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Biopesticides
Biopesticides are used to manage pests, weeds and diseases in the same way as synthetic crop protection products are often used together in so called integrated pest management programs. There is no universally accepted definition of a biopesticide but, essentially, it describes a substance derived from nature that is formulated and used like a conventional pesticide. Biopesticide active substances generally fall into three categories: microorganisms, botanicals and semiochemicals.
生物生物的监管框架在全世界各不相同，并继续发展。美国EPA框架可能是最“适合的目的”，因为它反映了生物活性物质的独特要求。在其他地区，例如欧盟，生物化学通过专为常规化学品设计的立法来调节，具有疏忽。尽管适应性，但立法仍然可以设置不可成熟的端点需求和批准缓慢。联合国粮农组织的指导，世卫组织有助于在全球范围内简化和提高生物农业批准过程。
Covance监管团队的相关洞察力及其监管科学的指挥将使您与您的生物农业批准进行追踪。
- Dedicated team of regulatory scientists with knowledge of biopesticide regulations, microbiology and chemistry
- Comprehensive management of all aspect of the administrative, technical and scientific aspects of biopesticide dossier preparation and submission across global jurisdictions
- 通过欧盟/ EEA和美国的批准来经验转向生物生物学
您的需求
Understanding the scientific and regulatory requirements for biopesticides
As they are derived from nature, the regulation of biopesticides should be simple; however, this does not mean that they are necessarily safe and do not present an intrinsic hazard or risk if humans or the environment are exposed in a different way. So there is still a requirement to demonstrate safe use of your biopesticide product.. You will have to consider multiple questions to get a biopesticide through approval. What safety and efficacy endpoints are needed and accepted? What data already exists and how can it be leveraged? What data waivers are appropriate? How to generate the endpoint information needed? How to make convincing scientific arguments that are acceptable to regulators? What are the different data requirements for active substances and products?
Our Capabilities
Planning a streamlined journey through biopesticide regulatory requirements
监管科学的协作方法和专业知识使我们能够通过所有监管要求试验您的生物农药活性物质和产品。卓越在利用现有发布和未发表的数据中确保科学的论据是强大的，并且最小化的额外测试。
Experience navigating a range of global biopesticide regulations and data requirements including:
- Regulation (EU) 1107/2009 (Regulation concerning placing of plant protection products on the market)
- Regulation (EU) 2017/1432 (amendment to Regulation (EU) 1107/2009 to recognize low-risk substances)
- 条例（欧盟）283/2013（活性物质的数据要求）
- 法规（欧盟）284/2013（植物保护产品的产品要求）
- 美国法规40 CFR部分158数据要求
用量身定制的研究识别和填充额外的生物特素数据要求
Our integrated approach and joined-up thinking mean studies are tailored to meet the specific needs of your biopesticide. This streamlines programs and optimizes cost effectiveness.
Covance can generate a range of endpoints for your biopesticide, dependent on category, including:
- 鉴定和表征：身份，组成，生物学性质，5分批分析，缺乏微生物病原体，储存稳定性等
- Human health impact: acute toxicity/pathogenicity, sensitization, genotoxicity
- 环境中的命运和行为：持久性，故障和分解途径
- 生态毒理学：对非靶毒性有机体构成的风险