Order 2019-87-11-01 Amending the Domestic Substances List: SOR/2019-302
Canada Gazette, Part II, Volume 153, Number 18
Registration
SOR/2019-302 August 16, 2019
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Whereas the Minister of the Environment has been provided with information under paragraph 87(5)(a) of the Canadian Environmental Protection Act, 1999 footnote a in respect of each substance referred to in the annexed Order that is added to the Domestic Substances List footnote b pursuant to subsection 87(5) of that Act;
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 subsection 87(5) of the Canadian Environmental Protection Act, 1999 footnote a, makes the annexed Order 2019-87-11-01 Amending the Domestic Substances List.
Gatineau, August 14, 2019
Catherine McKenna
Minister of the Environment
Order 2019-87-11-01 Amending the Domestic Substances List
Amendments
1 Part 1 of the Domestic Substances List footnote 1 is amended by adding the following in numerical order:
- 406-78-0 N
- 68555-14-6 N-P
- 68783-29-9 N
- 84731-70-4 N
- 1415477-49-4 N-P
- 2244880-58-6 N
2 Part 3 of the List is amended by adding the following in numerical order:
19356-4 N-P |
Hexanoic acid, trialkyl-, polymer with 2,2-dimethyl-1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-1,3-propanediol and hydro-1,3-dioxo-heteromonocycle Acide trialkylhexanoïque polymérisé avec du 2,2-diméthylpropane-1,3-diol, du 2-éthyl-2-(hydroxyméthyl)propane-1,3-diol et un hydrohétéromonocycle-1,3-dione |
---|---|
19357-5 N |
Oil, polymer with 2,3-dihydroxypropyl stearate and 1,1′-methylenebis[4-isocyanatobenzene] Huile polymérisée avec de l’octadécanoate de 2,3-dihydroxypropyle et du 1,1′-méthylènebis[4-isocyanatobenzène] |
19358-6 N |
Oil, polymer with 2,3-dihydroxypropyl stearate and 1,1′-methylenebis[isocyanatobenzene] Huile polymérisée avec de l’octadécanoate de 2,3-dihydroxypropyle et du méthylènebis[isocyanatobenzène] |
19359-7 N |
Hexanedioic acid, polymer with α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1′-methylenebis[isocyanatobenzene] and 2,2′-oxybis[ethanol], reaction products with alkyl alcohol Acide hexanedioïque polymérisé avec de l’α-hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)], du méthylènebis[isocyanatobenzène] et du 2,2′-oxybis[éthanol], produits de la réaction avec un alcanol |
19360-8 N |
Hexanedioic acid, polymer with α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1′-methylenebis[4-isocyanatobenzene] and 2,2′-oxybis[ethanol], reaction products with alkyl alcohol Acide hexanedioïque polymérisé avec de l’α-hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)], du 1,1′-méthylènebis[4-isocyanatobenzène] et du 2,2′-oxybis[éthanol], produits de la réaction avec un alcanol |
19361-9 N-P |
Alkanoic acid, substituted-, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl ester, polymer with butyl 2-propenoate, 2-ethylhexyl 2-propenoate and methyl 2-methyl-2-propenoate, ammonium salt Alcanoate substitué de 2-[(2-méthylprop-2-ènoyl)oxy]éthyle polymérisé avec du prop-2-ènoate de butyle, du prop-2-ènoate de 2-éthylhexyle et du 2-méthylprop-2-ènoate de méthyle, sel d’ammonium |
19363-1 N |
Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, polymer with 1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-, oil, polymer with diethylene glycol, phthalic anhydride and polypropylene glycol ether with glycerol (3:1) and 1,1′-methylenebis[isocyanatobenzene] α-Hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)] polymérisé avec du 2-éthyl-2-(hydroxymethyl)propane-1,3-diol, une huile polymérisée avec du 3-oxapentane-1,5-diol, de la 2-benzofurane-1,3-dione, de l’oxyde de poly(propane-1,2-diol) et de propane-1,2,3-triol (3/1) et du méthylènebis[isocyanatobenzène] |
19364-2 N |
Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, polymer with propanol, oxybis-, oil, polymer with diethylene glycol, phthalic anhydride and polypropylene glycol ether with glycerol (3:1) and 1,1′-methylenebis[4-isocyanatobenzene] α-Hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)] polymérisé avec de l’oxybispropanol, une huile polymérisée avec du 3-oxapentane-1,5-diol, de la 2-benzofurane-1,3-dione et de l’oxyde de poly(propane-1,2-diol), du propane-1,2,3-triol (3/1) et du 1,1′-méthylènebis[4-isocyanatobenzène] |
19365-3 N |
Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, polymer with propanol, oxybis-, oil, polymer with diethylene glycol, phthalic anhydride and polypropylene glycol ether with glycerol (3:1) and 1,1′-methylenebis[isocyanatobenzene] α-Hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)] polymérisé avec de l’oxybispropanol, une huile polymérisée avec du 3-oxapentane-1,5-diol, de la 2-benzofurane-1,3-dione et de l’oxyde de poly(propane-1,2-diol) et de propane-1,2,3-triol (3/1) et du méthylènebis[isocyanatobenzène] |
19366-4 N |
Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, polymer with 1,3-propanediol, 2-ethyl-2-(hydroxymethyl)-, oil, polymer with diethylene glycol, phthalic anhydride and polypropylene glycol ether with glycerol (3:1) and 1,1′-methylenebis[4-isocyanatobenzene] α-Hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)] polymérisé avec du 2-éthyl-2-(hydroxyméthyl)propane-1,3-diol, une huile polymérisée avec du 3-oxapentane-1,5-diol, de la 2-benzofurane-1,3-dione, de l’oxyde de poly(propane-1,2-diol) et de propane-1,2,3-triol (3/1) et du 1,1′-méthylènebis[4-isocyanatobenzène] |
