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  1. News & Events from CFSAN

FDA Issues Draft Guidance on Food Contact Substances for Use with Infant Formula and Human Milk

FDA Issues Draft Guidance on Food Contact Substances for Use with Infant Formula and Human Milk

Constituent Update

December 8, 2016

The U.S. Food and Drug Administration has issued draft guidance to provide additional information on how to prepare Food Contact Notifications (FCNs) for food contact substances that will come into contact with infant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Although the FDA evaluates the safety of all packaging materials before they enter the marketplace, the new draft guidance provides more specific advice on how to conduct the safety assessment for food contact substances that would come into contact with infant formula or human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.

From birth to about 6 months, infants are typically fed only breast milk and/or infant formula (other foods are added as the infant grows older). For a number of reasons, infants can be more susceptible to the possible health effects of chemical substances that may be released from the packaging. Once finalized, the recommendations in the draft guidance are meant to help industry understand the FDA’s process for evaluating the safety of food contact substances, a process that incorporates the latest scientific thinking about the effects chemical substances may have on infant health.

Although the draft guidance will apply to new FCN submissions once finalized, the agency re-reviewed a sample of FCNs for substances currently used in infant formula and human milk packaging using the same approach detailed in the draft guidance. The results of this review affirmed that the sample of the FCN materials currently on the market remains safe for use; the FDA would have allowed the notifications to become effective following the recommendations in the draft guidance.

The comment period for this draft guidance opens December 9, 2016. Although comments are accepted at any time, to ensure that the agency considers comments on this draft guidance before it begins work on the final version of this guidance, submit either electronic or written comments on the draft guidance by February 7, 2017.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 http://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 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.

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