Guidance for responding to the Notice with respect to certain nanomaterials in Canadian Commerce

Published in the Canada Gazette, Part I, on July 25, 2015

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This document provides guidance for responding to the Notice with respect to certain nanomaterials in Canadian commerce (the Notice) published in the Canada Gazette, Part I, on July 25, 2015, pursuant to paragraph 71(1)(b) of the Canadian Environmental Protection Act, 1999 (the Act). In case of discrepancy between this document and the Notice or the Act, the official versions of the Notice and the Act take precedence.

Table of Contents

1. Overview
2. Who does the Notice apply to?
3. Information required
4. Sections of the Notice to be completed
5. Request for confidentiality
6. Blind submission
7. Declaration of Stakeholder Interest
8. Declaration of Non-Engagement
9. Submission of voluntary information
10. Responding to the Notice
11. What if I need more time to comply with the Notice?
12. Contact information

1. Overview

1.1- Purpose of the Notice

Nanotechnology is a rapidly emerging field with the potential for use in a wide variety of applications across a broad range of sectors. Nanomaterials are substances that are manufactured at the nanoscale (between 1 to 100 nanometres, inclusive), or have internal or surface structures in the nanoscale (such as surface modified silica). Some nanomaterials exhibit unique properties which may give rise to new exposures and effects which need to be assessed for their potential risk to human health and the environment. Presently, consistent with chemicals, polymers and living organisms, nanoscale forms of substances that are not listed on the Domestic Substances List (DSL) are subject to the New Substances Notification Regulations (Chemicals and Polymers) under the Act. Nanoscale forms of substances listed on the DSL are considered existing nanomaterials and generally have not been considered in risk assessments conducted under the Act. Environment Canada and Health Canada want to ensure that nanomaterials currently in commerce in Canada are addressed as some may require further action to determine if they pose any potential risks to the environment or to human health, similar to the approach used with chemicals and living organisms.

In 2011, the Canada-United States Regulatory Cooperation Council (RCC) Nanotechnology Initiative^Footnote[1] was launched to increase alignment in regulatory approaches for nanomaterials between Canada and the US to reduce risk to human health and the environment; to promote sharing of scientific and regulatory expertise; and to foster innovation. Completed in February 2014, the RCC Nanotechnology Initiative included a work element on Commercial Information.^Footnote[2] This work element was aimed at increasing knowledge of commercial uses of nanomaterials in Canada and the US. The primary output from this work element was a Nanomaterials Use Matrix which identified nanomaterials by type and use category based on the most up-to-date information, at the time, on commercially available nanomaterials. The nanomaterial types were cross-referenced with the DSL to identify nanomaterials which could be considered existing in Canada. The result is a preliminary reference list and may not be comprehensive of all nanomaterials. Ongoing engagement with stakeholders through voluntary initiatives and other fora will inform further development of the list of existing nanomaterials in Canada.

The purpose of the Notice is to gather information on 206 nanomaterials identified as potentially in commerce in Canada from the primary reference list. The information collected from the Notice will support the development of a list of nanomaterials in commerce in Canada by confirming their commercial status, and subsequent prioritization activities for these substances, which may include risk assessment and risk management activities, if required. This will ensure that future decision making is based on the best available information.

An electronic copy of the Notice is available on the Chemical Substances Web site.

1.2- Reportable substances

Schedule 1 of the Notice lists 206 substances by their Chemical Abstracts Service Registry Number (CAS RN), which are listed in the table below.  The substances are reportable under the Notice only if they have a size of between 1 and 100 nanometres, in at least one external dimension, or internal or surface structure, and if they are found in the list below. Please see section 2 of this document for more information on the reporting criteria.

1.3- Determining if a substance is at the nanoscale

For the purposes of the Notice, nanoscale means a size range between 1 to 100 nanometres, inclusive, in any one external dimension, or internal or surface structure.

• External dimension refers to the length, width, or height of a substance.
• Internal structure refers to a feature on the inside of a substance, such as engineered pores, and the pores are externally accessible so as to have an effect.
• Surface structure refers to a feature on the surface of a substance, such as a substance with nanoscale beads engineered on its surface.

Examples:

• Substance A consists of particles with a diameter of 10 nm.  Substance A is considered a nanomaterial.
• Substance B is a porous material with a pore diameter of 50 nm.  Substance B is considered a nanomaterial.
• The surface of substance C is intentionally modified and as a result, substance C has a surface structure at the nanoscale.  Substance C is considered a nanomaterial.
• Substance D has particles greater than 150 nm in external dimension but a surface structure less than 100 nm.  Substance D is considered a nanomaterial.
• Substance E consists only of particles greater than 150 nanometres in all dimensions, including internal and surface structures.  Substance E is not considered a nanomaterial.
• Information available on Substance F claims the average particle size for Substance F is 800 nanometres in all dimensions and has no internal or surface structures in the nanoscale. Substance F is not considered a nanomaterial.

