Prohibition of Certain Toxic Substances Regulations, 2012

Prohibition of Certain Toxic Substances Regulations, 2012 Whereas, pursuant to subsection 332(1)a of the Canadian Environmental Protection Act, 1999b, the Minister of the Environment published in the Canada Gazette, Part I, on July 23, 2011, a copy of the proposed Prohibition of Certain Toxic Substances Regulations, 2012, substantially in the annexed form, 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; Whereas, pursuant to 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; And whereas, in the opinion of the Governor in Council, pursuant to 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, His Excellency the Governor General in Council, on the recommendation of the Minister of the Environment and the Minister of Health, pursuant to subsection 93(1) of the Canadian Environmental Protection Act, 1999b, makes the annexed Prohibition of Certain Toxic Substances Regulations, 2012. S.C. 2004, c. 15, s. 31 S.C. 1999, c. 33 S.C. 2002, c. 7, s. 124 Application Subject to sections 2 and 3, these Regulations apply to toxic substances that are both specified in the List of Toxic Substances in Schedule 1 to the Canadian Environmental Protection Act, 1999 and set out in either Schedule 1 or 2 to these Regulations. Non-application — substance These Regulations do not apply to any toxic substance that is contained in a hazardous waste, hazardous recyclable material or non-hazardous waste to which Division 8 of Part 7 of the Canadian Environmental Protection Act, 1999 applies; is contained in a pest control product as defined in subsection 2(1) of the Pest Control Products Act; or is present as a contaminant in a chemical feedstock that is used in a process from which there are no releases of the toxic substance and on the condition that the toxic substance is destroyed or completely converted in that process to a substance that is not a toxic substance set out in either Schedule 1 or 2. Non-application — use These Regulations, except for subsections (2) and (3), do not apply to any toxic substance or to any product containing it that is to be used in a laboratory for analysis, in scientific research or as a laboratory analytical standard. Information to Minister — more than 10 g Every person must submit to the Minister in any calendar year the information set out in Schedule 3 for each toxic substance or a product containing it that they intend to use for a purpose referred to in subsection (1) as soon as feasible before the use of more than 10 g of the substance, by itself or in a product, in that calendar year. The information must be submitted only once in a calendar year in respect of each substance or product. Added substance — Schedule 2.1 Any person that is using a toxic substance set out in column 1 of Schedule 2.1 or a product containing it on the date set out in column 2 in respect of that substance, for a purpose referred to in subsection (1), must, if the quantity of the toxic substance used, by itself or in a product, exceeded 10 g in the calendar year in which that day occurs, submit to the Minister, within 60 days after that day, the information referred to in Schedule 3. The information must be submitted only once in a calendar year in respect of each substance or product. Toxic substance — Schedule 1 Subject to sections 5 and 9, a person must not manufacture, use, sell, offer for sale or import a toxic substance set out in Schedule 1 or a product containing it unless the toxic substance is incidentally present. Non application Subsection (1) does not apply to a product that is a manufactured item that is formed into a specific physical shape or design during its manufacture and that has, for its final use, a function or functions dependent in whole or in part on its shape or design, if a toxic substance set out in Part 2 of Schedule 1 is present in that product. Non-application — certain products Subsection (1) does not apply to products other than those set out in column 2 of Part 3 of Schedule 1 that contain the toxic substance set out in column 1 of that Part. Exception — inventory of substance A person may use, sell or offer for sale a toxic substance set out in item 13 of Part 1 of Schedule 1 that was manufactured or imported before January 1, 2017. Exception — inventory of products A person may use, sell, or offer for sale any product set out in column 2 of Part 3 of Schedule 1 that contains a toxic substance set out in item 13 of Part 1 of Schedule 1 if the product was manufactured or imported before January 1, 2017. Exception — manufactured or imported before March 14, 2013 A person may use, sell or offer for sale a product containing a toxic substance set out in item 11 or 12 of Part 1 of Schedule 1 if the product was manufactured or imported before March 14, 2013. Exception — manufactured or imported before coming into force of subsection A person may use, sell or offer for sale a product containing the toxic substance set out in item 5 of Part 2 of Schedule 1, with the molecular formula C12H(10-n)BrnO in which n=10, if the product was manufactured or imported before the day on which this subsection comes into force. Toxic substance — Schedule 2 Subject to subsections (2) to (2.5) and sections 7 and 9, a person must not manufacture, use, sell, offer for sale or import a toxic substance set out in column 1 of Part 1, 1.1, 1.2, 2, 3 or 3.1 of Schedule 2 or a product containing