AOAC expanded its infant formula initiative to include new priority nutrients: carnitine, iodine, and pantothenic acid. The Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN), chaired by Darryl Sullivan of Covance Laboratories, reached consensus on fitness-for-purpose statements for all three nutrients.

In support of a contract with the International Formula Council (IFC), AOAC is facilitating establishment of voluntary consensus standard method performance requirements (SMPRs) for infant formula and adult/pediatric nutritional formula. Stakeholders expressed an urgent need for dispute resolution methodology with global acceptance.

During the stakeholders’ meeting in September 2011, consensus on fitness-for-purpose was reached by some 70 key experts from government, infant formula manufacturers, contract research organizations, technology providers, academia, trade associations, standards-developing organizations, raw ingredient suppliers, retailers, and consumer groups, among others. International representation is critical in ensuring that methods are accepted worldwide and meet regulatory testing requirements. The initiative is supported by a contract between AOAC and IFC, with Abbott Nutrition, Nestlé, Mead Johnson Nutrition, Fonterra, Danone, PBM, and Pfizer as funding partners.

Acceptable methods must be compatible with formula made from any combination of milk, soy, rice, whey, hydrolyzed protein, starch, and amino acids, with and without intact protein; and with test samples in ready-to-feed liquid, concentrated liquid, and powdered form. The ultimate objective of the project is to select and evaluate reference methods that can be used for dispute resolution.

For carnitine, prospective methods must be able to determine supplemented and endogenous L-carnitine in infant formula and adult/ pediatric nutritional formula. L-carnitine methods should have a limit of quantification (LOQ) of ≤2.0 mg/100 g and an analytical range of 2.0 to 20 mg/100 g.

For iodine, candidate methods must be able to determine total iodine in infant formula and adult/pediatric nutritional formula. Methods should have an LOQ of ≤5 mcg/100 g and an analytical range up to 1000 mcg/100 g.

Finally, methods for pantothenic acid must be able to determine d-pantothenic acid (and pantothenate salts) in infant formula and adult/pediatric nutritional formula. Methods should have an LOQ of ≤300 mcg/100 g.

Based on approved fitness-for-purpose statements, AOAC issued calls for methods for carnitine, iodine, and pantothenic acid on November 4, 2011. Working groups will develop draft standard method performance requirements (SMPRs). Once approved by SPIFAN, SMPRs will be used by an AOAC expert review panel (ERP) to evaluate the most promising candidate methods. Methods meeting SMPRs will be considered for First Action status by the ERP. Ultimately, reference methods will be adopted that can be used for dispute resolution.

Full coverage is scheduled for the November/December 2011 issue of Inside Laboratory Management.

For more information on SPIFAN, visit http://www.aoac.org/SPIFAN/aoac.htm or contact Anita Mishra, executive for scientific business development, at amishra@aoac.org or Deborah McKenzie, senior director, standards development, at dmckenzie@aoac.org.

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