Compliance

UK FSA Novel Food (post-Brexit)

In short

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 records next to the work they concern.

Deviations, corrective actions and quality review sit in the same system as production, so each quality record references the work order, step and lot it concerns.

Document control — one version in force, every change signed and explained.

Draft the next revision while the current one stays in use, approve it under your sign-off route, and track training on it — with the history kept.

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 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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