In the EU, a novel food is defined as a food, food ingredient or manufacturing process that has not been consumed or used in the EU before 15th May 1997.
There are 10 novel food categories listed in the Novel Food Regulation and alternative proteins tend to fall under the following categories:
(i) food with a new or intentionally modified molecular structure, where that structure was not used as, or in, a food within the Union before 15 May 1997;
(ii) food consisting of, isolated from or produced from micro organisms, fungi or algae;
(iv) food consisting of, isolated from or produced from plants or their parts;
(vi) food consisting of, isolated from or produced from cell culture or tissue culture derived from animals, plants, micro- organisms, fungi or algae;
(vii) food resulting from a production process not used for food production within the Union before 15 May 1997, which gives rise to significant changes in the composition or structure of a food, affecting its nutritional value, metabolism or level of undesirable substances.
All novel foods, must be approved before being placed on the market.
To obtain approval, an applicant must prepare and submit a novel food dossier to the European Commission. The novel food dossier should be built in compliance with the latest Implementing Acts and EFSA guidance documents. An applicant must demonstrate that their product is safe under the proposed conditions of use.
Once completed, the dossier must be submitted via the e-submission food chain platform.
The typical timeline for dossier evaluation by EFSA is 9-18 months. Whereas the typical timeline from submission to approval is 1.5-3 years depending on the quality of your dossier & supporting data.
With Amgen´s help, we can reduce the time to approval by building an excellent dossier & presenting the data in a compliant way.
Please note that from 27th March 2021, the new EU regulation on transparency has applied to all regulated products in the food chain, including novel foods. To find out more click here.
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