Guidance manual for responding to: Notice with respect to certain substances on the Revised In Commerce List

Official title: Guidance manual for responding to: Notice with respect to certain substances on the Revised In Commerce List, including biopolymers, plant extracts, mineral extracts, proteins, fats, animal extracts, waxes, and carbohydrates

Published in the Canada Gazette, Part I on March 12, 2022

1. General information

1.1 Introduction

On March 12, 2022, the Notice with respect to certain substances on the Revised In Commerce List, including biopolymers, plant extracts, mineral extracts, proteins, fats, animal extracts, waxes, and carbohydrates (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 September 14, 2022, and applies to 712 substances, covering 725 substance identifiers (see part 2.1 for information on multiple substance identifiers). The purpose of the notice is to collect information on the commercial status and use of the substances.

The collected information will be used to:

• identify whether the substances are in commerce in Canada;
• inform Revised In Commerce List (R-ICL) administrative decisions; and
• inform priority setting and risk assessment.

Visit the Information Gathering Initiatives webpage for a link to the notice and information on how to submit. For more information on the management of chemical substances, please visit the Government of Canada’s Chemicals Management Plan webpage. For more information on the R-ICL, visit the About the Revised In Commerce List 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 knowledge of the substances’ processing methods to determine if it meets the definition of naturally occurring. When importing a substance or applicable product, 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.

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 may have information that you may not be aware of. For example, your suppliers may be able to provide you with the composition of imported applicable products. 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. This 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 (see Part 12). 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.

1.3 Calendar years targeted by the notice

The notice applies to the 2019 and 2020 calendar year. If you meet the reporting requirements for either year, you are required to provide information for both years.

If you do not meet the reporting requirements for 2019 or 2020, you are not legally obligated to respond to the notice. However, if you imported or manufactured a reportable substance in a different calendar year, the information is of interest to the Government, and you are encouraged to provide information via a Declaration of Stakeholder Interest (SHI) (see part 15).

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) (see part 16).

1.4 Reporting deadline

Mandatory responses to the notice must be provided no later than September 14, 2022, and must be completed using the online reporting system through Environment and Climate Change Canada’s Single Window (see part 13).

2. Schedule 1 of the notice – Reportable substances

Schedule 1 of the notice lists the 725 reportable substance identifiers subject to this notice.

Many substances subject to this notice may be derived from natural sources. Only substances that do not meet the definition of naturally occurring are subject to the notice (see part 4A for the definition of naturally occurring).

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

2.1 Multiple substance identifiers

While 725 substance identifiers are subject to this notice, there are 712 unique substances.

The list of substances with multiple identifiers is in Table 1. The most commonly used substance identifier is marked with an asterisk ‘*’ and is in bold.

When a substance is represented by more than one identifier, the total quantities imported or manufactured for this substance should be reported under the substance identifier in bold. For example, although identified by two different CAS RNs (Chemical Abstracts Service Registry Number), the following substance is in fact the same:

• CAS RN 84696-51-5: Spearmint, ext.
• CAS RN 90064-01-0: Spearmint, ext.

Therefore, if 90 kg was imported under CAS RN 84696-51-5 and 85 kg was imported under CAS RN 90064-01-0, the total quantity of 175 kg meets the quantity threshold for the substance, spearmint, ext., and should be reported under CAS RN 84696-51-5.

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

The notice applies to any person who, during the 2019 or 2020 calendar year, manufactured or imported any reportable substance:

1. in a total quantity greater than 100 kg/year (for either activity); and
2. that is in, or is intended to be in, an applicable product.

3.1 Total quantity

Total quantity must be calculated for each activity (manufacture, import) with each substance separately. The following examples illustrate how to determine whether the reporting criteria of the notice are met:

