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Registration

SOR/2012-157 July 27, 2012

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2012-87-05-01 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 2012-87-05-01 Amending the Domestic Substances List.

Gatineau, July 25, 2012

PETER KENT
Minister of the Environment

ORDER 2012-87-05-01 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:

10124-41-1 N

28774-87-0 N-P

168017-36-5 N-P

362603-93-8 N-P

362603-94-9 N-P

364066-32-0 N-P

519165-16-3 N-P

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

15563-2 N-P

Diglycidyl ether of bisphenol A, polymer with bisphenol A, dienoic acid and linoleic acid

Bis(2,3-époxypropoxy)bisphénol A polymérisé avec du bisphénol A, un acide diènoïque et de l’acide linoléique

16795-1 N-P

Methacrylic acid, polymer with butyl acrylate, azadimethyldioxoalkene and methyl methacrylate

Acide méthacrylique polymérisé avec de l’acrylate de butyle, un azadiméthyldioxoalcène et du méthacrylate de méthyle

17300-2 N-P

2-Propenoic acid, 2-methyl-, alkyl ester, polymer with chloroethene, alkyl 2-propenoate and perfluoroalkyl ethyl 2-methyl-2-propenoate

2-Méthyl-2-propénoate d’alkyle polymérisé avec le chloroéthène, le 2-propénoate d’alkyle et le 2-méthyl-2-propénoate de perfluoroalkyle éthyle

17743-4 N

Perfluoroalkylhydroxyaminoazetidinium polymer

Polymère de perfluoroalkylhydroxyaminoazétidinium

17932-4 N

2-Propenoic acid, 2-methyl-, alkyl ester, polymer with alkylaminoalkyl 2-methyl-2-propenoate, 2-hydroxyethyl 2-methyl-2-propenoate and perfluoroalkylethyl 2-methyl-2-propenoate, acetate (salt)

2-Méthyl-2-propénoate d’alkyle polymérisé avec le 2-méthyl-2-propénoate d’alkylaminoalkyle, le 2-méthyl-2-propénoate de 2-hydroxyéthyle et le 2-méthyl-2- propénoate de perfluoroalkyléthyle, acétate (sel)

18304-7 N

Fatty acids, reaction products with alkanolamine and alkyloxide

Acides gras, produits de réaction avec une alcanolamine et un oxyde d’alkyle

18344-2 N-P

Hexanedioic acid, polymer with 2,2-bis(hydroxymethyl)-1,3-propanediol, alkyldiol, 1,6-hexanediol and 2,2′-oxybis[ethanol]

Acide adipique polymérisé avec du 2,2-bis(hydroxyméthyl)propane-1,3-diol, un alcanediol, de l’hexane-1,6-diol et du 2,2′-oxybis[éthanol]

18385-7 N

Zinc alkyl dithiophosphate

Dithiophosphate d’alkyle et de zinc

18403-7 N-P

2-Propenoic acid, 2-methyl-, polymer with butyl 2-methyl-2-propenoate, butyl 2-propenoate, ethenylbenzene, 2-hydroxyethyl 2-methyl-2-propenoate and methyl 2-methyl-2-propenoate, compd. with alkylaminoalcohol

Acide méthacrylique polymérisé avec du méthacrylate de butyle, de l’acrylate de butyle, du styrène, du méthacrylate de 2-hydroxyéthyle et du méthacrylate de méthyle, composé avec un alkylaminoalcool

18411-6 N-P

2-Propenoic acid, 2-methyl-, 1,1′-(1,2-ethanediyl) ester, polymer with diethenylbenzene, substituted alkyl-2-propenoate, ethenylbenzene and ethenylethylbenzene, 4,4′-(1,2-diazenediyl)bis[4-cyanopentanoic acid]-initiated

Bisméthacrylate d’éthane-1,2-diyle polymérisé avec du diéthénylbenzène, du méthacrylate d’alkyle substitué, du styrène et de l’éthényl(éthyl)benzène, amorcé avec de l’acide 4,4′-(diazène-1,2-diyl)bis[4-cyanopentanoïque]

18433-1 N-P

Alkylated fatty acids, polymers with adipic acid, 5-amino-1,3,3-trimethylcyclohexanemethanamine, 1,6-hexanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, isophthalic acid and 1,1′-methylenebis[4-isocyanatocyclohexane], compds. with triethylamine

Acides gras alkylés polymérisés avec de l’acide adipique, de la 5-amino-1,3,3-triméthylcyclohexaneméthanamine, de l’hexane-1,6-diol, de l’acide 2,2 bis(hydroxyméthyl)propanoïque, de l’acide isophtalique et du 1,1′ méthylènebis[4-isocyanatocyclohexane], composés avec la N,N-diéthyléthanamine

