AOAC SPIFAN ERP Report (December 14, 2021)

AOAC Stakeholder Program on Infant Formula and Adult Nutritionals (SPIFAN) NUTRIENTS EXPERT REVIEW PANEL

REPORT December 14, 2021

AOAC INTERNATIONAL 2275 Research Blvd., Suite 300 Rockville, MD, 20850 USA

dboyd@aoac.org 301.924.7077 x126

AOAC INTERNATIONAL Stakeholder Program on Infant Formula and Adult Nutritionals (SPIFAN) Nutrients Expert Review Panel (ERP)

The AOAC SPIFAN Nutrients Expert Review Panel (ERP) Chair confirms the following ERP Report has been reviewed and approves the final version

Official Chair’s Report for SPIFAN Nutrients December 14, 2021

Darryl Sullivan (Dec 22, 2021 09:43 CST) Darryl Sullivan

Signature

Dec 22, 2021

Date

AOAC INTERNATIONAL Stakeholder Panel for Infant Formula and Adult Nutritionals (SPIFAN) “Virtually” Meeting at AOAC INTERNATIONAL 2275 Research Blvd. Suite 300, Rockville, MD, USA Tuesday, December 14, 2021 REPORT OF THE NUTRIENTS EXPERT REVIEW PANEL (ERP) PROCEEDINGS

Expert Review Panel Members (in attendance): Darryl Sullivan

Eurofins Food Integrity & Innovation (Chair)

Sneh Bhandari

Independent Consultant

AdrienneMcMahon/Esther Campos-Giménez/

Wyeth Nutrition/Société des Produits Nestlé S.A.

Sean Austin Hans Cruijsen/Martin van Gool

FrieslandCampina Fonterra Cooperative Abbott Nutrition

Brendon Gill

Philip Haselberger Maria Ofitserova Karen Schimpf Estela Kneeteman Shay Phillips Yannis Vrasidas David Woollard Jinchuan Yang

Pickering Lab

Melissa Phillips/Kate Rimmer

NIST

Abbott Nutrition

INTI

Reckitt TIM Co.

Massey University

Waters Corp.

Expert Review Panel Members (not in attendance):

Scott Christiansen

Perrigo Nutrition

Don Gilliland

Independent Consultant

Thomas Vennard

Reckitt

AOAC Staff Includes: Palmer Orlandi (Deputy Executive Director & CSO) Delia Boyd Deborah McKenzie Alicia Meiklejohn Tien Milor Observers: Hiroshi Arase Simone Carron, Mérieux NutriSciences David Ellingson, Eurofins US Lisa Fledderjohann, Abbott Nutrition Jennifer Frueh, Reckitt Bertram Fong, Fonterra Cooperative Christophe Fuerer, Nestlé Anli Gao, University of Guelph Michael Gray, Reckitt Ajai Gupta, IIIM-CSIR Kiel Henderson, Chromadex Steve Holroyd, Fonterra Cooperative Harvey Indyk, Fonterra Cooperative (Retired) Justyce Jedlicka, MilliporeSigma Erik Konings, Société des Produits Nestlé S.A. Kevin Ma, Fonterra Cooperative Pierre Metra, Mérieux NutriSciences Salvatore Parisi, Lourdes Matha Institute Giampaolo Perinello, Mérieux NutriSciences Lars Reimann, Eurofins US Peter Sanders, Eurofins Dustin Starkey, Abbott Nutrition Karla Steele, RB Corporation Keisuke Yamamoto, Morinaga Milk Industry Co. Int. Hong You, Eurofins US Michel van Bruijnsvoort, Triskelion Jeroen von Soest, Eurofins US

AOAC SPIFAN Expert Review Panel Report December 14, 2021 Final Version

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

Recommendations

Reviewer(s)

Motion: Recommend method as First Action Official Methods SM status for infant formula & powders only Maria Ofitserova moved Martine van Gool second Yes-10/No-0/Abstain-1 Unanimous

