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                CFSAN Constituent Updates

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          FDA Issues Guidance on Food Contact Substances for Use with Infant Formula and/or Human MilkCFSAN Constituent Updates FDA Issues Guidance on Food Contact Substances for Use with Infant Formula and/or Human Milk
  
  	
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May 8, 2019

The U.S. Food and Drug Administration 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 market place, 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 6 months, infants are typically fed only human 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.  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 re-reviewed 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.

**For additional information:**

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

                                                                                  Content current as of:
      05/08/2019
              
              
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Milk/Milk Product
			  			     			  			     Infant Formula & FoodsCFSAN Constituent Updates
 
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