Food supplements regulations for UK and EU compliance teams

Food supplements regulations control composition, safety, labelling and claims. England uses the Food Supplements (England) Regulations 2003, while the EU framework is Directive 2002/46/EC, implemented through national law. Scotland, Wales and Northern Ireland have separate instruments. General food-information and claims rules also apply. (England regulations, UK guidance, EU Directive)

Start with the destination market. Great Britain and the EU have separate permitted nutrient-source lists. Northern Ireland ordinarily follows relevant EU rules, with special arrangements for qualifying retail movements from Great Britain. A single formula or label review cannot assume these regimes are identical. (DHSC guidance, retail movement regulations)

Which food supplement regulations apply?

A food supplement supplements the normal diet with concentrated nutrients or other substances that have a nutritional or physiological effect. It is sold in dose form, such as tablets, capsules, sachets or drop-dispensing bottles. Supplements supplied to the final consumer must be prepacked. Medicinal products fall outside this definition. (England regulations, regulations 2–4, Directive, articles 1–2)

For a UK or EU launch, separate the markets before checking ingredients or artwork:

The FSA guidance identifies the UK instruments. The Directive establishes the EU framework and allows national label-notification requirements.

For Northern Ireland, check eligibility under the Northern Ireland Retail Movement Scheme before relying on GB standards. The 2023 retail movement regulations provide special arrangements for qualifying consignments, not a general exemption for every supplement sold there.

Check permitted vitamins, minerals and their sources

Permission to use a vitamin or mineral does not permit every chemical form. In England, regulation 5 points to the permitted nutrients in Schedule 1 and sources in Schedule 2 of the 2019 Nutrition Regulations. Applicable purity criteria also matter. (England regulations, Schedule 1, Schedule 2)

For EU sales, check Annexes I and II of the Food Supplements Directive. An EU list amendment does not automatically update GB law. Separate novel-food conditions can apply even when a source appears on a permitted list. Check both permissions before signing off the formula. (DHSC guidance, Directive)

Recent magnesium-source amendments show why effective dates matter. The EU added magnesium L-threonate from 26 November 2025, subject to its novel-food listing. England's magnesium L-threonate monohydrate amendment took effect on 12 August 2026. Similar names do not establish identical authorisation conditions. (EU amendment, England amendment)

Are there maximum vitamin and mineral levels?

Article 5 of the Directive provides a mechanism for setting maximum and minimum amounts. It does not supply a numerical ceiling table. The European Commission's published overview says no proposal for harmonised amounts has yet been presented. That does not remove safety obligations, national restrictions or ingredient-specific conditions. (Directive, Commission overview)

Food supplement labelling requirements

For England, regulations 6–7 require the following supplement-specific information. Articles 6–9 of the Directive set corresponding EU requirements. (England regulations, Directive)

• The name "food supplement".
• The categories of characterising nutrients or substances, or an indication of their nature.
• The portion recommended for daily consumption.
• A warning not to exceed the stated recommended daily dose.
• A statement that supplements should not substitute for a varied diet.
• A statement that the product should be stored out of young children's reach.
• Numerical amounts of the relevant vitamins, minerals and other active substances.

Use "food supplement", rather than importing the US label term "dietary supplement". Declare amounts per recommended daily portion, in the prescribed units. These must be average amounts based on the manufacturer's analysis. Required information must be clear, legible, indelible, conspicuous and not hidden. (FSA guidance, England regulations)

This list is not the full pack checklist. General food-information requirements include ingredients, emphasised allergens, responsible-business details, date marking and appropriate storage or use information. Check address requirements for each destination. For ordinary Northern Ireland sales, the FSA identifies an NI or EU business or importer address. (FSA guidance)

What does %NRV mean?

%NRV means percentage of the nutrient reference value. Vitamins and minerals with a reference value in Annex XIII must also be declared as a percentage of that value. The adult labelling NRV for vitamin D is 5 micrograms. A daily portion containing 10 micrograms therefore supplies 200% NRV. That calculation is neither dosage advice nor evidence of a safe maximum. (England regulations, Annex XIII)

Use the current legal units when checking artwork. The current GB Schedule 1 specifies both zinc and copper in mg. DHSC's 2021 guidance still describes the zinc-unit correction as pending. Use the current schedule rather than that older passage. (Current Schedule 1)

Check claims on the pack and in advertising

Supplement labelling, presentation and advertising must not claim that the product prevents, treats or cures human disease. They must not suggest that a balanced, varied diet cannot generally provide appropriate nutrients. (Directive, food-information rules, article 7)

Nutrition and health claims have separate conditions under Regulation 1924/2006. For GB, check the GB Nutrition and Health Claims Register rather than assuming an EU authorisation applies. General health or wellbeing claims require an accompanying specific authorised health claim. Health claims can also require diet, lifestyle, consumption and warning information. (GB register, article 10)

Do not confuse disease-risk-factor reduction claims with disease-prevention claims. Article 14 provides separate authorisation and statement requirements for the former. It does not permit claims that a supplement prevents or treats disease. Botanical on-hold or transitional cases need their own claim-specific assessment. (Claims Regulation)

Registration, notification and enforcement

Supplement sellers must register their food business with the local authority. For England, Wales and Northern Ireland, registration guidance requires this at least 28 days before trading. It also covers online businesses. Check Scotland's arrangements separately rather than applying that guidance page UK-wide. (FSA supplement guidance, business registration guidance)

Business registration is not product approval. DHSC says the UK did not adopt routine prior notification through submission of supplement labels. It does not approve individual supplement labels or compositions. Separate novel-food or medicinal-product authorisation requirements can still apply. (DHSC guidance)

EU member states may require label notification under article 10. Check each destination's procedure rather than looking for a single EU-wide supplement notification. (Directive)

In England, regulation 8 assigns enforcement to the relevant food authority. For product-specific advice, DHSC directs businesses to local Trading Standards or Environmental Health. Neither business registration nor the absence of routine label notification replaces the operator's compliance checks. (England regulations, DHSC guidance)

Before releasing a supplement

Keep a market-specific sign-off record covering the permitted nutrient and source, any separate ingredient conditions, and the daily portion. Review the complete pack, including %NRV calculations and business address. Then check claims against the applicable regime and confirm registration or notification requirements. Use the current legislation linked above, not an assumption that an existing pack works in every market.

RegAffairs AI provides a citation-backed answer on UK and EU food supplement rules.

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