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Biological agents; application for a permit for activities involving biological agents

Employers must apply for a permit from the responsible trade supervisory office at the government before starting a specific activity with biosubstances of protection level 3 or 4.

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Procedure details

Activities involving biological agents (bio-substances) can be hazardous to health. Employees who carry out such activities must therefore be given special protection.

Biological agents are microorganisms, cell cultures and endoparasites (parasites that live in humans) - including their genetically modified forms. The term also includes agents associated with TSEs (prions). Biological agents can endanger humans through infections, infection-related acute or chronic diseases, toxin formation or sensitizing effects.

The employer requires a permit from the competent authority before activities of protection level 3 or 4 are undertaken for the first time in laboratories, in laboratory animal husbandry or in biotechnology.

This also applies to health service facilities that are intended for activities at protection level 4.

The permit includes all structural, technical and organizational requirements for the protection of employees and other persons from the hazards of these activities.

Compliance with the structural, technical, organizational and requirements of the BioStoffV to protect employees and other persons from the hazards of the activities.

  • The following documents in particular are required for the application:
    1. Name and address of the employer
    2. Assignment of tasks in accordance with Section 13 (2) of the Act on the Implementation of Occupational Health and Safety Measures to Improve the Safety and Health Protection of Employees at Work (ArbSchG) of the person responsible
    3. In the case of approval under genetic engineering law: copy of the approval notice
    4. Name and qualification of the person appointed in accordance with Section 10(2) or Section 11(7)(3) of the Ordinance on Safety and Health Protection during Activities involving Biological Agents (BioStoffV)
      • Proof of professional qualification in accordance with TRBA 200 No. 6 Para. 3
      • Proof of professional experience in accordance with TRBA 200 No. 6 Para. 3
      • Proof of occupational health and safety competencies in accordance with TRBA 200 No. 6 Para. 3
      • Copy of the written appointment
    5. Certified copy of the permit in accordance with Section 44 of the Infection Protection Act (not necessarily to be enclosed if a permit from the responsible government has already been issued) or confirmation of exemption from the permit by the responsible government in accordance with Section 45 of the Act on the Prevention and Control of Infectious Diseases in Humans (IfSG)
    6. Site plan
    7. Floor plan and designation of the premises
    8. Plan of escape and rescue routes
    9. List of biological agents according to § 7 para. 2 BioStoffV
    10. Description of activities
    11. Documentation of protective measures:
      • structural
      • technical
      • organizational
      • personal
    12. Maintenance and servicing concept
    13. Internal company plan for hazard prevention (plan in accordance with Section 13 (3))
    14. Information on waste and wastewater disposal
    15. Measures for occupational health precautions
      (mandatory and optional precautions in accordance with the Ordinance on Occupational Health Precautions Ordinance on Occupational Health Precautions (ArbmedVV))

    Further documents can be requested if required.

The permit must be applied for in writing or electronically at the responsible trade supervisory office.

The permit is granted if the requirements of the BioStoffV are met, which are necessary to ensure the protection of employees and other persons from the hazards of biological substances.

If the application is submitted electronically, the office may also request multiple copies and the submission of the documents to be attached to the application in written form.

  • Permit for activities at protection level 3: EUR 1,500 to EUR 15,000
  • Permit for activities in protection level 4: EUR 5,000 to 25,000

The permit must be applied for before the activity is taken up for the first time. The activity may only be commenced after the permit has been issued (reservation of permit with prohibition of activity).

The permit is granted if the requirements of the BioStoffV are met, which are necessary to ensure the protection of employees and other persons from the hazards of biological substances.

If another official decision, in particular a permit or authorization under public law, includes the permit in accordance with BioStoffV, the requirement is fulfilled by sending a copy of this official decision to the Trade Supervisory Office.
However, further documents may be requested if necessary.

Status: 02.03.2026
Editorially responsible for prodecure description: Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
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