A regulatory change is expected in Spain. A draft of a new Royal Decree on fertilising products has been published, which will replace Royal Decree 506/2013. The draft is currently in the public consultation phase.
Key points:
- New categories explicitly recognized
Categories that were previously unclear or outside the regulatory framework are now clearly included:
- Biostimulants (now with their own identity)
- Growing media (previously regulated separately)
- Inhibitors (urease, nitrification)
- Products derived from sludge
- Fertilisers from waste
- RENURE fertilisers
2. From a closed system to a more flexible model
The system moves away from a limited, closed list of residues:
- Increased use of by-products and secondary materials
- Introduction of raw material categories (similar to the EU model)
3. Increased control of higher-risk products
Special focus on:
- Sewage sludge
- Complex traceability waste
- Products containing microorganisms
4. Reorganisation of the classification system
The new Royal Decree structures fertilisers into 11 groups. Of these, the draft specifies that the following must be registered with the competent authority prior to placing on the market:
- Group 1.5 (RENURE)
- Group 2 (organic)
- Group 3 (organo-mineral)
- Group 4.3 (microorganisms)
- Group 6 (organic amendments)
- Group 8.1.A (specific growing media)
- Group 10 (sludge)
- Group 11 (waste-derived products)
5. Mutual Recognition
If, based on its composition, a product falls within a group requiring registration → it must also be registered in Spain.
⚠️The draft Royal Decree updating Spanish legislation on fertilising products continues to move forward.
At the AEFA Technical Conference held in Madrid, attended by representatives of the Ministry, the key issues and those that have generated the most debate—regarding the current amendment of Royal Decree 506/2013 on fertilisers and plant biostimulants were discussed.
1. Amino acids of ruminant origin
The Ministry maintains that amino acids obtained from ruminant materials must have a molecular weight below 10 kDa in order to exclude risks associated with prions.
The main difficulty lies in demonstrating compliance with this requirement in complex products. Although suitable analytical techniques are available, they may be expensive and difficult to apply routinely to all formulations.
The options being considered include controlling the starting raw materials, allowing pure amino acid products, requiring specific registrations, or accepting reports issued by specialised laboratories and technical centres. No final decision has yet been adopted.
2. New definition of plant biostimulant
The definition of plant biostimulant will be revised to align it more closely with Regulation (EU) 2019/1009 and to prevent Spanish legislation from extending or modifying the European definition.
It has been agreed to distinguish clearly between:
- The stimulation of plant nutrition processes.
- The improvement of tolerance to abiotic stress.
This change is particularly important because the reference to abiotic stress was not sufficiently clear in previous versions. The new wording will make it possible to classify correctly products intended to help plants cope with drought, salinity, extreme temperatures or other environmental factors, provided that they do not have a plant protection function.
The wording concerning the availability of confined nutrients still needs to be reviewed to ensure that the final definition correctly reflects all the functions recognised under European legislation.
3. REACH and Omnibus VI
The Ministry will review the references to REACH in order to avoid inconsistencies with future changes arising from Omnibus VI.
The aim is to maintain consistency with Regulation (EU) 2019/1009 and to avoid national requirements that differ from or go beyond those applicable to EU fertilising products.
4. Mutual recognition
Mutual recognition applications will be submitted through the Ministry of Agriculture, Fisheries and Food, which will act as the entry point and coordinate the assessment with the competent health, environmental and control authorities.
The authorisation or lawful marketing of a product in another Member State will be taken into account, but it will not automatically replace the Spanish assessment. The company will have to demonstrate that the product provides a level of protection equivalent to that required in Spain, particularly regarding health, environmental protection and heavy metal limits.
Spain will not necessarily be able to require efficacy trials carried out within Spanish territory. However, it may apply the conditions of use authorised in the country of origin. For example, if a product is approved only for use on rapeseed in France, recognition in Spain would not automatically allow its use on other crops.
No simplified procedure is currently foreseen for imported products, and applications must be complete and accompanied by all the necessary supporting documentation.
MAPA is considering a transitional period of approximately 18 months for the new registration of products originating from mutual recognition procedures in other countries. Companies are therefore advised to begin preparing their dossiers as early as possible.
The competent authorities, particularly the Ministry of Health, still need to clarify the parameters, studies and documents that must be included in the dossiers. Clear criteria will be essential to avoid different interpretations by individual companies.
5. Marketing and placing on the market
The industry has requested clarification on when the transitional period for adapting product labels should begin.
The current definition of “placing on the market” could require the relabelling of products already stored at distributors’ facilities.
The industry proposes that products delivered and invoiced before the new legislation enters into force should be considered already marketed and should be allowed to remain in distribution until stocks are exhausted, without the need to change their labels.
Preparing in advance
Although the decree may still change, companies should already begin reviewing the composition, classification and documentation of their products. All indications suggest that the change will be particularly significant for biostimulants, products containing amino acids of ruminant origin and mutual recognition applications.
We will keep you informed of future updates.
14 july 2026
#Fertilisers #Regulation #Agriculture #CircularEconomy #Sustainability