Regulation of Residues of Antimicrobial Veterinary Medicinal Products in Food in the European Union

Abstract

The current regulation of residues of antimicrobial veterinary medicinal products resulting from the treatment of food-producing animals in the European Union (EU) is reviewed and results of the application of the regulation are presented. European legislation concerning the control of residues of veterinary medicinal products requires the evaluation of antimicrobial properties of residues of such products. Three evaluation approaches are accepted: (i) human data, (ii) data to demonstrate no-observed-effect-levels obtained in gnotobiotic human gut ora associated (HFA) animals or (iii) the calculation of a microbiological acceptable daily intake (ADI) from in vitro minimum inhibition concentration (MIC) data. By September 1999, a total of 55 antimicrobial substances of 16 different classes were evaluated in the EU with respect to the safety of their residues to the consumer and for 46 of these the microbiological effects of their residues was assessed. In most instances (41 substances) in vitro MIC data were used for the evaluation and an arbitrary microbiological ADI was calculated. Suf cient human data were present only for tetracyclines (tetra-, chlortetra-, oxytetra-and doxycycline) and adequate data from gnotobiotic animals (human gut ora-associated rats or mice) were available only for tilmicosin. However, only for 39 of the 55 compounds the antimicrobial effects of residues were considered the most relevant for the overall safety assessment, while for 16 compounds of 5 different classes the toxicological effects were most relevant and their overall evaluation was based on a toxicological ADI. Key words: In uence on human gut ora, microbiological safety of residues, regulation, residues of veterinary medicinal products, review article, safety evaluation.