Novel foods: Safety assessment and authorisation

Understand different authorisation routes for novel foods, and how to get authorisation for novel food in Northern Ireland, Great Britain and Europe.

Novel food law requires all novel foods to undergo a formal safety assessment and authorisation before they can be placed on the market. There are two main routes for the authorisation of novel foods under the regulation that applies in Northern Ireland and Europe.

Authorisation of traditional foods from countries outside NI or the EU

This is a simplified route for foods that are new to the EU or NI, based on a documented history of their safe use in their country of origin. Businesses apply through an online notification to the European Commission. This route has reduced dossier requirements and a shorter assessment process than for other novel foods. Read the European Food Safety Authority (EFSA) guidance on the authorisation of traditional foods from third countries.

Full application for all non-traditional novel foods

For all non-traditional novel foods, you must submit a full application to the European Commission through their e-submission food chain platform. For your application, you must prepare a detailed dossier describing the food, production, uses, consumers and safety rationale. Once the Commission has validated the application, they will ask EFSA to carry out a scientific safety assessment.

The safety assessment for a full application normally covers:

composition
nutritional value
metabolism
intended use and target consumers
presence of undesirable substances, such as contaminants
production process and any changes to the final composition
toxicology
allergenicity

If the assessment is favourable, the product will be added to the Union list of authorised novel foods and can be lawfully marketed in the EU subject to any conditions of use.

If you want to market a novel food in NI that is not yet authorised in the EU, read the full guidance on procedures to request a novel food authorisation.

Novel food authorisation in Great Britain

In Great Britain, novel foods are authorised under the UK-regulated products framework, using the Food Standards Agency (FSA) risk assessment. Businesses apply for authorisation through the UK-regulated products application service. GB also maintains its own list of authorised regulated food and feed products.

If you plan to sell in both Great Britain and Northern Ireland/EU, you will need to be aware of the relevant Windsor Framework or Unfettered Market Access requirements.

For GB products moving into NI, you may need both GB and EU novel food authorisations, unless the goods are moving under the Northern Ireland Retail Movement Scheme (NIRMS). Under the Windsor Framework, some GB-authorised pre-packed retail products may be supplied into Northern Ireland via the NIRMS, subject to scheme conditions and product scope.

Novel foods produced in Northern Ireland must follow EU Regulation (EU) 2015/2283, however can be placed onto the GB market, provided they are Qualifying Northern Ireland Goods.

What this means for NI food businesses

If you place products directly on the Northern Ireland market, you must comply with EU novel foods rules and ensure the product is on the EU Union list, unless the product is moved under NIRMS. If you develop or import a new product, you may need: