Novel Foods Regulation: Questions and Answers

Questions and answers on new European Regulatory Framework on novel foods, in partnership with Entomofago.eu

 

Q.2 (Entomofago.eu)With the new procedure, how long will it take for the applicant company to be fully authorized after submitting a request for authorization (assuming the documents are in order)?
 

R.2 (D. Pisanello, food lawyer):

Undoubtedly the terms of the new authorization procedure are clearer and more defined compared to the former regime. It was actually one of the Commission’s goals.
 

The ordinary time-limits for the conclusion of a novel food authorization procedure should be seven months, plus nine months in case the Commission wants to obtain an assessment from EFSA. Then there might be particular cases where supplementary information must be provided or in the event that there are dissenting opinions of some National Authorities.


Different terms instead apply for the notification of traditional foods from third countries: in this case the Commission shall transmit the documentation to the Member States and to EFSA within one month from the receipt of a notification; moreover within four months from the date of notification a Member State or the Authority can submit duly justified objections to the Commission. In case of no objections, the notification is registered in a specific section of the unionist list; if objections are raised instead, the procedure is stopped and the applicant may submit an ordinary request for authorization under the already mentioned terms. 

 

 

Q.1 (Entomofago.eu): In order to make an application for authorization according to what established by the latest Regulation 2015/2283 / EU on Novel Food, a company operating in the "edible insects" sector will have to wait until January 2018, preparing in the meantime all the documentation, or the procedure can be started immediately in order to be instantly authorized when the legislation will come into force? Is it still possible to apply for authorization according to the former Regulation 258/1997?

R.1 (D. Pisanello, food lawyer): 

The regulation on novel foods (Reg. 258/97) can be applied until 1 January 2018: this means that the application for authorization submitted up to that date will be regulated by the above mentioned Regulation.
One has to proceed with caution when dealing with "edible insects", because the situation is not very clear. In Italy there are no explicit laws that allow the use of edible insects, on the contrary, the Legislator conceive them as "parasites" that should not infest food. In short, we are on the watershed between the old and the new.
Given that, I would differentiate between the issue of "whole insects or their parts" and the issue of foods obtained by transforming raw materials obtained from insects. The latter issue, in my opinion, may fall into the "old regulation", because it refers to the category considered by art. 1.2 (e) of Reg. (EC) n. 258/97 according to which novel foods are "foods and food ingredients made from plants or isolated from plants and food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices that have a safe historically proven food use".
Regulation 2015/2283, in particular concerning the matter of edible insects, does not clarify whether the scope of the new regulation is the same of the previous regulation or not: "The scope of this Regulation should in principle remain the same of Regulation (EC) No. 258/97. Nonetheless, given the scientific and technological developments since 1997, it should be appropriate to review, clarify and update the categories of foods that constitute new foods. These categories should include whole insects and their parts".
Independently of the interpretation of the rules, however, the fact is that from a regulatory point of view on the subject of edible insect, we are at Year Zero, as well as for nano-ingredients. The Commission itself is aware of this and has therefore promptly asked for a first intervention of EFSA, aimed at approving guidelines on the submission of applications under the new Regulation. There’s no doubt that much work will be devoted to the issue of food made from insects or their parts.

We'll discuss about these issues during the Seminar "Novel food" that will take place in Bologna, on the 24th of June.