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The US Food and Drug Administration (FDA) drafted an industry guidance for food contact substances used with infant formula and human milk. The draft is entitled Draft Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk.

This draft guidance specifies FDA’s current thinking on recommendations for preparation of food contact notification (FCN) submissions for food contact substances (FCSs) used in contact with infant formula and/or human (breast) milk.

The draft guidance also provides recommendations regarding how the scientific information in FCNs for infant food uses should demonstrate that the FCS is safe for the specific intended use.

Comments are accepted until February 7, 2017 before the final guidance is released.



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