Public Law 119-73 (01/23/2026)

21 U.S.C. § 346

Tolerances for poisonous or deleterious substances in food; regulations

section 342(a) of this titlesection 342(a) of this titlesection 342(a) of this titleAny 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 ; 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 . 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 . 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.

June 25, 1938, ch. 675, § 40652 Stat. 1049Pub. L. 85–929, § 3(c)72 Stat. 1785Pub. L. 86–618, title I, § 103(a)(1)74 Stat. 398(, ; , , ; , , .)

Editorial Notes

Amendments

Pub. L. 86–6181960— repealed subsec. (b) which required Secretary to promulgate regulations for listing of coal-tar colors.

Pub. L. 85–9291958—Subsec. (a). substituted “clause (2)(A)” for “clause (2)” in first sentence.

Statutory Notes and Related Subsidiaries

Effective Date of 1960 Amendment

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

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

section 3(b) of Pub. L. 86–13973 Stat. 288Effective date of subsec. (a) as in force prior to , with respect to particular commercial use of a nematocide, plant regulator, defoliant, or desiccant in or on a raw agricultural commodity made before , see , , .

Effective Date of 1958 Amendment

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

Executive Documents

Transfer of Functions

84 Stat. 2086Functions 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. , 35 F.R. 15623, , set out in the Appendix to Title 5, Government Organization and Employees.

section 321 of this titleFor 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 .