New Substances Notification Regulations (Chemicals and Polymers) — 7
Manufacture or import: quantities greater than 1 000 kg and 10 000 kg 7 (1) Every person that manufactures or imports a chemical that is on the NDSL — other than a chemical referred to in section 5 — must provide to the Minister (a) at least 30 days before the day on which the quantity of the chemical exceeds 1 000 kg in a calendar year, (i) the information specified in Schedule 4, and (ii) if the chemical is a biochemical, the information specified in items 1 to 3 of Schedule 2; and (b) at least 60 days before the day on which the quantity of the chemical exceeds 10 000 kg in a calendar year, (i) the information specified in Schedule 5, and (ii) if the chemical is a biochemical, the information specified in items 1 to 4 of Schedule 2 and (A) if the biochemical is a nucleic acid, the information specified in items 5 and 6 of Schedule 2, and (B) if the biochemical possesses enzymatic capability, the information specified in items 7 to 13 of Schedule 2. Quantity greater than 50 000 kg and exceeding 3 kg released per day (2) If the quantity of the chemical exceeds 50 000 kg in a calendar year — and the chemical is released to the aquatic environment in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment — the person must, in addition to the information referred to in subsection (1), provide to the Minister the following information in respect of the chemical, at least 75 days before the day on which the quantity exceeds 50 000 kg: (a) for chemicals having a water solubility of greater than or equal to 200 µg/L, (i) adsorption-desorption screening test data, and (ii) the hydrolysis rate as a function of pH and, if known, an identification of the products of the hydrolysis; and (b) the data from a repeated-dose mammalian toxicity test of the chemical of at least 28 days duration, using the most significant route of potential human exposure to the chemical, namely, oral, dermal or inhalation, plus (i) the age, sex, number, species, strain and source of the animals tested, (ii) the route by which the chemical is administered and the conditions under which the test is conducted, and (iii) the dose of the chemical, the vehicle by means of which the chemical is administered and its concentration in that vehicle. Quantity greater than 50 000 kg and significant exposure (3) If the quantity of the chemical exceeds 50 000 kg in a calendar year and if the public may be significantly exposed to the chemical in a product, the person must, in addition to the information referred to in subsection (1), provide to the Minister the following information in respect of the chemical, at least 75 days before the day on which the quantity exceeds 50 000 kg: (a) the data from a repeated-dose mammalian toxicity test of the chemical of at least 28 days duration, using the most significant route of potential human exposure to the chemical, namely, oral, dermal or inhalation, plus (i) the age, sex, number, species, strain and source of the animals tested, (ii) the route by which the chemical is administered and the conditions under which the test is conducted, and (iii) the dose of the chemical, the vehicle by means of which the chemical is administered and its concentration in that vehicle; and (b) the data obtained from an in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells or the data from a previously existing in vivo mammalian test for chromosomal aberrations that, together with data substantiating that the tissue investigated was exposed to the chemical or its metabolites, permits an assessment of in vivo clastogenicity.