Canada Gazette, Part I, Volume 157, Number 19: GOVERNMENT NOTICES
May 13, 2023
DEPARTMENT OF THE ENVIRONMENT DEPARTMENT OF HEALTH
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Publication of final decision after screening assessment of a substance — 2H-1-benzopyran-2-one, 7-(diethylamino)-4-methyl- (coumarin 1), CAS RN footnote 1 91-44-1 — specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)
Whereas coumarin 1 is a substance identified under subsection 73(1) of the Canadian Environmental Protection Act, 1999;footnote 1
Whereas a summary of the screening assessment conducted on coumarin 1 pursuant to section 74 of the Act is annexed hereby;
And whereas it is concluded that the substance meets 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 this substance be added to Schedule 1 to the Act.
Notice is furthermore given that the ministers are releasing a proposed risk management approach document for coumarin 1 on the Canada.ca (Chemical substances) website to continue discussions with stakeholders on the manner in which the ministers intend to develop a proposed regulation or instrument respecting preventive or control actions in relation to the substance.
Public comment period on the proposed risk management approach
Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the proposed risk management approach document. 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 email to substances@ec.gc.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.
Steven Guilbeault
Minister of the Environment
Jean-Yves Duclos
Minister of Health
ANNEX
Summary of the screening assessment of coumarin 1
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 2H-1-benzopyran-2-one, 7-(diethylamino)-4-methyl-, hereinafter referred to as coumarin 1. The Chemical Abstracts Service Registry Number (CAS RN) for coumarin 1 is 91-44-1. This substance was identified as a priority for assessment as it met categorization criteria under subsection 73(1) of CEPA.
According to information submitted in response to a CEPA section 71 survey, coumarin 1 was not reported to be manufactured in Canada above the reporting threshold of 100 kg in 2011, while a quantity in the range of 1 000 kg to 10 000 kg was imported into Canada in the same calendar year. Reported uses in Canada included commercial applications in fabric, textile and leather articles. Coumarin 1 is also used in certain cosmetic products in Canada, such as temporary hair dyes, nail polishes, and body, lip and facial makeup (including eye makeup). Coumarin 1 is also used as a stabilizer in a carpet cleaner and as a fragrance ingredient in other cleaning products (e.g. multi-purpose cleaners).
The ecological risk of coumarin 1 was 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 based on their hazard and exposure profiles. Based on the outcome of the ERC analysis, coumarin 1 is 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 coumarin 1. It is concluded that coumarin 1 does not meet the criteria under paragraph 64(a) or (b) of CEPA as it is 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 health effects dataset for coumarin 1 was considered to be limited. To address this limitation, a read-across approach was applied to inform the health effects assessment. Based on the available data on the analogues, developmental toxicity was considered to be the critical effect. Exposure of the general population in Canada to coumarin 1 occurs predominantly through the use of certain cosmetic products, such as temporary hair dyes, nail polishes, and body, lip and facial makeup (including eye makeup), as well as cleaning products. A comparison of levels of coumarin 1 that Canadians may be exposed to in drinking water, nail polish, temporary powder hair dye, facial makeup, lipstick / lip gloss, multi-purpose spray cleaner and carpet cleaner with levels associated with adverse effects in laboratory studies results in margins that are considered adequate to address uncertainties in the health effects and exposure datasets. However, the margins between exposure to coumarin 1 from the occasional use of specialty body makeup (for ages 4 years and older) and temporary gel hair dye (for ages 2 to 13 years) and the critical effect levels for coumarin 1 are considered inadequate to address uncertainties in the health effects and exposure datasets.
Considering all the information presented in this screening assessment, it is concluded that coumarin 1 meets the criteria under paragraph 64(c) of CEPA as it is 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.
Overall conclusion
It is therefore concluded that coumarin 1 meets one or more of the criteria set out in section 64 of CEPA.
It is also concluded that coumarin 1 meets the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.
