This chapter applies to the risk assessment for activities involving biological substances (biological agents). According to the German Ordinance on Biological Agents (BioStoffV), biological agents are microorganisms (bacteria, viruses, protozoa, fungi), cell cultures and endoparasites, including their genetically modified forms, as well as agents associated with transmissible spongiform encephalopathy (TSE), which can endanger humans through infections, infection-related acute or chronic diseases, toxin formation or sensitising effects.
Equivalent to biological substances are 1. ectoparasites that can cause independent diseases or sensitising or toxic effects in humans, 2. engineered biological entities with new properties that can endanger humans in the same way as biological substances.
In addition to pathogens, there are many biological substances that pose no danger to humans and those that are beneficial to health.
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