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

Interpretation

Marginal note:Definitions

• 1 (1) The following definitions apply in these Regulations.

  Act

  Act means the Canadian Environmental Protection Act, 1999. (Loi)

  animal

  animal includes a part of an animal, but does not include an animal or a part of an animal that exists primarily as a single cell and is without the organization that characterizes tissues or organs. (animal)

  anionic polymer

  anionic polymer means a polymer that has one or more monomer units that are covalently bound and bear a net negative charge. (polymère anionique)

  biochemical

  biochemical means a substance, other than a polymer, that

  • (a) is produced by a micro-organism; or

  • (b) is a protein or nucleic acid that is derived from a plant or an animal. (substance biochimique)

  biopolymer

  biopolymer means a polymer that

  • (a) is produced by a micro-organism; or

  • (b) is a protein or nucleic acid that is derived from a plant or an animal. (biopolymère)

  CAS registry number

  CAS registry number means the identification number assigned to a substance by the Chemical Abstracts Service Division of the American chemical Society. (numéro d’enregistrement CAS)

  cationic polymer

  cationic polymer means a polymer that has one or more monomer units that are covalently bound and bear a net positive charge. (polymère cationique)

  chemical

  chemical means a substance that is not a polymer. (substance chimique)

  consumed

  consumed, in respect of a substance, means destroyed or completely converted to another substance. (consommée)

  contained

  contained, in respect of a site-limited intermediate substance or an export-only substance, means an absolute release limit of 1 kg per day per site to the aquatic environment after wastewater treatment. (confinée)

  DSL

  DSL means the Domestic Substances List maintained by the Minister under subsection 66(1) of the Act, as amended from time to time. (liste intérieure)

  material safety data sheet

  material safety data sheet[Repealed, SOR/2015-19, s. 1]

  micro-organism

  micro-organism means a microscopic organism that is

  • (a) classified in the Bacteria, the Archaea, the Protista, which includes protozoa and algae, or the Fungi, which includes yeasts;

  • (b) a virus, virus-like particle or sub-viral particle;

  • (c) a cultured cell of an organism not referred to in paragraph (a) or (b), other than a cell used to propagate the organism; or

  • (d) any culture other than a pure culture. (micro-organisme)

  monomer unit

  monomer unit means the reacted form of a monomer in a polymer. (unité monomère)

  NDSL

  NDSL means the Non-domestic Substances List maintained by the Minister under subsection 66(2) of the Act, as amended from time to time. (liste extérieure)

  plant

  plant includes a part of a plant, but does not include a plant or part of a plant that exists primarily as a single cell and is without the organization that characterizes tissues or organs. (végétaux)

  polymer

  polymer means a substance that consists of

  • (a) molecules characterized by the sequence of one or more types of monomer units;

  • (b) greater than 50% by weight of molecules having three or more monomer units that are covalently bound to one or more other monomer units or reactants;

  • (c) less than 50% by weight of molecules of the same molecular weight; and

  • (d) molecules distributed over a range of molecular weights whose differences in molecular weights are primarily attributable to differences in the number of monomer units. (polymère)

  reactant

  reactant, in respect of a polymer, means a substance that is used in the manufacture of the polymer and becomes part of its chemical composition, and includes a monomer. (réactif)

  reactive functional group

  reactive functional group means atoms or an associated group of atoms in a substance that are intended or may reasonably be expected to undergo facile chemical reaction. (groupe fonctionnel réactif)

  reduced regulatory requirement polymer

  reduced regulatory requirement polymer means one of the polymers described in section 9. (polymère à exigences réglementaires réduites)

  research and development substance

  research and development substance means a substance that is undergoing systematic investigation or research, by means of experimentation or analysis other than test marketing, whose primary objective is any of the following:

  • (a) to create or improve a product or process;

  • (b) to determine the technical viability or performance characteristics of a product or process; or

  • (c) to evaluate the substance prior to its commercialization, by pilot plant trials, production trials, including scale-up, or customer plant trials, so that technical specifications can be modified in response to the performance requirements of potential customers. (destinée à la recherche et au développement)

  safety data sheet

  safety data sheet, in respect of a substance, has the same meaning as in section 2 of the Hazardous Products Act. (fiche de données de sécurité)

  site-limited intermediate substance

  site-limited intermediate substance means a substance that is consumed in a chemical reaction used for the manufacture of another substance and that is

  • (a) manufactured and consumed at the site of manufacture;

  • (b) manufactured at one site and transported to a second site where it is consumed; or

  • (c) imported and transported directly to the site where it is consumed. (intermédiaire limitée au site)

  test marketing

  test marketing, in respect of a product, means the exploration of its market capability in a competitive situation where the creation or improvement of the product is not the primary objective. (test de marché)

• Marginal note:Safety data sheet

  (1.1) Every safety data sheet referred to in these Regulations must meet the requirements set out in the Hazardous Products Regulations.

