Applying for permission to work with biological agents

To work with biosubstances of protection levels 3 and 4, you require a permit from the competent authority.

Biological agents in risk groups 3 and 4 are highly pathogenic agents. For this reason, the BioStoffV stipulates a permit procedure before starting activities at protection level 3 and 4 in laboratories, in laboratory animal husbandry and in biotechnology as well as protection level 4 in special isolation stations. The relevant activities may only be carried out once the competent authority has granted the employer this permit.

Note: If 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 have not been significantly changed after 30 September 2021, no permit is required in accordance with Section 15 (1) BioStoffV.

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State Trade Inspectorate of Lower Saxony

Application for a permit in accordance with § 15 of the Biological Agents Ordinance

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

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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 structural, technical and organizational requirements in accordance with the BioStoffV and therefore all operational requirements.

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

Applications for permits must be submitted to the relevant regional inspectorates within the scope of their designated local responsibilities. They can assist you with any questions you may have regarding the application.

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