Reg. (EU) 2015/2283A food not consumed to a significant degree in the EU before 15 May 1997 is a novel food. It needs EU authorisation before it can be sold.
Regulatory toxicology and an evidence platform for EU novel food applications. Every finding source-linked, every result signed off by a named expert.
Request a novelty screeningEvery application has to document composition, production process, stability, nutrition, toxicology and allergenicity before EFSA can assess it.
mean time from submission to published authorisation.
additional data requests per application, on average.
of the evaluation time is attributable to the applicant's responses.
Studies at the wrong time. In our survey, all four companies named working out the required safety and toxicology evidence as their main challenge. Three saw the greatest value before committing budget to safety studies. The sample is small and exploratory.
The EU food and drink industry has about 309,000 companies, and 99% of them are SMEs. Most have no regulatory toxicology team of their own.
P0 and P1 run in our fast lane: standard templates, a platform pre-screen and one reviewing scientist, delivered in days rather than weeks. P2 to P4 are scoped individually, led by a named expert and billed by milestone.
| Code | Package | What you get | Effort | Price |
|---|---|---|---|---|
| P0 | Novelty ScreeningEntry · fast lane | Is your ingredient a novel food under EU law? A documented classification with evidence: consumption records before 15 May 1997, comparison with the Status Catalogue and the Union list, assessment of new production techniques. | ≈ 4 expert days | €4,500Request |
| P1 | Evidence Gap AssessmentEntry · fast lane | Evidence gaps identified before you commission studies. Your existing data mapped against current EFSA requirements, missing studies and endpoints flagged, with study recommendations. | ≈ 10 expert days | €12,000Request |
| P2 | Safety-Readiness PackageProject lane | The gap assessment taken further: prioritised next studies and a draft safety narrative before you commission expensive work. | ≈ 22 expert days | €30,000 |
| P3 | Regulatory Action PackageProject lane | Precedent analysis, submission strategy and drafted dossier sections, including a reserve for answering EFSA data requests. | ≈ 45 expert days | €55,000 |
| P4 | Full Dossier ProgrammeProject lane | A complete, submission-ready dossier under Regulation (EU) 2015/2283, approved by our toxicologists, including responses to EFSA data requests. | ≈ 120 expert days | €120,000 |
Ongoing compliance after authorisation: conditions of use, specification and label changes, post-market surveillance.
Access to the ToxiCore platform for in-house regulatory teams.
Prices exclude VAT. Toxicology studies are subcontracted to accredited contract research organisations; study costs and authority fees are passed through separately. We do not guarantee an authorisation outcome or a shorter EFSA assessment.
The platform handles retrieval, extraction, mapping, gap detection and first drafts. Judging sources and uncertainty, scientific judgement and regulatory relevance stay with named experts, who sign off every deliverable.
Biochemist and toxicologist with more than 15 years in regulatory toxicology and human health risk assessment, mainly for industrial chemicals under EU REACH and consumer goods. National scientific expert in the EFSA network on nanotechnologies in food and feed.
Physicist who has applied machine learning in academic and industrial settings for more than 15 years, leading knowledge-informed AI projects. Built point-of-care instruments under strict regulatory requirements at Abbott. PhD in cellular biophysics, University of Freiburg.
Engineer with more than ten years in manufacturing and operations leadership at Robert Bosch GmbH, including building a greenfield plant in China through to stable serial production. M.Sc. Production Systems Engineering, TU Braunschweig and University of Waterloo.
Industrial biotechnologist with 15 years in strain development and entrepreneurship. Precision fermentation and novel foods have been his research focus for five years, including single cell oils and single cell proteins.
An anonymised P0 report shows the structure and depth: novelty triage, evidence gaps, prioritised studies and traceable sources.
Request the sample reportAn AI assistant on a curated, versioned knowledge base, starting with EFSA and EU requirements. We are looking for three to five pilot partners. There is no price list yet.
Join the waitlist