The FAMHP invites establishments of human body material to apply for regularisation as stool banks. The term "stool" is no longer excluded from the scope of the law of 30 October 2018 on human body material. Establishments carrying out activities on faecal material as described in this law are subject to the implementing Royal Decrees and should apply for regularisation as stool bank.
The law of 30 October 2018 contains provisions amending the law of 19 December 2008 on the acquisition and use of human body material for the purpose of medical application to humans or scientific research (hereafter: HBM Law). Article 4, section 1 of the law of 30 October 2018 removes the word "stool" from article 3 of the HBM Law. This means that stool is no longer outside the scope of the HBM Law.
The HBM Law applies to the donation, removal, procurement, testing, processing, preservation, storage, distribution and use of human body material and manufactured products derived from human body material, intended for applications to humans or for scientific research purposes.
In this regard, the FAMHP invites all stakeholders carrying out the aforementioned activities on faecal material to regularise themselves and to submit an application for approval as an establishment for human body material as described in the Royal Decree of 28 September 2009. This decree lays down the general conditions which shall be met by banks for human body materials, intermediary structures and production establishments.
Report nº 9202 of the Superior Health Council on recommendations concerning the therapeutic indications, the procedures, the safety and quality of transplantation of faecal material.