Regulatory solutions for Bee Risk Assessment in the European Market
The risk assessment of plant protection products (PPPs) is undertaken in line with legal requirements (for the approval of PPPs under Regulation EC 1107/2009), taking into account effects on honey bee larvae and honey bee behaviour. To support this process the European Food Safety Authority (EFSA) developed and published a draft Guidance document for the risk assessment of Plant Protection Products (PPP´s) on pollinators (EFSA Journal 11(7): 3295, 2013). The new risk assessment scheme includes additional species and new thresholds challenging future registration of agrochemicals in the EU. The new requirements for bees extend the previous data set as already given in the EU regulations 283/2013 (active substance) and 284/2013 (plant protection products), which have already entered into force since 1st January 2016.
Due to developing regulations, new laboratory testing requirements for bees as well as new higher tier studies combined with complex and sophisticated risk assessment procedures will become standard for dossier submissions of agrochemicals. In addition, several Member States have published their own data requirements and risk assessment procedures for bees, such as the risk assessment for bumblebees or the risk from contaminated water.
We‘ll keep you on track with our bee services:
- Strategic planning of bee studies for active substance and product dossier submission on EU and national level
- Planning, monitoring and reporting of regulatory bee studies under GLP
- Acute and chronic laboratory toxicity studies with honey bees, bumble bees and solitary bees
- Higher-tier semi-field and field studies
- Residue studies in bee-relevant matrices
- Quality improvement of studies and reporting
- Validity check of existing bee studies considering recent guidelines
- Dossier preparation for active substance and product(s)
- Refinement approaches for the pollinator risk assessment, e.g. Tier 2 calculations for exposure refinement using the SHVAL tool developed by EFSA
For your support with extensive experience in bee risk assessment preparation and study monitoring of lower- and higher-tier bee studies, please contact the knoell Bee Service Expert Team or check out our Crop Protection website.