CFR

152.43—Alternate formulations.

(a) A product proposed for registration must have a single, defined composition, except that EPA may approve a basic formulation and one or more alternate formulations for a single product.

(b) An alternate formulation must meet the criteria listed in paragraph (b) (1) through (4) of this section. The Agency may require the submission of data to determine whether the criteria have been met.

(1) The alternate formulation must have the same certified limits for each active ingredient as the basic formulation.

(2) If the alternate formulation contains an inert ingredient or impurity of toxicological signficance, the formulation must have the same upper certified limit for that substance as the basic formulation;

(3) The label text of the alternate formulation product must be identical to that of the basic formulation.

(4) The analytical method required under § 158.355 of this chapter must be suitable for use on both the basic formulation and the alternate formulation.

(c) Notwithstanding the criteria in this section, the Agency may determine that an alternate formulation must be separately registered. If EPA makes this determination, the Agency will notify the applicant of its determination and its reasons. Thereafter the application for an alternate formulation will be treated as an application for new registration, and the alternate formulation will be assigned a new registration number.

Code of Federal Regulations

[53 FR 15978, May 4, 1988, as amended at 72 FR 61027, Oct. 26, 2007]

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