Canada Gazette, Part I, Volume 154, Number 11: GOVERNMENT NOTICES

March 14, 2020

DEPARTMENT OF THE ENVIRONMENT

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2020-87-07-02 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 a, makes the annexed Order 2020-87-07-02 Amending the Non-domestic Substances List.

Gatineau, March 2, 2020

Jonathan Wilkinson
Minister of the Environment

Order 2020-87-07-02 Amending the Non-domestic Substances List

Amendments

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

2 Part II of the List is amended by deleting the following:

18546-6 N

Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine and alkanoic acid

Acide 12-hydroxyoctadécanoïque, produits de la réaction avec de l’éthane-1,2-diamine et un acide alcanoïque

Coming into Force

3 This Order comes into force on the day on which Order 2020-87-07-01 Amending the Domestic Substances List comes into force.

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of 15 substances of the Acyclic, Monocyclic, and Bicyclic Monoterpenes Group specified on the Domestic Substances List (paragraph 68(b) and (c) or subsection 77(1) of the Canadian Environmental Protection Act, 1999)

Whereas eight of the 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 draft screening assessment conducted on seven substances pursuant to paragraphs 68(b) and (c) of the Act and on eight substances pursuant to section 74 of the Act is annexed hereby;

And whereas it is proposed to conclude that rose oil, mandarin oil, tangerine oil, turpentine oil, and turpentine meet one or more 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 recommend to Her Excellency the Governor in Council that these five substances be added to Schedule 1 of the Act;

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

Notice therefore is hereby given that the ministers propose to take no further action at this time under section 77 of the Act for six of the substances identified under subsection 73(1) of the Act.

Notice is further given that the ministers propose to take no further action on the other four substances at this time.

Notice is furthermore given that the ministers have released a risk management scope document for rose oil, mandarin oil, tangerine oil, turpentine oil, and turpentine to initiate discussions with stakeholders on the development of risk management actions.

Public comment period

Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, by email to eccc.substances.eccc@canada.ca, or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate

On behalf of the Minister of the Environment

Gwen Goodier
Director General
Industrial Sectors and Chemicals Directorate

On behalf of the Minister of the Environment

Greg Carreau
Acting Director General
Safe Environments Directorate

On behalf of the Minister of Health

ANNEX

Summary of the draft screening assessment of the Acyclic, Monocyclic, and Bicyclic Monoterpenes 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 of 15 of 76 substances referred to collectively under the Chemicals Management Plan as the Terpenes and Terpenoids Group. These 15 substances were identified as priorities for assessment as they met the categorization criteria under subsection 73(1) of CEPA or were considered a priority on the basis of other human health concerns. Four of the other 61 substances were subsequently determined to be of low concern for risk to ecological and human health and the decision for these substances are provided in separate reports. footnote 2, footnote 3 Decisions on the remaining 57 substances will be communicated in several separate risk assessments. Accordingly, this screening assessment addresses the 15 substances listed in the table below, which will hereinafter be referred to as the Acyclic, Monocyclic, and Bicyclic Monoterpenes Group. The Chemical Abstracts Service Registry Numbers (CAS RNs footnote 4), the Domestic Substances List (DSL) names and the names used in this assessment of these substances are listed in the table below.

Substances in the Acyclic, Monocyclic, and Bicyclic Monoterpenes Group

CAS RN

DSL name

Name used in this assessment

80-56-8

Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-

alpha-Pinene

1113-21-9

1,6,10,14-Hexadecatetraen-3-ol, 3,7,11,15-tetramethyl-, (E,E)-

Geranyllinalool

8000-46-2 table a2 note a table a2 note b

Oils, geranium

Geranium oil

8002-09-3 table a2 note a

Oils, pine

Pine oil

8006-64-2 table a2 note a

Turpentine, oil

Turpentine oil

8007-01-0 table a2 note a

Oils, rose

Rose oil

8007-02-1 table a2 note a

Oils, lemongrass

Lemongrass oil

8008-31-9 table a2 note a table a2 note b

Oils, mandarin

Mandarin oil

8008-52-4 table a2 note a

Oils, coriander

Coriander oil

8008-57-9 table a2 note a

Oils, orange, sweet

Sweet orange oil

8014-19-5 table a2 note a table a2 note b

Oils, palmarosa

Palmarosa oil

8015-77-8 table a2 note a table a2 note b

Oils, bois de rose

Bois de rose oil

8016-85-1 table a2 note a table a2 note b

Oils, tangerine

Tangerine oil

8021-28-1 table a2 note a table a2 note b

Oils, fir

Fir oil

9005-90-7 table a2 note a table a2 note b

Turpentine

Turpentine

Table a2 note(s)

Table a2 note a

This substance is a UVCB (substance of unknown or variable composition, complex reaction product, or biological material).

Return to table a2 note a referrer

Table a2 note b

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 a2 note b referrer

Terpenes have repeating isoprene units and they are grouped according to the number of isoprene units they contain. Monoterpenes are the smallest unit and contain two isoprene units. Plant-derived essential oils have many components that can be extracted from different parts of a plant (e.g. leaves, seed, stem, flower, root, fruits, woods, bark, grass, gum, tree blossoms, bulbs, flower buds). The concentration of these main components can be affected by different factors, such as the origin of the plant, its species, temperature, soil, and geography. In addition, many of these oils have different chemotypes (i.e. different major chemical components produced from plants with the same genus and species). Therefore, the essential oils extracted from these plants may be chemically different even though their origin is the same.

