The European Food Safety Authority (EFSA) has reaffirmed that it cannot conclude on the safety for consumers of the feed additive Sangrovit Extra, consisting of Macleaya cordata extract and leaves, when used in feed for suckling and weaned piglets and other growing Suidae. In a scientific opinion adopted on 1 July 2026 and published on 21 July 2026, EFSA's Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed new data submitted by the applicant, Phytobiotics Futterzusatzstoffe GmbH, but found that the negative results of an in vitro mammalian gene mutation assay did not override previous concerns about the genotoxicity of the alkaloids sanguinarine and chelerythrine present in the additive.
The opinion follows a previous EFSA assessment of 17 April 2024, in which the FEEDAP Panel had already identified a safety concern for consumers because exposure to sanguinarine and chelerythrine via the additive exceeded the threshold of toxicological concern for DNA-reactive mutagens and carcinogens (0.0025 μg/kg body weight per day). At that time, the Panel could not conclude on consumer safety, though it found the additive safe for target animals and the environment, and noted it is an eye irritant but not a skin irritant or sensitiser. The European Commission subsequently gave the applicant the opportunity to submit supplementary information to address the genotoxicity issue.
In the new assessment, the applicant provided an in vitro L5178Y gene mutation assay at the hprt locus, conducted according to OECD Test Guideline 476 and claimed to be GLP-compliant. The study tested Macleaya cordata extract at concentrations up to cytotoxic levels, both with and without metabolic activation. No statistically significant increases in mutant frequency were observed, and the Panel considered the results negative. However, the FEEDAP Panel noted that, in line with EFSA's statement on genotoxicity of chemical mixtures, negative results with the extract could be due to the presence of multiple chemicals affecting assay sensitivity. Therefore, the findings do not change the earlier conclusion on the genotoxicity of the individual alkaloids sanguinarine and chelerythrine. The Panel thus cannot conclude on consumer safety for Sangrovit Extra.
The additive is currently authorised for use in poultry for fattening, but the new opinion leaves its authorisation for piglets and other Suidae uncertain. The European Commission will consider EFSA's opinion in its decision on whether to grant Union authorisation for the new target species. The opinion impacts the applicant, Phytobiotics, which seeks market expansion, as well as pig farmers and consumers who may face continued restrictions on the additive's use. The European Union Reference Laboratory confirmed that previous analytical methods for controlling sanguinarine levels remain valid.