EU Novel Food Regulation — When It Applies to Your Supplement Ingredients

A supplement brand preparing for EU market entry recently brought me a formulation that included an adaptogenic botanical extract that had been used in their US products for several years. The extract had a reasonable safety profile, was well-tolerated in their customer base, and had been reviewed by a US toxicologist. What the brand had not checked was whether the extract had a documented history of safe food use in the EU before 15 May 1997 — the date that defines the boundary between conventional food ingredients and novel foods under EU law. It did not. The ingredient was subject to Regulation (EU) 2015/2283 on novel foods, and placing the product on the EU market without authorisation would have been unlawful.

This article is for supplement brand owners, regulatory affairs managers, and formulation teams evaluating EU market entry. It explains the novel food framework, how to determine whether an ingredient triggers novel food status, and what the authorisation pathway involves.

What Is a Novel Food Under EU Law?

Regulation (EU) 2015/2283 of the European Parliament and of the Council on novel foods defines a novel food as any food that was not used for human consumption to a significant degree within the EU before 15 May 1997. The regulation replaced the earlier Novel Food Regulation (EC) No 258/97 and introduced a centralised authorisation procedure managed by the European Commission, with safety assessments conducted by the European Food Safety Authority (EFSA).

The categories of novel foods covered by the Regulation include:

Food with a new or intentionally modified molecular structure
Food consisting of, isolated from, or produced from microorganisms, fungi, or algae
Food consisting of, isolated from, or produced from material of mineral origin
Food consisting of, isolated from, or produced from plants or their parts, obtained by non-traditional propagation practices
Food consisting of, isolated from, or produced from animals or their parts
Food consisting of, isolated from, or produced from cell culture or tissue culture derived from animals, plants, microorganisms, fungi, or algae
Food resulting from a production process not used before 15 May 1997 that gives rise to significant changes in composition or structure
Vitamins, minerals, and other substances used in accordance with specific EU legislation, where a novel production process has been applied
Nanomaterials as defined in the Regulation

For supplement brands, the most practically relevant categories are botanical extracts (particularly those derived from plants not traditionally consumed in the EU), certain fermentation-derived ingredients, and ingredients produced using novel extraction or concentration processes.

The 15 May 1997 Threshold

The critical question for any ingredient is whether it was used for human consumption to a significant degree within the EU before 15 May 1997. “Significant degree” is not defined numerically in the Regulation, but EFSA and the Commission have interpreted it to mean more than negligible or incidental use — the ingredient must have been part of the normal diet of a meaningful portion of the EU population.

This threshold creates a significant asymmetry between the EU and North American markets. Many botanical ingredients that have been used in traditional medicine or dietary supplements in North America, Asia, or other regions for decades may have had little or no presence in the EU food supply before 1997. Traditional use in a non-EU context does not establish pre-1997 EU consumption history.

How to Check Novel Food Status

The European Commission maintains the EU Novel Food Catalogue, an online database that provides guidance on the novel food status of specific ingredients. The Catalogue is not legally binding — it reflects the current views of member state competent authorities — but it is the most practical starting point for a novel food status assessment.

The Catalogue lists ingredients with entries indicating whether the ingredient is considered novel, not novel, or whether the status is under review or unclear. For botanical ingredients, the Catalogue often distinguishes between different parts of the plant (leaf, root, seed, fruit) and different preparation forms (dried, extract, essential oil), as novel food status can vary depending on the specific form used.

If an ingredient is not listed in the Catalogue, or if its status is unclear, a formal consultation with the national competent authority of a member state — or a request for a Commission opinion — may be necessary to establish status before launch.

The Novel Food Authorisation Process

If an ingredient is determined to be a novel food, it must be authorised before it can be used in food supplements sold in the EU. The authorisation process under Regulation (EU) 2015/2283 involves:

Application to the European Commission: The applicant submits a dossier to the Commission, which forwards it to EFSA for safety assessment.

EFSA safety assessment: EFSA evaluates the dossier and issues a scientific opinion on the safety of the novel food. The dossier must include data on the production process, composition, specifications, history of use (including use outside the EU), proposed conditions of use, and toxicological and nutritional data. The preparation of a compliant dossier is a substantial scientific and regulatory undertaking.

Commission decision: If EFSA’s opinion is favourable, the Commission issues an implementing regulation authorising the novel food and specifying the conditions of use (including maximum levels, labeling requirements, and any post-market monitoring obligations).

The authorisation process can take several years from application to decision. Brands that identify a novel food issue late in their EU launch planning face a choice between reformulation, seeking a traditional food from a third country status (a separate but related pathway), or delaying launch pending authorisation.

Traditional Food from a Third Country

Regulation (EU) 2015/2283 introduced a simplified notification procedure for traditional foods from third countries — foods that have a history of safe food use in a non-EU country for at least 25 years as part of the customary diet of a significant number of people. If a botanical ingredient has a well-documented 25-year history of safe use in, for example, a specific Asian or South American country, it may be eligible for this pathway.

The notification procedure is faster than full authorisation, but it still requires a dossier demonstrating the history of safe use, and EFSA and member state competent authorities can raise safety objections that block the notification.

Practical Action Step

Use this checklist when evaluating supplement ingredients for EU novel food status:

Check each ingredient against the EU Novel Food Catalogue for current status
For botanical ingredients, check status by specific plant part and preparation form
For ingredients not listed or with unclear status, consult a qualified EU regulatory expert before proceeding
If an ingredient is novel, assess whether the traditional food from a third country pathway is available
If full authorisation is required, assess the timeline and cost implications for your EU launch plan
Consider reformulation with non-novel alternatives if the authorisation timeline is incompatible with your launch schedule
Document your novel food status assessment for each ingredient as part of your compliance file

Novel food status assessment requires specialist knowledge of both the EU regulatory framework and the scientific evidence base for specific ingredients. Consult a qualified EU regulatory expert before finalising your formulation for EU market entry.

Care Europe supports supplement brands with novel food status assessments, dossier preparation, and EU market entry strategy. Contact us to discuss your ingredient portfolio.

EU Novel Food Regulation — When It Applies to Your Supplement Ingredients