EU Plant Protection Products Regulation

Plant Protection Products Regulation (EU) No. 1107/2009规定了所有植物保护产品的放置规则和程序, including biopesticides, onto the EU market.

TSG's EU plant protection regulation consulting

  • We offer a wealth of expertise, gained from industry, government, and research providing you with effective support and guidance for ensuring and gaining regulatory compliance for active substances and plant protection products
  • Our multidisciplinary team of scientists, 监管和注册专家使我们能够在各个领域提供支持, including study monitoring, task force management and dossier preparation, including CADDY services
  • 我们拥有使用IUCLID软件应用程序的核心知识和专业知识. Our regulatory experts routinely use IUCLID for Biocidal Products Regulation and REACH submissions. We are thus well placed to support PPP clients with the new IUCLID submission requirements arising from the EU Transparency Regulation (2019/1381)
  • We have a proven record of achieving numerous successful regulatory outcomes with applications for new active substances and renewals of existing active substances (under the AIR programmes)
  • 我们在所有类型的产品授权(Art下的再授权)方面经验丰富. 43, zonal applications under Art. 33、相互承认和其他类型的国家授权)
  • We have extensive experience in dealing with regulators; and with our network of offices in France, Spain, Germany and the UK, 我们继续提供广泛的泛欧产品注册和再授权服务
  • We provide strong and proactive project management to ensure that our clients’ needs are identified and met in a timely manner

Need support with a new active substance dossier?


TSG为公司提供高质量的bet8注册下载服务. We aim to understand our clients' goals and objectives, learn the scientific and technical aspects of projects and anticipate compliance challenges to plan a strategic path forward. TSG的专家团队以截止日期为中心,反应迅速,并致力于专业. 我们非常尊重我们工作的机密性, strong project management skills, 大力培育与客户的长期合作伙伴关系.

Our professionals

TSG's team of scientists and regulatory consultants manage all aspects of approving active substances and products for the plant protection industry. 

EU plant protection products - frequently asked questions

The procedure for obtaining approval for a new active substance is complex and can take anywhere between 3 to 5 years. One of the key things that will help expedite the process is good advice during pre-submission preparation.

我们创建了一个方便的指南来概述这个过程,可以在这里下载: 确保欧盟植物保护产品活性物质批准的12个步骤.

我们的顾问经常在原料药审批过程中为公司提供支持, 帮助评估可用的选项,以便客户可以决定最佳的前进方式.

Get in touch at [email protected] to have a no-obligation chat with our plant protection team about obtaining EU active substance approval for your products.

申请人必须在有效期前3年申请原料药的续期. 第一步是分析当前所有的数据需求, identify data gaps and focus the the GAP where needed. Then, the dossier must be prepared and submitted to the Rapporteur Member State at least 36 months before the expiry date.

TSG制作了一个方便的指南,概述了这个过程,可以在这里下载: 确保植物保护产品欧盟活性物质更新的11个步骤.

Get in touch at [email protected] to learn more about how TSG can support you through the application and dossier submission process.

The Annex I Renewal - or AIR - programme relates to EU regulation that has been put in place to control the process of renewing EU approval of active substances in plant protection products.

在欧盟,活性物质的批准状态最长期限为10-15年. 在此之后(如果当局认为合适的话,可以提前), 活性物质必须被重新批准在欧盟使用和销售.

尽管生物农药被认为是一种更“自然”的产品, 它们仍受植物保护规例(欧盟. 1107/2009.

在欧盟提交欧盟活性物质档案的格式在法规中是强制性的. Typically this is EU format, with CADDY 是一种方便的档案电子格式(CADDY在某些地区是强制性的).

2021 is seeing the introduction of mandatory IUCLID submission platform use for all active substance and MRL dossiers.

The EU Transparency Regulation (2019/1381), which comes into effect on 27 March 2021, requires the following plant protection product submission types to be made via the IUCLID platform:

  • 活性物质档案的提交和管理(法规(EC) No 1107/2009)
  • 最大残留限量(MRL)和进口容许量(IT)应用(法规(EC) No 396/2005)

为使用IUCLID平台提供支持,并为相关的EFSA超级护理计划提供指导, get in touch with us at [email protected]. Our regulatory experts routinely use IUCLID for Biocidal Products Regulation and REACH submissions and are well placed to support you in this new, challenging process.

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