Triclosan: P2 notice consultation document

1 Objective

The main objectives of this consultation are to inform the public on the key elements of a proposed Pollution Prevention Planning Notice (P2 Notice) for triclosan and to invite stakeholders to provide their feedback on the design of the P2 Notice. All stakeholders may comment in writing to the address provided in section 7 of this document by February 11, 2018.

Interested stakeholders may include the public, non-governmental organizations, provincial and territorial governments, and industry, particularly manufacturers, importers, retailers, and associations in the cosmetics, natural health products, drugs, and cleaning product industries. 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 of the P2 Notice.

2 Summary

Triclosan is used in many everyday products available to consumers, such as cosmetics, natural health products, drugs, (body washes, hand soaps, toothpastes etc.) and cleaning products (dishwashing detergents, all-purpose cleaners etc.), to kill bacteria and prevent fungus and mildew. Products that contain triclosan can be washed off and rinsed down the drain, making their way out of wastewater treatment plants into waterways, where triclosan can affect fish, algae, and other aquatic species

The Government of Canada conducted a scientific assessment^{Footnote 1} of triclosan and found that it is toxic to the environment above certain levels, but is not toxic to humans at current levels of exposure. The Federal Water Quality Guideline (FWQG) for the protection of aquatic life from triclosan identified a level of triclosan at and below which harm is not expected to occur in the aquatic environment. In November 2016, the Government published a “Proposed Risk Management Approach”^{Footnote 2} document that outlines how it plans to use a P2 Notice to reduce releases from the use of products available to consumers that contain triclosan to attain levels that are protective of the environment.

The proposed Risk Management Approach takes into consideration that Canada already restricts the amount of triclosan that can be used in cosmetics, natural health products, and non-prescription drugs. Since 2014, triclosan has not been registered under the Pest Controls Products Act for use in plastics, polymers, and textiles in Canada. In addition, many companies have committed to or have already moved away from using triclosan. The P2 Notice will recognize entities have already taken action, while encouraging reductions from others.

A P2 Notice is a regulatory and enforceable instrument under the Canadian Environmental Protection Act, 1999 (CEPA) that requires entities to prepare and implement a pollution prevention plan (P2 Plan). A P2 Plan documents how a facility will prevent or minimize the creation of pollutants and waste. The proposed objective of the P2 Notice is to reduce the total amount of triclosan releases from products that are imported into and manufactured in Canada by 30% from 2011 levels. This target was selected to be precautionary and to ensure that the amount of triclosan that enters waterways is at a level that is unlikely to cause harm to the aquatic environment. The proposed content of the P2 Notice is outlined in detail in section 6 of this document.

Past P2 Notices to control chemicals in products, such as the P2 Notice for nonylphenol and its ethoxylates in products^{Footnote 3}, have been successful at achieving their objectives and protecting the environment. Environment and Climate Change Canada will track and monitor triclosan levels in the Canadian environment, and measure any reductions achieved once the P2 Notice is implemented. If levels of triclosan continue to be found at levels of concern in the environment, the Government could take further action on triclosan.

3 Background

3.1 Triclosan risk management approach

Under the Chemicals Management Plan, triclosan^{Footnote 4} was identified as a priority for assessment under CEPA. 

Health Canada and Environment and Climate Change Canada published the final assessment for triclosan on November 26, 2016. Based on evidence presented, the assessment concluded that triclosan meets the criteria under paragraph 64(a) of CEPA as it is 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. Therefore, the Government of Canada proposed to add triclosan to the List of Toxic Substances in Schedule 1 of CEPA. Triclosan was not found to pose a health risk to Canadians at current levels of exposure.

A Proposed Risk Management Approach for triclosan was published on November 26, 2016, for a 60-day public comment period, outlining that the recommended risk management instrument was a P2 Notice.

