Vol. 149, No. 14 — July 15, 2015

Registration

SOR/2015-174 June 24, 2015

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2015-87-06-01 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) and (5) of the Canadian Environmental Protection Act, 1999 (see footnote d), makes the annexed Order 2015-87-06-01 Amending the Domestic Substances List.

Gatineau, June 16, 2015

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2015-87-06-01 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:

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

14766-6 N 4,4′-(1-Methylethylidene)bisphenol, polymer with (chloromethyl)oxirane, 2,2′-iminobisethanol, 2,2′-[(3-aminoalkyll)imino]bisethanol and acetic acid (salts)
  4,4′-(Propane-2-ylidène)bisphénol polymérisé avec du (chlorométhyl)oxirane, du 2-(2-hydroxyéthylamino)éthanol, du 2,2′-[(3-aminoalkyl)azanediyl]biséthanol et de l’acide acétique (sels)
17081-8 N-P Heteropolycycle, halogenated, polymer with benzenediamine, 5-chloro-1,3-isobenzofurandione, 1,3-isobenzofurandione and 4,4′-(1-methylethylidene)bis[phenol]
  Hétéropolycycle halogéné polymérisé avec de la benzènediamine, de la 5-chloro-2-benzofurane-1,3-dione, de la 2-benzofurane-1,3-dione et du 4,4′-(propane-2-ylidène)bis[phénol]
18063-0 N-P Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, ether with polyhydric alcohol, 3-oxobutanoate
  α-Hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)], oxyde avec un alcool polyhydrique, 3-oxobutanoate
18826-7 N-P Poly[oxy(methyl-1-2-ethanedilyl)], alpha-(2-propylalkyl)-omega-hydroxy-
  alpha-(2-Propylalkyl)-oméga-hydroxypoly[oxy(propane-1-2-diyle)]
18827-8 N-P Poly(oxy-1,2-ethanediyl), α-hydro-ω-hydroxy-, polymer with 1,6-diisocyanatohexane, alkanol-blocked
  α-Hydro-ω-hydroxypoly(oxyéthane-1,2-diyle) polymérisé avec du 1,6-diisocyanatohexane, séquencé avec un alcanol
18829-1 N Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and polyol
  Huile de coco, produits de la réaction avec de l’acide borique (H3BO3), du 2-(2-hydroxyéthylamino)éthanol et un polyol
18830-2 N-P Phenol, 4,4′-(1-methylethylidene)bis-, polymer with 2-(chloromethyl)oxirane, alkyl ethers, compds. with 2-(dimethylamino)ethanol
  4,4′-(Propane-2-ylidène)bisphénol polymérisé avec du 2-(chlorométhyl)oxirane, oxydes alkyliques, composés avec du 2-(diméthylamino)éthanol
18831-3 N-P 5-lsobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, alkanediol and 1,2,3-propanetriol
  Acide 1,3-dihydro-1,3-dioxo-isobenzofurane-5-carboxylique polymérisé avec du 2-éthyl-2-(hydroxyméthyl)propane-1,3-diol, un alcanediol et du propane-1,2,3-triol
18834-6 N-P Benzenesubstituted, polymer with 1,2-ethanediol and 1,3-isobenzofurandione
  Benzène substitué polymérisé avec de l’éthane-1,2-diol et de la 2-benzofurane-1,3-dione
18835-7 N-P 1,3-Benzenedicarboxylic acid, polymer with 1,3-bis(1-isocyanato-1-methylethyl)benzene, dihydro-3-(tetrapropenyl)-2,5-furanedione, dihydroxypropyl methyl alkanoate, 2-ethylhexyl 2-propenoate, hexanedioic acid, 1,6-hexanediol and 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, reaction products with diethanolamine, compds. with 2-(dimethylamino)ethanol
