SOR/2017-75: Domestic Substances List — Order 2017-87-04-01 Amending Canadian Environmental Protection Act, 1999
REGISTRATION OF FEDERAL REGULATION - VIA PART II OF THE GAZETTE
April 29, 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 environment... (Click for more)
Published on May 20, 2017
SOR/2017-75: Domestic Substances List — Order 2017-87-04-01 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. However, when substances are suspected to pose a risk to human health or the environment if used in potential new activities, they can be added to the DSL with restrictions under CEPA. This provides industry with access to substances while protecting human health and the environment in Canada. Under the authority of CEPA, the Government of Canada (the Government) assessed information on 10 substances new to Canada and added them to the DSL under the Order 2017-87-04-01 Amending the Domestic Substances List. The Government also maintained the significant new activity (SNAc) (see footnote 2) provisions of CEPA to the substance Chemical Abstracts Service Register Number (CAS RN) 670241-72-2. 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 3) and the New Substances Notification Regulations (Organisms). (see footnote 4) Substances on the DSL The DSL is an inventory of substances in the Canadian marketplace that was published in the Canada Gazette, Part II, in May 1994 (see footnote 5) 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 6) 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 10 substances to the DSL The Government assessed information on 10 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. Maintaining SNAc requirements on one substance Under subsection 87(3) or 112(3) of CEPA reporting obligations may be imposed, varied, and rescinded in relation to significant new activities associated with substances on the DSL, if the Government deems it necessary based on available information. The information submitted enables the Government to assess risks associated with proposed new uses of substances and determine whether additional risk management may be required. The Government assessed information on the substance CAS RN 670241-72-2 and identified potential human health concerns if the substance is used in certain new activities. For this reason, the SNAc provisions under CEPA were applied to the substance in January 2007, (see footnote 7) before its addition to the DSL. In order to maintain the reporting requirements on the substance, SNAc requirements were added to the DSL under this Order. Objectives The objectives of this Order are to comply with subsection 87(1) and 87(5) of CEPA by adding 10 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); contribute to the protection of human health by maintaining the SNAc requirements associated with the substance CAS RN 670241-72-2. The information collected will enable the Government to assess the substance in relation to the significant new activities and to determine whether further risk management actions are necessary. Description This Order added 10 substances to the DSL. One substance was added to Part 1 of the DSL, one substance was added to Part 2 of the DSL along with a description of the significant new activities and associated reporting requirements, and 8 substances were added to Part 3 of the DSL. To protect confidential business information, 8 of the 10 substances have masked chemical names. (see footnote 8) This Order indicated that the substance CAS RN 670241-72-2 is subject to the SNAc provisions under CEPA. This Order has been registered and is now in force. It is therefore mandatory to meet the requirements of subsection 81(3) of CEPA before manufacturing, importing or using the substance for a significant new activity as defined in this Order. According to the requirements of subsection 81(3) of CEPA, any person who intends to use, manufacture or import the substance for a significant new activity must submit a Significant New Activity Notification (SNAN) containing all of the information prescribed in the Order at least 90 days prior to the beginning of the significant new activity. The significant new activities requiring a SNAN submission are defined as any use of the substance in Canada in the manufacture of toys and articles that are designed for children from 0 to 3 years old. The requirements of subsection 81(3) of CEPA do not apply to uses of the substance that are regulated under any of the following Acts of Parliament listed in Schedule 2 of CEPA: the Pest Control Products Act, the Fertilizers Act and the Feeds Act. They also do not apply to transient reaction intermediates that are not isolated and are not likely released, impurities, contaminants, or partially unreacted materials related to the preparation of a substance or in some circumstances to items such as wastes, mixtures or manufactured items. However, it should be noted that individual components of a mixture may be notifiable under subsection 81(3) of CEPA. See subsection 81(6) and section 3 of CEPA, and section 3.2 of the Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers) for additional details. (see footnote 9) Information must be provided to the Minister of the Environment 90 days prior to the beginning of the significant new activity. Environment Canada and Health Canada will use the information submitted in the SNAN to conduct human health and environmental assessments within 90 days after the complete information is received. 