3.1.1 Comments received on the risk management approach

The public comment period on the Proposed Risk Management Approach ended on January 25, 2017. Fifty-one organizations submitted comments^{Footnote 5}, including forty-six from non-governmental organizations, three from industry, one from a provincial government, and one from a municipality. Emails were also received from approximately 3,500 individuals. The comments received from non-governmental organizations and individuals were focused on health issues and the assessment’s conclusion that triclosan was not toxic to humans. Many comments submitted by non-governmental organizations and individuals requested a complete ban in all products or harmonization with the U.S. rule to ban triclosan in consumer antiseptic hand and body washes.  

3.2 Current uses

Triclosan is used as a preservative and as an antimicrobial agent in a wide range of products used by consumers including cosmetics, natural health products, non-prescription drugs, and cleaning products. The Government of Canada currently restricts the amount of triclosan that can be used in cosmetics, natural health products, and non-prescription drugs under the Food and Drugs Act. Triclosan use in products has declined in recent years; for example, the number of triclosan-containing cosmetic products notified to Health Canada has decreased by approximately 80% between 2011 and 2016. In addition, since December 31, 2014, triclosan is no longer registered in Canada as a pest control product under the Pest Control Products Act (i.e., can no longer be used to treat textiles, leather, paper, plastics or rubber materials manufactured in Canada).

The Government of Canada used the mandatory survey requirements under section 71 of CEPA and requested information on the manufacture, import, use, and release of triclosan in a quantity greater than 10 kg and at a concentration of 0.001% w/w or more for the year 2011. Results from this survey indicated that triclosan was not manufactured in Canada. Forty-six entities responded to the survey and the total quantity of triclosan reported as either imported or used was between 10 000 and 100 000 kg. This included quantities used to manufacture products and triclosan imported into Canada, either as a pure substance to manufacture products or as an ingredient in products.

The survey confirmed that triclosan was being used in a variety of products available to consumers including cosmetics, natural health products, non-prescription drugs, and cleaning products. Reported products available to consumers included antibacterial soaps, skin cleansers, toothpastes, make-up, deodorants, skin creams, fragrances, general-purpose cleaners, dish soaps, and detergents.

3.3 Identified risks

The main source of release of triclosan to the Canadian environment is through the use of triclosan-containing products by consumers. These products are typically released down the drain to wastewater treatment plants and then released to aquatic ecosystems via the effluents from the wastewater treatment plants. Secondary wastewater treatment is more effective in removing triclosan compared to other forms of treatment but may create methyl-triclosan, a substance that is potentially more persistent and more bioaccumulative than triclosan.

The main exposure of concern for triclosan is in aquatic ecosystems. Measured concentrations of triclosan in surface water are available for numerous water bodies across Canada from 2002 to 2017. The average triclosan concentrations in all of the waterbodies tested were below the level of concern. In the period from 2002-2005, five water bodies had samples with maximum concentrations above the level of concern. In sampling campaigns since 2012, only one location’s maximum concentrations exceeded the level of concern.

Even though the majority of measured triclosan concentrations in surface water are below the level of concern, the fact that concentrations have been found that exceed this level indicates that triclosan could reach levels of potential harm to aquatic ecosystems. 

To safeguard the environment, Environment and Climate Change Canada is proposing to use a precautionary target for reduction in the quantity of triclosan released from products. Monitoring data and modelling results indicate that reducing the total quantity of triclosan released from products in Canada by 30% from 2011 levels would achieve protective levels.

4 Pollution prevention planning

CEPA defines Pollution Prevention as “the use of processes, practices, materials, products, substances or energy that avoid or minimize the creation of pollutants and waste, and reduce the overall risk to the environment or human health.”

A P2 Notice is an enforceable instrument under Section 56 of CEPA that requires designated persons to prepare and implement a P2 plan and to report on that plan. A P2 plan documents how a facility will prevent or minimize the creation of pollutants and waste. Those subject to the Notice have the flexibility to develop and implement a range of actions that are best suited for their specific situation, while considering all factors outlined in the Notice.

4.1 Key elements within a P2 Notice

A P2 Notice specifies the substance or group of substances to be covered in the P2 Plan, who is required to prepare and implement a plan, the activities that will be considered, and the deadlines for preparing and implementing the plan.

