Safety of a feed additive consisting of Macleaya cordata (Willd.) R. Br. extract and leaves (Sangrovit® Extra) for suckling and weaned piglets and other growing Suidae (Phytobiotics Futterzusatzstoffe GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of a feed additive consisting of Macleaya cordata (Willd.) R. Br. extract and leaves (Sangrovit® Extra) as a zootechnical feed additive for suckling and weaned piglets and other growing Suidae. In its previous assessment, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) had no safety concerns for the target species when the additive is used at the recommended level of 0.750 mg sanguinarine/kg complete feed for suckling and weaned piglets and other growing Suidae. However, owing to the presence of the DNA intercalators sanguinarine and chelerythrine, a concern for genotoxicity was identified for the additive and the FEEDAP Panel could not conclude on the safety for the consumer. The use of the additive was considered safe for the environment. The additive was shown to be irritant to the eyes but not irritant to skin or a skin sensitiser. In the current assessment, the applicant provided an in vitro mutagenicity assay in mammalian cells with Macleaya cordata extract. Although the study gave negative results, these would not change the conclusions on the genotoxicity of sanguinarine and chelerythrine reached in the previous assessment. Therefore, the FEEDAP Panel cannot conclude on the safety of Sangrovit® Extra for consumers when used in feed for suckling and weaned piglets and other growing Suidae.