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Registration

SOR/2011-271 November 22, 2011

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2011-87-09-01 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), hereby makes the annexed Order 2011-87-09-01 Amending the Domestic Substances List.

Gatineau, November 17, 2011

PETER KENT
Minister of the Environment

ORDER 2011-87-09-01 AMENDING THE DOMESTIC SUBSTANCES LIST
AMENDMENTS

1. (1) Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:

68664-06-2 N

(2) Part 1 of the List is amended by adding the following in numerical order:

1071-93-8 N

57033-22-4 N-P

127312-13-4 N

163183-04-8 N-P

1283712-54-8 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

68664-06-2 N-S

  1. Any activity involving the use of the substance Phosphonic acid, P-methyl-, diphenyl ester, polymer with 4,4′(1-methylethylidene)bis[phenol] in Canada
    • (a) in foams for mattresses and household upholstered furniture; or
    • (b) in any other items intended for use by or for children.
  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 proposed 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 from a repeated-dose mammalian toxicity test of the substance of at least 28 days duration, using the most significant route of potential human exposure to the substance, namely, oral, dermal or inhalation, including
      1. (i) the age, sex, number, species, strain and source of the animals tested,
      2. (ii) the route by which the substance is administered and the conditions under which the mammalian toxicity test is conducted, and
      3. (iii) the dose of the substance, vehicle by means of which the substance is administered and its concentration in that vehicle;
    • (e) the information specified in subitems 10(a) and (b) of Schedule 11 to those Regulations; and
  3. The test described in paragraph 2(d) must be conducted in conformity with the laboratory practices described by the Organisation for Economic Co-operation and Development (“OECD”) in the “OECD Principles of Good Laboratory Practice”, as set out in Annex II of the OECD Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted by the OECD on May 12, 1981, and that 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:

10139-5 N-P

2-Propenoic acid, 2-methyl-, polymer with butyl 2-methyl-2-propenoate, butyl 2-propenoate, methyl 2-methyl-2-propenoate and 2-(2-oxo-1-heteromonocycle)ethyl 2-methyl-2-propenoate

Acide 2-méthylpropén-2-oïque polymérisé avec le 2-méthylpropén-2-oate de butyle, le propén-2-oate de butyle, le 2-méthylpropén-2-oate de méthyle et le 2-méthylpropén-2-oate de 2-(2-oxo-1-hétéromonocycle)éthyle

16065-0 N-P

Alkanoic acid, 3-oxo-, 2-(2-methyl-1-oxo-2-propenyloxyl) ethyl ester, polymer with alkyl 2-propenoate, 2-hydroxyethyl 2-propenoate, methyl 2-alkyl-2-propenoate and rel-(1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl 2-methyl-2-propenoate

3-Oxoalcanoate de 2-(2-méthyl-1-oxoprop-2-ènyloxyl) éthyle, polymérisé avec de l’acrylate d’alkyle, de l’acrylate de 2-hydroxyéthyle, du 2-alkylacrylate de méthyle et du méthacrylate de rel-(1R,2R,4R)-1,7,7-triméthylbicyclo[2.2.1]hept-2-yle

16169-5 N-P

2-Propenoic acid, 2-alkyl-, 2-substitutedalkyl ester, polymer with ethenylbenzene, 2-propenoic acid and rel-(1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl 2-methyl-2-propenoate, 2-hydroxy-3-(1-oxoneodecyl)oxy]propyl ester

2-Alkylacrylate d’alkyle substitué en position 2, polymérisé avec du styrène, de l’acide acrylique et du méthacrylate de rel-(1R,2R,4R)-1,7,7-triméthylbicyclo[2.2.1]hept-2-yle, ester 2-hydroxy-3-(1-oxonéodécyl)oxy]propylique

16256-2 N

Alkanoic acid, -hydroxy-, polymer with 3-hydroxy-2-(hydroxymethyl)-2-alkylpropanoic acid and 2-oxepanone, octanoate, polymer with butyl 2-methyl-2-propenoate and oxiranylmethyl 2-methyl-2-propenoate reaction products with 1H-isoindole-1,3(2H)-dione and N-methylbenzene methanamine, isononaoates (salts)

Acide hydroxyalcanoïque polymérisé avec de l’acide 2,2 bis(hydroxyméthyl)alcanoïque et de l’oxépan-2-one, octanoate, polymérisé avec des produits de réaction de l’acrylate de butyle et du méthacrylate d’oxiranylméthyle avec du 1H-isoindole-1,3(2H)-dione et de la N-tolylméthylamine, isononaoates (sels)

16304-5 N

Alkanedioic acid, polymer with 2,2-dialkyl-1,3-propanediol, 2-alkyl-2-(hydroxymethyl)-1,3-propanediol and hexahydro-1,3-isobenzofurandione

