Conclusion on the peer review of the pesticide risk assessment of the active substance glyphosate

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Article
European Food Safety Authority
EFSA Journal
EFSA Journal 2015;13(11):4302 [107 pp.].
doi
10.2903/j.efsa.2015.4302
Type
Conclusion on Pesticides
On request from
European Commission
Question Number
EFSA-Q-2014-00546
EFSA-Q-2015-00279
Approved
30 October 2015
Published
12 November 2015
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

The conclusions of the European Food Safety Authority (EFSA), following the peer review of the initial risk assessments carried out by the competent authority of the rapporteur Member State Germany, for the pesticide active substance glyphosate are reported. The context of the peer review was that required by Commission Regulation (EU) No 1141/2010 as amended by Commission Implementing Regulation (EU) No 380/2013. The conclusions were reached on the basis of the evaluation of the representative uses of glyphosate as a herbicide on emerged annual, perennial and biennial weeds in all crops [crops including but not restricted to root and tuber vegetables, bulb vegetables, stem vegetables, field vegetables (fruiting vegetables, brassica vegetables, leaf vegetables and fresh herbs, legume vegetables), pulses, oil seeds, potatoes, cereals, and sugar- and fodder beet; orchard crops and vine, before planting fruit crops, ornamentals, trees, nursery plants etc.] and foliar spraying for desiccation in cereals and oilseeds (pre-harvest). The reliable endpoints, concluded as being appropriate for use in regulatory risk assessment and derived from the available studies and literature in the dossier peer reviewed, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified. Following a second mandate from the European Commission to consider the findings from the International Agency for Research on Cancer (IARC) regarding the potential carcinogenicity of glyphosate or glyphosate-containing plant protection products in the on-going peer review of the active substance, 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.

Summary

Commission Regulation (EU) No 1141/2010 (hereinafter referred to as ‘the Regulation’), as amended by Commission Implementing Regulation (EU) No 380/2013, lays down the procedure for the renewal of the approval of a second group of active substances and establishes the list of those substances. Glyphosate is one of the active substances listed in the Regulation.

The rapporteur Member State (RMS) provided its initial evaluation of the dossier on glyphosate in the Renewal Assessment Report (RAR), which was received by EFSA on 20 December 2013. The peer review was initiated on 22 January 2014 by dispatching the RAR for consultation of the Member States and the applicants of the European Glyphosate Task Force, represented by Monsanto Europe S.A.

Following consideration of the comments received on the RAR, it was concluded that EFSA should conduct an expert consultation in the areas of mammalian toxicology, residues, environmental fate and behaviour and ecotoxicology and EFSA should adopt a conclusion on whether glyphosate can be expected to meet the conditions provided for in Article 4 of Regulation (EC) No 1107/2009 of the European Parliament and the Council. On 6 August 2014 EFSA received a mandate from the European Commission for the peer review of the active substance glyphosate.

On 30 April 2015 EFSA received another mandate from the European Commission to consider the findings by the International Agency for Research on Cancer (IARC) regarding the potential carcinogenicity of glyphosate or glyphosate-containing plant protection products in the ongoing peer review of the active substance. EFSA accepted the mandate on 19 May 2015 and has included its views in the conclusion of the peer review. After the IARC monograph 112 was published, EFSA asked the European Commission for an extension of the overall deadline to 30 October 2015, which was accepted, to take into account the findings of IARC as regards the potential carcinogenicity in line with the Commission’s request.

The conclusions laid down in this report were reached on the basis of the evaluation of the representative uses of glyphosate as a herbicide on emerged annual, perennial and biennial weeds in all crops [crops including but not restricted to root and tuber vegetables, bulb vegetables, stem vegetables, field vegetables (fruiting vegetables, brassica vegetables, leaf vegetables and fresh herbs, legume vegetables), pulses, oil seeds, potatoes, cereals, and sugar- and fodder beet; orchard crops and vine, before planting fruit crops, ornamentals, trees, nursery plants etc.] and foliar spraying for desiccation in cereals and oilseeds (pre-harvest), as proposed by the applicants. Full details of the representative uses can be found in Appendix A to this report.

A series of data gaps was identified in the section identity concerning additional validation data for the determination of impurities, batch data and updated specifications. Data gaps were also identified for further information on analytical methods of residues in order to get a complete database to enable an evaluation according to EU Guidance Document SANCO/825/00 rev. 8.1.

Data gaps were identified in the mammalian toxicology area to address the relevance of all individual impurities present in the technical specifications (except for the two already identified relevant impurities, formaldehyde and N-Nitroso-glyphosate), in particular impurities that elicited toxicological alerts according to quantitative structure-activity relationship (QSAR) assessments and the ones specified at higher level than the reference specification, in comparison with the toxicity profile of the parent compound. Regarding carcinogenicity, the EFSA assessment focused on the pesticide active substance and considered in a weight of evidence all available information. In contrast to the IARC evaluation, the EU peer review experts, with only one exception, 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 on classification, labelling and packaging (CLP Regulation). Glyphosate is not classified or proposed to be classified as carcinogenic or toxic for reproduction category 2 in accordance with the provisions of Regulation (EC) No 1272/2008 (harmonised classification supported by the present assessment), and therefore, the conditions of the interim provisions of Annex II, Point 3.6.5 of Regulation (EC) No 1107/2009 concerning human health for the consideration of endocrine disrupting properties are not met. To address the potential for endocrine-mediated mode of action, the full battery of Tier I screening assays according to the US Environmental Protection Agency Endocrine Disruptor Screening Program (EDSP), or Level 2 and 3 tests currently indicated in the OECD Conceptual Framework are needed. Toxicological data allowing a consumer risk assessment to be performed for the metabolites N-acetyl-glyphosate and N-acetyl-AMPA, which are relevant for uses on genetically modified (GM) glyphosate-tolerant plant varieties that are imported into the EU, are missing.

Based on the available information, residue definitions for monitoring and risk assessment were proposed for plant and animal commodities. These residue definitions were proposed considering the metabolism observed in conventional and in glyphosate-tolerant GM plants. Additional residue trials on olives and rapeseed were requested. Based on the representative uses, that were limited to conventional crops only, chronic or acute risks for the consumers have not been identified.

Regarding fate and behaviour in the environment, further information is needed to assess the contamination route through run off (especially in situations where application to hard surfaces might occur) and subsequent surface water contamination and bank infiltration to groundwater. In addition, degradation of the major soil metabolite AMPA needs to be investigated in acidic soils (pH = 5–6). 

For the section on ecotoxicology, two data gaps were identified to provide an assessment to address the long-term risk for small herbivorous mammals and for insectivorous birds. For aquatic organisms, the risk was considered low, using the FOCUS step 2 PECsw values. The risk for bees, non-target arthropods, soil macro- and micro-organisms and biological methods for sewage treatment was considered low. The risk to non-target terrestrial plants was considered low, but only when mitigation measures are implemented. 

Keywords
glyphosate, peer review, risk assessment, pesticide, herbicide
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Number of Pages
107