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Protection of bees
The EU’s policy on the protection of bees and other pollinators in relation to pesticides is part of the approval system for active substances used in plant protection products. The objective is to ensure a high level of protection for bees and other pollinators when decisions are taken on pesticide approvals. This policy is aligned with the European Green Deal, the Farm to Fork Strategy, and the EU Biodiversity Strategy.
Under Bee guidance document – latest developments, the most recent scientific reference is EFSA’s revised guidance document on the risk assessment of plant protection products and bees, published on 11 May 2023. It covers honeybees, bumblebees and solitary bees, and is intended to provide the updated methodology for assessing how pesticides affect pollinators.
Under What will happen next?, the next regulatory step is to amend the relevant implementing rules so that the revised EFSA guidance can be endorsed and used in the EU authorisation system. EFSA also organised an information session on 13 June 2023 to explain the revised guidance and the work behind it.
Under What does the pesticides legislation say about the protection of bees and pollinators?, the legal basis is Regulation (EC) No 1107/2009, together with its predecessor, Directive 91/414/EEC. The legislation lays down criteria for the approval of active substances and for the authorisation of plant protection products by Member States. A substance can be approved only if the science-based risk assessment shows either negligible exposure of honey bees or no unacceptable acute or chronic effects on colony survival and development. The dossiers must comply with the data requirements in Commission Regulation (EU) No 283/2013 and Commission Regulation (EU) No 284/2013.
Under How is the legislation implemented?, the EU relies on scientific guidance developed by the Commission and EFSA. The earlier reference was the 2002 guidance document on terrestrial ecotoxicology, which already included a section on honey-bee risk. EFSA then produced the 2012 Scientific Opinion on the science behind the development of a risk assessment of Plant Protection Products on bees and, in 2013, the Bee Guidance Document.
Under What has been done to implement the 2013 EFSA Bee Guidance Document?, endorsement of the 2013 guidance was blocked for years because a clear majority of Member States opposed parts of it, especially the sections dealing with chronic toxicity for honeybees, bumblebees and solitary bees. In July 2019, Member States supported a draft Commission Regulation that would have implemented only the part on acute toxicity to honeybees, but in October 2019 the European Parliament objected, arguing that broader parts of the EFSA guidance should be implemented, especially on acute and chronic toxicity for honeybees and acute toxicity for bumblebees.
Under What is the current situation?, the 2013 EFSA Bee Guidance Document still cannot be fully applied in the routine assessment of applications for approval or renewal of active substances. As a result, the 2002 Commission guidance remains the operative basis for these assessments. Even so, the 2013 guidance was used in the review of the three neonicotinoid active substances under Article 21 of the Plant Protection Products Regulation, which led to the ban on all outdoor uses. In March 2019, the Commission also mandated EFSA to review the 2013 guidance in light of newer scientific knowledge and to involve both EU experts and interested parties in the process.
Under What are EFSA and the Commission doing about the review of the guidance document?, EFSA described how it conducted the review, including work by a working group consisting of EFSA staff and external experts and consultations with Member States through the Pesticide Steering Network. The review also involved cooperation between EFSA and the European Chemicals Agency to harmonise approaches under the plant protection products and biocidal products frameworks. An important milestone was EFSA’s 2020 technical report on the review of the evidence on bee background mortality.
Under Specific protection goals, the key issue is the threshold of acceptable effects on bees. In March 2020, the Commission organised a first workshop with Member States on how such protection goals had originally been set. EFSA then examined four possible scientific approaches in a supporting document. In June 2020, a second workshop discussed that EFSA paper together with a Commission background document. The majority of Member States preferred an approach based on the normal operating range of colony size for honey bees, and this was confirmed in the Standing Committee meeting of July 2020.
That debate continued into 2021. EFSA prepared another supporting document for a Commission information session on 13 January 2021. On 23 February 2021, Member States further discussed the simulation results on natural variability in honey-bee colony size and the practical design of field studies. Most participating Member States agreed that the variability simulated by EFSA was more conservative than what is observed in nature and that a protection threshold should take account of that and of the practical limits of field testing.
Views diverged on the acceptable reduction in colony size: some Member States accepted up to 23%, others preferred a range of 10% to 12.8%, while four supported retaining the 7% threshold from the 2013 EFSA guidance. On 15 March 2021, the Chair of the European Parliament’s ENVI Committee supported maintaining the 7% protection goal, and on 24 March 2021 the Commission presented the results to the Standing Committee, where Member States confirmed the positions already expressed.
