Novel food assessments

Under the 'Novel Foods Regulation' (Regulation (EC) No 258/97), a novel food is defined as a food that does not have a significant history of consumption within the European Union (EU) before 15 May 1997. Such foods are subject to a pre-market safety assessment before a decision is made on EU-wide authorisation.

In the UK, the assessment is normally carried out by an independent committee of scientists appointed by the Agency, the Advisory Committee on Novel Foods and Processes (ACNFP). Assessments include a detailed study of potential for toxic, nutritional and allergic effects.

If a food was commercialised in at least one Member State before 15 May 1997, it can be marketed elsewhere in the EU under the 'principle of mutual recognition' and the Novel Foods Regulation does not apply.

See the regulation on the European Commission website via the link at the end of this page.

Novel food applications

Novel food applications comprise a range of foods, and past applications include oils, sweeteners and berries.

Food companies may wish to introduce novel foods because they are produced more efficiently or because they might have advantages for the health and nutrition of consumers, such as lowering cholesterol or providing a source of desirable types of fatty acids.

In 2006 the Commission held a public consultation on possible improvements to the Novel Foods Regulation. The aim of revising the Novel Foods Regulation was to create more innovative foods, improve trade, and increase consumer choice. See the consultation on the Commission website at the link at the bottom of this page.

Submitting an application

A novel food application is first made to a single EU Member State. Commission Recommendation 97/618/EC sets out what should be included in the scientific information and safety assessment report submitted by the company. See Commission Recommendation 97/618/EC on the Commission website via the link below.

Once the application has been accepted, the Member State has 90 days to produce an initial opinion. This opinion is then circulated to all EU Member States, who are then given a further 60 days to comment or make a reasoned objection. If there are no objections, the novel food will be authorised (or rejected) at the end of the 60 days in line with the initial opinion. Otherwise a decision on the authorisation will be taken by a vote among Member States at the Standing Committee on the Food Chain and Animal Health. If necessary, the European Food Safety Authority will first be asked for its opinion on any outstanding safety questions.

Simplified procedure

The Novel Foods Regulation includes a simplified procedure for marketing certain types of novel food or novel food ingredient in the EU if it is considered ‘substantially equivalent’ to an existing food or food ingredient that is already marketed within the EU. In these cases, the company can submit a notification to the European Commission after obtaining an opinion on equivalence from an EU Member State.

In the UK, the Food Standards Agency is the Competent Authority, advised by the ACNFP, that gives an opinion on equivalence. The company must provide the Agency with specific data when requesting such an opinion. The company’s application dossier should show how the novel food or novel food ingredient may be substantially equivalent to an existing food or food ingredient as regards to its:

  • composition (such as the source organism and preparation method)
  • nutritional value
  • metabolism
  • intended use (such as a food ingredient or supplement)
  • level of undesirable substances (such as contaminants, mycotoxins and allergens)

Full guidance on what is required can be found in the ACNFP's guidelines on demonstrating substantial equivalence; these can be found at the link below.