Vol. 147, No. 11 — May 22, 2013

Registration

SOR/2013-92 May 6, 2013

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2013-87-03-01 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 2013-87-03-01 Amending the Domestic Substances List.

Gatineau, April 26, 2013

PETER KENT
Minister of the Environment

ORDER 2013-87-03-01 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:

  • 77226-90-5 N
  • 710292-85-6 N

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

1310-53-8 N-S

  1. Any activity involving, in any one calendar year, the use of more than a total of 100 kg of the substance germanium dioxide engineered to contain particles of a size ranging from 1 to 100 nm in one or more dimensions.

  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 that 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 Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (d) the analytical information used to determine the size of the primary and secondary particles;
    • (e) 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 have access, and that are relevant to identifying hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance; and
    • (f) the identification of every other government agency, either outside or within Canada, that has been notified of the significant new activity by the person proposing it and, if known, the agency's file number and the outcome of the assessment and, if any, the risk management actions in relation to the substance imposed by the agency.
  3. 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:

18275-5 N-P

1,3-Benzenedicarboxylic acid, polymer with alkanediol, 2,2-dimethyl-1,3-propanediol, 2-ethyl-2-(hydroxymethyl)1,3-propanediol, hexanedioic acid and 1,3-isobenzofurandione

Acide isophtalique polymérisé avec un alcanediol, du néopentanediol, du 2-éthyl-2-(hydroxyméthyl)propane-1,3-diol, de l'acide adipique et de l'isobenzofurane-1,3-dione

18548-8 N

Phenol, 4,4′-(1-methylethylidene)bis-, polymer with diisocyanatoalkane and substituted, substituted-polyoxyalkyldiyl

4,4′-(Propane-2-ylidène)bisphénol polymérisé avec un diisocyanatoalcane et un poly(oxyalcane-diyle) substitué

18551-2 N-P

1,4-Benzenedicarboxylic acid, polymer with alkanedioic acid and alkanediamine

Acide téréphtalique polymérisé avec un acide alcanedioïque et une alcanediamine

18553-4 N-P

2-Propenoic acid, 2-methyl-, polymer with ethyl 2-alkenoate and α-(2-methyl-1-oxo-2-propen-1-yl)-ω-[2,4,6-tris(1-phenylethyl)phenoxy]poly(oxy-1,2-ethanediyl) and α-(2-methyl-1-oxo-2-propen-1-yl)-ω-[hydroxy-, alkyl ethers]poly(oxy-1,2-ethanediyl)

Acide méthacrylique polymérisé avec un alc-2-ènoate d'éthyle, de l'α-(2-méthylprop-2-énoyl)-ω-[2,4,6-tris(1-phényléthyl)phénoxy]poly(oxyéthane-1,2-diyle) et de l'α-(2-méthylprop-2-énoyl)-ω-[hydroxyalcoxy]poly(oxyéthane-1,2-diyle)

18554-5 N-P

1,4-Benzenedicarboxylic acid, polymer with alkanedioic acid and alkanediamine

Acide téréphtalique polymérisé avec un acide alcanedioïque et une alcanediamine

18555-6 N-P

2-Propenoic acid, 2-methyl-, 2-substitutedalkyl ester, polymer with hexadecyl 2-propenoate, octadecyl 2-propenoate and polyfluoroalkyl 2-methyl-2-propenoate

Méthacrylate d'un alkyle substitué en position 2, polymérisé avec de l'acrylate d'hexadécyle, de l'acrylate d'octadécyle et un méthacrylate de polyfluoroalkyle

18556-7 N-P

1,3-Benzenedicarboxylic acid, polymer with 1,3-bis(1-isocyanato-1-methylethyl)benzene, substituted carbomonocycle, 2,2-dimethyl-1,3-propanediol, hexanedioic acid, 1,6-hexanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and 2,2′-oxybis(ethanol), diethanolamine-blocked, compds. with 2-(dimethylamino)ethanol