• In 2020, your company imported 75 kg of a reportable substance at a concentration of 100%. In 2020, you also imported 750 kg of an applicable product containing a reportable substance at a concentration of 10% (equal to 75 kg of the reportable substance). The total quantity of the reportable substance imported in 2020 is 150 kg. The quantity threshold (>100 kg imported) reporting criterion is met. You are required to submit this information through the Excel Reporting File.
• In 2019, your company imported 75 kg of a reportable substance alone and did not import it in any applicable product. The total quantity imported in 2019 is 75 kg. The quantity threshold (>100 kg imported) reporting criterion is not met for 2019. You are encouraged to submit this information through a Declaration of Stakeholder Interest.
• In 2020, your company imported 750 kg of an applicable product containing a reportable substance at a concentration of 10%, but did not import it in that year alone or in any other applicable product. The total quantity imported in 2020 is 75 kg. The quantity threshold (>100 kg imported) reporting criterion is not met for 2020. You are encouraged to submit this information through a Declaration of Stakeholder Interest.
• In 2019, your company imported 75 kg of reportable Substance X. In 2020, your company imported 75 kg of Substance X and you also manufactured 50 kg of reportable Substance X. The total quantity imported in 2019 is 75 kg. The total quantity imported in 2020 is 75 kg and the total quantity manufactured in 2020 is 50 kg. The quantity threshold (>100 kg per activity) is not met for manufacturing or importing for either year. You are encouraged to submit this information through a Declaration of Stakeholder Interest.

3.2 Applicable product

Applicable product means a cosmetic, novel food, food additive, therapeutic product or natural health product subject to the Food and Drugs Act.

A reportable substance “that is in, or is intended to be in, an applicable product” means that the substance is in an applicable product or the substance is alone or in a mixture, but is destined to be used in an applicable product. Both scenarios of the substance (in an applicable product or destined to be in an applicable product) are reportable under the notice.

• Cosmetic includes any substance or mixture of substances used to clean, improve or change the complexion, skin, hair, nails or teeth, and is defined in Section 2 of the Food and Drugs Act.
  This includes beauty preparations (such as make-up, perfume, skin cream, nail polish) and grooming aids (such as soap, shampoo, shaving cream, deodorant).
• Novel food, simply put, is a food product that is new or changed compared to existing foods, and is defined in Division 28 part B, Food and Drug Regulations.
  Examples of novel food includes canned genetically modified (GM) pineapple, GM soybean, GM yeast for wine making, novel bacteria used in yogurt, CRISPR oranges.
  Record of Decision of Novel Foods, regulated under Division 28 of the Food and Drug Regulations are listed on Health Canada’s website. Please note that not all novel foods are listed.
• Food additive is any chemical substance that is added to food during preparation or storage and either becomes a part of the food or affects its characteristics for the purpose of achieving a particular technical effect, and is defined in Section B.01.001 of Div.1, Part B (Foods) of the Food and Drug Regulations.
  Examples of food additives include colouring agents that give foods an appetizing appearance, anticaking agents that keep powders free-running, emulsifiers, preservatives, etc.
  All food additives on the R-ICL are listed in the Tables of Division 16 of the Food and Drug Regulations.
• Therapeutic product means a drug or device or any combination of drugs and devices, but does not include a natural health product within the meaning of the Natural Health Products Regulations as defined in Section 2 of the Food and Drugs Act.
  Example of a therapeutic product: Glumetza (active ingredient: metformin hydrochloride) is an extended-release tablet used to control hyperglycemia in adult patients with type 2 (non-insulin-dependent, mature onset) diabetes.
• Natural health product, simply put, is a product that contains one or more naturally occurring substances that is used to restore or maintain good health and is defined in Section 1 of the Natural Health Products Regulation.
  Examples of natural health products include probiotics, herbal remedies, vitamins and minerals, homeopathic medicines (for example, a topical herbal remedy to speed scar healing), traditional medicines (such as Indigenous, traditional Chinese and Ayurvedic), and other products like amino acids and essential fatty acids.

Tip: If you manufacture or import a reportable substance and do not know what the substance is used for, you may need to contact your domestic users to determine if you are required to respond to the notice.

3.3 Reportable activities

3.3.1 Manufacture

“Manufacture” relates to the creation or production of the substance itself. Manufacture does not refer to the manufacture of an applicable product containing the substance.

Manufacturing a reportable substance may refer to the processing of a naturally occurring substance in a manner that means it no longer meets the definition of “naturally occurring (see part 4.1).

Sometimes there is confusion between the terms "use" and "manufacture". Using a reportable substance to fabricate an applicable product is NOT considered "manufacture" for the purposes of reporting to the notice, as you are not creating the substance. In this case, the activity would be considered as "use to produce an applicable product”.

