Article 2

Definitions For the purpose of this Directive: "biological agents" shall mean micro-organisms, including those which have been genetically modified, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity; "micro-organism" shall mean a microbiological entity, cellular or non-cellular, capable of replication or of transferring genetic material; "cell culture" shall mean the in-vitro growth of cells derived from multicellular organisms. "Biological agents" shall be classified into four risk groups, according to their level of risk of infection: 1. group 1 biological agent means one that is unlikely to cause human disease: 2. group 2 biological agent means one that can cause human disease and might be a hazard to workers; it is unlikely to spread to the community; there is usually effective prophylaxis or treatment available; 3. group 3 biological agent means one that can cause severe human disease and present a serious hazard to workers; it may present a risk of spreading to the community, but there is usually effective prophylaxis or treatment available; 4. group 4 biological agent means one that causes severe human disease and is a serious hazard to workers; it may present a high risk of spreading to the community; there is usually no effective prophylaxis or treatment available.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.