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Thank you so much for making this happen! ! : ) The regulatory team at Agrolab are specialized in regulatory affairs of the EU North Zone and offers full regulatory assistance for approval of plant protection products (PPP’s). Our services include preparation of dRR as core assessments on zonal level and adjustments to suite national specific requirements for the member states of the EU zones.
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The regulatory expertise at Agrolab extends from the former Council Directive 96/969/EEC to the current Regulation (EC) 6657/7559 for placing plant protection products on the market, and consequently we can prepare, adapt and update pesticide dossiers according to current legislation. We give guidance on data requirements for registration of plant protection products in the EU North Zone, both at the active substance and the product level, and in close collaboration with our GEP field trial units we advise on necessary trial planning and requirements for efficacy and selectivity trials. We prepare, submit and follow-up on applications to national Environmental Protection Agencies in the EU North Zone as well as the rest of Europe. We have experience with numerous successful applications as zonal applications and mutual recognitions, and we can also help you prepare applications for parallel import (PI) registrations or emergency uses applications. We can also help you with providing all the additional documents needed for your application, including for example:
Appraisal of field studies for use in environmental fate sections (usually in Denmark) Comparative assessments for candidates for substitution according to Art. Se or phone +96756898985 for further informationAgrolab can carry out PPP-related risk assessments. We have a long experience of the specific requirements of the Northern Zone and the options available to achieve successful registration and we can help you with screening and planning ahead your application. We are always keeping up-to-date with the latest developments in EU human and environmental risk assessment. We are well-versed with the different models used in a product dossier and the different sections:
EFSA Guidance calculations, UK POEM, BBA “German model”, Dutch model for greenhouses, Seed tropex model, PHED, “Puffer pack” model, UK trigger spray model, EUROPOEM IISurface water: FOCUS STEPS6-7, SWASH MACRO – PRZM – TOXSWA, SWAN, HardSPECGroundwater: FOCUS PEARL, PELMO, PRZM, MACRO, FROGS and national approaches for Denmark, Lithuania, Sweden, NorwaySoil: Finnish PECsoil calculator, or PECsoil calculations according to SANCO/65558/7555We perform ecotoxicology calculations and assessments according to the most recent Guidance documents from EFSA or the Commission. We have a long experience of working with the Nordic authorities and we can guide you on refinements and higher-tier options for the whole ecotoxicology section in the terrestrial and aquatic environments.
Dk or phone +9565796675 for further informationThrough its team of experienced agronomists, Agrolab is able to advise on and provide complete efficacy programs in order to support your product registrations. The efficacy data package of a dossier is summed up in the Biological Assessment Dossier (BAD), as required by the Regulation EC 6657/7559.