Vol. 146, No. 12 — June 6, 2012

Registration

SOR/2012-108 May 17, 2012

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2012-87-02-01 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 2012-87-02-01 Amending the Domestic Substances List.

Gatineau, May 14, 2012

PETER KENT
Minister of the Environment

ORDER 2012-87-02-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

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

460-73-1 N

1013910-41-2 N

1022990-65-3 N

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

52007-36-0 N-P

52255-41-1 N-P

72892-39-8 N-P

116462-49-8 N-P

205234-78-2 N-P

709654-72-8 N-P

932746-75-3 N-P

1227870-90-7 N-P

1323833-56-2 N-P

1342800-49-0 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

460-73-1 N-S

  1. Any activity involving, in any one calendar year, more than 1 000 kg of Propane, 1,1,1,3,3-pentafluoro, other than
    1. (a) its use in closed-loop cooling systems, whether for refrigeration or air conditioning; or

    2. (b) its use as a foam-blowing agent or aerosol solvent.
  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 quantity of the substance exceeds 1 000 kg in any one calendar year:
    1. (a) a description of the significant new activity in relation to the substance;

    2. (b) the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);

    3. (c) the information specified in item 8 and subitems 10(a) to (d) of Schedule 5 to those Regulations;

    4. (d) the pollution prevention measures proposed to prevent or reduce releases of the substance into the environment; and

    5. (e) the specific substance name, the Chemical Abstracts Service registry number, if any, and the molecular formula of the substance it is replacing.
  3. The above information will be assessed within 90 days after the day on which it is received by the Minister.

1013910-41-2 N-S

  1. Any activity involving the use of the substance Oxirane, 2-ethyl-, polymer with Oxirane, mono-C12-14-sec-alkyl ethers, in pulp and paper production operations or textile wet processing in a quantity greater than 2 000 kg in any one calendar year at the same facility.
  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 quantity of the substance exceeds 2 000 kg in any one calendar year:
    1. (a) a description of the significant new activity in relation to the substance;

    2. (b) the information specified in Schedule 9 to the New Substances Notification Regulations (Chemicals and Polymers);

    3. (c) the information specified in item 5 of Schedule 10 to those Regulations; and

    4. (d) all 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 proposed 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.

1022990-65-3 N-S
  1. Any activity involving the use of the substance Oxirane, 2-ethyl-, polymer with Oxirane, mono-C11-15-sec-alkyl ethers in pulp and paper production operations or textile wet processing in a quantity greater than 2 000 kg in any one calendar year at the same facility.
  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 quantity of the substance exceeds 2 000 kg in any one calendar year:
    1. (a) a description of the significant new activity in relation to the substance;

    2. (b) the information specified in Schedule 9 to the New Substances Notification Regulations (Chemicals and Polymers);

    3. (c) the information specified in item 5 of Schedule 10 to those Regulations; and

    4. (d) all 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 proposed 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. Part 3 of the List is amended by adding the following in numerical order:

14887-1 N-P

Alkyl acrylate, polymer with alkylmethacrylate, aromatic vinyl monomer, aliphatic isocyanate aromatic vinyl monomer alkyl, 2-alkyl-substituted peroxoate-initiated, 2-aminoethanol and hydroxylalkyl urea and hydroxypolyalkane-blocked

 

Acrylate d’alkyle polymérisé avec un méthacrylate d’alkyle, un monomère aromatique vinylique et un monomère d’isocyanate aliphatique substitué par un cycle aromatique vinylique, amorcé avec un peroxoate, bloqué avec du 2-aminoéthanol, un hydroxylalkylurée et un hydroxypolyalcane

15495-6 N-P

1-Butanol, 4-(ethenyloxy)-, polymer with chlorotrifluoroethene and alkoxyethene, hydrogen alkanedioate
 

4-(Éthényloxy)butan-1-ol polymérisé avec du chlorotrifluoroéthylène et de l’oxyde d’alkyle et d’éthényle, hydrogénobutanedioate

