New Substances Notification Regulations (Chemicals and Polymers)

New Substances Notification Regulations (Chemicals and Polymers) Whereas, pursuant to subsection 332(1)a of the Canadian Environmental Protection Act, 1999b, the Minister of the Environment published in the Canada Gazette, Part I, on October 30, 2004, a copy of the proposed New Substances Notification Regulations (Chemicals and Polymers), substantially in the annexed form, and persons were given an opportunity to file comments with respect to the proposed Regulations or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection; S.C. 2004, c. 15, s. 31 S.C. 1999, c. 33 Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 89(1) of the Canadian Environmental Protection Act, 1999b, hereby makes the annexed New Substances Notification Regulations (Chemicals and Polymers). Definitions The following definitions apply in these Regulations. Act means the Canadian Environmental Protection Act, 1999. (Loi) 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 means a polymer that has one or more monomer units that are covalently bound and bear a net negative charge. (polymère anionique) biochemical means a substance, other than a polymer, that is produced by a micro-organism; or is a protein or nucleic acid that is derived from a plant or an animal. (substance biochimique) biopolymer means a polymer that is a protein or nucleic acid that is derived from a plant or an animal. (biopolymère) 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 means a polymer that has one or more monomer units that are covalently bound and bear a net positive charge. (polymère cationique) chemical means a substance that is not a polymer. (substance chimique) consumed, in respect of a substance, means destroyed or completely converted to another substance. (consommée) 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 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[Repealed, SOR/2015-19, s. 1] micro-organism means a microscopic organism that is classified in the Bacteria, the Archaea, the Protista, which includes protozoa and algae, or the Fungi, which includes yeasts; a virus, virus-like particle or sub-viral particle; a cultured cell of an organism not referred to in paragraph (a) or (b), other than a cell used to propagate the organism; or any culture other than a pure culture. (micro-organisme) monomer unit means the reacted form of a monomer in a polymer. (unité monomère) 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 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 means a substance that consists of molecules characterized by the sequence of one or more types of monomer units; 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; less than 50% by weight of molecules of the same molecular weight; and 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, 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 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 means one of the polymers described in section 9. (polymère à exigences réglementaires réduites) 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: to create or improve a product or process; to determine the technical viability or performance characteristics of a product or process; or 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, 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 means a substance that is consumed in a chemical reaction used for the manufacture of another substance and that is manufactured and consumed at the site of manufacture; manufactured at one site and transported to a second site where it is consumed; or imported and transported directly to the site where it is consumed. (intermédiaire limitée au site) 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) Safety data sheet Every safety data sheet referred to in these Regulations must meet the requirements set out in the Hazardous Products Regulations. Meaning of substance For greater certainty, substance has the meaning given that word by subsection 3(1) and section 80 of the Act. Government agencies 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 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 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. Avoiding regulatory duplication 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 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. Maximum exempt quantities 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. Quantity greater than 1 000 kg 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 chemical that is a research and development substance; a chemical that is a contained site-limited intermediate substance; or a chemical that is a contained export-only substance. Biochemical research and development substance 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 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 if the biochemical is a nucleic acid, the information specified in items 5 and 6 of Schedule 2; and 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 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 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. 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 polymer that is a research and development substance; a polymer that is a contained site-limited intermediate substance; or a polymer that is a contained export-only substance. Biopolymer research and development substance 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 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 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. Manufacture or import: quantities greater than 1 000 kg and 10 000 kg 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 at least 30 days before the day on which the quantity of the chemical exceeds 1 000 kg in a calendar year, the information specified in Schedule 4, and if the chemical is a biochemical, the information specified in items 1 to 3 of Schedule 2; and at least 60 days before the day on which the quantity of the chemical exceeds 10 000 kg in a calendar year, the information specified in Schedule 5, and if the chemical is a biochemical, the information specified in items 1 to 4 of Schedule 2 and if the biochemical is a nucleic acid, the information specified in items 5 and 