Vol. 149, No. 10 — May 20, 2015

Registration

SOR/2015-102 May 5, 2015

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2015-87-03-01 Amending the Domestic Substances List

Whereas the Minister of the Environment has been provided with information under either paragraph 87(1)(a) or (5)(a) of the Canadian Environmental Protection Act, 1999 (see footnote a) in respect of each substance referred to in the annexed Order;

Whereas, in respect of the substances being added to the Domestic Substances List (see footnote b) pursuant to subsection 87(1) of that Act, the Minister of the Environment and the Minister of Health are satisfied that those substances have been manufactured in or imported into Canada, by the person who provided the information, in excess of the quantity prescribed under the New Substances Notification Regulations (Chemicals and Polymers) (see footnote c);

Whereas the period for assessing the information under section 83 of that Act has expired;

And whereas no conditions under paragraph 84(1)(a) of that Act in respect of the substances are in effect;

Therefore, the Minister of the Environment, pursuant to subsections 87(1), (3) and (5) of the Canadian Environmental Protection Act, 1999 (see footnote d), makes the annexed Order 2015-87-03-01 Amending the Domestic Substances List.

Gatineau, May 1, 2015

LEONA AGLUKKAQ
Minister of the Environment

ORDER 2015-87-03-01 AMENDING THE DOMESTIC SUBSTANCES LIST

AMENDMENTS

1. Part 1 of the Domestic Substances List (see footnote 1) is amended by adding the following in numerical order:

2. Part 2 of the List is amended by adding the following in numerical order:

Column 1

Substance		 Column 2

Significant new activity for which substance is subject to subsection 81(3) of the Act
1356964-77-6 N-S
  • 1. The use, in a quantity greater than 1000 kg in a calendar year, of the substance 9-decenamide, N,N-dimethyl- in any cosmetic or drug, as defined in section 2 of the Food and Drugs Act, or in any natural health product, as defined in subsection 1(1) of the Natural Health Products Regulations.
  • 2. For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before its commencement:
    • (a) a description of the significant new activity in relation to the substance;
    • (b) the anticipated annual quantity of the substance to be used;
    • (c) the information specified in item 7 of Schedule 4 to the New Substances Notification Regulations (Chemicals and Polymers);
    • (d) the name of every government department or government agency, either outside or within Canada, to which the person proposing the significant new activity has provided information regarding the use of the substance and, if known, the department’s or agency’s file number and, if any, the outcome of the department’s or agency’s assessment and the risk management actions in relation to the substance imposed by the department or agency; and
    • (e) the test data and a test report from a dermal toxicity study, in respect of the substance, conducted according to the methodology described in the Organisation for Economic Co-operation and Development (OECD) Test Guideline No. 411, entitled Subchronic Dermal Toxicity: 90-day Study and in conformity with the practices described in the OECD Principles of Good Laboratory Practice ("Principles of GLP") set out in Annex II of the Decision of the Council Concerning the Mutual Acceptance of Data in the Assessment of Chemicals, adopted on May 12, 1981, using the Test Guideline and Principles of GLP that are current at the time the test data are obtained.
  • 3. All other information and test data in respect of the substance that are in the possession of the person intending to use the substance for the proposed significant new activity, or to which they have access, and that are relevant to determining whether the substance is toxic or capable of becoming toxic.
  • 4. The above information will be assessed within 90 days after the day on which it is received by the Minister.

3. Section 1 in column 2 of Part 2 of the List, opposite the reference to the substance “1356964-77-6 N-S” in column 1, is replaced by the following:

  1. The use, in a quantity greater than 100 kg in a calendar year, of the substance 9-decenamide, N,N-dimethyl- in any cosmetic or drug, as defined in section 2 of the Food and Drugs Act, or in any natural health product, as defined in subsection 1(1) of the Natural Health Products Regulations.

