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In 2018, Ministerial Decree n° 6793 repealed Decree n° 18534 of November 2009 and provided new labelling obligations and other provisions, for instance as regards to mixing, using co-formulants,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 >
1. Terms and conditions of use
Welcome to SCIBASICS SPRL (“Company” or “SCIBASICS” or “We”) web site, www.scibasics.com (“Website” or “Site”). By using the Site, you agree to be bound by the following terms and all applicable laws and regulations. In addition, you agree to indemnify and defend Company against any and all claims by third parties arising out of your use of the Site in violation of these Terms and Conditions of Use. If you do not agree to these Terms and Conditions of Use, you are not permitted to use the Site.
SCIBASICS is a Belgian company with headquarters located in Rue Alphonse Libert 6A, B-4520 Bas-Oha and registered in the Belgian registry of under number BE0893 600 424.
SCIBASICS provides various services related to product authorisation in the field of mainly plant protection products, biocides for veterinary use and fertilisers. We help our clients with dossier set up and submission, product mapping and positioning, label compliance checks and label set up, intelligence and strategic decisions.
You may find many content and resources on our Site such as reports, articles and/or pieces of legislation translated in English.
License of Use
Every content on the Site or that SCIBASICS provides to you by any other means (email or any other electronic communication system) is copyrighted or otherwise protected and owned by SCIBASICS. Unless otherwise expressly noted, nothing that you read or see on the Site may be copied or used except as provided in these Terms and Conditions of Use or with the prior written approval of the Company.
We grant you non-exclusive, limited, non-transferable, revocable license to use the services as we intend for them to be used.
As a registered user, you are licensed to keep, for your own personal records, electronic or physical copies of documents, unless otherwise expressly noted, for your own personal, and business use in learning about and evaluating the services or products offered on the Site.
No other permission is granted to you to print, copy, reproduce, distribute, license, transfer, sale, transmit, upload, download, store, display in public, alter, modify or create derivative works of these materials. This grant of permission is not a transfer of title, and under this permission you may not:
· remove any copyright, trademark or other proprietary notations from the materials; or
· transfer the materials to another person or “mirror” the materials on any other server, except as permitted by law.
· we make no warranties or representations to you that your use of any materials displayed on the Site will not infringe the rights of third parties.
All content, layout, imagery, and logos that appear within the SCIBASICS email updates and documents are owned by SCIBASICS and all rights reserved.
Unless otherwise indicated, all logos, names, package designs, and marks on the Site are trademarks or service marks owned or used under license by us or our business partners. The use or misuse of any of these marks or other information is strictly prohibited.
You may not hack, "scrape" or "crawl" our Site whether directly or through intermediaries such as spiders, robots, crawlers, scrapers, framing, iframes or RSS feeds, or otherwise access or attempt to access any information SCIBASICS has not intentionally made available to you on its Website or via purchased subscription. Your use of the Website does not entitle you to resell any of our content without prior express written consent from SCIBASICS.
To obtain full access to the Site, you may be required to complete a registration. In consideration of your use of the Site, you agree to: (a) provide accurate, current and complete information about you as may be prompted by any registration forms on the Site; (b) maintain the security of your password and identification; and (c) maintain and promptly update the Registration Data, and any other information you provide to us.
You are responsible for safeguarding and maintaining the secrecy of your password and identification at all times. You shall notify us promptly of any unauthorized use of your password and identification. You accept responsibility for all activities that occur under your account or password and such use shall be deemed to be use by you. If you are using our Services as the employee or agent of an organization, you are agreeing to these Terms and conditions of use on behalf of that organization.
You will ensure that all use of your account fully complies with these Terms and Conditions of Use. Transfer of the account by you to any other person or entity is prohibited.
Any Service subscribed by you is indicated and itemised in a purchase order.
The present Terms and conditions of use, purchase order and, where applicable, special conditions form an indivisible whole. In the event of incompatibility between the present Terms and conditions of use and more specific conditions mentioned on the purchase order, the latter conditions shall prevail.
The User subscribes to the service on the website. This process allows the User to submit its order, confirm it after having taken cognisance of it, then to receive an email acknowledging receipt and containing the purchase order.
Any order implies acceptance of the prices and description of the services (such as delivery terms) itemised before the online order. These descriptions of services are confirmed on the Purchase Order submitted to the User. These descriptions shall prevail in the event of dispute.
Price and Payment
The due price of a Service is determined exclusively in line with the stipulations shown on the online purchase order.
These stipulations correspond to our general pricing structure in force at the moment of the online order.
