---
name: supplement-compliance
description: >
  UK/EU food supplement compliance guide — ingredient checks, health claim
  restrictions, labelling rules, and pre-production verification checklist. Use when:
  (1) evaluating a new ingredient or formulation for a supplement product,
  (2) writing marketing copy, product descriptions, or health claims for any supplement,
  (3) preparing labels, packaging, or COAs for production,
  (4) deciding whether an ingredient needs novel food approval or FSA notification,
  (5) assessing if a product risks MHRA reclassification as a medicine,
  (6) reviewing supplier documentation for compliance gaps,
  (7) any mention of "health claims", "novel food", "FSA", "EFSA", "MHRA", "borderline",
  "supplement regulations", "label requirements", "compliance", "Can I say...",
  "is this ingredient legal", or "do I need approval for...".
author: colin
license: MIT
originally_built_for: [Your Brand]
---

> Originally developed for a supplement subscription business, now genericized for universal use.

# UK/EU Supplement Compliance Guide

## Quick Reference — The Golden Rules

1. **Food supplements are foods, not medicines.** Never claim to treat, cure, prevent, or diagnose any disease.
2. **Only EU-approved health claims may be used.** See [references/health-claims-guide.md](references/health-claims-guide.md) for brand-specific examples.
3. **Novel foods need pre-approval.** If an ingredient was not consumed significantly in the EU before May 1997, it needs a novel food authorisation.
4. **Labels are legally binding.** Every claim, every nutrient value, every allergen warning must be accurate and substantiated.
5. **Post-Brexit UK operates a parallel but similar regime.** FSA handles UK notifications; GB-retained EU law still applies for now.

---

## Pre-Production Ingredient Checklist

Use this checklist before ordering samples or committing to a formulation. If any item fails, stop and resolve before proceeding.

### 1. Ingredient Legality & Novel Food Status

| Check | Status | Notes |
|-------|--------|-------|
| Is the ingredient on the **EU Union List of Novel Foods**? | ☐ Pass ☐ Fail ☐ N/A | If listed, ensure the specific form/use is authorised. |
| Is the ingredient on the **GB (UK) Novel Food Register**? | ☐ Pass ☐ Fail ☐ N/A | Post-Brexit: check both EU and GB lists. |
| Was this ingredient consumed significantly in the EU before **May 1997**? | ☐ Yes ☐ No ☐ Unknown | If No → likely novel food. |
| Is the ingredient a **vitamin or mineral** on the EU Permitted Lists? | ☐ Pass ☐ Fail ☐ N/A | Only permitted forms may be used. |
| Is the ingredient a **botanical** with known novel food issues? | ☐ Pass ☐ Fail ☐ N/A | See [references/novel-foods-list.md](references/novel-foods-list.md). |
| Does the supplier provide a **novel food status letter** or equivalent? | ☐ Yes ☐ No | Request in writing. Keep on file. |
| Is the ingredient **banned or restricted** in the UK/EU? | ☐ Pass ☐ Fail ☐ N/A | Check FSA/EFSA alerts, member state bans. |
| Is the ingredient at a **dosage within safe upper limits**? | ☐ Pass ☐ Fail ☐ N/A | Check EFSA tolerable upper intake levels (ULs). |

**If any check fails → STOP.** Do not order samples until resolved.

### 2. Health Claims Verification

| Check | Status | Notes |
|-------|--------|-------|
| Have all proposed marketing claims been checked against the **EU Register of Nutrition & Health Claims**? | ☐ Pass ☐ Fail | Only claims on the EU Register may be used. |
| Are all claims made in the **exact wording** from the Register? | ☐ Pass ☐ Fail | Paraphrasing is not allowed. |
| Are claims **conditioned** on the stated intake level? | ☐ Pass ☐ Fail ☐ N/A | Many claims require a minimum daily dose. |
| Has the copy been reviewed for **implied medicinal claims**? | ☐ Pass ☐ Fail | No "treats", "cures", "prevents", "restores". |
| Has the copy been reviewed for **prohibited claims**? | ☐ Pass ☐ Fail | No "detox", "superfood", "boosts immunity" (unless registered). |
| Are testimonials/reviews being used? | ☐ Yes ☐ No | If yes, they must not make unsubstantiated claims. |

**Critical:** See [references/health-claims-guide.md](references/health-claims-guide.md) for a full table of what [Your Brand] can and cannot say for each product category.