6 of Schedule 2, and Quantity greater than 50 000 kg and exceeding 3 kg released per day 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: for chemicals having a water solubility of greater than or equal to 200 µg/L, adsorption-desorption screening test data, and the hydrolysis rate as a function of pH and, if known, an identification of the products of the hydrolysis; and 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 the age, sex, number, species, strain and source of the animals tested, the route by which the chemical is administered and the conditions under which the test is conducted, and the dose of the chemical, the vehicle by means of which the chemical is administered and its concentration in that vehicle. Quantity greater than 50 000 kg and significant exposure 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: the dose of the chemical, the vehicle by means of which the chemical is administered and its concentration in that vehicle; and 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. Manufacture or import: quantities greater than 100 kg, 1 000 kg and 10 000 kg 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 at least 5 days before the day on which the quantity of the chemical exceeds 100 kg in a calendar year, if the chemical is a biochemical, the information specified in items 1 to 3 of Schedule 2; at least 60 days before the day on which the quantity of the chemical exceeds 1 000 kg in a calendar year, if the biochemical possesses enzymatic capability, the information specified in items 7 to 13 of Schedule 2; and at least 75 days before the day on which the quantity of the chemical exceeds 10 000 kg in a calendar year, the information specified in Schedule 6 and Notification 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). Description A reduced regulatory requirement polymer is 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; 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 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. 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, the information specified in Schedule 9; and if the polymer is a biopolymer, the information specified in items 1 to 3 of Schedule 2. 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, the information specified in Schedule 10; and 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 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: 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 the route by which the polymer is administered and the conditions under which the test is conducted, and the dose of the polymer, the vehicle by means of which the polymer is administered and its concentration in that vehicle; and the mutagenicity data obtained from an in vitro test, with and without metabolic activation, for gene mutation or chromosomal aberrations in mammalian cells. 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: the dose of the polymer, the vehicle by means of which the polymer is administered and its concentration in that vehicle; the mutagenicity data obtained from an in vitro test, with and without metabolic activation, for gene mutation; and 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 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 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: aldehydes whose functional group equivalent weight is less than or equal to 1 000 daltons; vinyl ethers whose functional group equivalent weight is less than or equal to 5 000 daltons; or sulphonic acids whose functional group equivalent weight is less than or equal to 5 000 daltons. 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, the information specified in Schedule 11; and 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 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: Five years 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. Information and certification Any information to be provided to the Minister under these Regulations must include all of the following: 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; 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; 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 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 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 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. Conditions and test procedures 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 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: acute mammalian toxicity tests; repeated-dose mammalian toxicity tests; genotoxicity tests; tests to assess skin irritation; skin sensitization tests; acute fish, daphnia or algae toxicity tests; and biodegradation tests. Consistency 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). Research and development, site-limited intermediate and export-only substances 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 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: 5 days after receiving the information referred to in paragraph 8(1)(a); 30 days after receiving the information referred to in paragraph 7(1)(a); subject to subsection (3), 60 days after receiving the information referred to in paragraph 7(1)(b) or 8(1)(b); and 75 days after receiving the information referred to in subsection 7(2) or (3) or paragraph 8(1)(c). Addition on the NDSL 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 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: 30 days after receiving the information referred to in section 10; and 60 days after receiving the information referred to in section 11 or 12. Prescribed quantity 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 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 in the case of a chemical or a biochemical that is on the NDSL, a quantity that exceeds in any calendar year 50 000 kg if 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 the public may be significantly exposed to the chemical or biochemical in a product, or 10 000 kg, in any other case. Prescribed information 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 notice from the person who provides the information, stating that the person has manufactured or imported the chemical or biochemical; in the case of a biochemical, the information specified in items 1 to 4 of Schedule 2, and if the biochemical possesses enzymatic capability, the information specified in items 7 to 13 of Schedule 2; if the chemical or biochemical is on the NDSL, the information specified in Schedules 4 and 5, 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 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 if the chemical or biochemical is not on the NDSL, the information specified in Schedules 4 to 6. 