Recent additions and changes to this website
Ajouts et modifications récents à ce site
Nieuwigheden en recente wijzigingen op deze website
19/12/2024 - Update: Procedural changes in the notification procedure for contained use of GMOs and/or pathogens in the Flemish Region, starting from 1st March 2025. To clarify these changes and address your questions, an online info session will be held by the competent authority on 11 February 2025, from 10:00 to 12:00 CET. Save the date! Further details and a registration link will be shared early 2025. This session will provide an opportunity to ask questions and gain insights into the new procedures.
27/11/2024 - Update: Notification form "administratieve gegevens" for contained use notifications in the Flemish region (version "Nov 2024" in the form's footer)
09/11/2024 - Update: Procedural changes in the notification procedure for contained use of GMOs and/or pathogens in the Flemish Region, starting from 1st March 2025.
09/10/2024 - New: Communication: Biological safety for diagnostics and research on the Marburg virus
02/10/2024 - Updated data: Clinical trials with GMOs: Some figures
01/10/2024 - Updated data: Contained use activities in Belgium - Some figures
05/09/2024 - Update: Notification form "administratieve gegevens" for contained use notifications in the Flemish region (version "Sept 2024" in the form's footer)
22/08/2024 - Update: Biosafety guidelines for the contained use of mpox virus, in French and Dutch
18/04/2024 - Update: Notification procedures: Clinical Trials with GMOs for human or veterinary use: deletion of the paragraph on the specific case of COVID-19 clinical trials, since the conditions for the application of Regulation (EU) 2020/1043 are no longer fulfilled.
14/12/2023 - New: Biosafety guidelines for contained use activities with arthropods (PDF file in English, French, Dutch)
20/11/2023 - Update: Notification procedures: Clinical Trials with GMOs for human or veterinary use: Belgian regulatory guidance on the use of genetically modified organisms in a clinical trial (PDF, latest version: October 2023)
20/11/2023 - Addition: Remark concerning the page Contained use - Risks associated with the use of viral vectors
14/11/2023 - Update: Contained use of GMOs and/or pathogens: Notification procedure in the Brussels-Capital Region (clarification of the content of the biosafety dossier)
18/10/2023 - New SBB publication: Onnockx, S.; Baldo, A.; Pauwels, K. Oncolytic Viruses: An Inventory of Shedding Data from Clinical Trials and Elements for the Environmental Risk Assessment. Vaccines 2023, 11, 1448
16/10/2023 - Update: Contained use - Criteria and other protective measures for containment level G3 in Dutch and French
12/10/2023 - Addition: Contained use - Criteria and other protective measures for containment level G3 in Dutch and French
11/10/2023 - Update: Contained use of GMOs and/or pathogens: Notification procedure in the Brussels-Capital Region (clarification of the procedure for subsequent use of risk class 1)
14/09/2023 - Update: Commercialisation of GMO medicinal products: Some figures
07/09/2023 - Update: Safety measures for the transport of GMOs and/or pathogens
27/04/2023 - Update: Poliomyelitis eradication and poliovirus laboratory containment - WHO Global Action Plan (GAP)
31/03/2023 - Update: Guideline for Part B PCR detection method
14/03/2022 - Updated data: Contained use activities in Belgium - Some figures
14/03/2022 - Updated data: Clinical trials with GMOs: Some figures
07/02/2023 - Update: Tools - Belgian classification for micro-organisms based on their biological risks
31/01/2023 - Update: Tools - Belgian classification for micro-organisms based on their biological risks
25/01/2023 - Update: Belgian regulatory framework for the deliberate release of GMOs.
25/01/2023 - Update: Contact person of the federal competent authority and information for submitting a notification for an environmental release in Belgium of a GMO for experimental purposes
17/10/2022 - New: We are looking for scientists to join our panel of experts ! Watch our video and find out more here !
