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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: 21CFR170.265]



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. 170.265 What FDA will do with a GRAS notice.

(a)(1) We will conduct an initial evaluation of your submission to determine whether to file it as a GRAS notice for evaluation of your view that the notified substance is GRAS under the conditions of its intended use.

(2) If we file your submission as a GRAS notice, we will send you a letter that informs you of the date of filing.

(3) If we do not file your submission as a GRAS notice, we will send you a letter that informs you of that fact and provides our reasons for not filing the submission as a GRAS notice.

(4) We will consider any timely amendment that you submit to a filed GRAS notice, to update your GRAS notice or in response to a question from us, before we respond to you by letter in accordance with paragraph (b)(1) of this section, if we deem that doing so is feasible within the timeframes established in paragraph (b) of this section. If we deem that considering your amendment is not feasible within the timeframes established in paragraph (b) of this section or if we have granted your request to cease to evaluate your notice, we will inform you that we are not considering your amendment.

(b)(1) Within 180 days of filing, we will respond to you by letter based on our evaluation of your notice. We may extend the 180 day timeframe by 90 days on an as needed basis.

(2) If we extend the timeframe, we will inform you in writing of the extension as soon as practicable but no later than within 180 days of filing.

(3) If you ask us to cease to evaluate your GRAS notice in accordance with 170.260(b), we will send you a letter informing you of our decision regarding your request.

(c) If circumstances warrant, we will send you a subsequent letter about the notice.

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