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Proposed Regulations for Microbeads in Personal Care Products Used to Exfoliate or Cleanse

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1 Introduction

1.1 Rationale

Environment and Climate Change Canada has prepared this consultation document to inform the public and stakeholders and to solicit feedback on the key elements of the proposed risk management measure for microbead-containing personal care productsFootnote1 used to exfoliate or cleanse.

On March 24, 2015, the House of Commons voted unanimously for the government to take immediate measures to add microbeads to the List of Toxic Substances. To that end, the Government of Canada prioritized the review of microbeads under the Chemicals Management Plan.

In July 2015, Environment Canada completed this scientific review and analysis of over 130 scientific papers as well as consultation with experts on the impact of microbeads on the environment. This review showed that microbeads may pose a concern to the environment as they contribute to plastic litter in lakes and rivers, accumulating in the environment. In laboratory studies, microbeads have shown adverse short-term and long-term effects in aquatic organisms. The science summary concludes that microbeads are toxic to the environment under subsection 64(a) of the Canadian Environmental Protection Act, 1999 (CEPA 1999) as they are entering or may enter the environment in a quantity or concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity. A proposed order to list microbeads on the List of Toxic Substances was published in Canada Gazette, Part I on August 1, 2015, for a 60-day public comment period.

As well, a Notice of Intent was published on August 1, 2015, stating that Environment Canada is initiating the development of proposed regulations under CEPA 1999 to prohibit the manufacture, import, sale or offer for sale of microbead-containing personal care products that are used to exfoliate or cleanse. Comments received on the Notice of Intent are discussed further in section 6.2. The proposed regulations are intended to be developed for pre-publication in the Canada Gazette, Part I, in 2016.

1.2 Objectives and Interested Stakeholders

The main objective of this consultation is to invite stakeholders to provide their feedback on the proposed regulations.

The specific objectives are to:

  • inform the public and interested stakeholders of the intention to develop regulations to control microbead-containing personal care products that are used to exfoliate or cleanse;
  • provide the public and interested stakeholders with an opportunity to provide input with regard to the proposed risk management measure;
  • solicit information with respect to the economic and technical considerations of the proposal; and
  • solicit information on the challenges and needs of small businesses that would be impacted.

Interested stakeholders may include non-governmental organizations, provincial and territorial government departments, and industry, particularly manufacturers, importers, retailers and associations in the personal care product industry.

The Government of Canada is committed to providing interested or affected stakeholders with the opportunity to take part in consultations at all stages of the development process. All stakeholders may comment in writing by mail, fax or email to the address provided in Section 6.4 of this document by March 10, 2016.

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2 Background

2.1 Microbeads

Microbeads can vary in chemical composition, size, shape, density and function. Microbeads are manufactured for specific purposes, including for use in personal care products (including cosmetics, non-prescription drugs and natural health products) such as scrubs, bath products, facial cleansers, and toothpastes.

Microbeads are a contributor of plastic litter in the environment. Microbeads from “down the drain” products will likely be released into the aquatic environment after wastewater treatment. Microbeads may reside in the environment for a long time, and continuous release of these substances to the environment may result in long-term effects on biological diversity and the ecosystems.

2.2 Current Uses

In 2015, the Canadian Cosmetic, Toiletry, and Fragrance Association (CCTFA) voluntarily surveyed its members on the use of synthetic plastic microbeads for exfoliating and cleansing, and it shared this usage information with the Government of Canada. The annual quantities of microbeads reported to be used in Canada by CCTFA members ranged from 30 kg/year to 68 000 kg/year.

Of the 14 members of the CCTFA that responded to the voluntary survey and have used or were using microbeads in 2015, 5 had already eliminated the use of microbeads for exfoliating or cleansing and 9 had committed to do the same by 2018 or 2019, consistent with U.S. legislation. CCTFA member companies cover the majority of personal care products sold in Canada that contain microbeads.

Further data on usage of microbeads in personal care products that are used to exfoliate and cleanse was gathered through a mandatory survey notice under CEPA 1999 section 71. This survey was designed to gather information on the import, export and manufacture of certain microbead-containing personal care products in Canada. Deadline for response to the survey was October 15, 2015. This survey has helped to identify quantities used, concentrations of microbeads in products, product details and implicated stakeholders to support the development of the regulatory proposal.

2.3 Situation in Canada

2.3.1 Federal Activities

At the June 22-23, 2015, meeting of the Canadian Council of Ministers of the Environment (CCME), ministers acknowledged the efforts by industry to eliminate the use of plastic microbeads from consumer products and supported the Government of Canada’s scientific review of microbeads in personal care products as part of the listing process under Schedule 1 of the CEPA 1999. They noted that provinces and territories may take additional complementary actions to restrict the use of microbeads.

Two bills (C-680 and C-684) on microbeads were tabled during the 41st session of Parliament to amend the Food and Drugs Act and Part 7 of CEPA 1999, but they did not proceed prior to dissolution of Parliament.

Microbeads are not specifically regulated in Canada; however, cosmetics, natural health products and non-prescription drugs such as toothpastes may contain microbeads and are regulated under the Food and Drugs Act (including the Cosmetic Regulations and the Natural Health Products Regulations).

2.3.2 Provinces and Municipalities

On March 9, 2015, a Private Member’s bill in Ontario was introduced to phase out microbeads in consumer products. This bill proposed a prohibition on the manufacture of microbeads or addition of microbeads to cosmetics, soaps or similar products. In this bill, microbeads were defined as non-biodegradable solid plastic particles measuring less than one millimetre in diameter that are used in cosmetics, soaps or similar products as cleansing or exfoliating agents. The bill has passed second reading.

In addition, the cities of Toronto and Montréal, as well as the Quebec Metropolitan Community, have passed motions encouraging bans on the use of plastic microbeads in personal care products at the federal and provincial levels.

2.3.3 Industry

Many Canadian and multi-national users of microbeads have made voluntary commitments to phase out their use in certain products under similar timelines to legislation in U.S. states. 

2.4 Actions in the United States

Currently nine states in the U.S. including Illinois, Colorado, Wisconsin, Indiana, Maine, Maryland, New Jersey, Connecticut and California have passed laws that prohibit selling and manufacturing of microbeads in personal care products. Timelines for the prohibitions range from 2015 to December 31, 2019.

In addition, a U.S. federal bill (H. R. 1321) entitled “The Microbeads-Free Waters Act of 2015” was signed into law on December 28, 2015, that will place restrictions on the manufacture or introduction or delivery for introduction into interstate commerce of rinse-off cosmetics containing plastic microbeads. The law will pre-empt State microbead laws. The prohibition will come into effect on July 1, 2017, for manufacture, and on July 1, 2018, for sale. For non-prescription drugs, the timelines would be July 1, 2018, for manufacturing and July 1, 2019, for sale. Products covered under this law align with the Canadian regulatory proposal.

2.5 Actions in the European Union

In December 2014, at the European Union Environmental Council meeting, Austria, Belgium, the Netherlands, Luxembourg and Sweden jointly called on European Union member states to ban the addition of microbeads to personal care products, in order to protect the aquatic environment from pollution. According to a petition response issued on April 29, 2015, an arm of the European Commission is gathering the necessary information and evidence for developing options to achieve a reduction of microplastics in cosmetic products. These efforts are being made in light of requests at the European Union Environmental Council meeting to ban microplastics in cosmetic products.

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3 Elements of the Proposed Regulations

This regulatory proposal aims to prevent the release of microbeads to the aquatic environment from microbead-containing personal care products that are designed for exfoliation and cleansing.

The proposed regulations would be made under section 93 of Canadian Environmental Protection Act (CEPA) 1999. Section 93 enables the making of regulations with respect to a substance specified on the List of Toxic Substances in Schedule 1.

