Order 2018-87-06-01 Amending the Domestic Substances List: SOR/2019-17

Canada Gazette, Part II, Volume 153, Number 3

Registration

SOR/2019-17 January 23, 2019

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the Minister of the Environment has been provided with information under paragraph 87(5)(a) of the Canadian Environmental Protection Act, 1999 footnote a in respect of each substance referred to in the annexed Order that is added to the Domestic Substances List footnote b pursuant to subsection 87(5) of that Act;

Whereas the period for assessing the information under section 83 of that Act has expired;

And whereas no conditions under paragraph 84(1)(a) of that Act in respect of the substances are in effect;

Therefore, the Minister of the Environment, pursuant to subsections 87(3) and (5) of the Canadian Environmental Protection Act, 1999 footnote a, makes the annexed Order 2018-87-06-01 Amending the Domestic Substances List.

Gatineau, January 18, 2019

Catherine McKenna
Minister of the Environment

Order 2018-87-06-01 Amending the Domestic Substances List

Amendments

1 Part 1 of the Domestic Substances List footnote 1 is amended by adding the following in numerical order:

2 Part 2 of the List is amended by adding the following in numerical order:

Column 1

Substance

Column 2

Significant New Activity for which substance is subject to subsection 81(3) of the Act

13308-51-5 N-S
  • 1 The use of the substance boron phosphate (B(PO4)), when that substance does not contain nanoscale particles (1 to 100 nanometres), in a quantity greater than 1 000 kg in a calendar year in the manufacture of any of the following products such that the substance is present in a concentration that is greater than or equal to 0.1% by weight:
    • (a) a consumer product to which the Canada Consumer Product Safety Act applies;
    • (b) a natural health product, as defined in subsection 1(1) of the Natural Health Products Regulations, or any other drug, as defined in section 2 of the Food and Drugs Act; or
    • (c) a cosmetic, as defined in section 2 of the Food and Drugs Act.
  • 2 The use of the substance boron phosphate (B(PO4)), when that substance does not contain nanoscale particles (1 to 100 nanometres), in a quantity greater than 1 000 kg in a calendar year in of any of the following products in which the substance is present in a concentration that is greater than or equal to 0.1% by weight:
    • (a) a consumer product to which the Canada Consumer Product Safety Act applies;
    • (b) a natural health product, as defined in subsection 1(1) of the Natural Health Products Regulations, or any other drug, as defined in section 2 of the Food and Drugs Act; or
    • (c) a cosmetic, as defined in section 2 of the Food and Drugs Act.
  • 3 Any of the following uses of the substance boron phosphate (B(PO4)), when that substance contains nanoscale particles
    (1 to 100 nanometres):
    • (a) in a calendar year, its use in a quantity greater than 100 kg in the manufacture of any of the following products such that the substance is present in the product in a concentration that is greater than or equal to 0.1% by weight:
      • (i) a consumer product to which the Canada Consumer Product Safety Act applies,
      • (ii) a natural health product, as defined in subsection 1(1) of the Natural Health Products Regulations, or any other drug, as defined in section 2 of the Food and Drugs Act, or
      • (iii) a cosmetic as defined in section 2 of the Food and Drugs Act;
    • (b) in a calendar year, its use in a quantity greater than 100 kg in any of the following products in which the substance is present in a concentration that is greater than or equal to 0.1% by weight:
      • (i) a consumer product to which the Canada Consumer Product Safety Act applies,
      • (ii) a natural health product, as defined in subsection 1(1) of the Natural Health Products Regulations, or any other drug, as defined in section 2 of the Food and Drugs Act, or
      • (iii) a cosmetic, as defined in section 2 of the Food and Drugs Act; or
    • (c) in a calendar year, its use, other than a use described in paragraph (a) or (b), in a quantity greater than 1 000 kg.
  • 4 Despite sections 1 to 3, a use of the substance is not a significant new activity if the substance is used
    • (a) as a research and development substance or site-limited intermediate substance, as those terms are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers); or
    • (b) in a product that is referred to in those sections and is intended only for export.
  • 5 For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the activity begins:
    • (a) a description of the significant new activity in relation to the substance;
    • (b) the anticipated annual quantity of the substance to be used in relation to the significant new activity;
    • (c) the information specified in item 8 of Schedule 5 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (d) all other information or test data in respect of the substance that are in the possession of the person who is proposing the significant new activity, 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 substance;
    • (e) the name of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency;
    • (f) the name, civic and postal addresses, telephone number and, if any, fax number and email address of the person who is proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf;
    • (g) a certification that the information is accurate and complete, dated and signed by the person who is proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf;
    • (h) in the case of a significant new activity described in section 1 or 2, the test data and test report from
      • (i) a toxicity test in respect of the substance that is conducted in accordance with the methodology described in the Organization for Economic Cooperation and Development (OECD) Test Guideline No. 422, entitled Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, that is current at the time the test is conducted,
      • (ii) an in vivo mammalian test for chromosomal aberrations or gene mutations in respect of the substance, and
      • (iii) if the activity involves dermal exposure to the substance, an in vitro dermal absorption test in respect of the substance that is conducted in accordance with the methodology described in the OECD Test Guideline No. 428, entitled Skin Absorption: In Vitro Method, that is current at the time the test is conducted; and
    • (i) in the case of a significant new activity described in section 3,
      • (i) the analytical information that is necessary to determine the substance’s primary and secondary particle size (i.e., its length, width and thickness), and
      • (ii) the information that is necessary to determine the substance’s agglomeration and aggregation state, shape, surface area and surface charge.
  • 6 The tests referred to in paragraph 5(h) must be conducted in accordance with the Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted by the OECD on May 12, 1981, that are current at the time the tests are conducted. Furthermore, if the substance contains nanoscale particles, the tests referred to in that paragraph must be conducted in accordance with the principles described in the OECD Series on the Safety of Manufactured Nanomaterials Publication No. 36, entitled Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials, that are current at the time the tests are conducted.
  • 7 The information referred to in paragraph 5(i) must be determined in accordance with the principles described in the OECD Series on the Safety of Manufactured Nanomaterials, Publication No. 41, entitled Report of the OECD Expert Meeting on the Physical Chemical Properties of Manufactured Nanomaterials and Test Guidelines, that is current at the time of the determination.
  • 8 The information provided under section 5 will be assessed within 90 days after the day on which it is received by the Minister.

