Services for the registration of plant health products
Agri 2000 boasts ten years’ experience in preparing biological efficacy dossiers for formulations subject to reregistration or first registration. The Regulatory Unit consists of experienced personnel who work full time on services in the regulatory ambit. The work group possesses specific regulatory competence and can rely on the synergy with the test centre technicians regarding agronomic competence and knowledge of the territory. The wide-ranging professionality and the habit of dialogue with expert assessors in various European countries enable the unit to provide its clients with reliable support in the definition of GAP, in the selection of trials and studies and in the choice of the best arguments to support the requested uses.
Identification of registration strategies• Analysis and optimization of the GAP of a product • Identification of strategic uses to be authorized • Support in the planning of studies • Optimization of experimental protocols
Biological efficacy dossiers for plant health products (BAD/dRR)• Preparation of national and zonal BAD in compliance with the requirements foreseen in the SANCO norms and in the EPPO guidelines. (Agri 2000 has completed over 60 BADs in the last 10 years) • Client assistance in the evaluation phase by competent authorities
Data package analysis• Analysis of data available to support registration (on the basis of the minimum requirements necessary and the major and minor recognized uses in the relevant member countries) • Elaboration and summary of data with customized software solutions
Analysis and management of resistance• Analysis of the degree of resistance of an active principle • Analysis of the risk of the development of resistance • Development of strategies for the management of risk connected to the development of resistance Documents to support the process of comparative assessment (Art 50, Reg. EU 1107/2009)
Taint Tests, processing tests, vinification trials
Agri 2000 has a panel of sensory expert testers to conduct taint tests on all fresh and processed agricultural products in conformity with the EPPO guideline PP 1/242 (2). Agri 2000 produces many types of processed foods independently (for example from fruit, tomato and potatoes: juices, jams, concentrated and frozen; olive oil and table olives). For processes which include an organic factor (such as yeasts in fermentation) processing studies are carried out to identify significant parameters in the process (such as acidity, brine concentration, etc.) with the aim of identifying or excluding possible negative influences of field and after harvest applications of experimental products. Conformity with the EPPO PP 1/243 (2) guideline. Agri2000 is in a position to carry out vinification trials working with specialised organizations to assess the influence of field applications on the vinification process and on the quality of wine obtained. Conformity with EPPO PP 1/268 (1) guideline.