CFR - Code of Federal Regulations Title 21

The information on this page is current as of Dec 22, 2023.

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

[Code of Federal Regulations]

[Title 21, Volume 3]

[CITE: 21CFR170.275]

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. 170.275 Public disclosure of a GRAS notice.

(a) The data and information in a GRAS notice (including data and information submitted in any amendment or supplement to your GRAS notice or incorporated into your GRAS notice) are:

(1) Considered a mandatory, rather than voluntary, submission for purposes of their status under the Freedom of Information Act and our public information requirements in part 20 of this chapter; and

(2) Available for public disclosure in accordance with part 20 of this chapter as of the date that we receive your GRAS notice.

(b) We will make the following readily accessible to the public:

(1) A list of filed GRAS notices, including the information described in § 170.225(c)(2) through (c)(5);

(2) The text of any letter that we issue under § 170.265(b)(1) or (c); and

(3) The text of any letter that we issue under § 170.265(b)(3) if we grant your request that we cease to evaluate your notice.

(c) We will disclose all remaining data and information that are not exempt from public disclosure in accordance with part 20 of this chapter.