The US Food and Drug Administration (US FDA) has issued draft guidance to provide additional information on how to prepare Food Contact Notifications (FCNs) for food contact substances that will come into contact with infant formula and human (breast) milk. Although the US FDA evaluates the safety of all packaging materials before they enter the marketplace, the new draft guidance provides more specific advice on how to conduct the safety assessment for food contact substances that would come into contact with infant formula or human milk compared to food contact substances used in packaging of other foods. This guidance applies to material that may be used in infant formula packaging and baby bottles, bottle inserts, nipples, and any other products used to collect and store human milk.
Although comments are accepted at any time, to ensure that the agency considers comments on this draft guidance before it begins work on the final version of this guidance, submit either electronic or written comments on the draft guidance by February 7, 2017. Submit electronic comments to regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. All comments should be identified with the docket number FDA-2016-D-1814 listed in the notice of availability that publishes in the Federal Register. For additional information, please visit the US FDA website.