it unless the toxic substance is incidentally present. Permitted activities — Schedule 2 The prohibition to manufacture, use, sell, offer for sale or import a toxic substance set out in column 1 of Part 1, 2 or 3 of Schedule 2 or a product containing it does not apply if the toxic substance set out in column 1 of Part 1 of Schedule 2 or the product containing it is designed for a use set out in column 2 in respect of that substance; the toxic substance set out in column 1 of Part 2 of Schedule 2 or a product containing it is designed for a use set out in column 2 and that activity occurs before the date set out in column 3; or a product set out in column 2 of Part 3 of Schedule 2 contains the toxic substance set out in column 1 in a concentration less than or equal to that set out in column 3, including any incidental presence of the substance. Permitted use and import — Part 1.1 of Schedule 2 The prohibition to use or import a product containing a toxic substance set out in column 1 of item 1 of Part 1.1 of Schedule 2 does not apply to a product set out in column 2 of that item that contains that substance. Permitted activities — Part 1.1 of Schedule 2 The prohibition to use, sell, offer for sale or import a product containing a toxic substance set out in column 1 of any of items 2 to 5 of Part 1.1 of Schedule 2 does not apply to a product set out in column 2 of those items that contains that substance. Permitted use — Part 1.2 of Schedule 2 The prohibition to use a product containing a toxic substance set out in column 1 of Part 1.2 of Schedule 2 does not apply to a product set out in column 2 that contains that substance. Non-application — manufactured items The prohibition to use, sell, offer for sale or import a product containing a toxic substance set out in column 1 of any of items 2 to 5 of Part 2 of Schedule 2 does not apply to a product that is a manufactured item that is formed into a specific physical shape or design during its manufacture and that has, for its final use, a function or functions dependent in whole or in part on its shape or design. Permitted use — Part 3.1 of Schedule 2 The prohibition to use a product containing a toxic substance set out in column 1 of Part 3.1 of Schedule 2 does not apply to a product set out in column 2 that contains the substance in a concentration less than or equal to that set out in column 3, including any incidental presence of the substance. Exception — incidental presence For greater certainty, the exception of the incidental presence referred to in subsection (1) does not apply in the case of a product described in paragraph (2)(c). Exception — personal use Subsection (1) does not apply to the use or import of a product containing a toxic substance set out in column 1 of Part 2 of Schedule 2 if the product is used or intended to be used for a personal use. [Repealed, SOR/2016-252, s. 5] Exception — temporary permitted uses A person may use, sell, or offer for sale a product set out in column 2 of Part 2 of Schedule 2 containing a toxic substance set out in column 1 of Part 2 of Schedule 2 if the product is manufactured or imported before the expiry date set out in column 3 of Schedule 2. Exception — products A person may use, sell or offer for sale a product containing a toxic substance that is set out in any of items 2 to 5 of Part 2 of Schedule 2, if the product was manufactured or imported before the coming into force of this subsection; or containing a toxic substance that is set out in item 2 of Part 3 of Schedule 2, if the product was manufactured or imported before March 14, 2013. Exception — manufactured items A person may use, sell or offer for sale a product that was manufactured or imported before May 29, 2008 and that contains the toxic substance set out in item 1 of Part 3.1 of Schedule 2 if the product is a manufactured item that was formed into a specific physical shape or design during its manufacture and that has, for its final use, a function or functions dependent in whole or in part on its shape or design. Exception — manufacture or import under permit A person may use, sell or offer for sale a toxic substance or a product containing it, if the substance or the product is manufactured or imported in accordance with a permit that is issued under section 10. Requirement for permit Any person that, on March 14, 2013, is a manufacturer or importer of a toxic substance or a product containing it that is prohibited under section 4 or 6 may continue to manufacture or import the substance or product if they have been issued a permit under section 10. Addition of substance Subject to subsection (3), in the case of a toxic substance that, after March 14, 2013, is either added to Schedule 1 and prohibited under section 4 — other than the toxic substance set out in item 13 of Part 1 of Schedule 1 — or added to Schedule 2 and prohibited under section 6, any person that is a manufacturer or importer of the toxic substance or a product containing it on the date set out in column 2 of Schedule 2.1 in respect of that substance may continue to manufacture or import the substance or a product containing it if they have been issued a permit under section 10. Temporary permitted uses Any person that, under paragraph 6(2)(b), manufactures or imports a toxic substance that is set out in Part 2 of Schedule 2 or a product containing it on the date set out in column 3 in respect of that substance may continue