Canada Gazette, Part I, Volume 158, Number 45: GOVERNMENT NOTICES
November 9, 2024
DEPARTMENT OF CITIZENSHIP AND IMMIGRATION
IMMIGRATION AND REFUGEE PROTECTION ACT
Ministerial Instructions for the Student Direct Stream Program
These Instructions are published in the Canada Gazette in accordance with subsection 87.3(6) of the Immigration and Refugee Protection Act (the Act).
These Instructions are given pursuant to section 87.3 of the Act by the Minister of Citizenship and Immigration (the Minister) as, in the opinion of the Minister, these Instructions will best support the attainment of the immigration goals established by the Government of Canada.
These Instructions are consistent with the objectives of the Act, as set out in section 3.
These Instructions are directed to officers who are charged with handling and/or reviewing certain applications for study permits, and establish conditions that must be met for these study permits to receive priority processing. For the purposes of these Instructions, “priority processing” refers to an expedited processing time for study permit applications meeting those conditions as compared to the regular study permit application processing time.
Considerations
Canada’s immigration objectives, as set out in section 3 of the Act, include the establishment of fair and efficient procedures to maintain the integrity of the Canadian immigration system.
The Student Direct Stream (SDS) was an optional program initiative under which study permit applicants could, if eligible, receive expedited study permit processing if their application was submitted before November 8, 2024, at 2:00 p.m., Eastern standard time (EST). This program has now ended.
Scope
These Instructions set out the conditions that study permit applications need to meet in order to be eligible to receive expedited processing under the SDS and apply to study permit applications submitted for expedited SDS processing eligibility on or before the date on which the Instructions take effect.
Any application received on or after November 8, 2024, 2:00 p.m., EST, will not be eligible to receive expedited processing under the SDS, as the program has ended. SDS-specific eligibility documents would no longer be required up front as of the effective date.
Instructions to process on a expedited basis certain study permit applications
Officers are instructed to no longer give expedited processing to study permit applications received under the SDS on or after 2:00 p.m., EST, on November 8, 2024, given that the program has ended. Individuals who submit a complete SDS application after this time will have their application processed under the regular Study Permit Stream.
All complete applications received prior to November 8, 2024, at 2:00 p.m., EST, will be processed in accordance with the provisions below, pursuant to subsection 87.3(3.1) of the Act;
Officers are instructed that study permit applications that meet the following conditions may receive expedited processing under the SDS.
Student Direct Stream
To be eligible for priority processing under the SDS, the study permit application must have been submitted before November 8, 2024, at 2:00 p.m., EST, and must have been made by an applicant who is a legal resident of Antigua and Barbuda, Brazil, China, Colombia, Costa Rica, India, Morocco, Pakistan, Peru, Philippines, Saint Vincent and the Grenadines, Senegal, Trinidad and Tobago, or Vietnam.
In addition, applicants must provide the following documentation at the time they present their study permit application:
- (1) An acceptance letter from a postsecondary designated learning institution, as per section 211.1 of the Immigration and Refugee Protection Regulations (IRPR);
- (2) Evidence that the tuition has been paid to the postsecondary designated learning institution referred to in provision (1) for the first year of study;
- (3) For applicants intending to study at a postsecondary designated learning institution outside Quebec, a Guaranteed Investment Certificate (GIC) that is equal to 75% of the low income cut off (LICO),
- (a) For applicants intending to study at a postsecondary designated learning institution in Quebec, a Guaranteed Investment Certificate (GIC) equal to the amount set by Schedule C of the Québec Immigration Regulation;
- (4) the results of a medical examination, as per section 29 of the IRPR;
- (5) a police certificate;
- (6) recent secondary or postsecondary school transcript(s);
- (7) a language test result, as described in these Instructions;
- (8) Applicants intending to study in Quebec must have a Québec Acceptance Certificate (CAQ) from the Ministère de l’Immigration, de la Francisation et de l’Intégration.