19367-5 N-P |
1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-butanediamine compd. with 1,6-hexanediamine 1,4-benzenedicarboxylate (1:?:?) and branched alkyl diamine Acide benzène-1,3-dicarboxylique polymérisé avec de l’acide benzène-1,4-dicarboxylique, de la butane-1,4-diamine composée avec du benzène-1,4-dicarboxylate d’hexane-1,5-diamine (1/?/?) et un (alcane ramifié)diamine |
19368-6 N-P |
2-Propenoic acid, 2-methyl-, telomer with butyl 2-propenoate, ethenylbenzene, 2-hydroxyethyl 2-propenoate, 2-substitutedethanol methyl 2-methyl-2 propenoate, and carbomonocyclelidenepoly alkyl peroxide – initiated Acide 2-méthylprop-2-ènoïque télomérisé avec du prop-2-ènoate de butyle, du styrène, du prop-2-ènoate de 2-hydroxyéthyle, un éthanol substitué en 2 et du 2-méthylprop-2-ènoate de méthyle, amorcé avec un carbomonocyclediylpoly[peroxyde d’alkyle] |
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
The Minister of the Environment and the Minister of Health (the Ministers) assessed information on 18 substances (chemicals and polymers) new to Canada and determined that they meet the criteria for addition to the Domestic Substances List set out in the Canadian Environmental Protection Act, 1999 (CEPA). Therefore, under the authority of subsection 87(5) of CEPA, the Minister of the Environment (the Minister) is adding these 18 substances to the Domestic Substances List.
Background
Assessment of substances new to Canada
Substances that are not on the Domestic Substances List are considered new to Canada and are subject to notification and assessment requirements set out in sections 81, 83, 106 and 108 of CEPA, as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). CEPA and these regulations ensure that new substances introduced to the Canadian marketplace over certain quantities are assessed to identify potential risks to the environment and human health, and that appropriate control measures are taken, if deemed necessary.
For more information on the thresholds and scope of the regulations, please see section 1 in the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers and section 2 of the Guidelines for the Notification and Testing of New Substances: Organisms.
Domestic Substances List
The Domestic Substances List (SOR/94-311) provides an inventory of substances in the Canadian marketplace. It was originally published in the Canada Gazette, Part II, in May 1994. The current structure of the Domestic Substances List was established in 2001 [Order 2001-87-04-01 Amending the Domestic Substances List (PDF) (SOR/2001-214)], and amended in 2012 [Order 2012-87-09-01 Amending the Domestic Substances List (SOR/2012-229)]. The Domestic Substances List is amended, on average, 12 times per year to add, update or delete substances.
The Domestic Substances List includes eight parts defined as follows:
Part 1 |
Sets out chemicals and polymers, except those referred to in Part 2, 3 or 4, that are identified by their Chemical Abstract Service Registry Number (CAS RN),footnote 2 or their Substance Identity Number assigned by the Department of the Environment and the name of the substance. |
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Part 2 |
Sets out chemicals and polymers subject to Significant New Activity (SNAc) requirements that are identified by their CAS RN. |
Part 3 |
Sets out chemicals and polymers, except those referred to in Part 4, that are identified by their masked name and their Confidential Accession Number (CAN) assigned by the Department of the Environment. |
Part 4 |
Sets out chemicals and polymers subject to SNAc requirements that are identified by their masked name and their CAN. |
Part 5 |
Sets out inanimate biotechnology products and living organisms, except those referred to in Part 6, 7 or 8, that are identified by their American Type Culture Collection (ATCC) number, International Union of Biochemistry and Molecular Biology (IUBMB) number or specific substance name. |
Part 6 |
Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their ATCC number, IUBMB number or specific substance name. |
Part 7 |
Sets out inanimate biotechnology products and living organisms, except those referred to in Part 8, that are identified by their masked name and their CAN. |
Part 8 |
Sets out inanimate biotechnology products and living organisms subject to SNAc requirements that are identified by their masked name and their CAN. |
Adding substances to the Domestic Substances List
Chemicals or polymers must be added to the Domestic Substances List under section 66 of CEPA if they were manufactured or imported into Canada by any person (individual or corporation) between January 1, 1984, and December 31, 1986, in a quantity greater than or equal to 100 kg in any one calendar year, or if, during this period, they were in Canadian commerce or used for commercial manufacturing purposes in Canada.