4. Part 3 of the List is amended by adding the following in numerical order:

13456-1 T-P 1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 1,4-butanediol, decanedioic acid, 1,3-diisocyanatomethylbenzene, 1,2-ethanediol, hexanedioic acid, 2-oxepanone and alkanediol
  Acide isophtalique polymérisé avec de l’acide téréphtalique, du butane-1,4-diol, de l’acide décanedioïque, du 1,3-bis(isocyanatométhyl)benzène, de l’éthane-1,2-diol, de l’acide hexanedioïque, de l’oxépan-2-one et un alcanediol
16516-1 N-P 2-Alkenoic acid, 2-methyl, 1,2-ethanediyl ester, polymer with ethenylbenzene and 2-hydroxy-1,3-propanediyl bis(2-methyl-2-propenoate), 4,4-azobis[4-cyanopentanoic acid]-initiated
  Bis(2-méthylalc-2-énoate) d’éthane-1,2-diyle polymérisé avec du styrène et du bis(méthacrylate) de 2 hydroxypropane-1,3-diyle, amorcé avec du 4,4′-diazènediylbis[acide 4-cyanopentanoïque]
16989-6 N-P Alkyl-2-propenoate, polymer with hydroxypropyl-2-propenoate, and 2-methyl-1-propene, bis(1,1-dimethylpropyl) peroxide-initiated
  Acrylate d’alkyle polymérisé avec de l’acrylate d’hydroxypropyle et du 2-méthylprop-1-ène, amorcé avec du peroxyde de bis(2-méthylbutane-2-yle)
18112-4 N Hexanedioic acid, polymer with 2-(chloromethyl)oxirane polymer with 2-ethyl-2(hydroxymethyl)-1,3-propanediol, hexanedioic acid, 4,4′-(1-methylethylidene)bis[phenol] and oxirane 2-propenoate, 2,2-dimethyl-1,3-propanediol, alkanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane, compd. with N,N-diethylthanamine
  Acide hexanedioïque polymérisé avec du 2-(chlorométhyl)oxirane polymérisé avec du 2-éthyl-2(hydroxyméthyl)propane-1,3-diol, de l’acide hexanedioïque, du 4,4′-(propane-2,2-diyl)bis[phénol] et de l’acrylate d’oxiranyle, du néopentanediol, un alcanediol et de l’acide 2,2-bis(hydroxyméthyl)propanoïque et du 5-isocyanato-1-(isocyanatométhyl)-1,3,3-triméthylcyclohexane, composé avec la N,N-diethyléthanamine
18803-2 N-P 2-Propenoic acid, 2-methyl-, polymer with butyl 2-methyl-2-propenoate, ethenylbenzene, 2-ethylhexyl 2-propenoate, 2-hydroxyethyl 2-methyl- 2-propenoate, heteromonocycle and 1,2-propanediol mono-2-propenoate, tert-BU peroxide-initiated
  Acide méthacrylique polymérisé avec du méthacrylate de butyle, du styrène, de l’acrylate de 2-éthylhexyle, du méthacrylate de 2-hydroxyéthyle, un hétéromonocycle et du monoester d’acide acrylique et de propane-1,2-diol, amorcé avec du peroxyde de tert-butyle
18804-3 N-P Glycols, α,ω-, C4-6, polymers with 1,6-diisocyanatoalkane and 1,3-dioxolan-2-one, 3,5-dimethyl-1H-pyrazole-blocked
  Alcane-α,ω-diols en C4-6 polymérisés avec un 1,6-diisocyanatoalcane et de la 1,3-dioxolan-2-one, séquencés avec du 3,5-diméthyl-1H-pyrazole
18805-4 N-P 1,3-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, heteromonocycledione, hexanedioic acid and 1,3-isobenzofurandione
  Acide isophtalique polymérisé avec du néopentanediol, un hétéromonocycledione, de l’acide hexanedioïque et de l’isobenzofurane-1,3-dione
18806-5 N Alkyl aromatic isocyanate polymer with alkyl oxirane polymer with oxirane ether with oxybis[alkanol]
  Ester d’acide isocyanique et de poly(alkylaryle) polymérisé avec un alkyloxirane polymérisé avec de l’oxyde d’oxirane et un oxybis[alcanol]
18807-6 N-P 1,3-benzenedicarboxylic acid, polymer with hexanedioic acid, 1,6-hexanediol, diamine, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid, 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, and castor oil
  Acide isophtalique polymérisé avec de l’acide hexanedioïque, de l’hexane-1,6-diol, une diamine, de l’acide 2,2-bis(hydroxyméthyl)propanoïque, de l’isocyanate de 3-isocyanatométhyl-3,5,5-triméthylcyclohexane et de l’huile de ricin
18808-7 N-P Fatty acids, sunflower-oil, conjugated, polymers with maleic anhydride, polyalkylene glycol allyl Me ether, polyalkylene glycol acetate allyl ether and tall-oil fatty acids, hydrolyzed
  Acides gras d’huile de tournesol, conjugués, polymérisés avec de la furane-2,5-dione, de l’oxyde de poly(alcane-1,2-diol), de prop-2-èn-1-yle et de méthyle, de l’oxyde d’acétate de poly(alcane-1,2-diol) et de prop-2-èn-1-yle et des acides gras de tallöl, hydrolysés
18809-8 N-P Alkyl alkenoic acid,1,1′-[2-ethyl-2-[[(2-methyl-1-oxo-2-propen-1-yl)oxy]methyl]-1,3-propanediyl]ester, polymer with methyl 2-methyl-2-propenoate, 2,2′-(1,2-diazenediyl)bis[2-methylbutanenitrile]-initiated
  Bis(alkylalcénoate) de [2-éthyl-2-[[(2-méthylprop-2-énoyl)oxy]méthyl]propane-1,3-diyle] polymérisé avec du methacrylate de méthyle, amorcé avec du 2,2′-(diazènediyl)bis[2-méthylbutanenitrile]
18810-0 N-P 2-Propenoic acid, 2-methyl-, polymer with 1,1-dimethylethyl alkyl alkenoate, ethenylbenzene, 2-ethyl-hexyl 2-propenoate, 2-hydroxethyl 2-methyl-2-propenoate and 2-methylpropyl 2-methyl-2-propenoate, bis(1,1-dimethylpropyl) peroxide- and 1,1-dimethylpropyl 2-ethylhexaneperoxoate-initiated
  Acide méthacrylique polymérisé avec un alkylalcénoate de tert-butyle, du styrène, de l’acrylate de 2-éthylhexyle, du méthacrylate de 2-hydroxéthyle et du méthacrylate de 2-méthylpropyle, amorcé avec du peroxyde de bis(2-méthylbutane-2-yle) et du 2-éthylhexaneperoxoate de 2-méthylbutane-2-yle

