Novel food authorization delays for botanical ingredients

For manufacturers and distributors, that threshold can turn a sourcing decision into a multi-year regulatory project: an empirical analysis of 292 EFSA applications submitted between 2018 and 2024 found an average of 2.56 years from submission to publication of the assessment.

The headline duration matters, but it does not tell a company where a particular application is in the process or whether its own ingredient can legally be sold. That requires checking classification, the status of any relevant dossier, and the evidence behind the botanical’s identity and consumption history. The practical question is how to check novel food authorization delays for botanical ingredients without treating a catalogue entry or a statutory deadline as a market-access guarantee.

The 1997 threshold and the first classification decision

Regulation (EU) 2015/2283 sets the central test: a food not consumed to a significant degree by humans in the EU before 15 May 1997 may be classified as novel and require authorization before market placement. For a botanical, the assessment is tied to the ingredient and its intended use. A plant’s long history as a traditional remedy, for example, does not by itself establish a history of significant food consumption.

That makes the initial classification exercise a supply-chain control, not a paperwork formality. A manufacturer needs to understand precisely what the proposed ingredient is: the botanical species, plant part, preparation, extraction process and intended conditions of use. Evidence relating to one form of a plant may not settle the status of a materially different extract or use. If the material changes, the prior conclusion may not carry across.

The European Commission’s Novel Food Status Catalogue is a useful orientation tool. It is non-binding, however, and should not be treated as a definitive authorization or a legal determination. Where status remains uncertain, a food business operator can consult the competent authority of an EU Member State under Article 4. The authority has a four-month determination window. That route can help resolve a classification question, but it is separate from the full authorization process and does not itself grant authorization for an ingredient that is novel.

For a B2B distributor, the decision tree is operational:

1. If the ingredient appears to have established pre-1997 food use, assemble evidence for the specific botanical and form being supplied, then assess whether the intended use is consistent with that history.

2. If the catalogue indicates possible novelty or the evidence is inconclusive, do not convert that indication into a definitive legal conclusion. Consider an Article 4 consultation with the relevant Member State authority.

3. If the ingredient is novel, establish whether an authorization already covers the ingredient and proposed conditions of use, or whether an application must be pursued before market placement.

The evidence file should follow the ingredient through procurement and formulation. Gaps in botanical identity, plant part, processing history or use conditions can make it difficult to connect historical evidence to the material actually being sold. They can also create avoidable friction if a regulator requests clarification later.

Why a nine-month assessment can take more than two years

The statutory EFSA risk-assessment phase is set at nine months under Regulation (EU) 2015/2283. That is a defined stage in a longer process, not a reliable estimate of the time from application to a published assessment. EFSA conducts a suitability check, for which the stated period is 30 working days, before a suitable application proceeds to scientific assessment. Requests for additional information can then stop the clock while the applicant prepares a response.

The scale of that effect is visible in the application analysis: cases received an average of 2.7 additional data requests, and applicants took approximately 130 days to respond to each request. Those figures do not mean every dossier will receive the same number of requests or take the same time to answer them. They do show why a nine-month statutory assessment period cannot be used as a simple launch-date calculation.

The same analysis found an average total duration of 2.56 ± 1.19 years, or 937 ± 436 days, from submission to publication for 292 applications submitted to EFSA between 2018 and 2024. The variation is material. A portfolio team should plan around a range of possible outcomes and the uncertainty created by data requests, rather than assume that an average is a deadline for an individual application.

The nine-month clock describes the statutory risk-assessment phase. It does not describe the full elapsed time from filing to an assessment that can support a business decision.

There is also a distinction between an EFSA risk assessment and the wider authorization pathway. Publication of an assessment is an important milestone, but operators should track the status of the relevant application and the applicable regulatory steps before treating an ingredient as cleared for sale. The timing of an individual dossier cannot be inferred from the average alone.

For manufacturers deciding whether to reformulate, qualify a supplier or defer a launch, the core planning problem is therefore exposure to delay. A product timeline that depends on an unresolved novel food status should carry a contingency: an alternative ingredient, a revised launch sequence, or a decision point tied to verifiable regulatory milestones. The appropriate option depends on the product and contract, but relying on a hoped-for completion date leaves the operational risk with the manufacturer.

