Vol. 151, No. 5 — March 8, 2017

Registration

SOR/2017-24 February 21, 2017

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2017-87-02-01 Amending the Domestic Substances List

Whereas the Minister of the Environment has been provided with information under 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 that is added to the Domestic Substances List (see footnote b) pursuant to subsection 87(1) or (5) of that Act;

Whereas, in respect of the substances being added to the Domestic Substances List (see footnote c) 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 d);

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 e), makes the annexed Order 2017-87-02-01 Amending the Domestic Substances List.

Gatineau, February 17, 2017

Catherine McKenna
Minister of the Environment

Order 2017-87-02-01 Amending the Domestic Substances List

Amendments

1 (1) Part 1 of the Domestic Substances List (see footnote 1) is amended by deleting the following:

(2) Part 1 of the List 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

1357160-95-2 N-S

1 The use of the substance fatty acids, C12-20, 1,2,2,6,6-pentamethyl-4-piperidinyl esters, in a quantity greater than 100 kg in a calendar year, in the manufacture of

  • (a) a consumer product to which the Canada Consumer Product Safety Act applies;
  • (b) a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations or any other drug as defined in section 2 of the Food and Drugs Act; or
  • (c) a cosmetic as defined in section 2 of the Food and Drugs Act.

2 The use, in a quantity greater than 100 kg in a calendar year, of fatty acids, C12-20, 1,2,2,6,6-pentamethyl-4-piperidinyl esters, in

  • (a) a consumer product to which the Canada Consumer Product Safety Act applies;
  • (b) a natural health product as defined in subsection 1(1) of the Natural Health Products Regulations or any other drug as defined in section 2 of the Food and Drugs Act; or
  • (c) a cosmetic as defined in section 2 of the Food and Drugs Act.

3 Sections 1 and 2 do not include

  • (a) the use of the substance as a research and development substance or site-limited intermediate substance as those terms are defined in subsection 1(1) of the New Substances Notification Regulations (Chemicals and Polymers); or
  • (b) the use of the substance in a consumer product, a natural health product, any other drug or a cosmetic — as described in those sections — that is for export only.

4 For each proposed significant new activity, the following information must be provided to the Minister at least 90 days before the day on which the activity begins:

  • (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 information specified in item 8 of Schedule 5 to those Regulations;
  • (e) the information specified in item 11 of Schedule 6 to those Regulations;
  • (f) 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;
  • (g) the test data and a test report from a reproduction and developmental toxicity test in respect of the substance that is conducted via the dermal route and in accordance with the methodology described in the Organisation for Economic Co-operation and Development (OECD) Test Guideline for the Testing of Chemicals No. 422, entitled Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, that is current at the time the test data are developed;
  • (h) the test data and a test report from a genotoxicity test, with fluorescence in situ hybridization, that, in respect of the substance, is designed to detect clastogenic and aneugenic events and that is conducted in accordance with the methodology described in the OECD Test Guideline for the Testing of Chemicals No. 487, entitled In Vitro Mammalian Cell Micronucleus Test, that is current at the time the test data are developed;
  • (i) all other information or test data in respect of the substance that are in the possession of the person who is proposing the 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 and the degree of environmental and public exposure to the substance;
  • (j) the name, civic and postal addresses, telephone number and, if any, the fax number and email address of the person who is proposing the significant new activity and, if they are not resident in Canada, of the person resident in Canada who is authorized to act on their behalf; and
  • (k) a certification that the information is accurate and complete, dated and signed by the person who is proposing the significant new activity if they are resident in Canada or, if not, by the person resident in Canada who is authorized to act on their behalf.

5 The test data and the test reports referred to in paragraphs 4(g) and (h) must be in conformity with the practices described in the OECD Principles of Good Laboratory Practice 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 by the OECD, using the Principles of Good Laboratory Practice that is current at the time the test data are developed.

6 The information provided under section 4 will be assessed within 90 days after the day on which it is received by the Minister.

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

14160-3 N-P

2-Propenoic acid, polyalkyl ester, polymer with 2-propenamide

Acrylate de polyalkyle polymérisé avec de l’acrylamide

18421-7 N-P

1,3-Benzenedicarboxylic acid, polymer with alkanoic acid, 1,3-diisocyanatomethylbenzene, 2,2-dimethyl-1,3-propanediol and 1,2-ethanediol

Acide isophtalique polymérisé avec un acide alcanoïque, du 1,3-di(isocyanatométhyl)benzène, du 2,2-diméthylpropane-1,3-diol et de l’éthane-1,2-diol

18892-1 N

Phosphonic acid, [[[2-(2-substituted alkoxy)ethyl]-imino]bis(alkyl)]bis-

[[[2-(Alcoxy substitué en 2)éthyl]azanediyl]bis(alcanediyle)]bis[acide phosphonique]

19004-5 N

Dioxadithiatetradecanedioic acid, 4,11-dimethyl-1,14-bis(2-ethylhexyl) ester

4,11-Diméthyl-dioxa-dithiatétradécanedioate de bis(2 éthylhexyle)

19102-4 N-P

2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2-propenoate, dialkyloxoalkyl-2-propenamide and alkyl 2-propenoate

