Pre-submission review · Reg. (EU) 2015/2283

A second pair of eyes on your novel food dossier.

Borgh reads each section against EFSA's scientific guidance and 240 published opinions, and flags what a panel reviewer would — compositional gaps, missing analytical methods, inconsistencies between your data and your text. Not just whether a section is there, but whether your data clears the bar.

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Built for

Precision fermentationInsect proteinMicroalgaeCell cultureUpcycled ingredientsPlant extractsHMOs

Dossier · Specimen Upcycled

Live review

Applicant

Specimen Foods B.V.

Sections reviewed

12 / 14

Subject

Upcycled rapeseed protein concentrate

Findings · 234 high · 11 med · 8 low

HighBatch-to-batch compositional data covers 3 batches; EFSA guidance expects 5 for this category.

MedAnalytical method for anti-nutritional factors stated but not validated against a reference.

LowProduction-process flow diagram lacks critical control-point temperatures.

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A 90-second walkthrough: paste a section, run the review, read the findings.

91% of post-2018 novel food dossiers receive additional data requests.

Each additional data request stops the clock — months of delay and rework before you can resubmit, on a dossier that already costs €100,000–€250,000 to bring to EFSA. Borgh catches the gaps before you submit, so your first version is the strong one.

91%

Clock-stop rate · post-2018

16.4

Months median to opinion

€100–250k

Cost of a full dossier

Sources · EFSA novel food applications register and published scientific opinions, 2018–2024.

Anatomy of a clock-stop

What a single missing detail costs.

One novel food dossier, told as a timeline. It cleared admissibility — then stalled on a detail Borgh would have flagged in seconds. Watch the months tick by.

Month 0
Dossier submitted to EFSA
Month 4
Admissibility passed
The dossier looked complete. The science review began.
Month 7 · Clock stopped
Additional data request — only three batches of compositional data
The Panel could not conclude on consistency. The assessment clock stopped. Nine months of new analyses, drafting and review began.
Month 16
Resubmitted with five batches
Month 19
Opinion finally adopted
A detail caught pre-submission would have saved the better part of a year.

9 monthslost to one additional data request — on a dossier that had already passed admissibility.

How it works

Three steps. Under ten minutes.

Paste your dossier section

Copy your draft text — compositional data, toxicology, production process — and select which EFSA section it covers.

AI reviews against EFSA guidance

Borgh checks your text against the 2024 scientific guidance, 240 published opinions, and real ADR patterns from clock-stopped dossiers.

Get structured findings with sources

Each finding is categorised by severity — from admissibility blockers to recommendations — with a direct reference to the relevant guidance paragraph.

Features

Built on EFSA's published record, not guesswork.

Dossier Review

Full section review against EFSA guidance

Paste or upload a dossier section. Borgh consults EFSA's published case law, then returns structured findings categorised by severity — admissibility blockers, clock-stop risks, panel challenges, and recommendations.

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Regulatory Q&A

Ask regulatory questions, get sourced answers

Not ready for a full review? Ask specific questions about EFSA requirements — batch counts, stability data, allergenicity assessments — and get answers linked to the exact guidance paragraph.

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Section Guide

See what EFSA asked of comparable dossiers

Precedent, mined from every published novel food opinion: which deficiencies recur per dossier section, and which ones predict a clock-stop. Know what triggers a data request before you submit.

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The deliverable

A report you can hand off.

Every review exports as a clean, sourced document — in Borgh's own typography. Share it with your consultant, your team, or attach it to your internal sign-off.

→Findings grouped by severity, each with its guidance reference.
→Suggested actions and the cited passage from your text.
→PDF or shareable link — the source stays yours.

Export · coming soon

Gap report · §3 Compositional dataSPECIMEN FOODS B.V.

Findings

7 FINDINGS1 BLOCKER4 CLOCK-STOPS1 REC.

Compositional data covers only three batchesAdmissibility blocker

Guidance expects at least five independent, representative production batches for this category.

EFSA 2024 Scientific Guidance §3.3

Hexane extraction — residual solvent data missingClock-stop risk

Residual hexane must be reported and assessed against Directive 2009/32/EC limits.

Directive 2009/32/EC

Stability study on a single batch onlyClock-stop risk

Multiple batches and microbiological parameters are expected to demonstrate consistency.

EFSA 2024 Scientific Guidance §3.9

Borgh · pre-submission screeningPage 1 of 3

The applicant did not provide sufficient information to characterise the production process. The Panel could not conclude on the safety of the novel food.

— EFSA NDA Panel
Production-process characterisation gaps recur across 66 of the 239 opinions we analysed

Security

Your data, protected.

EU-based & GDPR compliant

Netherlands-based. Your account and review data are stored in the EU (Frankfurt). Sub-processors operate under GDPR data-processing agreements.

No AI training

Your dossier content is never used to train AI models. Anthropic retains API data for 30 days for safety monitoring, then automatically deletes it.

You control your data

Your reviews are saved to your account so you can revisit them. Uploaded files are not retained beyond text extraction. Delete your data at any time.

Encrypted in transit

All connections secured with TLS encryption. Industry-standard HTTPS on every request.

Pricing

Free during beta.

Borgh is built to lower the regulatory bottleneck for the people moving the food system forward. While we're in beta, every review is free.

Long term, Borgh will run on a single low fee that covers running costs — no per-seat pricing. Beta users will hear well before anything changes.

Beta access

€0

Unlimited reviews while Borgh is in beta. No card, no commitment.

✓Unlimited dossier reviews

✓Citations, Section Guide & regulatory Q&A

✓Review history & export

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Questions

Frequently asked.

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Paste a section and get structured findings in under ten minutes. Free while Borgh is in beta.

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