Upper levels of nutrients in infant formulas: Comparison of analytical data with the revised Codex infant formula standard

The Codex Alimentarius Commission adopted a revised standard for infant formula in 2007. This standard provides a regulatory framework for infant formula, including provisions for its essential composition. The recommendations for the essential composition specify minimum levels and either maximum values (MVs) or guidance upper levels (GULs) for 31 nutrients. As part of the revision process, the first cooperative survey of levels of nutrients in infant formulas was conducted by several global manufacturers. Whereas formulas met proposed minimum levels of all nutrients, 15 nutrients were identified whose levels were likely to exceed the proposed MV or GUL: vitamins A and K, thiamine, riboflavin, niacin, vitamin B6, folic acid, vitamin B12, vitamin C, iron, copper, manganese, potassium and iodine. Analytical data were collected for those nutrients from 21,385 batches of milk-based infant formula and 9070 batches of soy-based infant formula, whose total volumes were sufficient to feed more than 33 million infants for periods of three months. The number of batches analyzed ranged from 440 (vitamin K) to 27,920 (vitamin C). Of nutrients with an MV, only levels of vitamin A in some batches exceeded the maximum; no batch contained levels previously reported in the literature to be associated with adverse effects. There were several nutrients with GULs for which there were batches that exceeded the suggested upper limit. Data for some nutrients showed considerable variability, which related to form (liquid vs. powder), inherent levels of nutrients in formula ingredients, protein source, nutrient stability, analytical variability and effects of process, package and container size.