New Substances Notification Regulations (Chemicals and Polymers) (SOR/2005-247)

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Regulations are current to 2024-11-26 and last amended on 2018-02-02. Previous Versions

PART 2Required Information for Chemicals and Polymers other than Research and Development, Contained Site-limited Intermediate and Contained Export-only Substances

Chemicals and Biochemicals on the NDSL

Marginal note: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.
Marginal note: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.
Marginal note: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.

Chemicals and Biochemicals Not on the NDSL

Marginal note:Manufacture or import: quantities greater than 100 kg, 1 000 kg and 10 000 kg

8 (1) Every person that manufactures or imports a chemical that is not on the NDSL — other than a chemical referred to in section 5 — must provide to the Minister
- (a) at least 5 days before the day on which the quantity of the chemical exceeds 100 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;
- (b) at least 60 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 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; and
- (c) at least 75 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 6 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.
Marginal note:Notification
(2) Any person that submitted the information referred to in paragraph (1)(b), together with the information referred to in section 10 of Schedule 5, in respect of a chemical or biochemical that is subsequently added to the NDSL may, once the listing has occurred, advise the Minister, in writing, that that information is to be considered as having been submitted under paragraph 7(1)(b).

SOR/2018-11, s. 19

Previous Version

Reduced Regulatory Requirement Polymers

Marginal note:Description

9 A reduced regulatory requirement polymer is

(a) a polymer that is not one of the types listed in items 1 to 4 of Schedule 7 and that has a number average molecular weight greater than 10 000 daltons, with less than 2% of its components having molecular weights of less than 500 daltons and less than 5% of its components having molecular weights of less than 1 000 daltons;
(b) a polymer that is not one of the types listed in Schedule 7 and that has a number average molecular weight greater than 1 000 daltons and equal to or less than 10 000 daltons, with less than 10% of its components having molecular weights of less than 500 daltons and less than 25% of its components having molecular weights of less than 1 000 daltons; or
(c) a polymer that is a polyester manufactured solely from reactants listed in Schedule 8, or an anhydrous form of those reactants, other than the reactants or their anhydrous forms that include both 1-butanol and fumaric or maleic acid.

Polymers and Biopolymers — General Requirements

Marginal note:Quantity greater than 1 000 kg

10 Every person that manufactures or imports a polymer — other than a polymer referred to in section 6 — must provide to the Minister, at least 30 days before the day on which the quantity of the polymer exceeds 1 000 kg in a calendar year,

(a) the information specified in Schedule 9; and
(b) if the polymer is a biopolymer, the information specified in items 1 to 3 of Schedule 2.

Polymers and Biopolymers on the NDSL or All of Whose Reactants Are on the DSL or NDSL

Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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.
Marginal note: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 weight is less than or equal to 5 000 daltons.

Polymers and Biopolymers Not on the NDSL