New Substances Notification Regulations (Chemicals and Polymers) — 11
Quantity greater than 10 000 kg 11 (1) Subject to subsections (4) and (5), every person that manufactures or imports either a polymer that is on the NDSL or a polymer all of whose reactants are on the DSL or NDSL must provide to the Minister, at least 60 days before the day on which the quantity of the polymer exceeds 10 000 kg in a calendar year, (a) the information specified in Schedule 10; and (b) if the polymer is a biopolymer, the information specified in items 1 to 4 of Schedule 2, and, if the biopolymer is a nucleic acid, the information specified in items 5 and 6 of that Schedule. Quantity greater than 50 000 kg and 3 kg released per day (2) If the quantity of the polymer exceeds 50 000 kg in a calendar year — and the polymer 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 polymer, at least 60 days before the day on which the quantity exceeds 50 000 kg: (a) the data from a repeated-dose mammalian toxicity test of the polymer of at least 28 days duration, using the most significant route of potential human exposure to the polymer, 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 polymer is administered and the conditions under which the test is conducted, and (iii) the dose of the polymer, the vehicle by means of which the polymer is administered and its concentration in that vehicle; and (b) the mutagenicity data obtained from an in vitro test, with and without metabolic activation, for gene mutation or chromosomal aberrations in mammalian cells. Quantity greater than 50 000 kg and significant exposure (3) If the quantity of the polymer exceeds 50 000 kg in a calendar year and if the public may be significantly exposed to the polymer 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 polymer, at least 60 days before the day on which the quantity exceeds 50 000 kg: (a) the data from a repeated-dose mammalian toxicity test of the polymer of at least 28 days duration, using the most significant route of potential human exposure to the polymer, 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 polymer is administered and the conditions under which the test is conducted, and (iii) the dose of the polymer, the vehicle by means of which the polymer is administered and its concentration in that vehicle; (b) the mutagenicity data obtained from an in vitro test, with and without metabolic activation, for gene mutation; and (c) 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 polymer or its metabolites, permits an assessment of in vivo clastogenicity. Exception (4) The information referred to in this section is not required if the polymer is referred to in section 6 or is a reduced regulatory requirement polymer. Exception: Information in Schedule 10 (5) The information referred to in subsections (2) and (3) and item 4 of Schedule 10 is not required if the polymer does not meet the criteria for a reduced regulatory requirement polymer solely owing to the presence of any of the following functional groups: (a) aldehydes whose functional group equivalent weight is less than or equal to 1 000 daltons; (b) vinyl ethers whose functional group equivalent weight is less than or equal to 5 000 daltons; or (c) sulphonic acids whose functional group equivalent w