Order 2020-87-07-01 Amending the Domestic Substances List: SOR/2020-41

Canada Gazette, Part II, Volume 154, Number 6

Registration

SOR/2020-41 March 5, 2020

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Whereas the Minister of the Environment has been provided with information under paragraph 87(1)(a) or (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(1) or (5) of that Act;

Whereas, in respect of the substances being added to the Domestic Substances List 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) 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 footnote a, makes the annexed Order 2020-87-07-01 Amending the Domestic Substances List.

Gatineau, March 2, 2020

Jonathan Wilkinson
Minister of the Environment

Order 2020-87-07-01 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 (1) 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

1200806-67-2 N-S

1 The use, during the period beginning on the day on which this section comes into force and ending on December 31, 2020, of 100 kg or more of the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl)ester in the manufacture 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 child care article or a toy, as those terms are defined in section 1 of the Phthalates Regulations;
  • (b) a natural health product, as defined in subsection 1(1) of the Natural Health Products Regulations, or any 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, during the period beginning on the day on which this section comes into force and ending on December 31, 2020, of 100 kg or more of the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl)ester 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:

  • (a) a natural health product, as defined in subsection 1(1) of the Natural Health Products Regulations, or any drug, as defined in section 2 of the Food and Drugs Act; or
  • (b) a cosmetic, as defined in section 2 of the Food and Drugs Act.

3 Sections 1 and 2 do not include:

  • (a) the use of the substance 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) the use of the substance in a product, as described in those sections, that is for export only.

4 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;
  • (c) the information specified in paragraphs 7(c) and (d) of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
  • (d) the information specified in paragraphs 8(f) and (g) of Schedule 5 to those Regulations;
  • (e) the function of the substance in the product;
  • (f) the quantity of the toy, child care article, natural health product, drug or cosmetic expected to be sold in Canada in a calendar year by the person proposing the significant new activity;
  • (g) the test data and the test report from a toxicity test in respect of the substance that is conducted in accordance with the methodology described in the Organisation for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals, Test No. 416: Two-Generation Reproduction Toxicity, that is current at the time the test is conducted;
  • (h) all other information or test data in respect of the substance that are in the possession of the person proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of the adverse effects that the substance may have on the environment and human health and the degree of environmental and public exposure to the substance;
  • (i) 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;
  • (j) 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; and
  • (k) in the case of a significant new activity described in paragraph 1(a), the test data and the test report from an oral migration test in respect of the substance that is conducted in accordance with the "Head over Heels" methodology described in the Standard Operation Procedure for the Determination of Release of Di-Isononylphthalate (DINP) in Saliva Simulant from Toys and Childcare Articles Using a Head Over Heels Dynamic Agitation Device, published by the European Commission’s Joint Research Centre, that is current at the time the test is conducted; and
  • (l) in the case of a significant new activity described in paragraph 1(b) or (c) or section 2, the test data and the test report from the following:
    • (i) a toxicity test of at least 24 hours in duration in respect of the substance that is conducted in accordance with the methodology described in the OECD Guidelines for the Testing of Chemicals, Test No. 428: Skin Absorption: In Vitro Method, that is current at the time the test is conducted, using rat skin,
    • (ii) a toxicity test of at least 24 hours in duration in respect of the substance that is conducted in accordance with the methodology described in the OECD Guidelines for the Testing of Chemicals, Test No. 428: Skin Absorption: In Vitro Method, that is current at the time the test is conducted, using human skin, and
    • (iii) a toxicity test of at least 24 hours in duration in respect of the substance that is conducted in accordance with the methodology described in the OECD Guidelines for the Testing of Chemicals, Test No. 427, Skin Absorption: In Vivo Method, that is current at the time the test is conducted, using rats; and
  • (m) a certification that the information is accurate and complete, dated and signed by the person 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.

5 The tests referred to in paragraphs 4(g), 4(k) and 4(l) 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 on May 12, 1981 by the OECD, that are current at the time the tests are conducted.

6 The information provided under section 4 is to be assessed within 90 days after the day on which it is received by the Minister.

