1107/2009: where are we now and what does the future hold?
Guidance on registering products under 1107/2009
Overview of Regulation 1107/2009:
- Understanding the fundamentals and objectives of the regulation
- Key definitions and concepts
Registration Process
- Detailed explanation of the application and registration process for plant protection products.
- Requirements for data submission and evaluation
Impact of horizontal legislation on PPPs
- Examining the interplay between the PPP regulation and REACH
- Examining the interplay between the PPP regulation and the Biocidal Products Regulation
Data Requirements
- In-depth discussion of the data needed for different categories of plant protection products
- Data requirements for active substances and formulated products
Risk Assessment and Risk Management
- Explanation of the risk assessment process for human health, animal health, and the environment.
- Strategies for risk management and mitigation measures
Endocrine Disruptors
- Understanding the criteria and assessment of endocrine-disrupting properties
- Implications for product registration
Fertiliser Products Regulation (FPR)
- Assessing the safety, efficacy, and environmental impact of fertiliser products in different member states
- Facilitating trade and promoting a level playing field for manufacturers across the EU
- Accelerating the time to market for new products and promoting innovation
Zonal Authorisation
- Explanation of the zonal authorization process and collaboration among EU Member States
- Challenges and solutions in the zonal authorization system post Covid
Market Monitoring & Enforcement
- Overview of post-market monitoring obligations for manufacturers and regulatory authorities
- Enforcement information