In 1985 the European Commission for the Control of Foot-and-Mouth Disease (EuFMD) at the Food and Agriculture Organization (FAO) of the United Nations adopted a document entitled “Minimum Standards for Laboratories working with FMDV in vitro and in vivo”. This document described a set of precautions to be taken by foot-and-mouth disease (FMD) laboratories to avoid an escape of virus. Council Directive 90/423/EEC, amending Directive 85/511/EEC on Community measures for the control of FMD, made the above standards a condition for the approval and operation of laboratories handling infectious FMD virus (FMDV) inside Europe.  

Although this document dealt with all the important aspects of FMD containment, it was necessary to review it with special reference to the need for more specific technical and general requirements as a consequence of changes in Europe to the policy of non-vaccination. The security standards as specified in the 1993 revision were to be considered as minimum requirements for FMD laboratories located in FMD-free countries with or without systematic prophylactic vaccination. Article 65 of Council Directive 2003/85/EC on Community measures for the control of FMD and repealing Directive 85/511/EEC made the FMD laboratory standards, as amended in 1993, a condition for the approval and operation of laboratories handling infectious FMDV. Effective 21 April 2021, the FMD directive 2003/85/EC was repealed and replaced by Regulation (EU) 2016/429 of the European Parliament and of the Council of 9 March 2016 on transmissible animal diseases and amending and repealing certain acts regarding animal health, and its delegated and implementing acts. Article 6 of Regulation 2016/429 obliges laboratories handling disease agents to follow relevant international standards and take appropriate measures to prevent the escape of these agents. In accordance with Article 16(2) of that Regulation, the Commission is empowered to adopt delegated acts concerning the safety measures for the prevention and control of listed and emerging diseases as regards laboratories, facilities and other natural or legal persons handling the disease agents, vaccines and other biological products in relation to biosecurity, biosafety and bio-containment measures and movement requirements for disease agents, vaccines and other biological products.