For the authorization of a Novel Food according to the Novel Food Regulation (EU) 2015/2283, LAUS can support you with experimental data in the following areas:
- Chemical Identity/characterization and composition (CoA)
- Dissolution in artificial body fluids
Scientific data must show that the Novel Food does not pose a safety risk to human health. EFSA requires in the context of Regulation (EU) 2015/2283 the following data (EFSA Journal 2016;14(11):4594):
- Information on the Identity of the Novel Food including qualitative and quantitative data on the composition as well as physicochemical and biochemical properties
- Genotoxicity data:
The Scientific Committee recommends the use of a basic battery of in vitro tests as the first step in testing (EFSA Journal 2011;9(9):2379):
- Bacterial reverse mutation test: Ames (OECD TG 471)
- In vitro mammalian cell micronucleus test (OECD TG 487)
They further consider simulating physiological conditions in the gastrointestinal tract after food consumption a key approach for nanomaterial in food. A short simulation of mouth conditions, followed by a gastric phase at pH 3 for 2 h and an intestinal phase at pH 7 for 2 h provides information for the “risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain” (EFSA Journal 2018;16(7):5327). LAUS offers the study in a static set-up and will soon be able to provide dynamic/flow through testing, too:
- Dissolution in artificial body fluids (bioaccessability), static and dynamic; GLP
Novel Food is per definition food that had not been used to a significant degree by humans in the EU before 15 May 1997 and that falls into one of the categories of the Novel Food Regulation. These include for example food
- from cell or tissue cultures
- that have been manufactured using a novel, unusual process
- from engineered nanomaterials
- which are vitamins, minerals and other substances
- with a new or specifically modified molecular structure
- from microorganisms, fungi or algae
- from materials of mineral origin
- from plants / animals or parts thereof
A positive list of approved novel foods can be found here.
LAUS gladly offers support in generating the necessary scientific data. Many years of scientific expertise in the field of regulatory compliance can be easily applied to Novel Food. Don’t hesitate to contact us.
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