Payment are made by bank and/or credit card through our on-line payment service which is managed by Acuityscheduling.com and Digistore24.com
Any issue with your account shall authorise us to suspend any online order for any services until it has been resolved.
Unless otherwise specified and expressly accepted by the Parties the payment must be settled in full and the price paid before commencement of performance of the Services by us.
Computerised records, kept in our computer systems under reasonable conditions of security, shall be considered as proof of communications, of the online order and of payments taking place between the Parties.
We reserve the right to suspend any online order management in the event of refusal to authorise payment on the part of officially accredited bodies or in the event of non-payment.
In the event of difficulty encountered during payment requiring a verification procedure, we in particular reserve the right to refrain from delivering an online order.
Any problem with your account (non-payment, non-functional email address, etc.) shall authorize Us to suspend your online order until it has been resolved.
In the event of unavailability of a service subscribed on-line due to a technical issue, you have the choice between a cancellation of the online order or an exchange of service. In the case of a request for cancellation, only the unavailable service is cancelled and refunded by us within a reasonable period of time, while the rest of the online orders remains firm and final.
No other refund may be ordered or reclaimed, unless exceptional circumstances justify it and are a subject to a written agreement explaining these circumstances.
Right of Withdrawal
In accordance with article 16(m) of the Directive 2011/83/EU of the European Parliament and of the Council of 25 October 2011 on consumer rights, the supply of digital content which is not supplied on a tangible medium if the performance has begun with the consumer’s prior express consent and his acknowledgment that he thereby loses his right of withdrawal, are not subject to the application of the right of withdrawal.
Consequently, when you will order any digital content via our Website or any other electronic mean an email confirmation shall be sent to you in order to acknowledge the loss of your right of withdrawal[JAdc1] .
The right of withdrawal is a facility for customers who purchase for purposes that are not related to a business. Under the current regulations, customers who have purchased for commercial, professional or VAT purposes are excluded from this right of withdrawal. The right is likewise understood to exclude purchases that are not covered under "distance sales" and products that have been modified or customized on request.
2. Disclaimer and Limitation of Liability
The information on this Site is solely intended to provide users with general information on matters that they may find of interest. While every effort is made to offer current and accurate information, errors can occur. Furthermore, this Website may contain references to certain laws, regulations and other, publicly available documents. Laws, regulations and documents can and will change over time and should be interpreted only in the light of particular circumstances.
SCIBASICS DISCLAIMS ALL LIABILITY AND RESPONSIBILITY FOR ANY ERRORS OR OMISSIONS IN THE CONTENT CONTAINED ON THIS WEBSITE.
All content on the Website and all services provided through it are provided "as is", with no guarantees of completeness, accuracy or timelines, and without representations, warranties or other contractual terms of any kind, express or implied. SCIBASICS does not represent or warrant that this Website, the various services provided through this Website, and/or any information, software or other material downloaded from this Website, will be accurate, current, uninterrupted, error-free, omission-fee or free of viruses or other harmful components.
TO THE FULLEST EXTENT PERMISSIBLE PURSUANT TO APPLICABLE LAW, SCIBASICS DISCLAIMS ALL LIABILITY TO YOU AND EVERYONE ELSE IN RESPECT OF THE CONTENT ON THIS WEBSITE AND ALL SERVICES PROVIDED THROUGH IT, WHETHER UNDER ANY THEORY OF TORT, CONTRACT, WARRANTY, STRICT LIABILITY OR NEGLIGENCE OR OTHERWISE, AND WHETHER IN RESPECT OF DIRECT, INDIRECT, CONSEQUENTIAL, SPECIAL, PUNITIVE OR SIMILAR DAMAGES, EVEN IF SCIBASICS WAS ADVISED, KNEW OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES.
SCIBASICS provides a platform for general information and self-help. The information presented on this Website should not be construed as regulatory, legal, scientific or any professional advice or service.
More specifically, the information provided by SCIBASICS long with the content on our website related to legal matters ("Legal Information") is provided for your private use and does not constitute legal advice. We do not review any information you provide us for legal accuracy or sufficiency, draw legal conclusions, provide opinions about your selection of forms, or apply the law to the facts of your situation.
In case you need to that kind of advice you should consult with SCIBASICS directly or any other professional advisor familiar with your particular factual situation for advice concerning specific legal, regulatory or scientific matters before making any decision.
Neither SCIBASICS nor any Legal Information provided by SCIBASICS is a substitute for legal advice from a qualified attorney licensed to practice in an appropriate jurisdiction. SCIBASICS is not a law firm, please note that communications between you and SCIBASICS may not be protected as privileged communications under the attorney-client privilege.