3.3.2 Import

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

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

• Your Canadian company purchased a substance 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 a reportable substance from a foreign supplier, and the mixture was shipped directly from the foreign supplier to your distribution warehouse in Canada.
• Your Canadian company received an applicable product containing a reportable substance from a foreign source, and the applicable product 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 an applicable product containing a reportable substance from a warehouse located in Canada.
• Your Canadian company transferred an applicable product containing a reportable substance across provincial borders to be stored in a different warehouse.
• Your Canadian company purchased or received a reportable substance alone, or in an applicable product, that was already located in Canada.
• Applicable products are shipped from Europe to the Port of Halifax where they are transferred to rail cars, which transport them to British Columbia where they are transferred to trucks which bring them to their final destination in Washington. While in Canada, these applicable products are considered “in transit” and do not meet the definition of import.

3.3.3 Foreign suppliers and importers of records

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 12 of this manual 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.

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 an applicable product that:

Part 4.1 meets the definition of a naturally occurring substance;

Part 4.2 is used solely as food, as defined under the Food and Drugs Act, that is intended for human consumption;

Part 4.3 is only in transit through Canada;

Part 4.4 is manufactured or imported for a use that is regulated under any Act or regulations other than the Food and Drugs Act; or

Part 4.5 is a transient reaction intermediate, an incidental reaction product, an impurity, a contaminant or a partially unreacted material.

4.1 Naturally occurring substance

Naturally occurring substance^{Footnote 1} means a substance that is derived from nature (including the land, water, atmosphere and life forms which naturally inhabit the earth) and is either:

1. unprocessed or processed only by manual, mechanical or gravitational means; by dissolution in water; by flotation; or by heating solely to remove water; or
2. extracted from air by any means.

The interpretation of the criteria is literal and strict. For example, distillation is not considered a mechanical process, and dissolution in solvents other than water does not fall within this definition.

Isolated substances, or those which are part of mixtures, which are produced by chemical modification of naturally occurring products, or are separated by physical processing, may be subject to the notice.

Methods of processing a substance occurring in nature that are within the scope of the naturally occurring substance definition include:

• filtration;
• milling, cutting, pressing;
• any gravitational separation (decantation/centrifugal methods);
• processing by electrostatic means; or
• extraction with water (not with other solvents).

Substances processed using these methods are not subject to the notice.

Physical processing methods that are not within the scope of the naturally occurring substance definition include:

• distillation;
• steam distillation;
• crystallization;
• sublimation;
• heating for reasons other than to remove water;
• salting out; or
• ion exchange (products obtained by).

Substances processed using these methods (and any other methods that do not meet the definition) are subject to the notice. All processing, including how the substance is obtained from its original source, must be considered.

The following two scenarios illustrate examples of substances that do and do not meet the definition of naturally occurring, dependent on the processing method. To understand whether your processing method qualifies you for mandatory reporting, please review the following scenarios:

Scenario 1:

• In 2019, you extracted a substance from the fruit or seed of a plant by cold-pressing in a Canadian facility. The substance produced would meet the definition of naturally occurring and therefore, you would not be required to report under this notice.
• However, if the substance is subsequently purified (e.g., by ion exchange), then it would not meet the definition of naturally occurring and you would be required to report.

Scenario 2:

• In 2020, you dried and ground plant material by mechanical means and then used water to obtain an extract. The extracted substance would meet the definition of naturally occurring and therefore, you would not be required to report under this notice.
• However, if the substance is produced by extraction with a solvent other than water, such as ethanol or supercritical CO₂, then the substance would not meet the definition of naturally occurring and you would be required to report.

4.2 Food

Food includes any article manufactured, sold or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose.

Examples include flour, cumin powder, black salt, etc.

This notice does not apply if your substance is a food, as defined under the Food and Drugs Act, which is intended for human consumption. However, if your substance is a food as defined under the Food and Drugs Act, but has intended uses that are non-food uses (such as in a cosmetic) it may not be exempt from reporting, unless other exemption criteria (such as naturally occurring substances) are met.

4.3 “In transit”

“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 applicable products at the time of entry into Canada. Cases where applicable products are warehoused in Canada and then sold and distributed to foreign customers are reportable.

The following two scenarios illustrate what may and may not be considered "in transit":

• Applicable products are shipped from Europe to the Port of Halifax, where they are transferred to trucks that transport them to Toronto, where the applicable products 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 applicable products are considered "in transit”.
• Applicable products are shipped from Europe to the Port of Halifax, where they are transferred to trucks and transported to a Toronto-based destination. The applicable products 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 applicable products are not considered "in transit”.

