AOAC OMA# 2011.06 Final Action Review-OMB

1894  B handari et al . : J ournal of AOAC I nternational V ol . 101, N o . 6, 2018

The method is suitable for routine compliance testing and as a reference method to demonstrate product compliance in relation to folate levels against relevant regulations or guidelines and specifications.

Hua Chen, Mead Johnson Nutrition, Ltd (Guangzhou, People’s Republic of China) Nick Collopy, Merieux NutriSciences, Silliker Chemistry Laboratory (Crete, IL) Ryan McKenna, EMSLAnalytical, Inc. (Cinnaminson, NJ) Isabelle Malaviole, Laboratoire Aquanal (Pessac, France) References (1) Blakley, R.L. (1987) Eur. J. Biochem. 168 , 251–253. doi:10.111/j.1432-1033.1987.tb13413.x (2) Konings, E.J. (1999) J. AOAC Int. 82 , 119–127 (3) Stokes, P., & Webb, K. (1999) J. Chromatogr A. 864 , 59–67. doi:10.1016/S0021-9673(99)00992-9 (4) Hanson, A.D., & Gregory, J.F. (2011) Annu. Rev. Plant Biol. 62 , 105–125. doi:10.1146/annualrev-arplant-042110-103619 (5) Institute of Medicine (1998) in Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline , The National Academies Press, Washington DC, pp 195–305. doi:10.17226/6015 (6) Imbard, A., Benoist, J., & Blom, J.H. (2013) Int. J. Environ. Res. Public Health 10 , 4352–4389. doi:10.3390/ijerph 10094352 (7) U.S. Food and Drug Administration (1996) in Federal Register 61 , 8781–8797 (8) CODEX (2007) STAN 72-1981. Standard for Infant Formula and Formulas for Special Medical Purposes Intended for Infants , 1–17 (9) Koontz, J.L, Katherine, P.M., Wunderlich, K.M, Exler, J., Holden, J.M., Gebhardt, S.E., & Haytowitz, D.B. (2005) J. AOAC Int. 88 , 805–813 (10) DeVries, J.W., Rader, J.I., Keagy, P.M., & Hudson, C.A. (2005) J. AOAC Int. 88 , 5–15 (11) Puwastien, P., Pinprapai, N., Judprasong, K., & Tamura, T. (2005) J. Food Comps. Anal. 18 , 387–397. doi:10.1016/j.jfca.2004.02.011 (12) Indyk, H., Evans, E., Caselunghe, M.C., Persson, B.S., Finglas, P.M., Woollard, D., & Filonzi, E. (2000) J. AOAC Int. 83 , 1141–1148 (13) Umegaki, K., Sekine, Y., Sato, Y., Chiba, T., & Sonoda, M. (2016) J. Nutr. Sci. Vitaminol. 62 , 134–138. doi:10.3177/jnsv.62.134 (14) National Institutes of Health (2018) Folate: Dietary Supplement Fact Sheet, http://ods.od.nih.gov/factsheets/Folate- HealthProfessional/ (accessed July 18, 2018) (15) Gregory, J.F. (2001) J. Nutr. 131 , 1376S–1382S. doi.org/10.1093/jn/131.4.1376s (16) U.S. Food and Drug Administration (2016) in Federal Register 81 , 33742–33999 (17) Szpylka, J., DeVries, J., Cheney, A., & House, S. (2012) J. AOAC Int. 95 , 1547–1554 (18) Konings, E., Bhandari, S., Hostetler, G., McMahon, A., Phillips, M., Seegers, M., Mariappan, M., Camara, J., & Rankin, R. (2017) J. AOAC Int. 100 , 1213–1214. doi:10.5740/jaoacint.SMPR2011-006 (19) Official Methods of Analysis (2005) 18th Ed., AOAC INTERNATIONAL, Rockville, MD, Appendix D

Conclusions

An MLT study of the AOAC First Action Official Method 2011.06 , an LC-MS/MS method employing the trienzyme extraction and weak anion exchange purification for folate analysis in infant formula and adult nutritionals, was undertaken. The method was evaluated in 11 laboratories worldwide by analyzing total folate in 11 different samples in blind duplicates. The method has demonstrated its compliance with the applicability as required by the folate SMPR 2011.006 (18) and has been found to be suitable for the analysis of folate in a wide range of infant formula and adult nutritional matrices. The method performance with respect to the accuracy, RSD r , and RSD R was found to be satisfactory and met the folate SMPR requirements. These results were submitted to SPIFAN in September 2017. Based on the satisfactory accuracy, RSD r , and RSD R performance, the method was recommended to advance forward to Final Action status. We thank Robert Rankin (Infant Nutrition Council of America, Washington, DC) for help in starting the study and Erik Konings (Nestle Research Center, Lausanne, Switzerland) for a thorough review of protocols. We thank Shellie Stassi (Covance Laboratories, Madison, WI) for shipping the MLT samples. We would like to thank the following individuals for their participation in this study: Rima Juskelis, NOW Foods (Bloomingdale, IL) Oscar Lopez, Merieux NutriSciences (Barcelona, Spain) Robert Grahn, Covance Laboratories (Madison, WI) Jessy Wang, Merieux NutriSciences (Ningbo, People’s Republic of China) Jack Stevens, General Mills Inc. (Golden Valley, MN) Ming Gao, Chem. R&D, Merieux NutriSciences, Silliker Food Science Center (Crete, IL) Kundachalil Mandody Prabeesh, Eurofins Technology Service (Suzhou), Co. (Suzhou, Jiangsu Province, People’s Republic of China) Eystein Oveland, Institute of Marine Research (Bergen, Norway) Acknowledgments