Guidance manual for responding to: Notice with respect to bisphenol A (BPA) and BPA structural analogues and functional alternatives

Official title: Guidance manual for responding to: Notice with respect to bisphenol A (BPA) and BPA structural analogues and functional alternatives

Published in the Canada Gazette, Part I on November 13, 2021

1. General information

1.1 Introduction

On November 13, 2021, the Notice with respect to bisphenol A (BPA) and BPA structural analogues and functional alternatives (the notice) was published in the Canada Gazette, Part I, pursuant to paragraph 71(1)(b) of the Canadian Environmental Protection Act, 1999 (the Act). The notice has a deadline of March 16, 2022, and applies to 188 substances.

The purpose of the notice is to gather information from Canadian manufacturers, importers and users on the commercial status, industrial processes (e.g., facility releases), and downstream use of BPA and BPA structural analogues and functional alternatives (BPA SAFAs) in Canada.

The collected information will be used to inform:

• prioritization decisions;
• risk assessment actions by Environment and Climate Change Canada and Health Canada; and
• risk management measures, if needed.

For more information on the management of chemical substances, please visit the Government of Canada’s Chemicals Management Plan webpage. For more information on BPA SAFAs, visit the BPA SAFAs webpage.

This document only provides guidance for responding to the notice. In the case of a discrepancy between this document and the notice or the Act, the official versions of the notice and the Act take precedence.

1.2 Reasonably accessible information

If you are subject to the notice, you are required to provide information that your organization (company) possesses or to which you may be reasonably expected to have access. Manufacturers would be reasonably expected to have access to their formulations. When importing a substance or good, it is reasonable that the importer has access to import records and relevant Safety Data Sheets (SDS). Additional sources of information that may be useful in locating required information that is not found in the previously listed sources include industry trade journals, patents or books/encyclopedias (CRC Press, Ullmann’s Encyclopedia of Industrial Chemistry, etc.).

Tip: The terms “organization” and “company” capture the legal business name or the name of the person, as specified in the notice in paragraph 6(a), and are used interchangeably.

Your supply chain and sector association may be able to provide more detailed information on the product composition. Suppliers or customers may have information that you may not be aware of. For example, your customers may be able to provide you with information on substances in final goods available for sale to end users and your suppliers may be able to provide you with the composition of imported goods. Although an SDS is an important source of information on the composition of a product, it should be noted that the goal of the SDS is to protect the health of workers in the workplace from specific hazards of chemical products. Therefore, an SDS may not list all product ingredients that may be subject to the notice. Any person requiring more detailed information on product composition is encouraged to contact their supplier.

To that purpose, a Government of Canada letter for communicating with your foreign suppliers is available upon request by contacting the Substances Management Information Line via email. The letter may help you obtain information from your suppliers in order to complete your response to the notice.

Working and communicating with your supply chain to obtain the requested information and meet the reporting obligations will help the Government of Canada ensure all activities related to substances in this notice are considered before taking any further action.

Suppliers who wish to protect their data can submit the information directly to the Government of Canada as a blind submission. Contact the Substances Management Information Line and provide your justification for confidentiality, the sections/subsections of the notice for which you have information, and the contact information for the person with access to the remaining information to complete the response to the notice.

Tip: You are not required to conduct tests to comply with the notice. However, you are expected to make reasonable efforts to obtain information through your supply chain.

1.2.1 Not reasonably accessible information clause

The following data elements requested in this notice may be considered as not reasonably accessible (NRA) if your company is not in the possession of these AND reasonable efforts to obtain information across the supply chain did not yield the necessary information OR if monitoring did not occur in 2019:

• Section 8
  • Annual average concentration [of the substance in discharged effluent] (μg/L)
  • Annual maximum concentration [of the substance in discharged effluent] (μg/L)
• Section 10
  • The concentration, or range of concentrations, of the substance [in a good] by weight (w/w%)
  • The quantity, or quantity range, of the substance [in a good] in kilograms
  • Whether the substance is intended to or may be in direct contact with food or beverage, as opposed to being on the exterior of the packaging or container
  • The types of foods or beverage that could be contained in and in contact with the packaging or container
• Section 11
  • The chemical identity or Chemical Abstracts Service Registry Number (CAS RN^{Footnote 1} ) of the reactants or components of the substance
  • The concentration, or range of concentrations, of each reactant or component [of a reportable substance] by weight (w/w%)

Note that for Section 8, the concentration in effluent is only requested if it is available for 2019; new or additional monitoring is not requested.

However, please note that the above information is necessary to help the Government of Canada ensure that all activities representative of the Canadian context (e.g., commercial activities, levels of substance use, substance quantities) are considered before taking any further action. The absence of information may result in the use of conservative assumptions in risk assessments. Consequently, risk management measures may be implemented that impact your ability to sell certain substances or goods containing these substances in Canada.

1.3 Reporting deadline

Mandatory responses to the notice must be provided no later than March 16, 2022, and must be completed using the online reporting system available through Environment and Climate Change Canada’s Single Window (see Parts 14 and 15).

2. Schedule 1 of the notice – Reportable substances

Schedule 1 of the notice lists 188 reportable substances subject to this notice and is divided into two separate parts.

• Part 1 contains 181 substances including BPA and BPA SAFAs.
• Part 2 contains 7 substances of unknown or variable composition, complex reaction products or biological materials (UVCBs) that are considered as BPA SAFAs for the purposes of this notice.

For Part 1 substances, information is required for Sections 7 to 10 of the notice. For Part 2 substances, information is also required for Section 11 if the substance is manufactured or used to produce a good.

For the complete list of reportable substances, refer to the notice. An Excel version of the list is also available under the “Substances and Code Lists” tab of the Excel Reporting File (available through the Information gathering initiatives page).

3. Sections 2 and 3 of the notice – Persons required to provide information

The notice applies to any person who, during the 2019 calendar year, satisfied any of the following criteria:

• manufactured a total quantity greater than 10 kg of a substance;
• imported a total quantity greater than 10 kg of a substance, whether the substance was:
  1. alone;
  2. at a concentration equal to or above 0.02% by weight (w/w%) in a mixture or in a product; or
  3. at a concentration equal to or above 0.02% by weight (w/w%) in a reportable manufactured item*; or
• used a total quantity greater than 10 kg of a substance, whether the substance was alone or at a concentration equal to or above 0.02% in a good, to produce a good.

*The 12 categories of reportable manufactured items are listed, with examples, in Table 1 of subpart 3.3 of this document.

Tip: You must consider each activity (manufacture, import, used to produce) with each substance separately. Examples are provided in subpart 3.5

The subparts that follow provide additional details on the reporting criteria that you must consider when determining whether you are required to respond to the notice:

• calendar year;
• reportable activities;
• substances and mixtures, products, or manufactured items (goods);
• quantity and concentration thresholds (of substance itself); and
• exclusions.

Your answers to the questions in the top part of Figure 1 will provide an indication of whether you are required to report under the notice. Subpart 3.5 of this document also provides information on calculating the total quantity of a substance in a mixture, product or manufactured item and includes examples of companies that meet or do not meet the reporting criteria of the notice.

3.1 Calendar year targeted by the notice

The notice applies to the 2019 calendar year.

If you do not meet the reporting requirements for 2019, you are not legally obligated to respond to the notice. However, if you had activity with a reportable substance (e.g., imported, manufactured, exported the substance, or used the substance to produce a good) for a different calendar year but not in 2019, the information may be of interest to the Government, and you are encouraged to provide this information via a Declaration of Stakeholder Interest (SHI).

Please note that persons who do not meet the requirements of the notice and have no interest in the substances may submit a Declaration of Non-Engagement (DNE).

3.2 Reportable activities

Three activities are subject to the notice: manufacture, import and use to produce a good.

3.2.1 Manufacture

“Manufacture” relates to the creation or production of the substance itself and includes both the intentional and the incidental production of the substance. Manufacture does not refer to the manufacture of a good (mixture, product or manufactured item) containing the 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.

Sometimes there is confusion between the terms "use" and "manufacture". Typically, using a reportable substance to fabricate a good is NOT considered "manufacture" for the purposes of reporting to Environment and Climate Change Canada as you are not creating the substance. In this case, the activity would be considered as “use to produce a good”, which is another type of reportable activity (Part 3.2.3).

3.2.2 Import

“Import” relates specifically to the movement into Canada from another country of any substance identified in the notice, whether alone or in a good.

