Scientific regulatory affairs
Regulatory support for biostimulants
Austria does currently not have a list of registered fertilisers - but it is planned to have one soon.
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. Any change must be notified using a specific change request form.
Austria has been granted a derogation from Regulation (EC) 2003/2003, allowing it to prohibit the placing on the market of fertilisers exceeding the limits of cadmium in relation to their phosphorus content.
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English translation of the complete 2004 Austrian Fertiliser Legislation (including Annexes)
This document is the translation from German to English of the Austrian Ordinance of the Federal Minister of Agriculture, Forestry, Environment and Water Management, with the provisions for the implementation of the Fertiliser Act 1994 are enacted (Fertiliser Ordinance 2004) StF: BGB1. II No. 100/2004.Original title: Verordnung des Bundesministers für Land- und Forstwirtschaft, Umwelt und Wasserwirtschaft, mit der Bestimmungen zur Durchführung des Düngemittelgesetzes 1994 erlassen werden (Düngemittelverordnung 2004) StF: BGB1. II Nr. 100/2004This legislation provides specifications for fertilisers, soil improvers, biostimulants and growth substrates in terms of composition, tolerances, contaminants, and labeling. All annexes (1-4) have been translated as well and are included in the document.
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English translation of the form to apply for an authorisation to place a biostimulant on the market
This document is the english translation of the form (in German) to apply for an authorisation to place a biostimulant product on the Austrian market (Request in line with §9a of the 1994 Fertiliser Law for the authorisation of a fertiliser, soil improver, plant biostimulant or growth substrate)
Original title: Antrag gem. §9a Düngemittelgesetz 1994 (BGBI.Nr. 513) idgF. Auf Zulassung eines Düngemittels, Bodenhilfsstoff, Pflanzenhilfsmittel oder Kultursubstrats
This document contains:
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Regulatory Overview for Biostimulants in Austria
This document summarises the regulatory situation for biostimulants in Austria.
Date of publication : 07 August 2020
Summary: Biostimulants can be placed on the market in Austri either with or without authorisation prior to marketing.
Placing on the market without an authorisation is possible in these cases:
In case the product does not fulfil one of the above-mentioned criteria, an authorisation has to be requested under §9 a of the 1994 Fertilizer law. Also, if the product contains microorganisms or algae extracts, an authorisation has to be requested.
The document provides indications for labelling and and specific labelling requirements as regards to certain special biostimulant products.
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Austria has been granted in 2006 a derogation from Regulation (EC) 2003/2003 on the allowable cadmium concentrations in fertilisers. These limits are more restrictive and these have been accepted.
Article 1 reads:
"In derogation from Regulation (EC) No 2003/2003, the Austrian provisions which prohibit the placing on the Austrian market of phosphorous mineral fertilisers (containing 5% P2O5 or more) with a cadmium content exceeding 75 mg/kg P2O5 are approved".
"The derogation shall apply until harmonised measures on cadmium in fertilisers are applicable at Community level."
scientific regulatory affairs | regulatory support for biostimulants
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