For the purposes of these Instructions, results from the following language tests are accepted:
- Results of an evaluation from a designated language-testing organization using a general language test approved pursuant to subsection 74(3) of the IRPR: IELTS General, CELPIP General, TEF Canada and TCF Canada; with a score that is equivalent to a Canadian Language Benchmarks score of at least 7 for each of the four language abilities (speaking, listening, reading, and writing);
- Results of an academic language test from a language-testing organization designated pursuant to subsection 74(3) of the IRPR: IELTS Academic (minimum overall score of 6), CAEL (minimum overall score of 60), Pearson PTE Academic (minimum overall score of 60), TEF - 5 épreuves (minimum overall score of 400) and TCF - tout public (minimum overall score of 400), with results from each of the four language abilities (speaking, listening, reading, and writing); or
- Results from the academic language test from the Educational Testing Service (ETS): TOEFL iBT Test (minimum overall score of 83), with results from each of the four language abilities (speaking, listening, reading, and writing).
In addition, all above-noted tests must be taken in their in-person format to be accepted for the SDS. Online remotely proctored tests will not be accepted for the purposes of the SDS.
EFFECTIVE DATE
Applications to be submitted with language test results
These Instructions take effect November 8, 2024, at 2:00 p.m., EST.
Repeal
The following Instructions are repealed, effective November 8, 2024, at 2:00 p.m., EST: Ministerial Instructions for the Student Direct Stream Program, signed December 19, 2023.
Retention and dispositions
Applications received by the Department of Citizenship and Immigration on or after the Instructions take effect that do not meet the conditions set out in these Instructions will not receive priority processing.
October 10, 2024
The Honourable Marc Miller, P.C., M.P.
Minister of Citizenship and Immigration
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Notice of intent to amend the Domestic Substances List under subsection 87(3) of the Canadian Environmental Protection Act, 1999 to indicate that subsection 81(3) of that Act applies to four substances
Whereas the four substances set out in this notice are specified on the Domestic Substances List ;footnote 1
Whereas the Minister of the Environment and the Minister of Health (the ministers) have conducted a screening assessment of each of the four substances under sections 68 and 74 of the Canadian Environmental Protection Act, 1999 ,footnote 2 as it read before the coming into force of the Strengthening Environmental Protection for a Healthier Canada Act ;footnote 3
And whereas the ministers suspect that the information concerning a significant new activity in relation to any of the four substances set out in this notice may contribute to determining the circumstances in which any of the substances are toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999,
Notice is hereby given that the Minister of the Environment intends to amend the Domestic Substances List, pursuant to subsection 87(3) of the Canadian Environmental Protection Act, 1999, to indicate that subsection 81(3) of that Act applies to any significant new activities relating to the four substances, as set out in this notice.
Public comment period
Any person may, within 60 days of publication of this notice, file with the Minister of the Environment comments with respect to this proposal. All comments must cite the Canada Gazette, Part I, and the date of publication of this notice and can be submitted using the online reporting system available through Environment and Climate Change Canada’s Single Window, or be sent by mail to the Director, Regulatory Operations, Policy, and Emerging Sciences Division, Department of the Environment, Gatineau, Quebec K1A 0H3 or by email to substances@ec.gc.ca.
The final screening assessment for the substances may be obtained from the Canada.ca (Chemical substances) website.
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. A request for confidentiality must indicate which specific information or data should be treated as confidential, and it must be submitted with reasons taking into account the criteria referred to in subsection 313(2) of the Act.
Marc D’Iorio
Assistant Deputy Minister
Science and Technology Branch
On behalf of the Minister of the Environment
Megan Nichols
Assistant Deputy Minister
Environmental Protection Branch
On behalf of the Minister of the Environment
ANNEX
1. Part 1 of the Domestic Substances List is proposed to be amended by deleting the following:
- 548-62-9
- 569-64-2
- 2390-59-2
- 2390-60-5
| Column 1 Substance |
Column 2 Significant New Activity for which substance is subject to subsection 81(3) of the Act |
|---|---|
|
|
| 569-64-2 S’ |
|
COMING INTO FORCE
3. This Order would come into force on the day on which it is registered.
EXPLANATORY NOTE
(This explanatory note is not part of the notice of intent.)
