"Investigating the development of metabolic dysfunction- associated steatotic liver disease (MASLD) and insulin resistance"
If there are any questions, additional/more in-depth information is available via the links below. If the questions are not answered, please contact the BSO.
GMO legislation
BVF-platform
The Netherlands Commission on Genetic Modification (COGEM)
Bureau GGO (BGGO)
Loket gentherapie
The Netherlands Food and Consumer Safety Authority (NVWA) - animal by-products
The Nagoya Protocol
The minimal instructions that an ABV/VM/OL must give to new GMO employees or employees who need access to GMO laboratories can be found via this link. When the instructions have been given, the ABV can apply for admission of the employee to the GMO laboratories. This can be done by sending the approval form to the BSO. Criteria for admitting employees to the various containment levels can be found in the procedure Approval of GMO workers to various containment levels.
In the Master Biomedical Sciences, a Biosafety course is given annually by the BSO. This usually takes place in November/December and is also accessible to employees. If the course is successfully completed, a Biosafety certificate is received. Employees can register for this course via the BSO.
Activities with biological material for educational/demonstration purposes must always take place in laboratories. If animal material is used, the animal by-products regulation must also be complied with. Animal material approved for consumption (bought in the store) is also subject to this regulation because the animal material is not used for consumption. For more information, contact the BSO.
The Nagoya Protocol concerns regulations regarding access to genetic resources. The Nagoya Protocol creates rights and obligations for countries that have signed it. The protocol gives countries that own genetic resources the possibility to ask for compensation from citizens and companies that use their resources. The Netherlands has adopted this legislation regarding the Nagoya Protocol since 16 April 2016.
You can read about the implications for scientists and what scientists must do before they start working with genetic resources on the FHML website.
Questions regarding the Nagoya Protocol can be sent to info-nagoyaprotocol@maastrichtuniversity.nl.
To prevent the spread of (pathogenic) microorganisms, and to protect humans and the environment, there are strict procedures for sending and transporting various biological materials. The applicable procedures are described below.
GMO/Biological material
The applicable rules for shipping genetically modified organisms (GMO) and biological material (by road and by air) are described in the work instruction Transport of GMOs and biological material.
Animal by-products (ABP) that are used for scientific research or education must be handled, used, processed, or disposed of correctly. ABP is defined as dead animals or parts of animals, products of animal origin, or other products obtained from animals that are not intended or used for human consumption. Live animals and human material are not considered ABP. Researchers can contact the BSO with questions regarding ABP.
Shipping/transport of animal by-products within the EU and the Netherlands
A completed trade document is required for shipping/transporting ABP within the European Union, including the Netherlands. The document must also contain a cat. 1 label. In this link, information about how to fill in the trade document can be found.
Animal by-products outside the EU
For the shipment of ABP outside the European Union (EU), a distinction must be made between sending and importing ABP. For sending ABP to non-EU countries, the applicable procedures of the receiving country must be followed.
An import exemption is required for importing ABP from non-EU countries. A copy of this import exemption can be requested from the BSO. Importing ABP is subject to strict conditions, which are described in the procedure Importing animal by-products from non-EU countries.
Note: The United Kingdom, Norway, and Switzerland are non-EU countries
Before maintenance can take place on equipment and/or laboratories, it must be stated that the equipment and/or laboratory is free of GMOs. This is registered via the release forms. There is a release form for equipment in general, a form for the release of all BSCs, and a form for the release of GMO laboratories.
When a device is moved to a lower containment level / outside the containment level, the device must also be released.
Also, BSCs present out of containment (not in a GMO laboratory) must be released. There is a separate form for this.
If there is a need to (re)build GMO laboratories, the BSO must be contacted at an early stage to determine what work will take place in the laboratory and what legal requirements apply. The final drawing for this construction/renovation must be approved by the BSO. When renovations/adjustments have been made to a GMO laboratory, the BSO must formally declare that the GMO laboratory (still) meets the legal requirements. For this purpose, the BSO will always visually inspect the GMO laboratory.
In the Maastricht University Hospital (MUMC), research can be conducted in which GMOs are administered to patients; we call these gene therapy studies. These gene therapy studies are part of the GMO legislation, and for this part of the GMO legislation, an environmental safety officer (ESO) is appointed. This ESO supervises all activities covered by the permit and the implementation of/compliance with the legal regulations or measures listed in the permit. The ESO is approved by the Ministry of Infrastructure and Water Management (IenW) and mandated by the Board of Directors of the MUMC.
Gene therapy studies always take place at the Maastricht University Hospital (MUMC), under the responsibility of a physician. That is why the procedures for gene therapy studies can be found on the ODIN portal (online protocol system of the MUMC).
If you have any questions about gene therapy studies, you can contact the ESO.
Please see the Gene Therapy Office website for additional information on the licensing procedures for clinical gene therapy studies and more insight into the procedures for researchers.
Activities with biological agents (including human and animal material) fall under the Working Conditions Act (ARBO legislation). This legislation has been translated into various procedures and work instructions that can be found on this page.
When it comes to activities with biological agents, a distinction is made between two types of actions. Working with material that can contain microorganisms (non-targeted activities) and working with a specific microorganism (targeted activities). For the targeted activities, it has been agreed that a risk assessment will be carried out together with the Biological Safety Officer (BSO).
The BSO offers support to researchers when working with biological agents. The aim is to create safe working conditions for employees and the environment when working with biological agents by:
Deployment in the event of incidents or calamities.
See below for procedures, work instructions, and forms relevant to working with biological agents (not genetically modified):
Specific legislation applies to activities involving genetically modified organisms (GMOs), the GMO legislation and regulations (RGGO2013). Based on this legislation and regulations, it is mandatory to appoint a BSO. The Executive Board of Maastricht University (UM) and the Board of Directors of the Maastricht University Medical Center (MUMC) have mandated the BSO to implement the GMO legislation and monitor compliance.
The BSO offers support to researchers working with GMOs. The aim is to create safe working conditions for employees and the environment when working with GMOs by:
Deployment in the event of incidents or calamities.
See below, for procedures, work instructions, and forms resulting from the GMO legislation.
The Biological Safety Officer (BSO) supervises the activities involving genetically modified organisms (GMOs). In addition, the BSO advises on activities with biological agents in accordance with the Working Conditions Act. The BSO is also the point of contact for questions about the animal by-products regulation (under the supervision of the Netherlands Food and Consumer Product Safety Authority (NVWA)). The BSO offers support to researchers and support staff when working with GMOs and biological agents.
All this, with the aim of creating safe working conditions for employees, students, and the environment when working with (genetically modified) biological agents and laboratory animals.