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In the European Union (EU), Novel Foods are legally defined as any food that was not used for human consumption to a significant degree within the Union before 15 May 1997.
(Regulation (EU) 2015/2283)
Regulatory Check – Does my innovative food require authorization as a Novel Food?
Over the years, competent authorities in the EU countries have received this question on a regular basis. All these information requests pertaining to the legal status of potentially Novel Foods have been compiled by the European Commission into a list, the EU Novel Food Catalogue. https://food.ec.europa.eu/safety/novel-food/novel-food-status-catalogue_en
This list of products of animal and plant origin, algal species, food cultures and other substances serves as orientation on whether a product will need an authorization under the EU Novel Food Regulation and is a legally non-binding tool.
For microorganisms the so-called Qualified Presumption of Safety (QPS)-status list has been compiled indicating the species that are considered safe to be used by consumers. https://www.efsa.europa.eu/en/topics/topic/qualified-presumption-safety-qps
Procedure
Procedure
In the EU, the authorization for the marketing of Novel Foods is regulated by the Novel Foods Regulation (EU) 2015/2283. This regulation is intended to ensure that newly introduced foods are safe for human consumption.
A request for marketing authorization takes the form of a Novel Food application.
The primary goal of a Novel Food application is to compile a pre-defined set of data from which EFSA can establish that the Novel Food is safe for consumption by consumers at the recommended intake level.
The submission of a Novel Food application proceeds through the E-Submission Food Chain Platform.
The scientific evaluation of the application is carried out by the European Food Safety Authority. (EFSA)
Marketing authorization is made public through a regulation issued by the European Commission.
The Application
A Novel Food assessment aims at establishing whether a food is safe for consumption by consumers at the proposed intake level.
The key features of a Novel Food application are therefore proof of:
- unambiguous characterization of the Novel Food
- non-toxicity, including nano-toxicity, of the Novel Food
- safety of intake at the proposed intake levels
- not causing nutritional imbalance of the normal diet of the target population
EFSA has issued a set of guidance documents to assist the applicant with the assessment of these various safety aspects.
In addition, EFSA has also provided for guidance on the administrative issues pertaining to the preparation and submission of a Novel Food application.
Both the EU Novel Food Regulation and EFSA Technical and Administrative Guidance documents provide for a framework to assist the applicant.
It is noted, however, that these guidance are not created to serve a one-size-fits-all principle. It often requires creative semantical and technical flexibility and a nutrition-focused mindset to successfully navigate your Novel Food though EFSA and the EC.
Submission
The Novel Food authorization process involves both the European Commission and the European Food Safety Authority. Applications are submitted, through an online portal, to the European Commission.
The online submission process is an art in and of itself. Countless administrative actions have to be completed to validly submit just one document.
Following a check for completeness, which may include several subsequent requests for information (RFI), the application is forwarded to EFSA which will perform the safety assessment, potentially including several rounds of requests for technical information.
The output of this assessment is published in a scientific opinion, which is sent back to the EC. If no health concerns pertaining to the consumption of the novel food have been identified by EFSA, the EC issues a regulation authorizing placing of the novel food on the EU-market.
Services NutriClaim
NutriClaim provides full project management services pertaining to Novel Food authorizations, from regulatory check, through organization and management of the toxicity studies, to preparation of the application and the follow-up of the submission.
NutriClaim BV, from its establishment in 2007 onwards, has gained a wealth of experience in this area at the intersection of science, legislation and level-headed approach towards toxicity testing and small particle analysis.
Stoffer, a trained nutritionist at Wageningen University (Wageningen, the Netherlands), brings a nutritional/physiological perspective to the table, which is imperative in discussions with animal toxicity testing laboratories, where a pharmacological mindset prevails, and nanotechnology laboratories, having a nanotechnology-focused mindset. Protocols may need adaptation towards physiological relevance. In addition, interpretation of results often differ from a nutrition/physiology-oriented perspective.
Since 2007, NutriClaim BV has been involved in over 20 Novel Food projects. Projects that have led to submission have resulted in authorization of the Novel Food by the EC.
