Vol. 145, No. 21 — October 12, 2011

Registration

SOR/2011-199 September 29, 2011

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2011-87-08-01 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 2011-87-08-01 Amending the Domestic Substances List.

Gatineau, September 28, 2011

PETER KENT
Minister of the Environment

ORDER 2011-87-08-01 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:

1320-51-0 N
65597-02-6 N
68958-56-5 N-P
126758-35-8 N
758689-39-3 N-P
835620-70-7 N-P
1287268-63-6 N-P
1287268-64-7 N-P

2. The portion of column 2 of Part 2 of the List, opposite the reference to the substance 149879-98-1 N-S in column 1, is replaced by the following:

Column 1

Substance

Column 2
Significant New Activity for which substance is subject to subsection 81(3) of the Act

149879-98-1 N-S

  1. Any activity involving the use of the substance 1-Propanaminium, N-(carboxymethyl)-N,N-dimethyl-3-[[(13Z)-1-oxo-13-docosenyl]amino]-, inner salt, in Canada, in any quantity, other than as a chemical additive in sub-surface treatment fluids used in oil and gas production.
  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 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (c) the information specified in item 8 of Schedule 5 to those Regulations;
    • (d) the information specified in item 11 of Schedule 6 to those Regulations;
    • (e) the concentration of the substance in the final product; and
    • (f) any test data or other information 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.

3. (1) Part 3 of the List is amended by deleting the following:

15800-5 N

 

 1,4 Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from, polymer with diethylene glycol, reaction products with Me carbomonocyclecarboxylate and Me methylcarbomonocyclecarboxylate

Benzène-1, 4-dicarboxylate de diméthyle, sous-produits de fabrication, polymérisé avec le diéthylèneglycol, produits de réaction avec un carbomonocyclecarboxylate de méthyle et un méthylcarbomonocyclecarboxylate de méthyle

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

15800-5 N

1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from, polymers with diethylene glycol, hydroxyalkyl esters, arylcarboxylate methylarylcarboxylate

Téréphtalate de diméthyle, produits ou sous-produits, polymérisés avec des esters hydroxyalkyliques de diéthylèneglycol, arylcarboxylates méthylarylcarboxylates

17014-4 N-P

2-Propenoic acid, 2-methyl, 2-alkylalkyl ester, polymer with 2-methylalkyl 2-propenoate

Méthacrylate de 2-alkylalkyle polymérisé avec de l’acrylate de 2-méthylalkyle

18077-5 N

Carboxylic acid, polymer with sodium ethenesulfonate, peroxydisulfuric acid [(HO)S(O)2]2O2 disodium salt-initiated, reaction products with tetrasodium ethenylidenebis(phosphonate)

Acide carboxylique, polymérisé avec l’éthènesulfonate de sodium, amorcé avec le peroxydisulfate de disodium [(HO)S(O)2]2O2, produits de réaction avec l’éthénylidènebis(phosphonate) de tétrasodium

18221-5 N-P

Fatty acids, C18-unsatd., dimers, polymers with glycidyl alkanoate, hydrazine, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 1,1′-methylenebis[4-isocyanatocyclohexane], 4-oxopentanoic acid, polyethylene-polypropylene glycol 2-[[3-(2-hydroxyethoxy)-3-oxopropyl]amino]propyl Me ether and trimethylolpropane, compds. with triethylamine

Dimères d’acides gras insaturés en C18 polymérisés avec un alcanoate de glycidyle, de l’hydrazine, de l’acide 2,2-bis(hydroxyméthyl)propanoïque, du 1,1′ méthylènebis[4 isocyanatocyclohexane], de l’acide 4-oxopentanoïque, de l’oxyde de (2-[[3-(2-hydroxyéthoxy)-3-oxopropyl]amino]propyl)-polyéthylène-polypropylèneglycol et de méthyle et de l’hexaglycérine, composés avec la N,N diéthyléthylamine

18288-0 N-P

2-Propenoic acid, 2-methyl-, 2-alkylalkyl ester, polymer with ethenylbenzene, 2-hydroxyalkyl 2-methyl-2-propenoate, 2-propenoic acid, 2-propenoic acid, 2-methyl-, (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl ester, rel- and 2-propenoic acid, 2-methyl-, monoester with 1,2-propanediol, peroxide, bis(1-methyl-1-phenylethyl) initiated

Méthacrylate de 2-alkylalkyle polymérisé avec du styrène, du méthacrylate de 2 hydroxyalkyle, de l’acide acrylique, du méthacrylate de (1R,2R,4R)-1,7,7-triméthylbicyclo[2.2.1]hept-2-yle, du méthacrylate de 2-hydroxypropyle et du méthacrylate de 1-hydroxyprop-2-yle, amorcé avec du peroxyde de bis(2-phénylpropyle)

18302-5 N-P

Fatty acids, coco, reaction products with organic acid and trimethylolpropane

Acides gras de coco, produits de reaction avec un acide organique et de l’hexaglycérine

18306-0 N-P

2-Propenoic acid, 2-methyl-, telomer with alkyl 2-methyl-2-propenoate, 3-mercaptopropanoic acid and methyl-2-propenoate, ammonium salt

Acide méthacrylique télomérisé avec du méthacrylate d’alkyle, de l’acide 3 mercaptopropanoïque et de l’acrylate de méthyle, sel ammoniacal

18308-2 N-P

Plant oil, ester with pentaerythritol, polymer with α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl), 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, compds. with triethylamine