COMING INTO FORCE

5. (1) Subject to subsection (2), this Order comes into force on the day on which it is registered.

(2) Section 3 comes into force on January 1, 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 (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.

Environment Canada and Health Canada assessed the information on 33 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). Under CEPA 1999, the Minister of the Environment must add a substance to the DSL within 120 days after the criteria listed in section 87 have been met.

Significant new activity (SNAc) provisions of CEPA 1999 have been applied to one of the 33 substances, as Environment Canada and Health Canada have determined that appropriate information must be provided to the Minister of the Environment prior to the commencement of a new activity associated with the substance. The SNAc provisions were originally applied to this substance pursuant to a notice published in Part I of the Canada Gazette, in March 2015. Given the substance is now being added to the DSL, SNAc provisions are being applied pursuant to this Order to maintain the reporting requirements.

Background

The Domestic Substances List

The DSL is a list of substances (chemicals, polymers, nanomaterials, and living organisms) that are considered “existing” in Canada for the purposes of CEPA 1999. “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. These 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) [hereafter referred to as the NSNR (Chemicals and Polymers)] and the New Substances Notification Regulations (Organisms) [hereafter referred to as the NSNR (Organisms)].

The DSL was published in the Canada Gazette, Part II, in May 1994. (see footnote 2) The DSL is amended 10 times a year, on average; these amendments may add or remove substances or make corrections to the DSL.

The Non-domestic Substances List

The Non-domestic Substances List (NDSL) is a list of substances “new” to Canada that are subject to reduced notification and assessment requirements when manufactured in or imported into Canada in quantities above 1 000 kg per year. The NDSL only applies to chemicals and polymers.

