Scientific Opinion on the use of Gum Acacia modified with Octenyl Succinic Anhydride (OSA) as a food additive

The Panel on Food Additives and Nutrient Sources added to Food provides a scientific opinion on the use of OSA modified gum acacia as an emulsifier for flavourings, and other uses. The SCF in 1990 and 1999 considered that the existing data on gum acacia (E 414) did not point to any toxicological concern. In 2009, JECFA allocated a temporary ADI “not specified” to OSA modified gum arabic. The Panel notes that OSA modified gum acacia is not of concern with respect to mutagenicity. From a 90-day study in the rat, NOAELS of 3411 and 4052 mg/kg bw/day (the highest dose tested), for male and female rats, respectively, were derived. The Panel considers that reading across from data on gum acacia (E 414) and food starch sodium octenyl succinate (E1450) there would be no requirements for additional toxicity data on OSA modified gum acacia. The Panel considers the available toxicological dataset to be insufficient to derive an ADI. The mean dietary exposure to OSA modified gum acacia from its combined uses as an emulsifier in flavour-oil emulsions and other emulsifier uses ranges from 4.1 mg/kg bw/day in female adults, to 12 mg/kg bw/day in children (age 1.5-4.5 years). The highest potential exposure (97.5th percentile) ranges from 12 mg/kg bw/day in male adults to 33 mg/kg bw/day in children. Given these intake estimates and taking the lowest derived NOAEL (3411 mg/kg bw/day), a margin of safety of about 280 for male adults and of about 100 for children can be calculated. The Panel considers in this case these margins dequate. Based on the results of the available studies, the information on gum acacia itself and on other OSA modified starches, the Panel concludes that the use of OSA modified gum acacia as an emulsifier in foods at the proposed uses and use levels is of no safety concern.