Ensuring a high level of protection of bees and other pollinators is very important for the European Commission when deciding on the approval of active substances for use in plant protection products.
Bee guidance document – Latest developments
Based on the technical report published by EFSA on 28 January 2022, the Commission initiated discussions with Member States on setting specific protection goals for bumblebees and solitary bees in a meeting on 17 February 2022.
During and after the meetings of the Standing Committee Plants, Animals, Food and Feed of March and May 2022, a majority of Member States supported to proceed at this stage with an undefined threshold approach for specific protection goals for both bumblebees and solitary bees. It was also decided to require by default (in case of potential exposure of bees) field studies on bumblebees and solitary bees unless:
- the lower tier risk assessments for honeybees and non-target arthropods other than bees show no effects for the active substance, or
- semi-field (cage or tunnel studies) with bumblebees and solitary bees show absence of effects.
This decision was due to the absence of sufficiently robust evidence and until further data becomes available.
Furthermore, semi-field or field testing with bumblebees would also not be needed if laboratory studies according to OECD test methods No 246 and 247, show an LD50 > 100 µg active substance/bumblebee.
The Commission informed the EFSA on 21 June 2022 of this outcome.
What will happen next?
On 18 July 2022, the European Food Safety Authority (EFSA) launched a public consultation on its draft guidance document on the risk assessment of plant protection products and bees, covering honey bees, bumble bees and solitary bees. This public consultation is open for comments online until 3 October 2022.
On 5 October 2022, the Commission and EFSA intend to jointly organise a workshop to discuss the draft guidance document.
What does the pesticides legislation say about the protection of bees and pollinators?
The EU legislation on plant protection products (Regulation (EC) No 1107/2009) and its predecessor (Directive 91/414/EEC) provide clear criteria for the approval of active substances and for the authorisation of each plant protection product containing such substances by Member States. These criteria include the consideration of effects on honey bees.
Active substances can be approved only if - based on a comprehensive science based risk assessment - it has been demonstrated that their use in plant protection products under the proposed conditions
- will result in negligible exposure of honey bees, or
- has no unacceptable acute or chronic effects on colony survival and development
The dossiers to be submitted for the approval of active substances and the authorisation of plant protection products have to comply with the data requirements set under Commission Regulation (EU) 283/2013 and Commission Regulation (EU) 284/2013, respectively.
How is the legislation implemented?
To implement these provisions of the legislation, the European Commission and EFSA have developed guidance on how to conduct the risk assessment for pesticides in relation to bees.
In 2002, the Commission published guidance for implementing the provisions of the former Directive 91/414/EEC regarding Terrestrial Ecotoxicology. This guidance document includes a section on the assessment of the risk that pesticides pose to honey bees.
- In 2011, the Commission requested from EFSA a scientific opinion as a basis for the development of a risk assessment of plant protection products for bees (Apis mellifera and Bombus spp.) and to prepare a guidance document to conduct such a risk assessment
- In 2012, EFSA published the Scientific Opinion on the science behind the development of a risk assessment of Plant Protection Products on bees (Apis mellifera, Bombus spp. and solitary bees)
- In 2013, EFSA published the Bee Guidance Document
The Commission then invited Member States to endorse this Guidance Document in order to replace the one from 2002 (see next section).
What has been done to implement the 2013 EFSA Bee Guidance Document?
Since 2013, despite the efforts of the European Commission to obtain endorsement for this guidance document in the Standing Committee for Plants, Animals, Food and Feed, a clear majority of Member States consistently objected to such an endorsement. In particular because some parts of the guidance document related to chronic toxicity for honey bees, bumble bees and solitary bees.
Endorsement by Member States is needed for it to be applied during the scientific assessments conducted in respect of the approval and renewal of approval of active substances and the authorisation of plant protection products.
In July 2019, Member States supported a draft Commission Regulation that would have allowed to implement the part of the 2013 EFSA Bee Guidance document for which there was agreement, i.e. the part related to acute toxicity to honey bees.
However, in October 2019, the European Parliament objected to this draft Regulation. It considered that additional provisions of EFSA's Bee Guidance Document should be implemented, in particular with regard to acute and chronic toxicity for honey bees and acute toxicity for bumble bees.
What is the current situation?
