NEW

Recent additions and changes to this website

Ajouts et modifications récents à ce site

Nieuwigheden en recente wijzigingen op deze website

 

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 RegionBrussels-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 RegionBrussels-Capital Region and Wallonia

24/07/2019 - Update: Commercialisation of GMO medicinal products: Some figures

12/06/2019 - UpdateContained 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 RegionBrussels-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 RegionBrussels-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 - UpdateOnline occupational bio-incident notification platform

07/08/2018 - Updated forms: Contained use of GMOs and/or pathogens: Notification procedure in the Flemish RegionBrussels-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)