Scientific Opinion on the safety and efficacy of Lancer (lanthanide citrate) as feed additive for weaned piglets

Lancer is a feed additive mainly consisting of two rare earth elements, lanthanum (La) and cerium (Ce), in their citrate forms. In the absence of an adequate tolerance study in weaned piglets, the FEEDAP Panel cannot conclude on the safety of the additive for the target species. Lancer is not genotoxic. Although one study suggests that La and Ce are not deposited in tissues in piglets, this is apparently not consistent with data found in other species (cattle and rats). Consequently, the Panel is reluctant to conclude that there is no potential for consumer exposure. In addition, in the absence of a no observed adverse effect level, the Panel is unable to relate any possible exposure to evidence of a safe dose. Lancer is not irritant to skin and eyes and does not induce skin sensitisation. The high proportion of particles of diameter less than 10 μm and the high dusting potential suggest that the material can be inhaled deep into the lungs of workers. Although the acute respiratory toxicity data indicate that the dust is of low toxicity, prolonged/repeated exposure should be avoided. The use of Lancer as a feed additive will probably increase the levels of La and Ce above those naturally occurring in the environment. Lanthanum is potentially toxic to environmental relevant species, but its toxicity is highly dependent on speciation. Because of the low solubility of La and Ce, in most situations the additive would probably not give rise to concern for the aquatic environment. There are no data on toxicity of the additive to terrestrial organisms. In the absence of such data, a full environmental assessment cannot be completed. Based on three studies in which growth of piglets was positively affected, the Panel considers that Lancer has the potential to be efficacious