Order 2018-87-02-01 Amending the Domestic Substances List: SOR/2018-44

Canada Gazette, Part II: Volume 152, Number 7

Registration

March 19, 2018

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 c 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 d;

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 e, makes the annexed Order 2018-87-02-01 Amending the Domestic Substances List.

Gatineau, March 14, 2018

Catherine McKenna
Minister of the Environment

Order 2018-87-02-01 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

6712-98-7 N-S

1 The use of the substance 2-propanol, 1-[bis(2-hydroxyethyl)amino]- in the manufacture of any of the following products, in such a manner 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 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 in a quantity greater than 10 kg in a calendar year of the substance 2-propanol, 1-[bis(2-hydroxyethyl)amino]-, 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 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 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 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 following information concerning the substance in relation to the significant new activity:
    • (i) whether it is anticipated to be used in products intended for use by or for children,
    • (ii) the anticipated degree of direct human exposure to the substance, including its concentration in the consumer product, cosmetic, natural health product or drug, as well as the duration, frequency and circumstances of exposure and the factors that may limit direct human exposure, and
    • (iii) historical and other likely uses;
 
  • (d) if the significant new activity could result in dermal exposure of the substance to the population, the test data and a test report from a developmental and reproductive toxicity test conducted via the dermal route, in respect of the substance, according to one of the following:
    • (i) the methodology described in the Organisation for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals, Test No. 415: One-Generation Reproduction Toxicity Study, that is current at the time the test data are developed; or
    • (ii) the methodology described in the OECD Guidelines for the Testing of Chemicals, Test No. 416: Two-Generation Reproduction Toxicity Study, that is current at the time the test data are developed;
  • (e) a summary of all other information or test data in respect of the substance that is in the possession of the person who is proposing the significant new activity, or to which they have access, and that are relevant to identifying the hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance;
  • (f) 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;
  • (g) 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; and
  • (h) 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.
 

5 The studies referred to in paragraph 4(d) must be conducted by a laboratory whose practices conform with those described in 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 is current at the time the test data are developed.

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

numerical order

amended list

19234-2 N-P

2-Propenoic acid, 2-methyl-, polymer with cyclohexyl 2-methyl-2-propenoate, 2-hydroxyethyl 2-propenoate
and methyl 2-methyl-2-propenoate, 2,2′-(1,2-diazenediyl)bis[alkyl-alkylnitrile]-initiated
 

Acide méthacrylique polymérisé avec du méthacrylate de cyclohexyle, de l’acrylate de 2-hydroxyéthyle et
du méthacrylate de méthyle, amorcé avec du 2,2′-(diazènediyl)bis[alkyl(alcanenitrile)]

19235-3 N-P

1,3-Benzenedicarboxylic acid, polymer with dihydrodioxo carboxypolyheterocyclic acid,
2-ethyl-2-(hydroxymethyl)-1,3-propanediol, hexahydro-1,3-isobenzofurandione and 1,6-hexanediol,
compd. with 2-(dimethylamino)ethanol
 

Acide isophtalique polymérisé avec un acide dihydrodioxo-polyhétérocycle-carboxylique, du
2-éthyl-2-(hydroxyméthyl)propane-1,3-diol, de l’hexahydro-2-benzofurane-1,3-dione et de
l’hexane-1,6-diol, composé avec du 2-(diméthylamino)éthanol

19238-6 N-P

Ethene, alkoxy-, polymer with (methoxyalkoxy)ethene, hydrogenated
 

Oxyde d’alcényle et d’éthyle polymérisé avec du (2 méthoxyalcoxy)éthène, hydrogéné

19240-8 N-P

Poly(oxy-1,2-ethanediyl), α-(alkyl-2-hydroxyethyl)-, ω-hydroxy-, ω-branched alkyl ethers
 

Oxydes d’alkyle ramifié et d’α-2-hydroxyalkyl-ω-hydroxypoly(oxyéthane-1,2-diyle)

19241-9 N

Octadecanoic acid, 12-hydroxy-, reaction product with alkenediamine and alkanoic acid
 

Acide 12-hydroxyoctadécanoïque, produit de la réaction avec un acide alcanoïque et une alcanediamine

19242-0 N-P

Fatty acids, dehydrated castor-oil, polymers with p-tert-butylphenol, formaldehyde, glycerol, pentaerythritol, phthalic anhydride, rosin, fatty acids and tripropylene glycol
 

Acides gras d’huile de ricin déshydratée polymérisés avec du 4-(tert-butyl)phénol, du formaldéhyde, du
propane-1,2,3,triol, du 2,2-bis(hydroxyméthyl)propane-1,3-diol, de la 2-benzofurane-1,3-dione, de la colophane, des acides gras et du tri(propanediol)

19243-1 N

Octadecanoic acid, 12-hydroxy-, reaction product with alkanoic acid and alkanediamine
 

Acide 12-hydroxyoctadécanoïque, produit de la réaction avec un acide alcanoïque et une alcanediamine

19244-2 N-P

Alkane dicarboxylic acid, polymer with 1,3-bis ((5-isocyanato-1,3,3-trimethylcyclohexyl)methyl)-
1,3-diazetidine-2,4-dione and alkanediol
 

Acide alcanedicarboxylique polymérisé avec du 5 isocyanato-1-cyanatométhyl-1,3,3-triméthylcyclohexane,
du 1,3-diazacyclobutane-2,4-dione et un alcanediol

19245-3

Siloxanes and Silicones, 3-[(2-aminoalkyl)amino]alkyl, alkoxy, alkoxy alkyl, alkoxy-terminated
 

Poly[oxy-((3-(2-aminoalkyl)amino)alkyl-alcoxysilyl)-oxy-(alcoxy(alkyl)silyle)] à terminaisons alcoxy

19246-4 N-P

(Di-substituted ethyl) heteromonocycle di-ol, trialkanoate, polymer with di-substituted alkane
 

Trialcanoate d’(éthyl disubstitué)hétéromonocyle-diol polymérisé avec un alcane disubstitué

Coming into Force

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

(2) Section 2 comes into force on April 1, 2018.

N.B. The Regulatory Impact Analysis Statement for this Order appears following SOR/2018-45, Order 2018-112-02-01 Amending the Domestic Substances List.