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Title 21 — Food and DrugsRelease 119-73

§346 Tolerances for poisonous or deleterious substances in food; regulations

Title 21 › Chapter CHAPTER 9— - FEDERAL FOOD, DRUG, AND COSMETIC ACT › Subchapter SUBCHAPTER IV— - FOOD › § 346

Last updated Apr 6, 2026|Official source

Summary

Any poisonous or harmful substance added to food is treated as unsafe unless that substance is needed to make the food or cannot be avoided by proper manufacturing. If the substance is needed or unavoidable, the Secretary must make rules that limit how much of it can be in or on the food to protect public health. Amounts above those limits are also treated as unsafe. While those limits are in effect, food that contains only an allowed amount is not considered adulterated. When setting limits, the Secretary must consider how much is required for each food and how consumers might be affected by that substance or other harmful substances.

Full Legal Text

Title 21, §346

Food and Drugs — Source: USLM XML via OLRC

Any poisonous or deleterious substance added to any food, except where such substance is required in the production thereof or cannot be avoided by good manufacturing practice shall be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title; but when such substance is so required or cannot be so avoided, the Secretary shall promulgate regulations limiting the quantity therein or thereon to such extent as he finds necessary for the protection of public health, and any quantity exceeding the limits so fixed shall also be deemed to be unsafe for purposes of the application of clause (2)(A) of section 342(a) of this title. While such a regulation is in effect limiting the quantity of any such substance in the case of any food, such food shall not, by reason of bearing or containing any added amount of such substance, be considered to be adulterated within the meaning of clause (1) of section 342(a) of this title. In determining the quantity of such added substance to be tolerated in or on different articles of food the Secretary shall take into account the extent to which the use of such substance is required or cannot be avoided in the production of each such article, and the other ways in which the consumer may be affected by the same or other poisonous or deleterious substances.

Legislative History

Notes & Related Subsidiaries

Editorial Notes

Amendments

1960—Pub. L. 86–618 repealed subsec. (b) which required Secretary to promulgate

Regulations

for listing of coal-tar colors. 1958—Subsec. (a). Pub. L. 85–929 substituted “clause (2)(A)” for “clause (2)” in first sentence.

Statutory Notes and Related Subsidiaries

Effective Date

of 1960 AmendmentAmendment by Pub. L. 86–618 effective July 12, 1960, subject to the provisions of section 203 of Pub. L. 86–618, see section 202 of Pub. L. 86–618, set out as a note under section 379e of this title.

Effective Date

of Nematocide, Plant Regulator, Defoliant, and Desiccant Amendment of 1959

Effective Date

of subsec. (a) as in force prior to July 22, 1954, with respect to particular commercial use of a nematocide, plant regulator, defoliant, or desiccant in or on a raw agricultural commodity made before Jan. 1, 1958, see section 3(b) of Pub. L. 86–139, Aug. 7, 1959, 73 Stat. 288.

Effective Date

of 1958 AmendmentFor

Effective Date

of amendment by Pub. L. 85–929, see section 6(b), (c) of Pub. L. 85–929, set out as a note under section 342 of this title.

Executive Documents

Transfer of Functions

Functions vested in Secretary of Health, Education, and Welfare [now Health and Human Services] in establishing tolerances for pesticide chemicals under this section together with authority to monitor compliance with tolerances and effectiveness of surveillance and

Enforcement

and to provide technical assistance to States and conduct research under this chapter and section 201 et seq. of Title 42, The Public Health and Welfare, transferred to Administrator of Environmental Protection Agency by Reorg. Plan No. 3 of 1970, § 2(a)(4), eff. Dec. 2, 1970, 35 F.R. 15623, 84 Stat. 2086, set out in the Appendix to Title 5, Government Organization and Employees. For

Transfer of Functions

of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration to Federal Security Agency, see notes set out under section 321 of this title.

Reference

Citations & Metadata

Citation

21 U.S.C. § 346

Title 21 — Food and Drugs

Last Updated

Apr 6, 2026

Release point: 119-73