AOAC OMA# 2011.14 (Final Action Review)-OMB

2011.14 (Oct. 2018) – MTE-03 Final Action Review FOR ERP USE ONLY DO NOT DISTRIBUTE

Introduction The Code of Federal Regulations (CFR) Title 21, Chapter I, Subchapter B, Part 107 (21CFR107) details the regulations for infant formula, including nutrient minimum and maximum levels, in order to ensure proper nutrition for infants (1). Compliance with 21CFR107 and dispute resolution requires reliable and accurate methods of analysis for each of the nutritional components. The AOAC Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) has developed Standard Method Performance Requirements (SMPRs ® ) for Official Methods of Analysis for a variety of analytes in a variety of infant and adult/pediatric nutritional products. Since 2010, SPIFAN has approved over 30 SMPRs (2). One of these, SMPR 2014.004 (3), details the performance requirements for methods targeting 9 minerals and trace elements, specifically Ca, Cu, Fe, K, Mg, Mn, Na, P, and Zn, in infant, adult and/or pediatric formula products including powders, ready-to-feed (RTF) liquids, and liquid concentrates (see Table 1). Poitevin recently reviewed the Official Methods currently active that could be applied to these matrixes (4). Most of the AOAC, ISO, EN, and IDF official methods currently used and validated for the determination of minerals and trace elements in infant formula and milk products are multielemental based on AAS and ICP-AES techniques after dry- ashing or high-pressure digestion. Many of these methods and additional single-analyte methods are outdated and in some cases poorly validated for the scope . Official Method 2011.14 is based on inductively coupled plasma atomic emission spectrometry (ICP- AES) and received Final Action status in 2013 for determination of the 9 target elements in chocolate milk powder, dietetic milk powder, infant cereal, peanut butter, and wheat gluten . In response to SMPR 2014.004 and a call for methods, OMA 2011.14 was