The P2 Notice requires designated persons to consider all factors outlined in the Notice when preparing their Plan. Factors may include current best management practices, the risk management objective, P2 techniques and available technologies.

Persons subject to the P2 Notice would be required to:

• prepare a P2 Plan
• ensure that the "factors to consider" are adequately addressed
• submit a Schedule 1: Declaration that a Pollution Prevention Plan has been Prepared and is Being Implemented that includes descriptions of anticipated actions and reductions (the information proposed to be collected in Schedule 1 is summarized in section 6.8)
• implement the P2 Plan
• submit a Schedule 5: Declaration That a Pollution Prevention Plan Has Been Implemented that includes quantities of triclosan, descriptions of actions taken and results achieved (the information proposed to be collected in Schedule 5 is summarized in the section 6.8)
• respect all deadlines for preparation and implementation of the Plan
• keep a copy of the P2 Plan on-site

4.2 Why a P2 Notice was selected for triclosan

A P2 Notice was chosen to address the environmental risks associated with triclosan because the P2 Notice requires those subject to prepare and implement a P2 Plan that addresses a reduction objective. The P2 Notice could include, as a factor to consider, that entities subject to the Notice should consider using alternative substances that reduce or minimize harmful effects to the environment or to health while complying with all other relevant existing legislation.

The P2 Notice provides public accountability as persons subject to the Notice have mandatory reporting requirements, and all non-confidential information, such as results and how entities addressed all factors to consider, is publicly available on the P2 Planning website. The P2 Notice can be used as a complementary tool to existing regulatory controls on triclosan in products available to consumers and minimizes regulatory burden on stakeholders.

A previous P2 Notice that focused on products available to consumers on nonylphenol and its ethoxylates was successful and the quantity used to make products in Canada and in imported products was reduced by 96%^{Footnote 6}.

While the P2 Notice is expected to manage the environmental risks identified in the triclosan assessment, results will be evaluated and levels of triclosan in the Canadian environment will continue to be monitored to ensure that levels stay below the point where there could be a concern. If levels were found to increase above protective levels, the Government could take further action on triclosan.

5 Risk management considerations

5.1 Alternatives

The availability of alternatives to triclosan was considered when selecting the risk management approach for triclosan. There are many classes of preservatives that may be used for product preservation, including organic acids and their salts, paraben esters, quaternary ammonium compounds, formaldehyde donors, alcohols, and other miscellaneous chemicals. Commonly used preservatives, other than triclosan, that are allowed in cosmetic products in Canada and the United States include benzoic acid, sodium benzoate, sorbic acid, potassium sorbate, parabens, dehydroacetic acid and salts, imidazolidinyl urea, diazolidinyl urea, DMDM hydantoin, methylchloroisothiazolinone (MCI) and methylisothiazolinone (MI) mixture, MI alone, chlorphenesin, benzyl alcohol, caprylyl glycol, and iodopropynyl butylcarbamate. Alternatives, such as those listed above, are also listed in the Natural Health Products Ingredients Database with a non-medicinal role for use as preservative antimicrobial in natural health products, with different route of administration, quantity, and/or concentration restrictions.

Several antiseptic categories also exist. Health Canada’s Drug Product Database (DPD) contains product-specific information on drugs approved for use in Canada. The database includes human pharmaceutical and biological drugs, veterinary drugs, and disinfectant products. Most of the products containing triclosan as an active ingredient outlined in the DPD are antibacterial and antimicrobial soap/skin cleansers and toothpastes. A search of the database indicates that active ingredients, other than triclosan, reported for antibacterial and antimicrobial soap/skin cleansers in the DPD include benzalkonium chloride, chloroxylenol, bronopol, and chlorhexidine gluconate.

While some of the substances discussed above may have a use function similar to triclosan in certain applications, it is important to note that most have not been assessed under CEPA and could be risk assessed and risk managed if deemed necessary in the future. For more information on substances assessed under this Act as part of the Chemicals Management Plan, please refer to the Chemical Substances website^{Footnote 7}.

