Regulatory Processes and Dossier Structure for the Authorisation of Plant Protection Products in the EU

Your benefit

The training course introduces the regulatory framework for authorisation of plant protection products in the European Union under Regulation 1107/2009, with a focus on the regulatory processes for formulated products and renewal of approval of actives.

Content

• Understanding the EU Legal framework: Plant Protection Product regulations, environmental policy, International Agreements, trade barriers for food and feed, citizens rights to access information, intellectual property issues
• Brief overview of Regulation 1107/2009: key points
• Hazard, Risk identification, Risk assessment, Risk management
• Decision-making for approvals at EU level and authorisations at Member State level
• Types of substances and products regulated under Plant Protection framework (low risk, basic substances, adjuvants, co-formulants, synergist, safeners, etc.)
• Interplay between the Regulation 1107/2009, the Sustainable Uses Directive and the MRLs regulation for food
• Active substance approval and approval renewal procedure (AIR program of reviews)
• “Chemical” vs non-chemical active substances: where are the difference in the process for approval
• Renewal of Authorisation (Article 43) post AIR process, Plant Protection product authorisation procedure (Zonal authorisation, Mutual Recognition, Parallel trade, Role of EFSA, National Authorities and the European Commission)
• Product dossier structure: Zonal Core Dossiers, National Addenda, Interzonal dossiers
• Active substances dossiers (SANCO vs OECD): structure, building and publishing Access to study data and reports: data protection and data sharing
• Claims on data protection versus claims on confidentiality
• Impact of the risk-assessment on the product label: mitigation measures and restrictions of uses