Canada Gazette, Part I, Volume 154, Number 52: GOVERNMENT NOTICES

December 26, 2020

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2020-87-15-02 Amending the Non-domestic Substances List

Whereas, pursuant to subsection 87(5) of the Canadian Environmental Protection Act, 1999 footnote a, the Minister of the Environment has added the substances referred to in the annexed Order to the Domestic Substances List footnote b;

Therefore, the Minister of the Environment, pursuant to subsection 87(5) of the Canadian Environmental Protection Act, 1999 footnote c, makes the annexed Order 2020-87-15-02 Amending the Non-domestic Substances List.

Gatineau, December 10, 2020

Jonathan Wilkinson
Minister of the Environment

Order 2020-87-15-02 Amending the Non-domestic Substances List

Amendment

1 Part I of the Non-domestic Substances List footnote 1 is amended by deleting the following:

Coming into Force

2 This Order comes into force on the day on which Order 2020-87-15-01 Amending the Domestic Substances List comes into force.

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of eight substances in the Used and Re-refined Oils Group specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas the eight substances identified in the annex below are substances identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the screening assessment conducted on these substances pursuant to section 74 of the Act is annexed hereby;

And whereas it is concluded that the substances do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action on these substances at this time under section 77 of the Act.

Jonathan Wilkinson
Minister of the Environment

Patty Hajdu
Minister of Health

ANNEX

Summary of the screening assessment of the Used and Re-refined Oils Group

Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of eight of nine substances referred to collectively under the Chemicals Management Plan as the Used and Re-refined Oils Group. Substances in this group were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA.

The ninth substance, lubricant oils, used (CAS RN footnote 270514-12-4), was found to meet the broad classification of used crankcase oils, and is considered to have been addressed through the Priority Substances List Assessment Report of Waste/Used Crankcase Oil in 1994 and the follow-up report in 2005. This substance will not be subject to further risk assessment work at this time under the Chemicals Management Plan (CMP) given previous regulatory activities. Accordingly, this screening assessment addresses the eight substances listed in the table below, which will hereinafter be referred to as the Used and Re-refined Oils Group. The Chemical Abstracts Service Registry Number (CAS RN), the Domestic Substances List (DSL) names, and the simplified names of these substances are listed in the table below.

Substances in the Used and Re-refined Oils Group
CAS RN table 1 note a DSL name Simplified name
68476-77-7 Lubricating oils, refined used Refined used oil
92045-41-5 Lubricant oils, used, vacuum distd. Used vacuum gas oil
125471-97-8 Lubricating oils (petroleum), hydrotreated, used, distd., residues Hydrotreated used residue
129566-94-5 Hydrocarbons, C12-25, dehydrated used lubricating oil distillates C12-25 used distillate
129893-17-0 Lubricant oils, used, residues Used oil residue
129893-18-1 Lubricating oils, used, vacuum distd., clay-treated Clay-treated used oil
132538-91-1 Lubricant oils, used, distd., C5-18 fraction C5-18 used distillate
132538-93-3 Lubricant oils, used, distd., light oil Used light oil

Table 1 note(s)

Table 1 note a

All CAS RNs are UVCB substances (substances of unknown or variable composition, complex reaction products, or biological materials).

Return to table 1 note a referrer

The Used and Re-refined Oils Group includes used oil and substances produced during the reprocessing and re-refining process. Used oil refers to all used lubricant oils that are collected, transported, and stored. Used oil residue applies to a non-volatile residual stream generated as a by-product of re-refining and reprocessing operations. Refined used oil and clay-treated used oil are base oils with commercial and industrial applications, and are the end product of the re-refining process. The remaining substances are intermediate lubricant oils generated as by-products during the re-refining and/or reprocessing operations and have various industrial applications.

The substances in the Used and Re-refined Oils Group have similar physical and chemical properties and uses to the used crankcase oils, asphalts, base oils, and other substances that have been previously assessed under CEPA. Exposures from these uses were characterized in those assessments. No environmental and general population exposures of these eight substances, beyond those that were previously assessed, are expected.