Living organisms must be added to the Domestic Substances List under section 105 of CEPA if they were manufactured or imported into Canada by any person between January 1, 1984, and December 31, 1986, and if, during this period, they entered or were released into the environment without being subject to conditions under an Act of Parliament or the legislature of a province.
In addition, new substances must be added to the Domestic Substances List under subsection 87(1), 87(5) or 112(1) of CEPA within 120 days after the following criteria have been met:
- The Minister has been provided with the regulatory information regarding the substance. The information to be provided is set out in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms);
- The Ministers are satisfied that the substance has already been manufactured in or imported into Canada in the prescribed quantity or conditions by the person who provided the information;
- The period prescribed for the assessment of the information submitted for the substance under sections 83 and 108 of CEPA has expired; and
- The substance is not subject to any conditions imposed pursuant to paragraph 84(1)(a) or 109(1)(a) of CEPA on its import or manufacture.
Adding 18 substances to the Domestic Substances List
The Ministers assessed information on 18 substances new to Canada (chemicals and polymers) and determined that they meet the criteria for addition to the Domestic Substances List, under subsection 87(5) of CEPA. These 18 substances are therefore being added to the Domestic Substances List and, as a result, are no longer subject to the New Substances Notification Regulations (Chemicals and Polymers).
Objective
The objective of Order 2019-87-11-01 Amending the Domestic Substances List (the Order) is to add 18 substances to the Domestic Substances List. The Order is expected to facilitate access to these substances for businesses as the substances are no longer subject to requirements under section 81 of CEPA.
Description
The Order is a legal instrument made by the Minister pursuant to subsection 87(5) of CEPA to add 18 substances (chemicals and polymers) to the Domestic Substances List:
- Six substances identified by their CAS RN are added to Part 1 of the Domestic Substances List; and
- Twelve substances identified by their masked name and their CAN are added to Part 3 of the Domestic Substances List. Masked names are regulated under the Masked Name Regulations and are created to protect confidential business information.
Regulatory development
Consultation
As CEPA does not prescribe any public comment period before adding a substance to the Domestic Substances List, no consultation period for the Order was deemed necessary.
Modern treaty obligations and Indigenous engagement and consultation
The Order is not expected to have any impact on Indigenous groups. Therefore, no modern treaty obligations and associated Indigenous engagement and consultations were identified.
Instrument choice
Under CEPA, the Minister is required to add substances to the Domestic Substances List when they are determined to meet the criteria for addition. An order amending the Domestic Substances List is the only regulatory instrument available to comply with this obligation.
Regulatory analysis
Costs and benefits
The Order does not have any impact (costs or benefits), as it is administrative in nature, and is a federal obligation under subsection 87(5) of CEPA that is triggered once a substance meets the criteria for addition to the Domestic Substances List.
Small business lens
An assessment under the small business lens concluded that the Order does not have any impact on small businesses.
“One-for-One” Rule
An assessment of the “One-for-One” Rule concluded that the rule does not apply to the Order.
Regulatory cooperation and alignment
There are no international agreements or obligations directly associated with the Order.
Strategic environmental assessment
In accordance with The Cabinet Directive on the Environmental Assessment of Policy, Plan and Program Proposals, a preliminary scan on additions to the Domestic Substances List concluded that a strategic environmental assessment is not required for the Order.
Gender-based analysis plus (GBA+)
The Order is not expected to have any impact on specific groups based on factors such as sex, gender identity, ethnicity, ability, age, religion, language, geography, culture, income, sexual orientation or education.
Implementation, compliance and enforcement
Implementation
The Order is now in force. Developing an implementation plan is not required when adding substances to the Domestic Substances List. The Order does not constitute an endorsement from the Government of Canada of the substances to which it relates, nor an exemption from any other laws or regulations that are in force in Canada and that may apply to these substances or activities involving them.
Compliance
Developing a compliance strategy is not required when adding substances to the Domestic Substances List. Where a person has questions concerning their obligations to comply with an Order, believes that they may be out of compliance or would like to request a pre-notification consultation, they are encouraged to contact the Substances Management Information Line at eccc.substances.eccc@canada.ca (email), 1‑800‑567‑1999 (toll-free in Canada) or 819‑938‑3232 (outside of Canada).
Enforcement
The Order is made under the authority of CEPA, which is enforced in accordance with the Compliance and enforcement policy for the Canadian Environmental Protection Act, 1999. In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, effectiveness in achieving compliance with CEPA and its regulations, and consistency in enforcement when deciding which enforcement measures to take. Suspected violations can be reported to the Enforcement Branch by email at ec.enviroinfo.ec@canada.ca.
Contact
Nicole Davidson
Acting Executive Director
Program Development and Engagement Division
Department of the Environment
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: eccc.substances.eccc@canada.ca