Prohibition of Certain Toxic Substances Regulations, 2012
P.C. 2012-1714 December 13, 2012
Whereas, pursuant to subsection 332(1) (see footnote a) of the Canadian Environmental Protection Act, 1999 (see footnote b), 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 6 (see footnote c) 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, 1999 (see footnote d), makes the annexed Prohibition of Certain Toxic Substances Regulations, 2012.
PROHIBITION OF CERTAIN TOXIC SUBSTANCES REGULATIONS, 2012
APPLICATION
Application
1. 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
2. These Regulations do not apply to any toxic substance that
(a) 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;
(b) is contained in a pest control product as defined in subsection 2(1) of the Pest Control Products Act; or
(c) 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
3. (1) These Regulations, except for subsections (2) to (4), 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
(2) 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 in that calendar year. The information must be submitted only once in a calendar year in respect of each substance or product.
On-going use
(3) Any person that, on the day on which these Regulations come into force, is using a toxic substance or product referred to in subsection (1) for a purpose referred to in that subsection must, if the quantity of the toxic substance used, by itself or in a product, exceeded 10 g in the calendar year of the coming into force of these Regulations, submit to the Minister, within 60 days after the day on which these Regulations come into force, 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.
Addition of substance
(4) If, after the coming into force of these Regulations, a toxic substance is added to Schedule 1 or 2, any person that, on the day on which the Regulations adding the toxic substance come into force, is using the toxic substance or a product containing it 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 of the coming into force of the Regulations adding the toxic substance, submit to the Minister, within 60 days after the day on which those Regulations come into force, 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.
PROHIBITIONS AND PERMITTED ACTIVITIES
Toxic substance — Schedule 1
4. (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
(2) 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.
Exception — manufactured or imported before coming into force
5. 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 is manufactured or imported before the day on which these Regulations come into force.
Toxic substance — Schedule 2
6. (1) Subject to subsections (2) and (4) 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, 2 or 3 of Schedule 2 or a product containing it unless the toxic substance is incidentally present.
Permitted activities — Schedule 2
(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
(a) the toxic substance set out in column 1 of Part 1 of Schedule 2 or a product containing it, other than a substance or product set out in item 3 or 4, is designed for a use set out in column 2;
(b) 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
(c) a product set out in column 2 of Part 3 of Schedule 2 containing 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.
Exception — incidental presence
(3) 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 — permitted use
(4) The prohibition to use a product that contains a toxic substance set out in column 1 of Part 1 of Schedule 2 does not apply to a product set out in item 3 or 4 of column 2.
Exception — personal use
(5) Subsection (1) does not apply to the use or import of a product containing a toxic substance set out in item 1 of Part 2 of Schedule 2, if the product is used or intended to be used for a personal use.
Exception — temporary permitted uses
7. (1) 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 — Tributyltins
(2) A person may use, sell, or offer for sale a product containing a toxic substance set out in item 2 of Part 3 of Schedule 2 if it is manufactured or imported before the day on which these Regulations come into force.
Exception — manufacture or import under permit
8. 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.
PERMITS
APPLICATION
Requirement for permit
9. (1) Any person that is a manufacturer or importer of a toxic substance or a product containing it that is prohibited under section 4 or 6, on the day on which these Regulations come into force, may continue to manufacture or import the substance or product if they have been issued a permit under section 10.
Addition of substance
(2) In the case of a toxic substance added either to Schedule 1 and prohibited under section 4, or added to Schedule 2 and prohibited under section 6, any person that is a manufacturer or importer of a toxic substance or a product containing it, on the day on which the Regulations adding the toxic substance come into force 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
(3) Any person that manufactures or imports a toxic substance set out in Part 2 of Schedule 2 or a product containing it under paragraph 6(2)(b), on the day on which the period set out under that paragraph for which a temporary permitted use expires, may continue that activity if they have been issued a permit under section 10.
Required information
(4) An application for a permit must be submitted to the Minister and contain the information referred to in Schedule 4.
ConDITIONS OF ISSUANCE
Issuance
10. (1) Subject to subsection (2), the Minister must issue the permit if the following conditions are met:
(a) 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;
(b) 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
(c) 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
(2) The Minister must refuse to issue a permit if
(a) the Minister has reasonable grounds to believe that the applicant has provided false or misleading information in support of their application; or
(b) 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
(3) 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. The validity of the first permit may only be extended twice, subject to the same conditions.
REVOCATION
Revocation
11. (1) 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
(2) The Minister must not revoke a permit unless the Minister has provided the permit holder with
(a) written reasons for the revocation; and
(b) an opportunity to be heard, by written representation, in respect of the revocation.
