Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Search for FDA Guidance Documents

Search for FDA Guidance Documents

                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents Home
          Regulatory Information
          Search for FDA Guidance Documents
          Guidance for Industry:  Preparation of Food Contact  Substance Notifications (Administrative)Search for FDA Guidance Documents GUIDANCE DOCUMENT
	Guidance for Industry:  Preparation of Food Contact  Substance Notifications (Administrative)
					
		
		October 2021


	Download the  Final Guidance Document
	    
      	      		Read the Federal Register Notice 

    Final

	  
	  
	Share
    Post
    Linkedin

    Email
    PrintDocket Number:
		    FDA-2000-D-0138
	    	    		    Issued by:
		    Guidance Issuing Office
          Center for Food Safety and Applied Nutrition


*This guidance represents the current thinking of the Food and Drug Administration (FDA or we) on this topic.  It does not establish any rights for any person and is not binding on FDA or the public.  You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.  To discuss an alternative approach, contact the FDA staff responsible for this guidance at the phone number listed on the title page.*

Section 409 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) establishes a food contact substance notification (FCN) process as the primary means by which FDA regulates food additives that are food contact substances (FCSs).  An FCS is any substance that is intended for use as a component of materials used in manufacturing, packing, packaging, transporting, or holding food if the use is not intended to have any technical effect in such food (section 409(h)(6) of the FD&C Act).

Notifications for an FCS must contain sufficient scientific information to demonstrate that the substance that is the subject of the notification is safe for the intended use (section 409(h) of the FD&C Act).  Because the safety standard is the same for all food additives, whether subject to the petition process or the FCN process, information in an FCN should be comparable to that recommended for inclusion in a food additive petition or in a “Threshold of Regulation” submission (see 21 CFR 170.39).

The contents of this document do not have the force and effect of law and are not meant to bind the public in any way, unless specifically incorporated into a contract.  This document is intended only to provide clarity to the public regarding existing requirements under the law.  FDA guidance documents, including this guidance, should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.  The use of the word *should* in FDA guidances means that something is suggested or recommended, but not required.

Download the Guidance

*This guidance was revised to include Paperwork Reduction Act information, containing non-substantive formatting or editorial revisions to the guidance, which was last issued in May 2002. Revisions are noted by date at the end of the guidance.*

Related Information

Ingredients, Additives, GRAS & Packaging Guidance Documents & Regulatory Information


 
	Submit Comments
	   		  			    		Submit Comments Online
					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:
						Dockets Management
							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-2000-D-0138.

                                                                                  Content current as of:
      10/20/2021
         
                  
Regulated Product(s)
		 Food & Beverages
			  			     			  						              
			
			
			
			
			
						  Food & Color AdditivesTopic(s)
			  Food Contact Substances (FCS)
				  				     				  				  
				  
				   
				  
				  				  IngredientsSearch for FDA Guidance Documents

        Search for FDA Guidance Documents

          
                        Search General and Cross-Cutting Topics Guidance Documents
          Advisory Committee Guidance Documents
          Import and Export Guidance Documents
          Cross-cutting Guidance Documents
 
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop