Scientific Opinion on the use of calcium lignosulphonate (40-65) as a carrier for vitamins and carotenoids

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the safety of calcium lignosulphonate (40-65) when used as a carrier for vitamins and carotenoids intended to be added to foods for colouring and nutrient purposes. Calcium lignosulphonate (40-65) has been evaluated by JECFA and an ADI of 20 mg/kg bw/day was established. Calcium lignosulphonate (40-65) is poorly absorbed following oral administration. From the results obtained in vitro from one bacterial reverse mutation assay and one mammalian chromosomal aberration assay it can be concluded that there is no indication for a genotoxic potential of calcium lignosulphonate (40-65). In a short-term 28-day toxicity study, a NOAEL of 1500 mg/kg bw/day was identified for calcium lignosulphonate (40-65) based on minimal focal/multifocal chronic inflammation in the rectum of male rats. In a 90-day subchronic toxicity study the petitioner identified a NOAEL of 2000 mg/kg bw/day for calcium lignosulphonate (40-65), the highest dose tested. The Panel, however, considered this study inadequate for evaluating the safety of calcium lignosulphonate (40-65) due to the high incidence of lymphoid hyperplasia and lymphoid infiltration in the mandibular and mesenteric lymph nodes, in the Peyer’s patches and in the liver in all animals, including controls. Therefore, the Panel considers that available data on calcium lignosulphonate (40-65) are insufficient to establish an ADI. Furthermore, the Panel considers that long-term toxicity studies are needed to elucidate whether the histiocytosis in the mesenteric lymph nodes of the rats observed in the inadequate 90-day toxicity study may progress into a more adverse state with time. Overall, based on the available information, the Panel concludes that the safety of use of calcium lignosulphonate (40-65), as a carrier for vitamins and carotenoids intended to be added to foods for colouring and nutrient purposes, cannot be assessed.