Trends in Novel Food applications

The EFSA is still facing a high number of Novel Food applications from business operators. Last year, the EFSA released a notice of call for expressions of interest, for scientific and technical support in several areas – including risk assessment of Novel Foods. Interestingly, this notice deals with the fact that risk assessment agencies in the Member States (e.g., the Anses in France) may provide such help, as they used to be involved in the evaluation of Novel Food files under the former Novel Food Regulation.

Most of these applications submitted to the EFSA are dealing with cannabidiol (CBD); for all of those, the EFSA recently published a specific opinion quoting all the scientific gaps that should be filled by business operators. Apart from CBD, the innovation is driven by insect-derived ingredients: proteins are at stake, but recently the very first application for lipids of insects was submitted to the EFSA. Speaking of innovation in the food sector, the media usually talk about cellular agriculture, and precision fermentation-derived ingredients: so far, no application was made in this area. But undoubtedly, we should be able to see in the forthcoming years the very first applications of this kind.

 

Transparency Regulation: new rules

On March 27th, 2021, the new Transparency Regulation amending the General Food Law came into force. This regulation has several major consequences on the evaluation by the EFSA of Novel Food applications and introduces new tools and practices to be adopted for building a Novel Food application.

The main change introduced by the Transparency Regulation is that the whole Novel Food technical file is made open access to all, once the EFSA starts the risk assessment step. The whole dossier is made available in the corresponding question number on the Open EFSA website. Some countries are used to that kind of transparency: in the USA for instance, all GRAS dossiers are made open access and can be viewed by anyone in the GRAS Notices Inventory. The consequence of such transparency is the possibility for business operators to ask for confidentiality treatment for several parts of the technical dossier. For instance, one can easily guess that some details of the production process section should remain confidential. However, to make a balance between confidentiality and transparency, one should bear in mind that the EFSA also assesses the validity of each confidential treatment request, and may not validate several requests if not properly justified.

The Transparency Regulation also emphasizes the importance of the pre-submission phase. Business operators used to build their technical dossier in a hidden way. One major change is the mandatory notification of all studies/experiments carried out by business operators. Such notification to the EFSA prevents any selection bias regarding the outcomes of the corresponding studies and ensures that all data (both in support or in disfavour) are provided to the EFSA. In fact, upon receiving a Novel Food application, the EFSA checks in its database if (1) every notified study has been indeed provided in the technical dossier, and (2) every provided study in the technical dossier has been indeed notified previously. Notification of studies should be made on the EFSA Connect platform. If one of those two conditions is not met, and the justifications are not deemed sufficient by the EFSA, a six-month delay penalty shall be given to the business operators. Following this new rule, we have already noticed several Novel Food applications having a 6-month delay penalty.

In agreement with the importance of the pre-submission phase, the Transparency Regulation finally introduces the so-called General Pre-Submission Advice (GPSA). According to this procedure, the business operator can ask questions to the EFSA’s staff about the overall building of the application. As for the notification of studies, GPSA should be asked through the EFSA Connect platform. Should any answer be provided by the EFSA, the questions and the corresponding answer will be made open access on the EFSA Open website, under the corresponding question number. At first sight, GPSA is a very useful procedure. However, keep in mind that any questions dealing with the design of experiments/adaptation of protocols do not usually fall into the scope of EFSA. Thus, the value of the GPSA procedure strongly depends on the « novelty » of the ingredient.

 

Nanomaterials: additional studies needed

Regulation (EU) 2015/2283 defines engineered nanomaterials: these correspond to « any intentionally produced material that has one or more dimensions of the order of 100 nm or less or that is composed of discrete functional parts, either internally or at the surface, many of which have one or more dimensions of the order of 100 nm or less, including structures, agglomerates or aggregates, which may have a size above the order of 100 nm but retain properties that are characteristic of the nanoscale ». Any business operator should therefore know whether its Novel Food corresponds to a nanomaterial, given that the intention to deal with nanoscale is usually sought for particular properties. For instance, one can consider that new sources of nutrients under a nanoscale form will have improved bio-accessibility properties. Such engineered nanomaterials are assessed by the EFSA in agreement with specific Guidance. On August 4th, 2021, the EFSA updated this Guidance related to the risk assessment of nanomaterials (the so-called “Nano-RA Guidance”).

Still on August 4th, 2021, the EFSA also released the so-called “Particle-TR Guidance”, which describes the studies to be carried out to establish the presence of nanoparticles in any Novel Food. It is worth underlining that such Guidance is dedicated to all food and feed products that are regulated and assessed by the EFSA: Novel Foods of course, but also food additives, feed additives, pesticides, and food contact materials. To put it in another way, it is assumed that regulated food and feed products (including Novel Foods) do have nanomaterials and should be assessed as such unless the converse is demonstrated. The Particle-TR Guidance, therefore, lists the so-called appraisal routes to demonstrate that the Novel Food is devoid of nanoparticles, or rather that the consumers will not be exposed to nanoparticles if any. In case of detection of nanoparticles, the business operator should refer to the Nano-RA Guidance, as the corresponding Novel Food should be assessed like an engineered nanomaterial.

This change about nanomaterials is quite tricky since no update was made on the EFSA Guidance on Novel Foods: the update made on March 27^th, 2021, is still in force. Furthermore, the EFSA did not formally settle a cut-off date as of which any dossier submitted would be assessed under the Particle-TR Guidance; unlike what was done when the Transparency Regulation came into force (27^th of March defined as the cut-off date). Several applications that could have been challenged for nanomaterials have made it through; conversely, other recent applications are currently facing the need of demonstrating that Novel Food is free of nanomaterials. Consequently, at the current time, any business operator relying only on the last Novel Food Guidance is very likely to overlook the nanomaterial aspect, especially for Novel Food that does not have a fraction of nanoparticles at first sight (e.g., oils, powders). It is hoped that the EFSA is to release soon an update on Novel Food Guidance taking into account the changes in nanomaterials.

 

Foodinnov and Novel Food Regulation

Foodinnov’s experts in regulation and science are here to help you regarding the regulatory status of your ingredients, following Regulation (EU) 2015/2283:

• Novel Food status of ingredients (search for history of consumption, consultation process on Novel Food status);
• Novel Food application, according to Article 10 of Regulation (EU) 2015/2283 (gap analysis, search for scientific information, building of the dossier, submission and follow-up);
• Novel Food application, according to Article 14 of Regulation (EU) 2015/2283 (gap analysis, search for scientific information, building of the dossier, submission and follow-up).