As a consequence of the Member States’ position and the Parliament’s objection, the 2013 EFSA Bee Guidance Document cannot currently be implemented during the assessment of applications for approval or for the regular renewal of approval of active substances.
Therefore, the Commission guidance from 2002 remains the basis for conducting the risk assessment for pesticides to bees in these processes.
Nevertheless, the 2013 Bee Guidance Document was used during the unscheduled review of the approvals of 3 neonicotinoid active substances under the specific procedure described in Article 21 of the Plant Protection Products Regulation, which led to the ban of all outdoor uses.
Also, when adopting its conclusions on the peer review of the risk assessment of active substances to bees based on the guidance from 2002, EFSA includes further information using the 2013 Bee Guidance Document in order to provide the maximum knowledge to the Commission and the Member States.
In March 2019, and in line with a request from most Member States, the Commission mandated EFSA to review the 2013 Bee Guidance Document.
The Commission asked EFSA to take fully into account new scientific knowledge that has emerged since 2013. Therefore, the reviewed comprehensive guidance is expected to contain the most up-to-date methodologies for conducting risk assessments for honey bees, bumble bees and solitary bees.
The Commission also asked EFSA to closely involve EU experts and interested parties in the process to ensure that all views are taken into account.
What are EFSA and the Commission doing about the review of the guidance document?
EFSA has outlined on its website how it conducts the review of the 2013 Bee Guidance Document. For this purpose, EFSA has created a working group consisting of EFSA staff and external experts. The working group has regular meetings and is involved in the drafting process. The Commission is invited as an observer to its meetings. At regular intervals, as indicated in the outline, EFSA consults Member States via the Pesticide Steering Network and a range of stakeholders via a dedicated stakeholder group.
On 28 July 2020, EFSA published a technical report on the review of the evidence on bee background mortality, which constitutes a milestone for the review of the Bee Guidance Document.
Specific protection goals
Another important step in the outline of the review of the 2013 EFSA Bee Guidance Document is the setting of specific protection goals (i.e. the threshold of acceptable effects) for bees. These specific protection goals need to be agreed with the risk managers from the Member States on the basis of scientific information, which is prepared by EFSA in the form of supporting documents.
In March 2020, the Commission organised a first workshop with risk managers and risk assessors from the EU Member States. In this workshop EFSA explained how the specific protection goals had been set in 2013 and EU countries were given the opportunity to ask questions and comment on the approach taken in 2013.
Based on the feedback received during the workshop in March 2020 and comments received during a consultation of the stakeholder group, the EFSA working group analysed 4 different possible scientific approaches which could help risk managers in the decision-making process for Specific Protections Goals. These approaches are described in a supporting document.
In June 2020, the Commission organised a second workshop with risk managers and risk assessors from the EU Member States, where the supporting document from EFSA and a background document prepared by the Commission were discussed. A majority of Member States indicated a preference for an approach based on the normal operation range of colony sizes for honey bees (approach Number 2 in EFSA’s supporting document). This was confirmed during the meeting of the Standing Committee on Plants, Animals, Food and Feed in July 2020.
Subsequently, several NGOs and members of the European Parliament Committee on the Environment, Public Health and Food Safety raised a number of questions as to the suitability of the approach for defining protection goals.
On 13 January 2021, the Commission organised an information session for EU Member States and the stakeholder group established by EFSA, allowing for an exchange of views between all interested parties. In this session, as a basis for the discussion, EFSA prepared a comprehensive supporting document, and presented its content in detail at the meeting.
On 23 February 2021, the Commission organised a meeting with Member States to further discuss
- the outcome of the simulations of the natural variability of honey-bee colony size development, as presented by EFSA during the info session of 13 January 2021
- what kind of set-up of field studies could reliably measure a given reduction in colony size
The 23 Member States that were present at this meeting agreed that the results of EFSA’s simulations of the variability of honey-bee colony size were more conservative than the variability observed in nature (i.e. the simulated variability is smaller than what has been observed in field studies for honey-bee colonies not exposed to pesticides). Therefore, they agreed that setting a threshold for a maximum permitted reduction in honey-bee colony size due to pesticides within this simulated range would offer sufficient protection.
They also agreed to take account of the practicalities of field studies, as otherwise it will not be possible to actually measure whether or not the protection goal had been achieved.
