White blood cell reduction in animal studies
In rat feeding studies, doses above 400 mg/kg body weight per day produced statistically significant, dose-dependent falls in white blood cell and lymphocyte counts. The EFSA panel reviewed the raw data and confirmed the effect was real, but could not identify the biological mechanism or determine whether it has any relevance to humans at food-use levels. Because the mechanism remained unexplained, the panel treated it as an unresolved safety signal rather than dismissing it.
Dose-dependent decreases in white blood cell and lymphocyte counts were observed in rats at doses above 400 mg/kg bw/day; the toxicological relevance of these haematological findings could not be determined by the panel.
2019AnimalEFSA CONTAM Panel, EFSA Journal
Reproductive signal in female rat offspring
In a multi-generation rat study, female offspring exposed to the highest test dose (around 500 mg/kg body weight per day) showed vaginal opening approximately four days later than controls. EFSA considered this a toxicologically relevant endpoint, though it occurs at doses far above any realistic food exposure. The applicant argued it was transient; the panel disagreed with that characterisation.
Delayed vaginal opening in female rat offspring was observed at the highest dose tested and was considered a toxicologically relevant finding by EFSA.
2019AnimalEFSA CONTAM Panel, EFSA Journal
ADI and children's exposure
The original EFSA review in 2007 set an acceptable daily intake of 0.5 mg/kg body weight per day. A 2019 review was triggered by a request to extend permitted uses and raise the ADI to 5 mg/kg, a tenfold increase. EFSA refused: it found that even at the existing, lower maximum levels, toddlers and children eating processed meat regularly could already reach the current ADI at the 95th percentile of intake. The proposed extensions would have pushed mean intakes above the ADI for all age groups.
EFSA maintained the ADI at 0.5 mg/kg bw/day and refused the proposed tenfold increase, noting that toddlers and children could reach this limit at the 95th percentile under existing permitted levels.
2019Regulatory reviewEFSA CONTAM Panel, EFSA Journal
Antimicrobial mechanism and spectrum
Laboratory studies confirm that ethyl lauroyl arginate disrupts bacterial cell membranes across a broad range of pathogens including Listeria monocytogenes, Salmonella, E. coli and Staphylococcus aureus. The effect is primarily surface-level: it works when food is coated or sprayed rather than throughout the bulk of the product.
Ethyl lauroyl arginate showed broad-spectrum antimicrobial activity against both gram-positive and gram-negative bacteria in laboratory tests, acting by disrupting cell membrane integrity.
2007LabEFSA ANS Panel, initial opinion, EFSA Journal