This page was automatically translated using the online service DeepL. The translation is intended to aid understanding and may contain language-specific inaccuracies. The official text is written in German. Any discrepancies or differences resulting solely from the translation are not legally binding. In case of doubt, the German version shall prevail. It is recommended to consult a qualified translator in case of doubt.

Report Activities Involving Pathogens

Teaser

If you have a permit to work with pathogens and wish to begin such work for the first time, you must notify the appropriate authority.

  • Service description

    The term "pathogen" refers to agents capable of reproduction. These include, for example:

    • Viruses
    • Bacteria
    • Mushrooms
    • Parasites
    • or other biologically transmissible agents

    They can cause an infection or a communicable disease in humans.

    If you, as the responsible person or as a license holder, intend to engage in activities involving pathogens—whether such activities are exempt from licensing or require a license—you must notify the competent authority.

    The reporting requirement applies to a new activity that has not yet been reported. However, it also applies if this activity was previously reported by another responsible person or permit holder. The activity is considered to have commenced only if the responsible person has never previously worked with the pathogen.

    Employees who work under the supervision of a person who holds the required authorization to work with pathogens are not required to report such activities.

    The following are considered activities involving pathogens:

    • Experiments with pathogenic microorganisms capable of reproduction,
    • Microbiological tests and methods for detecting notifiable pathogens using procedures designed to specifically enrich or culture pathogens.

    Even if no permit is required, a person who works with pathogens must still report this activity.

  • Procedure

    You must notify the appropriate authority of the activity at least 30 days before the intended start date.

  • Competent Authority

    The relevant public health department

  • Prerequisites

    • Permission, Exception, or Exemption
    • There is no cause for concern regarding public health. This is primarily due to
      • there are facilities or premises suitable for the nature and scope of the activities, and
      • The conditions for safe disposal have been met.

  • What documents are required?

    • A certified copy of the permit issued under the Infection Protection Act, if it was issued by another authority, or information regarding the exemption from the permit requirement
    • Information on the nature and scope of the intended activities
    • Information on disposal procedures:
      • Listing or naming of pathogens
      • Overview of Disposal Routes and Methods for Infectious Waste
    • Information on the Presence of an Animal Shed
    • Information on the condition of the rooms and facilities:
      • Submission of the floor plan showing the functions of the rooms, i.e., identification of the floor, depiction of access routes,
      • Naming of laboratory spaces for microbiological work,
      • Description of the functions of the laboratory rooms.
      • Description of the demarcation from other areas where no activities involving biological agents of the specified risk group are carried out.
      • An assessment of the risk and classification of activities into a protection level
      • Description of the room's furnishings and layout. A detailed description of the work areas is required, particularly regarding surfaces, laboratory benches, fixtures, ventilation systems, windows, and desks.
      • A diagram showing the supply and disposal areas, ancillary rooms, any animal stalls, and technical equipment.
      • Compilation of a list of laboratory equipment, including their locations, with a detailed description of the steam sterilizer used for the disposal of biological agents.
      • Information on maintenance, effectiveness checks, and a description of the waste containers used for the disposal of microbiological waste.
    • Description of the protective measures:
      • Documentation of protective measures for targeted and non-targeted activities involving biological agents in laboratories
      • Illustration of the labeling of workplaces, specifically the placement of doors, collection containers, and furnishings marked with the biohazard symbol
    • Submission of the Operating Instructions
    • Submission of the Hygiene Plan
    • Information on the Presence of an Animal Shed

  • What fees apply?

    Prepayment: No

  • What deadlines do I have to observe?

    The activity must be reported at least 30 days before the intended start date.

    The business may not begin operations until the application is complete and authorization has been granted following an inspection of the documents and the premises.

  • Processing time

    30 days after receipt of the complete documentation.

  • Legal basis

    DIN EN 12740 - Guidelines for the Treatment, Inactivation, and Testing of Waste

    DIN 30739 - Containers for infectious waste with a nominal volume of 30 L to 60 L

    DIN 58956-10 - Medical Microbiology; Medical Microbiology Laboratories; Safety Labeling

    DIN 58956-3 - Medical Microbiology; Medical Microbiology Laboratories; Requirements for the Organizational Chart

    DIN 58956-5 - Medical Microbiology; Medical Microbiology Laboratories; Requirements for the Hygiene Plan

  • Legal remedy

    Administrative Court Action

  • What else should I know?

    All activities involving pathogens, including those that do not require a permit, must be reported.


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