Certain Products Containing Toxic Substances Regulations

Certain Products Containing Toxic Substances Regulations Whereas, under subsection 332(1)a of the Canadian Environmental Protection Act, 1999b, the Minister of the Environment published in the Canada Gazette, Part I, on November 18, 2023, a copy of the proposed Certain Products Containing Toxic Substances Regulations, and persons were given an opportunity to file comments with respect to the proposed Regulations or to file a notice of objection requesting that a board of review be established and stating the reasons for the objection; S.C. 2023, c. 12, s. 55 S.C. 1999, c. 33 Whereas, under subsection 93(3) of that Act, the National Advisory Committee has been given an opportunity to provide its advice under section 6c of that Act; S.C. 2015, c. 3, par. 172(d) And whereas, in the opinion of the Governor in Council, under subsection 93(4) of that Act, the proposed Regulations do not regulate an aspect of a substance that is regulated by or under any other Act of Parliament in a manner that provides, in the opinion of the Governor in Council, sufficient protection to the environment and human health; Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, makes the annexed Certain Products Containing Toxic Substances Regulations under subsection 93(1)d of the Canadian Environmental Protection Act, 1999b. S.C. 2023, c. 12, ss. 33(1) to (6) Definition of regulated product For the purposes of these Regulations, regulated product means a product that belongs to a product category specified in section 13, 17 or 21 and that contains the toxic substance that is specified both in that section and on the list of toxic substances in Schedule 1 of the Canadian Environmental Protection Act, 1999. Product category For the purposes of these Regulations, a product belongs to a product category if, according to information on its container or included in any documentation relating to the product that is made available by the manufacturer or importer or their authorized representative, the product may be used as a product that belongs to that category. Non-application These Regulations do not apply to waste or a product that is at the end of its useful life and that is to be recycled. Application A manufacturer or importer who wishes to obtain a permit referred to in paragraph 14(a), 18(a) or 22(b) must submit an application to the Minister in accordance with sections 8 and 9 that contains the following information and documents: respecting the applicant, their name, civic and postal addresses, telephone number, email address and, if any, business number assigned by the Minister of National Revenue, and if applicable, the name, title, civic and postal addresses, telephone number and email address of their duly authorized representative; respecting the regulated product, its common or generic name and, if any, trade name and trademark, the product category, any information establishing that the regulated product belongs to that category and the part of these Regulations that applies in respect of the product, the total quantity and concentration of the toxic substance contained in the regulated product and the units of measurement used to express that quantity and concentration, the estimated quantity of the regulated product to be manufactured, imported or sold, as the case may be, by the applicant in each calendar year of the validity period of the permit requested under paragraph (e) and, if applicable, the unit of measurement used to express that quantity, and an identification and description of its intended use and any of its other potential uses; evidence — along with all supporting documents — that, at the time of the application, it is not technically or economically feasible for the applicant to use an alternative to or a substitute for the regulated product or the toxic substance contained in the regulated product that achieves a similar result as would be achieved by using the toxic substance, and has a less harmful effect on the environment or on human health than the toxic substance; a plan that identifies and describes the measures that the applicant will take to minimize or eliminate any harmful effect that the toxic substance contained in the regulated product has or may have on the environment and human health, including measures to ensure that the toxic substance is handled and transported safely and is not released into the environment during normal use of the regulated product and at the end of its useful life, and the measures that the applicant will take to, within a stated period, eliminate the toxic substance contained in the regulated product or reduce its concentration to the point that these Regulations no longer apply to the product; and the requested validity period for the permit which must not exceed three years with reasons for that requested period. Clarifications The Minister may, on receiving the application, require any clarifications respecting the information or documents provided that are necessary for the application to be processed. Notice of change to information The applicant must notify the Minister in accordance with sections 8 and 9 of any change to the information and documents provided under this section and must do so within 30 days after the day on which the change occurs. Issuance The Minister may issue only one permit per regulated product to each applicant. Conditions Subject to subsection (3), the Minister must issue the permit if the following conditions are met: the applicant has established that, at the time of the application, it is not technically or economically feasible for them to use an alternative to or a substitute for the regulated product or the toxic substance contained in the regulated product that has a less harmful effect on the environment or on human health than the toxic substance; and the applicant has submitted the plan referred to in paragraph 3(1)(d) and that plan identifies and describes measures that can reasonably be considered to minimize or eliminate any harmful effect that the toxic substance contained in the regulated product has or may have on the environment and human health, including measures to ensure that the toxic substance is handled and transported safely and is not released into the environment during normal use of the regulated product and at the end of its useful life, and measures that can reasonably be considered to, within a stated period, eliminate the toxic substance contained in the product or reduce its concentration to the point that these Regulations no longer apply to the product. Refusal The Minister must refuse to issue a permit if the Minister has reasonable grounds to believe that the applicant has provided false or misleading information in support of their application; the information and documents required under section 3 have not been provided or are insufficient to enable the Minister to process the application; or the Minister has reasonable grounds to believe that, if the permit were issued, the manufacturing, importing or selling, as the case may be, of the regulated product would pose a threat of serious or