Industry Feedback on the Plant Protection Products Regulation (EC) No. 1107/2009

Industry Feedback on the Plant Protection Products Regulation (EC) No. 1107/2009

At the Dublin PPP Symposium in November 2023, Bart Vanhoof from UPL, Netherlands, shared his industry feedback regarding experiences with the Plant Protection Products Regulation (EC) No. 1107/2009.

Along with Regulation 1107/2009 are several associated legislations such as the MRL Regulation (396/2005), Transparency legislation, Regulation 1272/2008 for classification and labeling, and various guidance documents. Additionally, evolving requirements and guidance continually impact the regulatory landscape, posing challenges for the industry, which must constantly adapt its strategy to navigate them effectively.

Bart presented several case studies highlighting these challenges, the first on Cypermethrin renewal, which took place in 2017. The 2018 EFSA conclusion identified concerns, including an unacceptable risk to aquatic organisms, in-field risk to bees, and off-field risk to non-target arthropods, even with a 95% drift reduction. Following a Commission mandate, EFSA revisited drift reduction values, suggesting that a combination of mitigation measures could achieve a 98.7% reduction for cereals and 99.5% for potatoes. The industry learned that combining risk mitigation measures is a viable option.

In the case of considered was copper, renewed in December 2018, EFSA’s conclusion limited the proposed rates of application and the number of treatments. However, EFSA acknowledged that the methodology for risk assessments is not entirely suitable for covering metal compounds. Subsequent guidance developments excluded metals from the evaluation of persistence, therefore copper is not included in the list of candidates for substitution. The lesson learned here is that new guidance can open new opportunities for metal assessments.

Bart also outlined the difficulties industry faces with evaluation timelines. Ongoing evaluations for active substances experience continuous delays, leading to postponed renewal dates. Consequently, new applicants face longer waiting times to enter the market or may be rejected for failing to submit within the renewal timeframe. The key takeaway here is that expiry date extensions result in significant market entry delays.

Finally, various issues were outlined in using IUCLID. IUCLID’s cloud lacks sufficient storage for simultaneous work by different users. Other problems include incoming questions for completeness checks, Member-State comments, and requests for sanitization. The pesticide dossier template in IUCLID is not well-suited for non-standard tests, and during assessments, changes and resubmissions lack clarity and consistency with evolving guidance. The overarching lesson is that the IUCLID tool is too rigid to handle the complexity of PPP applications and requires further refinement.

In conclusion, Bart highlighted that while Regulation 1107/2009 provides a solid foundation, added complexities necessitate adaptive strategies, leading to potential delays and challenges that regulatory professionals confront on a daily basis.

A copy of all the presentations is available on the publications section of the Kerona website https://kerona.ie/product/ppp-symposium-presentations/

Please contact the experts at Kerona info@kerona.ie if you need assistance with the registration of plant protection products.