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Registration

SOR/2012-5 January 24, 2012

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2011-87-11-01 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 2011-87-11-01 Amending the Domestic Substances List.

Gatineau, January 19, 2012

PETER KENT
Minister of the Environment

ORDER 2011-87-11-01 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:

460-73-1 N
754-12-1 N
26445-96-5 N-P
61981-26-8 N-P
70693-43-5 N-P
96278-62-5 N-P
106214-58-8 N-P
139873-90-8 N
148788-55-0 N
148812-65-1 N
195158-82-8 N-P
288260-02-6 N-P
321573-76-6 N-P
914913-11-4 N-P
1013910-41-2 N
1022990-65-3 N

2. Part 2 of the List is amended by deleting substance “460-73-1 N-S” in column 1 and the Significant New Activity for which substance is subject to subsection 81(3) of the Act opposite the reference to that substance in column 2.

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

17304-6 N

1-Alkaneaminium, N-alkyl-N,N-dimethyl-, carbonate (1:1)

N-Alkyl-N,N-diméthylalcane-1-aminium, carbonate (1:1)

17305-7 N

1-Alkaneaminium, N-alkyl-N,N-dimethyl-, carbonate (2:1)

N-Alkyl-N,N-diméthylalcane-1-aminium, carbonate (2:1)

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

16978-4 N-P

2-Propenoic acid, 2-methyl-, monoester with alkanediol, polymer with ethenylbenzene and rel-(1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl 2-methyl-2-propenoate, hydroxyalkanoate

Monométhacrylate d’alcanediol polymérisé avec du styrène et du méthacrylate de rel-(1R,2R,4R)-1,7,7-triméthylbicyclo[2.2.1]hept-2-yle, hydroxyalcanoate

17122-4 N

Oxirane, polymer, monoalkyl ether

Oxirane, polymérisé, éther monoalkylique

17147-2 N-P

Alkanediol, polymer with 1,4-cyclohexanedicarboxylic acid, alkanedioic acid, 1,3-isobenzofurandione, hexahydro- and 1,3-propanediol, 2-alkyl-2-(hydroxymethyl)-

Alcanediol polymérisé avec de l’acide cyclohexane-1,4-dicarboxylique, un acide alcanedioïque, de l’hexahydroisobenzofuran-1,3-dione et un 2,2-bis(hydroxyméthyl)alcanol

17512-7 N-P

Benzene, ethenyl-, polymer with 2-alkylalkyl 2-methyl 2-propenoate, 2-hydroxyalkyl 2-methyl-2-propenoate, (1R,2R,4R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl 2-methyl-2-propenoate and monoester, 1,2-propanediol 2-methyl-2-propenoate, 1,1-dimethylethyl peroxyhexanoate and bis(1,1-dimethylethyl)peroxide-initiated

Styrène polymérisé avec un méthacrylate de 2-alkylalkyle, un méthacrylate de 2-hydroxyalkyle, du méthacrylate de (1R,2R,4R)-1,7,7-triméthylbicyclo[2.2.1]hept-2-yle et du monométhacrylate de propane-1,2-diol, amorcé avec du peroxyhexanoate de tert-butyle et du peroxyde de di-tert-butyle

18346-4 N-P

Neodecanoic acid, oxiranylmethyl ester, polymer with ethenylbenzene, ethylalkyl 2-methyl-2-propenoate, 2-hydroxyethyl 2-methyl-2-propenoate, and 2-propenoic acid, bis(1,1-dimethylpropyl)peroxide-initiated

Néodécanoate d’oxiranylméthyle polymérisé avec du styrène, du méthacrylate d’éthylalkyle, du méthacrylate de 2-hydroxyéthyle et de l’acide acrylique, amorcé avec du peroxyde de bis(tert-pentyle)

18356-5 N

Distillates, (Fischer-Tropsch), heavy, branched, cyclic and linear

Distillats, (Fischer-Tropsch), lourds, ramifiés, cycliques et linéaires

18357-6 N

Residual oils, (Fischer-Tropsch), base oil production, branched, cyclic and linear

Huiles résiduelles, (Fischer-Tropsch), production d’huile de base, ramifiées, cycliques et linéaires

18358-7 N-P

2-Propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-alkylalkyl 2-propenoate, 2-substituted alkyl 2-propenoate, N-(substituted methyl)-2-methyl-2-propenamide and methyl 2-methyl-2-propenoate, ammonium salt

Acide méthacrylique polymérisé avec du styrène, un acrylate de 2-alkylalkyle, un acrylate de 2-(alkyle substitué), du N-(méthyl substitué)-2-méthylprop-2-ènamide et du méthacrylate de méthyle, sel ammoniacal

