The following document provides an update to the overview document of the main points relating to the Ecotoxicological risk assessment for glyphosate and the Annex I renewal dossier submission made by the Glyphosate Renewal Group (GRG, the applicant).
The previous version of this document provided the applicant’s opinion of the ecotoxicological evaluation made by the RMS (the Assessment Group for Glyphosate (AGG) that consists of the competent authorities of France, Hungary, Netherlands and Sweden) as it appeared in the draft renewal assessment report (dRAR). This included indications of the areas where the applicant agreed with the evaluation of the RMS and pointed towards how the applicant intended to respond to issues raised in the dRAR.
Since the commenting by Member States, registrants and the general public have commented on the dRAR for glyphosate. An additional information request was received from EFSA on 14th March, 2022 in accordance with Article 13 (3) of Commission Implementing Regulation (EU) No 844/2012, and relates to the following areas;
Information relevant for harmonized classification and labelling in accordance with Regulation (EC) No 1272/2008.
New study reports from laboratory studies conducted to support the Ecotoxicological risk assessment.
Position papers to further support and elucidate on the risk assessment presented in the submitted dossier were indicated as either a data gap in the dRAR or on specific request by EFSA from the 14th March additional information request.
Tier II summaries of public literature papers already submitted and new public literature papers considered as relevant to the evaluation by the RMS were also requested to be submitted in the interests of complete transparency.
Some study information, e.g., summaries for studies already summarised in the dRAR, have been updated to reflect – as necessary, changes resulting from the RMS’ evaluation or comments, for the technical product (CA) and the representative formulation (CP) parts of the ecotoxicology dossier.
For example, in the bird study summary presented under Vol 3 (CA), 18.104.22.168/005 ‘Sub-chronic toxicity and reproduction to birds’ study (1978), in the additional information request, EFSA requested information relating to the frequency of diet renewal, parameters subject to statistical analysis and details of how the endpoint based on mg/kg diet were converted into daily dose values. These have now been provided in an updated study summary.
The following contains targeted summaries of information pertinent to the risk assessment and builds upon the transparency document previously uploaded by the applicant onto the Glyphosate transparency website (see footnote).
- See the GRG website (www.glyphosate.eu), under “Transparency” – “Scientific Dossier” – “GRG Position on Scientific Topics” – “Effects on Non-Target Species”, where the GRG provided brief summaries of different elements of the dRAR, including indications of how the GRG is intending to respond to the topics raised by the RMS, where appropriate. The full position document covering key areas of the ecotoxicological risk assessment can be accessed via this link.