To determine if the substance is at the nanoscale, there are several types of information that can be considered.  These include technical data on material characterization (such as particle size), information from patents, and marketing claims (see section 3.1 of this document).

Many substances will have a distribution of particle sizes.  For the purposes of the Notice, the criteria set out in section 1 of Schedule 1 of the Notice would apply if the substance has 10% or more, by number count, of its particles in the nanoscale range (1 to 100 nanometres, inclusive).  This approach is consistent with approaches used in other jurisdictions.^{Footnote[3], Footnote[4], Footnote[5]}

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2. Who does the Notice apply to?

2.1- Reporting criteria

To determine whether a company is required to respond, the following factors must be considered:

• Type of substance (i.e., nanoscale form)
• Type of activity
• Calendar year
• Quantity
  • The quantity should be determined based on the quantity of the substance itself at the nanoscale, and not on the quantity of the product or mixture containing the substance.

The purpose of the Notice is to gather information on nanomaterials in commerce in Canada. A response is only required if the conditions set out in Schedule 1 and Schedule 2 of the notice are met.

The Notice applies to any person who, during the 2014 calendar year, satisfied any of the following criteria:

• Manufactured a total quantity greater than 100 kg of a substance listed in Schedule 1 that is at the nanoscale.
• Imported a total quantity greater than 100 kg of a substance listed in Schedule 1 that is at the nanoscale, at any concentration, whether alone, in a mixture or in a product.

The reporting threshold of 100 kg is based on activity with the substance in the nanoscale (i.e. you manufacture, or imported a total quantity greater than 100 kg of a substance with a size between 1 and 100 nanometres, inclusive, in at least one external dimension, or internal or surface structure).

Your response to the information requested should also be based on activities with the substance in the nanoscale.

If you are engaged with a substance that is not in the nanoscale (i.e. same CAS RN, but not nanoscale) and would like to identify yourself as a stakeholder for that substance, you may submit a Declaration of Stakeholder Interest (see section 7 of this document).

2.2- Exclusions

The following are excluded from the Notice:

• A substance set-out in the Notice, whether alone, in a mixture or in a product that:
• is in transit through Canada;
• is naturally occurring;
• is incidentally produced;
• is, or is contained in, a hazardous waste or hazardous recyclable material within the meaning of the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations and that was imported in 2014 pursuant to a permit issued under those Regulations;
• is, or is contained in, a pest control product within the meaning of subsection 2(1) of the Pest Control Products Act where that pest control product is registered under the Pest Control Products Act;
• is, or is contained in, a fertilizer or supplement within the meaning of section 2 of the Fertilizers Act where that fertilizer or supplement is registered under the Fertilizers Act; 
• is, or is contained in, a feed within the meaning of section 2 of the Feeds Act where that feed is registered under the Feeds Act; or
• is mixed with, or attached to, a seed within the meaning of section 2 of the Seeds Act where that seed is registered under the Seeds Act.

In addition, please note that the Notice does not apply to substances imported in a manufactured item.

For the purposes of the Notice, it is important to note the following:

• “naturally occurring” means a substance that occurs in nature and has not been processed, or has only been processed by manual or gravitational means, by dissolution in water, by flotation or by heating solely to remove water; or extracted from air by any means.  A substance that has been processed by mechanical means to create particles in the nanoscale, such as grinding, is not considered a naturally occurring substance and is reportable if the requirements outlined in Schedule 2 of the Notice have been met.
• “incidentally produced” refers to a reaction, during the process of blending or formulating of a specific substance, resulting in the manufacturing of a substance that is reportable under the Notice. This applies to substances that are incidentally produced during manufacturing, as well as incidentally produced substances that are imported, alone, in a mixture, or in a product. The Notice specifically targets nanomaterials intentionally produced. If a nanomaterial is produced as an unavoidable or unintentional by-product, impurity or contaminant as a result of a process, it is not considered intentionally produced. Incidental production of a substance is excluded from reporting.

