Guidance for responding to the Notice with respect to microbeads in certain personal care applications

Published in the Canada Gazette, Part I, on August 1, 2015

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This document provides guidance for responding to the Notice with respect to microbeads in certain personal care applications (the Notice) published in the Canada Gazette, Part I, on August 1, 2015, pursuant to paragraph 71(1)(b) of the Canadian Environmental Protection Act, 1999 (the Act). In case of discrepancy between this document and the Notice or the Act, the official versions of the Notice and the Act take precedence. For the purpose of this document, the term ‘microbeads’ will be defined as: synthetic polymer particles that, at the time of their manufacture, are greater than 0.1 micrometers and less than or equal to 5 mm in size. The notice applies to microbeads that are in a mixture or product intended to be applied to the human body for the purpose of exfoliating or cleansing, and the conditions of use are such that they may be released to water.

Table of Contents

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

1. Overview

1.1- Purpose of the Notice

Microbeads are synthetic polymer particles that, at the time of their manufacture, are greater than 0.1 μm and less than or equal to 5 mm in size. This includes different forms of particles including solid, hollow, amorphous, etc. They are used in a variety of products, including personal care products such as toothpastes, shampoos, face washes, exfoliating creams and moisturizers.

On July 30, 2015, the House of Commons voted unanimously for the government to take immediate measures to add microbeads to the List of Toxic Substances.  A substance may be added to Schedule 1 when the Governor in Council is satisfied that the substance is toxic to human health or the environment based on the recommendation of the Minister of the Environment and the Minister of Health. Once on the List of Toxic Substances, the Government of Canada has the authority to use regulations or other instruments to prevent or control the use and/or release of these substances.

On July 25, 2015, Environment Canada published a science summary outlining available data on microbeads in the environment. Information included in this report indicates that microbeads have shown adverse short-term and long-term effects in aquatic organisms in laboratories. In addition, microbeads may reside in the environment for a long time and continuous release of these particles to the environment may result in long term effects on biological diversity and the ecosystems. As a precautionary step, the Government of Canada is proposing to recommend that this substance be added to the Toxic Substances List in Schedule 1 of the Canadian Environmental Protection Act, 1999.

The purpose of the Notice is to gather information on microbeads imported, exported or used in certain applications products in Canada in 2014, as well as information related to the size and revenues of companies involved. The data that is being gathered is needed to identify uses and sources of microbeads used in certain personal care applications that may be released to water, to inform the cost and benefits analysis of any potential risk management actions. This will ensure that future decision making is based on the best available information.

An electronic copy of the Notice and the science summary on microbeads are available at the Chemical Substances Web site.

1.2- Reportable substance

Schedule 1 of the Notice identifies the reportable substance as synthetic polymer particles that, at the time of their manufacture, are greater than 0.1 μm and less than or equal to 5 mm in size. The Notice applies to all substances that meet this definition that are used in mixtures or products intended to be applied to the human body for the purpose of exfoliating or cleansing that are used in such a way that they may be released to water.

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

• The Notice applies to microbeads that are solid at room temperature in the reportable mixtures or products.
• The term synthetic means man-made. The Notice does not apply to ‘naturally occurring’ polymers.
• Naturally occurring substances are defined as naturally occurring and must be unprocessed; processed only by manual, gravitational or mechanical means, by dissolution in water, by flotation or by heating solely to remove water; or extracted from air by any means. For example, naturally derived latex particles are naturally occurring substances but synthetic latex particles are not.

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2. Who does the Notice apply to?

2.1- Reporting criteria

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

• Substance
• Type of activity
• Calendar year
• Quantity

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

• Imported a total quantity greater than 10 kg of microbeads in a mixture or product intended to be applied to the human body for the purpose of exfoliating or cleansing that are used in such a way that the may be released to water.
• Exported a total quantity greater than 10 kg of microbeads in a mixture or product intended to be applied to the human body for the purpose of exfoliating or cleansing that are used in such a way that the may be released to water.
• Used a total quantity greater than 10 kg of microbeads in the manufacture of a mixture or product intended to be applied to the human body for the purpose of exfoliating or cleansing that are used in such a way that the may be released to water.

The reporting threshold is based on activity with microbeads (i.e. the import, export or use) of greater than 10 kg in the 2014 calendar year.