ANNUAL REPORTS
Certain substances
12. 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
(a) 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;
(b) 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
(c) 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
Accredited laboratory
13. Any concentration or quantity to be determined under these Regulations must be determined, in accordance with generally accepted standards of scientific practice, by a laboratory that is accredited under the International Organization for Standardization standard ISO/IEC 17025:2005, entitled General requirements for the competence of testing and calibration laboratories, as amended from time to time, or by a laboratory that meets an equivalent standard.
PRESENTATION OF INFORMATION
Certification
14. (1) 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
(2) 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.
RECORD KEEPING
Records
15. (1) 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
(2) 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.
TRANSITIONAL
Activity referred to in Prohibition of Certain Toxic Substances Regulations, 2005
16. A permit must not be obtained under these Regulations for an activity prohibited under the Prohibition of Certain Toxic Substances Regulations, 2005.
REPEAL
17. The Prohibition of Certain Toxic Substances Regulations, 2005 (see footnote 1) are repealed.
COMING INTO FORCE
Three months after registration
18. These Regulations come into force three months after the day on which they are registered.
(Sections 1 to 5 and 9 and Schedule 3)
PART 1
PROHIBITED TOXIC SUBSTANCES
| Item | Toxic Substance |
|---|---|
| 1. | Dodecachloropentacyclo [5.3.0.02,6.03,9.04,8] decane (Mirex) |
| 2. | Polybrominated Biphenyls that have the molecular formula C12H(10-n)Brn in which “n” is greater than 2 |
| 3. | Polychlorinated Terphenyls that have the molecular formula C18H(14-n)Cln in which “n” is greater than 2 |
| 4. | Bis(chloromethyl) ether that has the molecular formula C2H4Cl2O |
| 5. | Chloromethyl methyl ether that has the molecular formula C2H5ClO |
| 6. | (4-Chlorophenyl) cyclopropylmethanone, O-[(4-nitrophenyl)methyl] oxime that has the molecular formula C17H15ClN2O3 |
| 7. | N-Nitrosodimethylamine, which has the molecular formula C2H6N2O |
| 8. | Hexachlorobutadiene, which has the molecular formula C4Cl6 |
| 9. | Dichlorodiphenyltrichloroethane (DDT), which has the molecular formula C14H9Cl5 |
| 10. | Hexachlorobenzene |
| 11. | Polychlorinated naphthalenes, which have the molecular formula C10H8-nCln in which “n” is greater than 1 |
| 12. | Chlorinated alkanes that have the molecular formula CnHxCl(2n+2-x) in which 10 ≤ n ≤ 13 |
PROHIBITED TOXIC SUBSTANCES UNLESS PRESENT IN MANUFACTURED ITEMS
| Item | Toxic Substance |
|---|---|
| 1. | Hexane, 1,6-diisocyanato-, homopolymer, reaction products with alpha-fluoro-omega-2-hydroxyethyl-poly(difluoromethylene), C16-20-branched alcohols and 1-octadecanol |
| 2. | 2-Propenoic acid, 2-methyl-, hexadecyl ester, polymers with 2-hydroxyethyl methacrylate, gamma-omega-perfluoro-C10-16-alkyl acrylate and stearyl methacrylate |
| 3. | 2-Propenoic acid, 2-methyl-, 2-methylpropyl ester, polymer with butyl 2-propenoate and 2,5 furandione, gamma-omega-perfluoro-C8-14-alkyl esters, tert-Bu benzenecarboperoxoate-initiated |
| 4. | 2-Propen-1-ol, reaction products with pentafluoroiodoethane tetrafluoroethylene telomer, dehydroiodinated, reaction products with epichlorohydrin and triethylenetetramine |
(Sections 1 to 3, 6, 7, 9 and 12 and Schedule 3)
PERMITTED USES, ConCENTRATION LIMITS AND REPORTING THRESHOLDS
PART 1
PERMITTED USES
| Item | Column 1 Toxic Substance | Column 2 Permitted Uses |
|---|---|---|
| 1. | Benzidine and benzidine dihydrochloride that have the molecular formulas C12H12N2and C12H12N2·2HCl, respectively | (a) Staining for microscopic examination, such as immunoperoxidase staining, histochemical staining or cytochemical staining; (b) Reagent for detecting blood in biological fluids; (c) Niacin test to detect some micro-organisms; and d) Reagent for detecting chloralhydrate in biological fluids. |
| 2. | 2-Methoxyethanol, which has the molecular formula C3H8O2 | (a) Adhesives and coatings for aircraft refinishing; and (b) Semiconductor manufacturing process. |
| 3. | Pentachlorobenzene, which has the molecular formula C6HCl5 | Use with chlorobiphenyls contained in equipment or liquids in the service of such equipment in which their use is permitted under the PCB Regulations |
| 4. | Tetrachlorobenzenes, which have the molecular formula C6H2Cl4 | Use with chlorobiphenyls contained in equipment or liquids in the service of such equipment in which their use is permitted under the PCB Regulations |
| 5. | Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene | Additive in rubber, except in tires |
TEMPORARY PERMITTED USES