2.3- Flowchart

The following flowchart can be used to determine whether a company is required to respond to the Notice:

Figure 1:  Reporting Diagram for Nanomaterials

2.4- Examples of how to determine whether the reporting criteria are met

The following are examples of how to determine whether the reporting criteria of the Notice are met:

1. Company meets the reporting criteria:
   • In 2014, if your company manufactured 4 000 kg of a reportable substance which contained 10% at the nanoscale, then the total quantity imported of the reportable substance is 400 kg and the reporting criteria are met.
   • In 2014, if your company imported 500 kg of Mixture X that contains 10% of a reportable substance and 300 kg of Product Y that contains 50% of the same reportable substance, then a total quantity of 200 kg of the substance was imported. The reporting criteria are met.
2. Company does not meet the reporting criteria:
   • If your company imported 1 000 kg of a reportable substance during the 2013 calendar year only, then the reporting year is not met.
   • In 2014, if your company purchased a reportable substance from a Canadian supplier and used greater than 100 kg of the substance to formulate a mixture or product, then the reportable activity type is not met.
   • In 2014, if your company imported 500 kg of a substance listed in Schedule 1, which contained 10% at the nanoscale, then the total quantity imported of the nanoscale substance is 50 kg and the quantity threshold of greater than 100 kg is not met.

2.5- Do I manufacture?

Manufacture relates to the creation or production of the substance itself, and not to the manufacture of a mixture or product containing the substance.

Manufacture activity under this notice refers to the intentional production or preparation of a nanomaterial. This includes the deliberate processing or engineering of a substance to exhibit the properties found when the substance is present at the nanoscale.

The Notice specifically targets nanomaterials intentionally produced. If during the process of blending or formulating a reaction occurs that results in the production of a nanomaterial as an unavoidable or unintentional by-product, impurity or contaminant, it is considered incidental production of the substance. For the purposes of the Notice, incidental production of a substance is excluded from reporting.

• For example, if you weld and/or grind metals to produce fabricated and/or smooth articles, the welding fume and/or grinding particulates generated by these activities are incidentally produced and are not reportable under the Notice.

Possible situations where you are considered to manufacture a substance include, but are not limited to, the following examples:

• You reacted substance A with substance B to produce substance C. You manufactured substance C (e.g. you reacted tetrachloroaurate with a reducing agent to produce gold nanoscale particles).
• You reacted a nanoparticle D with a surface agent E to produce a surface coated nanomaterial F.  You report on substance F (e.g. you reacted silicon dioxide nanoparticles with a surface agent to produce surface modified silica.  You report on the surface modified silica).
• You reacted substance G with substance H to make substance J and substance K was also produced as a reaction by-product. You manufactured substances J and K, but since K was incidentally produced it is not reportable under the Notice. 
• You mechanically grind substance L to produce nanoscale particles. Since nanomaterials produced by mechanically grinding are not considered naturally occurring for the purposes of the Notice, you report on nanomaterial L as you have manufactured it.
• You produce substance X through a chemical reaction and as a result, substance Y is also produced and is present in the nanoscale as an unavoidable impurity of substance X. Substance Y is incidentally produced and is not reportable under the Notice as it was not deliberately manufactured.
• You mechanically grind substance X to produce particles that are not nanomaterials and as a result, substance Y is also produced and is present in the nanoscale as an unavoidable impurity of substance X. Substance Y is incidentally produced and is not reportable under the Notice as it was not deliberately manufactured.

It is important to note that for the purpose of the Notice, using a substance set out in Schedule 1 (either alone, in a mixture or in a product) to create or produce a mixture or product would not be considered manufacture of the substance itself.

2.6- Do I import?

Import relates specifically to the movement into Canada from another country. Import activity under this notice is applicable when the imported substance is at the nanoscale, or a mixture or product contains a reportable substance at the nanoscale.

The Notice specifically targets nanomaterials intentionally produced. It does not apply to substances that are incidentally produced during manufacturing, as well as incidentally produced substances that are imported, alone, in a mixture, or in a product.

For the purposes of the Notice, possible situations where you are considered to import a substance include, but are not limited to, the following examples:

• You purchased a reportable substance from a foreign supplier, and the substance was shipped directly from the foreign supplier to your location in Canada.
• You ordered a mixture containing a reportable substance from a foreign source, and the mixture containing the substance was shipped directly from the foreign source to a distribution warehouse in Canada, on your request.
• You received a product containing a reportable substance as an internal company transfer from a location outside of Canada.

Your activities do not meet the definition of import if you purchased or received a reportable substance whether alone, in a mixture, or in a product that was already located in Canada.

Possible situations where you are not considered to import a substance include, but are not limited to, the following examples:

• You purchased goods from a Canadian company
• You ordered a product from a warehouse located in Canada
• You transferred a product containing a reportable substance across provincial borders to be stored in a different warehouse

2.7- What is a mixture?

