Post by knoell

💡𝗟𝗮𝘁𝗲𝘀𝘁 𝗮𝗿𝘁𝗶𝗰𝗹𝗲: Stereochemistry - Regulatory Challenges in the Approval of Plant Protection Products.   Stereochemistry is not merely a technical detail. It can be decisive for the marketability of your active ingredient, directly dictating success or failure in terms of efficacy, toxicity profile, and environmental behaviour.   Stereochemistry impacts 25% of all active substances and one in four projects is affected. That means it is not only a corner case; it represents a central regulatory risk. With the EFSA guidance on stereochemistry (2019), also actively applied in Northern Ireland (since 2021) and Great Britain (since 2024), what was once unnoticed became a primary trigger for regulatory concerns and objections.   𝗧𝗵𝗲 𝗰𝗿𝗶𝘁𝗶𝗰𝗮𝗹 𝗰𝗵𝗮𝗹𝗹𝗲𝗻𝗴𝗲𝘀 𝗶𝗻𝗰𝗹𝘂𝗱𝗲: 🔹 Mandatory characterisation of every relevant stereoisomer and metabolite, as partial data is no longer sufficient 🔹 Isomers with a different ISO name treated as impurities under Regulation (EU) 283/2013, requiring full toxicological profiling 🔹 Entire exposure and risk assessments that may no longer be valid if stereochemistry is insufficiently addressed   Many existing datasets were generated before these requirements went into force. This is exactly where submissions stall, data requests multiply, and timelines stretch indefinitely.   Do your active substances and PPPs truly meet today's stereochemical requirements, or do hidden data gaps persist?   👉 𝗥𝗲𝗮𝗱 𝘁𝗵𝗲 𝗳𝘂𝗹𝗹 𝗮𝗿𝘁𝗶𝗰𝗹𝗲: https://lnkd.in/eMSuMi8P knoell - your go-to partner for registration, worldwide.   #Stereochemistry #PlantProtectionProducts #CropProtection #RegulatoryAffairs #EFSA #ActiveSubstances #Pesticides #knoell