What next for plant biostimulants? – a regulatory perspective

The European plant biostimulant market is forecast to double to €2billon in revenue by 2030. A huge driver for this will be the implementation of EU2019/1009 Fertilising Product Regulations (FPR) in July 2022. Whilst the UK is outside of EU regulations (except for Northern Ireland which remains in the Single Market to preserve the benefits of the Good Friday Accords) it will still benefit, as manufacturers need to export across Europe to spread their investments in product development and production.

In an age of bureaucratic bonfires, it seems strange to applaud more regulation, but the reality is that good regulation fosters innovation and market development. The new FPR is an excellent piece of regulation. It started life nearly 10 years ago as part of a European wide ‘circular economy initiative’ to improve the sustainability of food production aligned with public health and the environment. At its conception, a group of like-minded plant biostimulant manufacturers, including IntraCrop, formed the European Biostimulant Industry Council (EBIC) to work with European regulators in defining what biostimulants were and how they could assist in this ambition.

Until now the plant biostimulant market has been almost anarchic. Not recognised as a product category, biostimulants have often been sold as “fertilisers” with biostimulant components mixed with nutritional elements to justify the classification. Companies haven’t been required to provide efficacy data to justify their product claims, although manufacturers do need to navigate different national requirements depending on the circumstances.

The new FPR provides a single market for clearly defined plant biostimulants under category PFC6. The genius of this legislation, something that EBIC proposed, is in defining plant biostimulants by their function and not their ingredients. The exact wording in PFC6 is:

A plant biostimulant shall be an EU fertilizing product the function of which is to stimulate plant nutrition processes independently of the product’s nutrient content with the sole aim of improving one or more of the following characteristics of the plant or the plant rhizosphere:

(a) nutrient use efficiency,

(b) tolerance to abiotic stress,

(d) availability of confined nutrients in the soil or rhizosphere.

As a result, manufacturers, most of which are relatively small, have the security to invest in products without the need to expose or patent their formulations. This is a huge saving. On the other hand, it means they now have to invest in trials data to substantiate their product claims. This is not a problem for companies that are serious about plant biostimulants, as trials are a key part of product development. The provision of efficacy data is as important as the prescribed product composition, method of analysis and safety data.

For the first time, the EC mark for a plant biostimulant means that farmers can be confident about the function, efficacy and safety of the product. The new FPR will cut through all the spurious claims and complicated ingredients lists to provide a degree of transparency and credibility to the benefit of all.

IntraCrop welcomes the new FPR, as it chimes with our Science Led approach. We are committed to establishing and communicating the active component content and mode of action of all our products, verified by independent agronomic trials.

Some challenges remain. The process of establishing assessment standards within Conformity Assessment Bodies (CAB), also known as Notified Bodies (NBs), has taken longer than expected. This means that, to date, there is only a handful of accredited CABs ready to act in reviewing and approving new product dossiers. The inevitable backlog of product submissions and approvals will take time to process. However, transitionary measures are in place. According to Article 52 of the FPR, EC Fertilisers may continue to be sold as long as they are placed on the market by 15 July 2022, and national regulations will continue to co-exist with the European framework.

Possibly the most significant challenge, certainly from an IntraCrop perspective, is what happens to phosphite? The new regulation explicitly excludes phosphite from EC Fertilising Products. This dates back to concerns raised almost a decade ago about MRL exceedances from phosphite “fertilisers” being applied. The interpretation at the time was that since the only recognised agronomic use for phosphonate (phosphite’s sister molecule) was as a fungicide, the only appropriate regulatory pathway was under the plant protection framework.

Two things have changed since then: the scientific evidence for biostimulant functions of phosphite plant biostimulants has become more robust, and biostimulants were explicitly anchored within “fertilising products” and excluded from plant protection products when Regulation (EU) 2019/1009 was agreed.

IntraCrop is actively engaged within two EBIC project teams to address this. We are also founder members of the Phosphite Biostimulant Stewardship Group (PBSG) which has sponsored research and communication to publicise the plant biostimulant mode of action alongside the agronomic, environmental and economic benefits of better root development and nutrient use efficiency in arable crops. It would seem that these efforts are bearing fruit. Member States within the EU Expert Group on Fertilising Products seem persuaded that phosphite is indeed a plant biostimulant and positive feedback has been received from the body responsible for drafting and implementing the new regulation (DG GROW). EBIC has since provided a proposed amendment to the FPR for the re-inclusion of phosphite-containing products within PFC6 of the new regulations. We are now hopeful that this challenge will be overcome in time for applications on next season’s crops.