12/08/2022 - Update: Belgian classification for micro-organisms based on their biological risks: Revised lists of pathogens and their corresponding class of biological risk (bacteria pathogenic for humans and animals)
05/08/2022 - Update: Contained use activities in Belgium - Some figures
14/07/2022 - Update: Belgian classification for micro-organisms based on their biological risks: Revised lists of pathogens and their corresponding class of biological risk (bacteria pathogenic for humans and animals, unconventional agents pathogenic for humans and animals, phytopathogenic bacteria)
30/06/2022 - New: Biosafety guidelines for the diagnostic and research activities involving the Monkeypox virus, in French and Dutch
30/06/2022 - Update: Commercialisation of GMO medicinal products: Some figures
10/03/2022 - New SBB publication: Mark H. J. Sturme, Jan Pieter van der Berg, Lianne M. S. Bouwman, Adinda De Schrijver, Ruud A. de Maagd, Gijs A. Kleter, and Evy Battaglia-de Wilde (2022). Occurrence and Nature of Off-Target Modifications by CRISPR-Cas Genome Editing in Plants. ACS Agricultural Science & Technology
18/01/2022 - Updated data: Clinical trials with GMOs: Some figures
11/01/2022 - Updated guidelines: Biological waste inactivation and disposal: PDF file in French and in Dutch, part of the Tools for risk assessment and risk management of activities of contained use.
03/01/2022 - Update: Contact e-mail addresses of the Flemish government for dossiers related to the contained use of GMOs and/or pathogens
10/12/2021 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2, in French and Dutch
09/11/2021 - New page (FR): Formation en biosécurité, organisée par la Haute Ecole Bruxelles-Brabant, Ecole d’Ingénieurs industriels ISIB, en partenariat avec le SBB.
20/10/2021 - Update: Contained use of GMOs and/or pathogens: Notification procedure in Wallonia: procedure for contained use activities of risk class 1.
20/10/2021 - Update: Belgian classification for micro-organisms based on their biological risks: note on modified risk classes for some micro-organisms
03/05/2021 - New SBB publication: Baldo, A.; Leunda, A.; Willemarck, N.; Pauwels, K. Environmental Risk Assessment of Recombinant Viral Vector Vaccines against SARS-Cov-2. Vaccines 2021, 9, 453. https://doi.org/10.3390/vaccines9050453
13/04/2021 - Addition: Clinical trials with GMOs: Tools for risk assessment and risk management
02/04/2021 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2, in French and Dutch
09/03/2021 - Update: Guideline for Part B PCR detection method
15/02/2021 - Updated data: Clinical trials with GMOs: Some figures
19/08/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2, in French and Dutch
30/07/2020 - Update: Poliomyelitis eradication and poliovirus laboratory containment - GAPIII (Global Action Plan III)
22/07/2020 - Addition: Clinical trials with investigational medicinal products for COVID-19 containing or consisting of GMOs: Temporary derogation from the GMO legislation (in French, Dutch and English)
18/06/2020 - Update: Kleine aanpassing in de kennisgevingsprocedure voor activiteiten van “ingeperkt gebruik” in Vlaanderen. Gezien de wijziging van milieuvergunningen van bepaalde duur naar omgevingsvergunningen van onbepaalde duur, zijn we procedureel verplicht volgende wijziging door te voeren. Kennisgevingen zijn enkel nog mogelijk voor het melden van wijzigingen (doelstelling, lokalen, biologisch materiaal, aangewende technieken,…) in reeds toegelaten activiteiten. Nieuwe activiteiten dienen steeds via een toelatingsaanvraag te gebeuren. Indien er een toelating wordt verstrekt, zal deze geldig zijn voor een specifieke periode (te bepalen door de technisch deskundige). In geval van een kennisgeving wordt de geldigheidstermijn van de in het verleden vergunde activiteit (waarop de kennisgeving van de wijziging slaat) overgenomen.