### 3. Label & Packaging Compliance

| Check | Status | Notes |
|-------|--------|-------|
| Does the label state **"Food Supplement"** clearly? | ☐ Pass ☐ Fail | Required. Not "nutraceutical", "health product", etc. |
| Is the **recommended daily dose** stated? | ☐ Pass ☐ Fail | Must be clear and unambiguous. |
| Is a **nutritional information panel** present? | ☐ Pass ☐ Fail | Per-serving amounts for all active ingredients. |
| Are **%NRV (Nutrient Reference Values)** shown for vitamins/minerals? | ☐ Pass ☐ Fail ☐ N/A | Required for vitamins and minerals. |
| Are **allergens** highlighted in the ingredients list? | ☐ Pass ☐ Fail | EU Regulation 1169/2011. |
| Is the **full ingredients list** present in descending order of weight? | ☐ Pass ☐ Fail | Including excipients and carriers. |
| Is the **net weight** or number of portions stated? | ☐ Pass ☐ Fail | Required. |
| Is a **best before date** or **use by date** shown? | ☐ Pass ☐ Fail | Best before for supplements (usually). |
| Is a **batch/lot number** present? | ☐ Pass ☐ Fail | Required for traceability. |
| Are **storage conditions** stated? | ☐ Pass ☐ Fail | E.g., "Store in a cool, dry place." |
| Is the **manufacturer/distributor name and UK address** shown? | ☐ Pass ☐ Fail | Required. EU address if sold in EU. |
| Is a **country of origin** stated where relevant? | ☐ Pass ☐ Fail ☐ N/A | If imported, state origin. |
| Is the **Food Business Operator (FBO) name and address** on pack? | ☐ Pass ☐ Fail | This is the responsible entity. |
| Is the **E number** or full chemical name used for additives? | ☐ Pass ☐ Fail ☐ N/A | If additives are present. |
| Is the label in **English** (and local language for EU markets)? | ☐ Pass ☐ Fail | English mandatory for UK. |

See [references/label-requirements.md](references/label-requirements.md) for full label specification and example layout.

### 4. MHRA Borderline Assessment

| Check | Status | Notes |
|-------|--------|-------|
| Does the product contain any **medicinal ingredients**? | ☐ Yes ☐ No | If Yes → may be a medicine, not a supplement. |
| Are any claims made about **treating, preventing, or curing disease**? | ☐ Yes ☐ No | If Yes → reclassified as medicine. Illegal to sell as food. |
| Is the product presented as having **pharmacological action**? | ☐ Yes ☐ No | E.g., "lowers blood pressure", "reduces inflammation" → medicine. |
| Does the product contain ingredients at **pharmaceutical dosages**? | ☐ Yes ☐ No | Very high doses of otherwise-food ingredients can trigger reclassification. |
| Is the route of administration **non-oral** (e.g., injection, suppository)? | ☐ Yes ☐ No | Non-oral routes are almost always medicines. |

**If any borderline check is "Yes" → seek MHRA borderline advice immediately.** See [references/mhra-borderline.md](references/mhra-borderline.md) for detailed guidance and case examples.