Acide alcanedioïque polymérisé avec du 2,2-dialkylpropane-1,3-diol, du 2-alkyl-2-(hydroxyméthyl)propane1,3-diol et de l’hexahydroisobenzofuran-1,3-dione

18312-6 N

Aromatic isocyanate, polymer with alkyl oxirane, polymer with oxirane, ether with alkyl diol

Isocyanate aromatique, polymérisé avec un alkyloxirane, polymérisé avec de l’oxirane, éther avec un alkyldiol

18314-8 N-P

Fatty acids, C18-unsatd., dimers, polymers with alkyldiamine, glycidyl neodecanoate, α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl), 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, neopentyl glycol, 4-oxopentanoic acid and trimethylolpropane, compds. with triethylamine

Dimères d’acides gras insaturés en C18 polymérisés avec une alkyldiamine, du néodécanoate de glycidyle, de l’α-hydro-ω-hydroxypoly(oxybutane-1,4-diyle), de l’acide 2,2-bis(hydroxyméthyl)propanoïque, du 5-isocyanate de 1 (isocyanatométhyl)-1,3,3-triméthylcyclohexane, du néopentylglycol, de l’acide 4-oxopentanoïque et de l’hexaglycérine, composés avec la N,N-diéthyléthylamine

18315-0 N-P

2-Propenoic acid, substitutedalkyl ester, polymer with ethenylbenzene, 2-oxepanone, homopolymer, 2-[(1-oxo-2-propen-1-yl)oxy]ethyl ester and 2-propenoic acid, alkyl ester, ethaneperoxoic acid, 1,1-dimethylethyl ester initiated

Acrylate d’alkyle substitué, polymérisé avec du styrène, un ester 2-[(1-oxoprop-2-èn-1-yl)oxy]éthylique d’oxépan 2-one homopolymérisée et un acrylate d’alkyle, amorcé avec de l’éthaneperoxoate de tert-butyle

18316-1 N-P

2-Propenoic acid, alkyl ester, polymer with ethenylbenzene and substituted-2-propenoate, bis(1-methyl-1-phenylethyl) peroxide-initiated

Acrylate d’alkyle, polymérisé avec du styrène et un acrylate substitué, amorcé avec du peroxyde de bis(2-phénylprop-2-yle)

18317-2 N-P

2-Propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-hydroxyalkyl 2-methyl-2-propenoate, alkyl 2-alkyl-2-propenoate and α-(2-methyl-1-oxo-2-propenyl)-ω-hydroxypoly [oxy(methyl-1,2-ethanediyl)], compd. with 2-(dimethylamino) ethanol

Acide méthacrylique polymérisé avec du styrène, du méthacrylate de 2 hydroxyalkyle, du méthacrylate d’alkyle et de l’α-(2-méthyl-1-oxoprop-2-ènyl)-ω-hydroxypoly[oxypropan-1,2-diyle)], composé avec le 2-(diméthylamino)éthanol

18319-4 N-P

2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with ethenylbenzene, alkyl 2-methyl-2-propenoate and 2-alkylalkyl-2-methyl-2-propenoate, peroxide, bis(1-methyl-1-phenylethyl) initiated

Méthacrylate de 2-hydroxyéthyle, polymérisé avec du styrène, du méthacrylate d’alkyle et du méthacrylate de 2-alkylalkyle, amorcé avec du peroxyde de bis(2-phénylprop-2-yle)

18320-5 N-P

2-Propenoic acid, 2-methyl-, substitutedalkyl ester, polymer with 1,1′-(1,6-hexanediyl) di-2-propenoate, heteromonocycle, 2-oxo and rel-(1R, 2R, 4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl 2-propenoate

Méthacrylate d’alkyle substitué, polymérisé avec du diacrylate de 1,1′-(hexane-1,6-diyle), un hététeromonocycle, de l’acrylate de 2-oxo et de rel-(1R, 2R, 4R)-1,7,7-triméthylbicyclo[2.2.1]hept-2-yle

18321-6 N-P

2-Propenoic acid, 2-methyl-, alkyl ester, polymer with alkyl 2-propenoate, ethenylbenzene, substituted heteromonocycle homopolymer 2-[(1-oxo-2-propen-1-yl)oxy]ethyl ester and 2-propenoic acid, 2,2′-(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated

Méthacrylate d’alkyle polymérisé avec de l’acrylate d’alkyle, du styrène, un ester 2 [(1-oxoprop-2-èn1-yl)oxy]éthylique d’homopolymère d’hétéromonocycle substitué et de l’acide acrylique, amorcé avec du 2,2′-(diazène-1,2-diyl)bis[2-méthylbutanenitrile]