18436-4 N-P

2-Propenoic acid, 2-methyl-, alkoxy ester, polymer with alkyl 2-propenoate, ethene, alkenyl benzene and ethyl 2-propenoate

Méthacrylate d’alcoxy polymérisé avec un acrylate d’alkyle, de l’éthène, un alcénylbenzène et de l’acrylate d’éthyle

18440-8 N-P

2-Propenoic acid, 2-methyl-, substituted alkylpropyl ester, polymer with alkyl alkenoate

Méthacrylate de propyle substitué par un alkyle, polymérisé avec un alcénoate d’alkyle

18444-3 N-P

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

3-Oxobutanoate de 2-[(2-méthyl-1-oxoprop-2-èn-1-yl)oxy]éthyle polymérisé avec du méthacrylate de butyle, un acrylate d’alkyle, du styrène et de l’acide acrylique

3. (1) Part 4 of the List is amended by deleting substance “17300-2 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 “17743-4 N-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 “17932-4 N-S” in column 1 and the Significant New Activity in column 2 opposite the reference to that substance.

(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

18430-7 N-S

  1. Any of the following activities involving the substance Metal hydroxy phosphate:
    • (a) the use of the substance in inks, paint or coatings in a quantity that exceeds 10 000 kg in any one calendar year;
    • (b) the manufacture of the substance in a quantity that exceeds 1000 kg in any one calendar year; or
    • (c) any use of the substance where it is engineered to contain particles of particle size ranging from 1 to 100 nanometres, in a quantity that exceeds 10 kg in any one 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) for a significant new activity described in paragraph 1(a)
      • (i) the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers),
      • (ii) the information specified in item 8 of Schedule 5 to those Regulations, and
      • (iii) the information specified in item 11 of Schedule 6 to those Regulations;
    • (c) for a significant new activity described in paragraph 1(b)
      • (i) the information specified in Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers),
      • (ii) the information specified in item 8 of Schedule 5 to those Regulations,
      • (iii) the information specified in item 11 of Schedule 6 to those Regulations,
      • (iv) a brief description of the manufacturing process that details precursors of the substance, reaction stoichiometry, batch or continuous nature of the process, and scale of the process,
      • (v) a flow diagram describing the manufacturing process and its main components such as process tanks, holding tanks and distillation towers, and
      • (vi) a brief description of the major steps in manufacturing operations, the chemical conversions, the points of entry of all feedstock, the points of release of substances, and the processes to eliminate environmental releases;
    • (d) for a significant new activity described in paragraph 1(c)
      • (i) the information specified in Schedule 6 to the New Substances Notification Regulations (Chemicals and Polymers),
      • (ii) the analytical information to determine the primary and secondary particle size of the substance,
      • (iii) the information describing the agglomeration and aggregation state, shape, surface area and surface charge of the substance,
      • (iv) the analytical information to determine the leachability potential of the substance and its precursors from any final product resulting from the significant new activity,
      • (v) the test data and a test report on the water solubility of the substance conducted in accordance with the Organization for Economic Co-operation and Development Series on Testing and Assessment, Number 29, titled Guidance Document on Transformation/Dissolution of Metals and Metal Compounds in Aqueous Media, and that is current at the time the test data are developed,
      • (vi) the analytical information to determine the primary and secondary particle size of the test substance as administered in the health and ecological toxicity tests required under subparagraph (i), and
      • (vii) the information describing the agglomeration and aggregation state, shape, surface area and surface charge of the test substance as administered in the health and ecological toxicity tests required under subparagraph (i); and
    • (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 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

4. 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 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

Nineteen 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 has placed 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.

The DSL also needs to be modified to reflect more accurate information on three substances.

3. Objectives

The objectives of the Order 2012-87-05-01 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 19 substances and to make the DSL more accurate.

4. Description

The Order adds 19 substances to the DSL and modifies the description of 3 substance identifiers in Part 4 of the DSL. To protect confidential business information, 12 of the 19 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 2012-87-05-02 would delete six substances that are being added to the DSL from the NDSL.

Additions to the Domestic Substances List

The Order adds 19 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 1999 permits the Minister of Environment to indicate on the DSL that significant new activities provisions apply to the substance.

Modifications to the Domestic Substances List

The Order modifies the description of three substance identifiers in Part 4 of the DSL to make the information reflected by this identifier more accurate.

Publication of masked names

The Order masks the chemical names for 12 of the 19 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

Nineteen “new” substances have met the necessary conditions to be placed on the DSL. The Order adds these 19 substances to the DSL, and exempts them from further reporting requirements under section 81 of CEPA 1999. In addition, the description of three substance identifiers on the DSL has 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 19 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 three 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/archives/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.