Compliance Checklist

GPSR (General Product Safety Regulation)
Dietary Supplements
United Kingdom 🇬🇧

UK product safety for dietary supplements on Amazon UK: Food Supplements Regulations, FSA requirements, UK Responsible Person, health claims and common mistakes post-Brexit.

Overview

In the United Kingdom, dietary supplements are subject to a standalone regulatory framework decoupled from EU legislation after Brexit. The Food Supplements (England) Regulations 2003 (SI 2003/1387), with parallel regulations for Wales, Scotland and Northern Ireland, form the product-specific basis. These are supplemented by the General Food Regulations 2004, the retained General Food Law (formerly EU Regulation 178/2002) and the Food Safety Act 1990. Unlike the EU, the UK does not apply the GPSR – instead, the General Product Safety Regulations 2005 serve as a general safety net. The Food Standards Agency (FSA) is the central regulatory authority for England, Wales and Northern Ireland, while Food Standards Scotland (FSS) covers Scotland. Enforcement is carried out by local Trading Standards Officers. Amazon.co.uk increasingly requires compliance documentation and the designation of a UK Responsible Person for food products.

Does this apply to my product?

This checklist applies to all dietary supplements sold on Amazon.co.uk: vitamins, minerals, amino acids, plant extracts, probiotics, omega-3 fatty acids, sports nutrition, collagen, creatine, protein powders and all foods intended to supplement the normal diet offered in dosage form (capsules, tablets, powders, liquids in measured quantities). Covers UK manufacturers, importers from the EU and third countries, private label providers and Amazon FBA sellers.

Step-by-Step Guide

Progress0/17 (0%)

Verify Legal Classification and Authorisation Status in the UK

Before market entry you must ensure your product is classified as a dietary supplement in the UK and all ingredients are permitted. The UK has its own substance lists and its own Novel Food process, which differs from the EU system.

Estimated time: 1-3 weeks

Demarcation from medicinal products under UK law verifiedRequired

Check whether your product could be classified as a medicinal product under the Human Medicines Regulations 2012. The MHRA (Medicines and Healthcare products Regulatory Agency) decides in doubtful cases. High dosages or medicinal claims can lead to medicine classification. The UK may apply different thresholds than the EU – e.g. for Vitamin D and melatonin.

UK Novel Food status of all ingredients verifiedRequired

Since Brexit, the UK has its own Novel Food process under the FSA. Ingredients not consumed to a significant degree in the UK before 15 May 1997 are classified as Novel Food and require FSA authorisation. The UK Novel Food catalogue may differ from the EU catalogue. Examples: CBD (regulated in UK under Novel Food), certain algae extracts, synthetic trans-resveratrol.

Novel Food status check for all ingredients (UK FSA catalogue)

Permitted vitamins, minerals and their forms verifiedRequired

The Food Supplements (England) Regulations 2003 Schedule 1 lists permitted vitamins and minerals, Schedule 2 the permitted forms (compounds). Only substances and forms listed there may be used in supplements. Since the UK adopted EU Directive 2002/46/EC as retained law, the lists are currently largely identical – but may diverge in future.

Cross-check of all ingredients against Schedule 1 and Schedule 2 of the Food Supplements Regulations

Appoint UK Responsible Person and Fulfil Food Business Operator Obligations

For the GB market (England, Wales, Scotland) a UK Responsible Person must be appointed. Additionally, you must be registered as a Food Business Operator (FBO) with the relevant local authority.

Estimated time: 1-2 weeks

UK Responsible Person with UK address appointedRequired

The UK Responsible Person must be a natural or legal person based in Great Britain. They are responsible for compliance with food regulations, must be informed about product composition and act as a contact point for authorities. Their name and address must appear on the packaging or label.

Agreement with UK Responsible Person

Registration as Food Business Operator with local authorityRequired

Every food business operator in the UK must register with the relevant local authority (Environmental Health / Trading Standards) at least 28 days before commencing business. This also applies to online sellers. Registration is free and done through the local council. The UK does not have a central notification portal like the BVL in Germany.

Food Business Registration confirmation

HACCP-based food safety management system establishedRequired

Under retained EU Regulation 852/2004 (food hygiene), every food business operator must implement a HACCP-based system. For supplements this includes supplier qualification, incoming goods control, storage conditions, traceability and recall procedures.

Labelling for the UK Market

Supplements in the UK must meet specific labelling requirements based on the retained Food Information to Consumers Regulation (formerly EU 1169/2011) and the Food Supplements Regulations. All information must be in English.

