Guidance for responding to the Notice with respect to certain polymers on the Domestic Substances List

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 polymers on the Domestic Substances List (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

As part of the Chemicals Management Plan (CMP), Environment Canada and Health Canada have committed to assess and manage, where appropriate, the potential health and ecological risks of approximately 600 polymeric substances identified as priorities for action based on the categorization exercise completed in 2006. Polymers are a unique class of substances, where the same Chemical Abstracts Service Registry Number (CAS RN) can be used to describe substances that have different molecular weights, toxicity, and physical and chemical properties. Therefore, a tailored approach was developed to address the complexity of the polymers assessment, and a final version entitled Approach under the Canadian Environmental Protection Act, 1999 to address polymers on the Domestic Substances List that were identified as priorities during categorization  was published on the Chemical Substances website in December 2014.

Preliminary information was collected for the polymers through the second phase of the Domestic Substances List Inventory Update (DSL IU2) in December 2012. Information submitted in response to the DSL IU2 indicated whether a candidate substance was in commerce in Canada at a quantity above the reporting threshold of 1 000 kg during the 2011 calendar year. Polymers identified through DSL IU2 as not being in commerce at greater than 1 000 kg were assessed using a rapid screening approach. The draft rapid screening assessment for polymers was published in February 2015.

In February 2015, a voluntary information gathering initiative on polymers was initiated by the Government of Canada to obtain additional information from importers and manufacturers in order to inform future risk assessment for the polymers reported to be in commerce above 1 000 kg under DSL IU2, and some polymers that were identified as requiring further assessment based on the rapid screening approach. Based on an analysis of the data received, it was determined that further information gathering through a mandatory section 71 notice is needed on approximately 300 polymers to inform risk assessment.

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

1.2- Reportable substances

Schedule 1 of the Notice lists the reportable substances by either their CAS RN, or their Confidential Accession Number if they are listed on the confidential portion of the DSL. Schedule 1 is divided into two parts:

• Part 1 lists polymers that are reportable under the Notice at greater than 1 000 kg
• Part 2 lists polymers that are reportable under the Notice at greater than 100 kg

There are a total of 302 polymers included in the Notice, and they are listed below:

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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 activity
• Calendar year
• Concentration
• Quantity
• • This is the quantity of the substance itself, and not the quantity of the product or mixture containing the substance.

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

• Manufactured a total quantity greater than 1 000 kg of a substance listed in Part 1 or greater than 100 kg of a substance listed in Part 2 of Schedule 1.
• Imported a total quantity greater than 1 000 kg of a substance listed in Part 1 or greater than 100 kg of a substance listed in Part 2 of Schedule 1, at a concentration equal to or above 1% by weight (w/w%), whether:
  1. alone, in a mixture, in a product; or
  2. in a manufactured item that is:
     1. intended to come into contact with the mucosa of an individual, other than eyes;
     2. cookware, or a cooking or serving utensil that is intended to come into direct contact with heated food within a residence, unless the component that comes into direct contact with heated food is made of glass, stainless steel or porcelain;
     3. food packaging that is intended to come into direct contact with food, unless the component that comes into direct contact with food is made of glass, stainless steel or porcelain;
     4. a reusable food or beverage container, unless the component that comes into direct contact with the food or beverage is made of glass, stainless steel or porcelain; or
     5. intended to release the substance during conditions of use such that the substance may be inhaled or come into dermal contact with an individual.
• Used a total quantity greater than 1 000 kg of a substance listed in Part 1 or greater than 100 kg of a substance listed in Part 2 of Schedule 1, at a concentration equal to or above 1% by weight (w/w%), to manufacture (i.e., to create or produce) a mixture, product or manufactured item, whether the substance is used alone, in a mixture or in a product.

2.2- Exclusions

The following are excluded from the Notice:

• A substance listed in Schedule 1, whether alone, in a mixture, in a product, or in a manufactured item that:
• • is in transit through Canada;
  • 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 was imported in 2014 pursuant to a permit issued under these 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, any person who submitted information for a reportable substance as part of the voluntary information gathering phase of the Polymer Approach under the CMP conducted in 2015, is not required to respond to the Notice for that substance. However, if a person was engaged with other substances listed in the Notice for which voluntary information was not provided, they are still required to respond for those substances.

