- HEAL-How-the-EU-risks-greenlighting-a-pesticide-linked-to-cancer-2022

https://open.efsa.europa. eu/consultation/a0c1v00000HePrzAAF On 30th May 2022, ECHA’s Committee for Risk Assessment (RAC) concluded that glyphosate does not meet the criteria to be labeled as a carcinogenic or genotoxic agent: https://echa.europa.eu/nl/-/ glyphosate-no-change-proposed-to-hazardclassification 14. Regulation (EC) 283/2013 setting out the data requirements for active substances. OJ L 93, 3.4.2013. 15. https://www.nature.com/articles/6600622

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16. Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending OJ L 353, 31.12.2008. 17. OECD, 2012. Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting Test Guidelines 451, 452 and 453. https://doi.org/10.1787/9789264221475-en 18. ECHA, 2017. Guidance on the Application of the CLP Criteria. https://echa.europa.eu/ documents/10162/2324906/clp_en.pdf 19. EFSA, 2015. Principles and process for dealing with data and evidence in scientific assessments. Scientific Report. EFSA Journal 2015;13(6):4121 doi.org/10.2903/j. efsa.2015.4121 20. OECD Guidance 116, p. 123 and 133. https://doi.org/10.1787/20777876 21. According to EFSA, a biologically relevant effect can be defined as an effect considered by expert judgement as important and meaningful for human, animal, plant or environmental health [EFSA Journal 2011;9(9):2372]. https://doi.org/10.2903/j.efsa.2011.2372 22. OECD Guidance 116, Appendix 1 “Moreover, the lower the body weight, the less sensitive the animal may be to agent-induced toxicity, including cancer. A significant decrease in body-weight gain therefore could reduce the animal’s ability to respond to compound-induced toxicities”. 23.

Historical controls are control, unexposed, animals from experiments that have taken place in the past, other than the one under evaluation (called the concurrent control). 24. Outlier is a data value that differs significantly from other observations. When this value is not reproduced in other studies it is considered an error and should be removed from the data set.

HEAL – How the EU risks green-lighting a cancer-linked pesticide – 2022

25. On p. 282 of the dRAR, the AGG acknowledged that the HCD incidence of 19.2% in one study with 6 other studies below 6% is considered an outlier. 26. dRAR/CLH Volume 1, 3.6.5 Long term toxicity and carcinogenicity, Section 3.6.5.1.1.3, p. 258-298. 27. Portier J.C., 2020. A comprehensive analysis of the animal carcinogenicity data for glyphosate from chronic exposure rodent carcinogenicity studies. Environmental Health (2020) 19:18. https://doi.org/10.1186/s12940-020-00574-1 28. Smith MT, Guyton KZ, Gibbons CF, Fritz JM, Portier CJ, Rusyn I, et al. (2016). Key characteristics of carcinogens as a basis for organising data on mechanisms of carcinogenesis. Environmental Health Perspectives 124:713-721. 29. Ren X. et al. 2018 ‘Effects of glyphosate on the ovarian function of pregnant mice, the secretion of hormones and the sex ratio of their fetuses’, Environmental Pollution, 243, pp. 833–841. doi:10.1016/j. envpol.2018.09.049; Gao H., et al., 2019 ‘Activation of the N-methyl-D-aspartate receptor is involved in glyphosate-induced renal proximal tubule cell apoptosis’. Journal of Applied Toxicology 2019:1-9 doi: 10.1002/jat.3795; Zhang, L. et al., 2021 ‘Involvement of mitochondrial fission in renal tubular pyroptosis in mice exposed to high and environmental levels of glyphosate combined with hard water’, Environmental Pollution, 283, p. 117082. doi:10.1016/j. envpol.2021.117082.

30. Nersesyan A.,and Knasmueller S, 2021. Evaluation of the scientific quality of studies concerning genotoxic properties of glyphosate. https://www.global2000.at/sites/global/files/ Analyse-Glyphosat-Studien.pdf 31. Commission Communication in the framework of the implementation of Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances,Regulation (EC) 283/2013 setting out the data requirements for active substances OJ C 95, 3.4.2013, p. 1–20.

