EFSA is currently reviewing its guidance document on the risk assessment of plant protection products and bees (Apis mellifera, Bombus spp. and solitary bees), which was published in 2013 but has never been endorsed by Member State representatives on the European Commission’s Standing Committee for Plants, Animals, Food and Feed.
Endorsement by Member States is needed for the guidance to be applied during the scientific assessments conducted in respect of the approval and renewal of approval of active substances used in pesticides.
To address this impasse, the European Commission and Member States asked EFSA to review the guidance, taking into account new scientific knowledge that has emerged since 2013. The reviewed guidance will therefore contain the most up-to-date methodologies for conducting risk assessments for honey bees, bumble bees and solitary bees.
The review is being carried out by a working group consisting of EFSA staff and external experts. Throughout the process EFSA is consulting Member States via the Pesticide Steering Network and a range of stakeholders via a dedicated stakeholder group. EFSA has also taken part in a series of workshops and information sessions for Member State representatives and stakeholders. Documents related to these meetings can be found in the Milestones section below.
The reviewed guidance is currently expected to be published in the spring of 2023, following a public consultation, which ran between July and October 2022. Depending on the changes triggered by the consultation, the publication timeline may need to be updated, however. More background information on the guidance review is available on the European Commission website.
Following the closure of EFSA’s public consultation on its revised guidance for the risk assessment of plant protection products and bees, EFSA and the European Commission organised a workshop with representatives of Member States and the stakeholder group. The workshop held on 5 October 2022 provided an opportunity for participants to discuss their comments on the draft guidance update and possible ways to address them.
EFSA launches a public consultation on its revised guidance on the risk assessment of plant protection products and bees, covering honey bees, bumble bees and solitary bees, which ran until 3 October.
EFSA publishes a document to support risk managers in their decision whether to establish specific protection goals (SPGs) for wild bees. The document – requested by the European Commission – provides an overview of the available data and tools, considers existing approaches for SPGs in the area of ecotoxicology, and highlights knowledge gaps.
Preliminary work carried out on the supporting document on wild bees is presented to the stakeholder group and Member State experts at a special information session organised by the European Commission.
Information session for the stakeholder group to explain how specific protection goals for honey bees will be implemented in the risk assessment.
The European Union’s Agriculture and Fisheries Council (Agrifish) establishes an SPG of 10% as the maximum permitted level of colony size reduction resulting from exposure of honey bees to pesticides.
EFSA’s working group publishes a method for defining specific protection goals (SPGs) for honey bees on the basis of the background variability of colony sizes. EFSA developed the document in response to a request from risk managers to provide scientific background to support them in their decision-making process about what needs to be protected and to what extent.
EFSA publishes a second document to support risk managers in setting SPGs for bees. The document lays out an approach for deriving a threshold of acceptable effects on colony size based on background variability.
Information session held to give the stakeholder group a progress report on the revision of the guidance document.
A comprehensive analysis of the available scientific evidence on bee mortality is carried out. The report is based on the largest systematic collection of evidence on mortality rates ever conducted, and covers the three bee groups – honey bees, bumble bees and solitary bees.
EFSA publishes a supporting document offering risk managers a choice of four approaches to reviewing the SPGs – i.e. the threshold of acceptable effects – for bees.
Stakeholder group and Member States consulted to gather feedback on the draft protocol on for the GD revision.
Consultation with the stakeholder group, experts from Member States, and with the bee guidance working group to gather input on the draft protocol on data collection on bee background mortality.
Consultation with stakeholder group and Member State experts to collect initial thoughts on the revision of the guidance document.
The European Commission asks EFSA to review the guidance on risk assessment of pesticides and bees, which was published in 2013. EFSA establishes a scientific working group to carry out the review, supported by a stakeholder consultative group. The group is being consulted at various stages during the review and providing input to the working group.