All of the substances in the Acyclic, Monocyclic, and Bicyclic Monoterpenes Group, except turpentine oil, have been included in surveys issued under section 71 of CEPA and were found to be generally used as fragrances in personal care products footnote 5 (e.g. body lotion, shampoos, drugs and natural health products), cleaning products, and air fresheners.

The ecological risks of substances in the Acyclic, Monocyclic, and Bicyclic Monoterpenes Group were characterized using the ecological risk classification of organic substances (ERC) approach, 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 Acyclic, Monocyclic, and Bicyclic Monoterpenes Group are considered unlikely to be causing ecological harm.

Considering all available lines of evidence presented in this draft screening assessment, there is a low risk to the environment from the 15 substances in the Acyclic, Monocyclic, and Bicyclic Monoterpenes Group. It is proposed to conclude that the 15 substances in the Acyclic, Monocyclic, and Bicyclic Monoterpenes Group 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.

Human exposure was characterized from use of personal care products, cleaning products, air fresheners containing the monoterpenes, and use as a solvent to clean paint brushes and remove paint.

With respect to human health, bois de rose oil, palmarosa oil, geranium oil, geranyllinalool and sweet orange oil demonstrated a low hazard potential, and thus were assessed qualitatively. Given the low hazard potential, the risk to human health is also considered to be low.

Critical health effects associated with exposure to coriander oil were kidney and liver effects as well as changes in serum biochemistry. A comparison of estimated levels of exposure to coriander oil from food and products available to consumers and critical effect levels results in margins of exposure that are considered to be adequate to address uncertainties in exposure and health effects data used to characterize risk.

For rose oil, critical health effects were significant and dose related: a decrease in hematocrit and hemoglobin values, along with significant increases in spleen weights were found. A comparison of estimated levels of exposure of infants and toddlers to rose oil from a body moisturizer containing 3% rose oil and critical effect levels results in margins of exposure that are considered potentially inadequate to address uncertainties in exposure and health effects data used to characterize risk.

As there were no health effect studies available for lemongrass oil, health effects information from lemongrass extract and from citral, the main component of lemongrass oil, were used. In repeated dose studies, lemongrass extract exhibited increased levels of certain liver enzymes, as well as vascular congestion and scarring in the liver. Citral exhibited reproductive toxicity. A comparison of estimated levels of exposure to lemongrass oil from food and products available to consumers and critical effect levels results in margins of exposure that are considered adequate to address uncertainties in exposure and health effects data used to characterize risk.

No relevant toxicity data were identified for mandarin and tangerine oils and, as such, the health effects information available for their main components (i.e. limonene, gamma-terpinene, and citral) were considered. While limonene showed a low hazard potential, one isomer of gamma-terpinene (alpha-terpinene) showed a potential to act as a developmental or reproductive toxicant. Therefore, the critical health effect was developmental toxicity. In addition, effects by the inhalation route were based on effects observed in an inhalation study with citral. A comparison of estimated levels of exposure to mandarin and tangerine oils from the use of a body moisturizer and a dietary supplement and critical effect levels results in margins of exposure that are considered potentially inadequate to address uncertainties in exposure and health effects data used to characterize risk.

For alpha-pinene, the critical health effects, depending on the duration of exposure, were effects on the kidney and liver, or effects on the bladder and decreased sperm cauda. Comparisons of estimated levels of exposure to alpha-pinene from food, environmental media, and products available to consumers, and critical effect levels result in margins of exposure that are considered to be adequate to address uncertainties in exposure and health effects data used to characterize risk.

For turpentine and turpentine oil, critical health effect information was based on effects observed with its main component, alpha-pinene. Comparisons of estimated levels of exposure to turpentine and turpentine oil from its use as a paint thinner and remover, and its presence as a non-medicinal ingredient in a topical medicated vapour product and counterirritant product, and critical effect levels result in margins of exposure that are considered potentially inadequate to address uncertainties in exposure and health effects data used to characterize risk.

Critical health effect information for fir oil was also based on effects observed with its main component, alpha-pinene. A comparison of estimated levels of exposure to fir oil from food and products available to consumers and critical effect levels results in margins of exposure that are considered to be adequate to address uncertainties in exposure and health effects data used to characterize risk.

For pine oil, the critical health effects were reproductive toxicity and systemic toxicity. Comparisons of estimated levels of exposure to pine oil from food and products available to consumers and critical effect levels result in margins of exposure that are considered to be adequate to address uncertainties in exposure and health effects data used to characterize risk.

For rose oil, mandarin oil, tangerine oil, turpentine oil, and turpentine, comparisons of levels at which critical health effects occur with levels to which Canadians may be exposed result in margins of exposure considered potentially inadequate to address uncertainties in the health effects and exposure databases.

On the basis of the information presented in this draft screening assessment, it is proposed to conclude that bois de rose oil, palmarosa oil, geranium oil, geranyllinalool, coriander oil, lemongrass oil, sweet orange oil, alpha-pinene, fir oil and pine 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.

On the basis of the information presented in this draft screening assessment, it is proposed to conclude that rose oil, mandarin oil, tangerine oil, turpentine oil and turpentine meet the criteria under paragraph 64(c) of CEPA, as they are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

Proposed overall conclusion

Therefore, it is proposed to conclude that rose oil, mandarin oil, tangerine oil, turpentine oil and turpentine meet one or more of the criteria set out in section 64 of CEPA and that the remaining 10 substances in the Acyclic, Monocyclic, and Bicyclic Monoterpenes Group do not meet any of the criteria set out in section 64 of CEPA.