The screening assessment and the risk management approach document for this substance are 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 Other Polymers Group specified on the Domestic Substances List (subsection 77(6) of the Canadian Environmental Protection Act, 1999)
Whereas the four 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 DGEBA-DA resin, soya alkyd resin and polyurethane-33 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;
And whereas it is concluded that PHMB meets one or more of the criteria set out in section 64 of the Act,
Notice therefore is hereby given that the ministers propose to recommend to Her Excellency the Governor in Council that PHMB be added to Schedule 1 to the Act.
Notice is furthermore given that the ministers are releasing a proposed risk management approach document for PHMB on the Canada.ca (Chemical substances) website to continue discussions with stakeholders on the manner in which the ministers intend to develop a proposed regulation or instrument respecting preventive or control actions in relation to the substance.
Public comment period on the proposed risk management approach
Any person may, within 60 days after publication of the proposed risk management approach document, file with the Minister of the Environment written comments on the proposed risk management approach document. 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 email to substances@ec.gc.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.
Steven Guilbeault
Minister of the Environment
Jean-Yves Duclos
Minister of Health
ANNEX
Summary of the screening assessment of the Other Polymers Group
Pursuant to section 74 of the Canadian Environmental Protection Act, 1999 (CEPA), the Minister of Environment and the Minister of Health have conducted a screening assessment of four substances referred to collectively under the Chemicals Management Plan as the Other Polymers 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 Number (CAS RNfootnote 1), the Domestic Substances List (DSL) names and the abbreviations of these substances are listed in the table below.
| CAS RN |
DSL name |
Abbreviation |
|---|---|---|
55818-57-0 |
Phenol, 4,4′-(1-methylethylidene)bis-, polymer with (chloromethyl)oxirane, 2-propenoate |
DGEBA-DA resin |
32289-58-0 27083-27-8 table 1 note a |
Poly(iminocarbonimidoyliminocarbonimidoylimino-1,6-hexanediyl), hydrochloride Guanidine, N,N′′′-1,6-hexanediylbis[N′-cyano-, polymer with 1,6-hexanediamine, hydrochloride |
PHMB |
67762-15-6 |
Soybean oil, polymer with maleic anhydride, pentaerythritol and phthalic anhydride |
Soya alkyd resin |
125826-44-0 |
Hexanedioic acid, polymer with 2,2-dimethyl-1,3-propanediol, 1,6-hexanediol, hydrazine, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and 1,1′-methylenebis |
Polyurethane-33 |
Table 1 note(s)
|
||
DGEBA-DA resin, PHMB (CAS RNs 32289-58-0 and 27083-27-8), soya alkyd resin, and polyurethane-33 were identified in the second phase of polymer rapid screening (ECCC, HC 2018) as having either low water solubility/extractability or low potential for exposure, and were characterized as having low potential for ecological risk. However, they were identified on the basis of structural alerts, toxicological information and/or uses associated with significant consumer exposure as requiring further assessment due to potential human health risk. The present assessment further elaborates on the potential for DGEBA-DA resin, PHMB (CAS RNs 32289-58-0 and 27083-27-8), soya alkyd resin, and polyurethane-33 to cause harm to human health in order to reach an overall conclusion under section 64 of CEPA.
While conducting this assessment, it was determined that CAS RN 27083-27-8 is synonymous with CAS RN 32289-58-0; the former is described by the starting monomers, and the latter is described by the resulting polymer. As a result, the two CAS RNs can be used interchangeably. Although it had been determined that CAS RN 27083-27-8 did not meet the criteria under section 64 of CEPA during the second phase of polymer rapid screening, this CAS RN is being reassessed in this report. It is additionally noted that PHMB may also be identified by two other CAS RNs (28757-47-3 and 1802181-67-4) outside of Canada; these additional CAS RNs are not on the DSL and would be subject to notification and assessment under the New Substances Notification Regulations (Chemicals and Polymers) [NSNR (C&P)] prior to being imported or manufactured in Canada.
