Definition of HBM

Human Bodily Material (HBM) is defined by law as any biological material, including human tissues and cells, gametes, embryos, fetuses, as well as the substances derived thereof, regardless of their degree of processing/transformation (DNA, RNA, proteins, …).

This implies that for instance blood, urine, stool, tears, hairs, nails, … but also cell lines or HBM imported from abroad are within the scope of this law.

Established human cell lines

As no distinction is made based on the HBM-type within the Human Body Material law, established cell lines fall within the scope of this law and should therefore be obtained through a notified biobank. This implies that for any project that includes cell lines, regardless of whether these will be commercially obtained, provided by collaborating researchers or originate from own production, an application has to be with the biobank for the use of these cell lines within scientific research.

Import/export of HBM

All samples imported from abroad for use in Belgium or exported outside Belgium, to the extent that they fall within the scope of the Human Bodily Material Law must be registered within a notified Belgian biobank with which a contract or framework agreement is concluded upon entry into Belgium or before being sent abroad. This obligation is independent of whether it concerns samples from another biobank, a commercial organization, university or a hospital.

Last edit: 9 September 2022