EU agencies consider phenylbutazone detected in horsemeat of low concern for consumers; recommend improved horse traceability and monitoring of veterinary medicinal residues

The request for advice from the European Commission follows the recent identification of beef products adulterated with horsemeat and the discovery of the anti-inflammatory drug phenylbutazone in horse carcasses illegally entering the food chain.

Phenylbutazone was previously evaluated by EMA in 1997 to establish maximum residue limits (MRLs) in food products of animal origin. The data available at that time did not allow a conclusion to be drawn on the level of phenylbutazone that could be considered safe in food of animal origin. As no MRL The maximum amount of a pesticide residue allowed in foods or animal feeds, expressed as milligrams per kilogram. could be established, animals treated with phenylbutazone are not allowed to enter the food chain.  In their joint risk assessment  A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation., experts from EFSA and EMA used all currently available scientific evidence to assess the toxicity The potential of a substance to cause harm to a living organism. of phenylbutazone and reconfirmed these conclusions.

EFSA and EMA identified the health hazards associated with phenylbutazone and assessed whether consumer exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time. to this substance through its illegal presence in horsemeat could be of concern.

Phenylbutazone is occasionally used in human medicine for the treatment of patients with severe rheumatoid arthritis and has been linked to rare occurrence The fact or frequency of something (e.g. a disease or deficiency in a population) happening. of a blood disorder,  aplastic anemia, which has been observed in 1 in 30,000 people treated.  The report concluded that the likelihood that a predisposed individual consume horsemeat contaminated with the drug and develop this condition is low – between 2 in a trillion and 1 in 100 million.  This estimate takes into account the likelihood of consumers being exposed to phenylbutazone on a given day from the consumption of horsemeat itself or from beef products adulterated with horsemeat. 

EFSA and EMA found that while the genotoxicity When a substance is capable of damaging the DNA in cells. of phenylbutazone (that is, its potential to damage human DNA A complex chain-like molecule that carries the genetic material, present in living organisms and some viruses. DNA (deoxyribonucleic acid) is capable of copying itself and carries the instructions for all the proteins used to create and sustain life.) could not be excluded, this was considered unlikely.  The report also concluded that the risk of carcinogenicity Cancer-causing property of a substance when an animal or human is exposed to it. is of very low concern given the estimated infrequency of consuming horsemeat containing residues of  phenylbutazone (consumed as such or in beef products adulterated with horsemeat) and the estimated low levels of the drug to which consumers could be exposed through the diet. In estimating possible levels of phenylbutazone in foods, scientists used the highest concentration of the drug reported in the testing programme carried out by Member States.

Traceability The ability to track the journey of a foodstuff or ingredient through all stages of production, processing and distribution. and monitoring

EFSA and EMA provided advice to further reduce the risk to consumers from the illegal presence of phenylbutazone in horsemeat. Proposed EU-wide measures include introduction of a reliable identification system for horses and other so-called solipeds, harmonising checks of phenylbutazone and improving the reporting of monitoring data for its possible presence in foods. This final suggestion echoes a recommendation made by EFSA in its latest report on Veterinary Medicines Residues.

• Joint Statement of EFSA and EMA on the presence of residues of phenylbutazone in horse meat
• Report for 2011 on the results from the monitoring of veterinary medicinal product residues and other substances in live animals and animal products
• European Commission Q&A on horsemeat
• European Medicines Agency