Overview of Canada New Substance Notification Regulation (NSNR)

Canadian chemical substance list includes two parts: the Domestic Substance List (DSL), which records more than 23000 substances, and Non-Domestic Substance List (NDSL) which records almost 58000 substances.

DSL is used to identify whether a substance is classified as a new substance in Canada. If the substance is not on the DSL, the substance is regarded as a new substance. It shall be notified prior to manufacturing or importing. The NDSL determines the information to be provided. If a new substance is listed on the NDSL, a reduced data for notification may be required.

NSNR is appropriate for:

1. The domestic manufacturers in Canada

2. The importer within the borders of Canada

NSNR is inappropriate for:

1. The substance or polymer listed in DSL;

2. The packaged substance transferred via Canada; or

3. The substance regulated by other acts, such as Pest Control Act, Fertilizer Act, Feeds Act etc..

Notification type

1. Chemicals and biochemicals

If the substance is referred to following paragraphs:

1) a chemical that is a research and development substance;

2) a chemical that is a contained site-limited intermediate substance;

3) or (c) a chemical that is a contained ex-port-only substance

Every person that manufactures or imports a chemical referred to in one of the above paragraphs must provide to the Minister the information specified in Schedule 1 (the information doesn’t refer to physicochemical, toxicity and eco-toxicity properties) at least 30 days before the day on which the quantity of the chemical exceeds 1000 kg in a calendar year. The detailed requirements are indicated in appendix Schedule 1.

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.

2. Polymers and biopolymers

Every person that manufactures or imports a polymer referred to in one of the following paragraphs:

1） a polymer that is a research and development substance;

2） a polymer that is a contained site limited intermediate substance; or

3） a polymer that is a contained export only substance.

Above polymer 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. The detailed requirements are indicated in appendix Schedule 3.

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.

3. Chemicals and biochemicals on NDSL

1 Additional information specified in Schedule 2 is also required if the chemical is a biochemical- see subparagraph 7(1)(a)(ii).

2 Additional information specified in Schedule 2 is also required if the chemical is a biochemical- see subparagraph 7(1)(a)(ii). No further information will be required unless: (a) the chemical is released to the aquatic environment in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment- see subsection 7(2) - or (b) the public may be significantly exposed to the chemical in a product – see subsection 7(3).

1) Every person that manufactures or imports a chemical that is on the NDSL must provide to the Minister at least 30 days before the day on which the quantity of chemical exceeds 1000kg 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.

2) Every person that manufactures or imports a chemical that is on the NDSL must provide to the Minister at least 60 days before the day on which the quantity of chemical exceeds 10000kg 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.

3) If the quantity of the chemical on NDSL 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 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:

(i) the information specified in Schedule 5, and

(ii) 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

(iii) 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.

4) If the quantity of the chemical on NDSL 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 provide to the Minister the following information in respect of the chemical, at least 75 days before the day on which the quantity exceeds 50000 kg:

(i) the information specified in Schedule 5, and

(ii) 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, and

(iii) 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.

4. Chemicals and biochemicals not on the NDSL

3 Notification must be sent to the Minister if: the chemical or biochemical is specified on the NDSL following submission of the information referred to in subparagraph 8(1)(b)(i) and item 10 of Schedule 5- see subsection 8(2).

4 Additional information specified in Schedule 2 is also required if the chemical is a biochemical- see subparagraphs 8(1)(a)(ii), b(ii) and c(ii).

1) Every person that manufactures or imports a chemical that is not on the NDSL must provide to the Minister at least 5 days before the day on which the quantity of chemical exceeds 100kg 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.

2) Every person that manufactures or imports a chemical that is not on the NDSL must provide to the Minister at least 60 days before the day on which the quantity of chemical exceeds 1000kg 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.

3) Every person that manufactures or imports a chemical that is not on the NDSL must provide to the Minister at least 75 days before the day on which the quantity of chemical exceeds 10 000kg 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.

