Biological agents; notification of activities involving biological agents

Employers must notify the responsible trade supervisory office at the government of, among other things, the first-time commencement of a specific activity with biosubstances of risk group 2 and risk group 3(**).

Description

Prerequisites

If necessary, a permit must be applied for in accordance with Section 44 of the Infection Protection Act (IfSG) or Section 2 of the Animal Pathogens Ordinance (TierSEV) or exemption from the permit must be justified in accordance with Section 45 IfSG or Section 3 TierSEV.

Procedure

The notification must be submitted in writing to the responsible trade supervisory office.

Special notes

The obligation to notify may also be fulfilled by submitting a copy of a notification, authorization or permit under another legal provision to the competent trade supervisory office within the period specified in the next section if this contains equivalent information.

Deadlines

The notification must be made at least 30 days

  • before the commencement of notifiable activities,
  • before changing the permitted or notified activities or
  • before discontinuation of an activity requiring a permit.

The notification

  • the admission of an infected patient to a patient ward of protection level 4
  • the decommissioning of the patient ward

must be made immediately.

Processing time

The obligation to notify is deemed to have been fulfilled if the notification is received by the responsible trade supervisory office by the deadline. As a rule, there is no confirmation of notification, but the office may request further documents or, if the requirements are not met (Annexes BioStoffV, TRBA 100, etc.), it may demand that the deficiencies be rectified.

Required documents

  • Certified copy of the permit according to § 44 IfSG or § 2 TierSEV or statement/justification for exemption from permit according to § 45 IfSG or § 3 TierSEV

    (not necessarily to be attached if permission from the competent government has already been obtained)

  • Location sketch, floor plan of the rooms

  • List of bio-substances used or occurring in accordance with § 7 Para. 2 BioStoffV (list of bio-substances)

Online procedures

Status:11.12.2023

Responsible for editing:Bayerisches Staatsministerium für Umwelt und Verbraucherschutz

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  • Online transactions, Bavaria-wide
  • Online transactions, locally limited
  • Form, Bavaria-wide
  • Form, locally limited
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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