FDA Issues Final Guidance on FCN Requirements for FCS in Contact with Infant Formula and Human Milk

We are writing this memo to bring to your attention that the Food and Drug Administration (FDA) recently published a new final guidance titled: “Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk” (FCN Guidance). 

The guidance contains recommendations regarding how the scientific information in food contact notifications (FCNs) for infant food use should demonstrate that the food contact substance (FCS) is safe for the specific intended use in contact with infant food. FDA has previously provided guidance for the safety assessment of FCSs.

However, the earlier guidance document did not specifically address dietary exposure and safety assessment considerations related to the migration of chemical substances from packaging and other food contact articles as it pertains to infants. FDA meant to fill the gap with this new guidance and the FCSs that would be affected by this guidance document include infant formula packaging for liquid and powdered formula, baby bottles, bottle inserts, nipples, and any other materials that are in contact with infant food.

In this post, we highlight the FDA’s chemistry and toxicology recommendations. Click here to read more.


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