Phenylbutazone in horsemeat of low concern, say EU agencies

The presence of phenylbutazone residues in horsemeat poses little threat to consumers, the European Food Safety Authority (EFSA) and the European Medicines Agency (EMA) have said. Consumers should not be concerned, the organisations said, due to the low likelihood of exposure and the overall low likelihood of toxic effects.

According to the EFSA and EMA, 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.

The agencies have delivered a series of recommendations to further reduce the risk of phenylbutazone entering the food chain, focusing on measures to strengthen traceability. The agencies highlighted the need to improve monitoring and reporting of data on veterinary medicine residues in live animals and food products of animal origin across the EU.

Proposed EU-wide measures include introduction of a reliable identification system for horses and other solipeds, harmonising checks of phenylbutazone and improving the reporting of monitoring data for its possible presence in foods.

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.

The agencies found that while the genotoxicity of phenylbutazone (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 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.