Biosafety data requirements
This document provides the data compiled for regulatory risk assessment, which is essential for making informed decisions on plant or product authorization. These data are prerequisites for any safety evaluation using a comparative approach, following internationally agreed commitments.
The data requirements vary according to the six regulatory options defined in the GeneBEcon project (referred to as Options 1-6). Overall, data generation involves variable resources, which are expressed as ‘monetary costs’ for comparative purposes and socio-economic evaluation.
Access the D1.1 – Report on biosafety data requirements. Read more here
Read the Policy Brief based on an extensive report on biosafety data requirements here
Regulatory assessment
Technical report “Regulatory Options for New Genomic Techniques in the European Union” – Read More
In this document we have provided six options considering the potential regulatory design of such changes. These options also cover the widest spectrum of possibilities, ranging from working within the framework of the current legislation (Option 1) to streamlining NGT regulatory design with one of the other acts on risk regulation in the EU (Option 6). We included in the development of our six regulatory options for NGTs the following regulatory tools: (A) Authorisation; (B) Post-approval / Postmarket-requirements; (C) Labelling; (D) Traceability; (E) Implications as Incentives (EU / International / Liability / Economic Impact); and (F) Future Proof.
Access the D1.6 – NGT Policy Directions – A policy-based report will provide background and highlight necessary policy directions. Read more here
Read the Policy Brief based on an extensive report on NGT Policy Direstions here
Safety data requirements
More information coming soon.
Economic assessment
More information coming soon.
System Map
The system maps development has already started. The first step was taken on a workshop in March 2023.
The key results from this first effort are:
- There are many elements that are important to think about when introducing NGT-derived organisms in the European bioeconomy. These can be grouped in four subsystems: 1) Economic, 2) Ecological, 3) Social, and 4) Regulatory.
- Everything is connected. Elements influence each other within groups, as well as between subsystems. When one element changes, this will impact the whole system.
Read the report on the GeneBEcon´s First Systems Approach workshop [link]
Consumer and stakeholder perception
The GeneBEcon research on consumer and stakeholder acceptance explores how New Genomic Techniques (NGTs) are received, understood, and accepted by various audiences.
It will focus on consumer acceptance of biobased products derived from NGTs, using representative consumer surveys conducted in five European countries. Additionally, a qualitative focus group discussion will be held with key agri-food chain stakeholders who may develop, use, or sell NGT-derived products in Europe.
The research will assess current and anticipated levels of understanding of this technology and propose strategies to raise awareness and create a positive environment for the adoption of NGTs.
Access the GeneBEcon Consumer Acceptance poster here.
Access the Report on consumer and stakeholder acceptance of NGTs here.
Advancing NGTs in R&I for microalgae and potato
This document outlines the development of a publicly accessible Toolbox, designed for broad applicability beyond just potato and microalgae, extending its utility to other organisms and species. To ensure global compatibility, sustainable access, and transparent documentation, all plasmids will be based on internationally standardized cloning vector systems.
Access the D2.1 – Preliminary toolbox for gene editing – the creation of the preliminary Toolbox, which includes the first version containing existing protocols for plant transfection and regeneration used by EV-ILVO, SLU, and INRAE for gene editing in various crops. Additionally, it provides information on 76 plasmids designed for the delivery of CRISPR/Cas elements. Read more here
Innovating the Production Processes
The GeneBEcon project is dedicated to innovating production processes by investigating how New Genomic Techniques (NGTs) can drive advancements in energy-efficient, low-input, and zero-pollution agricultural production and industrial processing.
One of the crops under investigation in the project is the microalgae Chlorella, with the goal of extracting Mycosporine-like Amino Acids (MAAs) for pharmaceutical and other relevant applications. The project will develop a gentle extraction method that avoids harsh chemicals, enabling the residual biomass to be utilized as animal feed.
Access the D3.1 – Report on upscaling of WT microalgae strain – This report describes the upscaling of wild type Chlorella microalgae from a few millilitres to pilot scale production in a 250 liter photobioreactor. Read more here
Communication and Engagement
The Initial Communication and Engagement Plan outlines the project’s communication objectives and strategy. It details the target audiences and stakeholders, key messages to be conveyed, and the tools and channels to be utilized. Additionally, it includes a three-year action plan and the engagement strategy for GeneBEcon.
Access the D4.1 – Initial Communication and Engagement Plan – to describe the strategy that will be used by GeneBEcon partners to ensure that the vision and mission of the project, as well as its progress and outcomes are communicated to a wide range of audiences. Read more here
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