It is also proposed to conclude that rose oil, turpentine oil, and turpentine do not meet the persistence or bioaccumulation criteria, while mandarin and tangerine oil meet the bioaccumulation criteria but not the persistence criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

The draft screening assessment and the risk management scope document for these substances are available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication after screening assessment of five substances of the Salicylates Group specified on the Domestic Substances List (paragraphs 68(b) and (c) or subsection 77(1) of the Canadian Environmental Protection Act, 1999)

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

And whereas it is proposed to conclude that wintergreen oil, salicylic acid and homosalate meet one or more 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 recommend to Her Excellency the Governor in Council that wintergreen oil, salicylic acid and homosalate be added to Schedule 1 of the Act.

And whereas it is proposed to conclude that the remaining substances phenethyl salicylate and Betula alba extract do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the ministers propose to take no further action on phenethyl salicylate and Betula alba extract at this time under section 77 of the Act.

Notice is furthermore given that the ministers have released a risk management scope document for wintergreen oil, salicylic acid and homosalate to initiate discussions with stakeholders on the development of risk management actions.

Notice is further given that options are being considered for follow-up activities to track changes in human exposure to phenethyl salicylate.

Public comment period

As specified under subsection 77(5) of the Canadian Environmental Protection Act, 1999, any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be addressed to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, by email to eccc.substances.eccc@canada.ca, or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate

On behalf of the Minister of the Environment

Gwen Goodier
Director General
Industrial Sectors and Chemicals Directorate

On behalf of the Minister of the Environment

Greg Carreau
Acting Director General
Safe Environments Directorate

On behalf of the Minister of Health

ANNEX

Summary of the draft screening assessment of the Salicylates 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 five substances referred to collectively as the Salicylates Group. Substances in this group were identified as priorities for assessment as they met the categorization criteria under subsection 73(1) of CEPA. The Chemical Abstracts Service Registry Numbers (CAS RNs footnote 6), the Domestic Substances List (DSL) names and the common names of these substances are listed in the table below.

Substances in the Salicylates Group

CAS RN

DSL name

Common name

68917-75-9 table a3 note a

Oils, wintergreen

Wintergreen oil

69-72-7

Benzoic acid, 2-hydroxy-

Salicylic acid

118-56-9

Benzoic acid, 2-hydroxy-, 3,3,5-trimethylcyclohexyl ester

Homosalate

87-22-9

Benzoic acid, 2-hydroxy-, 2-phenylethyl ester

Phenethyl salicylate

84012-15-7 table a3 note a

Birch, Betula alba, ext.

Betula alba extract

Table a3 note(s)

Table a3 note a

This CAS RN is a UVCB (substance of unknown or variable composition, complex reaction product, or biological material).

Return to table a3 note a referrer

In this assessment, the substances in the group are discussed in the order outlined in the table above as the health effects data for methyl salicylate footnote 7 (found in wintergreen oil) and salicylic acid form the basis of the discussion for some of the other substances.

With the exception of Betula alba extract, the substances in this screening assessment are structurally similar insofar as they contain a salicylate moiety composed of a carboxyl group occupying the ortho position of a phenol. These four substances differ in the substituents forming the ester bond with the carboxyl carbon. Betula alba extract is a UVCB (substance of unknown or variable composition, complex reaction product, or biological material) derived primarily from Betula alba, a species of the family Betulaceae. Major components of this substance vary depending on the part of the plant extracted, the extraction method, and the type of extract. Although wintergreen oil is also considered a UVCB, spectroscopic analysis has demonstrated that the oil typically contains up to 99% methyl salicylate, a discrete chemical.

Wintergreen oil, salicylic acid, and Betula alba extract are naturally present in the environment, whereas homosalate and phenethyl salicylate are not known to naturally occur. All of the substances in the Salicylates Group have been included in surveys issued pursuant to CEPA section 71 notices. Wintergreen oil, salicylic acid, and homosalate were reported to be imported into Canada in quantities of 100 kg to 1 000 kg, 87 437 kg, and 100 000 kg to 1 000 000 kg, respectively, while phenethyl salicylate and Betula alba extract were not reported to be imported into Canada above the 100 kg reporting threshold during the 2011 reporting year. None of the substances were reported to be manufactured in Canada, according to information submitted under section 71.

Wintergreen oil is reported to be used in Canada as an ingredient in cosmetics and pesticides and as a non-medicinal (NMI) and medicinal ingredient (MI) in natural health products (NHPs). The substance is a component of wintergreen extract, wintergreen essence, and wintergreen flavour, which are standardized flavouring preparations in Canada.

In Canada, salicylic acid is used as an ingredient in cosmetics and food packaging materials and as an NMI and MI in NHPs and drugs. The substance was also identified in cleaning products, such as dishwashing detergents.

Homosalate is primarily used as an active ingredient in sunscreen formulations, where it functions as a UV filter. The substance was reported to be used in a variety of cosmetic products in Canada.

In Canada, phenethyl salicylate is used as an ingredient in cosmetics and may be used as an NMI in NHPs. The substance may also be used as a food flavouring ingredient.

Betula alba extract was reported to be used in Canada as an ingredient in self-care products. footnote 8

The ecological risks of the substances in the Salicylates 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 Salicylates Group are considered unlikely to be causing ecological harm.

