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Guidance for Industry: Preparation of Food Contact Substance Notifications (Toxicology Recommendations) October 2021

Docket Number:
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 the food (section 409(h)(6) of the FD&C Act).

An FCS that is a food additive must be regulated for its intended use in 21 CFR Parts 173-178, be exempted from regulation under our Threshold of Regulation Policy (21 CFR 170.39), or be the subject of a notification under section 409(h) of the FD&C Act that is effective (section 409(a)(3) of the FD&C Act).  Both FCNs and food additive petitions (FAPs) for FCSs must contain sufficient scientific information to demonstrate that the substance that is the subject of the notification or petition is safe for the intended use (sections 409(h)(1) and 409(b) of the FD&C Act).  Section 409(b) of the FD&C Act sets forth the statutory requirements for data in a FAP to establish the safety of a food additive.  These requirements include full reports of investigations made with respect to the safety of the additive.  Because the safety standard is the same for all food additives, whether subject to the FCN process or the petition process, the data and information that should be included in an FCN or FAP are comparable.

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.

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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 originally issued in April 2002. Revisions are noted by date at the end of the guidance.

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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-1999-D-0062.

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