This regulation applies to activities in which workers are exposed (e.g. vaccine production) or are likely to be exposed (e.g. healthcare, veterinary medicine, agriculture) to biological agents during their work.

On this page

• Regulatory framework
• Definitions
• Procedures
• Competent Authority

Regulatory framework

The regulation in force in Belgium is the Act on well-being of workers, Book VII - Biological agents, Title 1 - General provisions, amended by the Royal Decree of 14 May 2019 amending the Code on well-being of workers as regards periodic health surveillance (M.B. 11.6.2019). This Act is available in French or Dutch.
This regulation corresponds to the implementation of European Directives 90/679/EEC, 93/88/EEC, 95/30/EC, 97/59/EC and 97/65/EC. Directive 90/679/EEC was repealed by Directive 2000/54/EC in September 2000.

Definitions

"Biological agents" are micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity.

Biological agents are classified into four risk groups, according to their level of risk of infection to workers: group 1 includes the less hazardous (agents that are unlikely to cause human disease); group 4 concerns the more hazardous (agents that can cause severe human disease; they present a high risk of spreading to the community, for which there is no effective treatment). Annex I of the Decree provides a list of biological agents and their classification.

Procedures

Risk assessment must be carried out for all professional activities that may expose workers to biological agents. The nature, degree and duration of exposure shall be determined in order to plan preventive and protection measures. This assessment must be renewed regularly.

If the results of the assessment show that the exposure is to a group 1 biological agent only, with no identifiable health risk to workers, the principles of good occupational safety and hygiene should be observed.

In case of exposition to biological agents of group 2, 3 ou 4, protection and preventive measures shall be applied, concerning in particular information and training, hygiene rules, operational procedures, physical containement (containment mesures are described in annexes of the Decree), medical surveillance and vaccination.

Before using group 2, 3 or 4 biological agents for the first time, an employer must notify the "Direction générale Contrôle du Bien-être au Travail - Algemene directie Toezicht op het Welzijn op het Werk"). Any subsequent use (for the first time) of a biological agent of group 4 shall also be notified (with the exception of laboratories carrying out diagnostic activities).

In August 2005, a collaboration protocol was drawn up between Sciensano and the General Division for the Monitoring of Well-being at the Workplace ("Direction générale Contrôle du Bien-être au travail" - CBE; "Algemene directie Toezicht op het Welzijn op het Werk") of the FPS Employment, Labour and Social Consultation. This protocol enables an exchange of information and an annual update regarding risk group 3 (and 4) contained use in Belgium.

Under this protocol, it is agreed that the SBB will extract from its global database the information on risk group 3 contained use which presents a risk to man and forward this information to the CBE. This is sent on an annual basis but data relating to the use of risk group 4 biological agents that represent a risk to man would require immediate notification. The CBE provides the SBB with data at its disposal on cases of laboratory acquired diseases due to the exposure of workers during the contained use of GM or non-GM biological agents. These data are made anonymous before sending.

Competent Authority

Federal Public Service Employment, Labour and Social Dialogue