Examples of activities that meet the definition of “import”:

• Your Canadian company purchased one of the substances listed in the notice from a foreign supplier, and the substance was shipped directly from the foreign supplier to your location in Canada.
• Your Canadian company ordered a mixture containing one of the substances from a foreign supplier, and the mixture was shipped directly from the foreign supplier to your distribution warehouse in Canada.
• Your Canadian company received a polymer or pre-polymer containing a monomeric component listed as reportable substance during an internal company transfer from a foreign source.
• Your Canadian company 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.

Examples of activities that do not meet the definition of “import”:

• Your Canadian company ordered a product containing one of the substances from a warehouse located in Canada.
• Your Canadian company transferred a mixture or product containing one of the substances across provincial borders to be stored in a different warehouse.
• Your Canadian company purchased or received one of the substances alone, or in a mixture or product, that was already located in Canada.

3.2.2.1 Foreign suppliers and Importers of record

An importer is the person responsible for the movement of a reportable substance into Canada from another country. For the purposes of the notice, the person responsible for responding to the notice is the company who “caused” the substance to come into Canada. In other words, the substance came into Canada on their request. This should not be confused with an “Importer of Record”, which is a term used by the Canadian Border Services Agency and may or may not be the same company that is required to report to a notice.

The foreign supplier (i.e., exporting to Canada, located outside of Canada) is not required to respond to the notice. Rather, the receiver (who imports to Canada) is subject to the notice if the requirements are met. Foreign suppliers are encouraged to inform their Canadian customers (i.e., Canadian importers) that they import a reportable substance and may meet the reporting requirements of the notice. Foreign suppliers can also choose to submit information and respond to the notice on behalf of Canadian importers. If Confidential Business Information (CBI) cannot be shared with Canadian importers to allow them to respond to the notice, please refer to Part 13 of the document for information on the blind submission process. This process allows foreign suppliers and their Canadian importers to collaborate and provide all the information required in the notice while still protecting CBI.

3.2.3 Use to produce a good

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

Tip: Any manufactured item produced in Canada containing the substance, even those not within the list of imported reportable manufactured items categories, are reportable.

Examples of activities that meet the definition of use to produce a good:

• 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 0.02% 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 reportable substance as a monomer component in the process of producing a polymer.
• You use a reportable substance alone as a plasticizer to produce Product X.
• You use a small, manufactured item containing a reportable substance to produce a bigger manufactured item.

Examples of activities that do not meet the definition of use to produce a good:

• You use Product V, 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 V.

3.3 Substance and mixtures, products or manufactured item (goods)

A “substance” means any substance listed in Part 1 and 2 of Schedule 1 of this notice.

A “mixture” is a combination of substances that does not produce a substance that is different from the substances that were combined, including, but not limited to, a prepared formulation, hydrate, and reaction mixture that are characterized in terms of their constituents, and homogenous and heterogeneous alloys.

A “product” is anything that does not meet the definition of a substance (Schedule 1 substance), mixture or manufactured item. For the purposes of this notice, a polymer or pre-polymer is considered a product.

Examples of mixtures or products that may be reportable if they contain a substance listed in Schedule 1 of the notice:

• paints and coatings
• ink toners and colourants
• thermal paper coating
• cosmetics and personal care products such as lipstick, mascara, eye shadow, toothpaste, mouthwash, creams (including sunscreen), and lotions
• cleaning liquids, gels or sprays
• putties, epoxy resins, adhesives, glues and lubricants
• dental sealants
• polymers

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.

Twelve categories of imported manufactured items are reportable under this notice, targeting items that are considered to be key sources of exposure to the general population. Schedule 1 substances imported in other manufactured items are not reportable under the notice.

Tip: For a specific substance, one or more of the categories identified in Table 1 can be applicable.

Important definitions to consider:

• Food packaging material means anything in which a food or beverage is wholly or partly contained, placed, or packed.
• Mucosa is defined as a group of mucous membranes that line parts of the body which lead to the outside and are exposed to air (i.e., mouth and digestive tract, urogenital tract (urethra and vagina), respiratory tract (including the nose), eyes, and ears).
• Direct contact with food occurs when a manufactured item (e.g., cookware, cooking or serving utensils, reusable food or beverage containers, or food packaging) is not separated from the food or beverage by an effective functional barrier, so there is potential for substances to migrate to the food or beverage.
• Textile fibre means any natural or manufactured matter that is capable of being made into a yarn or fabric and includes human hair, kapok, feathers and down and animal hair or fur that has been removed from an animal skin.
• Fabric means any material woven, knitted, crocheted, knotted, braided, felted, bonded, laminated or otherwise produced from, or in combination with, a textile fibre.

A “good”, for the purpose of this notice, is a mixture, a product or a manufactured item.

3.4 Quantity and concentration thresholds

According to the thresholds provided in Table 2 any person who manufactured a substance, imported a substance, whether alone or in a good, or used a substance, whether alone or in a good, to produce a good, must respond to the notice.

^a Use to produce a mixture, product or any manufactured item (not only those within categories listed in Table 1)
^b The concentration threshold is applicable to the good that is used, not to the good that is produced.

When responding to the notice, you must report the quantities of the reportable substance itself, in kilograms (kg), and not the quantity of the mixture, product or manufactured item containing the substance. Refer to subpart 3.5 of this document for additional information on calculating quantities of a reportable substance.

Tip: Remember that the quantity threshold applies to each activity and each substance, on a company-wide basis.

If you imported substance in a good in 2019, you will need to determine whether you meet the applicable concentration threshold. Similarly, if you used a good containing a reportable substance to produce another good, you will also need to determine whether you meet the applicable concentration threshold.

3.5 How do I determine if I need to respond?

Your answers to the questions in the top part of Figure 1 above can provide an indication of whether you are required to report under the notice if an exclusion does not apply to your situation. Equation 1(a) and 1(b) provide the general formula for determining the quantity of a substance in a good as well as conversion factors for concentration.

The sample calculation and examples below may also help you determine whether your company meets the reporting criteria of the notice.

Equation 1(a): General formula for determining the total quantity of a substance in goods

Total Quantity_{(Substance A)} = (Quantity_{(Good X)} x % Concentration_{(Substance A)}) + (Quantity_{(Good Y)} x % Concentration_{(Substance A)})

Where,
Quantity = quantity in kilograms
Substance A = a substance listed in Schedule 1 of the notice;
Good X and Y = any mixture, product or manufactured item containing substance A; and
% Concentration = percent concentration of Substance A by weight (w/w %) in a mixture, product of manufactured item.

Equation 1(b): Conversion factors for concentration

x_(%) = x_(ppm) ÷ 10 000

1% = 10 000 ppm and 1 ppm = 0.0001%

Example for total import quantity of a substance:

• In 2019, your company imported 8 kg of reportable substance Y alone, 500 kg of Good X, which contained 200 ppm of reportable Substance Y, and 75 kg of Good Y also containing 200 ppm of Substance Y. The concentration of Substance Y is determined as follows in each good:

$0.02\%=200ppm÷10000$

Therefore, Substance Y meets the concentration threshold of ≥ 0.02% for an imported good; however, Substance Y must also meet the total quantity threshold, which is determined as follows:

${TotalQuantity}_{\left(SubstanceY\right)}={8kg+(500kg}_{\left(GoodX\right)}\times {\frac{0.02}{100}}_{\left(SubstanceY\right)})+{(75kg}_{\left(GoodY\right)}\times {\frac{0.02}{100}}_{\left(SubstanceY\right)})$

${TotalQuantity}_{\left(SubstanceY\right)}=8.115kg$

Since the total quantity of the imported substance is less than the total quantity threshold of >10 kg, you do not meet the reporting criteria for the substance even if the ≥ 0.02% concentration threshold is met. You are therefore not required to report the import of Substance Y.

Example for total quantity used to produce a good:

• In 2019, your company used 300 000 kg of Mixture X that contained 0.03% of Substance Y to produce a Good Z. The total quantity of Substance Y that is used is determined as follows:

${Quantity}_{\left(SubstanceY\right)}={300000kg}_{\left(MixtureX\right)}\times {\frac{0.03}{100}}_{\left(SubstanceY\right)}$

${Quantity}_{\left(SubstanceY\right)}=90kg$

Since the total quantity of the substance used (i.e., 90kg) is above the total quantity reporting threshold of >10kg and the concentration of the substance in the mixture that is used is above the ≥ 0.02% concentration threshold, you meet the reporting criteria for the substance. You are therefore required to report the use of Substance Y.

