Vol. 151, No. 17 — August 23, 2017

Registration

SOR/2017-158 August 2, 2017

CANADIAN ENVIRONMENTAL PROTECTION ACT, 1999

Order 2017-87-06-01 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 2017-87-06-01 Amending the Domestic Substances List.

Gatineau, July 31, 2017

Catherine McKenna
Minister of the Environment

Order 2017-87-06-01 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 3 of the List is amended by adding the following in numerical order:

19162-0 N-P

1,6-Hexanedioic acid, polymer with dimethyl derivative, 2,2-dimethyl-1,3-propanediol, 1,2-ethanediamine, 1,6-hexanediol, 3-hydroxy-2-(hydroxymethyl)-2-methylpropanoic acid and 1,1′-methylenebis[4-isocyanatocyclohexane], compd. with N,N-diethylethanamine

 

Acide hexane-1,6-dioïque polymérisé avec un diméthyle substitué, du 2,2-diméthylpropane-1,3-diol, de l’éthane-1,2-diamine, de l’hexane-1,6-diol, de l’acide 2,2-bis(hydroxyméthyl)propanoïque et du 1,1′-méthylènebis[4-isocyanatocyclohexane], composé avec de la N,N-diéthyléthanamine

19163-1 N-P

Linseed oil, polymer with alkanediol, pentaerythritol and TDI

 

Huile de lin polymérisée avec un alcanediol, du 2,2-bis(hydroxyméthyl)propane-1,3-diol et du diisocyanate de toluène

19164-2 N

2,5-Furandione, polymer with ethene and alkene, heteromonocycle alkyl imide

 

Furane-2,5-dione polymérisée avec de l’éthène et un alcène, (hétéromonocycle)alcanimide

19165-3 N

Benzoic acid, hydroxyl, mono-alkyl derivs., calcium salts (2:1)

 

Monoalkyl-hydroxybenzoates de calcium (2/1)

19167-5 N-P

Terephthalic acid polymer with 1,4:3,6-dianhydro-heteropolycycle-ol, 1,4-cyclohexanedimethanol and 1,2-ethandiol

 

Acide téréphtalique polymérisé avec du 1,4:3,6-dianhydro-hétéropolycycle-ol, du cyclohexane-1,4-diméthanol et de l’éthane-1,2-diol

19169-7 N-P

2-Propenoic acid, 2-methyl-, 1,1-dimethylethyl ester, polymer with dodecyl 2-methyl-2-
propenoate, ethenylbenzene, 2-hydroxyethyl 2-methyl-2-propenoate and oxo-heteromonocycle, tert-Bu 2-ethylhexaneperoxoate-initiated

 

Méthacrylate de tert-butyle polymérisé avec du methacrylate de dodécyle, du styrène, du methacrylate de 2-hydroxyéthyle et un oxo-hétéromonocycle, amorcé avec du 2-éthylhexaneperoxoate de tert-butyle

19170-8 N

Alkylalcohol reaction products with phosphorus oxide, compds. with alkylalkaneamine

 

Alkylalcool, produits de la réaction avec de l’oxyde de phosphore, composés avec une alkylalcanamine

3 Part 4 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

19100-2 N-S

1 The use, in the manufacture of a consumer product to which the Canada Consumer Product Safety Act applies or a cosmetic, as defined in section 2 of the Food and Drugs Act, of the substance heteromonocycle, 2-methyl-, polymer with oxirane, carboxymethyl octadecyl ether in a quantity greater than 1000 kg in a calendar year and in such a manner that the substance is present in the consumer product or cosmetic.

 

2 The use, in a quantity greater than 1000 kg in a calendar year, of heteromonocycle, 2-methyl-, polymer with oxirane, carboxymethyl octadecyl ether in a consumer product to which the Canada Consumer Product Safety Act applies or 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 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 items 1, 3 to 7, 9 to 12 and 13(d) of Schedule 9 to the New Substances Notification Regulations (Chemicals and Polymers);
  • (d) if the significant new activity involves the use of the substance in a quantity greater than 50 000 kg in a calendar year, the information specified in
    • (i) paragraphs 11(3)(a) and (c) of those Regulations, and
    • (ii) items 5(a) to (g) of Schedule 10 to those Regulations;
  • (e) the information specified in item 5(h) of Schedule 10 to those Regulations;
  • (f) the test data and the test report obtained from a skin sensitization study, in respect of the substance, that is conducted in accordance with the Organisation for Economic Co-operation and Development (OECD) Guideline for the Testing of Chemicals No. 429, entitled Skin Sensitization: Local Lymph Node Assay, that is current at the time the study is conducted;
  • (g) a summary of all other information or test data in respect of the substance that is in the possession of the person who is proposing the significant new activity, or to which they have access, and that are relevant to identifying the hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance;
  • (h) 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;
  • (i) 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
  • (j) 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 study referred to in paragraph 4(f) must be conducted by a laboratory whose practices conform with those 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.