Estimated time: 1-2 weeks

Mandatory information on label complete and in EnglishRequired

Mandatory information includes: designation 'food supplement', name of nutrient or substance category, recommended daily dose, warning not to exceed stated recommended daily dose, statement that supplements are not a substitute for a varied diet, keep out of reach of children notice, full ingredients list, nutrition declaration, name and address of UK food business operator, best before date, net quantity, batch number and allergen labelling.

Complete UK-compliant label for review

Nutrient amounts per daily dose declaredRequired

The amounts of vitamins and minerals must be declared per recommended daily dose, both as absolute amount and as percentage of UK Nutrient Reference Values (NRVs). For other ingredients (e.g. plant extracts) the amounts per daily dose must be stated.

No prohibited or misleading statements on labelRequired

The label must not attribute to the product any property of preventing, treating or curing a disease (this would constitute a medicinal claim). Statements such as 'cures', 'treats' or 'prevents' are prohibited. Only authorised health claims under the retained Nutrition and Health Claims Regulation are permitted.

Verify Health Claims and Nutrition Claims

In the UK, the retained Nutrition and Health Claims Regulation (formerly EU 1924/2006) applies. Only pre-authorised claims may be used. The UK maintains its own register of authorised claims, which currently largely matches the EU register but may diverge in future.

Estimated time: 3-7 days

All health claims cross-checked against the UK register of authorised claimsRequired

Check every health claim on your label, in your Amazon listing and in your advertising against the Great Britain nutrition and health claims (NHC) register. Only claims listed there in the exact approved wording may be used. The conditions of use (e.g. minimum amount of nutrient) must also be met.

Documentation of health claims used with reference to NHC register

Amazon listing and advertising material checked for prohibited claimsRequired

The Advertising Standards Authority (ASA) and the Committee of Advertising Practice (CAP) strictly monitor supplement advertising in the UK. Amazon listings, A+ content, bullet points and product images must be free of unauthorised health claims, medicinal claims and misleading statements. The ASA can investigate complaints and require corrective action.

Meet Amazon.co.uk Compliance Requirements

Amazon.co.uk has specific requirements for selling dietary supplements that may go beyond statutory minimum requirements. Prepare all required documents and product information.

Estimated time: 3-7 days

UK Responsible Person registered in Amazon Seller CentralRequired

Register the UK Responsible Person with full UK address in Seller Central. Amazon may deactivate supplement listings without this information. The RP must match on product labels and in the listing.

Compliance documentation prepared for Amazon requirementsRequired

Keep the following documents ready as Amazon may request them at any time: Certificate of Analysis (CoA) for each batch, laboratory test results (heavy metals, microbiology, identity), Food Business Registration, label proof with all mandatory information, HACCP documentation and Novel Food authorisation if applicable.

Certificate of Analysis (CoA), lab reports, Food Business Registration, label samples

Product category and Restricted Products Policy checkedRequired

Check Amazon's Restricted Products Policy for the UK market. Certain supplement ingredients (e.g. high-dose caffeine, DMAA, certain pre-workout ingredients) are restricted or prohibited on Amazon even if they may be legal in the UK. Ensure your product is listed in the correct browse node category.

Quality Assurance and Ongoing Obligations

After market entry, ongoing obligations for quality assurance, traceability and market surveillance apply under UK food law.

Estimated time: ongoing

Batch traceability and recall procedure establishedRequired

Under Article 18 of the retained General Food Law, food business operators must ensure traceability at all stages of the supply chain (one step back, one step forward). Establish a recall procedure that complies with FSA reporting obligations. In case of a safety issue, you must inform the competent authority without delay.

Traceability and recall plan

Regular batch testing and laboratory analysesRequired

Conduct regular laboratory analyses: identity and purity of active ingredients, heavy metal contamination (lead, cadmium, mercury, arsenic), microbiological testing (total plate count, yeasts, moulds, E. coli, Salmonella), and pesticide residue testing for plant extracts if applicable. Retain Certificates of Analysis (CoA) for at least 5 years.

Actively monitor changes in UK regulation

The UK regulatory environment for supplements is evolving dynamically post-Brexit. The Product Safety and Metrology Bill (PSMB) is expected to modernise general product safety law. Monitor FSA consultations, changes to authorised health claims and new Novel Food decisions. The UK may set its own maximum levels for vitamins and minerals in future.

