EU Plant Protection Products Regulation

Plant Protection Products Regulation (EU) No. 1107/2009订明所有植物保护产品放置的规则和程序, including biopesticides, onto the EU market.

利记网址 can help

  • We offer a wealth of expertise, gained from industry, government, 研究为您提供有效的支持和指导,确保和获得活性物质和植物保护产品的法规遵从性
  • Our multidisciplinary team of scientists, 监管和注册专家使利记在线网址能够在多个领域提供支持, including study monitoring, task force management and dossier preparation, including CADDY services
  • We hold core knowledge and expertise in the use of the IUCLID software application. 利记在线网址的监管专家经常使用IUCLID进行生物杀菌产品监管和REACH申报. 因此,根据欧盟透明度法规(2019/1381)提出的IUCLID提交新要求,利记在线网址完全有能力支持PPP客户。
  • 利记在线网址在新活性物质的申请和现有活性物质的更新方面取得了多项成功的规管成果(根据空气清新计划),这已被证实。
  • 利记在线网址在所有类型的产品授权(根据Art条款的再授权)方面都有经验. 43, zonal applications under Art. 33, mutual recognition, and other types of national authorisations)
  • We have extensive experience in dealing with regulators; and with our network of offices in France, Spain, Germany and the UK, 利记在线网址继续提供广泛的泛欧洲产品注册和再授权服务
  • 利记在线网址提供强有力和积极主动的项目管理,以确保利记在线网址的客户的需求被发现和及时满足

Need support with a new active substance dossier?

Why 利记网址

利记网址为企业提供高质量的监管和科学的咨询服务. We aim to understand our clients' goals and objectives, 了解项目的科学和技术方面,预测合规挑战,以计划前进的战略路径. 利记网址的专家团队注重截止日期,响应及时,并致力于专业. We have the utmost respect for the confidentiality of our work, strong project management skills, and take great measure to cultivate long-term partnerships with clients.

Our professionals

利记网址的科学家和监管顾问团队管理植物保护行业原料药和产品的批准的所有方面. Key professionals working in the plant protection team include Iain Watt – Head of Plant Protection, Philippe Kuenemann, Gareth Marshall, Lesley Last and Elinor Smith.

Frequently asked questions

获得新活性物质批准的程序很复杂,可能需要3到5年的时间. 帮助加快这一过程的一个关键因素是在提交前准备阶段提供良好的建议.

We’re created a handy guide outlining the process, which can be download here: 12 steps to secure EU active substance approval for plant protection products.

利记在线网址的顾问通常支持公司在活性物质审批过程中, 帮助评估可用的选项,以便客户决定最好的前进道路.

Get in touch at 与利记在线网址的植物保护团队就您的产品获得欧盟活性物质批准进行无义务交谈.

申请人必须在有效期届满前3年为其活性物质申请续期. The first step is to analyse all the current data requirements, identify data gaps and focus the the GAP where needed. Then, 档案必须在截止日期至少36个月前准备好并提交给报告员会员国.

利记网址已编制一份简便的指引,概述有关的程序,可在此下载: 11 steps to secure EU active substance renewal for plant protection products.

Get in touch at ,以了解利记网址如何协助你完成申请及提交档案的程序.


在欧盟,活性物质的批准状态最长可达10-15年. After this (although it could be earlier if the authorities deem it appropriate), the active substance must be re-approved for use and sale in the EU.

Although biopesticides are perceived as a more ‘natural’ type of product, they are still regulated under the Plant Protection Regulation (EU) No. 1107/2009.

欧盟活性物质申报的格式在法规中是强制性的. Typically this is EU format, with CADDY 作为档案的一种方便的电子格式(CADDY在某些地区是强制性的).


The EU Transparency Regulation (2019/1381), which comes into effect on 27 March 2021, 要求通过IUCLID平台提交的植物保护产品类型如下:

  • 原料药申报和管理(法规(EC) No 1107/2009)
  • 最大残留限量(MRL)和进口公差(IT)应用(法规(EC)第396/2005号)

为使用IUCLID平台提供支持,并为EFSA相关的超级保健计划提供指导, get in touch with us at 利记在线网址的监管专家经常使用IUCLID进行生物杀菌产品监管和REACH申报,并在这一新的领域支持您, challenging process.

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