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 Part 1 Polymer substances

Figure 2:  Reporting Diagram for Part 2 Polymer substances

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:
2. • In 2014, if your company imported 4 000 kg of Product X that contains 50% of a reportable substance, then a total quantity of 2 000 kg of the substance was imported. The reporting criteria are met.
   • In 2014, if your company imported 500 kg of Mixture X that contains 10% of a reportable substance in Part 2 and 300 kg of Product Y that contains 20% of the same substance, then a total quantity of 110 kg of the substance was imported. The reporting criteria are met.
3. Company does not meet the reporting criteria:
4. • If your company imported greater than 1 000 kg of a Part 1 substance in product at a concentration greater than or equal to 1% during the 2013 calendar year only, then the reporting year is not met.
   • In 2014, if your company used a cleaning product containing greater than 100 kg of a Part 2 substance to clean equipment, then the reportable activity type is not met.
   • In 2014, if your company used greater than 1 000 kg of a Part 1 substance at a concentration less than 1%, then the concentration threshold of greater than or equal to 1% is not met.
   • In 2014, if your company used a total quantity of 90 kg of a Part 2 substance alone, then 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, product or manufactured item containing the substance.

Manufacture includes to produce or to prepare a substance, and also the incidental production of a substance.

Incidental production of a substance may occur if, during the process of blending or formulating, a chemical reaction occurs that results in the production of a substance that is 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.
• You blended substance D with substance E, and during the process a chemical reaction occurred that produced substance F as a by-product. You manufactured substance F.

It is important to note that for the purpose of the Notice, using a substance listed in Schedule 1 (either alone, in a mixture or in a product) to create or produce a mixture, product or manufactured item would not be considered “manufacture” of the substance itself. In this case, you are using the substance. See Section 2.7 of this document for more information on the reporting requirements for users.

2.6- Do I import?

Import relates specifically to the movement into Canada from another country of any substance identified in the Notice, whether alone, in a mixture, in a product or in a manufactured item that contains such a reportable substance.

For the purposes of the Notice, possible situations where you are considered to import 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.
• You purchased a manufactured item that contains a reportable substance from a foreign source, and the manufactured item was shipped directly from the foreign source to your location in Canada.

Your activities do not meet the definition of import if you purchased or received a reportable substance whether alone, in a mixture, in a product or in a manufactured item 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 imported a manufactured item that is not defined by one of the categories of manufactured items in Schedule 2, Section 2(b) of the Notice.
• You purchased a substance 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- Do I use?

Use relates specifically to using a reportable substance, whether alone, in a mixture, or in a product, to manufacture (i.e., to create or produce) another mixture, product or manufactured item.

Your activities do not meet the definition of use if:

• your activity with a reportable substance, or with a mixture or product containing a reportable substance, is an end-use
• you extrude/mold polymer beads to manufacture a manufactured item (e.g. you form polymer beads/pellets into manufactured items with no chemical alterations to the polymer).  For example, melting polymer beads and extruding them to form a pipe, tube or rod. 

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

• You blend a reportable substance with other components to make Mixture Z.
• You react a reportable substance with Substance C to prepare Product Y.
• You blend a mixture containing a reportable substance as an impurity, present at 5% concentration, with other components to make another mixture.
• You blend a mixture containing a reportable substance with other components to produce a manufactured item.
• You use a product containing a reportable substance in the process of manufacturing a manufactured item.
• You use a reportable substance alone as a plasticizer to manufacture Product Z.

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

• You use Product X, which contains a reportable substance, to service machinery and equipment, including machinery and equipment used in the manufacture of your products. You are not required to report since you are considered an end-user of Product X.
• You load a reportable substance onto a carrier and ship the substance to three other companies.
• You purchase Mixture Y which contains a reportable substance from your supplier in Canada, and distribute the mixture to your customers.
• You use a manufactured item (e.g., rubber equipment parts) containing a reportable substance to make equipment.