The following examples provide additional guidance for determining whether you meet the reporting criteria of the notice.

Your company meets the reporting criteria if:

• In 2019, your company imported 170 500 kg of a mixture, that contained 250 ppm (0.025%) of a substance described in Schedule 1 of the notice. Therefore, the quantity of the reportable substance imported was 42.63 kg. 100 000 kg of the mixture (containing 25kg of the substance) was then used by the company to produce thermal paper in the same calendar year. In this case, the company meets the calendar year, concentration (≥ 0.02%) and quantity (>10 kg) thresholds of the reporting criteria for the import activity. The company also meets the quantity and concentration reporting criteria for the use to produce a good activity; therefore, you are required to respond to the notice for both activities.
• In 2019, the company manufactured 40 kg of a substance described in Schedule 1 of the notice. In this case, you meet the calendar year, reportable activity and quantity threshold (>10 kg) of the reporting criteria.
• In 2019, your company imported 60 000 kg of food packaging that contained a substance described in Schedule 1 of the notice. The concentration of that substance was 0.02%. As a result, the total quantity of the reportable substance imported was 12 kg. Therefore, the company meets the calendar year, reportable activity, concentration threshold (≥ 0.02%) and quantity threshold (>10 kg) for responding to the notice.
• In 2019, a reportable substance was imported alone from a foreign supplier and is shipped directly to each of your four Canadian facilities. The facilities receive 9 kg, 8 kg, 5 kg, and 40 kg of the reportable substance respectively. You imported a total of 62 kg of the reportable substance on a company-wide basis. In this case, the company meets the calendar year and quantity (>10 kg) threshold of the reporting criteria for the import activity.
• In 2019, your company imported 70 000 kg of an adhesive which contained 300 ppm (0.03%) of a substance described in Schedule 1 of the notice (equal to 21 kg of the substance) and 500 000 kg of food cans that contained 30 ppm (0.003%) of the same substance (equal to 15 kg of the substance). As the food cans do not meet the concentration threshold of ≥ 0.02%, you are not required to consider the food cans in your calculations. However, since the company meets the substance quantity threshold (>10 kg), concentration threshold (≥ 0.02%), calendar year and reportable activity for the adhesive, you are only required to report on the adhesive (containing 21 kg of the substance).

Tip: If you know that the quantity threshold is met but the concentration information is not available to you even after reasonable efforts were made to obtain that information from your supply chain, you should respond to the notice and inform your supplier of the blind submission process.

Your company does not meet the reporting criteria if:

• The company manufactured 100 kg of a substance described in Schedule 1 of the notice during the 2018 calendar year only. In this case, the company does not meet the calendar year criterion for reporting.
• In 2019, your company imported 110 000 kg of a manufactured item that contained 0.01% of a substance described in Schedule 1 of the notice. Therefore, the total quantity of the substance imported was 11 kg. Although the company meets the substance quantity threshold (>10 kg), it does not meet the concentration threshold (≥ 0.02%).
• In 2019, your company used 500 kg of a mixture that contained 600 ppm (0.06%) of a substance described in Schedule 1 of the notice to produce a product. Although you meet the substance concentration threshold (≥ 0.02%), you do not meet the quantity threshold (>10 kg) as only 0.3 kg of the substance was used.
• Your records indicate that you do not have an interest in any of the substances listed in Schedule 1 of the notice.
  • You may submit a Declaration of Non Engagement.
• In 2019, your dental office imported dental sealants containing 50 kg of a substance described in Schedule 1 of the notice.
  • Although dental offices are excluded from reporting to the notice, information on dental sealants could inform risk assessment. You may provide the information on the substance, by submitting a Declaration of Stakeholder Interest.

Tip: If you had activities with a reportable substance below the thresholds, it is still valuable information that you are encouraged to report. You can submit the information via a Declaration of Stakeholder Interest.

4. Section 4 – Exclusions

There are several exclusions that apply to this notice, which are found in Section 4 of the notice. The notice does not apply to a substance, whether alone or in a good, that:

• is only in transit through Canada;
  • “In transit” refers to the portion of an international transboundary movement of a substance through the territory of a country that is neither the point of origin nor the final destination. Whether something is considered in transit has to do with shipping destinations of the goods at the time of entry into Canada. Cases where goods are warehoused in Canada and then sold/distributed to foreign customers are reportable.
    
    The following two scenarios illustrate what may and may not be considered "in transit":
    • Goods are shipped from Europe to the Port of Halifax, where they are transferred to trucks that transport them to Toronto, where the goods are transferred to rail cars that transport them to British Columbia before being transferred to another truck, which transports them to their final destination in Seattle, Washington. While in Canada, these goods are considered "in transit".
    • Goods are shipped from Europe to the Port of Halifax, where they are transferred to trucks and transported to a Toronto-based destination. The goods remain on their pallets, shrink wrapped, and are stored in a distribution warehouse until such time as they are sold internationally (for example, to a company located in Seattle, Washington) and subsequently shipped accordingly (exported). While in Canada, these goods are not considered "in transit".

• 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 pursuant to a permit issued under these Regulations;
• is, or is contained in, a pest control product registered under the Pest Control Products Act;
• is, or is contained in, a fertilizer or supplement registered under the Fertilizers Act;
• is, or is contained in, a feed registered under the Feeds Act;
• is mixed with, or attached to, a seed registered under the Seeds Act;
• is contained in recycled paper received by paper recycling mills;
• is bisphenol A (CAS RN 80-05-7) contained in a medical device; or
• is manufactured, imported or used to produce a good by laboratories, academic institutions, research facilities or dental offices.
  • Please note that this exclusion does not apply to research facilities and laboratories involved in development activities for industrial and commercial stakeholders.

5. Section 5 – Amalgamated information for multiple facilities

A company that owns more than one facility must respond to the applicable questions in the notice on a company-wide basis. Your response for each question must be an amalgamated response that includes information from all facilities owned by the company, with the exception of questions for Section 8 of the notice.

6. Section 6 – Contact identification for organization (company)

All persons who are subject to the notice are required to provide the following information:

• the name of the person;
• the address;
• the Federal Business Number^{Footnote 2} ;
• the name, email and phone number of an individual authorized to act on behalf of the company; and
• a declaration that the information is accurate and complete.

The Excel Reporting File will ask only for the business name and the Federal Business Number. The remaining information required to complete the requirements of Section 6 of the notice must be entered in Environment and Climate Change Canada’s Single Window online reporting system.

Tip: the information above will automatically be auto-populated from your Environment and Climate Change Canada’s Single Window account. Make sure that your account information is up to date or update it for this notice directly in the CM general initiative of the online reporting system.

Sections of the notice to be completed:

7. Section 7 – Total quantity

Section 7 of the notice applies to all Schedule 1 substances and for all activities (manufacture, import or use to produce), for which the reporting criteria are met.

For each reportable substance, you are required to provide the total quantity of the substance you manufactured, imported, used to produce a good and exported for the entire year.

Quantities reported in this section of the notice should be:

• for the substance itself, reported in kilograms (kg), and not the quantity of the good containing the reportable substance; and
• rounded to the nearest kg. If that is not possible, rounding to the nearest 10 kg is also accepted.

Tip: Export is not an activity that triggers reporting to the notice. Only reporters who manufacture, import or use to produce a good AND also export a reportable substance are required to provide the quantity of substance exported.

Example of information required for Section 7 of the notice

In 2019, your company:

• imported 400 kg of a household cleaner containing Substance A at a concentration of 5% (equal to 20 kg of Substance A). You also imported 800 kg of another good containing Substance A at a concentration of 20% (equal to 160 kg of Substance A). The total quantity of Substance A imported in 2019 is 180 kg.
• manufactured 125 kg of Substance B to produce a polymer (good). The total quantity of Substance B manufactured is 125 kg and the total quantity used to produce a good is 125 kg. The polymer is primarily sold to customers in Canada, but some of the polymer containing 15 kg of Substance B was sold to customers outside of Canada. The total quantity exported is 15 kg.
• used 90 kg of Substance C alone to produce an epoxy resin.

Subpart 3.5 of this document provides other examples for determining the total quantity of a substance manufactured, imported or used to produce a good.

8. Section 8 – Facilities

Section 8 of the notice applies to all Schedule 1 substances for which the reporting criteria are met. This section requires you to report 2019 information on your Canadian facilities where a reportable substance was:

• manufactured;
• imported, alone or in a mixture; or
• used, whether alone or in a good, to produce another good.