Description
The notice of intent (NOI) provides an opportunity for the public to comment on the proposed amendments to the Domestic Substances List footnote 1 (DSL) to apply the Significant New Activity (SNAc) provisions of the Canadian Environmental Protection Act, 1999 footnote 2 (CEPA), pursuant to subsection 87(3) of that Act, to the following four substances:
- Methanaminium, N-[4-[bis[4-(dimethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, chloride (Chemical Abstracts Service Registry Number [CAS RNfootnote 4 548-62-9]), also known as Basic Violet 3;
- Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, chloride (CAS RN 569-64-2), also known as Malachite Green;
- Ethanaminium, N-[4-[bis[4-(diethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, chloride (CAS RN 2390-59-2), also known as Basic Violet 4; and
- Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, chloride (CAS RN 2390-60-5), also known as Basic Blue 7.
These four substances were proposed for addition to Schedule 1 to CEPA on April 2, 2022, following the publication of the final screening assessment, published on October 17, 2020. The screening assessment concluded that the four substances meet the criteria under paragraph 64(a) of CEPA, as they are entering or may enter 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. Malachite Green additionally 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. Concurrently with the final screening assessment, the Risk management approach for certain triarylmethanes was also published outlining the proposed risk management actions, which included the recommendation to apply the SNAc provisions to the four substances.
Within 60 days of publication of the NOI, any person may submit comments to the Minister of the Environment (the Minister). These comments will be taken into consideration during the development of the Order amending the DSL to apply the SNAc provisions to these substances.
The DSL amendments are not in force until the Order is adopted by the Minister pursuant to subsection 87(3) of CEPA and registered. The Order must be published in the Canada Gazette, Part II.
Applicability of the proposed Order
It is proposed that the Order amending the DSL require any person (individual or corporation) engaging in a significant new activity in relation to any of the four substances to submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 180 days before the day on which the significant new activity begins.
In order to address human health concerns, the Order would target the use of any of the four substances in consumer products to which the Canada Consumer Product Safety Act applies. Consumer products are potential sources of direct and significant human exposure to these substances.
For the manufacture of consumer products, notification would be required when the concentration of any of the four substances in the consumer product is greater than 0.1% by weight.
For the importation of any of the four substances in consumer products, notification would be required when the total quantity of the substance thus imported by any person (individual or corporation) in a calendar year is greater than 10 kg, and the concentration of the substance in the consumer product is greater than 0.1% by weight.
Activities not subject to the proposed Order
For the manufacture of a consumer product, any of the four substances would not be subject to the proposed Order if the substance is used in the manufacture of the following products:
- (a) a component in commercial printing inks; or
- (b) a dye in paper products.
For the importation of a total quantity of more than 10 kg of any of the four substances in a calendar year, the proposed Order would not apply if the substance is imported in the following products:
- (a) a component in commercial printing inks; or
- (b) a dye in paper products.
For the manufacture of a consumer product, Malachite Green would not be subject to the proposed Order if the substance is used in the manufacture of a product for treating water in any artificial aquatic environment, such as aquariums and ornamental ponds.
For the importation of a total quantity of more than 10 kg of Malachite Green in a calendar year, the proposed Order would not apply if the substance is imported in a product for treating water in any artificial aquatic environment, such as aquariums and ornamental ponds.
The use or importation of any of the four substances as a research and development substance, a site-limited intermediate substance, or an export-only substance would not require the submission of a SNAN, as these activities are not expected to result in exposure to the general population in Canada. The terms “research and development substance” and “site-limited intermediate substance” are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers). An activity would not require the submission of a SNAN if the substance, or the product that contains the substance, is intended only for export.
The proposed Order would not apply to uses of any of the four substances that are regulated under the Acts of Parliament listed in Schedule 2 to CEPA, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act. The proposed Order would also not apply to transient reaction intermediates, impurities, contaminants, or partially unreacted intermediates, or in some circumstances to items such as wastes, mixtures or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the proposed Order. See subsection 81(6) and section 3 of CEPA, and section 3 of the Guidance document for the New Substances Notification Regulations (Chemicals and Polymers) for additional information.
