The final version of the US Food and Drug Administration's (FDA) "Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk," has now been published. The guidance provides detailed chemistry, toxicology, and administrative recommendations on the preparation and submission of food contact notifications (FCNs) for substances intended to contact infant formula and human milk, including components of infant formula packaging and baby bottles.
The final version of the guidance does not differ significantly from the draft version, which was issued on December 8, 2019. The only substantive changes are:
The addition of a footnote to clarify that FDA supports the principles of reduction, refining, and replacing animal use in testing when feasible, so that the agency "encourage[s] sponsors to consult with us if they wish to use a non-animal testing method they believe is suitable, adequate, validated, and feasible" (see footnote 17 at page nine of the guidance).
Modification of the exposure-based toxicology testing tiers two and three to make them consistent with FDA's "Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances: Toxicology Recommendations." In this regard, the upper bound of tier two now includes an exposure equal to or less than two and a half micrograms per kilogram of body weight per day (µg/kg bw/day), and the lower bound of tier three is now greater than two and a half µg/kg bw/day (see Table 1, "Tier Values," at page eight of the guidance).
Comments on any FDA guidance may be submitted at any time. Electronic or written comments on this draft guidance should reference Docket No. FDA-2016-D-1814.