There are no specific regulations in the European Union that set parameters for biofertilizers. Each country locally regulates this matter. For example, the Polish Law on Fertilizers and Fertilization of July 10th 2007 includes “growth stimulators” in the category of plant conditioners. These are products which have “a positive impact on plant growth or other metabolic processes of plants in other ways than plant nutrients” and shall “pose no threat to [the] health of humans or animals or to the environment after their use according to use and storage instruction”. This definition can be applied to biofertilizers, but no specific requirements are foreseen for such a category of products.
Spain, which is the second largest producer of conventional fruit and vegetables after Italy and among the leading countries in organic crops in Europe, does not include the term ‘biofertiliser’ in its legislation. The newest legal provision dealing with fertilizers (Real Decreto 506/2013) defines the number of microorganisms in organic amendments and compost but does not mention plant beneficial microorganisms. Fertilizers are defined as “Products used in agriculture or gardening, which, for their nutrient content, facilitate plant growth, increase performance and improve crop quality or which, by their specific action, amending, as appropriate, modify soil fertility or its physical, chemical or biological properties and that meet the requirements of Article 4.2 of this Royal Decree characteristics.” Fertilizers, specialty products and amendments are also included in this definition. The Spanish administrative system allows local administrations to additionally regulate the matter (http://www.juntadeandalucia.es).
In Italy, only the mycorrhizal fungi inoculants are included within the group of “Products with action on the soil” and in the miscellaneous category of “Products with specific action” foreseen in the Decreto Legislativo of 29th April 2010, n. 75. The quality requirements established by the legal provision foresee that the inoculum is reproduced under sterile conditions on roots of sorghum in a substrate formed by an organic soil conditioner and rhizosphere bacteria. These conditions, particularly the “sterile conditions” requirement, are practically very difficult to achieve, considering the need of organic substrate. Besides, the presence of rhizosphere bacteria requires, from the point of view of the mycorrhizal fungus, unsterile conditions of the substrate. The label of such products shall indicate which organic matrix is used (presumably as a carrier), the name of the mycorrhizal fungal species included, and the name of rhizosphere bacteria and trichoderma species, even though the last two types of microorganisms are not AMF. No genetically modified organisms are allowed to be utilized for making this product; pathogens such as Salmonella spp., Escherichia coli, and other aerobic mesophilic microorganisms and nematode eggs shall not be present.
The overall EU policy for the development of the agricultural sector in the next programming period (EU COM (2020)) underlines the need of reducing the impact on the environment of agricultural practices and the possibility of an increased use of alternatives to chemical inputs. The achievement of the objectives of rural development, which contribute to the Europe 2020 strategy for smart, sustainable and inclusive growth shall be pursued, among others, through the improvement of soil management, the preservation of biodiversity, the fostering of knowledge transfer and innovation and the promotion of resource efficiency. Furthermore, there is a strong emphasis on a wider application of agricultural practices based on low input (e.g. EU Directive 2009/128 on the sustainable use of pesticides) and on organic farming practices. Based on these policies, the support to research dedicated to biotechnological processes and products has a strong focus through the Horizon 2020 Programme (EU COM (2011) 808). In such a context, it is thus feasible to expect an increased interest among producers to develop products based on biological compounds and microorganisms.
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