SPIFAN ERP Report March 19, 2014
AOAC INTERNATIONAL Stakeholder Panel for Infant Formula and Adult Nutritionals (SPIFAN) Meeting at the Gaithersburg Marriott Washingtonian Center
9751 Washingtonian Boulevard Gaithersburg MD 20878, USA Wednesday, March 14, 2018 - 3:00pm (Eastern US) REPORT OF THE MCPD EXPERT REVIEW PANEL (ERP) PROCEEDINGS
Expert Review Panel Members (in attendance): Katerina Mastovska
Covance Labs (Chair)
Nestlé
Mathieu Dubois/Greg Jaudzems
Stefan Ehling Jan Kuhlmann
Abbott Nutrition SGS Germany
US FDA
Shaun MacMahon/Jessica Leigh
Joe Romano
Waters Corp.
Cheryl Stephenson Sudhakar Yadlapalli
Eurofins
First Source Laboratory Solutions, LLP
Expert Review Panel Members (unable to attend): Celine Lesueur
Danone
Jie Zhang
Mead Johnson
AOAC Staff Includes: Delia Boyd Scott Coates (CSO) Chris Dent Jennifer Diatz Arlene Fox Dawn Frazier Jonathan Goodwin (Interim Executive Director) Observers: Lei Bao, Nestlé Sneh Bhandari, Silliker Laboratories Joe Boison, Consultant Sara Bryson, Conagra Brands Dominik Burger, DSM Nutritional Products Scott Christiansen, Perrigo Hans Cruijsen, FrieslandCampina Jean-Luc Deborde, SCL Aurelie Dubois, IDF Jaap Evers, IDF Brendon Gill, Fonterra Erik Konings, Nestlé Mary Krogull, Eurofins Scientific, Inc. Joanne Mayer, ADM Sean McClure, Abbott Nutrition
Nora Marshall Krystyna McIver Deborah McKenzie Alicia Meiklejohn Tien Milor Bob Rathbone
Maria Ofitserova, Pickering Laboratories Melissa Phillips, NIST Shay Phillips, Mead Johnson Aubrey Shahriari, FDA David Singer, GERSTEL Dustin Starkey, Abbott Nutrition Darryl Sullivan, Covance Robert Rankin, INCA Kate Rimmer, NIST Martine van Gool, FrieslandCampina Lindell Ward, Lilly Wayne Wargo, Abbott Nutrition Jinchuan Yang, Waters Corp. Jupiter Yeung, Nestlé
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AOAC SPIFAN MCPD Expert Review Panel Report March 14, 2018 Final Version
I.
WELCOME AND INTRODUCTIONS Katerina Mastovska welcomed all participants to the ERP meeting and introduced the ERP members. II. REVIEW OF METHODS BY EXPERT REVIEW PANEL (ERP) FOR FIRST ACTION OFFICIAL METHOD SM STATUS For each method, the ERP discussed methods submitted. Two (2) methods were received and reviewed. Recommendations by the ERP to be completed prior to methods receiving First Action Official Method SM status.
Method Title
Reviewer(s) Stefan Ehling Shaun MacMahon
Vote
Recommendations/Comments
Method
MCPD-01 - Single Lab Validation - Determination of 2- and 3- MCPD, 2- and 3-MCPD esters and glycidyl esters (GE) in infant and adult/pediatric nutritional formula.
RECOMMENDATIONS: 1. Applicable or not applicable matrices (Shaun M. will send matrices to method author) 2. SPE confirmatory step for low level GE findings near the level of concern 3. Additional spike levels or incurred samples at higher level 4. Liquid concentrate to discuss applicability of the method COMMENTS: There are issues with the fat extraction Safety not defined Recommend sample size Reagent (blank) not included in the raw data Include internal standard at the beginning Use of triple quadrupole GC-MS/MS with backflushing (include minimum requirements for method performance) RECOMMENDATIONS: 1. Address system suitability (min. 1 control sample per batch) 2. Verify the purity of the labelled standard with every run/batch 3. Verify the response factors over the analytical range to demonstrate linearity on every system 4.Written in AOAC format a. Check for missing steps and information details b. Add safety section COMMENTS: Requires a separate method for powder and liquid samples LOQ/accuracy meets the SMPR® Single quad GC-MS used Complete extraction procedures for liquid Include daily analysis of blank and reference samples (option) Option for a multi-point calibration There is question about the GE Issue with shelf life of samples Better define the exception(s)
Motion: to recommend for First Action Official Method SM status. Sudhakar Yadlapalli (moved) Shaun MacMahon (second) Yes 4/No 4/Abstain 1 Motion: to accept the First Action recommendations as presented. Stephan Ehling (moved) Sudhakar Yadlapalli (second) Yes 7/No 0/Abstain 1
MCPD
Motion Passed ( see recommendations )
MCPD-02 – 2-Monochloropropanediol (2- MCPD), 3-Monochloropropanediol (3- MCPD) and Glycidol in in Infant and Adult/Pediatric Nutritional Formula Gas Chromatographic / Mass spectrometric (GC/MS) Method
Motion: not to recommend for First Action Official Method SM status. Shaun MacMahon (moved) Cheryl Stephenson (second) Yes 6/No 0/Abstain 2
Jessica Leigh Cheryl Stephenson
Motion: to accept the First Action recommendations as presented. Stephan Ehling (moved) Sudhakar Yadlapalli (second)
Yes 6/No 0/Abstain 2
Motion Passed ( see recommendations )
III.