The United States and Canada have similar new substances programs to assess new chemicals’ impact on human health and the environment prior to manufacture in or import into the country. Substances are eligible for listing on the United States Toxic Substances Control Act (TSCA) Inventory once they have undergone a new substances assessment in the United States. Substances that have been listed on the public portion of the TSCA Inventory for a minimum of one calendar year and that are not subject to risk management controls in either country are eligible for listing on the NDSL. On a semi-annual basis, Canada subsequently updates the NDSL based on amendments to the United States TSCA Inventory.

While chemicals and polymers on the DSL are not subject to the NSNR (Chemicals and Polymers), those on the NDSL remain subject to them but with lesser reporting requirements, in recognition that they have undergone notification and assessment in the United States. This protects human health and the environment by ensuring that NDSL substances will undergo risk assessments in Canada, but leverages assessments conducted in the United States to lessen the reporting requirements imposed on industry.

Once substances are added to the DSL, they must be deleted from the NDSL, as a substance cannot be on both the DSL and the NDSL simultaneously because these lists involve different regulatory requirements.

Addition and communication of SNAc requirements

The assessment of one of the substances in this package (9-decenamide, N,N-dimethyl-, Chemical Abstracts Service registry number 1356964-77-6) identified potential concerns related to dermal toxicity as well as irritation to the eyes, corrosiveness to the skin and effects on the kidney. For this reason, the significant new activity provisions of CEPA 1999 were applied in March 2015 pursuant to a notice published in the Canada Gazette to require information that will enable the Government of Canada to further assess the substance if it is used in cosmetics or drugs, as defined in section 2 of the Food and Drugs Act, or in natural health products, as defined in subsection 1(1) of the Natural Health Products Regulations. Given the substance is now being added to the DSL, SNAc provisions are included in this Order to maintain the reporting requirements.

Objectives

The objectives of the Order 2015-87-03-01 Amending the Domestic Substances List (hereafter referred to as the Order) are to comply with the requirements under CEPA 1999 and facilitate access to and use of 33 substances by removing reporting requirements under the New Substances Program associated with their import or manufacture. Another objective of the Order is to contribute to the protection of human health and the environment by maintaining the reporting requirements for significant new activities associated with the substance 9-decenamide, N,N-dimethyl- before they are undertaken. The information collected will enable the Government of Canada to assess the substance in relation to the significant new activity and to determine whether further risk management actions are necessary.

Description

The Order adds 33 substances to the DSL. To protect confidential business information, 12 of the 33 substances will have masked chemical names.

Furthermore, as substances cannot be on both the DSL and the NDSL simultaneously, the proposed Order 2015-87-03-02 Amending the Non-domestic Substances List will delete 7 of the 33 substances from the NDSL, as they meet the necessary criteria for addition to the DSL.

Additions to the Domestic Substances List

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:

Addition of SNAc requirements

The Order adds the substance 9-decenamide, N,N-dimethyl- to Part 2 of the DSL; and indicates that the substance is subject to the SNAc provisions of CEPA 1999. (see footnote 4)

The Order has been registered and is now in force. It is therefore mandatory to meet all the requirements of this Order should a person wish to use the substance 9-decenamide, N,N-dimethyl- for a significant new activity, as defined in the Order.

Applicability of the SNAc requirements

The SNAc requirements apply to any person that intends to use 9-decenamide, N,N-dimethyl-, for a significant new activity.

Any person engaging in a significant new activity in relation to the substance 9-decenamide, N,N-dimethyl- must submit a Significant New Activity notification (SNAN) containing all of the information prescribed in the Order at least 90 days prior to the use of the substance for the significant new activity.

The activities with respect to the substance 9-decenamide, N,N-dimethyl-, requiring a SNAN submission involve its use in any cosmetic or drug, as defined in section 2 of the Food and Drugs Act or its use in a natural health product, as defined in subsection 1(1) of the Natural Health Products Regulations. These activities have not been identified as presently occurring in Canada.