Considering all available lines of evidence presented in this draft screening assessment, there is a low risk of harm to the environment from wintergreen oil, salicylic acid, homosalate, phenethyl salicylate and Betula alba extract. It is proposed to conclude that wintergreen oil, salicylic acid, homosalate, phenethyl salicylate and Betula alba extract 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.

With respect to human health, effects on the liver and developmental effects were identified to be the critical effects associated with exposure to wintergreen oil on the basis of information available for its main component, methyl salicylate. A comparison of the estimated oral exposure to wintergreen oil from use as a food flavouring ingredient and as an ingredient in antacid tablets and toothpastes resulted in margins of exposure that are considered adequate to address uncertainties in the health effects and exposure databases.

A comparison of the estimated exposure levels of wintergreen oil from its use as an ingredient in cosmetics, including massage oils and face moisturizers, resulted in margins of exposure that are considered potentially inadequate to account for uncertainties in the health effects and exposure databases. A comparison of the estimated exposure level of wintergreen oil from its use as an ingredient in analgesic creams resulted in margins of exposure that are also considered potentially inadequate to address uncertainties in the health effects and exposure databases.

Critical effects associated with salicylic acid are effects on the liver and kidney, as well as developmental effects. Comparison of exposure to salicylic acid from its presence in environmental media and food to the critical effect levels resulted in margins of exposure that are considered adequate to address the uncertainties in the health effects and exposure databases. A comparison of estimated exposure levels of salicylic acid from its use in a hair spray resulted in margins of exposure that are considered adequate to account for uncertainties in the health effects and exposure databases.

With respect to dermal exposure to salicylic acid from the use of certain cosmetics, a comparison of the critical effect levels to the estimated exposures resulted in margins of exposure that are considered potentially inadequate to address uncertainties in the health effects and exposure databases.

With respect to dermal and oral exposure to salicylic acid from the use of certain NHPs and drugs, including sunscreens, liquid antacids, analgesic creams, acne creams, and after-shave creams, a comparison of the estimated exposure to the critical effect levels resulted in margins of exposure that are considered potentially inadequate to address uncertainties in the health effects and exposure databases.

On the basis of the available information, the critical effects associated with exposure to homosalate are reproductive effects and effects on the kidneys, thymus and thyroid. A comparison of exposure to homosalate from the use of tanning products resulted in a margin of exposure that is considered potentially inadequate to address uncertainties in the health effects and exposure databases. Use of face moisturizers (creams and aerosols) resulted in margins of exposure that are considered adequate to address these uncertainties.

On the basis of toxicity data from structurally related analogues (i.e. methyl salicylate), the critical effects associated with exposure to phenethyl salicylate are effects on the liver and developmental effects. A comparison of the estimates of exposure to phenethyl salicylate from its use as an ingredient in cosmetics and as a food flavour ingredient to the critical effect level resulted in margins of exposure that are considered adequate to address uncertainties in the health effects and exposure databases.

The available health effects information on Betula alba extract and its main components indicate that this substance is of low hazard potential, and therefore the risk to human health is considered to be low.

On the basis of the information presented in this draft screening assessment, it is proposed to conclude that wintergreen oil, salicylic acid, and homosalate meet the criteria under paragraph 64(c) of CEPA, as they are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

On the basis of the information presented in this draft screening assessment, it is proposed to conclude that phenethyl salicylate and Betula alba extract 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.

Proposed overall conclusion

Therefore, it is proposed to conclude that wintergreen oil, salicylic acid, and homosalate meet one or more of the criteria set out in section 64 of CEPA.

It is also proposed to conclude that phenethyl salicylate and Betula alba extract do not meet any of the criteria set out in section 64 of CEPA, and it is proposed that salicylic acid does not meet the persistence or bioaccumulation criteria, that homosalate meets the bioaccumulation criteria but not the persistence criteria, and that wintergreen oil meets the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

Considerations for follow-up

While exposure of the general population to phenethyl salicylate is not of concern at current levels, this substance is associated with human health effects of concern. Therefore, there may be a concern for human health if levels of exposure were to increase. Follow-up activities to track changes in exposure or commercial use patterns are under consideration.

Stakeholders are encouraged to provide, during the 60-day public comment period on the draft screening assessment, any information pertaining to these substances that may help inform the choice of follow-up activity. This could include information on new or planned import, manufacture or use of this substance, if the information has not previously been submitted to the ministers.

The draft screening assessment and the risk management scope document for these substances are available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF THE ENVIRONMENT
DEPARTMENT OF HEALTH

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Publication of results of investigations and recommendations for seven substances of the Parabens Group specified on the Domestic Substances List (paragraphs 68(b) and (c) of the Canadian Environmental Protection Act, 1999)

Whereas a summary of the draft screening assessment conducted on seven substances pursuant to paragraphs 68(b) and (c) of the Act is annexed hereby;

Whereas it is proposed to conclude that methylparaben, propylparaben, butylparaben and iso-butylparaben meet one or more 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 recommend to Her Excellency the Governor in Council that these substances be added to Schedule 1 to the Act;

And whereas it is proposed to conclude that ethylparaben, benzylparaben and iso-propylparaben do not meet any of the criteria set out in section 64 of the Act,

Notice therefore is hereby given that the ministers propose to take no further action on these substances at this time.

