Novel foods

Novel foods, ingredients and processes covered by the Novel Foods Regulation must have a pre-market safety assessment before they are authorised for use throughout the European Union.

This applies to any food and food ingredient that hadn't been used in the EU for human consumption to a significant degree before May 1997 - see what are novel foods.

To apply for an authorisation of a novel food in Great Britain, use the UK's regulated products application service.

Process for authorisation of a novel food in Northern Ireland

If you intend to market a novel food which has not yet been authorised, you will need to apply for authorisation. There are two authorisation routes under the relevant EU regulation. In both cases, you must provide a dossier of information and submit it to the European Commission (EC) through their e-submission food chain platform.

Traditional foods from countries outside the UK or EU

This is a simplified route for food products that are new to the EU but have a safe history of consumption within their country of origin. This route offers reduced data requirements and a shorter process of assessment than that of other non-traditional novel food.

The European Food Safety Authority (EFSA) provides guidance on applications for authorisation of traditional foods from third countries.

Full application for all other novel foods

For all novel foods other than traditional foods, application will require a full set of information to be submitted to the EC which will then ask the EFSA to carry out a safety assessment where appropriate. The food safety assessment will look at things like:

• composition
• nutritional value
• metabolism
• intended use
• presence of unwanted substances such as contaminants
• production process - if the final composition of a food changes in production this can make it a novel food
• toxicology assessment
• allergen assessment

Once the safety assessment is complete, the EC will form an opinion on the novel food. If the opinion is positive, they will add food to the EU list of novel foods, which means you can then market it in the EU.

Before applying for authorisation, read the EFSA's guidance for applicants submitting applications on novel foods in the European Union.