The substance 9-decenamide, N,N-dimethyl- was, before the adoption of this Order, a new chemical substance on the NDSL, and as a result, it could be manufactured or imported in Canada in a quantity of up to 1 000 kg in any given calendar year without the need to provide information to the Minister of the Environment under subsection 81(1) of CEPA 1999.

A transitional period for the SNAc requirements is included in the Order to facilitate compliance by persons who already have imported or manufactured up to a 1 000 kg of the substance and started activities with it. The SNAc requirements come into force immediately with a threshold of 1 000 kg per calendar year to define what constitutes a significant new activity. However, on January 1, 2016, this threshold will be lowered to 100 kg per calendar year.

Activities not subject to the SNAc requirements

The SNAc requirements do not apply to uses of the substance 9-decenamide, N,N-dimethyl- that are regulated under any of the following Acts of Parliament listed in Schedule 2 of CEPA 1999: 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 intermediates 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 the Order. See subsection 81(6) and section 3 of CEPA 1999, and section 3.2 of the Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers) for additional details. (see footnote 5)

Information to be submitted

The Order sets out the information that must be provided to the Minister of the Environment 90 days before the day on which the substance 9-decenamide, N,N-dimethyl- is used for a significant new activity. With regard to the information requested from a dermal toxicity study, particular attention should be made for α2u globulin-mediated renal toxicity to explain potential toxicological pathways. This information is required to determine if the results are specific to rat or whether they could occur in humans. 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.

Some of the information requirements of the Order reference the NSNR (Chemicals and Polymers) to describe the specific information being requested. (see footnote 6) Additional guidance on preparing a SNAN can be found in section 1.3 of the Guidelines for the Notification and Testing of New Substances (Chemicals and Polymers).

Implementation, enforcement and service standards

Compliance

When assessing whether or not a particular SNAc applies, a person is expected to make use of information in their possession or to which they ought to have access. (see footnote 7) 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 an 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, an SDS may not list all product ingredients 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 9-decenamide, N,N-dimethyl- is toxic or capable of becoming toxic, the person in possession of or that has knowledge of the information and is involved in activities with the substance is obligated, under section 70 of CEPA 1999, 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 9-decenamide, N,N-dimethyl- from another person, he or she may not be required to submit a SNAN, under certain conditions, if his or her 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 8)

A pre-notification consultation (PNC) is recommended for notifiers who wish to consult with the 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 has questions concerning his or her obligations to comply with this Order or believes that he or she may be out of compliance, or, would like to request a PNC, he or she is encouraged to contact the Substances Management Information Line. (see footnote 9) The Program will work with the person to help him or her comply with the Order.

CEPA 1999 is enforced in accordance with the publicly available Compliance and Enforcement Policy. (see footnote 10) 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.

Publication of masked names

The Order masks the chemical name of 12 of the 33 substances being added to the DSL. 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 is not expected to add any administrative or compliance burden to small businesses. Rather, the Order provides industry with better access to the 33 substances being added to the DSL.

Consultation

As the Order is administrative in nature and does not contain any information that would be subject to comment or objection by the general public, no consultation is required.

Rationale

Thirty-three substances have met the necessary conditions for addition to the DSL. The Order adds these substances to the DSL to exempt them from assessment and reporting requirements under subsection 81(1) of CEPA 1999.

The Order will benefit Canadians by enabling industry to use these substances in larger quantities. The Order will also benefit industry by reducing the administrative burden associated with the current regulatory status of these substances. As a result, it is expected that there will be no incremental costs to the public, industry or governments associated with the Order. However, the Government of Canada may still decide to assess any substance on the DSL under the existing substances provisions of CEPA 1999 (section 68 or 74) should an assessment be deemed necessary.

Implementation, enforcement and service standards

The DSL identifies substances that, for the purposes of CEPA 1999, are not subject to the requirements of the NSNR (Chemicals and Polymers) or the NSNR (Organisms). As the Order only adds substances to the DSL, developing an implementation plan or a compliance strategy or establishing a service standard is not required.

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: 819-953-7155
Email: substances@ec.gc.ca