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 in the case of a reduced regulatory requirement polymer, a quantity that exceeds 1 000 kg in any calendar year; and in the case of any other polymer or biopolymer, a quantity that exceeds in any calendar year 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 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 the public may be significantly exposed to that polymer or biopolymer in a product, or 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 notice from the person who provides the information, stating that the person has manufactured or imported the polymer or biopolymer; 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; 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; 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, the information specified in Schedules 9 and 10, 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 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 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. Coming into force These Regulations come into force 60 days after the day on which they are registered. The type of substance: research and development substance, contained site-limited intermediate substance or contained export-only substance. The new substances pre-notification consultation number if it has been assigned and if known. The chemical name of the chemical, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. The trade names of the chemical and the synonyms of its chemical name, if known. The CAS registry number of the chemical, if such a number can be assigned. The following identification information in respect of the chemical: its molecular formula; its structural formula; its gram molecular weight; the degree of purity in its technical grade composition, if applicable; known impurities present and their concentration by weight; and any additives, stabilizers and solvents present when the chemical is tested and their concentration by weight. A safety data sheet in respect of the chemical, if available. The following exposure information respecting the chemical: the anticipated annual quantity to be manufactured, if applicable; the anticipated annual quantity to be imported, if applicable; the anticipated uses; its anticipated concentration in products and, if known, in end-use products; a description of the expected modes for its transportation and storage; a description of the size and type of container used for its transportation and storage; an identification of the components of the environment into which it is anticipated to be released; its anticipated releases into municipal wastewater systems; a description of the methods recommended for its destruction or disposal; whether the public is anticipated to be significantly exposed to the chemical in a product taking into account factors including its concentration, duration, frequency and circumstances of exposure and factors that may limit direct human exposure and, if not, information substantiating that the public is not anticipated to be significantly exposed; and for site-limited intermediate substances, the location of use. A summary of all other information and test data in respect of the chemical that are in the possession of the manufacturer or importer or to which they may reasonably be expected to have access and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the chemical. The identification of the other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the chemical and, if known, the agency’s file number, the outcome of the assessment and the risk management actions imposed by those agencies. The identification of the organism, hereinafter referred to as “production organism”, and the organ, if applicable, from which the biochemical or biopolymer is isolated, including synonyms and common and superseded names, if known; and its source and history. A description of any known adverse environmental or human health effects associated with exposure to the production organism. The concentration of the viable production organism in the biochemical or biopolymer and, if known, in end-use products. A description of the method used to separate the production organism from the biochemical or biopolymer. The identification of the encoded products, if known. A description of any known biological activity or adverse environmental or human health effects associated with the nucleic acid or with the encoded products specified under item 5. A description of all known catalytic functions. The Enzyme Commission (EC) number as designated by the nomenclature committee of the International Union of Biochemistry and Molecular Biology (IUBMB), if available. The known substrate specificity for each of the catalytic functions specified under item 7. The optimum pH and temperature for the substrates specified under item 9. The catalytic constants Km and Kcat and the conditions under which they were measured. The known cofactors necessary for enzymatic activity. The enzymatic activity per unit of weight of products and, if known, of end-use products. The new substances pre-notification consultation number if it has been assigned, and if known. The chemical name of the polymer, established in accordance with the chemical nomenclature rules of the International Union of Pure and Applied Chemistry or the Chemical Abstracts Service. The trade names of the polymer and the synonyms of its chemical name, if known. The CAS registry number of the polymer, if such a number can be assigned. The molecular formula of the polymer. The structural formula of the polymer, if possible, or else a partial structural formula. For contained site-limited intermediate substances and contained export-only substances: its number average molecular weight (Mn); and the maximum concentrations, expressed