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EU Novel Food Submission Services

Unlock EU market access for innovative ingredients and food supplements with end-to-end Novel Food strategy, dossier preparation, and regulatory support.

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What Is a Novel Food?

A novel food is defined under Regulation (EU) 2015/2283 as any food or ingredient not consumed to a significant degree in the EU before May 15, 1997.

Novel foods include:

  • Innovative food ingredients (e.g., bioactives, plant isolates, algae, fungi, alternative proteins).
  • Foods made with new production processes or technologies that change composition or structure.
  • Traditional foods from third countries that have been part of the diet elsewhere for at least 25 years.

All novel foods must receive pre-market authorization by the European Commission after a safety assessment by the European Food Safety Authority (EFSA) to demonstrate they are safe under the proposed conditions of use.

When Is a Novel Food Submission Required?

  • Introducing a new ingredient or extract without prior EU consumption history.
  • Using a new or modified production process that alters a food’s composition or safety profile.
  • Launching proprietary strains (e.g., probiotics, yeasts, enzymes, algae) for supplements or foods.
  • Bringing a traditional food from a third country to the EU market.
  • Marketing bioactive compounds or isolates derived from plants, fungi, or cell-cultured sources.
  • Expanding globally—leveraging EU Novel Food approval as an international benchmark for safety and compliance.

The Novel Food Authorization Process

  • Pre-Dossier Consultation: Evaluate product eligibility and identify data requirements.
  • Submission to the European Commission: Initial administrative and applicability review (~30 working days).
  • EFSA Scientific Assessment: Comprehensive safety evaluation (~9 months, excluding time for data requests).
  • Commission & Member State Approval: Regulation enacted to grant EU-wide market authorization (typical total 1.5–3 years).

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Our EU Novel Food Services

  • Novel Food Status Determination: Evaluate whether your product requires full authorization or qualifies as traditional food from a third country.
  • Feasibility & Gap Analysis: Assess existing data and identify missing safety or toxicological information.
  • Dossier Preparation & Submission: Develop EFSA-compliant dossiers (identity, production, specifications, ADME, toxicity, allergenicity).
  • Scientific & Literature Review: Aggregate historical use data, published studies, and proprietary research to support safety.
  • Study Design & Coordination: Recommend or oversee required toxicology, stability, or clinical studies where needed.
  • EFSA & EU Liaison: Guide communications and respond to follow-up queries during the review process.
  • Post-Authorization Compliance: Advise on labeling, claims, and post-market surveillance for continued compliance.

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Why Choose dicentra?

  • 23 years of experience in ingredient safety and global regulatory approvals.
  • A multi-disciplinary team of toxicologists, regulatory scientists, and EU compliance specialists.
  • Extensive experience with innovative ingredients including probiotics, bioactives, and alternative proteins.
  • Proven track record preparing successful scientific dossiers for EFSA and other global authorities.
  • End-to-end support—from initial eligibility assessment to market authorization and post-approval guidance.
  • Strategic insights to minimize approval timelines and mitigate regulatory risks.

Related Regulatory Pathways

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