Vol. 148, No. 20 — September 24, 2014

Registration

SOR/2014-201 September 2, 2014

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2014-87-07-01 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 2014-87-07-01 Amending the Domestic Substances List.

Gatineau, August 29, 2014

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2014-87-07-01 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. (1) Paragraph 1(a) in column 2 of Part 2 of the French version of the List, opposite the reference to the substance “1344-37-2 S’” in column 1, is replaced by the following:

(2) Paragraph 1(a) in column 2 of Part 2 of the French version of the List, opposite the reference to the substance “12656-85-8 S’” in column 1, is replaced by the following:

(3) 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
37237-76-6 N-S
  • 1. The use, in a quantity greater than 1000 kg in a calendar year, of the substance poly[oxy(methyl-1,2-ethanediyl)], α,α′,α″-1,2,3-propanetriyltris[ω-(oxiranylmethoxy)- in consumer products, as defined in section 2 of the Canada Consumer Product Safety Act, in a manner that the substance is present in the products in its unreacted form.
  • 2. The following information must be provided to the Minister at least 90 days before the commencement of the proposed significant new activity:
    • (a) a description of the proposed significant new activity in relation to the substance;
    • (b) the information specified in Schedule 9 of the New Substances Notification Regulations (Chemicals and Polymers);
    • (c) the information specified in item 5 of Schedule 10 to those Regulations; and
    • (d) the test data and test reports from
      • (i) a bacterial reverse mutation test in respect of the substance, conducted according to the Organisation for Economic Co-operation and Development ("OECD") Test Guideline No. 471, titled Bacterial Reverse Mutation Test,
      • (ii) an in vitro chromosomal aberration test in respect of the substance, conducted according to OECD Test Guideline No. 473, titled In Vitro Mammalian Chromosome Aberration Test,
      • (iii) a mammalian in vivo micronucleus test in respect of the substance, conducted according to OECD Test Guideline No. 474, titled Mammalian Erythrocyte Micronucleus Test, and
      • (iv) a local lymph node assay in respect of the substance, conducted according to OECD Test Guideline No. 429, titled Skin Sensitisation: Local Lymph Node Assay.
  • 3. The test data and the test report from a 28-day repeated dose dermal mammalian toxicity test, conducted according to OECD Test Guideline No. 410, titled Repeated Dose Dermal Toxicity: 21/28-day Study, must be provided to the Minister at least 90 days before the day on which the quantity of the substance involved in the significant new activity exceeds 50 000 kg in a calendar year.
  • 4. The test data described in paragraph 2(d) and item 3 must be in conformity with the laboratory practices described in the OECD Principles of Good Laboratory Practice, set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981, that are current at the time the test data are developed.
  • 5. The information provided under items 2 and 3 is to be assessed within 90 days after the day on which it is received by the Minister.

3. Section 1 in column 2 of Part 2 of the List, opposite the reference to the substance “37237-76-6 N-S” in column 1, is replaced by the following:

1. The use, in a quantity greater than 100 kg in a calendar year, of the substance poly[oxy(methyl-1,2-ethanediyl)], α,α′,α″-1,2,3-propanetriyltris[ω-(oxiranylmethoxy)- in consumer products, as defined in section 2 of the Canada Consumer Product Safety Act, in a manner that the substance is present in the products in its unreacted form.

1.1 For greater certainty, in respect of calendar year 2015, the quantity of the substance referred to in section 1 does not include any quantity of the substance that is used before July 1 of that calendar year.

