ARCHIVED — Vol. 147, No. 1 — January 2, 2013

Registration

SOR/2012-304 December 18, 2012

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2012-87-10-01 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 2012-87-10-01 Amending the Domestic Substances List.

Gatineau, December 14, 2012

PETER KENT
Minister of the Environment

ORDER 2012-87-10-01 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:

  • 21743-27-1 N
  • 150180-89-5 N-P
  • 158916-23-5 N-P
  • 1062609-13-5 N-P
  • 1115230-13-1 N-P
  • 1130609-15-2 N-P
  • 1203962-19-9 N-P
  • 1283712-49-1 N-P
  • 1283712-50-4 N-P
  • 1360913-99-0 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

1224429-82-6 N-S

  1. Any activity involving the use of the substance phosphoric acid, mixed esters with polyethylene glycol and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-1-octanol, ammonium salts in Canada in any quantity:
    • (a) in aerosol or spray-applied household products other than paints and coatings applied by spray; or
    • b) in any other household products at a concentration greater than 1% by weight, other than in paints, coatings, floor waxes and floor finishes.
  2. For each 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) for the significant new activity described in paragraph 1(a)
      • (i) the identification of the equipment to be used or recommended by the product manufacturer to apply the product, such as a low pressure hand-held pump spray, an aerosolizing applicator with propellant, or a pneumatic sprayer using a compressor,
      • (ii) the information describing the equipment and its operation, including its normal operating pressure,
      • (iii) the information describing the size and shape of the nozzle of the equipment which controls the spread of the jet,
      • (iv) the information regarding the particle size distribution of the applied spray produced by the equipment characterized by mean mass median aerodynamic diameter,
      • (v) any information regarding safety labelling for the product containing the substance, such as recommended ventilation and personal protective equipment for users, and
      • (vi) the test data and a test report from a 28-day repeated-dose inhalation toxicity study of the substance, conducted according to the methodology described in the Organisation for Economic Co-operation and Development (“OECD”) Test Guideline No. 412 titled Subacute Inhalation Toxicity: 28-Day Study;
    • (b) for the significant new activity described in paragraph 1(b), the test data and a test report from a 28-day repeated-dose dermal toxicity study of the substance, conducted according to the methodology described in the OECD Test Guideline No. 410 titled Repeated Dose Dermal Toxicity: 28-day study;
    • (c) a description of the proposed significant new activity in relation to the substance;
    • (d) the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (e) the information specified in items 8 and 10 of Schedule 5 to those Regulations;
    • (f) the anticipated annual quantity of the substance to be used in relation to the significant new activity;
    • (g) the identification of every other government agency, either outside or within Canada, that the person proposing the significant new activity has notified of the use of the substance 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;
    • (h ) if known, the three sites in Canada where the greatest quantity of the substance, in relation to the significant new activity, is anticipated to be used or processed and the estimated quantity by site; and
    • (i) all other information or test data concerning the substance that are in the possession of or accessible to the person who proposes 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 test data and the test reports described in subparagraph 2(a)(vi) and paragraph 2(b) must be in conformity with the laboratory practices described by the OECD in the “OECD Principles of Good Laboratory Practice” (“Principles of GLP”) 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 both the Test Guidelines and Principles of GLP are current at the time the test data are developed.
  4. 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:

16064-8  N-P

Phenol, 4,4′-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, oxoalkanoate
4,4′-(Propane-2,2-diyl)bisphénol polymérisé avec du (chlorométhyl)oxirane, oxoalcanoate

18420-6 N-P

Dicarboxylic acid, polymer with 1,6-diisocyanatohexane, 1,2-ethanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and 1,1′-methylenebis[4-isocyanatocyclohexane], compd. with N,N-diethylethanamine
Acide dicarboxylique polymérisé avec du 1,6-diisocyanate d’hexane, de l’éthane-1,2-diol, de l’acide 2,2-bis(hydroxyméthyl)propanoïque et du 1,1′-méthylènebis[4-isocyanatocyclohexane], composé avec de la N,N-diéthyléthanamine

18431-8 N-P

Alkyl methylalkenoates, polymers with alkene, alkyl methylalkenoate, alkyl methylalkenoate and ethenyl alkanoate
Méthylalcénoates d’alkyle polymérisés avec un alcène et un alcanoate d’éthényle

18447-6 N

Fatty acids, tall oil, polymers with aliphatic acid, diethylene glycol, methyloxoheteromonocycle, modified carbomonocycle process stream, phthalic anhydride and terephthalic acid
Acides gras de tallöl polymérisés avec un acide aliphatique, de l’éthane-1,2-diol, un méthyloxohétéromonocycle, un extrait d’hydrocarbure monocyclique modifié, de la 2 benzofurane-1,3-dione et de l’acide téréphtalique

