Based on the results of the available studies, the Panel on Food Additives and Nutrient Sources added to Food (ANS) considers that the use of OSA modified gum acacia as an emulsifier in foods at the proposed uses and use levels gives rise to no safety concerns.
OSA modified gum acacia is proposed as an emulsifier in flavour-oil preparations for use in a wide range of food applications from baked goods, breakfast cereals and snacks, to meat, fish and egg products, and is also proposed by the petitioner for a number of other emulsifier uses including in fruit flavoured beverages, salad dressings, sauces and icing.
EFSA said that the manufacturer requested the authorisation of OSA modified gum acacia for these uses under Directive 95/2/EC.
According to the applicant, the additive is produced by the introduction of lipophilic groups to gum acacia by a controlled esterification process analogous to the production of starch sodium octenyl succinate (E 1450). The starting material acacia gum (E 414) is an authorised food additive under Directive 95/2/EC.
The EFSA panel notes that the allergenicity of OSA modified gum acacia might be similar to that of other gums, and it said that the available toxicological dataset is insufficient to derive an acceptable daily intake (ADI).
While no absorption, distribution, metabolism and excretion (ADME) studies on OSA modified gum acacia are available, the Panel found that studies in animals show that gum acacia itself is almost completely digested and degraded in the caecum, and it added that a study in humans shows that it is metabolised in the colon.
“In a 90-day subchronic dietary study in the rat, administration of OSA modified gum acacia in the diet for 13 weeks did not produce any adverse effects,” states the EFSA opinion.
However, the Panel noted that chemical modification reduces the extent of enzyme-catalyzed hydrolysis in starch and gives rise to a modified food starch with increased levels of slowly digestible starch and resistant starch.
Therefore, it considers that “the OSA-modification of gum acacia could also result in a reduction in digestion/fermentation by colonic microflora of the large intestine as compared to gum acacia itself.”
The Panel reported that the estimated worst case exposure (97.5th percentile) to OSA modified gum acacia from its proposed combined uses as emulsifier in flavour-oil emulsions and as emulsifier in specified food categories is equal to 12 mg/kg bw/day in male adults, and to 33 mg/kg bw/day for children (age 1.5-4.5 years).
“Given these estimates and taking the lowest NOAEL derived from the 90-day study (3411 mg/kg bw/day), the Panel calculated a margin of safety of about 280 for male adults and of about 100 for children," stated the ANS.
And the Panel said that it considers these margins of safety resulting from the proposed use levels of OSA modified gum acacia adequate.