How long does EU novel food approval take? Lessons from IPE’s eight-year journey

If a food company wants to sell a genuinely new ingredient in the EU — something not commonly used before 1997 — it usually needs novel food authorisation first. Without that approval, the ingredient cannot lawfully be placed on the EU market.

Inulin-propionate ester (IPE) is one recent example. It is a fibre-based ingredient made by combining inulin, a plant fibre, with propionate. Researchers and developers have studied it in connection with appetite and satiety, and the commercial interest is clear: put it into everyday foods such as bars or drinks.

In June 2026, the EU authorised IPE as a novel food. But the journey from application to authorisation took more than eight years.

For food founders, ingredient developers and Regulatory Affairs teams, the useful question is not only what was approved. It is where an application can slow down, what evidence may attract further questions, and whether the final authorisation will actually cover the products the company wants to launch.

Explore more practical guidance in the rukola EU Food Law Guide.

What exactly has the EU authorised?

On 9 June 2026, the European Commission adopted Implementing Regulation (EU) 2026/1219, authorising IPE as a novel food.

Although some coverage describes IPE as a fibre-based food additive, its legal status under this decision is an authorised novel food. The authorisation does not permit its unrestricted use in any food.

The current conditions are:

Products containing it must use the designation “inulin-propionate ester” on the label. The Regulation also establishes compositional, chemical and microbiological specifications for the ingredient.

These conditions matter because finding an ingredient in the Union list of novel foods is only the beginning. A company must still check whether its supplier, ingredient, product category, use level and proposed communication fit the authorisation.

How long did the IPE approval take?

The publicly documented timeline contains four principal milestones:

From submission to entry into force, the process took approximately eight years and four months. These dates are documented in the final Commission Regulation.

That does not mean EFSA spent more than seven uninterrupted years reviewing a complete dossier.

EFSA’s scientific opinion on IPE states that the assessment used information from the original application as well as supplementary and additional data supplied following EFSA’s requests.

Under the procedure applying to applications submitted today, EFSA explains that an assessment should take nine months if the application contains all the necessary information. When further information is required, EFSA can stop the assessment clock while the applicant prepares its response — see EFSA’s novel food application procedure.

After EFSA adopts its opinion, responsibility moves to the European Commission and EU Member States. They decide whether to authorise the novel food and under which conditions.

The European Commission’s authorisation guidance describes a further period of up to seven months for submitting a draft implementing act following publication of EFSA’s opinion. These procedural provisions apply to applications submitted from 27 March 2021, so they should not be applied retrospectively to judge an application submitted in 2018.

For a new project, the nine-month EFSA period is therefore not a complete submission-to-market estimate. Dossier preparation, suitability checks, requests for information, Commission decision-making and commercial implementation can all extend the overall timeline.

If you are preparing a novel food application

One of the clearest lessons from the IPE opinion concerns ingredient identity and batch consistency.

IPE is produced by reacting inulin with propionic anhydride. The applicant needed to characterise the resulting material and quantify parameters including inulin, total propionate, free propionate and esterified propionate.

EFSA reports that it requested further analyses and that the Panel identified several issues with the original batch-to-batch information. Additional or repeated analyses were requested on several occasions — see EFSA’s IPE assessment.

The lesson is not that submitting a particular number of batches guarantees a successful application. It is that the following elements must consistently describe the same ingredient:

• manufacturing process;
• ingredient composition;
• representative batch results;
• analytical methods;
• proposed specifications;
• stability information;
• material used in safety studies;
• intended commercial product.

If the analytical method cannot reliably measure a proposed specification—or if the batches used in studies differ from the material intended for commercial production—additional work may be needed.

That could include producing new batches, repeating analyses, validating a method or explaining unexpected variability. Each response takes time, particularly when work must be coordinated across manufacturing partners, laboratories and external experts.

Product strategy also affects the dossier. Proposed food categories, maximum levels, serving sizes and target populations determine the exposure assessment. Asking for more uses can create a larger commercial opportunity, but it can also increase the number and complexity of the consumption scenarios that must be supported.

The intended product portfolio should therefore be defined before the application is finalised—not after a positive opinion has been received.

If your application is already with EFSA

A submitted dossier cannot be treated as a static archive.

Product development may continue while the application is being assessed. A company might change a supplier, manufacturing step, analytical method, specification or intended use.

A change in one area can affect several parts of the application. A new manufacturing process may alter the ingredient’s composition. A broader use may increase anticipated intake. A changed specification may no longer correspond to the batches used in safety studies.

When a change occurs, the team should be able to determine:

• what changed and why;
• which parts of the dossier are affected;
• whether the existing evidence remains applicable;
• whether new evidence is needed;
• which document contains the current information;
• who will prepare a response if EFSA asks about it.

This becomes especially important during a clock stop. If application information is spread across emails, folders, consultants and separate internal teams, preparing a consistent response may become a major project of its own.

The formal assessment period resumes when the requested information is supplied. The company’s ability to locate, evaluate and connect its evidence can therefore influence how efficiently the application moves forward.

If you want to use IPE in a product

The correct question is not simply, “Has IPE been approved?”

It is: does the authorisation cover this ingredient, from this commercial source, in this product and at the intended level?

The current authorisation covers cereal bars and fruit smoothies. It does not automatically cover bread, yoghurts, supplements, breakfast cereals, meal replacements or concentrated beverage shots.

The authorisation also relies on protected proprietary evidence. Until 30 June 2031, only Imperial College Hammersmith Campus may place IPE on the EU market unless another applicant obtains an independent authorisation or acts with Imperial College’s agreement — see Commission Implementing Regulation (EU) 2026/1219.

Before investing in formulation and packaging, a company would need to confirm:

• access through an authorised commercial route;
• conformity with the authorised specification;
• an authorised food category;
• compliance with the maximum use level;
• the required ingredient designation;
• the permissibility of the intended claims;
• labelling that matches the finished product—see EU food labelling requirements.

The last point is easily overlooked.

Novel food authorisation establishes that an ingredient is safe under specified conditions. It does not automatically permit statements that the ingredient suppresses appetite, increases satiety, prevents weight gain or offers an alternative to GLP-1 medicines.

Statements concerning slimming and weight control fall within the separate EU nutrition and health claims framework — see the European Commission’s health-claims guidance.

A product can therefore contain an authorised ingredient while its preferred marketing proposition remains unavailable.

Preparing a novel food for the EU?

A novel food application connects the ingredient identity, manufacturing process, batch analyses, specifications, proposed uses and scientific evidence. When one element changes, several parts of the application may need to be reconsidered.

rukola is building an AI Regulatory Affairs workspace for food to connect product information, regulatory requirements and supporting evidence. It is designed to help food companies:

• assess whether a food or ingredient may require EU novel food authorisation;
• identify the requirements relevant to the product;
• structure application information and supporting evidence;
• identify gaps and inconsistencies;
• connect regulatory findings to product decisions;
• monitor relevant EU regulatory developments;
• maintain traceable assessments with legal references.

The novel food workflow is not yet publicly available. Join the early-access list to follow its development and be among the first to review a novel food project with rukola.

Have questions about the planned novel-food workflow? Contact rukola.

Frequently asked questions

Editorial note: This article was reviewed against the cited European Commission, EFSA and EUR-Lex sources on 23 July 2026. EU rules, authorisations and guidance can change. Check the current Union list and applicable requirements before making a product or market-access decision.