Low Lactose ERP - Review Book

AOAC SMPR ERPs - 2019 METHOD REVIEW FORM

Submission Date

2019-09-05 13:23:37

Name

Angelika Semmler

E-mail

dkanse@chr-hansen.com

Organization

Chr Hansen A/S

Title of Method

Determination of Lactose in Low-Lactose or Lactose-free Milk, Milk Products, and Products Containing Dairy Ingredients

AOAC Candidate Method Number (e.g. ALN-01)

LAC-005

Applicable SMPR

SMPR-2018.009

I. Summary of the Method

The method is intended for confirming compliance with regulatory standards and dispute resolution of Lactose in Low-Lactose or Lactose-free milk, milk products, and products containing dairy. The reviewed candidate method is based on ion chromatography and combines online dialysis, ion chromatography and pulsed amperometric detection. The concentration of lactose is calculated by comparison with standards of known concentration. The working range of the method is 0.1 mg/kg to 40 mg/kg. NO The submitter themselves are requesting an extension for a re-submission, as the method was not fully validated. They anyhow do not specify the planned remaining experiments. The submitted method was only tested with pure reference material (muva-ML- 2310, muva-ML-2311, muva-CA-0904 and SRM 1869a) and milk. There is a clear demand for a method according to AOAC SMPR 2018.009 to cover for a broad product/matrix range. It is not shown and proved that the method can be applied to more complex milk products. (e.g. fermented milk products, cheese, butter, yoghurt, desserts, cream, formulations with milk (e.g. ready to drink coffee-milk mixes, drink chocolate, etc.) and infant formula). NO The submitter themselves are requesting an extension for a re-submission, as the method was not fully validated. They anyhow do not specify planned remaining experiments. The list of potential interferences was not investigated sufficiently. Missing potential interferants: complex sample matrices, sugar alcohols, carbohydrate polymers, organic acid activity, enzyme activity, amine-containing compounds.

II. Review of the Method Only 1. Does the applicability of the method support the applicability of the SMPR? If not, please explain what is missing.

2. Does the analytical technique(s) used in the method meet the SMPR? If not, please specify how it differs from what is stated in the SMPR.

3. Are the definitions specified in the SMPR used and applied appropriately in the method? If no, please indicate how the terms are used.

YES