2.8- What is a manufactured item?

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.

The categories of manufactured items included in the Notice are listed below with examples to help determine whether your imported manufactured item is reportable or not:

• items intended to come into contact with the mucosa of an individual, other than eyes
  • This category includes: cotton-tipped applicators, personal hygiene items (such as toothbrush and floss), mouth guards, pacifiers, baby bottle nipples and mouthing toys, etc.
• cookware, or cooking or serving utensils that are intended to come into direct contact with heated food within a residence
  • This category includes: pots, pans, woks, griddles, soup ladles, plates, bowls and serving spoons, etc.
• food packaging that is intended to come into direct contact with food
  • This category includes: cereal liner bags, plastic food wrap, internal coating on metal cans, plastic food containers, and lids of jars, etc.
• reusable food or beverage containers
  • This category includes: water bottles, travel mugs, jugs, cups, and food storage containers and lids, etc.
• items intended to release the substance during conditions of use such that the substance may be inhaled or come into dermal contact with an individual
  • This category includes: scented candles, air fresheners, scented markers, dryer sheets, and cleaning wipes , etc.

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

• Direct contact with a food or beverage occurs when a manufactured item is not separated from the food or beverage by an effective functionalbarrier, so there is potential for substances to migrate to the food or beverage.
• Inhalation or dermal contact is reasonably expected to occur if the substance is intentionally released when used in accordance with instructions or as intended by the manufacturer.

2.9- 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:

• prepared formulations
• reaction mixtures that are characterized in terms of their constituents

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

• fragrance mixtures
• printing inks
• gelling agent mixtures and solvent mixtures

2.10- 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 a product.

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 colourants
• cosmetics and personal care products such as lipstick, mascara, eye shadow, toothpaste, mouthwash, 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 or Confidential Accession Number
• Name or masked name of the substance
• Quantity of the substance manufactured, imported or used in 2014
• North American Industry Classification System (NAICS) codes
• Substance function codes and consumer and commercial codes
• Molecular weight data
• Structural formula of the polymer and chemical identity of the monomers
• Physical form of the substance when sold
• Description and the common or generic name of the substance
• Intended uses and concentrations of the substance
• Environmental release information
• Technical, product specification, and safety data sheets
• Physical-chemical properties of the substance
• Titles and descriptions of unpublished data or studies on human health and ecological endpoints

3.1- Quantities

Within the Notice, it is necessary to report the total quantities of substances listed that were manufactured, imported, or used 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 and not the quantity of the mixture, product or manufactured item containing the reportable substance.

3.2- 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, product or manufactured item containing the substance. You should report the code(s) that best describes your involvement with the substance, or the mixture, product, or manufactured item 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.

3.3- 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 with regards to the intended physical or chemical characteristic for which a chemical substance is consumed as a reactant; incorporated into a formulation, mixture, or product; 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 in a mixture or in a product containing the 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, and products 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 substance, mixture, product or manufactured item containing the substance, must be provided, and the description should be as concise as possible.

• If the substance is an impurity, select code U999- Other (impurity), which will be available as an option to select in the online reporting tool.

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.

3.3.1- 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.

3.3.2- Substance Function Codes and Corresponding Descriptions

3.2.3- Consumer and Commercial Codes and Corresponding Descriptions

3.4- Molecular weight data

Polymers can have various molecular weight ranges under the same CAS RN.  Gel permeation chromatography (GPC) can provide the number average molecular weight (Mn) and molecular weight distribution of polymers, including the percentage, by weight, of oligomeric material (i.e. low molecular weight) below 1 000 and 500 Daltons.

For cases where there are more than three different grades of the same substance, the Mn and percentages below 1 000 and 500 Daltons may be reported as a range, or molecular weight data may be provided for the low, medium and high molecular weights.

