Statement on the safety of calcium lignosulphonate (40-65) as a food additive

In 2010, the Panel on Food Additives and Nutrient Sources added to Food (ANS) of the European Food Safety Authority (EFSA) provided 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. The manufacturer for the use of calcium lignosulphonate (40-65) as a carrier provided a pathological assessment on a 90-day oral toxicity study in Wistar rats which was previously evaluated by the ANS Panel in its opinion. The Panel considers that the new information submitted by the petitioner on calcium lignosulphonate (40-65) does not address the questions raised by the Panel in the previous opinion. The Panel had considered that a chronic toxicity study of at least 12 months duration was needed to elucidate whether the reported histiocytosis in the mesenteric lymph nodes of the rats in the 90-day oral toxicity study could progress into a more adverse state with time and at lower doses. The Panel had considered that interim evaluation groups would be beneficial to the 12 months duration study design.