On July 16, the European Fertilizing Product Regulation came into force, which clarifies the regulatory framework for biostimulants, but leaves some doubts regarding their commercialization. Agronutrient manufacturers in Spain organized a conference where they analyzed the scope of the new regulation and the doubts it leaves regarding the marketing of these products.
In the words of Estefanía Hinarejos, Spanish representative of EBIC (European Biostimulants Industry Council), which brings together European manufacturers of bioinputs, the fundamental advance of the new regulation is that companies can use a single harmonized regulation to place these products on the market.
Until 2019, there were 27 regulations for marketing biostimulants in the European Union, which increased the cost of marketing products and discouraged the supply of products to countries with lower market potential. In any case, joining harmonization is optional, as manufacturers can continue to be governed by national regulations.
Hinarejos and Irene Sobrado, also part of the EBIC, participated in the conference organized by the Spanish Association of Agronutrients Manufacturers (AEFA), to address "the problems and uncertainties faced by manufacturers of fertilizers and biostimulants who want to put their products on the market in accordance with the new European marking".
The Spanish representatives of EBIC, which seeks to ensure that biostimulant technologies are valued as an integral part of sustainable agriculture, within a favorable regulatory framework, referred to several points of the regulation. A sector that, according to a market study by the consultancy Dunham Trimmer, could grow by around 12.6% between 2022 and 2027, needs to be embedded in an integrated legal framework. For Sobrado, "plant biostimulants are the fourth leg of sustainable agriculture, along with improved seeds, plant protection products and fertilizers".
On the occasion, they discussed the definition of biostimulant, understood as a fertilizer product whose function is to stimulate plant nutrition, independent of the nutrient content of the product, with the sole objective of improving one or more of the characteristics of plants and their rhizosphere. "It delimits the boundaries between plant biostimulants, plant protection products and fertilizers," Hinarejos emphasizes.
One of the most important points of the new regulation is that manufacturers who want to market their products as plant biostimulants with the corresponding label must pass the conformity assessment procedure. Once it has been demonstrated that the product meets the requirements of the regulation, which includes a demonstration of the biostimulant function through efficacy trials, manufacturers will draw up a declaration of conformity and will be able to affix the CE marking (European Commission).
So far, only three entities have obtained accreditation to be notified bodies and assess the conformity of these products and EBIC estimates that thousands of products will apply for conformity assessment. This could be a problem that Hinarejos predicts "bottlenecks and delays in obtaining CE marking". Institutions such as CAAE, an international organic certifier, which has already applied for accreditation as a notifying body, could ease the congestion in product registration.
The small variety of microorganisms recognized by the regulations as components of microbial biostimulants could pose another problem. There are basically four types: Azotobacter spp., mycorrhizal fungi, Rhizobium spp. and Azospirillum spp. Article 42 establishes the criteria for expanding the list, but does not describe the procedure to be followed.
The EC plans to launch a Europe-wide consultation for manufacturers to request the inclusion of new microorganisms in the regulation, entering relevant information on safety, agronomic efficacy and market potential, which will be evaluated between 2023 and 2025, delaying their commercialization by several years. "We are stuck on the microbial part," Hinarejos acknowledges.
Another point of contention in the regulation is that it prevents the entry into the market of biostimulants containing phosphites, despite scientific evidence of their biostimulant effects under certain conditions of use. It is the only multiple-use component that has been specifically excluded from the regulation. Because of this, EBIC drafted a proposal in December to incorporate phosphite-based biostimulants into the standard. Several member states of the council were willing to support the proposal and, although none publicly stated their opposition, no further progress has been made on the proposal for the time being.
