EU Novel Food Application & EFSA Dossier Support

What Is a Novel Food in the EU?

Under Regulation (EU) 2015/2283, a Novel Food is generally a food that had not been used for human consumption to a significant degree within the European Union before 15 May 1997. Novel Foods may include newly developed foods, foods produced using new technologies or production processes, foods obtained from new sources, and foods traditionally consumed outside the EU.

A Novel Food may be placed on the EU market only after the European Commission has processed the application and adopted an implementing act authorising the food and updating the Union list of authorised Novel Foods. The Union list includes authorised Novel Foods, their conditions of use, specific labelling requirements, and specifications.

The European Commission is responsible for authorisation and risk management, while the European Food Safety Authority (EFSA) performs the scientific safety assessment where requested. EFSA assesses whether the Novel Food is safe under the proposed conditions of use and whether its consumption is nutritionally disadvantageous when it is intended to replace another food.

Who May Need an EU Novel Food Application?

A Novel Food status assessment is strongly recommended before launching, supplying, or expanding the use of an innovative food ingredient in the EU.

Products that may fall within the scope of the EU Novel Food Regulation include:

• Human milk oligosaccharides, including synthetic or fermentation-derived HMOs;

• Microbial, fungal, algal, or fermentation-derived ingredients;

• Precision fermentation products and cell-culture-derived ingredients;

• Alternative proteins, including plant proteins, insect proteins, and microbial proteins;

• Plant extracts, concentrated botanicals, or ingredients produced through novel extraction processes;

• Algae oils, microalgae ingredients, and other marine-derived ingredients;

• Ingredients with a new or intentionally modified molecular structure;

• Foods produced using new processes that significantly change composition, nutritional value, metabolism, or levels of undesirable substances;

• Engineered nanomaterials used in food;

• Ingredients previously used only in food supplements before 15 May 1997 but now intended for broader food categories.

Applicants may include food business operators, ingredient manufacturers, brand owners, industry associations, or authorised representatives, whether located inside or outside the EU.

Three Types of EU Novel Food Application

There is no single pathway for all Novel Foods. The correct route depends on the product’s source, history of consumption, production process, intended use, and available safety evidence.

Regular Novel Food Authorisation

This pathway applies to newly developed or innovative foods, synthetic or fermentation-derived substances, microbial ingredients, HMOs, engineered nanomaterials, alternative proteins, insect proteins, and products produced using novel technologies.

A full application usually requires a comprehensive scientific dossier covering identity, production process, composition, specifications, proposed uses, intake assessment, ADME, toxicology, nutritional information, allergenicity, and other safety data.

Traditional Food Notification from a Third Country

This pathway may apply to foods with a history of safe food use in one or more non-EU countries for at least 25 years, provided the product also meets the relevant criteria under the Novel Food Regulation.

Compared with a full Novel Food application, this pathway places greater emphasis on documented history of safe use, traditional consumption patterns, and supporting safety evidence.

Modification of an Existing Authorisation

If an already authorised Novel Food undergoes changes in specifications, production process, conditions of use, labelling, or target food categories, a modification application may be required. The applicant must demonstrate that the proposed change does not adversely affect the existing safety conclusion.

When May a Novel Food Application Not Be Required?

Not every innovative ingredient automatically requires Novel Food authorisation. Before investing in a full application, companies should assess whether the product is excluded, exempt, or regulated under another EU framework.

A Novel Food application may not be the correct route where the product is regulated as:

• Genetically modified food;

• Food enzyme;

• Food additive;

• Food flavouring;

• Extraction solvent;

• Feed material;

• Food contact material;

• Medicinal product or another regulated category.

A product may also fall outside the Novel Food Regulation if there is sufficient evidence of significant human consumption in the EU before 15 May 1997.

However, an exemption from Novel Food authorisation does not remove general EU food safety obligations. Companies must still ensure compliance with the EU General Food Law, applicable food category rules, labelling requirements, and national requirements in the intended EU markets.

How to Determine the Right EU Novel Food Pathway

REACH24H recommends a structured assessment before starting a Novel Food project.

Step 1: Confirm the Product Scope

Determine whether the product is a food or food ingredient and clarify its intended use, target population, dosage, food categories, and route to market.

Step 2: Check Other Regulatory Frameworks

Assess whether the product is better regulated as a food additive, enzyme, flavouring, GMO, nutrient source, food supplement ingredient, or another product category.

