GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
New Substances Notification Regulations (Chemicals and Polymers) — New Substances Notification Regulations (Chemicals and Polymers)
reduced regulatory requirement polymer means one of the polymers described in section 9. ( polymère à exigences réglementaires réduites )
New Substances Notification Regulations (Chemicals and Polymers) — (a)
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 )
New Substances Notification Regulations (Chemicals and Polymers) — New Substances Notification Regulations (Chemicals and Polymers)
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 )
New Substances Notification Regulations (Chemicals and Polymers) — (a)
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 )
New Substances Notification Regulations (Chemicals and Polymers) — New Substances Notification Regulations (Chemicals and Polymers)
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 )
New Substances Notification Regulations (Chemicals and Polymers) — 2
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. 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.
New Substances Notification Regulations (Chemicals and Polymers) — 3
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. 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.
New Substances Notification Regulations (Chemicals and Polymers) — 4
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.
New Substances Notification Regulations (Chemicals and Polymers) — 5
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. 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. 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. 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. 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.
New Substances Notification Regulations (Chemicals and Polymers) — 6
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. 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. 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. 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.
New Substances Notification Regulations (Chemicals and Polymers) — 8
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. 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
New Substances Notification Regulations (Chemicals and Polymers) — 9
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.
New Substances Notification Regulations (Chemicals and Polymers) — 10
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.
New Substances Notification Regulations (Chemicals and Polymers) — 12
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. 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. 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.
New Substances Notification Regulations (Chemicals and Polymers) — 13
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.
New Substances Notification Regulations (Chemicals and Polymers) — 14
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. 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. 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. SOR/2018-11, s. 20
New Substances Notification Regulations (Chemicals and Polymers) — 15
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. 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. 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).
New Substances Notification Regulations (Chemicals and Polymers) — 16
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. 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). 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). 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.
New Substances Notification Regulations (Chemicals and Polymers) — 17
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. 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.
New Substances Notification Regulations (Chemicals and Polymers) — 18
Prescribed quantity 18 (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 polymer or a biopolymer prescribed for the purposes of subparagraph 87(1)(b)(iii) of the Act is (a) in the case of a reduced regulatory requirement polymer, a quantity that exceeds 1 000 kg in any calendar year; and (b) in the case of any other polymer or biopolymer, a quantity that exceeds in any calendar year (i) 50 000 kg if the polymer or biopolymer is on the NDSL, or one that is not on the NDSL but all of its reactants are on the DSL or the NDSL and (A) that polymer or biopolymer 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 that polymer or biopolymer in a product, or (ii) 10 000 kg, in any other case. 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 polymer or a biopolymer 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 polymer or biopolymer; (b) in the case of a reduced regulatory requirement polymer, the information specified in Schedule 9 and, if the reduced regulatory requirement polymer is a biopolymer, the information specified in items 1 to 3 of Schedule 2; (c) in the case of a biopolymer, other than a reduced regulatory requirement polymer, 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; (d) if the polymer or biopolymer, other than a reduced regulatory requirement polymer, is on the NDSL, or one that is not on the NDSL but all of its reactants are on the DSL or the NDSL, (i) the information specified in Schedules 9 and 10, (ii) the information specified in paragraphs 11(2)(a) and (b) if the quantity of the polymer or biopolymer exceeds 50 000 kg in a calendar year and the polymer or biopolymer 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 11(3)(a) and (b) if the quantity of the polymer or biopolymer exceeds 50 000 kg in a calendar year and if the public may be significantly exposed to the polymer or biopolymer in a product; and (e) if the polymer or biopolymer is not on the NDSL, other than a reduced regulatory requirement polymer or a polymer or biopolymer subject to paragraph (d), the information specified in Schedules 9 and 11.
New Substances Notification Regulations (Chemicals and Polymers) — 19
Coming into force 19 These Regulations come into force 60 days after the day on which they are registered.