FEDERAL REG

SOR/2017-49: Domestic Substances List — Order 2017-87-03-01 Amending Canadian Environmental Protection Act, 1999

REGISTRATION OF FEDERAL REGULATION - VIA PART II OF THE GAZETTE

Registered
March 27, 2017


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues Under the Canadian Environmental Protection Act, 1999 (CEPA), substances (i.e. chemicals, polymers, nanomaterials and living organisms) new to Canada are subject to notification and assessment requirements before they can be manufactured or imported. This limits market access until human health and environmenta... (Click for more)


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Senate

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Published on April 19, 2017

Bill Summary

SOR/2017-49: Domestic Substances List — Order 2017-87-03-01 Amending Canadian Environmental Protection Act, 1999

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues Under the Canadian Environmental Protection Act, 1999 (CEPA), substances (i.e. chemicals, polymers, nanomaterials and living organisms) new to Canada are subject to notification and assessment requirements before they can be manufactured or imported. This limits market access until human health and environmental impacts associated with the new substances are assessed and managed where appropriate. The Domestic Substances List (DSL) is an inventory of substances in the Canadian marketplace. When substances new to Canada meet the criteria for addition to the DSL, they must be added to this list. This provides industry with access to larger quantities of these substances, which is expected to reduce costs associated with products consumed by Canadians. Under the authority of CEPA, the Government of Canada (the Government) assessed information on 15 substances new to Canada and added them to the DSL under the Order 2017-87-03-01 Amending the Domestic Substances List. Based on new information, the Government also updated the identifier of two substances on the DSL under this Order. Background Substances new to Canada Substances that are not on the DSL are considered new to Canada and are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. These requirements are set out in subsections 81(1) and 106(1) of CEPA, as well as in the New Substances Notification Regulations (Chemicals and Polymers) (see footnote 2) and the New Substances Notification Regulations (Organisms). (see footnote 3) Substances on the DSL The DSL is an inventory of substances in the Canadian marketplace that was first published in the Canada Gazette, Part II, in May 1994 (see footnote 4) and is amended on average 10 times a year to add or delete substances. A substance must be added to the DSL under subsection 87(1), 87(5) or 112(1) of CEPA within 120 days once all of the following criteria are met: the Minister of the Environment has been provided with information regarding the substance; (see footnote 5) the Minister of the Environment and the Minister of Health are satisfied that the substance has already been manufactured in or imported into Canada under the conditions set out in section 87 or 112 of CEPA by the person who provided the information; the period prescribed for the assessment of the information submitted for the substance has expired; and the substance is not subject to any conditions imposed pursuant to paragraph 84(1)(a) or 109(1)(a) of CEPA on its import or manufacture. Adding 15 substances to the DSL The Government assessed information on 15 new substances reported to the New Substances Program and determined that they meet the criteria for their addition to the DSL. These substances were therefore added to the DSL under this Order. Updating the identifier of two substances by removing the letter “P” The letter “P” after a substance identifier indicates that the substance was assessed and added to the DSL on the basis that it met the Reduced Regulatory Requirements (RRR) (see footnote 6) polymer criteria. The “P” flag indicates that relevant information respecting the flagged polymer must be notified if anyone, including the original notifier, manufactures or imports the polymer in Canada, in a form that no longer meets the RRR polymer criteria. The Government assessed information on the substances CAS RN 51447-37-1 and CAS RN 709654-72-8 under a form that does not meet the RRR polymer criteria and determined that the non-RRR form of the substances also meet the conditions for their addition to the DSL. The letter “P” after the CAS RN of both substances was therefore removed from the DSL under this Order. Objectives The objectives of this Order are to 1. comply with subsection 87(1) and 87(5) of CEPA by adding 15 substances to the DSL. This will facilitate their import or manufacture by removing the notification and assessment requirements under the New Substances Notification Regulations (Chemicals and Polymers); and 2. update the identifier of two substances on the DSL, based on new information available. Description This Order added 15 substances to the DSL. Eight substances were added to Part 1, and 7 substances to Part 3 of the DSL. To protect confidential business information, 7 of the 15 substances have masked chemical names. (see footnote 7) This Order also removed the letter “P” after the substances CAS RN 51447-37-1 and CAS RN 709654-72-8 in Part 1 of the DSL. Consultation As this Order does not contain any information expected to generate comments by stakeholders, no further consultation is deemed necessary. Rationale Under CEPA, substances new to Canada are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. This limits market access until human health and environmental impacts associated with the new substances are assessed and managed where appropriate. The Government assessed information on 15 substances new to Canada, and determined that they meet the criteria for their addition to the DSL. These substances have been added to the DSL under this Order. The Government assessed information on the substances CAS RN 51447-37-1 and CAS RN 709654-72-8 under a form that does not meet the RRR polymer criteria and determined that the non-RRR form of the substance meet the conditions for their addition to the DSL. The identifier of the substances on the DSL was therefore updated under this Order by removing the letter “P” after the substances CAS RN. This Order will benefit Canadians by enabling industry to have access to larger quantities of these substances while managing potential human health or environmental risks associated with them where appropriate. This is expected to reduce costs associated with products consumed by Canadians. It is also expected that there will be no incremental costs to the public, industry, or governments associated with this Order. “One-for-One” Rule and small business lens This Order does not trigger the “One-for-One” Rule, as it does not add any additional costs to business. Also, the small business lens does not apply to the Order, as it does not add any administrative or compliance burden to small businesses. Implementation, enforcement and service standards Developing an implementation plan, a compliance strategy, or establishing a service standard is not required when adding substances to the DSL, or updating a substance identifier on the DSL. Contact Greg Carreau Executive Director Program Development and Engagement Division Department of the Environment Gatineau, Quebec K1A 0H3 Substances Management Information Line: 1-800-567-1999 (toll-free in Canada) 819-938-3232 (outside of Canada) Fax: 819-938-5212 Email: [email protected] Footnote a S.C. 1999, c. 33 Footnote b SOR/94-311 Footnote c SOR/94-311 Footnote d SOR/2005-247 Footnote e S.C. 1999, c. 33 Footnote 1 SOR/94-311 Footnote 2 For more information, please see http://laws-lois.justice.gc.ca/PDF/SOR-2005-247.pdf. Footnote 3 For more information, please see http://laws-lois.justice.gc.ca/PDF/SOR-2005-248.pdf. Footnote 4 The Order 2001-87-04-01 Amending the Domestic Substances List (SOR/2001-214), published in the Canada Gazette, Part II, in July 2001, establishes the structure of the DSL. For more information, please see SOR/2001-214 at http://publications.gc.ca/gazette/archives/p2/2001/2001-07-04/pdf/g2-13514.pdf. Footnote 5 The most comprehensive package depends on the class of a substance. The information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms) made under CEPA. Footnote 6 For more information on the RRR, please see section 3.4.1.3 of the Guidelines for the Notification and Testing of New Substances: Chemicals and Polymers at http://publications.gc.ca/site/eng/9.687775/publication.html. Footnote 7 Masked names are allowed by CEPA to protect confidential business information. The procedure for creating a masked name is set out in the Masked Name Regulations. Anyone who wishes to determine if a substance is on the DSL under a masked name must file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program.

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