DGEBA-DA resin does not occur naturally in the environment. In Canada, it is reported to be used as a binder, sealant, and reactive oligomer in the coating, automotive and adhesive industries, as well as in printing inks and overprint varnishes, packaging (including food packaging materials), books, newsprint, cosmetics, toners, and colourants. According to the information submitted in response to a CEPA section 71 survey, between 100 000 kg and 1 000 000 kg of DGEBA-DA resin were either manufactured in or imported into Canada in 2014. Although DGEBA-DA resin contains acrylates (a reactive functional group [RFG] associated with adverse human health effects), almost all DGEBA-DA resin in commercial and consumer applications is present in its cured form, lacking the free acrylates present in the monomers and any other RFGs or structural features associated with human health concerns. Acrylate groups present in the uncured substance are associated with dermal sensitization, subchronic toxicity with effects on the prostate, and genotoxicity. However, a negligible amount of unreacted material is expected to be present in the cured DGEBA-DA resin. Neither direct exposure (oral, inhalation, dermal) nor indirect exposure of the general population to DGEBA-DA resin through residues in drinking water is expected.
PHMB does not occur naturally in the environment. PHMB is used globally as a preservative or antimicrobial agent, mostly in cosmetics, natural health products, non-prescription drugs, pesticides, fabric softeners, contact lens solutions, and hand washes (including hand sanitizers). According to the information submitted in response to a CEPA section 71 survey, the substance is not manufactured in Canada, but between 100 kg and 1 000 kg of PHMB were imported into Canada in 2014. In Canada, direct exposure (oral, dermal, inhalation) of the general population to PHMB is expected. The greatest risk is associated with inhalation exposure. On April 7, 2017, the European Commission’s Scientific Committee on Consumer Safety adopted the opinion that the use of PHMB as a preservative in cosmetic products at concentrations up to 0.1% is safe, but that its use in sprayable formulations is not advised. PHMB has high inhalation toxicity, and Commission Regulation (EU) 2019/831 states that PHMB should not be used in applications that may lead to exposure of the end user’s lungs by inhalation (EU 2019). Cosmetic products containing PHMB can be purchased by Canadians. The International Nomenclature of Cosmetic Ingredients (INCI) database identifies CAS RN 32289-58-0 under the INCI name of “polyaminopropyl biguanide,” and according to notifications submitted under the Cosmetic Regulations to Health Canada, this substance has been present in 271 cosmetics since 2015. Around half of these products list this substance at less than 0.1%, but a small number of products show concentrations of up to 3%. Considering a concentration of 0.1% PHMB in a cosmetic spray product, margins of exposure (MOEs) of 22.7 and 7.4 for adults and children, respectively, were estimated. The calculated MOEs for cosmetic spray products are considered inadequate to address uncertainties in the health effects and exposure databases. In the Natural Health Products Ingredients Database, PHMB is listed with a non-medicinal role for topical use only, up to 0.1%, as a preservative antimicrobial, and is not permitted in sprayable formulations. Indirect exposure of the general population to PHMB through environmental residues in drinking water is not anticipated. PHMB is also a dermal sensitizer. Cross-sensitization from respiratory exposure is not known; therefore, the MOEs for PHMB when used in applications where it can be inhaled are not sufficient to address uncertainties in the health effects and exposure datasets.
On the basis of further evaluation, soya alkyd resin and polyurethane-33 were identified as meeting the criteria used to identify polymers of low concern of the NSNR (C&P). Both of these substances are used in coatings such as paints. Polymers of low concern are generally of low ecological and human health hazard. These two polymers are therefore not a concern to human health.
Considering all available lines of evidence presented in this screening assessment, there is a low risk of harm to the environment from DGEBA-DA resin, PHMB (CAS RNs 32289-58-0 and 27083-27-8), soya alkyd resin, and polyurethane-33. It is concluded that these substances 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.
Considering all the information presented in this screening assessment, it is concluded that DGEBA-DA resin, soya alkyd resin, and polyurethane-33 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 to human life or health in Canada. However, it is concluded that PHMB (CAS RNs 32289-58-0 and 27083-27-8) meets the criteria under paragraph 64(c) of CEPA as it is 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.
