Data gaps flagged by the EFSA re-evaluation
When EFSA's Panel on Food Additives and Flavourings re-evaluated E479b in 2018, it identified three significant data absences: no absorption, distribution, metabolism or excretion (ADME) data; no genotoxicity studies of any kind; and no adequate developmental or reproductive toxicity studies. These gaps mean the existing ADI cannot be fully supported by the current evidence base, even though the margin between estimated consumer exposure and the doses used in animal studies is large.
No genotoxicity data were available for E479b; the Panel was therefore unable to assess whether the substance or its degradation products carry a genotoxic hazard.
2018Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal
No developmental or reproductive toxicity studies with adequate reporting were available, leaving the safety of E479b during pregnancy and foetal development uncharacterised.
2018Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal
The Panel concluded the toxicological data available were insufficient to support the previously established ADI of 25mg/kg body weight per day set by the Scientific Committee on Food.
2018Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal
Animal chronic study and margin of safety
The primary long-term study used to assess E479b was a 2.5-year rat chronic and carcinogenicity study. No adverse effects were observed up to the highest dose tested (5,400mg/kg body weight per day in males), and EFSA calculated that estimated maximum human exposure at the 95th percentile for toddlers reaches roughly 10mg/kg body weight per day, giving a margin of safety of approximately 540-fold against the animal NOAEL. The limitation is that the NOAEL is also the highest dose tested, so the true no-effect level could be lower.
A 2.5-year rat study found no observed adverse effects at the highest dose tested of 5,400mg/kg body weight per day (males); this dose was used as the NOAEL.
2018AnimalEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal
Estimated maximum dietary exposure to E479b reached 10.1mg/kg body weight per day at the 95th percentile for toddlers, yielding a margin of safety of approximately 540 compared to the animal NOAEL.
2018Regulatory reviewEFSA Panel on Food Additives and Flavourings (FAF), EFSA Journal
Soya allergen consideration
E479b is derived from soya, which is a declarable allergen under UK food law. The manufacturing process involves high-temperature oxidation and chemical reaction, which may alter or degrade the soya proteins that typically trigger allergic responses. Regulators have not formally exempted E479b from allergen labelling obligations in the way that highly refined oils are sometimes treated, so individuals with soya allergy or intolerance should treat its presence on a label with caution.
Soya is listed as a major allergen requiring declaration under UK food law (assimilated EU Regulation 1169/2011, Annex II). Highly refined soya oil is exempt from allergen labelling, but E479b is a chemically modified derivative rather than a simple refined oil.
RegulatoryUK Food Information Regulations; assimilated EU Regulation 1169/2011