19101-3 N-S

1 The use, in the manufacture of a consumer product to which the Canada Consumer Product Safety Act applies or a cosmetic, as defined in section 2 of the Food and Drugs Act, of the substance heteromonocycle, 2-methyl-, polymer with oxirane, carboxymethyl hexadecyl ether in a quantity greater than 1000 kg in a calendar year and in such a manner that the substance is present in the consumer product or cosmetic.

 

2 The use, in a quantity greater than 1000 kg in a calendar year, of heteromonocycle, 2-methyl-, polymer with oxirane, carboxymethyl hexadecyl ether in a consumer product to which the Canada Consumer Product Safety Act applies or 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 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 items 1, 3 to 7, 9 to 12 and 13(d) of Schedule 9 to the New Substances Notification Regulations (Chemicals and Polymers);
  • (d) if the significant new activity involves the use of the substance in a quantity greater than 50 000 kg in a calendar year, the information specified in
    • (i) paragraphs 11(3)(a) and (c) of those Regulations, and
    • (ii) items 5(a) to (g) of Schedule 10 to those Regulations;
  • (e) the information specified in item 5(h) of Schedule 10 to those Regulations;
  • (f) the test data and the test report obtained from a skin sensitization study, in respect of the substance, that is conducted in accordance with the Organisation for Economic Co-operation and Development (OECD) Guideline for the Testing of Chemicals No. 429, entitled Skin Sensitization: Local Lymph Node Assay, that is current at the time the study is conducted;
  • (g) a summary of all other information or test data in respect of the substance that is in the possession of the person who is proposing the significant new activity, or to which they have access, and that are relevant to identifying the hazards of the substance to the environment and human health and the degree of environmental and public exposure to the substance;
  • (h) 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;
  • (i) 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
  • (j) 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 study referred to in paragraph 4(f) must be conducted by a laboratory whose practices conform with those 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.

4 (1) Sections 1 and 2 in column 2 of Part 4 of the List, opposite the reference to the substance “19100-2 N-S” in column 1, are replaced by the following:

(2) Sections 1 and 2 in column 2 of Part 4 of the List, opposite the reference to substance “19101-3 N-S” in column 1, are replaced by the following:

Coming into Force

5 (1) This Order, except section 4, comes into force on the day on which it is registered.

(2) Section 4 comes into force on February 28, 2018.

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the orders.)

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 over the thresholds set in the New Substances Notification Regulations (Chemicals and Polymers) (see footnote 2) and the New Substances Notification Regulations (Organisms). (see footnote 3) 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. Substances on the DSL are not subject to notification and assessment requirements under the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms).

When substances are suspected of posing a risk to human health or the environment if used in certain new activities, they can be added to the DSL with requirements under the significant new activity (SNAc) (see footnote 4) provisions of CEPA. This enables the Government of Canada (the Government) to assess risks associated with these activities, before they are undertaken in Canada. When substances are not suspected of posing a risk, they can be added to the DSL without reporting requirements.

Under the authority of CEPA, the Government assessed information on 15 substances new to Canada and determined that they meet the criteria for addition to the DSL. These substances were added to the DSL under the Order 2017-87-06-01 Amending the Domestic Substances List. SNAc requirements for 2 of these 15 substances were also maintained. Furthermore, the Government updated the masked names of two substances on the DSL under the Order 2017-66-06-01 Amending the Domestic Substances List.

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 set out in subsections 81(1) and 106(1) of CEPA, as well as in the New Substances Notification Regulations (Chemicals and Polymers) and the New Substances Notification Regulations (Organisms). These regulations were created to ensure that no new substance is introduced to the Canadian marketplace over certain thresholds before a risk assessment is completed and the appropriate control measures taken, if deemed necessary.

Substances on the DSL

The DSL is an inventory of substances in the Canadian marketplace published in the Canada Gazette, Part II, in May 1994. (see footnote 5) The DSL is amended on average 10 times a year to add or delete substances. These amendments may also include additions, variations, or rescissions of SNAc requirements on the DSL.

The current structure of the DSL was established in July 2001, (see footnote 6) and it includes eight parts defined as follows:

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 15 substances to the DSL (Order 2017-87-06-01 Amending the Domestic Substances List)

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. This will remove the notification and assessment requirements under the New Substances Notification Regulations (Chemicals and Polymers).

