It is carried out in contained vessels using axenic large-scale microbiological techniques. The fermentation is routinely tested to ensure cultural purity, the quality control as described can be considered to be of the highest standard to exclude contamination. The final fermentation process will be performed in practice in compliance with Good Industrial Large-Scale practice. After fermentation the whole broth is pasteurised to ensure that no viable cells of the production organism are present in the final product. The further processing is designed to remove cell debris, DNA and contaminants.
Hydrochloric acid is added as the only purification agent.
The concentration of acid and the temperature conditions chosen were shown to degrade any DNA still present, so that it can no longer serve as a substrate in transformation or as a template in a polymerase chain reaction. The riboflavin produced by fermentation is intended to be used for the same purposes as the chemically synthesised product. No increased consumption is expected as no new applications exclusive to the fermentation-derived product are anticipated. As the synthetic product and the fermentation product have identical specifications and quality criteria and the same application levels, it is unlikely that there will be any difference in bioavailability, when one product is substituted for the other. Hence a nutritional assessment is unnecessary.