SPIFAN Approves SMPRs and Reviews Data for Method Developer Studies for First Five Nutrients
The Stakeholder Panel on Infant Formula and Adult Nutritionals (SPIFAN) approved on April 4-6, 2011, standard method performance requirements (SMPRs) for vitamins A, D, and B12, folic acid, and inositol in infant formulas and adult/pediatric nutritional formulas. In addition, SPIFAN reviewed preliminary data from method development studies for methods—identified by working groups in November 2010 as closely meeting SMPRs--to assess their potential for further evaluation by an expert review panel (ERP). An ERP will review methods against approved SMPRs and consider those with acceptable data for possible adoption under the new alternative pathway to First Action status.
In support of a contract with the International Formula Council (IFC), five working groups on November 8-12, 2010, at AOAC headquarters in Gaithersburg, Maryland, USA, developed draft SMPRs against which methods could be evaluated. Draft SMPRs were posted on the AOAC Web site in February 2011 for a 30-day public comment period. All comments received were carefully considered and reconciled.
Draft SMPRs, reflecting editorial and technical comments received from the open comment period were presented at the SPIFAN meeting on April 4-6, 2011. In general, technical feedback focused on precision, RSDR, and recovery parameters; and definitions of recovery and blank check sample. SPIFAN approved in April 2011 all SMPRs for the first five nutrients. Approved SMPRs will be published in the Journal of AOAC INTERNATIONAL and OMA.
Also in April 2011, SPIFAN reviewed preliminary validation data of 12 candidate methods for vitamin A, vitamin D, vitamin B12, folic acid, and inositol, as recommended by working groups in November 2010 as most likely to meet fitness-for-purpose and SMPRs. High-technology methods using UPLC-MS/MS were chosen for the most part. In early 2011, AOAC and working groups identified Study Directors for each of the candidate methods.
It is planned that an ERP, chaired by Darryl Sullivan of Covance Laboratories, will be formed to evaluate the candidate methods against approved SMPRs for possible adoption under the new approach to First Action status. A single method will be selected by the panel for each nutrient. The ERP will review new data and/or other information about the methods in order to determine whether they should be granted Official Final Action status.
The next SPIFAN meeting is scheduled for June 29-30, 2011, as part of the Standards Development and International Harmonization: AOAC INTERNATIONAL Mid-Year Meeting. It is expected that draft SMPRs for vitamin E, which were posted for public comment on May 16, 2011, will be reviewed for possible approval during the mid-year meeting. (A call for vitamin E method was also issued on May 16, 2011).
For more information on SPIFAN SMPRs, contact Scott Coates, chief scientific officer, at firstname.lastname@example.org. For information on SPIFAN, contact Anita Mishra, executive for scientific business development, at email@example.com or Deborah McKenzie, senior director of methods development and approval processes, at