Docket 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.

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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

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