Notice is furthermore given that the ministers have released a risk management scope document for methylparaben, propylparaben, butylparaben and iso-butylparaben to initiate discussions with stakeholders on the development of risk management actions.

Public comment period

Any person may, within 60 days after publication of this notice, file with the Minister of the Environment written comments on the measure the ministers propose to take and on the scientific considerations on the basis of which the measure is proposed. More information regarding the scientific considerations may be obtained from the Canada.ca (Chemical Substances) website. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and be sent to the Executive Director, Program Development and Engagement Division, Department of the Environment, Gatineau, Quebec K1A 0H3, by fax to 819‑938‑5212, by email to eccc.substances.eccc@canada.ca, or by using the online reporting system available through Environment and Climate Change Canada’s Single Window.

In accordance with section 313 of the Canadian Environmental Protection Act, 1999, any person who provides information in response to this notice may submit with the information a request that it be treated as confidential.

Jacqueline Gonçalves
Director General
Science and Risk Assessment Directorate

On behalf of the Minister of the Environment

Gwen Goodier
Director General
Industrial Sectors, Chemicals and Waste Directorate

On behalf of the Minister of the Environment

Greg Carreau
Acting Director General
Safe Environments Directorate

On behalf of the Minister of Health

ANNEX

Summary of the draft screening assessment of the Parabens Group

Pursuant to section 68 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of the Environment and the Minister of Health have conducted a screening assessment of seven substances referred to collectively as the Parabens Group. Substances in this group were identified as priorities for risk assessment as part of the 2015 review of the identification of risk assessment priorities (IRAP) approach on the basis of human health concerns. The Chemical Abstracts Service Registry Numbers (CAS RNs footnote 9), the Domestic Substances List (DSL) names and the common names of these substances are listed in the table below.

Substances in the Parabens Group

CAS RN

DSL name

Common name

94-13-3

Benzoic acid, 4-hydroxy-, propyl ester

Propylparaben

94-18-8

Benzoic acid, 4-hydroxy-, phenylmethyl ester

Benzylparaben

94-26-8

Benzoic acid, 4-hydroxy-, butyl ester

Butylparaben

99-76-3

Benzoic acid, 4-hydroxy-, methyl ester

Methylparaben

120-47-8

Benzoic acid, 4-hydroxy-, ethyl ester

Ethylparaben

4191-73-5

Benzoic acid, 4-hydroxy-, 1-methylethyl ester

iso-Propylparaben

4247-02-3

Benzoic acid, 4-hydroxy-, 2-methylpropyl ester

iso-Butylparaben

According to information submitted in response to a survey under section 71 of CEPA, methylparaben was reported to be manufactured and imported in Canada in 2011 in volumes of 981 kg and 563 000 kg, respectively. In a separate survey, ethylparaben, propylparaben, butylparaben, iso-propylparaben, and iso-butylparaben were not reported to be manufactured in Canada above the reporting threshold of 100 kg, but were reported to be imported into Canada in 2016 at volumes of 4 000 kg, 8 500 kg, 100 to 1 000 kg, 280 kg and 230 kg, respectively. Benzylparaben was not reported to be imported or manufactured above threshold values in 2016.

Parabens are widely used as preservatives and fragrance ingredients in cosmetic products, such as moisturizers, makeup, toothpaste, and hair and shaving products, and are used as antimicrobial preservatives, fragrance ingredients and flavour enhancers in natural health products (NHPs). Parabens are also used in pest control products, consumer products, and in prescription and non-prescription drugs. Methylparaben and propylparaben are permitted for use as preservatives in certain foods and beverages sold in Canada. Parabens are also naturally present in foods, such as berries, fruit, wine and vanilla.

The ecological risks of the substances in the Parabens Group were characterized using the ecological risk classification of organic substances (ERC), which is a risk-based approach that uses 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 based on their hazard and exposure profiles. According to the outcome of the ERC analysis, substances in the Parabens Group are considered unlikely to be causing ecological harm.

Considering all available lines of evidence presented in this draft screening assessment, there is a low risk of harm to the environment from methylparaben, ethylparaben, propylparaben, butylparaben, benzylparaben, iso-propylparaben, and iso-butylparaben. It is proposed to conclude that methylparaben, ethylparaben, propylparaben, butylparaben, benzylparaben, iso-propylparaben and iso-butylparaben 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.

Animals exposed to methylparaben in a repeat dose study showed clinical signs of ill health, stomach erosion, spleen and thyroid atrophy, and mortality at the highest dose. Adverse effects were not reported in reproductive and prenatal developmental toxicity studies or in a study of male reproductive development. Predominant sources of exposure of the general population of Canada to methylparaben include cosmetics, NHPs, and prescription and non-prescription drugs. The margins of exposure based on biomonitoring data from the general population aged 3 to 79 years were considered adequate. The margins of exposure between the critical effect level and estimates of exposure to certain NHPs are considered potentially inadequate to account for uncertainties in the health effects and exposure databases.

Repeated exposure to ethylparaben at high doses resulted in depression, decreased motor activity and mortality in animal studies. Gestational exposure to ethylparaben resulted in enlargement of brain ventricles and hydronephrosis in fetuses. Prenatal development of the male reproductive system and male pubertal development were not affected by ethylparaben exposure. The general population of Canada is predominantly exposed to ethylparaben via cosmetics, NHPs, and non-prescription drugs. The margins of exposure based on biomonitoring data from the general population were considered adequate to address uncertainties in the health effects and exposure databases.