2.2- Exclusions

The following are excluded from the Notice:

• Microbeads, whether in a mixture or in a product that:
  • are in transit through Canada;
  • are, or are contained in, a hazardous waste or hazardous recyclable material within the meaning of the Export and Import of Hazardous Waste and Hazardous Recyclable Material Regulations and that was imported in 2014 pursuant to a permit issued under those Regulations;
  • are, or are contained in, a pest control product within the meaning of subsection 2(1) of the Pest Control Products Act where that pest control product is registered under the Pest Control Products Act;
  • are, or are contained in, a fertilizer or supplement within the meaning of section 2 of the Fertilizers Act where that fertilizer or supplement is registered under the Fertilizers Act; or
  • are, or are contained in, a prescription drug within the meaning of  “prescription drug” under The Food and Drugs Regulations.

In addition, any person who submitted information for microbeads in 2015 as part of voluntary data submission, either directly or through a third party such as an association, a response from that person is not required under this Notice if the Minister is satisfied with its completeness.

It is important to note that microbeads that are imported in, exported in or used to manufacture products or mixtures other than those used for the purpose of exfoliating and cleansing the human body are excluded from the Notice.

2.3- Flowchart

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

Figure 1:  Reporting Diagram

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

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

1. Company meets the reporting criteria:
   • In 2014, if your company imported 200 kg of a rinse-off cleansing product intended to be applied to the human body which contained 10% of microbeads then the total quantity imported of microbeads is 20 kg and the reporting criteria are met because the 10 kg import threshold for the substance in 2014 has been exceeded.
   • In 2014, if your company purchased 50 kg of microbeads in a mixture or product from a domestic supplier, which was used to make an exfoliating personal care product used in such a way that the microbeads may be released to water, the reporting criteria are met because the 10 kg use threshold for the substance in 2014 has been exceeded.
2. Company does not meet the reporting criteria:
   • In 2014, if your company imported 500 kg of a facial cleansing product which contained 1% microbeads, then the total quantity imported of microbeads is 5 kg and the reporting criteria are not met because the 10 kg threshold has not been met for the year 2014.
   • In 2014, if your company imported 1000 kg of a facial exfoliating product which exclusively contained crushed apricot shells within the 1 mm to 5 mm size range, and no polymer particles, the reporting criteria are not met because the product does not contain microbeads.

2.5- Do I import?

Import relates specifically to the movement into Canada from another country. Import activity under this Notice is applicable when synthetic polymer particles are imported in a mixture or product that is intended to be applied to the human body for the purpose of exfoliating or cleansing.

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

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

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

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

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

2.6- Do I export?

Export relates specifically to the movement out of Canada to another country. Export activity under this Notice is applicable when synthetic polymer particles are exported in a mixture or product that is intended to be applied to the human body for the purpose of exfoliating or cleansing.

2.7- Do I use?

Use relates specifically to microbeads alone (or in a mixture or product) used in the manufacture of (i.e., to create or produce) a mixture or product that is intended to be applied to the human body for the purpose of exfoliating or cleansing.

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

• You blend microbeads with other components to make Mixture Z.
• You repackage Mixture A that contains microbeads to make Product B

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

• You load a product containing microbeads onto a carrier and ship the substance to three other companies in Canada.
• You purchase Mixture Y which contains microbeads from your supplier in Canada, and distribute the mixture to your customers in Canada.
• You use microbeads to make a product used for industrial purposes.

2.8- What mixtures and products are reportable?

For the purposes of the Notice, reportable mixtures and products are those that are  intended to be applied to the human body for the purpose of exfoliating or cleansing that are used in such a way that microbeads may be released to water. Such mixtures or products include:

• Face wash
• Toothpaste
• Body wash
• Shower gels
• Pumice scrub lotions

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3. Information required

The type of information requested in the Notice includes:

• Consumer and commercial codes
• Quantity of mixture(s) or product(s) containing microbeads imported or exported, and quantity of microbeads used in 2014
• Concentration of microbeads by weight in mixture(s) or product(s)
• Proportion of microbeads contained in the mixture(s) or product(s) used for exfoliating or cleansing
• Stock keeping units (SKUs)
• Information on the company importing, exporting or using microbeads

3.1- Consumer and commercial codes

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

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

• All consumer and commercial codes begin with the letter C, followed by three numbers and a decimal with two numbers.
• Refer first to the group descriptions to determine which subset of codes would be most applicable to your substance.

