EU Novel Food Regulatory Services

From Innovation to EU Market Access: Strategic Support for Novel Food Authorisation

Intertek Assuris Food & Nutrition has prepared and facilitated numerous successful Novel Food submissions in the European Union, supporting companies from early innovation through to regulatory authorisation and market access. Our multidisciplinary team enables companies to navigate the scientific, regulatory, and strategic requirements for Novel Foods, translating complex data packages into robust, authority-ready submissions.

The EU Novel Food framework is currently governed by Regulation (EU) 2015/2283, which applies to foods and food ingredients that had not been consumed to a significant degree in the European Union before 15 May 1997 and fall within one of the categories defined in the Regulation. These include newly developed ingredients, foods produced using innovative technologies or processes, naturally derived ingredients and extracts from plants, microorganisms, fungi or algae, alternative proteins, fermentation-derived ingredients, postbiotics, and traditional foods from third countries.

Under the current EU regulatory and legal framework, Novel Foods may only be placed on the EU market once they have been authorised by the European Commission and included in the Union list of authorised Novel Foods, unless the product is demonstrated to fall outside the scope of the Novel Food Regulation or another regulatory pathway applies. Applicants may need to consider different routes depending on the product and its intended use, including an Article 4 Novel Food status consultation, a full Article 10 Novel Food application, a traditional food notification from a third country, an extension of use, or an amendment to existing specifications or conditions of use.

The success of a Novel Food application depends on much more than compiling scientific data. It requires a clear regulatory strategy, strong product characterisation, fit-for-purpose toxicological and nutritional assessments, well-substantiated exposure modelling, and coherent safety narratives aligned with EFSA scientific guidance and relevant Technical Notes.

This is particularly important under EFSA's updated Novel Food guidance, which applies to applications submitted from February 2025 and places increased emphasis on dossier completeness, product identity, production process, compositional data, safety assessment, nanoparticle safety evaluation where relevant, and well-justified proposed conditions of use.

EU Novel Food Solutions

Intertek Assuris Food & Nutrition provides strategic and technical support across the full Novel Food authorisation lifecycle. Our services include:

•	Determination of Novel / Not Novel classification.
•	Article 4 consultation strategy and dossier preparation.
•	Feasibility assessments to evaluate whether existing data are sufficient to support a Novel Food application.
•	Regulatory pathway analysis, including full Novel Food application, traditional food notification, extension of use, or amendment of existing authorisations.
•	Data gap analysis and recommendations for additional analytical, toxicological, nutritional, or manufacturing data.
•	Design, placement, and monitoring of human and clinical studies.
•	Dietary exposure assessments using recognised food consumption databases and appropriate intake scenarios.
•	Safety assessments, including toxicology, allergenicity, nutritional evaluation, contaminants, impurities, and unwanted substances.
•	Preparation and submission to EFSA of high-quality Novel Food dossiers.
•	Stewardship of submissions during EFSA risk assessment, including support in responding to Requests for Information.
•	Strategic engagement support with the European Commission, EFSA, and relevant Member State authorities.

Strategic support for innovation-driven SMEs and investors

For SMEs and innovation-driven companies, Intertek Assuris provides pragmatic, tailored regulatory strategies designed to reduce uncertainty, prioritise critical data needs, and avoid unnecessary development costs. We enable companies to identify the most efficient route to market, anticipate regulatory hurdles, and build a dossier strategy proportionate to the product’s risk profile, intended use, and commercial objectives.

For investors and venture capital funds, Intertek Assuris supports regulatory due diligence by assessing the feasibility, timing, cost, and probability of success of Novel Food authorisation pathways.

Our evaluations give investors the regulatory evidence-based clarity required to assess market-access feasibility, identify value-critical scientific gaps, and anticipate regulatory risks that may affect investment decisions and commercial timelines.

With extensive experience in EU Novel Food authorisations and global food regulatory strategy, Intertek Assuris Food & Nutrition supports food businesses, ingredient developers, and investors in transforming innovation into safe, compliant, and commercially viable products.

Frequently Asked Questions

A novel food is defined as any food that was not used for human consumption to a significant degree within the EU before 15 May 1997. In short, approval requires compiling of a scientific dossier and submitting to the European Commission for risk assessment by EFSA and legislative procedure by the European Commission.

To help determine the novel status of a food ingredient, food business operators can engage in a consultation process with a Member State. The novel food consultation dossier is submitted to one Member State, and this Member State has 4 months (extendable by up to 4 months) to issue an opinion as to whether they consider the food ingredient to be “novel.” Decisions on the status of an ingredient reviewed by a Member State via the novel food consultation process are listed on the EC website. Alternatively, Intertek can perform novelty assessments to determine the status of a food ingredient, or compile the novel food consultation dossier.

From submission to authorization, approval typically takes 2 to 3 years. Timing is highly dependent on the types of questions raised and the need for additional technical or safety studies.

Approval is generic, unless an applicant has developed proprietary scientific data needed by EFSA to conclude on the ingredients safety. In that case, exclusivity is granted for 5-years. Thus, once exclusivity has been granted to an applicant, no other applicants can reference that study for a period of 5 years, even if it is publicly available. Once the 5-year exclusivity period expires, other applicants can refer to that publicly available data for their application but cannot claim that it is proprietary to them.

A traditional food is defined as being derived from primary production with a history of safe food use in a third country (consumption for at least 25 years in the customary diet of a significant number of people in at least one third country). The applicant must prepare a notification, which is submitted to the European Commission for authorization. If there are any safety concerns, a full application must be submitted.

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