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Country's Decision or any other Communication
(DEC)
last updated: 12 Mar 2025
No
Decision on field trial B/BE/20/V1
EN
06 Apr 2020
No
- Decision on LMOs for intentional introduction into the environment (according to Article 10 or domestic regulatory framework)
No
No
-
- Organization: VIB - Flanders Interuniversity Institute for Biotechnology () | BCH-CON-SCBD-42293-1Organization:VIB - Flanders Interuniversity Institute for Biotechnology ()Rijvisschestraat 120 9052 Zwijnaarde, Belgium Tel.: +09 244 66 11,
, BelgiumPhone:Fax: +09 244 66 10,Email: vib@vib.be,Website: www.vib.be,
Yes
No
No
Approval of the import and/or use of the LMO(s) with conditions
(AI-generated courtesy translation, see the original Dutch attached below)
- The experiment must be carried out as described in the application (the test protocol with proposed containment, follow-up, and monitoring measures) and the responses to the questions from the Biosafety Council dated 24/02/20, and is intended solely for research purposes (Chapter II of the Royal Decree of 21/02/2005).
- In accordance with Article 13, §2, f) of the Royal Decree, V.I.B. assumes full civil liability for any damage caused to human and animal health, property, or the environment as a result of the experiments. The legal responsibility is borne by V.I.B., represented here by the Managing Director, Jo Bury.
- In accordance with Article 13, §2, h) of the Royal Decree, V.I.B. will provide SBB with the necessary control samples along with the associated scientific information no later than 15 days after the start of the experiment.
- All precautions (e.g., regarding the transport of transgenic material, cleaning of used machines, destruction/storage of harvested material, etc.) must be taken to prevent the plants used in the experiments or their reproductive material from falling into unauthorized hands.
- The notifier must keep a logbook in which all operations mentioned in the test protocol are recorded. A copy of the permit is attached to the logbook. The logbook remains available to inspectors from the Federal Public Service (FPS) Health, Food Chain Safety, and Environment.
- All V.I.B. personnel involved in the field trial must be trained to work with GMOs and will be informed of the test conditions and the terms of this permit. The V.I.B. official in charge of the trial must always try to be present on-site when work is being carried out.
- All possible precautions must be taken to prevent the spread of plants, plant parts, or their reproductive material. This means that at least the following containment and monitoring measures must be applied (see also the technical dossier, the opinion of the Biosafety Council, and the responses to the Council's questions): a) The experiment is conducted in an existing maize field, with a 3-meter buffer of non-genetically modified maize plants around it, which will be destroyed after harvest along with the test plot. b) Access to the site is restricted by a fully enclosed fence and wire mesh. c) Any equipment used that may retain plant material must be cleaned within the test site's enclosure. d) The plants (both genetically modified and buffer non-genetically modified) must be harvested very carefully and manually to ensure that no cobs or seeds are lost, even the very small ones. e) Harvesting must take place no later than the end of October. f) The harvested material will be destroyed after the experiment, possibly following laboratory analysis. g) The experiment will be visually monitored. This visual inspection will occur at least twice a month, with increased frequency during the male flowering period (at least every 2 days from the moment the last leaf is formed, until September 15).
- At least one week in advance, an overview of the planting and harvesting dates as well as the plowing date must be communicated to the FPS by email. Any changes to these dates due to unforeseen circumstances must be reported by email no later than the day before.
- V.I.B. agrees either to stop the experiment or to adjust the experimental conditions at the simple request of the FPS, should this service receive new information indicating potential harmful effects, or at the request of FPS inspectors.
- V.I.B. must submit annual activity reports to the FPS. The first annual activity report must be delivered no later than December 31, 2020. When preparing this report, the applicant must include the following points:
- The precise location and period of release,
- The exact surface area of the test field and the plot design,
- The objective(s) of the experiment and the nature of the released transformants,
- A copy of the logbook (see point 5),
- The frequency and nature of field observations,
- The dates and identity of the cobs, stems, and leaves taken from the field and their transport conditions,
- Information on irregularities and unforeseen circumstances,
- Measures taken to prevent unintended release of transgenic material outside the test field,
- An overview of site monitoring,
- Any other relevant information about the experiment.
11. At the end of the release period, a final report must be submitted to the FPS no later than January 31, 2023. The reporting form provided in Decision 2003/701/EC of the European Commission must be used.
12. The FPS must be immediately informed of any irregularity or unforeseen event that may occur.
13. This decision allows no exceptions. Any modification or unintended change that could affect health or environmental risks must be handled in accordance with Article 20 of the Royal Decree of 21/02/2005.
(AI-generated courtesy translation, see the original Dutch attached below)
Considering the following:
Considering the following:
- The notification complies with the provisions of the Royal Decree of 21 February 2005.
- The favorable opinion of the Biosafety Council dated 10 March 2020 concludes that, based on the scientific assessment of the dossier by Belgian experts, it is highly unlikely that this small-scale field experiment with GMO maize will pose any harm to human health, animal health, or the environment, provided that the trial is conducted as described in the dossier.
- The public was consulted from 14/01/2020 to 13/02/2020, and a summary of the consultation was published (see annex).
Since this does not concern an application for market authorization, comments regarding the socio-economic impact of GMOs—being a criterion not included in the current legislation—are not justified in this specific case. - The absence of the use of the veto right by the Flemish Region (in accordance with Article 18 §2 of the Royal Decree of 21/02/05).
No
-
BCH-LMO-SCBD-277137-1 Living Modified Organism Maize with modified growth characteristicsVIB - Flanders Interuniversity Institute for Biotechnology | Changes in physiology and/or production (Growth rate, Yield), Resistance to herbicides (Glufosinate)
-
BCH-RA-BE-272756-1 Risk Assessment generated by a regulatory process Scientific field evaluation of maize with modified growth characteristics (B/BE/20/V1)Maize with modified growth characteristics | Resistance to herbicides, Resistance to antibiotics, Changes in physiology and/or production
- bbe20v1_authorization.pdf [ Dutch ]
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