Navigating the EU Novel Food (NF) Application: A Complete Guide

What Is EU Novel Food?

Under Regulation (EU) 2015/2283, Novel Food (NF) refers to food products that were not widely consumed in the EU before May 15, 1997. This includes:

• Newly developed or innovative foods
• Foods produced using new technologies or processes
• Foods with a history of traditional consumption outside the EU

To legally market a product containing Novel Food ingredients in the EU, companies must complete the NF authorization process. This ensures that all Novel Foods are rigorously assessed for safety before reaching consumers.

Why Apply for EU Novel Food Authorization?

The EU Novel Food authorization process is mandatory for products containing Novel Food ingredients. It involves:

• European Commission (EC): Responsible for receiving and authorizing applications.
• European Food Safety Authority (EFSA): Conducts the safety assessment.

This pre-market evaluation ensures consumer safety and compliance with EU regulations, allowing your product to enter the EU market legally.

Types of EU Novel Food Applications

Authorization Application

Required for:

• Foods derived from animals, plants, microorganisms, fungi, algae, or minerals, including cell and tissue cultures.
• Foods produced using new processes or structures (e.g., nanomaterials, molecular modifications).
• Foods transitioning from food supplements to general food categories.

Notification Application

Applicable to traditional foods from non-EU countries with a documented history of consumption for at least 25 years.

Note: Novel Foods do not include GMOs, food enzymes, food additives, flavorings, or extraction solvents used in food production.

Required Documentation for EU Novel Food Applications

As per the updated EFSA guidelines (2024), the following materials are required:

• Description and identification of the substance
• Detailed production process
• Compositional data analysis
• Product specifications
• History of consumption of the NF or its source
• Proposed uses, usage levels, and expected intake
• ADME (Absorption, Distribution, Metabolism, Excretion) data
• Toxicological studies
• Nutritional analysis
• Allergenicity assessment

Important Update: Starting February 2025, all NF applications must comply with new regulations and assessment standards. Stay informed to ensure timely compliance.

Our Services

Feasibility Analysis

We provide a thorough assessment of your product’s market potential and regulatory pathway, helping you determine the best approach for NF authorization.

End-to-End Application Support

From document preparation and dossier submission to ongoing communication with regulatory authorities, we handle every step to ensure a smooth and successful approval process.

Why Choose Us?

• Expert Team: Our team of regulatory specialists and food scientists brings deep expertise in EU food regulations, ensuring accurate and efficient solutions.
• Proven Client Satisfaction: We have earned high praise from global clients, including Fortune 500 companies, for successfully guiding them into the Chinese market.
• Global Network: With offices worldwide and strong ties to regulatory authorities and industry organizations, we deliver localized support with a global perspective.
• End-to-End Solutions: From initial assessment to post-approval support, we offer one-stop services to ensure your product remains compliant.