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

16677-0 N 2-Propenoic acid, alkyl ester, polymer with substituted ethene and alkenyl acetate
  Acrylate d’alkyle polymérisé avec un éthène substitué et un acétate d’alcényle
18694-1 N-P Formaldehyde, polymers with 1,3-dioxolan-2-one, 2-substituted carbopolycycle and succinic anhydride polyisobutylene derivs.
  Formaldéhyde polymérisé avec de la 1,3-dioxolan-2-one, un carbopolycycle substitué en position 2 et des dérivés polyisobutyléniques de l’oxolane-2,5-dione
18703-1 N-P 2,5-Furandione, polymer with 2,4,4-trimethylalkene, reaction products with ammonium hydroxide
  Furane-2,5-dione polymérisée avec un 2,4,4-triméthylalcène, produits de la réaction avec de l’hydroxyde d’ammonium
18704-2 N-P Hydroxy alkyl methacrylate polymer with alkyl acrylate, dialkyl amino alkyl methacrylamide, styrene, alkyl methacrylate, poly(alkyl glycol) alkyl ether methacrylate and hydroxyalkyl alkylene urea methacrylate, tert-Bu 2-ethylhexaneperoxoate –initiated
  Méthacrylate d’hydroxyalkyle polymérisé avec un acrylate d’alkyle, un (dialkylaminoalkyl) méthacrylamide, du styrène, un méthacrylate d’alkyle, un méthacrylate d’oxyde de poly(alkyléthane-1,2-diol) et un méthacrylate d’hydroxyalkyl(alkylène)urée, amorcé avec du 2-éthylhexaneperoxoate de tert-butyle
18705-3 N-P 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, alkanedioic acid, dimethyl-alkanediol, alkanediol and alkanedioic acid
  Acide isophtalique polymérisé avec de l’acide téréphtalique, un acide alcanedioïque, un diméthylalcanediol, un alcanediol, et un autre acide alcanedioïque
18706-4 N-P 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, dimethyl-alkanediol, alkanediol, alkanedioic acid and 2-methylenealkanedioic acid
  Acide isophtalique polymérisé avec de l’acide téréphtalique, un diméthylalcanediol, un alcanediol, un acide alcanedioïque et un acide 2-méthylènealcanedioïque
18707-5 N-P 2-Propenoic acid, 2-methyl-, polymer with butyl 2-propenoate, ethenylbenzene, alkyl 2-propenoate and 2-hydroxyalkyl 2-methyl-2-propenoate
  Acide méthacrylique polymérisé avec de l’acrylate de butyle, du styrène, un acrylate d’alkyle et un méthacrylate d’hydroxalkyle
18708-6 N Alkanenedioic acid, polymer with hexanedioic acid, 1,6-hexanediol, α-hydro-ω -hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,3-isobenzofurandione, 1,1′-methylenebis [4-isocyanatobenzene], 2-oxepanone and 2,2′-oxybis[ethanol]
  Acide alcanedioïque polymérisé avec de l’acide hexanedioïque, de l’hexane-1,6-diol, de l’α hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)], de la 2-benzofurane-1,3-dione, du 1,1′- méthylènebis[4-isocyanatobenzène], de l’oxépan-2-one et du 2,2′-oxybis[ethanol]
18710-8 N-P Waste plastics, poly(ethylene terephthalate), depolymd. with diethylene glycol, substituted heteropolycycle and oil
  Déchets de matières plastiques, poly(téréphtalate d’éthylène), dépolymérisés avec du 3 oxapentane-1,5-diol, un hétéropolycycle substitué et une huile
18711-0 N-P Soybean oil, polymer with diethylene glycol, methylalkanediol, phthalic anhydride and terephthalic acid
  Huile de soja polymérisée avec du 3-oxapentane-1,5-diol, un méthylalcanediol, de la 2 benzofurane-1,3-dione et de l’acide téréphtalique
18713-2 N-P 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, alkyl alkyl-2-propenoate, dialkyl-alkanediol, alkanediol, alkanedioic acid, 2-methylenealkanedioic acid and alkyl alkyl-2-propenoate
  Acide isophtalique polymérisé avec de l’acide téréphtalique, un alkylacrylate d’alkyle, un dialkylalcanediol, un alcanediol, un acide alcanedioïque, de l’acide 2 méthylènealcanedioïque et un autre alkylacrylate d’alkyle
18714-3 N-P Fatty acid ethoxylated, propoxylated, maleate
  Acide gras, éthoxylée, propoxylée, maléate
18715-4 N-P 2-Propenoic acid, 2-methyl-, alkyl ester, polymer with butyl 2-propenoate and 1-ethenyl-2-pyrrolidinone
  Méthacrylate d’alkyle polymérisé avec de l’acrylate de butyle et de la 1 éthénylpyrrolidin-2-one
18716-5 T Alcohols, alkoxylated
  Alcools alcoxylés
18717-6 N-P Propanoic acid, 3-hydroxy-2-(hydroxyalkyl)-2-methyl-, polymer with 1,6-diisocyanatohexane, α-hydro-ω -hydroxypoly (oxy-1,4-butanediyl) and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane
  Acide 2-hydroxyméthyl-2-hydroxyalkylpropanoïque polymérisé avec du 1,6 diisocyanatohexane, de l’α-hydro-ω-hydroxypoly(oxybutane-1,4-diyle) et du 5 isocyanato-1-(isocyanatométhyl)-1,3,3-triméthylcyclohexane
18718-7 N Fatty acids, C18-unsatd., dimers, polymers with acrylic acid, pentaerythritol and heteropolycycle
  Dimères d’acides gras en C18 insaturés polymérisés avec de l’acide acrylique, du 2,2-bis(hydroxyméthyl)propane-1,3-diol et un hétéropolycycle
18719-8 N-P 2-Propenoic acid, 2-methyl-, alkyl ester, telomer with 1,1′-(1,1-dimethyl-3-methylene-1,3-propanediyl) bis[benzene] and 2-hydroxyethyl 2-methyl-2-propenoate, bis(1,1-dimethylpropyl) peroxide-initiated, polymers with acrylic acid, N,N-dimethyl-2-propenamide and N-(1-methylethyl)-2-propenamide
  Méthacrylate d’alkyle télomérisé avec du 1,1′-(4-méthylpent-1-èn-2,4-diyl)bis[benzène] et du méthacrylate de 2-hydroxyéthyle, amorcé avec du peroxyde de di(2-méthylbutane-2-yle), polymérisé avec de l’acide acrylique, du N,N-diméthylacrylamide et du N-(propane-2-yl)acrylamide

