Canada Gazette, Part I, Volume 153, Number 13: GOVERNMENT NOTICES
March 30, 2019
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Ministerial Condition No. 19882
Ministerial condition
(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)
Whereas the Minister of the Environment and the Minister of Health (the ministers) have assessed information pertaining to the substance iron(1+), chloro[dimethyl 9,9dihydroxy-3-methyl-2,4-di(2-pyridinyl-κN)-7-[(2-pyridinylκN)methyl]- 3,7-diazabicyclo[3.3.1]nonane-1,5-dicarboxylateκN3, κN7]-, chloride (1:1), Chemical Abstracts Service Registry No. 478945-46-9;
And whereas the ministers suspect that the substance is toxic or capable of becoming toxic within the meaning of section 64 of the Canadian Environmental Protection Act, 1999 (the Act),
The Minister of the Environment, pursuant to paragraph 84(1)(a) of the Act, hereby permits the manufacture or import of the substance in accordance with the conditions of the following annex.
Nancy Hamzawi
Assistant Deputy Minister
Science and Technology Branch
On behalf of the Minister of the Environment
ANNEX
Conditions
(Paragraph 84(1)(a) of the Canadian Environmental Protection Act, 1999)
1. The following definitions apply in these ministerial conditions:
- “notifier” means the person who has, on March 7, 2019, provided to the Minister of the Environment the prescribed information concerning the substance, in accordance with subsection 81(1) of the Act;
- “paint” or “coating” means a product, either in liquid or aerosol form, that is intended to be applied onto or impregnated into a substrate and that is water-based, alcohol-based, oil-based or solvent-based, and includes interior and exterior paint, wood stain, primer, varnish, and lacquer, whether tinted or untinted;
- “solvent system” means any liquid diluent added to a paint or coating during the formulation process for the purpose of adjusting the viscosity of the formulation; and
- “substance” means iron(1+), chloro[dimethyl 9,9- dihydroxy- 3-methyl-2,4-di(2-pyridinyl-κN)-7-[(2-pyridinyl- κN)methyl]- 3,7-diazabicyclo[3.3.1]nonane-1,5-dicarboxylate- κN3, κN7]-, chloride (1:1), Chemical Abstracts Service Registry No. 478945-46-9.
2. The notifier may manufacture or import the substance in accordance with the present ministerial conditions.
Restrictions
3. The substance shall only be used to manufacture a paint or a coating and the following conditions must be met:
- (a) the concentration of the substance in the paint or coating is less than or equal to 100 parts per million (ppm);
- (b) the paint or coating is manufactured with a waterborne solvent system or an alcohol-based solvent system (e.g. propylene glycol, ethylene glycol); and
- (c) the paint or coating is not intended for use by children under the age of 18.
4. The notifier shall transfer the physical possession or control of the substance only to a person who will use it in accordance with item 3.
5. At least 120 days prior to beginning manufacturing the substance in Canada, the notifier shall inform the Minister of the Environment, in writing, and provide the following information:
- (a) the information specified in paragraph 7(a) of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
- (b) the address of the manufacturing facility within Canada;
- (c) the information specified in paragraphs 8(a) to (e), item 9 and paragraph 10(b) of Schedule 5 to those Regulations; and
- (d) the following information related to the manufacturing of the substance in Canada:
- (i) a brief description of the manufacturing process that details the precursors of the substance, the reaction stoichiometry and the nature (batch or continuous) and scale of the process,
- (ii) a flow diagram of the manufacturing process that includes features such as process tanks, holding tanks and distillation towers, and
- (iii) a brief description of the major steps in manufacturing operations, the chemical conversions, the points of entry of all feedstock and the points of release of the substance, and the processes to eliminate environmental release.
Record-keeping requirements
6. (1) The notifier shall maintain electronic or paper records, with any documentation supporting the validity of the information contained in these records, indicating
- (a) the use of the substance;
- (b) the quantity of the substance that the notifier manufactures, imports, purchases, sells and uses;
- (c) the name and address of each person to whom the notifier transfers the physical possession or control of the substance; and
- (d) the concentration of the substance in the paint or coating manufactured with the substance.
(2) The notifier shall maintain electronic or paper records mentioned in subsection (1) at their principal place of business in Canada, or at the principal place of business in Canada of their representative, for a period of at least five years after they are made.
Other requirements
7. The notifier shall inform any person to whom they transfer the physical possession or control of the substance, in writing, of the terms of the present ministerial conditions. The notifier shall obtain, prior to the first transfer of the substance, written confirmation from this person that they were informed of the terms of the present ministerial conditions. This written confirmation shall be maintained at the principal place of business in Canada of the notifier or of their representative in Canada for a period of at least five years from the day it was received.
Coming into force
8. The present ministerial conditions come into force on March 13, 2019.
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Notice of waiver of information requirements for living organisms (subsection 106(9) of the Canadian Environmental Protection Act, 1999)
Whereas any person who proposes to import or manufacture a living organism that is not on the Domestic Substances List must provide to the Minister of the Environment the information required under subsection 106(1) of the Canadian Environmental Protection Act, 1999;
Whereas a person may, pursuant to subsection 106(8) of the Canadian Environmental Protection Act, 1999, request any of the requirements to provide information under subsection 106(1) of the Canadian Environmental Protection Act, 1999 to be waived;
Whereas a waiver may be granted by the Minister of the Environment under subsection 106(8) of the Canadian Environmental Protection Act, 1999 if
- (a) in the opinion of the Ministers, the information is not needed in order to determine whether the living organism is toxic or capable of becoming toxic;
- (b) the living organism is to be used for a prescribed purpose or manufactured at a location where, in the opinion of the Ministers, the person requesting the waiver is able to contain the living organism so as to satisfactorily protect the environment and human health; or
- (c) it is not, in the opinion of the Ministers, practicable or feasible to obtain the test data necessary to generate the information.
Therefore, notice is hereby given, pursuant to subsection 106(9) of the Canadian Environmental Protection Act, 1999, that the Minister of the Environment waived some requirements to provide information in accordance with the following annex pursuant to subsection 106(8) of that Act.
Nicole Davidson
Acting Executive Director
Program Development and Engagement Division
On behalf of the Minister of the Environment
ANNEX
Person to whom a waiver was granted | Information concerning a living organism in relation to which a waiver was granted |
---|---|
AquaBounty Technologies Inc. | Data from a test to determine the ecological effects of the living organism (pathogenicity, toxicity or invasiveness) |
GlaxoSmithKline Inc. | Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed Data from a test to determine the effects of the living organism on terrestrial plant and invertebrate species likely to be exposed Data from tests of antibiotic susceptibility |
Iovance Biotherapeutics, Inc. | Data from a test to determine the effects of the living organism on aquatic plant, invertebrate, and vertebrate species likely to be exposed Data from a test to determine the effects of the living organism on terrestrial plant and invertebrate species likely to be exposed Data from tests of antibiotic susceptibility |
EXPLANATORY NOTE
The decision to grant a waiver is made on a case-by-case basis by Environment Canada in consultation with Health Canada. Every year an average of 500 regulatory declarations are submitted for chemicals, polymers and living organisms under subsections 81(1), (3) and (4) and 106(1), (3) and (4) of the Canadian Environmental Protection Act, 1999 and around 100 waivers are granted yearly for chemicals, polymers and living organisms under subsections 81(8) and 106(8) of the Canadian Environmental Protection Act, 1999.
