How novel foods are assessed
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 EU.
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.
Process for authorisation of a novel food
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 through an electronic portal.
Traditional foods from countries outside the UK or EU
This is 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 Advisory Committee Novel Food & Processes (ACNFP) has a detailed overview of the traditional food assessment process. The European Food Safety Authority (EFSA) has also published guidance on 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 European Commission which will then ask the EFSA to carry out a safety assessment where appropriate. The food safety assessment will look at things like:
- nutritional value
- 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, an opinion on the novel food will be formed. If the opinion is positive, the food will be added to the Union list of novel foods, which means it can now be marketed in the EU.
The European Commission recommends what to include in the scientific information and safety assessment report that you submit as part of your application. ACNFP also provides a full overview of the full application process for novel foods.
Application process for novel foods will be changing as of January 2020 when the EU Exit transition period ends. Find out more about submitting a regulated product authorisation application from 1 January 2021.