Cross-contamination of non-target feedingstuffs by decoquinate authorised for use as a feed additive - Scientific opinion of the Panel on Contaminants in the Food Chain
Decoquinate sodium is a quinoline coccidiostat agent that is authorised as a feed additive under Regulations (EC) No 1289/2004 for use in chickens for fattening at a minimummaximum concentration of 20-40 mg/kg complete feed withdrawal period of 3 days for all target animals. Despite the requirements set for feed business operators in Regulation (EC) No 183/2005, it is generally acknowledged that under practical conditions during the production of mixed feeds, a certain percentage of a feed
... tage of a feed batch remains in the production circuit and these residual amounts can contaminate the subsequent feed batches. This cross 1 For citation purposes: Opinion of the Scientific Panel on Contaminants in the Food chain on a request from the European Commission on cross-contamination of non-target feedingstuffs by decoquinate authorised for use as a feed additive, The EFSA Journal (2008) 656, 1-26. Cross-contamination of non-target feedingstuffs by decoquinate The EFSA Journal (2008) 656, 2-26 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 species have been evaluated. Toxicological studies in laboratory animals have identified the dog as the most sensitive species with a NOAEL of 15 mg/kg b.w. per day for subdued behaviour, reduced activity and emesis in a 12-week oral toxicity study. Based on limited tolerance studies on pigs, ruminants, horses and rabbits, it is considered that accidental ingestion of feed intended for chickens containing decoquinate at the maximum authorised level of 40 mg/kg feed 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 decoquinate would be well below the overall NOAEL value. 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 decoquinate sodium in feed for target animals. Consumer exposure was estimated from the results of kinetic studies in chickens and laying hens. Linear extrapolation from the results of the kinetic studies gave an estimate of the residue concentrations in chickens that had been fed diet that was cross-contaminated at levels of 10% (4 mg/kg feed) at a withdrawal time of essentially zero. By linear extrapolation of the data at 24 hours withdrawal, chickens fed a diet cross-contaminated with 10% decoquinate would be expected to have concentrations of 12, 51, 63, 30 and 75 µg decoquinate equivalents/kg in eggs, liver, kidney, muscle and skin/fat, respectively. Overall, the estimated human exposure would correspond to a total of 33.4 µg/person per day (0.56 µg/kg b.w. per day for a 60 kg person). This exposure is well below (0.75%) the ADI of 75 µg/kg b.w as established by the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP). Therefore, the CONTAM Panel concluded that there is no indication of appreciable risk to consumers' health from ingestion of decoquinate residues in tissues of animals exposed to feed cross-contaminated up to a hypothetical level of 10% of the maximum level authorised for target animal species.