as a percentage, of all residual constituents having molecular weights of less than 500 daltons and of all residual constituents having molecular weights of less than 1 000 daltons. For research and development substances, the target number average molecular weight (Mn) of the polymer. The known impurities present and their concentration by weight. The composition of the polymer including constituents — such as monomers and other reactants, additives, stabilizers and solvents — which constituents are present when the polymer is tested, and their concentration by weight. A safety data sheet in respect of the polymer, if available. The physical state of the polymer. Whether the polymer is formulated for dispersal in water. The following exposure information respecting the polymer: whether the public is anticipated to be significantly exposed to the polymer in a product taking into account factors including its concentration, duration, frequency and circumstances of exposure and factors that may limit direct human exposure and, if not, information substantiating that the public is not anticipated to be significantly exposed; and A summary of all other information and test data in respect of the polymer that are in the possession of the manufacturer or importer or to which they may reasonably be expected to have access and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the polymer. The identification of the other government agencies, either outside or within Canada, that the person has notified of the manufacture or importation of the polymer and, if known, the agency’s file number, the outcome of the assessment and the risk management actions imposed by those agencies. Whether the chemical is on the NDSL. the anticipated uses within Canada; and its anticipated concentration in products and, if known, in end-use products. A summary of all other information and test data in respect of the chemical that are in the possession of the manufacturer or importer and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the chemical. The information specified in Schedule 4 or, if that information has been previously provided, the date (year, month, day) of the submission of that information and, if they are known, the new substances pre-notification consultation number, if it has been assigned, and the new substances notification number. The following physical and chemical data in respect of the chemical: its melting point or the temperature at which the chemical decomposes expressed in degrees Celsius if its melting point or the temperature at which it decomposes is –25°C or greater but not greater than 300°C, and in any other case, expressed as less than –25°C or greater than 300°C, as appropriate; its boiling point or the temperature at which the chemical decomposes expressed in degrees Celsius if its boiling point or the temperature at which it decomposes is –50°C or greater but not greater than 300°C, and in any other case, expressed as less than –50°C or greater than 300°C, as appropriate; its density; its vapour pressure if it has a standard boiling point of 0°C or greater; its water solubility; and for chemicals having a water solubility of less than or equal to 5 g/L, its octanol/water partition coefficient. Ready biodegradation test data in respect of the chemical and, if known, identification of the products of biodegradation. * Data from one acute fish, daphnia or algae toxicity test in respect of the chemical. * Data from an oral, dermal or inhalation type of acute mammalian toxicity test in respect of the chemical, selected on the basis of the most significant route of potential human exposure to the chemical and the following information: the age, sex, number, species, strain and source of the animals tested; the route by which the chemical is administered and the conditions under which the test is conducted; and the dose of the chemical, the vehicle by means of which the chemical is administered and the concentration of the chemical in the vehicle. * Mutagenicity data obtained from one in vitro test in respect of the chemical, with and without metabolic activation, for gene mutations. * whether it is anticipated to be used in products intended for use by or for children; the anticipated degree of direct human exposure to the chemical, including concentration, duration, frequency and circumstances of exposure and factors that may limit direct human exposure; and if known, the three sites in Canada where the greatest quantity of the chemical, manufactured or imported by the person, is anticipated to be used or processed and the estimated quantity by site. If the chemical is on the NDSL, the following additional exposure information respecting the chemical: its historical and other likely uses; any factors that may limit environmental exposure; whether it is released to the aquatic environment in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment and, if the release is less than or equal to 3 kg per day, per site, the data substantiating the quantity released; and whether the public is anticipated to be significantly exposed to the chemical in a product taking into account factors including the concentration of the chemical, duration, frequency and circumstances of exposure and factors that may limit direct human exposure and, if not, information substantiating that the public is not anticipated to be significantly exposed. Note: The asterisks (*) appearing at the end of certain provisions indicate that laboratory practices to be followed in developing data for the test referred to in that provision must comply with those practices set out in the “Principles of Good Laboratory Practice”. See subsection 15(2) of the New Substances Notification Regulations (Chemicals and Polymers). The information specified in Schedules 4 and 5 or, if that information has been previously provided, the date (year, month, day) of the submission of that information and, if they are known, the new substances pre-notification consultation number, if it has been assigned, and the new substances notification number. one of an infra-red, ultra-violet, mass or nuclear magnetic resonance spectrum suitable for characterization of the chemical; for chemicals having a water solubility of greater