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GUIDANCE DOCUMENT

Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk May 2019

Final

Guidance for Industry: Preparation of Food Contact Notifications for Food Contact Substances in Contact with Infant Formula and/or Human Milk

Docket Number:
FDA-2016-D-1814
Issued by:
Guidance Issuing Office
Office of Food Additive Safety

We are providing this guidance to represent our 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.

This document is intended to provide specific guidance to help manufacturers or suppliers submitting an FCN in the safety assessment of substances that are intended for use in contact with infant formula and/or human milk. FCSs that would be affected by this guidance document may include infant formula packaging for both liquid (concentrate and ready to feed) and powdered formula, baby bottles, bottle inserts, nipples, and any other materials that are in contact with infant food.

Download the Guidance

More on Ingredients, Additives, GRAS & Packaging


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-1814.