C.R.S.
Section 25-5-413
Limit of adulteration
- rule or regulation
(1)
Any added poisonous or deleterious substance, food additive, pesticide chemical in or on a raw agricultural commodity, or color additive, with respect to any particular use or intended use, shall be deemed unsafe for the purpose of application of section 25-5-410 (1)(b) with respect to any food, section 25-5-414 (1)(a) to (1)(f) with respect to any drug or device, or section 25-5-416 (1)(a) with respect to any cosmetic, unless there is in effect a regulation pursuant to section 25-5-419 or subsection (2) of this section limiting the quantity of such substance and the use or intended use of such substance is within the limits prescribed by such regulation. While such a regulation relating to such substance is in effect, a food, drug, or cosmetic, by reason of bearing or containing such substance in accordance with the regulations, shall not be considered adulterated within the meaning of section 25-5-410 (1)(b), 25-5-414 (1)(a) to (1)(f), or 25-5-416 (1)(a).(2)
The department, whenever public health or other considerations so require, is authorized to adopt, amend, or repeal regulations upon its own motion or upon the petition of any interested party, whether or not in accordance with regulations promulgated under the federal act. Such regulations may prescribe tolerances for any added poisonous or deleterious substances, food additives, pesticide chemicals in or on raw agricultural commodities, or color additives, including but not limited to zero tolerances. The department may prescribe exemptions from tolerances in the case of pesticide chemicals in or on raw agricultural commodities. The department may also promulgate regulations prescribing the conditions under which a food additive or a color additive may be safely used and exemptions if such food additive or color additive is to be used solely for investigational or experimental purposes. It shall be incumbent upon any petitioner to establish that a necessity exists for such regulation and that its effect will not be detrimental to the public health. If the data furnished by the petitioner are not sufficient to allow the department to determine whether such regulation should be promulgated, the department may require additional data to be submitted, and failure to comply with the request shall be sufficient grounds for denial of the request. In adopting, amending, or repealing regulations under this section, the department shall consider, among other relevant factors, the following, which the petitioner, if any, shall furnish:(a)
The name and all pertinent information concerning such substance, including, where available, its chemical identity and composition; a statement of the conditions of the proposed use, including directions, recommendations, suggestions, and specimens of proposed labeling; all relevant data bearing on the physical or other technical effects; and the quantity required to produce such effect;(b)
The probable composition of any substance formed in or on a food, drug, or cosmetic resulting from the use of such substance;(c)
The probable consumption of such substance in the diet of man and animals taking into account any chemically or pharmacologically related substance in such diet;(d)
Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of such substances for the uses for which they are proposed to be used, are generally recognized as appropriate for the use of animal experimentation data;(e)
The availability of any needed practicable methods of analysis for determining the identity and quantity of:(I)
Such substance in or on an article;(II)
Any substance formed in or on such article because of the use of such substance; and(III)
The pure substance and all intermediates and impurities;(f)
Facts supporting a contention that the proposed use of such substance will serve a useful purpose.
Source:
Section 25-5-413 — Limit of adulteration - rule or regulation, https://leg.colorado.gov/sites/default/files/images/olls/crs2023-title-25.pdf (accessed Oct. 20, 2023).
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