Tip: You must not report facilities to which you solely import a product or a manufactured item.

Tip: Section 8 applies to your facilities, not your customers’ facilities.

You are required to report your facility if, for example, in 2019 your company did one of the following:

• Imported a mixture containing reportable Substance A to the Mississauga plant to be used on-site to clean surfaces.
• Imported Substance B to the Montreal plant and used it to produce a polycarbonate plastic on site.
• Manufactured Substance C at the Richmond plant since it was incidentally produced during the making of a household cleaner. Substance B is considered to be manufactured in this plant.
• In 2019 your company imported Substance C and D alone as well as mixtures containing these substances to the Halifax warehouse where they are later distributed to customers in Canada. Since you imported reportable substances alone and in a mixture to the warehouse, you must report the facility even if activities at that facility consist solely of warehousing and distribution of mixtures and substances.
• Imported a coating product containing Substance F to the Guelph manufacturing plant, which is then used on site as a water repellant in food packaging. Since the product is not only solely imported to the plant, but is also used to produce a good, the facility must be reported.

You are not required to report your facility if, for example, in 2019 your company did one of the following:

• Imported an adhesive product containing reportable Substance A to your Toronto distribution center that was packaged into boxes and shipped to customers to fulfill online sales. Since you imported a product that is not used to produce another good, the Toronto distribution center does not need to be reported as a facility.
• Imported a sunscreen containing reportable Substance B in bulk containers to your facility in Montreal to be repackaged into smaller containers that are sold to retailers. Since you imported a product that is not used to produce another good, the Montreal facility does not need to be reported.
• Imported children’s toys (manufactured items) containing Substance B to retail stores in Winnipeg.

You are required to provide the following information for your reportable facilities:

• Facility name and address;
• Distribution or warehousing only activities (Yes or No);
• Physical forms of the substance throughout manufacture, processing, handling and use to produce a good;
• Summary of the manufacture, processing and handling of the substance and its use to produce a good;
• Substance releases and losses to air, water or land;
• Description of prevention or mitigation measures in place to prevent or minimize releases of the substance;
• Concentration of substance in effluent discharged; and
• Other monitoring results of releases of the substance.

8.1 Facility name and address

You are required to provide in paragraph 8(a) the name and the address of each of your reportable facilities, including the facility physical street address, city, province and postal code.

Tip: The “Section 8 – Facilities” tab of the Excel Reporting File will allow you to generate your own list of facilities that you will be able to then use for reporting on each substance, if applicable, for questions in the “Section 8” tab.

8.2 Distribution and warehousing only activities

You are required to identify in paragraph 8(b) any reportable facility in Canada that is used solely for distribution or warehousing purposes. In such facilities, manufacturing, processing, handling (including repackaging) and use of the substances or mixtures, products and manufactured items containing the substance do not occur.

For example:

Mixtures containing Substances C and D are imported to the British Columbia warehouse where they are distributed a few weeks later to customers in Canada. Since you are importing a mixture to the warehouse, the warehouse should be reported as a facility. However, since the mixture is not repackaged, processed or used to make another good, the British Columbia warehouse should be flagged as a facility used solely for distribution and warehousing purposes.

8.3 Physical forms of the substance throughout manufacture, processing, handling and use to produce a good

You are required to provide in paragraph 8(c) all the physical forms of the substance throughout manufacture, processing, handling and use to produce a good, including the forms at the time of arrival at the facility, at the different stages of manufacturing, processing, handling, at the time it is reacted and as it leaves the facility.

For each substance at each site, you must report as many physical forms as applicable by selecting from the following 6 physical forms:

• dry powder,
• pellets or large crystals,
• water- or solvent- wet solid (i.e., water-wet solid or solvent-wet solid),
• other solid,
• gas or vapour, or
• liquid.

8.4 Summary of the manufacture, processing and handling of the substance and its use to produce a good

You are required to provide in paragraph 8(d) a summary of the manufacture, processing, and handling of the substance and its use to produce a good, whether used alone or in a good. Your summary should include major steps and tasks in the operation, including the physical forms of the substance reported in paragraph 8(c) at every stage throughout the operation, potential sources of exposure to workers and controls in place to reduce worker exposure.

Exposure to workers means an exposure to a chemical substance which, under foreseeable conditions of manufacture, processing, distribution in commerce, or use of the chemical substance, is likely to occur (for example, through inhalation, ingestion, or skin contact). Accidental or theoretical exposures do not need to be reported.

Such exposures could include, but would not be limited to activities such as:

• charging reactor vessels,
• drumming,
• bulk loading,
• cleaning equipment,
• maintenance operations,
• materials handling and transfers, and
• analytical operations.

The summary can also include:

• a description of entry and exit points of incoming and outgoing materials containing the substance (e.g., feedstocks, reactants, solvents, catalysts, and waste products);
• whether it is a batch or continuous process, open or closed process, dry or wet process, or process using closed-loop, pressurized or vacuum system;
• the frequency and scale of the process including facility production rates (e.g., kg/day processed, hours/day and days/year); and
• the process equipment cleaning frequency (e.g., per day or per batch) and type of cleaning solution, if used (e.g., steam, hot water, aqueous caustic solution, and toluene).

The summary should also include a description of the controls in place to reduce potential exposure of the substance to workers, such as:

• engineering controls- includes designs or modifications to plants, equipment, ventilation systems, and processes that reduce the source of exposure (e.g., automated processes, ventilation/fume hoods);
• personal protective equipment- equipment worn by individuals to reduce exposure to chemicals (e.g., protective clothing, type of masks/respirators, type of gloves, etc.); and
• administrative controls- controls that alter the way the work is done, including timing of work, policies and other rules, and work practices such as standards and operating procedures (including training, housekeeping, and equipment maintenance, and personal hygiene practices).

A summary may be provided as a flow diagram attached to your submission that illustrates the manufacture, processing, handling and use of the substance in the production of a good that occurred within the facility. If you choose to provide a flow diagram, input “See “X file name” for summary” in the dedicated cell for paragraph 8(d) of the ‘Section 8’ tab of the Excel Reporting File.

8.5 Substance releases or losses to air, water or land

You are required to indicate in paragraph 8(e) of the notice whether the substance is known to, is anticipated to or may be released or lost from the facility to air, water or land and provide a qualitative description of the potential releases and losses of the substance in subparagraph 8(e)(i).

The term “release” reads in subsection 3(1) of the Act as follows:

"release includes discharge, spray, inject, inoculate, abandon, deposit, spill, leak, seep, pour, emit, empty, throw, dump, place and exhaust.”

Release includes direct or indirect emissions or discharges of a substance in any form (liquid, solid or gas) and into any media (air, water or soil), whether the release is intentional or non-intentional during normal operations.

The following are examples of different sources of releases of a substance in either solid (e.g., powder, pellet), liquid (e.g., sludge, solution) or gaseous (e.g., vapour), state:

• emissions to air – discharges through a stack, vent or other point release, losses from storage and handling of the substance or products containing the substance, fugitive emissions, spills and accidental releases, and other non-point releases;
• releases to surface waters – direct and indirect discharges to water bodies, including discharges to municipal wastewater and stormwater collection and/or treatment systems, spills and leaks; or
• releases to land – underground injections, discharges to groundwater, and discharges resulting from spills, leaks and other.

For greater clarity, any loss of the substance from the facility, even if indirect, should be reported. Losses can occur, for example, during cleaning of floors, cleaning of lines or from release of contact cooling waters.

When describing potential releases and losses of the substance, specify if a transfer to an off-site waste management facility is part of your standard practice. A transfer to an off-site waste management facility is any movement of a substance, including a mixture, product or manufactured item containing the substance, to a facility, including a third-party facility, which will handle, recycle or dispose of the substance (either as a recyclable, hazardous waste, or non-hazardous waste).

8.6 Description of prevention or mitigation measures in place to prevent or minimize release of the substance

You are required to provide in subparagraph 8(e)(ii) a description of the prevention or mitigation measures in place to prevent or minimize releases of the substance.

