A quiet revolution in pollinator protection
Over the past two decades, the European Union has profoundly transformed the way plant protection products (PPPs) are assessed for their potential impacts on pollinators.
What began in the early 2000s as a relatively simple acute toxicity assessment on adult honey bees has progressively evolved into one of the most sophisticated environmental risk assessment frameworks in the world. Today’s approaches increasingly integrate chronic exposure, colony dynamics, multiple pollinator species, and even landscape-level population modelling.
This article retraces the key milestones of this regulatory evolution — from the SANCO 2002 guidance to the EFSA 2023 bee guidance — highlighting how scientific advances and policy priorities have reshaped pollinator protection in the EU.
1. The Early Framework: SANCO/10329/2002
In the early 2000s, bee risk assessment in the EU was largely based on the SANCO/10329/2002 guidance document, developed under Directive 91/414/EEC. The approach was relatively straightforward and focused almost exclusively on acute toxicity to adult worker honey bees (Apis mellifera), measured through standard laboratory studies. The central metric used was the Hazard Quotient (HQ), calculated as the ratio between the application rate and the acute toxicity endpoint (LD50).
This framework provided a practical and harmonised starting point for regulators. However, it also had important limitations. In particular, it largely overlooked:
- chronic exposure effects
- potential impacts on bee larvae
- risks to non-Apis pollinators, such as bumble bees and solitary bees.
2. Catalysts for Change: Pollinator Declines and Regulatory Reform
During the late 2000s, growing evidence of pollinator declines across Europe triggered widespread scientific and regulatory concern.
Several high-profile incidents involving bee mortality events highlighted the need for a more robust and comprehensive risk assessment framework.
In response, the European Commission’s Communication on Honey Bee Health (2010) tasked the European Food Safety Authority (EFSA) with revising the existing risk assessment schemes.
This process coincided with the entry into force of Regulation (EC) No 1107/2009, which introduced stricter environmental protection requirements and explicitly required that plant protection products must have no unacceptable effects on bees.
3. Transitional Data Requirements: Regulations 544/2011 and 545/2011
While these regulations modernised several aspects of ecotoxicological testing, the bee risk assessment framework still largely reflected the earlier paradigm. In practice, applicants were mainly required to provide:
- acute toxicity studies on adult honey bees
- brood studies only when specific modes of action (such as insect growth regulators) suggested potential developmental effects.
4. The 2013 Paradigm Shift: The First EFSA Bee Guidance
A major step forward occurred with the publication of the EFSA Bee Guidance Document in 2013, which introduced a much broader and more protective assessment framework.
For the first time, the scope of the assessment expanded beyond honey bees to include:
- bumble bees (Bombus spp.)
- solitary bees (Osmia spp.)
The guidance also introduced new testing requirements designed to capture longer-term exposure scenarios, including:
- 10-day chronic toxicity studies on adult bees
- repeated-exposure larval studies
Another important innovation was the introduction of the Exposure Toxicity Ratio (ETR) approach, enabling more refined evaluations of chronic and larval risks.
Perhaps most significantly, the guidance introduced Specific Protection Goals (SPGs), linking regulatory decisions to measurable ecological outcomes. For honey bees, the proposed objective was to limit colony size reductions to less than 7%.
Unfortunately, the European Food Safety Authority 2013 guidance proved to be overly ambitious and, in some respects, difficult to implement. A well-known analysis conducted by the European association of plant protection product manufacturers, European Crop Protection Association (ECPA, now CropLife Europe), showed that, if the provisions of Appendix O of the EFSA 2013 guidance were followed to the letter, a single field study would have required the use of an area of 448 km² (a rectangle measuring 16 × 28 km). This and other arguments put forward by additional stakeholders convinced the majority of Member States not to approve the guidance, which is currently adopted only by a few.
The European Commission therefore mandated EFSA to revise the document. After extensive public discussion, this process resulted in the updated version published in the EFSA Journal in 2023. Endorsement of this new version is expected in 2026, following the necessary updates to Regulations Commission Regulation (EU) No 283/2013 (data requirements for active substances), Commission Regulation (EU) No 284/2013 (data requirements for formulated products), and Commission Regulation (EU) No 546/2011 (uniform principles), which have been on the agenda of the Standing Committee on Plants, Animals, Food and Feed for several months (as previously discussed here). 🌱📄
5. Legal Codification: Regulations 283/2013 and 284/2013
The evolution of bee risk assessment was further consolidated through Regulations (EU) No 283/2013 and 284/2013, which established updated data requirements for active substances and plant protection products.
These regulations introduced more explicit requirements for:
- chronic toxicity data for bees
- evaluation of brood development
- consideration of metabolites
- assessment of potential synergistic effects within formulated products
Together, these elements marked a clear shift toward a more comprehensive environmental risk assessment paradigm.
6. The Modern Framework: EFSA 2023 and the PESPG Concept
Following years of scientific debate and implementation challenges, EFSA published a revised Bee Guidance Document in 2023.
The updated framework introduces several important refinements, including the integration of different exposure pathways into a single metric known as the Overall Predicted Effect (PESPG).
This combined approach allows regulators to simultaneously consider:
- contact exposure
- acute dietary exposure
- chronic dietary exposure
- larval exposure
The guidance also introduces new exposure refinement tools, such as the Pre-flowering Factor (PFF), designed to estimate exposure when products are applied before crop flowering.