  Acide isophtalique polymérisé avec du 1,3-bis(2-isocyanatopropane-2-yl)benzène, de la 3-(dodéc-2-ényl)oxolane-2,5-dione, un méthylalcanoate de dihydroxypropyle, de l’acrylate de 2-éthylhexyle, de l’acide hexanedioïque, de l’hexane-1,6-diol et de l’acide 2,2-bis(hydroxyméthyl)propanoïque, produits de la réaction avec du 2-(2-hydroxyéthylamino)éthanol, composés avec le 2-(diméthylamino)éthanol
18836-8 N-P Siloxanes and silicones, di-Me, 3-(-2-hydroxyethoxy)propyl group-terminated, polymers with 5-amino-1,3,3-trimethylcyclohexanemethanamine, di-Et carbonate, alkanediol and 1,1′-methylenebis[4-isocyanatocyclohexane], Me Et ketone oxime-blocked
  Polydiméthylsiloxane à terminaisons 3-(-2-hydroxyéthoxy)propyles polymérisés avec de la 5-amino-1,3,3-triméthylcyclohexaneméthanamine, du carbonate de diéthyle, un alcanediol et du 1,1′-méthylènebis [4-isocyanatocyclohexane], séquencé avec de la butanone-oxime
18837-0 N-P 9-Octadecenoic acid (9Z)-, 2,2-bis(hydroxymethyl)butyl ester, polymer with (chloromethyl)oxirane, 2-ethyl-2-(hydroxymethyl)-alkanediol, α-hydro-ω-(2-aminomethylethoxy)poly[oxy(methyl-1,2-ethanediyl)ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, 1,1′-methylenebis[4-isocyanatocyclohexane],4,4′-(1-methylethylidene)bis[phenol], 2-oxepanone, and 1,3,5-tris(6-isocyanatohexyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
  (Z)-2,2-Bis(hydroxyméthyl)-octadéc-9-énoate de butyle polymérisé avec du (chlorométhyl)oxirane, du 2-éthyl-2-(hydroxyméthyl)alcanediol, de l’oxyde d’α-hydro-ω-(2-aminométhyléthoxy)poly[oxy(propane-1,2-diyle) et de 2-éthyl-2-(hydroxyméthyl)propane-1,3-diol (3/1), du 5-isocyanato-1-(isocyanatométhyl)-1,3,3-triméthylcyclohexane, du 1,1′-méthylènebis[4-isocyanatocyclohexane], du 4,4′-(propane-2-ylidène)bis[phénol], de l’oxépan-2-one et de la 1,3,5-tris(6-isocyanatohexyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione
18838-1 N-P 1,3-Benzenedicarboxylic acid, polymer with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, 1,3-isobenzofurandione and 1,2,3-propanetriol, hexadecanoate alkanoate octadecanoate
  Acide isophtalique polymérisé avec du 2-éthyl-2-(hydroxyméthyl)propane-1,3-diol, de la 2-benzofurane-1,3-dione et du propane-1,2,3-triol, hexadécanoate, alcanoate et octadécanoate
18839-2 N-P Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with adipic acid, 1,3-bis(1-isocyanato-1-methylethyl)benzene, 1,4-butanediol, 2,3-dihydroxypropyl methacrylate, N-(1,1-dimethyl-3-oxybutyl)-2-propenamide, 2-ethylhexyl acrylate, 1,6-hexanediol, substituted substitutedmethyl-methylpropanoic acid, isophthalic acid and Me methacrylate, diethanolamine-blocked, compds. with 2-(dimethylamino)ethanol
