples is well documented.

The calibration results show that the artificial milk solution show proper results within SMPR criteria. Two control samples (MUVA, EPQS661 2017) were analyzed (two similar samples?). These two samples show proper RSDr and Recovery, though it is a very limited number for system suitability tests to my opinion. I would like to see results for more reference materials as stated in the SMPR.

The method is clear and concise, no revisions needed, except for some clarity about the correction for the fat content.

- Simple - Rapid result - Good selectivity, based on the results of potential interferents - Robust - Good tracking per sample via QR code - Many matrices included - Many potential interferents included

6. Based on the supporting information, what are the cons/weaknesses of the method?

- Needs correction for samples high in fat - Requires specific equipment, software and reagents (availability, alternative suppliers?) - Only one time use per biosensor - Needs more elucidation on safety aspects - Needs proven functionality for the CRMs listed in the SMPR - Not validated for infant formula and dried products The method seems promising, but not for the whole applicability scope of the smpr. It needs extra confirmation for CRMs listed in the SMPR, it needs information about safety aspects and needs extra explanation on the calculation for high-fat samples. The results are very nice, but for a dispute resolution method it needs to be verified if there are alternative suppliers of the equipment and reagents showing similar performance.

7. Any general comments about the method?

V. Final Recommendation Do you recommend this method be adopted as a First Action and published in the Official Methods of Analysis of AOAC INTERNATIONAL? Please specify rationale.

Based on the current data I make a motion to delay the decision for potential first action status of this method pending the remarks and suggestions made.