PLANT PROTECTION PRODUCTS REGULATION SERVICES IN EUROPE
Plant protection product regulation (EC No. 1107/2009) in EU poses significant regulatory and scientific challenges for clients seeking to introduce their products within the European Union market. The ongoing updating of regulatory and guidance documents under the European Food Safety Authority (EFSA) adds to the complexity of regulatory compliance. Auxilife services assists throughout the product life cycle by navigating agrochemicals regulatory consultations and pesticide registration. The United Kingdom withdrew from the European Union following Brexit in 2020. The UK's registration of plant protection products is impacted by Brexit. The Health and Safety Executive (HSE) became in charge of pesticide registration for Great Britain (England, Scotland, and Wales), even though Northern Ireland still follows EU laws. Plant protection products approved by the EU can still be used in Great Britain, but it can now set its own standards for new approvals. Auxilife provides all Key Plant Protection Products Registration Regulation Services for EU & UK region.
Auxilife by leveraging their expertise helps navigate the complex world of regulatory compliance. By compiling comprehensive dossiers, conducting scientific and risk assessments, and liaising with regulatory authorities, we gain product approvals. The team of experts monitor regulatory updates and changes to ensure safety, efficacy, and environmental concerns are addressed.
Data generation management and study monitoring
Auxilife offers consultancy services with valuable expertise and support throughout the data generation, study monitoring, GLP/BPE studies, field trials, and study plans in collaboration with GLP labs worldwide. Our team excels in designing efficacy field trials based on EPPO zones and creating study plans for product registration.
Risk assessment
It serves as a vital step to evaluate the effectiveness and safety of your product. Auxilife conducts risk assessment ensuring compliance with both EU and national regulations along with necessary strategic mitigations if required. This assessment comprises of several key areas: • Consumer risk assessment • Non- Dietary risk assessment • Environmental fate and behavior (Surface water, soil, and groundwater risk assessment) • Ecotoxicology (Aquatic and Terrestrial risk assessment)
Data Gap Analysis
Our team meticulously analyses all relevant information to identify gaps as mentioned below for a seamless registration process. • Chemistry • Residues • Bio-efficacy • Toxicology • Fate and behaviour in the environment • Ecotoxicology
Dossier preparation
The preparation of regulatory dossiers is an important responsibility in pesticide registration. We specialize in preparing dossiers for active and product. The Draft Registration Reports, comprising core assessments and accommodating national addendum as mandated by Regulation (EU) No. 283/2013 for active substances and Regulation (EU) No. 284/2013 for product formulations, from conception to completion. We are skilled in production and submission of dossiers in IUCLID format for the registration of pesticides in EU.
Project Management
Auxilife as EU Plant Protection Registration Consultant combines your insights with our expertise in a collaborative decision-making process, aligning with your business objectives for a successful outcome. Auxilife conducts preliminary assessments and customizes a roadmap to achieve full regulatory compliance. This roadmap outlines the necessary steps, potential timelines, and clear communication with authorities and clients during dossier preparation, submission and post-submission to ensure a successful registration process.
General services
• Authorization and Renewal of active substances and plant protection products • Dossier preparation for active substances and products • Technical equivalency • Data matching • Conducting, monitoring field trials and preparation of Biological Assessment Dossier • Human and environmental risk assessment • Endocrine disruptor assessment for active and co-formulants • Mutual/Zonal recognition application in EU countries • Classification and labelling of hazards
List of countries we served as Plant Protection Products Regulation Consultant in Europe & United Kingdom
Auxilife has successfully provided its services to all 27 member states of the European Union, encompassing nations such as Italy, France, Denmark, Spain, Czech Republic, Sweden, Malta, Poland, Netherlands, Germany, Lithuania, and many others.