It is important to note that number 999 is reserved for the “Other” code in consumer and commercial codes (C999). This code should only be used when there is no existing code match for the application of the mixture or product. When selecting this code, a written description of the consumer and commercial application of a mixture or product containing the substance, must be provided, and the description should be as concise as possible. A written description of the consumer and commercial application is also required when codes C563 (Drugs) and C564 (Natural Health) are used.

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

3.1.1- Code numbering system for consumer and commercial codes

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

[Type] is expressed by the letter “C” for consumer and commercial use.

[Group #] is a one-digit number to indicate a grouping of chemical substances or products having similar uses. Consumer and commercial codes use six different group numbers (groups 1 – 5 and group 9). For the purpose of this Notice, only groups 1, 5 and 9 are used.

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

In this Notice code C108 has been further divided into ‘sub-codes’ with an additional two digit code. The intent is to obtain more detailed information regarding consumer and commercial activities related to this code. When responding to the Notice for codes that have sub-codes please use the sub-code number that best describes the activity.

Please refer to the code names and descriptions below to determine if any of the pre-set codes applies to your mixture or product containing microbeads. Wording in the description (but not in the title of the code) may identify the use of the mixture or product.

Exemple 1:

3.1.2- Substance Function Codes and Corresponding Descriptions

3.2- Quantities

Within the Notice, it is necessary to report the total quantities of mixtures or products containing microbeads that were imported or exported, and the total quantity of microbeads used during the 2014 calendar year, as well as the concentration percentage of microbeads in mixtures or products, as follows:

• All quantities should be reported in kilograms (kg), rounded to two significant digits. For example:
  • 0.0368 should be reported as 0.037
  • 5 423 should be reported as 5 400
  • 83.29 should be reported as 83

3.3- Concentration of microbeads by weight in mixture(s) or product(s)

The concentration by weight (%w/w) of microbeads in the product(s) or mixture(s) reported is required to determine the quantity of microbeads. You can provide the concentration or a range of concentrations.

3.4- Proportion of microbeads contained in the mixture(s) or product(s) used for exfoliating or cleansing

The product(s) or mixture(s) for which information is gathered may contain microbeads that serve other purposes than exfoliation and cleansing. It is therefore required in the notice to indicate for each applicable consumer and commercial code the concentration or range of concentrations of microbeads present in the product(s) or mixture(s) that are used specifically for the purpose of exfoliating or cleansing.

3.5- Stock keeping units

Stock keeping units (SKU) are assigned by a company to individual products for the purposes of inventory tracking. For example, if a person imported four different face wash products and two different toothpaste products containing microbeads, each would have a distinct SKU. Information on SKUs is required in the Notice to provide Environment Canada with information concerning which products in Canada contain microbeads.

3.6- Number of employees and gross annual receipts

Information related to the size and gross annual receipts of your company is required to inform the cost-benefit analysis of any potential risk management measures. See section 4.3 below for more information.

3.7- Unpublished or published data or studies

Full data or studies related to microbeads can be submitted voluntarily as an attachment to your submission. An example of relevant studies is the biodegradability of microbeads in aquatic or terrestrial environments. If available, the journal reference should also be provided. You are encouraged to provide the data or studies in electronic format (either on a CD, DVD or USB memory stick), or if the file size is small enough, you can submit it by email. Please note that compressed files (e.g., .zip, .rar) are not accepted for security reasons.

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

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

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

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

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4. Sections of the Notice to be completed

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

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

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

• the person agrees that the previously submitted information is their response to Schedule 3 to this Notice; and
• the person identifies the program at Environment Canada or at Health Canada to which the information was previously submitted.

4.1- Section 5 of Schedule 3

For microbeads contained in a mixture or product intended to be applied to the human body for the purpose of exfoliating or cleansing, that a person imported or exported during the 2014 calendar year, for which the reporting criteria have been met, the person shall provide the following information:

• in (a), each consumer and commercial code(s) that apply to the mixture(s) or product(s) containing microbeads.
  • Choose the consumer and commercial code(s) that are consistent with the most complete and accurate information available to you. If none of the consumer and commercial codes provided apply, then code C999 should be used. A written description of the consumer and commercial application (such as the product the substance is found in) is also required when codes C563 (Drugs) and C564 (Natural Health) are used.
• in (b), for each applicable consumer and commercial code listed in (a), indicate the total quantity of the mixture(s) or product(s).
• in (c), for each applicable consumer and commercial code listed in (a), indicate the concentration, or range of concentrations of microbeads by weight (w/w%) in the mixture(s) or product(s).
• in (d), for each applicable consumer and commercial code listed in (a), indicate the proportion in percentage of microbeads contained in the mixture(s) or product(s) used to exfoliate or cleanse.
• in (e), for each applicable consumer and commercial code listed in (a), indicate the number of distinct saleable stock keeping units containing the substance.

