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U.S. Department of Health and Human Services

Food

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How to Submit a GRAS Notice


This information was adapted from Federal Register 62 FR 18937 April 17, 1997 and includes updated contact information. Additional information on the GRAS program is available from FDA's Food Ingredient and Packaging GRAS Notification Program page.


Notice of a claim for exemption based on a GRAS determination

    1. 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 generally recognized as safe (GRAS).
    2. Notice to the agency of this section shall not constitute compliance with:
      1. Section 101.14(b)(3)(ii) of this chapter. Any person who submits a health claim petition under Sec. 101.14 of this chapter shall comply in full with Sec. 101.14(b)(3)(ii) regardless of whether the agency has been notified under this section about a substance and regardless of the nature of the agency's response.
      2. Section 106.120(b)(6)(ii) of this chapter. Any person who submits a new infant formula submission under proposed Sec. 106.120 of this chapter shall comply in full with proposed Sec. 106.120(b)(6)(ii) regardless of whether the agency has been notified under this section about a substance and regardless of the nature of the agency's response.
  1. A notice of a GRAS exemption claim shall be submitted in triplicate to the Office of Food Additive Safety (HFS-200), Center for Food Safety and Applied Nutrition, Food and Drug Administration, 5100 Paint Branch Pkwy, College Park, MD 20740.
  2. Notifiers shall submit the following information:
    1. 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 Federal Food, Drug, and Cosmetic Act (the act) because the notifier has determined that such use is GRAS. Such GRAS exemption claim shall include:
      1. The name and address of the notifier;
      2. The common or usual name of the substance that is the subject of the GRAS exemption claim (i.e., the ``notified substance'');
      3. 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;
      4. The basis for the GRAS determination (i.e., through scientific procedures or through experience based on common use in food); and
      5. A statement that the data and information that are the basis for the notifier's GRAS determination are available for the Food and Drug Administration's (FDA) review and copying at reasonable times at a specific address set out in the notice or will be sent to FDA upon request.
    2. 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 toxicants, and specifications for food-grade material;
    3. Information on any self-limiting levels of use; and
    4. 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.
      1. For a GRAS determination through scientific procedures, such summary shall include:
        1. 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;
        2. A comprehensive discussion of any reports of investigations or other information that may appear to be inconsistent with the GRAS determination; and
        3. The basis for concluding, in light of the data and information described under paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(i)(A), and (c)(4)(i)(B) of this section, 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.
      2. For a GRAS determination through experience based on common use in food, such summary shall include:
        1. A comprehensive discussion of, and citations to, generally available data and information that the notifier relies on to establish safety, including evidence of a substantial history of consumption of the substance by a significant number of consumers;
        2. A comprehensive discussion of any reports of investigations or other information that may appear to be inconsistent with the GRAS determination;
        3. The basis for concluding, in light of the data and information described under paragraphs (c)(1), (c)(2), (c)(3), (c)(4)(ii)(A), and (c)(4)(ii)(B) of this section, 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.
  3. Within 30 days of receipt of the notice, FDA shall acknowledge receipt of a notice by informing the notifier in writing of the date on which the notice was received.
  4. Within 90 days of receipt of the notice, FDA shall respond to the notifier in writing.
    1. Any GRAS exemption claim submitted under paragraph (c)(1) of this section shall be immediately available for public disclosure on the date the notice is received. All remaining data and information in the notice shall be available for public disclosure, in accordance with part 20 of this chapter, on the date the notice is received.
    2. For each GRAS notice submitted under this section, the following information shall be readily accessible for public review and copying:
      1. A copy of the GRAS exemption claim submitted under paragraph (c)(1) of this section.
      2. A copy of any letter issued by the agency under paragraph (e) of this section.
      3. A copy of any subsequent letter issued by the agency regarding such notice.
    1. Any GRAS affirmation petition that was filed by FDA under Sec. 170.35 prior to (date the final rule becomes effective) and is still pending as of (date the final rule becomes effective) shall be presumptively converted to a notice under the provisions of this section on (date the final rule becomes effective).
    2. Any person who submitted a GRAS affirmation petition that is converted to a notice under paragraph (g)(1) of this section may amend such converted petition to meet the requirements of this section by submitting to the agency a claim, dated and signed by the notifier (i.e., the former petitioner), 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 GRAS exemption claim shall include:
      1. The name and address of the notifier;
      2. The applicable GRAS affirmation petition number;
      3. The common or usual name of the substance that was the subject of the converted GRAS affirmation petition (i.e., the notified substance);
      4. The applicable conditions of use of the notified substance that are supported by data and information in the referenced GRAS petition, 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;
      5. The basis for the GRAS determination (i.e., through scientific procedures or through experience based on common use in food); and
        1. A statement that the complete record that supports the GRAS determination has been submitted to the agency in the applicable GRAS petition; or
        2. A statement that the data and information that are the basis for the notifier's GRAS determination are available for FDA review and copying at reasonable times at a specific address set out in the claim or will be sent to FDA upon request.
      1. A petition that is converted to a notice under the provisions of paragraph (g)(1) of this section and that is amended according to the provisions of paragraph (g)(2) of this section shall be reviewed and administered according to the provisions of paragraphs (d), (e), and (f) of this section. For the purposes of paragraphs (d), (e), and (f) of this section, the date of receipt of the amendment described in paragraph (g)(2) of this section shall be the date of receipt of the notice.
      2. After (date 90 days after date of publication of the final rule), FDA will inform any person who submitted a GRAS affirmation petition that is converted to a notice under the provisions of paragraph (g)(1) of this section, and who has not amended such petition according to the provisions of paragraph (g)(2) of this section, that the converted petition is inadequate as a notice under this section.
 

Contact FDA

(240)-402-1192
GRAS Notification Program

Additional Contact Information

Office of Food Additive Safety

5100 Paint Branch Parkway

College Park, MD 20740