AMGEN Regulatory Focus: Precision Fermentation
In this article, we look at the status of approvals for alternative products derived from precision fermentation in the EU and USA, and review the key regulatory challenges faced in each region.
In the EU, products derived from precision fermentation fall in scope of the novel food regulation if there are no viable cells or DNA from the production microorganism present in the final product.
Using a QPS (Qualified Presumption of Safety) microorganism can save you time and money. Although non-QPS strains such as E. coli are widely used as production organisms, you will need to generate more data to support the safety of non-QPS strains.
Currently there are no approved alternative proteins or fats derived from precision fermentation in the EU, although there are some useful precedents.
In the USA, proteins derived from precision fermentation can be GRAS (Generally Recognised as Safe) even if there is host strain DNA present in the final product. If this is the case then the final product should be labelled as a Bioengineered Food.
The USA is leading the way in terms of precision fermentation and there are currently four alternative proteins that have received a no questions letter from the Food and Drug Administration (FDA), which means they can be marketed in the US. The average time from
submission of the GRAS notice to obtaining a no questions letter was 14.5 months. In addition, Remilk has just self-affirmed that their animal-free milk proteins are GRAS and can now place their product on the market.
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