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U.S. Department of Health and Human Services

Animal & Veterinary

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How to Submit a GRAS Notice to CVM


This information was excerpted from Federal Register 75 FR 31800 June 4, 2010. Additional information on the GRAS program may be accessed from the Center for Veterinary Medicine's Animal GRAS Notification Program page.


Any person may notify FDA of a claim that a particular use of a substance is exempt from the statutory premarket approval requirements based on the notifier’s determination that such use is GRAS. Notifiers should submit triplicate copies of their notices of GRAS determination to the Division of Animal Feeds (HFV-224), Office of Surveillance and Compliance, Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855.

Notifiers should submit the following information:

  • A claim, dated and signed by the notifier, or by the notifier's attorney or agent, or (if the notifier is a corporation) by an authorized official, that a particular use of a substance is exempt from the premarket approval requirements of the act because the notifier has determined that such use is GRAS.  Such a claim should include:
    • The name and address of the notifier;
    • The common or usual name of the substance that is the subject of the GRAS determination claim (i.e., the "notified substance'');
    • The applicable conditions of use of the notified substance, including the foods in which the substance is to be used, levels of use in such foods, and the purposes for which the substance is used, including, when appropriate, a description of the population expected to consume the substance.  The population description should include the specific animal species intended to consume the substance. 
    • The basis for the GRAS determination (i.e., through scientific procedures or through experience based on common use in food); and
    • A statement that the data and information that are the basis for the notifier's GRAS determination are available for the FDA’s review and copying at reasonable times at a specific address set out in the notice or will be sent to FDA upon request.
  • Detailed information about the identity of the notified substance, including, as applicable, its chemical name, Chemical Abstracts Service (CAS) Registry Number, Enzyme Commission number, empirical formula, structural formula, quantitative composition, method of manufacture (excluding any trade secrets and including, for substances of natural biological origin, source information such as genus and species), characteristic properties, any content of potential human or animal toxicants, and specifications for feed-grade material;
  • Information on any self-limiting levels of use; and
  • A detailed summary of the basis for the notifier's determination that a particular use of the notified substance is exempt from the premarket approval requirements of the act because such use is GRAS.  Such determination may be based either on scientific procedures or on common use in food.
    • For a GRAS determination through scientific procedures, such summary should include:
      • A comprehensive discussion of, and citations to, generally available and accepted scientific data, information, methods, or principles that the notifier relies on to establish safety, including a consideration of the probable consumption of the substance and the probable consumption of any substance formed in or on food because of its use and the cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substances in such diet.  Where a substance is intended for use in the food of an animal used to produce human food, this should include a comprehensive discussion of, and citations to, generally accepted scientific data, information, methods, or principles about both safety to the target animal and human food safety.  The scientific data, information, methods, or principles provided should be sufficient to show that the substance is generally recognized among qualified experts to be safe for animals consuming food containing the substance as well as to humans consuming food derived from such animals (i.e., under its intended conditions of use);
      • A comprehensive discussion of any reports of investigations or other information that may appear to be inconsistent with the GRAS determination; and
      • The basis for concluding, in light of the data and information submitted, that there is consensus among experts qualified by scientific training and experience to evaluate the safety of substances added to food that there is reasonable certainty that the substance is not harmful under the intended conditions of use.
    • For a GRAS determination through experience based on common use in food, such summary should include:
      • A comprehensive discussion of, and citations to, generally available data and information that the notifier relies on to establish safety, including documented evidence of a substantial history of consumption of the substance by a significant number of animals.  Where a substance is intended for use in the food of an animal used to produce human food, this should include a comprehensive discussion of, and citations to, generally accepted scientific data, information, methods, or principles about both safety to the target animal and human food safety.  The scientific data, information, methods, or principles provided should be sufficient to show that the substance is generally recognized among qualified experts to be safe for animals consuming food containing the substance as well as to humans consuming food derived from such animals (i.e., under its intended conditions of use);
      • A comprehensive discussion of any reports of investigations or other information that may appear to be inconsistent with the GRAS determination;
      • The basis for concluding, in light of the data and information submitted, that there is consensus among experts qualified by scientific training and experience to evaluate the safety of substances added to food that there is reasonable certainty that the substance is not harmful under the intended conditions of use.