Huile végétale, ester avec du pentaérythrol, polymérisé avec 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, composés avec la N,N-diéthyléthylamine

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

18143-8 N-P-S

  1. Any activity involving the use of the substance Alkyl dioic acid, polymer with carbonic dichloride and carbopolycyclic diol, substituted phenyl ester:
    • (a) in any quantity in baby bottles or food packaging materials intended for infants up to 18 months of age; or

    • (b) in any quantity that contains unreacted residual Bisphenol A that exceeds 100 kilograms per 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) 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) if the significant new activity is the one described in paragraph 1(a):
      1. (i) the test data and a test report from a study on the migration of the substance out of the product, conducted according to methodology described in the document from the Food and Drug Administration titled Guidance for Industry: Preparation of Premarket Submissions for Food Contact Substances: Chemistry Recommendations that is current at the time the test data are developed, or any other similar study or information that will permit the assessment of the migration of the substance out of the product,
      2. (ii) the hydrolysis rate of the substance as a function of pH and, if known, an identification of the products of the hydrolysis, and
      3. (iii) any other information or test data concerning the substance that are in the possession of or accessible to the person that will permit the assessment of the exposure of the public to residual Bisphenol A and free Bisphenol A derived from the degradation of the substance;
    • (e) if the significant new activity is the one described in paragraph 1(b) and the substance is manufactured in Canada:
      1. (i) a brief description of the manufacturing process that details precursors of the substance, batch or continuous nature of the process, scale of the process, and reaction conditions such as temperature, pressure, catalysts and reaction stoichiometry,
      2. (ii) a flow diagram of the manufacturing process and its main components such as process tanks, holding tanks and distillation towers, and
      3. (iii) a brief description of the major steps in process operations, chemical conversions, points of entry of all feedstock, points of release of the substance or Bisphenol A and processes to eliminate environmental release of the substance or Bisphenol A; and
    • (f) 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 Order.)

Issue and objectives

The purpose of the Order 2011-87-08-01 Amending the Domestic Substances List (hereafter referred to as “the Order”), made under subsections 87(1), (3) and (5) of the Canadian Environmental Protection Act, 1999, is to add 16 substances to the Domestic Substances List, make a correction to the information on one substance and make a correction to the significant new activities for 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 three substances from the Non-domestic Substances List is being proposed.

Description and rationale


The Domestic Substances List

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

The Domestic Substances List was published in the Canada Gazette, Part Ⅱ, in May 1994. However, the Domestic Substances List is not a static list and is subject, from time to time, to additions, deletions or corrections that are 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 has 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. Substances added to the Non-domestic Substances List remain subject to notification and scientific assessment as new substances in Canada when manufactured or imported quantities exceed 1 000 kg per year, in order to protect the environment and human health. However, they are subject to fewer information requirements.

Additions to the Domestic Substances List

Subsection 87(1) of the Canadian Environmental Protection Act, 1999 requires the Minister to add a chemical or a polymer to the Domestic Substances 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.

Where a substance is specified on the Domestic Substances List, subsection 87(3) of the Canadian Environmental Protection Act, 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 that subsection.

Subsection 87(5) of the Canadian Environmental Protection Act, 1999 requires the Minister to add a chemical or a polymer to the Domestic Substances 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 16 substances met the criteria under subsections 87(1), (3) or (5), the Order adds them to the Domestic Substances List.

Corrections to the Domestic Substances List

Corrections to the Domestic Substances List are made by deleting and replacing erroneous information. As the information for one substance listed on the Domestic Substances List was not appropriate, the Order 2011-87-08-01 makes the necessary correction to the List. In addition, the Significant New Activity Notice for one substance is amended to more accurately reflect the targeted activities.

Publication of masked names

Section 88 of the Canadian Environmental Protection Act, 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 the Canadian Environmental Protection Act, 1999. The procedure to be followed for creating such a name is set out in the Masked Name Regulations. The Order 2011-87-08-01 adds eight masked names to the Domestic Substances List. Despite section 88, the identity of these substances may be disclosed by the Minister in accordance with section 315 or 316 of the Canadian Environmental Protection Act, 1999. Persons that wish to determine if a substance is listed on the confidential portion of the Domestic Substances 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 the Canadian Environmental Protection Act, 1999. Three substances that are being added to the Domestic Substances List are present on the Non-domestic Substances List, and will therefore be deleted.

Alternatives

The Canadian Environmental Protection Act, 1999 sets out a process for updating the Domestic Substances List in accordance with strict timelines. Since the 16 substances covered by the Order met the criteria for addition to that List, no alternative to their addition has 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 Domestic Substances List will benefit the public and governments by identifying additional substances that are in commerce in Canada, and will also benefit industry by exempting them from all assessment and reporting requirements under section 81 of the Canadian Environmental Protection Act, 1999. In addition, the Order 2011-87-08-01 will improve the accuracy of the List by making one necessary correction to the information on one substance and making one correction to the significant new activities for one substance to more accurately reflect the targeted activities.

Costs

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

Consultation

As the Order is administrative in nature and does 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 Domestic Substances List identifies substances that, for the purposes of the Canadian Environmental Protection Act, 1999, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers). Furthermore, as the Order only adds 16 substances to the Domestic Substances 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 listed 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 www.gazette.gc.ca/rp-pr/p2/2001/2001-07-04/pdf/g2-13514.pdf.