than or equal to 200 µg/L, adsorption-desorption screening test data; and for chemicals having a water solubility of greater than or equal to 200 µg/L, its hydrolysis rate as a function of pH and, if known, an identification of the products of the hydrolysis. Data from the two tests mentioned in item 5 of Schedule 5 for which data was not submitted under that item, namely, the remaining two out of the following three tests: acute fish, daphnia and algae toxicity tests. * Unless the chemical boils below 0°C and has been tested for acute inhalation toxicity under item 6 of Schedule 5, data from one of the remaining types of acute mammalian toxicity test of the chemical, namely, oral, dermal or inhalation, that was not completed for the submission of item 6 of Schedule 5 and that is selected on the basis of the most significant route of potential human exposure to the chemical. * Information sufficient to assess skin irritation in respect of the chemical. * Data from a skin sensitization test in respect of the chemical. * Data from one repeated-dose mammalian toxicity test in respect of the chemical, of at least 28 days duration, which test is selected on the basis of the most significant route of potential human exposure to the chemical, namely, oral, dermal or inhalation. * For the tests referred to in items 4 to 7, the following additional information: Mutagenicity data obtained from one in vitro test in respect of the chemical, with and without metabolic activation, for chromosomal aberrations in mammalian cells. * Mutagenicity data obtained from one in vivo mammalian test of the chemical for chromosomal aberrations or gene mutations or another indicator of mutagenicity that, together with data substantiating that the tissue investigated was exposed to the chemical or its metabolites, permits an assessment of in vivo mutagenicity. * its historical and other likely uses; and any factors that may limit environmental exposure. A cationic polymer or a polymer that is reasonably expected to become cationic in a natural aquatic environment, except a polymer whose cationic group has a combined equivalent weight greater than 5 000 daltons; or a polymer that is a solid material, that is not soluble or dispersible in water and that will be used only in the solid phase, such as polymers that can be used as ion exchange beads. A polymer that is designed, or can be expected, to substantially degrade, decompose or depolymerize, including polymers that could substantially degrade, decompose or depolymerize after manufacture and use, even though they are not intended to do so. Degradation, decomposition and depolymerization refer to the types of changes that convert a polymeric substance into simpler, smaller substances, through processes including but not limited to oxidation, hydrolysis, attack by solvents, heat, light and microbial action. A polymer that has, as an integral part of its composition, only one or none of the following atomic elements: carbon, hydrogen, nitrogen, oxygen, silicon and sulphur. A polymer that has any atomic elements other than carbon, hydrogen, nitrogen, oxygen, silicon, sulphur, fluorine, chlorine, bromine or iodine covalently bound to carbon; any monoatomic counterions other than chlorine ion, bromine ion, iodine ion, sodium ion, divalent magnesium, trivalent aluminium, potassium ion or divalent calcium; or 0.2% or more by weight of any atomic element or combination of the following atomic elements: lithium, boron, phosphorus, titanium, manganese, iron, nickel, copper, zinc, tin or zirconium. A polymer that has reactive functional groups other than carboxylic acid groups, aliphatic hydroxyl groups, unconjugated olefinic groups that are considered “ordinary”*, butenedioic acid groups, blocked isocyanates including ketoxime-blocked isocyanates, thiols, unconjugated nitrile groups, halogens excluding reactive halogen groups such as benzylic or allylic halides, and conjugated olefinic groups present in naturally occurring fats, oils and carboxylic acids, in combined equivalent weights of less than 5 000 daltons;

or in which the only reactive functional groups present are part of acid halides, acid anhydrides, aldehydes, hemiacetals, methylol-amides, methylol-amines, methylol-ureas, alkoxysilanes with alkoxy greater than C2-alkoxysilanes, allyl ethers, conjugated olefins, cyanates, epoxides, imines, unsubstituted positions ortho or para to phenolic hydroxyl, in combined equivalent weights of less than 1 000 daltons. Not specially activated either by being part of a larger functional group, such as a vinyl ether, or by other activating influences, for example, strongly electron-withdrawing sulfone group with which the olefinic groups interact. Chemical substance of unknown or variable composition, complex reaction products and biological materials (UVCB) This substance may not be used in a substance manufactured from fumaric or maleic acid because of potential risks associated with esters, which may be formed by reaction of those reactants. The type of polymer: a reduced regulatory requirement polymer; a polymer on the NDSL; a polymer with all of its reactants on the DSL or the NDSL; or a polymer with one or more reactants not on either the DSL or NDSL. The reaction scheme if the polymer is a reduced regulatory requirement polymer, unless it is a polymer referred in paragraph 9(c) of these Regulations. The following physical and chemical data in respect of the polymer: if the polymer is not a reduced regulatory requirement polymer, the anticipated concentration of the polymer in products and, if known, in end-use products, the anticipated degree of direct human exposure to the polymer, including concentration, duration, frequency and circumstances of exposure and factors that may limit direct human exposure, whether the polymer is anticipated to be used in products intended for use by or for children, and if known, the three sites in Canada where the greatest quantity of the polymer, manufactured or imported by the person, is anticipated to be used or processed and the estimated quantity by site. A summary of all other information and test data in respect of the polymer that are in the possession of the manufacturer or importer and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the