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

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).

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

Marginal note:Quantity greater than 10 000 kg

• 12 (1) Subject to subsections (2) and (3), every person that manufactures or imports a polymer that is not on the 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 11; 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:Exception

  (2) The information is, however, not required if the polymer is referred to in section 6 or is a reduced regulatory requirement polymer or a polymer all of whose reactants are on the DSL or the NDSL.

• Marginal note:Exception: Information in Schedule 11

  (3) Despite paragraph (1)(a), the information referred to in items 5 to 10 of Schedule 11 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.

PART 3Administrative Matters

Retention of Information

Marginal note:Five years

13 A person that is required to provide information to the Minister under these Regulations must keep a copy of that information and any supporting data at the person’s principal place of business in Canada or at the principal place of business in Canada of a representative of that person. The information and the supporting data must be kept for a period of five years after the year in which the information is provided.

Administrative Requirements

Marginal note:Information and certification

• 14 (1) Any information to be provided to the Minister under these Regulations must include all of the following:

  • (a) the name, civic and postal addresses and telephone number, as well as the fax number and e-mail address, if any, of the manufacturer or importer of the substance;

  • (b) the name, title, civic and postal addresses and telephone number, as well as the fax number and e-mail address, if any, of the person authorized to act on behalf of the manufacturer or importer of the substance, if any;

  • (c) an indication of whether the substance will be manufactured in or imported into Canada and the civic address of the site of manufacture in Canada of the substance or, if known, the port of entry into Canada of the substance, as the case may be; and

  • (d) a certification that the information is accurate and complete, dated and signed by the manufacturer or importer if they are resident in Canada or, if not, by the person authorized to act on their behalf.

• Marginal note:Recipient

  (2) Two copies of any information provided under these Regulations must be sent in English or French to the Minister, care of the Substances Management Coordinator, Department of the Environment, Ottawa, Ontario K1A 0H3.

• Marginal note:Agent

  (3) If a person that provides the information under these Regulations is not resident in Canada, they must identify, under paragraph (1)(b), a person resident in Canada that is authorized to act on their behalf to whom any notice or correspondence may be sent and that is required to keep the information and any supporting data under section 13.

Testing Requirements

Marginal note:Conditions and test procedures

• 15 (1) The conditions to be met and test procedures to be followed in developing test data for a substance in order to comply with the information requirements of section 81 of the Act — or requests for information under paragraph 84(1)(c) of the Act — must be consistent with the conditions and procedures set out in the “OECD Test Guidelines” that are current at the time the test data are developed. The Guidelines are set out in Annex 1 of the OECD Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted by the Organisation for Economic Co-operation and Development on May 12, 1981.

• Marginal note:Laboratory practices

  (2) Subject to subsection (3), the laboratory practices to be followed in developing data for the following tests must comply with the practices set out in the “Principles of Good Laboratory Practice” that are current at the time the test data are developed. The Principles are set out in Annex 2 of the OECD Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted by the Organisation for Economic Co-operation and Development on May 12, 1981:

  • (a) acute mammalian toxicity tests;

  • (b) repeated-dose mammalian toxicity tests;

  • (c) genotoxicity tests;

  • (d) tests to assess skin irritation;

  • (e) skin sensitization tests;

  • (f) acute fish, daphnia or algae toxicity tests; and

  • (g) biodegradation tests.

• Marginal note:Consistency

  (3) If the test was commenced or completed before the day on which these Regulations come into force, the laboratory practices must be consistent with those referred to in subsection (2).

PART 4Obligations of the Minister of the Environment and the Minister of Health

Assessment Periods

Marginal note:Research and development, site-limited intermediate and export-only substances

• 16 (1) For the purposes of subsection 83(1) of the Act, the period within which the Ministers must assess the information respecting research and development, contained site-limited intermediate and contained export-only substances provided under section 5 or 6 is 30 days after receiving it.

• Marginal note:Chemicals and biochemicals

  (2) For the purposes of subsection 83(1) of the Act, the periods within which the Ministers must assess the information respecting chemicals and biochemicals provided under section 7 or 8 are as follows:

  • (a) 5 days after receiving the information referred to in paragraph 8(1)(a);

  • (b) 30 days after receiving the information referred to in paragraph 7(1)(a);

  • (c) subject to subsection (3), 60 days after receiving the information referred to in paragraph 7(1)(b) or 8(1)(b); and

  • (d) 75 days after receiving the information referred to in subsection 7(2) or (3) or paragraph 8(1)(c).

• Marginal note:Addition on the NDSL

  (3) If a chemical or biochemical is added to the NDSL after the Minister of the Environment’s receipt of the information referred to in subparagraph 8(1)(b)(i), together with the information referred to in item 10 of Schedule 5, but the Minister has not received the information referred to in paragraph 8(1)(c), the period within which the Ministers must assess the information referred to in paragraph 7(1)(b) respecting that chemical or biochemical is 60 days after receipt of the notification referred to in subsection 8(2).

• Marginal note:Polymers and biopolymers

  (4) For the purposes of subsection 83(1) of the Act, the periods within which the Ministers must assess the information respecting polymers and biopolymers provided under any of sections 10 to 12 are as follows:

  • (a) 30 days after receiving the information referred to in section 10; and

  • (b) 60 days after receiving the information referred to in section 11 or 12.

Additions to the DSL — Chemicals and Biochemicals

Marginal note:Prescribed quantity

• 17 (1) With respect to the obligation of the Minister of the Environment to add a substance to the DSL, other than research and development, contained site-limited intermediate and contained export-only substances, the quantity of a chemical or a biochemical prescribed for the purposes of subparagraph 87(1)(b)(iii) of the Act is

  • (a) in the case of a chemical or a biochemical not on the NDSL, a quantity that exceeds 10 000 kg in any calendar year; and

  • (b) in the case of a chemical or a biochemical that is on the NDSL, a quantity that exceeds in any calendar year

    • (i) 50 000 kg if

      • (A) the chemical or biochemical is released to the aquatic environment in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment, or

      • (B) the public may be significantly exposed to the chemical or biochemical in a product, or

    • (ii) 10 000 kg, in any other case.

• Marginal note:Prescribed information

  (2) With respect to the obligation of the Minister of the Environment to add a substance to the DSL, the information that is prescribed with respect to a chemical or a biochemical for the purposes of paragraph 87(5)(a) of the Act is

  • (a) a notice from the person who provides the information, stating that the person has manufactured or imported the chemical or biochemical;

  • (b) in the case of a biochemical, the information specified in items 1 to 4 of Schedule 2, and

    • (i) if the biochemical is a nucleic acid, the information specified in items 5 and 6 of Schedule 2, and

    • (ii) if the biochemical possesses enzymatic capability, the information specified in items 7 to 13 of Schedule 2;

  • (c) if the chemical or biochemical is on the NDSL,

    • (i) the information specified in Schedules 4 and 5,

    • (ii) the information specified in paragraphs 7(2)(a) and (b) if the quantity of the chemical or biochemical exceeds 50 000 kg in a calendar year — and the chemical or biochemical is released to the aquatic environment in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment, and

    • (iii) the information specified in paragraphs 7(3)(a) and (b) if the quantity of the chemical or biochemical exceeds 50 000 kg in a calendar year and if the public may be significantly exposed to the chemical or biochemical in a product; and

  • (d) if the chemical or biochemical is not on the NDSL, the information specified in Schedules 4 to 6.