What Is a Novel Food Ingredient and When Does It Require Authorisation?

A novel food ingredient is any food or food component that lacks a significant history of human consumption in a specific region before a benchmark date, such as 15 May 1997 in the European Union. It requires a pre-market safety evaluation and formal authorisation before it can be legally sold. This covers newly developed ingredients, foods produced using new technologies, and foods traditionally eaten outside the region but new to that market.

The regulatory landscape differs across jurisdictions. In the EU, the framework is Regulation (EU) 2015/2283. In the UK, post-Brexit rules largely mirror the EU system but operate separately, so a product authorised in one market does not automatically gain approval in the other. For supplements, the same ingredient may also need to meet uk food supplement regulations alongside novel food requirements.

What Counts as a Novel Food Ingredient in Practice

The definition is broader than many assume. It includes:

• Ingredients from new sources, such as microalgae, fungi, or insects like crickets and yellow mealworms

• Foods produced through new processes, including precision fermentation proteins and cell-cultured products

• Foods consisting of engineered nanomaterials

• Traditional foods from non-EU countries without a documented consumption history in the EU before May 1997

“Natural” does not automatically mean “not novel.” An ingredient can be completely natural and still be novel if people in that region have not eaten it to a significant degree before the cut-off date.

The EU Novel Food Authorisation Process

Regulation (EU) 2015/2283 centralised what was previously a fragmented process. Before 2015, applications went to individual Member States, and the average timeline stretched to around three and a half years. The reformed procedure is designed to be faster, though actual timelines still vary depending on data quality and the complexity of the safety questions involved.

 The EU Novel Food Regulation, established under Regulation (EU) 2015/2283, sets out the requirements and procedures for assessing and authorising novel food ingredients before they enter the European market. 

The Novel Food Approval Process involves several stages: 

1. The applicant submits a dossier to the European Commission

2. EFSA conducts the scientific risk assessment

3. The Commission prepares an authorisation decision based on EFSA’s conclusions

4. Approved ingredients are added to the Union list of authorised novel foods

For traditional foods from outside the EU, there is a separate notification route. If the applicant can demonstrate a history of safe use in the country of origin and no Member State or EFSA raises safety concerns, the food can be placed on the market through a simpler notification procedure.

Novel Food Safety Assessment: What the Dossier Must Show

A Novel Food Safety Assessment is a structured evaluation covering the ingredient’s identity, production process, compositional data, proposed uses, anticipated intake, toxicology, allergenicity, and nutritional impact. EFSA publishes detailed guidance on what each section must contain, and gaps in the dossier are one of the most common reasons applications stall. These evaluations help ensure compliance with the Novel Food Regulatory Requirements before market authorisation. 

Under the current regulation, newly developed scientific evidence and proprietary data cannot be used to support another applicant’s submission for five years after authorisation. This creates a commercial window for companies that invest in original research.

Comparing Regulatory Routes by Market

The US approach is fundamentally different. There is no “novel food” category as such. Instead, new ingredients enter through the GRAS (Generally Recognized as Safe) pathway or a food additive petition. An ingredient approved as a novel food in the EU may still need a separate US strategy.

Common Mistakes That Delay Applications

The most frequent error is submitting a dossier before the ingredient’s identity and production process are fully characterised. EFSA cannot assess safety for an ingredient that is not precisely defined. Another recurring issue is underestimating the intake assessment. If the applicant proposes use across multiple food categories, the anticipated intake calculation must reflect realistic consumption patterns, not optimistic assumptions.

A third mistake is treating the novel food question as an afterthought. If a company develops a food supplement and only later discovers the active ingredient is novel, the entire launch timeline shifts. Checking novel status early is far cheaper than reworking a product after formulation and packaging decisions are already made.

Practical Steps to Take Now

Start by determining whether your ingredient is actually novel. The European Commission maintains a searchable Novel Food Catalogue that lists the status of many ingredients, though the catalogue is indicative rather than legally binding. If the status is unclear, you can seek clarification from the Member State where you intend to first market the product.

If the ingredient is novel, map out the data you already have against EFSA’s guidance before commissioning new studies. This gap analysis often reveals that existing literature can answer some questions, reducing the need for expensive new toxicology work.

For companies navigating multiple markets, the sequence matters. An EU Novel Food Authorisation can strengthen a subsequent UK or Swiss submission, but the reverse is not automatic. Planning the regulatory strategy across jurisdictions from the start avoids duplicated work and conflicting data packages.

Regulatory specialists such as OMC Medical can support this process, particularly where the ingredient is intended for use in a food supplement and the dossier must address both novel food and supplement-specific requirements, including Food Requirements in Switzerland where relevant.