Biological substances; notification of activities involving biological agents
Among other things, employers must notify the competent trade supervisory office at the government of the first start of a targeted activity with biosubstances of risk group 2 as well as risk group 3(**).
Activities involving biological agents (biosubstances) can endanger 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. In addition, 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 must notify the competent authority
- in laboratories, in laboratory animal husbandry and in biotechnology, the initial inclusion of
- of targeted activities with biomaterials of risk group 2 as well as with biomaterials of risk group 3 marked with (**),
- non-targeted activities of protection level 2 with biosubstances of risk group 3 including those marked with (**), provided that the activities are targeted at these biosubstances and are to be carried out on a regular basis,
- any change in the permitted or indicated activities if these are significant for safety and health protection, for example, activities aimed at increasing the virulence of the biocontaminant or the inclusion of activities with additional risk group 3 or 4 biocontaminants,
- the commissioning of a patient care unit of protection level 4 when an infected patient is admitted and the subsequent decommissioning,
- the discontinuation of an activity requiring a permit in accordance with § 15 of the German Biological Substances Ordinance (BioStoffV).
The notification must include the following information:
- Name and address of the employer,
- description of the intended activities, including the designation of the premises in which these activities are to be carried out,
- the result of the risk assessment according to § 4 BioStoffV,
- the nature of the biostuff,
- the measures envisaged to protect the safety and health of employees.
If necessary, a permit according to § 44 Infektionsschutzgesetz (IfSG) or § 2 Tierseuchenerreger-Verordnung (TierSEV) has to be applied for or the exemption from permission according to § 45 IfSG or § 3 TierSEV has to be justified.
The notification must be submitted in writing to the relevant trade supervisory office.
The obligation to notify may also be fulfilled by submitting to the competent labor inspectorate, within the period specified in the next section, a copy of a notification, permit or authorization under another legal regulation, if it contains equivalent information.
The notification must be made at least 30 days
- before the commencement of notifiable activities,
- before a change in the permitted or notified activities, or
- before the cessation of an activity requiring a permit.
- the admission of an infected patient to a patient care unit of protection level 4
- the decommissioning of the patient ward
shall be made immediately.
The obligation to notify is considered to have been fulfilled if the notification is received by the responsible trade supervisory office in due time. As a rule, there is no confirmation of notification, but further documents can be requested by the office or, if the requirements are not met (Annexes BioStoffV, TRBA 100, etc.), rectification of the deficiencies can be demanded.
Certified copy of the permit according to § 44 IfSG or § 2 TierSEV or statement/justification for exemption from permit according to § 45 IfSG or § 3 TierSEV
(not necessarily to be attached if permission from the competent government has already been obtained)
Location sketch, floor plan of the rooms
List of bio-substances used or occurring in accordance with § 7 Para. 2 BioStoffV (list of bio-substances)
Links to more information
Responsible for editing:Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
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