Environment and Climate Change Canada is currently considering options for the development of a stand-alone regulation or a regulatory amendment with the following key elements:

3.1 Microbead Definition

Microbeads were proposed for addition to Schedule 1 of CEPA 1999 on August 1, 2015, 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”. Comments received following the publication of the proposed order on the definition of microbeads have been considered. As a result, alternative language is proposed: “Plastic microbeads that are > 0.5 μm but ≤ 2 mm in size”. The definition of microbeads for the purposes of the regulations will be aligned with the final addition to Schedule 1.

An explanatory note is expected to be published with the final order adding plastic microbeads to Schedule 1 to provide further clarification on the definition.

3.2 Application and Prohibitions

The proposed regulations would apply to any person who manufactures, imports, sells or offers for sale microbead-containing personal care products including cosmetics, non-prescription drugs and natural health products that are used to exfoliate or cleanse.

The proposed regulations would not apply to a microbead-containing personal care product that:

  • is in transit through Canada; or
  • is a prescription drug within the meaning of “prescription drug” under the Food and Drug Regulations.

3.3 Testing

There are no anticipated testing requirements for those affected by the proposed regulation. 

Any analysis/determination performed by Environment and Climate Change Canada for the purpose of enforcement of the regulations must be conducted by a laboratory that is accredited under the International Organization for Standardization (ISO) standard ISO/IEC 17025:2005, entitled General requirements for the competence of testing and calibration laboratories.

3.4 Reporting and Record Keeping Requirements

While there will be no reporting requirements under this regulation, regulatees benefitting from the proposed in-transit exemption to the regulations as outlined in section 3.2 of this document will be required to keep records as evidence that demonstrate how they meet the exemption.

3.5 Coming into Force

The regulations applying to microbeads as defined in section 3.1 are proposed to come into force on:

  • December 31, 2017, prohibiting the manufacture and import of microbead-containing personal care products, including cosmetics, that are used to exfoliate or cleanse, excluding non-prescription drugs and natural health products.
  • December 31, 2018, prohibiting the sale or offer for sale of microbead-containing personal care products, including cosmetics, that are used to exfoliate or cleanse, excluding non-prescription drugs and natural health products.
  • December 31, 2018, prohibiting the manufacture and import of a microbead-containing non-prescription drug or natural health product that is used to exfoliate or cleanse.
  • December 31, 2019, prohibiting the sale or offer for sale of a microbead-containing non-prescription drug or natural health product that is used to exfoliate or cleanse.

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4 Potential Benefits of Regulations

4.1 Environmental and Health Benefits

Scientific literature indicates that microbeads are readily taken up by a variety of organisms including fish, mussels and several types of zooplankton and have shown adverse short-term and long-term effects in aquatic organisms (Environment Canada, 2015). The concentrations of microplastics are expected to increase linearly in the ecosystem. In order to improve the overall health of the marine environment, action is required to reduce the amount of plastic pollution from personal care products, which are a key source of releases to water.

A regulation banning the manufacture, import, sale or offer for sale of microbead-containing personal care products used to exfoliate or cleanse would be expected to reduce the quantity of microplastics entering the aquatic environment, benefitting marine mammals, fish, invertebrates and fish-eating birds.

A review of scientific literature did not identify studies that indicated concerns for human health related to the presence of microbeads in personal care products.

It is expected that microbeads present in personal care products applied to the skin are not absorbed by the body but rather are rinsed off or leave the body and are ultimately released to the environment (Environment Canada, 2015). Although potential effects to human health through consumption of seafood containing microbeads have been flagged by some members of the public as a concern, the limited information on this source of exposure does not indicate a basis for review of potential risk to human health from exposure to microbeads (Environment Canada, 2015).

4.2 Alignment with Other Jurisdictions

The government recognizes the importance of regulatory alignment between Canada and the U.S. and of ensuring a level playing field for Canadian and U.S. companies and enterprises. Canada will therefore endeavour to align measures for microbeads in personal care products with those of the U.S. to the extent possible and will work towards an approach that takes both our environment and our economy into account.