Step 3: Review EU Consumption History Before 15 May 1997

Evaluate scientific literature, historical sales records, regulatory databases, Member State information, traditional recipes, import records, and other evidence to determine whether the product has a significant history of human consumption in the EU.

Step 4: Assess Traditional Food Eligibility

Where EU consumption history is insufficient, determine whether the product has at least 25 years of safe food use in one or more non-EU countries and whether a traditional food notification may be feasible.

Step 5: Select the Application Strategy

Based on the evidence, determine whether to proceed with a full Novel Food application, traditional food notification, authorisation modification, or formal Novel Food status consultation under Article 4.

Food business operators are responsible for verifying whether a food they intend to place on the EU market falls within the scope of Regulation (EU) 2015/2283. Where the status is uncertain, consultation with the competent authority of the Member State where the product will first be marketed may be required.

EU Novel Food Authorisation Procedure and Timeline

The EU Novel Food authorisation timeline depends heavily on product complexity, data availability, study design, and the quality of the application dossier.

A typical project may include:

1. Pre-application strategy and data gap analysis
   Assessment of product status, regulatory pathway, existing data, missing studies, and risk areas.

2. Study planning and Study ID management
   Under the EU transparency framework, relevant studies intended to support an application must be notified before they start. Failure to comply may create serious procedural risks.

3. Dossier preparation
   Compilation of administrative data, product identity, manufacturing process, compositional data, specifications, proposed uses, intake assessment, scientific literature, toxicology, ADME, nutritional assessment, allergenicity assessment, and non-confidential dossier versions.

4. ESFC submission and suitability check
   Applications are submitted electronically through the E-Submission Food Chain platform.

5. EFSA scientific assessment
   EFSA reviews the scientific safety of the Novel Food. The standard assessment period is 9 months, but the clock may stop if additional information is requested.

6. European Commission authorisation procedure
   Following EFSA’s opinion, the European Commission prepares the implementing act and updates the Union List if authorisation is granted.

In practice, a Novel Food application may take approximately 1.5 to 2.5 years or longer from formal submission to authorisation, depending on data completeness, EFSA questions, suitability checks, and stop-the-clock periods. A 2025 analysis of EU Novel Food applications submitted between 2018 and 2024 found an average duration of about 2.56 years from submission to publication of EFSA opinion, with substantial variability

What Data Are Required for an EFSA Novel Food Dossier?

The exact data requirements vary depending on the nature of the Novel Food. A typical dossier may include:

Administrative Information

• Applicant and manufacturer information;

• Cover letter;

• Regulatory status outside the EU;

• Confidentiality requests and non-confidential dossier versions.

Product Identity and Characterisation

• Name, description, source, and identity of the Novel Food;

• Physical, chemical, biological, or molecular characterisation;

• Batch-to-batch consistency data.

Production Process

• Manufacturing flow chart;

• Key processing steps and control points;

• Quality management systems, such as GMP, HACCP, or ISO-based controls;

• Process-related impurities or residues.

Composition and Specifications

• Analytical data from representative production batches;

• Proposed specifications and justification for specification limits;

• Contaminants, impurities, residues, and microbiological parameters.

Proposed Uses and Intake Assessment

• Target food categories;

• Maximum use levels;

• Target populations;

• Estimated daily intake and exposure assessment.

Safety Assessment

• Literature review strategy and results;

• History of use, where relevant;

• ADME information;

• Toxicological studies, such as genotoxicity and subchronic toxicity studies;

• Nutritional assessment;

• Allergenicity assessment.

Special Data Requirements

Additional data may be needed for specific products, including:

• Whole-genome sequencing and antimicrobial resistance assessment for microbial Novel Foods;

• Viable cell or DNA residue analysis for microbial ingredients;

• Particle size, shape, distribution, and physicochemical characterisation for engineered nanomaterials;

• Relative bioavailability data for novel nutrient sources;

• Traditional use evidence for traditional foods from third countries.

EFSA updated its scientific and administrative guidance for Novel Food applications in 2024, with the updated framework applicable to applications submitted from 1 February 2025.

Cost Considerations for EU Novel Food Applications

The EU Novel Food authorisation itself does not usually involve a standard official administrative application fee, but companies should plan for several major cost categories.

