In Spain, biostimulants can be placed on the market through the European Fertiliser Regulation (EFR), obviously, but also - and we would like to add : fortunately - via the Spanish national regulatory framework.

Biostimulants that are registered through the European Fertiliser Regulation (EU) 2019/1009 can be freely placed on the Spanish market.

Under the national legislation, it is Royal Decree 506/2013 which governs the placing on the market of fertilisers, soil conditioners, and plant biostimulants.

The Spanish Ministry of Agriculture, Fisheries, and Food (MAPA) is the authority responsible for overseeing these regulations. So-called "national" or "non-harmonised" biostimulantsmust generally be authorised or registered before they can be placed on the Spanish market, unless they are covered by the European Fertiliser Regulation (EU) 2019/1009.

If a biostimulant is made up of substances or microorganisms not included under the EU Fertiliser Regulation (EU) 2019/1009, the producer must apply for authorisation at the national level in Spain.

The usual data requirements range from the product composition up to information about safety for the environment, humans and animals. The dossier to be prepared and submitted will also include evidence that the biostimulant performs the claimed effects and the label in Spanish in compliance with Spanish regulations.

If the biostimulant contains novel or non-listed substances, additional safety evaluations may be required.

Mutual Recogition according to Regulation (EU) 2019/515 is also possible in Spain, though not as straigthforward as one would wish.

In principle, the Mutual Recognition Principle is that "a product legally marketed in one EU Member State can be sold in another, even if it doesn’t meet the technical rules of the destination country—unless justified by overriding public interest (e.g. safety, environment)."

However, we have seen that is does not always work like that, especially for biostimulants with microorganisms, things might toughen up and anyway, a notification to the authorities is required.

Spain can then accept the product and allow it to be sold (typically listing in it in its Registro de Productor Fertilzantes) or request additional information or it can also refuse it (in principle, it must then justify it under Article 36 of the TEFU (e.g. because of presumed risks to human health, environment etc. ) but our experience tells otherwise.

Need help with your product for the Spanish market ?

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We are always happy to help,

The sciBASICS Team.