If GPC data are not available, or if the substance is not suitable for GPC testing, you may provide alternative analytical data (e.g., melt flow index, viscosity measurements, membrane or vapour pressure osmometry, matrix-assisted laser desorption/ionization-time of flight mass spectrometry, etc.) as an indicator of molecular weight.

You are encouraged to submit the supporting analytical data and methods used to determine molecular weight, including: GPC chromatograms and spectral analyses (e.g., C- or H-nuclear magnetic resonance (NMR) spectra or mass spectra (MS)). Note that in cases where supporting analytical data have not been provided, you may be contacted for follow-up. 

3.5- Structural formula of the polymer and chemical identity of the monomers

The structural formula of the polymer should be reported with repeating unit and chain-end groups shown. The structural diagram must clearly indicate the identity of the atoms and the nature of the bonds joining them. Common abbreviations are acceptable in structural diagrams as long as they are unambiguous.

You may wish to contact your supplier to obtain information on the chemical identity of the monomers, if this information is not known to you.

3.6- 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, product or manufactured item. Therefore, when completing this section of the Notice, respond using the most complete and accurate information available to you.

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, a product, or a manufactured item, 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 an imported manufactured item (e.g., mouthing toys) that is sold or made available to consumers.
• Substance is contained in a product (e.g., sealant) sold or made available to consumers for do-it-yourself home maintenance.
• Substance is contained in food packaging items that are sold or made available to consumers for their personal use.

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

For the purpose of section 7 of Schedule 3 only, "Children" are considered persons 14 years of age or younger.

Your substance, whether alone, in a mixture, in a product, or in a manufactured item 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, in a product, or in a manufactured item 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, product, or manufactured item 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, product, or manufactured item containing the substance, aimed at children age 14 or younger?

For example, certain manufactured items such as bottles, diapers, and pacifiers are typically to be used by children age 14 or younger. Other types of products and manufactured items such as household cleaning products, automotive supplies, and lubricants are not typically intended to be used by children age 14 or younger.

3.7- Titles and descriptions of unpublished 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. If available, the study title should include the author(s) and the year in which the study was performed, and a brief description summarizing the results of the study should be provided. Abstracts and robust study summaries are acceptable forms of study descriptions.

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.

3.8- 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.

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

If a person meets the reporting criteria, they must respond to the Notice by completing the sections of Schedule 3 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.

4.1- Section 3 of Schedule 3

For each substance listed in the Notice that a person manufactured, imported or used 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 name of the substance or the Confidential Accession Number of the substance and the masked name of the substance;
• in (b), each applicable six-digit North American Industry Classification System (NAICS) code(s) with respect to the substance, or the mixture, product or manufactured item containing the substance reported in (a); and
• in (c), the total quantity of the substance manufactured, imported, or used, reported in kilograms (rounded to two significant digits).

Example 2:

In 2014, you imported a total of 20 670 kg of a reportable substance (Confidential Accession Number 11200-4) and used all of the substance in the 2014 calendar year to manufacture soap (NAICS code 325620).

4.2- Section 4 of Schedule 3

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

• in (a), the CAS RN or the Confidential Accession Number of the substance;
• in (b), the number average molecular weight (Mn) of the substance;
• in (c), the percentage, by weight, of the substance that is oligomeric material below 1 000 daltons; and
  • in (d), the percentage, by weight, of the substance that is oligomeric material below 500 daltons.

Note that if you imported a substance in a product or in a manufactured item, this question does not apply to you.

Example 3:

In 2014, you imported a mixture containing a reportable substance (CAS RN 9003-53-6). Your supplier has provided you with a GPC analysis for the substance, indicating the number average molecular weight range to be 500- 10 000 Daltons, and the percent below 1 000 Daltons is 0-80% and the percent below 500 Daltons is 0-40%.

4.3- Section 5 of Schedule 3

For each substance listed in the Notice, that a person manufactured or imported, whether alone or in a mixture, 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 or the Confidential Accession Number of the substance;
• in (b), the structural formula of the substance with repeating unit and chain-end groups shown;
• in (c), the chemical identity and the CAS RN of the monomers of the substance reported in (a); and
• in (d), the concentration, or range of concentrations, of each of the monomers of the substance listed in (c) as a weight percentage expressed as w/w%.