For more information, please see the waivers web page on the New Substances website.
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Notice of waiver of information requirements for substances (subsection 81(9) of the Canadian Environmental Protection Act, 1999)
Whereas any person who proposes to import or manufacture a substance that is not on the Domestic Substances List must provide to the Minister of the Environment the information required under subsection 81(1) of the Canadian Environmental Protection Act, 1999;
Whereas a person may, pursuant to subsection 81(8) of the Canadian Environmental Protection Act, 1999, request any of the requirements to provide information under subsection 81(1) of the Canadian Environmental Protection Act, 1999 to be waived; and
Whereas a waiver may be granted by the Minister of the Environment under subsection 81(8) of the Canadian Environmental Protection Act, 1999 if
- (a) in the opinion of the Ministers, the information is not needed in order to determine whether the substance is toxic or capable of becoming toxic;
- (b) the substance is to be used for a prescribed purpose or manufactured at a location where, in the opinion of the Ministers, the person requesting the waiver is able to contain the substance so as to satisfactorily protect the environment and human health; or
- (c) it is not, in the opinion of the Ministers, practicable or feasible to obtain the test data necessary to generate the information.
Therefore, notice is hereby given, pursuant to subsection 81(9) of the Canadian Environmental Protection Act, 1999, that the Minister of the Environment waived some requirements to provide information pursuant to subsection 81(8) of that Act and in accordance with the following annex.
Nicole Davidson
Acting Executive Director
Program Development and Engagement Division
On behalf of the Minister of the Environment
ANNEX
Person to whom a waiver was granted | Information concerning a substance in relation to which a waiver was granted |
---|---|
BASF Canada Inc. | Data in respect of octanol/water partition coefficient Data in respect of hydrolysis rate as a function of pH |
Dow Chemical Canada ULC | Data from an in vivo mammalian test for chromosomal aberrations or gene mutations |
H.B. Fuller Canada | Data in respect of octanol/water partition coefficient (2) table 1 note 1 Data in respect of hydrolysis rate as a function of pH (2) |
INEOS Oligomers USA LLC | Data in respect of hydrolysis rate as a function of pH |
Rohm and Haas Canada LP | Data in respect of octanol/water partition coefficient |
Showa Denko K.K. | Data in respect of water solubility Data from an acute mammalian toxicity test (oral, dermal or inhalation) Data from an in vitro mutagenicity test for chromosomal aberrations in mammalian cells |
Solenis Canada ULC | Data in respect of octanol/water partition coefficient Data in respect of hydrolysis rate as a function of pH |
W.R. Grace & Co.-Conn. | Data in respect of vapour pressure Data in respect of octanol/water partition coefficient Data in respect of ready biodegradation Data in respect of adsorption-desorption |
Table 1 Note
|
EXPLANATORY NOTE
The decision to grant a waiver is made on a case-by-case basis by Environment Canada in consultation with Health Canada. Every year an average of 500 regulatory declarations are submitted for chemicals, polymers and living organisms under subsections 81(1), (3) and (4) and 106(1), (3) and (4) of the Canadian Environmental Protection Act, 1999 and around 100 waivers are granted yearly for chemicals, polymers and living organisms under subsections 81(8) and 106(8) of the Canadian Environmental Protection Act, 1999.
For more information, please see the waivers web page on the New Substances website.
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Notice with respect to the availability of an equivalency agreement
Pursuant to subsection 10(4) of the Canadian Environmental Protection Act, 1999, notice is hereby given that the Minister of the Environment makes available, before it is entered into, An Agreement on the Equivalency of Federal and British Columbia Regulations Respecting the Release of Methane from the Upstream Oil and Gas Sector in British Columbia, 2020.
The proposed agreement is available as of March 30, 2019, on the Department of the Environment’s Environmental Registry.
Any person may, within 60 days after the publication of this notice, file with the Minister comments or a notice of objection. All such comments and notices must cite the present notice and its date of publication in the Canada Gazette, Part I, and be sent to the following contact person.
Contact
Cam Carruthers
Executive Director
Oil, Gas and Alternative Energy Division
Department of the Environment
351 Saint-Joseph Boulevard
Gatineau, Quebec
K1A 0H3
Email: ec.methane-methane.ec@canada.ca
DEPARTMENT OF THE ENVIRONMENT
CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999
Notice with respect to the availability of an equivalency agreement
Pursuant to subsection 10(4) of the Canadian Environmental Protection Act, 1999, notice is hereby given that the Minister of the Environment makes available, before it is entered into, the Agreement on the equivalency of federal and Nova Scotia regulations for the control of greenhouse gas emissions from electricity producers in Nova Scotia.
The proposed agreement is available as of March 30, 2019, on the Department of the Environment’s Environmental Registry.
Any person may, within 60 days after the publication of this notice, file with the Minister comments or a notice of objection. All such comments and notices must cite the present notice and its date of publication in the Canada Gazette, Part I, and be sent to the following contact person.
Contact
Magda Little
Director
Electricity and Combustion Division
Department of the Environment
351 Saint-Joseph Boulevard
Gatineau, Quebec
K1A 0H3
Email: ec.electricite-electricity.ec@canada.ca
DEPARTMENT OF THE ENVIRONMENT
Significant New Activity Notice No. 19794
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 2-Propenoic acid, 2-methyl-, methyl ester, polymer with isooctyl 2- propenoate and 3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]-1-disiloxanyl]propyl 2-methyl-2-propenoate, Chemical Abstracts Service Registry No. 175283-06-4, 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.
March 11, 2019
The Honourable Catherine McKenna
Minister of the Environment
ANNEX
Information requirements
(Section 85 of the Canadian Environmental Protection Act, 1999)
1. The following definition applies in this notice:
- “substance” means 2-Propenoic acid, 2-methyl-, methyl ester, polymer with isooctyl 2-propenoate and 3-[3,3,3- trimethyl-1,1-bis[(trimethylsilyl)oxy]-1-disiloxanyl]propyl 2-methyl-2-propenoate, Chemical Abstracts Service Registry No. 175283-06-4.
2. In relation to the substance, a significant new activity is
- (a) the use of the substance in the manufacture of any of the following products such that the substance is present in a concentration that is greater than or equal to 1% by weight:
- (i) a consumer product to which the Canada Consumer Product Safety Act applies, which releases or sprays the substance in airborne particles of less than or equal to 10 µm in size, or
- (ii) a cosmetic as defined in section 2 of the Food and Drugs Act, which releases or sprays the substance in airborne particles of less than or equal to 10 µm in size; and
- (b) the distribution for sale of the substance in a quantity greater than 10 kg in a calendar year in any of the following products in which the substance is present in a concentration that is greater than or equal to 1% by weight:
- (i) a consumer product to which the Canada Consumer Product Safety Act applies, which releases or sprays the substance in airborne particles of less than or equal to 10 µm in size; or
- (ii) a cosmetic as defined in section 2 of the Food and Drugs Act, which releases or sprays the substance in airborne particles of less than or equal to 10 µm in size.
3. Despite section 2, a use of the substance is not a significant new activity if the substance is used
- (a) as a research and development substance or as a site-limited intermediate substance as those terms are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers); or
- (b) in the manufacture of a product that is referred to in this section and is intended only for export.