A mixture is a combination of substances that does not produce a substance that is different from the substances that were combined (i.e., does not result in the formation of a new substance with its own CAS RN). For the purposes of the Notice, mixtures include, but are not limited to, the following examples:

• hydrates
• prepared formulations (e.g., a dispersion of a nanomaterial in a resin)
• reaction mixtures that are characterized in terms of their constituents

Hydrates of a substance or hydrated ions formed by association of a substance with water are considered to be a mixture of that substance and water. Therefore, if you manufactured or imported any hydrated form of an anhydrous substance set out in Schedule 1, then you are required to report on this substance if you meet the reporting criteria. The hydrated form is considered a mixture.

For the purposes of the Notice, mixtures that may contain reportable substances may include, but are not limited to, the following examples:

• fragrance mixtures
• textile inks
• printing inks
• gelling agent mixtures and solvent mixtures,
• PVC, plastisol, cellulosic plastics, polystyrene, polyurethane, polyacrylates, polyacetates, and other similar preparations containing nanomaterials.

2.8- What is a product?

A product is anything that does not meet the definition of a mixture or manufactured item. A substance alone is not considered to be a product.

• Note that a manufactured item is an item that is formed into a specific physical shape or design during manufacture and has, for its final use, a function or functions dependent in whole or in part on its shape or design. Manufactured items include sporting goods, furniture, appliances, electronics, batteries, medical devices, etc. For the purpose of the Notice, manufactured items are not reportable.

For the purpose of the Notice, products that may contain reportable substances may include, but are not limited to, the following examples:

• paints and coatings
• ink toners and colorants
• cosmetics and personal care products such as lipstick, mascara, eye shadow, creams, and lotions
• cleaning liquids, gels or sprays
• adhesives and glues

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3. Information required

The type of information requested in the Notice includes:

• CAS RN and name of the substance
• Basis for determining if the substance is at the nanoscale form
• Quantity of the substance manufactured or imported in 2014
• North American Industry Classification System (NAICS) codes
• Substance function codes and consumer and commercial codes
• Intended uses of the substance
• Titles of unpublished or published data or studies on the substance

3.1- Basis for determining if the substance is at the nanoscale form

Within the Notice, it is necessary to indicate the basis on which it was determined that the substances listed in Schedule 1 are the nanoscale form of the substances. Other sources/types of information that demonstrate how it is determined that the substance is at the nanoscale will be considered where appropriate.

• “Research & Development sources” refers to information and data from academic and other research institutions.
• “Technical data” refers to information and data from a supplier or from within a company.
• “Information available from patents” refers to information or data identified in a patent claim or application.
• “Marketing claim” refers to information used to promote or sell a substance, mixture, or product.
• “Assumption” refers to a supposition without proof or certain knowledge.
• “Other (specify)” should be indicated if the basis of your determination is not described by any of the options provided, and a written description of the source of information or data must be provided.

3.2- Quantities

Within the Notice, it is necessary to report the total quantities of substances set out in the Notice that were manufactured or imported during the 2014 calendar year, as follows:

• All quantities should be reported in kilograms (kg), rounded to two significant digits. For example:
  • 0.0368 should be reported as 0.037
  • 541 231 should be reported as 540 000
  • 831.29 should be reported as 830
• The quantities reported in the Notice must be for the reportable substance itself (i.e. the quantity in the nanoscale) and not the quantity of the mixture or product containing the reportable substance.

3.3- North American Industry Classification System codes

The North American Industry Classification System (NAICS) is an industrial classification system established to identify production processes by grouping similar activities. The codes were developed by Statistics Canada, the U.S. Office of Management and Budget, and Mexico's Instituto Nacional de Estadistica Geografia e Informatica, to enable the national agencies to collect comparable statistical data.

You are required to report each applicable six-digit NAICS code with respect to each substance, or the mixture, or product containing the substance. You should report the code(s) that best describes your involvement with the substance, or the mixture, or product, containing the substance. The code(s) will provide general information on the number and types of sectors involved with the substances listed in the Notice.

To determine which NAICS code applies to your activity with the substance on which you are reporting, the NAICS 2012 list of codes is available at the Statistics Canada Web site.

3.4- Substance function codes and consumer and commercial codes

Substance function codes and consumer and commercial codes are an accepted list of codes used to describe the function or use of a substance in a consistent manner. Substance function codes and consumer and commercial codes were developed jointly among the United States Environmental Protection Agency, Health Canada and Environment Canada in order to facilitate the exchange of information between the United States and Canada and to encourage consistency in reporting on chemical substances by industry.

Substance Function Code refers to the function of the substance itself with regards to the intended physical or chemical characteristic for which a chemical substance is consumed as a reactant; incorporated into a formulation, mixture, product, or manufactured item; or used.