18359-8 N

1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, polyester polyol, hexanedioic acid, 1,6-hexanediol, 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,1′-methylenebis[isocyanatobenzene] and 2-oxepanone

Acide isophtalique polymérisé avec de l’acide téréphtalique, du téréphtalate de diméthyle, du néopentanediol, de l’acide dodécanedioïque, un polyol de polyester, de l’acide adipique, de l’hexane-1,6-diol, du 3-hydroxy-2,2-diméthylpropanoate de 3 hydroxy-2,2-diméthylpropyle, du 1,1′-méthylènebis[isocyanate de benzène] et de l’oxépan-2-one

18360-0 N

1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-butanediol, dimethyl 1,4-benzenedicarboxylate, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, polyester polyol, hexanedioic acid, 1,6-hexanediol, α-hydro-ω-hydroxypoly [oxy(methyl-1,2-ethanediyl)], 3-hydroxy-2-2-dimethylpropyl 3-hydroxy-2,2,-dimethylpropanoate, 1,3-isobenzofurandione, 1,1′-methylenebis[isocyanatobenzene], 2-oxepanone, 2,2′-oxybis[ethanol] and α,α′,α″-1,2,3-propanetriyltris[ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)]]

Acide isophtalique polymérisé avec de l’acide téréphtalique, du butane-1,4-diol, du téréphtalate de diméthyle, du néopentanediol, de l’acide dodécanedioïque, un polyol de polyester, de l’acide adipique, de l’hexane-1,6-diol, de l’α-hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)], du 3-hydroxy-2,2,-diméthylpropanoate de 3-hydroxy-2-2-diméthylpropyle, de l’isobenzofuran-1,3-dione, du 1,1′ méthylènebis[isocyanate de benzène], de l’oxépan-2-one, du 2,2′-oxybis[éthanol] et de l’α, α′, α″-propane-1,2,3-triyltris[ω-hydroxypoly[oxy(propane-1,2-diyle)]]

18361-1 N-P

Poly(fluoroalkylene oxide), polymer with 3-N-methylaminopropylamine, N,N-dimethyldipropylenetriamine and poly(hexamethylenediisocyanate)

Poly(oxyde de fluoroalkylène) polymérisé avec de la 3-(méthylamino)propylamine, de la N-(3-aminopropyl)-3-(diméthylamino)propylamine et du poly(diisocyanate d’hexane-1,6-diyle)

18362-2 N

Alkyl oxirane, polymer with alkyl oxirane, alkyl ether, polymer with polyalkylene glycol, alkyl isocyanate and polyalkylene glycol

Alkyloxirane polymérisé avec un alkyloxirane, éther alkylique, polymérisé avec un polyalkylèneglycol, un isocyanate d’alkyle et un autre polyalkylèneglycol

18363-3 N

1,3-isobenzofurandione, hexahydroalkyl-, polymer with 2,2-bis(hydroxyalkyl)-1,3-propanediol, alkyloxirane and hexahydro-1,3-isobenzofurandione

Hexahydroxyalkylisobenzofuran-1,3-dione polymérisée avec du 2,2-bis(hydroxyalkyl)propane-1,3-diol, un alkyloxirane et de l’hexahydroisobenzofuran-1,3-dione

18364-4 N-P

Fatty acids, linseed-oil, reaction products with 2-amino-2-(hydroxymethyl)-1,3-propanediol and formaldehyde, polymers with alkyl methacrylate, 2-(dialkylsubstituted)ethyl methacrylate, 2-hydroxyethyl acrylate and Me ethacrylate, 1,1-dimethylpropyl 2-ethylhexaneperoctoate-initiated

Acides gras d’huile de lin, produits de réaction avec du 2-amino-2-(hydroxyméthyl)propane-1,3-diol et du formaldéhyde, polymérisés avec un méthacrylate d’alkyle, un méthacrylate de 2-(dialkyl substitué)éthyle, de l’acrylate de 2-hydroxyéthyle et de l’éthacrylate de méthyle, amorcé avec du 2 éthylhexaneperoctoate de tert-pentyle

18365-5 N-P

2-Propenoic acid, 2-methyl-, butyl ester, polymer with ethenyl benzene, 2-alkylalkyl-2-methyl-2-propenoate, 2-hydroxyalkyl 2-propenoate and methyl 2-methyl-2-propenoate

Méthacrylate de butyle polymérisé avec du styrène, un méthacrylate de 2-alkylalkyle, un acrylate de 2-hydroxyalkyle et du méthacrylate de méthyle

18366-6 N-P

1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol, 1,2-ethanediol, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and 2,2′-oxybis[ethanol], fatty acid

Acide isophtalique polymérisé avec de l’acide téréphtalique, du néopentanediol, de l’éthylèneglycol, du 2,2-bis(hydroxyméthyl)butanol et du 2,2′ oxybis[éthanol], acide gras

18368-8 N-P

Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with cycloalkanediamine, alkanediamine and sebacic acid

Dimères d’acides gras insaturés en C18, hydrogénés, polymérisés avec une cycloalcanediamine, une alcanediamine et de l’acide sébacique

4. (1) Part 4 of the List is amended by deleting substance “17122-4 N-S” in column 1 and the Significant New Activity for which substance is subject to subsection 81(3) of the Act opposite the reference to that substance in column 2.