16758-0 N

Benzoic acid, 4-[(substitutednaphthalenyl)azo]-, strontium salt
 

Acide 4-[(substituénaphtyl)azo]benzoïque, sel de strontium

17849-2 N-P

Hexane, 1,6-diisocyanato-, homopolymer, polyhalosubstituted-1-alkanol blocked
 

1,6-diisocyanatohexane homopolymérisé bloqué avec l’alcane-1-ol-polyhalosubstitué

18096-6 N-P

Hexane, 1,6-diisocyanato-, homopolymer, polyethylene glycol mono-Me ether- and perhalo-1-alkanol blocked
 

Diisocyanate d’hexane-1,6-diyle, homopolymérisé, bloqué par l’éther monométhylique du polyéthylèneglycol et un perhalo-1-alcanol

18214-7 N

2-Propenoic acid, 2-methyl-, polymer with 2-(substituted)alkyl 2-methyl-2-propenoate, 2-propenoic acid and polyfluoroalkyl 2-methyl-2-propenoate, acetate
 

Acide méthacrylique polymérisé avec du méthacrylate d’alkyle substitué, de l’acide acrylique et de l’acrylate de polyfluoroalkyle, acétate

18353-2 N-P

Hexanedioic acid, polymer with 5-amino-1,3,3-trimethylcyclohexanemethanamine, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 1,1′-methylenebis[isocyanatocyclohexane] and substituted alkanediol, compd. with N,N-diethylethanamine
 

Acide adipique polymérisé avec de la (5-amino-1,3,3-triméthylcyclohexane)méthanamine, du 2-éthyl-2-(hydroxyméthyl)propane-1,3-diol, de l’acide 3-hydroxy-2-(hydroxyméthyl)propanoïque, du 1,1′-méthylènebis[isocyanatocyclohexane] et un alcanediol substitué, composé avec la N,N-diéthyléthanamine

18384-6 N-P

Hexanedioic acid polymer with 2,2-dimethyl-1,3-propanediol, 4,4′-methylenedicyclohexyldiisocyanate, 2,2-dimethyl-1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, castor oil, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, alkanedihydrazide, N-(2-hydroxyethyl)-1,2-diamino ethane, formaldehyde, 1,3-benzenedimethanamine
 

Acide adipique polymérisé avec du néopentanediol, du 4,4′ méthylène(diisocyanatocyclohexane), du 2-éthyl 2-(hydroxyméthyl)propane-1,3 diol, de l’huile de ricin, de l’acide 3-hydroxy-2-(hydroxyméthyl)propanoïque, un alcanedihydrazide, de la N-(2 hydroxyéthyl)éthane-1,2-diamine, du formaldéhyde et de la benzène, 1,3-diméthanamine

18392-5 N-P

Alkanedioic acid, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 1,3-isobenzofurandione, 2-oxiranylmethyl neodecanoate and 1,2,3-propanetriol, 3,5,5-trimethylhexanoate
 

Acide alcanedioïque polymérisé avec du 2-éthyl-2-(hydroxyméthyl)propane-1,3-diol, de l’isobenzofurane-1,3-dione, du néodécanoate d’oxiran-2-ylméthyle et du propane-1,2,3-triol, 3,5,5-triméthylhexanoate

18399-3 N-P

2-Propenoic acid, 2-methyl-, polymer with ethenylbenzene, ethyl 2-propenoate, 2-hydroxyethyl 2-propenoate and methyl 2-methyl-2-propenoate, substituted ethylhexaneperoxoate-initiated, compds. with 2-amino-2-methyl-1-propanol
 

Acide méthacrylique polymérisé avec du styrène, de l’acrylate d’éthyle, de l’acrylate de 2-hydroxyéthyle et du méthacrylate de méthyle, amorcé avec un éthylhexaneperoxoate substituté, composé avec du 2-amino-2-méthylpropan-1-ol

18408-3 N

Fatty acids of natural waxes, 1,3-butylene glycol esters, part saponified
 

Esters d’acides gras de cires naturelles et de butane-1,3-diol, saponifiés partiellement

