Scientific regulatory affairs
Regulatory support for biostimulants
Register of Fertilisers in Spain
There are no “biostimulants” as such in the Spanish legislation. However, they can be placed on the market as so-called “other fertilizers and special fertilizers” (“otros abonos y productos especiales”) of group 4 of Royal Decree 506/2013. These “other products” are defined in Article 14 as products that provide an other kind of fertilizer, either to soil or to the plant, substances that promote and regulate the absorption of nutrients or that correct physiological anomalies.
This Royal Decree of 2013 has been updated in 2017 by Royal Decree 999/2017. In this new regulation, another product category (4.4) has been added, such as microbial biostimulants. For these products an authorisation must be obtained before they can be placed on the market. The evaluation and granting of authorisation is done by the Directorate General of Agricultural Productions and Markets of the Ministry of Agriculture, Food and the Environment ( Dirección General de Producciones y Mercados Agrarios del Ministerio de Agricultura, Alimentación y Medio Ambiente ).
The dossier to be submitted must include efficacy trials done in in Spain or regions with a similar climate. A description of what is needed has been made available by the authorities.
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