According to the European Regulation for plant protection products ((EC) 1107/2009), the scientific dossier submitted by an applicant has to include scientific peer-reviewed open literature on the active substance and all relevant metabolites, published within the last ten years before the date of a renewal submission.
Different stakeholders have raised concerns regarding the selection process of the open literature studies included in the dossiers submitted to the regulatory authorities as part of the re-evaluation process of the active substance glyphosate. It has been implied that the industry is being biased in the evaluation process, making selective use of studies, omitting published data, and favoring industry-funded studies over peer-reviewed open literature studies.
However, applicants submitting a scientific dossier for active substance authorization (as was the case for the GRG’s scientific dossier) have to follow a defined and approved evaluation process to ensure no relevant open literature studies get overlooked.
As part of the GRG transparency efforts, we are providing an overview of the process of literature evaluation in preparation of a scientific dossier, which also took place in preparation of the 2020 dossier (the steps taken are also shown in diagrammatic form below).
As a first step, numerous different databases were searched, and wide generic search terms were used to gather “as much relevant scientific peer-reviewed open literature as possible” as stated in the EFSA guidance on peer-reviewed open literature submission. In total, 39,482 publications were part of the original search results for glyphosate studies.
The results were then screened, and all duplications were removed. Following the removal of duplicates, a total number of 13,707 records went into the next step of the process: the relevance check.
The relevance check includes a first check on title and studies’ abstract level, followed by a detailed assessment at full-text level in case of uncertainties about the relevance of the open literature for the scientific evaluation. In total, 9,784 publications were deemed as “not relevant” to the renewal process after the relevance assessments.
The last step of the literature review process was the reliability assessment of the full text of the studies identified.
A total of 178 studies were deemed relevant and reliable and were included in the scientific dossier submitted by the GRG to the AGG. The AGG scrutinized the proposed selection of relevant and reliable public literature articles and asked the GRG subsequently to submit about 100 additional open literature related to toxicology and about 380 open literature studies related to environmental safety, to be included within the comprehensive scientific evaluation of glyphosate.
It is important to note that while some literature is deemed not relevant, together with a justification for each, these are listed in the dossier for later review by the AGG, EFSA, or the general public.
Industry studies are not preferred over peer-reviewed open literature studies.
Reliability, Replication, and Validity are the basis for including any relevant and reliable scientific study information into the safety evaluation for an active ingredient for plant protection products, like glyphosate.
Meanwhile the draft Renewal Assessment Report is publicly available on EFSA and ECHA websites. This provides access to the information about how AGG evaluated the public literature.
The following documents are of interest and contain detailed comments about AGG’s opinion about the relevance and reliability assessment and their request for additional public literature articles:
- Tox: Document “Glyphosate_RAR_14_Volume_3CA_B-6.7 – B-6.10_2021-08-10.pdf” – pages 770 – 922
- Ecotox: Document “Glyphosate_RAR_20_Volume_3CA_B-9_Appendix literature search_2021-08-10.pdf” – 580 pages
- Biodiversity: Document “Glyphosate_RAR_30_Volume_3CP_MON 52276_B-9_App_lit_biodiv_2021-08-10.pdf” – 97 pages
 The figures can be found on the Literature Review Report: Scientific peer-reviewed open literature for the approval of pesticide active substances glyphosate and metabolites (“KCA 9-001_108689-CA9-1_LRR_Anonymus_2020.pdf”), which is available for ordering via our GRG website.
To order it, go to this link , click on reference list for 2020, go to last page of the downloaded pdf (page 51) and click to order your copy. After agreeing to terms and conditions you will receive a copy of the report in a few days.