  Dimères d’acides gras insaturés en C18, hydrogénés, polymérisés avec de l’acide hexanedioïque, du 1,3-bis(2-isocyanatopropane-2-yl)benzène, du butane-1,4-diol, du méthacrylate de 2,3-dihydroxypropyle, du N-(2-méthyl-4-oxypentane-2-yl)acrylamide, de l’acrylate de 2-éthylhexyle, de l’hexane-1,6-diol, de l’acide (méthyl substitué)méthylpropanoïque substitué, de l’acide isophtalique et du méthacrylate de méthyle, séquencé avec du 2-(2-hydroxyéthylamino)éthanol, composés avec du 2-(diméthylamino)éthanol
18840-3 N-P 2-Propenoic acid, 2-methyl-, butyl ester, polymer with ethenylbenzene, methyl 2-methyl-2-propenoate, alkanediol mono(2-methyl-2-propenoate and 2-propenoic acid, ester with 2,3-dihydroxypropyl neodecanoate, compd. with 2-(dimethylamino)ethanol
  Méthacrylate de butyle polymérisé avec du styrène, du méthacrylate de méthyle, un monoester d’acide méthacrylique et d’alcanediol et de l’acide acrylique, ester avec le néodécanoate de 2,3-dihydroxypropyle, composé avec le 2-(diméthylamino)éthanol
18841-4 N-P 2-Propenoic acid, 2-methyl-, methyl ester, polymer with butyl 2-propenoate, ethenylbenzene, alkanediol mono(2-methyl-2-propenoate) and 2-propenoic acid, tert-Bu 2-ethylhexaneperoxoate-initiated, compds. with 2-(dimethylamino)ethanol
  Méthacrylate de méthyle polymérisé avec de l’acrylate de butyle, du styrène, un monoester d’acide méthacrylique et d’alcanediol et de l’acide acrylique, amorcé avec du 2-éthylhexaneperoxoate de tert-butyle, composés avec le 2-(diméthylamino)éthanol
18842-5 N-P 2-Propenoic acid, 2-methyl-, methyl ester, polymer with butyl 2-propenoate, ethenylbenzene, alkanediol mono(2-methyl-2-propenoate) and 2-propenoic acid, 2-hydroxy-3-[(1-oxoneodecyl)oxy]propyl ester, tert-Bu 2-ethylhexaneperoxoate-initiated
  Méthacrylate de méthyle polymérisé avec de l’acrylate de butyle, du styrène, un monoester d’acide méthacrylique et d’alcanediol et de l’acide acrylique, ester 2-hydroxy-3-[(1-oxonéodécyl)oxy]propylique, amorcé avec du 2-éthylhexaneperoxoate de tert-butyle
18843-6 N-P 1,3-Isobenzofurandione, polymer with 2,2-dimethyl-1,3-propanediol and 1,2-ethanediol, di[substituted carbomonocycle ester]
  2-Benzofurane-1,3-dione polymérisée avec du 2,2-diméthylpropane-1,3-diol et de l’éthane-1,2-diol, di(ester carbomonocyclique substitué)
18844-7 N-P 2-Propenoic acid, 2-methyl, polymer with N-(1,1-dimethyl-3-oxobutyl)-2-propenamide, ethenylbenzene, 2-ethylhexyl 2-propenoate, alkanediyl di-propanoate and 2-hydroxyethyl 2-methyl-2-propenoate
  Acide méthacrylique polymérisé avec du N-(2-méthyl-4-oxopentane-2-yl)acrylamide, du styrène, de l’acrylate de 2-éthylhexyle, un diacrylate d’alcanediyle et du méthacrylate de 2-hydroxyéthyle
18845-8 N-P 2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with butyl 2-propenoate, ethenylbenzene, hydroxyl alkyl 2-propenoate and 2-methylpropyl 2-methyl-2-propenoate and 2-propenoic acid, tert-Bu 2-ethylhexaneperoxoate-initiated, compds. with 2-(dimethylamino)ethanol
  Méthacrylate de 2-hydroxyéthyle polymérisé avec de l’acrylate de butyle, du styrène, un acrylate d’hydroxyalkyle, du méthacrylate de 2-méthylpropyle et de l’acide acrylique, amorcé avec du 2-éthylhexaneperoxoate de tert-butyle, composés avec le 2-(diméthylamino)éthanol

