On September 28th 2023, Kerona Scientific held their first Dublin FPR Symposium dealing with key regulatory aspects relevant to the registration of products under the Fertilising Products Regulation (FPR, Regulation (EU) 2019/1009). Neal Sanders, Operations Manager at IntraCrop Ltd, UK, presented his industry insight into the FPR from a Plant Biostimulant perspective.
Neal introduced IntraCrop, a division of Frontier, which was founded 40 years ago and is dedicated to the development and sale of novel plant biostimulants and adjuvants. Neal shared IntraCrop’s journey with plant biostimulants, which started with Regulation (EC) 2003/2003. Neal outlined how, due to omission of plant biostimulants from Regulation (EC) 2003/2003, manufacturers were faced with the challenges of national regulations for plant biostimulants being different (or non-existent) which impacted the practicality of the mutual recognition (MR) route. Additionally, the lack of efficacy data requirements enabled dubious claims and disreputable practice for some products in the market. This all started to change ten years ago with the formation of the European Biostimulants Industry Council (EBIC), of which IntraCrop is a member and whose mission is to ensure plant biostimulants technologies are valued as integral to sustainable agriculture while securing an enabling regulatory framework for all of them.
Neal sees the FPR as a breakthrough, with the appearance of the first legal definition of plant biostimulants as well as its emphasis on function claim rather than product content, which leads to conformity assessment based on efficacy and proof of claims. Furthermore, Neal regards as clever the FPR’s use of existing REACH regulation for use, consumer and environmental safety data and retaining conformity assessment rather than a plant protection product (PPP) type approval process. The FPR regulation is a gamechanger allowing the marketing of pure plant biostimulant products without any nutritional content, which is a huge step forward.
Neal listed the hiccups of the FPR, the first of which was the lack of Conformity Assessment Bodies (CAB) to start with, which caused backlog that meant the continued need to rely on national registration and MR. Other hiccups include the developing of guidelines alongside implementation, specific limits for micronutrients in PRC 7 leading to the possible need for reformulation and the REACH interpretation which firstly obliges a chemical safety report (CSR) for all substances regardless of content (disproportionate and overly precautioous) and secondly is requires approval for reaction products of components.
Neal confirmed that there is still work to be done such as dealing with the issue of multiple use components with MRLs, how to get new microbial streams included, and setting up a central register of products passing conformity assessment.
Overall, Neal feels that the legislation is well crafted and that standards are already being raised. He is optimistic that in time it will be faster and more cost effective and advises to stay in close contact with CABs, as, based on his experience, they are very approachable and helpful.
If you missed the FPR Symposium, a copy of all the presentations is available on the publications section of the Kerona website at the link https://kerona.ie/product/fpr-symposium-presentations/
If you need assistance with registration of fertiliser products in the EU, please do not hesitate to contact the experts at Kerona info@kerona.ie