EU regulatory framework on biosafety: Protection of workers exposed to biological agents at work

(All the links provided below refer to Eur-lex, the electronic Official Journal of the EU - © European Union, 1998-2016)

The EU has established specific protection rules to ensure the health and safety of workers exposed to biological agents (i.e. micro-organisms, cell cultures and human endoparasites, which may be able to provoke any infection, allergy or toxicity). The regulatory framework classifies biological agents into four risk groups, according to the risk of infection involved, and describes containment measures to be applied according to the nature of the activities, the assessment of risk to workers, and the nature of the biological agent concerned. It also defines employers’ obligations. Since biological agents also include those which have been genetically modified, there is a clear link between this legislation and the one applicable to the contained use of GMOs.

  • DIRECTIVE 2000/54/EC of the European Parliament and of the Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work (seventh individual directive within the meaning of Article 16(1) of Directive 89/391/EEC). (OJ L 262, 17.10.2000, p.21)
  • COUNCIL DIRECTIVE 89/391/EEC of 12 June 1989 on the introduction of measures to encourage improvements in the safety and health of workers at work. (OJ L 183, 29.6.1989, p. 1)​

Previous EU legislation (repealed by the abovementioned Directive)

  • COUNCIL DIRECTIVE 90/679/EEC of 26 November 1990 on the protection of workers from risks related to exposure to biological agents at work. (OJ L 374, 31.12.1990, p.1)
  • COUNCIL DIRECTIVE 93/88/EEC of 12 October 1993 amending Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work. (OJ L 268, 29.10.1993, p.71)
  • COMMISSION DIRECTIVE 95/30/EC of 30 June 1995 adapting to technical progress Council Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work. (OJ L 155, 6.7.1995, p.41)
  • COMMISSION DIRECTIVE 97/59/EC of 7 October 1997 adapting to technical progress Council Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work. (OJ L 282, 15.10.1997, p.33)
  • COMMISSION DIRECTIVE 97/65/EC of 26 November 1997 adapting, for the third time, to technical progress Council Directive 90/679/EEC on the protection of workers from risks related to exposure to biological agents at work. (OJ L 335, 6.12.1997, p.17)