EDTA and its Salts Group - information sheet

Overview

The Government of Canada conducted a science-based evaluation, called a screening assessment, of the EDTA and its Salts Group to address the potential for harm to Canadians and to the environment.
Under the Canadian Environmental Protection Act, 1999 (CEPA 1999), the risk posed by a substance is determined by considering both its hazardous properties (its potential to cause adverse human health or ecological effects) and the amount of exposure there is to people and the environment. A substance may have hazardous properties; however, the risk to human health or to the environment may be low depending upon the level of exposure.
- More information on assessing risk can be found in the Overview of Risk Assessment and related fact sheets, particularly on Types of Risk Assessment Documents and the Risk Assessment Toolbox.
The ecological hazard and exposure potentials of these substances were classified using the Ecological Risk Classification of Organic Substances Approach.
The risk posed by substances in the EDTA and its Salts Group is low at current levels of exposure; therefore, it is concluded that these substances are not harmful to human health or to the environment.

This screening assessment focuses on 4 substances referred to collectively as the EDTA and its Salts Group. The substances addressed in this screening assessment are EDTA, tetrasodium EDTA, ferric monosodium EDTA, and ferric ammonium EDTA.
These substances were assessed as part of the third phase of the Chemicals Management Plan (CMP).
The Government gathers information on substances, including details on their commercial status in Canada, to support risk assessment and risk management of substances under the CMP.
These substances do not occur naturally in the environment.
In Canada, some of these substances may be used as chelating agents (compounds that bind metal ions) or preservatives in cleaning products, cosmetics, prescription and non-prescription drugs, and natural health products.
They may also be used in the manufacture of products for printing inks, paints and coatings, ion exchange agents, automotive care, water treatment, food packaging, and pest control.
Some of these substances may be present in certain food packaging materials in Canada; however, exposure from food packaging is considered to be negligible.

Canadians may be exposed to these substances through the use of products available to consumers, such as household cleaners, hair products, and sunscreens.
EDTA, tetrasodium EDTA and ferric monosodium EDTA were identified as having low ecological exposure potential. Ferric ammonium EDTA, however, was identified as having moderate ecological exposure potential based on moderate reported quantities of the substance in Canada.

To identify health hazard information, international reports of data on substances within the EDTA and its Salts Group were reviewed. These included reviews by the Organisation for Economic Co-operation and Development (OECD), European Commission's former European Chemicals Bureau (ECB), and European Food Safety Authority (EFSA).
There were limited data for these substances; therefore, a comparative approach using similar chemicals, called read-across, was used for assessing potential health effects.
Using these existing assessments and data available for similar substances, the substances in the EDTA and its Salts Group are not considered to have adverse effects on human health.
For the ecological assessment, all 4 substances in this group were identified as having a low ecological hazard potential.

The substances within the EDTA and its Salts Group have been assessed by the OECD Cooperative Chemicals Assessment Programme and Screening Information Data Set (SIDS) Initial Assessment Profiles (SIAPs) are available.
These assessments undergo extensive review (including peer-review) and endorsement by international governmental authorities. Health Canada and Environment and Climate Change Canada are active participants in these processes, and consider these assessments reliable.
EDTA and tetrasodium EDTA have also been assessed by ECB and European Union Risk Assessment Reports (EU RARs) are available.
Ferric monosodium EDTA has also been assessed by the EFSA and was used to inform this screening assessment.
Based upon the information presented in this screening assessment, the risk to human health from these 4 substances is considered to be low.
The Ecological Risk Classification of Organic Substances Approach characterized these 4 substances as posing a low risk of harm to the environment.
The Government of Canada published the Final Screening Assessment for the EDTA and its Salts Group on May 5, 2018.

As a result of this assessment, the Government concluded that EDTA, tetrasodium EDTA, ferric monosodium EDTA, and ferric ammonium EDTA are not harmful to human health at current levels of exposure.
The Government also concluded that these 4 substances are not entering the environment at levels that are harmful to the environment.

These substances may be found in certain products available to consumers. Canadians should follow any safety warnings and directions on product labels and dispose of products responsibly.
Canadians who may be exposed to these substances in the workplace can consult with their employer and an occupational health and safety (OHS) representative about safe handling practices, applicable laws, and requirements under OHS legislation and the Workplace Hazardous Materials Information System (WHMIS).