Acacia gum in infant formula and food additive specifications
What it found
The authors found no reason for health concern from acacia gum in infant formula for babies under 16 weeks, based on large margins of safety.
They also called for tighter limits on toxic elements and new limits for aluminium, microbes and protein residues.
What they found
Studies in people
Adult studies
Two studies in adults looked at gut effects. Up to 40 g per day of gum arabic for 4 weeks in healthy volunteers, and up to 25 g per day in patients with stool incontinence, did not show adverse effects.
Animal and lab studies
Margins of safety
The highest doses tested without adverse effects in rats and mice were 5,000 and 20,000 mg per kg body weight per day. Compared with the high infant exposure estimate, the margins of safety were roughly 2,000 and 8,000.
Other findings
Exposure in infants
For babies under 16 weeks drinking infant formula, the average amount of acacia gum taken in was estimated at 2 mg per kg body weight per day. The high level was 2.6 mg per kg body weight per day.
Toxic elements in samples
In 29 samples of acacia gum, arsenic, cadmium and mercury were all below the detection limits of 0.05, 0.01 and 0.008 mg/kg. Lead ranged from below 0.005 to 0.048 mg/kg.
Aluminium levels
Aluminium in acacia gum samples ranged from 3.1 to 235.2 mg/kg, with a median of 25.9 mg/kg. The authors said a maximum limit for aluminium should be added to the specifications.
Microbes and protein
The authors said limits should be added for total aerobic microbes, yeast and mould, and protein residues. They also said Salmonella, Cronobacter sakazakii and Listeria monocytogenes should be absent in set amounts.
Enzymes in manufacture
No information was provided on oxidising enzymes. The authors recommended that oxidases and peroxidases should be inactivated by heating during manufacturing.
What the authors conclude
“These large MOS indicate that there is no reason for health concern.”
Also in their conclusions
- They conclude that there is no reason for health concern for infants below 16 weeks of age, considering the large margins of safety of roughly 2,000 and 8,000.
- They recommend that the European Commission considers lowering the limits for toxic elements and introducing specifications for aluminium, microbiological criteria and protein residues.
- They recommend that the European Commission considers requiring that oxidases and peroxidases in acacia gum should be inactivated during the manufacturing process.
How it was done
The European Food Safety Authority is re-checking food additives that were already in use before 20 January 2009. Acacia gum had not been assessed for infants under 12 weeks, and some data gaps were left from the earlier check.
They looked at analytical data on acacia gum samples, published studies in adults and animals, and estimated how much acacia gum babies under 16 weeks would take in from infant formula. They compared the highest doses tested in rats and mice without adverse effects to the estimated infant exposure.
What it can’t tell you
- No toxicological or clinical data were provided for infants below 16 weeks of age, so the safety check for this group relied on animal data and exposure estimates.
- The studies in adults cannot show what happens in infants below 16 weeks of age.
- The authors could not assess the effects on the microbiome because the science is not yet clear enough.
The paper
- Title
- Opinion on the re-evaluation of acacia gum (E 414) as a food additive in foods for infants below 16 weeks of age and the follow-up of its re-evaluation as a food additive for uses in foods for all population groups
- Type
- Scientific opinion of the European Food Safety Authority
- Evidence
- Studies in people · animals · lab
- Summarised from
- Full text
- Licence
- CC BY-ND. Words in quotation marks are the authors’; the rest is our summary.
- Cite
- EFSA Panel on Food Additives and Flavourings (FAF), Younes M, Aquilina G, et al (2019). Opinion on the re-evaluation of acacia gum (E 414) as a food additive in foods for infants below 16 weeks of age and the follow-up of its re-evaluation as a food additive for uses in foods for all population groups. EFSA journal. European Food Safety Authority. doi:10.2903/j.efsa.2019.5922Free full textPubMed 32626209DOI
Summary written 26 Sep 2026. Check it against the paper before it changes what you eat. How we summarise papers · Report an error