4.4 Regulated under any other Act or regulation

Regulated under any other Act or regulation refers to a substance that is manufactured or imported for a use that is regulated under any Act or regulations other than the Food and Drugs Act and includes, for example, a substance that:

• is, or is contained in, a hazardous waste or hazardous recyclable material within the meaning of the Cross-border Movement of Hazardous Waste and Hazardous Recyclable Material Regulations and that was imported pursuant to a permit issued under those 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; or
• is mixed with, or attached to, a seed registered under the Seeds Act.

4.5 Transient reaction intermediates

Transient reaction intermediates are substances produced within a sequence of chemical reactions between the starting materials and the end product and are:

1. contained in a reaction vessel or a closed manufacturing system (including process holding tanks) located within a single building or single process area;
2. intended to be fully consumed in the course of the chemical reaction;
3. part of an uninterrupted manufacturing process (e.g., at any one time, starting materials or intermediates within the reaction sequence are being processed, except in the event of an unscheduled shutdown); and
4. not likely to be released into the environment during normal operations, and measures are in place to minimize releases during accidental breaches of the closed manufacturing system.

Incidental reaction products are substances produced when a substance undergoes a chemical reaction that is incidental to the use to which the substance is put or that results from storage or from environmental factors.

Examples include substances formed from chemical reactions during:

1. exposure to environmental factors such as air, moisture, microbial organisms and sunlight (substances produced from deliberate reactions with water are subject to the New Substances Notification Regulations, e.g., metal hydroxides formed from a metal oxide and water);
2. storage (e.g., partial polymerization of drying oils);
3. the intended use of a substance or mixture (e.g., adhesives, paints, cleansers, combustion products from fuels, fuel additives and water softeners); and
4. the blending of a formulation when there is no intention to produce new substances and any ensuing chemical reactions do not enhance the value of the formulation (e.g., blending monomers to a precise ratio for customer convenience would not result in a notifiable substance even if some reactions occurred; however, intentional manufacture of a pre-polymer to satisfy a customer’s processing specifications would produce a notifiable substance).

Impurities and contaminants are substances that are normally found in minimal concentration in the starting materials or are the result of secondary reactions that occur during the manufacturing process. These substances and partially unreacted starting materials that are present in the final product are the direct result of the preparation; are not necessary to the end use of the product; have not been intentionally added to the substance; and do not enhance the value of the substance.

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 7(a)(i) and 8 of the notice.

For example:

• Your company owns four facilities in Canada. A reportable substance is imported from a foreign supplier and shipped directly to each of your facilities. The facilities receive 20 kg, 15 kg, 50 kg, and 40 kg of the reportable substance, respectively. You import a total of 125 kg of the reportable substance on a company-wide basis and therefore have met the quantity threshold for responding to 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. Details on how to create and manage an account can be found in part 13 – Online reporting system.

Tip: Part of the information above will be auto-populated from your Environment and Climate Change Canada’s Single Window account. Make sure that your account information is up to date.

Sections of the notice to be completed:

7. Section 7 – Total quantity

Section 7 of the notice applies to all reportable substances that you manufactured or imported in the 2019 and 2020 calendar years. For each reportable substance, you are required to provide the total quantity of the substance you manufactured, imported (alone and in applicable products) and exported in kilograms for both calendar years.

Quantities reported in this section of the notice should be:

• for the substance itself, reported in kilograms (kg), and not the quantity of the applicable product containing the reportable substance; and
• rounded to the nearest kg. If that is not possible, rounding to the nearest 100 kg is also accepted.

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

If you manufactured a reportable substance, you are required to provide the highest annual quantity manufactured at a single facility. If you manufactured for both reporting years, you are required to provide the highest annual quantity manufactured at a single facility for either 2019 OR 2020.

