Evaluating the Safety and Efficacy of Macleaya cordata Extract in Feeding Piglets and Growing Pigs

In May 2024, the European Food Safety Authority (EFSA) issued a scientific opinion on the safety and efficacy of Macleaya cordata (Willd.) R. Br. extract and leaves (Sangrovit® Extra) as a zootechnical feed additive for suckling and weaned piglets as well as other growing pigs. This evaluation was conducted at the request of the European Commission.

The key findings from the EFSA assessment are as follows:

1. Safety Concerns: The presence of the DNA intercalators sanguinarine and chelerythrine in the additive raised concerns about potential genotoxicity. While EFSA did not identify safety concerns for the target animal species when the additive is used at the recommended level, the exposure of consumers to sanguinarine and chelerythrine exceeds the threshold of toxicological concern for DNA reactive mutagens and/or carcinogens. As a result, EFSA could not conclude on the overall safety for consumers.

2. Irritation and Sensitization: The additive was found to be irritant to the eyes but not to the skin. EFSA could not exclude the potential for the additive to be a respiratory sensitizer. Appropriate measures to reduce user exposure were recommended when handling the additive.

3. Environmental Safety: The use of Sangrovit® Extra as a feed additive under the proposed conditions was considered safe for the environment.

4. Efficacy: The additive was shown to have the potential to be efficacious in improving the performance of weaned piglets at the recommended level of 0.600 mg sanguinarine/kg complete feed. This conclusion was extended to suckling piglets and extrapolated to other growing pigs.

In summary, while the EFSA panel identified potential safety concerns related to the genotoxic compounds present in the Macleaya cordata extract, they recognized the additive's potential to improve the performance of piglets and growing pigs. Further research and risk mitigation measures may be necessary to fully address the safety concerns before the additive can be approved for use in the EU.