AOAC SPIFAN ERP Report (April 29, 2021)

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

REPORT

Thursday, April 29, 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, April 29, 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 Adrienne McMahon Scott Christiansen Hans Cruijsen/Martin van Gool Brendon Gill

Eurofins Food Integrity & Innovation (Chair) Independent Consultant Société des Produits Nestlé S.A. Wyeth Perrigo Nutritionals FrieslandCampina Fonterra Cooperative Abbott Nutrition INTI Pickering Labs, Inc. NIST Independent Consultant Reckitt Benckiser (formerly Mead Johnson) Waters Corp.

Philip Haselberger Estela Kneeteman Maria Ofitserova Melissa Phillips/Kate Rimmer Yannis Vrasidas Thomas Vennard/Shay Phillips Jinchuan Yang

Expert Review Panel Members (not in attendance):

Abbott Nutrition Independent Consultant

Don Gilliland/Karen Schimpf David Woollard

AOAC SPIFAN Expert Review Panel Report April 29, 2021 Final Version

AOAC Staff Includes:

Deborah McKenzie Alicia Meiklejohn Tien Milor

Palmer Orlandi (Deputy Executive Director & CSO) Saliha Argubie Delia Boyd

Observers: Thierry Bénet, Société des produits Nestlé S.A. Simone Carron, Mérieux NutriSciences Renee Erney, Abbott Nutrition Ping Feng, Wyeth Nutrition Jennifer Frueh, RB Corporation Christophe Fuerer, Société des Produits Nestlé SA Mia H. Kiel Henderson, Chromadex Steve Holroyd, Fonterra Cooperative Justyce Jedlicka, MilliporeSigma Erik Konings, Société des Produits Nestlé S.A.

Kevin Kubachka, FDA Sookwang Lee, FDA Karen Mandy, Danone

Elaine Marley, R-Biopharm Rhône Ltd. Pierre Metra, Mérieux NutriSciences Son Pham, Abbott Nutrition Robert Rankin, INCA Ben Roth, Abbott Nutrition Jeff Shippar, Eurofins Dustin Starkey, Abbott Nutrition Karla Steele, Mead Johnson Nutrition Marina Graciela Torres, LATU Jeroen van Soest, Eurofins Ye Yinghui, CTC CAIQ Fengxia Zhang, China Feihe Limited

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AOAC SPIFAN Expert Review Panel Report April 29, 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 & III For each method, the ERP/Working Group Co-Chairs discussed method(s) submitted and reviewed the method(s) received First Action Official Method SM status.

Method Title

Reviewer(s)

Vote

Comments

Method FLUORIDE

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

1. Include raw data &

Scott Christiansen Jinchuan Yang

Motion: To delay consideration for the method. Scott Christiansen moved Jinchuan Yang second (unanimous) 2 nd Motion : For ERP to accept recommendations to send to study author(s). Scott Christiansen moved Jinchuan Yang second (unanimous) Motion: To delay consideration for the method. Yannis Vrasidas moved Philip Haselberger second (Nestlé abstains) – Pass 2 nd Motion: For ERP to accept recommendations to send to study author(s). Vote

information including sample size on infant formula tested. 2. Is method measuring total or free/weakly bound fluoride (please comment). Additional Comments:  Please see Reviewer Forms comments / recommendations

Method Title

Reviewer(s)

Comments

Method

HMO

(HMO-02) – Determination of Seven Human Milk Oligosaccharides (HMO) in Infant Formula and Adult Nutritionals

 See Reviewer forms

Yannis Vrasidas Philip Haselberger

Philip Haselberger moved Yannis Vrasidas second (Nestlé abstains) – Pass

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AOAC SPIFAN Expert Review Panel Report April 29, 2021 Final Version

LACTOFERRIN

(Lacto-02) - Lactoferrin in Infant formula and Adult Nutritional Formula by HPLC

 See Reviewer forms

Adrienne Mahon Estela Kneeteman

Motion: To delay consideration for the method. Adrienne Mahon moved Sneh Bhandari second (unanimous) 2 nd Motion : For ERP to accept recommendations to send to study author(s).

See recommendation(s): 1. Concerns that the method lacks sufficient selectivity to demonstrate the required method performance. 2. To address the selectivity issue significant changes to the sample prep, separation and/or detection 3. Review comments from reviewers 4. Show or share chromatogram of sample before/after heat treatment. a. Areas & heights b. More raw data 5. See the purity of the reference standard determined by a separate method. See recommendation(s):  Include all observations from the 2 reviews.  Concerns that the method lacks sufficient selectivity to demonstrate the required method performance.  To address the selectivity issue significant changes to the sample prep, separation and/or detection  See the purity of the reference standard determined by a separate method.  Send method authors an example of SLV document.  See Reviewer forms

Adrienne Mahon moved Maria Ofitserova second (unanimous)

LACTOFERRIN

(Lacto-03) - Determination of Lactoferrin in Infant Formula Milk by High Performance Liquid Chromatography

Brendon Gill Martine van Gool

Motion: To delay consideration for the method. Brendon Gill moved Martine van Gool second (unanimous) 2 nd Motion : For ERP to accept recommendations to send to study author(s). Brendon Gill moved Martine van Gool second (unanimous)

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AOAC SPIFAN Expert Review Panel Report April 29, 2021 Final Version

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

Method

Method Title

Reviewer(s)

Vote

Comments

AMINO ACIDS

AOAC OMA# 2018.06 (Amino-01) – Total Amino Acids by UHPLC-UV in Infant Formulas and Adult Nutritionals (AOAC First Action 2018.06) – Multi-Laboratory Trial

1. Initial exclusion of outliers can be supported by statistical tests.

Maria Ofitserova Estela Kneeteman Tom Vennard/Shay Phillips

Motion: To affirm recommendation for final action by ERP Maria Ofitserova moved Estela Kneeteman second (Nestlé abstains) – Pass

IV. NEXT STEPS/FEEDBACK FROM EXPERT REVIEW PANEL Darryl Sullivan provided next steps including recommendations from the Expert Review Panel including the review of the Single Laboratory Validation guidelines.

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