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

Examples of information required for Section 7 of the notice:

• In 2019, your company manufactured 240 kg of Substance A in a manufacturing facility in Mississauga Ontario, 235 kg in Vancouver British Columbia, and 250 kg in Dartmouth Nova Scotia. In 2020, your company manufactured 150 kg of Substance A in a single facility in Dartmouth Nova Scotia. The total quantity of Substance A manufactured in 2019 is 725 kg, the total quantity manufactured in 2020 is 150 kg and the highest annual quantity manufactured at a single facility is 250 kg.
• In 2020, your company manufactured 350 kg of Substance B in a facility in Edmonton Alberta to produce a perfume. The total quantity of Substance B manufactured is 350 kg. The highest quantity of Substance B manufactured at a single facility in 2020 is 350 kg. The perfume is primarily sold to customers in Canada, but some, containing 35 kg of Substance B, was sold to customers outside of Canada. The total quantity of Substance B exported in 2020 is 35 kg.
• In 2020, your company imported 60 kg of Substance C at a concentration of 100% that was intended to be in an applicable product. You also imported 95 kg of an applicable product containing Substance C at a concentration of 60% (equal to 57 kg of Substance C). The total quantity of Substance C imported alone in 2020 is 60 kg and the total quantity imported in applicable products in 2020 is 57 kg.
• In 2020, your company imported 60 kg of an applicable product containing Substance D at a concentration of 100%. You also imported 95 kg of an applicable product containing Substance D at a concentration of 60% (equal to 57 kg of Substance D). The total quantity of Substance D imported in applicable products in 2020 is 117 kg.
• In 2020, your company manufactured 150 kg of Substance E in a manufacturing facility in Sudbury Ontario, and 90 kg in a facility in Dorval Quebec. In 2020, you also imported 90 kg of an applicable product containing Substance E at a concentration of 70% (equal to 63 kg of Substance E) and 45 kg of an applicable product containing substance E at a concentration of 100%. The total quantity of substance E manufactured in 2020 is 240 kg, and the highest annual quantity manufactured at a single facility is 150 kg. The total quantity of Substance E imported in applicable products in 2020 is 108 kg.

8. Section 8 – Used to produce an applicable product

Section 8 of the notice applies to all reportable substances used to produce an applicable product. “Used to produce an applicable product” refers specifically to using a reportable substance, whether alone, in a mixture or in a product, to produce (i.e., to create, to make) an applicable product. For each reportable substance used to produce an applicable product you are required to provide the highest annual quantity, reported in kg, used at a single facility for either 2019 OR 2020 calendar years.

Tip: You are not required to provide the highest annual quantity used at a facility for both calendar years.

For example:

• Your company imports 120 kg of a substance (spearmint extract) and uses it to produce an aromatherapy product that is composed of spearmint extract and other substances. You produced this product in 2019 at a single facility. The highest annual quantity used at a single facility is 120 kg.

9. Section 9 – Reportable codes

When submitting your response to Section 9, you are required to consider 2 sets of codes:

• Substance function codes (see Appendix 1)
• Application codes (see Appendix 2)

9.1 Schedule 2 of the notice – Substance function codes

Substance function codes, begin with the letter U, and 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 to:

• Polish a surface, select “U001 – Abrasives”;
• Remove facial oils with cleaning wipes, select “U029 – Solvents (for cleaning or degreasing)”;
• Adjust the thickness of a hair shampoo, select “U032 – Viscosity adjustors”; or
• Enhance flavour in a natural health product, select “U063 – Flavourants”.

Code U999 can only be used when there is no other code to match the function of the substance. When selecting this code, a concise written description of the substance function must be provided. The substance function codes are listed in Appendix 1 with their descriptions.

9.2 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 or product containing a substance with regards to its purpose in a consumer or commercial setting.

For example, if the substance is contained in:

• A hair and skin conditioner, select “C108 – Personal care and cosmetics”;
• A colour additive, select “C562 – Food”; or
• A probiotic, select “C564 – Natural Health”.

If an applicable product has more than one application, you are required to report the applicable code that best describes the application. As with U999, C999 can only be used when there is no other code to match the application of the substance. The application codes are listed in Appendix 2 with their descriptions and some examples.

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

Section 9 of the notice applies to all reportable substances, whether imported in an applicable product or used to produce an applicable product for both 2019 AND 2020 calendar years.

For each reportable substance imported in an applicable product or used to produce an applicable product, you are required to provide all applicable substance function codes. For each substance function code, you will need to provide the application code for each applicable product.

For each combination of substance function and application codes, you are required to provide the concentration or concentration range of the substance by weight (w/w %) in the applicable product. You are also required to indicate whether the known or anticipated final applicable products containing the substance are intended for use in commercial activities, in consumer activities, or by or for children 14 years of age or younger. Finally, you must provide a written description of the known or anticipated applicable product.

