Glyphosate molecule has a different toxicological profile from Glyphosate Trimesium, which has not been sold in the EU in the past 20 years.
Media reports have been flagging a recent study published in the Environmental Health Journal alleging that several plant protection companies withheld developmental neurotoxicity (DNT) studies on a few of their products when applying for EU authorisation, despite submitting them to the US Environmental Protection Agency (EPA) in their pesticide evaluation process.
As the GRG is seeking the renewal of the EU authorisation of the active substance Glyphosate, it would like to comment on the relevance for the re-approval process of one of the DNT studies conducted in 2001 for the active substance Glyphosate Trimesium.
The GRG members have not been selling Glyphosate Trimesium based plant protection products in the EU for about 20 years.
It is important to highlight that the Glyphosate Trimesium molecule has a different toxicological profile than Glyphosate, and the two are considered different active substances.
The GRG has always acted in full compliance with the applicable EU legislation. In June 2020, the GRG submitted to the competent authorities of the evaluating Member States a dossier comprising all studies and information required to be submitted under the applicable EU regulations. The DNT study for Glyphosate Trimesium was not included in the scientific dossier as it was not relevant for the regulatory assessment.
This was confirmed during the EFSA peer review process as one of EFSA’s experts’ groups (Mammalian Toxicology)concluded that Glyphosate-Trimesium is not representing Glyphosate from the qualitative toxicological profile perspective.
The Committee for Risk Assessment (RAC) of the European Chemical Agency (ECHA) highlighted that this particular glyphosate salt [Glyphosate Trimesium] is not sold anymore and had previously been regulated separately from other forms of Glyphosate. The relevant data were thus excluded from ECHA’s assessment of the developmental toxicity of Glyphosate as provided by the Regulation on Classification, Labelling, and Packaging (CLP).
The GRG remains committed to complying with all relevant aspects of the EU re-authorisation procedure. Consumers and civil society at large can have confidence in the EU system for regulating pesticide active substances which is among the most stringent in the world.
We stand for transparency. As part of its transparency commitment, the GRG grants unrestricted access to the various parts of the robust scientific dossier submitted to the European authorities as part of its application via its website.