Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers

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APPENDIX 4 - Schedules Under the Regulations

Schedule 1

(Subsections 2(2) and 5(1) to (4))

INFORMATION RESPECTING CHEMICALS AND BIOCHEMICALS THAT ARE RESEARCH AND DEVELOPMENT SUBSTANCES, CONTAINED SITE-LIMITED INTERMEDIATE SUBSTANCES OR CONTAINED EXPORT-ONLY SUBSTANCES*

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:
   1. its molecular formula;
   2. its structural formula;
   3. its gram molecular weight;
   4. the degree of purity in its technical grade composition, if applicable;
   5. known impurities present and their concentration by weight; and
   6. 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:
   1. the anticipated annual quantity to be manufactured, if applicable;
   2. the anticipated annual quantity to be imported, if applicable;
   3. the anticipated uses;
   4. its anticipated concentration in products and, if known, in end-use products;
   5. a description of the expected modes for its transportation and storage;
   6. a description of the size and type of container used for its transportation and storage;
   7. an identification of the components of the environment into which it is anticipated to be released;
   8. its anticipated releases into municipal wastewater systems;
   9. a description of the methods recommended for its destruction or disposal;
   10. 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
   11. 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.

*See section 4.2 of these Guidelines for definition of these special categories.

Schedule 2

(Subsections 2(2), 5(2) to (4) and 6(2) to (4), subparagraphs 7(1)(a)(ii) and (b)(ii) and 8(1)(a)(ii), (b)(ii) and (c)(ii) and paragraphs10(b), 11(1)(b), 12(1)(b), 17(2)(b) and 18(2)(b)and (c))

INFORMATION RESPECTING BIOCHEMICALS AND BIOPOLYMERS

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:
   1. synonyms and common and superseded names, if known; and
   2. 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 K_m and K_cat 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

(Subsection 2(2) and section 6)

INFORMATION RESPECTING POLYMERS AND BIOPOLYMERS THAT ARE RESEARCH AND DEVELOPMENT SUBSTANCES, CONTAINED SITE-LIMITED INTERMEDIATE SUBSTANCES OR CONTAINED EXPORT-ONLY SUBSTANCES*

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 Abstract 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. For contained site-limited intermediate substances and contained export-only substances:
   1. its number average molecular weight (M_n); and
   2. 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 (M_n) 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.
14. Whether the polymer is formulated for dispersal in water.
15. The following exposure information respecting the polymer:
    1. the anticipated annual quantity to be manufactured, if applicable;
    2. the anticipated annual quantity to be imported, if applicable;
    3. the anticipated uses;
    4. its anticipated concentration in products and, if known, in end-use products;
    5. a description of the expected modes for its transportation and storage;
    6. a description of the size and type of container used for its transportation and storage;
    7. an identification of the components of the environment into which it is anticipated to be released;
    8. its anticipated releases into municipal wastewater systems;
    9. a description of the methods recommended for its destruction or disposal;
    10. 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
    11. 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.

*See section 4.2 of these Guidelines for definition of these special categories.

Schedule 4

(Subsection 2(2), subparagraphs 7(1)(a)(i), 8(1)(a)(i) and 17(2)(c)(i) and paragraph 17(2)(d))

INFORMATION RESPECTING OTHER CHEMICALS AND BIOCHEMICALS NOT ON THE NDSL (100 KG) OR ON THE NDSL (1 000 KG)

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:
   1. the anticipated annual quantity to be manufactured, if applicable;
   2. the anticipated annual quantity to be imported, if applicable;
   3. the anticipated uses within Canada; and
   4. its anticipated concentration in products and, if known, in end-use 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

(Subsection 2(2), subparagraphs 7(1)(b)(i), 8(1)(b)(i), subsections 8(2) and 16(3), subparagraph 17(2)(c)(i) and paragraph 17(2)(d))

INFORMATION RESPECTING OTHER CHEMICALS AND BIOCHEMICALS NOT ON THE NDSL (1 000 KG) OR ON THE NDSL (10 000 KG)

