EFSA safety review
EFSA's food additives panel reviewed E423 in 2010 and concluded that use as an emulsifier at the proposed levels raised no safety concern. The panel noted that no numerical acceptable daily intake could be set because the toxicological dataset was limited, but it drew on data from plain gum arabic (E414) and OSA-modified food starch (E1450) to fill the gap. A 90-day rat feeding study found no adverse effects even at the highest doses tested, and there was no evidence of mutagenicity.
EFSA concluded that OSA modified gum arabic as an emulsifier in foods at the proposed uses and use levels is not of safety concern. No numerical ADI was set; the panel read across from data on gum acacia (E414) and food starch sodium octenyl succinate (E1450).
2010Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal 2010;8(3):1539
In a 90-day rat study, no observed adverse effect levels of approximately 3,400 mg/kg body weight per day (males) and 4,050 mg/kg body weight per day (females) were derived at the highest dose tested, with no mutagenicity signals observed.
2010AnimalEFSA Journal 2010;8(3):1539
JECFA evaluation
The Joint FAO/WHO Expert Committee on Food Additives (JECFA) also evaluated OSA modified gum arabic and found no toxicological concern at levels used in food. JECFA's database lists it with an acceptable daily intake classified as 'not specified', meaning the available evidence did not indicate a need for a numerical limit at typical food use levels.
JECFA listed OSA modified gum arabic with an ADI 'not specified', indicating no toxicological concern at levels used in food.
RegulatoryJECFA (FAO/WHO), JECFA food additives database, chemical ID 5881
Relationship to plain gum arabic (E414)
Plain gum arabic (E414) was re-evaluated by EFSA in 2017 and also raised no safety concern; that broader data set informed confidence in the modified form. The OSA modification is relatively minor in terms of the overall molecule structure, and the gum backbone is the same natural polysaccharide.
EFSA re-evaluated plain acacia gum (E414) in 2017 and found no safety concern, which informed the read-across supporting E423's regulatory assessment.
2017Regulatory reviewEFSA Journal 2017;15(4):4741