On this page
- Scientific support to the competent authorities
- Implementation of the European regulatory framework
- European Food Safety Authority (EFSA)
- European Enforcement Project (EEP)
- UN Cartagena Protocol on biosafety
- WHO: Poliomyelitis laboratory containment and eradication plan
- Organisation for Economic Cooperation and Development (OECD)
- European Committee for Standardisation (CEN)
- Other international activities and networking
The SBB provides scientific support to the Belgian Competent Authorities in official fora dealing with biosafety matters at EU and international level, ensuring the continuity of technical and scientific expertise and the scientific consistency of Belgium's position within the different bodies. A single point of contact also makes it possible to simplify the flow of information to authorities and government agencies.
SBB scientific activities at the international level can be split into two broad categories: firstly, direct scientific support to the Belgian authorities within the scope of the official authorities' work or the implementation of the GMO regulatory framework. Secondly, participation in activities of various professional organisations working to support actors in the field of biosafety.
Scientific support to the competent authorities
From the late 1980s and the negotiation of the first GMO Directives in Europe, the Belgian authorities have benefitted from the ongoing technical and scientific support of the SBB during discussions in the European institutions (Commission, Council). The SBB has been involved in the different phases of the evolution of the European regulation, in the adaptation to the technical and scientific progress of annexes of directives and regulations, and with the drafting of guidelines or explanatory notes to support the implementation of Directives and Regulations.
Currently, the scientific support provided by the SBB to the federal or regional authorities mainly translates into participation in meetings of the competent authorities and committees dealing with application of Directives 2009/41/EC and 2001/18/EC, Regulation (EC) 1829/2003 and Regulation (EC) 726/2004.
In addition to the aforementioned official meetings, the European Commission also organises technical meetings where general or specific questions about biosafety are addressed. This is generally done within the framework of working groups in which the SBB regularly participates at the request of the competent authorities. The themes addressed in the expert groups include e.g. the general principles of risk assessment, the monitoring of insect-resistant plants, the use of antibiotic resistance markers, the molecular characterisation of GMOs and the development of a common register of molecular data.
A more recent example is the participation of experts from the SBB in the "New Techniques Working Group", which was set up by the European Commission to assess whether the use of certain techniques leads to genetic modification within the meaning of the definition of GMO in Directives 2009/41/EC and 2001/18/EC.
In order to build mutual understanding of the principles underlying the risk assessment of GMOs and to provide increased transparency in the current process between Member States and the European Food Safety Authority, EFSA established a scientific network for risk assessment of GMOs. The purpose of the network is to enhance cooperation between scientists involved in GMO risk assessment at EFSA and in the EU Member States. It is composed of scientific experts with expertise in GMO food and feed risk assessment and scientific experts with expertise in GMO environmental risk assessment.
The SBB is participating in the activities of this network.
The European Enforcement Project (EEP) was set up in 1997. It is composed of representatives of the Member States of the EU (plus Iceland, Norway and Switzerland) involved in inspectorate activities associated to GMOs. The EEP is a platform for discussion and exchange of information between inspectors in relation to problems stemming from inspection, surveillance and compliance of the two GMO Directives. Information and expertise is exchanged through seminars and joint inspections.
From the outset, the SBB has participated in the activities of this network, to support the competent regional and federal authorities in Belgium. In 2008, the SBB actively contributed to establishing the scientific programme of the annual meeting of the members of the network, organised in Belgium by the Flemish Community and the Federal Public Service for Health, Food Chain Safety and Environment.
The Cartagena Protocol on biosafety is a multilateral treaty that regulates the international exchange of genetically modified organisms (known as "living modified organisms" in this context). The negotiation and implementation of this treaty have mobilized the expertise of the SBB significantly for several years.
Belgium became involved in the negotiation process in 1996, when an international working group was set up with the mission of drawing up a biosafety protocol. The SBB not only provided its scientific expertise at the time, but also took on a coordination role in Belgium throughout the negotiation process. After the adoption of the Protocol in January 2000, the central role of the SBB in the process culminated with the role of coordinator during the Belgian Presidency of the EU in 2001.
The implementation of the treaty in Belgium, which followed its ratification in 2004, led to the distribution of responsibilities between the different bodies concerned. The SBB has maintained its traditional role of technical and scientific support to the authorities for matters concerning risk assessments. The Biosafety Advisory Council is also consulted from time to time for some of these matters.
Moreover, the SBB has been entrusted with the role of national focal point for the Biosafety Clearing-House (BCH) due to its significant experience in the development and management of biosafety information exchange systems. Shortly after the adoption of the Protocol, the SBB also participated in the international panel of experts set up by the Secretariat of the Convention on Biological Diversity to provide technical assistance for the development of the BCH. As the focal point for the BCH, the SBB developed the Belgian component of the BCH, the "Belgian Biosafety Clearing-House". It also ensures that Belgium's obligations with regard to the exchange of information established by the Protocol are fulfilled.
In 1988, the World Health Organization (WHO) adopted a resolution calling for global eradication of poliomyelitis. Within the framework of this global eradication plan, the SBB has been appointed "National Coordinator" in order to supervise the different phases of the plan.
Within the scope of its role as national coordinator, the SBB performed several tasks. For further details, please consult the specific section on this website.
Various initiatives have been taken (particularly by the United Nations as well as at the European level) to reduce the potential risks linked to a terrorist attack or a deliberate or accidental release of biological material or pathogenic agents, whether genetically modified or not.