18322-7 N-P

Hexanedioic acid polymer with 1,6-hexanediol, polyester polyol, polycaprolactone, polypropylene glycol, butyl methacrylate, hydroxyethyl methacrylate, methacrylate acid, methyl methacrylate, and diphenylmethene diisocyanate

Acide adipique polymérisé avec de l’hexane-1,6-diol, du polyester de polyol, du polycaprolactone, du polypropylèneglycol, du méthacrylate de butyle, du méthacrylate d’hydroxyéthyle, de l’acide méthacrylique, du méthacrylate de méthyle et du diisocyanate de diphénylméthane

18323-8 N

Distillates (Fischer-Tropsch), branched and linear

Distillats (Fischer-Tropsch), ramifiés et linéaires

18324-0 N

Kerosine (Fisher-Tropsch), full range, branched and linear

Kérosène (Fisher-Tropsch), total, ramifié et linéaire

18325-1 N

Naphtha (Fischer-Tropsch), light, branched and linear

Naphta (Fischer-Tropsch), léger, ramifié et linéaire

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

18277-7 N-S

  1. Any activity involving either of the following uses of the substance 5,5′-(Polyalkenylalkanediyl)bis(3-substituted-4H-1,2,4-triazole), in Canada, in any quantity:
    • (a) as a component in lubricating fluids for consumers or as a component in lubricating fuels for consumers, when the concentration of the substance is greater than 0.5%; or
    • (b) as a component in personal care products.
  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 mutagenicity test data obtained from each of the following tests of the substance:
      1. (i) one in vitro test, with and without metabolic activation, for gene mutations,
      2. (ii) one in vitro test, with and without metabolic activation, for chromosomal aberrations in mammalian cells, and
      3. (iii) one in vivo mammalian test for chromosomal aberrations or gene mutations or another indicator of mutagenicity, together with data substantiating that the tissue investigated was exposed to the substance or its metabolites, that permits an assessment of in vivo mutagenicity; and
    • (e) any other information or test data concerning the substance that are in the possession of or accessible to the person who intends to use the substance for the significant new activity 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.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the orders.)

Issue and objectives

The purpose of the Order 2011-87-09-01 Amending the Domestic Substances List and the Order 2011-66-09-01 Amending the Domestic Substances List (hereafter collectively referred to as “the Orders”), made under subsections 66(3), 87(1), (3) and (5) of the Canadian Environmental Protection Act, 1999 (CEPA 1999), is to add 24 substances to the Domestic Substances List and make a correction to the information on one substance. In addition, since a substance cannot appear on both the Domestic Substances List and the Non-domestic Substances List, an order to remove five substances from the Non-domestic Substances List is also being proposed.

Description and rationale

The Domestic Substances List

Subsection 66(1) of CEPA 1999 requires that the Minister of the Environment maintain a list of substances, to be known as the Domestic Substances List (or the List), which specifies all substances that, in the case of chemicals or polymers, “the Minister is satisfied were, between January 1, 1984 and December 31, 1986, (a) manufactured in or imported into Canada by any person in a quantity of not less than 100 kg in any one calendar year; or (b) in Canadian commerce or used for commercial manufacturing purposes in Canada.”

For the purposes of CEPA 1999, the List is the sole basis for determining whether a substance is “existing” or “new” to Canada. Substances on the List, except those identified with the indicator “S”, “S’ “ or “P” (see footnote 2), are not subject to the requirements of section 81 of CEPA 1999 or the New Substances Notification Regulations (Chemicals and Polymers) made under section 89 of CEPA 1999. Substances that are not on the List will require notification and assessment as prescribed by these Regulations before they can be manufactured in or imported into Canada.

The List, published in the Canada Gazette, Part Ⅱ, in May 1994, is not static and is subject, from time to time, to additions, deletions or corrections that are also published in the Canada Gazette. The Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214), published in the Canada Gazette, Part Ⅱ, on July 4, 2001, establishes the structure of the List, whereby substances or living organisms are listed by categories based on certain criteria. (see footnote 3)

The Non-domestic Substances List

The United States Toxic Substances Control Act Inventory had been chosen as the basis for the Non-domestic Substances List. On a semi-annual basis, the Non-domestic Substances List is updated based on amendments to the American inventory. The Non-domestic Substances List only applies to substances that are chemicals and polymers.

In order to protect the environment and human health, substances that are added to the Non-domestic Substances List remain subject to notification and scientific assessment as new substances in Canada when manufactured or imported quantities of the substance exceed 1 000 kg per year. However, these substances are subject to fewer information requirements under the New Substances Notification Regulations (Chemicals and Polymers).

Additions to the Domestic Substances List

Where a substance was not included on the Domestic Substances List and the Minister of the Environment subsequently learns that, between January 1, 1984, and December 31, 1986, the substance was, (a) manufactured in or imported into Canada by any person in a quantity of not less than 100 kg in any one calendar year; or (b) in Canadian commerce or used for commercial manufacturing purposes in Canada, subsection 66(3) of CEPA 1999 requires the Minister to add the substance to the List.

