Reference Materials: Critical Importance to the Infant Formula Industry.

Infant formula is one of the most regulated foods in the world. It has advanced in complexity over the years as a result of numerous research innovations. To ensure product safety and quality, analytical technologies have also had to advance to keep pace. Given the rigorous performance demands expected of these methods and the ever-growing array of complex matrixes, there is the potential for gaps to exist in current Official MethodsSM and other recognized international methods for infant formula and adult nutritionals. Food safety concerns, particularly for infants, drive the need for extensive testing by manufacturers and regulators. The net effect is the potential for an increase in time- and resource-consuming regulatory disputes. In an effort to mitigate such costly activities, AOAC INTERNATIONAL, under the direction of the Infant Formula Council of America-a trade association of manufacturers and marketers of formulated nutritional products-agreed to establish voluntary consensus Standard Method Performance Requirements, and, ultimately, to identify and publish globally recognized, fit-for-purpose standard methods. To accomplish this task, nutritional reference materials (RMs), representing all major commercially available nutritional formulations, were (and continue to be) a critical necessity. In this paper, various types of RMs will be defined, followed by review and discussion of their importance to the infant formula industry.

The History of Infant Formula: Quality, Safety, and Standard Methods.

Food-related laws and regulations have existed since ancient times. Egyptian scrolls prescribed the labeling needed for certain foods. In ancient Athens, beer and wines were inspected for purity and soundness, and the Romans had a well-organized state food control system to protect consumers from fraud or bad produce. In Europe during the Middle Ages, individual countries passed laws concerning the quality and safety of eggs, sausages, cheese, beer, wine, and bread; some of these laws still exist today. But more modern dietary guidelines and food regulations have their origins in the latter half of the 19th century when the first general food laws were adopted and basic food control systems were implemented to monitor compliance. Around this time, science and food chemistry began to provide the tools to determine "purity" of food based primarily on chemical composition and to determine whether it had been adulterated in any way. Since the key chemical components of mammalian milk were first understood, infant formulas have steadily advanced in complexity as manufacturers attempt to close the compositional gap with human breast milk. To verify these compositional innovations and ensure product quality and safety, infant formula has become one of the most regulated foods in the world. The present paper examines the historical development of nutritional alternatives to breastfeeding, focusing on efforts undertaken to ensure the quality and safety from antiquity to present day. The impact of commercial infant formulas on global regulations is addressed, along with the resulting need for harmonized, fit-for-purpose, voluntary consensus standard methods.