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

Employers require a permit from the responsible trade supervisory office at the government before starting activities of protection level 3 or 4 for the first time.

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

You can find everything you need to know about notifiable activities under "Biological substances; notification of activities involving biological agents"

Biological agents are microorganisms, cell cultures and endoparasites (parasites that live in humans) - including their genetically modified forms. The term also covers 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.

• 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.

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

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 risks posed by 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.

If another official decision, in particular an authorization or permit under public law, includes the permit in accordance with the 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.