Apply for permission to work with biological agents

Prerequisites

Fulfillment of the structural, technical, organizational and personal requirements of the BioStoffV to protect employees and other people from the risk of the activities

Documents required

Required documents and evidence are listed in the application form.

Please note

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

The authority must grant permission if all the requirements of the BioStoffV have been met, which must be complied with in order to ensure the protection of employees and other people from the hazards 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 offers both sides (authorizing authority and employer) legal certainty.

If an activity mentioned there is taken up without a permit according to § 15 paragraph 1 sentence 1 BiostoffV, this constitutes an administrative offence. If it is an intentional act that endangers the life or health of an employee, this is according to § 26 number 2 of the Occupational Safety and Health Act punishable.

Deadlines

The permit must be applied for before starting work for the first time. The activity may only be taken up after the permit has been issued (permission reservation with activity ban).

Procedure

• Complete the relevant application form in writing or electronically and send it to the Occupational Health and Safety Office, including the documents listed in the application.
• If the documents or information required for processing are incomplete, you will be contacted by the administrative department.
• If the necessary requirements are met, you will receive the permit notice.
• The decision will be sent to you by e-mail or by post.
• The notice of fees will usually be sent to you later.

Processing time

Approx. 4 weeks

Fees

The level of fees is determined by the fee schedule for the areas of occupational safety and plant and product safety (ArbSchGebO HA).


Subheading 2.6.3.1 Issuing a permit according to § 15 paragraph 1 BioStoffV

Legal remedies

Objections to the decision can be lodged with the competent authority/department within one month of notification. The unsuccessful objection procedure is subject to a fee.

Legal basis

Section 15 Biological Substances Ordinance (BioStoffV)

As an employer, you are obliged to apply for a permit from the Office for Occupational Safety and Health for the following activities:

• in laboratories, in laboratory animal husbandry and in biotechnology, the first start of activities of protection level 3 or 4
• in health service facilities, protection level 4 work, i.e. activities involving highly pathogenic biological substances.