EFSA is working to protect bees and shape the future of environmental risk assessment

Europe is pursuing its ambition for a climate-neutral, sustainable future. The European Commission’s Green Deal, an important step in this direction, has at its heart the protection of the European Union (EU)’s biodiversity and the resilience of its ecosystems. Reducing the use and risk of pesticides and reversing the decline of pollinators are but two of the ‘calls-to-action’ embedded, respectively, in the Green Deal’s Farm to Fork and Biodiversity Strategies. Much of the science supporting policymakers on these highly complex bodies of work falls within the remit of the European Food Safety Authority (EFSA). EFSA scientists are working to help address these challenges, as reflected in the release in 2021 of two important scientific reports. The first report addresses a mandate from the European Commission for a review of the 2013 bee guidance document on the risk assessment of pesticides in relation to honey bees, bumble bees and solitary bees; the second responds to the European Parliament’s request for a scientific opinion on the development of an integrated and holistic approach for the environmental risk assessment (ERA) of multiple stressors in managed honey bees (Apis mellifera) – known as the MUST-B project

Analysis of the evidence to support the definition of Specific Protection Goals for bumble bees and solitary bees

In the context of the definition of Specific Protection Goals for bees, risk managers asked EFSA to provide the scientific background to support the decision-making process about what needs to be protected and to what extent. In this document, information, data and tools have been investigated to support the risk managers in deciding on the Specific Protection Goals for bumble bees and solitary bees. In particular, EFSA summarised the relevant information on biology and ecology and investigated the possibility of performing an analysis of background variability to support the definition of a threshold of acceptable effects. Accounting for the current level of knowledge, EFSA concluded that this analysis is complex, and it would require information that is not yet available and tools that have not yet been fully evaluated. Nevertheless, based on the limited data available, represented by the control groups of few experimental field studies, an analysis of variability of different relevant endpoints was provided. By taking into account the results of this analysis, the biology and ecology of bumble bees and solitary bees, as well as the impact for risk assessment, EFSA illustrated possible approaches that could be followed by risk managers

Revised guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

The European Commission asked EFSA to revise the risk assessment for honey bees, bumble bees and solitary bees. This guidance document describes how to perform risk assessment for bees from plant protection products, in accordance with Regulation (EU) 1107/2009. It is a review of EFSA’s existing guidance document, which was published in 2013. The guidance document outlines a tiered approach for exposure estimation in different scenarios and tiers. It includes hazard characterisation and provides risk assessment methodology covering dietary and contact exposure. The document also provides recommendations for higher tier studies, risk from metabolites and plant protection products as mixture

Revised guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

Abstract The European Commission asked EFSA to revise the risk assessment for honey bees, bumble bees and solitary bees. This guidance document describes how to perform risk assessment for bees from plant protection products, in accordance with Regulation (EU) 1107/2009. It is a review of EFSA's existing guidance document, which was published in 2013. The guidance document outlines a tiered approach for exposure estimation in different scenarios and tiers. It includes hazard characterisation and provides risk assessment methodology covering dietary and contact exposure. The document also provides recommendations for higher tier studies, risk from metabolites and plant protection products as mixture

Supplementary information to the revised guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees)

The European Commission asked EFSA to revise the guidance on the risk assessment for honey bees, bumble bees and solitary bees for Regulation (EU) 1107/2009. The guidance document is a review ofEFSA’s existing guidance document, which was published in 2013. The guidance document outlines the approach for exposure estimation in different scenarios and tiers. It includes hazard characterisation and provides risk assessment methodology covering dietary and contact exposure. The guidance documental so provides recommendations for higher tier studies, risk from metabolites and mixture. This document includes supplementary information for the guidance

Peer review of the pesticide risk assessment for the active substance thiabendazole in light of confirmatory data submitted

Abstract The conclusions of the EFSA following the peer review of the initial risk assessment carried out by the competent authority of the rapporteur Member State, Spain, for the pesticide active substance thiabendazole are reported. The context of the peer review was that requested by the European Commission following the submission and evaluation of confirmatory information with regard to the endocrine disruption potential of the substance. The conclusions were reached on the basis of the evaluation of the representative uses of thiabendazole as a fungicide on seed potato, apple and pear and citrus. Assessments not finalised together with the missing information identified as being required by the mandate are listed. Concerns are identified

Peer review of the pesticide risk assessment of the active substance heptamaloxyloglucan

Abstract The conclusions of the EFSA following the peer review of the initial risk assessments carried out by the competent authorities of the rapporteur Member State, France, and co‐rapporteur Member State, Spain, for the pesticide active substance heptamaloxyloglucan and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012, as amended by Commission Implementing Regulation (EU) No 2018/1659. The conclusions were reached on the basis of the evaluation of the representative use of heptamaloxyloglucan as a plant elicitor on grapevines for protection against frost damage (field use). The reliable end points, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are not identified

Peer review of the pesticide risk assessment of the active substance Trichoderma atroviride strain AGR2

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, France, for the pesticide active substance Trichoderma atroviride strain AGR2 and the considerations as regards the inclusion of the substance in Annex IV of Regulation (EC) No 396/2005 are reported. The context of the peer review was that required by Regulation (EC) No 1107/2009 of the European Parliament and of the Council. The conclusions were reached on the basis of the evaluation of the representative use of Trichoderma atroviride strain AGR2 as a fungicide on winter and spring oil seed rape (field use). The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are identified

Peer review of the pesticide risk assessment of the active substance glyphosate

Abstract The conclusions of EFSA following the peer review of the initial risk assessments carried out by the Assessment Group on Glyphosate (AGG), consisting of the competent authorities of France, the Netherlands, Sweden and Hungary, acting jointly as rapporteur Member State for the pesticide active substance glyphosate are reported. The context of the peer review was that required by Commission Implementing Regulation (EU) No 844/2012. The conclusions were reached on the basis of the evaluation of the representative uses of glyphosate as a herbicide as proposed by the applicants, covering uses pre‐sowing, pre‐planting and pre‐emergence plus post‐harvest in vegetables and sugar beet; post‐emergence of weeds in orchards, vineyards, row vegetables, railway tracks against emerged annual, biennial and perennial weeds. Moreover, uses as spot treatment against invasive species in agricultural and non‐agricultural areas, and in vegetables and sugar beet against couch grass are also included. The reliable endpoints, appropriate for use in regulatory risk assessment, are presented. Missing information identified as being required by the regulatory framework is listed. Concerns are reported where identified