4. For each proposed significant new activity, the following information must be provided to the Minister of the Environment at least 90 days before the day on which the activity begins:
- (a) a description of the proposed significant new activity in relation to the substance;
- (b) the information specified in paragraph 13(c) and subparagraphs 13(d)(i) to 13(d)(iv) of Schedule 9 to the New Substances Notification Regulations (Chemicals and Polymers);
- (c) a description of the particle size distribution of the substance released or sprayed during use of the product;
- (d) the anticipated annual quantity of the substance to be used in relation to the significant new activity;
- (e) the anticipated annual quantity of the consumer product or cosmetic to be sold in Canada in a calendar year by the person who proposes the significant new activity;
- (f) the test data and a test report from one of the following:
- (i) a toxicity test in respect of the substance, that is conducted in accordance with the methodology described in the Organisation for Economic Co-operation and Development (OECD) Test No. 413, entitled Subchronic Inhalation Toxicity: 90-Day Study, that is current at the time the test is conducted, or
- (ii) a toxicity test in respect of the substance, that is conducted in accordance with the methodology described in the OECD Test No. 412, entitled Subacute Inhalation Toxicity: 28-Day Study, that is current at the time the test is conducted;
- (g) the tests referred to in paragraph 4(f) must be conducted in accordance with the OECD Principles of Good Laboratory Practice set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981, that are current at the time the test is conducted;
- (h) the name of every government department or agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency; and
- (i) all other information or test data in respect of the substance that is in the possession of the person who is proposing the significant new activity, or to which they may reasonably be expected to have access, and that permit the identification of hazards to the environment and human health and the degree of environmental and public exposure to the substance.
5. The information provided under section 4 will be assessed within 90 days after the day on which it is received by the Minister of the Environment.
Transitional provisions
6. Despite section 2, in the period between the date of publication of the present notice and March 30, 2020, a significant new activity is the use of the substance in a quantity greater than or equal to 1 000 kg in a calendar year in the manufacture or distribution for sale of the following products in which the substance is present in a concentration greater than or equal to 1% by weight:
- (a) a consumer product to which the Canada Consumer Product Safety Act applies, which releases or sprays the substance in airborne particles of less than or equal to 10 µm in size; or
- (b) a cosmetic as defined in section 2 of the Food and Drugs Act, which releases or sprays the substance in airborne particles of less than or equal to 10 µm in size.
7. For greater certainty, in respect of calendar year 2020, the quantity of substance that is used before March 30 of that calendar year is not considered for the purposes of section 2.
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 2-Propenoic acid, 2-methyl-, methyl ester, polymer with isooctyl 2-propenoate and 3-[3,3,3- trimethyl-1,1-bis[(trimethylsilyl)oxy]-1-disiloxanyl]propyl 2-methyl-2-propenoate, Chemical Abstracts Service Registry No. 175283-06-4. The Notice is now in force. It is therefore mandatory to meet all the requirements of the Notice should a person intend to use the substance for a significant new activity as defined in the Notice.
A SNAc Notice does not constitute an endorsement from the Department of the Environment or the Government of Canada of the substance to which it relates, or 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 SNAc in relation to 2-Propenoic acid, 2-methyl-, methyl ester, polymer with isooctyl 2- propenoate and 3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]-1-disiloxanyl]propyl 2-methyl-2-propenoate, Chemical Abstracts Service Registry No. 175283-06-4, 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 SNAc.
In order to address the human toxicity concerns, the Notice requires notification in relation to the use of the substance in the manufacture of consumer products or cosmetics intended for applications that generate airborne particles of less than or equal to 10 µm when the concentration of the substance is greater or equal to 1% by weight. The Notice also requires notification in relation to the distribution for sale of the substance in these finished products. For example, notification is required if a person plans to manufacture or distribute an aerosol cosmetic product containing the substance that generates respirable airborne particles of less than or equal to 10 µm, and the concentration of the substance is greater or equal to 1% by weight.
The Notice targets any use of the substance in consumer products to which the Canada Consumer Product Safety Act (CCPSA) applies, or in a cosmetic as defined in the Food and Drugs Act (FDA). A SNAN is required 90 days before the use of the substance in a SNAc.
Activities not subject to the Notice
The following activities are not significant new activities:
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 of the Guidelines for the Notification and Testing of New Substances: 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 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 2-Propenoic acid, 2-methyl-, methyl ester, polymer with isooctyl 2-propenoate and 3-[3,3,3- trimethyl-1,1-bis[(trimethylsilyl)oxy]-1-disiloxanyl]propyl 2-methyl-2-propenoate, Chemical Abstracts Service Registry No. 175283-06-4, is used for a SNAc. 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 earlier assessment of the substance identified potential concerns associated with uses of the substance in consumer spray applications that generate respirable airborne particles of less than or equal to 10 µm. This acrylate silicone copolymer with high molecular weight and water-insoluble components can potentially cause pulmonary complications if inhaled. The SNAc Notice is issued to gather toxicity information in the event that the substance is used in a consumer spray application that generates airborne particles of less than or equal to 10 µm to ensure that the substance will undergo further assessment before SNAcs 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. 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 1.3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers.
Transitional provision
A transitional provision is included in the Notice to facilitate compliance by persons who may already have imported or manufactured up to 1 000 kg of the substance and started activities with it in concentrations that are greater than or equal to 1% by weight in the product matrix. The Notice comes into force immediately. However, if the substance is used to manufacture or distribute for sale consumer products to which the CCPSA applies or cosmetics as defined in the FDA that release or spray the substance in airborne particles of less than or equal to 10 µm in size, a threshold of more than or equal to 1 000 kg per calendar year applies and a concentration equal to or greater than 1% by weight applies for the period between the publication of the Notice and March 30, 2020. On March 31, 2020, the threshold will be lowered to 0 kg per calendar year when the substance is used to manufacture consumer or cosmetic products that release or spray the substance in airborne particles of less than 10 µm in size, and the concentration will remain greater than or equal to 1% by weight. On March 31, 2020, the threshold will be lowered to 10 kg per calendar year when consumer or cosmetic products that release or spray the substance in airborne particles of less than or equal to 10 µm in size are intended for distribution for sale, and the concentration will remain greater than or equal to 1% by weight.
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.
If any information becomes available that reasonably supports the conclusion that 2-Propenoic acid, 2-methyl-, methyl ester, polymer with isooctyl 2-propenoate and 3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]-1-disiloxanyl] propyl 2-methyl-2-propenoate, Chemical Abstracts Service Registry No. 175283-06-4, is toxic or capable of becoming toxic, the person who is in possession of or that has knowledge of the information and is involved in activities with the substance 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. The Substances Management Advisory Note “Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999” provides more detail on this subject.
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.
Where a person has questions concerning their obligations to comply with a notice, believes they may be out of compliance, or would like to request a PNC, they are encouraged to discuss their particular circumstances with the program by contacting the Substances Management Information Line (eccc.substances.eccc@canada.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 factors such as the nature of the alleged violation, potential harm, intent, and history of compliance.
DEPARTMENT OF HEALTH
CANNABIS ACT
Increase of fees
The Cannabis Fees Order (SOR/2018-198) was published in the Canada Gazette, Part II, on October 17, 2018, and came into force on the same date.
Section 2 of the Order provides that “the fees set out in sections 3 to 5 are to be adjusted in each fiscal year on April 1 by the percentage change over 12 months in the April All-items Consumer Price Index for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year and rounded to the next highest dollar.”
Notice is hereby given that the following fees will be adjusted effective April 1, 2019, by the 2018 Consumer Price Index of 2.2%.
