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Glyphosate: BfR Has Reviewed and Assessed the Original Studies of the Applicants in Depth

Update – Herbicide Glyphosate – Health Risk Assessment – The German Federal Institute for Risk Assessment (BfR) has clarified that in its recent review of glyphosate, it has “… in detail reviewed and assessed under its own responsibility both the legally required studies of the applicants as well as all other relevant and available studies … BfR lists its own, independent assessments of the relevance, scientific quality and validity of all of these studies and publications in accordance with the legal stipulations … In the [most recent] European Food Safety Authority (EFSA) Conclusion, the majority of the European experts also confirm the health assessment of the [BfR] stating that, when used correctly and in line with its intended purpose in agriculture, glyphosate is not expected to pose any carcinogenic, mutagenic or reprotoxic risks … Following their own assessments using established, internationally recognised, standard toxicological methods, all assessment authorities worldwide who had access to these original data have reached the conclusion that glyphosate should not be classified as carcinogenic based on current knowledge …”

Document Title: * The title of the September 15, 2017 BfR Communication is “Glyphosate: BfR has reviewed and assessed the original studies of the applicants in depth”
* The title of the May 30, 2017 BfR Communication is “No new findings on the risk assessment of glyphosate”
* The title of the March 15, 2017 ECHA News Release is “Glyphosate not classified as a carcinogen by ECHA”
* The title of the December 9, 2016 EFSA News Story is “Glyphosate: EFSA shares raw data from risk assessment”
* The title of the September 29, 2016 EFSA News Story is “Glyphosate: EFSA to share raw data”
* The title of the August 11, 2016 New Zealand Environmental Protection Authority Media Release is “EPA report concludes glyphosate an unlikely carcinogen”
* The title of the May 2, 2016 Monsanto Press Release is “Once Again, EPA Concludes That Glyphosate Does Not Cause Cancer”
* The title of the November 19, 2015 EFSA News in Brief is “Glyphosate: background documents published”
* The titles of the November 2015 BfR FAQs are:
– “Frequently asked questions on the assessment of the health risk of glyphosate”
– “Frequently asked questions on the procedure for the re-assessment of glyphosate within the framework of the EU active substance review”
– “Frequently asked questions regarding the different assessments of the carcinogenic effect of glyphosate by BfR and IARC”
* The title of the November 12, 2015 EFSA News Release is “Glyphosate: EFSA updates toxicological profile”
* The title of the November 12, 2015 EFSA document is “Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate”
* The title of the November 3, 2015 EFSA News in Brief is “Glyphosate conclusion to be published next week”
* The title of the September 8, 2015 BfR Communication Number 028/2015 is “BfR review of the IARC monograph of glyphosate brought into the European assessment process”
* The title of the July 30, 2015 BfR Communication Number 024/2015 is “BfR reviews monograph of the International Agency for Cancer Research (IARC) on glyphosate – divergence procedure within the WHO still in progress”
* The title of the July 30, 2015 EFSA News in Brief is “Glyphosate: EFSA assesses IARC findings”
* The title of the June 8, 2015 BfR Communication Number 016/2015 is “Does glyphosate cause cancer? – Expert group to address diverging assessments within the WHO”
* The title of the April 2, 2015 BfR Communication Number 008/2015 is “BfR-contribution to the EU-approval process of glyphosate is finalised; BfR recommends the consideration of the Report of the International Agency for Research on Cancer (IARC) in the EU-Approval process”
* The title of the March 23, 2015 BfR Communication Number 007/2015 is “Does glyphosate cause cancer?”
* The title of the March 20, 2015 WHO IARC News Release is “IARC Monographs Volume 112: evaluation of five organophosphate insecticides and herbicides”

Organization: * German Federal Institute for Risk Assessment (BfR)
* European Chemicals Agency (ECHA)
* European Food Safety Authority (EFSA)
* New Zealand Environmental Protection Authority
* Monsanto Company
* International Agency for Research on Cancer (IARC) of the World Health Organization (WHO)

Source: * September 15, 2017 BfR Communication Number 028/2017 which was posted in English on September 18, 2017
* May 30, 2017 BfR Communication Number 008/2017 which was posted in English on June 2, 2017
* March 15, 2017 ECHA News Release
* December 9, 2016 and September 29, 2016 EFSA News Stories
* August 11, 2016 New Zealand Environmental Protection Authority Media Release
* May 2, 2016 Monsanto Press Release
* November 19, 2015 EFSA News in Brief
* November 12, 2015 BfR Frequently Asked Questions (FAQs)
* November 12, 2015 EFSA News Release and Conclusion on Pesticides which was approved on October 30, 2015 and published in the EFSA Journal 2015;13(11):4302
* November 3, 2015 and July 30, 2015 EFSA News in Briefs
* September 8, 2015, July 30, 2015, June 8, 2015, April 2, 2015, and March 23, 2015 BfR Communications
* March 20, 2015 News Release issued by the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO)