Considering all available lines of evidence presented in this screening assessment, there is a low risk of harm to the environment from used oil residue, used vacuum gas oil, C12-25 used distillate, C5-18 used distillate, used light oil, hydrotreated used residue, refined used oil and clay-treated used oil. It is concluded that used oil residue, used vacuum gas oil, C12-25 used distillate, C5-18 used distillate, used light oil, hydrotreated used residue, refined used oil and clay-treated used oil do not meet the criteria under paragraph 64(a) or (b) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

On the basis of the information presented in this screening assessment, exposures to used oil residue, used vacuum gas oil, C12-25 used distillate, C5-18 used distillate, used light oil, hydrotreated used residue, refined used oil and clay-treated used oil for the general population are not expected. These substances are used as industrial intermediates and do not appear in products available to consumers. It is concluded that used oil residue, used vacuum gas oil, C12-25 used distillate, C5-18 used distillate, used light oil, hydrotreated used residue, refined used oil and clay-treated used oil do not meet the criteria under paragraph 64(c) of CEPA as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Overall conclusion

Therefore, it is concluded that used oil residue, used vacuum gas oil, C12-25 used distillate, C5-18 used distillate, used light oil, hydrotreated used residue, refined used oil and clay-treated used oil do not meet any of the criteria set out in section 64 of CEPA.

The screening assessment for these substances is available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of final decision after screening assessment of four substances in the Substituted Alkyl Imidazolines Group specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(6) of the Canadian Environmental Protection Act, 1999)

Whereas the substances bearing CAS RNs footnote 3 95-38-5, 27136-73-8, and 68966-38-1 are substances identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;

Whereas a summary of the screening assessment conducted on the substance bearing CAS RN 68442-97-7 pursuant to paragraphs 68(b) and (c) of the Act and on the remaining three substances pursuant to section 74 of the Act is annexed hereby;

And whereas it is concluded that the substances do not meet any of the criteria set out in section 64 of the Act,

Therefore, notice is hereby given that the Minister of the Environment and the Minister of Health (the ministers) propose to take no further action at this time under section 77 of the Act for the three substances identified under subsection 73(1) of the Act.

Notice is further given that the ministers propose to take no further action on the remaining substance at this time.

Jonathan Wilkinson
Minister of the Environment

Patty Hajdu
Minister of Health

ANNEX

Summary of the screening assessment of the Substituted Akyl Imidazolines Group

Pursuant to section 68 or 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment on four of eight substances referred to collectively under the Chemicals Management Plan as the Alkyl Imidazolines and Salts Group. These four substances were identified as priorities for assessment as they met categorization criteria under subsection 73(1) of CEPA or were considered a priority on the basis of other human health concerns. The other four substances were either subsequently determined to be of low concern through other approaches, and decisions for these substances are provided in separate reports footnote 4, footnote 5 or are part of a separate screening assessment. footnote 6 The four substances addressed in this screening assessment will hereinafter be referred to as the Substituted Alkyl Imidazolines Group.

Substances in the Substituted Alkyl Imidazolines Group
CAS RN table 2 note a Domestic Substances List name
95-38-5 1H-Imidazole-1-ethanol, 2-(8-heptadecenyl)-4,5-dihydro-
27136-73-8 1H-Imidazole-1-ethanol, 2-(heptadecenyl)-4,5-dihydro-
68442-97-7 table 2 note b, table 2 note c 1H-Imidazole-1-ethanamine, 4,5-dihydro-, 2-nortall-oil alkyl derivs.
68966-38-1 1H-Imidazole-1-ethanol, 4,5-dihydro-2-isoheptadecyl-

Table 2 note(s)

Table 2 note a

The Chemical Abstracts Service Registry Number (CAS RN) is the property of the American Chemical Society, and any use or redistribution, except as required in supporting regulatory requirements and/or for reports to the Government of Canada when the information and the reports are required by law or administrative policy, is not permitted without the prior, written permission of the American Chemical Society.

Return to table 2 note a referrer

Table 2 note b

This CAS RN is a UVCB (unknown or variable composition, complex reaction products, or biological materials).