Under Bee guidance document – latest developments, the most recent scientific reference is EFSA’s revised guidance document on the risk assessment of plant protection products and bees, published on 11 May 2023. It covers honeybees, bumblebees and solitary bees, and is intended to provide the updated methodology for assessing how pesticides affect pollinators.
Under What will happen next?, the next regulatory step is to amend the relevant implementing rules so that the revised EFSA guidance can be endorsed and used in the EU authorisation system. EFSA also organised an information session on 13 June 2023 to explain the revised guidance and the work behind it.
Under What does the pesticides legislation say about the protection of bees and pollinators?, the legal basis is Regulation (EC) No 1107/2009, together with its predecessor, Directive 91/414/EEC. The legislation lays down criteria for the approval of active substances and for the authorisation of plant protection products by Member States. A substance can be approved only if the science-based risk assessment shows either negligible exposure of honey bees or no unacceptable acute or chronic effects on colony survival and development. The dossiers must comply with the data requirements in Commission Regulation (EU) No 283/2013 and Commission Regulation (EU) No 284/2013.
Under How is the legislation implemented?, the EU relies on scientific guidance developed by the Commission and EFSA. The earlier reference was the 2002 guidance document on terrestrial ecotoxicology, which already included a section on honey-bee risk. EFSA then produced the 2012 Scientific Opinion on the science behind the development of a risk assessment of Plant Protection Products on bees and, in 2013, the Bee Guidance Document.
Under What has been done to implement the 2013 EFSA Bee Guidance Document?, endorsement of the 2013 guidance was blocked for years because a clear majority of Member States opposed parts of it, especially the sections dealing with chronic toxicity for honeybees, bumblebees and solitary bees. In July 2019, Member States supported a draft Commission Regulation that would have implemented only the part on acute toxicity to honeybees, but in October 2019 the European Parliament objected, arguing that broader parts of the EFSA guidance should be implemented, especially on acute and chronic toxicity for honeybees and acute toxicity for bumblebees.
Under What is the current situation?, the 2013 EFSA Bee Guidance Document still cannot be fully applied in the routine assessment of applications for approval or renewal of active substances. As a result, the 2002 Commission guidance remains the operative basis for these assessments. Even so, the 2013 guidance was used in the review of the three neonicotinoid active substances under Article 21 of the Plant Protection Products Regulation, which led to the ban on all outdoor uses. In March 2019, the Commission also mandated EFSA to review the 2013 guidance in light of newer scientific knowledge and to involve both EU experts and interested parties in the process.
Under What are EFSA and the Commission doing about the review of the guidance document?, EFSA described how it conducted the review, including work by a working group consisting of EFSA staff and external experts and consultations with Member States through the Pesticide Steering Network. The review also involved cooperation between EFSA and the European Chemicals Agency to harmonise approaches under the plant protection products and biocidal products frameworks. An important milestone was EFSA’s 2020 technical report on the review of the evidence on bee background mortality.
Under Specific protection goals, the key issue is the threshold of acceptable effects on bees. In March 2020, the Commission organised a first workshop with Member States on how such protection goals had originally been set. EFSA then examined four possible scientific approaches in a supporting document. In June 2020, a second workshop discussed that EFSA paper together with a Commission background document. The majority of Member States preferred an approach based on the normal operating range of colony size for honey bees, and this was confirmed in the Standing Committee meeting of July 2020.
That debate continued into 2021. EFSA prepared another supporting document for a Commission information session on 13 January 2021. On 23 February 2021, Member States further discussed the simulation results on natural variability in honey-bee colony size and the practical design of field studies. Most participating Member States agreed that the variability simulated by EFSA was more conservative than what is observed in nature and that a protection threshold should take account of that and of the practical limits of field testing.
Views diverged on the acceptable reduction in colony size: some Member States accepted up to 23%, others preferred a range of 10% to 12.8%, while four supported retaining the 7% threshold from the 2013 EFSA guidance. On 15 March 2021, the Chair of the European Parliament’s ENVI Committee supported maintaining the 7% protection goal, and on 24 March 2021 the Commission presented the results to the Standing Committee, where Member States confirmed the positions already expressed.
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