Certification of Nutrients in Standard Reference Material 1846: Infant Formula

Abstract

In 1996, the National Institute of Standards and Technology (NIST) released Standard Reference Material 1846 (Infant Formula), which can be used as a control material for assigning values to in-house control materials and for validating analytical methods for measurement of proximates, vitamins, and minerals in infant formula and similar matrixes. The SRM was manufactured by preparing a spray-dried formula base containing fat, protein, carbohydrates, and minerals and then combining that formula base with a dry-blend vitamin premix that supplied the vitamins. The Certificate of Analysis for SRM 1846 provides assigned values for concentrations of proximates (fat, protein, etc.), vitamins, and minerals for which product labeling is required by the Infant Formula Act of 1980 and by the Nutrition Labeling and Education Act of 1990. These assigned values were based on agreement of measurements by NIST and/or collaborating laboratories. Certified values are provided for vitamins A (trans), E, C, B2, and Be and niacin. Noncertified values are provided for solids, ash, fat, nitrogen, protein, carbohydrate, calories, vitamin D, δ-tocopherol, γ-tocopherol, vitamin Bi, vitamin B12, folic acid, pantothenic acid, biotin, choline, inositol, calcium, phosphorus, magnesium, iron, zinc, copper, sodium, potassium, and chloride. Information values are provided for iodine, manganese, selenium, and vitamin K.

Contribution of folic acid-fortified foods to fertile women’s folate Recommended Nutrient Intake through breakfast simulation models

“…The analysis of FA-fortified food products involved the following steps: (i) tri-enzyme extraction from the food matrix ( 25 ) ; (ii) purification and concentration by affinity chromatography with folate-binding protein; and (iii) finally separation and quantification by reversed-phase HPLC with UV detection ( 26 , 27 ) . A Standard Reference Material (SRM 1846) and an International Standard ( 28 , 29 ) were used throughout the analysis to test for accuracy. FA was used as standard and obtained from Sigma (Spain) in analytical grade.…”

From urban dust and marine sediment to Ginkgo biloba and human serum—a top ten list of Standard Reference Materials (SRMs)

“…The focus for the infant formula SRM certification, however, was not on constituents related to safety but on the content of vitamins and nutrients. SRM 1846 was issued with certified values for only four vitamins and iodine; however, reference values were available (and many were added in later years) for 38 additional vitamins and nutrients (both organic and elements) [44]. The limited number of certified values for vitamins was primarily due to the lack of reliable multiple analytical methods at NIST to provide measurements of the required quality to assign certified values.…”

Evolution of reference materials for the determination of organic nutrients in food and dietary supplements—a critical review

“…SRM 1544 was significant for several reasons: (1) it was the first frozen food-matrix CRM, as prior materials were all freeze-dried, (2) it was a natural (non-fortified) composite of foods rather than a single food material, and (3) it was the first NIST food-matrix CRM with values assigned for individual fatty acids. SRM 1846 infant formula was issued to address directly the measurement needs established by the IFA regulations; however, it was also the first food-matrix CRM intended to address the broad scope of NLEA with values assigned for vitamins, nutritional elements, and proximates [35]. In 1997 SRM 2383 baby food composite was issued as a custom-designed mixture of foods selected to provide measurable content of carotenoids and vitamins [36, 37].…”

“…Reference/indicative values were often assigned using only the results from collaborating laboratories when NIST did not have the measurement capabilities for some nutrients at the time. Examples of the value assignment approach for several first-generation NIST food-matrix CRMs have been reported [35–38, 53–55]. The major group of collaborating laboratories contributing to value assignment for the NIST food-matrix CRMs has been the Grocery Manufacturers Association (GMA), formerly the National Food Processors Association.…”

“…SRM 1849 infant/adult nutritional formula also represented a significant increase in the number of values assigned for organic nutrients in a food-matrix CRM. The first infant formula CRM (SRM 1846) [35] was issued in 1996 with certified values assigned for only 4 WSVs and 2 FSVs, and reference/indicative values for an additional 29 nutrient constituents including 10 vitamins, which were assigned as reference/indicative values primarily based on measurements from collaborating laboratories with no measurements at NIST. In addition to the ID LC-MS and ID LC-MS/MS methods described above for the vitamins, in the late 2000s two independent GC methods, GC-FID and GC-MS, were implemented for determination of fatty acids in food.…”