EFSA’s Panel on Food Additives and Nutrient Sources (ANS) noted that despite an acceptable daily intake (ADI) of 20 mg/kg bw/day being established by the Joint FAO/WHO Expert Committee on Food Additives (JECFA), it could not determine safety at that or any other level.
“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),” the ANS stated.
But after assessing several trials it deemed inconclusive, the ANS concluded: “The Panel considers that available data on calcium lignosulphonate (40-65) are insufficient to establish an ADI.”
It said more long-term toxicity studies were required, “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.”
The petition was submitted by DSM Nutritional Products which noted calcium lignosulphonate (40-65) is sourced from soft wood pulp and was different to other calcium lignosulphonates due to lower degrees of lignin polymerisation and higher content of sugars.
DSM intended to use it with water dispersible forms of β-carotene, zeaxanthin, lutein, lycopene, canthaxanthin, β-apo-8’-carotenal, vitamin A, vitamin D, Vitamin E and vitamin K.
Lignosulphonates are used in a variety of food manufacturing applications including dispensing, binding, complexing and emulsifying.
The ANS said that while studies indicated a No Observed Adverse Effect Level (NOAEL) of up to 2000 mg/kg bw/day, the studies were compromised by factors such as the use of unhealthy patients.