COMING INTO FORCE

5. (1) Subject to subsection (2), this Order comes into force on the day on which it is registered.

(2) Section 3 comes into force on July 1, 2015.

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 (chemicals, polymers, 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 24 new substances reported, under subsection 81(1) of CEPA 1999, 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.

Significant new activity (SNAc) provisions under subsection 81(3) of CEPA 1999 have been applied to one of the 24 substances, as Environment Canada and Health Canada have determined that appropriate information must be provided to the Minister of the Environment prior to the commencement of a new activity.

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.

Addition of SNAc provision requirements

Experimental evidence considered in the assessment of one of the substances in this package (Chemical Abstracts Service Registry No. 37237-76-6) suggests the potential for skin sensitization. For this reason, the significant new activity provisions of CEPA are applied to require information (including a local lymph node assay which allows the characterization of its skin sensitization potential) and ensure that the substance undergoes further assessment if used in consumer products under certain conditions.

This substance was a new polymer substance that could be manufactured or imported in a quantity of up to 1 000 kg in a calendar year without providing information to the Minister of the Environment under subsection 81(1) of CEPA 1999. For this reason, a transitional period of approximately one year is provided during which the significant new activities will be defined with a threshold of 1 000 kg per calendar year. Following this period, the significant new activities will be defined with a threshold of 100 kg per year.

Objectives

The objectives of the Order 2014-87-07-01 Amending the Domestic Substances List is to comply with the requirements of CEPA 1999 and facilitate access to and use of 24 substances by removing reporting requirements under the New Substances Program associated with their import or manufacture. SNAc provisions have been put in place for one substance to ensure the Government would assess the substance associated with its significant new use. Furthermore, additional objective of the Order is to modify the SNAc wordings for two substances on Part 2 of the DSL to reconcile the discrepancy between the English and the French wordings.

Description

The Order adds 24 substances to the DSL. To protect confidential business information, 17 of the 24 substances being added to the DSL will have masked chemical names.

Furthermore, as substances cannot be on both the DSL and the NDSL simultaneously, the proposed Order 2014-87-07-02 Amending the Non-Domestic Substances List will delete 4 of the 24 substances from the NDSL, as they meet the necessary criteria for addition to the DSL.

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:

Furthermore, SNAc provision requirements may be added on the DSL in relation to a substance to require further information before such activities begin. This Order adds SNAc requirements (SNAc 17639) concerning one substance (Chemical Abstracts Service Registry No. 37237-76-6) to Part 2 of the DSL to ensure further assessment is conducted prior to the commencement of any use of the substance in consumer products.

Modifications to the Domestic Substances List

The Order modifies the SNAc wording for two substances on Part 2 of the DSL to reconcile the discrepancies between the English and the French wordings.

Publication of masked names

The Order masks the chemical name of 17 of the 24 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 is not expected to add any administrative or compliance burden to small businesses. Rather, the Order provides industry with better access to the 24 substances being added to the DSL. The Government of Canada may conduct further risk assessments on any substance on 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-four 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).

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 add 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)
819-953-7156 (outside of Canada)
Fax: 819-953-7155
Email: substances@ec.gc.ca