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32. Nersesyan A.,and Knasmueller S, 2021. Evaluation of the scientific quality of studies concerning genotoxic properties of glyphosate. https://www.global2000.at/sites/global/files/ Analyse-Glyphosat-Studien.pdf

41. Zhang L, Rana I, Shaffer RM, Taioli E, Sheppard L. Exposure to glyphosate-based herbicides and risk for non-Hodgkin lymphoma: A meta-analysis and supporting evidence. Mutat Res Rev Mutat Res. 2019 Jul-Sep;781:186-206. doi: 10.1016/j.mrrev.2019.02.001

33. https://patents.google.com/patent/US7771736B2/ en (phytotoxicant, 1971)

42. Submission to the glyphosate public consultation of ECHA by Portier, C.J. 2021 on the assessment of the epidemiological studies on glyphosate. https://echa.europa.eu/ documents/10162/46afc076-5464-dde9-684217834cdcb1ad (folder name: Comments)

34. https://patents.google.com/patent/US7771736B2/ en (anti-biotic, 2010) 35. https://www.theguardian.com/business/2021/ jul/02/glyphosate-herbicide-roundup-corporatesafety-studies 36. ECHA, 2017. Committee for Risk Assessment (RAC) Opinion proposing harmonised classification and labelling at EU level of glyphosate. https://echa.europa.eu/ documents/10162/2f8b5c7f-030f-5d3a-e87e0262fb392f38 37. Commission Communication in the framework of the implementation of Commission Regulation (EU) No 283/2013 of 1 March 2013 setting out the data requirements for active substances, OJ C 95, 3.4.2013, p. 1–20. 38. IARC monographs on the Evaluation of Carcinogenic Risks to Humans, 2015. Some Organophosphate Insecticides and Herbicides. The Lancet. Volume 112. http://www.thelancet.com/pdfs/journals/lanonc/ PIIS1470-2045%2815%2970134-8.pdf 39. HEAL’s response to the public consultations on the EU’s initial assessment of glyphosate. https://www.env-health.org/wp-content/ uploads/2022/02/HEALsinput-to-publicconsultation_Overview_FINAL-designed.pdf 40. Weisenburger DD. A Review and Update with Perspective of Evidence that the Herbicide Glyphosate (Roundup) is a Cause of NonHodgkin Lymphoma. Clin Lymphoma Myeloma Leuk. 2021 Sep;21(9):621-630. doi:10.1016/j.clml.2021.04.009

HEAL – How the EU risks green-lighting a cancer-linked pesticide – 2022

43. The Treaty on the Functioning of the European Union (TFEU) enhanced the importance of health policy by stipulating that ‘a high level of human health protection shall be ensured in the definition and implementation of all Community policies and activities’ (Article 168(1) of the TFEU). 44. Robinson et al (2020). Achieving a High Level of Protection from Pesticides in Europe: Problems with the Current Risk Assessment Procedure and Solutions. European Journal of Risk Regulation, 11(3), 450-480. doi:10.1017/err.2020.18 45. Regulation (EC) 1107/2009 on the placement of plant protection products on the market. Article 1.4 “The provisions of this Regulation are underpinned by the precautionary principle in order to ensure that active substances or products placed on the market do not adversely affect human or animal health or the environment. In particular, member states shall not be prevented from applying the precautionary principle where there is scientific uncertainty as to the risks with regard to human or animal health or the environment posed by the plant protection products to be authorised in their territory”. Also Article 13 ‘Approval Regulation’ on the PAFF Committee.

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The Health and Environment Alliance (HEAL) is the leading not-for-profit organisation addressing how the environment affects human health in the European Union (EU) and beyond. HEAL works to shape laws and policies that promote planetary and human health and protect those most affected by pollution, and raise awareness on the benefits of environmental action for health. HEAL’s over 90 member organisations include international, European, national and local groups of health professionals, not-for-profit health insurers, patients, citizens, women, youth, and environmental experts representing over 200 million people across the 53 countries of the WHO European Region. As an alliance, HEAL brings independent and expert evidence from the health community to EU and global decision-making processes to inspire disease prevention and to promote a toxic-free, low-carbon, fair and healthy future. HEAL website: www.env-health.org HEAL’s EU Transparency Register Number: 00723343929-96

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