Controlled Products Regulations

33. (1) For the purpose of establishing that a product, material or substance is included in a class listed in Schedule II of the Act or falls into a division of a class, the supplier shall use, subject to subsection (2),

• (a) results from testing that he has carried out with respect to the product, material or substance in accordance with sections 34 to 66, as applicable; or

• (b) evaluation and scientific judgment based on test results with respect to

  • (i) the product, material or substance, or

  • (ii) where appropriate, a product, material or substance that has similar properties.

(2) For the purpose of establishing that a product, material or substance is or is not included in Class D — Poisonous and Infectious Material, the supplier may use information of which the supplier is aware or ought reasonably to be aware in place of the criteria set out in subsection (1).

(3) Where the test results referred to in paragraph (1)(b) are results from toxicological studies, the studies shall have been carried out in accordance with

• (a) the applicable OECD Test Guideline referred to in this Part; or

• (b) where there are no tests carried out in accordance with the applicable OECD Test Guidelines referred to in this Part, one of the following tests or methods:

  • (i) in the case of a 90 day test or a chronic test, a test or method described in U.S. Food and Drug Administration (FDA) guidelines or U.S. Environmental Protection Agency (EPA) guidelines, as published in the Federal Register and as amended from time to time,

  • (ii) in the case of a test for skin or eye irritation, the Draize Test as described in volume 82 of The Journal of Pharmacology and Experimental Therapeutics, dated 1944, at pages 377 to 390,

  • (iii) in the case of a test for teratogenicity, a test or method described in Principles for the Testing of Drugs for Teratogenicity, Technical Report Series Number 364, published in 1967 by the World Health Organization,

  • (iv) in the case of a test for mutagenicity, a test or method described by the U.S. Environmental Protection Agency (EPA) in “Proposed Guidelines for Registering Pesticides in the U.S.; Hazard Evaluation: Human and Domestic Animals”, as published in volume 43 of the Federal Register (No. 163), dated 1978, at pages 37,336 to 37,403, or

  • (v) any other test or method that is carried out in accordance with generally accepted standards of good scientific practice at the time the test is carried out.