Compliance

UK FSA Novel Food (post-Brexit)

TL;DR

Post-Brexit, novel-food authorisation for the UK market is run by the FSA in England & Wales (and FSS in Scotland) under the retained Regulation (EU) 2015/2283. A novel ingredient (no significant history of UK consumption before 15 May 1997) needs a separate UK authorisation — an EU authorisation does not carry across. The most-cited examples for supplements: CBD isolates and broad-spectrum extracts (mandatory FSA-validated application), monacolin K, certain mushroom extracts, novel peptides.

Regulatory anchors

Regulation (EU) 2015/2283 (retained)

How V5 handles it

QMS — quality engineered into every action, not bolted on.

Because V5 owns the operator action, the QMS sees the data the second it’s captured — not at the end of the shift.

Document control with hard kiosk-level training enforcement.

Versioned SOPs are only useful if operators are actually trained on the current version. V5 enforces it at the kiosk.

Score your compliance gap — then download the validation pack.

A guided self-assessment walks you against the regulator clauses that apply to your industry. The validation pack — IQ/OQ/PQ scripts, traceability matrix, risk assessment, intended-use statement — generates from the same evidence so you can hand it to an auditor on day one.

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