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The Aromatic Azo- and Benzidine-Based Substances Approach

Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.

The aromatic azo- and benzidine-based substances are among those identified as priorities for action through the categorization process. They are the substances which may break down to certain aromatic amines or benzidines, and the corresponding aromatic amines or benzidines. Some substances within this class have been identified by other jurisdictions as a concern due to the potential cleavage of the azo bonds that can lead to the release of aromatic amines that are known or are likely to be carcinogenic or genotoxic. In addition, recent data gathering initiatives have confirmed some of these substances are found in imported consumer products (for example, clothing, leather products) in Canada.

• Section 71 Notice (Mandatory Survey)
• The Path Forward on Aromatic Azo- and Benzidine-based Substances
• Timelines
• Background

Section 71 Notice (Mandatory Survey)

In December 2011, a Notice was issued in the  Canada Gazette, Part I: Vol.145, No.51 - December 17, 2011 ( PDF Version - 5 372 K) under section 71 of the Canadian Environmental Protection Act, 1999 (CEPA 1999). This Notice applies to a  Subset of the Aromatic Azo- and Benzidine-based Substances covered in this initiative.

Every person to whom this Notice applies is required to comply with the Notice by no later than 3:00 p.m. EST, April 16, 2012. Please note that under subsection 71(4) of the Act, extensions may be granted upon written request. To apply for an extension, a written request must be received by the  Minister of the Environment prior to the deadline. In order to facilitate reporting, a  List of generic trade names that may contain the substances listed in the Notice is available. Please also see the  Guidance Document for completing the CEPA section 71 Notice.

Persons who do not meet the requirements to respond to this Notice may complete a  Declaration of Non-Engagement for the Notice, or if they have a current or future interest in a substance within this class, they may identify themselves as a stakeholder by completing the voluntary  Stakeholder Interest Form. Organizations that may be interested in submitting additional information include those that manufacture, import, export or use a substance, whether alone, in a mixture or in a product. In addition to information on types of uses and volumes imported and manufactured, there is specific interest in unpublished data or studies which could help inform the risk assessment process (for example, data on toxicity, metabolism, degradation, physical-chemical properties, migration from products, etc.). Information on industrial best-practices and environmental releases are also of interest. This Stakeholder Interest Form allows the person to provide other information that would be beneficial to inform the risk assessment and potential management of the substances. The person will be included in future mailings regarding these substances and may be contacted for further information regarding their interest in these substances.

The information collected from this section 71 Notice will inform the risk assessment and, if necessary, risk management for these substances. Information provided to Environment Canada and Health Canada under previous initiatives will also be taken into consideration.

Respondents are encouraged to submit their section 71 Notice, Stakeholder Interest Form or Declaration of Non-Engagement Form online. The new Chemicals Management Plan eSubmissions online system will be available in January 2012.  Respondents will be required to register for a  Government of Canada Access Key for this new system. Links to the mandatory survey and related materials are available:

• CEPA 1999 section 71 Notice with respect to certain aromatic amines and aromatic azo- and benzidine-based substances:  Canada Gazette, Part I: Vol.145, No.51 - December 17, 2011 ( PDF Version - 5 372 K)
•  Guidance Document for completing the CEPA section 71 Notice
•  Stakeholder Interest Form
•  Declaration of Non-Engagement Form

The Path Forward on Aromatic Azo- and Benzidine-based Substances

To address this class of substances efficiently, the Government of Canada is currently developing subgroups among these approximately 360 Aromatic Azo- and Benzidine-based Substances. These subgroups will cluster substances based on structural similarities (benzidines, monoazo substances, disazo substances, polyazo substances, aromatic amines); common functional uses and applications (pigments, solvent dyes, disperse dyes, direct dyes, acid dyes, basic dyes, reactive dyes, etc.); physical-chemical properties (solubilities, molecular weight, log K_ow, etc.). Potential subgroupings will be made available in the coming months.

To identify data gaps in class assessment of these substances, the Government of Canada has conducted literature searches and identified studies on parameters such as physical-chemical properties, ecological toxicity endpoints, and human health effect endpoints, which are available in the public domain for each substance. This information can be found in the  Aromatic Azo- and Benzidine-based Substances List. Data which were previously submitted to Environment Canada were also included in this table. Note that the reliability of the data identified to date has not been determined. The Government of Canada is currently determining the reliability of the data identified. Generally speaking, limited data have been identified for many substances.

The Government of Canada will apply weight of evidence and precaution in decision-making. Accordingly, where data is limited, the Government of Canada will apply conservative assumptions in the risk assessment for factors such as:

• the potential for these substances to degrade or metabolize to component aromatic amines;
• the potential for these substances to migrate or leach from finished products;
• the potential for dermal uptake from products in contact with the skin;
• the potential for these substances to cause health effects or degrade or metabolize to substances which may cause health effects;
• the potential for these substances to cause harm to biota in the environment; and
• the potential for these substances to bioaccumulate.

Draft screening assessments for subgroups will be released in phases and there will be 60-day public comment period for each release.

Timelines

Timelines	Activity
December 17, 2011	Release of the section 71 Notice with respect to certain aromatic amines and aromatic azo- and benzidine-based substances and the accompanying technical documents.
Winter 2011/2012	Stakeholder consultation on subgrouping of aromatic amines and aromatic azo- and benzidine-based substancesand technical discussions on assessment approach.
April 16, 2012	Deadline for submission of information for the section 71 Notice on this class of substances (without an extension).
June 18, 2012	Deadline for submission of any voluntary information by interested stakeholders.
Winter 2012/2013	Anticipated release of first set of draft screening assessments for various subgroups in Canada Gazette and start of 60-day public comment period.

Background

As part of the Chemicals Management Plan (CMP), the Government of Canada has committed to addressing approximately 4,300 substances prioritized through the categorization process by 2020. To date, some of these substances have been or are being addressed through the Challenge, the Petroleum Sector Stream Approach and other initiatives.

Of the list of priorities from Categorization, a number of substances still remain to be addressed. Therefore, in June 2010, the Government of Canada published a Notice of intent to address a class of approximately 360  Aromatic Azo- and Benzidine-based Substances in the  Canada Gazette, Part I: Vol. 144, No. 23 - June 5, 2010 ( PDF Version - 1,170 K).

The Notice of intent indicates that the Government of Canada plans to assess the potential health and ecological risks of these substances. If, through the assessment process, it is determined that any of these substances are considered harmful to human health or the environment, then management action would be considered for those substances where appropriate.

Public comments on the Notice of intent were received through the 60-day public comment period. The Government of Canada has considered the comments received and a  Summary of the Main Public Comments Received on the Notice of Intent and Government Response is available.

For the address to submit your response to the Notice to the Minister of the Environment or for general inquiries please contact us. Indicate on the envelope or subject line "CMP Aromatic Azo- and Benzidine-based Substances Approach".