that activity if they have been issued a permit under section 10. Required information An application for a permit must be submitted to the Minister and contain the information referred to in Schedule 4. Issuance Subject to subsection (2), the Minister must issue the permit if the following conditions are met: there is no technically or economically feasible alternative or substitute available to the applicant at the time of the application, other than a substance regulated under these Regulations, for the toxic substance; the applicant has taken the necessary measures to minimize or eliminate any harmful effect of the toxic substance on the environment and human health; and a plan has been prepared respecting the toxic substance identifying the measures that will be taken by the applicant to comply with these Regulations, and the period within which the plan is to be implemented does not exceed three years after the day on which a permit is first issued to the applicant. Grounds for refusing permit 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; or information required under subsection 9(4) has not been provided or is insufficient to enable the Minister to process the application. Expiry and permit renewal A permit expires 12 months after the day on which it is issued unless, at least 30 days before the day on which the permit expires, the applicant submits an application for renewal to the Minister that contains the information referred to in Schedule 4. Limits on renewal A permit may only be renewed twice and subsections (1) and (2) apply to any renewal. Revocation The Minister must revoke a permit if the conditions set out in paragraphs 10(1)(a) to (c) are no longer met or if the Minister has reasonable grounds to believe that the permit holder has provided false or misleading information to the Minister. Conditions for revocation The Minister must not revoke a permit unless the Minister has provided the permit holder with written reasons for the revocation; and an opportunity to be heard, by written representation, in respect of the revocation. Certain substances Every person that manufactures or imports a toxic substance set out in column 1 of Part 4 of Schedule 2 or a product containing it, whether incidentally or not, must submit to the Minister a report that contains the information referred to in Schedule 5 by March 31 following the end of the calendar year during which either the toxic substance or a product containing it was manufactured or imported if, in that year the total annual quantity of the toxic substance manufactured or imported was equal to or greater than that set out in column 2, if any; the product imported contained the toxic substance in an annual weighted average concentration equal to or greater than that set out in column 3, if any; or the total annual quantity of the toxic substance contained in a product manufactured or imported and its annual weighted average concentration in the product were equal to or greater than those set out in column 4, if any. 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 an application for a permit required to be submitted to the Minister under these Regulations must bear the signature of the interested person or their authorized representative and be accompanied by a certification dated and signed by the interested person or the person authorized to act on their behalf, stating that the information is accurate and complete. Writing or electronic format The information, application for a permit and certification may be submitted either in writing or in an electronic format that is compatible with the one that is used by the Minister. Records Every person that submits information to the Minister under these Regulations must keep a record containing a copy of that information, a copy of the certification and any documents supporting the information, including test data if applicable, for a period of at least five years beginning on the date of the submission of the information. Location The records must be kept at the person’s principal place of business in Canada or, on notification to the Minister, at any other place in Canada where the records can be inspected. Records moved If the records are moved, the person must notify the Minister, in writing, of the civic address of the new location within 30 days after the day of the move. Activities prohibited under repealed regulations A permit must not be obtained under these Regulations for an activity that is prohibited under the Prohibition of Certain Toxic Substances Regulations, 2005, the Perfluorooctane Sulfonate and its Salts and Certain Other Compounds Regulations or the Polybrominated Diphenyl Ethers Regulations. [Repeal] Three months after registration These Regulations come into force three months after the day on which they are registered. Staining for microscopic examination, such as immunoperoxidase staining, histochemical staining or cytochemical staining; Reagent for detecting blood in biological fluids; Niacin test to detect certain micro-organisms; and Reagent for detecting chloralhydrate in biological fluids. Adhesives and coatings for aircraft refinishing; and Semiconductor manufacturing process. Photoresists or anti-reflective coatings for photolithography processes; and Photographic films, papers and printing plates. Military operation means any operation taken to protect national security, support humanitarian relief