3 (1) The portion of paragraph 5(h) before subparagraph (i) in column 2 of Part 2 of the List, opposite the reference to the substance “13308-51-5 N-S” in column 1 is replaced by the following:

Column 2

Significant New Activity for which substance is subject to subsection 81(3) of the Act
  • (h) in the case of a significant new activity described in section 1 or 2 or paragraph 3(a) or (b),

(2) Paragraph 5(i) in column 2 of Part 2 of the List, opposite the reference to the substance “13308-51-5 N-S” in column 1 is replaced by the following:

Column 2

Significant New Activity for which substance is subject to subsection 81(3) of the Act
  • (i) in the case of a significant new activity described in paragraph 3(a) or (b), the test data and test reports referred to in paragraph 5(h) must include
    • (i) the analytical information that is necessary to determine the primary and secondary particle size (i.e., its length, width and thickness) of the test sample used to conduct the test, and
    • (ii) the information that is necessary to determine the agglomeration and aggregation state, shape, surface area and surface charge of the test sample used to conduct the test; and
  • (j) in the case of a significant new activity described paragraph 3(c),
    • (i) the analytical information that is necessary to determine the substance’s primary and secondary particle size (i.e., its length, width and thickness), and
    • (ii) the information that is necessary to determine the substance’s agglomeration and aggregation state, shape, surface area and surface charge.

(3) Section 7 in column 2 of Part 2 of the List,  opposite the reference to the substance “13308-51-5 N-S” in column 1, is replaced by the following:

Column 2

Significant New Activity for which substance is subject to subsection 81(3) of the Act

7 The information referred to in paragraphs 5(i) and (j) must be determined in accordance with the principles described in the OECD Series on the Safety of Manufactured Nanomaterials, Publication No. 41, entitled Report of the OECD Expert Meeting on the Physical Chemical Properties of Manufactured Nanomaterials and Test Guidelines, that is current at the time of the determination.

