BfRshort forGerman Federal Institute for Risk Assessment FAQ, 12 November 2015
Active substances used in pesticides are subject to approval by the European Commission. Following the first application, this approval is limited to a maximum period of 10 years. Before the end of this period, the manufacturers must apply for renewed approval if they want to continue to use this active substance in pesticides. Once the application has been filed, the active substance is re-assessed. Within the framework of the approval procedure, the Commission appoints a member state to act as Rapporteur Member State (RMS). In the case of glyphosate, the Federal Republic of Germany was named RMS. The German government appointed the Federal Office of Consumer Protection and Food Safety (BVLshort forGerman Federal Office of Consumer Protection and Food Safety) as the lead authority for the drafting of the Renewal Assessment Rapport (RAR).
In the re-assessment procedure, the German Federal Institute for Risk Assessment (BfRshort forGerman Federal Institute for Risk Assessment) was commissioned to assess the health risk of the active substance and one representative formulation.
BfRshort forGerman Federal Institute for Risk Assessment has prepared questions and answers on the procedure for the re-assessment of the active substance glyphosate within the framework of the EU active substance evaluation.
[Accordion] Frequently asked questions on the procedure for the re-assessment of glyphosate within the framework of the EU active substance review
The first draft of the assessment report based on the GTF application documents and BfRshort forGerman Federal Institute for Risk Assessment's own literature research was compiled up to the end of 2013 in line with the timetable stipulated by the European Commission and forwarded by the Federal Office of Consumer Protection and Food Safety (BVLshort forGerman Federal Office of Consumer Protection and Food Safety) to the European Food Safety Authority (EFSAshort forEuropean Food Safety Authority). The report comprises the findings of the work performed by BfRshort forGerman Federal Institute for Risk Assessment, which assesses the health risk for humans and animals, as well as the reports of the Federal Environmental Protection Agency (UBAshort forGerman Environment Agency; investigation of impacts on the environment) and the Julius Kühn Institute (investigation of efficacyPositive Predictive ValueTo glossary and impacts on the health of bees).
The consultation with the experts from the other member states and the applicants took place at the beginning of 2014 in a peer review process, as did a public consultation under the lead management of EFSAshort forEuropean Food Safety Authority. The German authorities involved in the process then incorporated the comprehensive comments and additionally supplied studies from the consultation process with the member states and the interested members of the general public in the revised overall report and submitted the report as requested to EFSAshort forEuropean Food Safety Authority in December 2014. Following a consultation with the experts of the member states at EFSAshort forEuropean Food Safety Authority in February 2015, some questions remained that needed to be addressed. BfRshort forGerman Federal Institute for Risk Assessment sent all the requested additional findings to BVLshort forGerman Federal Office of Consumer Protection and Food Safety on 1 April 2015, who then forwarded the revised overall report to EFSAshort forEuropean Food Safety Authority.
Following the publication of the monograph by the International Agency for Research on Cancer (IARC) on the classification of glyphosate as "probably carcinogenic to humans, carcinogenic in Group 2A" at the end of July 2015, BfRshort forGerman Federal Institute for Risk Assessment was commissioned by the German government and EFSAshort forEuropean Food Safety Authority to review this assessment by IARC. BfRshort forGerman Federal Institute for Risk Assessment completed this review during the month of August 2015 and forwarded its report to the Federal Office of Consumer Protection and Food Safety (BVLshort forGerman Federal Office of Consumer Protection and Food Safety) in the form of an addendum to the Renewal Assessment Report. BVLshort forGerman Federal Office of Consumer Protection and Food Safety passed the German assessment on to EFSAshort forEuropean Food Safety Authority. During the month of September 2015, EFSAshort forEuropean Food Safety Authority organised a peer review on the addendum and an additional expert meeting of the member states. This meeting was also attended by representatives of the World Health Organisation (WHO), IARC and the United States Environmental Protection Agency (USEPA). As a result, it was possible to take account of the IARC assessment in the re-assessment of glyphosate within the context of the EU active substance review. Based on the revised RAR and the addendum, the experts at EFSAshort forEuropean Food Safety Authority prepared the summarised report (EFSAshort forEuropean Food Safety Authority Conclusion) for the assessment of glyphosate for the purpose of renewed approval. This completed the scientific assessment process in the approval procedure.
