Biological agents; notification of activities involving biological agents

Employers must notify the responsible trade supervisory office at the government of, among other things, the first-time commencement of a specific activity with biosubstances of risk group 2 and risk group 3(**).

The employer requires a permit from the responsible trade supervisory office at the government before activities of protection level 3 or 4 are started for the first time.
You can find everything you need to know about this under "Biological agents; applying for a permit for activities involving biological agents"

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 must notify the competent authority:

1. in laboratories, in laboratory animal husbandry and in biotechnology, the first commencement of
   • targeted activities with biosubstances of risk group 2 and with biosubstances of risk group 3 that are marked with (**),
   • non-targeted activities of protection level 2 with biosubstances of risk group 3, including those marked with (**), provided that the activities are aimed at these biosubstances and are to be carried out regularly,
2. any change to the permitted or notified activities if these are significant for safety and health protection, for example activities aimed at increasing the virulence of the biosubstance or the inclusion of activities with other risk group 3 or 4 biosubstances,
3. the commissioning of a patient ward of protection level 4 upon admission of an infected patient and the subsequent decommissioning,
4. the cessation of an activity requiring a permit in accordance with Section 15 of the German Ordinance on Biological Substances (BioStoffV).

The notification must include the following information

• Name and address of the employer,
• a description of the planned activities, including the name of the premises in which these activities are to be carried out
• the result of the risk assessment in accordance with § 4 BioStoffV,
• the type of biosubstance,
• the measures planned to protect the health and safety of employees.

• In the online form

  all relevant information is requested and the necessary documents are submitted by uploading them.

  Alternative option:
  All information listed under "The notification must include the following information" and

  • Certified copy of the permit in accordance with Section 44 IfSG or Section 2 TierSEV or details/reasons for exemption from the permit in accordance with Section 45 IfSG or Section 3 TierSEV (not necessarily to be enclosed if a permit has already been issued by the responsible government)
  • Location sketch, floor plan of the rooms
  • List of biological substances used or occurring in accordance with Section 7 (2) BioStoffV (list of biological substances)

The notification must be made at least 30 days

• before the commencement of notifiable activities,
• before changing the permitted or notified activities or
• before discontinuation of an activity requiring a permit.

The notification

• the admission of an infected patient to a patient ward of protection level 4
• the decommissioning of the patient ward

must be made immediately.

The obligation to notify is deemed to have been fulfilled if the notification is received by the responsible trade supervisory office in full and on time. As a rule, there is no confirmation of notification, but the office may request further documents or, if the requirements are not met (Annexes BioStoffV, TRBA 100, etc.), it may demand that the deficiencies be rectified.

The obligation to notify may also be fulfilled by submitting a copy of a notification, authorization or permit under another legal provision to the competent trade supervisory office within the period specified in the next section if this contains equivalent information.