4 Part 3 of the List is amended by adding the following in numerical order:

19272-0 N-P

Neodecanoic acid, ethenyl ester, polymer with butyl 2-propenoate, alkyl 2-methyl-2-propenoate and 2-methyl-2-propenoic acid

Néodécanoate d’éthényle polymérisé avec du prop-2-ènoate de butyle, un 2-méthylprop-2-ènoate d’alkyle et de l’acide 2 méthylprop-2-ènoïque

19297-5 N-P

Linseed oil, ester with pentaerythritol, polymer with adipic acid, 1,4-cyclohexanedimethanol, 2-alkyl-1,3- propanediol-trimethylolpropane polymer (5-ethyl-1,3-dioxan-5-yl)methyl ethers, 1,6-hexanediol, hydrazine, 3- hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3- trimethylcyclohexane and neopentyl glycol

Ester d’huile de lin et de 2,2-bis(hydroxyméthyl)propane-1,3-diol, polymérisé avec de l’acide hexanedioïque, du cyclohexane-1,4-diméthanol, des oxydes de (5-éthyl-1,3-dioxan-5-yl)méthyle et de polymère de 2-alkylpropane-1,3-diol et de 2-éthyl-2-(hydroxyméthyl)propane-1,3-diol, de l’hexane-1,6-diol, de l’hydrazine, de l’acide 2,2 bis(hydroxyméthyl)propanoïque, du 5-isocyanato-1-(isocyanatométhyl)-1,3,3-triméthylcyclohexane et du 2,2 diméthylpropane-1,3-diol

19298-6 N-P

Polycarbomonocyclic acid, polymer with alkanepolyol, cycloalkane polycarboxyacid, cycloalkanepolyol, polyalkylalkanepolyol and alkyl-hydroxyalkyl-alkanediol

Acide polycarbomonocyclique polymérisé avec un alcanepolyol, un acide cycloalcanepolycarboxylique, un cycloalcanepolyol, un polyalkylalcanepolyol et un alkyl(hydroxyalkyl)alcanediol

19299-7 N-P

2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with butyl 2-propenoate, methyl 2-methyl-2-propenoate and polyalkyl polycyclo alkyl alkylalkenoate, 1, 1-dimethylpropyl 2-ethylhexaneperoxoate-initiated

2-Méthylprop-2-ènoate de 2-hydroxyéthyle polymérisé avec du prop-2-ènoate de butyle, du 2-méthylprop-2-ènoate de méthyle et un alkylalcènoate de polyalkylpolycycloalkyle, amorcé avec du 2 éthylhexaneperoxoate de 2-méthylbutane-2-yle

19300-8 N-P

Poly(oxy-1,2-ethanediyl), α-hydro-ω-hydroxy-, polymer with 1,6-diisocyanatoalkane, polyethylene glycol monoalkyl ether-blocked

α-Hydro-ω-hydroxypoly(oxyéthane-1,2-diyle) polymérisé avec un 1,6-diisocyanatoalcane, séquencé avec un oxyde de monoalkyle et de poly(éthane-1,2-diol)

19301-9 N-P

2-Propenoic acid, 2-[[(alkylamino)carbonyl]oxy]ethyl ester, polymer with 2-propenamide, peroxydisulfuric acid ([(HO)S(O)2]2O2) sodium salt (1:2)-initiated

Prop-2-ènoate de 2-[(alkylcarbamoyl)oxy]éthyle polymérisé avec du prop-2-ènamide, amorcé avec du peroxydisulfate ([(HO)S(O)2]2O2) de disodium

19302-0 N-P

2-Propenoic acid, polymer with ethenylbenzene and (1-methylethenyl)benzene, compd. with substituted alkyl alkanol

Acide prop-2-ènoïque polymérisé avec du styrène et du (prop-1-èn-2-yl)benzène, composé avec un alkylalcanol substitué

5 Part 4 of the List is amended by adding the following in numerical order:

Column 1

Substance

Column 2

Significant New Activity for which substance is subject to subsection 81(3) of the Act

