On May 9, 2019, the U.S. Food and Drug Administration (FDA) submitted a notice to the Federal Register announcing the availability of the guidance for industry entitled “Preparation of food contact notifications for food contact substances in contact with human formula and/or human milk.” A public consultation has been held on the draft guidance published in December 2016 (FPF reported), and the now-released final version has been modified “where appropriate” in response to “a few comments” received then.
The guidance outlines FDA’s “current thinking on how to prepare a food contact notification (FCN) submission for . . . review and evaluation of the safety of food contact substances (FCSs) used in contact with infant formula and/or human milk.” The recommendations address chemical, toxicological, and administrative topics. Chemistry recommendations focus in particular on migration testing and exposure estimation. Toxicology recommendations introduce “exposure based testing tiers” and outline “minimum testing recommendations.” Further, “age dependent cancer risk analysis of carcinogenic constituents” is discussed. Administrative recommendations explain FDA’s procedures related to the “acknowledgement of an FCN” or “nonacceptance of an FCN,” as well as issuing of a “final letter” and inclusion in the FDA’s “Inventory of effective FCNs.”
The guidance “does not establish any rights for any person and is not binding on FDA or the public.” Therefore, any “alternative approach [can still be used] if it satisfies the requirements of the applicable statutes and regulations”
Federal Register (May 9, 2019). “Preparation of food contact notifications for food contact substances in contact with infant formula and/or human milk; Guidance for industry; Availability.” A notice by the Food and Drug Administration.
Chemical Watch (May 9, 2019). “US FDA ussies guidance on notifying infant formula FCMs.”