Fee Description | Current Fee | Adjusted Fee Effective April 1, 2019 |
---|---|---|
Screening of a licence application | ||
|
$1,638 | $1,675 |
|
$3,277 | $3,350 |
|
$1,638 | $1,675 |
|
$1,638 | $1,675 |
|
$3,277 | $3,350 |
|
$3,277 | $3,350 |
Application for security clearance | $1,654 | $1,691 |
Application for import or export permit | $610 | $624 |
John Clare
Acting Director General
Strategic Policy Directorate
Controlled Substances and Cannabis Branch
DEPARTMENT OF HEALTH
DEPARTMENT OF HEALTH ACT
Notice of annual increase of Health Canada’s Drug Master Files and Certificate of a Pharmaceutical Product fees
Notice is hereby given that the Minister of Health, under the Ministerial Authority to Enter into Contract, hereby updates the fees that are payable for the provision of Drug Master Files and Certificate of a Pharmaceutical Product services by 2%, beginning April 1, 2019.
The current fees and the fees updated as of April 1, 2019, are listed below.
Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or hc.cro- brc.sc@canada.ca (email).
Services | Fee as of April 1, 2018 | Fee as of April 1, 2019 |
---|---|---|
Certificate of Pharmaceutical Product (or a supplemental copy of a Certificate of Pharmaceutical Product) | $88 | $90 |
New Master Files — file registration | $1,224 | $1,248 |
Drug Master Files — letter of access | $173 | $176 |
Drug Master Files — update | $530 | $541 |
DEPARTMENT OF HEALTH
FINANCIAL ADMINISTRATION ACT
Notice of annual increase of fees pursuant to the Fees in Respect of Drugs and Medical Devices Regulations
Notice is hereby given, under section 19.2 of the Financial Administration Act, that in keeping with section 4 of the 2011 Fees in Respect of Drugs and Medical Devices Regulations, every fee outlined by the Regulations is to be increased annually by 2%, rounded up to the nearest dollar.
The current fees and the fees updated as of April 1, 2019, are listed below.
Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or hc.cro-brc.sc@canada.ca (email).
Fee Category | Section in Fees in Respect of Drugs and Medical Devices Regulations | Fee as of April 1, 2018 | Fee as of April 1, 2019 |
---|---|---|---|
PART 2 — DRUGS Fees For Examination Services — Schedule 1 |
|||
New active substance | 6 | $348,606 | $355,579 |
Clinical or non-clinical data and chemistry and manufacturing data | 6 | $176,569 | $180,101 |
Clinical or non-clinical data only | 6 | $82,410 | $84,059 |
Comparative studies | 6 | $49,811 | $50,808 |
Chemistry and manufacturing data only | 6 | $23,551 | $24,023 |
Published data only | 6 | $19,530 | $19,921 |
Switch from prescription to non-prescription status | 6 | $47,421 | $48,370 |
Labelling only | 6 | $3,174 | $3,238 |
Administrative submission | 6 | $331 | $338 |
Disinfectants | 6 | $4,392 | $4,480 |
Drug identification number application — labelling standards | 6 | $1,761 | $1,797 |
Remission | |||
Remission processing fee | 11(1)(a)9)iii) | $578 | $590 |
Establishment Licence Fees Fabrication of Drugs — Schedule 2 | |||
Basic fee | 19(1), 27, 28(1)(a), 28(2)(a) | $17,751 | $18,107 |
Each additional category | 19(1)(a) | $4,449 | $4,538 |
Dosage form classes: | |||
2 classes | 19(1)(b) | $8,883 | $9,061 |
3 classes | 19(1)(b) | $17,751 | $18,107 |
4 classes | 19(1)(b) | $22,198 | $22,642 |
5 classes | 19(1)(b) | $26,629 | $27,162 |
6 classes | 19(1)(b) | $31,064 | $31,686 |
Each additional class | 19(1)(b) | $1,783 | $1,819 |
Sterile dosage forms | 19(1)(c) | $8,883 | $9,061 |
Packaging/Labelling of Drugs — Schedule 3 | |||
Basic fee | 20(1), 20(3)(a), 28(1)(b), 28(2)(b) | $11,869 | $12,107 |
Each additional category | 20(1)(a) | $2,966 | $3,026 |
Dosage form classes: | |||
2 classes | 20(1)(b) | $5,920 | $6,039 |
3 or more classes | 20(1)(b) | $8,883 | $9,061 |
Importation and Distribution of Drugs — Schedule 4 | |||
Basic fee | 21(a), 22, 28(1)(c) and (d), 28(2)(c) and (d) | $7,402 | $7,551 |
Each additional category | 21(a)(i), 22(a) | $1,853 | $1,891 |
Dosage form classes: | |||
2 classes | 21(a)(ii), 22(b) | $3,703 | $3,778 |
3 or more classes | 21(a)(ii), 22(b) | $7,402 | $7,551 |
Each fabricator | 21(b)(i) | $1,783 | $1,819 |
Each additional dosage form class for each fabricator | 21(b)(ii) | $899 | $917 |
Distribution or Wholesaling | |||
Distribution or wholesaling fee | 23 | $4,449 | $4,538 |
Testing | |||
Testing fee | 24 | $2,966 | $3,026 |
Drug Analysis — Schedule 5 | |||
Vaccines (1) | 25 | $29,582 | $30,174 |
Drugs, not included in items 1, 6 and 9 of this Schedule, that are listed in Schedule D to the Food and Drugs Act | 25 | $11,836 | $12,073 |
Drugs for human use that are listed in Schedule F to the Food and Drug Regulations or that are controlled drugs or narcotics | 25 | $8,883 | $9,061 |
Drugs for human use, not included in any other item, for which a drug identification number has been assigned | 25 | $4,449 | $4,538 |
Radiopharmaceuticals | 25 | $0 | $0 |
Whole blood and its components (6) | 25 | $0 | $0 |
Hemodialysis products | 25 | $0 | $0 |
Drugs that are labelled as disinfectants, including those listed in paragraph 9(f) of this Schedule, but excluding other drugs labelled as disinfectants of medical devices | 25 | $0 | $0 |
Drugs that meet the requirements of a class monograph having one of the following titles (9): | $0 | $0 | |
Acne Therapies | 25 | $0 | $0 |
Antidandruff Products | 25 | $0 | $0 |
Antiperspirants | 25 | $0 | $0 |
Antiseptic Skin Cleaners | 25 | $0 | $0 |
Athlete’s Foot Treatments | 25 | $0 | $0 |
Contact Lens Disinfectants 9(f) | 25 | $0 | $0 |
Fluoride-Containing Anti-Caries Products | 25 | $0 | $0 |
Medicated Skin Care Products | 25 | $0 | $0 |
Sunburn Protectants | 25 | $0 | $0 |
Throat Lozenges | 25 | $0 | $0 |
Fees for the Examination of Dealer’s Licence Applications Dealer’s Licence |
|||
Dealer’s licence | 31(1) | $5,184 | $5,288 |
Fees for Right to Sell Drugs | |||
Annual fee | 35(1) | $1,176 | $1,200 |
PART 3 — MEDICAL DEVICE FEES Fees for the Examination of Medical Device Licence Applications Class II Medical Devices |
|||
Class II — Licence application | 39(1) | $405 | $414 |
Class III Medical Devices — Schedule 6 | |||
Licence application | 40(1)(a), 41(a) | $5,805 | $5,922 |
Licence application for a near patient in vitro diagnostic devices | 40(1)(a), 41(a) | $9,881 | $10,079 |
Change referred to in paragraph 34(a) of the Medical Devices Regulations that relates to manufacturing | 40(1)(a), 41(a) | $1,462 | $1,492 |
Any other change referred to in paragraph 34(a) or (b) of the Medical Devices Regulations | 40(1)(a), 41(a) | $5,437 | $5,546 |
Class IV Medical Devices — Schedule 7 | |||
Licence application | 40(1)(b), 41(b) | $13,500 | $13,770 |
Licence application for devices that contain human or animal tissue | 40(1)(b), 41(b) | $12,594 | $12,846 |
Licence application for near patient in vitro diagnostic device | 40(1)(b), 41(b) | $23,012 | $23,473 |
Change referred to in paragraph 34(a) of the Medical Devices Regulations that relates to manufacturing | 40(1)(b), 41(b) | $1,462 | $1,492 |