The biosecurity and biorisk aspects (greatly) exceed the field of competence of public health and are not currently covered by the duties formally entrusted to the SBB by the Cooperation Agreement on biosafety. Nevertheless, this subject obviously has several points in common with biosafety. The scientific and technical expertise of the SBB can therefore be used in the field of biosecurity, particularly in relation to the contained use of GMOs or pathogens (risk assessments, formulation of motivated advices, containment measures, laboratory inspections, updating risk groups of human, animal and plant pathogenic organisms). It is within this context that the SBB has already been asked several times to provide scientific support to the Belgian FPS for Foreign Affairs, Foreign Trade and Development Cooperation.
For further details, please consult the specific section on this website.
The SBB has been appointed as the expert representing Belgium in two OECD experts groups that deal with matters directly related to biosafety: the Working Group for Harmonisation of Regulatory Oversight in Biotechnology, and the Working Group for the Safety of Novel Foods and Feeds.
The main activities of these groups consist in developing and publishing scientific reports (known as "consensus documents") that can be used as a source of information in the preparation of applications for the environmental release or food/feed use of GMOs or within the framework of risk assessments of these GMOs.
The SBB participates in meetings of the groups and intersessional activities (workshops, etc.). It directly contributes to the drafting of some documents. In some cases, experts from the common list of the Biosafety Council and the SBB are consulted to provide a more specific scientific contribution to the preparation of certain documents.
The development of European standards in the field of modern biotechnology was started in December 1992 by the European Commission, to complement the implementation of Directives 90/219/EEC, 90/220/EEC and 90/679/EEC. The Commission tasked the CEN, namely its technical committee TC233, with developing 54 standards covering several fields of application of these Directives.
The CEN has worked in close collaboration with the Member State authorities responsible for implementing the above-mentioned Directives, as well as with the committees of experts set up to adapt those Directives to technical progress. It is within this context that the SBB contributed to the drawing up and use of standards.
The standards prepared by TC233 were one of the technical instruments used in the revision of the regional regulations on the contained use of GMOs at the end of the 1990s. The work of the TC233 Committee ended in the early 2000s .
Other international activities and networking
In addition to its activities of scientific support for Belgian authorities and representation in official organisations, the SBB participates in the activities of various professional organisations at the European and international levels that directly or indirectly address the issue of biosafety.
The cooperation between the SBB and the American Biological Safety Association (ABSA) dates back to 1996, when the Belgian Biosafety Server website was being developed by the SBB (ABSA already had a website at that time). Since then, the SBB has regularly participated in the annual conference organised by ABSA in the United States. This participation enables the SBB to update its information and maintain contacts in the field of risk analysis and management, mainly in relation to the handling of GMOs or pathogenic organisms in a contained environment.
The SBB also contributes to the content of the ABSA journal through the publication of scientific articles. In 2010, the SBB has been awarded by the American Biological Safety Association Council and Awards Committee for its publication entitled “Contained Use of Bacteriophages: Risk Assessment and Biosafety Recommendations”. The Richard C. Knudsen award is given to the authors of an article published in Applied Biosafety that describes significant contributions in areas of scientific investigations and/or health and safety.
Like ABSA in the United States, the European Biosafety Association (EBSA) is a centre of interest in Europe and a place to exchange information relating to all matters connected with biosafety.
The SBB made a contribution from the first stages of the founding of EBSA in 1996, particularly by contributing to the implementation of the first scientific activities and the development of the association's website. Since 1996, the SBB has regularly participated in meetings and other activities organised by EBSA. Here too, the aim is to meet and exchange information with other European scientists involved in biosafety.
Within the framework of EBSA’s activities, the SBB participated also in the EBSA Biosafety Professional (BSP) Competence Task Group (aiming at better defining the tasks and responsibilities of biosafety professionals), and on developing the Laboratory Biorisk Management Standard Guidance CWA 1579 (aiming at establishing the necessary requirements for controlling risks associated to activities in microbiological containment laboratories)
The Belgian Biosafety Professionals association provides a forum for those responsible for biosafety in Belgium, which has the objective of sharing experience in biosafety practices and regulation. It is also a local section of the EBSA. Since the creation of this association in March 2006, the SBB and the BBP have collaborated with the common aim of helping biosafety professionals to implement biosafety measures within the installations concerned. Within this framework, symposia and workshops have been organised by the BBP, to which members of the SBB have contributed several times, particularly with talks.
Since 2006, a network of European Advisory Committees on Biosafety in the field of contained use and deliberate release of GMOs has been set up.
The SBB and the Biosafety Advisory Council became involved in this network from the outset and participate in the annual meetings. In 2009, the Council and the SBB organised the 4th annual meeting, which was held in Brussels on 29 and 30 October.
The European Federation of Biotechnology (EFB) was founded in 1978. Its aim is to promote interdisciplinary cooperation between scientific institutions and companies in Europe in the field of biotechnology.
The SBB mainly participated in the activities of the EFB towards the end of the 1990s. At that time, a working group (Working Party on Safety in Biotechnology) was in place to deal with aspects of biosafety associated with the use of biotechnology. Through that participation, the SBB notably contributed to the publication of three scientific papers on the transport of infectious and biological material, assessment of the risk of releasing microorganisms into the environment, and the DNA content of biotechnological process waste.