18409-4 N-P

Butanoic acid, 3-oxo-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester, polymer with butyl 2-propenoate, ethenylbenzene and sodium vinylsulfonate
 

3-Oxobutanoate de 2-[(2-méthyl-1-oxo-prop-2-èn-1-yl)oxy]éthyle polymérisé avec de l’acrylate de butyle, du styrène et du vinylsulfonate de sodium

18410-5 N

Reaction mass of bis[2,4-bis(2-methylalkyl-2-yl)phenyl] 4-(2-methylalkyl-2-yl)phenyl phosphite and 2,4-bis(2-methylalkyl-2-yl)phenyl bis[4-(2-methylalkyl-2-yl)phenyl] phosphite and tris[4-(2-methylalkyl-2-yl)phenyl]phosphite
 

Mélange de phosphite de bis[2,4-bis(2-méthylalkyl-2-yl)phényle], de phosphite de 4-(2-méthylalkyl-2-yl)phényle et de 2,4-bis(2-méthylalkyl-2-yl)phényle, de phosphite de bis[4-(2-méthylalkyl-2-yl)phényle] et de phosphite de tris[2,4-bis(2-méthylalkyl-2-yl)phényle]

4. (1) Part 4 of the List is amended by deleting substance “17849-2 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 deleting substance “18096-6 N-P-S” in column 1 and the Significant New Activity in column 2 opposite the reference to that substance.

(3) Part 4 of the List is amended by deleting substance “18214-7 N-S” in column 1 and the Significant New Activity in column 2 opposite the reference to that substance.

(4) The portion of column 2 of Part 4 of the List, opposite the reference to the substance “16329-3 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

16329-3 N-S

  1. Any activity involving the use of the substance Poly(oxy-alkanediyl), α-(carboxy-oxo-alkenyl)-ω-hydroxy-alkyl ethers, in Canada, in any quantity
    1. (a) in any personal care product; or

    2. (b) in any household product where the substance is not adsorbed to, or chemically reacted with, pigments or other substrates in the product.
  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:
    1. (a) a description of the significant new activity in relation to the substance;

    2. (b) the information specified in Schedule 9 to the New Substances Notification Regulations (Chemicals and Polymers);

    3. (c) the information specified in item 5 of Schedule 10 to those Regulations;

    4. (d) the test data and the test report from a skin sensitization study in respect of the substance, which establishes the concentration of the substance that will generate the minimal dose to induce a stimulation of proliferation in draining lymph nodes that is threefold the negative control (EC3 value), conducted according to the methodology described in the Organisation for Economic Co-operation and Development (“OECD”) Test Guideline for the Testing of Chemicals No. 429 (“Test Guideline”) titled Skin Sensitisation: Local Lymph Node Assay, and in conformity with the laboratory practices 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, and that both the Test Guideline and Principles of GLP are current at the time the test data are developed; and

    5. (e) all 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 proposed significant new activity and that are relevant to determining whether the substance is toxic or capable of becoming toxic.
  3. For each significant new activity, the information specified in paragraphs 11(3)(a) to (c) of the New Substances Notification Regulations (Chemicals and Polymers) must be provided to the Minister at least 90 days before the day on which the quantity of the substance used for the proposed significant new activity exceeds 50 000 kg in any one calendar year.
  4. The above information will be assessed within 90 days after the day on which it is received by the Minister.

(5) The portion of column 2 of Part 4 of the List, opposite the reference to the substance “18097-7 N-P-S” in column 1, is amended by adding “and” at the end of paragraph 2(d) and by replacing paragraphs 2(e) and (f) with the following:

Column 1


Substance

Column 2

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

18097-7 N-P-S

  1. (e) all 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 proposed significant new activity and that are relevant to determining whether the substance is toxic or capable of becoming toxic.

