Efficacy requitements for fertilising products including plant biostimulants

Until now, organic or organic-mineral fertilisers, biostimulants, soil aids, etc. have been regulated by national legislations in absence of an EU wide regulation. Only for inorganic fertilisers, a harmonised EU regulation (Regulation 2003/2003) is available. The national requirements for efficacy of fertiliser and biostimulant products range from “not required” (e.g. Germany, Austria, etc.) to comprehensive efficacy data sets, including field trials for certain products (e.g. France, Romania, Poland etc.).

A new European Fertiliser Regulation 2019/1009 entered into force on 5 June 2019 and has been applicable since 16 July 2022. The regulation applies to the following so called Product Function Categories (PFCs): fertilisers, liming materials, soil improvers, growing media, inhibitors and plant biostimulants as well as blends of those PFCs. The regulation allows EU wide marketing of a fertilising product under the CE mark. In parallel, the option to market national fertilisers and biostimulants registered according to national regulations still remains.

Regarding “efficacy”, the new regulation states, that “EU fertilising products should be placed on the market only if they are sufficiently effective”. For EU fertilising products “scientific evidence that they ensure agronomic efficiency” needs to be provided. Inhibitors, for example, need to “fulfill certain efficacy criteria” and plant biostimulants “shall have the effects that are claimed on the label for the plants specified thereon”. Possible claims for plant biostimulants are improvement of “(a) nutrient use efficiency, (b) tolerance to abiotic stress, (c) quality traits, or (d) availability of confined nutrients in the soil or rhizosphere”.

Harmonised standards to allow justification of label claims for fertilising products, including biostimulants, are currently under development by the European Committee for Standardisation (CEN) and are expected to be published in the near future. The new EU Regulation is part of EUs Circular Economy Strategy and therefore partially incorporates the respective IP requirements. Based on the Green Deal, focused on Farm-to-Fork and Biodiversity strategies and Action Plans from the EU, the harmonised standards to be developed will further harmonise IP standards in the EU.