Plant protection products (PPPs) are regulated in the EU by Regulation (EC) No 1107/2009. This Regulation lays down the approval procedure and approval criteria for active substances and products containing these substances. Active substances are assessed at EU level for approval for use in PPPs. When proven safe, an active substance is included on the Approved List of active substances. Products containing these active substances must be assessed and registered by Member States in order to be approved for marketing and use. A product approval can be obtained through zonal authorisation or by mutual recognition.

ARCHE Consulting can support you in the preparation and submission of active substance and product dossiers for EU-wide, zonal and national registrations as applicable. We can also assist you in the third phase of the renewal program (AIR3), which covers substances whose current approvals will expire between 2013 and 2018. We can prepare all or part of a dossier, depending on client needs. ARCHE Consulting has a profound knowledge of the current legislation and relevant guidance documents (SANCO, OECD, EFSA, etc.). Moreover, we stay up-to-date with the national and European legislation concerning PPPs by actively participating in national and international conferences and by our broad professional network of regulators.

• Provide strategic advice
• Customized training
• Preparation of active substance dossiers in accordance with OECD guidelines
• Preparation of core draft Registration Reports (dRRs) and where applicable National Addenda, hereby implementing the risk envelope approach
• Classification according to CLP regulation (EC) No 1272/2008.
• Submission of dossiers to the competent authorities
• Follow-up of submitted dossiers with the Competent Authorities till approval
• Data gap analysis
• Monitoring and coordination of required tests
• Compilation of Exposure and Risk assessments, (including higher-tier approaches)
• Preparation of single dossier sections (Physical chemical properties, analytical methods, toxicology and human exposure and risk assessment, residues, environmental fate, ecotoxicology and biological assessment dossier)