Conventional crop protection chemicals have never been under so much scrutiny. Driven by scientific progress and consumer concerns over the environment, human safety and animal health, regulators are continually developing new data requirements and revising existing guidance to which you need to comply to gain approval for your product. In addition, as regulations tighten, previously approved active ingredients and their products are undergoing periodic review and reapproval requiring new and expanded data sets beyond those accepted historically. The world of crop protection regulation is getting increasingly more challenging. You need an experienced partner to navigate you through the evolving challenges to maximize your substance's potential around the globe.
It can be challenging to take a joined-up approach to crop protection regulatory approval
Knowing where to start crafting regulatory arguments for specific products can be challenging. What does the existing data look like? Is new data needed? How can you optimize limited or missing data? Can read-across and weight-of-evidence arguments be made? What specific requirements exist in different jurisdictions? How can you leverage data across different countries and markets?
Expertise in regulatory jurisdictions across the globe
Our team has vast regulatory, scientific and business expertise gained in industry, regulatory agencies, consultancies and research institutes. Our dedicated crop protection team sits in offices across the U.S., Europe and Asia. Having this on-the-ground regulatory insight enhances regulatory success. We have a proven track record of working with worldwide crop protection regulations, like those of the EU, EPA, JMAFF and OECD. This means you can be confident in receiving the right support to meet your commercial and regulatory objectives.
A comprehensive range of crop protection regulatory services across multiple chemistries
Given our heritage, Labcorp has experience of working on multiple chemical classes including:
- Herbicides: sulphonylurea, amide, oxazole, carbonate (benzoylpyrazole) urea
- Fungicides: triazole, aryl phenol ketone, anilinopyrimidine, amide, thiazole
- Insecticides: pyrethroid, organophosphate, carbamate, plant extracts
Scientific regulatory services Labcorp undertakes for both synthetic and biological active substances include:
- Planning and managing global new active substance safety testing
- Planning and managing new plant protection product safety testing
- Preparation of core OECD dossiers for active substances
- Preparation of regional (e.g. EU, NAFTA) or country specific (e.g. U.S., Japan) active substance and plant protection product dossiers
- EU re-registrations (AIR) of active substances and plant protection products
- Global MRLs and import tolerance applications
- Hazard and risk assessments
- Waivers and Expert statement
- (Q)SAR assessments of metabolites and impurities