19216-4 N-S
  • 1 Any of the following uses of the substance quaternary ammonium compounds, bis(derivative oil alkyl)dimethyl, salts with smectite group minerals, when that substance contains nanoscale particles (1 to 100 nanometres):
    • (a) in a calendar year, its use in a quantity greater than 100 kg but less than or equal to 1 000 kg;
    • (b) in a calendar year, its use in a quantity greater than 1 000 kg but less than or equal to 10 000 kg in the manufacture of any of the following products such that the substance is present in the product in a concentration that is greater than or equal to 1% by weight:
      • (i) a consumer product to which the Canada Consumer Product Safety Act applies,
      • (ii) a natural health product, as defined in subsection 1(1) of the Natural Health Products Regulations, or any other drug, as defined in section 2 of the Food and Drugs Act, or
      • (iii) a cosmetic, as defined in section 2 of the Food and Drugs Act;
    • (c) in a calendar year, its use in a quantity greater than 1 000 kg but less than or equal to 10 000 kg in any of the following products in which the substance is present in the product in a concentration that is greater than or equal to 1% by weight:
      • (i) a consumer product to which the Canada Consumer Product Safety Act applies,
      • (ii) a natural health product, as defined in subsection 1(1) of the Natural Health Products Regulations, or any other drug, as defined in section 2 of the Food and Drugs Act, or
      • (iii) a cosmetic, as defined in section 2 of the Food and Drugs Act;
    • (d) in a calendar year, any use, other than one referred to in paragraph (b) or (c), in a quantity greater than 1 000 kg but less than or equal to 10 000 kg; or
    • (e) in a calendar year, its use in a quantity greater than 10 000 kg.
  • 2 Despite section 1, a use of the substance is not a significant new activity if the substance is used
    • (a) as a research and development substance or site-limited intermediate substance, as those terms are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers); or
    • (b) in a product that is referred to in paragraph 1(b) or (c) and is intended only for export.
  • 3 For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the activity begins:
    • (a) a description of the significant new activity in relation to the substance;
    • (b) the anticipated annual quantity of the substance to be used in relation to the significant new activity;
    • (c) the information specified in items 2 and 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (d) all other information or test data in respect of the substance that are in the possession of the person who is proposing the significant new activity, 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 substance;
    • (e) the name of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency;
    • (f) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person who is proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf;
    • (g) a certification that the information is accurate and complete, dated and signed by the person who is proposing the significant new activity or, if they are not resident in Canada, by the person resident in Canada who is authorized to act on their behalf;
    • (h) in the case of a significant new activity described in paragraph 1(a),
      • (i) the analytical information that is necessary to determine the substance’s primary and secondary particle size (i.e., its length, width and thickness), and
      • (ii) the information that is necessary to determine the substance’s agglomeration and aggregation state, shape, surface area and surface charge;
    • (i) in the case of a significant new activity described in paragraph 1(b) or (c), the test data and test report from
      • (i) a dermal acute toxicity test that is conducted in accordance with the Organization for Economic Co-operation and Development (OECD) Test No. 402: Acute Dermal Toxicity: Fixed Dose Procedure, that is current at the time the test is conducted,
      • (ii) a skin sensitization test that establishes a dose-response relationship, allows an assessment of potency and is conducted in accordance with OECD Test No. 429: Skin Sensitization: Local Lymph Node Assay, that is current at the time the test is conducted,
      • (iii) an in vitro genotoxicity test for chromosomal aberrations in mammalian cells that is conducted in accordance with OECD Test No. 473: In Vitro Mammalian Chromosomal Aberration Test, that is current at the time the test is conducted,
      • (iv) an in vivo mammalian genotoxicity test for chromosomal aberrations that is conducted in accordance with OECD Test No. 474: Mammalian Erythrocyte Micronucleus Test, that is current at the time the test is conducted,
      • (v) if the activity involves dermal exposure to the substance, a 28-day repeated dose dermal mammalian toxicity test that is conducted in accordance with OECD Test No. 410: Repeated Dose Dermal Toxicity: 21/28-day Study, that is current at the time the test is conducted, and
      • (vi) if the activity involves a spray application of the substance,
        • (A) an in vivo 90-day repeated dose mammalian inhalation test that is conducted in accordance with OECD Test No. 413: Subchronic Inhalation Toxicity: 90-Day Study, that is current at the time the test is conducted, including a satellite (reversibility) test, and with histopathological evaluation performed for all tissues and organs, and