• All substance function codes begin with the letter U followed by 3 numbers.

Consumer and Commercial Code refers to the application of a substance alone, or the mixture, product or manufactured item containing a substance with regards to its purpose in a consumer (end application) or commercial setting (i.e., the anticipated application of the substance, item or product).

• All consumer and commercial codes begin with the letter C, followed by three numbers.
• Refer first to the group descriptions to determine which subset of codes would be most applicable to your substance.
• Although the codes are entitled “Consumer and Commercial Codes”, these codes do apply to substances, mixtures, products, and manufactured items that may only be used in an industrial setting or for an industrial application.  

It is important to note that number 999 is reserved for the “Other” code in both substance function codes (U999) and consumer and commercial codes (C999). These codes should only be used when there is no existing code match for the application or function of the substance. When selecting this code, a written description of the substance function or the consumer and commercial application of a mixture, product, or manufactured item containing the substance, must be provided, and the description should be as concise as possible.

If a substance has more than one function or application, you should report all the applicable codes. For each code selected, additional information to describe the function or your application with the substance in more detail, can be provided in the “Notes” field of the online reporting form.

3.4.1- Code numbering system for substance function codes and consumer and commercial codes

All code numbers consist of one letter followed by a three-digit number. A basic structure of [Type][Group #][Subgroup #] is applied to all codes where:

[Type] is expressed by either the letter “U” for substance function or the letter “C” for consumer and commercial use.

[Group #] is a one-digit number to indicate a grouping of chemical substances or products having similar uses. Substance function codes are listed in alphabetical order and are not separated into different groups; therefore, all substance function codes have a group number 0. Consumer and commercial codes use six different group numbers (groups 1 – 5 and group 9).

[Subgroup #] is a two-digit number to indicate a specific use or function (within each group for consumer and commercial codes).

Please refer to the code names and descriptions below to determine if any of the pre-set codes applies to your substance. Wording in the description may indicate the use or function of the substance.

3.4.2- Substance Function Codes and Corresponding Descriptions

3.4.3- Consumer and Commercial Codes and Corresponding Descriptions

3.5- Intended uses

Not all persons responding to the Notice may know the exact or anticipated final use of the substance or the substance in the mixture or product. Therefore, when completing this section of the Notice, respond using the most complete and accurate information available to you.

Commercial activity refers to the use of a substance or the use of a mixture, or product containing a substance, by a commercial enterprise providing saleable goods or services. For example:

• Substance is contained in a mixture, and the mixture is sold to an enterprise as a resin.
• Substance is contained in a coating that is used by a company when providing their painting services to other persons or companies.

Consumer activity refers to the use of a substance that is directly sold or made available to consumers, whether alone or as part of a mixture or a product, for their use in or around a permanent or temporary household or residence, a school, or a recreational area. For example:

• Substance is contained in a paint sold or made available to consumers for household use.
• Substance is contained in a cleaning product sold or made available to consumers for household use.

When responding to whether the known or anticipated final substance, mixture, or product, containing the reportable substance is intended for use by or for children, the following guidance can be considered:

For the purpose of section 5 of Schedule 3 only, "Children" are considered persons 14 years of age or younger.

Your substance, whether alone, in a mixture or in a product, containing the reportable substance, is intended for use by or for children, when you answer “yes” to at least one of the following questions:

1. Is the substance, whether alone, in a mixture, or in a product, commonly recognized (i.e., by a reasonable person) as being intended for children age 14 or younger?
2. Does the manufacturer of the substance, or mixture, or product, containing the substance, state through product labeling or other written materials that the product is intended for or will be used by children age 14 or younger?
3. Is the advertising, promotion, or marketing of the substance, or mixture, or product, containing the substance, aimed at children age 14 or younger?

For example, certain products such as personal care products (e.g., baby shampoo, children’s toothpaste) and finger paints are typically to be used by children age 14 or younger.  Other types of products such as household cleaning products, and lubricants are not typically intended to be used by children age 14 or younger.

3.6- Titles of unpublished or published data or studies

For the purposes of the Notice, data or studies are considered "unpublished" if they are not readily found using standard search engines (e.g., Scopus, Pubmed, Toxline, etc.). The unpublished data or studies submitted can be from any calendar year.

The titles of unpublished data or studies related to the nanoform of the substance should be submitted. Note that if you are in possession of studies on the non-nanoscale form of the substance but feel it may be relevant to the nanoscale form, you are encouraged to provide that information. For example, a study title on a physical-chemical property used to characterize the nanoscale form of a substance such as particle size distribution is required to be reported under the Notice.

