FEDERAL REG

SOR/2016-17: Domestic Substances List — Order 2016-87-03-01 Amending Canadian Environmental Protection Act, 1999

REGISTRATION OF FEDERAL REGULATION - VIA PART II OF THE GAZETTE

Registered
February 11, 2016


REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues Canadians depend on substances that are used in hundreds of goods, from medicines to computers, fabric and fuels. Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), substances (i.e. chemicals, polymers, nanomaterials and living organisms) “new” to Canada are subject to reporting requirements bef... (Click for more)


Published on February 11, 2016

Bill Summary

SOR/2016-17: Domestic Substances List — Order 2016-87-03-01 Amending Canadian Environmental Protection Act, 1999

REGULATORY IMPACT ANALYSIS STATEMENT (This statement is not part of the Order.) Issues Canadians depend on substances that are used in hundreds of goods, from medicines to computers, fabric and fuels. Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), substances (i.e. chemicals, polymers, nanomaterials and living organisms) “new” to Canada are subject to reporting 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 Government of Canada assessed information on 23 new substances reported to the New Substances Program and determined that they meet the necessary criteria for their addition to the Domestic Substances List (DSL). These substances have therefore been added to the DSL. Background “New” substances are not on the DSL and are subject to notification and assessment requirements before they can be manufactured in or imported into Canada. The notification and assessment requirements are set out in subsections 81(1) and 106(1) of CEPA 1999 as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). These requirements do not apply to substances listed on the DSL, as these substances are considered “existing” in Canada for the purposes of CEPA 1999. The DSL was published in the Canada Gazette, Part II, in May 1994 (see footnote 2) and is amended on average 10 times a year. These amendments may add or remove substances or make corrections to the DSL. A substance must be added to the DSL under subsections 87(1) or (5) of CEPA 1999 within 120 days once all of the following conditions are met: the Minister of the Environment has been provided with information regarding the substance; (see footnote 3) 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 of CEPA 1999 by the person who provided the information; the period prescribed for the assessment of the submitted information for the substance has expired; and the substance is not subject to any conditions imposed pursuant to paragraph 84(1)(a) of CEPA 1999 on its import or manufacture. Environment Canada and Health Canada assessed information on 23 new substances reported to the New Substances Program and determined that they meet the criteria for addition to the DSL. Objectives The objective of the Order 2016-87-03-01 Amending the Domestic Substances List (the Order) is to comply with the requirements under subsections 87(1) and (5) of CEPA 1999 by adding 23 substances to the DSL. These substances are therefore no longer subject to the notification and assessment requirements under the New Substances Notification Regulations (Chemicals and Polymers). Description The Order adds 23 substances to the DSL. To protect confidential business information, 14 of the 23 substances have masked chemical names. Masked names are allowed by CEPA 1999 if the publication of the explicit chemical or biological name of a substance would result in the release of confidential business information. The procedure to be followed for creating a masked name is set out in the Masked Name Regulations under CEPA 1999. Substances with a masked name are added under the confidential portion of the DSL. Anyone who wishes to determine if a substance is on the confidential portion of the DSL must file a Notice of Bona Fide Intent to Manufacture or Import with the New Substances Program. “One-for-One” Rule and small business lens The 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. Consultation As the Order does not contain any information expected to generate comments or objections by stakeholders, no consultation is deemed necessary. Rationale Twenty-three substances have met the conditions for addition to the DSL. The Order adds these substances to the DSL and exempts them from the notification and assessment requirements under subsection 81(1) of CEPA 1999. The Order will benefit Canadians by enabling industry to have better access to larger quantities of these substances, which is expected to reduce costs associated with uses of these substances in products consumed by Canadians. The Order will also benefit industry by removing the cost associated with regulatory requirements for “new” substances. As a result, it is expected that there will be no incremental costs to the public, industry or governments associated with the Order. Implementation, enforcement and service standards The DSL identifies substances that, for the purposes of CEPA 1999, are not subject to the requirements of the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). Developing an implementation plan and a compliance strategy or establishing a service standard is not required when adding substances to the DSL. Contact Greg Carreau Executive Director Program Development and Engagement Division Environment Canada 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/2005-247 Footnote d S.C. 1999, c. 33 Footnote 1 SOR/94-311 Footnote 2 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 Domestic Substances List. For more information, please visit http://publications.gc.ca/gazette/archives/p2/2001/2001-07-04/pdf/g2-13514.pdf. Footnote 3 The most comprehensive package, with information about the substances, depends on the class of a substance. The information requirements are set out in the New Substances Notification Regulations (Chemicals and Polymers) under CEPA 1999.

This Bill does not amend any statutes.

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