Note that if you imported a substance in a product or in a manufactured item, this question does not apply to you.

Example 4:

In 2014, you imported a mixture containing a reportable substance (CAS RN 1415-93-6). Your supplier has provided you with the structural formula for the substance and indicated that the substance is composed of Component A at 30-35% and Component B at 65-70%.

Note that a document containing the structural formula of the substance can be uploaded in the online reporting tool.

4.4- Section 6 of Schedule 3

For each substance listed in the Notice, that a person manufactured, imported or used, 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 or the Confidential Accession Number of the substance;
• in (b), 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 5:

In 2014, you manufactured a reportable polymer (CAS RN 9003-28-5) and intend to use it to bond other substances (substance function code U002).

4.5- Section 7 of Schedule 3

For each substance listed in Schedule 1, that a person manufactured, imported or used, during the 2014 calendar year, for which the criteria set out in Schedule 2 have been met, the person shall provide the following information:

• in (a), the CAS RN or the Confidential Accession Number of the substance;
• in (b), the physical form of the substance when it is sold to customers by indicating if it is a “pellet”, “powder”, “liquid” or “other”;
  • If “other” is applicable, then a written description of the physical form of the substance when it is sold to customers must be provided and the description should be as concise as possible.
• in (c), each consumer and commercial code that applies to the substance, or to the known or anticipated final mixture, product or manufactured item 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, product or manufactured item containing the substance, must be provided when using this code and the description should be as concise as possible.
• in (d), for each applicable consumer and commercial code listed in (c), a statement identifying the description and the common or generic name of the substance or the known or anticipated final mixture, product or manufactured item containing the substance;
  • The statement should be as concise as possible. Using trade names is an effective way of summarizing this information.
• in (e), for each applicable consumer and commercial code listed in (c), indicate with a “Yes” or “No” whether any known or anticipated final substance, mixture, product or manufactured item containing the substance is intended for use in consumer activities.
• in (f), for each applicable consumer and commercial code listed in (c), indicate with a “Yes” or “No” whether any known or anticipated final substance, mixture, product or manufactured item containing the substance is intended for use by or for children 14 years of age or younger.

Example 6:

In 2014, you imported a reportable substance (CAS RN 32610-77-8), which was used in the manufacture of paints and coatings (consumer and commercial code C202) and soap (consumer and commercial code C108).

4.6- Section 8 of Schedule 3

For each substance listed in Schedule 1, that a person used 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 or the Confidential Accession Number of the substance;
• in (b), the concentration or range of concentrations of the substance, by weight (w/w%), contained within the mixture, product or manufactured item that was sold or transferred off site.

Example 7:

In 2014, you imported a reportable substance (Confidential Accession Number 11200-4), and used it to manufacture a paint that was then sold to customers. The substance is present in the paint at 3-5%.

4.7- Section 9 of Schedule 3

For each substance listed in the Notice, that a person manufactured, imported, or used 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 or the Confidential Accession Number of the substance;
• in (b), a description of any known or anticipated environmental releases of the substance and the waste management practices, policies or technological solution in place to prevent or minimize releases;
  • Waste management practices, policies or technological solutions relate to means put in place at your facility (or facilities) to prevent or minimize releases of the substance to the environment, or exposure of individuals in Canada to the substance. Examples of technological solutions include, but are not limited to:
    • scrubbers, thermal oxidizers and bag filters to prevent releases to air;
    • collection tanks to capture wash water from facility’s floors and drains for treatment and/or disposal;
    • lagoons and ponds to capture storm water and site run-offs for treatment prior to discharge;
    • oil-water separators; and
    • primary, secondary or tertiary on/off-site wastewater treatment equipment systems.
• in (c), technical data sheets, product specification sheets and safety data sheets available related to the substance, or to the mixture, product or manufactured item containing the substance.
  • For cases where there are more than three grades of the same substance, you may provide the technical data sheets, product specification sheets and safety data sheets available for the low, medium and high molecular weights.
  • Provide the representative technical data sheets, product specification sheets and safety data sheets available related to the mixture, product or manufactured item containing the substance.