Alkylacrylate d’alkyle polymérisé avec un acrylate d’alkyle, un [dialkyl(oxo)alkyl]acrylamide et un autre acrylate d’alkyle

19103-5 N-P

2-Propenoic acid, alkyl-, alkyl ester, polymer with alkyl 2-propenoate, dialkyloxoalkyl-2-propenamide, ethenylbenzene and alkyl 2-propenoate

Alkylacrylate d’alkyle polymérisé avec un acrylate d’alkyle, un [dialkyl(oxo)alkyl]acrylamide, du styrène et un autre acrylate d’alkyle

19104-6 N

1,3-Benzenedicarboxylic acid, polymer with 1,4-benzenedicarboxylic acid, 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, alkanediol, hexanedioic acid, 1,6-hexanediol, α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropanoate, 1,3-isobenzofurandione, 1,1′-methylenebis[isocyanatobenzene], 2-oxepanone and 2,2′-oxybis[ethanol]

Acide isophtalique polymérisé avec de l’acide téréphtalique, du 2,2-diméthylpropane-1,3-diol, de l’acide dodécanedioïque, un alcanediol, de l’acide hexanedioïque, de l’hexane-1,6-diol, de l’α-hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)], du 3-hydroxy-2,2-diméthylpropanoate de 3-hydroxy-2,2-diméthylpropyle, de la 2-benzofurane-1,3-dione, du 1,1′-méthylènebis[isocyanatobenzène], de l’oxépan-2-one et du 2,2′-oxybis[éthanol]

19105-7 N-P

2,5-Furandione, polymer with alkenylbenzene, C22-28-alkyl 2-alkylalkyl esters

Furane-2,5-dione polymérisée avec un alcénylbenzène, esters alkyliques en C22-28 et 2-alkylalkyliques

19106-8 N

1,4-Benzenedicarboxylic acid, polymer with dodecanedioic acid, 1,2-ethanediol, hexanedioic acid, 1,6-hexanediol, hexane derivative, α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,3-isobenzofurandione, 1,1′-methylenebis[4-isocyanatobenzene] and 2,2′-oxybis[ethanol]

Acide téréphtalique polymérisé avec de l’acide dodécanedioïque, de l’éthane-1,2-diol, de l’acide hexanedioïque, de l’hexane-1,6-diol, un hexane substitué, de l’α-hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)], de la 2-benzofurane-1,3-dione, du 1,1′-méthylènebis[4-isocyanatobenzène] et du 2,2′-oxybis[éthanol]

19107-0 N

Dodecanedioic acid, polymer with 2,2-dimethyl-1,3-propanediol, alkanediol, hexanedioic acid, 1,6-hexanediol, α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,1′-methylenebis[4-isocyanatobenzene] and α,α′,α″-1,2,3-propanetriyltris[ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)]]

Acide dodécanedioïque polymérisé avec du 2,2-diméthylpropane-1,3-diol, un alcanediol, de l’acide hexanedioïque, de l’hexane-1,6-diol, de l’α-hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)], du 1,1′-méthylènebis[4-isocyanatobenzène] et de l’α,α′,α″-(propane-1,2,3-triyl)tris[ω-hydroxypoly[oxy(propane-1,2-diyle)]]

19108-1 N

1,4-Benzenedicarboxylic acid, polymer with 2,2-dimethyl-1,3-propanediol, dodecanedioic acid, alkanediol, hexanedioic acid, 1,6-hexanediol, α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 1,3-isobenzofurandione, 1,1′-methylenebis[4-isocyanatobenzene], 2-oxepanone and 2,2′-oxybis[ethanol]

Acide téréphtalique polymérisé avec du 2,2-diméthylpropane-1,3-diol, de l’acide dodécanedioïque, un alcanediol, de l’acide hexanedioïque, de l’hexane-1,6-diol, de l’α-hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)], de la 2-benzofurane-1,3-dione, du 1,1′-méthylènebis[4-isocyanatobenzène], de l’oxépan-2-one et du 2,2′-oxybis[éthanol]

19109-2 N

Dodecanedioic acid, polymer with butyl 2-methyl-2-propenoate, hexanedioic acid, alkanediol, α-hydro-ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)], 2-hydroxyethyl 2-methyl-2-propenoate, 1,1′-methylenebis[4-isocyanatobenzene], methyl 2-methyl-2-propenoate, 2-methyl-2-propenoic acid and 2-oxepanone

Acide dodécanedioïque polymérisé avec du méthacrylate de butyle, de l’acide hexanedioïque, un alcanediol, de l’α-hydro-ω-hydroxypoly[oxy(propane-1,2-diyle)], du méthacrylate de 2-hydroxyéthyle, du 1,1′-méthylènebis[4-isocyanatobenzène], du méthacrylate de méthyle, de l’acide méthacrylique et de l’oxépan-2-one