4.3 Level Playing Field

The proposed regulations could help to provide a “level playing field” for manufacturers and importers of microbead-containing personal care products. A regulatory approach provides assurance, for the purposes of business decision making, that all manufacturers and importers must meet the same requirements for the products to be regulated.

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5 Alternatives

Various alternatives to microbeads have been under review since the increasing public awareness of the potential detrimental effects that microbeads have on the aquatic ecosystem. The main category of alternatives that can be used to replace microbeads found in personal care products are natural exfoliates.

Natural exfoliates such as apricot seeds, walnut shells, bamboo, sugar, salt, almonds and oatmeal can be used as an alternative to microbeads. Natural exfoliates are currently on the market; however, it has been reported that these natural exfoliates are not as smooth as microbeads and may be harsh for the skin.

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6 Next Steps

6.1 Information Gathering

The Government of Canada instituted the policy that a cost-benefit analysis (CBA) must be carried out for all significant regulatory proposals to assess their potential impacts on the environment, workers, businesses, consumers and other sectors of society. The objective of the CBA is to assess the incremental impacts that are expected to occur as a result of a regulatory proposal. These impacts of the proposed regulation will then be assessed in accordance with the Treasury Board Secretariat Canadian Cost-Benefit Analysis Guide.

In order to fill data gaps and obtain the necessary information to conduct a cost-benefit analysis for the proposed regulations, a section 71 survey under the Canadian Environmental Protection Act 1999 (CEPA 1999) has been issued to assess the current situation, including the quantity of microbeads in commerce in personal care products that may be released to water, identification of product types, and the number and size of companies impacted by the proposed regulations.

In addition to the data requested by the section 71 survey, we are also looking for information on a number of other data gaps, including:

  • How microbeads are used in the personal care products covered by the regulatory proposal. For each functional use, not related to exfoliating or cleansing, please provide:
    • a description of the function of the microbeads
    • size range, composition and concentration of the microbeads in the finished product
  • Alternatives and potential environmental impacts
  • The typical size (mass or volume) of a product that contains microbeads
  • The cost of microbeads per unit (kg)
  • The price of a product, per unit (kg) that currently contains microbeads
  • Percentage increase in raw material costs of using an alternative to achieve comparable effectiveness in products; or if available, the incremental cost of using an alternative to achieve comparable effectiveness per unit (kg)
  • Reformulation costs involved in reformulating products that contain microbeads to using the alternative
  • The impact on quality of the products for consumers
  • An overview of the importance of the substance or products containing the substance for the Canadian economy (including key economic indicators and statistics)

This information will be used to support the development of the regulatory proposal and to assess the incremental impacts of the proposed regulation. Please provide the above-listed information to the Environment and Climate Change Canada contact listed at the end of this document. Indicate “Consultation on Proposed Regulations for Microbeads” as your subject line.

6.2 Consultation

A proposed Order to add microbeads to the List of Toxic Substances under CEPA 1999 was published on August 1, 2015. The Government of Canada also published a Notice of Intent to develop regulations under CEPA 1999 that would prohibit the manufacture, import, sale and offer for sale of microbead-containing personal care products used to exfoliate or cleanse. The publication of the Notice of Intent to regulate was followed by a 30-day public comment period.

Comments on the proposed order and notice of intent were received on behalf of 25 industry associations and 10 other stakeholders as well as over 200 individuals on a variety of topics including the definition of microbeads, harmonization with the U.S., biodegradation, scope of the proposed regulations and alternatives. These comments will be taken into consideration during the development of the proposed regulations.

Comments received on the consultation document will also be taken into consideration during the development of the proposed regulations.

6.3 Regulatory Reform

As part of its Red Tape Reduction Action Plan, the Government of Canada has introduced the One-for-One Rule and the Small Business Lens. In moving forward with the proposed regulations, Environment and Climate Change Canada will apply these two reforms to ensure that the administrative burden on business is reduced where possible and that small businesses are taken into account with respect to any administrative and compliance challenges.

