21 C.F.R. § 109.4 Establishment of tolerances, regulatory limits, and action levels.
Title 21 - Food and Drugs
(a) When appropriate under the criteria of §109.6, a tolerance for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart B of this part under the provisions of section 406 of the act. A tolerance may prohibit any detectable amount of the substance in food. (b) When appropriate under the criteria of §109.6, and under section 402(a)(1) of the act, a regulatory limit for an added poisonous or deleterious substance, which may be a food additive, may be established by regulation in subpart C of this part under the provisions of sections 402(a)(1) and 701(a) of the act. A regulatory limit may prohibit any detectable amount of the substance in food. The regulatory limit established represents the level at which food is adulterated within the meaning of section 402(a)(1) of the act. (c)(1) When appropriate under the criteria of §109.6, an action level for an added poisonous or deleterious substance, which may be a food additive, may be established to define a level of contamination at which a food may be regarded as adulterated. (2) Whenever an action level is established or changed, a notice shall be published in the (d) A regulation may be established in subpart D of this part to identify a food containing a naturally occurring poisonous or deleterious substance which will be deemed to be adulterated under section 402(a)(1) of the act. These regulations do not constitute a complete list of such foods. [42 FR 52819, Sept. 30, 1977, as amended at 55 FR 20785, May 21, 1990]
Title 21: Food and Drugs
PART 109—UNAVOIDABLE CONTAMINANTS IN FOOD FOR HUMAN CONSUMPTION AND FOOD-PACKAGING MATERIAL
Subpart A—General Provisions
§ 109.4 Establishment of tolerances, regulatory limits, and action levels.
