Vol. 148, No. 9 — April 23, 2014
SOR/2014-87 April 9, 2014
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Order 2014-87-03-01 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 2014-87-03-01 Amending the Domestic Substances List.
Gatineau, April 7, 2014
Minister of the Environment
ORDER 2014-87-03-01 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:
- 68605-80-1 N-P
- 1346107-02-5 N-P
- 1393736-46-3 N
- 1463475-59-3 N-P
2. Part 3 of the List is amended by adding the following in numerical order:
Domestic substances list
|14891-5 T-P||Hydroxy alkanoic acid polymer with alkyl methacrylate, methacrylic acid, alkyl thiol, epoxy methacrylate and hydroxy alkyl methacrylate, branched alkyl-substituted peroctoate-initiated|
|Acide hydroxyalcanoïque, polymérisé avec un méthacrylate d’alkyle, de l’acide méthacrylique, un alcanethiol, un méthacrylate d’époxyalkyle et un méthacrylate d’hydroxyalkyle, amorcé avec un octaneperoxoate d’alkyle ramifié|
|18649-1 N-P||2-Propenoic acid, telomer with butyl 2-propenoate, alkyl mercaptan and 2-ethylhexyl 2-propenoate|
|Acide acrylique télomérisé avec de l’acrylate de butyle, un alcanethiol et de l’acrylate de 2 éthylhexyle|
|18650-2 N-P||2-Propenoic acid, 2-methyl-, methyl ester polymer with 2-propenoic acid, butyl ester and 2-propenamide, N-(1,1-dialkyl-3-oxobutyl)-|
|Méthacrylate de méthyle polymérisé avec de l’acrylate de butyle et du N-(1,1-dialkyl-3-oxobutyl)acrylamide|
|18651-3 N-P||Butanoic acid, 2,2-bis(hydroxymethyl)-, polymer with 2-(chloromethyl)oxirane polymer with 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trialkylcyclohexane and 4,4′-(1-methylethylidene)bis[phenol] 4-oxopentanoate (ester), 1,6-diisocyanatohexane, α-hydro-ω-hydroxypoly(oxy-1,4-butanediyl) and 1,1′-methylenebis[4-isocyanatocyclohexane], compd. with N,N-diethylethanamine|
|Acide 2,2-bis(hydroxyméthyl)butanoïque, polymérisé avec du 2-(chlorométhyl)oxirane polymérisé avec du 5-isocyanato-1-(isocyanatométhyl)-1,3,3-trialkylcyclohexane et du 4-oxopentanoate de 4,4′-(propane-2,2-diyl)bis[phénol] (ester), du 1,6-diisocyanatohexane, de l’α-hydro-ω-hydroxypoly(oxybutane-1,4-diyle) et du 1,1′-méthylènebis[4 isocyanatocyclohexane], composé avec le N,N-diéthyléthanamine|
|18653-5 N-P||2-Propenoic acid, 2-methyl-, telomer with alkyl 2-propenoate, 3-mercaptopropionic acid and methyl 2-methyl-2-propenoate, potassium salt|
|Acide méthacrylique télomérisé avec un acrylate d’alkyle, de l’acide 3-mercaptopropionique et du méthacrylate de méthyle, sel de potassium|
|18656-8 N-P||2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, polymer with 2-ethylhexyl 2-propenoate and methyl 2-methyl-2-propenoate, carbon substituted|
|Méthacrylate de 2-hydroxyéthyle polymérisé avec de l’acrylate de 2-éthylhexyle et du méthacrylate de méthyle, carbone substitué|
|18657-0 N-P||Sunflower oil, polymer with isophthalic acid, pentaerythritol, phthalic anhydride and carbon substituted|
|Huile de tournesol polymérisée avec de l’acide isophtalique, du 2,2 bis(hydroxyméthyl)propane-1,3-diol, de l’isobenzofurane-1,3-dione et un carbone substitué|
|18658-1 N-P||Alkenoic acid, sodium salt, polymer with 1-propanesulfonic acid, 2-methyl-2-[(1-oxo-2-propenyl)amino]-, monosodium salt and 2-propenamide|
|Alcénoate de sodium polymérisé avec de l’acide 2-méthyl-2-[(1-oxoprop-2-ényl)amino]propane-1-sulfonique, sel de monosodium et acrylamide|
|18659-2 N-P||2-Propenoic acid, 2-methyl-, methyl ester, polymer with oxaoxooctene, ethyloxaoxodecene, methyloxaoxoheptadiene and tris(2-propen-1-yloxy)-heteromonocycle|
|Méthacrylate de méthyle polymérisé avec un oxaoxooctène, un éthyloxaoxodécène, un méthyloxaoxoheptadiène et un tris(prop-2-én-1-yloxy)-hétéromonocycle|
|18660-3 N-P||Fatty acid oil, ethoxylated, polymer with bisphenol A, epichlorohydrin and 3a,4,7,7a-tetrahydro-1,3-isobenzofurandione|
|Acide gras, éthoxylé, polymérisé avec du bisphénol A, du 1-chloro-2,3-époxypropane et de la 3a,4,7,7a-tétrahydro-isobenzofurane-1,3-dione|
|18661-4 N-P||Fatty acids, C18-unsatd., dimers, hydrogenated, polymers with adipic acid, alkyldiol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane and polyethylene-polypropylene glycol 2-[[3-(2-hydroxyethoxy)-3-oxopropyl]amino]propyl Me ether compds. with 1-ethylpiperidine|
