On December 9, 2016 the U.S. Food and Drug Administration (FDA) published a notice in the Federal Register regarding a draft guidance for industry on “Food Contact Notifications for food contact substances in contact with infant formula and/or human milk” (FPF reported). When finalized, the guidance shall “provide industry with our current thinking on how to prepare a food contact notification (FCN) submission for our review and evaluation of the safety of food contact substances (FCSs) used in contact with infant formula and/or human milk,” the FDA explains.
The draft guidance provides information and recommendations regarding chemistry, migration testing and exposure estimation, toxicology and exposure-based testing tiers, minimum testing, and age-dependent cancer risk analysis of carcinogenic constituents. Also, administrative aspects such as acknowledgement and non-acceptance of an FCN, the final letter, the inventory of effective FCNs, and premarket notification consultations are covered.
The FDA advises to provide comments on the draft guidance by February 7, 2017.
Federal Register (December 9, 2016). “Preparation of Food Contact Notifications for food contact substances in contact with infant formula and/or human milk; draft guidance for industry; availability.”
David Stegon (December 9, 2016). “U.S. FDA issues draft guidance on infant food FCMs.” Chemical Watch
Mary Ellen Shoup (December 8, 2016). “FDA drafts recommendations on handling substances that come in contact with infant formula and breast milk.” Dairy Reporter