Tracking a dossier through OpenEFSA

OpenEFSA provides digital access to ongoing risk assessments and public consultation documents. It is the practical place to follow a dossier once an application is in the EFSA process. The portal can help establish whether a case is ongoing and what documents or consultations are available; it does not provide a guaranteed completion date or a public real-time position in an internal queue.

A disciplined search starts with the exact ingredient and applicant details available to the operator. Botanical naming can vary across commercial documentation, and a broad search may return material that is not the same as the ingredient under review. Match the dossier against the botanical identity and form, then read the available documents rather than relying on a listing alone.

For an ongoing file, record the following:

• the application identity and the ingredient description associated with it;
• the stage visible in OpenEFSA and the date of the latest public update;
• whether public consultation documents are available and what evidence they address;
• whether the proposed conditions of use appear relevant to the manufacturer’s intended application.

These checks support status monitoring, not a legal conclusion that a product is authorized. A dossier concerning a related plant preparation may not cover a supplier’s extract, plant part or use conditions. If the public record does not establish that the material is the same, the discrepancy should be resolved before the dossier is used to support a commercial decision.

The EFSA Compendium of Botanicals is another useful screening resource. It includes 2,701 plant species and 1,538 naturally occurring substances of potential health concern, helping scientific assessors identify hazards during novelty and safety reviews. Its presence can alert a company to safety issues that may require attention in a dossier. It does not determine novel food status, nor does a listing alone establish that an ingredient is prohibited or authorized.

The two resources answer different questions. The Novel Food Status Catalogue helps orient an operator on possible novelty; OpenEFSA tracks assessment activity; the Compendium supports hazard identification. Treating them as interchangeable creates a traceability problem: a company may mistake a preliminary classification signal or a hazard reference for a market authorization.

Additional data requests and the cost of a weak dossier

Additional data requests are a central source of clock-stops. When EFSA needs more information, the assessment timeline pauses while the applicant responds. With an average response period of approximately 130 days per request in the analyzed applications, incomplete or poorly aligned evidence can have a substantial scheduling effect.

The most useful mitigation occurs before submission. The dossier should connect the identity of the ingredient to its production process, proposed specifications, intended conditions of use and safety evidence. For botanical materials, this means ensuring that the evidence describes the actual preparation under review. If a supplier changes the extraction method or raw material specification during the process, the applicant may need to assess whether the change affects the dossier and supporting evidence.

When a request arrives, the response plan should be managed as a formal workstream rather than a general regulatory follow-up. Assign ownership for each question, identify whether the answer depends on supplier records or new analysis, and track the response against the request’s scope. A response that supplies abundant material but fails to address the specific information gap can prolong the exchange.

Supply agreements should reflect this dependency. Manufacturers relying on a botanical ingredient under review need a clear route to obtain technical records from the supplier and notification of material changes. Without that access, the applicant may be accountable for answering a regulator while lacking control over the underlying production data. That is a preventable weakness in traceability and dossier governance.

Article 4 consultation and the decision to proceed

Article 4 consultation is relevant when the unresolved issue is whether an ingredient is novel. A food business operator may ask a Member State authority to determine the status, with a four-month determination window. This is a defined route for resolving classification uncertainty; it should not be confused with an EFSA safety assessment or treated as a shortcut to authorization.

Before using the route, the operator should define the question narrowly and provide evidence tied to the exact ingredient. A broad claim that a botanical has been used historically may leave the key issues unanswered: whether the evidence concerns food consumption, whether it predates the 1997 threshold, and whether it relates to the same plant part and preparation now proposed. The quality of the submission affects how useful the determination will be for the business decision.

If the authority concludes that the ingredient is not novel, the company should retain the determination and its supporting evidence in the compliance file, and ensure the commercial material remains consistent with the description assessed. If the ingredient is considered novel, the business will need to evaluate the authorization route and its timing before committing to market placement. If the evidence remains ambiguous, the uncertainty should be reflected in procurement and launch planning rather than silently converted into an assumption of clearance.

For manufacturers and distributors, the immediate next steps are concrete: confirm the identity and intended use of the botanical, check the Commission catalogue as an orientation reference, review any relevant OpenEFSA dossier, and decide whether an Article 4 determination is needed. Where authorization is required, build the evidence plan and supplier obligations before setting a launch date. The regulatory bottleneck is often visible early; the liability becomes harder to contain once product, contracts and production schedules are already committed.