You should not send any confidential information to SCIBASICS until you have received agreement from SCIBASICS to perform the services you request.
The following web link activities are explicitly prohibited by SCIBASICS and may constitute copyright infringement: links to any pages of our Website other than our home page, located at www.scibasics.com, unless otherwise expressly agreed by us; links that involve unauthorised use of our logo; and framing, layout or metatags.
SCIBASICS does not bear any responsibility whatsoever for the content, accuracy or security of any websites that are linked (by way of hyperlink or otherwise) to this Website.
Certain links on this Website lead to servers maintained by individuals or organisations over which SCIBASICS has no control. SCIBASICS makes no representations or warranties regarding the accuracy or any other aspect of the information located on such servers. A link to a third party's website should not be construed as an endorsement by either SCIBASICS or that third party of the other or its products and services.
3. Intellectual Property Rights
SCIBASICS retains all right, title and interest in and to its products and services, including, without limitation, software, images, text, graphics, illustrations, logos, service marks, copyrights, photographs, videos, music, and all related intellectual property rights. Except as otherwise provided in this Terms and conditions of use, you may not, and may not permit others to:
reproduce, modify, translate, enhance, decompile, disassemble, reverse engineer or create derivative works of any of our products and services;
sell, license, sublicense, rent, lease, distribute, copy, publicly display, publish, adapt or edit any of our products and services; or
circumvent or disable any security or technological features of our products and services.
The design, text, graphics and selection and arrangement thereof and services and the legal forms, documents, guidance and all other content found on our website ("Service Content") are copyright © SCIBASICS Incorporated. All rights reserved.
The names of actual companies and products you might encounter through us may be the trademarks of their respective owners. Nothing in these Terms and conditions of use should be understood as in any way granting any license or right to use any of SCIBASICS 's trademarks displayed on our website. All goodwill generated from the use of SCIBASICS's trademarks is reserved for the use of SCIBASICS, exclusively.
Breaches of these Terms and conditions of use
Without prejudice to SCIBASICS’s other rights under these Terms and conditions of use, if you breach these terms and conditions in any way, SCIBASICS may take such action as it deems appropriate to deal with the breach, including suspending your access to our services, prohibiting you from accessing the website, blocking computers using your IP address from accessing the application, contacting your internet service provider to request that they block your access to the application and/or bringing court proceedings against you.
These Terms and condition of use constitute the entire agreement between you and SCIBASICS with respect to the subject matter of these Terms and conditions of use and supersede and replace any other prior agreements.
13. Waiver, Severability and Assignment
SCIBASICS 's failure to enforce a provision is not a waiver of its right to do so later. If a provision is found unenforceable, the remaining provisions of the Terms and conditions of use will remain in full effect and an enforceable term will be substituted reflecting our intent as closely as possible. You may not assign any of your rights under these Terms and conditions of use, and any such attempt will be void.
We may revise these Terms and conditions of use from time to time and will always post the most current version on our website. By continuing to use or access the Services after the revisions come into effect, you agree to be bound by the revised Terms and conditions of use.
4. Law and jurisdiction
These Terms and conditions of use will be governed by and construed in accordance with Belgian Law, and any disputes relating to these terms and conditions will be subject to the exclusive jurisdiction of the courts of Brussels.
We take the protection of your data very seriously and treat your personal data as confidential and in accordance with legislative provisions.
Please bear in mind that data transfer on the internet may in principle be subject to security gaps. Total protection from third party access is not achievable.
When you visit our website, data about access to the site are recorded and stored as “server log files”. This includes the following data, among others:
- Pages or sections visited
- Date and time of access
- Dwell time
- Source/link from which you came to the site
- Browser used
- Operating system used
- IP address used
- Search terms used
The data recorded are used only for statistical evaluations and for improving the website. We accept no liability for the content or data protection of websites to which we provide links.
Dealing with contact data
If you contact us via the contact options provided, for instance during an enquiry, your statements are stored so that we can access them so as to be able to process and reply to your enquiry.
We undertake not to pass your personal data on to third parties. All information serving to identify you as an individual and that may be traced to you is deemed to be personal data – thus for example your name, email address and telephone number.
The user’s rights: information, correction and deletion
You as the user will upon enquiry receive information free of charge about what personal data concerning you have been stored. Provided that your wish does not conflict with a statutory duty to retain data, you are entitled to the correction of incorrect data and the deletion of your personal data.