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 10 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. Due to human health concerns, SNAc requirements have been added to the DSL for the substance CAS RN 670241-72-2. This will enable the Government to assess the risks associated with significant new activities involving the substance before they are undertaken. 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 maintaining SNAc requirements. When assessing whether or not a particular activity meets the definition of significant new activity on the DSL, a person is expected to make use of information in their possession or to which they ought to have access. (see footnote 10) The phrase “to which they ought to have access” means information in any of the company’s offices worldwide or other locations where the notifier can reasonably have access to the information. For example, manufacturers are expected to have access to their formulations, while importers or users of a substance, mixture or product, are expected to have access to import records, usage information and the relevant Safety Data Sheet (SDS). Although a SDS is an important source of information on the composition of a purchased product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, a SDS may not list all substances that may be subject to SNAc provisions due to public health or environmental concerns. Any person requiring more detailed information on product composition is encouraged to contact their supplier. If any information becomes available that reasonably supports the conclusion that the substance is toxic or capable of becoming toxic, the person who obtains the information and is involved in activities with the substance is obligated, under section 70 of CEPA, to provide that information to the Minister of the Environment without delay. A company can submit a SNAN on behalf of its clients. For example, in cases where a person receives possession and control of the substance from another person, they may not be required to submit a SNAN, under certain conditions, if their activities were covered by the original SNAN. The Substances Management Advisory Note, Clarification in relation to the submission of Significant New Activity Notifications in application of the Canadian Environmental Protection Act, 1999, provides more detail on this subject. (see footnote 11) A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the New Substances program during the planning or preparation of their SNAN to discuss any questions or concerns they have about the prescribed information and test plans. Where a person/notifier has questions concerning their obligations to comply with the order or believes they may be out of compliance, or, would like to request a PNC, they are encouraged to discuss their particular circumstances with the program by contacting the Substances Management Information Line. (see footnote 12) CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy. (see footnote 13) In instances of non-compliance, consideration is given to factors such as the nature of the alleged violation, potential harm, intent and history of compliance. Contact Jake Sanderson Acting 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 The Policy on the Use of Significant New Activity Provisions of the Canadian Environmental Protection Act, 1999 is available at http://www.ec.gc.ca/ese-ees/5CA18D66-CB04-4B03-89C8-0F8C6E4899C2/SNAc%20Policy_EN.pdf. Footnote 3 For more information, please see http://laws-lois.justice.gc.ca/PDF/SOR-2005-247.pdf. Footnote 4 For more information, please see http://laws-lois.justice.gc.ca/PDF/SOR-2005-248.pdf. Footnote 5 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 6 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 7 For more information, please visit http://publications.gc.ca/gazette/archives/p1/2007/2007-01-06/pdf/g1-14101.pdf. Footnote 8 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. Footnote 9 The Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers) is available at http://publications.gc.ca/site/eng/280464/publication.html. Footnote 10 A comprehensive listing of substances that are subject to SNAc provisions is available at http://www.ec.gc.ca/subsnouvelles-newsubs/default.asp?lang=En&n=0F76206A-1. Footnote 11 The Advisory Note is available at http://www.ec.gc.ca/subsnouvelles-newsubs/CC526AE6-A739-4781-B02D-786EDC8211BB/Advisory%20Note%20%282012-01%29%20-%20EN.pdf. Footnote 12 The Substances Management Information Line can be contacted at [email protected] (email), 1-800-567-1999 (toll free in Canada), 819-938-3232 (outside of Canada). Footnote 13 The Compliance and Enforcement Policy is available at https://www.ec.gc.ca/alef-ewe/default.asp?lang=en&n=AF0C5063-1.
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