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:
   1. its molecular formula;
   2. its structural formula;
   3. its gram molecular weight;
   4. the degree of purity in its technical grade composition, if applicable;
   5. known impurities present and their concentration by weight; and
   6. any additives, stabilizers and solvents present when the chemical is tested and their concentration by weight.
3. The following physical and chemical data¹ in respect of the chemical:
   1. its melting point or the temperature at which the chemical decomposes
      1. 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
      2. in any other case, expressed as "less than -25 °C" or "greater than 300 °C", as appropriate;
   2. its boiling point or the temperature at which the chemical decomposes
      1. 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
      2. in any other case, expressed as "less than -50 °C" or "greater than 300 °C", as appropriate;
   3. its density;
   4. its vapour pressure if it has a standard boiling point of 0 °C or greater;
   5. its water solubility; and
   6. 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:
   1. the age, sex, number, species, strain and source of the animals tested;
   2. the route by which the chemical is administered and the conditions under which the test is conducted; and
   3. 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:
   1. a description of the expected modes for its transportation and storage;
   2. a description of the size and type of container used for its transportation and storage;
   3. an identification of the components of the environment into which it is anticipated to be released;
   4. its anticipated releases into municipal wastewater systems;
   5. a description of the methods recommended for its destruction or disposal;
   6. whether it is anticipated to be used in products intended for use by or for children;
   7. 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
   8. 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:
    1. its historical and other likely uses;
    2. any factors that may limit environmental exposure;
    3. 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
    4. 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 Regulations.

¹ Additional test requirements prescribed in subsection 7(2) and 7(3) of the Regulations must be submitted if the quantity of the chemical exceeds 50 000 kg in a calendar year and is released to the aquatic environment in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment and/or if the public is anticipated to be significantly exposed to the chemical in a product.

Schedule 6

(Subsection 2(2), subparagraph 8(1)(c)(i) and paragraph 17(2)(d))

INFORMATION RESPECTING OTHER CHEMICALS AND BIOCHEMICALS NOT ON THE NDSL (10 000 KG)

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:
   1. one of an infra-red, ultra-violet, mass or nuclear magnetic resonance spectrum suitable for characterization of the chemical;
   2. for chemicals having a water solubility of greater than or equal to 200 µg/L, adsorption-desorption screening test data; and
   3. 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. Data¹ 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:
   1. the age, sex, number, species, strain and source of the animals tested;
   2. the route by which the chemical is administered and the conditions under which the test is conducted; and
   3. 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:
    1. its historical and other likely uses; and
    2. any factors that may limit environmental exposure.

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 Regulations.

¹ Additional test requirements prescribed in subsection 7(2) and 7(3) of the Regulations must be submitted if the quantity of the chemical exceeds 50 000 kg in a calendar year and is released to the aquatic environment in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment and/or if the public is anticipated to be significantly exposed to the polymer in a product.

Schedule 7

(Subsection 2(2) and paragraphs 9(a) and (b))

TYPES OF POLYMERS

1. A cationic polymer or a polymer that is reasonably expected to become cationic in a natural environment, except
   1. a polymer whose cationic group has a combined equivalent weight greater than 5 000 daltons; or
   2. 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
   1. any atomic elements other than carbon, hydrogen, nitrogen, oxygen, silicon, sulphur, fluorine, chlorine, bromine or iodine covalently bound to carbon;
   2. any monoatomic counterions other than chlorine ion, bromine ion, iodine ion, sodium ion, divalent magnesium, trivalent aluminum, potassium ion or divalent calcium; or
   3. 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
   1. 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
   2. 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 activation influences, for example, strongly electron-withdrawing sulfone group with which the olefinic groups interact.

Schedule 8

(Subsection 2(2) and paragraph 9(c))

LIST OF REACTANTS AND THEIR CAS REGISTRY NUMBER

1. Monobasic Acids and Natural Oils

2. Dibasic and Tribasic Acids and Esters

3. Polyols

4. Modifiers

* 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.

Schedule 9

(Subsection 2(2), paragraphs 10(a) and 18(2)(b), subparagraph 18(2)(d)(i) and paragraph 18(2)(e))

INFORMATION RESPECTING REDUCED REGULATORY REQUIREMENT POLYMERS AND OTHER POLYMERS AND BIOPOLYMERS (1 000 KG)

1. The type of polymer:
   1. a reduced regulatory requirement polymer;
   2. a polymer on the NDSL;
   3. a polymer with all of its reactants on the DSL or the NDSL; or
   4. 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 the Regulations.
9. The following physical and chemical data in respect of the polymer;
   1. its number average molecular weight (M_n); and
   2. 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:
    1. the anticipated annual quantity to be manufactured, if applicable;
    2. the anticipated annual quantity to be imported, if applicable;
    3. the anticipated uses within Canada; and
    4. if the polymer is not a reduced regulatory requirement polymer,
       1. the anticipated concentration of the polymer in products and, if known, in end-use products,
       2. 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,
       3. whether the polymer is anticipated to be used in products intended for use by or for children, and
       4. 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

(Subsection 2(2), paragraph 11(1)(a), subsection 11(5), subparagraph 18(2)(d)(i))

INFORMATION RESPECTING OTHER POLYMERS AND BIOPOLYMERS ON THE NDSL OR ALL OF WHOSE REACTANTS ARE ON THE DSL OR NDSL (10 000 KG)

