AOAC SPIFAN Chlorates ERP Report (12-13-21)

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

CONTAMINANTS EXPERT REVIEW PANEL REPORT December 13, 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) Contaminants Expert Review Panel (ERP)

The AOAC SPIFAN Contaminants 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 Chlorates/Perchlorates December 13, 2021

Katerina Mastovska (Jan 3, 2022 08:52 EST) Katerina Mastovska

Signature

Jan 3, 2022

Date

AOAC SPIFAN Contaminants Expert Review Panel Report December 13, 2021 Final Version 2

AOAC INTERNATIONAL Stakeholder Program on Infant Formula and Adult Nutritionals (SPIFAN) “Virtually” Meeting at AOAC INTERNATIONAL 2275 Research Blvd. Suite 300, Rockville, MD, USA Monday, December 13, 2021 REPORT OF THE CONTAMINANTS EXPERT REVIEW PANEL (ERP) PROCEEDINGS

Expert Review Panel Members ( in attendance ):

Katerina Mastovska Jonathan Draher

Eurofins Scientific (Chair)

Abbott Nutrition Metrohm USA Nestlé Research

Jay Gandhi

José Fernando Huertas Pérez

Melissa Phillips Tom Phillips

NIST

SCS MDA

Marina Torres Rodriguez

LATU

Andrew Savage

Nestlé Quality Assurance Center

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AOAC SPIFAN Contaminants Expert Review Panel Report December 13, 2021 Final Version 2

AOAC Staff Includes: Palmer Orlandi (Deputy Executive Director & CSO) Delia Boyd Alicia Meiklejohn Allison Baker

Observers: Esther Campos Gimenez, Société des Produits Nestlé S.A.

Hans Cruijsen, FrieslandCampina Srinivas Jayanthi, DB Science-NWA Justyce Jedlicka, MilliporeSigma

Erik Konings, Société des Produits Nestlé S.A. William Lipps, Shimadzu Scientific Instruments David Mangan, Neogen Salvatore Parisi, Lourdes Matha Institute HMCT Giampaolo Perinello, MxNS italy Darryl Sullivan, Eurofins US

Michel van Bruijnsvoort, Triskelion David Woollard, Massey University

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AOAC SPIFAN Contaminants Expert Review Panel Report December 13, 2021 Final Version 2

I. WELCOME AND INTRODUCTIONS Katerina Mastovska welcomed all participants to the ERP meeting and the ERP members were introduced.

II. REVIEWOF 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.

Method Title

Reviewer(s)

Vote

Method

Comments

Chlorate-01 – Chlorate and Perchlorate in Baby Foods, Infant/Adult Formulas, and Their Ingredients

CHLORATE / PERCHLORATE

See requirements and recommendations below

Marina Torres Rodriguez Melissa Phillips Jonathan Draher J. Fernando Huertas Pérez

Motion: Method not recommended for First Action Official Methods SM status

CHLORATE-01 ERP REQUIREMENTS:  Request to see the chromatograms at the LOQ levels for each individual transition in each representative matrix, corresponding matrix blanks and all calibration solutions  Clarify the calculation of the results and consider simplified formula based on internal standard ratios ( an example provided to the method authors )  Update the references based on reviewer comments and also ion ratio requirements  Please reference Reviewer 2 comments for coverage of matrices  None of the matrix categories are fully covered  Based on the SMPR, in table 1 (footnote) please check requirements for validation  Specifically, infant/adult formula category is important  Whey protein concentrate is not the same as whey protein hydrolysate  Table 11 – validation results have to be provided for each representative matrix and concentration level individually  Validation should be done at the LOQ and at 10x LOQ as the minimum

 Provide summary tables for the LOQs  Follow the SMPR for LOQ determination  Concentration in blanks used for validation needs to be provided

CHLORATE-01 ERP RECOMMENDATIONS:  Consider improving chromatography to achieve narrower and symmetrical peak shapes (peak symmetry below 1.5)  If isocratic elution is used, consider a gradient elution

Motion to accept these requirements and recommendations for Chlorate-01 (First Action) Melissa Phillips/Marina Torres Rodriguez

III. NEXT STEPS/FEEDBACK FROM EXPERT REVIEW PANEL Katerina Mastovska provided next steps including requirements and recommendations from the Expert Review Panel to stakeholders.

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