Overall conclusion
It is concluded that DGEBA-DA resin, soya alkyd resin, and polyurethane-33 do not meet any of the criteria set out in section 64 of CEPA, but that PHMB (CAS RNs 32289-58-0 and 27083-27-8) does meet the criteria in section 64 of CEPA.
It is also concluded that PHMB (CAS RNs 32289-58-0 and 27083-27-8) meets the persistence criteria but not the bioaccumulation criteria as set out in the Persistence and Bioaccumulation Regulations of CEPA.
The screening assessment and the risk management approach document for this substance are available on the Canada.ca (Chemical substances) website.
DEPARTMENT OF HEALTH
FOOD AND DRUGS ACT
Notice of intent to consult on Health Canada’s proposed fees for natural health products
On May 12, 2023, Health Canada (the Department) launched a public consultation on the proposed introduction of fees for natural health products (NHPs).
Purpose
This notice informs interested stakeholders of the intent of the Minister of Health to implement new fees for the review and sale of natural health products in Canada.
Background
Under the Natural Health Products Regulations, NHPs are considered to be naturally occurring substances used to restore health or maintain good health. Health Canada regulates these products in its role as the federal authority responsible for the safety, efficacy and quality of all products affecting the health and safety of people in Canada. Health Canada regulates NHPs via the Natural Health Products Regulations of the Food and Drugs Act (FDA). Through the FDA, the Minister of Health has the authority to set fees for the Department’s regulatory activities.
Health Canada has been charging fees to industry for its regulatory services related to drugs and medical devices since the mid-1990s, consistent with international practices. NHPs are the only line of health products for which all regulatory activities are funded by the public. The Department committed to introducing fees to address significant risk issues identified in the 2021 audit from the Commissioner of the Environment and Sustainable Development (CESD). Fees will help provide predictable and sustainable funding for necessary program improvements and increased regulatory oversight.
Fee proposal
Health Canada has developed a fee proposal that lays out the fees for NHPs that would support activities under the Natural Health Products Regulations. The proposed fees are tailored to NHPs and include mitigation and accountability measures that follow best practices already in place for drugs and medical devices.
There are three proposed fee lines:
- site licence (SL) fees
- right to sell (RTS) fees
- pre-market evaluation fees
This proposal includes mitigation measures for small businesses to help minimize the impact of fees. The industry can further expect enhanced predictability in program delivery via clear service standards, while Canadians will benefit from a more reliable and safer NHP market as a result of increased regulatory oversight.
The fee proposal is subject to a 75-day consultation period. The feedback received will be used to refine the proposal as the Department seeks to implement fees that reflect the NHP program in a fair and transparent way. The fee proposal will then be finalized, and a fee order will be published in the Canada Gazette, Part II. Fees are planned to come into force on April 1, 2025.
Consultation
Stakeholders and the public are invited to review Health Canada’s proposed fees and associated performance standards for NHPs. The fee proposal may be found on the Department’s website.
Please visit the fee proposal consultation page for details on how to participate in the consultation. The fee proposal will be posted for 75 calendar days, ending July 26, 2023.
The Department is committed to respecting the privacy of consultation participants. All personal information created, held or collected by the Department will be treated in accordance with the Privacy Act.
Contact information
You can direct any inquiries to the following address:
Natural and Non-prescription Health Products Directorate
Health Products and Food Branch
Health Canada
2 Constellation Drive, PL 2607A
Nepean, Ontario
K1A 0K9
Email: nnhpd.consultation-dpsnso@hc-sc.gc.ca
INNOVATION, SCIENCE AND ECONOMIC DEVELOPMENT CANADA
RADIOCOMMUNICATION ACT
Notice No. SPB-001-23 — Decision on a Non-Competitive Local Licensing Framework, Including Spectrum in the 3900-3980 MHz Band and Portions of the 26, 28 and 38 GHz Bands
The intent of this notice is to announce the release of the document entitled SPB-001-23, Decision on a Non- Competitive Local Licensing Framework, Including Spectrum in the 3900-3980 MHz Band and Portions of the 26, 28, and 38 GHz Bands, which sets out the decisions of Innovation, Science and Economic Development Canada (ISED) with respect to a non-competitive local licensing framework and its application to the spectrum in the 3900-3980 MHz band (referred to as the 3900 MHz band) and portions of the 26/28 GHz and 38 GHz bands (millimetre wave bands, or mmWave bands).
