Novel Foods: When is an ingredient too new for the EU market? 

What makes a Food Novel? 

Under Regulation (EU) 2015/2283, a novel food is generally a food that was not consumed to a significant degree within the European Union before 15 May 1997 and falls within one of the categories defined by the legislation.  

But Novel does not necessarily mean newly invented. It can refer to innovative foods, ingredients produced using new technologies or production processes, including foods traditionally consumed outside Europe.  

This means that an ingredient with a long history of consumption in another part of the world may still be considered novel when introduced to the EU market. 

For food supplement manufacturers, a history of consumption is only part of the process. What matters is whether the ingredient satisfies the conditions for entering the EU market. 

From traditional use to EU market access 

Before placing a Novel Food on the EU market, it generally needs to undergo an authorisation process that considers its safety under the proposed conditions of use.  

The European Commission maintains a Novel Food Catalogue, highlighting information of the novel food status of various ingredients. Considered a useful starting point, but it is not an exhaustive of legally binding list.  

Botanical ingredients are an interesting example of this. While the EU has established common rules for novel foods, certain uses of plants, algae and mushrooms in food supplements remains subject to different EU Member State requirements.  

For instance, Germany has developed lists through its Federal Office of Consumer and Protection and Food Safety to help classify plants and other substances according to their suitability for use in foods. Other Member States have also established their own different approaches, showing longstanding differences in how herbal preparations have been regulated.  

Ingredient check matters 

Even when an ingredient is not considered novel, other restrictions may still apply. Certain botanicals and other substances are subject to national requirements, meaning that an ingredient accepted in one EU Member State may face different conditions in another.  

For Food Business Operators (FBO) developing supplements for several European markets, this makes the initial ingredient assessment crucial. The formulation, ingredients and intended markets need to be put into account, including any applicable national notification requirements.  

At Obelis Group, these considerations also form part of the compliance review, examining product formulations, technical documentation and country-specific requirements before proceeding with regulatory notifications.

References 

European Parliament and Council of the European Union. (2015). Regulation (EU) 2015/2283 of 25 November 2015 on novel foods, amending Regulation (EU) No 1169/2011 and repealing Regulation (EC) No 258/97 and Commission Regulation (EC) No 1852/2001. Retrieved on 12/10/2026. 

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