How novel foods are assessed
What the compulsory pre-market safety assessment for novel foods covers and how to get authorisation for novel food.
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.
Under current operating arrangements for Northern Ireland, businesses seeking a new authorisation for novel foods placed on the NI market will continue to follow EU food rules. From Autumn 2023, the Windsor Framework will allow GB public health standards to apply for pre-packed retail goods moved via a new NI retail movement scheme and placed on the NI market. Therefore, goods moving via this route containing GB authorised products will be able to be placed on the NI market.
To apply for an authorisation of a novel food in Great Britain, use the UK's .
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 .
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 .
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 , which means you can then market it in the EU.
Before applying for authorisation, read the EFSA's .