        • (B) a test on bronchoalveolar lavage conducted following the last exposure to the substance during the subchronic inhalation toxicity test required under clause (A) that is conducted in accordance with the OECD Series on Testing and Assessment, Publication No. 125, entitled Guidance Document on Histopathology for Inhalation Toxicity Studies, Supporting Test No. 412 (Subacute Inhalation Toxicity: 28-Day Study) and Test No. 413 (Subchronic Inhalation Toxicity: 90-Day Study) , that is current at the time the test is conducted;
    • (j) in the case of a significant new activity described in paragraph 1(d),
      • (i) the information specified in items 2 to 4 of Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers),
      • (ii) the test data and test report from a dermal acute toxicity test that is conducted in accordance with OECD Test No. 402: Acute Dermal Toxicity: Fixed Dose Procedure, that is current at the time the test is conducted,
      • (iii) the test data and test report from a skin sensitization test that establishes a dose-response relationship and allows an assessment of potency that is conducted in accordance with OECD Test No. 429: Skin Sensitization: Local Lymph Node Assay, that is current at the time the test is conducted,
      • (iv) the test data and the test report from a 28-day repeated dose mammalian toxicity test for the most significant route of potential human exposure to the substance that is conducted in accordance with OECD Test No. 407: Repeated Dose 28-day Oral Toxicity Study in Rodents, OECD Test No. 410: Repeated Dose Dermal Toxicity: 28-day Study, or OECD Test No. 412: Subacute Inhalation Toxicity: 21/28-Day Study, that are current at the time the test is conducted,
      • (v) the test data and a test report from an in vitro genotoxicity test for chromosomal aberrations in mammalian cells that is conducted in accordance with OECD Test No. 473: In Vitro Mammalian Chromosomal Aberration Test, that is current at the time the test is conducted, and
      • (vi) the test data and a test report from an in vivo mammalian genotoxicity test for chromosomal aberrations that is conducted in accordance with OECD Test No. 474: Mammalian Erythrocyte Micronucleus Test, that is current at the time the test is conducted; and
    • (k) in the case of a significant new activity described in any of paragraphs 1(b) to (e),
      • (i) the information specified in items 3 and 8 of Schedule 5 to the New Substances Notification Regulations (Chemicals and Polymers),
      • (ii) the test data and test report from an acute inhalation toxicity test that is conducted in accordance with the OECD Test No. 403: Acute Inhalation Toxicity, that is current at the time the test is conducted, and
      • (iii) the test data and test report from an in vitro mammalian cell gene mutation test with and without metabolic activation that is conducted in accordance with OECD Test No. 476: In Vitro Mammalian Cell Gene Mutation Tests Using the Hprt and xprt genes, or OECD Test No. 490: In vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene, that are current at the time the test is conducted.
  • 4 The information referred to in paragraph 3(h) must be determined in accordance with the OECD Series on the Safety of Manufactured Nanomaterials Publication, No. 41, entitled Report of the OECD Expert Meeting on the Physical Chemical Properties of Manufactured Nanomaterials and Test Guidelines, as amended from time to time.
  • 5 The tests referred to in paragraphs 3(i) to (k) must be developed in accordance with the OECD Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981, by the OECD, using the Principles of Good Laboratory Practice that are current at the time the tests are conducted. Furthermore, all tests regarding the substance must be conducted in accordance with the principles described in
    • (a) the OECD Series on the Safety of Manufactured Nanomaterials Publication No. 36 entitled, Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials, as amended from time to time; and
    • (b) the OECD Series on the Safety of Manufactured Nanomaterials Publication No. 40 entitled, Ecotoxicology and Environmental Fate of Manufactured Nanomaterials: Test Guidelines, as amended from time to time.
  • 6 For each test referred to in paragraphs 3(i) to (k), the test data and test reports must include the following information that is determined in accordance with the OECD Series on the Safety of Manufactured Nanomaterials Publication No. 41, entitled, Report of the OECD Expert Meeting on the Physical Chemical Properties of Manufactured Nanomaterials and Test Guidelines, that is current at the time of the determination:
    • (a) the analytical information that is necessary to determine the primary and secondary particle size (i.e., its length, width and thickness) of the test sample used to conduct the test; and
    • (b) the information that is necessary to determine the agglomeration and aggregation state, shape, surface area and surface charge of the test sample used to conduct the test.
  • 7 The information provided under section 3 will be assessed within 90 days after the day on which it is received by the Minister.