irreversible damage to the environment or human health or would not contribute to sustainable development. Expiry Unless the permit is renewed under subsection 5(3), it expires on the day indicated in the permit, which must not be later than three years after the day on which the permit is issued. Renewal of permit A permit may be renewed only once and for a period of not more than three years. Renewal application A renewal application must be submitted in accordance with section 3 at least 90 days before the day on which the permit expires and must contain the information and documents specified in paragraphs 3(1)(a) to (e); the permit number; the actual quantity of the regulated product that was manufactured, imported or sold, as the case may be, by the applicant in each calendar year of the validity period of the permit and, if applicable, the unit of measurement used to express that quantity; and information about the implementation of the plan that was contained in the original application for a permit under paragraph 3(1)(d), including — if that plan was not fully implemented — an explanation of why it was not fully implemented and how the applicant will ensure that the plan contained in the renewal application will be fully implemented within the period referred to in subparagraph 3(1)(d)(ii) . Renewal or refusal The Minister must renew the permit if the conditions set out in paragraphs 4(2)(a) and (b) are met and must refuse to renew the permit in any of the circumstances set out in paragraphs 4(3)(a) to (c). Grounds for revocation The Minister must revoke a permit if the permit holder requests the revocation; the Minister has reasonable grounds to believe that the permit holder has provided false or misleading information; or the permit holder has not, for reasons within their control and to the extent feasible, implemented the plan that was contained in the permit application. Conditions for revocation Before revoking a permit, the Minister must provide the permit holder with written reasons and an opportunity to make written representations concerning the revocation. Accredited laboratory Any analysis performed to determine the concentration of a toxic substance for the purposes of these Regulations must be performed by a laboratory that meets the following conditions at the time of the analysis: it is accredited under the International Organization for Standardization standard ISO/IEC 17025, entitled General requirements for the competence of testing and calibration laboratories, by an accrediting body that is a signatory to the International Laboratory Accreditation Cooperation Mutual Recognition Arrangement, or under the Environment Quality Act, CQLR, c. Q-2; and subject to subsection (2), the scope of its accreditation includes the analysis performed to determine the concentration of the toxic substance. Standards of good practice If no method has been recognized by a standards development organization in respect of the analysis performed to determine the concentration of the toxic substance and the scope of the laboratory’s accreditation does not therefore include that analysis, the analysis must be performed in accordance with standards of good scientific practice that are generally accepted at the time that it is performed. Certification Any information or document that is submitted to the Minister under these Regulations must be accompanied by a certification, dated and signed by the individual submitting the information or document, or by their authorized representative, stating that the information or document is accurate and complete. Electronic submission Any information or document submitted to the Minister under these Regulations must be submitted electronically in a format that is compatible with the format used by the Minister. Electronic signature If the certification referred to in section 8 is submitted electronically, it may be signed electronically. Paper submission Despite subsection (1), if it is not feasible for a person to submit information or a document electronically in accordance with that subsection due to circumstances beyond their control, they may submit the information or document on paper in the format specified by the Minister. If the Minister has not specified a format, the person may submit the information or document in any format. Records Subject to sections 16 and 20, the following persons must maintain records: any person who manufactures or imports a regulated product; and any person who sells a regulated product for export only. Information The records must be maintained in English or French or both languages and must contain the following information and all supporting documents: in the case of a manufacturer, the regulated product’s common or generic name and, if any, trade name and trademark, the product category to which the regulated product belongs, any information establishing that the regulated product belongs to that category, the part of these Regulations that applies in respect of the product and, if the regulated product is an aerosol or liquid, or if it is in a pump-spray container, a statement to that effect, the date of the regulated product’s manufacture, the quantity of the regulated product manufactured at each manufacturing plant and, if applicable, the unit of measurement used to express that quantity, the total quantity and concentration of the toxic substance contained in the regulated product and the units of measurement used to express that quantity and concentration, and if applicable, the results of any analysis conducted to determine the concentration of the toxic substance in the regulated product, either as diluted in accordance with the manufacturer’s written instructions — in the case of a product that is to be diluted — or as it is manufactured, as well as any supporting documents related to the analysis and the name and civic address of the laboratory that performed the analysis; in the case of an importer, the product category to which the regulated product belongs, any information establishing that the regulated product belongs to that category, the part of these Regulations that applies in respect of the product and, if the product is an aerosol or liquid, or if it is in a pump-spray container, a statement to that effect, the date on which the regulated product was imported and the port of entry, the quantity of the regulated product imported and, if applicable, the unit of measurement used to express that quantity, if applicable, the results of any analysis conducted to determine the concentration of the toxic substance in the regulated product, either as diluted in accordance with the manufacturer’s written instructions — in the case of a product that is to be diluted — or as it is manufactured, as well as any supporting documents related to the analysis and the name and civic address of the laboratory that performed the analysis, the name, civic and postal addresses, telephone number and email address of the principal place of business of the shipper, the Harmonized Commodity Description and Coding System number for the regulated product, as set out in the Customs