Web site: The September 15, 2017 BfR Communication is posted at
http://www.bfr.bund.de/cm/349/glyphosate-bfr-has-reviewed-and-assessed-the-original-studies-of-the-applicants-in-depht.pdf

The May 30, 2017 BfR Communication is posted at
http://www.bfr.bund.de/cm/349/no-new-findings-on-the-risk-assessment-of-glyphosate.pdf

The March 15, 2017 ECHA News Release is posted at
http://echa.europa.eu/-/glyphosate-not-classified-as-a-carcinogen-by-echa

The December 9, 2016 EFSA News Story is posted at
http://www.efsa.europa.eu/en/press/news/161209

Background documents relating to EFSA’s peer review of glyphosate are available at
http://www.efsa.europa.eu/en/press/news/151119a

The September 29, 2016 EFSA News Story is posted at
http://www.efsa.europa.eu/en/press/news/160929a

The August 11, 2016 New Zealand Environmental Protection Authority Media Release is posted at
http://www.epa.govt.nz/news/epa-media-releases/Pages/EPA-glyphosate-report-released.aspx
* The August 2016 report, titled “Review of the Evidence Relating to Glyphosate and Carcinogenicity”, is posted at
http://www.epa.govt.nz/Publications/EPA_glyphosate_review.pdf
* A Summary is posted at
http://www.epa.govt.nz/Publications/Glyphosate_report_lay_summary.pdf

The May 2, 2016 Monsanto Press Release is posted at
http://news.monsanto.com/press-release/corporate/once-again-epa-concludes-glyphosate-does-not-cause-cancer

The November 19, 2015 EFSA News in Brief is posted at
http://www.efsa.europa.eu/en/press/news/151119a
* The Peer Review Report and revised Renewal Assessment Report is posted at
http://registerofquestions.efsa.europa.eu/roqFrontend/outputLoader?output=ON-4302
* The Renewal Assessment Report is posted at
http://dar.efsa.europa.eu/dar-web/provision
* The Summary dossier is posted at
http://registerofquestions.efsa.europa.eu/roqFrontend/outputLoader?output=ON-4302

The November 12, 2015 BfR FAQs are posted at
* http://www.bfr.bund.de/en/frequently_asked_questions_on_the_assessment_of_the_health_risk_of_glyphosate-127871.html
* http://www.bfr.bund.de/en/frequently_asked_questions_on_the_procedure_for_the_re_assessment_of_glyphosate_within_the_framework_of_the_eu_active_substance_review-195637.html
* http://www.bfr.bund.de/en/frequently_asked_questions_regarding_the_different_assessments_of_the_carcinogenic_effect_of_glyphosate_by_bfr_and_iarc-195635.html

The November 12, 2015 EFSA News Release is posted at
http://www.efsa.europa.eu/en/press/news/151112

The November 12, 2015 EFSA Conclusion on Pesticides is posted at
http://www.efsa.europa.eu/en/efsajournal/pub/4302
* Specifically at
http://www.efsa.europa.eu/sites/default/files/scientific_output/files/main_documents/4302.pdf
* A Summary of the findings is posted at
http://www.efsa.europa.eu/en/corporate/pub/glyphosate151112

The November 12, 2015 BfR Communication, titled “Glyphosate: EFSA and Experts from EU Member States Confirm Scientific Assessment of German Authorities”, is posted at
http://www.bfr.bund.de/cm/349/glyphosate-efsa-and-experts-from-eu-member-states-confirm-scientific-assessment-of-german-authorities.pdf

The November 3, 2015 EFSA News in Brief is posted at
http://www.efsa.europa.eu/en/press/news/151103

The September 8, 2015 BfR Communication, which was released to the public on September 11, 2015, is posted at
http://www.bfr.bund.de/cm/349/bfr-review-of-the-iarc-monograph-of-glyphosate-brought-into-the-european-assessment-process.pdf

The July 30, 2015 BfR Communication, which was released to the public on August 4, 2015, is posted at
http://www.bfr.bund.de/cm/349/bfr-reviews-monograph-of-the-international-agency-for-cancer-research-iarc-on-glyphosate-divergence-procedure-within-the-who-still-in-progress.pdf

The July 30, 2015 EFSA News in Brief is posted at
http://www.efsa.europa.eu/en/press/news/150730.htm