Coming into Force

6 (1) This Order, except section 3, comes into force on the day on which it is registered.

(2) Section 3 comes into force on January 1, 2019, but if the Order is registered after that day, it comes into force on the day on which the Order is registered.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the Order.)

Issues

The Government of Canada (the Government) assessed information on 18 substances new to Canada and determined that they meet the criteria for addition to the Domestic Substances List (DSL). Therefore, the Government added 18 substances to the DSL under the Order 2018-87-06-01 Amending the Domestic Substances List (Order 2018-87-06-01).

The Government identified potential human health and environmental concerns if 2 of the 18 substances (Chemical Abstracts Service Registry Number [CAS RN] 13308-51-5 and Confidential Accession Number [CAN] 19216-4) are used in certain new activities. For this reason, the SNAc provisions under the Canadian Environmental Protection Act, 1999 (CEPA) were applied to both substances before their addition to the DSL. As these substances are added to the DSL under Order 2018-87-06-01, reporting obligations under the significant new activity (SNAc) provisions of CEPA were maintained under the same Order.

Background

Assessment of substances new to Canada

Substances that are not on the DSL are considered new to Canada and are subject to notification and assessment requirements set out in sections 81, 83, 106 and 108 of CEPA, as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). These regulations are administered by the New Substances Program and were made to ensure that new substances introduced to the Canadian marketplace over certain thresholds are risk assessed to identify potential hazards to the environment and human health, and that appropriate control measures are taken, if deemed necessary. For more information on the thresholds and scope of the regulations please see section 1 in the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers and section 2 of the Guidelines for the Notification and Testing of New Substances: Organisms

Domestic Substances List

The DSL (SOR/94-311) is an inventory of substances in the Canadian marketplace published in the Canada Gazette, Part II, in May 1994. The current structure of the DSL was established in June 2001 (the Order 2001-87-04-01 Amending the Domestic Substances List [SOR/2001-214] (pdf), published in the Canada Gazette, Part II, in July 2001, establishes the structure of the DSL) and it includes eight parts defined as follows:

Criteria for addition of substances to the DSL

The DSL is amended on average 10 times a year to add, update or delete substances. A chemical or polymer must be added to the DSL under section 66 of CEPA if between January 1, 1984, and December 31, 1986, it was manufactured or imported into Canada by any person in a quantity greater than or equal to 100 kg in any one calendar year, or if it was in Canadian commerce, or used for commercial manufacturing purposes in Canada.

A living organism must be added to the DSL under section 105 of CEPA if it was manufactured in or imported into Canada by any person between January 1, 1984, and December 31, 1986, and if during this period it entered or was released into the environment without being subject to conditions under an Act of Parliament or of the legislature of a province.

In addition, a substance must be added to the DSL under subsection 87(1), 87(5), or 112(1) of CEPA within 120 days once all of the following criteria are met:

Criteria for adding, varying or rescinding SNAc requirements under CEPA for substances to be added to or already on the DSL

Amendments to the DSL may also add, vary, or rescind reporting obligations imposed under the SNAc provisions of CEPA. When substances are suspected to pose a risk to human health or the environment if used in certain new activities, they can be added to the DSL with reporting obligations under subsection 87(3) or 112(3) of CEPA. The information submitted enables the Government to assess risks associated with proposed new activity involving substances before they are undertaken in Canada and determine whether additional risk management may be required.

Adding 18 substances to the DSL

The Government assessed information on 18 new substances (chemicals and polymers) reported to the New Substances Program and determined that they meet the criteria for their addition to the DSL, under subsections 87(1) and 87(5) of CEPA. These 18 substances were therefore added to the DSL and are no longer subject to the notification and assessment requirements under sections 81 and 83 of CEPA.

Two of the 18 substances were subjected to SNAc provision under CEPA before their addition to the DSL:

The SNAc provisions were applied to the two substances as the Government identified potential environmental and human health concerns if the substances are used in certain new activities. In order to maintain the reporting obligations associated with these substances, SNAc requirements are carried over, as both substances are added to the DSL under Order 2018-87-06-01.

Objectives

Order 2018-87-06-01 is made pursuant to subsections 87(1), 87(3) and 87(5) of CEPA to add 18 substances (chemicals and polymers) to the DSL and maintain the SNAc requirements associated with substances CAS RN 13308-51-5 and CAN 19216-4.

When substances are added to the DSL, these substances are no longer subject to the notification and assessment requirements under sections 81 and 83 of CEPA. This is expected to facilitate access to these substances.

Description

The Order 2018-87-06-01 adds 18 substances (chemical and polymers) to the DSL:

In addition, under the Order 2018-87-06-01, the application of the SNAc provisions of CEPA to boron phosphate (B(PO4)) [CAS RN 13308-51-5] and quaternary ammonium compounds, bis(derivative oil alkyl)dimethyl, salts with smectite group minerals (CAN 19216-4) is maintained. It is therefore mandatory to meet the requirements of subsection 81(3) of CEPA before manufacturing, importing or using these substances for a significant new activity as defined in this Order. The Policy on the Use of Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999 is available online.