Prevention or mitigation measures relate to practices, policies or technological solutions at your facility to prevent or minimize releases of the substance to the environment, or exposure of Canadians to the substance. Examples include, but are not limited to:

• scrubbers, thermal oxidizers and bag filters to prevent releases to air;
• collection tanks to capture wash water from the 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;
• primary, secondary or tertiary on/off-site wastewater treatment equipment systems; and
• spill protocol and employee training

Example of information required for subparagraph 8(e)(ii)

In 2019, you used Substance A 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 use of the substance in the production of Resin 123. You imported Substance B in a lubricant, also listed in Schedule 1, to another facility. The substance was shipped to you in bulk in tank containers. You then stored the containers at your facility in Big Town ON, before repackaging the substance into smaller containers (drums) for sale to your customers.

8.7 Concentration of the substance in discharged effluent

If you reported releases to water in subparagraph 8(e)(i) in the form of effluent discharge, you are required to provide in subparagraph 8(e)(iii) the annual average AND maximum concentration of the substance in effluent discharged from the facility, in μg/L, as well as the method used for determining the concentration. When describing the methods used, include analytical methods, monitoring frequency and detection limits, if available. 

Note that the concentration in the effluent is only required if it is available for 2019; new or additional monitoring is not requested.

Tip: If you have not monitored the substance in the effluent discharged from the facility, you will be able to indicate this as not reasonably accessible in the Excel Reporting File. 

“-“ will be displayed as a gray cell in the Excel Reporting Form, indicating that data is not required based on the responses provided.

8.8 Other monitoring results of releases of the substance

If other monitoring results of releases of the substance into air, water or land are available, you are required to provide them in subparagraph 8(e)(iv), including monitoring frequency and methodology.

Other monitoring results of interest may include, but are not limited to:

• The presence or concentration of the substance in samples from your air emissions, results of these tests, units, method detection limits as well as sampling and analytical methods used.
• For releases of the substance to air, an indication as to whether the emissions are from a point source or fugitive, the duration and frequency of the emissions, and ground concentration (specify the units).
• If a spill occurred, monitoring of substance in ground water or soil (e.g., concentration, units used, monitoring method and frequency).

9. Section 9 – Unpublished studies

Section 9 of the notice requires you to provide for each reportable substance:

• any unpublished data or studies with regard to occupational exposure, such as:

(i) monitoring data collected in the workplace (e.g., air monitoring or biomonitoring data of urine or blood measuring the reportable substance in workers); or
(ii) studies examining workers handling the substance in the workplace (e.g., dosimetry, patches, charcoal badges, personal air monitors, urine/blood samples).

• any unpublished data or studies with regards to any of the following, that have not already been provided to the Government of Canada to comply with the New Substances Notification Regulations (Chemicals and Polymers) and that do not pertain only to Bisphenol A, CAS RN 80-05-7:

(i) mammalian study endpoints:

(A) acute toxicity (oral, dermal, and inhalation),
(B) short-term toxicity (oral, dermal, and inhalation),
(C) subchronic toxicity (oral, dermal, and inhalation),
(D) carcinogenicity,
(E) in vitro genotoxicity (mutagenicity or clastogenicity),
(F) in vivo genotoxicity (mutagenicity or clastogenicity), developmental and reproductive toxicity,
(G) absorption, distribution, metabolism and excretion,
(H) endocrine effect(s),
(I) dermal absorption, and
(J) any additional unpublished data or studies not listed that may be relevant to the evaluation of the potential of the substance to affect human health.

(ii) ecological study endpoints:

(A) biodegradation,
(B) bioaccumulation factor, bioconcentration factor, and biomagnification factor,
(C) ecotoxicity (experimental acute and chronic studies for pelagic, benthic, and terrestrial organisms),
(D) environmental monitoring and presence,
(E) persistence,
(F) chemical transformation,
(G) leaching potential, and
(H) any additional unpublished data or studies not listed that may be relevant to the evaluation of the potential of the substance to affect the environment.

(iii) physical-chemical properties, such as:

(A) melting point,
(B) boiling point,
(C) vapour pressure,
(D) water solubility or water extractability,
(E) octanol-water partition coefficient (log Kow),
(F) organic carbon-water partition coefficient (log Koc), and
(G) acid dissociation constant.

(iv) degradation, characterization, or the release, leaching or migration of the substance from the final mixture, product or manufactured item, including measurements or calculations of migration into food.

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, Google). The unpublished data or studies submitted can be from any calendar year.

Full data or studies should be submitted as an attachment to your online submission. Please note that the online reporting system has a file size upload limit of 20 MB per file and compressed files (e.g., .zip, .rar) are not accepted for security reasons.

Tip: If your unpublished study or data document has a file size larger than 20 MB, it can be broken down into smaller size files and uploaded to the online reporting system.

You are also required to report the title of the data or study as well as the name of the file uploaded. If available, the title should include the author(s) and the year in which the study was performed. The file name(s) should correspond to the exact file name(s) uploaded to the online reporting tool, including extension types (e.g. .docx, .pdf, .xlsx). For example, the following information should be reported in the Excel Reporting File for an acute toxicity study:

• Title of study: A 48-hour flow-through acute toxicity test with Daphnia magna (Peter et al. 2011)
• File name: acute toxicity test Daphnia magna 2011.pdf

Examples of additional data or studies not listed above that may be relevant to risk assessment are hazard and ecotoxicology data for a surrogate substance or new approach methodologies including but not limited to mechanistic, transcriptomic and metabolomics assays.

Tip: unpublished data or studies with regard to occupational exposure are the only types of studies or data requested for Bisphenol A (CAS RN 80-05-7)

Unpublished studies or data on substances that do not meet the reporting criteria

You are only required to provide unpublished data or studies for substances that meet the reporting thresholds. However, you are encouraged to submit unpublished studies on your Schedule 1 substances that do not meet the reporting thresholds in a Declaration of Stakeholder Interest. Please note that Section 70 of CEPA may also be applicable for substances that do not meet the threshold and is a mandatory information gathering provision under CEPA. Examples of information that may be submitted under section 70 include, but are not limited to, toxicity studies, information on physical-chemical properties, absorption/leaching potential, concentrations, quantities, uses, monitoring data.

10. Section 10 – Information on known or anticipated final goods

Section 10 of the notice applies to all Schedule 1 substances for all activities (manufacture, import or use to produce) for which reporting criteria are met.

For each reportable substance, you are required to provide:

• the substance function code(s) (U codes) that describe the substance function in the known or anticipated final goods that have the same application code;
  • If code U999 (Other) is selected, you must provide a written description of the function;
• for each substance function code provided, the application code(s) (C codes) that describes the known or anticipated final goods containing the substance with that function;
  • If codes C301.01(Food packaging material, single-serve, single-use or disposable) or C301.02 (Reusable food and beverage container) are selected, you must provide information on food and beverage contact substances and food or beverage types

Tip: It is possible to have several combinations of U and C codes for the same reported substance.

• for each combination of substance function code and application code, the person shall provide the following information for the known or anticipated final goods:
  • the concentration, or range of concentrations, of the substance by weight (w/w%) in the goods;
  • the quantity, or quantity range, of the substance in kilograms (kg) in the goods;
  • a description of the goods;
  • the common, generic, or trade names of the goods, if not already provided to the Government of Canada to comply with the New Substances Notification Regulations (Chemicals and Polymers);
  • whether the goods are intended for use in commercial activities;
  • whether the goods are intended for use in consumer activities; and
  • whether the goods are intended for use by or for children 14 years of age or younger.

Known or anticipated final goods containing the substance

The notice requires that the above information be reported on the “known or anticipated final goods containing the substance”. “Known or anticipated final goods” refers to the goods containing the substance that is offered for sale to the end users. Final goods can be the substance alone, or a mixture, product, or manufactured item containing the substance.

Not everyone responding to the notice will have information on the final goods containing the substance, especially if their own goods, the goods the reporting company is involved with, are part of the beginning of the supply chain (e.g., raw substance or mixture). You may need to contact your customers to determine the “known or anticipated final goods containing the substance”. When responding to the notice, respond using the most complete and accurate information available to you.

Person’s own goods

If you do not have information on the known or anticipated final goods AND your reasonable efforts to obtain this information (e.g., request for information across the supply chain) did not yield the necessary information, you may report on information requested in Section 10 on your own goods (i.e., the goods your company is involved with, not the final goods containing the substance that is sold to end users).

If you are reporting on your own goods, you are encouraged to provide additional information on the steps you have taken to try to obtain the substance function code and application code as well as related information for known or anticipated final goods and why these steps did not yield the necessary information.