If available, the study title should include the author(s), and the year in which the study was performed.  If available, the journal reference should also be provided.

Full data or studies can be submitted voluntarily as an attachment to your submission. You are encouraged to provide the data or studies in electronic format (either on a CD, DVD or USB memory stick), or if the file size is small enough, you can submit it by email.  Please note that compressed files (e.g., .zip, .rar) are not accepted for security reasons.

If you are in possession of studies on the bulk (non-nanoscale) form of the substance that you feel may be relevant or may apply to the nanoscale form of the substance, you are encouraged to submit that information via a Declaration of Stakeholder Interest (see section 7 of this document).  

3.7- Information to which you may reasonably be expected to have access

You are required to provide information that your company possesses or to which you may reasonably be expected to have access. For example, when importing a substance, mixture or product, you may reasonably be expected to have access to import records and the relevant Safety Data Sheet (SDS). A SDS is an important source of information on the composition of a purchased product. Note that the goal of the SDS is to protect the health of the workers, not the environment. Therefore, a SDS may not list all product ingredients on which the Minister of the Environment is requiring information under the Notice. You may wish to contact your supplier for more detailed information on product composition. Manufacturers would be reasonably expected to have access to their formulations.

Also, a company may have access to information from its parent company regarding substances, mixtures, or products.

You are not required to conduct tests to comply with the Notice.

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4. Sections of the Notice to be completed

A person must respond to the Notice if they meet the reporting criteria listed in Schedule 2 by completing the sections of the Notice applicable to their activity:

If you are a company who owns more than one facility, then you must respond to the Notice on a company-wide basis, and your response for each applicable question in the Notice should be an amalgamated response to include information from all facilities owned by the company.

As indicated in Schedule 3 of the Notice, where information required has already been submitted to the Minister of the Environment, or to the Minister of Health, it may be relied on as a response to any question in the Notice if:

• the information previously submitted is applicable to the 2014 calendar year;
• the information meets the requirements of the specific question;
• the person agrees that the previously submitted information referred to is their response to the specified provision of Schedule 3 to the Notice; and
• the person provides the following information:
  • the CAS RN of the substance(s) to which the submitted information relates;
  • the specific section; subsection; or paragraph to the Notice to which the submitted information relates;
  • the date on which the information was submitted;
  • the name of the person who submitted the information; and
  • the program and individuals at Environment Canada or at Health Canada to which the information was submitted.

It is important to note that the previously submitted information is not required to be resubmitted under the Notice; however, the information specified above must be provided as an attachment to your submission.

Example 2:

Section 6 of Schedule 3 to the Notice requests the submission of study title(s) of any unpublished or published data or studies on reportable substance(s) with regards to ecotoxicity. If, during a previous voluntary or mandatory data collection initiative, your company provided studies to the Minister of the Environment or Minister of Health for a substance set out in the Notice, and the data is still applicable, you should reference the previously submitted information in response to the applicable section(s) of Schedule 3.

4.1- Section 4 of Schedule 3

For each substance set out in the Notice that a person manufactured or imported during the 2014 calendar year, for which the reporting criteria have been met, the person shall provide the following information:

• in (a) the CAS RN and the name of the substance;
• in (b) the basis on which the substance identified in (a) was determined to be in nanoscale form by indicating “Research & Development sources”, “technical data”, “information available from patents”, “marketing claim”, “assumption”, or “other (specify)”;
  • If “other (specify)” is indicated, then a written description of the source of information or data must be provided.
• in (c) the total quantity of the substance manufactured or imported, reported in kilograms (rounded to 2 significant digits);
• in (d) each applicable six-digit North American Industry Classification System (NAICS) code(s) with respect to the substance, or the mixture, or product containing the substance reported in (a); and
• in (e) each substance function code that applies to the function of the substance.
  • Choose the substance function code(s) that are consistent with the most complete and accurate information available to you.
  • If the substance has a function that is not described in any of the substance function codes provided, then code U999 should be used. A written description of the function of the substance must be provided when using this code and the description should be as concise as possible.
  • Not all persons may know the intended function of the substance. Therefore, a substance function code may be difficult to identify. However, when completing this section of the Notice, respond using the most complete and accurate information available to you.

Example 3:

In 2014, you imported a total of 2 000 kg of a reportable substance (CAS RN 63231-67-4) within a product, which was intended to serve as a paint additive (substance function code U034). The substance was determined to be in nanoscale form after consulting with your company’s technical data. The NAICS code that best describes your involvement with the substance is code 238320 (Paint and wall cover contractors).