Deze aanpassing is van toepassing vanaf 1/07/2020. Voor de dossiers die vóór 1/07/2020 werden ingediend en positief worden geadviseerd, zal automatisch een schriftelijke toelating met een geldigheidstermijn van 5 of 10 jaar (te bepalen door technisch deskundige) uitgeschreven worden, tenzij de activiteit nog onder een milieuvergunning/omgevingsvergunning van bepaalde duur valt.
18/06/2020 - Update: FAQ W5 (dossierrechten ingeperkt gebruik voor het Vlaams Gewest)
05/06/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2, in French and Dutch
29/05/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2, in French and Dutch
07/05/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2, in French and Dutch
15/04/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2 (2019-nCoV), in French and Dutch
10/04/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2 (2019-nCoV), in French and Dutch
25/03/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2 (2019-nCoV), in French and Dutch
04/03/2020 - Update: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2 (2019-nCoV), in French and Dutch
11/02/2020 - New: Biosafety guidelines for the diagnostic and research activities involving the SARS-CoV-2 (2019-nCoV), in French and Dutch
10/02/2020 - Update: Contained use of GMOs and/or pathogens: Notification procedure in the Flemish Region
09/01/2020 - Updated data: Clinical trials with GMOs: Some figures
07/01/2020 - Update: Notification procedures: Clinical Trials with GMOs for human or veterinary use
24/10/2019 - Updated forms: Contained use of GMOs and/or pathogens: Notification procedure in the Flemish Region, Brussels-Capital Region and Wallonia
27/09/2019 - Update: Contained use of GMOs and/or pathogens: Notification procedure in Wallonia
26/09/2019 - Updated forms: Contained use of GMOs and/or pathogens: Notification procedure in the Flemish Region, Brussels-Capital Region and Wallonia
24/07/2019 - Update: Commercialisation of GMO medicinal products: Some figures
12/06/2019 - Update: Contained use of GMMs: Emergency planning
11/06/2019 - Addition: Documents containing recommendations on storage and internal transport for activities of contained use (only in FR and NL).
11/06/2019 - Update: User request forms for the classification of micro-organisms which don't appear on the lists of pathogenic micro-organisms.
20/05/2019 - Update: Information for notification forms for certain clinical trials in humans in the frame of notifications for contained use activities in the Flemish Region, Brussels-Capital Region and Wallonia
20/05/2019 - Update: Clinical trials with GMOs: Some figures
13/05/2019 - Update: Guidance on the use of GMOs in clinical trials
13/05/2019 - Added event: International course Principles of Biosafety
11/04/2019 - Updated forms: Contained use of GMOs and/or pathogens: Notification procedure in the Flemish Region, Brussels-Capital Region and Wallonia
22/02/2019 - Update: A new request for a clinical trial with a medicinal GMO (notification B/BE/19/BVW2) has been submitted by BioMarin. It is currently evaluated by the Biosafety Advisory Council.
07/11/2018 - Update: Notification procedures for clinical trials with GMOs for human or veterinary use, updated explanations to the procedures and added template documents.
22/10/2018 - Update: Legal status of organisms obtained by targeted genome editing, following the ruling of the European Court of Justice of 25 July 2018.
17/10/2018 - Addition: Translations in English of the containment and protective measures documents for containment levels L1, L2, HR1 and HR2.
04/10/2018 - Addition: Biological incident report form for the notification of a Laboratory Acquired Infection or a biological incident during an activity of contained use
04/10/2018 - Update: Online occupational bio-incident notification platform
07/08/2018 - Updated forms: Contained use of GMOs and/or pathogens: Notification procedure in the Flemish Region, Brussels-Capital Region and Wallonia
24/07/2018 - Update: Notification procedures: Clinical Trials with GMOs for human or veterinary use (in particular "Information requested for a ‘deliberate release’ dossier")
07/06/2018 - Addition: Flowchart for decision for the handling of environmental or patient samples in containment (page on the application of the GMO legislation in the case of pathogenic micro-organisms)