Placing a biostimulant on the European market

How to place a biostimulant on the European market?

In Europe, a harmonized regulation is currently in force for inorganic fertilizers and some liming materials only. Marketing of these products is covered by Regulation (EC) No 2003/2003. All other fertilizing products, including plant biostimulants, are still subject to national regulations. The marketing process for these products follows national rules and the requirements vary from one Member State to another.

Thanks to the work carried out by EBIC and the European Commission, the new Regulation (EU) n°2019/1009, that will fully apply in July 2022, provides a clear definition of biostimulants linked to their function (s) and thereby delineates a frontier with Plant Protection Products.

A “plant biostimulant” is a product that stimulates the nutritional processes of plants independently of the nutrients it contains, with the sole aim of improving one or more of the following characteristics of plants or their rhizosphere:

1. the efficiency of nutrient use;
2. tolerance to abiotic stress;
3. qualitative characteristics;
4. the availability of nutrients confined in the soil or rhizosphere

Once the new Regulation (EU) 2019/1009 is in force, it will then be possible to place all fertilizers and growing media on the market according to the newly established framework.

What does it mean for biostimulants?

From July 2022 onwards, there will be two options for placing biostimulants on the market.

1. It will still be possible to go down the route of national regulations. This means, a product will be legally placed on the market in one Member State following national rules and requirements. Afterwards it is possible to use the principle of mutual recognition in accordance with Regulation (EU) 2019/515 to request an authorization in another Member State. The procedures and requirements (particularly with regard to the assessment of risks to human health and the environment) are made on a case-by-case basis, depending on the product and the country where the Mutual Recognition is sought.
2. It will be possible to follow a EU harmonized marketing process for biostimulants following the framework established in the new Regulation (EU) 2019/1009. Once a EU-type certificate will be granted to a biostimulant, the marketer will be able to affix the CE mark and the product will have the access to the whole EU market.

EAR can support you in all aspects of biostimulants market access:

• Market access study
• Regulatory strategy development
• Literature search
• Data gap analysis
• Data generation support (study monitoring, labelling preparation)
• Dossier preparation
• Post-submission support

Our promise to you:

Provide the highest quality service to address all your current and future regulatory challenges

For further information, please contact us