Information to be submitted
The NOI sets out the proposed requirements for information that would have to be provided to the Minister at least 180 days before the day on which the significant new activity begins. The Department of the Environment and the Department of Health will use the information submitted in the SNAN and other information to conduct environmental and human health assessments within 180 days after the complete information is received.
The information requirements in the proposed Order relate to general information in respect of the substance, details surrounding its use, and exposure information. Some of the proposed information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers).
Additional guidance on preparing a SNAN can be found in section 4 of the Guidance document for the New Substances Notification Regulations (Chemicals and Polymers).
Compliance
When assessing whether or not a substance is subject to SNAc provisions,footnote 5 a person is expected to make use of information in their possession or to which they may reasonably be expected to have access. This means information in any of the notifier’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information, and the relevant Safety Data Sheet (SDS).
Although an SDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to an order due to human health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier.
Where a person involved in activities with the substance obtains information that reasonably supports the conclusion that the substance is toxic or capable of becoming toxic, the person is obligated, under section 70 of CEPA, to provide that information to the Minister without delay.
Under section 87.1 of CEPA, any person who transfers the physical possession or control of a substance subject to an Order shall notify all persons to whom the physical possession or control is transferred of the obligation to comply with the Order, including the obligation to notify the Minister of any significant new activity and to provide all the required information outlined above.
In cases where a person receives possession or control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if the activities were covered by a SNAN submitted by the supplier on behalf of its clients.
A pre-notification consultation (PNC) is available for notifiers who wish to consult during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.
Where a person has questions concerning their obligations to comply with an order, believes they may be out of compliance, or would like to request a PNC, they are encouraged to contact the Substances Management Information Line.footnote 6
The CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999 (CEPA, 1999). In instances of non-compliance, consideration is given to the following factors, when deciding which enforcement measure to take: nature of the alleged violation, effectiveness in achieving compliance with CEPA and its regulations, and consistency in enforcement.
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Significant New Activity No. 21849
Significant New Activity Notice
(Section 85 of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment and the Minister of Health have assessed information in their possession in respect of the substance iron potassium oxide, Chemical Abstracts Service Registry Number 12022-41-2, under section 83 of the Canadian Environmental Protection Act, 1999;
Whereas the substance is not specified on the Domestic Substances List;
And whereas the ministers suspect that a significant new activity in relation to the substance may result in the substance becoming toxic within the meaning of section 64 of the Act,
Therefore, the Minister of the Environment indicates, pursuant to section 85 of the Canadian Environmental Protection Act, 1999, that subsection 81(4) of that Act applies with respect to the substance in accordance with the Annex.
The Honourable Steven Guilbeault
Minister of the Environment
ANNEX
Information requirements
(Section 85 of the Canadian Environmental Protection Act, 1999)
1. The following definitions apply in this notice:
- “substance”
- means iron potassium oxide, Chemical Abstracts Service Registry Number 12022-41-2.
- “nanomaterial”
- means having one or more dimensions at the nanoscale (1–100 nanometres inclusive) where the substance has 10% or more of its primary particle distribution by number in the nanoscale range or at least 1% (by mass) of the particles in the nanoscale.
2. In relation to the substance, a significant new activity is the use of the substance, other than as a catalyst, where the substance is a nanomaterial.
3. Despite section 2, a use of the substance is not a significant new activity if the substance is used as a research and development substance or site-limited intermediate substance, as these terms are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers) [the Regulations], or is used to manufacture an export-only product.
4. The following information must be provided to the Minister of the Environment at least 90 days before using more than 100 kg of the substance in a year in a significant new activity:
- (a) the information specified in Schedule 4 to the Regulations;
- (b) a description of the proposed significant new activity in relation to the substance;
- (c) the analytical information to determine the average particle size and particle size distribution of the substance obtained in accordance with the Organisation for Economic Co-operation and Development (OECD) Guidelines for the Testing of Chemicals, Test No. 125 entitled, Nanomaterial Particle Size and Size Distribution of Nanomaterials;
- (d) the information describing the agglomeration/aggregation state, shape, surface area and surface charge of the substance; and
- (e) in relation to paragraphs 4(c) and 4(d), the data from a test developed in accordance with the OECD Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials or guidance that is equivalent.