Examples:

• In 2019, your company imported 120 kg of Substance A, of which 30 kg was used to make essential oils and 90 kg was used to make hair shampoo for all ages. The essential oil and hair shampoo were distributed to various retailers and hotel companies. Substance A was used to impart odour in both applicable products; the function of Substance A is “odour agents” (U018). The application codes for the known or anticipated applicable product is C564 (Natural health) and C108 (Personal care and cosmetics). Both applicable products are intended for commercial and consumer use, and the hair shampoo is intended for use by or for 14 years of age or younger. The concentration of Substance A is 96-100 w/w % in the essential oil and 0.075-0.35 w/w % in the hair shampoo. The concentration may be reported with up to three-decimal precision as shown in Table 2. The written description will indicate that the known final applicable product is essential oils and hair shampoo.
• In 2020, your company imported Substance B in makeup cleaning solution at a concentration of 10 w/w % that was distributed to various pharmacies and grocery stores. The function of Substance B is “solvent which becomes part of a formulation” (U030). The application code for the known or anticipated final applicable product is C108 (Personal care and cosmetics). The makeup cleaning solution is intended for consumer use, but not intended for use by or for children 14 years of age or younger. The written description will indicate that the known final applicable product is a makeup cleaning solution.

* Are generally not expected to be confidential, see part 11

9.2.1 Additional information related to application codes

9.2.1.1 Concentration of the substance in the applicable products

For each combination of substance function code and application code, you must provide the concentration, reported as a weight percentage (w/w%) of the substance contained in the known or anticipated final applicable products. The concentration can be reported with up to three-decimal precision.

If you do not know the concentration of the substance in the reported applicable products, even after making reasonable efforts to obtain the data, you may indicate in the Excel Reporting File that the range provided is your best estimate.

9.2.1.2 Intended application of the known or anticipated final applicable products

When providing information on application codes, two additional factors should be considered.

The notice explains that application codes are intended to describe the “known or anticipated applicable product containing the substance”. “Known or anticipated applicable product” refers to the applicable products containing the substance that are offered for sale.

Not everyone responding to the notice will have information on the final applicable products containing the substance. You may need to contact your customers to determine the “known or anticipated applicable product containing the substance”. When responding to the notice, respond using the most complete and accurate information available to you.

For example:

• Company A imports tangerine extract, which is then sold to Company B who uses it to produce a hair conditioner. In this example, the final applicable products are hair conditioner. If Company A knows or can anticipate that the tangerine extract is being used in the hair conditioner, Company A should provide code C108 (Personal care and cosmetics) as the appropriate application code for this situation and provide a written description of the known or anticipated final applicable product as hair conditioner. If Company A does not know what the known or anticipated final applicable products containing the tangerine extract are, they should contact their customers. As tangerine extract is a food, if Company A cannot anticipate and cannot determine what Company B will do with the tangerine extract, C562 (Food) should be used to reflect the application of the substance. In the written description, Company A should specify that the known or anticipated applicable product is the substance itself.
• If Company A imports a pure substance, sells it as is, and has no knowledge of what its customers do with the substance and no way of obtaining this information, C999 (Other) should be used, with a written description that the known or anticipated final applicable product is the substance itself.

When providing information on the intended application of the known or anticipated applicable product, you will also need to consider if the applicable product is 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 an applicable product containing a substance, by a commercial enterprise providing saleable applicable products or services.

Examples:

• Substance A is contained in an applicable product (e.g., disinfectant or cleaning solution) that is distributed for use in health care clinics.
• Substance B is contained in an applicable product (e.g., shampoo or hair conditioner) that is distributed to hotel companies.

Consumer use refers to the use of a substance that is directly, or as part of an applicable product, 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.

Examples:

• Substance C is contained in an imported applicable product (e.g., body lotion or disinfectant wipes) that is sold or made available to consumers.
• Substance D is contained in a product (e.g., fruit extracts) sold or made available to consumers for a do-it-yourself personal care product.

Intended to be used by or for children refers to an applicable product intended for use by or for children 14 years of age or younger.

Examples:

• Multivitamins intended for consumption by children.
• Probiotic capsules intended for consumption by children.
• Moisturizing oil intended for infant use.
• Wipes to clean infant and children genitalia, noses, mouths and/or hands.
• Hand soap intended for consumer use including anticipated use by children.

