Novel Food

The novel food application

The hard way to the highway!

Succeed with your ingredient in all EU countries

An ingredient is to be considered novel food in Europe by the European food safety authority (EFSA) if the ingredient has not been consumed for human consumption to a significant degree in the EU before 15 May 1997. These ingredients are regulated by Regulation 258/1997/EU and amendments.

The regulation applies to any food and food ingredient which:

  • consists of foods or food ingredients with a new or intentionally modified primary molecular structure
  • consists of or is isolated from micro-organisms, fungi or algae
  • consists of or is isolated from plants or food ingredients isolated from animals, except for foods and food ingredients obtained by traditional propagating or breeding practices that have a history of safe food use
  • a production process not currently used has been applied to and this process gives rise to significant changes in the composition or structure of the food or food ingredient which affect the nutritional value, metabolism or level of undesirable substances of the food or food ingredient.

  How to deal with the novel food status of your food or food ingredient?         

  1. Novel food application
  2. Substantial equivalence
  3. Non Novel statement

These three options are opportunities that in every single way can be used to bring a new ingredient to market. With every new ingredient it is a consideration which option is the best for the customer with the implications and requirements of each choice entails.

Scope of your novel food application

When the novel status for an ingredient has been decided you have to decide what kind of novel food application you want. Are you going for the ingredient as a food ingredient or only as an ingredient used for supplements? This decision should reflect your business strategy in order to avoid leaving out markets you need later.

We will in conjunction with you discuss different options and clarify the consequences your choices are giving. This process is extremely important and should be initiated as early in the process as possible as study-design etc. should reflect later use. Doing this saves time and money in the entire process.


We treasure confidentiality between our client and us. As a result when we are asked for references we will provide references matching you inquiry upon the acceptance of the client we have worked for previously.

If you wish to receive references, please contact us for details.