When the Department of the Environment or Health Canada suspects that certain new activities in relation to a substance may result in the substance becoming toxic, the SNAc provisions under CEPA are applied to the substance to ensure that adequate additional information is provided by the notifier or any other proponent who wishes to manufacture, import or use the substance for the significant new activities specified in the Order. A Significant New Activity notification (SNAN) containing all prescribed information specified in the Order 2018-87-06-01 must then be provided within the prescribed time and prior to undertaking a significant new activity regarding substances with CAS RN 13308-51-5 and CAN 19216-4.

An order amending the DSL is a legal instrument adopted by the Minister of the Environment. The Order is now in force.

The following information pertains to SNAc requirements carried over for two substances:

Applicability of the significant new activities

The Order requires that any person (individual or corporation) engaging in a significant new activity in relation to boron phosphate (B(PO4)), CAS RN 13308-51-5, submits a SNAN containing all of the information prescribed in the Order at least 90 days prior to using the substance for the significant new activity.

In order to address human health concerns, the Order targets the use of the substance boron phosphate (B(PO4)), at identified quantities, when it does not contain particles at the nanoscale (i.e. 1 to 100 nanometers) to manufacture consumer products, natural health products, drugs or cosmetics.

A SNAN is required for the manufacture of such products with the substance in such a manner that the substance is present in a concentration that is greater than or equal to 0.1% by weight.

For some activities where the substance contains particles at the nanoscale (i.e. 1 to 100 nanometers), notification is required when, during a calendar year, the total quantity of the substance used is greater than 100 kg.

For example, a notification is required if a person plans to use a consumer product (e.g. paint) in which the substance is present at the nanoscale in a concentration that is greater or equal to 0.1% by weight and where there is more than 100 kg of the substance involved in a calendar year. Examples of products of concern include, but are not limited to paints, coatings, adhesives, sealants, and epoxies. The substance is not known to be currently used in consumer products, natural health products, drugs or cosmetics in Canada.

Activities that are not subject to the Order

Activities involving the use of the substance as a research and development substance, a site-limited intermediate or an export-only substance are excluded from the Order.

The terms “research and development substance” and “site-limited intermediate substance” are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers). An export-only substance is a substance that is manufactured in or imported into Canada and destined solely for foreign markets.

Uses of the substance that are regulated under the Acts of Parliament listed in Schedule 2 of CEPA, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act are also excluded from the application of the SNAc provisions of CEPA. The Order also does not apply to transient reaction intermediates, impurities, contaminants, partially unreacted materials, or in some circumstances to items such as, but not limited to, wastes, mixtures, or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the SNAc provisions of CEPA. See subsection 81(6) and section 3 of CEPA, and section 3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers for additional information.

Information to be submitted

The Order sets out the information that must be provided to the Minister 90 days before the day on which the substance is used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct human health and environmental assessments within 90 days after the complete information is received.

The earlier assessment of the substance identified concerns associated with potential activities and human chronic exposure that could result in systemic and developmental toxicity to the consumer. The SNAc provisions of CEPA are applied to the substance to obtain information to ensure that the substance will undergo further assessment before significant new activities are undertaken.

The information requirements in the Order relate to general information in respect of the substance, details surrounding its use, exposure information, and developmental and reproductive toxicity data in respect of the substance. Some of the information requirements reference the New Substances Notification Regulations (Chemicals and Polymers).

Additional guidance on preparing a SNAN can be found in section 4 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

Transitional provision

The SNAcs contain a transitional period for the phasing in of the requirements. The transitional period will end on January 1, 2019, or on the day on which Order 2018-87-06-01 is registered, whichever is later.

Applicability of the significant new activities

The Order requires that any person (individual or corporation) engaging in a significant new activity in relation to quaternary ammonium compounds, benzylalkyldimethyl, salts with bentonite, CAN 19216-4, submit a Significant New Activity notification (SNAN) containing all of the information prescribed in the Order at least 90 days prior to using the substance for the significant new activity.

In order to address human health concerns, the Order targets the use of the substance containing particles at the nanoscale (i.e. 1–100 nanometres) in commercial manufacturing activities. The activities include the use of the substance to manufacture consumer products, natural health products, drugs or cosmetics.

A SNAN is required for the manufacture of such products with the substance in such a manner that the substance is present in a concentration that is greater than or equal to 1% by weight.

Notification is also required for other activities when, during a calendar year, the total quantity of the substance used containing particles at the nanoscale (i.e. 1–100 nanometres) is greater than the specified trigger quantities mentioned in the Order. For example, notification is required if a person plans to use more than 100 kg of the substance containing particles at the nanoscale (i.e. 1–100 nanometres) in a calendar year.

