Did you know that in the EU an ingredient can be classified as a Novel Food, but still be considered non-novel when used in food supplements?
Although this may sound contradictory, it is a real regulatory scenario under EU food law. Let’s explore what it means and how to determine whether your product falls into this category.
What is a Novel Food in the EU?
Under Regulation (EU) 2015/2283, a food or ingredient is considered Novel Food if it was not consumed to a significant degree in the European Union before May 15, 1997.
The regulation covers various categories of foods and ingredients, including those derived from new sources, produced through innovative processes, or newly introduced into the food supply. When a product falls under this definition, it must undergo a pre-market authorization process before being placed on the EU market.
Can an ingredient be Novel Food and Non-novel in food supplements?
Yes, this situation does occur. In some cases, an ingredient may require Novel Food authorization for use in conventional foods but not for use in food supplements.
This regulatory status is sometimes described as “Novel Food – non-novel in food supplements.”
The reason lies in the intended use and historical consumption patterns associated with different product categories.
Why does this distinction exist?
Although food supplements fall within the general definition of food, regulators recognize that they represent a specific category with unique characteristics.
According to EU regulation, food supplements are concentrated sources of nutrients or other substances with nutritional or physiological effects, typically marketed in dose form such as capsules, tablets, or measured liquids, with the purpose of supplementing the normal diet.
Due to their nature, food supplements are typically consumed in controlled quantities and often targeted to specific population groups, whereas conventional foods are generally consumed more broadly across all age groups and dietary patterns. Consequently, it is possible for an ingredient to demonstrate a documented history of consumption in food supplement form even if there is limited or no evidence of significant consumption as a conventional food prior to 15 May 1997.
This distinction is also reflected in several national botanical lists across EU Member States, such as the BELFRIT list or national inventories of plants permitted in supplements.
Where can I find examples?
Examples of ingredients with this regulatory status can be found in the EU Novel Food Catalogue, which provides guidance on the Novel Food status of many substances and ingredients used in the food sector. Examples are Maqui berries, Sour cherry seeds and Aqueous extract from fig leaves.
How can you determine the status of your ingredient?
Identifying whether an ingredient is Novel Food, or potentially not novel in food supplements, requires a detailed regulatory evaluation.
This typically involves assessing historical consumption, reviewing regulatory databases, analyzing production processes, and considering the intended use of the ingredient.
When uncertainty remains, companies may initiate a Novel Food status consultation under Article 4 of Regulation (EU) 2015/2283 with a competent authority.
Final takeaway
Understanding whether an ingredient is Novel Food, non-novel, or “non-novel in food supplements” is a crucial step for companies planning to enter the European market.
At Chemsafe, we support companies through Novel Food status assessments, regulatory strategy development, and Article 4 consultations, helping you determine the correct regulatory pathway for your ingredient and ensure compliance with EU requirements.
Are you unsure about the status of your product? Contact us! Our experts can assist you with a preliminary regulatory evaluation and the full Novel Food consultation process.
