Display activities with pathogens

  • Performance specification

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

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

    These can cause an infection or a transmissible disease in humans.

    If you, as the responsible person or permit holder, intend to take up activities with pathogens, whether without a permit or subject to a permit, you must notify the competent authority.

    The obligation to notify applies to new activities that have not yet been reported. However, it also applies if this activity has already been reported previously by another responsible person or licence holder. The activity is only deemed to have commenced if the responsible person has never previously worked with the pathogen.

    Employees who work under the supervision of a person who has the necessary authorisation to work with pathogens are not required to notify the authorities.

    Activities with pathogens are considered to be:

    • Experiments with pathogens capable of reproduction,
    • Microbiological tests and methods for the detection of reportable pathogens using process steps for the targeted enrichment or multiplication of pathogens.

    Even if a licence is not required, a person who works with pathogens must still report this activity.

  • Which documents are required?

    • Notarised copy of the permit under the Infection Protection Act, if this was issued by another authority, or information on exemption from the permit
    • Information on the nature and scope of the intended activities
    • Information on disposal measures:
      • Listing or naming of the pathogens
      • Presentation of the disposal routes and disposal procedures for infectious waste
    • Information on the presence of an animal stable
    • Information on the condition of the rooms and facilities:
      • Submission of the floor plan with functional designation of the rooms, i.e. designation of the floor, representation of the access routes,
      • Designation of laboratory rooms for microbiological work,
      • Description of the function of the laboratory rooms.
      • Description of the demarcation to other areas in which no activities involving biological agents of the specified risk group are carried out.
      • An assessment of the hazard and assignment of the activities to a protection level
      • Description of the room equipment and room layout. A detailed description of the workspaces is required, in particular a description of the surfaces, laboratory benches, installations, ventilation systems, windows and desks.
      • Illustration of the supply and disposal areas, the ancillary rooms, any animal stalls and the technical equipment.
      • Creation of a list of laboratory equipment with location details, in particular a description of the steam steriliser, which is used for the disposal of biological agents.
      • Information on maintenance, efficacy checks and description of waste containers for the disposal of microbiological waste.
    • Presentation of the protective measures:
      • Proof of protective measures for targeted and non-targeted activities with biological agents in laboratories
      • Illustration of the labelling of workplaces, in particular the positioning of doors, collection containers and furnishings with the biohazard symbol
    • Submission of the operating instructions
    • Presentation of the hygiene plan
    • Information on the presence of an animal stable

  • What are the fees?

    Prepayment: No

  • What deadlines do I have to observe?

    The activity must be notified at least 30 days before the intended commencement of activities.

    The activity may only commence once the notification is complete and the activity is authorised after the documents and premises have been checked.

  • Legal basis

    DIN EN12740 - Guidance for the treatment, inactivation and testing of waste

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

    DIN 58956-10 - Medical microbiology; medical microbiological laboratories; safety labelling

    DIN 58956-3 - Medical microbiology; medical microbiology laboratories; requirements for the organisation plan

    DIN 58956-5 - Medical microbiology; medical microbiological laboratories; requirements for the hygiene plan

  • What else should I know?

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


Responsible departments