The European Food Safety Authority (EFSA) has begun its evaluation of a novel food application for a tocotrienol-rich extract from the seeds of the tropical Annatto shrub (Bixa orellana L.).
Applicant American River Nutrition already sells the extract as a powder, oil and softgel under the brand name DeltaGold in the US, where it received Generally Recognized As Safe (GRAS) status in 2014.
This will not be the first time EFSA looks at annatto.
Advice to replace
Last week the Parma-based authority published a safety report advising some food colouring additives derived from annatto be replaced due to a lack of data.
"No reliable conclusion on the genotoxic potential of annatto extracts (E 160b) can be drawn from the available published studies, which use non-validated test methods or suffer from methodological shortcomings and inadequate reporting," the EFSA opinion concluded.
Asked if these safety doubts could pose a problem for its own novel food application, American River Nutrition manager Anne Trias told us: “Concerns regarding annatto colour are not applicable to DeltaGold because, due to the process conditions, the carotenoid concentrations in the final product are very low or not detected.”
Colouring pigments present in annatto come from the carotenoids bixin and norbixin, levels which Trias said were “insignificantly low or not detected” in DeltaGold.
Part of the family
The vitamin E family is made up of eight separate but related molecules: four tocopherols (alpha, beta, gamma, delta) and four tocotrienols (alpha, beta, gamma, delta).
While alpha-tocopherol is found in most multivitamins and is supplemented in foods, emerging evidence has suggested it interferes with the uptake and function of tocotrienols.
Tocotrienols are derived from three major sources: rice, palm and annatto. Yet annatto is the only tocopherol-free source of tocotrienols.
The company says its DeltaGold typically contains 90% delta-tocotrienol and 10% gamma-tocotrienol.