Please note that information on final goods is essential to the risk assessment process. It is in your company’s best interest to make reasonable efforts to obtain this information throughout the supply chain. The absence of information on final goods may result in the use of conservative assumptions in risk assessments. Consequently, risk management measures may be implemented that impact your ability to sell certain substances or goods containing these substances in Canada.

Examples of reporting on known or anticipated final goods containing the substance vs. own goods containing the substance:

• Company A imports a pure reportable substance and formulates a coating that is then sold to a company who manufactures thermal paper. In this example, the company’s own good is the coating and the final good is the thermal paper. If Company A knows or can anticipate that the coating is being used in thermal paper, Company A must provide code C302.02 (Thermal paper) for this situation and provide a written description of the known or anticipated final good (e.g., cash receipts). Concentration and quantity requested in Section 10 should be reported on the substance within the thermal paper and common, generic or trade names and intended uses should be reported on the thermal paper.
  • If Company A does not know what the known or anticipated final goods containing the coating are, they may contact their customers by email to request information on final goods. If Company A does not receive a response, they cannot determine or cannot anticipate what the customer will do with the coating. C202.01 (Paints and coatings) should be used to reflect Company A’s own application of the substance, and a written description of the type of coating reported should be provided. Other information requested in Section 10 should be reported on the substance within the coating and the coating itself. Steps taken to try to obtain information on final goods may also be provided (i.e., email to customers did not yield necessary information).

• Company C imports a coating containing a reportable substance that they resell to over 100 customers. Company C verifies their records and determines that 80% of the coating is sold to two customers. Company C does not have the resources to request information on final goods from all their customers; they therefore contact their two top customers to request Section 10 information. The two customers inform them that the coating is used in can lids and provide other requested information. Company C therefore reports code C301.01 (Food packaging material, single-serve, single-use or disposable) in Section 10 along with other requested information on the can lids. A note can be added to Section 10 explaining that information reported represents 80% of the activity with the substance.

10.1 Reportable codes

When submitting your response to Section 10, you are required to consider 2 sets of codes:

• substance function codes
• application codes

Tip: The Excel Reporting File allows you to view the list of codes to help you pick the most appropriate one.

10.1.1 Schedule 2 of the notice – substance function codes

Substance function codes, beginning with the letter U, are used to describe 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, or product; or used.

For example, if the substance function is:

• A monomer to make polycarbonate plastic, select “U015 – Intermediate”;
• To reduce friction or heat in a vehicle lubricant, select “U017 – Lubricants and lubricant additives”;
• To both develop color and provide heat resistance in thermal paper, select “U999 – Other”.

Tip: Code U999 can only be used when there is no other code to match the function of the substance. It can also be used when the substance has more than one function. When selecting this code, a concise written description of the substance function(s) must be provided.

Tip: Importers of manufactured items can use code U067 if the substance function is unknown.

The substance function codes are listed in Appendix 1 with their descriptions and some examples.

10.1.2 Schedule 3 of the notice – application codes

Application codes, formerly called Consumer and Commercial Codes, begin with the letter C and are used to identify the application of the mixture, product or manufactured item containing a substance with regards to its purpose in a consumer or commercial setting.

For example, if the substance is contained in:

• A sunscreen, select “C563 – Drugs” or “C564 – Natural Health”;
• A plastic lid of a glass food container, select “C301.02 – Reusable food and beverage container”;
• A plastic toy truck, select “C304 – Toys, playground and sporting equipment”;
• A PVC water pipe, select “C303.01 - Plastic materials not otherwise covered in this table”.

If a good has more than one application, you are required to report the applicable code that best describes the application.

C999 can only be used when there is no other code to match the application of the good.

The application codes are listed in Appendix 2 with their descriptions and some examples.

10.1.3 Additional information related to application codes

10.1.3.1 Concentration and quantity of the substance in the goods

For each combination of substance function code and application code, you must provide the concentration, reported as a weight percentage (w/w%), as well as quantity, reported in kilograms (kg), of the substance contained in the known or anticipated final goods. If you have reported a substance function code and application code based on your own goods, you should provide the concentration and quantity of the substance within your own goods. The concentration can be reported with up to a three decimal precision.

If you do not know the concentration and quantity of the substance in the reported goods, even after making reasonable efforts to obtain the data, you may indicate in the Excel Reporting File that this information is not reasonably accessible and will not be provided.

10.1.3.2 Description of the goods

For each application code provided, you are required to provide a concise written description of the goods that they capture.

For example, the following descriptions can be provided:

• Makeup foundations for application code “C108 – Personal care”;
• Cash register receipts for application code “C302.02 – Thermal paper”;
• Polycarbonate tubing for application code “C303.01 – Plastic materials not otherwise covered in this table”.

10.1.3.3 Common, generic or trade names

In addition to providing the application codes, you must provide the common, generic or trade name of the known or anticipated final goods containing the substance unless you have already provided it to the Government of Canada to comply with the New Substances Notification Regulations (Chemicals and Polymers).

For example:

• In 2019, your company imported outdoor apparel containing a substance listed in Schedule 1 of the notice. In this case, you should select the application code “C104 – Fabric, textile and leather articles not otherwise covered in this table” and you must provide the common, generic or trade name of the final goods (e.g., “Women’s Classic Rain Coat”).

10.1.3.4 Intended application of the known or anticipated final goods

When providing information on the intended application of the known or anticipated final goods or your own goods, you will also need to consider if the goods are destined for commercial use, consumer use, or use by or for children 14 years of age or younger.

Commercial use refers to the use of a substance or a good containing a substance, by a commercial enterprise providing saleable goods or services.

For example:

• Substance is contained in a good sold to a company as heavy factory machinery.
• Substance is contained in a good (e.g., commercial carpet cleaning liquid) that is distributed to professional office carpet cleaning companies.

Consumer use refers to the use of a substance that is directly, or as part of a good, sold to or made available to consumers 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 good (e.g., body lotion or disinfectant wipes) that is sold or made available to consumers.
• Substance is contained in a product (e.g., paint) that is sold or made available to consumers for do-it-yourself crafts.

Intended to be used by or for children refers to a good intended for use by or for children 14 years of age or younger.

For example:

• Moisturizer intended for infant use
• Wipes to clean infant and children genitalia, noses, mouths and/or hands
• Craft products intended for children use
• Toys intended for children use
• Infant formula packaging intended for infant use

10.1.3.5 Food and beverage contact substances and food and beverage types

If you report codes C301.01 (Food packaging material, single-serve, single-use or disposable) or C301.02 (Reusable food and beverage container) in subparagraph 10(1)(c), you are required to provide in paragraph 10(2) the following information:

• whether the substance is intended to or may be in direct contact with food or beverage, as opposed to being on the exterior of the packaging or container; and
• the types of food or beverage that could be contained in and in contact with the packaging or container.

If the anticipated final good is food packaging or a food and beverage container, the packaging or container itself is intended to or may come into contact with food or beverage. However, depending on where the substance is located within the packaging or container, the substance itself may or may not come into direct contact with the food or beverage. If you are aware of the location of the substance within the packaging or container, you must report whether or not the substance is intended to or may be in direct contact with food or beverage.

You must also indicate the types of food or beverage that could be contained in and in contact with the packaging or container, not only the parts of the packaging containing the substance. The food categories below or individual food or beverage descriptions may be reported.

• Aqueous or Acidic Foods
  • Nonacid, aqueous products: may contain salt or sugar or both (pH above 5.0).
  • Acid, aqueous products: may contain salt or sugar or both and include oil-in-water emulsions of low- or high-fat content.
  • Dairy products and modifications: oil-in-water emulsions, high- or low-fat.
  • Beverages: nonalcoholic.
  • Moist bakery products with surface containing no free fat or oil.

Examples of food or beverage descriptions for this category: pasta, milk, green or dry cooked yellow split peas, tofu and vegetables with soy based sauce, candy milk chocolate coated coffee beans, cream of celery soup (canned, condensed, reduced fat, milk added), olive (ripe, canned, small to extra large), roasted chicken, raw chicken breast, pickled vegetables, frozen fruit.

• Low or High Alcoholic Foods
  • Beverages: containing up to 8% alcohol or more than 8% alcohol.

Examples of food or beverage descriptions for this category: rum cooler, non-alcoholic wine, beer, vodka and frozen margarita.

• Fatty Foods
  • Aqueous, acid or nonacid products containing free oil or fat; may contain salt, and include water-in-oil emulsions of low- or high-fat content.
  • Dairy products and modifications: water-in-oil emulsions, high or low fat.
  • Low-moisture fats and oil.
  • Moist bakery products with surface containing free fat or oil.
  • Dry solids with the surface containing free fat or oil.

