Vol. 149, No. 19 — September 23, 2015

Registration
SOR/2015-216 September 10, 2015

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2015-87-10-01 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) and (5) of the Canadian Environmental Protection Act, 1999 (see footnote d), makes the annexed Order 2015-87-10-01 Amending the Domestic Substances List.

Gatineau, August 31, 2015

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2015-87-10-01 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:

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

17146-1 N-P 2-Propenoic acid, 2-methyl-, alkyl ester, polymer with butyl 2-propenoate and 2-hydroxyethyl 2-propenoate, bis(1,1-dimethylpropyl) peroxide-initiated
  Méthacrylate d’alkyle polymérisé avec de l’acrylate de butyle et de l’acrylate de 2-hydroxyéthyle, amorcé avec du peroxyde de bis(2-méthylbutane-2-yle)
18856-1 N Hexanedioic acid, polymer with (chloroalkyl)oxirane polymer with (alkylalkylidene)bis[phenol] 2-propenoate, 1,6-diisocyanatohexane, 2,2-dimethyl-1,3-propanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and alkyltriyltris[ω-hydroxypoly[oxy(alkyl-alkyldiyl)]] 2-propenoate
  Acide hexanedioïque polymérisé avec un (chloroalkyl)oxirane polymérisé avec un ester d’acide acrylique et d’(alkylalcanediyl)bisphénol, du 1,6-diisocyanatohexane, du 2,2 diméthylpropane-1,3-diol, de l’acide 2,2 bis(hydroxyméthyl)propanoïque, du 5-isocyanato-1-(isocyanatométhyl)-1,3,3-triméthylcyclohexane et un ester d’acide acrylique et d’(alkyltriyl)tris[ω-hydroxypoly[oxy(alkylalcanediyle)]]
18857-2 N 2-Propenoic acid, tetraester with 2,2′-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol], polymer with (chloroalkyl) oxirane polymer with (alkylalkylidene)bis[phenol] 2-propenoate, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and 1,1′-methylenebis[4-isocyanatocyclohexane], dipentaerythritol pentaacrylate-blocked, compds. with triethylamine
  Tétraester d’acide acrylique et de 2,2′-[oxybis(méthylène)]bis[2-(hydroxyméthyl)propane-1,3-diol] polymérisé avec un (chloroalkyl)oxirane polymérisé avec un ester d’acide acrylique et d’(alkylalcanediyl)bisphénol, de l’acide 2,2-bis(hydroxyméthyl)propanoïque et du 1,1′-méthylènebis[4-isocyanatocyclohexane], séquencé avec du pentaester d’acide acrylique et de di[2,2-bis(hydroxyméthyl)propane-1,3-diol], composés avec la N,N-diéthyléthanamine
18858-3 N Propanoic acid, 3-hydroxy-2-(hydroxymethyl)-2-methyl-, polymers with (alkylalkylidene)bis[phenol]-(chloroalkyl) oxirane polymer acrylate, 1,1′-methylenebis[4-isocyanatocyclohexane] and Poly[oxy(alkyl-alkyldiyl)], alkytriyltris.ω-hydroxy-, 2-propenoate, Poly[oxy(alkyl-alkyldiyl)], alkytriyltris.ω-hydroxy-, diacrylate-blocked, compds. with triethylamine
  Acide 2,2-bis(hydroxyméthyl)propanoïque polymérisé avec un ester d’acide acrylique et d’(alkylalcanediyl)bisphénol polymérisé avec un (chloroalkyl)oxirane, du 1,1′-méthylènebis[4-isocyanatocyclohexane] et un ester d’acide acrylique et d’(alkyltriyl)tris.ω-hydroxypoly[oxy(alkylalcanediyle)], séquencé avec un diester d’acide acrylique et d’(alkyltriyl)tris.ω-hydroxypoly[oxy(alkylalcanediyle)], composés avec la N,N diéthyléthanamine
18859-4 N-P Propanol, 2-alkane-2‍(substituted methyl)-, polymer with hexane derivative and α-hydro-ω-substituted poly(oxy-1,4-butanediyl), N-(1-methylalkane)-2-propanamine-blocked
  2-Alkyl-2‍(méthyl substitué)propanol polymérisé avec de l’hexane substitué et de l’α-hydro-ω-(radical)poly(oxybutane-1,4-diyle), séquencé avec de la N-(alcane-2-yl)propan-2-amine
18860-5 N-P Propenoic acid, alkyl- alkyl ester polymer
  Alkylacrylate d’alkyle polymérisé
18861-6 N-P Formaldehyde, polymers with branched alkylphenol
  Formaldéhyde polymérisé avec un (alkyl ramifié)phénol
18862-7 N Benzenedicarboxylic acid, polymer with (chloroalkyl) oxirane, 2,2-dimethyl-1,3-propanediol, hexanedioic acid, 2-[[3-hydroxy-2,2-bis[[(1-oxo-2-propenyl)oxy]methyl]propoxy]methyl]-2-(hydroxymethyl)-1,3-propanediyl di-2-propenoate, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 1,1′-methylenebis [4-isocyanatocyclohexane], (alkylalkylidene)bis[phenol] and 2-propenoic acid, dipentaerythritol pentaacrylate-blocked, compds. with triethylamine
  Acide benzènedicarboxylique polymérisé avec un (chloroalkyl)oxirane, du 2,2-diméthylpropane-1,3-diol, de l’acide hexanedioïque, du diacrylate de 2-[[3-hydroxy-2,2-bis[[(prop-2-énoyl)oxy]méthyl]propoxy]méthyl]-2-(hydroxyméthyl)propane-1,3-diyle, de l’acide 2,2-bis(hydroxyméthyl)propanoïque, du 1,1′-méthylènebis [4-isocyanatocyclohexane], un (alkylalcanediyl)bisphénol et de l’acide acrylique, séquencé avec du pentaester d’acide acrylique et de di[2,2-bis(hydroxyméthyl)propane-1,3-diol], composés avec de la N,N diéthyléthanamine