Finally, risk managers agreed on a revised Specific Protection Goal, allowing a maximum 10% reduction in honey bee colony size.
7. Bridging Laboratory Data and Real Colonies: The Rise of Ecological Modelling
One of the most significant developments in recent years has been the increasing use of ecological and population models to bridge the gap between laboratory toxicity data and real-world colony dynamics.
Among the most important modelling tools currently under development are:
BEEHAVE
An agent-based model that simulates honey bee colony dynamics and interactions with environmental stressors. This model is the one currently used in the guidance EFSA 2023.
ApisRAM
A complex systems-based model designed to support holistic environmental risk assessments by integrating pesticides, pathogens (such as Varroa and Nosema), and beekeeping practices at the landscape scale.
SolBeePop and SolBeePopecotox
New individual-based models specifically developed to assess risks to solitary bee populations, particularly the red mason bee (Osmia bicornis).
These models represent the frontier of pollinator risk assessment and may play an increasingly important role in future regulatory decision-making.
8. Navigating Today’s Fragmented Risk Assessment Landscape
Although the EFSA 2023 bee guidance represents the most scientifically advanced framework currently available, it has not yet been formally implemented in EU legislation (at least as of today).
The ongoing revision of the data requirements Regulations (EU) No 283/2013 and 284/2013, together with the update of the Uniform Principles (Regulation (EU) No 546/2011), is expected to provide the legal basis for its future adoption.
In the meantime, regulatory practice across the EU remains highly heterogeneous.
Depending on the Member State involved, applicants may encounter different expectations, including:
- the traditional Hazard Quotient (HQ) approach derived from SANCO/10329/2002
- the framework of the EFSA 2013 Bee Guidance, requested by some Member States — notably Spain
- exposure refinements based on EPPO Standard PP 1/170 (2010), incorporating chronic exposure concepts originally developed by Rortais et al.
For companies preparing dossiers for plant protection products, this means that multiple assessment paradigms often need to be considered simultaneously.
9. Further reading
- European Commission (2002). SANCO/10329/2002 rev 2 final: Guidance Document on Terrestrial Ecotoxicology Under Council Directive 91/414/EEC.
- Commission Regulation (EU) No 544/2011. Regolamento che attua il regolamento (CE) n. 1107/2009 per quanto riguarda i requisiti relativi ai dati per le sostanze attive.
- Commission Regulation (EU) No 545/2011. Regolamento che attua il regolamento (CE) n. 1107/2009 per quanto riguarda i requisiti relativi ai dati per i prodotti fitosanitari.
- European Food Safety Authority (2013). Guidance Document on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees). EFSA Journal 2013;11(7):3295.
- Commission Regulation (EU) No 283/2013. Regolamento che stabilisce i requisiti relativi ai dati per le sostanze attive.
- Commission Regulation (EU) No 284/2013. Regolamento che stabilisce i requisiti relativi ai dati per i prodotti fitosanitari.
- European Food Safety Authority (2023). Revised guidance on the risk assessment of plant protection products on bees (Apis mellifera, Bombus spp. and solitary bees). EFSA Journal 2023;21(5):7989.
- Duan et al. (2025). The third version of an agent-based honey bee colony model (ApisRAM.03) for the risk assessment of pesticides. EFSA Supporting Publication 2025:EN-9293.
- ISPRA (2020). Il declino delle api e degli impollinatori. Le risposte alle domande più frequenti. Quaderni Natura e Biodiversità n.12/2020.
- ISPRA (2011). Indagine tecnico-conoscitiva sul fenomeno della moria delle api all’interno delle aree naturali protette. Rapporto Finale.
- Rortais, Agnès, Gérard Arnold, Marie-Pierre Halm, and Frédérique Touffet-Briens. ‘Modes of Honeybees Exposure to Systemic Insecticides: Estimated Amounts of Contaminated Pollen and Nectar Consumed by Different Categories of Bees’. Apidologie 36, no. 1 (2005): 71–83.
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Would Your Product Pass the EFSA 2023 Risk Assessment?
With the regulatory transition already underway, an increasingly relevant question for applicants is:
Would your product meet the protection goals defined in the EFSA 2023 guidance?
Anticipating the requirements of the upcoming framework can be critical for:
- product development decisions
- dossier preparation and study planning
- early identification of data gaps
- long-term regulatory strategy
Understanding how a product performs under both current national practices and the future EFSA framework can significantly reduce regulatory uncertainty.
How Euregulator Can Help
Euregulator supports companies navigating the evolving landscape of pollinator risk assessment in the European Union.
Our services include:
- preliminary EFSA 2023-based pollinator risk assessments
- evaluation of current Member State expectations
- data gap analysis for bee studies
- support in defining study strategies and testing plans
- interpretation of complex regulatory guidance
Need support with bee risk assessment?
✔ EFSA 2013 and EFSA 2023 risk assessment
✔ HQ-based assessments (SANCO 2002)
✔ EPPO-based assessments
✔ Data gap analysis and study strategy
✔ Support for EU regulatory submissions
📩 Contact: info@euregulator.eu
🌐 Website: www.euregulator.eu