The term “novel foods” refers to new foods, that is, ingredients that had no significant human consumption in the European Union before 1997. Since EU Regulation 2015/2283, a precise framework governs their evaluation and marketing authorization. The European Food Safety Authority (EFSA) plays a central role in this rigorous evaluation procedure. What is the current state of regulations, methodology, and prospects for these innovative foods? A complete analysis follows. The concept of “novel foods” and its regulatory framework: The notion of novel foods emerged with the European Union’s desire to guarantee both agri-food innovation and strict consumer protection. Whether of plant or animal origin, natural extracts, isolated substances, or innovative technical processes: all fall under this status as long as their documented food use before 1997 remains negligible. The foundational texts governing the definition and authorization of these products have evolved considerably since the late 1990s. The current European regulation, namely EU Regulation 2015/2283, provides new safeguards. It clearly defines the categories concerned, establishes a centralized procedure, and promotes transparency at every stage leading to the marketing of a new food ingredient. This requires stakeholders in the sector to exercise increased vigilance regarding their declarations and innovation strategy. EFSA’s central role in safety assessmentEFSA plays a key role in the approval process for novel foods. Responsible for safety assessment,this agency analyzes each submitted dossier from various scientific and toxicological perspectives. Its objective remains unchanged since its creation: to guarantee the non-harmfulness of new food ingredientsoffered to the general public. Its expertise also extends to verifying the composition, safety, and
traceability
. Thanks to its precise guidelines , each applicant is provided with a clear roadmap for structuring their application. Only after a favorable EFSA opinioncan a marketing authorizationbe considered by the
European Commission . Criteria assessed during the scientific analysis When anassessment dossier is submitted, several criteria are examined. EFSAfocuses in particular on the origin of the ingredient, its method of production, and potential contaminants. The stability and metabolic effects of the new food are also taken into account, as is the proposed acceptable daily intake. Sometimes extensive testing is required depending on the nature of the compound being studied:
animal studies,
human clinical trials, in vitro simulations, etc. The conclusions drawn are used to formulate anEFSA opinion which will guide the final decision regarding safety in use.Administrative procedure and discussions between bodiesThe interaction between the EFSA,the European Commission, national authorities, and industry makes the process particularly technical. An iterative dialogue takes place to refine the understanding of the dossier, clarify certain uncertainties, or answer regulatory questions raised during the review, point by point.
In case of areas of uncertainty, the European Commission reserves the right to request additional information, or even impose further restrictions, before anymarketing authorization.This collective reflection always aims to guarantee compliance with current European regulations and optimal consumer protection.Focus on the evaluation procedure for new foods To obtain approval, each operator must compile arobust dossier meeting all the requirements set out inEU Regulation 2015/2283 This registration applies to both European producers and importers of raw materials from further afield. The dossier includestechnical and scientific data
, safety evidence, risk analyses – as well as proof of the absence of
human consumption on a significant scale prior to 1997 Any documented omission or deficiency may result in the outright rejection of the application. Data on the product’s composition and stability Toxicological studies sometimes conducted on several species Exposure analyses of different population groups Historical evidence of use (or lack of prior use)
Detailed justifications regarding origin and purity From there, the process follows a structured framework involving successive submissions, in-depth discussions, and then a public consultation phase before the final issuance of an independent EFSA opinion. In certain specific cases, especially for traditional foods from non-EU countries, a simplified procedure exists. However, this requires comprehensive documentation demonstrating a long history of consumption without any proven adverse effects, in order to reassure all stakeholders. Among the files that have been closely monitored in recent years are those relating to CBD-based food products, which are subject to increased scrutiny regarding their authorization. For example, only new CBD-based foods that have received official authorization can be marketed in the United Kingdom, in accordance with an approach aimed at standardizing market quality. More details on this subject are available in this article on the evolution of regulations surrounding CBD foods. Contemporary Issues Surrounding Novel FoodsThe field of novel foods is constantly expanding, fueled by innovation, nutritional research, the quest for naturalness, and the growing interest in alternative sources (plant proteins, algae, insects, extracts of exotic plants). The slightest oversight during the evaluation process can hinder access to these innovations. Between the creativity of the agri-food industry and regulatory rigidity, each product launch must contend with bureaucratic hurdles. Certain products, such as hemp extracts containing CBD or certain microalgae, illustrate the inherent delays in the procedure related to the innovative nature of these substances. These delays are often explained by the difficulty in reaching a scientific consensus on safety and the validity of the arguments presented in the initial dossier.
The Role of EFSA Opinions and New European Challenges
Each EFSA opinion profoundly influences the dynamics of the sector. If the opinion is positive, the European Commission then begins drafting an official decision, which could lead to market expansion. Conversely, a refusal can result in several months (or even years) of review or outright withdrawal of the application.With the rapid evolution of biotechnology and consumer expectations, new challenges are emerging. Optimizing the evaluation procedure requires simultaneously accelerating evidence gathering and scientific harmonization across the EU. Finally, the seamless integration of ingredients such as CBD requires continuous adaptation on both a regulatory and scientific level, in line with the standards recently adopted in the United Kingdom, as seen in the management of applications for CBD food products.Summary Table: Main Stages of Bringing Novel Foods to Market To better visualize the process mandated by European regulations, see below the different phases, from dossier submission to marketing: Stage
Description Actors Involved Dossier Preparation Compilation of the evaluation dossier including all required informationIndustry, scientists Submission to EFSA Official submission and verification of the application’s completeness
EFSA, European Commission
Scientific Analysis Toxicological and nutritional evaluation EFSA, external experts EFSA OpinionPublication of the opinion, open consultation
EFSA, stakeholders Final Decision Adoption of a decision authorizing or prohibiting marketing European CommissionFrequently Asked Questions about Novel Foods and EFSA Which foods are covered by European regulations on novel foods? Novel foods are defined as those whose human consumption remained negligible in the European Union before 1997. This includes ingredients from other cultures, new additives or plant extracts, as well as compounds created by new technological processes. European regulations (EU Regulation 2015/2283) detail the categories considered, thus providing a clear legal framework for operators.
- Imported traditional foods
- Enriched or processed ingredientsNew processes (nano, innovative fermentation, etc.)
- How does EFSA assess the safety of novel foods?
- EFSA scientifically examines each dossier based on clear guidelines. It requests toxicological, nutritional, and epidemiological analyses, primarily based on published and validated studies. His EFSA opinion
- The decision rests on the quality of the dossier, the results of the studies, and the consistency of the data submitted by the applicant.
Comprehensive review of dossiersMulti-criteria assessment
(allergies, toxicity, exposure) Possible dialogue with the applicant for additional informationWhat is the average duration of the evaluation procedure up to marketing authorization?Depending on the complexity of the dossier
and the quality of the data submitted, it generally takes between
18 and 30 months to reach a marketing authorization decision. Additional processing times may be required if clarifications are requested or if the EFSA opinionnecessitates further studies. Strict adherence to the regulation requirements facilitates faster processing. Phase Indicative Duration Application Preparation & Submission
3-6 months EFSA Analysis & Exchanges 12-20 monthsOpinion & Final Decision 3-4 months
What happens after a negative EFSA opinion on a new food product?
If the EFSA opinion is unfavorable, the applicant can resubmit their application by expanding their dossier
or providing new supporting evidence. Without a satisfactory response, the application frequently results in the project being abandoned, or even in a temporary ban on the import or production of the ingredient in question. Extended deadlines for resubmissions New studies recommended Dialogue with EFSA and the European Commission mandatory