Examples of food or beverage descriptions for this category: cooked vermicelli made from soy, restaurant prepared spaghetti and meatballs, cheese croissant, phyllo dough, frozen vanilla ice cream, commercial peanut butter cookie, cheese, chocolate cake or cupcake, cooked roasted lamb, crispy fried chicken, and canned salmon.

• Dry Foods
  • Dry solids with the surface containing no free fat or oil.

Examples of food or beverage descriptions for this category: dry pasta, unprepared rice, flour, couscous, oat bran, bread, dinner roll, cracker, english muffin, cake mix, cereal, biscuit, granola bar, dry milk, nuts, dehydrated soup, dried fruits, tea, coffee, baby food cereal, spices and chewing gum.

• Infant Formula

Examples of food or beverage descriptions for this category: powdered formula or prepared liquid formula.

For example:

• Code 301.01 is reported for food cans containing coconut milk. The food can itself is designed to come into direct contact with food. The reportable substance is contained in the interior epoxy-resin lining of the can. The substance itself is also therefore in direct contact with the food. The type of food contained in and in contact with the packaging to be reported is a fatty food.

• Code C301.02 is reported for a travel mug. The mug itself is designed to come into direct contact with the beverage. However, the inside of the mug is in stainless steel and the outside is made out of a polycarbonate material that contains the reportable substance. The substance is therefore not in direct contact with food or beverage. The type of food that could be contained in and in contact with the packaging is decided by the consumer but consists typically of aqueous or acidic foods.

Tip: If the location of the substance within the packaging or the types of foods that may be contained in and in contact with the packaging are unknown, indicate “Not reasonably accessible” or “unknown” in the Excel Reporting File.

Example of information required for Section 10:

In 2019, your company imported a total quantity of 120 kg of Substance A, as reported in Section 7. Ten (10) kg of Substance A was used as an intermediate to make reusable plastic containers and 30 kg was used to make disposable bowls. The containers were distributed to various retailers and the bowls to various hotel companies. Your retailers informed you that the consumers who buy the containers use them as they wish. The hotels informed you that they use the bowls as takeaway containers for soups. Hotel use of the containers is considered a commercial use. The concentration of Substance A in the container is 0.02 w/w% and 0.01-0.2 w/w% in the disposable bowls. The concentration may be reported with up to a three decimal precision as shown in Table 9.

Your company also manufactured in 2019 Substance B and used 1 000 kg of it as a monomer to produce an epoxy adhesive at a concentration of 0.03 w/w% that was distributed to more than 100 customers that you know further use the substance to make goods which are unknown to you. After trying to obtain Section 10 information on anticipated or final goods from your customers with no success, you decide that it would not be reasonably possible to report on final goods. You therefore report for Section 10 on your own good (i.e., the adhesive).

Furthermore, your company manufactured 10 000 kg of Substance C. You sell Substance C to over 150 customers, with 60 % going to Customer X. You work with your Customer X and determine that the substance is sold for commercial purposes as color developer in airline tickets. However, you are unable to determine the concentration of the substance in the tickets. Your other customers do not respond to your request for information.

^a Are generally not expected to be confidential, see part 12.
“-“ will be displayed as a gray cell in the Excel Reporting Form, indicating that data is not required based on the responses provided.

11. Section 11 – Reactants or components of Part 2 substances

Section 11 of the notice applies to Schedule 1 Part 2 reportable substances that were manufactured or used to produce a good, whether alone or in a good, for which the reporting criteria are met. For greater clarity, Section 11 does not apply to Part 1 substances and does not apply to Part 2 substances that are solely imported alone or within goods. Section 11 in the Excel Reporting File will narrow this down for you based on your responses to earlier Sections of the notice.

For each substance in Section 11 of the Excel Reporting File, you are required to provide:

• the chemical identity or CAS RN of the reactants or components of the substance; and
• the concentration, or range of concentrations, of each reactant or component by weight (w/w%).

Each reactant or component identified should at minimum level of specificity represent a distinct homologous group with a unique molecular formula and weight. Chemical identity is to be represented by CAS RN where known, otherwise a description of the chemical identity including representative structures of the components can be provided either in the Excel Reporting File or as an attachment to your submission.

The identity of the reactants or components of the substance may have been determined through analytical data and methods such as: chromatograms, spectral analyses (e.g., C or H-nuclear), nuclear magnetic resonance (NMR) spectra data, infrared or UV-VIS spectra data, mass spectra (MS) or atomic absorption spectra (AAS) data); and/or reference to peer reviewed articles supporting chemical identity and concentration information, or reference to industry or analytical standards such as the color index or International Organization for Standardization (ISO)-Standards for essential oils. You may wish to contact your supplier to obtain information on the chemical identity of the reactants or components of the substance.

The concentration or range of concentrations of each reactant or component forming the substance reported should be provided as a weight percentage (w/w%).

If the information on the identity of the reactants or components or their concentrations are not available, you will have the option in the Excel Reporting File to indicate that the information is not reasonably accessible.

Example of information required for Section 11

In 2019, you imported 1 000 kg of a substance from your supplier. The supplier has indicated that the substance is composed of Component A at 30-35%, Component B at 10-15%, and Component C at 50 to 60% and provided you with gas chromatography – mass spectral (GC-MS) data. The substance is used to produce a good. The substance is still present in the final good.

If available, you are encouraged to provide the GC-MS data as supplementary information as an attachment to your submission or through a Declaration of Stakeholder Interest.

If the composition of the reported substance is unknown, your supplier may be able to provide information on the chemical identity of the monomers, reactants or components of the substance.

12. Request for confidentiality

Pursuant to section 313 of the Act, any person who provides information in response to the notice may submit a written request that it be treated as confidential.

A request for confidentiality should only be made for information that is considered confidential under Canadian law.

If you provide information in response to the notice and have reason to believe your information is truly confidential, you are required to provide the reason for requesting confidentiality for each data element. Information can be declared as confidential for the following reasons:

• it is a trade secret of the submitter;
• it is information of a financial, commercial, scientific or technical nature that is treated consistently in a confidential manner by the submitter;
• 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,
• its disclosure could reasonably be expected to interfere with contractual or other negotiations of the submitter.

Please note that as per the Approach to disclose confidential information and promote transparency in chemicals management, certain data elements are generally not expected to be confidential. Release of their information is seen as desirable to promote transparency. That is the case for the two following data elements requested in this notice:

• Common, generic or trade names
• Intended application of the known or anticipated final goods

Additional clarifications may be required to justify your request for confidentiality. If that is the case, you will be notified and given 20 days to provide further written justification for your request.

13. Blind submissions

To determine whether you meet the reporting criteria of the notice, and in order to fill out your response, communicating your needs up the supply chain is critical, including requesting information from a supplier of imported goods. The supplier may be reluctant to provide it to you if it is Confidential Business Information. In such a case, either the foreign supplier should report on your behalf or you and your supplier can agree to both participate in a joint response via blind submissions, where each party submits part of the information directly to the Substances Management Information Line, allowing you to meet your reporting obligation, while protecting the supplier’s trade secrets.

In instances where a blind submission is needed, you or your supplier will be required to provide a reason for the confidentiality request, and indicate which sections of the notice you and your supplier will be submitting to complete the submission.

Blind submissions can also be initiated by a supplier who knows or suspects that a customer should report, based on quantities purchased. In any case, a cover letter or note should be provided with each part of the blind submission indicating that the supplier’s submission completes the customer’s submission and indication of the substances or goods involved. Both parties must agree to this approach.

Example:

During 2019, you imported Product 123 into Canada from a foreign supplier. You follow up with your supplier to obtain information on the composition of Product 123 (CAS RN and concentration of the reportable substance in the product). Your supplier confirms that Product 123 contains a reportable substance and that based on the total quantity of Product 123 you purchased in 2019, you meet the reporting criteria outlined in Section 2 of the notice. However, your supplier is reluctant to share the composition of Product 123 since their formulation is confidential. After contacting the Substances Management Information Line to explain your particular situation and obtaining steps to follow, you submit a "Blind Submission" jointly with your supplier, in which:

• Based on information in your possession, you respond to the notice providing as much information as you can (e.g., the quantity of Product 123 imported in 2019, application codes, intended use). Along with your submission, you should provide a cover letter to clearly explain the situation and identify your foreign supplier; and
• Your supplier provides the confidential information required to complete your submission directly to the Government of Canada (e.g., CAS RN, concentration of the reportable substance in the product and applicable substance function code). Along with their submission, your supplier should provide a cover letter to clearly indicate that their information is confidential and that it completes your submission.