5.2 Socio-economic and technical considerations

Several technical and socio-economic factors have been considered in the design of the proposed P2 Notice.

These considerations include:

• Triclosan is not toxic to human health at current levels of exposure and therefore the risk management objective is to ensure triclosan levels in surface waters are below the level of concern.
• Environmental monitoring across Canada from 2002 to 2017 showed that while some triclosan levels exceeded the level of concern, the average concentrations of triclosan in surface water were all below the level of concern; in 2012-2017, only one site’s maximum concentrations exceeded the level of concern.
• There are existing risk management actions in Canada that restrict the level of triclosan in certain products. Under the Food and Drugs Act, Canada already restricts the level of triclosan in mouthwashes, cosmetics, natural health products, and non-prescription drugs. For instance, triclosan is listed as a restricted ingredient on Health Canada’s List of Prohibited and Restricted Ingredients in Cosmetics (more commonly referred to as the Cosmetic Ingredient Hotlist). An instrument to manage triclosan’s risk to the environment should complement these existing restrictions.
• Triclosan usage has declined in recent years. Many companies have reported that they have or will be phasing out the use of triclosan in all or some of their products. For example, the number of triclosan-containing cosmetic products notified to Health Canada has decreased by approximately 80% between 2011 and 2016.
• Minimizing impacts on small businesses.

As a result of these considerations, it is proposed that the P2 Notice apply to entities that manufacture or import cosmetics, natural health products, drugs, or cleaning products and who use, purchase or acquire 100 kg or more of triclosan. A 100 kg threshold will capture 99% of the quantity of triclosan used in products available to consumers but will not impact the majority of small businesses.

In consideration of the risks and monitoring data identified in the assessment, it is proposed that entities subject to the Notice on the day it is published aim to reduce the total quantity of triclosan used or imported annually by 30% from a base year, as defined in section 6.1. This proposed approach would provide flexibility for those subject to the Notice on the day of its publication to choose a base year, which can be no earlier than 2011, and would recognize any early actions taken.

For entities that become subject to the Notice after its publication, as new users of the substance, reductions may be measured only from the year they become subject to the Notice. For these entities, a reduction of 95% of the total mass of triclosan used or imported annually is proposed when compared to the year they become subject to the Notice.

The reduction targets were set to be precautionary and were based on section 71 data, environmental monitoring, and modelling results.

6 Content of the P2 Notice for triclosan

The P2 Notice would set the requirements for the preparation and implementation of P2 Plans in respect of triclosan. Comments received on this consultation document will be used to develop a draft Notice that will be published in the Canada Gazette, Part I. The publication of the Proposed Notice will initiate a 60-day public comment period. A Final Notice requiring the preparation and implementation of P2 Plans will be published in the Canada Gazette, Part I following review of the comments received.

6.1 Definitions

6.2 Persons subject to the Notice

The Notice would apply to any person or class of persons, who on the date of publication of the Final Notice and any time thereafter,

The Notice would apply to any person or class of persons who is the successor or is a person appointed by the persons identified in this section.

6.3 Activities in relation to which the P2 Plan is to be prepared

All persons identified in section 6.2 would be required to prepare and implement a P2 Plan in relation to the following activities:

6.4 Factors to consider when preparing the P2 Plan

P2 Notices list the “factors to consider” for the preparation of a P2 Plan. These are the issues or activities that must be addressed in preparing the P2 Plan. A description of how the specified factors were addressed when preparing the P2 Plan will be required to be reported in the declarations (see section 6.8 for more information). The factors to consider that are proposed to be included in the P2 Notice for triclosan are outlined below.

Note: Information on Persons Subject to the Notice, Activities and Factors to Consider will be reported in Schedules 1 and 5, which are summarized in section 6.8 of this document.

6.5 Time provided to prepare the P2 Plan

The Declaration of Preparation is the first declaration that must be submitted by persons subject to the Notice. This declaration states that a P2 Plan has been prepared and is being implemented. For more information on this declaration, see Schedule 1, which is summarized in section 6.8 of this document.