(6) 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

18326-2 N-P-S

  1. Any activity involving the use of the substance tall oil acids, reaction products with dialkyleneamine and acid anhydride, compounds with polyalkylene glycol hydrogen maleate alkyl ethers, in Canada, in any quantity
    1. (a) in any personal care product; or

    2. (b) in any household product where the substance is not adsorbed to, or chemically reacted with, pigments or other substrates in the product.
  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:
    1. (a) a description of the significant new activity in relation to the substance;

    2. (b) the test data specified in paragraphs 11(3)(a) to (c) of the New Substances Notification Regulations (Chemicals and Polymers);

    3. (b) the information specified in Schedule 9 to those Regulations;

    4. (d) the information specified in item 5 of Schedule 10 to those Regulations;

    5. (e) the test data and the test report from a skin sensitization study in respect of the substance, which establishes the concentration of the substance that will generate the minimal dose to induce a stimulation of proliferation in draining lymph nodes that is threefold the negative control (EC3 value), conducted according to the methodology described in the Organisation for Economic Co-operation and Development (“OECD”) Test Guideline for the Testing of Chemicals No. 429 (“Test Guideline”) titled Skin Sensitisation: Local Lymph Node Assay, and in conformity with the laboratory practices 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, and that both the Test Guideline and Principles of GLP are current at the time the test data are developed; and

    6. (f) all 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 proposed 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.)

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 or the New Substances Notification Regulations (Chemicals and Polymers) for substances and in section 106 of CEPA 1999 or the New Substances Notification Regulations (Organisms) for living organisms.

The DSL was published in the Canada Gazette, Part Ⅱ, in May 1994. From time to time, substances are added to, deleted from, or modified on the DSL. 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 based on the United States Toxic Substances Control Act inventory, which is updated semi-annually based on amendments to the American inventory. Furthermore, the NDSL only applies to chemicals and polymers.

2. Issue

Twenty-one substances have met the necessary conditions for addition to the DSL. 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, which places a burden on the importers and manufacturers of the substance. As sufficient information has been collected for these substances, reporting is no longer required. The DSL also needs to be modified to reflect more accurate information on eight substances.

3. Objectives

The objectives of the Order 2012-87-02-01 Amending the Domestic Substances List (hereafter referred to as “the Order”) are to remove the unnecessary reporting burden associated with the import or manufacture of these 21 substances and to make the DSL more accurate.

4. Description

The Order adds 21 substances to the DSL and modifies eight substance identifiers in Parts 1, 3 and 4 of the DSL. To protect confidential business information, 11 of the 21 substances being added to the DSL will have their chemical names masked.

Furthermore, as substances cannot be on both the DSL and the NDSL, the proposed Order 2012-87-02-02 would delete four substances that are being added to the DSL from the NDSL.

Additions to the Domestic Substances List

The Order adds 21 substances to the DSL. 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 substance has been manufactured in or imported into Canada above a quantity set out in paragraph 87(1)(b) of CEPA 1999, or 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, where a substance is specified on the DSL, CEPA 1999 permits the Minister of the Environment to indicate on the DSL that significant new activities provisions apply to the substance.

Modifications to the Domestic Substances List

The Order modifies eight substance identifiers in Parts 1, 3 and 4 of the DSL to make the information reflected by these identifiers more accurate.

Publication of masked names

The Order masks the chemical names for 11 of the 21 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 DSL must file a Notice of Bona Fide intent to manufacture or import with the New Substances program.

5. 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.

6. Rationale

Twenty-one “new” substances have met the necessary conditions to be placed on the DSL. The Order adds these 21 substances to the DSL, and exempts them from further reporting requirements under section 81 of CEPA 1999. In addition, eight substance identifiers on the DSL have been modified to make the information more accurate.

CEPA 1999 sets out a process for updating the DSL in accordance with strict timelines. Since the 21 substances covered by the Order 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 Order will benefit the public and governments by identifying additional substances that are in commerce in Canada. Also, it will benefit the industry by exempting these substances from assessment and reporting requirements under subsection 81(1) of CEPA 1999. Furthermore, the Order will improve the accuracy of the DSL by making necessary modifications to the information for eight substances. There will be no incremental costs to the public, industry or governments associated with the Order.

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 Order only adds substances to the DSL, developing an implementation plan or a compliance strategy or establishing a service standard is not required.

8. 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
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.