(2) The portion of section 1 before paragraph (a) in column 2 of Part 2 of the List, opposite the reference to the substance “1200806-67-2 N-S” in column 1, is replaced by the following:

1 The use of the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester in the manufacture of any of the following products in which the substance is present in a concentration equal to or greater than 0.1% by weight:

(3) The portion of section 2 before paragraph (a) in column 2 of Part 2 of the List, opposite the reference to the substance “1200806-67-2 N-S” in column 1, is replaced by the following:

2 The use, in a quantity greater than 1 kg in a calendar year, of the substance 1,2-cyclohexanedicarboxylic acid, 1-butyl 2-(phenylmethyl) ester 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:

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

18546-6 N

Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine and alkanoic acid

Acide 12-hydroxyoctadécanoïque, produits de la réaction avec de l’éthane-1,2-diamine et un acide alcanoïque

19414-2 N-P

1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol and methylalkanediol

Acide benzène-1,3-dicarboxylique polymérisé avec de l’acide benzène-1,4-dicarboxylique, du 2,2-diméthylpropane-1,3-diol, de l’éthane-1,2-diol et un méthylalcanediol

19418-6 N

Plant-based oil, polymer with alkyl aldehyde-alkyl aldehyde reaction by-products, diethylene glycol, ethylene glycol, 4-alkylbenzoic acid, phthalic anhydride, sorbitol, terephthalic acid, tetraethylene glycol and triethylene glycol

Huile végétale polymérisée avec des sous-produits de la réaction d’un alcanal avec un autre alcanal, du 3-oxapentane-1,5-diol, de l’éthane-1,2-diol, un acide 4-alkylbenzoïque, de la 2-benzofurane-1,3-dione, du sorbitol, de l’acide benzène-1,4-dicarboxylique, du 3,6,9-trioxaundécane-1,11-diol et du 3,6-dioxaoctane-1,8-diol

19419-7 N-P

2-Propenoic acid, 2-methyl-, alkyl ester, polymer with alkyl 2-propenoate

2-Méthylprop-2-ènoate d’alkyle polymérisé avec un prop-2-ènoate d’alkyle

19420-8 N-P

Dicarboxycarbomonocycle, polymer with butyl acrylate, disubstitutedacrylamide, 1,3-dihydroxy-2-methylpropane, dimethylolpropionic acid, 2-hydroxyethyl methacrylate, hydroxypivalyl hydroxypivalate, isophorone diisocyanate and methyl methacrylate

Acide carbomonocycledicarboxylique polymérisé avec du prop-2-ènoate de butyle, un prop-2-ènamide disubstitué, du 2-méthylpropane-1,3-diol, de l’acide diméthylolpropionique, du 2-méthylprop-2-ènoate de 2-hydroxyéthyle, de l’hydroxy-2,2-diméthylpropanoate d’hydroxy-2,2-diméthylpropanoyle, du diisocyanate de 3,5,5-triméthylcyclohex-2-ène-1-one et du 2-méthylprop-2-ènoate de méthyle

19421-9 N

2-Propenoic acid, 2-methyl-, C12-15- alkyl esters, polymers with cetyl methacrylate, 2-(dialkyllamino)ethyl methacrylate and stearyl methacrylate, tert-Bu 2-ethylhexaneperoxoate-initated

2-Méthylprop-2-ènoates d’alkyle en C12-15, polymérisés avec du 2-méthylprop-2-ènoate d’hexadécyle, du 2-méthylprop-2-ènoate de 2-(dialkylamino)éthyle et du 2-méthylprop-2-ènoate d’octadécyle, amorcé avec du 2-éthylhexaneperoxoate de tert-butyle

Coming into Force

4 (1) This Order, except subsections 2(2) and (3), comes into force on the day on which it is registered.

(2) Subsections 2(2) and (3) come into force on January 1, 2021.

N.B. The Regulatory Impact Analysis Statement for this Order appears following SOR/2020-42, Order 2020-112-07-01 Amending the Domestic Substances List.