A joint assessment from the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) concludes that the illegal presence of residues of phenylbutazone in horsemeat is of low concern for consumers due to the low likelihood of exposure and the overall low likelihood of toxic effects. EFSA and EMA confirm that it is not possible to set safe levels for phenylbutazone in food products of animal origin and therefore its use in the food chain should remain prohibited.
As part of this remit, EFSA and EMA delivered a series of recommendations to further reduce the risk of this substance entering the food chain, focusing on measures to strengthen traceability. The agencies reiterate the need to improve the monitoring and reporting of data on the presence of residues of veterinary medicines in live animals and food products of animal origin across the European Union (EU).
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 could be established, animals treated with phenylbutazone are not allowed to enter the food chain. In their joint risk assessment, experts from EFSA and EMA used all currently available scientific evidence to assess the toxicity of phenylbutazone and reconfirmed these conclusions.
EFSA and EMA identified the health hazards associated with phenylbutazone and assessed whether consumer exposure 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 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 of phenylbutazone (that is, its potential to damage human DNA) could not be excluded, this was considered unlikely.The report also concluded that the risk of carcinogenicity is of very low concern given the estimated infrequency of consuming horsemeat containing residues ofphenylbutazone (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 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.