18500-5 N-P

Hexanedioic acid, polymer with α-[2,2-bis(hydroxy, methyl)alkyl-ω-methoxypoly(oxy-1,2-ethanediyl), 2,2-dimethyl-1,3-propanediol, 1,2-ethanediamine, 1,6-hexanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and 1,1′-methylenebis[4-isocyanatocyclohexane], compd. with N,N-diethylethandiamine

 

Acide adipique polymérisé avec de l’α-[2,2-bis(hydroxyméthyl)alkyl]-ω-méthoxypoly(oxyéthane1,2-diyle), du néopentanediol, de l’éthane-1,2-diamine, de l’hexane 1,6-diol, de l’acide 2,2-bis(hydroxyméthyl)propanoïque et du 1,1′ méthylènebis[4-isocyanatocyclohexane], composé avec de la N,N-diéthyléthanediamine

18501-6 N-P

Benzene, ethenyl-, polymer with 2-substituted alkyl 2-methyl-2-propenoate, 2-oxepanone, alkanediol mono-2-methyl-2-propenoate, and (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1.]hept-2-yl 2-methyl-propenoate
Styrène polymérisé avec du méthacrylate d’alkyle substitué en position 2, de l’oxepan-2-one, un monométhacrylate d’alcanediol et du méthacrylate de (1R,2R,4R)-1,7,7-triméthylbicyclo[2.2.1.]hept-2-yle

18502-7 N-P

2-Propenoic acid, 2-methyl-, (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl ester, rel-, polymer with alkanediol, alkyl 2-propenoate, dimethyl carbonate, alkanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and alkanediol, diethanolamine-blocked, compds. with 2-(dimethylamino)ethanol
Méthacrylate de rel-(1R,2R,4R)-1,7,7-triméthylbicyclo[2.2.1]hept-2-yle polymérisé avec un alcanediol, un acrylate d’alkyle, du carbonate de diméthyle, un deuxième alcanediol, de l’acide 2,2-bis(hydroxyméthyl)propanoïque, du 5-isocyanate de 1-(isocyanatométhyl)-1,3,3-triméthylcyclohexane et un troisième alcanediol, séquencé avec du 2,2′ iminobiséthanol, composés avec du 2-(diméthylamino)éthanol

18503-8 N-P

2-Propenoic acid, 2-methyl-, polymer with alkyl 2-propenoate and 1,1′-(1,6-hexanediyl)di-2-propenoate and octadecyl 2-propenoate
Acide méthacrylique polymérisé avec un acrylate d’alkyle, du diacrylate d’hexane-1,6-diyle et de l’acrylate d’octadécyle

18505-1 N-P

2-Propenoic acid, 2-methyl-, 2-substituted alkyl ester, polymer with ethenylbenzene, 2-methyl alkyl 2-methyl-2-propenoate, 2-propenoic acid and neodecanoic acid, 2-oxiranylmethyl ester, peroxide, bis(1-methyl-1-phenylethyl)-initiated and ethanol, 2-(dimethylamino)neutralized
Méthacrylate d’alkyle substitué en position 2, polymérisé avec du styrène, du méthacrylate de 2 méthylalkyle, de l’acide acrylique et de l’acide néodécanoïque, ester(oxiran-2-yl)méthylique, amorcé avec du peroxyde de bis(2-phénylpropan-2-yle), neutralisé avec du 2-(diméthylamino)éthanol

18507-3 N-P

2-Propenoic acid, 2-methyl-, (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl ester, rel-, polymer with alkanediol, alkyl 2-propenoate, 1,3-dioxolan-2-one, alkanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and alkanediol, diethanolamine-blocked, compds. with 2-(dimethylamino)ethanol
Méthacrylate de rel-(1R,2R,4R)-1,7,7-triméthylbicyclo[2.2.1]hept-2-yle polymérisé avec un alcanediol, un acrylate d’alkyle, de la 1,3-dioxolan-2-one, un deuxième alcanediol, de l’acide 2,2-bis(hydroxyméthyl)propanoïque, du 5-isocyanate de 1-(isocyanatométhyl)-1,3,3-triméthylcyclohexane et un troisième alcanediol, séquencé avec 2,2′ iminobiséthanol, composés avec du 2-(diméthylamino)éthanol

18508-4 N-P

Alkyl methylalkenoate, polymer with alkene, alkenyl alkanoate, hydroxyalkyl methylalkenoate, alkyl methylalkenoate and alkyl methylalkenoate
Méthyalcénoate d’alkyle polymérisé avec un alcène, un alcanoate d’alcényle, un méthylalcénoate d’hydroxyalkyle, un deuxième méthyalcénoate d’alkyle et un troisième méthyalcénoate d’alkyle

