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The European Plant Protection Organisation's resistance risk analysis guideline is here - now it's time for change

机译:欧洲工厂保护组织的抵抗风险分析指南在这里 - 现在是改变的时候了

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Commission Directive 91/414 EEC on the inclusion of new and existing active substances requires assessment of the risk of resistance being developed by target organisms and for management strategies to be introduced to address these risks. The European and Mediterranean Plant Protection Organisation (EPPO) worked with regulatory authorities and industry to develop a resistance risk analysis guideline that would fulfil this need. Registration applicants within the European Union and other EPPO countries are obliged to comply with this guideline. Implementation of EPPO's new resistance risk analysis guideline will force significant change in the way crop protection products are developed, registered and used. It will be necessary to evaluate resistance risk and develop use patterns, with "acceptable" levels of risk, early in the development process. Registration applications for uses that are associated with "unacceptable" resistance risks may be denied. If registrations are denied because of resistance risk, it will be necessary to modify use patterns to reduce these risks to "acceptable" levels. To change use patterns at this late stage would be likely to result in significant delays and as a result loss of sales. Significant additional work would also be required if the original residue and efficacy dossiers no longer support the revised use pattern. Key to the process of change is the interpretation of what constitutes an "acceptable resistance risk".
机译:委员会指令91/414 EEC纳入新的和现有的活性物质需要评估目标生物的抵抗风险,并旨在引入管理策略来解决这些风险。欧洲和地中海植物保护组织(EPPO)与监管机构和行业合作,开发抵抗风险分析指南,该指南将满足这种需求。欧洲联盟和其他EPPO国家的注册申请人有义务遵守本指南。 EPPO的新阻力风险分析指南的实施将迫使作物保护产品开发,注册和使用的方式发生重大变化。有必要评估抵抗风险和开发使用模式,具有“可接受的”风险水平,在开发过程中早期。可以拒绝与“不可接受”电阻风险相关的用途的注册申请。如果由于抵抗风险而被拒绝注册,则有必要修改使用模式以将这些风险降至“可接受”的水平。在此后期改变使用模式可能会导致显着的延误,结果销售损失。如果原始残留物和疗效档案不再支持修订的使用模式,则也需要进行重要的额外工作。改变过程的关键是对构成“可接受的抵抗风险”的解释。

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