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 data¹ in respect of the polymer:
   1. its physical state;
   2. whether it is formulated for dispersal in water;
   3. its water extractability measured at:
      1. pH 7 for anionic and neutral polymers,
      2. pH 2 and 7 for cationic polymers, or
      3. pH 2, 7 and 9 for amphoteric polymers;
   4. its octanol-water partition coefficient; and
   5. 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:
   1. the age, sex, number, species, strain and source of the animals tested;
   2. the route by which the polymer is administered and the conditions under which the test is conducted; and
   3. the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle.*²
5. The following exposure information respecting the polymer:
   1. a description of the expected modes for its transportation and storage;
   2. a description of the size and type of container used for its transportation and storage;
   3. its anticipated releases into municipal wastewater systems;
   4. a description of the methods recommended for its destruction or disposal;
   5. its historical and other likely uses;
   6. any factors that may limit environmental exposure;
   7. 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
   8. 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.

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 Regulations.

¹ Additional test requirements prescribed in subsections 11(2) and 11(3) of the Regulations must be submitted if the quantity of the polymer exceeds 50 000 kg in a calendar year and is released to the aquatic environment in a quantity exceeding 3 kg per day, per site, averaged monthly and after wastewater treatment and/or if the public is anticipated to be significantly exposed to the polymer in a product.²

² Information referred to in item 4 of Schedule 10 and the additional data requirements prescribed in subsections 11(2) and 11(3) of the Regulations is not required for polymers that do not meet the criteria for RRR polymer as per subsection 11(5) of the Regulations.

Schedule 11

(Subsection 2(2), paragraph 12(1)(a), subsection 12(3) and paragraph 18(2)(e))

INFORMATION RESPECTING OTHER POLYMERS AND BIOPOLYMERS NOT ON THE NDSL (10 000 KG)

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:
   1. its physical state;
   2. whether it is formulated for dispersal in water;
   3. its water extractability measured at:
      1. pH 7 for anionic and neutral polymers,
      2. pH 2 and 7 for cationic polymers, or
      3. pH 2, 7 and 9 for amphoteric polymers;
   4. its octanol-water partition coefficient; and
   5. 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:
   1. if the sensitivitiy 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;
   2. 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
   3. 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.*¹
6. Information sufficient to assess skin irritation in respect of the polymer.*¹
7. Data from a skin sensitization test in respect of the polymer.*¹
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.*¹
9. For the tests referred to in items 5 to 8, the following additional information:
   1. the age, sex, number, species, strain and source of the animals tested;
   2. the route by which the polymer is administered and the conditions under which the test is conducted; and
   3. the dose of the polymer, the vehicle by means of which the polymer is administered and the concentration of the polymer in the vehicle.*¹
10. Mutagenicity data obtained from each of the following tests of the polymer:
    1. one in vitro test, with and without metabolic activation, for gene mutations;
    2. one in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells; and
    3. 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.*¹
11. The following exposure information respecting the polymer:
    1. a description of the expected modes for its transportation and storage;
    2. a description of the size and type of container used for its transportation and storage;
    3. an identification of the components of the environment into which it is anticipated to be released;
    4. its anticipated releases into municipal wastewater systems;
    5. a description of the methods recommended for its destruction or disposal;
    6. its historical and other likely uses; and
    7. 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.

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 Regulations

¹ Information referred to in items 5 to 10 of Schedule 11 are not required for polymers that do not meet the criteria for RRR polymer as per subsection 12(3) of the Regulations.

Schedule 12

(Subsection 2(2))

OVERVIEW OF INFORMATION REQUIREMENTS

1. The information required under the New Substances Notification Regulations (Chemicals and Polymers) is divided into three flowcharts according to the type of substance:
   1. research and development, contained site-limited intermediate and contained export-only substances - Flowchart 1;
   2. chemicals and biochemicals other than research and development, contained site-limited intermediate and contained export-only substances - Flowchart 2; and
   3. polymers and biopolymers other than research and development, contained site-limited intermediate and contained export-only substances - Flowchart 3.
2. 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.
3. 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.
4. The shapes used in the flowcharts distinguish their contents as follows:
   1. the ovals identify the type of substance referred to in the flowchart, as more particularly described in the flowchart's title;
   2. the diamonds identify the timeline and quantity trigger; and
   3. the rectangles identify the required information.
5. Shapes outlined with a broken line signal that information is required only in certain circumstances.
6. Additional information is set out in footnotes to each flowchart.
7. 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.

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¹ Additional information specified in Schedule 2 is also required if the chemical is a biochemical – see subsections 5(2), (3) and (4).

² Additional information specified in Schedule 2 is also required if the polymer is a biopolymer – see subsections 6(2), (3) and (4).

Flowchart 2 Chemicals/Biochemicals Other Than Those in Flowchart 1

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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)(b)(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).

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 the 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).

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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).

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 environment 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).

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).