5. The following information must be provided to the Minister of the Environment at least 90 days before using more than 1 000 kg of the substance in a year in a significant new activity:
- (a) the information specified in Schedule 5 to the Regulations, with the information specified in section 7 of that Schedule obtained from one in vitro mammalian cell genotoxicity test in respect of the substance, with and without metabolic activation;
- (b) the data from a test developed in accordance with the OECD Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials or guidance that is equivalent; and
- (c) the data from a test developed in accordance with the OECD Series on Testing and Assessment No. 317 Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials or guidance that is equivalent.
6. The following information must be provided to the Minister of the Environment at least 90 days before using more than 10 000 kg of the substance in a year in a significant new activity:
- (a) the information specified in Schedule 6 to the Regulations;
- (b) the information specified under Schedule 5, section 7, to the Regulations obtained from one in vitro mammalian cell genotoxicity test in respect of the substance, with and without metabolic activation;
- (c) the data from a test developed in accordance with the OECD Guidance on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials or guidance that is equivalent; and
- (d) the data from a test developed in accordance with the OECD Series on Testing and Assessment No. 317 Guidance Document on Aquatic and Sediment Toxicological Testing of Nanomaterials or guidance that is equivalent.
7. The information provided under sections 4, 5 and 6 will be assessed within 90 days after the day on which it is received by the Minister.
EXPLANATORY NOTE
(This explanatory note is not part of the Significant New Activity Notice.)
Description
This Significant New Activity (SNAc) Notice is a legal instrument adopted by the Minister of the Environment pursuant to section 85 of the Canadian Environmental Protection Act, 1999 (the Act) to apply the SNAc provisions of that Act to the substance iron potassium oxide, Chemical Abstracts Service (CAS) Registry Number 12022-41-2. The Notice is now in force and it has force of law. It is therefore mandatory for a person who intends to use the substance for a significant new activity as defined in the Notice to meet all the applicable requirements set out in the Notice.
A SNAc Notice does not constitute an endorsement from the Minister of the Environment, the Department of the Environment or the Government of Canada of the substance to which it relates, nor does it constitute an exemption from any other laws or regulations that are in force in Canada and that may apply to this substance or activities involving the substance.
Applicability of the Significant New Activity Notice
The Notice requires that any person (individual or corporation) engaging in a significant new activity in relation to the substance iron potassium oxide, Chemical Abstracts Service (CAS) Registry Number 12022-41-2, submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Notice at least 90 days prior to using the substance for the significant new activity.
In order to address potential toxicity concerns, the Notice requires notification in relation to the use of the substance, other than as a catalyst, where the substance is a nanomaterial.
When determining the applicability of the SNAc requirements, it is recommended to use methods specified in the Organisation for Economic Cooperation and Development (OECD) Guidelines for the Testing of Chemicals, Test No. 125 or, in either OECD Series on the Safety of Manufactured Nanomaterials, No. 36 or No. 41 when the substance is a nanomaterial.
A SNAN is required 90 days before the use of the substance in a significant new activity.
Activities not subject to the Notice
Uses of the substance that are regulated under the Acts of Parliament listed in Schedule 2 of the Act, including the Pest Control Products Act, the Fertilizers Act and the Feeds Act are excluded from the Notice. The Notice also does not apply to transient reaction intermediates, impurities, contaminants, partially unreacted materials, or in some circumstances to items such as, but not limited to, wastes, mixtures, or manufactured items. However, it should be noted that individual components of a mixture may be subject to notification under the provisions of the Act. See subsection 81(6) and section 3 of the Act, and section 3.2 of the Guidance Document for the New Substances Notification Regulations (Chemicals and Polymers) for additional information.
