European Union — Revised Proposal for the Categorization of Compounds as Endocrine Disruptors of 19 February 2013 by DG Environment

STATEMENT BY CANADA TO THE TBT COMMITTEE, 8-9 NOVEMBER 2017

The following communication, dated 17 November 2017, is being circulated at the request of the delegation of Canada.

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1.  Canada is concerned with the hazard-based approach the EU is taking on the regulation of active ingredients.

2.  First, as we have mentioned on numerous occasions in both this Committee and the WTO SPS Committee, hazard-based cut-offs, without giving any consideration to exposure or without performing a complete risk assessment, can unnecessarily restrict trade. There is a growing number of examples where active ingredients are prevented from going through the re-authorization process in the EU based on hazard-based cut-offs, such as glufosinate ammonium, and now possibly propiconazole.

3.  Second, as we have expressed in past meetings, Canada is concerned with the EU's proposed criteria for identifying compounds as Endocrine Disruptors.

4.  Even more concerning is the hazard-based approach to regulatory decision-making once a compound is identified as an endocrine disruptor, or meets other hazard-based cut-offs, such as for reproductive toxicants. Such European Chemical Agency classification decisions trigger regulatory non-approval and default maximum residue limits (MRLs), regardless of actual risk, in the opinion of the European Food Safety Authority.

5.  Now, while there was hope that the derogation process would provide a way to address trade-related concerns, Canada was disappointed that the regulatory amendment for derogation based on negligible risk was not introduced in the European Parliament. This means that default MRLs for food and feed are required once a substance is identified as an 'endocrine disrupting chemical', regardless of actual risk under real world exposure scenarios.

6.  Canada was further dismayed to learn of the European Parliament's 4 October 2017 decision to object to the European Commission's draft regulation setting out criteria for identifying endocrine disruptors in the area of plant protection products (PPPs).

7.  While this objection temporarily delays the adoption of the criteria, which Canada has not supported without the accompanying derogation, it creates further long-term uncertainty and unpredictability for exporters seeking to gain or maintain access to the European market.

8.  In the wake of this objection, the implementation of the European Union's interim criteria have the potential to remove twice as many pesticide active ingredients from the market than those set out in the proposed criteria.