Scientific regulatory affairs
Regulatory support for biostimulants
Italian Registry of Fertilisers
Italy is one of the European countries where there is a specific legislation for so-called biostimulant products.
Regulatory Overview on the Biostimulant legislation in Italy
This document summarises the legislative situation in Italy, including two annexes, of which one is the most recent update of biostimulant product types that can be placed on the Italian market without prior authorisation.
Number of pages: 15Date of publication: 11 August 2020
Summary: Italy is one of the European countries that have a specific legislative framework for biostimulants, which are called “corroboranti” in Italian. "Corroboranti" have been defined in 2001 as being “invigorating substances, substances that enhance plant defence and that substances of natural origin, other than fertilisers, that are applied to improve the plant’s resistance against harmful organisms and to protect plants from damage other than the one caused by pests. Of course, within the European 1107/2009 that is very borderline with the current function of plant protection product and hence the Italians have specified the function of biostimulants a bit more, drawing a clear line between what a biostimulant is (and what it is not). Indeed, in 2012, Presidential Decree n°55 on plant protection products stated that biostimulants (or enhancers of plant defense), as “substances of natural origin, other than fertilisers, which improve the resistance of a plant against harmful organisms and protect plants from damage other than the one caused by pests” and they are not considered being plant protection products, nevertheless, they have a useful action to achieve these properties. Biostimulants have no direct effect on pests.
Ministerial Decree n°18354 in 2009 listed 10 types of biostimulant products that could be placed on the market without prior authorisation. In 2013, this list was supplemented by four other product types.
In 2018, Ministerial Decree n° 6793 repealed Decree n° 18534 of November 2009 and provided new labelling obligations and other provisions, for instance as regards to mixing, using co-formulants, experimental trials and data protection. Annex 2 of that Decree n°6793 lists the (now 14) types of biostimulants products that can be placed on the market without prior authorisation.
Label requirements are also provide by Ministerial Decree n°6793 and it foresees that “fancy” names leading to misunderstanding what the product is about are forbidden. Rather, the name has to clearly recall the function of the product.
€ 600 | BUY NOW >
Translation of the form to request the approval of a biostimulant
This document is the english translation of the annex (form) to request the approval of a biostimulant referred to in Article 17 of the Decree of the President of the Republic of 28 February 2012 n°55.
Original title: Allegato – AI Ministero delle politiche Agricole, alimentary e forestali. Dipartimento delle politiche competitive della qualità agroalimentare e della pesca. Dossier per la richiesta di approvazione di “Corroboranti potenziatori delle difese delle piante.” Di cui all’articulo 17 del Decreto del Presidente della Repubblica del 28 febbraio 2012 n. 55
Number of pages: 10Date of publication: 09 August 2020
€ 48 | BUY NOW >
Translation of Annex 2 of Ministerial Decree n°6793 - List of biostimulant types
This document is the english translation of Annex 2 of Ministerial Decree n°6793 of the Ministry for Agricultural, forestry and tourism policies, listing the (now 14) biostimulant product types that can be placed on the Italian market without prior authorisation.
Original title: Allegato 2. PRODOTTI IMPIEGATI COME CORROBORANTI, POTENZIATORI DELLE DIFESE NATURALI DEI VEGETALI. Elenco tipologie di “Corroboranti potenziatori delle difese delle piante” di cui al decreto del Presidente della Repubblica n°55 del 28 februaio 2012.
The document includes the original.
Number of pages: 7Date of publication: 11 August 2020
€ 36 | BUY NOW >
Translation of Annex 3 of Ministerial Decree n°4416 of 22 April 2013 - Guidelines for the presentation of the dossier requesting the approval of a biostimulant
This document is the translation of Annex 3 of Ministerial Decree n°4416 of 22 April 2013 - Guidelines for the presentation of the dossier requesting the approval of a biostimulant.
Original title: Allegato 3 - Linee guida per la presentazione del Dossier di richiesta di approvazione di un «corroborante» ai sensi del decreto ministeriale n. 4416 del 22 aprile 2013
Number of pages: 8Date of publication: 11 August 2020
€ 60 | BUY NOW >
scientific regulatory affairs | regulatory support for biostimulants
Regulatory support for
Scibasics | Scientific Regulatory Affairs | email me >