Show activities with biological agents

Prerequisites

If necessary, a permit according to § 44 Infection Protection Act (IfSG) or § 2 Animal Epidemic Ordinance (TierSEV) must be applied for or the exemption from a permit according to § 45 IfSG or § 3 TierSEV must be justified.

Documents required

Required documents and evidence are listed in the notification form

The duty of notification can also be fulfilled by sending the competent authority a copy of a notification, permit or permit under another legal regulation within the time limit if this contains equivalent information.

Please note

If a report is not made, not made correctly, not completely or not made in time according to § 16 paragraph BiostoffV, this constitutes an administrative offence. If it is an intentional act that endangers the life or health of an employee, this is according to § 26 number 2 of the Occupational Safety and Health Act.

Deadlines

The advertisement has a maximum of 30 days

• before starting activities that are subject to notification,


• before changing the permitted or reported activities or


• before cessation of an activity requiring a permit.

Admission of an infected patient to a protection level 4 patient ward must be reported immediately.

Procedure

• Complete the notification form in question and send it to the Occupational Health and Safety Office, including the documents listed in the notification.
• If the documents or information required for processing are incomplete, you will be contacted by the administrative department
• As a rule, there is no confirmation of the advertisement

Processing time

The obligation to report is deemed to have been fulfilled if the report is received by the responsible district government in a timely manner. As a rule, there is no confirmation of the notification, but further documents can be requested or, if the requirements are not met (Annexes BioStoffV, TRBA 100 etc.), the rectification of the defects can be requested.

Fees

for free

Legal basis

Section 16 Biological Substances Ordinance (BioStoffV)

As an employer, you are obliged to notify the competent authority of the following activities:

• in laboratories, in laboratory animal husbandry and in biotechnology for the first time
  • a specific activity with biological substances of risk group 2
  • an activity with biological substances of risk group 3, insofar as the activities are not subject to a permit requirement according to § 15
• any change to the permitted or notified activities if these are significant for safety and health protection, for example activities aimed at increasing the virulence of the biological substance or the start of activities with other biological substances of risk group 3 or 4
• the admission of an infected patient to a patient ward of protection level 4,
• the cessation of an activity that requires a permit according to § 15 Biological Substances Ordinance (BioStoffV).