The July 2015 IARC Monograph Volume 112 on Glyphosate is posted at
http://monographs.iarc.fr/ENG/Monographs/vol112/mono112-02.pdf

The June 8, 2015 BfR Communication, which was released to the public on June 15, 2015, is posted at
http://www.bfr.bund.de/cm/349/does-glyphosate-cause-cancer-expert-group-to-address-diverging-assessments-within-the-who.pdf

The April 2, 2015 BfR Communication is posted at
http://www.bfr.bund.de/cm/349/bfr-contribution-to-the-eu-approval-process-of-glyphosate-is-finalised.pdf

The March 23, 2015 BfR Communication is posted at
http://www.bfr.bund.de/cm/349/does-glyphosate-cause-cancer.pdf

The March 20, 2015 WHO IARC News Release is posted at
http://www.iarc.fr/en/media-centre/iarcnews/pdf/MonographVolume112.pdf

The research article published online March 20, 2015 in the journal Lancet Oncology, titled “Carcinogenicity of tetrachlorvinphos, parathion, malathion, diazinon, and glyphosate”, is posted at
http://www.thelancet.com/journals/lanonc/article/PIIS1470-2045%2815%2970134-8/fulltext

Information about the European Chemicals Agency (ECHA) is available at
http://echa.europa.eu/about-us

The previous FIEN message related to this topic is posted at
http://www.fien.com/articleDisplay.php?id=40421

Contact: * The German Federal Institute for Risk Assessment has a Contact form available at
http://www.bfr.bund.de/en/contact.html

Summary: The text of the September 15, 2017 BfR Communication follows:

In response to the inquiries regarding the Renewal Assessment Report (RAR) on glyphosate, the German Federal Institute for Risk Assessment (BfR) would like to explain the legally prescribed procedure. Individual reports in the media have suggested that the BfR copied its assessment from authorisation applications of the applicants. In reality, however, the BfR has painstakingly and in detail reviewed and assessed under its own responsibility both the legally required studies of the applicants as well as all other relevant and available studies. For the sections in the RAR pertaining to analytical monitoring methods, toxicology, metabolism and the residue assessment, the BfR assessed all the studies and publications submitted by the applicants, as well as studies published in scientific journals, which were researched by the BfR.

The legally prescribed procedure for the approval of active substances on EU level explicitly stipulates that the applicants must submit study summaries. For reasons of transparency, the BfR also outlined the detailed study descriptions and the assessments of the applicants In Volume 3 of the RAR – for the original toxicological studies – but added its own critical comments (in italics). As a result, the reader can determine whether the BfR and the applicants arrived at the same or differing assessments in the case of each individual study. In other words, the BfR lists its own, independent assessments of the relevance, scientific quality and validity of all of these studies and publications in accordance with the legal stipulations. The independent health assessment of the BfR for the entirety of the studies submitted by the applicants and for the researched literature can be found in Volume 1.

In the renewal procedure, the German Federal Institute for Risk Assessment (BfR) was commissioned to assess the health risk of the active substance glyphosate. This assessment was the initial part of the European approval procedure, which was independently peer reviewed by the experts of the member states and the European Food Safety Authority (EFSA) in a transparent assessment process, and confirmed the basic statements made by the BfR. During the public and expert consultations of EFSA on glyphosate, the comments of the scientific community, the public, the policymakers, industry and non-governmental organisations were incorporated in the process in line with the procedure established on EU level that governs all active substances. The assessments in the RAR on health and environmentally relevant risks were thoroughly reviewed, commented on and discussed in depth by EFSA and experts from the competent authorities of the member states. In the EFSA Conclusion, the majority of the European experts also confirm the health assessment of the German Federal Institute for Risk Assessment (BfR) stating that, when used correctly and in line with its intended purpose in agriculture, glyphosate is not expected to pose any carcinogenic, mutagenic or reprotoxic risks. EFSA has published its Conclusion on its website together with other documents including the RAR.

Following their own assessments using established, internationally recognised, standard toxicological methods, all assessment authorities worldwide who had access to these original data have reached the conclusion that glyphosate should not be classified as carcinogenic based on current knowledge.

These authorities include:

* The European Food Safety Authority (EFSA) as well as the experts and risk assessment authorities of the EU member states
* The Environmental Protection Agency (EPA) in the USA
* The Canadian Pest Management Regulatory Agency (PMRA)
* The Australian Pesticides and Veterinary Medicines Authority (APVMA)
* The Japanese Food Safety Commission
* The EPA in New Zealand
* The Joint FAO/WHO Meeting on Pesticide Residues (JMPR)
* The European Chemicals Agency (ECHA)

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