Regulation on the obligation to report in the BioStoffV difficult to understand

According to Section 16 of the BioStoffV, targeted activities involving biological agents in risk group 2 and activities involving biological agents in risk group 3, unless subject to a permit requirement under Section 15 of the BioStoffV, in laboratories, animal facilities, and biotechnology facilities must be reported 30 days before they commence. Any change to the permitted or notified activity that is significant for safety and health protection must also be reported, such as an increase in the virulence of a biological agent or the intended commencement of activities involving additional biological agents in risk groups 3 or 4. For the healthcare service, it is further stipulated that a notification must be made immediately upon admission of an infected patient to a patient ward at protection level 4. Furthermore, the cessation of an activity requiring a permit must be reported.

This can be summarized in tabular form for laboratories, laboratory animal husbandry and biotechnology as follows:

– first-time Recording of targeted activities with biological agents of risk group 2

– first-time Recording activities involving biological agents of risk group 3**

– important for safety and health protection Changes for targeted activities involving biological agents of risk group 2, for activities involving biological agents of risk group 3** and 3 and 4

- Recording other activities with biological agents of risk group 3 or 4

– Attitude activities involving biological agents of risk groups 3 and 4

It should be noted that the 30-day period is a preliminary period. This applies to the initial commencement, modification, and cessation of work involving biological agents.

This publication can also be found on the website of the law firm Dr. Kauch .