4.2- Section 5 of Schedule 3

For each substance set out in the Notice that a person manufactured or imported during the 2014 calendar year, for which the reporting criteria have been met, the person shall provide the following information:

• in (a) the CAS RN of the substance;
• in (b) each consumer and commercial code that applies to the substance, or to the known or anticipated final, mixture, or product containing the substance;
  • Choose the consumer and commercial code(s) that are consistent with the most complete and accurate information available to you.
  • If none of the consumer and commercial codes provided apply, then code C999 should be used. A written description of the application of the substance, or of the mixture, or product containing the substance, must be provided when using this code and the description should be as concise as possible.
• in (c), for each applicable consumer and commercial code listed in (b), indicate with a “Yes” or “No” whether the substance or the known or anticipated final mixture, or product containing the substance is intended for use in commercial activities.
• in (d), for each applicable consumer and commercial code listed in (b), indicate with a “Yes” or “No” whether any known or anticipated final substance, mixture, or product containing the substance is intended for use in consumer activities.
• in (e), for each applicable consumer and commercial code listed in (b), indicate with a “Yes” or “No” whether any known or anticipated final substance, mixture, or product containing the substance is intended for use by or for children 14 years of age or younger.

Example 4:

In 2014, you imported a mixture which contained two reportable substances, Substance A (CAS RN 7631-86-9 with pores in the nano range), and Substance B (CAS RN 1344-28-1 with 15% of particles at the nanoscale).  The mixture was used in the production of an adhesive/sealant and a plastic/rubber material (consumer and commercial codes C201 and C303).

4.3- Section 6 of Schedule 3

For each substance set out in the Notice that a person manufactured or imported during the 2014 calendar year, for which reporting criteria have been met, the person shall provide the following information from any calendar year:

• in (a) the CAS RN of the substance;
• in (b) provide the study title(s) for any unpublished or published data or studies on the substance with regards to any of the following:
  1. physical-chemical properties,
  2. bioaccumulation,
  3. persistence,
  4. toxicity,
  5. metabolism,
  6. degradation,
  7. release or disposal of the substance from the final mixture or product.

Example 5:

A person who responds to the Notice possesses published studies on particle size distribution and dermal toxicity for a reportable substance. In addition, the person also possesses unpublished studies on degradation for the same substance.  Therefore, this person should include the study title of both of these studies.

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5. Request for confidentiality

Pursuant to section 313 of the Act, any person who provides information in response to the Notice may submit, with the information, a written request that it be treated as confidential. A request for confidentiality may be submitted for all or part of the information provided.

A request should only be made for information that is truly confidential.

When submitting a request for confidentiality, the following criteria should be considered:

• the information is confidential to your company and has consistently been treated as such by your company;
• your company has taken, and intends to continue to take, measures that are reasonable in the circumstances to maintain the confidentiality of the information;
• the information is not, and has not been, reasonably obtainable by third persons by use of legitimate means, except with the consent of your company;
• the information is not available to the public;
• disclosure of the information may reasonably be expected to cause substantial harm to the competitive position of your company; or
• disclosure of the information may reasonably be expected to result in a material financial loss to your company or a material financial gain to your company’s competitors.

Upon receipt of a request for confidentiality under section 313 of the Act, in relation to information submitted pursuant to the Notice, the Minister of the Environment shall not disclose that information, except in accordance with the law.

Any person who provides information in response to the Notice, and requests that the information be treated as confidential is encouraged to include a rationale indicating the reason for requesting confidentiality. The rationale is requested for each substance on which the person has reported in their response to the Notice. Through the online reporting tool, the rationale is provided by selecting at least one of the following criteria that applies to the information identified as confidential:

1. it is a trade secret of the submitter;
2. it is information of a financial, commercial, scientific or technical nature that is treated consistently in a confidential manner by the submitter;
3. its disclosure could reasonably be expected to result in material financial loss or gain to, or could reasonably be expected to prejudice the competitive position of the submitter; or
4. its disclosure could reasonably be expected to interfere with contractual or other negotiations of the submitter.

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6. Blind submission

A “Blind Submission” is a two-part submission where customers and their suppliers collaborate to meet the obligation to respond to the Notice.

The customer responds to the Notice, completing as much information as they can.  If customers do not possess some information, they may ask their suppliers if the mixtures or products they purchase contain substances set out in Schedule 1 to the Notice.

Suppliers looking to protect their formulations as confidential business information may be reluctant to provide the information to their customers. In this case, the customer submits all information in their possession and the supplier submits the remainder of the information directly to the Substances Management Coordinator, to complete the submission. A cover letter or note should be provided with each submission indicating that the supplier’s submission completes the customer’s submission.

