Proposed Code of Practice for methanone, diphenyl- (Benzophenone) in paint, stain and/or coating products available to consumers in Canada

1. Objective of the Code of Practice

The objective of this code of practice (herein referred to as the “Code”) is to help reduce exposure of people in Canada to methanone, diphenyl-(benzophenone) contained in certain exterior and interior paint, stain and/or coating products available to consumers to levels that are protective of human health. The Code will help meet this objective by facilitating a reduction in both dermal and inhalation exposures to the general public from benzophenone during application of paint, stain and coating products. All applicable municipal, provincial, territorial and federal legal requirements pertaining to this substance and the associated products must still be met and a commitment by any person to adopt the practices and procedures set out in the Code does not remove obligations to comply with all applicable statutory and regulatory requirements.

This Code outlines the following recommended practice:

• The concentration of benzophenone present in a paint, stain and/or coating product available to a consumer in Canada should not be more than 2,000 mg/kg (also expressed as 0.2% w/w)

2. Background

Benzophenone was assessed in the third phase of the Government of Canada’s Chemicals Management Plan (CMP). The final screening assessment concluded that benzophenone is entering the environment in a quantity or concentration or under conditions that constitute or may constitute a danger in Canada to human life or health and therefore meets the criteria set out in section 64(c) of the Canadian Environmental Protection Act, 1999 (CEPA). The exposure sources of concern identified in the screening assessment are from the use of nail polishes, exterior and interior paints, as well as stains.

The risk management approach document outlines the proposed risk management actions to reduce exposure of the general population to benzophenone to levels that are protective of human health. The proposed risk management actions include listing benzophenone as a restricted ingredient on the Health Canada Cosmetic Ingredient Hotlist, and a code of practice to reduce concentrations in paint, stain and/or coating products that are available to consumers in Canada.

The published risk management approach document proposed a target concentration of 0.1% w/w in exterior and interior paint, stain and/or coating products. Comments were received from some stakeholders who expressed concerns over the proposed 0.1% w/w concentration limit. These stakeholders indicated that they would be more supportive and compliant should the limit be raised to 0.2% w/w. These comments were taken into consideration when developing the code of practice. As well, following the publication of the risk management approach, additional consideration on the occasional use of these products by the general population in Canada, and the health effects observed in the critical study identified in the CMP assessment, a higher acceptable limit of 0.2% w/w in paints, stains, and/or coatings was determined.

This Code sets out elements of best practices and recommendations that can help reduce exposure of the general population to benzophenone in paint, stain and/or coating products, while maintaining flexibility for effective and efficient implementation.

3. Elements of exposure mitigation for consumer paints, stains and coating products

It is recommended that the concentration of total benzophenone present in a paint, stain and/or coating product available to a consumer in Canada not exceed 2,000 mg/kg when a wet sample is tested in accordance with a method that conforms to good laboratory practices (see Appendix 1). Note: 2,000 mg/kg = 0.2% w/w.

4. Persons to whom the Code applies

This Code may be adopted by any person who:

1. manufactures paint, stain and/or coating products containing benzophenone above 0.2% w/w for use by consumers in Canada; and/or
2. imports paint, stain and/or coating products containing benzophenone above 0.2% w/w for use by consumers in Canada

5. Products to which the Code applies

This Code is only applicable to exterior, interior, and dual interior/exterior paint, stain and/or coating products containing benzophenone above 0.2% w/w available to consumers and is not applicable to any other products.

6. Record keeping and reporting

6.1 Record keeping: Any person who adopts this Code is asked to provide written notice to the Minister of Health and keep electronic or paper records of the information below for a period of at least 6 years after the day on which the records were completed in order to satisfy reporting requirements as outlined in section 6.2

1. The total quantity of benzophenone (expressed in kg) used in paint, stain and/or coating products available to consumers above 2,000 mg/kg (also expressed as 0.2% w/w)

6.2 Reporting: Any person who adopts this Code should send a report to the Minister of Health by March 31 of the calendar year following the adoption of the Code in order to establish baseline data. The report should cover the previous calendar year’s activities. Subsequent reports should be sent every three years by March 31 of the reporting year and should cover activities relevant to the previous calendar year. The report should include the information listed in section 6.1

6.3 The Minister of Health should also be notified in writing when anyone who has adopted the Code permanently ceases to manufacture or import applicable products containing benzophenone

7. Confidentiality

7.1 In this section, “confidential business information,” in respect of a person to whose business or affairs the information relates, means business information:

1. that is not publicly available
2. in respect of which the person has taken measures that are reasonable in the circumstances to ensure that it remains not publicly available, and
3. that has actual or potential economic value to the person or their competitors because it is not publicly available, and its disclosure would result in a material financial loss to the person or a material financial gain to their competitors

7.2 Requests for confidentiality

A person who provides information to the Minister of Health under this Code may submit a written request identifying the specific information to be treated as confidential business information as well as a rationale for the request.

If the Minister considers that the information does not meet the definition of confidential business information, a written notice will be given to this effect to the person who had provided the information to the Minister.

The Minister of Health will use and disclose confidential business information in respect of which a request for confidentiality has been made as permitted by law.

For greater certainty, personal information as defined in section 3 of the Privacy Act will be used and disclosed in accordance with that Act.

8. Contact information to submit declarations and reports

Declarations and reports should be submitted to Minister of Health by mail or email to the following addresses (see Appendix 2). Please type “Declaration for Code of Practice for Benzophenone” or “Report on Implementation of the Code of Practice for Benzophenone,” as appropriate, in the subject line of your submission.

