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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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The information on this page is current as of April 1 2018.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 3]
[Revised as of April 1, 2018]
[CITE: 21CFR170.225]



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER B--FOOD FOR HUMAN CONSUMPTION (CONTINUED)

PART 170 -- FOOD ADDITIVES

Subpart E--Generally Recognized as Safe (GRAS) Notice

Sec. 170.225 Part 1 of a GRAS notice: Signed statements and certification.

(a) Part 1 of your GRAS notice must be dated and signed by a responsible official of your organization, or by your attorney or agent.

(b) Except as required by paragraph (c)(8) of this section, you must not include any information that is trade secret or confidential commercial information in Part 1 of your GRAS notice.

(c) In Part 1 of your GRAS notice, you must:

(1) Inform us that you are submitting a GRAS notice in accordance with this subpart;

(2) Provide the name and address of your organization;

(3) Provide the name of the notified substance, using an appropriately descriptive term;

(4) Describe the intended conditions of use of the notified substance, including the foods in which the substance will be used, the levels of use in such foods, and the purposes for which the substance will be used, including, when appropriate, a description of a subpopulation expected to consume the notified substance;

(5) Inform us of the statutory basis for your conclusion of GRAS status (i.e., through scientific procedures in accordance with 170.30(a) and (b) or through experience based on common use in food in accordance with 170.30(a) and (c));

(6) State your view that the notified substance is not subject to the premarket approval requirements of the Federal Food, Drug, and Cosmetic Act based on your conclusion that the notified substance is GRAS under the conditions of its intended use;

(7) State that, if we ask to see the data and information that are the basis for your conclusion of GRAS status, either during or after our evaluation of your notice, you will:

(i) Agree to make the data and information available to us; and

(ii) Agree to both of the following procedures for making the data and information available to us:

(A) Upon our request, you will allow us to review and copy the data and information during customary business hours at the address you specify for where these data and information will be available to us; and

(B) Upon our request, you will provide us with a complete copy of the data and information either in an electronic format that is accessible for our evaluation or on paper;

(8) State your view as to whether any of the data and information in Parts 2 through 7 of your GRAS notice are exempt from disclosure under the Freedom of Information Act, 5 U.S.C. 552 (e.g., as trade secret or as commercial or financial information that is privileged or confidential).

(9) Certify that, to the best of your knowledge, your GRAS notice is a complete, representative, and balanced submission that includes unfavorable information, as well as favorable information, known to you and pertinent to the evaluation of the safety and GRAS status of the use of the substance;

(10) State both the name and position or title of the person who signs the GRAS notice; and

(11) When applicable, state as required by 170.270 whether you:

(i) Authorize us to send any trade secrets to the Food Safety and Inspection Service (FSIS) of the U.S. Department of Agriculture; or

(ii) Ask us to exclude any trade secrets from the copy of the GRAS notice that we will send to FSIS.

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