Plant Protection Products
Under the European Plant Protection Products (PPPs) Directive 91/414/EEC all new and reviewed PPPs intended for use in the EU must appear on a positive list (Annex I) before Member States (MS) can authorise their marketing and use (Annex III). For an active substance to be considered for inclusion on Annex I or Annex III, notifying companies must submit a complete data package (dossier) on both the active substance and at least one PPP containing that active substance. An important component of the dossier is environmental concerns, including ecotoxicology, fate and behaviour and risk assessments.
Detailed guidance documents on data requirements are available at the National and European levels, and the complexity in assessing the fate and behaviour of PPPs in the environment often leads to difficulties in demonstrating acceptable exposure risks to regulators. Often lower-tier risk assessments will predict unacceptable adverse effects in the environment and additional higher-tier risk assessment evaluations are required.
CEA has extensive expertise and a proven track record in delivering solutions to environmental problems encountered by our clients at all stages in the registration/review of PPPs. We specialise in delivering higher-tier solutions and work with our clients to address uncertainties in their risk assessments and support their registration requirements.
Key Skills:
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Review of environmental sections of dossiers (fate and behaviour and ecotoxicological sections)
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Identifying data gaps and designing higher-tier studies
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Exposure modelling (FOCUS suite of models)
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Mesocosm Facility
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Landscape risk assessments
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Development of higher-tier exposure scenarios
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Post registration surveillance
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Product stewardship
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In use monitoring
Recent Studies:
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Groundwater vulnerability assessment across Europe to target future borehole monitoring campaigns under Directive 91/414/EEC
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Development of the Guidance Document for higher-tier environmental fate assessments in the UK (Defra contracts PL0546 and PS2202)
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Design, conduct and interpretation of a mesocosm study in support of an agrochemical product under the Plant Protection Products Directive 91/414/EEC
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Design and execution of arthropod residues study to support avian risk assessment under Plant Protection Products Directive 91/414/EEC
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Soil dissipation and leaching- Field/semi-field studies to determine mobility and transport processes in a range of soil types representing high leaching risk
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Development of higher-tier exposure modelling strategies to support European registration under Directive 91/414/EEC and at Member State level | 