Any other change referred to in paragraph 34(a) or (b) of the Medical Devices Regulations | 40(1)(b), 41(b) | $6,195 | $6,319 |
Remission | |||
Remission processing fee | 44(1)(a)(iii) | $63 | $65 |
Fee for Right to Sell Licensed Class II, III or IV Medical Devices | |||
Fee (if annual gross revenue medical device sales is less than $20,000) | 48(1)(a) | $63 | $65 |
Fee (in any other case) | 48(1)(b) | $383 | $391 |
Establishment Licence Fees | |||
Medical devices establishment licence | 51(1) | $8,272 | $8,438 |
DEPARTMENT OF HEALTH
FINANCIAL ADMINISTRATION ACT
Notice of annual increase of Health Canada’s veterinary drug fees
Notice is hereby given, under section 17.1 of the Service Fees Act (a fee is adjusted in each fiscal year, on the anniversary of a date that is selected by the responsible authority with respect to the fee before the first adjustment, by the percentage change over 12 months in the April All-items Consumer Price Index for Canada, as published by Statistics Canada under the Statistics Act, for the previous fiscal year), that every fee outlined in the Veterinary Drug Evaluation Fees Regulations, the Establishment Licensing Fees (Veterinary Drugs) Regulations, the Licensed Dealers for Controlled Drugs and Narcotics (Veterinary Use) Fees Regulations, and the Authority to Sell Veterinary Drugs Fees Regulations is to be increased by 2.2%. Health Canada has chosen April 1 as the anniversary date.
The current fees and the fees updated as of April 1, 2019, are listed below.
Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or hc.cro-brc.sc@canada.ca (email).
Fee Category | Fees as of April 1, 2018 | Fees as of April 1, 2019 | |
---|---|---|---|
Veterinary Drug Evaluation Fees | |||
Item | New drug submission | ||
1 | Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in one animal species. (In the case of an antiparasitic drug, several indications in one food animal species). | $15,980.00 | $16,331.56 |
2 | Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species. | $9,680.00 | $9,892.96 |
3 | Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration, dosage form and two indications in one animal species. | $23,240.00 | $23,751.28 |
4 | Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species. | $31,470.00 | $32,162.34 |
5 | Comparative (pharmacodynamics, clinical or bioavailability) data to support an additional route of administration. | $2,900.00 | $2,963.80 |
6 | Comparative (pharmacodynamics, clinical or bioavailability) data to support each additional strength. | $480.00 | $490.56 |
7 | For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species. | $21,790.00 | $22,269.38 |
8 | For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species. | $29,050.00 | $29,689.10 |
9 | For food-producing animals, residue depletion studies to establish a withdrawal period for an additional dosage form, dosage or route of administration. | $2,900.00 | $2,963.80 |
10 | For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in an additional species. | $14,520.00 | $14,839.44 |
11 | Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug. | $4,840.00 | $4,946.48 |
12 | Chemistry and manufacturing data to support one strength of a single dosage form. | $4,840.00 | $4,946.48 |
13 | Chemistry and manufacturing data to support an additional strength of a single dosage form submitted at the same time as item 12. | $2,420.00 | $2,473.24 |
14 | Documentation to support a change of manufacturer. | $250.00 | $255.50 |
Supplement to a new drug submission | |||
1 | Efficacy data to support an additional indication in one animal species. | $12,590.00 | $12,866.98 |
2 | Efficacy and safety data (in the intended species) to support a single route of administration and dosage form for an antiparasitic drug in one non-food animal species. | $9,680.00 | $9,892.96 |
3 | Efficacy and safety data (in the intended species) to support an indication in another animal species. | $15,980.00 | $16,331.56 |
4 | Efficacy and safety data (in the intended species) to support a single route of administration, dosage form and indication in two animal species, or a single route of administration and dosage form and two indications in one animal species. | $23,240.00 | $23,751.28 |
5 | Efficacy and safety data (in the intended species) to support a growth promotion or production enhancement indication in one animal species. | $31,470.00 | $32,162.34 |
6 | Efficacy and safety data (in the intended species) to support the concurrent use of two drugs approved for the same animal species. | $7,740.00 | $7,910.28 |
7 | Comparative (pharmacodynamics, clinical or bioavailability) data to support an additional route of administration. | $2,900.00 | $2,963.80 |
8 | Comparative (pharmacodynamics, clinical or bioavailability) data to support each additional strength. | $480.00 | $490.56 |
9 | For food-producing animals, residue depletion studies to establish a new withdrawal period for a change in the dosage or route of administration of an approved dosage form in one species. | $2,900.00 | $2,963.80 |
10 | For food-producing animals, metabolism and residue depletion studies to establish a maximum residue limit and a withdrawal period for a single dosage and route of administration of an approved dosage form in an additional species. | $14,520.00 | $14,839.44 |
11 | For food-producing animals, toxicity studies to support a change of an established acceptable daily intake, maximum residue limit and withdrawal period. | $7,260.00 | $7,419.72 |
12 | For the concurrent use of two drugs in a species of food-producing animals, residue depletion studies to determine if an extension to existing withdrawal periods is required. | $5,810.00 | $5,937.82 |
13 | Chemistry and manufacturing data to support a change in the source of a medicinal ingredient or its manufacturing process. | $4,840.00 | $4,946.48 |
14 | Chemistry and manufacturing data to support a change in formulation or dosage form. | $2,420.00 | $2,473.24 |
15 | Chemistry and manufacturing data to support a change in packaging or in the sterilization process. | $1,930.00 | $1,972.46 |
16 | Chemistry and manufacturing data to support an extension of the expiry dating. | $1,450.00 | $1,481.90 |
17 | Chemistry and manufacturing data to support the concurrent use of two drugs. | $1,450.00 | $1,481.90 |
18 | Chemistry and manufacturing data to support a change in the manufacturing site for parenteral dosage forms. | $480.00 | $490.56 |
19 | Documentation to support a change to the name of a manufacturer or the brand name of a drug. | $250.00 | $255.50 |
Abbreviated new drug submission and supplement to an abbreviated new drug submission | |||
1 | Comparative (pharmacodynamics, clinical or bioavailability) data to support a single route of administration and dosage form. | $2,900.00 | $2,963.80 |
2 | For food-producing animals, residue depletion studies to confirm that the withdrawal period(s) for each species falls within the conditions of use for the Canadian reference product. | $2,900.00 | $2,963.80 |
