Expected changes in fertiliser and biostimulant registration in Spain

The registration of fertilisers and biostimulants in Spain is currently undergoing a regulatory transition. Royal Decree 506/2013 has been the main legal framework governing the placing on the market of fertilising products in Spain for more than a decade.

However, developments at EU level, particularly following the entry into force of Regulation (EU) 2019/1009, have highlighted the need to update national legislation in order to improve regulatory coherence and facilitate innovation in products such as biostimulants, natural extracts and microorganisms.

The recent public consultation on the new draft Royal Decree, open from 23 March to 14 April 2026, provides an opportunity to anticipate relevant changes that may affect fertiliser registration in Spain and the regulatory strategy of companies operating in this sector.

Current regulatory framework

For a detailed explanation of the regulatory routes available and how different types of products (including biostimulants and microorganisms) fit within the current legal framework, please refer to our article on fertiliser and biostimulant registration in Spain.

Understanding the current regulatory framework is essential in order to assess the scope of the proposed changes and their potential impact on market access strategies.

Why RD 506/2013 is being revised

The main objective of the revision is to adapt Spanish legislation to the updated European regulatory framework and improve consistency between different regulatory categories.

The experience gained during the implementation of RD 506/2013 has also highlighted the need to clarify certain requirements, particularly for innovative products and products based on microorganisms.

Main expected differences:

• Greater aligment with Regulation (EU)2019/1009

• Integration of growing media into the RD

• Inclusion of categories of component materials and by-products

• Greater clarity regarding requirements for microorganisms, including previously published criteria related to the demonstration of compliance with Article 4.2.c) of RD 506/2013 for products included in group 4.4 of Annex I (note published in December 2024).

• Creation of a register for products placed on the market under mutual recognition and further clarifies the requirements applicable to this regulatory pathway.

• Explicit inclusion of the term "biostimulant"

Impact on biostimulants and innovative products

The new Royal Decree may facilitate market access for innovative products, but will likely require:

• improved characterisation of component materials

• technical justification of the mode of action

• stronger demonstration of agronomic efficacy

• robust safety justification

Companies developing biostimulants, microorganisms and other innovative fertilising products should review their regulatory strategy in order to anticipate data requirements and optimise time to market.

Conclusion

Understanding the differences between the current framework and the future regulatory framework is key to defining an efficient strategy for fertiliser and biostimulant registration in Spain.

If you would like to analyse how these regulatory changes may affect the registration of your products in Spain, do not hesitate to contact us.