If a supplier knows/suspects that a customer should report, based on quantities purchased, the supplier may choose to inform the customer of this.

Example 6:

During 2014, Company A imported Product 123 into Canada from Company B. Company A follows up with Company B to obtain information on the composition of Product 123 to determine whether any substance set out in Schedule 1 is present in Product 123.  Company B confirms that Product 123 contains a substance set out in Schedule 1 to the Notice and that based on the total quantity of Product 123 sold to Company A in 2014, Company A would meet the reporting criteria outlined in Schedule 2 to the Notice for that reportable substance.  However, Company B is reluctant to share their product composition information with Company A which would identify a substance set out in Schedule 1 is contained in Product 123, since their formulation is confidential.

Company A can submit a "Blind Submission" jointly with Company B, in which:

• Based on information in their possession, Company A responds to the Notice providing as much information as they can (e.g., the quantity of Product 123 imported in 2014, and information on the known or anticipated final mixture, etc.).  Along with their submission, Company A should provide a cover letter to clearly explain the situation and identify Company B as their direct foreign supplier. 
• Company B provides the confidential information required to complete Company A's submission directly to the Substances Management Coordinator (e.g., the CAS RN, substance name and the substance function).  Along with their submission, Company B should provide a cover letter to clearly indicate that their information is confidential and that it completes Company A's submission.

The Substances Management Coordinator makes the necessary connection between the two submissions in order to complete the submission of Company A, while keeping all information confidential.

Please note that blind submissions cannot be submitted online via Environment Canada’s Single Window. For further information on how to submit a blind submission, contact the Substances Management Information Line (see section 12 of this document).

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7. Declaration of Stakeholder Interest

Persons not subject to the Notice, but who have a current or future interest in a substance listed in Schedule 1 of the Notice or in any other substances of interest, are encouraged to identify themselves as a “stakeholder” for the substance by completing the voluntary Declaration of Stakeholder Interest using the online reporting system via Environment Canada’s Single Window available from the Chemical Substances Web site.

Interested stakeholders will be included in future mailings regarding these substances and may be contacted for further information regarding their interest in these substances. When completing the declaration, you should:

• identify the substance(s) of interest to you, and
• specify your activity or potential activity with the substance(s) (e.g., import, manufacture, or use)

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8. Declaration of Non-Engagement

Persons who do not meet the requirements to respond to the Notice and have no commercial interest in the substances covered by the Notice may submit a Declaration of Non-Engagement for the Notice using the online reporting system via Environment Canada’s Single Window. The online reporting system is available from the Chemical Substances Web site.

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9. Submission of voluntary information

Interested stakeholders are encouraged to submit additional information that is deemed beneficial on any of the reportable substances voluntarily, through a Declaration of Stakeholder Interest using the online reporting system via Environment Canada’s Single Window. The online reporting system is available from the Chemical Substances Web site.

For example, if you did not have activity with a substance in 2014, but had activity in alternate calendar years, you are encouraged to provide information deemed beneficial for the alternate calendar years voluntarily by completing a Declaration of Stakeholder Interest.

When providing voluntary information, please clearly indicate that the information is voluntary and provide the calendar year for which it applies.

This information will help the Government of Canada improve decision making for these substances and ensure all activities are considered before moving forward with further actions regarding these substances.

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10. Responding to the Notice

Responses to the Notice must be provided no later than February 23, 2016, 5 p.m. Eastern Standard Time using the online reporting system available through Environment Canada’s Single Window available from the Chemical Substances Web site.

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11. What if I need more time to comply with the Notice?

If you require more time to comply with the Notice, you may submit a request in writing for an extension of time. The request should include the CAS RN of the substance(s) on which information will be reported and the reason for the request.

It is important to note that you must request an extension of time before the February 23, 2016, 5 p.m. Eastern Standard Time deadline. No extensions will be granted after the deadline has expired. It is recommended that any request for an extension be submitted at least five business days before February 23, 2016, 5 p.m. Eastern Standard Time, so that a request can be processed by the Minister of the Environment before expiry of the deadline.

Requests for an extension of time should be sent to the Minister of the Environment, to the attention of:

Substances Management Coordinator
Chemicals Management Plan
Gatineau QC, K1A 0H3
E-mail:  Substances@ec.gc.ca

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12. Contact information

Inquiries concerning the Notice may be directed to the Substances Management Information Line at:

• Telephone: 1-800-567-1999 (Toll-free in Canada) or 819-938-3232 (Outside of Canada)
• E-mail:  Substances@ec.gc.ca (Indicate in the subject line "Nanomaterials Inquiry")