(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

18227-2 N-P-S

  1. Any activity involving the use of the substance Carbopolycyclic diol polymer with carbonic dichloride and substituted phenol ester, in Canada, in any quantity, in food packaging materials intended for infants up to 18 months of age.
  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 proposed 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 a test report from a study on the migration of Bisphenol A out of the food packaging material that contains the substance, 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 that migration;
    5. (e) the hydrolysis rate of the substance as a function of pH and, if known, an identification of the products of the hydrolysis; and
    6. (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
      1. (i) 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; and
      2. (ii) 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 2011-87-11-01 Amending the Domestic Substances List (hereafter referred to as “the Order”), made under the Canadian Environmental Protection Act, 1999 (CEPA 1999 or the Act), is to add 30 substances to the Domestic Substances List (or DSL) and make four modifications to the information on four substances. In addition, since a substance cannot appear on both the DSL and the Non-domestic Substances List (or NDSL), an order to remove three substances from the NDSL is also being proposed.

Description and rationale

The Domestic Substances List

For the purposes of CEPA 1999, the DSL is the sole basis for determining whether a substance is “existing” in or “new” to Canada. Substances that are not on the DSL will require notification and assessment as prescribed by the requirements of section 81 of CEPA 1999 or the New Substances Notification Regulations (Chemicals and Polymers) before they can be manufactured in or imported into Canada.

The DSL, published in the Canada Gazette, Part Ⅱ, in May 1994, is not static and is subject, from time to time, to additions, deletions or modifications; these changes are also 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 DSL, whereby substances or living organisms are listed by categories based on certain criteria. (see footnote 2)

The Non-domestic Substances List

The United States Toxic Substances Control Act Inventory has been chosen as the basis for the NDSL. On a semi-annual basis, the NDSL is updated based on amendments to the American inventory. The NDSL only applies to substances that are chemicals and polymers.

In order to protect the environment and human health, substances that are added to the NDSL remain subject to notification and scientific assessment as new substances in Canada when manufactured or imported quantities of the substance exceed 1 000 kg per year. However, these substances are subject to fewer information requirements than there are under the New Substances Notification Regulations (Chemicals and Polymers).

Additions to the Domestic Substances List

Substances added under section 87 of CEPA 1999 must be added to the DSL within 120 days after the following conditions have been met:

  • the Minister has been provided with the information concerning the substance prescribed under section 81 or 82 of CEPA 1999, as well as the additional information or test results prescribed under subsection 84(1);
  • the Minister of the Environment and the Minister of Health are satisfied that the substances have already been manufactured in or imported into Canada 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 substances has expired; and
  • no conditions specified under paragraph 84(1)(a) of CEPA 1999 are in force in relation to the substances.

Modifications to the Domestic Substances List

The Order removes two substances from Part 3 of the DSL and adds them to Part 1 of the DSL as there is no longer concern with the substances’ confidentiality. The Order also removes one substance from Part 4 of the DSL and adds it to Part 3 of the DSL as there is no longer concern with the substance’s significant new activity. Lastly, the Order removes one substance from Part 2 of the DSL and adds it to Part 1 of the DSL as there is no longer concern with the substance’s significant new activity.

Publication of masked names

The CEPA 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 the Act. However, the identity of these substances may be disclosed by the Minister in accordance with section 315 or 316 of CEPA 1999. The procedure to be followed for creating such a name is set out in the Masked Name Regulations. Persons who wish 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. The Order adds 17 masked names to the DSL.

Deletions from the Non-domestic Substances List

Since substances cannot be on both the DSL and the NDSL, the order will delete the three substances that are being added to the DSL from the NDSL.

Alternatives

The CEPA 1999 sets out a process for updating the DSL in accordance with strict timelines. Since the 30 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.

Benefits and costs

Benefits

The amendment to the DSL 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 four necessary modifications to the information on four substances.

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 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.

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
For more information, please visit www.gazette.gc.ca/archives/p2/2001/2001-07-04/pdf/g2-13514.pdf.