LACTOFERRIN

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

ERP requests: 

Maria Ofitserova Martine van Gool

SLV data on liquid formulas

Documentation on characterizing a new antibody



Residual limits regarding the calibration curve



Broader range of concentration in the samples



Report the method limit for the LOQ



Motion to approve the recommendations Jinchuan Yang/David Woollard Fonterra abstains Unanimous

Vote

Method

Method Title

Recommendations

Reviewer(s)

Motion: Recommend method as First Action Official Methods SM status for infant formula & powders only Martine van Gool moved Maria Ofitserova second Yes-10/No-0/Abstain-1 Unanimous Motion to approve the recommendations Brendon Gill/Jinchuan Yang Reckitt abstains Unanimous

LACTOFERRIN (Lacto-04) - Determination of Lactoferrin in Infant Formula by

ERP requests: 

Martine van Gool Maria Ofitserova Brendon Gill

Demonstration of selectivity for Lactoferrin against minor protein (Lysozyme lactoperoxidase) on heparin and/or C4 columns Please comment on alternate suppliers for the heparin column

Reverse - Phase High Performance Liquid Chromatography/Diode Array Detection using External Standard Calibration



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AOAC SPIFAN Expert Review Panel Report December 14, 2021 Final Version

Method Title

Reviewer(s)

Vote

Method

Recommendations

(Fluor-05) - Determination of fluoride in Infant and Adult/Pediatric Nutritional Formula

Motion: Method not recommended for First Action; No action taken at this time

FLUORIDE

Jinchuan Yang

See ERP recommendations:

Fluor-05 RECOMMENDATIONS FROM ERP: • Supporting raw data for LOQ, analytical range, spike condition

• Need data to demonstrate the selectivity of the method • Submit method in AOAC format (provide examples) • Please comment on the forms of fluoride used in the study o Please provide the form of the fluoride reported • Compare data to common samples (provide samples/examples to method author) • Clarify the levels used in spiking

Motion to approve recommendations Jinchuan Yang/Sneh Bhandari

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

Motion: No ERP action recommended at this time.

HMO

Sean Austin Brendon Gill

See ERP recommendations:

Chromatography, with Pulsed Amperometric Detection

HMO-01 RECOMMENDATIONS FROM ERP: • Comments will be taken directly from Reviewer forms to method author Motion to accept recommendation

Sean Austin/Brendon Gill Abstain: Abbott Nutrition

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

See ERP recommendations:

Phil Haselberger Sean Austin

Motion: No ERP action recommended at this time

HMO-03 RECOMMENDATIONS FROM ERP: •

Consider spiked recovery(ies) in the middle range • Please consider additional experiments to demonstrate specificity and ruggedness (for each HMO) • Clarify the calculations for the final analyte Motion to accept recommendations Sean Austin/Phil Haselberger Eurofins abstains

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AOAC SPIFAN Expert Review Panel Report December 14, 2021 Final Version

Method Title

Reviewer(s)

Vote

Method

Recommendations

PHOSPHOLIPIDS (Phospho-01) - Quantitative analysis of Phospholipids in formulated dairy powder products such as infant formula and adult nutritional’s.

Motion: No ERP action recommended at this time

Adrienne McMahon Jinchuan Yang

See ERP recommendations:

Phospho-01 RECOMMENDATIONS FROM ERP: • The primary/secondary reviews will be provided to method author as comments/recommendations

Motion to accept recommendations Brendon Gill/Adrienne McMahon

III.

SINGLE LABORATORY VALIDATION (SLV) GUIDELINES REVIEW Martine van Gool (FrieslandCampina) presented the revised draft SPIFAN Single Laboratory Validation guidelines (version 10-26-21) for approval as reviewed by the AOAC Committee on Statistics and stakeholders.

MOTION: Motion to accept and move guidelines forward to the AOAC Official Methods Board (OMB) for approval

Martine van Gool/Maria Ofitserova Unanimous: Martine van Gool Abstains

IV.

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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