6.3.1 One-for-One Rule

The One-for-One Rule is aimed at reducing the administrative burden on business and at limiting the growth in the number of federal regulations. The One-for-One Rule requires the calculation of administrative burden on business in new regulations and in regulatory amendments. Any increases in administrative burden must be offset (equivalent reduction in administrative burden) from the existing stock of regulations. Also, for every new regulation introduced that imposes administrative burden on business, an existing regulation must be repealed.

Administrative burden is defined as anything that is necessary to demonstrate compliance with a regulation, including the collecting, processing, reporting and retaining of information, and completing of forms. The proposed regulations are not anticipated to trigger the One-for-One Rule as there is no expected administrative burden.

6.3.2 Small Business Lens

The purpose of the small business lens is to ensure that the specific needs of small business are considered and that the least burdensome but most effective approach to addressing these needs is identified. A small business is defined as any business, including its affiliates, that has fewer than 100 employees or has between $30,000 and $5 million in annual gross revenues.

6.4 Comment Period

Environment and Climate Change Canada welcomes the distribution of this consultation document to any interested and affected stakeholders.

The consultation will be followed by a 30-day comment period. Comments received during this period will be taken into consideration while drafting the proposed Regulations. Please submit comments in writing no later than March 10, 2016.

Interested stakeholders will be invited to participate in consultation sessions in winter 2015-2016.

Pursuant to section 313 of CEPA 1999, any person who provides information to the Minister of the Environment under CEPA 1999 may submit with the information a written request that it be treated as confidential. Please address comments to the Products Division with the subject “Consultation on Proposed Regulations for Microbeads”. Comments can be submitted by mail, email or fax:

By mail:

Products Division
Environment and Climate Change Canada
Place Vincent Massey, 9th Floor
351 St. Joseph Boulevard
Gatineau, Quebec
K1A 0H3

By email:

ec.produits-products.ec@canada.ca

By fax:

819-938-4480

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References

Bill 75: An Act with respect to microbeads (2015). 2nd reading, March 12, 2015. Legislative Assembly of the Province of Ontario. Retrieved from Legislative Assembly of the Province of Ontario website.

Bill C-680: An Act to amend the Food and Drugs Act (microbeads). (2015). 1st reading, May 13, 2015. 41st Parliament. 2nd session. Retrieved from the Parliament of Canada website.

Bill C-684: An Act to amend the Canadian Environmental Protection Act, 1999 (microplastics). (2015). 1st Reading, June 2, 2015. 41st Parliament, 2nd Session. Retrieved from the Parliament of Canada website.

Canada, 1985a. Food and Drugs Act, R.S.C. 1985, c.F-27.

Environment Canada, 2015. Microbeads – A Science Summary.

General Assembly Bill 1502, Section 50. (2015). June special session, 2015. Retrieved from State of Connecticut website.

House Bill 0216. (2015). 3rd reading, April 13, 2015. General Assembly of Maryland. Retrieved from General Assembly of Maryland website.

Health Canada, 2014. Cosmetic Regulations.

House Bill 1185. 3rd reading, February 3, 2015. Indiana General Assembly. Retrieved from Indiana General Assembly website.

Imhof, H. K., Ivleva, N. P., Schmid, J., Niessner, R., and Laforsch, C. (2013). Contamination of beach sediments of a subalpine lake with microplastic particles. Current biology, 23(19), R867-R868.

Legislative Document No. 85. (2015). 127th Maine Legislature, 1st Regular Session. Maine State Legislature.  Retrieved from Maine State Legislature website.

Senate Bill 15. (2015). 3rd reading, April 14, 2015. State of Wisconsin.

Senate Bill 2727. 3rd reading, May 22, 2014. 97th General Assembly, 1st Regular Session. Illinois General Assembly. Retrieved from Illinois General Assembly website.

Senate No. 2178 (2015). 1st reading, June 16, 2014. 216th Legislature, 1st Regular Session. State of New Jersey. Retrieved from New Jersey State Legislature website.

State of Colorado House Bill 15-1144 (PDF, 22KB) (2015). Colorado General Assembly 2015. 70th General Assembly, 1st Regular Session. Retrieved from State of Colorado website.

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