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Brussels, 18 December 2002

FMD: Commission proposes improved Directive to control outbreaks

The European Commission today adopted revised and improved legislation on EU measures to control outbreaks of foot-and-mouth disease (FMD). FMD is a highly contagious viral disease. It is not dangerous for humans but outbreaks among livestock are associated with exceptionally high economic consequences, as seen most recently in the EU in 2001. The amended Directive outlines procedures on how to recover "free of FMD without vaccination" status, which is of crucial importance for trade. Control actions are supplemented with measures to ensure a high level of preparation against the disease. The Commission is given a key role in managing an outbreak in partnership with the Member States.

Underlining the importance of the proposal, David Byrne, Commissioner for Health and Consumer Protection, said: "Outbreaks of foot-and-mouth disease in individual Member States impact on the EU as a whole as we saw last year. The amended law aims to maintain or, in the event of an outbreak, quickly regain the 'FMD-free' status that is of key importance for trade in animals and animal products. Emergency vaccination is moved to the forefront of control measures instead of being the last resort. Our proposal takes into account the lessons learned from the 2001 outbreak and takes up suggestions made by the European Parliament's Temporary Committee on FMD."

Emergency vaccination as a primary response in the case of an outbreak

The proposal, for the first time since 1992, gives emergency vaccination a central role in tackling an outbreak. However, l the proposal does not change the current policy banning prophylactic vaccination.

Recent modifications made to international recommendations for trade in live animals and products of animal origin, notably by the OIE (the World Organisation for Animal Health) in May 2002, and new technological developments allow the use of vaccination in a much more flexible way.

Laboratory tests are now available to differentiate between vaccinated herds and those infected by the virus. In line with OIE requirements, the proposal details the procedure for how to recover "free of FMD without vaccination" status - the best animal health standard in relation to FMD- within 6 months(1) of the last outbreak or completion of vaccination, whichever occurs last. This revised and more flexible procedure is to be used by a country that used emergency vaccination in combination with eradication of infected herds and post-vaccination surveillance testing.

Further new elements

The proposal adds detailed provisions for placing on the market of products derived from animals of susceptible species, such as meat and milk products, in the case of an outbreak. The draft law also provides for "regionalisation", limiting restrictions to the particular regions of a Member State that are affected by an outbreak.

The draft Directive outlines the measures to be taken in order to prepare for an outbreak. The main new elements are:

  • Veterinary services will be empowered to establish suspect restriction zones and to impose a temporary movement ban on large parts of affected Member States.

  • The control strategy combines measures to deal with infected animals that have been subject to emergency vaccination. Detailed rules are laid down for how to treat and use products such as milk and meat from animals under restriction and from vaccinated animals. These products are not dangerous to humans.

  • Provisions are made for diagnostic facilities, in particular a Community Reference Laboratory, including a bank for diagnostic reagents, test kits, etc.

  • Detailed provisions are laid down for the management of the European antigen bank and for access to this bank by Member States and, where required, third countries. Specific rules are laid down for the confidential treatment of information on the quantities and strains of antigens stored at the bank..

  • Emphasis is put on preparation of contingency plans, including the preparation for a "worst case" scenario. Contingency plans have to be regularly updated in the light of the results of alert exercises


The EU measures for the control of FMD are currently laid down in Directive 85/511/EEC(2). The "non-vaccination policy" was introduced by Council Directive 90/423/EEC(3), which also specified requirements for contingency planning and antigen stocks for the production of vaccines for emergency vaccination. In order to protect livestock against infection, it also made modifications to the conditions for intra-EU trade and imports from third countries of susceptible animals and animal products, such as milk and meat. The proposal for a new FMD Directive is based on the experience with classical swine fever in 1997 and the application in 2001 of the current measures for FMD control as well as intensive stakeholder consultation, and the report of the European Parliament adopted on 17th December 2002.

Next steps

The proposal is to be submitted to Council under Article 37 and the Council will request an opinion of the European Parliament. The Greek Presidency has signalled a great interest in the matter and hopes to finalise discussions during the spring of 2003.

(1)Before the change to its animal health code, the OIE required a 12-month waiting period.

(2)OJ L 315, 26.11.1985, p. 11.

(3)OJ L 224, 18.8.1990, p. 13.

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