Novel Food in the EU: When Do Exotic Ingredients Need Approval?

The EU Novel Food Regulation (EU) 2015/2283 governs which food ingredients can be sold in the European market. Any food that was not significantly consumed within the EU before 15 May 1997 is considered a “novel food” and requires pre-market authorisation before it can be placed on the market.

What Counts as a Novel Food?

Under Article 3 of Regulation 2015/2283, a food is considered “novel” if it falls into one of the following categories and was not consumed to a significant degree in the EU before May 1997:

• Foods with a new or intentionally modified molecular structure
• Foods consisting of, isolated from, or produced from microorganisms, fungi, or algae
• Foods consisting of, isolated from, or produced from plants or parts of plants (where the history of use is not established in the EU)
• Foods resulting from new production processes not previously used for food production
• Engineered nanomaterials used in food

The EU Novel Food Catalogue

The European Commission maintains a public Novel Food Catalogue that lists the novel food status of various plants and substances. This is the first place to check when assessing whether an ingredient requires authorisation. However, it is important to note that the catalogue is non-binding – the final determination lies with the competent authorities of EU member states.

Status of Common Exotic Ingredients

• Moringa oleifera (leaf): Listed as not novel in the EU Novel Food Catalogue. Moringa leaves and leaf powder have a documented history of consumption in the EU. However, moringa seed extracts may have a different status depending on the extraction process used
• Green banana powder: Not novel. Banana (Musa spp.) in all forms, including powder from green (unripe) bananas, has an established history of food use in the EU
• Baobab fruit pulp: Was authorised as a novel food ingredient in 2008 (Commission Decision 2008/575/EC). It is now listed on the EU Novel Food list
• Ashwagandha (Withania somnifera): The root is authorised as a novel food; the leaf is not authorised and cannot be sold as food in the EU
• CBD (cannabidiol): Considered novel. Requires EFSA safety assessment and Commission authorisation before market placement

What Happens If You Sell an Unauthorised Novel Food?

Placing an unauthorised novel food on the EU market is a regulatory offence. Consequences include:

• Product recalls and market withdrawal
• RASFF (Rapid Alert System for Food and Feed) notifications
• Fines and potential criminal liability depending on the member state
• Reputational damage for the importing company

How to Check Before You Import

1. Consult the EU Novel Food Catalogue for preliminary status information
2. If uncertain, submit a consultation request to the competent authority in the relevant EU member state
3. If the food is confirmed as novel, submit an application for authorisation to the European Commission, which will request an EFSA safety assessment
4. Alternatively, check if a “traditional food from a third country” notification (Article 14) applies, which offers a simplified procedure

Questions about the novel food status of our ingredients? Contact us.