COMING INTO FORCE

3. 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.)

Issues

Canadians depend on substances that are used in hundreds of goods, from medicines to computers, fabric and fuels. Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), substances (i.e. chemicals, polymers, nanomaterials, and living organisms) “new” to Canada are subject to reporting requirements before they can be manufactured or imported. This limits market access until human health and environmental impacts associated with the new substances are assessed and managed where appropriate.

Environment Canada and Health Canada assessed the information on 41 new substances reported to the New Substances Program and determined that they meet the necessary criteria for their addition to the Domestic Substances List (DSL). Under the CEPA 1999, the Minister of the Environment must add a substance to the DSL within 120 days after the criteria listed in section 87 have been met.

Background

The Domestic Substances List

The DSL is a list of substances (chemicals, polymers, and living organisms) that are considered “existing” in Canada for the purposes of the CEPA 1999. “New” substances are not on the DSL and are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. These requirements are set out in subsections 81(1) and 106(1) of the CEPA 1999, as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms).

The DSL was published in the Canada Gazette, Part II, in May 1994. (see footnote 2) The DSL is amended 10 times a year, on average; these amendments may add or remove substances or make corrections to the DSL.

The Non-domestic Substances List

The Non-domestic Substances List (NDSL) is a list of substances “new” to Canada that are subject to reduced notification and assessment requirements when manufactured in or imported into Canada in quantities above 1 000 kg per year. The NDSL only applies to chemicals and polymers.

The United States and Canada have similar new substances programs to assess new chemicals’ impact on human health and the environment prior to manufacture in or import into the country. Substances are eligible for listing on the United States Toxic Substances Control Act (TSCA) Inventory once they have undergone a new substances assessment in the United States. Substances that have been listed on the public portion of the TSCA Inventory for a minimum of one calendar year and that are not subject to risk management controls in either country are eligible for listing on the NDSL. On a semi-annual basis, Canada subsequently updates the NDSL based on amendments to the United States TSCA Inventory.

While chemicals and polymers on the DSL are not subject to the New Substances Notification Regulations (Chemicals and Polymers), those on the NDSL remain subject to them but with lesser reporting requirements, in recognition that they have undergone notification and assessment in the United States. This protects human health and the environment by ensuring that NDSL substances will undergo risk assessments in Canada, but leverages assessments conducted in the United States to lessen the reporting requirements imposed on industry.

Once substances are added to the DSL, they must be deleted from the NDSL, as a substance cannot be on both the DSL and NDSL simultaneously because these lists involve different regulatory requirements.

Objectives

The objectives of the Order 2015-87-06-01 Amending the Domestic Substances List are to comply with the requirements under CEPA 1999 and facilitate access to and use of 41 substances by removing reporting requirements under the New Substances Program associated with their import or manufacture.

Furthermore, as substances cannot be on both the DSL and the NDSL simultaneously, the proposed Order 2015-87-06-02 Amending the Non-domestic Substances List will delete 6 of the 41 substances from the NDSL as they meet the necessary criteria for addition to the DSL.

Description

The Order adds 41 substances to the DSL. To protect confidential business information, 20 of the 41 substances will have masked chemical names.

Additions to the Domestic Substances List

A substance must be added to the DSL under subsections 87(1) or (5) of CEPA 1999 within 120 days once all of the following conditions are met:

Publication of masked names

The Order masks the chemical name of 20 of the 41 substances being added to the DSL. Masked names are allowed by the CEPA 1999 if the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information. The procedure to be followed for creating a masked name is set out in the Masked Name Regulations under the CEPA 1999. Substances with a masked name are added under the confidential portion of the DSL. 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.

“One-for-One” Rule and small business lens

The Order does not trigger the “One-for-One” Rule, as it does not add any additional costs to business. Also, the small business lens does not apply to the Order, as it does not add any administrative or compliance burden to small businesses. Rather, the Order provides industry with better access to the 41 substances being added to the DSL.

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 is required.

Rationale

Forty-one substances have met the necessary conditions for addition to the DSL. The Order adds these substances to the DSL to exempt them from assessment and reporting requirements under subsection 81(1) of the CEPA 1999.

The Order will benefit Canadians by enabling industry to use these substances in larger quantities. The Order will also benefit industry by reducing the administrative burden associated with the current regulatory status of these substances. As a result, it is expected that there will be no incremental costs to the public, industry or governments associated with the Order. However, the Government of Canada may still decide to assess any substance on the DSL under the existing substances provisions of the CEPA 1999 (section 68 or 74) should an assessment be deemed necessary.

Implementation, enforcement and service standards

The DSL identifies substances that, for the purposes of the CEPA 1999, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). 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
Executive Director
Program Development and Engagement Division
Environment Canada
Gatineau, Quebec
K1A 0H3
Substances Management Information Line:

Fax: 819-938-3231
Email: substances@ec.gc.ca