3 | Chemistry and manufacturing data for a non-compendial medicinal ingredient of a drug. | $4,840.00 | $4,946.48 |
4 | Chemistry and manufacturing data to support a single dosage form. | $4,840.00 | $4,946.48 |
5 |
Documentation to support
|
$250.00 | $255.50 |
Drug identification number application | |||
1 | Information, other than that referred to in item 2, to support an application for a number, including the submission of labelling material for a second review, if required. | $720.00 | $735.84 |
2 | Published references or other data. | $500.00 | $511.00 |
3 | Documentation to support a change of manufacturer, a change to the name of a manufacturer or a change to the brand name of a drug. | $250.00 | $255.50 |
Preclinical new drug submission | |||
1 | Efficacy and safety data (in the intended species) and protocol to support the conduct of clinical studies relative to a single dosage form, route of administration and indication in one species. | $4,840.00 | $4,946.48 |
2 | Efficacy data and protocol to support the conduct of clinical studies relative to a single route of administration and indication with a dosage form for which a notice of compliance has been issued for use in the species to be treated. | $3,870.00 | $3,955.14 |
3 | For food-producing animals, toxicity, metabolism and residue depletion studies to establish a temporary acceptable daily intake, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species. | $14,520.00 | $14,839.44 |
4 | For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species. | $21,790.00 | $22,269.38 |
5 | For food-producing animals, toxicity, metabolism and residue depletion studies to establish an acceptable daily intake with a safety factor of less than 1,000, a maximum residue limit and a withdrawal period for a single dosage form, dosage and route of administration in one species. | $29,050.00 | $29,689.10 |
6 | For food-producing animals (once an acceptable daily intake with a safety factor of 1,000 or less has been established), metabolism studies to establish a withdrawal period for a single dosage form, dosage and route of administration in an additional species. | $7,260.00 | $7,419.72 |
7 | Chemistry and manufacturing data to support a single dosage form containing a non-compendial medicinal ingredient. | $4,840.00 | $4,946.48 |
8 | Chemistry and manufacturing data to support a single dosage form containing a compendial medicinal ingredient. | $2,420.00 | $2,473.24 |
Notifiable change or protocol review | |||
1 | Information and material to support an application for notifiable change. | $1,300.00 | $1,300.00 |
2 | Request for review of scientific information outside of a regular drug submission (i.e. review of a proposed trial protocol). | $1,300.00 | $1,300.00 |
Experimental studies certificate | |||
1 | Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a non-food-producing animal. | $960.00 | $981.12 |
2 | Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that for a previously authorized experimental studies certificate for a drug to be administered to a non-food-producing animal. | $480.00 | $490.56 |
3 | Information and material to support the issuance of an experimental studies certificate for a drug to be administered to a food-producing animal. | $2,900.00 | $2,963.80 |
4 | Information and material to support the issuance of an experimental studies certificate whose protocol is the same as that for a previously authorized experimental studies certificate for a drug to be administered to a food-producing animal. | $480.00 | $490.56 |
Emergency drug sale | |||
1 | Information and material to support the sale of a drug to be used in the emergency treatment of a non-food-producing animal. | $50.00 | $51.10 |
2 | Information and material to support the sale of a drug to be used in the emergency treatment of a food-producing animal. | $100.00 | $102.20 |
Veterinary Drug Establishment Licence Fees Good Manufacturing Practices Component A. Fabrication |
|||
Basic fee | $6,000.00 | $6,132.00 | |
Each additional category | $1,500.00 | $1,533.00 | |
Dosage form classes: | |||
2 classes | $3,000.00 | $3,066.00 | |
3 classes | $6,000.00 | $6,132.00 | |
4 classes | $7,500.00 | $7,665.00 | |
5 classes | $9,000.00 | $9,198.00 | |
6 classes | $10,500.00 | $10,731.00 | |
Each additional class | $600.00 | $613.20 | |
Sterile dosage forms | $3,000.00 | $3,066.00 | |
B. Packaging/Labelling | |||
Basic fee | $4,000.00 | $4,088.00 | |
Each additional category | $1,000.00 | $1,022.00 | |
Dosage form classes: | |||
2 classes | $2,000.00 | $2,044.00 | |
3 or more classes | $3,000.00 | $3,066.00 | |
C. Importation/Distribution | |||
Basic fee | $2,500.00 | $2,555.00 | |
Each additional category | $625.00 | $638.75 | |
Dosage form classes: | |||
2 classes | $1,250.00 | $1,277.50 | |
3 or more classes | $2,500.00 | $2,555.00 | |
Each fabricator | $600.00 | $613.20 | |
Each additional dosage form class for each fabricator | $300.00 | $306.60 | |
D. Distribution and Wholesaling | |||
Distribution and wholesaling fee | $1,500.00 | $1,533.00 | |
E. Testing | |||
Testing fee | $1,000.00 | $1,022.00 | |
Drug Analysis Component | |||
Drug identification numbers for veterinary use | $250.00 | $255.50 | |
Dealer’s Licence | |||
Dealer’s licence | $1,750.00 | $1,788.50 | |
Fees For Right To Sell Veterinary Drugs | |||
Annual fee | $250.00 | $255.50 |
DEPARTMENT OF HEALTH
HAZARDOUS MATERIALS INFORMATION REVIEW ACT
Filing of claims for exemption
Pursuant to paragraph 12(1)(a) of the Hazardous Materials Information Review Act, the Chief Screening Officer hereby gives notice of the filing of the claims for exemption listed below.
In accordance with subsection 12(2) of the Hazardous Materials Information Review Act, affected parties, as defined, may make written representations to the screening officer with respect to the claim for exemption and the safety data sheet (SDS) or label to which it relates. Written representations must cite the appropriate registry number, state the reasons and evidence upon which the representations are based and be delivered within 30 days of the date of the publication of this notice in the Canada Gazette, Part I, to the screening officer at the following address: Workplace Hazardous Materials Bureau, 269 Laurier Avenue West, 8th Floor (4908-B), Ottawa, Ontario K1A 0K9.
Véronique Lalonde
Chief Screening Officer
On February 11, 2015, the Hazardous Products Act (HPA) was amended, and the Controlled Products Regulations (CPR) and the Ingredient Disclosure List were repealed and replaced with the new Hazardous Products Regulations (HPR). The revised legislation (HPA/HPR) is referred to as WHMIS 2015.
The claims listed below seek an exemption from the disclosure of supplier confidential business information in respect of a hazardous product; such disclosure would otherwise be required under the provisions of the relevant legislation.