Activities involving the use of the substance as a research and development substance or a site-limited intermediate or to manufacture an export-only product are excluded from the Notice. The terms “research and development substance” and “site-limited intermediate substance” are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers).
Information to be submitted
The Notice sets out the information that must be provided to the Minister 90 days before the day on which the substance iron potassium oxide, Chemical Abstracts Service (CAS) Registry Number 12022-41-2 is used for a significant new activity. The Department of the Environment and the Department of Health will use the information submitted in the SNAN to conduct risk assessments within 90 days after the complete information is received.
The assessment of the substance identified potential toxicity concerns associated with exposure where the substance is a nanomaterial. The SNAc Notice is issued to gather toxicity information to ensure that the substance will undergo further assessment before significant new activities are undertaken.
The information requirements in the Notice relate to general information in respect of the substance, details surrounding its use, exposure information, and toxicity to human health and the environment. Some of the information requirements reference the New Substances Notification Regulations (Chemicals and Polymers).
Additional guidance on preparing a SNAN can be found in section 9.6.2 of the Guidance Document for the New Substances Notification Regulations (Chemicals and Polymers).
Compliance
When assessing whether or not a substance is subject to SNAc provisions, a person is expected to make use of information in their possession or to which they may reasonably have access. This means information in any of the notifier’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture, or product are expected to have access to import records, usage information and the relevant Safety Data Sheets (SDSs).
Although an SDS is an important source of information on the composition of a product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to a SNAc notice due to human health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier.
Where a person involved in activities with the substance obtains information that reasonably supports the conclusion that the substance is toxic or is capable of becoming toxic, the person is obligated, under section 70 of the Act, to provide that information to the Minister without delay.
A company can submit a SNAN on behalf of its clients. For example, in cases where a person takes possession or control of a substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by an original SNAN submitted by the person from whom they obtained the substance.
Under section 86 of the Act, any person who transfers the physical possession or control of a substance subject to a SNAc notice must notify all persons to whom the physical possession or control is transferred of the obligation to comply with the notice, including the obligation to notify the Minister of any SNAc and to provide all the required information outlined above.
A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans.
For further information, please contact the Substances Management Information Line (substances@ec.gc.ca [email], 1‑800‑567‑1999 [toll-free in Canada], and 819‑938‑3232 [outside of Canada]).
The Act is enforced in accordance with the publicly available Compliance and Enforcement Policy for the Canadian Environmental Protection Act, 1999. In instances of non-compliance, consideration is given to the following factors, when deciding which enforcement measure to take: nature of the alleged violation, effectiveness in achieving compliance with the Act and its regulations and consistency in enforcement.
DEPARTMENT OF HEALTH
FOOD AND DRUGS ACT
Notice of intent — Consultation on modernizing the medical device establishment licensing framework (Phase II)
Purpose
The purpose of this notice is to inform interested stakeholders of Health Canada’s (the Department) intent to amend the medical device establishment licensing framework in the Medical Devices Regulations (MDR) under the Food and Drugs Act.
Health Canada’s 2024–2026 Forward Regulatory Plan (FRP) and Regulatory Stock Review Plan (SRP) outline the Department’s intent to modernize the medical device establishment licensing framework in two phases. For Phase II, Health Canada communicated its intent in the FRP and SRP to clarify uncertainties around importation and to improve and modernize the regulatory oversight of the import and sale of medical devices in the supply chain in Canada.
Health Canada intends to use feedback received from this notice to better inform proposed regulatory amendments, policy, and program considerations.
Who is the focus of this consultation
Health Canada is interested in hearing from
- industry stakeholders
- members of the public
- health professionals
- other interested parties
Background
The Food and Drugs Act and its associated regulations establish the framework to protect health and safety by regulating activities such as the manufacture, sale, and advertisement of food, drugs, cosmetics, and medical devices. Health Canada is responsible for helping to ensure that medical devices continue to be safe, effective, and of high quality and to maintain oversight of import and sale of medical devices in the supply chain. This includes issuing medical device establishment licences (MDELs) to manufacturers of Class I devices, as well as to importers and distributors of all four device classes, to permit importation or distribution (sale) of medical devices in Canada.
