Toxic substances list: hexanedioic acid, bis(2-ethylhexyl) ester (DEHA)

The substance Hexanedioic acid, bis(2-ethylhexyl) ester (DEHA - CAS RN 103-23-1), was included in Batch 11 of the Challenge. DEHA is used primarily as a plasticizer in the flexible vinyl industry and widely used in flexible polyvinylchloride (PVC) food film (cling film). DEHA has also minor uses as a plasticizer, emollient or solvent in cosmetic products.

The final screening assessment report (FSAR) was published on September 10, 2011. The report concluded that DEHA is entering or may enter the environment in a quantity or a concentration or under conditions that have or may have an immediate or long-term harmful effect on the environment or its biological diversity, paragraph 64(a) of the Canadian Environmental Protection Act, 1999(CEPA1999). The final screening assessment report also concluded that DEHA is entering or may enter the environment in a quantity or a concentration or under conditions that constitute or may constitute a danger in Canada to human life or health (paragraph 64(c) of CEPA1999).

The proposed risk management objectives for DEHA were to prevent or minimize releases of DEHA to the aquatic environment to the greatest extent possible throughout its lifecycle and to prevent increases in exposure to Canadians.

Update on Risk Management Activities

The Proposed Risk Management Approach for DEHA (September 2011) listed the activities to be conducted in order to be able to develop appropriate and efficient controls. These activities aimed at refining the identification of the sources of releases in order to prevent releases of DEHA to the environment and to prevent increases in exposure to Canadians.

As committed to in the proposed Risk Management Approach (RMA), the Government of Canada has been working with stakeholders to further quantify the sources of releases of DEHA to the environment throughout its lifecycle to determine if further risk management control actions under CEPA 1999 would be required to address these releases. DEHA monitoring was conducted in 2011-2012 of industrial effluents, municipal wastewater treatment plants effluents and of the receiving environment (surface water and sediment). DEHA analysis was also included in a landfill leachate study.

Analysis of all this additional information has been documented in an ecological State of the Science report.  The results call into question the validity of published data that formed a key line of evidence in the screening assessment. As a result of the conclusion in the State of the Science report that DEHA no longer meets the criteria of paragraph 64(a) of CEPA 1999, no risk management is required for ecological purposes. Therefore, the implementation of the Significant New Activity (SNAc) provisions and the development of a control instrument addressing ecological concerns are not being pursued.

Following commitments in the Risk Management Approach to address health concerns, the Government of Canada investigated a suitable health protective restriction for DEHA, resulting in the proposed addition to Health Canada’s List of Prohibited and Restricted Cosmetic Ingredients (Cosmetic Ingredient Hotlist).  In addition, the Government of Canada has also performed targeted surveys of DEHA in foods and food packaging materials and has added DEHA to the Canadian Total Diet Studyto better define Canadian exposure to DEHAthrough dietary intake and determine whether further risk management actions are warranted.

For more information on this substance, please visit the Chemical Substances website.

Risk Assessment

• Screening Assessment Report (FSAR) for DEHA (September 2011)
• Order proposing the addition of DEHA to Schedule 1 of the Canadian Environmental Protection Act, 1999 was published in the Canada Gazette Part I on October 15, 2011.
• Ecological State of the Science Report on DEHA (September 2013)
• Response to Notice of Objection to the listing of DEHA on Schedule 1 of CEPA1999 (September 2013)

Risk Management Activities

• Proposed Risk Management Approach document (September 2011)

Consultations

Current public consultations:

• Proposed addition of DEHA to Health Canada’s Cosmetic Ingredient Hotlist - October 2013 (60 days)
• Ecological State of the Science Report on DEHA - October 2013 (60 days)

Past public consultation on the substance:

• Summary of Public Comments received on the Proposed Risk Management Approach for DEHA (CAS 103-23-1) from Batch 11 of the Challenge (comment period closed)
• Summary of Public Comments received on The Challenge Substance Hexanedioic acid, bis(2-ethylhexyl) ester (DEHA) (CAS No. 103-23-1) Draft Screening Assessment Report and Risk Management Scope for Batch 11(comment period closed)

Contact

Substances Management Information Line
Chemicals Management Plan
Gatineau, QC K1A 0H3

Telephone: 1-800-567-1999  (in Canada) or 819-938-3232
Fax: 819-938-3231
E-mail: eccc.substances.eccc@canada.ca

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