This document is a result of the consultation process initiated in SPB-003-22, Consultation on a Non-Competitive Local Licensing Framework, Including Spectrum in the 3900-3980 MHz Band and Portions of the 26, 28 and 38 GHz Bands.
Obtaining copies
Copies of this notice and of documents referred to herein are available electronically on ISED’s Spectrum Management and Telecommunications website.
Official versions of notices can be viewed on the Canada Gazette website.
May 3, 2023
Chantal Davis
Senior Director
Spectrum Regulatory Policy
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 |
|---|---|---|
Director |
Asia-Pacific Foundation of Canada |
|
Director |
Atomic Energy of Canada Limited |
|
Director |
Bank of Canada |
|
Chairperson |
Business Development Bank of Canada |
|
Director |
Business Development Bank of Canada |
|
Director |
Canada Deposit Insurance Corporation |
|
Director |
Canada Foundation for Sustainable Development Technology |
|
Director |
Canada Revenue Agency |
|
Director |
Canadian Commercial Corporation |
|
Member |
Canadian Cultural Property Export Review Board |
|
Director |
Canadian Energy Regulator |
|
Chief Commissioner |
Canadian Grain Commission |
|
Chief Commissioner |
Canadian Human Rights Commission |
|
Pay Equity Commissioner |
Canadian Human Rights Commission |
|
Member |
Canadian Human Rights Tribunal |
|
Member |
Canadian Institutes of Health Research |
|
President |
Canadian Institutes of Health Research |
|
Member |
Canadian International Trade Tribunal |
|
Trustee |
Canadian Museum of Immigration at Pier 21 |
|
Permanent Member |
Canadian Nuclear Safety Commission |
|
President |
Canadian Nuclear Safety Commission |
|
Member |
Canadian Radio-television and Telecommunications Commission |
|
Member |
Canadian Statistics Advisory Council |
|
Director |
Canadian Tourism Commission |
|
Chairperson |
Canadian Transportation Accident Investigation and Safety Board |
|
Member |
Canadian Transportation Accident Investigation and Safety Board |
|
Member |
Canadian Transportation Agency |
|
Director |
Export Development Canada |
|
Director |
First Nations Financial Management Board |
|
Commissioner |
First Nations Tax Commission |
|
Member |
Historic Sites and Monuments Board of Canada |
|
Commissioner |
International Commission on the Conservation of Atlantic Tunas |
|
President |
International Development Research Centre |
|
Commissioner |
International Joint Commission |
|
Chairperson |
Military Grievances External Review Committee |
|
Vice-Chairperson |
Military Grievances External Review Committee |
|
Chairperson |
National Advisory Council on Poverty |
|
Member |
National Advisory Council on Poverty |
|
Member (Children’s Issues) |
National Advisory Council on Poverty |
|
Commissioner |
National Battlefields Commission |
|
Director |
National Gallery of Canada |
|
Member |
Net-Zero Advisory Body |
|
Canadian Representative |
North Atlantic Salmon Conservation Organization |
|
Canadian Representative |
North Pacific Anadromous Fish Commission |
|
Conflict of Interest and Ethics Commissioner |
Office of the Conflict of Interest and Ethics Commissioner |
|
Public Sector Integrity Commissioner |
Office of the Public Sector Integrity Commissioner |
|
Member |
Patented Medicine Prices Review Board |
|
Vice-Chairperson |
Patented Medicine Prices Review Board |
|
Commissioner |
Public Service Commission |
|
President |
Public Service Commission |
|
Principal |
Royal Military College of Canada |
|
Member |
Standards Council of Canada |
|
Chief Executive Officer |
VIA Rail Canada Inc. |
|
Chief Executive Officer |
Windsor-Detroit Bridge Authority |