The registration of plant protection products (PPPs) in the EU is governed by Regulation (EC) No. 1107/2009. The regulation aims to ensure a high level of protection for human health and the environment, while promoting the development of new and innovative PPPs.

The registration process for PPPs can take several forms, including Mutual Recognition (MR), Article 34 (Art. 34), and the concerned, Member State (cMS), Zonal, and Mutual Recognition Zonal (MRz) procedures. The specific procedure used depends on the nature of the application and the type of product being registered.

Regardless of the procedure used, the registration process requires the submission of a detailed dossier containing all the necessary information about the PPP, including data on its composition, intended use, efficacy, and safety for human health and the environment. The dossier must include detailed information on the active substance(s) used in the PPP, including their physical and chemical properties, toxicology, and ecotoxicology.

For MR, the applicant must provide a complete dossier and a valid authorization in another Member State. The reference Member State evaluates the dossier and provides an assessment report, which is shared with the other Member States concerned. The concerned Member States then have 120 days to decide whether to accept the authorization or request additional information or further assessment.

For Art. 34, the applicant must submit a dossier containing all the necessary information for the PPP, including data on its composition, intended use, efficacy, and safety for human health and the environment. The Member State evaluates the dossier and provides an assessment report. If the assessment is favorable, the Member State may grant authorization for the PPP.

For the cMS, Zonal, and MRz procedures, the applicant submits the dossier to the relevant Member State(s). The evaluating Member State prepares an assessment report, which is shared with the other Member States concerned. The concerned Member States have 90 days to decide whether to approve the authorization or request additional information or further assessment.

In Hungary, which is part of the Central Zone under the zonal system, the registration process follows the requirements outlined in the regulation, with specific requirements for water scenarios. The registration process for PPPs in Hungary also follows the guidance provided by the European and Mediterranean Plant Protection Organization (EPPO).

Active substances used in PPPs must also be regularly reviewed and renewed to ensure their safety and efficacy. The renewal process involves the submission of a detailed dossier containing all the necessary information on the active substance. The renewal must be submitted at least three years before the expiration of the current approval.

Minor uses, minor crops, and non-PPPs may also be eligible for registration under specific procedures. These procedures aim to facilitate the registration of PPPs for uses that may not be economically viable under the standard registration procedures.

In summary, the registration of PPPs in the EU is a complex process that requires the submission of a detailed dossier containing all the necessary information on the product, including data on its composition, intended use, efficacy, and safety for human health and the environment. The specific registration procedure used depends on the nature of the application and the type of product being registered, with specific requirements for water scenarios in certain zones. Active substances must also be regularly reviewed and renewed to ensure their safety and efficacy, and specific procedures exist for the registration of minor uses, minor crops, and non-PPPs. The EPPO guidance should also be consulted for more information on the registration process.

EU Regulation 1107/2009 in 10 points:

EU Regulation 1107/2009 is a comprehensive regulation that governs the authorization, placing on the market, and use of plant protection products within the European Union. Here’s a short summary focusing on the major aspects related to plant protection products:

1. Objective: The regulation aims to ensure a high level of protection for human health and the environment while promoting the sustainable use of plant protection products.

2. Authorization Process: The regulation establishes a stringent and science-based authorization process for plant protection products. Companies seeking authorization must provide data and scientific evidence demonstrating the product’s safety, efficacy, and lack of unacceptable risks.

3. Risk Assessment: The regulation requires a thorough risk assessment of plant protection products to evaluate potential adverse effects on human health, animal health, and the environment. This includes assessing acute and chronic toxicity, carcinogenicity, reproductive toxicity, and environmental fate.

4. Zonal Approach: The regulation introduced a zonal approach, grouping member states into regulatory zones. The zonal procedure allows for the joint evaluation of applications within a zone and facilitates the mutual recognition of authorizations among member states within the same zone.

5. Data Protection: The regulation provides for the protection of data submitted by applicants during the authorization process. It sets rules on data exclusivity to encourage innovation and prevent unauthorized use of the data by third parties.

6. Endocrine Disruptors: The regulation includes provisions specifically addressing plant protection products that have endocrine-disrupting properties. It establishes criteria and procedures for the identification and regulation of such substances.

7. Transparency and Information: The regulation emphasizes transparency by requiring the publication of summaries of product characteristics and safety information. It also promotes the exchange of information among member states, stakeholders, and the public.

8. Monitoring and Enforcement: The regulation establishes monitoring and enforcement mechanisms to ensure compliance with the authorization requirements. Member states are responsible for monitoring the market, conducting inspections, and taking appropriate enforcement actions in case of non-compliance.

9. Review and Renewal: Authorized plant protection products are subject to periodic review and renewal. Renewal applications involve a re-evaluation of the product’s safety and efficacy based on updated scientific knowledge and regulatory standards.

10. Harmonization and Cooperation: The regulation aims to harmonize the authorization process across member states, ensuring consistent standards and procedures. It encourages cooperation and information sharing among member states, the European Commission, and the European Food Safety Authority (EFSA).

EU Regulation 1107/2009 plays a crucial role in regulating plant protection products in the European Union, balancing the need for effective pest control with the protection of human health and the environment. It establishes a robust framework for the evaluation, authorization, and use of these products while promoting sustainable agricultural practices.