AOAC SPIFAN ERP Report (August 5, 2021)

AOAC Stakeholder Program on Infant Formula and Adult Nutritionals

NUTRIENTS EXPERT REVIEW PANEL (ERP) REPORT

Thursday, August 5, 2021 AOAC INTERNATIONAL 2275 Research Blvd., Suite 300 Rockville, MD, 20850 USA

dboyd@aoac.org 301.924.7077 x126

AOAC INTERNATIONAL Stakeholder Panel for Infant Formula and Adult Nutritionals (SPIFAN) “Virtually” Meeting at AOAC INTERNATIONAL 2275 Research Blvd. Suite 300, Rockville, MD, USA Thursday, August 5, 2021 REPORT OF THE NUTRIENTS EXPERT REVIEW PANEL (ERP) PROCEEDINGS

Expert Review Panel Members (in attendance): Darryl Sullivan Sneh Bhandari Esther Campos-Giménez/Sean Austin Hans Cruijsen/Martin van Gool Brendon Gill Philip Haselberger Karen Schimpf Estela Kneeteman Thomas Vennard/Shay Phillips Jinchuan Yang

Eurofins Food Integrity & Innovation (Chair) Independent Consultant Société des Produits Nestlé S.A. FrieslandCampina Fonterra Cooperative Abbott Nutrition Abbott Nutrition INTI Reckitt Benckiser (formerly Mead Johnson) Waters Corp.

Expert Review Panel Members (not in attendance):

Perrigo Nutrition Abbott Nutrition (Retired) Wyeth Nutrition Pickering Lab NIST Independent Consultant Independent Consultant

Scott Christiansen Don Gilliland AdrienneMcMahon Maria Ofitserova Melissa Phillips/Kate Rimmer

Yannis Vrasidas DavidWoollard

AOAC Staff Includes: Palmer Orlandi (Deputy Executive Director & CSO) Delia Boyd

Deborah McKenzie Alicia Meiklejohn Tien Milor

Observers:

Keren Breiterman, Eurofins David Ellingson, Eurofins US Jennifer Frueh, RB Corporation Harvey Indyk, Fonterra Cooperative (Retired) Steve Holroyd, Fonterra Cooperative Ashraf Kotb, Musa lab for Environmental laboratories and consultations Giampaolo Perinello, Mérieux NutriSciences

Quang Son Pham, Abbott Nutrition Dustin Starkey, Abbott Nutrition Karla Steele, RB Corporation Michael Sussman, US Department of Agriculture

AOAC SPIFAN Expert Review Panel Report August 5, 2021 Version 1

I. WELCOME AND INTRODUCTIONS Darryl Sullivan welcomed all participants to the ERP meeting and introduced the ERP members.

II. REVIEWOF METHODS BY EXPERT REVIEW PANEL (ERP) FOR FIRST ACTION OFFICIAL METHOD SM STATUS – AOAC SPIFAN II For each method, the ERP/Working Group Co-Chairs discussed method(s) submitted and reviewed the method(s) for First Action Official Method SM status.

Vote

Method

Method Title

Comments

Reviewer(s) Maria Ofitserova Tom Vennard

LACTOFERRIN

(Lacto-01) - Analysis of Bovine Lactoferrin in Milk, Infant Formula, and Adult Nutritional Products by Optical Biosensor Immunoassay

 The current SMPR developed is for bovine lactoferrin (not goat lactoferrin)  The method(s) should be evaluated based on the current bovine lactoferrin SMPR  Due to the comments on goat lactoferrin, the ERP differed recommendation of the method and forwarded discussion to the stakeholder panel for review

Motion: Recommend method as First Action Official Methods SM status for infant formula & powders only Tom Vennard moved Martine van Gool second

Yes-6/No-1/Abstain-2

2 nd Vote: Yes-5/ No-1/Abstain-3 Due to comments

pertaining to this method concerning goat lactoferrin, the ERP did not recommend moving the method to First Action Official Method SM status.

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AOAC SPIFAN Expert Review Panel Report August 5, 2021 Version 1

Method Title

Reviewer(s)

Vote

Method

Comments

(HMO-01) - Method for the Determination of 2’- Fucosyllactose, 6’-Sialyllactose, and 3’-Sialyllactose by High Performance Anion Exchange Chromatography, with Pulsed Amperometric Detection

HMO

See recommendations:

Sean Austin Brendon Gill

Motion: To recommend method as First Action

Brendon Gill moved *No second

HMO-01 RECOMMENDATIONS FROM ERP: 1. Blank matrix 2. Larger chromatogram 3. Guidance on how cross impurities in combined standards are accounted for 4. Clarification of calibration standard calculation; how are the impurities other than moisture accounted for? Motion: Sean Austin/Brendon Gill Abstain: Abbott Nutrition

Recommendation from HMO-01 Reviewers:

 Based on the data presented I am confident this method is likely fit for purpose; however, I think the reporting needs to be improved so the design of the validation experiments is more clearly reported, and the method could be easier to follow.  I would like to see spike/recovery data at concentrations inside the SMPR to assess if the recovery is still within the requirements at lower spike levels for the following matrices: - o SPIFAN III adult powder (sucrose, 2’-FL) o Soy-based IF powder (sucrose)  I would like to see some calibration plots and plots of residuals  I would like to see LoQs confirmed by low spikes in blank matrices  I would like to see if the authors have checked that 3’SL and 6’SL are well separated from their N-glycolylneuraminyllactose counterparts.  No matrices containing probiotics have been included. So, we can either limit the scope to exclude those or give the authors time to test such matrices.

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AOAC SPIFAN Expert Review Panel Report August 5, 2021 Version 1

Vote

Method

Method Title

Comments

Reviewer(s)

HMO

(HMO-03) - Analysis of 7 Human Milk Oligosaccharides in Infant Formula and Adult Nutritionals by 2AB Labeling and Quantification with HILIC- FLD

Phil Haselberger Sean Austin

See recommendations:

Motion: None: ERP recommended to no action taken on this method

HMO-03 RECOMMENDATIONS FROM ERP: 1. 5 GC 2. Guidance on how cross impurities in combined standards are accounted for 3. LNnT/6’SL chromatogram 4. Calculate the resolution in the chromatogram for LNnT/6’SL/LNT

Recommendation from HMO-03 Reviewers:  SLV data set is incomplete.  Concerns that 2-AB based methods are not suitable for the determination of free HMOs due to back conversion of Maillard reaction products via the Schiff base chemistry.  The method shows promise, but the SLV is far from complete.  I recommend the authors resubmit the method with a complete SLV data set.  I also suggest the authors refer to the SPIFAN guidelines for running a SLV (OMA Appendix L).

III.

NEXT STEPS/FEEDBACK FROM EXPERT REVIEW PANEL Darryl Sullivan provided next steps including recommendations from the Expert Review Panel to stakeholders for discussions on bovine/goat lactoferrin.

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