The Food Supplements (England) Regulations 2003 (SI 2003/1387, with parallel SIs for Scotland, Wales, NI) implement the EU Food Supplements Directive 2002/46/EC and govern composition, labelling and notification of food supplements sold in the UK. They define a food supplement, set the permitted vitamins/minerals and their chemical forms (Annex I/II), require pre-market notification to the relevant Food Authority, and mandate the prescribed label statements — including 'food supplement' on the principal display.

Regulatory anchors

SI 2003/1387
Directive 2002/46/EC

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.

UK Food Supplements (England) Regulations 2003

Next step

UK Food Supplements (England) Regulations 2003

Next step