stakeholder panel on infant formula & adult nutritionals (spifan)

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AOAC Staff: Delia Boyd Scott Coates Jennifer Diatz Anita Mishra I. WELCOME AND INTRODUCTIONS Darryl Sullivan, Chair of the Stakeholder Panel on Infant Formula and Adult Nutrition (SPIFAN), welcomed the attendees/observers and called the meeting to order. Sullivan called attention to the AOAC policy documents for antitrust and volunteer conflict of interest. He reviewed meeting materials consisting of the method books that were signed out to each attendee. Sullivan introduced Jon DeVries, chair of the vitamin E working group and proceeded with the meeting. II. REVIEW DRAFT SMPR DeVries began the working group meeting with the applicability statement as described in the draft SMPR. It was determined that the applicability statement was the greatest concern. The term “methods maybe able to” should be added to the applicability statement. 1. Applicability a. Delete the words “should be” and replace with “that are” b. At the end of paragraph add “may be desirable” 2. Analytical Technique a. No change, keep as written 3. Definitions a. No change, keep as written 4. Method Performance Requirements a. In footnotes change “μ” to “m” 5. System suitability tests and/or analytical quality control a. No change, keep as written 6. Reference Material(s): a. No change, keep as written 7. Validation Guidance: a. No change, keep as written 8. Maximum Time‐To‐Signal: a. No change, keep as written Vitamin E Working Group Meeting Minutes PRE‐DECISIONAL ‐ DO NOT DISTRIBUTE Version 1 Page 2
III. REVISED DRAFT SMPR DRAFT AOAC SMPR 2011.XXX; Version 5; June 29, 2011 Method Name: Determination of Vitamin E in Infant and Adult/Pediatric Nutritional Formula Approved by: Stakeholder Panel for Infant Formula and Adult Nutritionals Final version date: Effective date: Intended Use: 1. Applicability: Determination of vitamin E in all forms of infant, adult, and/or pediatric formula (powders, ready-to-feed liquids, and liquid concentrates). For the purpose of this SMPR, vitamin E is focused on DL-alpha-tocopherol (CAS-10191-41- 0) and all-racemic-tocopherol (CAS 1406-18-4) and their esters. Other compounds of accepted vitamin E activity can be included in a method if the requirements of the SMPR are met. Methods that are capable of reporting alpha-tocopherol and alpha-tocopherol esters separately may be desirable. 2. Analytical Technique: Any analytical technique that meets the following method performance requirements is acceptable. 3. Definitions: Adult/Pediatric Formula Nutritionally complete, specially formulated food, consumed in liquid form, which may constitute the sole source of nourishment 1 , made from any combination of milk, soy, rice, whey, hydrolyzed protein, starch, and amino acids, with and without intact protein. Infant formula Breast-milk substitute specially manufactured to satisfy, by itself, the nutritional requirements of infants during the first months of life up to the introduction of appropriate complementary feeding 2 , made from any combination of milk, soy, rice, whey, hydrolyzed protein, starch, and amino acids, with and without intact protein. Limit of Detection (LOD) The minimum concentration or mass of analyte that can be detected in a given matrix with no greater than 5% false positive risk and 5% false negative risk. Limit of Quantitation (LOQ) The minimum concentration or mass of analyte in a given matrix that can be reported as a quantitative result Repeatability Variation arising when all efforts are made to keep conditions constant by using the same instrument and operator, and repeating during a short time period. Expressed as the repeatability standard deviation (SDr); or % repeatability relative standard deviation (%RSDr). Reproducibility The standard deviation or relative standard deviation calculated from among-laboratory data. Expressed as the reproducibility relative standard deviation (SDR); or % reproducibility relative standard deviation (% RSDR). Recovery The fraction or percentage of spiked analyte that is recovered when the test sample is analyzed using the entire method. 1 AOAC Stakeholders Panel for Infant Formula and Adult Nutritionals (SPIFAN); 2010. 2 Codex Standard 72 – 1981. Vitamin E Working Group Meeting Minutes PRE‐DECISIONAL ‐ DO NOT DISTRIBUTE Version 1 Page 3
Page 1: STAKEHOLDER PANEL ON INFANT FORMULA
Page 5 and 6: Table 1‐ Proposed Methods VITAMIN
Page 7: VITE‐12 Simultaneous Determinatio

stakeholder panel on infant formula & adult nutritionals (spifan)

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