Panel on food additives, flavourings, processing aids and materials in contact with food has been asked to re-evaluate the safety of sucrose esters of fatty acids (E 473).
Sucrose esters of fatty acids, E 473 (and sucroglycerides, E 474, which are a mixture of sucrose esters of fatty acids and mono-, di- and triglycerides from edible fats or oils) are food additives permitted in the European Union for use as emulsifiers and stabilisers for oil/water emulsions in several processed foods by Directive 95/2/EC on food additives other than colours and sweeteners.
The EC Scientific Committee for Food (SCF) considered sucrose esters of fatty acids (together with sucroglycerides) in 1992. The SCF established a group ADI of 0-20 mg/kg bw (expressed as sucrose monostearate) for sucrose esters of fatty acids and sucroglycerides derived from palm oil, lard and tallow fatty acids, providing that specifications would limit the presence of tetra and higher esters to no more than 7%.
The re-evaluation was requested in the light of new studies on short- and long-term toxicity in experimental animals as well as toxicokinetic studies in animals and humans. In addition, studies on laxative effects in humans had been provided.
Sucrose esters of fatty acids have low oral toxicity and do not raise concern of carcinogenicity. Metabolic studies in vitro and in rats, dogs and humans show that these esters are extensively hydrolysed in the gastrointestinal tract into well-known food constituents prior to absorption, that only small amounts of intact monoesters are absorbed, and that incompletely hydrolysed sucrose esters appear to be excreted in the faeces. It is unlikely that di- and higher esters are absorbed intact. There is no evidence of tissue accumulation of the absorbed monoesters. They are completely metabolised to carbon dioxide or integrated into other endogenous constituents.
From the new 2-year chronic toxicity/carcinogenicity study a NOAEL can be established at 5% sucrose esters of fatty acids in the diet of rats, equal to 1970 mg/kg bw/day in males. The sucrose esters of fatty acids tested was composed of sucrose esters of stearic and palmitic acids (70:30) with a high content of tetra- and higher esters. The main effects seen in rats in previous long-term studies on sucrose esters of fatty acids containing lower levels of higher esters at very high doses (³ 10% dietary levels) were a tendency towards lower body weights, soft stool and diarrhoea. The NOAEL of 2000 mg/kg bw/day from the new long-term rat study.
Concern about a potential laxative effect in humans was raised by results from an inadequate study in which laxation and related abdominal symptoms were reported in humans ingesting doses of sucrose esters of fatty acids exceeding 2g/day equivalent to 33 mg/kg bw/day. In a subsequent well designed and conducted human tolerance study no adverse effects were observed in men and women receiving divided daily doses of 1.5 g sucrose esters of fatty acids in bread for 5 days (equal to 27 mg/kg in men and 29 mg/kg in women). However, this was the only dose level tested, and it was lower than the dose range (33 – 75 mg/kg bw/day) reported to produce gastrointestinal symptoms in the first study.
Considering all the toxicity data with an overall NOAEL of 2000 a group ADI of 40 mg/kg bw/day can be established for sucrose esters of fatty acids (E 473) and sucroglycerides (E 474). However, in view of the human tolerance studies the Panel wishes to point out that at daily doses above 2 g/day in adults these substances may cause gastrointestinal symptoms. This ADI covers products containing mono-, di- and triesters with a content of tetra and higher esters of no more than 10%.
Conservative estimates of chronic intake of sucrose ester of fatty acids (E 473) and sucroglycerides (E 474) in the adult population were above 20 mg/kg bw/day at the 95th percentile. In young children, conservative estimates of the chronic intake approach the ADI. Refined chronic intake estimates are needed. Based on current Maximum Permitted Levels, for a variety of foods and beverages, a single eating occasion would lead to intakes of sucrose esters of fatty acids (E 473) and sucroglycerides (E 474) in the range of 1 g. High intakes on a one day basis could therefore be expected, particularly in children.
Taking both the new rat studies and the human tolerance studies into consideration a group ADI of 40 mg/kg bw/day was established for sucrose esters of fatty acids (E 473) and sucroglycerides (E 474).