Four Member States considered that accepting a colony size reduction covering the full simulated variability (i.e. up to 23%) would offer sufficient protection. Eleven Member States suggested a protection goal within a range of 10% to 12.8% of colony size reduction.
Four Member States indicated a preference for maintaining the same level of acceptable colony size reduction as in the 2013 EFSA Guidance Document (7%). Four Member States did not have any preference.
In a letter of 15 March 2021, the Chair of the Committee on the Environment, Public Health and Food Safety of the European Parliament reiterated the Committee’s support for maintaining the 7% protection goal and calling for the issue to be taken up at political level.
On 24 March 2021, the Commission presented the results of this meeting at the Standing Committee on Plants, Animals, Food and Feed, where all Member States confirmed the views expressed at the meeting on 23 February 2021 – those not having participated at that meeting did not express a preference as to the protection goal to be set.
On 27 April 2021, the European Commission wrote to the Presidency of the Council of Ministers and to the Chair of the Committee on the Environment, Public Health and Food Safety of the European Parliament proposing a public debate in order to solve the continuing disagreements at the June Council for Agriculture and Fisheries and inviting the institutions to agree on a protection goal that is ambitious, raising the protection above the current level from 2002, and is technically feasible.
At the meeting of the Agriculture Council on 28 June 2021 Commissioner Kyriakides invited Agriculture Ministers to support an EU wide, ambitious, feasible and measurable "Specific Protection Goal", limiting the maximum permitted level of honeybee colony size reduction at 10% after the use of a plant protection product for the reasons set out in her letter of 27 April 2021 to the Presidency of the Council and the Chair of the Environment Committee of the Parliament. Following the debate, the Commissioner welcomed that a clear majority of Ministers supported the Commissioner's proposal.
On 9 August 2021, the Commission requested EFSA to continue the review of the Guidance document on the basis of the supported specific protection goal for honeybees and to support risk managers in the setting of a specific protection goal for bumble bees and solitary bees.
On 15 November 2021, EFSA held an information session to explain how the specific protection goal for honeybees will be translated into decision-making criteria for the lower tiers (i.e. laboratory studies) in the risk assessment.
On 23 November 2021, the Commission organised two separate sessions to inform Member States and stakeholders on the available evidence on bumblebees and solitary bees. During these information sessions, EFSA presented the data available.
On 28 January 2022, the EFSA published a technical report with the analysis of the evidence to support the definition of Specific Protection Goals for bumblebees and solitary bees.
On 17 February 2022, the Commission organised a meeting with experts from the Member States regarding the specific protection goals for bumblebees and solitary bees with risk managers and risk assessors from 23 Member States. The meeting was also attended by EFSA and ECHA.
When is the revised Bee Guidance Document expected to be adopted?
When informing EFSA of the outcome of the debate among Ministers in the Agriculture and Fisheries Council on 28 June 2021, the Commission asked EFSA to update the timeline for the finalisation of the review of the Bee Guidance Document. An updated timeline was published by the EFSA in November 2021.
Transparency and involvement of interested parties and general public in the review process
The Commission considers that transparency and cooperation are key for acceptance of the revised guidance document.
Therefore, it requested EFSA to closely involve Member State experts and interested parties in the process to ensure that all views are taken into account. EFSA has outlined on its website how it conducts the review of the 2013 Bee Guidance Document.
A public consultation on the draft guidance document will be announced by EFSA on its website, to which the general public will have the possibility to contribute.
The Commission receives many letters asking for clarifications on policies under development including on the review of the Bee Guidance Document. Replies of public interest are made available below. For reasons of data protection all personal data is redacted.
- Reply to Pan Europe in July 2020
- Reply to a Member of the European Parliament in October 2020
- Reply to Copa Cogeca in November 2020
- Reply to PAN Europe in November 2020
- Letter to the European Parliament Committee on the Environment, Public Health and Food Safety in December 2020
- April 2021 - Letter to the Presidency of the Council of Ministers and the Chair of the European Parliament Committee on the Environment, Public Health and Food Safety
- April 2021 – Reply to BeeLife, Pollinis, Apimondia and PAN Europe
- May 2021: reply to Pollinis
- June 2021: reply to Beelife
- May 2022: reply to PAN