Registration of Fertilisers and Biostimulants in Spain: Available Regulatory Pathways

The registration of fertilisers and biostimulants in Spain can be carried out through three main regulatory pathways, depending on the nature of the product and its regulatory status in other markets.

• National registry, in accordance with Royal Decree 506/2013

• Certified as an EU fertiliser, in accordance with Regulation (EU) 2019/1009

• Mutual recognition procedure, for products lawfully marketed in other Member States

The main characteristics of each road are summarized below.

National Registration of Fertilisers and Biostimulants in Spain: Royal Decree 506/2013

Royal Decree 506/2013 regulates the types of fertilising products authorised in Spain, defining for each of them their name, permitted raw materials, composition requirements, production process and labelling conditions.

The products are classified into seven large groups:

1. National inorganic fertilizers

2. Organic fertilizers

3. Organo-mineral fertilizers

4. Other fertilizers and special products

5. Limestone Amendments

6. Organic amendments

7. Other amendments

Once the type of product has been identified, it is important to bear in mind that not all groups require prior registration in the Register of Fertilising Products.

• For groups 2, 3 and 6, as well as for certain products in group 4, prior registration is mandatory before placing on the market.

• For the rest of the categories, it is sufficient to comply with the manufacturing and labelling requirements established in the royal decree, without the need for individual registration of the product.

The content and form of the registration dossier depends on the type of product and requires an evaluation of the same.

Biostimulants and special products based on microorganisms

Royal Decree 506/2013 does not expressly contemplate the category of biostimulants. However, in practice, many of these products fall under group 4 (other fertilisers and special products), which includes, among others:

• Amino acids

• humic and fulvic acids

• Algae extracts

• nitrification and urease inhibitors

• Specialty products based on microorganisms

Special products based on microorganisms require a specific mention, since:

• they must be registered in the Register of Fertilising Products before they are marketed;

• they must comply with both the requirements of the Royal Decree and the explanatory notes and interpretative criteria subsequently published by the competent authorities.

In relation to microorganisms, the regulations distinguish between:

• mycorrhizal microorganisms, and

• non-mycorrhizal microorganisms.

Spain does not have a positive list of accepted species/strains but during the registration procedure, it is the manufacturer's responsibility to demonstrate that the species or strain used meets the safety, hygiene and efficacy requirements demanded by the Spanish authorities.

The evaluation period of the dossier in practice has an average evaluation time of 1 year, depending on the type of product, the uses requested and the agronomic tests required.

EU Fertiliser Certification as an Alternative to National Registration in Spain: Regulation (EU) 2019/1009

Spain, as a Member State, applies Regulation (EU) 2019/1009 on EU fertilising products.

A product certified in accordance with this regulation can be legally marketed in Spain, provided that it complies with the labelling and marketing requirements applicable at national level.

This regulation offers an alternative route to national registration, which we will discuss in more detail in a dedicated article.

Mutual Recognition as a Registration Pathway in Spain

The mutual recognition procedure is an option to be assessed for products that are already legally marketed in another EU Member State.

As explained in our article on mutual recognition of fertilisers and biostimulants, this route can be particularly interesting in certain scenarios, although its practical application requires a case-by-case analysis.

While the Spanish authorities are working on an update of the procedure, at the time of writing the explanatory notes currently in force are still applicable.

Strategic approach

The choice of the most appropriate regulatory route depends on multiple factors: type of product, composition, target market and commercial strategy.

If you want to analyse the available options and define the best strategy for accessing the Spanish market for your product, we can advise you in a personalised way.
Do not hesitate to contact us.