On the EFSA Web site there is written that “Dossiers should include data on the compositional, nutritional, toxicological and allergenic properties of the novel food as well as information relating to the production process, and the proposed uses and use levels”. Is it possible that the presentation of a highly detailed dossier as concerns production process and intended uses could prevent others producers or operators to use the authorization for placing the product on the market even though they use the same food?
The new novel food Regulation, likewise Reg. 258/1997/EC, provides that a novel food can be authorized following the submission of a detailed dossier containing information on farming/growing, production process, proposed uses and anticipate intake, nutritional and toxicological information. In particular, the dossier shall be drafted according to specifications set forth in the Guidance on the preparation and presentation of an application for authorization of a novel food in the context of Regulation (Eu) 2015/2283 which provides, among the others, the inclusion of the following information: the form of uses (e.g. as whole food, ingredient), the food categories in which the novel food is proposed to be used, the proposed maximum amounts in product(s) as consumed, the proposed average and maximum daily intakes for different age/gender groups as appropriate. Beside these information, when presenting an application for novel foods which consist of, are isolated from, or are produced from farmed insect, it shall be taken into account also the species and substrate to be used, the methods for farming and processing.
It follows that, when an edible insect species is authorized (e.g. Acheta domesticus), the authorization reasonably covers only the farming method, the substrate, the farming/production process, uses and intakes specified within the dossier. Producers and operators that intend to use the same authorization to place their product on the market shall fulfill the conditions of farming/production and uses addressed in the authorization, since the safety has been assessed with reference only with reference to these specifications.
For example, if the Acheta domesticus is authorized as whole food, this authorization cannot be used to place on the market the Acheta domesticus flour. The food operator, who intends to use the Acheta domesticus flour in bakery products, shall submit a new dossier and prove the safety of the product with reference to that specific use, specifying also the maximum amount in the product with reference to the expected daily intake.