• Exempt Infant Formulas (21 C.F.R. §107.50),

  • Nutrient Requirements for Infant Formulas (21 C.F.R. §107.100), and

  • Infant Formula Recall Requirements (21 C.F.R. §107.200–107.280).

FDA (1996) has proposed to revise these regulations to establish quality factors, current good manufacturing practices, and revised quality control procedures. Table 1-1 lists some of the U.S., Canadian, and European Union laws and regulations related to adding new ingredients to infant formulas.

Other Countries


The Canadian Food and Drug Regulations (Canada, 2001) include specific requirements for infant formulas, novel foods,1 and other ingredients. Division 25 of the Regulations provides for the addition to infant formulas of nutritive substances, in addition to specified vitamins and mineral nutrients, found in human milk, provided the nutritive substance is added to the formulas to the level found in human milk (section B.25.056). The Regulations include an inclusive list of those food additives that may be added to infant formulas (section B.25.062). Similar to the process in the United States, a new food additive must undergo premarket approval. The manufacturer must submit a request to the Minister of Health that includes all the details laid out in Division 16 of the Regulations. The request must include “detailed reports of tests made to establish the safety of the food additive under the conditions of use recommended” and “data establishing that the food additive will have the intended physical or other technical effect” (section B.16.002). Health Canada reviews the request and, if accepted, the Minister of Health recommends to the Governor-in-Council that the ingredient be added to the list of food additives in the Food and Drug Regulations. The Food and Drug Regulations also require a premarket notification for novel foods. The manufacturer of a novel food must submit a premarket notification for the food as required under Division 28 of the Regulations. Health Canada issues a written notice to the manufacturer if it is satisfied that information submitted establishes that the novel food is safe for consumption.

European Union

The European Union also has regulations in place for food additives, novel foods, and genetically modified organisms. However the European regulations are not specific for adding new ingredients to infant formulas.


As defined by the Food and Drug Regulations, a novel food is “a substance, including a microorganism, that does not have a history of safe use as a food; a food that has been manufactured, prepared, preserved or packaged by a process that (i) has not been previously applied to that food, and (ii) causes the food to undergo a major change; and a food that is derived from a plant, animal or microorganism that has been genetically modified (i) the plant, animal or microorganism exhibits characteristics that were not previously observed in that plant, animal or microorganism, (ii) the plant, animal or microorganism no longer exhibits characteristics that were previously observed in that plant, animal or microorganism, or (iii) one or more characteristics of the plant, animal or microorganism no longer fall within the anticipated range for that plant, animal or microorganism” (Canada, 2001, B.28.001).

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