efforts, participate in multilateral military or peace-keeping activities under the auspices of international organizations or defend a member state of the North Atlantic Treaty Organization. Information respecting the laboratory where a toxic substance or a product containing it is used or is to be used: the name, civic and postal addresses, telephone number and, if any, email address and fax number of the laboratory; and the name, title, civic and postal addresses, telephone number and, if any, email address and fax number of any person authorized to act on the laboratory’s behalf. Information respecting each toxic substance set out in Schedule 1 or 2, and each product containing it that is used or is to be used: the name of the toxic substance and the name of the product, if applicable; the anticipated period of its use; the estimated quantity of the toxic substance to be used in a calendar year and its unit of measurement; the identification of each proposed use and each actual use, as the case may be; and in the case of a product, the estimated quantity of the product to be used in a calendar year and its unit of measurement, and the estimated concentration of the toxic substance in that product and its unit of measurement. Information respecting the applicant: their name, civic and postal addresses, telephone number and, if any, email address and fax number; and the name, title, civic and postal addresses, telephone number and, if any, email address and fax number of any person authorized to act on the applicant’s behalf. In the case of a toxic substance referred to in either section 4 or 6 of these Regulations or a product containing it, the following information: the quantity of the toxic substance manufactured or imported during a 12-month period ending no more than six months before the day on which the application is submitted, and its unit of measurement; the estimated quantity of the toxic substance to be manufactured or imported during the period to which the permit will apply, and its unit of measurement; the quantity of the product manufactured or imported during any 12-month period ending no more than six months before the day on which the application is submitted, and its unit of measurement, the estimated quantity of the product to be manufactured or imported during the period to which the permit will apply, and its unit of measurement, and the estimated concentration of the toxic substance in that product or the estimated mass of the toxic substance contained in the product, and its unit of measurement; and the identification of each proposed use, if known. [Repealed, SOR/2016-252, s. 24] Information that demonstrates that there is no technically or economically feasible alternative or substitute available to the applicant at the time of the application, other than a substance regulated under these Regulations, for the toxic substance. Information that explains what measures have been taken to minimize or eliminate any harmful effect of the toxic substance on the environment and human health. A description of the plan prepared respecting the toxic substance identifying the measures that will be taken by the applicant to comply with these Regulations and the period within which the plan is to be implemented, which must not exceed three years after the day on which the permit is first issued. Information respecting the manufacturer or importer: their name, civic and postal addresses, telephone number of their principal place of business and, if any, email address and fax number; and the name, title, civic and postal addresses, telephone number and, if any, email address and fax number of any person authorized to act on behalf of the manufacturer or importer. Information respecting each toxic substance referred to in column 1 of Part 4 of Schedule 2 that is imported or manufactured and each product containing it that is imported or manufactured during a calendar year: the calendar year; the total quantity of the toxic substance manufactured, and its unit of measurement; the total quantity of the toxic substance sold in Canada, and its unit of measurement; the total quantity of the toxic substance imported, and its unit of measurement; the identification of each proposed use of the toxic substance and the product, if applicable; the annual weighted average concentration of the toxic substance in the product and its unit of measurement, if applicable; the analytical method used to determine the concentration of the toxic substance in the product, if applicable; the analytical method detection limit used to determine the concentration of the toxic substance in the product, if applicable; and the name, civic and postal addresses, telephone number and, if any, email address and fax number of each person in Canada to whom the manufacturer or importer sold the toxic substance or the product. The name, civic and postal addresses, telephone number and, if any, email address and fax number of the laboratory that determined the concentration of the toxic substance in the product, if applicable. Section 11 of the Perfluorooctane Sulfonate and its Salts and Certain Other Compounds Regulations, as it read immediately before the day on which these Regulations come into force, continues to apply until March 31, 2019 to any person to whom section 9 of those Regulations applied. The Prohibition of Certain Toxic Substances Regulations, 20122 are repealed. SOR/2012-285