| Item | Column 1 Toxic Substance | Column 2 Permitted Uses | Column 3 Expiry date |
|---|---|---|---|
| 1. | Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene | Additive in lubricants | 2 years after the coming into force of these Regulations |
PERMITTED ConCENTRATION LIMITS
| Item | Column 1 Toxic Substance | Column 2 Product Containing the Toxic Substance | Column 3 Concentration Limit of the Toxic Substance |
|---|---|---|---|
| 1. | 2-Methoxyethanol, which has the molecular formula C3H8O2 | Diethylene glycol methyl ether, which has the molecular formula C5H12O3 | 0.5 % (w/w) |
| 2. | Tributyltins, which contain the grouping (C4H9)3Sn | Tetrabutyltin, which has the molecular formula (C4H9)4Sn | 30 % (w/w) |
REPORTING THRESHOLDS
| Item | Column 1 Toxic Substance | Column 2 Annual Quantity | Column 3 Annual Weighted Average Concentration | Column 4 Annual Quantity and Annual Weighted Average Concentration |
|---|---|---|---|---|
| 1. | Benzidine and benzidine dihydrochloride that have the molecular formulas C12H12N2 and C12H12N2·2HCl, respectively | 1 kg | ||
| 2. | Chlorinated alkanes that have the molecular formula CnHxCl(2n+2-x) in which 10 ≤ n ≤ 13 | 1 kg and 0.5% (w/w) |
(Subsections 3(2) to (4))
INFORMATION RELATED TO THE USE OF CERTAIN TOXIC SUBSTANCES IN A LABORATORY FOR ANALYSIS, IN SCIENTIFIC RESEARCH OR AS A LABORATORY ANALYTICAL STANDARD
Information respecting the laboratory where a toxic substance or a product containing it is used or is to be used: (a) the name, civic and postal addresses, telephone number and, if any, email address and fax number of the laboratory; and
(b) 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: (a) the name of the toxic substance and the name of the product, if applicable;
(b) the anticipated period of its use;
(c) the estimated quantity of the toxic substance to be used in a calendar year and its unit of measurement;
(d) the identification of each proposed use and each actual use, as the case may be; and
(e) in the case of a product, (i) the estimated quantity of the product to be used in a calendar year and its unit of measurement, and
(ii) the estimated concentration of the toxic substance in that product and its unit of measurement. SCHEDULE 4
(Subsection 9(4) and 10(3))
INFORMATION REQUIRED IN AN APPLICATION FOR A PERMIT OR AN APPLICATION FOR RENEWAL OF A PERMIT
Information respecting the applicant: (a) their name, civic and postal addresses, telephone number and, if any, email address and fax number; and
(b) 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: (a) the name of the toxic substance and the name of the product, if applicable;
(b) the quantity of the toxic substance manufactured or imported during the 12 months before the day on which the application is submitted, and its unit of measurement;
(c) 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;
(d) in the case of a product, (i) the quantity of the product manufactured or imported during the 12 months before the day on which the application is submitted, and its unit of measurement,
(ii) 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
(iii) the estimated concentration of the toxic substance in that product and its unit of measurement; (e) the identification of each proposed use, if known; and
(f) if the applicant is a manufacturer or importer, the name, civic and postal addresses, telephone number and, if any, email address and fax number of each person in Canada to whom the applicant intends to sell a toxic substance or a product containing it and the name of each toxic substance or product.
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.SCHEDULE 5
(Section 12)
INFORMATION RELATING TO THE MANUFACTURE OR import OF A TOXIC SUBSTANCE OR THE import OF A PRODUCT ConTAINING IT
Information respecting the manufacturer or importer: (a) their name, civic and postal addresses, telephone number of their principal place of business and, if any, email address and fax number; and
(b) 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: (a) the name of the toxic substance and the name of the product, if applicable;
(b) the calendar year;
(c) the total quantity of the toxic substance manufactured, and its unit of measurement;
(d) the total quantity of the toxic substance sold in Canada, and its unit of measurement;
(e) the total quantity of the toxic substance imported, and its unit of measurement;
(f) the identification of each proposed use of the toxic substance and the product, if applicable;
(g) the annual weighted average concentration of the toxic substance in the product and its unit of measurement, if applicable;
(h) the analytical method used to determine the concentration of the toxic substance in the product, if applicable;
(i) the analytical method detection limit used to determine the concentration of the toxic substance in the product, if applicable; and
(j) 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.