19110-3 N-P

1,4-Benzenedicarboxylic acid, polymer with alkanedioic acid, 1,3-dihydro-1,3-dioxo-5-isobenzofurancarboxylic acid, ethenylbenzene, 2-ethylhexyl 2-propenoate, hexanedioic acid, α,α′-[(1-methylethylidene)di-4,1-phenylene]bis[ω-hydroxypoly(oxy-1,2-ethanediyl)], α,α′-[(1-methylethylidene)di-4,1-phenylene]bis[ω-hydroxypoly[oxy(methyl-1,2-ethanediyl)]] and 2-propenoic acid, tert-Bu peroxide-initiated

Acide téréphtalique polymérisé avec un acide alcanedioïque, de l’acide 1,3-dihydro-1,3-dioxo-2-benzofurane-5-carboxylique, du styrène, de l’acrylate de 2-éthylhexyle, de l’acide hexanedioïque, de l’α,α′-[(propane-2,2-diyl)di-4,1-phénylène]bis[ω-hydroxypoly(oxyéthane-1,2-diyle)], de l’α,α′-[(propane-2,2-diyl)di-4,1-phénylène]bis[ω-hydroxypoly[oxy(propane-1,2-diyle)]] et de l’acide acrylique, amorcé avec du peroxyde de tert-butyle

19111-4 N-P

Fatty acids, alkyl and C18-unsatd., polymers with isophthalic acid and pentaerythritol

Acides gras saturés et insaturés en C18 polymérisés avec de l’acide isophtalique et du 2,2-bis(hydroxyméthyl)propane-1,3-diol

Coming into Force

4 This Order comes into force on the day on which it is registered.

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 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 of posing 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 20 substances new to Canada and, under the Order 2017-87-02-01 Amending the Domestic Substances List, added the 20 new substances to the DSL. In addition, under this Order and based on new information, the Government updated the identifier of the substance Chemical Abstracts Service Register Number (CAS RN) 150409-28-2 by removing the letter “P” after its CAS RN on the DSL. The Government also applied the significant new activity (SNAc) (see footnote 2) provisions of CEPA to the substance CAS RN 1357160-95-2.

Background

Substances that are not on the DSL

These substances 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 that are on the DSL

The DSL 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:

Adding 20 substances to the DSL

The Government assessed information on 20 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 one substance 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 7) polymer criteria and that there was no suspicion of toxicity with this form of the substance. 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 substance CAS RN 150409-28-2 under a form that does not meet the RRR polymer criteria and determined that the non-RRR form of the substance also meets the conditions for its addition to the DSL. The letter “P” after the CAS RN of the substance was therefore removed from the DSL under this Order.

Applying SNAc requirements to 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 1357160-95-2 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 August 2016 (see footnote 8), 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

  1. comply with CEPA by adding 20 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);
  2. update the identifier of the substance CAS RN 150409-28-2 on the DSL based on new information available; and
  3. contribute to the protection of human health and the environment by maintaining the SNAc requirements associated with the substance CAS RN 1357160-95-2. 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 20 substances to the DSL. Six substances were added to Part 1 of the DSL, and 14 substances to Part 3 of the DSL. To protect confidential business information, 14 of the 20 substances have masked chemical names. (see footnote 9)

This Order removed the letter “P” after the substance CAS RN 150409-28-2 in Part 1 of the DSL.

This Order indicated that the substance CAS RN 1357160-95-2 is subject to the SNAc provisions under CEPA by moving the substance from Part 1 to Part 2 of the DSL, and adding a description of the significant new activities and associated information requirements. 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 in Canada.

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.

Significant new activities requiring a SNAN submission

1. The use of the substance, in a quantity greater than 100 kg in a calendar year, in the manufacture of

2. The use, in a quantity greater than 100 kg in a calendar year, of the substance, in

Activities not subject to the Order

The following activities with the substance CAS RN 1357160-95-2 do not require the submission of a SNAN.

1. The substance is used as a research and development substance, i.e. it is undergoing systematic investigation or research, by means of experimentation or analysis other than test marketing, whose primary objective is any of the following:

2. The substance is a site-limited intermediate, i.e. it is consumed in a chemical reaction used for the manufacture of another substance, and is

3. The substance is used in a consumer product, a natural health product, any other drug or a cosmetic — as described in the Order — that is for export only.

4. The substance is used in activities regulated under the Acts of Parliament listed in Schedule 2 of CEPA, namely the Pest Control Products Act, the Fertilizers Act and the Feeds Act.

5. The substance is a transient reaction intermediate that is not isolated and is not likely released, an impurity, a contaminant or a partially unreacted material related to the preparation of a substance or, in some circumstances, an item such as waste, mixture or manufactured item. 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 10)

Information must be provided to the Minister of the Environment 90 days prior to the beginning of the significant new activity. The Department of the Environment and the Department of Health 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 20 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 substance CAS RN 150409-28-2 under a form that does not meet the RRR polymer criteria and determined that the non-RRR form of the substance meets the conditions for its addition to the DSL. The identifier of the substance on the DSL was therefore updated under this Order by removing the letter “P” after the substance CAS RN.

Due to human health concerns, SNAc requirements have been added to the DSL for the substance CAS RN 1357160-95-2. 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, updating a substance identifier on 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 11) 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 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 12)

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 13)

CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy. (see footnote 14) 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

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: eccc.substances.eccc@canada.ca