Peer review of the pesticide risk assessment of the potential endocrine disrupting properties of glyphosate

Abstract

Abstract EFSA was requested by the European Commission to consider information on potential endocrine activity of the pesticide active substance glyphosate in accordance with Article 31 of Regulation (EC) No 178/2002. In this context, the conclusions of EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Germany, are reported, following the submission and evaluation of pertinent data made available by the applicants. The current conclusion presents a follow-up assessment to the existing EFSA Conclusion on the peer review for the renewal of the approval of glyphosate (EFSA Journal 2015;13(11):4302) focussed on the outstanding issues identified in relation to the potential endocrine activity of glyphosate. The current assessment concluded that the weight of evidence indicates that glyphosate does not have endocrine disrupting properties through oestrogen, androgen, thyroid or steroidogenesis mode of action based on a comprehensive database available in the toxicology area. The available ecotox studies did not contradict this conclusion. Summary On 12 November 2015, the European Food Safety Authority (EFSA) published its Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate in the framework of the renewal of the approval under Commission Regulation (EU) No 1141/2010 (EFSA Journal 2015;13 (11):4302). Based on the assessment of the representative uses evaluated during the peer review, EFSA noted that for certain effects observed in one study at parental toxic doses, signs of endocrine activity could not be completely ruled out and a data gap was identified. While pertinent data became available which could not be included in the renewal procedure, it was considered by the European Commission desirable to address this issue through a focussed scientific assessment. On 27 September 2016, EFSA received a mandate from the European Commission to consider information on potential endocrine activity of glyphosate in accordance with Article 31 of Regulation (EC) No 178/2002. In particular, EFSA has been requested to assess the available information on potential endocrine activity of glyphosate, and conclude whether the data gap set in the EFSA Conclusion published on 12 November 2015 (EFSA Journal 2015;13(11):4302) is addressed. On 4 October 2016, EFSA has requested relevant data related to potential endocrine activity of glyphosate from the applicant for the renewal of the approval of glyphosate, i.e. the Glyphosate Task Force. The initial assessment of the data submitted was carried out by the competent authority of the rapporteur Member State, Germany, in the format of an addendum to the renewal assessment report, which was received by EFSA on 31 March 2017. Subsequently, the addendum was distributed to Member States, the applicant and EFSA for comments on 3 April 2017. In addition, an expert consultation was conducted in the areas of mammalian toxicology and ecotoxicology. The current conclusion presents a follow-up assessment to the existing EFSA Conclusion on the peer review for the renewal of the approval of glyphosate (EFSA Journal 2015;13(11):4302) focussed on the data gap identified in relation to the endocrine activity of the substance. The current assessment concluded that glyphosate does not have oestrogen, androgen, thyroid and steroidogenesis (EATS)-mediated endocrine disrupting properties based on the facts that no endocrine- mediated adverse effects were identified in apical studies; the weak evidence seen in a limited number of supplementary in vitro studies was inconsistent with the findings of the acceptable OECD (Organisation for Economic Co-operation and Development) tests and it was not expressed in vivo in the OECD Level 4 and 5 studies; and no EATS-mediated endocrine mode of action was identified. Since the database available to reach this conclusion was quite comprehensive, it was concluded that the data gap identified in the previous EFSA conclusion (EFSA Journal 2015;13(11):4302) was adequately addressed. Glyphosate effects on reproductive parameters were observed in some ecotoxicology studies. However, these effects were not consistently observed and no indication was found that the effects are related to an androgenic, estrogenic, steroidogenic or thyroidal mode of action. No evidence was found in the available ecotoxicology studies which would contradict the conclusion of mammalian toxicology that there is no evidence of endocrine mode of action of glyphosate.