Regulation on safety and health protection in activities involving biological agents

The Biological Agents Ordinance (BioStoffV) is a German regulation that governs work with biological agents to protect employees and others from infections, toxins, or sensitising effects. It defines biological agents, classifies them into risk groups (1–4), and covers activities in laboratories, healthcare, and biotechnology. Employers must carry out risk assessments, implement hygiene and safety measures, provide training, and keep documentation. High-risk activities (protection levels 3–4) require official permits, restricted access, designated responsible personnel, and emergency plans.