Following detailed consultation with Regulatory experts, we can conclude that EirVit® is not a novel food in respect of European Regulation (EU) 2015/2283, and is Generally Regarded As Safe (GRAS) as per Title 21 of the US Food and Drug Administration (FDA) Code of Federal Regulations (21CFR184.1950). From a Regulatory perspective, EirVit® should be treated no differently to Lanolin (or other animal) origin Vitamin D3.
The critical point is that from reaching Cholesterol in the process, the same synthetic pathway is then followed for EirVit® as would be the case to produce Vitamin D3 from animal-origins including Lanolin. Cholecalciferol (Vitamin D3) legislation does not stipulate the source of Cholesterol.
Whereas we have proven the Phytosterol-derived Cholesterol starting material we use to synthesise Vitamin D3 meets USP and EP quality, that is not necessarily the case for other Vitamin D3 sources on the market. Lanolin-origin Vitamin D3 producers, for example, do not necessarily test or guarantee the quality/purity of their starting (animal-origin) Cholesterol. Therefore, on top of the plant-source and vegan-suitable credentials of EirVit®, our products are also of superior quality and purity to many Vitamin D3 sources in the market.