The Notice would require that all persons or class of persons that become subject to the Notice on the date of publication of the Final Notice prepare their plan no later than one year after publication of the Notice.

The Notice would require that all persons or class of persons that become subject to the Notice after the date of publication of the Final Notice prepare their plan no later than six months after the date the person becomes subject to the Notice.

A person may request an extension of time for preparing a P2 Plan by submitting a “Request for Time Extension for Preparation of a Pollution Prevention Plan” (Schedule 3). See Appendix 5 of the Guidelines for Implementation for an example of a Schedule 3.

6.6 Time provided to implement the P2 Plan

The Declaration of Implementation is the final declaration that must be submitted by persons subject to the Notice. This declaration states that a P2 Plan has been implemented. For more information on this declaration see Schedule 5 which is summarized in section 6.8 of this document.

The Notice would require that all persons or class of persons that become subject to the Notice on the date of the publication of the Final Notice implement the P2 Plan no later than 3 years after the publication of the Notice.

The Notice would require that all persons or class of persons that become subject to the Notice after the date of publication of the Final Notice implement the P2 Plan no later than 1 year after the date the person becomes subject to the Notice.

A person may request an extension of time for implementing a P2 Plan by submitting a “Request for Time Extension for Implementation of a Pollution Prevention Plan” (Schedule 3). See Appendix 5 of the Guidelines for Implementation for an example of a Schedule 3.

6.7 Reporting

Persons subject to the Notice would not have to submit their entire P2 Plans to Environment and Climate Change Canada unless specifically asked to do so. However, within 30 days of the deadlines listed in sections 6.5 and 6.6 of this document, they must submit both a Declaration of Preparation (Schedule 1) and a Declaration of Implementation (Schedule 5). The information to be submitted in the declarations is summarized in section 6.8 of this document, and will be submitted using the online Pollution Prevention Planning Notices reporting tool.

These Declarations would require the person or class of persons to include information outlined in detail in section 6.8.

The following reporting and extension request forms will be included in the Notice:

• Schedule 1: Declaration That a Pollution Prevention Plan Has Been Prepared and Is Being Implemented [Subsection 58(1) of CEPA]
• Schedule 2: Request for Waiver of the Requirement to Consider a Factor or Factors for Preparation of a Pollution Prevention Plan [Subsection 56(5) of CEPA]
• Schedule 3: Request for Time Extension for Preparation or Implementation of a Pollution Prevention Plan [Subsection 56(3) of CEPA]
• Schedule 5: Declaration That a Pollution Prevention Plan Has Been Implemented [Subsection 58(2) of CEPA]

Forms referred to in the Notice (Schedules 1, 2, 3, 5) will be published as part of the Notice and should be filled out electronically using the Pollution Prevention Planning Online Reporting Tool found on Environment and Climate Change Canada’s website.

Note that Schedule 4: Interim Progress Reports are not required for this Notice.

6.8 Draft schedules

It is proposed that the following information be collected and/or updated in all Schedules (i.e. in the declaration of preparation and implementation):

1. Contact and location information on the person or class of persons subject to the Notice
2. Identification of what activity/activities the person or class of persons is involved in (i.e. manufacture or import of cosmetics, natural health products, drugs or cleaning products)

If after filing Schedule 1 or 5, the information in the declarations has become false or misleading, an amended declaration must be filed within 30 days of the change. This is a requirement in CEPA.

Schedule 1: Declaration That a Pollution Prevention Plan Has Been Prepared and Is Being Implemented

It is proposed that the following information be collected in Schedule 1:

1. Nature of activity(ies) and types of products. For example, was triclosan used to manufacture and/or imported in cosmetics, natural health products, drugs or cleaning products. 
2. Base year and quantity of triclosan used to manufacture or imported in products in that year, in kilograms.
3. Year the P2 Plan was prepared and quantity of triclosan used to manufacture or imported in products in that year, in kilograms.
4. Year the P2 Plan is expected to be implemented and the predicted quantity of triclosan to be used to manufacture or imported in products in that year, in kilograms.
5. The maximum anticipated quantity of triclosan to be used to manufacture or imported in products in any year following the implementation of the plan.
6. A description of all anticipated actions to be taken in implementing the P2 Plan. If the anticipated action includes the use of alternative substances, identification of the chemical name or common name, and CAS RN (if available) of the substance, and a description of any hazard assessments conducted. Additional voluntary information on alternative substances will be collected, such as the anticipated quantity to be used by calendar year during implementation of the P2 Plan, the maximum anticipated quantity of the substance to be used or imported in products in any year following the implementation of the plan, as well as indication whether alternatives are one-for-one substitution or combinations. If the anticipated action includes the use of pollution control methods, a description of the method(s).
7. A description of how the reduction target and other pollution prevention actions identified in the P2 Plan will be maintained following implementation of the plan.
8. If the person anticipates that the P2 Plan will not meet the risk management objective, an explanation of why.
9. A description of what has been done to take into account the “Factors to Consider in Preparing the Plan”, except those factors for which a waiver, if applicable, has been granted by the Minister of Environment.
10. Signature of the person subject to the Notice or duly authorized representative to certify that a P2 Plan has been prepared and is being implemented and that the information provided is true, accurate and complete.

Schedule 5: Declaration That a Pollution Prevention Plan Has Been Implemented

It is proposed that the following information be collected in Schedule 5:

6.9 Content of the P2 Plan

Persons subject to this Notice must meet all the requirements set out in the Notice, including consideration of all of the factors to consider listed in section 6.4. However, Environment and Climate Change Canada does not prescribe the full content of the P2 Plan, nor the use of relevant techniques or technologies to be included in the P2 Plan. The Notice allows for environmental protection innovation. Persons subject to the Notice determine the appropriate elements of their P2 Plan and how they would meet the requirements of the Notice.

Guidance on preparing P2 Plans may be obtained from:

• The Pollution Prevention Planning section of the Government of Canada’s website

Additional information and guidance on pollution prevention can be found on:

• The Pollution Prevention section of the Government of Canada’s website

Copies of Environment and Climate Change Canada’s Pollution Prevention Planning Handbook, including a model Plan and other support tools, are also available.

For further inquiries regarding P2 planning and P2 practices, please email: ec.planp2-p2plan.ec@canada.ca

6.10 Record keeping

Persons subject to the Notice shall keep a copy of the P2 Plan at the place in Canada in relation to which the P2 Plan was prepared. In addition, the P2 Plan and any related support documentation would be required to be kept for a minimum of five years following the date the P2 Plan was implemented.

Where a person or persons subject to the Notice prepares a single P2 Plan for more than one facility, a copy of that plan would be required to be kept at each location.

6.11 Performance measurement and evaluation of the Notice

The Minister will evaluate the effectiveness of the Notice with respect to the risk management objective set out in section 6.4(2) of this document. This may include a data gathering initiative after the implementation of P2 Plans to verify use patterns and quantities in conjunction with environmental monitoring conducted by Environment and Climate Change Canada. This evaluation will determine whether other measures, including regulations, are needed to further prevent or reduce negative impacts on the environment from the release of triclosan.

7 Comment period

The information above presents the main elements of the proposed P2 Notice for triclosan. Environment and Climate Change Canada welcomes the distribution of this consultation document to any interested and affected stakeholders.

Interested stakeholders are invited to submit comments on this proposal in writing to the coordinates below by no later than February 11, 2018.

Email: ec.produits-products.ec@canada.ca

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

Fax: 819-938-4480 or 1-888-391-3695

Please address comments to the Products Division with the subject “Triclosan P2”. Pursuant to section 313 of CEPA, any person who provides information to the Minister of the Environment under CEPA may submit with the information a written request that it be treated as confidential.  

8 Next steps

Comments received during the public comment period will be taken into consideration while Environment and Climate Change Canada drafts the proposed P2 Notice. The proposed Notice is expected to be published in the Canada Gazette, Part I for a 60-day comment period no later than November 2018. The Final Notice is expected to be published in the Canada Gazette, Part I no later than May 2020.