5 . Polymer notification

Polymer notifications includes following types：

1. Reduced regulatory requirement polymers;
2. Polymers or biopolymers on the NDSL or all of whose reactants are on the DSL or NDSL;
3. Polymers and biopolymers not on the NDSL.

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 1000 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.

1) Reduced regulatory requirement polymers

1 Required for polymers/biopolymers including reduced regulatory requirement polymers. Additional information specified in Schedule 2 is also required if the polymer is a biopolymer- see paragraph 10(b).

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

(i) the information specified in Schedule 9, and

(ii) if the chemical is a polymer, the information specified in items 1 to 3 of Schedule 2.

2) Polymers and biopolymers on the NDSL or all of whole reactants are on the DSL or NDSL

2 Not required for reduced regulatory requirement polymers. Also subject to certain exceptions- see subsection 11(5). Additional information specified in Schedule 2 is also required if the polymer is a biopolymer-see paragraph 11(1)(b). No further information will be required unless: (a) the polymer is released to the aquatic environmental in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment- see subsection 11(2)-or (b) the public may be significantly exposed to the polymer in a product –see subsection 11(3).

a) 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,

(i) the information specified in Schedule 10; and

(ii) 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.

b) 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 specified in Schedule 10, 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:

(i) 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; and

(ii) the mutagenicity data obtained from an in vitro test, with and without metabolic activation, for gene mutation or chromosomal aberrations in mammalian cells.

Acute toxicity testing data of Schedule 10 and above information are 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:

(i) aldehydes whose functional group equivalent weight is less than or equal to 1 000 daltons;

(ii) vinyl ethers whose functional group equivalent weight is less than or equal to 5 000 daltons; or

(iii) sulphonic acids whose functional group equivalent weight is less than or equal to 5 000 daltons.

c) 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 specified in Schedule 10, 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:

(i) 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;

(ii) the mutagenicity data obtained from an in vitro test, with and without metabolic activation, for gene mutation ;and

(iii) 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.

Acute toxicity testing data of Schedule 10 and above information are 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:

(i) aldehydes whose functional group equivalent weight is less than or equal to 1 000 daltons;

(ii) vinyl ethers whose functional group equivalent weight is less than or equal to 5 000 daltons; or

(iii) sulphonic acids whose functional group equivalent weight is less than or equal to 5 000 daltons.

3)Polymers and biopolymers not on the NDSL

3 Not required for reduced regulatory requirement polymers. Also subject to certain exceptions- see subsection 12(3). Additional information specified in Schedule 2 is also required if the polymer is a biopolymer-see paragraph 12(1)(b).

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,

(i) the information specified in Schedule 11; and

(ii) 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.

The acute mammalian toxicity testing data, skin irritation testing data, skin sensitization testing data, repeated-dose mammalian toxicity testing data of at least 28 days duration and mutagenicity data of Schedule 11 are 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:

(i) aldehydes whose functional group equivalent weight is less than or equal to 1 000 daltons;

(ii) vinyl ethers whose functional group equivalent weight is less than or equal to 5 000 daltons; or

(iii) sulphonic acids whose functional group equivalent weight is less than or equal to 5 000 daltons.

Our Service:

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New substance notification in Canada

If you have any question, please contact us at Serive@jianzaoshiwang.cn.

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Appendix

Schedule 1

1. The type of substance: research and development substance, contained site-limited intermediate substance or contained export-only substance.

2. The new substances pre-notification consultation number if it has been assigned and if known.

3. 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.

4. The trade names of the chemical and the synonyms of its chemical name, if known. 5. The CAS registry number of the chemical, if such a number can be assigned.

6. The following identification information in respect of the chemical:

(a) its molecular formula;

(b) its structural formula;

(c) its gram molecular weight;

(d) the degree of purity in its technical grade composition, if applicable;

(e) known impurities present and their concentration by weight; and

(f) any additives, stabilizers and solvents present when the chemical is tested and their concentration by weight.

