Vol. 148, No. 20 — September 24, 2014
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
Minister of the Environment
ORDER 2014-87-07-01 AMENDING THE DOMESTIC SUBSTANCES LIST
1. Part 1 of the Domestic Substances List (see footnote 1) is amended by adding the following in numerical order:
- 68551-95-1 N-P
- 87189-25-1 N
- 141526-35-4 N-P
- 328076-96-6 N-P
- 1012318-97-6 N-P
- 1065544-88-8 N
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:
- a) composante dans le plastique utilisé à des fins industrielles ou commerciales ou destiné à l’exportation pour la vente;
(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:
- a) composante dans le plastique utilisé à des fins industrielles ou commerciales ou destiné à l’exportation pour la vente;
(3) Part 2 of the List is amended by adding the following in numerical order:
Significant new activity for which substance is subject to subsection 81(3) of the Act
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|
|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.)
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.
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.
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.
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:
- the Minister of the Environment has been provided with information regarding the substance; (see footnote 3) the Minister of the Environment and the Minister of Health are satisfied that the substance has already been manufactured in or imported into Canada by the person who provided the information 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 submitted information for the substance has expired; and
- the substance is not subject to any conditions imposed on its import or manufacture.
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.
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.
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.
Program Development and Engagement Division
Substances Management Information Line:
1-800-567-1999 (toll-free in Canada)
819-953-7156 (outside of Canada)
- Footnote a
S.C. 1999, c. 33
- Footnote b
- Footnote c
- Footnote d
S.C. 1999, c. 33
- Footnote 1
- 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, established the structure of the Domestic Substances List. For more information, please visit : http://gazette.gc.ca/rp-pr/p2/2001/2001-07-04/pdf/g2-13514.pdf.
- Footnote 3
The most comprehensive package, with information about the substances, depends on the class of a substance. The information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers) under CEPA 1999.