Division of Food Ingredients, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, USA.
Division of Food Ingredients, Office of Food Additive Safety, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration, USA.
Food Chem Toxicol. 2023 Aug;178:113876. doi: 10.1016/j.fct.2023.113876. Epub 2023 Jun 5.
While human milk is considered the optimal source of nutrition for infants for the first six and twelve months of age, with continued benefit of breastfeeding with complementary foods, a safe alternative, nutritionally adequate to support infant growth and development, is necessary. In the United States, the Food and Drug Administration (FDA) establishes the requirements necessary to demonstrate the safety of infant formula within the framework of the Federal Food, Drug, and Cosmetic Act. FDA's Center for Food Safety and Applied Nutrition/Office of Food Additive Safety evaluates the safety and lawfulness of individual ingredients used in infant formula, whereas the Office of Nutrition and Food Labeling oversees the safety of infant formula. Most infant formula ingredients are either from sources with history of safe consumption by infants or are like components in human milk. Information demonstrating the regulatory status of all ingredients is required in submissions for new infant formulas, and ingredient manufacturers often use the Generally Recognized as Safe (GRAS) Notification program to establish ingredient regulatory status. We provide an overview of ingredients used in infant formula evaluated through the GRAS Notification program to highlight trends and discuss the data and information used to reach these GRAS conclusions.
虽然人乳被认为是婴儿在最初 6 个月和 12 个月龄时的最佳营养来源，并且继续母乳喂养并添加补充食品也有益处，但仍需要一种安全的替代食品，其营养充足，能够支持婴儿的生长和发育。在美国，食品和药物管理局 (FDA) 在《联邦食品、药品和化妆品法案》的框架内，制定了证明婴儿配方奶粉安全性所需的要求。FDA 的食品安全和应用营养中心/食品添加剂安全办公室评估婴儿配方奶粉中使用的个别成分的安全性和合法性，而营养和食品标签办公室则负责监督婴儿配方奶粉的安全性。大多数婴儿配方奶粉的成分要么来自婴儿安全食用历史悠久的来源，要么与母乳中的成分相似。对于新的婴儿配方奶粉，提交的材料中需要提供所有成分的监管状态信息，并且成分制造商通常使用“一般认为安全”（GRAS）通知程序来确定成分的监管状态。我们提供了通过 GRAS 通知程序评估的婴儿配方奶粉中使用的成分概述，以突出趋势，并讨论用于得出这些 GRAS 结论的数据和信息。