18863-8 N-P Ethanaminium, polymethyl-2-[(2-methyl-1-oxo-2-propenyl)oxy]-,chloride, polymer with 2-hydroxyethyl 2-propenoate, 2-[(2-methyl-1-oxo-2-propenyl)oxy]ethyl 3-oxobutanoate, alpha-(1-oxo-2-propenyl)-omega-hydroxypoly(oxy-1,2-ethanediyl) and 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-propenoate
  Chlorure de polyméthyl-2-[(2-méthylprop-2 énoyl)oxy]éthanaminium polymérisé avec de l’acrylate de 2 hydroxyéthyle, du 3-oxobutanoate de 2-[(2-méthylprop-2-énoyl)oxy]éthyle, de l’alpha-(prop-2-énoyl)-oméga-hydroxypoly(oxyéthane-1,2-diyle) et de l’acrylate de 3,3,4,4,5,5,6,6,7,7,8,8,8-tridécafluorooctyle
18864-0 N 1,3-Benzenedicarboxylic acid, polymer with butyl 2-methyl-2-propenoate, hexanedioic acid, alkanediol, α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 2-hydroxyethyl 2-methyl-2-propenoate, 1,1′-methylenebis[4-isocyanatobenzene], methyl 2-methyl-2-propenoate, 2-methyl-2-propenoic acid and 2-oxepanone
  Acide isophtalique polymérisé avec du méthacrylate de butyle, de l’acide hexanedioïque, un alcanediol, de l’α-hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)], du méthacrylate de 2-hydroxyéthyle, du 1,1′-méthylènebis[4-isocyanatobenzène], du méthacrylate de méthyle, de l’acide méthacrylique et de l’oxépan-2-one
18867-3 N-P Poly(oxy-1,2-ethanediyl), α-hydro- ω-hydroxy-, polymer with 1,6-diisocyanatotrimethylalkane
  α-Hydro-ω-hydroxypoly(oxyéthane-1,2-diyle) polymérisé avec un 1,6-diisocyanatotriméthylalcane
18868-4 N-P 2-Propenoic acid, 2-methyl-, polymer with ethenylbenzene, 2-alkylhexyl 2-methyl-2-propenoate, hydroxyalkyl 2-propenoate and methyl 2-methyl-2 propenoate, tert-Bu peroxide-initiated
  Acide méthacrylique polymérisé avec du styrène, un méthacrylate de 2-alkylhexyle, un acrylate d’hydroxyalkyle et du méthacrylate de méthyle, amorcé avec du peroxyde de tert-butyle
18869-5 N-P 1,3-Benzenedicarboxylic acid, polymer with hexanedioic acid and 1,6-hexanediol, diamine, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 4,4′-methylenedicyclohexyl diisocyanate, and castor oil
  Acide isophtalique polymérisé avec de l’acide hexanedioïque, de l’hexane-1,6-diol, une diamine, de l’acide 2,2 bis(hydroxyméthyl)propanoïque, du 4,4′ méthylènebis(diisocyanatocyclohexane) et de l’huile de ricin
18870-6 N 1,3-Isobenzofurandione, polymer with alkanediol and α-hydro-ω-hydroxypoly (oxy-1,2-ethanediyl) ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 2-propenoate
  2-Benzofurane-1,3-dione polymérisée avec un alcanediol et de l’oxyde d’α-hydro-ω-hydroxypoly(oxyéthane-1,2-diyle) et de 2 éthyl-2-(hydroxyméthyl)propane-1,3-diol (3/1), acrylate
18871-7 N-P Poly[oxy(methyl-1,2-ethanediyl)], alpha-hydro-omega-hydroxy-, ether with alkyl substituted alkyl alkanediol, polymer with 1,1′- methylenebis[isocyanatobenzene]
  Oxyde d’alpha-hydro-oméga-hydroxypoly[oxypropane-1,2-diyle] et d’alkyl(alkyl substitué)alcanediol, polymérisé avec du 1,1′-méthylènebis[isocyanatobenzène]
18879-6 N-P Alkanedioic acid, polymer with propanediol, benzoate
  Acide alcanedioïque polymérisé avec du propanediol, benzoate

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 22 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 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 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 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 2015-87-10-01 Amending the Domestic Substances List are to comply with the requirements under CEPA 1999 and facilitate access to and use of 22 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 2015-87-10-02 Amending the Non-domestic Substances List will delete 4 of the 22 substances from the NDSL, as they meet the necessary criteria for addition to the DSL.

Description

The Order adds 22 substances to the DSL. To protect confidential business information, 16 of the 22 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 16 of the 22 substances being added to the DSL. Masked names are allowed 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. The procedure to be followed for creating a masked name is set out in the Masked Name Regulations under 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 22 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

Twenty-two 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 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 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 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:
1-800-567-1999 (toll-free in Canada)
819-938-3232 (outside of Canada)
Fax: 819-938-5212
Email: substances@ec.gc.ca