Vol. 147, No. 7 — March 27, 2013

Registration

SOR/2013-30 March 6, 2013

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2012-87-12-01 Amending the Domestic Substances List

Whereas the Minister of the Environment has been provided with information under either paragraph 87(1)(a) or (5)(a) of the Canadian Environmental Protection Act, 1999 (see footnote a) in respect of each substance referred to in the annexed Order;

Whereas, in respect of the substances being added to the Domestic Substances List (see footnote b) pursuant to subsection 87(1) of that Act, the Minister of the Environment and the Minister of Health are satisfied that those substances have been manufactured in or imported into Canada, by the person who provided the information, in excess of the quantity prescribed under the New Substances Notification Regulations (Chemicals and Polymers) (see footnote c);

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(1), (3) and (5) of the Canadian Environmental Protection Act, 1999 (see footnote d), makes the annexed Order 2012-87-12-01 Amending the Domestic Substances List.

Gatineau, March 4, 2013

PETER KENT
Minister of the Environment

ORDER 2012-87-12-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

  • 208852-57-7 N
    1262996-21-3 N-P
    1310362-62-9 N-P

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

124343-14-2 N-S
  1. Any activity involving the use of the substance magnesium hydroxide sulfate (Mg6(OH)10(SO4))
    • (a) in friction materials, insulation materials, construction materials or architectural coatings that are to be used in a consumer product as defined in section 2 of the Canada Consumer Product Safety Act, in a quantity greater than 100 kg in any one calendar year; or
    • (b) when the substance is engineered to contain particles of particle size ranging from 1 to 100 nanometres in one or more dimensions, in a quantity greater than 10 kg in any one calendar year.
  2. 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 significant new activity begins:
    • (a) a description of the significant new activity in relation to the substance;
    • (b) for a significant new activity described in paragraph 1(a):
      • (i) the information specified in item 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers),
      • (ii) the information specified in item 8 of Schedule 5 to those Regulations,
      • (iii) the information specified in item 11 of Schedule 6 to those Regulations,
      • (iv) the test data and a test report from a subchronic inhalation toxicity study of the substance, including a satellite (reversibility) study, conducted according to the methodology described in the Organisation for Economic Co-operation and Development ((iv) the test data and a test report from a subchronic inhalation toxicity study of the substance, including a satellite (reversibility) study, conducted according to the methodology described in the Organisation for Economic Co-operation and Development (“OECD” Subchronic Inhalation Toxicity: 90-Day Study, where the Test Guideline is current at the time the test data are developed, and
      • (v) the test data and a test report from a study on bronchoalveolar lavage conducted immediately following the last exposure and recovery in the subchronic inhalation toxicity test required in subparagraph (iv), conducted according to the methodology described in the OECD Series on Testing and Assessment, Guidance Document Number 125, titled Guidance Document on Histopathology for Inhalation Toxicity Studies, Supporting TG 412 (Subacute Inhalation Toxicity: 28-Day Study) and TG 413 (Subchronic Inhalation Toxicity: 90-Day Study), where the Guidance Document is current at the time the test data are developed;
    • (c) for a significant new activity described in paragraph 1(b):
      • (i) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers) including
        • (A) the analytical information to determine the primary and secondary particle size of the test substance as administered in the human health and ecological toxicity tests, and
        • (B) the information describing the agglomeration and aggregation state, shape, surface area and surface charge of the test substance as administered in the human health and ecological toxicity tests,
      • (ii) the analytical information to determine the primary and secondary particle size of the substance,
      • (iii) the information describing the agglomeration and aggregation state, shape, surface area and surface charge of the substance,
      • (iv) the analytical information to determine the leachability potential of the substance and its precursors from any final product resulting from the significant new activity, and
      • (v) the test data and a test report on the water solubility of the substance from a test conducted in accordance with the OECD Series on Testing and Assessment, Guidance Document Number 29, titled Guidance Document on Transformation/Dissolution of Metals and Metal Compounds in Aqueous Media, and that is current at the time the test is developed; and
    • (d) all other information or test data in respect of the substance that are in the possession of the person who intends to use the substance for the proposed significant new activity, or to which they have access, and that are relevant to determining whether the substance is toxic or capable of becoming toxic.
  3. The test data and the test reports described in subparagraphs 2(b)(iv) and (v) must be in conformity with the laboratory practices described in the OECD Principles of Good Laboratory Practice (“Principles of GLP”) 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, where the Principles of GLP are current at the time the test data are developed.
  4. The above information will be assessed within 90 days after the day on which it is received by the Minister.