Email: chemicalsubstances-chimiques@hc-sc.gc.ca

Mail:

Safe Environments Directorate, Risk Management Bureau
c/o Health Canada
219 Laurier Avenue West
Address Locator 4910A
Ottawa, Ontario
K1A 0K9

9. Review of progress and need for further action

9.1 Three years after publication of this Code in the Canada Gazette, Part I, the Minister of Health will initiate an interim review of progress achieved towards reducing dermal and inhalation exposure to benzophenone by the general public during application of exterior, interior, and dual interior/exterior paint, stain and/or coating products

9.2 A final review will be conducted at 6 years after the publication of the Code. The review will help determine if other steps up to and including regulatory action are needed to further reduce dermal and inhalation exposure to benzophenone by the general public during application of exterior, interior, and dual interior/exterior paint, stain and/or coating products

9.3 A periodic review of the adoption of the Code may be undertaken if it is deemed necessary after the final review is completed

10. Performance measurement targets

10.1 The performance measurement targets of the Code include

1. Measures of success for those that sign up for the Code; and
2. Measures of success for changes in the overall market

10.2 Measures of success for those that sign up for the Code

The performance measurement targets per company who adopt the Code are

1. Interim review – after 3 years
   1. 70% or more reduction in the quantity of benzophenone used in paint, stain and/or coating products available to consumers above 2,000 mg/kg (also expressed as 0.2% w/w) by each company; or
   2. less than 100 kg of benzophenone used in paint, stain and/or coating products available to consumers above 2,000 mg/kg (also expressed as 0.2% w/w) by each company
2. Final review – after 6 years
   1. 95% or more reduction in the quantity of benzophenone used in paint, stain and/or coating products available to consumers above 2,000 mg/kg (also expressed as 0.2% w/w) by each company; or
   2. less than 10 kg of benzophenone used in paint, stain and/or coating products available to consumers above 2,000 mg/kg (also expressed as 0.2% w/w) by each company

10.3 Measures of success for overall market

The overall performance measurement targets for the market in Canada are

1. Interim review – after 3 years
   1. 70% or more reduction in the total quantity of benzophenone used in paint, stain and/or coating products available to consumers above 2,000 mg/kg (also expressed as 0.2% w/w) in Canada overall; or
   2. less than 1,000 kg of benzophenone used in paint, stain and/or coating products available to consumers above 2,000 mg/kg (also expressed as 0.2% w/w) in Canada overall
2. Final review – after 6 years
   1. 95% or more reduction in the total quantity of benzophenone used in paint, stain and/or coating products available to consumers above 2,000 mg/kg (also expressed as 0.2% w/w) in Canada overall; or
   2. less than 100 kg of benzophenone used in paint, stain and/or coating products available to consumers above 2,000 mg/kg (also expressed as 0.2% w/w) in Canada overall

11. Glossary of terms

“CEPA” Canadian Environmental Protection Act, 1999

“Consumer Product” For the purpose of this Code, a consumer product is a product that may reasonably be expected to be obtained by an individual to be used for non-commercial purposes.

“Paint” For the purposes of this Code, the definition of a paint is the same as ‘surface coating material’ as found in the Surface Coating Materials Regulations under the Canada Consumer Product Safety Act (CCPSA), as amended from time to time: a paint or other similar material, with or without pigment, that forms a solid film after it is applied to a surface and that can be removed.

“Stain” For the purposes of this Code, a stain is a specialized material applied to a surface that is fully absorbed into the substrate to provide protection and enhance its appearance.

“Coating” For the purposes of this Code, the definition of a coating is the same as ‘surface coating material’ as found in the Surface Coating Materials Regulations under the Canada Consumer Product Safety Act (CCPSA), as amended from time to time: a paint or other similar material, with or without pigment, that forms a solid film after it is applied to a surface and that can be removed. 

“w/w” Weight per weight

“Good Laboratory Practice” Practices that are in accordance with the principles set out in the Organisation for Economic Co-operation and Development (OECD) document entitled OECD Principles of Good Laboratory Practice, Number 1 of the OECD Series on Principles of Good Laboratory Practice and Compliance Monitoring, ENV/MC/CHEM(98)17, the English version of which is dated January 21, 1998 and the French version (bonnes pratiques de laboratoire) of which is dated March 6, 1998.

Appendix 1: Definition of Good Laboratory Practices

The Principles of Good Laboratory Practice (GLP) have been developed to promote the quality and validity of test data used for determining the safety of chemicals and chemical products. It is a managerial concept (i.e., Quality Management System) covering the organizational process and the conditions under which laboratory studies are planned, performed, monitored, recorded and reported. Its principles are required to be followed by test facilities carrying out studies to be submitted to national authorities for the purposes of assessment of chemicals and other uses relating to the protection of human health and the environment. (From: OECD Principles on Good Laboratory Practice | OECD).

Appendix 2: Reporting requirements

Part 1: Declaration form

This declaration provides information to Health Canada in respect of section 8 of the Code of Practice.

1.1 Contact information

1. Name and civic address of the person declaring the information:
   1. Name of contact
   2. Name of company/corporation
   3. Civic and postal addresses
   4. Email address
   5. Telephone number
2. General/technical contact for the company (if different from authorized representative). This contact information will be used by Health Canada to correspond with your company on items related to your submission.
   1. Name of contact
   2. Name of company/corporation
   3. Civic and postal addresses
   4. Email address
   5. Telephone number

1.2 Declaration

I declare that [insert company name] has adopted the Code of Practice for Methanone, Diphenyl- (Benzophenone) in Paint, Stain and/or Coating Products Available to Consumers in Canada, and that the information I am submitting is accurate and complete.

Submitter name (print)

Position

Telephone number

Email address

Submitter signature

Date of signature

1.3 Request for confidentiality

Confidentiality will be considered as under section 7 of the Code of Practice. Please identify specific sections that are requested to be treated as confidential.