Example 8:

In 2014, you used a substance listed in Schedule 1 to make a product (Resin 123). You have practices in place at your facility to minimize release of the substance during processing and your supplier has provided you the SDS of the substance.

4.8- Section 10 of Schedule 3

For each substance listed in Schedule 1, that a person manufactured, or imported during the 2014 calendar year, for which the criteria set out in Schedule 2 have been met, the person shall provide the following information:

• in (a), the CAS RN or the Confidential Accession Number of the substance;
• in (b), for each substance listed in (a), indicate with a “Yes” or “No” whether the substance is designed to or expected to degrade, depolymerize or decompose,
  • degradation, decomposition and depolymerization refer to the types of changes that convert a polymeric substance into simpler, smaller substances, through processes including but not limited to oxidation, hydrolysis, attack by solvents, heat, light and microbial action.
• in (c), for each substance listed in (a), indicate with a “Yes” or “No” whether the substance has a water extractability greater than 2% by weight,
• • water extractability refers to the fraction of the polymer that can be extracted into an aqueous medium
• in (d), for each substance listed in (a), indicate with a “Yes” or “No” whether the substance is a water absorbing substance
  • a substance is considered water absorbing if it is capable of absorbing its weight (or greater) in water.
• In (e), provide the study title(s) for any unpublished data or studies on the substance with regards to any of the following:
  1. human health study endpoints:
     1. acute toxicity (oral, dermal, and inhalation),
     2. short-term toxicity (oral, dermal, and inhalation),
     3. sub-chronic toxicity (oral, dermal, and inhalation),
     4. carcinogenicity,
     5. genotoxicity (in vitro),
     6. genotoxicity (in vivo),
     7. developmental and reproductivity,
     8. absorption, distribution, metabolism and excretion,
     9. biomonitoring, and
     10. dermal absorption.
  2. ecological study endpoints:
     1. water solubility or water extractability,
     2. octanol-water partition coefficient,
     3. organic carbon-water partition coefficient,
     4. acid dissociation constant,
     5. biodegradation,
     6. bioaccumulation factor, bioconcentration factor, and biomagnification factor,
     7. ecotoxicity (experimental acute and chronic studies for pelagic, benthic, and terrestrial organisms),
     8. environmental monitoring and presence,
     9. chemical transformation, and
     10. leaching potential.
• In (f), a description of the unpublished data or study you have listed in (e);
  • the description of the study should be as concise as possible and include information on what was studied (i.e., concentration of CAS RN XXX-XX-X in urine samples of 20 human volunteers);
• In (g), the title of any additional unpublished data or studies not listed in (e) on the substance with regards to:
  1. physical-chemical properties,
  2. bioaccumulation,
  3. persistence,
  4. toxicity,
  5. metabolism,
  6. degradation,
  7. decomposition,
  8. depolymerisation,
  9. environmental monitoring,
  10. release,
  11. leaching, or
  12. migration of the substance from the final mixture, product or manufactured item.

Note that if you imported a substance in a product or in a manufactured item, this question does not apply to you.

Example 9:

In 2014, you manufactured a reportable substance (CAS RN 1338-51-8) and you have unpublished studies on mammalian toxicity for the substance, as well as an additional unpublished study for water solubility.

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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 listed 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 10:

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 listed in Schedule 1 is present in Product 123.  Company B confirms that Product 123 contains a substance listed 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 listed 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, product or manufactured item, technical data sheets, product specification sheets, 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, substance function, concentration of the reportable substance in Product 123, molecular weight data for the reportable substance in Product 123, any titles of any unpublished data or studies with regards to the reportable substance, etc.). 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 December 3, 2015, 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 December 3, 2015, 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 December 3, 2015, 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 following numbers or email address:

• 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 "Polymers Substances")