Bringing your product to the market and remaining compliant is an almost continuous complex regulatory process. Development, testing, performing risk assessments and evaluation by competent authorities take large investments in money and time. Furthermore, legislation keeps changing and mistakes can be costly.
That’s why we combine regulatory interpretation with regulatory consultancy, so you can make informed decisions on your continued compliance.
Plant Protection Products help protect crops against pests and diseases but can also influence the growth of a plant (growth regulator), or prevent growth of undesired plants (herbicides). Under EU Regulation 1107/2009 active substances and products must be authorised before they are placed on the market. Triskelion supports companies throughout the authorization process offering expertise in the registration process, dossier preparation and risk assessment compliant with regulatory expectations.
Regulation 1107/2009 lays out the rules for the authorization of active substances and registration of plant protection products in the EU Member States. In line with the regulation, first the authorization of an active substance is necessary on EU level. Once the active substance is authorized, registration of the plant protection product can be applied via a zonal application, The regulation sets out criteria for the preparation of a dossier to ensure that the plant protection product can be used safely for human health and the environment. It also requires demonstration of efficacy under practical conditions.
Applicants must meet strict requirements for toxicology, ecotoxicology, residues, fate and behavior of substances in the environment. In addition, risk assessments in compliance with European Food Safety Authority (EFSA) guidance should be prepared in the dossier, including risk assessments for professionals/workers/bystanders/residents, consumers, and non-target organisms such as birds and mammals, aquatic organisms, bees, soil organisms and non-target arthropods and plants.
We support manufacturers formulators and suppliers of plant protection products (traditional and biological) with:
We combine scientific depth with regulatory foresight:
Need to confirm compliance or solve an urgent safety issue?
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Our plant protection products expertise is relevant for:
