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European assessment of glyphosate was conducted with quality assurance and independently

41/2017, 11.10.2017

ECHA and EFSA confirm the correct procedure in the European assessment of glyphosate at the hearing on glyphosate in the European Parliament

A joint hearing of the Committee on Agriculture and Rural Development and Committee on the Environment, Public Health and Food Safety on the subject "Monsanto Papers and Glyphosate" took place in the European Parliament in Brussels on 11 October 2017. Experts from participating European authorities, such as the European Food Safety Authority (EFSA), as well as representatives of NGOs and universities, discussed the assessment result as well as the approval procedure for the plant protection product active substance glyphosate. After consultation with each individual EU member state and a public hearing, the EU risk assessment of the reapproval of the active substance glyphosate by EFSA and subsequent EU hazard analysis for classification and labelling by the European Chemicals Agency (ECHA) have been concluded. After making their own assessments on the basis of established, internationally recognised standard toxicological procedures, all assessment authorities worldwide which had access to the original data of the applicants come to the conclusion that, in accordance with the currently available knowledge, glyphosate should not be classified as "probably carcinogenic to humans", as proposed by the International Agency for Research on Cancer (IARC). "In light of this uniform assessment by authorities all over the world, a scientifically founded basis for the political decision on the reapproval of glyphosate has been established," says BfR President Professor Dr. Dr. Andreas Hensel. "Public discussion does not usually relate to the result of the scientific assessment but more to procedural issues. The BfR has long been proposing greater transparency with regard to the original data so that the European assessment can be fully understood," Hensel adds. The BfR offered the EU Parliament's Committee for Agriculture and Rural Development (AGRI) to take part in the public hearing at the EU Parliament should it prove particularly necessary to do so.

An integral part of the reassessment was the risk assessment of the plant protection product active substance glyphosate. This was concluded after consultation with all 28 European Union member states, EFSA and the European Chemicals Agency (ECHA). After making their own assessments on the basis of established, internationally recognised standard toxicological procedures, every single assessment authority in Europe and throughout the world which had access to the original data of the applicants also arrived at the conclusion that, in accordance with currently available knowledge, glyphosate should not be classified as carcinogenic. After the publication of the IARC report, the BfR as the rapporteur also re-examined the additional publications which formed the basis of the IARC assessment.

The hearing at the EU Parliament was also attended by the NGO consultant Christopher Portier, who claimed at the hearing that only the BfR assessed the original data. This was not the case. The rapporteur member state was the Federal Republic of Germany. EFSA and ECHA have clarified that in addition to the BfR assessment and comments of the member states, they and their independent panels of experts also had the original data at their disposal. Portier also addressed Commission President Jean-Claude Juncker in an open letter in May 2017 in which he claimed that tumour findings in animal studies had allegedly not been been  considered in the European risk assessment. In the meantime this has been refuted by EFSA with explicit reference to the original data in the corresponding studies. All of the original studies mentioned were taken into account in the assessments of the European authorities in accordance with their reliability and relevance and assessed in compliance with coordinated scientific principles and valid technical EU guidelines.

The European Food Safety Authority (EFSA) confirmed again at today’s hearing that the BfR did in no way adopt the view of the applicants and their interpretation of the corresponding studies without criticism or review, as was claimed by certain circles in the case of glyphosate. When preparing the Renewal Assessment Report (RAR), it is also standard practice for the rapporteur member state, after making a critical review, to integrate text from the original studies and study summaries of the applicants if it concurs with them.

http://audiovisual.europarl.europa.eu/Assetdetail.aspx?id=1d326827-91e9-4234-b0b4-a8090086e779

Germany was commissioned as rapporteur for the European approval process for glyphosate. The BfR was not the only institution to assess the plant protection product active substance glyphosate in this instance. The other German authorities Julius-Kühn Institute (JKI), Federal Environment Agency (UBA) and Federal Office of Consumer Protection and Food Safety (BVL) also prepared their input for the Renewal Assessment Report on the basis the applicants’ dossier. This RAR, including its addenda, was made available to EFSA,the coordinating authority, for the subsequent procedural steps.

All work areas of the BfR - science, assessment, communication and administration - have been certified since 2010 in accordance with the quality standard DIN EN ISO 9001. In addition to this, the work areas science, assessment and administration have also been certified by TÜV Nord since 2010 in line with DIN EN ISO 9001:2008. With these certificates, the BfR provides international documentation of its particularly high scientific quality standards and demonstrates that the significant task of consumer health protection is taken seriously.

About the BfR

The German Federal Institute for Risk Assessment (BfR) is a scientifically independent institution within the portfolio of the Federal Ministry of Food and Agriculture (BMEL) in Germany. It advises the Federal Government and Federal Laender on questions of food, chemical and product safety. The BfR conducts its own research on topics that are closely linked to its assessment tasks.

The BfR is celebrating its 15th anniversary this year. To mark the occasion, the institute has published a jubilee brochure (in German) which can be downloaded or ordered free of charge at http://www.bfr.bund.de/en/publication/brochures-61045.html.

This text version is a translation of the original German text which is the only legally binding version.

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