Do all fertilising products need to be registered before they can be marketed in Spain?

The short answer is no.

However, this does not mean that some fertilising products can be placed on the Spanish market without complying with any regulatory requirements.

Although not all fertilising products require prior registration with the Spanish Ministry of Agriculture, all products must comply with the applicable requirements regarding safety, composition, labelling and, where applicable, efficacy. In addition, products may only be marketed if they fall within one of the existing regulatory frameworks.

Products requiring national registration

In Spain, organic fertilisers, organo-mineral fertilisers and certain special products must be registered in the Fertilising Products Register of the Spanish Ministry of Agriculture before they can be placed on the market.

You can find more information about these procedures in our article on fertiliser and biostimulant registration in Spain.

What about products that do not require registration?

It might be assumed that certain inorganic fertilisers or some special products, such as humic acids or amino acids, can be marketed without further regulatory obligations.

However, this is not the case.

Even where prior product registration is not required, these products must comply with one of the fertiliser types defined under Royal Decree 506/2013, as well as with all the applicable technical and labelling requirements established for that category.

Besides Royal Decree 506/2013, what other legislation may apply?

In many cases, Regulation (EU) 2019/1009 on EU Fertilising Products should also be considered.

Depending on the company's commercial strategy and the characteristics of the product, it may be necessary to undergo a conformity assessment procedure involving a Notified Body. This may be required even where the same product could alternatively be marketed under the Spanish national legislation without prior product registration.

In addition, companies should also consider their obligations under REGFER. Although REGFER is not a product register, it is a mandatory register for manufacturers, importers and distributors placing certain fertilising products on the Spanish market.

The importance of a preliminary regulatory assessment

The absence of a national product registration requirement does not necessarily mean that this is the most appropriate regulatory pathway.

Before deciding how to place a product on the market, it is advisable to carry out a regulatory assessment that takes into account, among other factors:

• the nature and composition of the product;

• the target markets;

• the company's commercial strategy;

• the implications of Royal Decree 506/2013 and Regulation (EU) 2019/1009.

In many cases, the option that initially appears to be the simplest is not the one that offers the greatest advantages in the medium and long term.

FAQ

Which fertilisers must be registered in Spain?

Organic fertilisers, organo-mineral fertilisers and certain special products must be registered in the Fertilising Products Register before being placed on the Spanish market.

Other products may not require prior registration, although they remain subject to all applicable legal requirements.

Can a fertiliser be marketed without registration?

It depends on both the type of product and the regulatory framework under which it will be marketed.

The absence of a national product registration requirement does not mean that the product is exempt from complying with the applicable legislation regarding composition, safety, labelling or conformity assessment.

What is the difference between the Fertilising Products Register and REGFER?

The Fertilising Products Register is a register of specific products regulated under Royal Decree 506/2013.

REGFER, by contrast, is the register of economic operators (manufacturers, importers and distributors) placing fertilising products on the Spanish market. It is not a product register.

Which legislation should I apply: Royal Decree 506/2013 or Regulation (EU) 2019/1009?

This depends on the characteristics of the product and the company's commercial strategy.

In some cases, both regulatory pathways may be available, making it advisable to assess which route is more appropriate from both a regulatory and commercial perspective.

If you would like to assess a specific product or define the most appropriate regulatory strategy for placing your fertilising or biostimulant product on the Spanish or European market, we would be pleased to assist you.

Location

Madrid, Spain

Contact

regulatory@rizarra.com
+34 675 594 225