7. A material safety data sheet in respect of the chemical, if available.

8. The following exposure information respecting the chemical:

(a) the anticipated annual quantity to be manufactured, if applicable;

(b) the anticipated annual quantity to be imported, if applicable;

(c) the anticipated uses;

(d) its anticipated concentration in products and, if known, in endues products;

(e) a description of the expected modes for its transportation and storage;

(f) a description of the size and type of container used for its transportation and storage;

(g) an identification of the components of the environment into which it is anticipated to be released;

(h) its anticipated releases into municipal wastewater systems;

(i) a description of the methods recommended for its destruction or disposal;

(j) 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

(k) for site-limited intermediate substances, the location of use.

9. 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 ought to have access and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the chemical.

10. 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.

Schedule 2

1. 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

(a) synonyms and common and superseded names, if known; and

(b) its source and history.

2. A description of any known adverse environmental or human health effects associated with exposure to the production organism.

3. The concentration of the viable production organism in the biochemical or biopolymer and, if known, in end-use products.

4. A description of the method used to separate the production organism from the biochemical or biopolymer.

5. The identification of the encoded products, if known.

6. 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.

7. A description of all known catalytic functions.

8. The Enzyme Commission (EC) number as designated by the nomenclature committee of the International Union of Biochemistry and Molecular Biology (IUBMB), if available.

9. The known substrate specificity for each of the catalytic functions specified under item 7.

10. The optimum pH and temperature for the substrates specified under item 9.

11. The catalytic constants Km and Kcat and the conditions under which they were measured.

12. The known cofactors necessary for enzymatic activity.

13. The enzymatic activity per unit of weight of products and, if known, of end-use products.

Schedule 3:

1. The type of substance: research and development substance, contained site-limited intermediate substance or contained export-only substance.

2. The new substances pre-notification consultation number if it has been assigned, and if known.

3. 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.

4. The trade names of the polymer and the synonyms of its chemical name, if known.

5. The CAS registry number of the polymer, if such a number can be assigned.

6. The molecular formula of the polymer. 6. La formule moléculaire du polymère.

7. The structural formula of the polymer, if possible, or else a partial structural formula.

8. For contained site-limited intermediate substances and contained export-only substances:

(a) its number average molecular weight (Mn); and

(b) 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.

9. For research and development substances, the target number average molecular weight (Mn) of the polymer.

10. The known impurities present and their concentration by weight.

11. 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.

12. A material safety data sheet in respect of the polymer, if available.

13. The physical state of the polymer. 13. L’état physique du polymère.

14. Whether the polymer is formulated for dispersal in water.

15. The following exposure information respecting the polymer:

(a) the anticipated annual quantity to be manufactured, if applicable;

(b) the anticipated annual quantity to be imported, if applicable;

(c) the anticipated uses;

(d) its anticipated concentration in products and, if known, in endues products;

(e) a description of the expected modes for its transportation and storage;

(f) a description of the size and type of container used for its transportation and storage;

(g) an identification of the components of the environment into which it is anticipated to be released;

(h) its anticipated releases into municipal wastewater systems;

(i) a description of the methods recommended for its destruction or disposal;

(j) 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

(k) for site-limited intermediate substances, the location of use.

16. 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 ought to have access and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the polymer.

17. 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.

Schedule 4

1. Whether the chemical is on the NDSL.

2. The new substances pre-notification consultation number if it has been assigned and if known.

3. 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.

4. The trade names of the chemical and the synonyms of its chemical name, if known.

5. The CAS registry number of the chemical, if such a number can be assigned.

6. A material safety data sheet in respect of the chemical, if available.

7. The following exposure information respecting the chemical:

(a) the anticipated annual quantity to be manufactured, if applicable;

(b) the anticipated annual quantity to be imported, if applicable;

(c) the anticipated uses within Canada; and

(d) its anticipated concentration in products and, if known, in endues products.

8. 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 are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the chemical.

9. 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.

Schedule 5

1. 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.

2. The following identification information in respect of the chemical:

(a) its molecular formula;

(b) its structural formula;

(c) its gram molecular weight;

(d) the degree of purity in its technical grade composition, if applicable;

(e) known impurities present and their concentration by weight; and

(f) any additives, stabilizers and solvents present when the chemical is tested and their concentration by weight.