|Dimères d’acides gras insaturés en C18, hydrogénés, polymérisés avec de l’acide hexanedioïque, un alcanediol, de l’acide 2,2-bis(hydroxyméthyl)propanoïque, du 5 isocyanato-1-(isocyanatométhyl)-1,3,3-triméthylcyclohexane et de l’oxyde de poly[(éthane-1,2-diol)-(propane-1,2-diol)], de 2-[[3-(2-hydroxyéthoxy)-3-oxopropyl]amino]propyle et de méthyle, composés avec de la 1-éthylpipéridine|
|18663-6 N||9-octadecenoic acid, 12-hydroxy-, (9Z,12R)-, homopolymer, 3-(dimethylamino)akyl amide|
|Acide (9Z,12R)-12-hydroxyoctadéc-9-énoïque, homopolymérisé, 3 (diméthylamino)alkylamide|
|18664-7 N-P||2-Propenoic acid, 2-methyl-, 2-(mono-heterocyclic)ethyl ester, polymer with ethenylbenzene, 2-ethylhexyl 2-propenoate and 2-propenoic acid|
|Méthacrylate de 2-(monohétérocycle)éthyle, polymérisé avec du styrène, de l’acrylate de 2 éthylhexyle et de l’acide acrylique|
|18665-8 N-P||Alkanol, alkoxy hydroxyalkyl, phenylalkyl amino-, polymer with α-hydro-ω-hydroxypoly(oxy-1,2-ethanediyl) and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane|
|Alcoxy-[(hydroxyalkyl)(phénylalkyl)amino]alcanol, polymérisé avec de l’α-hydro-ω-hydroxypoly(oxyéthane-1,2-diyle) et du 5-isocyanato-1-(isocyanatométhyl)-1,3,3-triméthylcyclohexane|
|18666-0 N||1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol, hexanedioic acid, 5-isocyanato-1-(isocyanatomethyl)-polyalkycarbomonocycle and 2,2′-oxybis[ethanol]|
|Acide isophtalique polymérisé avec du néopentanediol, du 2-éthyl-2-(hydroxyméthyl)propane-1,3-diol, de l’acide hexanedioïque, du 5-isocyanato-1-(isocyanatométhyl)-polyalkylcarbomonocyle et du 2,2′-oxybis[éthanol]|
|18667-1 N-P||Fatty acids, dehydrated castor oil, polymers with acrylic acid, bisphenol A, epichlorohydrin, 2-ethoxyethanol, alkyl methacrylate, styrene and 2,4-TDI, tert-Bu peroxide-initiated, compds. with triethylamine|
|Acides gras d’huile de ricin déshydratée, polymérisés avec de l’acide acrylique, du bisphénol A, du 1-chloro-2,3-époxypropane, du 2-éthoxyéhanol, un méthacrylate d’alkyle, du styrène et du 2,4-diisocyanatotoluène, amorcé avec du peroxyde de tert-butyle, composés avec de la N,N-diéthyléthanamine|
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.)
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 20 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. Industry has open market access to substances that are added to the DSL.
The Domestic Substances List
The DSL is a list of substances (chemicals, polymers, and living organisms) that are considered “existing” for the purposes of CEPA 1999. “New” substances which are not on the DSL 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 Canada’s 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.
The objectives of the Order 2014-87-03-01 Amending the Domestic Substances List are to comply with the requirements of CEPA 1999 and facilitate access to and use of 20 substances by removing reporting requirements under the New Substances Program associated with their import or manufacture.
The Order adds 20 substances to the DSL. To protect confidential business information, 16 of the 20 substances being added to the DSL will have masked chemical names. (see footnote 3)
Furthermore, as substances cannot be on both the DSL and the NDSL simultaneously, the proposed Order 2014-87-03-02 will delete one of the 20 substances from the NDSL, as it meets 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 4)
- 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.
Publication of masked names
The Order masks the chemical name of 16 of the 20 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 20 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 substances have met the necessary conditions for addition to the DSL. The Order adds these substances to the DSL to exempt them from reporting requirements under subsection 81(1) of CEPA 1999. The Order will benefit Canadians by enabling industry to use these substances in larger quantities. Also, as the Order will exempt these substances from assessment and reporting requirements under the New Substances Program of CEPA 1999, it will 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 adds 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, establishes 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
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.
- Footnote 4
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.