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 6]

[CITE: 21CFR570.235]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER E - ANIMAL DRUGS, FEEDS, AND RELATED PRODUCTS

PART 570 -- FOOD ADDITIVES

Subpart E - Generally Recognized as Safe (GRAS) Notice

Sec. 570.235 Part 3 of a GRAS notice: Target animal and human exposures.

In part 3 of your GRAS notice, you must provide data and information about exposure to the target animal and to humans consuming human food derived from food-producing animals, regardless of whether your conclusion of GRAS status is through scientific procedures or through experience based on common use in food, as follows:

(a) For exposure to the target animal, you must provide:

(1) The amount of the notified substance that different target animal species are likely to consume in the animal food (including drinking water) as part of the animal's total diet, including the intended use and all other sources in the total diet; and

(2) When applicable, the amount of any other substance that is expected to be formed in or on food because of the use of the notified substance (e.g., hydrolytic products or reaction products);

(3) When applicable, the amount of any other substance that is present with the notified substance either naturally or due to its manufacture (e.g., contaminants or by-products);

(4) The data and information you rely on to establish the amount of the notified substance and the amounts of any other substance in accordance with paragraphs (a)(1) through (a)(3) of this section that different target animal species are likely to consume in the animal food (including drinking water) as part of the animal's total diet; and

(b) When the intended use is in food for food-producing animals, you must provide:

(1) The potential quantities of any residues that humans may be exposed to in edible animal tissues, including:

(i) Residues of the notified substance;

(ii) Residues of any other substance that is expected to be formed in or on the animal food because of the use of the notified substance; and

(iii) Residues from any other substance that is present with the notified substance whether naturally, due to its manufacture (e.g., contaminants or by-products), or produced as a metabolite in edible animal tissues when the notified substance is consumed by a food-producing animal; and

(2) The data and information you rely on to establish, in accordance with paragraph (b)(1) of this section, the potential quantities of any residues that humans may be exposed to in edible animal tissues.