10. Section 10 – Sold to organizations

Section 10 of the notice applies to all reportable substances that were manufactured or imported alone, for the purpose of distribution.

For each reportable substance manufactured or imported alone, you are required to provide information on the five customers per calendar year to which the greatest quantity of the substance was sold to in a quantity greater than 100 kg.

11. 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 following data elements requested in this notice:

• description of the known or anticipated applicable product;
• whether the applicable product is intended for use in commercial activities;
• whether the applicable product is intended for use in consumer activities; and
• whether the applicable product is intended for use by or for children 14 years of age or younger.

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.

12. 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 applicable products. The supplier may be reluctant to provide it to you if it is Confidential Business Information (CBI). 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 (see Part 11), 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 the substances or applicable products 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 (substance identifier and concentration of the reportable substance in the applicable 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 can 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, and intended use). Along with your submission, you 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 (e.g., substance identifier, concentration of the reportable substance in the applicable 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.

13. 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” link on the Single Window Information Manager page. Foreign suppliers and authorized third parties can also use the system to provide information. Refer to How to report using the Single Window Information Manager: guidance 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 Manager 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)
• 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)

14. How to submit a Section 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 14.1 and 14.2.

14.1 Download the excel reporting file

To prepare your response, download the R ICL N Excel Reporting File (ERF) and fill out the requested information making sure that the File Completion status in the File 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 are provided in the Excel Reporting File, please contact the Substances Management Information Line. Your completed Excel Reporting File should be saved in the following file naming format “ORGANIZATION NAME R ICL N s71 ERF.xlsx” before starting the submission process.

14.2 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 Single Window 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” 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 R ICL N” as the "Submission Purpose". Fill in the "Submission Title" as "R ICL N", 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".
   1. If you indicated any information in the Excel Reporting File as Confidential Business Information (CBI), click the lock symbol beside the "File Name".
   2. 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 R ICL N s71 ERF.xlsx". The ORGANIZATION NAME should be identical to the “Company Name” listed on the Identification page of “Chemicals Management – General” initiative in Environment and Climate Change Canada’s Single Window. 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 Excel 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. Select "Submit" under "Actions" to go to the Declaration page. Fill out the Declaration page and click on “Submit” at the bottom of the page.
   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.

15. Declaration of stakeholder interest

Persons not subject to the notice, but who have activity with reportable substance(s) 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. Some examples of when you should consider submitting an SHI:

• If you did not have activity with a reportable substance in 2019 or 2020, but had activity in another calendar year,
• If you imported or manufactured less than 100 kg of a reportable substance, or
• If you exported or used a reportable substance to produce an applicable product and did not otherwise meet the reporting criteria.

Stakeholder data supplementing a mandatory response to this notice can also be submitted. 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 15.1. A company submitting both SHI information and mandatory information must submit two different submissions.

15.1 How to submit an SHI

Once your SWIM profile and organization are set-up (see part 13), navigate to the home page of SWIM and click on the “Chemicals Management Plan” link. On the Chemical 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 the “Actions” menu 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 R ICL N" as the "Submission Purpose". Fill in the "Submission Title" as "R ICL N", and then click "Save".
   Note: Do not add substances.
3. On the "General Document Upload" page:
   1. Click "Add Document" and upload any pertinent documents. Under the “Notes” box, indicate the substance identifiers from the notice related to the document uploaded. Then click "Add".
      1. 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.
      2. Files should not exceed 20 MB. If they do, please contact the Substances Management Information Line.
   2. If applicable, you can select the appropriate justification(s) in the "Confidentiality Justification" section to provide a rationale regarding the nature of the confidentiality request.
   3. If you have not uploaded a document, indicate the substance identifiers 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. Select "Submit" under "Actions" to go to the Declaration page. Fill out the Declaration page and click on “Submit” at the bottom of the page.

16. 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 “R ICL N DNE” and specify your company name and its contact information.

17. Extensions

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

• the organization name;
• contact information;
• substance identifiers involved; and
• the reason for the request.

It is important to note that you must request an extension of time in writing before September 14, 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. Indicate in the subject line of the email “R ICL N Extension Request”.

18. Questions?

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

Appendix 1: Substance function codes and corresponding descriptions

Appendix 2: Application codes and corresponding descriptions