Cross-contamination of non-target feedingstuffs by robenidine authorised for use as a feed additive(1) Scientific Opinion of the Panel on Contaminants in the Food Chain

Robenidine hydrochloride is a non-ionophoric synthetic compound that is authorised as a coccidiostat for use in chickens for fattening and turkeys at a minimum-maximum concentration of 30-36 mg/kg complete feed, and in rabbits for fattening at a minimummaximum concentration of 50-66 mg/kg complete feed withdrawal period of 5 days for all target animals (Commission Regulation (EC) No 1800/20042). Despite the requirements set for feed business operators in Regulation No (EC) 183/2005, it is generally acknowledged that under practical conditions during the production of mixed feeds, a certain percentage of a feed batch remains in the production circuit and these residual amounts can contaminate the subsequent feed batches. This cross-contamination may result in the exposure of non-target animal species, and hence the potential health risks for non-target animal species as well as the potential residue deposition in foods derived from these non-target animal species have been evaluated. Based on limited tolerance studies performed by industry on laying hens, pigs and ruminants, it is considered that accidental ingestion of feed intended for chickens, turkeys and rabbits containing robenidine at the maximum authorised level of 36, 36 and 66 mg/kg feed, respectively, does not present a health risk for these non-target animal species. At a level of cross-contamination of 10% of the maximum authorised level, the intake of robenidine would be well below the overall no observed effect level (NOEL) of 7.5 mg/kg b. w. (based on liver enlargement derived from a 90 day dog study). Hence, the CONTAM Panel concluded that adverse effects are unlikely to occur in non-target animals as a result of cross-contamination of feed at a level up to 10% of the maximum authorised level of robenidine hydrochloride in feed for target animals. No kinetic or occurrence data were available to estimate the amount of robenidine residues in milk, meat or offal from non-target animal species. Hence, consumer exposure was estimated using kinetic data from chickens for fattening fed the maximum level authorised for rabbits (66 mg robenidine/kg feed). These data were extrapolated to a concentration of 6.6 mg/kg feed to correspond to feed cross-contaminated with robenidine at a level of 10% of the maximum authorised level. Consumption of such poultry products (100 g of liver, 300 g muscle, 90 g skin/fat and 10 g kidney and 100 g eggs) could give an intake of 1.6 mu g/kg b. w. for a 60 kg consumer, which represents 4.3% of the ADI of 37.5 mu g/kg b. w. per day established by the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP). Therefore, even though kinetics and tissue deposition can differ between chickens for fattening and non-target animal species, the ADI is unlikely to be exceeded. The CONTAM Panel concluded that the limited dataset provides no indication of an appreciable risk to consumers' health from the ingestion of robenidine residues in products from animals exposed to feed cross-contaminated up to a hypothetical level of 10% of the maximum authorised level for robenidine.