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Plant protection products

We are very experienced in the field of European registration procedures for crop protection products and active substances

Registration in the framework of Regulation (EC) No 1107/2009 is obligatory for bringing a new crop protection product on the market. Linge Agroconsultancy guides you through the entire registration process. Our extensive network of direct contacts within governing authorities, contract research organisations, universities and institutes enables us to assist our clients with the registration procedures with maximum efficiency. Our experience ranges from chemical products to (micro)biological products.
Linge Agroconsultancy is an evaluator for the competent authority in the Netherlands. Through regular meetings with the European authorities and by attending relevant workshops, we keep informed of the European legislation.

We also have experience with the preparation of various low risk plant protection dossiers. A low risk product will often require a different approach, with more focus on the mode of action of the active substance and non-standard extrapolations. Trial results with low risk products often ask for a different interpretation and should be presented so that the real benefit of the product is clear.

Registration services and project management

Linge Agroconsultancy offers you: Preparation of entire dossiers for active substance (renewal of) approval and product (renewal of) authorisation (dRR) This includes preparation of national addenda, zonal application, mutual recognition, label extension, comparative assessments, strategic consultancy, registration recommendations, management and monitoring of relevant studies, task force management. Linge supports you in pre-submission process/ pre submission meetings and submission of applications.

Data gap analysis

Analysis, administrative framework, coordinating missing studies.

All required dossier sections and administrative documents

Identity and physico-chemical parameters, analytical methodology, metabolism, toxicology and human exposure, food safety, dietary risk assessment and residues, efficacy, environmental behaviour (E-fate), ecotoxicology assessments, incl. higher tier risk assessments, modelling, and more.

Risk assessment and modelling

Human Exposure (EFSA OPEX online calculator, EUROPOEM, BfR template to support calculations on dermal absorption for in vitro studies, The Dutch greenhouse model, UK-model, German model, kasmodel), E-fate (Droplet, PERSAM, FOCUSPEARL, GeoPEARL, GroundwaterAtlas, FOCUS PELMO, PEARLNEQ v.5.1, GEM, Steps 1-2 in FOCUS, TOXSWA, SWASH, PRIZM, MACRO, SWAN, TOXSWA NL, The Pesticide Atlas, EVA, WUR Drift calculator, AppDate, assessment of monitoring data in drinking water from Vewin), Residues (EFSA PRIMo model, Animal burden calculator) Ecotoxicology (TER, HQ and MoS calculations for all required organisms, combitox, Bee-Tool, Birds and mammals calculator, benchmark dose (BMD) model).

Efficacy studies / biological assessment dossiers (BAD)

Data requirements, trial protocols, trial visits, completeness check, biological assessment dossier (BAD), draft registration report (dRR), resistance risk analysis, comparative assessment, literature study

MRL application

Advice on required studies, residue definition, evaluation of residue studies, MRL calculation and public health risk assessments

Equivalence check

Tier I and Tier II determinations of the similarity of active substances with regards to the chemical composition and hazard profile, produced from different sources (e. g. due to change to the manufacturing process and/or manufacturing location)

Literature review

Available scientific knowledge on active substances, preparation of project proposals and management

Preliminary risk assessment

In the course of renewal or approval of an active substance Linge offers a preliminary risk assessment to examine whether your product still complies with the current requirements as set out by EFSA and European authorities. Furthermore, preliminary risk assessments can be requested for identification of bottlenecks of an application for product authorisation or renewal.

Need help with other products or active substances?