The legal procedure in Europe stipulates that the applicant must perform and pay for the toxicological studies for the requested active substance. This corresponds to the general principle used in other approval procedures - such as those under the pharmaceutical laws - that the producer or distributing company bears responsibility for the safety of the products and must also prove their safety. The studies must be performed in line with Good Laboratory Practice (GLP) and the OECD guidelines on the toxicological testing of chemicals as well as EU Test Method Regulation No. 440/2008. The guidelines also stipulate the number and type of animals to be used, for example, as well as the control groups for the toxicological end points to be investigated in each case.
The sole criterion for the inclusion of study findings is the scientific quality and evidence of the studies. Possible interests of those commissioning the studies, political interests or interests of other stakeholders cannot and may not play any role in a scientific assessment.
The analysis of sources submitted by the applicants in the industry (Glyphosate Task Force) is part and parcel of the legally prescribed assessment process.
No. All the sources on which the assessment report is based were - as is the case with all other health risk assessments - evaluated solely by BfRshort forGerman Federal Institute for Risk Assessment staff. The health assessment of BfRshort forGerman Federal Institute for Risk Assessment draws exclusively on the original studies or on articles published in the scientific literature.
In its assessment report, BfRshort forGerman Federal Institute for Risk Assessment included the summary of the information on the experimental procedure and the findings of the Glyphosate Task Force (GTF) only for the toxicological studies - not for the studies on analysis, residue assessment and application safety. During this process, errors and redundancies were corrected and a separate BfRshort forGerman Federal Institute for Risk Assessment assessment was presented in the revised assessment report in a specially highlighted paragraph. As a result, the report and the assessment of active substance toxicology were clearly separate.
This means that BfRshort forGerman Federal Institute for Risk Assessment conducted its own assessment of each study or literature publication and did not rely on summaries compiled by the industry. BfRshort forGerman Federal Institute for Risk Assessment also conducted a fully independent risk assessment based on the hazard assessment and exposureExposureTo glossary estimate, and described this assessment once again in the form of a summary for the re-assessment of glyphosate in Volume 1 of the report, as stipulated by European law for every assessment of active substances in pesticides. The independent nature of the BfRshort forGerman Federal Institute for Risk Assessment risk assessment is reflected by, among other things, the differing assessments and conclusions arrived at by BfRshort forGerman Federal Institute for Risk Assessment and GTF.
The "BfRshort forGerman Federal Institute for Risk Assessment Committee for Pesticides and Their Residues" is not involved in the statutory tasks of BfRshort forGerman Federal Institute for Risk Assessment. In other words, it has no say in the assessment of substances in line with the legal remit of BfRshort forGerman Federal Institute for Risk Assessment.
BfRshort forGerman Federal Institute for Risk Assessment draws on the external expertise of the BfRshort forGerman Federal Institute for Risk Assessment Committee in order to take account of the current status of scientific and technological knowledge as well as the practical knowledge that exists in other institutions in the ongoing conceptual development of assessment concepts or the involvement of BfRshort forGerman Federal Institute for Risk Assessment in the drafting of technical guidelines.
The issues dealt with by the BfRshort forGerman Federal Institute for Risk Assessment Committee for Pesticides and Their Residues are outlined in the meeting minutes published on the BfRshort forGerman Federal Institute for Risk Assessment website:
http://www.bfr.bund.de/en/bfr_committee_for_pesticides_and_their_residues-23385.html
BfRshort forGerman Federal Institute for Risk Assessment revised the assessment report to take account of the comments received from the member states, EFSAshort forEuropean Food Safety Authority, the Glyphosate Task Force (GTF) and the public consultation.
All the documents subsequently requested from the GTF by the BfRshort forGerman Federal Institute for Risk Assessment were incorporated, as were articles from scientific journals that had not previously been taken into consideration or were only published last year. Overall, BfRshort forGerman Federal Institute for Risk Assessment reviewed and assessed 350 individual comments and notes (including those from individual persons and non-governmental organisations) and, where necessary, took them into account in the revision of the assessment report.
The number of incorporated literature references was significantly increased, and the scope of the sections on the detection of glyphosate in human urine, oxidative stress, epidemiological studies and the effects on farm animals was considerably expanded. The information on carcinogenicity and mutagenicity was also supplemented. Even if a higher intake via the skin is now assumed for the representative formulation (a pesticide containing the active substance glyphosate), there is no change in the fundamental assessment of the active substance.