NEXT STEPS/FEEDBACK FROM EXPERT REVIEW PANEL Katerina Mastovska provided next steps in the ERP process including the recommendations by the ERP.
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AOAC INTERNATIONAL Stakeholder Panel for Infant Formula and Adult Nutritionals (SPIFAN) AOAC Headquarters/Virtual Meeting 2275 Research Blvd. Suite 300 Rockville, MD 20850, USA Thursday, July 19, 2018 - 11:00am (Eastern US) REPORT OF THE MCPD EXPERT REVIEW PANEL (ERP) PROCEEDINGS
Expert Review Panel Members (in attendance): Katerina Mastovska
Covance Labs (Chair)
Nestlé
Mathieu Dubois/Greg Jaudzems
Stefan Ehling Jan Kuhlmann
Abbott Nutrition SGS Germany
US FDA
Shaun MacMahon/Jessica Leigh
COIF Association, Italy
Salvatore Parisi Joe Romano Cheryl Stephenson Sudhakar Yadlapalli
Waters Corp.
Eurofins
First Source Laboratory Solutions, LLP
Celine Lesueur
Danone
Jie Zhang
Mead Johnson
AOAC Staff Includes:
Observers:
Robert Rankin, INCA
Delia Boyd
Scott Coates (CSO) Deborah McKenzie Alicia Meiklejohn
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AOAC SPIFAN MCPD Expert Review Panel Report July 19, 2018 Final Version
I.
WELCOME AND INTRODUCTIONS Katerina Mastovska welcomed all participants to the ERP meeting and introduced the ERP members. II. REVIEW OF METHODS BY EXPERT REVIEW PANEL (ERP) FOR FIRST ACTION OFFICIAL METHOD SM STATUS The ERP reviewed and discussed two (2) methods that were submitted for re-evaluation. The methods were previously reviewed by the ERP on March 14, 2018 and given provisional approval.
The methods included the recommendations and comments originally provided by the ERP and after review, both methods received First Action Official Method SM status recommendation.
Method Title
Reviewer(s) Stefan Ehling Shaun MacMahon
Vote
Comments/Recommendations
Method
MCPD-01 – Fatty acid esters of 2- chloropropane-1,3-diol (2-MCPD), 3- chloropropane-1,2-diol (3-MCPD) and glycidol, free 2-MCPD and free 3-MCPD in Infant formula and Adult/Pediatric Nutritional formula.
RECOMMENDATIONS FOR FINAL ACTION: 1. Consider use of GC-MS (single quad) 2. Include at least 1 matrix to be cleaned by the SPE procedure in the collaborative study 3. Use the SPIFAN kit in the collaborative study 4. Consider using a reference material for oil (for lab qualification) 5. Method feedback Motion: to accept these recommendations/ requirements for Final Action recommendation Joe Romano (moved) Shaun MacMahon (second) Yes 10/No 0/Abstain 1 Motion Passed RECOMMENDATIONS FOR FINAL ACTION: 1. Consider use of GC-MS/MS 2. Use external multi-point calibration in the collaborative study & calculate the results using both single-point internal calibration and multi-point external calibration 3. Use the SPIFAN kit in the collaborative study 4. Consider using a reference material for oil (for lab qualification) 5. Method feedback Motion: to accept these recommendations/ requirements for Final Action recommendation
Motion: to move method to First Action Shaun MacMahon (moved) Cheryl Stephenson (second) Yes 10/No 0/Abstain 1
MCPD
Motion Passed
MCPD-02 – 2-Monochloropropanediol (2-MCPD), 3-Monochloropropanediol (3-MCPD) and Glycidol in Infant and Adult/Pediatric Nutritional Formula. Gas Chromatographic / Mass spectrometric (GC/MS) Method
Motion: to move method to First Action Cheryl Stephenson (moved) Shaun MacMahon (second) Yes 10/No 0/Abstain 1
Jessica Beekman Cheryl Stephenson
Motion Passed
Cheryl Stephenson (moved) Sudhakar Yadlapalli (second) Yes 10/No 0/Abstain 1 Motion Passed
III.
NEXT STEPS/FEEDBACK FROM EXPERT REVIEW PANEL Katerina Mastovska provided next steps in the ERP process including the First to Final Action recommendations by the ERP.
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