Acide isophtalique polymérisé avec du 1,3-bis(2-isocyanatopropane-2-yl)benzène, un carbomonocycle substitué, du néopentanediol, de l'acide adipique, de l'hexane-1,6-diol, de l'acide 2,2-bis(hydroxyméthyl)propanoïque et du 2,2′-oxybis(éthanol), séquencé avec du 2,2′-azanediylbiséthanol, composés avec du 2-(diméthylamino)éthanol

18557-8 N-P

Aromatic dicarboxylic acid, dimethyl ester, polymer with aliphatic diol, aliphatic diisocyanate, dioic acid and alkane diol

Ester diméthylique d'un acide aromatique dicarboxylique polymérisé avec un diol aliphatique, un diisocyanate aliphatique et un alcanediol

18558-0 N

Cyclohexanedicarboxaldehyde

Cyclohexanedicarbaldéhyde

18559-1 N

Cyclohexanedicarboxaldehyde

Cyclohexanedicarbaldéhyde

4. (1) Part 4 of the List is amended by deleting substance “18309-3 N-P-S” in column 1 and the Significant New Activity in column 2 opposite the reference to that substance.

(2) 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

18309-3 N-P-S

  1. Any activity involving the use of the substance 2-Propenoic acid, 2-methyl-, alkyl ester, polymer with perfluoroalkylethyl 2-methyl-2-propenoate and vinyl chloride in aerosol or spray-applied products intended to be applied in a location other than an industrial setting.

  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 that 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 and test report from the subchronic inhalation toxicity study, in relation to the substance in rats, on 6:2 Fluorotelomer alcohol, conducted according to the methodology described in the Organisation for Economic Co-operation and Development ("OECD") Test Guideline for the Testing of Chemicals No. 413 ("Test Guideline"), entitled Subchronic Inhalation Toxicity: 90-day Study, that is current at the time of the test, and 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 by the OECD on May 12, 1981, that is current at the time of the test, or from any other similar study or information that will permit assessment of the subchronic inhalation toxicity of 6:2 Fluorotelomer alcohol; and
    • (e) a summary of 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 have access, and that are relevant to identifying hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance.
  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.)

1. Background

The Domestic Substances List

The Domestic Substances List (DSL) is a list of substances or living organisms that are considered “existing” for the purposes of the Canadian Environmental Protection Act, 1999 (CEPA 1999). “New” substances or living organisms, which are not on the DSL, are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. These requirements are set out in section 81 of CEPA 1999 and the New Substances Notification Regulations (Chemicals and Polymers) for substances and in section 106 of CEPA 1999 and the New Substances Notification Regulations (Organisms) for living organisms.

The DSL was published in the Canada Gazette, Part II, in May 1994. The DSL is amended to add or remove substances or to make corrections 10 times a year on average. Substances or living organisms on the DSL are categorized based on certain criteria. (see footnote 2)

The Non-domestic Substances List

The Non-domestic Substances List (NDSL) is a list of substances subject to notification and assessment requirements when manufactured in or imported into Canada in quantities above 1 000 kg per year. Compared to the reporting requirements for a substance not listed on the DSL or the NDSL, there are fewer requirements for substances listed on the NDSL.

The NDSL is updated semi-annually based on amendments to the United States Toxic Substances Control Act Inventory. Furthermore, the NDSL only applies to chemicals and polymers.

2. Issue

Thirteen substances to be added to the DSL and one substance to be added to the NDSL have met the necessary conditions for addition. These substances are currently considered “new” and are therefore subject to reporting requirements before they can be manufactured in or imported into Canada above threshold quantities. This places unnecessary burden on the importers and manufacturers of the substance since sufficient information has been collected for these substances to be listed.

Furthermore, one substance, already specified on the DSL, is being modified to improve the grammatical accuracy of the significant new activity (SNAc) previously published on April 11, 2012, in the Order 2011-87-12-02 Amending the Domestic Substances List.

3. Objectives

The objectives of the Order 2013-87-03-01 Amending the Domestic Substances List and the Order 2013-87-03-02 Amending the Non-Domestic Substances List (hereafter referred to as “the Orders”) are to remove the unnecessary reporting burden associated with the import or manufacture of 15 substances, to make the DSL and NDSL more accurate and to comply with the requirements of CEPA 1999.

