The European Commission has asked the European Medicines Agency (EMA) and the European Food Safety Authority (EFSA) to carry out a joint assessment of the risks to human health from the presence in horsemeat of residues of the anti-inflammatory drug phenylbutazone. The request follows the recent identification of beef products contaminated with horsemeat and the discovery of phenylbutazone – also known as ‘bute’ – in a small number of horse carcasses intended for the food chain. The European Union (EU) agencies will provide scientific advice by 15 April 2013 to help inform decision-making of the European Commission with regard to these recent findings.


In carrying out the joint risk assessment, the two agencies will use all available scientific evidence and consider data and results of ongoing testing of horsemeat in Member States as these become available. In a joint statement, the EMA and EFSA will provide advice on any potential risk for consumers arising from the presence of phenylbutazone residues in horsemeat. In this regard, the agencies will consider both the risk posed from consumption of horsemeat itself and that arising from other products illegally contaminated with horsemeat. The agencies have been asked to advise, where appropriate, on whether additional control options are needed to minimise any risks identified.

Phenylbutazone is used sparingly in human medicine for the treatment of severe inflammatory conditions where no other treatment is considered suitable. In veterinary medicine, its use is permitted in some Member States for pain relief and to reduce inflammation in non-food-producing animals (dogs and sport horses).  Phenylbutazone is not permitted to be used in the treatment of animals destined for the human food chain and any presence of the substance in food of animal origin therefore results from the illegal use of carcasses of treated horses.



  • On 21 February 2013, the European Commission adopted a coordinated plan on controls with regard to fraudulent practices in the marketing of beef products. This includes a testing plan for phenylbutazone in horsemeat that foresees the testing of one sample for every 50 tonnes of horsemeat. Each Member State is required to carry out a minimum of five tests, the results of which will be reported regularly to the Commission.
  • EFSA publishes an annual report summarising the monitoring data provided by Member States on the presence of residues of veterinary medicinal products and certain substances in live animals and animal products in the EU. This report includes information on the presence of residues of phenylbutazone in horsemeat.
  • EFSA is currently carrying out a major piece of scientific work in support of the proposed modernisation of the meat inspection system in Europe. EFSA has already published scientific opinions on the public-health hazards to be addressed by poultry and swine meat inspection. In June 2013, it will produce a similar opinion on horsemeat inspection.
  • In the context of food safety in the EU, the EMA provides to the European Commission recommendations on the safe levels (maximum residue limits, MRLs) of residues of veterinary medicines in foodstuffs of animal origin.
  • The EMA assessed phenylbutazone in 1997 for the purpose of establishing MRLs and concluded that the data available did not allow for a recommendation for the establishment of MRLs to be made. As a consequence, phenylbutazone is not authorised for use in food-producing animals.


Posted on the EMA website on 7 March 2013