Each Food Business Operator (FBO) is responsible for the right qualification of its product. As stated in article 4 of Regulation (EU) 2015/2283 on novel foods (1) (NF Regulation), they “shall verify whether or not the food which they intend to place on the market within the Union falls within the scope of this Regulation”.

‘Novel food’ means any food that was not used for human consumption to a significant degree within the Union before 15 May 1997, and that falls under at least one of the 10 categories set up by the regulation. Precision fermentation’s product could fall under, at least, 6 of these categories, mainly:

(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 microorganisms, fungi or algae;

(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;

The use of precision fermentation generally leads to a ‘novel food’ qualification but might also fall under a GM qualification as well. However, both aspects shall be evaluated under only one procedure: the novel food one (2).

Anyway, for a FBO which has reasons to believe that a product would not fall under the novel food qualification but has some doubts, article 4 of the Regulation also introduced the possibility to consult the Member State where they first intend to place the food on the market, which may also consult other Member State or the Commission.

But if the product falls within the scope of the NF Regulation, the FBO has no choice but to strictly follow the full novel food procedure, detailed in Article 10 of the Regulation.

First and foremost, everything starts with a good and complete preparation of the dossier. This stage is crucial to the smooth running of the procedure with the European institutions. In order to properly prepare the submission, FBOs must proceed to different analyses regarding the substance itself, and adapt the drafting to the qualities and specificities of the substance (GM, nanomaterials…) (3). In general, the preparation of the dossier, from A to Z, may last between 12 and 18 months.

When the dossier is ready, the submission is e-submitted to the Commission which may refer it to EFSA for its opinion (it usually does, unless the case is straightforward). The EFSA should render the dossier within 7 months but in cases it identifies missing or insufficient information, the Authority will request additional details from the applicant, leading to an extension of the timeline, also called “stop-the-clock” procedure (4).

Once the EFSA has given a - positive - opinion, the Commission prepares a draft ‘implementing act’ authorizing the placing on the market within the EU of the novel food and will submit this draft to the Standing Committee on Plants, Animals, Food and Feed (SCOPAFF) composed of representatives of the Commission and of the Member States: all 27 Member States have a say in the procedure (5).

In total, if the dossier is complete, the whole procedure should take approximately 24 months.

Once published on the European list, the authorization will benefit to all and not only the applicant. This means that, provided that the conditions of use, labelling requirements and specifications of the authorised food are – fully – respected, any food business operator can use and place the authorised novel food on the market, as opposed to only the authorisation holder.

To balance with this ultra partes effect, the Regulation has introduced, in article 26, a mechanism of ‘data protection’ which is, in fact, a commercial exclusivity that can be granted to the novel food authorisation holder. The granting of this five years data protection is contingent upon a number of conditions: most importantly, the nature and ownership of the data and scientific evidence used by the applicant and the real value of this data and evidence in assessing the novel food dossier.

To date, it is mostly the animal-free dairy industry that is on the path for the obtention of PF novel food authorizations in Europe, but multiple efforts come from other proteins industries as well, such as for in vitro egg or heme proteins (6) production.