Example 2:

In 2014, you imported a product containing microbeads which is used to exfoliate and cleanse skin (consumer and commercial code C108.16 – Skin Cleanser).

4.2- Section 6 of Schedule 3

For microbeads that a person used during the 2014 calendar year to manufacture a mixture(s) or product(s) intended for use on the human body for the purpose of exfoliating or cleansing, for which the reporting criteria have been met, the person shall provide the following information:

• in (a), each consumer and commercial code(s) that apply to the mixture(s) or product(s) containing microbeads that was manufactured.
• in (b), for each applicable consumer and commercial code listed in (a), indicate the total quantity of microbeads.
• In (c), for each applicable consumer and commercial code listed in (a), indicate the proportion in percentage of microbeads contained in the mixture(s) or product(s) used to exfoliate or cleanse.
• in (d), for each applicable consumer and commercial code listed in (a), indicate the number of distinct saleable stock keeping units containing the substance.

Example 3:

In 2014, you used 1000 kg of microbeads in the manufacture of a skin cleanser (consumer and commercial code C108.16 – Skin Cleanser).

4.3- Section 7 of Schedule 3

In this Notice, persons who meet the reporting requirements must provide information on the size of the responding company based on employee number and gross annual receipts for 2014. This information is for the entire company, not solely the business unit focusing on microbeads. The information is requested in the following ranges:

• in (a), the range representing the number of employees and contract employees in Canada  (1 – 10, 11 – 100, 101 – 250, 251 – 500, 501 – 750, greater than 750), during the 2014 calendar year.
• in (b), company-wide, the range representing the gross annual receipts in Canada for calendar year 2014 (less than $500,000; $500,000 to $1 million; $1 million to $5 million; $5 million to $10 million; greater than $10 million).

Example 4:

In 2014, your company had 78 employees and gross annual receipts of $5.6 million.

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5. Request for confidentiality

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

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

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

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

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

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

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

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6. Blind submission

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

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

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

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

Example 5:

During 2014, Company A imported Product 123 into Canada from Company B. Company A follows up with Company B to obtain information on the composition of Product 123 to determine the concentration of microbeads.  Company B confirms that Product 123 contains microbeads and that based on the total quantity of Product 123 sold to Company A in 2014, Company A would meet the reporting criteria outlined in Schedule 2 to the Notice for the substance.  However, Company B is reluctant to share the composition of Product 123 since their formulation is confidential.

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

• Based on information in their possession, Company A responds to the Notice providing as much information as they can (e.g., the quantity of Product 123 imported in 2014).  Along with their submission, Company A should provide a cover letter to clearly explain the situation and identify Company B as their direct foreign supplier. 
• Company B provides the confidential information required to complete Company A's submission directly to the Substances Management Coordinator (e.g., the concentration of microbeads and the percentage proportion of microbeads used to exfoliate or cleanse).  Along with their submission, Company B should provide a cover letter to clearly indicate that their information is confidential and that it completes Company A's submission.

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

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

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7. Declaration of Stakeholder Interest

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

Interested stakeholders may be contacted for further information regarding their interest in microbeads. When completing the declaration, you should specify your activity or potential activity with the substance(s) (e.g., import, manufacture, or use).

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8. Declaration of Non-Engagement

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

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9. Submission of voluntary information

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

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

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

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

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10. Responding to the Notice

Responses to the Notice must be provided no later than October 15, 2015, 5 p.m. Eastern Standard Time using the online reporting system available through the Chemical Substances Web site.

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

If you require more time to comply with the Notice, you may submit a request in writing for an extension of time. The request should include the company name, contact information and the reason for the request.

It is important to note that you must request an extension of time before the October 15, 2015, 5 p.m. Eastern Daylight Time deadline. No extensions will be granted after the deadline has expired. It is recommended that any request for an extension be submitted at least five (5) business days before October 15, 2015, 5 p.m. Eastern Daylight Time, so that a request can be processed by the Minister of the Environment before expiry of the deadline.

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

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

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12. Contact information

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

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