A word of introduction

Biostimulants are products used in agriculture for various purposes: increasing yields, crop quality and other aspects such as physical traits (color, sugar content etc.). In contrast to biopesticides, biostimulants do not act directly against pests or diseases, but they improve the plant's vigour when faced with biotic or abiotic stress. Biostimulants help plant growth by acting, for instance, on nutrient availability in the soil. Plant biostimulants are as diverse as their purposes and include products made of algae, micro-organisms, proteins etc.

The applicable legislation for biostimulants in the EU is either the pesticides or the fertiliser legislation, depending on use, composition and label claims. Indeed, the line between what is considered being a PPP or a fertiliser is very thin for some products. Some biostimulants, for instance, would be considered being plant growth regulators which are regulated under the Plant Protection Regulation 1107/2009. 

 

To date, and until the updated European Fertiliser Regulation enters into force biostimulants are regulated by the national legislations in each country. Which is not what you would call a "harmonised" situation...as you will see from the information below :

Austria

26 July 2020

Ⓒ Evelyne Güsken

The legislative situation in Austria is quite straightforward. Biostimulants are regulated by the Austrian fertiliser legislation. Back in 1994, the Austrian Fertiliser Regulation (Düngemittelgesetz 1994, version of 8 May 2020) defines "fertilisers as substances that contain nutrients which are intended to - directly or indirectly - be added to plants to foster their growth, to improve their quality or their yield.

"Pflanzenhilfsstoffe" (biostimulants), are "substances without significant content in nutrients and which are applied to have an impact on the plant, to increase the plant's resistance and to influence the processing of organic substances."

Biostimulants can be placed on the market either with or without authorisation prior to marketing. Interestingly, plant strengtheners ("Pflanzenstärkungsmittel") sold on the German market can be placed on the market as biostimulants in Austria without authorisation. This is indeed interesting because these plant strengtheners are regulated under the German plant protection legislation, while biostimulants are typically regulated under the national fertiliser legislation!

In case a product is not eligible to be placed on the market without prior authorisation, an authorisation has to be requested and the fact that the authorisation has been requested (and obtained) must be marked on the label.

In any case a company intending to sell biostimulants on the Austrian market has to register before placing a product on the market. 

In our next update you will learn what biostimulants (description and specifications) are in Austria, how they can be placed on the market and what the criteria and requirements in terms of labelling are.

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Belgium

26 July 2020

Ⓒ Evelyne Güsken

The legislative situation for biostimulants is not straightforward in many European countries, and it starts with what these products are called in different countries. While in Austria, biostimulants could be any product being a soil improver or a "plant additive", in Belgium, the same is true. A biostimulant could be a soil improver, and a so-called "produit connexe" (which can be translated as "related product"). The Belgian authorities are very aware of the fact that some of these products are borderline plant protection products and that is not always easy to determine whether a product is a fertiliser or ... a plant protection product. 

 

Applicable to soil improvers and these "related products" is Royal Decree of 28 January 2011. For the sake of our short overview here, we will call "biostimulants" these soil improvers and "related products".

Biostimulants can be placed on the Belgian market if they comply with at least one of the following conditions:

- Be listed in Annex I of Royal Decree of 28 January 2013, or

- Be exempted from Royal Decree of 28 January 2013. In order to be exempted, a request for exemption must be submitted to the national competent authority, the Plant Protection Product and Fertilisers Service. Details on composition, nature and origin of raw materials, production process, agronomic valus, draft label and others must be provided.

- Be authorised, which boils down to requesting and obtaining a "derogation" from Royal Decree of 28 January 2011. To obtain an authorisation, a request must be submitted to the same competent authority as for the exemption request.

- Be authorised through Mutual Recognition.This one refers to the new EU regulation 2019/515 that entered into force on 19 April 2020.

In our next update you will learn what biostimulants (description and specifications) are in Belgium, how they can be placed on the market and what the criteria and requirements in terms of labelling are.

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Italy

26 July 2020

Ⓒ Evelyne Güsken

Italy is one of the few European countries with a clear definition of biostimulants and a list of biostimulant product types that can be placed on the market without an authorisation. This kind of "positive list" approach makes it simple : if your product is on that list, you can market it without authorisation. If the product is not the list, an authorisation must be obtained prior to marketing. 

In Italy, biostimulants ("corroboranti") are substances of natural origin, other than typical fertilisers, that

- Improve the resistance of plants against harmful organisms;

- Protect plants from damage not caused by pests;

- act physically or mechanically and which are not placed on the market as plant protection products, but nevertheless have useful effects on the plant as mentioned above.

It is Annex I of Decree n°18354 of 27 November 2009 that list of biostimulants that can be marketed without prior authorisation. In case a biostimulant is not on that list, it can be added and a request has to be sent to the competent authorities (MiPAAF). Since 2013 other biostimulant products have been added on that list, which now counts 14 entries. 

In our next update you will learn about details and the applicable legislation in Italy, as well as label requirements. 

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Sweden

28 July 2020

Ⓒ Evelyne Güsken

Sweden is somewhat more difficult to grasp in terms of understanding what the applicable legislation for biostimulants would be because... there is no legislation for biostimulants. No specific requirements are set for fertilisers either - the Swedish approach is simply a different one: the use and the impact of the use of any fertiliser (regardless of whether it is a regular fertiliser or a biostimulant) on the environment or animal/human health would be the key parameter. That is why there are for instance maximum allowable nitrogen input levels. As in other countries, there are many other legislations having impact on biostimulants, such as the chemicals legislation, animal by-products legislation, legislation on imports etc. etc. As a result, there are many different pieces of legislation that could apply to a given Biostimulant product. 

While there is no dedicated biostimulant legislation, there are still rules in terms of composition and manufacturing. Depending on source (raw) material, these rules vary widely. In most cases though, any raw material is to be sterilised before it can be used. Processed animal protein is always Category 3 material.

Whatever the product might be, if it is rightfully on the market in a different EU Member State it can be placed on the Swedish market without prior authorisation or notification.

There are also environmental requirements applicable to organic fertilisers and the cadmium content in any fertiliser must not exceed 100g/ton of phosphorus.

In terms of labelling, there are no specific guidelines, however, the product may not be confused with feed and a special marker is to be applied to the label.

In our next update there will be more details on applicable legislation. 

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