Propylparaben did not demonstrate significant adverse effects in repeat dose dietary toxicity studies. Adverse effects were not reported in a reproduction and developmental toxicity screen, or in studies of male and female pubertal and reproductive development. Predominant sources of exposure of the general population of Canada to propylparaben include cosmetics, NHPs, and prescription and non-prescription drugs. The margins of exposure based on biomonitoring data from the general population were considered adequate to address uncertainties in the health effects and exposure databases. The margins of exposure between the critical effect level and estimates of oral exposure to certain NHPs (at the highest dose and frequency recommended in the directions of use) are considered inadequate to address uncertainties in the health effects and exposure databases.

The critical effect for butylparaben was prenatal development of the reproductive system. Gestational exposure to butylparaben was associated with delayed onset of puberty, altered morphology of reproductive organs and reduced sperm count and motility in offspring. The general population of Canada is predominantly exposed to butylparaben via cosmetics, NHPs, and non-prescription drugs. The margins of exposure based on biomonitoring data from the general population aged 3 to 79 years were considered adequate. The margins of exposure between critical effects and estimates of exposure to certain cosmetics, non-prescription drugs and NHPs are considered potentially inadequate to account for uncertainties in the health effects and exposure databases.

The health effects database for benzylparaben is limited. A read-across approach was employed to select a critical effect of prenatal reproductive development based on butylparaben. No sources of exposure of the Canadian population to benzylparaben were identified. However, a biomonitoring study reported that benzylparaben was identified in the urine of pregnant Canadian women. The margins of exposure based on biomonitoring data from Canada, the United States and Europe are considered adequate to address uncertainties in the health effects and exposure databases.

Repeated exposure to iso-propylparaben resulted in changes in serum histochemistry, as well as renal and hepatic effects. The predominant source of exposure to iso-propylparaben is the use of cosmetics, NHPs, and non-prescription drugs. The margins of exposure between the critical effect level and estimates of exposure to iso-propylparaben are considered adequate to address uncertainties in the health effects and exposure databases.

The critical effect identified for iso-butylparaben was reduced sperm motility and reduced epididymal sperm count in young males after maternal dosing (gestational and postnatal). The predominant source of exposure to iso-butylparaben is the use of cosmetics, NHPs and non-prescription drugs. The margins of exposure between the critical effect level and estimates of exposure to cosmetics, non-prescription drugs and NHPs containing iso-butylparaben are considered potentially inadequate to address uncertainties in the health effects and exposure databases.

On the basis of the information presented in this draft screening assessment, it is proposed to conclude that methylparaben, propylparaben, butylparaben and iso-butylparaben meet the criteria under paragraph 64(c) of CEPA as they are entering or may enter the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health.

On the basis of the information presented in this draft screening assessment, it is proposed to conclude that ethylparaben, benzylparaben and iso-propylparaben 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.

Proposed conclusion

It is proposed to conclude that methylparaben, propylparaben, butylparaben and iso-butylparaben meet one or more of the criteria set out in section 64 of CEPA and that ethylparaben, benzylparaben and iso-propylparaben do not meet any of the criteria set out in section 64 of CEPA.

It is also proposed that methylparaben, propylparaben, butylparaben, and iso-butylparaben do not meet the persistence or bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.

The draft screening assessment and the risk management scope document for these substances are available on the Canada.ca (Chemical Substances) website.

DEPARTMENT OF TRANSPORT

CANADA SHIPPING ACT, 2001

Eastern Canada Response Corporation Ltd.

Notice of an amendment to the bulk oil cargo fees applicable to the Quebec/Maritimes Region, the Newfoundland Region and the Great Lakes Region charged by Eastern Canada Response Corporation Ltd. pursuant to an arrangement required by paragraphs 167(1)(a) and 168(1)(a) of the Canada Shipping Act, 2001

Description

Eastern Canada Response Corporation Ltd. (ECRC) is currently a certified response organization pursuant to subsection 169(1) of the Act in respect of a rated capability of 10 000 tonnes and a geographic area covering the Canadian waters south of 60° north latitude in the provinces of Newfoundland and Labrador, Prince Edward Island, Nova Scotia, New Brunswick, Quebec, Ontario, Manitoba, Saskatchewan and Alberta, excluding the waters in the primary areas of response associated with the designated ports of Saint John, New Brunswick, and Point Tupper, Nova Scotia. It includes but is not limited to the waters of the Atlantic Provinces, the waters of James Bay, Hudson Bay and Ungava Bay and the waters in the province of Quebec including the St. Lawrence River, the waters of the Canadian Great Lakes system and connecting channels within the province of Ontario including Lake Superior, the St. Mary’s River, Lake Huron, the St. Clair River, Lake St. Clair, the Detroit River, Lake Erie, Lake Ontario, the St. Lawrence River, the waters of Lake Winnipeg, the waters of the Athabasca River from Fort McMurray to Lake Athabasca and the waters of Lake Athabasca.

Definitions

1. In this notice of fees,

Bulk oil cargo fees

2. This part applies to the loading and unloading of oil at oil handling facilities located in each of the following regions.

Quebec/Maritimes Region

3. The total BOCF payable by an oil handling facility that has an arrangement with ECRC shall be determined by multiplying the total number of tonnes of bulk oil unloaded and (in the case of bulk oil intended for international destinations and destinations north of 60° north latitude) loaded at the oil handling facility, by the BOCF per tonne for each type of oil set out in sections 5 and 6 of this part.

