N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 352-1.5

Current through Register Vol. 46, No. 45, November 2, 2024

Section 352-1.5 - Compliance Evaluation

(a) A manufacturer must conduct a compliance evaluation to demonstrate compliance with the limitations set forth in section 352-1.3 of this Part for any household cleansing, personal care, or cosmetic product that is distributed, sold, offered or exposed for sale in the State. The compliance evaluation must include one or more of the following analyses:

(1) A reasonable inquiry and documentation by the manufacturer of its raw material suppliers regarding the chemical composition of the raw materials in the household cleansing, personal care, or cosmetic product(s), including;

(i) a reasonable assessment by the manufacturer of the sum of the concentrations of 1,4-dioxane contributed by each raw material in the finished product formulation, using documentation provided by raw material suppliers in accordance with section 352-1.4(b)(2)(ii)(a) through (c), and a calculation and attestation by the manufacturer in accordance with section 352-1.4(b)(2)(ii)(d) through (f), respectively; or

(ii) analytical testing conducted in accordance with the criteria in section 352-1.6 of this Part for the household cleansing, personal care, or cosmetic product(s) with documentation provided in accordance with section 352-1.4(b)(2)(i).

(2) If a manufacturer is aware or anticipates that variation may exist between formulations of a household cleansing, personal care, or cosmetic product which may affect the concentration of 1,4-dioxane in the product, such that it would alter compliance with the applicable threshold stated in section 352.1-3 of this Part, the manufacturer must conduct the products compliance evaluation actions for the formulation that the manufacturer expects to result in the highest 1,4-dioxane concentration and which may be distributed, sold or offered for sale in the State.

(3) A manufacturer must retain records demonstrating that a compliance evaluation was conducted for three years after the date of last production of a product, including any records demonstrating that laboratory testing was performed in accordance with section 352-1.6 of this Part.

(4) A manufacturer must submit the compliance evaluation to the department upon request within 30 days of the request.

N.Y. Comp. Codes R. & Regs. Tit. 6 §§ 352-1.5

Adopted New York State Register September 18, 2024/Volume XLVI, Issue 38, eff. 9/18/2024