| Summary: | Lenziaren is a polynuclear Fe(III) starch–saccharose complex intended to be used in food for adult cats to reduce phosphate absorption in the gastrointestinal tract in order to prevent chronic kidney disease. The recommended minimum and maximum levels are 0.25 and 1.0 g/cat per day, equivalent to 5 000 and 20 000 mg/kg complete feed, respectively. In a previous opinion, the Panel concluded that the minimum effective dose was 1 g/cat per day based on three studies which showed either a significant reduction in serum phosphorus or a reduction in urinary phosphate. Two of these studies showed an effect at 0.25 g/cat per day, while the third one only showed an effect at a level of 1 g/cat per day. The results of a new study submitted in this application showed that overall urine inorganic phosphorus concentrations significantly decreased in cats receiving Lenziaren at 0.25 g/day compared with the control group. Therefore, considering the two previous studies, which showed an effect at 0.25 g/cat per day, and the results of the new study, the FEEDAP Panel considers that Lenziaren has the potential to be efficacious in binding intestinal phosphorus at the minimum recommended dose of 0.25 g/cat per day (equivalent to 5 g/kg complete feed). On balance, the Panel considers that the sex difference seen in the new study is an anomaly, possibly owing, as the applicant suggests, to selective feed intake. However, the Panel notes that sex differences were not explored in the remaining efficacy studies. The Panel still has the reservations expressed in the previous opinion regarding the value of the long-term use of the additive in healthy cats.
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