Glyphosate: EFSA Confirms Regulatory Assessments

Brussels / BE. (gtf) The European Food Safety Authority (EFSA) has confirmed the outcome of previous risk evaluations, concluding that the herbicide glyphosate does not demonstrate carcinogenic or mutagenic properties and has no toxic effect on fertility, reproduction or embryonal development. EFSA concluded that «glyphosate is unlikely to pose a carcinogenic hazard to humans and the evidence does not support classification with regard to its carcinogenic potential according to Regulation (EC) No 1272/2008».

EFSA arrived at these conclusions after having reviewed a comprehensive set of studies and data related to glyphosate. EFSA’s conclusions emphasize the overwhelming weight of evidence, stating that there is «an exceptionally large» database on glyphosate and that «the toxicological evaluation adopted by the rapporteur member state and agreed during peer review rely on a magnitude of valid studies rather than on one key study for each endpoint».

Richard Garnett, chair of the European Glyphosate Task Force (GTF), stated that «The EFSA conclusion completes another key milestone in the process for the re-evaluation of glyphosate by the European regulatory authorities. It confirms the previous evaluations of glyphosate by regulatory authorities around the world, which have consistently concluded that the application of glyphosate poses no unacceptable risk to human health, animals or the environment».

Taking account of EFSA’s conclusions, the European Commission will prepare a Review Report, followed by a Regulation with a proposal that will be put to a vote by the representatives from the 28 member states at the Standing Committee on Plants, Animals, Food and Feed during the coming months.

The following companies are confirmed member of the GTF: Adama Agan Limited, Agria SA, Agro Trade GmbH, Albaugh UK Limited, Arysta Lifesciences SAS, Barclay Chemicals (Manufacturing) Limited., Brokden SL, Bros Spolka Jawna BP Miranowscy, Cheminova A/S, Coromandel International Limited, Dow AgroSciences LLC, Excel Crop Care (Europe) NV, Helm AG, Industrias Afrasa SA, Monsanto Europe SA/NV, Nufarm GmbH + Co KG, Rotam Agrochemical Europe Limited, Sapec Agro SA, Sinon Corporation, Société Financière de Pontarlier, Syngenta Limited, United Phosphorus Limited, Wynca UK Limited (Image: GTF).

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Glyphosate: EFSA updates toxicological profile

Brussels / BE. (11.12. / efsa) EFSA and the EU Member States have finalised the re-assessment of glyphosate, a chemical that is used widely in pesticides. The report concludes that glyphosate is unlikely to pose a carcinogenic hazard to humans and proposes a new safety measure that will tighten the control of glyphosate residues in food. The conclusion will be used by the European Commission in deciding whether or not to keep glyphosate on the EU list of approved active substances, and by EU Member States to re-assess the safety of pesticide products containing glyphosate that are used in their territories.

A peer review expert group made up of EFSA scientists and representatives from risk assessment bodies in EU Member States has set an acute reference dose (ARfD) for glyphosate of 0.5 milligrams per kilogram of body weight, the first time such an exposure threshold has been applied to the substance.

Jose Tarazona, head of EFSA’s Pesticides Unit, said: «This has been an exhaustive process – a full assessment that has taken into account a wealth of new studies and data. By introducing an acute reference dose we are further tightening the way potential risks from glyphosate will be assessed in the future. Regarding carcinogenicity, it is unlikely that this substance is carcinogenic».

Unlikely to be carcinogenic

The peer review group concluded that glyphosate is unlikely to be genotoxic (in example damaging to DNA) or to pose a carcinogenic threat to humans. Glyphosate is not proposed to be classified as carcinogenic under the EU regulation for classification, labelling and packaging of chemical substances. In particular, all the Member State experts but one agreed that neither the epidemiological data (in example on humans) nor the evidence from animal studies demonstrated causality between exposure to glyphosate and the development of cancer in humans.

EFSA also considered, at the request of the European Commission, the report published by the International Agency for Research on Cancer (IARC), which classified glyphosate as probably carcinogenic to humans.

The evaluation considered a large body of evidence, including a number of studies not assessed by the IARC which is one of the reasons for reaching different conclusions.

As well as introducing the ARfD, the review proposed other toxicological safety thresholds to guide risk assessors: the acceptable operator exposure level (AOEL) was set at 0.1 mg/kg body weight per day and an acceptable daily intake (ADI) for consumers was set in line with the ARfD at 0.5 mg/kg body weight per day.

Dr Tarazona added that EFSA will use the new toxicological values during its review of the maximum residue levels for glyphosate in food, which will be carried out in cooperation with Member States in 2016.

Next steps: The EFSA conclusion will inform the European Commission in deciding whether or not to retain the substance on the EU’s list of approved active substances. This is a condition for enabling Member States to authorise its continued use in pesticides in the EU.