Activities that are not subject to the Order

Activities involving the use of the substance as a research and development substance, a site-limited intermediate or an export-only substance are excluded from the Order. Uses of the substance that are regulated under the Acts of Parliament listed in Schedule 2 of CEPA, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act are also excluded from the application of the SNAc provisions of CEPA. The SNAc provisions of CEPA also does not apply to transient reaction intermediates, impurities, contaminants, partially unreacted materials, or in some circumstances to items such as, but not limited to, wastes, mixtures, or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the SNAc provisions of CEPA. See subsection 81(6) and section 3 of CEPA, and section 3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers for additional information.

Information to be submitted

The Order sets out the information that must be provided to the Minister 90 days before the day on which the substance quaternary ammonium compounds, benzylalkyldimethyl, salts with bentonite, CAN 19216-4 is used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct human health and environmental assessments within 90 days after the complete information is received.

The earlier assessment of the substance identified concerns associated with potential activities involving use of the substance containing particles at the nanoscale thereby resulting in exposure and toxicity to human health. The SNAc provisions of CEPA are applied to ensure that the substance will undergo further assessment before significant new activities are undertaken.

The information requirements in the Order relate to general information in respect of the substance, details surrounding its use, exposure information, and toxicity to human health. Some of the information requirements reference the New Substances Notification Regulations (Chemicals and Polymers).

Additional guidance on preparing a SNAN can be found in section 4 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.

Consultation

As the Order is administrative in nature, no consultation was deemed necessary.

Rationale

Substances new to Canada are subject to notification and assessment requirements before they can be manufactured or imported over the thresholds set in the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). These Regulations were made to ensure that new substances introduced to the Canadian marketplace over certain thresholds are risk assessed to identify potential hazards to the environment and human health and that appropriate control measures are taken, if deemed necessary.

The Government assessed information on 18 substances new to Canada, and determined that they meet the criteria for their addition to the DSL. These substances have been added to the DSL and, therefore, they are exempt from notification and assessment requirements under sections 81 and 83 of the Act.

Due to potential human health and environmental concerns, SNAc requirements for substances CAS RN 13308-51-5 and CAN 19216-4 have been maintained, as both substances were added to the DSL. This will enable the Government to assess the risks associated with significant new activities involving these substances before they are undertaken.

“One-for-One” Rule and small business lens

The Order does not trigger the “One-for-One” Rule, as it does not add any additional costs to business. Also, the small business lens does not apply to the Order, as it does not add any administrative or compliance burden to small businesses.

Implementation, enforcement and service standards

Developing an implementation plan, a compliance strategy, or establishing a service standard is not required when adding substances to the DSL or when SNAc requirements are maintained.

When assessing whether or not a substance is subject to SNAc provisions of CEPA, a person is expected to make use of information in their possession, or to which they reasonably have access to. Information to which a person reasonably has access to normally includes information in any of the person’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information and the relevant Safety Data Sheets, formerly “Material Safety Data Sheets” (MSDSs).

If any information becomes available that reasonably supports the conclusion that a substance added to the DSL through this Order is toxic or capable of becoming toxic, the person who is in possession of the information and is involved in activities with the substance is obligated, under section 70 of CEPA, to provide that information to the Minister without delay.

A company can submit a SNAN on behalf of its clients. For example, in cases where a person takes possession or control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN submitted by the person from whom they obtained the substance. The Substances Management Advisory Note “Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999” provides more detail on this subject.

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.

Where a person has questions concerning their obligations to comply with an order, believes they may be out of compliance, or would like to request a PNC, they are encouraged to discuss their particular circumstances with the program by contacting the Substances Management Information Line at eccc.substances.eccc@canada.ca (email), 1-800-567-1999 (toll-free in Canada), or 819-938-3232 (outside of Canada).

An order adding a substance to the DSL does not constitute an endorsement from the Department of the Environment or the Government of Canada of the substance to which it relates, or an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or activities involving the substance.

The Order is now in force. It is therefore mandatory to meet all the requirements of the Order should a person intend to use one of these substances for a significant new activity as defined in the Order.

CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999. In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent, and history of compliance.

Contact

Julie Thompson
Executive Director
Program Development and Engagement Division
Department of the Environment
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-938-3232 (outside of Canada)
Fax: 819-938-5212
Email: eccc.substances.eccc@canada.ca