### 5. Supplier & Documentation

| Check | Status | Notes |
|-------|--------|-------|
| Does the supplier hold **BRCGS/FSSC 22000 or equivalent** food safety certification? | ☐ Yes ☐ No | Minimum standard for food-grade manufacturing. |
| Can the supplier provide a **Certificate of Analysis (CoA)** for each batch? | ☐ Yes ☐ No | Required for every production batch. |
| Is the CoA within **shelf-life/retest date**? | ☐ Pass ☐ Fail | Check expiry on CoA. |
| Does the supplier provide **allergen statements**? | ☐ Yes ☐ No | Must cover all 14 EU allergens. |
| Does the supplier provide **GMO-free / non-GMO status** where claimed? | ☐ Yes ☐ No ☐ N/A | If you claim non-GMO, you need evidence. |
| Does the supplier provide **heavy metal / contaminant testing**? | ☐ Yes ☐ No | Lead, cadmium, mercury, arsenic — especially for botanicals. |
| Does the supplier provide **microbiological testing**? | ☐ Yes ☐ No | Total aerobic count, yeasts, moulds, pathogens. |
| Is there a **specification sheet** with full composition? | ☐ Yes ☐ No | Must match the label claim exactly. |
| Has the supplier confirmed **no unauthorised novel food status**? | ☐ Yes ☐ No | Get this in writing. |

---

## Regulatory Framework Overview

### EU Law (Retained in UK)

| Regulation | What It Covers |
|-----------|----------------|
| **EC 1925/2006** | Fortification of foods — which vitamins/minerals can be added |
| **EC 1924/2006** | Nutrition & health claims — the EU Register; only approved claims allowed |
| **EC 258/97** | Novel foods — pre-market approval required |
| **EU 2015/2283** | Updated novel food regulation (applies from Jan 2018) |
| **EU 1169/2011** | Food information to consumers — labelling rules |
| **EC 2002/46** | Food supplement directive — definition, compositional rules |

### UK Post-Brexit

| Body | Responsibility |
|------|---------------|
| **FSA (Food Standards Agency)** | UK food safety, novel foods in England/Wales, food supplement notifications |
| **FSS (Food Standards Scotland)** | Food safety in Scotland |
| **Defra** | Organic claims, certain feed/food matters |
| **MHRA** | Borderline products, medicines regulation |
| **Trading Standards** | Local enforcement of food law, label compliance |

**Key post-Brexit point:** The UK retained EU food law at the end of the transition period. The EU Register of health claims still applies in Great Britain (GB). Northern Ireland follows EU law under the Windsor Framework. The UK can now diverge, but as of 2026, the regimes remain very similar.

**FSA Notification:** In the UK, food supplement manufacturers or importers must notify the FSA of the product composition before placing it on the market. This is a notification, not an approval, but non-compliance is an offence.

---

## [Your Brand] Product Categories — Compliance at a Glance

> Adapt the product names and risks below to match your brand's actual product line.

| Product | Key Compliance Risk | Top Action Item |
|---------|--------------------|-----------------|
| **Core Daily** (multivitamin) | NRV overages, vitamin forms | Verify all vitamins on Permitted List; check ULs |
| **Gut Microbe** (probiotic/prebiotic) | Probiotic = novel food in many cases | Confirm strain-specific novel food status |
| **Sleep** (magnesium, herbs) | Melatonin = medicinal in many EU states; not legal in UK supplements | **Do not use melatonin in UK food supplements** |
| **Stress** (ashwagandha, magnesium, B-vitamins) | Ashwagandha = novel food; some forms restricted | Verify ashwagandha root extract is authorised |
| **Recovery** (protein, amino acids, anti-inflammatories) | Amino acids can trigger medicinal borderline | Keep doses food-like; avoid pharmacological claims |
| **Vitality** (energy, CoQ10, etc.) | CoQ10 = novel food; caffeine limits | Confirm CoQ10 authorisation; stay under 200mg caffeine/day |
| **Hormone Balance** (maca, B-vitamins, etc.) | DHEA = prescription medicine in UK; maca = novel food | **Never use DHEA**. Verify maca status. |
| **Men's Vitality** (zinc, fenugreek, etc.) | Testosterone-related claims are high-risk | Avoid any claim implying hormone modulation; use approved mineral claims only |

See [references/health-claims-guide.md](references/health-claims-guide.md) for the full permitted/prohibited claim tables for each category.

