Is your ingredient a novel food EU?

Was this ingredient consumed by humans in the EU, to a significant degree, before 15 May 1997?

You’ll need real evidence for this, such as sales records, publications, or recognized food use. A general impression isn’t enough. If you can’t point to solid evidence, answer “No,” and if you genuinely don’t know, answer “Not sure.”

Has the production process changed to one not used in the EU before 1997, in a way that significantly changes the ingredient’s composition, structure, nutritional value, metabolism, or level of undesirable substances?

This applies no matter how you answered Question 1, a process change can affect the outcome even for an ingredient with a long EU history.

Does the final ingredient contain engineered nanomaterials (particles 100 nanometers or smaller, or made of discrete functional parts at that scale)?

Was its EU use before 1997 limited to food supplements only, and are you now proposing to use it in another food category (for example, a drink, bar, or cereal)?

Is the raw material authorized in Europe and listed in positive lists or in the Novel Food Catalogue?

Has a similar ingredient been authorized as a Novel Food and listed in the Union list of novel foods (Regulation 2017/2470)?

Does it have a new or intentionally modified molecular structure not previously used in EU food?

Does it consist of, or is it isolated or produced from, animals or animal parts, without a traditional breeding history in the EU?

Is it produced using cell culture or tissue culture?

Is it a vitamin, mineral, or other nutrient substance made using a new production process, or containing engineered nanomaterials?

This is a narrower category than Questions 2 and 3; it applies specifically to nutrient substances used in food supplements or fortified foods.

Is there a well-documented history of safe food use outside the EU, spanning at least 25 continuous years, without considering a use in food supplements?

If there’s no EU history, this checks for a lighter-weight alternative path, sometimes called a “traditional food from a third country”, rather than full authorization.

Do you have, or can you obtain, identity and characterization data, a production process description, compositional data, and history-of-use evidence?

Whatever your result below, this documentation is the foundation of your case, either to support an authorization application, or to defend a “not novel” position if it’s ever questioned.