Scientific Studies and Testing

Key cost drivers may include:

• Genotoxicity studies;

• 90-day oral toxicity studies;

• Compositional analysis of representative batches;

• Stability studies;

• Contaminant and impurity testing;

• Whole-genome sequencing for microbial products;

• Antimicrobial resistance assessment;

• Additional studies triggered by EFSA questions.

Professional and Regulatory Consulting

Specialised support may be needed for:

• Regulatory status assessment;

• GPSA preparation;

• Study notification and Study ID management;

• Data gap analysis;

• Literature search strategy;

• EFSA dossier preparation;

• Confidentiality and data protection strategy;

• ESFC submission;

• Response to EFSA additional information requests.

Hidden or Indirect Costs

Companies should also consider:

• Translation of supplementary materials where needed;

• Copyright permissions for non-owned scientific literature;

• Additional study costs caused by poor initial study design;

• Commercial delay caused by incomplete dossiers or stop-the-clock periods.

Early regulatory pathway confirmation and study strategy planning can significantly reduce unnecessary testing, duplicated work, and avoidable delays.

Post-Authorisation Compliance

EU Novel Food compliance does not end once authorisation is granted. Food business operators must ensure that products placed on the EU market remain consistent with the conditions of authorisation.

Key post-authorisation obligations include:

• Compliance with Union List specifications;

• Compliance with authorised conditions of use and maximum use levels;

• Compliance with labelling requirements;

• Monitoring of new scientific or technical information that may affect safety;

• Notification to the European Commission where new information may influence the safety assessment;

• Modification application where specifications, production process, use conditions, or food categories change.

How REACH24H Supports EU Novel Food Applications

REACH24H provides one-stop compliance support for companies seeking EU Novel Food authorisation. Based on Regulation (EU) 2015/2283, EFSA guidance, and ESFC submission requirements, we help companies assess the right regulatory pathway, prepare application dossiers, manage authority communication, and maintain post-authorisation compliance.

• Novel Food Status Assessment: assessing whether the product has a significant history of consumption in the EU before 15 May 1997 and whether it falls within the scope of the EU Novel Food Regulation.

• Data Gap Analysis and Study Planning: reviewing existing data, identifying missing evidence, and helping design a practical testing and documentation strategy in line with EFSA expectations.

• EFSA Dossier Preparation and ESFC Submission: preparing or reviewing the technical dossier, supporting confidentiality and data protection strategy, and assisting with electronic submission through the E-Submission Food Chain platform.

• Regulatory Pathway Selection: evaluating whether the product should follow a full Novel Food application, Traditional Food Notification from a Third Country, modification of an existing authorisation, or Article 4 consultation.

• Authority Communication and Supplementary Response Support: assisting with EFSA or European Commission questions, additional information requests, and technical clarifications during the review process.

• Post-authorisation Compliance and Modification Support: reviewing authorised specifications, conditions of use and labelling requirements, and supporting modification applications when production process, specifications or intended uses change.

Access Your Free Resource: Regulatory Pathways for Novel Food Ingredients Worldwide

We are pleased to introduce our Regulatory Pathways for Novel Food Ingredients Worldwide. This guide provides a systematic overview of the regulatory frameworks for novel food ingredients in key markets, including China, the USA, the EU, Australia-New Zealand, Japan, South Korea, and Southeast Asia.

Key sections include:

• Regulatory Frameworks & Authorities

• Approval Processes & Documentation

• Key Compliance Strategies

FAQ: EU Novel Food Application and EFSA Dossier Support

Official Regulatory Resources

For companies preparing an EU Novel Food application, the following official resources may be useful for understanding the regulatory framework, application procedures, authorised Novel Foods, and EFSA dossier requirements:

• Regulation (EU) 2015/2283 on Novel Foods

• European Commission: Novel Food

• European Commission: Union List of Novel Foods

• European Commission: Novel Food Status Catalogue

• EFSA: Novel Food Application Procedure

• EFSA Scientific Guidance for Novel Food Applications

Related REACH24H Resources and Services

Explore more REACH24H resources on Novel Food, food ingredient compliance, and global food market access:

• U.S. FDA GRAS for Food Ingredients

• U.S. FDA New Dietary Ingredient (NDI) Notification

• Understanding Novel Food Ingredients in China

• GRAS vs. NDI: How to Choose the Right Regulatory Pathway