During previous consultations, industry stakeholders noted that elements of Health Canada’s regulatory frameworks were limiting a competitive business environment and were not aligned with other jurisdictions. More recently, Health Canada heard from industry stakeholders that the MDEL requirements for distributors outside Canada are burdensome, redundant, and could negatively affect the supply of devices in Canada.
Lessons learned during the pandemic also reflect the need for Health Canada to strengthen its ability to identify and trace non-compliant medical devices and establishments that may pose a risk of injury to health. Most of the medical devices sold in Canada are imported from other countries and there is a growing number of participants in the medical device supply chain, making it more challenging to trace potentially non-compliant medical devices when health and safety risks arise.
Proposal — Phase II
Health Canada’s modernization of the medical device establishment licensing framework (Phase II) proposes targeted amendments to the MDR. The proposal aims to reduce the burden for industry while still maintaining sufficient oversight to protect the health and safety of people in Canada.
Adopt a risk-based approach to licensing distributors outside Canada
Currently, subsection 44(3) of the MDR requires any person who imports a medical device to ensure that the person from whom they import it holds an MDEL. Health Canada is considering adopting a risk-based approach to licensing by removing the requirement for distributors outside Canada to hold an MDEL, if they are selling solely to Canadian importers already holding an MDEL. As a result, Canadian importers would no longer be required to verify that their distributors from outside Canada hold an MDEL. Persons without an MDEL who import (i.e. retailers and health care facilities) would continue to be required to verify that the person from whom they import holds an MDEL. The proposal would maintain all existing requirements for safety and effectiveness of the device and all safety requirements for importers. This would help reduce redundancy for stakeholders and facilitate greater international alignment.
Enable more targeted compliance and enforcement action with requirement for supplier lists
Health Canada currently requests that MDEL applicants and holders voluntarily provide their list of suppliers. A supplier is any person, other than the manufacturer, who distributes (sells) a medical device to an MDEL holder for the purpose of import or sale in Canada. Health Canada is considering making this a mandatory requirement, similar to the requirement for MDEL holders to provide their list of manufacturers. The proposed amendment would require MDEL applicants, and MDEL holders, to identify and list their suppliers during the initial application and once a year during the annual licence review. This would improve the Department’s ability to efficiently identify persons selling into and within Canada and allow for more targeted and efficient compliance and enforcement actions. This would support traceability when health and safety risks related to the import and distribution of medical devices in Canada arise.
Close enforcement gaps for standard operating procedures
Section 45 of the MDR requires MDEL applicants to attest to having procedures in place to manage health and safety risks related to the import and distribution of medical devices in Canada. Health Canada’s inspection observations revealed that these procedures are often lacking, that there are gaps in how procedures are documented and implemented, and that the procedures need to be kept updated. Health Canada is proposing explicit requirements to set clear expectations for MDEL holders to establish, implement, and maintain standard operating procedures, to better manage health and safety risks related to medical devices sold in Canada.
Feedback and public comments
Health Canada is looking for feedback from stakeholders to help inform the regulatory proposal.
In particular, the Department would like to know the following:
- Based on your perspective, what would be the impact of removing the requirement for MDEL holders in Canada to ensure that their distributors outside Canada have an MDEL?
- If you are an MDEL holder, what has been your experience with voluntarily submitting your list of suppliers to Health Canada? What would be the impact of making this a mandatory requirement?
- If you are an MDEL holder, do you have a system for implementing and maintaining your documented standard operating procedures?
- What other potential impacts should be taken into consideration when making these proposed changes?
Current status and next steps
Results of this consultation will be used to support Health Canada’s prepublication in the Canada Gazette, Part I. People in Canada will also have the opportunity to provide comments on the regulatory proposal during the Canada Gazette, Part I, public comment period, which is expected to take place in 2025.