polymer. The information specified in Schedule 9 or, if that information has been previously provided, the date (year, month, day) of the submission of that information and, if they are known, the new substances pre-notification consultation number, if it has been assigned, and the new substances notification number. its physical state; whether it is formulated for dispersal in water; its water extractability measured at pH 7 for anionic and neutral polymers, pH 2 and 7 for cationic polymers, or pH 2, 7 and 9 for amphoteric polymers; its octanol-water partition coefficient; and if water extractability is determined to be greater than 2%, its hydrolysis rate as a function of pH and, if known, an identification of the products of the hydrolysis. Unless the polymer has a water extractability at pH 7 of less than or equal to 2%, an acute toxicity test of the polymer for the most sensitive species: fish, daphnia or algae or, if the sensitivity of these three species is unknown, an acute algae toxicity test. * Data from one acute mammalian oral toxicity test of the polymer and the following information: the route by which the polymer is administered and the conditions under which the test is conducted; and the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle. * whether the public is anticipated to be significantly exposed to the polymer in a product taking into account factors including the concentration of the polymer, duration, frequency and circumstances of exposure and factors that may limit direct human exposure and, if not, information substantiating that the public is not anticipated to be significantly exposed. Data from a ready biodegradation test on the water-soluble portion of the polymer, unless the polymer has a water extractability at pH 7 of less than or equal to 2% or is a branched silicone or siloxane polymer. * Unless the polymer has a water extractability at pH 7 of less than or equal to 2%, the following tests: if the sensitivity of the three species is known, an acute toxicity test of the polymer for each of the two most sensitive species: fish, daphnia or algae; if the sensitivity of only one species is known and that species is not algae, an acute algae toxicity test and either a fish or daphnia acute toxicity test selected on the basis of the most sensitive of these species; or if the sensitivity of only one species is known and that species is algae or if the sensitivity of the three species is unknown, an acute algae toxicity test and either a fish or daphnia acute toxicity test. * Data from one acute mammalian oral toxicity test of the polymer. * Information sufficient to assess skin irritation in respect of the polymer. * Data from a skin sensitization test in respect of the polymer. * Data from one repeated-dose mammalian toxicity test in respect of the polymer, of at least 28 days duration, which test is selected on the basis of the most significant route of potential human exposure to the polymer, namely, oral, dermal or inhalation. * For the tests referred to in items 5 to 8, the following additional information: Mutagenicity data obtained from each of the following tests of the polymer: one in vitro test, with and without metabolic activation, for gene mutations; one in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells; and one in vivo mammalian test, for chromosomal aberrations or gene mutations or another indicator of mutagenicity that, together with data substantiating that the tissue investigated was exposed to the polymer or its metabolites, permits an assessment of in vivo mutagenicity. * The information required under the New Substances Notification Regulations (Chemicals and Polymers) is divided into three flowcharts according to the type of substance: research and development, contained site-limited intermediate and contained export-only substances — Flowchart 1; chemicals and biochemicals other than research and development, contained site-limited intermediate and contained export-only substances — Flowchart 2; and polymers and biopolymers other than research and development, contained site-limited intermediate and contained export-only substances — Flowchart 3. Choose the appropriate flowchart according to the type of substance. Each flowchart identifies the information to be provided and the quantity that triggers the regulatory obligation to provide it. References in the flowcharts are to provisions of the Regulations, in italics, and to schedules to the Regulations. Note that certain words and expressions used in the flowcharts are defined in section 1 of the Regulations. The shapes used in the flowcharts distinguish their contents as follows: the ovals identify the type of substance referred to in the flowchart, as more particularly described in the flowchart’s title; the diamonds identify the timeline and quantity trigger; and the rectangles identify the required information. Shapes outlined with a broken line signal that information is required only in certain circumstances. Additional information is set out in footnotes to each flowchart. The Minister of the Environment and the Minister of Health must assess the information within the same number of days as are afforded to the manufacturer or importer for provision of that information — see section 16 of the Regulations. For example, if a manufacturer or importer is required to provide information at least 30 days before the day on which a certain quantity is exceeded, then the Ministers must assess that information within 30 days after receiving it. In this section, former Regulations means the New Substances Notification Regulations (Chemicals and Polymers) as they read immediately before the day on which these Regulations come into force. These Regulations do not apply to a person that manufactures or imports a chemical or a polymer if the person manufactures or imports it on or after the first day on which both sections 114 and 115 of the Economic Action Plan 2014 Act, No. 1 are in force, but before a day to be fixed by order of the Governor in Council for the purposes of sections 131, 134 and 136 of that Act, and if the person would not, were the former Regulations in force at the time, be in contravention of the former Regulations.