Return to table 2 note b referrer

Table 2 note c

This substance was not identified under subsection 73(1) of CEPA but was included in this assessment, as it was considered a priority on the basis of other human health concerns.

Return to table 2 note c referrer

None of the substances in the Substituted Alkyl Imidazolines Group occurs naturally. According to information submitted in response to a CEPA section 71 survey, no manufacturing activities were reported above the reporting threshold of 100 kg for the substances in the Substituted Alkyl Imidazolines Group, and three of these substances were imported into Canada in total quantities in the range from 10 000 to 1 000 000 kg, in the 2011 reporting year. CAS RN 68966-38-1 had no importing activities reported above the reporting threshold of 100 kg in that same year. These substances may be used in various applications for consumer use in Canada, including do-it-yourself products and hair products. Industrial uses, such as components of certain lubricants and greases, in oil and natural gas extraction, and as raw material to blend into industrial products, were also identified in Canada.

The ecological risks of the substances in the Substituted Alkyl Imidazolines Group were characterized using the ecological risk classification of organic substances (ERC), which is a risk-based approach that employs multiple metrics for both hazard and exposure, with weighted consideration of multiple lines of evidence for determining risk classification. Hazard profiles are based principally on metrics regarding mode of toxic action, chemical reactivity, food web–derived internal toxicity thresholds, bioavailability, and chemical and biological activity. Metrics considered in the exposure profiles include potential emission rate, overall persistence, and long-range transport potential. A risk matrix is used to assign a low, moderate or high level of potential concern for substances on the basis of their hazard and exposure profiles. Based on the outcome of the ERC analysis, substances in the Substituted Alkyl Imidazolines Group are considered unlikely to be causing ecological harm.

Considering all available lines of evidence presented in this screening assessment, there is a low risk of harm to the environment from substances in the Substituted Alkyl Imidazolines Group. It is concluded that CAS RN 95-38-5, CAS RN 27136-73-8, CAS RN 68442-97-7, and CAS RN 68966-38-1 do not meet the criteria under paragraph 64(a) or (b) of CEPA, as they are not entering the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity or that constitute or may constitute a danger to the environment on which life depends.

The predominant sources of exposure to the Canadian general population are paint remover, lubricant and rust blocker, and hair conditioner for CAS RN 95-38-5, CAS RN 27136-73-8, and CAS RN 68966-38-1, respectively. There is also the potential for exposure through environmental media for CAS RN 95-38-5, CAS RN 27136-73-8, and CAS RN 68442-97-7.

With respect to human health, the adverse effects observed in a laboratory study of CAS RN 95-38-5 were point of contact effects, or secondary to such effects, via the oral route. Comparison of the No Observed Adverse Effect Level (NOAEL) to the estimated exposures for this substance for the Canadian general population resulted in margins of exposure that were considered adequate to address uncertainties in the exposure and health effects databases.

In the absence of substance-specific hazard information for CAS RN 27136-73-8 and CAS RN 68966-38-1, CAS RN 95-38-5 was selected as the analogue for these two substances based on the similarity of their chemical structures and physical and chemical properties. Comparison of the NOAEL to the estimated exposures for the Canadian general population resulted in margins of exposure that were considered adequate to address uncertainties in the exposure and health effects databases.

On the basis of available information, reduced body weight was observed in a laboratory study with CAS RN 68442-97-7 via the oral route. Comparison of the NOAEL observed in this study to the estimated exposure for the Canadian general population resulted in a margin of exposure that was considered adequate to address uncertainties in the exposure and health effects databases.

On the basis of the information presented in this screening assessment, it is concluded that CAS RN 95- 38-5, CAS RN 27136-73-8, CAS RN 68442-97-7, and CAS RN 68966-38-1 do not meet the criteria under paragraph 64(c) of CEPA, as they are not entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Overall conclusion

Therefore, it is concluded that CAS RN 95-38-5, CAS RN 27136-73-8, CAS RN 68442-97-7, and CAS RN 68966-38-1 do not meet any of the criteria set out in section 64 of CEPA.

The screening assessment for these substances is available on the Canada.ca (Chemical Substances) website.