• Marginal note:Meaning of substance

  (2) For greater certainty, substance has the meaning given that word by subsection 3(1) and section 80 of the Act.

• Marginal note:Government agencies

  (3) The definition of government in subsection 3(1) of the Act does not apply to the expression “government agencies” wherever it appears in these Regulations.

Purpose and Scope

Marginal note:Purpose

• 2 (1) These Regulations set out the information that a person must provide to the Minister of the Environment under subsection 81(1) of the Act before manufacturing or importing a chemical or polymer that is not on the DSL. The information is required so that the Minister may determine whether the chemical or polymer is toxic or capable of becoming toxic within the meaning of section 64 of the Act. These Regulations set out the periods within which the Minister of the Environment and the Minister of Health must assess the information received and the conditions under which the Minister of the Environment must add a chemical or polymer to the DSL under section 87 of the Act.

• Marginal note:Contents

  (2) The Regulations are divided into 4 Parts: Parts 1 and 2 set out the information requirements; Part 3, administrative matters; Part 4, the obligations of the Ministers. Schedules 1 to 6 and 9 to 11 set out information to be provided, Schedule 7, the types of polymers, Schedule 8, reactants and Schedule 12, flowcharts giving an overview of all the information requirements.

Marginal note:Avoiding regulatory duplication

• 3 (1) For greater certainty, these Regulations do not apply in respect of a substance that is manufactured or imported for a use that is regulated under any other Act or regulations listed in Schedule 2 to the Act.

• Marginal note:Transit

  (2) These Regulations also do not apply in respect of a substance that is loaded on a carrier outside Canada and moved through Canada to a location outside Canada, whether or not there is a change of carrier during transit.

Marginal note:Maximum exempt quantities

4 For the purposes of paragraph 81(6)(e) of the Act, a substance is exempt from the application of subsection 81(1) of the Act if it is manufactured or imported in a quantity that does not exceed the quantity that first triggers a requirement to provide information under these Regulations.

PART 1Required Information for Research and Development, Contained Site-limited Intermediate or Contained Export-only Substances

Chemicals and Biochemicals

Marginal note:Quantity greater than 1 000 kg

• 5 (1) Every person that manufactures or imports a chemical referred to in one of the following paragraphs must provide to the Minister the information specified in Schedule 1 at least 30 days before the day on which the quantity of the chemical exceeds 1 000 kg in a calendar year:

  • (a) a chemical that is a research and development substance;

  • (b) a chemical that is a contained site-limited intermediate substance; or

  • (c) a chemical that is a contained export-only substance.

• Marginal note:Biochemical research and development substance

  (2) If the chemical is a biochemical research and development substance, the person must provide, with the Schedule 1 information, the information specified in items 1 and 2 of Schedule 2.

• Marginal note:Biochemical site-limited intermediate or export-only substance

  (3) If the chemical is a biochemical contained site-limited intermediate substance that is not manufactured and consumed at the site of manufacture or is a biochemical contained export-only substance, the person must provide, with the Schedule 1 information, 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:Biochemical site-limited intermediate substance manufactured and consumed at the site of manufacture

  (4) If the chemical is a biochemical contained site-limited intermediate substance that is manufactured and consumed at the site of manufacture, the person must provide, with the Schedule 1 information, the information specified in items 1, 2 and 4 of Schedule 2.

• Marginal note:Quantity greater than 10 000 kg

  (5) The person must notify the Minister at least 30 days before the day on which the quantity of the chemical manufactured or imported exceeds 10 000 kg in any calendar year and, at that time, update the information previously provided under this section or indicate that there has been no change in the information.

Polymers and Biopolymers

Marginal note:Quantity greater than 10 000 kg

• 6 (1) Every person that manufactures or imports a polymer referred to in one of the following paragraphs must provide to the Minister the information specified in Schedule 3 at least 30 days before the day on which the quantity of the polymer exceeds 10 000 kg in a calendar year:

  • (a) a polymer that is a research and development substance;

  • (b) a polymer that is a contained site-limited intermediate substance; or

  • (c) a polymer that is a contained export-only substance.

• Marginal note:Biopolymer research and development substance

  (2) If the polymer is a biopolymer research and development substance, the person must provide, with the Schedule 3 information, the information specified in items 1 and 2 of Schedule 2.

• Marginal note:Biopolymer site-limited intermediate or export-only substance

  (3) If the polymer is a biopolymer contained site-limited intermediate substance that is not manufactured and consumed at the site of manufacture or is a biopolymer contained export-only substance, the person must provide, with the Schedule 3 information, 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:Biopolymer site-limited intermediate substance manufactured and consumed at the site of manufacture

  (4) If the polymer is a biopolymer contained site-limited intermediate substance that is manufactured and consumed at the site of manufacture, the person must provide, with the Schedule 3 information, the information specified in items 1, 2 and 4 of Schedule 2.

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.