Claimant | Product Identifier | Subject of the Claim for Exemption | Registry Number |
---|---|---|---|
Xypex Chemicals Corporation | Xypex Concentrate | C. of two ingredients C.i. and C. of three ingredients | 12366 |
Xypex Chemicals Corporation | Xypex Modified | C. of two ingredients C.i. and C. of three ingredients | 12367 |
Xypex Chemicals Corporation | Xypex Patch’n Plug | C. of two ingredients C.i. and C. of three ingredients | 12368 |
BASF Canada Inc. | Inoterra DWE | C.i. and C. of one ingredient C.i. of one ingredient | 12369 |
GREENSOLV Inc. (Produits Environnementaux Greensolv inc.) | GREENSOLV 294WL | C.i. and C. of four ingredients | 12370 |
Fluid Energy Group Ltd. | Enviro-Syn® HCR-7000FRAC | C.i. and C. of one ingredient | 03319747 |
Fluid Energy Group Ltd. | Enviro-Syn® HCR-7000FRAC-WL | C.i. and C. of one ingredient | 03319912 |
Power Service Products | DIESEL FUEL SUPPLEMENT + CETANE BOOST 1:400 Treatment Ratio | C.i. of eight ingredients | 03320727 |
Power Service Products | DIESEL FUEL SUPPLEMENT + CETANE BOOST 1:1,000 Treatment Ratio | C.i. of thirteen ingredients | 03320726 |
Power Service Products | DIESEL FUEL SUPPLEMENT + CETANE BOOST 1:1,500 Treatment Ratio | C.i. of fourteen ingredients | 03320725 |
Power Service Products | DIESEL KLEEN + CETANE BOOST 1:400 Treatment Ratio | C.i. of nine ingredients | 03320723 |
Power Service Products | DIESEL KLEEN + CETANE BOOST 1:1,000 Treatment Ratio | C.i. of nine ingredients | 03320722 |
Power Service Products | DIESEL KLEEN + CETANE BOOST 1:1,500 Treatment Ratio | C.i. of nine ingredients | 03320720 |
ROMIX, Inc. | BACK-SET MOLECULAR CEMENT DISSOLVER | C.i. and C. of one ingredient | 03320950 |
Imperial Oil Limited | VALVE GREASE NO.1 | C.i. and C. of one ingredient | 03320737 |
Multi-Chem Production Chemicals Co. (C/O Multi-Chem Group LLC) | RockOn™ MX 5-3447 | C.i. of three ingredients | 03319910 |
BASF Canada Inc. | Irgacor L 844 | C.i. and C. of one ingredient | 03319808 |
Fluid Energy Group Ltd. | Enviro-Syn® HCR-2000CEF | C.i. and C. of one ingredient | 03319909 |
BASF Canada Inc. | Irgalube 875 | C.i. of one ingredient | 03319809 |
Ecolab Co. | Ultrasil 09 | C.i. of one ingredient | 03320190 |
Canadian Energy Services LP | ENERSCAV C | C.i. and C. of one ingredient | 03321522 |
Integrity Bio-Chem | CleanSurf™ 55 | C.i. and C. of one ingredient | 03320815 |
Covestro LLC | DESMODUR WP 260 | C.i. and C. of one ingredient C. of one ingredient | 03320730 |
Flotek Chemistry | EZ Mulse | C.i. and C. of one ingredient | 03320862 |
Nalco Canada ULC | PARA01532A | C.i. and C. of one ingredient | 03320238 |
Nalco Canada ULC | MNE6200 | C.i. and C. of five ingredients | 03321150 |
Nalco Canada ULC | PARA01570A | C.i. and C. of one ingredient | 03321198 |
Nalco Canada ULC | DURASOFT™ 64870 | C.i. of two ingredients | 03321047 |
SUEZ Water Technologies & Solutions Canada | SPEC-AID 8Q107ULS | C.i. and C. of one ingredient | 03321005 |
SUEZ Water Technologies & Solutions Canada | PROSWEET S1791 | C.i. and C. of one ingredient | 03321485 |
SUEZ Water Technologies & Solutions Canada | PETROFLO 20Y99 | C.i. and C. of two ingredients | 03321004 |
SUEZ Water Technologies & Solutions Canada | PHILMPLUS 5K35 | C.i. and C. of three ingredients | 03321486 |
SUEZ Water Technologies & Solutions Canada | STYREX40 | C.i. and C. of one ingredient | 03321003 |
SUEZ Water Technologies & Solutions Canada | STYREX50 | C.i. and C. of one ingredient | 03321000 |
SUEZ Water Technologies & Solutions Canada | PETROFLO 20Y98 | C.i. and C. of two ingredients | 03320998 |
Covestro LLC | SOFTCEL POLYOL VE-1500 | C.i. and C. of one ingredient | 03321185 |
Covestro LLC | SOFTCEL POLYOL VE-1800 | C.i. and C. of one ingredient | 03321184 |
Nalco Canada ULC | ENTERFAST™ EC9008B | C.i. of one ingredient | 03321066 |
WD-40 Company (Canada) Ltd. | 3-IN-ONE® RVcare Rubber Seal Conditioner | C.i. of one ingredient | 03321767 |
Nalco Canada ULC | NALCO® EC1436A | C.i. of two ingredients | 03321073 |
Nalco Canada ULC | Clar10650A | C.i. of one ingredient | 03321187 |
Evonik Canada Inc. | Protectosil® CHEM-TRETE® PB 100 | C.i. and C. of two ingredients and one toxicological study | 03321312 |
Integrity Bio-Chem | CleanSurf™ 55W | C.i. of one ingredient | 03321656 |
SUEZ Water Technologies & Solutions Canada | GENGARD GN8020 | C.i. and C. of one ingredient | 03321738 |
SUEZ Water Technologies & Solutions Canada | GENGARD GN8220 | C.i. and C. of one ingredient | 03321739 |
SUEZ Water Technologies & Solutions Canada | GENGARD GN8221 | C.i. and C. of one ingredient | 03321740 |
SUEZ Water Technologies & Solutions Canada | GENGARD GN8222 | C.i. and C. of one ingredient | 03321741 |
SUEZ Water Technologies & Solutions Canada | GENGARD GN8224 | C.i. and C. of one ingredient | 03321742 |
SUEZ Water Technologies & Solutions Canada | GENGARD GN8225 | C.i. and C. of one ingredient | 03321744 |
SUEZ Water Technologies & Solutions Canada | GENGARD GN8240 | C.i. and C. of one ingredient | 03321745 |
SUEZ Water Technologies & Solutions Canada | GENGARD GN8021 | C.i. and C. of one ingredient | 03321746 |
Note: C.i. = chemical identity and C. = concentration
DEPARTMENT OF HEALTH
PATENT ACT
Notice of annual increase of fees pursuant to the Certificate of Supplementary Protection Regulations
Notice is hereby given that, in keeping with subsection 9(1) of the Certificate of Supplementary Protection Regulations, the fee will increase by the annual 2% amount, rounded up to the nearest dollar.
The current fee and the fee updated as of April 1, 2019, are listed below.
Any inquiries or comments about the updated fees can be directed to Etienne Ouimette, Director General, Resource Management Operations Directorate, Health Products and Food Branch, 613‑957‑6690 (telephone) or hc.cro-brc.sc@canada.ca (email).
Subsection in Certificate of Supplementary Protection Regulations | Fee as of April 1, 2018 | Fee as of April 1, 2019 | |
---|---|---|---|
Certificate of Supplementary Protection | 9(1) | $9,192 | $9,376 |
DEPARTMENT OF TRANSPORT
CANADA TRANSPORTATION ACT
Levy on shipments of crude oil by rail
Pursuant to subsection 155.4(4) footnote * of the Canada Transportation Act (the Act), the amount of the levy in respect of payments into the Fund for Railway Accidents Involving Designated Goods required by subsection 155.7(1)footnote * of the Act is $1.76 per tonne during the year commencing April 1, 2019.
March 4, 2019
Marc Garneau, P.C., M.P.
Minister of Transport
INNOVATION, SCIENCE AND ECONOMIC DEVELOPMENT CANADA
RADIOCOMMUNICATION ACT
Notice No. SMSE-003-19 — Release of Decision on the Technical and Policy Framework for White Space Devices and Decision on the Technical, Policy and Licensing Framework for Wireless Microphones
Notice is hereby given that Innovation, Science and Economic Development Canada (ISED) has published the following decisions:
- Decision on the Technical and Policy Framework for White Space Devices
- Decision on the Technical, Policy and Licensing Framework for Wireless Microphones
These decisions respectively address spectrum utilization by white space devices in the very high frequency and ultra-high frequency ranges, and wireless microphones in the ultra-high frequency and super high frequency ranges.