4. Description

The Orders add 13 substances to the DSL, including one with a SNAc notice; modify the wording of a SNAc notice for a substance already on the DSL; and add one substance to the NDSL. To protect confidential business information, 10 of the 13 substances being added to the DSL will have their chemical names masked.

As substances cannot be on both the DSL and the NDSL, the proposed Order 2013-87-03-02would delete three substances from the NDSL that are being added to the DSL.

Additions to the Domestic Substances List

The Orders add 13 substances to the DSL including one with a SNAc notice. Substances must be added to the DSL under section 66 of CEPA if they were, between January 1, 1984, and December 31, 1986, manufactured or imported by any person in a quantity greater than 100 kg in any one calendar year or if they were in Canadian commerce, or used for commercial manufacturing purposes in Canada. Substances added under section 87 of CEPA 1999 must be added to the DSL within 120 days once all of the following conditions are met:

  • the Minister has been provided with the most comprehensive package of information regarding the substance; (see footnote 3)
  • the Minister of the Environment and the Minister of Health are satisfied that the substances have already been manufactured in or imported into Canada by the person who provided the information in a quantity beyond that set out in section 87 of CEPA 1999, or that all prescribed information has been provided to the Minister of the Environment, irrespective of the quantities;
  • the period prescribed for the assessment of the submitted information for the substances has expired; and
  • the substance is not subject to any conditions imposed on the import or manufacture of the substance.

Furthermore, significant new activities (SNAcs) may be added to the DSL in relation to a substance to require further information before such activities begin. In this case, one substance is being added to the DSL with SNAcs to ensure further assessment is conducted prior to the commencement of any use of the substance when engineered to contain particles ranging in size from 1 to 100 nanometers in one or more dimensions.

Modifications to the Domestic Substances List

The Orders modify the SNAc wording for one substance in Part 4 of the DSL to improve grammatical accuracy.

Addition to the Non-domestic Substances List

The Orders add one substance to Part I of the NDSL to reflect the removal of the substance from the DSL.

Publication of masked names

The Orders mask the chemical names for 10 of the 13 substances being added to the DSL. Masked names are required by CEPA 1999 if the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information in contravention of CEPA 1999. The procedure to be followed for creating a masked name is set out in the Masked Name Regulations. Anyone who wishes to determine if a substance is on the confidential portion of the DSLmust file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program.

5. 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.

6. Rationale

Thirteen substances to be added to the DSL and one substance to be added to the NDSL have met the necessary conditions for addition. The Orders add 13 substances to the DSL that will be exempt from further reporting requirements under subsection 81(1) of CEPA 1999 and two substances that are subject to a SNAc notice remain subject to subsection 81(3) of CEPA 1999 because SNAcs are added.

CEPA 1999sets out a process for updating the DSL in accordance with strict timelines. Since the 13 substances covered by the Orders meet the criteria for addition to the DSL, no alternatives to their addition have been considered. Similarly, there is no alternative to the proposed NDSL amendments, since a substance name cannot be on both the DSL and the NDSL.

The Orders will benefit the public and governments by identifying additional substances that are in commerce in Canada. Also, they will benefit the industry by exempting these substances from assessment and reporting requirements under subsection 81(1) of CEPA 1999. There will be no incremental costs to the public, industry or governments associated with the Orders.

7. Implementation, enforcement and service standards

The DSL 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 Ordersonly add substances to the DSL, developing an implementation plan or a compliance strategy or establishing a service standard is not required.

8. Contact

Greg Carreau
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
    The Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214), published in the Canada Gazette, Part II, in July 2001, establishes the structure of the DSL. For more information, please visit www.gazette.gc.ca/rp-pr/p2/2001/2001-07-04/pdf/g2-13514.pdf.
  • Footnote 3
    The New Substances Notification Regulations (Chemicals and Polymers) under CEPA 1999 set out the most comprehensive package of information requirements.