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Application for permission according to § 15 Biosubstances Ordinance

Service Description

Biological agents of risk groups 3 and 4 are highly pathogenic pathogens. For this reason, the BioStoffV provides for a permit procedure prior to the commencement of activities of protection levels 3 and 4 in laboratories, in laboratory animal husbandry and in biotechnology, and of protection level 4 in special isolation stations. Only when the competent authority has granted the employer this permission may the corresponding activities be carried out.

Note: Provided that activities requiring a permit under the old Ordinance were notified before the BioStoffV of 15.03.2013 came into force and the structural, technical and organizational conditions on which the notification was based were not significantly changed after 30 September 2021, no permit is required under Section 15 (1) BioStoffV.

Who should I contact?

Locally responsible Regional Inspectorate of Department 6 Occupational Health and Safety Thuringian State Office for Consumer Protection

Which documents are required?

  • Assignment of tasks § 13 Para. 2 ArbSchG
  • Qualified person: Proof of professional qualification according to TRBA 200 No. 6 Para. 3
  • Qualified person: Proof of professional experience according to TRBA 200 No. 6 Para. 3
  • Qualified person: Proof of occupational health and safety competences according to TRBA 200 No. 6 Para. 3
  • Qualified person: Copy of written appointment
  • Copy of permit according to § 44 Infection Protection Act
  • Location sketch, floor plan of the rooms
  • List of biological agents according to § 7 Abs. 2 BioStoffV (Biostoffverzeichnis)
  • Activity description
  • Documentation of protective measures
  • Maintenance concept
  • Internal plan for danger prevention
  • Information on waste and wastewater disposal

What are the fees?

100 to 700 EURO

What deadlines do I have to pay attention to?

The activities can only be taken up after permission has been granted (reservation of permission with a ban on activities).

Legal basis

Appeal

Application for permission according to § 15 Biosubstances Ordinance

What else should I know?

This regulation of the BioStoffV represents a preventive ban with a reservation of permission. This takes into account the hazard potential of the corresponding activities and enables the necessary state control. The permit covers the constructional, technical and organizational requirements according to BioStoffV and thus all operational requirements.

The authority must issue the permit if all the requirements of the BioStoffV are met, which must be complied with in order to ensure the protection of employees and other persons from the hazards posed by biochemicals. It can determine the scope of the permit by means of ancillary provisions such as conditions and requirements (formative administrative act). A permit provides legal certainty for both parties (approving authority and employer).

Supporting institutions

Permit applications should be submitted to the appropriate regional inspectorates within the designated local jurisdiction. They can assist you with any questions that arise regarding the application process.

Author

The text was automatically translated based on the German content per DeepL.

Technically approved by

Thuringian Ministry of Labor, Social Affairs, Health, Women and Family Affairs

Professionally released on

05.04.2022

Source: Zuständigkeitsfinder Thüringen (Linie6PLus)

No competent authority found

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