Public comment period
This consultation will be open for 30 days, ending December 9, 2024. Interested parties may submit written comments, in English or in French, by email to prsd-questionsdspr@hc-sc.gc.ca or by mail to Jillian Andrews, Acting Associate Director, Compliance Policy and Regulatory Affairs, Policy and Regulatory Strategies Directorate, 200 Eglantine Driveway, Ottawa, Ontario K1A 0K9.
Jillian Andrews
Acting Associate Director
Compliance Policy and Regulatory Affairs
Regulatory Operations and Enforcement Branch
OFFICE OF THE SUPERINTENDENT OF FINANCIAL INSTITUTIONS
INSURANCE COMPANIES ACT
Markel International Insurance Company Limited — Order to insure in Canada risks
Notice is hereby given of the issuance, pursuant to subsection 574(1) of the Insurance Companies Act, of an order to insure in Canada risks, effective September 11, 2024, authorizing Markel International Insurance Company Limited, under the name Markel International Insurance Company Limited, in English, and, in French, Markel compagnie d’assurance internationale limitée, to insure risks falling within the classes of property, accident and sickness, boiler and machinery, fidelity, legal expenses, liability and surety insurance.
November 9, 2024
Peter Routledge
Superintendent of Financial Institutions
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 | Bank of Canada | |
| Chairperson | Canada Deposit Insurance Corporation | |
| Chairperson | Canada Industrial Relations Board | |
| Vice-Chairperson | Canada Industrial Relations Board | |
| Chairperson | Canada Infrastructure Bank | |
| Director | Canada Lands Company Limited | |
| Trustee | Canada’s National Museums | November 21, 2024 |
| Chief Executive Officer | Canadian Accessibility Standards Development Organization | |
| Director | Canadian Air Transport Security Authority | |
| Director | Canadian Commercial Corporation | |
| Director | Canadian Energy Regulator | |
| Assistant Chief Commissioner | Canadian Grain Commission | |
| Chief Commissioner | Canadian Human Rights Commission | |
| President | Canadian Institutes of Health Research | |
| Director | Canadian Race Relations Foundation | |
| Director | Canadian Tourism Commission | |
| President | Canadian Tourism Commission | |
| Chairperson | Civilian Review and Complaints Commission for the Royal Canadian Mounted Police | |
| Vice-Chairperson | Civilian Review and Complaints Commission for the Royal Canadian Mounted Police | |
| Member | Copyright Board | |
| Director | Defence Construction (1951) Limited | |
| Member | Employment Insurance Board of Appeal | December 16, 2024 |
| Regional Coordinator | Employment Insurance Board of Appeal | December 16, 2024 |
| President | Export Development Canada | |
| Vice-Chairperson | Federal Public Sector Labour Relations and Employment Board | |
| Director (Federal) | Halifax Port Authority | |
| Member | Historic Sites and Monuments Board of Canada | |
| Member | National Seniors Council | |
| Member | Natural Sciences and Engineering Research Council | |
| Member | Net-Zero Advisory Body | |
| Canadian Representative | North Atlantic Salmon Conservation Organization | |
| Commissioner of Official Languages | Office of the Commissioner of Official Languages | |
| Deputy Director of Public Prosecutions | Office of the Director of Public Prosecutions | |
| Ombudsperson for the Department of National Defence and the Canadian Forces | Office of the Ombudsperson for the Department of National Defence and the Canadian Forces | |
| Senate Ethics Officer | Office of the Senate Ethics Officer | |
| Member | Parole Board of Canada | November 19, 2024 |
| Member | Payments in Lieu of Taxes Dispute Advisory Panel | |
| Principal | Royal Military College of Canada | |
| Director | Sept-Îles Port Authority | |
| Administrator | Ship-source Oil Pollution Fund and Fund for Railway Accidents Involving Designated Goods | |
| Chief Statistician | Statistics Canada | |
| Co-chair | Sustainable Jobs Partnership Council | |
| Member | Sustainable Jobs Partnership Council | |
| Chairperson | The Jacques-Cartier and Champlain Bridges Inc. | |
| Secretary | The National Battlefields Commission | |
| Chairperson | VIA Rail Canada Inc. | |
| Chairperson | Windsor-Detroit Bridge Authority |