3. The following physical and chemical data in respect of the chemical:

(a) its melting point or the temperature at which the chemical decomposes

(i) 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

(ii) in any other case, expressed as “less than–25°C”or“greater than 300°C”, as appropriate;

(b) its boiling point or the temperature at which the chemical decomposes

(i) 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

(ii) in any other case, expressed as “less than–50°C”or“greater than 300°C”, as appropriate;

(c) its density;
(d) its vapour pressure if it has a standard boiling point of 0°C or greater;
(e) its water solubility; and

(f) for chemicals having a water solubility of less than or equal to 5 g/L, its octanol/water partition coefficient.

4. Ready biodegradation test data in respect of the chemical and, if known, identification of the products of biodegradation.

5. Data from one acute fish, daphnia or algae toxicity test in respect of the chemical.

6. 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:

(a) the age, sex, number, species, strain and source of the animals tested;

(b) the route by which the chemical is administered and the conditions under which the test is conducted; and

(c) the dose of the chemical, the vehicle by means of which the chemical is administered and the concentration of the chemical in the vehicle.

7. Mutagenicity data obtained from one in vitro test in respect of the chemical, with and without metabolic activation, for gene mutations.

8. The following exposure information respecting the chemical:

(a) a description of the expected modes for its transportation and storage;

(b) a description of the size and type of container used for its transportation and storage;

(c) an identification of the components of the environment into which it is anticipated to be released;

(d) its anticipated releases into municipal wastewater systems;

(e) a description of the methods recommended for its destruction or disposal;

(f) whether it is anticipated to be used in products intended for use by or for children;

(g) 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

(h) 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.

9. 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 ought to have access and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the chemical.

10. If the chemical is on the NDSL, the following additional exposure information respecting the chemical:

(a) its historical and other likely uses;

(b) any factors that may limit environmental exposure;

(c) 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

(d) 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.

Schedule 6

1. 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.

2. The following physical and chemical data in respect of the chemical:

(a) one of an infra-red, ultra-violet, mass or nuclear magnetic resonance spectrum suitable for characterization of the chemical;

(b) for chemicals having a water solubility of greater than or equal to 200 μg/L, adsorption-desorption screening test data; and

(c) 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.

3. 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.

4. 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.

5. Information sufficient to assess skin irritation in respect of the chemical.

6. Data from a skin sensitization test in respect of the chemical.

7. 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.

8. For the tests referred to in items 4 to 7, the following additional information:

(a) the age, sex, number, species, strain and source of the animals tested;

(b) the route by which the chemical is administered and the conditions under which the test is conducted; and

(c) the dose of the chemical, the vehicle by means of which the chemical is administered and the concentration of the chemical in the vehicle.

9. Mutagenicity data obtained from one in vitro test in respect of the chemical, with and without metabolic activation, for chromosomal aberrations in mammalian cells.

10. 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.

11. The following exposure information respecting the chemical:

(a) its historical and other likely uses; and

(b) any factors that may limit environmental exposure.

Schedule 7

1. A cationic polymer or a polymer that is reasonably expected to become cationic in a natural aquatic environment, except

(a) a polymer whose cationic group has a combined equivalent weight greater than 5 000 daltons; or

(b) 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.

2. 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.

3. 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.

4. A polymer that has

(a) any atomic elements other than carbon, hydrogen, nitrogen, oxygen, silicon, sulphur, fluorine, chlorine, bromine or iodine covalently bound to carbon;

(b) any monoatomic counterions other than chlorine ion, bromine ion, iodine ion, sodium ion, divalent magnesium, trivalent aluminium, potassium ion or divalent calcium; or

(c) 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.

5. A polymer

(a) 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

(b) in which the only reactive functional groups present are part of acid halides, acid anhydrides, aldehydes, hemiacetals, methylolamides, 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.

Schedule 9

1. The type of polymer:

(a) a reduced regulatory requirement polymer;

(b) a polymer on the NDSL;

(c) a polymer with all of its reactants on the DSL or the NDSL; or

(d) a polymer with one or more reactants not on either the DSL or NDSL.