Common Mistakes to Avoid

Assumed EU compliance is sufficient for the UK market

Consequence: Since Brexit, the UK has a standalone regulatory system. EU notifications, EU Responsible Person designations and EU health claims registers have no validity in the UK. Products can be seized and removed from the market.

Prevention: Treat the UK as a standalone market with its own requirements. Appoint a separate UK Responsible Person, register as FBO with a UK authority and check all claims against the UK NHC register.

Used unauthorised health claims on the Amazon listing

Consequence: Trading Standards can impose fines and prohibit sales. The ASA can impose advertising restrictions. Amazon may permanently deactivate the listing and in the worst case suspend the seller account.

Prevention: Use exclusively claims from the UK NHC register in the exact approved wording. Have all texts – including Amazon bullet points and A+ content – reviewed by a regulatory affairs specialist.

Missing or incomplete allergen labelling

Consequence: Missing allergen labelling is a serious violation of UK food law and can cause health harm to consumers. Trading Standards can remove products from the market, and the manufacturer faces criminal liability under the Food Safety Act 1990.

Prevention: Check all 14 declarable allergens against your formulation and supplier specifications. Emphasise allergens in the ingredients list (bold print). Also consider cross-contamination and declare 'may contain' notices if applicable.

Used Novel Food ingredients without UK FSA authorisation

Consequence: Selling products with unauthorised Novel Food ingredients is illegal in the UK. The FSA can initiate enforcement action, require product recalls and impose fines. Amazon removes such products immediately upon notification from authorities.

Prevention: Check every ingredient in the UK Novel Food Catalogue of the FSA. Pay special attention to CBD, exotic plant extracts and synthetic nutrient forms. Apply for Novel Food authorisation before market entry if required.

Ignored metric units and UK packaging requirements

Consequence: The UK Weights and Measures Act 1985 requires metric units for net quantities. Products with imperial units only or missing quantity information violate UK law. Trading Standards can prohibit sales.

Prevention: Always state the net quantity in metric units (g, mg, ml). Imperial units may be added supplementarily but must not stand alone. Also check the minimum font size for mandatory information.

Frequently Asked Questions

Q1Do I need a separate UK authorisation for supplements already sold in the EU?

There is no central authorisation procedure for supplements in the UK – unlike medicines. However, you must register as a Food Business Operator with the local UK authority, appoint a UK Responsible Person, adapt your labels to UK requirements and check all health claims against the UK NHC register. A product compliant in the EU is not automatically compliant in the UK.

Q2Does the EU GPSR 2023 also apply in the UK?

No. The UK has not adopted the EU GPSR (Regulation 2023/988). In the UK, the General Product Safety Regulations 2005 (SI 2005/1803) continue to apply as general product safety law. For food and supplements, the Food Safety Act 1990, the General Food Regulations 2004 and the Food Supplements Regulations are primarily relevant. The planned Product Safety and Metrology Bill (PSMB) is expected to modernise UK product safety law in future.

Q3Can I use the same Responsible Person for EU and UK?

No – the EU Responsible Person (with EU address) and the UK Responsible Person (with UK address) are two separate legal roles. For the UK market you need a person or company based in Great Britain. If your EU RP also has a UK branch, theoretically the same organisation can fulfil both roles, but there must be two separate designations with different addresses.

Q4What laboratory requirements apply for supplements in the UK?

There is no legal requirement to have supplements tested in an accredited laboratory before placing on market. However, the burden of proof that the product is safe lies with the food business operator. Laboratory tests (CoA with identity, purity, heavy metals and microbiology) are therefore de facto required. Amazon UK regularly requests CoAs. UKAS-accredited laboratories (such as Eurofins, SGS, Intertek) are recommended.

Q5What about Northern Ireland – do different rules apply there?

Yes. Under the Windsor Framework, Northern Ireland continues to follow EU food regulations. Products sold to Northern Ireland must comply with EU law. For Great Britain (England, Wales, Scotland) the UK's own regulations apply. If you sell on Amazon.co.uk and use FBA, warehouse locations in Northern Ireland may be relevant – check your inventory settings.

Q6How can SpaceGoats help me with UK market entry for supplements?

SpaceGoats supports supplement brands with the entire UK market entry via Amazon.co.uk: from arranging a UK Responsible Person through label review and health claims compliance to optimising your Amazon listings. As an experienced Amazon broker, we know the platform-specific requirements and help you avoid listing suspensions through proactive compliance documentation.

GPSR (General Product Safety Regulation)Dietary SupplementsUnited Kingdom 🇬🇧