4. The total BOCF payable by a ship (bulk oil) shall be determined,

5. The BOCF applicable in respect of oil other than asphalt is

6. The BOCF applicable in respect of asphalt is

Newfoundland Region

7. The total BOCF payable by an oil handling facility that has an arrangement with ECRC shall be determined by multiplying the total number of tonnes of bulk oil unloaded and (in the case of bulk oil intended for international destinations and destinations north of 60° north latitude) loaded at the oil handling facility, by the BOCF per tonne for each type of oil set out in sections 9 and 10 of this part.

8. The total BOCF payable by a ship (bulk oil) shall be determined,

9. The BOCF applicable in respect of oil other than asphalt is

10. The BOCF applicable in respect of asphalt is

Great Lakes Region

11. The total BOCF payable by an oil handling facility that has an arrangement with ECRC shall be determined by multiplying the total number of tonnes of bulk oil unloaded and (in the case of bulk oil intended for international destinations and destinations north of 60° north latitude) loaded at the oil handling facility, by the BOCF per tonne for each type of oil set out in sections 13 and 14 of this part.

12. The total BOCF payable by a ship (bulk oil) shall be determined

13. The BOCF applicable in respect of oil other than asphalt is

14. The BOCF applicable in respect of asphalt is

Interested persons may, within 30 days after the date of publication of this notice, send a request for information or comments to Paul Pouliotte, Eastern Canada Response Corporation Ltd., 275 Slater Street, Suite 1201, Ottawa, Ontario K1P 5H9, 613‑230‑7369 (telephone), 613‑230‑7344 (fax), ppouliotte@ecrc-simec.ca (email).

Interested persons may, within 30 days after the date of publication of this notice, file notices of objection that contain the reasons for the objection to the Manager, Environmental Response Program, Marine Safety and Security, Transport Canada, Place de Ville, Tower C, 330 Sparks Street, 10th Floor, Ottawa, Ontario K1A 0N5, 613‑993‑8196 (fax), marinesafety-securitemaritime@tc.gc.ca (email). All such representations must cite the Canada Gazette, Part I, the name of the response organization submitting the list of proposed amended fees, and the date of publication of the notice of proposed amended fees.

GLOBAL AFFAIRS CANADA

Proposed amendments to Annex 301 (Specific Rules of Origin) of the Canada-Colombia Free Trade Agreement

The purpose of this notice is to notify interested parties of proposed amendments to the Product Specific Rules of Origin (PSROs) in Annex 301 of the Canada-Colombia Free Trade Agreement (CCOFTA).

The proposed amendments are of a technical nature and are necessary to update the CCOFTA PSROs to reflect changes resulting from amendments to the Harmonized Commodity Description and Coding System (HS) that came into force on January 1, 2012 (HS 2012) and January 1, 2017 (HS 2017). The amendments are intended to be neutral in effect and are not intended to result in a loss or gain of preferential tariff treatment for products traded under the CCOFTA. The proposed amendments can be found on the Global Affairs Canada website.

Background

The CCOFTA includes a chapter on rules of origin and an annex of PSROs. These provisions are used to assess the originating status of goods to determine whether they are eligible to receive preferential tariff treatment provided under the CCOFTA.

The PSROs are based on tariff classification codes provided under the World Customs Organization’s Harmonized System. HS codes are used to classify products for trading purposes and form the basis of each country’s customs tariff legislation. The HS is amended every five years to take into account changes in technology, products and trade patterns by creating or deleting HS codes or by re-classifying certain products under different HS codes. The current version of the HS came into force on January 1, 2017. As a result of the changes to the HS in 2012 and 2017, Canadian and Colombian officials worked together to agree on the required technical amendments to the CCOFTA PSROs as provided for under subparagraph 3(d) of Article 2001 of the CCOFTA.

Submissions

Interested parties wishing to comment on the proposed amendments should submit their views in writing by April 13, 2020. In submitting comments on the proposed amendments, interested parties should focus on the impact that such amendments would have on the products of interest to them.

Address for submissions

Submissions should be sent by mail or email to the following: Tariffs and Goods Market Access Division, Global Affairs Canada, 125 Sussex Drive, Ottawa, Ontario K1A 0G2; tpg@international.gc.ca (email).

GLOBAL AFFAIRS CANADA

Proposed amendments to Annex 3-A (Product Specific Rules) of the Canada-Korea Free Trade Agreement

The purpose of this notice is to notify interested parties of proposed amendments to the Product Specific Rules of Origin (PSROs) in Annex 3-A of the Canada-Korea Free Trade Agreement (CKFTA).

The proposed amendments are of a technical nature and are necessary to update the CKFTA PSROs to reflect the new version of the Harmonized Commodity Description and Coding System (HS) that entered into force on January 1, 2017. The amendments are intended to be neutral in effect and are not intended to result in a loss or gain of preferential tariff treatment for products traded under the CKFTA. The proposed amendments can be found on the Global Affairs Canada website.

Background

The CKFTA includes a chapter on rules of origin and an annex of PSROs. These provisions are used to assess the originating status of goods to determine whether they are eligible for preferential tariff treatment provided under the CKFTA.

