AOAC SPIFAN Nutrients ERP Report (March 14, 2023)

AOAC Stakeholder Program on Infant Formula and Adult Nutritionals (SPIFAN)

Washington. DC

NUTRIENTS EXPERT REVIEW PANEL (ERP) REPORT

Tuesday, March 14, 2023

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

dboyd@aoac.org 301.924.7077 x126

AOAC Stakeholder Program on Infant Formula & 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 of the Official Chair’s Report for Nutrients March 14, 2023

______________________ Signature ______________________ Date Darryl Sullivan (Apr 17, 2023 07:25 CDT) Darryl Sullivan Apr 17, 2023

AOAC INTERNATIONAL Stakeholder Program on Infant Formula & Adult Nutritionals (SPIFAN) Meeting at AOAC INTERNATIONAL 2275 Research Blvd. Suite

300, Rockville, MD, USA Tuesday, March 14, 2023

REPORT OF THE NUTRIENTS EXPERT REVIEW PANEL (ERP) PROCEEDINGS

Expert Review Panel Members (in attendance):

Darryl Sullivan

Eurofins Food Integrity & Innovation (Chair)

Sean Austin Esther Campos-Giménez Christophe Fuerer

Société des Produits Nestlé S.A.

Sneh Bhandari

Independent Consultant FrieslandCampina Fonterra Cooperative

Hans Cruijsen/Martine van Gool

Brendon Gill

Philip Haselberger (HMO ONLY) Karen Schimpf Melissa Phillips/Kate Rimmer

Abbott Nutrition

NIST

Thomas Vennard David Woollard Jinchuan Yang

Reckitt

Independent Consultant

Waters Corp.

Estela Kneeteman

INTI

Shay Phillips

Reckitt

Yannis Vrasidas (HMO ONLY)

Independent Consultant

AOAC Staff Includes: David Schmidt (Executive Director) Delia Boyd

Jonathan Goodwin Alicia Meiklejohn Tien Milor

Observers: Charles Barber, FDA-CFSAN Emily Britton, Waters Marcel de Vreeze, NEN-ISO Carol Donnelly, R-Biopharm Rhone Ltd Renee Erney, Abbott Nutrition Giampaolo Perinello, MxNS Italy Sookwang Lee, FDA Giampaolo Perinello, MxNS Italy Dustin Starkey, Abbott Nutrition John Szpylka, Food Safety Net Services

Tetsuo Urushiyama, MAFF Japan Jeroen van Soest, Eurofins CCC Sudhakar Yadlapalli, First source laboratory solutions

I.

WELCOME AND INTRODUCTIONS Darryl Sullivan welcomed all participants to the ERP meeting and the ERP members were introduced along with roll call.

II. REVIEW OF METHODS BY EXPERT REVIEW PANEL (ERP) FOR FIRST ACTION OFFICIAL METHOD SM STATUS For each method, the ERP reviewed and discussed method(s) submitted for First Action Official Method SM status. NEXT STEPS/FEEDBACK FROM EXPERT REVIEW PANEL Darryl Sullivan provided next steps including recommendations from the Expert Review Panel to method authors including providing comparison data with the Willard Winter procedure. In addition, schedule a meeting to discuss the methods that have already received First Action Official Method SM status for HMO and Fluoride. The proposed meeting will be scheduled in conjunction with AOAC Analytical Methods Week (AMW) “Spring” session. III.

Fluor-04 Fluor-05 Fluor-06

Abbott Nutrition

  

Mérieux NutriSciences

Triskelion

REVIEW OF METHODS: A1/A2 BETA CASEIN

CODIFICATION: A1BC-01 METHOD TITLE: Determination of A1- and A2- type β -casein in infant formula, adult/pediatric formula and select milk and milk products by Capillary zone electrophoresis (CZE) REVIEWERS: Tom Vennard & Christophe Fuerer MOTION: No action taken - method not recommended for First Action Official Methods SM status

9 Yes/0 No/ 0 Abstain RECOMMENDATION: •

Include bullet points from Reviewer 2 assessment.

• Be able to perform/demonstrate method sensitivity in complex matrix • Reference standards need to be identified & definitions on how their used • Current method range needs to be defined o Section Ee

Motion to approve recommendations: Tom Vennard motioned & Christophe Fuerer second Vote: 9 Yes/0 No/0 Abstain

REVIEW OF METHODS: BIOTIN

CODIFICATION: Bio-04 METHOD TITLE: Determination of Biotin by UPLC Coupled with Immunoaffinity Column Clean-Up Extraction REVIEWERS: Melissa Phillips & Jinchuan Yang MOTION: To recommended method for First Action Official Methods SM status Brendon Gill motioned Melissa Phillips second Vote: 8 Yes/0 No/1 Abstain COMMENT(S): There is no biocytin standard preparation mentioned in this method. Please include the biocytin standard and its standard solution preparation in the method.

REVIEW OF METHODS: SN-2 PALMITATE

CODIFICATION: SN2-01 METHOD TITLE: Determination of fatty acids which are esterified at the Sn-2 position (beta) of the triacylglycerol molecules in infant formula, adult/pediatric formula and select milk and milk products by GC-MS REVIEWERS: Brendon Gill & Melissa Phillips MOTION: No action taken - method not recommended for First Action Official Methods SM status Vote: 9 Yes/0 No/0 Abstain RECOMMENDATION/COMMENTS:  Requires SLV  Clean-up is required prior to enzymatic digestion  Calculation in chromatography need to identify other fatty acids  Demonstration of the enzyme selectivity (for the types of fats used in infant formula)  Need validation data on the other fatty acids

Motion to approve recommendations: Brendon Gill motioned Melissa Phillips second Vote: 9 Yes/0 No/0 Abstain