Subsection 87(1) of CEPA 1999 requires the Minister to add a chemical or a polymer to the List within 120 days after the following conditions are met:

  • (a) the Minister has been provided with information in respect of the substance under section 81 or 82 and any additional information or test results required under subsection 84(1);
  • (b) the Ministers are satisfied that the substance has been manufactured in or imported into Canada by the person who provided the information in excess of
    1. (i) 1 000 kg in any calendar year,
    2. (ii) an accumulated total of 5 000 kg, or
    3. (iii) the quantity prescribed for the purposes of this section;
  • (c) the period for assessing the information under section 83 has expired; and
  • (d) no conditions specified under paragraph 84(1)(a) in respect of the substance remain in effect.

If a substance is specified on the List, subsection 87(3) of CEPA 1999 permits the Minister to indicate on the List that subsection 81(3) applies with respect to the substance and to specify the significant new activities for the application of this subsection.

Subsection 87(5) of CEPA 1999 requires the Minister to add a chemical or a polymer to the List within 120 days after the following conditions are met:

  • (a) the Minister has been provided with any information in respect of the substance under subsections 81(1) to (13) or section 82, any additional information or test results required under subsection 84(1), and any other prescribed information;
  • (b) the period for assessing the information under section 83 has expired; and
  • (c) no conditions specified under paragraph 84(1)(a) in respect of the substance remain in effect.

Since one substance met the criteria under subsection 66(3) and 23 substances met the criteria under subsections 87(1), (3) or (5), the Orders add them to the List.

Corrections to the Domestic Substances List

Corrections to the List are made by deleting and replacing erroneous information. As the information for one substance on the List was not appropriate, the Order 2011-87-09-01 makes the necessary correction to the List.

Publication of masked names

Section 88 of CEPA 1999 requires the use of a masked name where the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information in contravention of section 314 of CEPA 1999. The procedure to be followed for creating such a name is set out in the Masked Name Regulations. The Order 2011-87-09-01 adds 18 masked names to the List. Despite section 88, the identity of these substances may be disclosed by the Minister in accordance with sections 315 or 316 of CEPA 1999. Persons that wish to determine if a substance is on the confidential portion of the List must file a Notice of Bona Fide intent to manufacture or import with the New Substances program.

Deletions from the Non-domestic Substances List

Substances added to the Domestic Substances List, if they appear on the Non-domestic Substances List, shall be deleted from that List as indicated under subsections 87(1) and (5) of CEPA 1999. Five substances that are being added to the Domestic Substances List are present on the Non-domestic Substances List, and would therefore be deleted.

Alternatives

CEPA 1999 sets out a process for updating the List in accordance with strict timelines. Since the 24 substances covered by the Orders meet the criteria for addition to the List, no alternatives to their addition have been considered.

Similarly, there is no alternative to the proposed Non-domestic Substances List corrections, since a substance name cannot be on both the Domestic Substances List and the Non-domestic Substances List.

Benefits and costs

Benefits

The amendment of the List will benefit the public and governments by identifying additional substances that are in commerce in Canada. Also, it will benefit the industry by exempting them from assessment and reporting requirements under subsection 81(1) of CEPA 1999. Furthermore, the Order 2011-87-09-01 will improve the accuracy of the List by making one necessary correction to the information on one substance.

Costs

There will be no incremental costs to the public, industry or governments associated with the Orders.

Consultation

As the Orders are administrative in nature and do not contain any information that would be subject to comment or objection by the general public, no consultation was required.

Implementation, enforcement and service standards

The List identifies substances that, for the purposes of CEPA 1999, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers). Furthermore, as the Orders only add substances to the List, developing an implementation plan or a compliance strategy or establishing a service standard is not required.

Contact

Greg Carreau
Acting Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:
1-800-567-1999 (toll free in Canada)
819-953-7156 (outside of Canada)
Fax: 819-953-7155
Email: substances@ec.gc.ca

Footnote a
S.C. 1999, c. 33

Footnote b
SOR/94-311

Footnote c
SOR/2005-247

Footnote d
S.C. 1999, c. 33

Footnote 1
SOR/94-311

Footnote 2
Some substances on the Domestic Substances List with the indicator “S” or “S’ ” may require notification in advance of their manufacture, import or use for a significant new activity. Aswell, substances with the indicator “P” require notification in advance of their manufacture or import if they are in a form that no longer meets the reduced regulatory requirement criteria as defined in the New Substances Notification Regulations (Chemicals and Polymers).

Footnote 3
For more information, please visit http://gazette.gc.ca/archives/p2/2001/2001-07-04/pdf/g2-13514.pdf.