EFSA could not complete a standard risk assessment
When EFSA re-evaluated E175 in 2016, it found no subchronic or chronic toxicity studies and no genotoxicity data on elemental gold used as a food additive. The panel considered the data too limited to carry out a conventional risk assessment and did not set a numerical acceptable daily intake. It concluded that systemic effects were unlikely given gold's low solubility, but acknowledged this was a qualitative judgement rather than a data-driven one.
The Panel noted the limited data on absorption, distribution, metabolism and excretion of elemental gold and the absence of toxicological data on E 175, and considered the data too limited to perform a risk assessment.
2016Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), Scientific Opinion on the re-evaluation of gold (E 175) as a food additive, EFSA Journal 14(1):4362
No numerical ADI was established. The Panel concluded that systemic availability of elemental gold would not be expected given its low solubility, but this conclusion rested on the absence of observed effects rather than positive toxicological evidence.
2016Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal 14(1):4362
Nanoparticles are present in food-grade gold powder
Food-grade gold leaf and powder are not uniform bulk metal: the thinnest dimensions of the flakes and a measurable fraction of powder particles fall below 100 nm. EFSA recommended that specifications for E175 should include mean particle size, particle size distribution, and the percentage of particles in the nanoscale, information that was not systematically available at the time of the 2016 opinion. Separate analytical work confirmed that gold nanoparticles with a dominant size around 124 nm can be extracted from commercial gold-flake liqueurs.
EFSA recommended that E175 specifications must include mean particle size, particle size distribution, and the percentage (by number) of particles in the nanoscale with at least one dimension below 100 nm, for the powder form.
2016Regulatory reviewEFSA Panel on Food Additives and Nutrient Sources (ANS), EFSA Journal 14(1):4362
Gold nanoparticles ranging from 8.3 to 398 nm were detected in a commercial gold-flake liqueur; over 69% of particles by count were below 100 nm.
2024LabDetermination and Characterization of Gold Nanoparticles in Liquor Using Asymmetric Flow Field-Flow Fractionation Hyphenated with ICP-MS, PMC10780710
Animal study found gut and immune changes at relevant doses
A 90-day study fed mice food-grade E175 at doses spanning the range estimated for human exposure. No liver or intestinal tissue damage was found, and genotoxicity tests were negative. However, female mice showed altered gut bacteria composition, increased markers of intestinal inflammation, and reduced production of short-chain fatty acids at higher doses. Male mice showed the opposite immune pattern. The authors concluded the alterations were mostly non-toxic within the human dose range but called for toxic reference values to be established for safe use.
90-day oral exposure to food-grade E175 at 0.1, 1, and 10 micrograms/kg body weight/day altered gut microbiota composition and intestinal immune responses in mice in a sex-dependent manner; female mice showed gut dysbiosis and low-grade intestinal inflammation at higher doses.
2023AnimalQuaranta et al., Particle and Fibre Toxicology, 20:31
No histomorphological damage to the liver, spleen, or intestine was observed, and genotoxicity tests in the colon and liver were negative, but the authors recommended establishing toxic reference values for gold as a food additive.
2023AnimalQuaranta et al., Particle and Fibre Toxicology, 20:31
Gold nanoparticle studies in rats raise reproductive questions
Several laboratory and animal studies using synthesised gold nanoparticles (not necessarily food-grade E175) have found accumulation in testicular tissue, reduced testosterone production, and impaired sperm quality in male rodents. These studies used intravenous or other non-dietary routes of administration and particle characteristics that may not reflect actual dietary exposure from E175, so they cannot be read across directly. They nonetheless identify a potential hazard pathway that has not been investigated in the context of food use.
Gold nanoparticles (5 nm, intravenous) accumulated in Leydig cells of mouse testes, reducing testosterone production by down-regulating 17alpha-hydroxylase and impairing epididymal sperm quality.
2020AnimalThe Effects of Gold Nanoparticles on Leydig Cells and Male Reproductive Function in Mice, International Journal of Nanomedicine, Vol 15 (PMID 33281445, DOI 10.2147/IJN.S276606)
Reproductive toxicity studies in male rats exposed to gold nanoparticles showed testicular damage and histopathological changes; the authors noted the question of reversibility remained open.
2023AnimalAssessment of reproductive toxicity of gold nanoparticles and its reversibility in male albino rats, Toxicological Research, Springer Nature