18510-6 N

2-Propenoic acid, 2-methyl-, polymer with 2-(dialkylsubstituted)alkyl 2-methyl-2-propenoate and polyfluoroalkyl 2-methyl-2-propenoate, sodium salt
Acide méthacrylique polymérisé avec un méthacrylate d’alkyle substitué en position 2 et un méthacrylate de polyfluoroalkyle, sel de sodium

18511-7 N

2-Propenoic acid, 2-methyl-, polymer with 2-(dialkylsubstituted)alkyl 2-methyl-2-propenoate and polyfluoroalkyl 2-methyl-2-propenoate, ammonium sodium salt
Acide méthacrylique polymérisé avec un méthacrylate d’alkyle substitué en position 2 et un méthacrylate de polyfluoroalkyle, sel d’ammonium et de sodium

18512-8 N

2-Propenoic acid, 2-methyl-, polymer with 2-(dialkylsubstituted)alkyl 2-methyl-2-propenoate and polyfluoroalkyl 2-methyl-2propenoate, ammonium salt
Acide méthacrylique polymérisé avec un méthacrylate d’alkyle substitué en position 2 et un méthacrylate de polyfluoroalkyle, sel d’ammonium


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

18475-7 N-S

  1. Any activity involving the use of the substance alkanediol, reaction products with phosphorus oxide (P2O5), polyfluoro-1-alkanol,-ammonium salts in Canada in any quantity:
    • (a) in aerosol or spray-applied household products other than paints and coatings applied by spray; or
    • (b) in any other household products at a concentration greater than 1% by weight, other than in paints, coatings, floor waxes and floor finishes.
  2. For each 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 ) for the significant new activity described in paragraph 1(a)
      • (i) the identification of the equipment to be used or recommended by the product manufacturer to apply the product, such as a low pressure hand-held pump spray, an aerosolizing applicator with propellant, or a pneumatic sprayer using a compressor,
      • (ii) the information describing the equipment and its operation, including its normal operating pressure,
      • (iii) the information describing the size and shape of the nozzle of the equipment which controls the spread of the jet,
      • (iv) the information regarding the particle size distribution of the applied spray produced by the equipment characterized by mean mass median aerodynamic diameter, and
      • (v) any information regarding safety labelling for the product containing the substance, such as recommended ventilation and personal protective equipment for users;
    • (b) for the significant new activity described in paragraph 1(b), the test data and a test report from a 28-day repeated-dose dermal toxicity study of the substance, conducted according to the methodology described in the OECD Test Guideline No. 410 titled Repeated Dose Dermal Toxicity: 28-day Study;
    • (c) a description of the proposed significant new activity in relation to the substance;
    • (d) the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (e) the information specified in items 8 and 10 of Schedule 5 to those Regulations;
    • (f) the anticipated annual quantity of the substance to be used in relation to the significant new activity;
    • (g) the identification of every other government agency, either outside or within Canada, that the person proposing the significant new activity has notified of the use of the substance 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;
    • (h) if known, the three sites in Canada where the greatest quantity of the substance, in relation to the significant new activity, is anticipated to be used or processed and the estimated quantity by site; and
    • (i) all other information or test data concerning the substance that are in the possession of or accessible to the person who proposes 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 test data and the test reports described in paragraph 2(b) must be in conformity with the laboratory practices described by the OECD in the 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 both the Test Guidelines and Principles of GLP 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.

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.)

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, the DSL is amended to add or remove substances or to make corrections. 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

Twenty-seven 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. This places unnecessary burden on the importers and manufacturers of the substance since sufficient information has been collected for these substances and reporting is no longer required.

3. Objectives

The objectives of the Order 2012-87-10-01 Amending the Domestic Substances List and the Order 2012-112-10-01 Amending the Domestic Substances List (hereafter referred to as “the Orders”) are to remove the unnecessary reporting burden associated with the import or manufacture of these 27 substances, to make the DSL more accurate and to comply with the requirements of CEPA 1999.

4. Description

The Orders add 27 substances to the DSL. To protect confidential business information, 15 of the 27 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 2012-87-10-02 would delete two substances that are being added to the DSL from the NDSL.

Additions to the Domestic Substances List

The Orders add 27 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 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, where a substance is specified on the DSL,CEPA 1999permits the Minister of Environment to indicate on the DSL that significant new activities provisions apply to the substance.

Publication of masked names

The Orders mask the chemical names for 15 of the 27 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

Twenty-seven “new” substances have met the necessary conditions to be placed on the DSL. The Orders add these 27 substances to the DSL, and exempt them from further reporting requirements under subsection 81(1) of CEPA 1999.

CEPA 1999 sets out a process for updating the DSL in accordance with strict timelines. Since the 27 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, it 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
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.