Tariff, and the business number assigned to the importer by the Minister of National Revenue; and in the case of a person who sells a regulated product, the quantity of the regulated product sold and, if applicable, the unit of measurement used to express that quantity, and the date of sale of the regulated product. Timeline The records must be made no later than 30 days after the day on which the information or documents become available. Retention of records The records must be kept for a period of at least five years after the day on which they are made. Retention of information submitted to Minister Any person who submits information or documents to the Minister under these Regulations must keep a copy of that information or those documents for a period of at least five years after the day on which the information or documents are submitted. Place of retention The records referred to in section 10 and all copies of the information and documents that were submitted to the Minister under these Regulations must be kept at the person’s principal place of business in Canada or at any other place in Canada where they can be inspected. If they are kept at any other place in Canada where they can be inspected, the person must provide the Minister with the civic address of that place. Electronic form Any records, information and documents that are kept electronically must be in a readily readable form. Change of address If the civic address referred to in subsection (1) changes, the person must notify the Minister in accordance with sections 8 and 9 within 30 days after the change. This Part applies in respect of products that belong to any of the following categories of products containing coal tars and their distillates: pavement sealant products; roofing sealant products; and sealant products for industrial use on metal, structural steel or concrete components or on pipelines or other buried services. Manufacture or import A person must not, after October 1, 2025, manufacture or import a product that belongs to any of the categories specified in section 13 unless the person holds a permit issued under subsection 4(2); the product is manufactured for export only; or the product is in transit through Canada, from a place outside Canada to another place outside Canada. Sell A person must not, after December 31, 2025, sell a product that belongs to any of the categories specified in section 13 unless the product was manufactured or imported under a permit issued under subsection 4(2) and the sale occurs no later than one year after the expiry date of the permit; or the product is sold for export only. Temporary exception Despite subsection (1), a person may, until July 1, 2028, sell any product that belongs to the category specified in paragraph 13(c). Delayed application Section 10 does not apply in respect of a product that belongs to any of the categories specified in section 13 until October 1, 2025. This Part applies in respect of products that belong to any of the following categories of products containing polycyclic aromatic hydrocarbons, other than sealant products containing coal tars and their distillates: pavement sealant products; and roofing sealant products. A person must not, after October 1, 2025, manufacture or import a product that belongs to a category specified in section 17 and whose total concentration of polycyclic aromatic hydrocarbons exceeds 1,000 parts per million unless A person must not, after December 31, 2025, sell a product that belongs to a category specified in section 17 and whose total concentration of polycyclic aromatic hydrocarbons exceeds 1,000 parts per million unless Section 10 does not apply in respect of a product that belongs to any of the categories specified in section 17 until October 1, 2025. This Part applies in respect of the products that belong to any categories of products set out in column 1 of the table to this subsection that contain 2-butoxyethanol, which has the molecular formula C6H14O2, and that are for indoor use, except if they are for use in a manufacturing or processing activity; in a commercial activity as paints or coatings, including automobile refinish coatings; as a solvent in a laboratory for analysis; in scientific research; or as a laboratory analytical standard. Definition of cleaner For the purposes of items 6 and 7 of the table to subsection (1), cleaner means a product to be used to degrease and clean glass, floors and other surfaces, including bathroom and kitchen surfaces, but does not include automobile degreasers. A person must not manufacture or import a product that belongs to any of the categories set out in column 1 of the table to subsection 21(1) if its concentration of 2-butoxyethanol exceeds the limit set out in column 2 for that category unless the product is to be diluted before it is used, in accordance with the manufacturer’s written instructions, to a concentration equal to or less than the limit set out in column 2 for that category and that product is either labelled with or accompanied by those instructions in both official languages and those instructions would not result in dilution of the product to a concentration greater than the limit set out in that column for that category; the manufacturer or importer has been issued a permit under subsection 4(2) and, in the case of a product that is to be diluted before it is used, that product is either labelled with or accompanied by the manufacturer’s written dilution instructions in both official languages; A person must not sell a product that belongs to any of the categories set out in column 1 of the table to subsection 21(1) if its concentration of 2-butoxyethanol exceeds the limit set out in column 2 for that category unless the product is to be diluted before it is used, in accordance with the manufacturer’s written instructions, to a concentration equal to or less than the limit set out in column 2 for that category and that product is either labelled with or accompanied by those instructions in both official languages and those instructions would not result in dilution of the product to a concentration greater than the limit set out in that column for that category; or the product was manufactured or imported under a permit issued under subsection 4(2), the sale occurs no later than one year after the expiry date of the permit and, in the case of a product that is to be diluted before it is used, that product is either labelled with or accompanied by the manufacturer’s written dilution instructions in both official languages. Concentration of 2-butoxyethanol The concentration of 2-butoxyethanol contained in a regulated product is determined in accordance with the Reference method for the analysis of 2-butoxyethanol (2-BE) and other glycol ethers (GEs) in selected products (automotive and household cleaners, paints, paint strippers and solvents), published by the Department of the Environment, as it read on the day on which these Regulations came into force. [Amendments] The 2-Butoxyethanol Regulations2 are repealed. SOR/2006-347 Registration These Regulations come into force on the day on which they are registered.