The PSROs are based on the tariff classification codes (HS codes) provided under the World Customs Organization’s Harmonized System. HS codes are used to classify products for trading purposes and form the basis of each country’s customs tariff legislation. The HS is amended every five years to take into account changes in technology, products and trade patterns by creating or deleting HS codes. The current version of the HS came into force on January 1, 2017. As a result of the changes to the HS in 2017, Canadian and Korean officials worked together to agree on the required technical amendments to the CKFTA PSROs as provided for under subparagraph 3(b) of Article 4.14 of the CKFTA.

Submissions

Interested parties wishing to comment on the proposed amendments should submit their views in writing by April 13, 2020. In submitting comments on the proposed amendments to the CKFTA PSROs, interested parties should focus on the impact that such amendments would have on the products of interest to them.

Address for submissions

Submissions should be sent by mail or email to the following: Tariffs and Goods Market Access Division, Global Affairs Canada, 125 Sussex Drive, Ottawa, Ontario K1A 0G2; tpg@international.gc.ca (email).

INNOVATION, SCIENCE AND ECONOMIC DEVELOPMENT CANADA

RADIOCOMMUNICATION ACT

Notice No. SLPB-001-20 — Policy and Licensing Framework for Spectrum in the 3500 MHz Band

The intent of this notice is to announce the release of the document entitled Policy and Licensing Framework for Spectrum in the 3500 MHz Band (the Framework), which sets out Innovation, Science and Economic Development Canada’s (ISED) decisions with respect to the auction process for licences in the 3500 MHz band. In particular, the Framework announces the decisions related to the licensing process, auction format and rules, and the conditions of licence applicable to the 3500 MHz band.

This Framework is the result of the consultation process initiated through Canada Gazette Notice No. SLPB-002-19, Consultation on a Policy and Licensing Framework for Spectrum in the 3500 MHz Band.

Clarification questions

ISED will accept written questions seeking clarification of the rules and policies set out in this Framework until the deadline specified in the Table of key dates. Every effort will be made to post the questions received, along with ISED’s written responses, in the shortest time frame possible. Questions that are of a similar nature and subject matter may be grouped and summarized. Questions regarding bidding procedures will be addressed in mail-out packages intended for qualified bidders, and will not be included in this clarification process unless they are deemed to be critical information for potential bidders requiring an immediate response. These answers will be considered as clarification of the policies set out in this Framework. Applicants are encouraged to submit questions as soon as possible.

ISED may also amend or supplement the auction rules and procedures contained in this Framework. Any such amendment or supplement will be published on ISED’s website and will be sent to all qualified bidders.

Questions regarding the 3500 MHz band auction may be sent to the Manager, Auction Operations, at ic.spectrumauctions-encheresduspectre.ic@canada.ca.

All questions should cite the Canada Gazette, Part I, the publication date, the title and the notice reference number (SLPB-001-20). Questions and responses will be posted on the ISED Spectrum Management and Telecommunications website.

Obtaining copies

Copies of this notice and of documents referred to herein are available electronically on the ISED Spectrum Management and Telecommunications website.

Official versions of notices can be viewed on the Canada Gazette website.

March 6, 2020

Aline Chevrier
Senior Director
Spectrum Licensing and Auction Operations
Spectrum Licensing Policy Branch

PRIVY COUNCIL OFFICE

Appointment opportunities

We know that our country is stronger — and our government more effective — when decision-makers reflect Canada’s diversity. The Government of Canada has implemented an appointment process that is transparent and merit-based, strives for gender parity, and ensures that Indigenous peoples and minority groups are properly represented in positions of leadership. We continue to search for Canadians who reflect the values that we all embrace: inclusion, honesty, fiscal prudence, and generosity of spirit. Together, we will build a government as diverse as Canada.

We are equally committed to providing a healthy workplace that supports one’s dignity, self-esteem and the ability to work to one’s full potential. With this in mind, all appointees will be expected to take steps to promote and maintain a healthy, respectful and harassment-free work environment.

The Government of Canada is currently seeking applications from diverse and talented Canadians from across the country who are interested in the following positions.

Current opportunities

The following opportunities for appointments to Governor in Council positions are currently open for applications. Every opportunity is open for a minimum of two weeks from the date of posting on the Governor in Council appointments website.

Position

Organization

Closing date

Chairperson

Canada Council for the Arts

  

Chief Executive Officer

Canadian Centre on Substance Abuse

  

President

Canadian Commercial Corporation

  

Chief Executive Officer

Canadian Energy Regulator

  

Commissioner (full-time), Commissioner (part-time)

Canadian Energy Regulator

  

Director

Canadian Energy Regulator

  

Chairperson

Canadian International Trade Tribunal

  

Director

Canadian Museum for Human Rights

  

Member (Alberta and Northwest Territories)

Canadian Radio-television and Telecommunications Commission

  

Member (Atlantic and Nunavut)

Canadian Radio-television and Telecommunications Commission

  

President

Destination Canada

  

Chairperson

Federal Public Sector Labour Relations and Employment Board

  

Vice-Chairperson

Federal Public Sector Labour Relations and Employment Board

  

Chairperson

Great Lakes Pilotage Authority Canada

  

Chairperson

Marine Atlantic Inc.

  

Secretary

National Battlefields Commission

  

Auditor General of Canada

Office of the Auditor General of Canada

  

Member

Payments in Lieu of Taxes Dispute Advisory Panel

  

Director

Public Sector Pension Investment Board

  

President

Social Sciences and Humanities Research Council of Canada

  

Member

Transportation Safety Board of Canada

  

Member

Veterans Review and Appeal Board