Mutual recognition of fertilisers and biostimulants in Europe

In the European Union, two main routes currently coexist for placing fertilisers and biostimulants on the market, each with different regulatory and strategic implications.

Two regulatory frameworks for market access

On the one hand, Regulation (EU) 2019/1009, which has legally defined the concept of biostimulant and establishes a harmonised framework for the marketing of CE-marked fertilising products across all Member States.

On the other hand, national legislation in each Member State, which regulates the authorisation and marketing of fertilisers and related products at national level, in accordance with the specific requirements and procedures defined by each country. Not all Member States explicitly include the definition of biostimulant in their national regulations; however, they usually provide specific categories under which this type of product can be placed.

This second route, commonly referred to as national registration, allows a product to be placed on the market in a specific Member State provided that it complies with the applicable national regulatory framework. It also opens the door to an additional procedure for extending the marketing of the product to other Member States: mutual recognition.

What is mutual recognition?

Mutual recognition in the European Union is mainly regulated by Regulation (EU) 2019/515 and, in general terms, allows a product to be marketed in one Member State provided that it is legally marketed in another Member State.

However, it is a procedure with important limitations and specific conditions that must be analysed on a case-by-case basis before opting for this route.

Differences between Member States

Not all Member States have regulated the application of mutual recognition in the same way. Even among those that have, the requirements can vary significantly:

• In some countries, a voluntary declaration, accompanied by the translation of the original label into the national language, is sufficient.

• In others, explicit authorisation from the competent authority is required prior to placing the product on the market.

• In a minority of Member States, there's not a realistic procedure for placing products on the market through mutual recognition, with national registration or authorisation under Regulation (EU) 2019/1009 being the only available options.

General requirements for mutual recognition

If a product is eligible for mutual recognition in the country of destination, a number of general principles must be taken into account:

• It must be possible to demonstrate that the product is legally placed on the market in the Member State of origin, either by justifying the applicable regulatory framework or by providing a registration certificate, where available.

• In many cases, it is necessary to submit invoices or delivery notes proving that marketing in the country of origin is effective and genuine.

• The product may only be positioned in the new market under the same conditions as in the market of origin. Uses, application rates, crops, claims and other elements must be identical to those reflected on the original label.

• Any modification or loss of authorisation in the Member State of origin must be reflected in the countries where the product is marketed through mutual recognition. This means that, if uses or authorisation are lost at origin, the product can no longer be placed on the market in the destination countries.

• Although the label used for mutual recognition is largely based on that of the market of origin, it must comply with the labelling requirements of the destination country and cannot be considered a mere literal translation.

A strategic tool requiring prior assessment

Mutual recognition can be a very valuable strategic tool for the expansion of fertiliser and biostimulant products within the European Union. However, its viability depends on multiple regulatory, technical and commercial factors that must be carefully assessed.

If you are considering mutual recognition as part of your regulatory strategy, or if you are planning the entry or expansion of your products into European Union markets, do not hesitate to contact us to jointly assess the regulatory options that best fit your product, your company and your business objectives.