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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim); 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim). 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim). 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.
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Stable record: federal_law:legal_authorities:record_usc_ae29a895fd4513bd85e79c51 Source file: Laws/federal/codes/united-states-code/title-21/section-346-tolerances-for-poisonous-or-deleterious-substances-in-food-regulations--6a8ac76350.md Pages: Not recorded – Not recorded Passage SHA-256: 2048ce7dcda2e53dc32bb2fd11b1a2430d3512d113bc9c448ecd5d564c143efb Retained source evidence SHA-256: 6bf3f322dd10eb4d5e9759da5772669c1dc722b0cb1b8357ae6f14a2a6d0fe7b
Source location: Title 21, Chapter 9, § 346; chapter-009-federal-food-drug-and-cosmetic-act.md
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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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim); 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim). 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](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section342/a&num=0&edition=prelim). 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.
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Federal law — U.S. Code and appendices · legal_authorities
§ 346. Tolerances for poisonous or deleterious
substances in food; regulations
Any poisonous or deleterious substance added
to any food, except where such substance is re-
quired in the production thereof or cannot be
avoided by good manufacturing practice shall be
deemed to be unsafe for purposes of the applica-
tion of clause (2)(A) of section 342(a) of this title;
but when such substance is so required or can-
not be so avoided, the Secretary shall promul-
gate 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 appli-
cation of clause (2)(A) of section 342(a) of this
title. While such a regulation is in effect lim-
iting 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 dif-
ferent 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 af-
fected by the same or other poisonous or delete-
rious substances.
(June 25, 1938, ch. 675, § 406, 52 Stat. 1049; Pub. L.
85–929, § 3(c), Sept. 6, 1958, 72 Stat. 1785; Pub. L.
86–618, title I, § 103(a)(1), July 12, 1960, 74 Stat.
398.)
Editorial Notes
AMENDMENTS
1960—Pub. L. 86–618 repealed subsec. (b) which re-
quired Secretary to promulgate regulations for listing
of coal-tar colors.
1958—Su