Soy Canada Responds to European Commission’s Proposal to Amend Criteria for Endocrine Disruptors

Posted on: August 9, 2016

On July 28, Soy Canada submitted comments to the European Commission’s consultation process on its proposed amendment to criteria to identify endocrine disruptors for plant protection products.  The text of Soy Canada’s submission is below and can be viewed on the European Commission’s feedback webpage here:


We are writing to submit comment on the European Commission’s (EC) proposed criteria for determining endocrine disruption properties under the Plant Protection Products legislation.

Soy Canada is the national association representing the full soybean value chain in Canada. Our members include producer organizations, seed development companies, soybean exporters and processors. Canada is the European Union’s fourth largest supplier of soybeans, capturing seven percent of the total EU market. The EU imports approximately one million metric tonnes of Canadian soybeans annually.

Soy Canada considers the EC’s current proposal setting criteria for evaluating endocrine disrupting properties to be unacceptable as currently drafted. The proposal relies too heavily on intrinsic hazards and fails to take into account scientific evidence when studying substances for possible endocrine disruptor properties. All characteristics including potency, severity of effect, irreversibility, lead toxicity, dose and exposure are important factors that must be taken into account as part of a risk assessment and are critical to distinguishing between substances with real potential for harm and those that pose little or no risk. We believe that crop protection products should not be characterized as endocrine disruptors based on hazard assessments alone and must factor in realistic conditions of use as well as thorough science-based risk assessments.

To provide a predictable framework for assessing risk, it is important to align the EC’s evaluation assessments with risk-based approaches used by agencies in other countries. Canada’s Pest Management Regulatory Agency (PMRA) is responsible for regulating pesticides in Canada and has been actively involved in the endocrine disruptor issue for some time. Under the PMRA, substances are only made available to producers once they have passed rigorous environmental and safety tests, including testing for endocrine-mediated effects on crop protection tools. The PMRA is also actively involved in the US EPA’s endocrine disruptor screening program and we feel this ensures that all products registered for use in Canada will not create adverse health effects for users and consumers of crops using these products. The PMRA is a world leader in pesticide regulatory science and plays a key role at the OECD working group on pesticides and many of its working groups.

Further, we believe it is unacceptable for the proposal to be based almost exclusively on the World Health Organization’s (WTO) definition of endocrine disruption, which does not incorporate regulatory decision-marking criteria. For instance, using the WTO definition, some natural and synthetic substances would be classified endocrine disruptors despite posing little to no risk to human health or the environment.

Soy Canada questions whether the proposal violates the European Union’s commitments to WTO under the SPS agreement, which states that WTO members are required to ensure that their sanitary and phytosanitary protocols are rooted in “risk assessment techniques” and do not disrupt trade more than is required to achieve the appropriate level of protection.

Today, there are multiple layers of existing domestic and international crop protection product regulations aimed at protecting human health and the environment. It is essential that Canadian and European farmers have access to these resources in order to compete internationally. It is also critical that predictable regulations apply and that they are aligned between countries internationally to facilitate trade. Setting broad criteria for evaluating endocrine disruptors that do not take into account sound science will have a restrictive effect on the types of crop protection tools Canadian and European farmers have access to. The soybean sector in Canada is committed to promoting science-based assessments that ensure products are safe while benefiting producers.