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 2 of the 15 substances (CAN 19100-2 and CAN 19101-3) and identified potential human health concerns if the substances are used in certain new activities. For this reason, the SNAc provisions under CEPA were applied to these substances in February 2017, (see footnote 10) before their addition to the DSL. In order to maintain the reporting requirements on the substances, SNAc requirements were added to the DSL under this Order.

Updating the masked names for two substances (Order 2017-66-06-01 Amending the Domestic Substances List)

The masked names of two substances on Part 3 of the DSL (CAN 19113-6 and CAN 19116-0) have been updated to correct typographical errors.

Objectives

The objectives of Order 2017-87-06-01 Amending the Domestic Substances List are to comply with subsections 87(1) and (5) of CEPA by adding 15 substances to the DSL and to maintain the SNAc requirements associated with the substances CAN 19100-2 and CAN 19101-3.

The objective of Order 2017-66-06-01 Amending the Domestic Substances List is to update the masked names of CAN 19113-6 and CAN 19116-0 on the DSL.

Description

Order 2017-87-06-01 Amending the Domestic Substances List

This Order added 15 substances to the DSL. Six substances identified by their CAS RN were added to Part 1 of the DSL and seven substances identified by their masked name and their CAN were added to Part 3 of the DSL. This Order also added two substances identified by their masked name and their CAN to Part 4 of the DSL.

This Order indicated that the two substances (CAN 19100-2 and CAN 19101-3) added to Part 4 of the DSL are subject to the SNAc provisions under CEPA. Therefore, it is mandatory to meet the requirements of subsection 81(3) of CEPA before manufacturing, importing or using the substances 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 substances 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, in the manufacture of a consumer product to which the Canada Consumer Product Safety Act applies or a cosmetic, as defined in section 2 of the Food and Drugs Act, of the substance in a quantity greater than 1 000 kg in a calendar year and in such a manner that the substance is present in the consumer product or cosmetic.

2. The use, in a quantity greater than 1 000 kg in a calendar year, of the substance in a consumer product to which the Canada Consumer Product Safety Act applies or a cosmetic, as defined in section 2 of the Food and Drugs Act.

1. The use, in the manufacture of a consumer product to which the Canada Consumer Product Safety Act applies or a cosmetic, as defined in section 2 of the Food and Drugs Act, of the substance in such a manner that the substance is present in the consumer product or cosmetic in a concentration that is greater than or equal to 1% by weight.

2. The use, in a quantity greater than 10 kg in a calendar year, of the substance in a consumer product to which the Canada Consumer Product Safety Act applies or a cosmetic, as defined in section 2 of the Food and Drugs Act, in which the substance is present in a concentration that is greater than or equal to 1% by weight.

Activities not subject to the SNAc requirements

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:

a. to create or improve a product or process;

b. to determine the technical viability or performance characteristics of a product or process; or

c. to evaluate the substance prior to its commercialization, by pilot plant trials, production trials, including scale-up, or customer plant trials, so that technical specifications can be modified in response to the performance requirements of potential customers.

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 that is

a. manufactured and consumed at the site of manufacture;

b. manufactured at one site and transported to a second site where it is consumed; or

c. imported and transported directly to the site where it is consumed.

3. The substance is used in a consumer product 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 11)

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.

Order 2017-66-06-01 Amending the Domestic Substances List

This Order updated the masked names of two substances on Part 3 of the DSL (CAN 19113-6 and CAN 19116-0).

Consultation

As these orders do not contain any information expected to generate comments by stakeholders, no consultation is deemed necessary.

Rationale

Substances new to Canada are subject to notification and assessment requirements before they can be manufactured or imported over the thresholds set in the New Substances Notification Regulations (Chemicals and Polymers) or the New Substances Notification Regulations (Organisms). 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 and, therefore, they are exempt from notification and assessment requirements under the New Substances Notification Regulations (Chemicals and Polymers).

Due to potential human health concerns, SNAc requirements for the substances CAN 19100-2 and CAN 19101-3 have been maintained and added to the DSL. This will enable the Government to assess the risks associated with significant new activities involving these substances before they are undertaken.

The masked names of two substances on Part 3 of the DSL (CAN 19113-6 and CAN 19116-0) have been updated to correct typographical errors.

“One-for-One” Rule and small business lens

The orders do not trigger the “One-for-One” Rule, as they do not add any additional costs to business. Also, the small business lens does not apply to the orders, as they do 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, maintaining SNAc requirements, or updating masked names.

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 12) 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, 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 13)

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 orders 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 14)

CEPA is enforced in accordance with the publicly available Compliance and Enforcement Policy for CEPA. (see footnote 15) 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

Julie Thompson
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