EU Novel Food Application

Under Regulation (EU) 2015/2283, Novel Food (NF) refers to any food product that was not widely consumed within the European Union (EU) before May 15, 1997.

This classification includes:

• Innovative Foods: Newly developed or innovative products.
• New Technologies: Foods produced using novel processes or technologies.
• Traditional Foods from Non-EU Countries: Foods with a documented history of traditional consumption outside the EU.

To legally market these ingredients in the EU, companies must complete a mandatory NF authorization process to ensure they are rigorously assessed for safety before reaching consumers.

EU Novel Food Authorization

The authorization process is a mandatory pre-market evaluation that ensures consumer safety and regulatory compliance. It involves two key bodies:

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

This process allows your product to enter the EU market legally while maintaining high safety standards.

Types of EU Novel Food Applications

There are two primary pathways for seeking authorization based on the nature of the food:

Authorization Application

This is required for:

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

Notification Application

This simplified pathway is applicable to traditional foods from non-EU countries that have a documented history of safe consumption for at least 25 years.

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

Required Documentation for EU Novel Food Applications

According to the updated EFSA guidelines (2024), a complete dossier must include:

1. Identity and Composition: Detailed identification and compositional analysis.
2. Manufacturing Process: A thorough explanation of production.
3. Consumption History: Records of previous consumption of the NF or its source.
4. Usage Data: Proposed uses, expected intake, and usage levels.
5. Biological Data: ADME (Absorption, Distribution, Metabolism, Excretion) data and toxicological studies.
6. Safety Assessments: Comprehensive allergenicity assessment.

Important Update: Starting February 2025, all NF applications must comply with new regulations and assessment standards.

Proregulations' EU Novel Food Services

• Feasibility Analysis and Strategy
  We provide a thorough assessment of your product's market potential and regulatory pathway to determine the most effective approach for NF authorization.
• End-to-End Application Management
  From document preparation and dossier submission to ongoing communication with the EC and EFSA, we handle every step to ensure a successful approval.
• Safety and Toxicological Oversight
  Assisting in the management of required studies, such as ADME and toxicological data, to meet EFSA's rigorous scientific standards.
• Post-Market Compliance Monitoring
  Ensuring your product remains compliant with evolving EU regulations after receiving market authorization.

If you need to ensure your novel food ingredients meet EFSA standards or require assistance with the EC authorization process, please contact us.