Obtaining copies
Copies of this notice and of documents referred to herein are available electronically on the Spectrum Management and Telecommunications website.
Official versions of notices can be viewed on the Canada Gazette website.
March 2019
Martin Proulx
Director General
Engineering, Planning and Standards Branch
OFFICE OF THE SUPERINTENDENT OF FINANCIAL INSTITUTIONS
BANK ACT
Silicon Valley Bank — Order to commence and carry on business in Canada
Notice is hereby given of the issuance, pursuant to subsection 534(1) of the Bank Act, of an order authorizing a foreign bank, Silicon Valley Bank, to commence and carry on business in Canada, effective February 27, 2019. The foreign bank is permitted to carry on business in Canada under the name, in English, Silicon Valley Bank and, in French, Banque Silicon Valley.
March 12, 2019
Jeremy Rudin
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 |
---|---|---|
Chief Administrator | Administrative Tribunals Support Service of Canada | |
Chairperson | Asia-Pacific Foundation of Canada | |
Chairperson | Canada Development Investment Corporation | |
Chairperson | Canada Foundation for Sustainable Development Technology | |
Chairperson and Vice-Chairperson | Canada Industrial Relations Board | |
Chairperson | Canada Lands Company Limited | |
President and Chief Executive Officer | Canada Lands Company Limited | |
Chairperson (joint federal Governor in Council and provincial Lieutenant Governor appointment) | Canada–Newfoundland and Labrador Offshore Petroleum Board | |
Chairperson | Canada Science and Technology Museum | |
Vice-Chairperson | Canada Science and Technology Museum | |
Board Member (Anticipatory) | Canadian Accessibility Standards Development Organization | |
Chairperson (Anticipatory) | Canadian Accessibility Standards Development Organization | |
Chief Executive Officer (Anticipatory) | Canadian Accessibility Standards Development Organization | |
Vice-Chairperson (Anticipatory) | Canadian Accessibility Standards Development Organization | |
President and Chief Executive Officer | Canadian Commercial Corporation | |
Chairperson | Canadian Dairy Commission | |
Chairperson, Vice-Chairperson and Director | Canadian Energy Regulator | |
Chief Executive Officer (Anticipatory) | Canadian Energy Regulator | |
Lead Commissioner, Deputy Lead Commissioner and Commissioner | Canadian Energy Regulator | |
Pay Equity Commissioner | Canadian Human Rights Commission | |
Chairperson | Canadian Institutes of Health Research | |
Vice-Chairperson | Canadian Museum of Nature | |
Permanent Member | Canadian Nuclear Safety Commission | |
Regional Member (Quebec) | Canadian Radio-television and Telecommunications Commission | |
Chairperson and Member | Canadian Statistics Advisory Council | |
President (Chief Executive Officer) | Canadian Tourism Commission | |
President and Chief Executive Officer | Defense Construction (1951) Limited | |
Chairperson | Farm Credit Canada | |
President and Chief Executive Officer | Farm Credit Canada | |
Vice-Chairperson | Farm Products Council of Canada | |
Chairperson | The Federal Bridge Corporation Limited | |
Commissioner | Financial Consumer Agency of Canada | |
Chairperson | First Nations Financial Management Board | |
Chief Commissioner | First Nations Tax Commission | |
Deputy Chief Commissioner | First Nations Tax Commission | |
Director | Freshwater Fish Marketing Corporation | |
Director (Federal) | Hamilton Port Authority | |
Sergeant-at-Arms and Corporate Security Office | House of Commons | |
Member | International Authority | |
Commissioner and Chairperson | International Joint Commission | |
Member (appointment to roster) | International Trade and International Investment Dispute Settlement Bodies | |
Vice-Chairperson | Invest in Canada Hub | |
Chief Executive Officer | The Jacques Cartier and Champlain Bridges Incorporated | |
Librarian and Archivist of Canada | Library and Archives of Canada | |
President and Chief Executive Officer | Marine Atlantic Inc. | |
Vice-Chairperson | National Arts Centre Corporation | |
Member | National Capital Commission | |
Government Film Commissioner | National Film Board | |
Chairperson | National Research Council of Canada | |
President | Natural Sciences and Engineering Research Council of Canada | |
Canadian Ombudsperson | Office of the Canadian Ombudsperson for Responsible Enterprise | |
Chief Accessibility Officer (Anticipatory) | Office of the Chief Accessibility Officer | |
Ombudsperson | Office of the Ombudsperson for National Defence and Canadian Forces | |
Director (Federal) | Oshawa Port Authority | |
Chairperson | Pacific Pilotage Authority | |
Chief Executive Officer | Parks Canada | |
Vice-Chairperson and Member | Patented Medicine Prices Review Board | |
Member | Payment in Lieu of Taxes Dispute Advisory Panel | |
Commissioner | Public Service Commission | |
Member and Alternate Member | Renewable Resources Board (Gwich’in) | |
Member and Alternate Member | Renewable Resources Board (Sahtu) | |
Chairperson and Vice-Chairperson | Royal Canadian Mounted Police External Review Committee | |
Principal | Royal Military College of Canada | |
Vice-Chairperson (all streams) | Social Security Tribunal of Canada | |
Chairperson | Telefilm Canada | |
Member (Marine and Medical) | Transportation Appeal Tribunal of Canada | |
President and Chief Executive Officer | VIA Rail Canada Inc. |
BANK OF CANADA
ASSETS | Amount | Total |
---|---|---|
Cash and foreign deposits | 17.8 | |
Loans and receivables | ||
Securities purchased under resale agreements | 9,709.8 | |
Advances | — | |
Other receivables | 4.0 | |
9,713.8 | ||
Investments | ||
Treasury bills of Canada | 23,828.1 | |
Canada Mortgage Bonds | 252.3 | |
Government of Canada bonds | 79,490.0 | |
Other investments | 431.5 | |
104,001.9 | ||
Capital assets | ||
Property and equipment | 599.8 | |
Intangible assets | 46.4 | |
Right-of-use leased assets | 53.7 | |
699,9 | ||
Other assets | 187.7 | |
Total assets | 114,621.1 |
LIABILITIES AND EQUITY | Amount | Total |
---|---|---|
Bank notes in circulation | 86,328.4 | |
Deposits | ||
Government of Canada | 23,730.3 | |
Members of Payments Canada | 250.4 | |
Other deposits | 3,018.8 | |
26,999.5 | ||
Securities sold under repurchase agreements | — | |
Other liabilities | 769.7 | |
114,097.6 | ||
Equity | ||
Share capital | 5.0 | |
Statutory and special reserves | 125.0 | |
Investment revaluation reservefootnote 1* | 393.5 | |
523.5 | ||
Total Liabilities and Equity | 114,621.1 |
I declare that the foregoing statement is correct according to the books of the Bank.
Ottawa, March 15, 2019
Carmen Vierula
Chief Financial Officer and Chief Accountant
I declare that the foregoing statement is to the best of my knowledge and belief correct, and shows truly and clearly the financial position of the Bank, as required by section 29 of the Bank of Canada Act.
Ottawa, March 15, 2019
Stephen S. Poloz
Governor