14. Online reporting system

Environment and Climate Change Canada’s Single Window is an online data reporting system. Persons providing mandatory or voluntary responses to the notice shall use the system to provide a response through the “Chemicals Management Plan” (CMP) link on the Single Window Information Manager page. Foreign suppliers and authorized third parties can also use the system to provide information. Refer to the How to report using the Single Window Information Manager: guidance document for details on how to create and manage an account.

Once you have created an account, you will be logged into the Single Window Information Management system (SWIM) as a new user. You will then proceed to set up your profile. After that you must link your profile to your organization.

Tip: If the organization does not exist in the system, you will need to create it.

The following information is needed to create an organization in Single Window:

• Company name
• Canadian physical and mailing addresses (international physical and mailing address for foreign suppliers)
• Canadian Federal Business Number (9-digit number assigned by Canada Revenue Agency) (not required for foreign suppliers)
• Facilities in Canada owned by the organization (name and full physical address).
• Names of employees who will be assigned roles (note: Roles determine how the user can interact with the data entered in SWIM and access rights)
• Organization Lead (note: If you create a new organization, then you are automatically assigned the role of SWIM Organization Lead for that organization)

15. How to submit a s.71 response

If you meet the reporting criteria of the notice, you must provide your response using the online reporting system by following the steps described below in parts 15.1 and 15.2.

15.1 Download the excel reporting file

To prepare your response, download the BPA SAFA Excel Reporting File (ERF) and fill out the requested information making sure that the File Completion status in the STATUS tab is “Complete”. Detailed instructions for completing the file are included in the Instructions tab. If you need more rows for data entry than is provided in the Excel Reporting File, please contact the Substances Management Information Line. Your completed Excel Reporting File should be saved using the following file naming format "ORGANIZATION NAME BPA SAFA s71 ERF.xlsx" before starting the submission process.

15.2 Submit through Single Window

Once your SWIM profile and company are set-up and the Excel Reporting File is complete, navigate to the home page of SWIM and click on the "Chemicals Management Plan" link. On the Chemicals Management Plan's "Reporting Dashboard" page, select the "Chemicals Management – General" initiative and click on the "Search" button. The search result at the bottom of the page will display “CM – General” online form that should be used for uploading and submitting your Excel Reporting File. Click on the pencil icon under "Actions" on the right side of the form with status “New” to start the submission process.

Submitting via the "Chemicals Management – General" Initiative

1. Fill in the "Identification" page and click "Save".
2. On the "Substances to Report" page, which is accessed through the "Reporting Details" menu on the left side of the page, choose "Section 71 BPA SAFA" as the "Submission Purpose". Fill in the "Submission Title" as "BPA SAFA", and then click "Save".
   Note: Do not add substances. Substances only need to be selected in the Excel Reporting File.
3. On the "General Document Upload" page, click "Add Document" and upload your completed Excel Reporting File. Then click "Add".
   a. If you indicated any information in the Excel Reporting File as confidential business information (CBI), click the lock symbol beside the "File Name".
   b. If you did not indicate any information as CBI, do not click the lock symbol beside the "File Name".
   Note: Prior to uploading, ensure that your completed Excel Reporting File is saved using the file name format: "ORGANIZATION NAME BPA SAFA s71 ERF.xlsx". The ORGANIZATION NAME should be identical to the “Company Name” listed on the Identification page of CMP's Chemicals Management - General initiative in Environment and Climate Change Canada’s Single Window.
   Click “Add Document” again to upload any other document that should be included as part of the submission, such as unpublished studies or data, and choose the appropriate CBI status of the file as per 3a and 3b above.
   Files should not exceed 20 MB. If they do, please contact the Substances Management Information Line.
4. Do not complete the “Confidentiality Justification” section for the Chemicals Management – General. Should information be entered in this section, it will not override the confidentiality responses provided in the reporting file.
5. Click "Save" at the bottom of the "General Document Upload" page.
   Note: All pages must be saved (even if they are left blank) in order for the green check mark to appear under each of the "Reporting Details" on the left menu.
6. Return to the CMP "Reporting Dashboard" by clicking on the "Chemicals Management – General" link in the breadcrumbs at the top of the page and select "Submit" under "Actions".
   Note: A completed online form must have a "Submitted" status on the CMP "Reporting Dashboard" in order for the data to be transmitted correctly. You will also receive a "Confirmation of submission" email to acknowledge receipt. We strongly recommend that you retain a copy of all documents that you submit.

Tip: You can save the CM-General form at any stage in the process and return later to complete and submit. Additionally, it is possible to amend a CM-General form once submitted.

16. Declaration of stakeholder interest

Persons not subject to the notice, but who have information the Government may find useful related to BPA SAFA substances, are encouraged to submit this information through a Declaration of Stakeholder Interest (SHI) via Environment and Climate Change Canada’s Single Window online reporting system. Stakeholder data supplementing a mandatory response to this notice can also be submitted. For example, if you did not have activity with a reportable substance in 2019, but had activity in another calendar year, you are encouraged to provide information deemed beneficial for the alternate calendar years by completing an SHI.

When providing information through an SHI, please indicate if any of the information is confidential and provide a rationale.

Please note that an SHI submission must be submitted separately from a mandatory section 71 submission following instructions detailed in Part 16.1. A company submitting both SHI information and mandatory information must submit two different submissions.

16.1 How to submit an SHI

Once your SWIM profile and organization are set-up (see Part 14), navigate to the home page of SWIM and click on the "Chemicals Management Plan" link. On the Chemicals Management Plan's "Reporting Dashboard" page, select the "Chemicals Management – General" initiative and click on the "Search" button. The search result at the bottom of the page will display the “CM – General” form that should be used to submit your SHI. Click on the pencil icon under "Actions" on the right side of the form with status “New” to start the submission process.

1. Fill in the "Identification" page and click "Save".
2. On the "Substances to Report" page, which is accessed through the "Reporting Details" menu on the left side of the page, choose "SHI BPA SAFA" as the "Submission Purpose". Fill in the "Submission Title" as "BPA SAFA", and then click "Save".
   Note: Do not add substances.
3. On the "General Document Upload" page:
   a. Click "Add Document" and upload any pertinent documents. Under the “Notes” box, indicate the CAS RNs from the notice related to the document uploaded. Then click "Add".
   i. If any information in the uploaded file is considered as confidential business information (CBI), click the lock symbol beside the "File Name". Otherwise, do not click on the lock symbol.
   ii. Files should not exceed 20 MB. If they do, please contact the Substances Management Information Line.
   b. If applicable, you can select the appropriate justification(s) in the "Confidentiality Justification" section to provide rationale regarding the nature of the confidentiality request.
   c. If you have not uploaded a document, indicate the CAS RNs from the notice that you are reporting on and any specific information you are sharing on these in the "Notes" box at the bottom of the page.
4. Click "Save" at the bottom of the "General Document Upload" page.
   Note: All pages must be saved (even if they are left blank) in order for the green check mark to appear under each of the "Reporting Details" on the left menu.
5. Return to the CMP "Reporting Dashboard" by clicking on the "Chemicals Management – General" link in the breadcrumbs at the top of the page and select "Submit" under "Actions".

17. Declaration of non-engagement

Persons who have no involvement with any reportable substances and have no commercial interest may send a Declaration of Non-Engagement (DNE) email to the Substances Management Information Line. Indicate in the subject line of the email “BPA SAFA DNE” and specify your company name and its contact information.

18. Extensions

Requests for additional time to comply with this notice must be submitted in writing. The request must include:

• the organization name;
• contact information;
• CAS RN of substances involved; and
• the reason for the request.

It is important to note that you must request an extension of time in writing before March 16, 2022. 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 the deadline.

Requests for an extension of time should be sent to the Minister of the Environment, at the following email address: substances@ec.gc.ca.

19. Questions?

You may contact the Substances Management Information Line at 1-800-567-1999 (toll-free in Canada), 819-938-3232 (outside of Canada) or substances@ec.gc.ca for any inquiries concerning the notice. If using email, please indicate "BPA SAFA Notice Inquiry” in the subject line.

Appendix 1: Substance function codes and corresponding descriptions

Appendix 2: Application codes and corresponding descriptions