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

14007-3 N-P

2-Propenoic acid, 2-methyl-, polymer with styrene, methyl methacrylate, alkenylamide and isobornyl acrylate

Acide méthacrylique polymérisé avec du styrène, du méthacrylate de méthyle, d’amide alcényle et acrylate d’exo-1,7,7-triméthylbicyclo[2.2.1]hept-2-yle

14438-2 N-P

2-Propenoic acid, 2-methyl, 2-methylpropyl ester, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate, 2,5-furandione and 2-propenoic acid, methyl ester, alkylperoxoate-initiated

Méthacrylate de 2-méthylpropyle polymérisé avec du styrène, de l’acrylate de 2-éthylhexyle, de la furane-2,5-dione et de l’acrylate de méthyle, amorcé avec un alkylperoxoate

14444-8 N-P

1,3-Isobenzofurandione, hexahydro-, polymer with 2,2-bis(hydroxymethyl)-1,3-propanediol and hydroxyalkyl acid ester

Hexahydroisobenzofurane-1,3-dione polymérisée avec du 2,2-bis(hydroxyméthyl)propane-1,3-diol et un ester d’acide hydroxyalkylique

17340-6 N-P

2-Propenoic acid, 2-alkyl-, 1,2-ethanediyl ester, polymer with ethenylbenzene and methyl 2-methyl-2-propenoate

Di-(2-alkylacrylate) d’éthane-1,2-diyle polymérisé avec du styrène et du méthacrylate de méthyle

18531-0 N-P

Benzene, ethenyl-, polymer with alkenyloxy alkylalkane

Styrène polymérisé avec un oxyde d’alcényle et d’(alkyl)alkyle

18534-3 N

1,3-Benzenedicarboxylic acid, polymer with alkylated 1,3-propanediol, hexanedioic acid, 1,6-hexandiol, 1,1′-methylenebis[isocyanatobenzene] and 2,2′-oxybis[ethanol]

Acide isophtalique polymérisé avec du propane-1,3-diol alkylé, de l’acide adipique, de l’hexane-1,6-diol, du 1,1′-méthylènebis [isocyanatobenzène] et du 2,2′-oxybis[éthanol]

4. 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

18215-8 N-S
  1. Any activity involving the use of the substance aromatic isocyanate polymer, alkoxy-alkylamine blocked, in any quantity, in a consumer product as defined in section 2 of the Canada Consumer Product Safety Act, other than its use as
    • (a) a thixotropic agent in a high-solids moisture-curing polyurethane adhesive when the high solids have a composition of solids in a proportion that is equal to or greater than 90%; or
    • (b) a research and development substance as defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers).
  2. 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 significant new activity begins:
    • (a) a description of the significant new activity in relation to the substance;
    • (b) the information specified in Schedule 9 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (c) the information specified in item 5 of Schedule 10 to those Regulations;
    • (d) the test data specified in subsection 11(3) of those Regulations;
    • (e) the test data and a test report from a skin sensitization study concerning the substance that establishes the concentration of the substance that will generate the minimal dose to induce a stimulation of proliferation in draining auricular lymph nodes that is threefold the negative control (EC3 value), conducted according to the methodology described in the OECD Test Guideline No. 429 titled Skin Sensitisation: Local Lymph Node Assay, and in conformity with the laboratory practices described in the Principles of GLP 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, where both the Test Guideline and Principles of GLP are current at the time the test data are developed; and
    • (f) all other information or test data in respect of the substance that are in the possession of the person who intends to use the substance for the proposed significant new activity or to which they have access, and that are relevant to determining whether the substance is toxic or capable of becoming toxic.
  3. The above information will be assessed within 90 days after the day on which it is received by the Minister.

COMING INTO FORCE

5. This Order comes into force on the day on which it is registered.

N.B. The Regulatory Impact Analysis Statement for this Order appears following SOR/2013-31, Order 2012-66-12-01 Amending the Domestic Substances List.