2. The new substances pre-notification consultation number if it has been assigned and if known.

3. 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.

4. The trade names of the polymer and the synonyms of its chemical name, if known.

5. The CAS registry number of the polymer, if such a number can be assigned.

6. The molecular formula of the polymer.

7. The structural formula of the polymer, if possible, or else a partial structural formula

8. 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.

9. The following physical and chemical data in respect of the polymer:

(a) its number average molecular weight (Mn); and

(b) 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.

10. The known impurities present and their concentration by weight.

11. 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.

12. A material safety data sheet in respect of the polymer, if available.

13. The following exposure information respecting the polymer:

(a) the anticipated annual quantity to be manufactured, if applicable;

(b) the anticipated annual quantity to be imported, if applicable;

(c) the anticipated uses within Canada; and

(d) if the polymer is not a reduced regulatory requirement polymer,

(i) the anticipated concentration of the polymer in products and, if known, in end-use products,

(ii) 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,

(iii) whether the polymer is anticipated to be used in products intended for use by or for children, and

(iv) 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.

14. 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 are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the polymer.

15. 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.

Schedule 10

1. 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.

2. The following physical and chemical data in respect of the polymer:

(a) its physical state;

(b) whether it is formulated for dispersal in water;

(c) its water extractability measured at

(i) pH 7 for anionic and neutral polymers,

(ii) pH 2 and 7 for cationic polymers, or

(iii) pH 2, 7 and 9 for amphoteric polymers;

(d) its octanol-water partition coefficient; and

(e) 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.

3. 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.

4. Data from one acute mammalian oral toxicity test of the polymer and the following information:

(a) the age, sex, number, species, strain and source of the animals tested;

(b) the route by which the polymer is administered and the conditions under which the test is conducted; and

(c) the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle.

5. The following exposure information respecting the polymer:

(a) a description of the expected modes for its transportation and storage;

(b) a description of the size and type of container used for its transportation and storage;

(c) its anticipated releases into municipal wastewater systems;

(d) a description of the methods recommended for its destruction or disposal;

(e) its historical and other likely uses;

(f) any factors that may limit environmental exposure;

(g) 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

(h) 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.

6. 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 ought to have access and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the polymer.

Schedule 11

1. 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.

2. The following physical and chemical data in respect of the polymer:

(a) its physical state;

(b) whether it is formulated for dispersal in water;

(c) its water extractability measured at

(i) pH 7 for anionic and neutral polymers,

(ii) pH 2 and 7 for cationic polymers, or

(iii) pH 2, 7 and 9 for amphoteric polymers;

(d) its octanol-water partition coefficient; and

(e) 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.

3. 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.

4. Unless the polymer has a water extractability at pH 7 of less than or equal to 2%, the following tests:

(a) 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;

(b) 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

(c) 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.

5. Data from one acute mammalian oral toxicity test of the polymer.

6. Information sufficient to assess skin irritation in respect of the polymer.

7. Data from a skin sensitization test in respect of the polymer.

8. 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.

9. For the tests referred to in items 5 to 8, the following additional information:

(a) the age, sex, number, species, strain and source of the animals tested;

(b) the route by which the polymer is administered and the conditions under which the test is conducted; and

(c) the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle.

10. Mutagenicity data obtained from each of the following tests of the polymer:

(a) one in vitro test, with and without metabolic activation, for gene mutations;

(b) one in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells; and

(c) 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.

11. The following exposure information respecting the polymer:

(a) a description of the expected modes for its transportation and storage;

(b) a description of the size and type of container used for its transportation and storage;

(c) an identification of the components of the environment into which it is anticipated to be released;

(d) its anticipated releases into municipal wastewater systems;

(e) a description of the methods recommended for its destruction or disposal;

(f) its historical and other likely uses; and

(g) any factors that may limit environmental exposure.

12. 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 ought to have access and that are relevant to identifying hazards to the environment and human health and the degree of environmental and public exposure to the polymer.