---

## Dosage Safety — Key Upper Limits (EFSA)

These are adult tolerable upper intake levels. Stay well below these in formulations:

| Nutrient | EFSA UL (adults) | [Your Brand] Target |
|----------|------------------|---------------------|
| Vitamin A (retinol) | 3,000 µg/day | ≤ 1,500 µg |
| Vitamin D | 100 µg (4,000 IU)/day | ≤ 50 µg (2,000 IU) |
| Vitamin E | 300 mg/day | ≤ 200 mg |
| Vitamin B6 | 25 mg/day | ≤ 15 mg |
| Niacin (nicotinic acid) | 10 mg/day (as nicotinic acid) | ≤ 10 mg or use nicotinamide |
| Folic acid | 1,000 µg/day | ≤ 400 µg |
| Iron | 25 mg (supplements only) | ≤ 14 mg |
| Zinc | 25 mg/day | ≤ 15 mg |
| Copper | 5 mg/day | ≤ 1 mg |
| Iodine | 600 µg/day | ≤ 200 µg |
| Selenium | 255 µg/day | ≤ 200 µg |
| Magnesium (supplements) | 250 mg (laxative effect) | ≤ 200 mg or use well-absorbed forms |
| Calcium | 2,500 mg/day | ≤ 800 mg |

**Note:** ULs apply to total intake from all sources (diet + supplements). Design formulations to keep total intake safe even for high-diet consumers.

---

## Enforcement & Consequences

| Violation | Likely Outcome |
|-----------|---------------|
| Unauthorised health claim | Trading Standards warning → product recall → prosecution |
| Unauthorised novel food | FSA enforcement → product seizure → fines |
| Medicinal claim on food | MHRA involvement → product reclassified → cannot sell as food |
| Misleading label | Trading Standards prosecution, fines up to unlimited (Crown Court) |
| Missing allergen info | Criminal offence, potential for serious harm liability |
| No FSA notification | Enforcement action, product withdrawal |

---

## When to Read Which Reference File

| Situation | Read This |
|-----------|-----------|
| Writing product copy, website descriptions, social media posts | [references/health-claims-guide.md](references/health-claims-guide.md) |
| Evaluating a new ingredient, checking if it's novel | [references/novel-foods-list.md](references/novel-foods-list.md) |
| Designing labels, reviewing pack copy, preparing artwork | [references/label-requirements.md](references/label-requirements.md) |
| Uncertain if a product is a food or a medicine | [references/mhra-borderline.md](references/mhra-borderline.md) |
| Supplier sends a new ingredient spec sheet | All four reference files — cross-check everything |

---

## Quick Decision Tree

```
New ingredient or formulation
        │
        ▼
Is it a vitamin/mineral?
   ├─ Yes → Is it on the EU Permitted List?
   │          ├─ Yes → Check ULs → Proceed to health claims check
   │          └─ No  → STOP. Cannot use.
   └─ No  → Is it a novel food?
              ├─ Yes → Is it authorised for this use?
              │          ├─ Yes → Proceed to health claims check
              │          └─ No  → STOP. Need novel food approval.
              └─ No  → Proceed to health claims check
                          │
                          ▼
                Any proposed health claims?
                   ├─ Yes → Are they on the EU Register?
                   │          ├─ Yes → Use exact wording → Check label
                   │          └─ No  → STOP. Remove or reformulate claim.
                   └─ No  → Check label requirements only
                                │
                                ▼
                     Any risk of medicinal classification?
                        ├─ Yes → Seek MHRA advice → Do not produce
                        └─ No  → PROCEED TO PRODUCTION
```