Safety and efficacy of Lantharenol® (Lanthanum carbonate octahydrate) as a feed additive for cats according to Regulation (EC) No 1831/2003
Lantharenol®, the brand name of lanthanum carbonate octahydrate, is a synthetic additive intended to be used in the feed of adult cats to restrict the intestinal absorption of phosphorus. The applicant suggests that restricting phosphorus uptake may act to prevent/reduce chronic renal malfunction in ageing animals. Lantharenol® is proposed to be added to complete feedingstuffs of adult cats at the dose range of 1500 to 7500 mg kg-1 complete feed. The proposed duration of administration is continuous throughout the adult life of the cat. The applicant provided six studies with adult cats to support the efficacy of Lantharenol® in which phosphorus excretion and digestibility were measured. Supplementation of diets with Lantharenol® results in a decrease in phosphorus excretion via urine and an increase in its excretion via faeces, linked to a decrease in apparent phosphorus digestibility. It is concluded that Lantharenol® can reduce the phosphorus absorption in adult cats at the lowest recommended dose (1500 mg kg-1). The FEEDAP Panel is not in a position to comment on whether the changes to phosphorus absorption following the addition of Lantharenol® to the diet of cats will have any long-term effects on renal function. No negative effects were seen after supplementing the diet with at least a ten-fold overdose suggesting that Lantharenol® is safe for cats under the conditions of use proposed. However, it should be noted that tolerance studies are not intended or capable of detecting any adverse effects that might occur over a life-long exposure to Lantharenol®. For this reason, it is recommended that a post-market monitoring plan able to recognise any long-term adverse effects should be introduced. The results of the toxicological studies provided give sufficient reassurance of the safety of Lantharenol® for the user/owner, when used as a feed additive for cats. The use of Lantharenol® as a feed additive for cats is not considered to pose any risk to the environment.