FDA issues guidance on food contact substances for use with infant formula, human milk

May 9, 2019

The U.S. Food and Drug Administration (FDA) has issued 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/or human (breast) milk. The FDA evaluates the safety of all packaging materials before they enter the marketplace, including material that may be used in infant formula packaging, such as baby bottles, bottle inserts, nipples, and any other products used to collect and store human milk. This guidance provides specific advice on how to conduct a safety assessment for food contact substances that intend to come into contact with infant formula and/or human milk.

From birth to about six months, infants are typically fed only human milk and/or infant formula. For several reasons, infants can be more susceptible to the possible health effects of chemical substances that may be released from the packaging. The recommendations in this guidance are meant to help industry understand the FDA’s process for evaluating the safety of food contact substances, which incorporates the latest scientific thinking about the effects chemical substances may have on infant health.

Although this guidance applies to new FCN submissions, the agency rereviewed a sample of effective FCNs for substances intended for use in infant formula and/or human milk packaging using the same approach detailed in the guidance. The results of this review affirmed that these food contact materials are safe for use in packaging for infant formula and human milk.

Constituent update