Exporting Food Supplements to the UK
FSA, BTOM and Assimilated Law: A Practical Guide for EU Manufacturers

Brexit did not result in a one-off change to the rules. UK law is evolving independently of EU law, and from 1 January 2024 the very concept of "retained EU law" was replaced by the term "assimilated law" under the Retained EU Law (Revocation and Reform) Act 2023. A manufacturer exporting food supplements from the EU to the UK must simultaneously comply with EU requirements (for manufacturing) and UK requirements (for placing the product on the UK market). Between these two systems, divergences are emerging that may result in consignment detention at the border, refusal of market access, or criminal liability under the Food Safety Act 1990.

Assimilated Law: The Legal Structure Governing Food in the UK After 1 January 2024

From 1 January 2024, the concept of "retained EU law" formally no longer exists in UK law. Under the Retained EU Law (Revocation and Reform) Act 2023 (REUL Act), former EU law preserved in the UK legal system acquired a new legal status: assimilated law. This terminological change has real consequences: assimilated law can be amended by ordinary Act of Parliament or delegated legislation (statutory instrument) without the procedures previously required for retained EU law.

For food supplements, the following hierarchy is critical:

• Assimilated Regulation (EU) No 1169/2011 (Food Information to Consumers): still provides the substantive basis for food labelling requirements in the UK, including food supplements. It sets out the obligations regarding ingredient lists, nutrition information, allergen declarations and the manner of presenting information.
• The Food Information Regulations 2014 (SI 2014/1855): these are enforcement regulations that implement the mechanism for enforcing Regulation 1169/2011 in England. They do not replace Regulation 1169/2011 substantively. Equivalent SIs apply in Scotland, Wales and Northern Ireland.
• Food Safety Act 1990: the overarching framework statute for food safety in the UK. Section 14 (selling food not of the nature, substance or quality demanded) and Section 15 (falsely describing or presenting food) form the basis for criminal liability for product non-compliance.
• Retained EU Law (Revocation and Reform) Act 2023: the act that changed the legal status of all EU law preserved in the UK; from 1 January 2024, such law is "assimilated", not "retained".

Expert Tip: A manufacturer preparing a label for the UK market should not treat FIR 2014 (SI 2014/1855) as the standalone basis for labelling requirements. FIR 2014 is the enforcement layer. The substantive requirements for label content still derive from assimilated Regulation 1169/2011. The colloquial statement that "FIR 2014 replaces Regulation 1169/2011" is incorrect and may lead to omission of obligations arising from the Regulation.

Border Target Operating Model (BTOM): Full SPS Controls From 30 April 2024

The Border Target Operating Model (BTOM) is the UK's target border control framework, implemented in phases from January 2024. The key date for food exporters from the EU is 30 April 2024, when full sanitary and phytosanitary (SPS) controls were launched covering both products of animal origin (POAO) and products not of animal origin (non-POAO), including food supplements.

Practical consequences of BTOM for food supplement manufacturers:

• Pre-notification in IPAFFS (Import of Products, Animals, Food and Feed System): every consignment of food supplements must be notified in IPAFFS before arrival in the UK. Responsibility for notification rests with the UK importer, but the EU manufacturer must supply complete product data.
• Documentary checks: verification of compliance of accompanying documentation with IPAFFS data. This includes health certificates where required.
• Physical inspections: physical inspections of consignments at Border Control Posts (BCPs). Physical inspection rates are set by APHA (Animal and Plant Health Agency) and Defra based on the product's risk category. These rates are subject to change, and export logistics planning should not rely on a single fixed percentage.
• Risk categorisation: food supplements are classified within the BTOM risk system. The risk category affects the frequency of physical and documentary checks.

For food supplements containing ingredients of animal origin (e.g. fish oil, collagen, chondroitin), additional requirements apply: the manufacturing establishment must appear on the APHA approved establishments list, and the consignment must be accompanied by an Export Health Certificate (EHC) issued by the competent authority of the exporting country.

Expert Tip: Do not plan export logistics on the basis of a specific, fixed physical inspection rate at the UK border. These rates are set administratively and are subject to change depending on risk analysis outcomes, seasonality and policy decisions. Manufacturers should build flexibility into delivery schedules and maintain time reserves for potential inspections.

FSA, OPSS and Market Surveillance: Who Controls Food Supplements in the UK

In the EU, food supplement manufacturers are accustomed to the RASFF (Rapid Alert System for Food and Feed) as the notification mechanism for food hazards. In the UK, RASFF has not applied since 1 January 2021. Market surveillance in respect of food safety is carried out by:

• FSA (Food Standards Agency): the central body responsible for food safety in England, Wales and Northern Ireland. In Scotland, the equivalent is Food Standards Scotland (FSS). The FSA issues guidance, maintains the novel food register, manages authorisations and coordinates product recalls.
• OPSS (Office for Product Safety and Standards): the market surveillance body within the Department for Business and Trade. OPSS is responsible for enforcing product standards, including for food supplements, on the UK market. It is OPSS, not RASFF, that serves as the UK's market surveillance system.
• Local Authorities / Trading Standards: local enforcement bodies operating at the retail and distribution level. They may conduct inspections, take samples and initiate criminal proceedings under the Food Safety Act 1990.

An EU manufacturer must understand that in the UK there is no equivalent of the Polish Chief Sanitary Inspectorate (GIS) as a single central authority controlling supplements. Responsibility is distributed between the FSA (policy and standards), OPSS (market surveillance) and local authorities (enforcement). This results in a less predictable control system than in Poland, but also potentially more severe consequences: the Food Safety Act 1990 provides in Sections 14 and 15 for criminal liability (unlimited fine, up to 2 years' imprisonment) for placing non-compliant food on the market.

Natasha's Law: PPDS Labelling Obligations From 1 October 2021

The Food Information (Amendment) (England) Regulations 2019, known as Natasha's Law, came into force on 1 October 2021 and extended the obligation for full ingredient labelling (including allergens) to products that are prepacked for direct sale (PPDS). The legislation was introduced following the death of Natasha Ednan-Laperouse in 2016, caused by an allergic reaction to an unlabelled PPDS product.

For food supplement manufacturers, Natasha's Law is relevant in the following scenarios:

• A supplement packed at the point of sale (e.g. a pharmacy preparing custom supplement sets to order) must contain a full ingredient list with allergen emphasis, even if intended for immediate sale on site.
• A supplement in manufacturer packaging (prepackaged) was already subject to these requirements under Regulation 1169/2011, so Natasha's Law does not directly change the obligations of a B2B manufacturer. However, it has strengthened regulatory awareness of allergen issues throughout the supply chain.
• A manufacturer supplying supplements to UK businesses offering personalisation services (custom packs) must ensure that the UK recipient has full ingredient and allergen data necessary for PPDS labelling.

Allergens: Assimilated Law, Natasha's Law and the VITAL Approach

Allergen labelling in the UK is based on assimilated Regulation 1169/2011, Annex II (14 major allergens). The requirements are aligned with EU law, but manufacturers must account for differences in enforcement and interpretation.

In the context of allergen reaction thresholds and labelling of trace amounts of allergens, particular caution is required. The EFSA opinion from 2014 (EFSA Journal 2014;12(11):3894) on reference doses for major food allergens expressed reference doses as protein doses (mg protein), not as concentrations in the final food product (mg/kg of food). Transposing these values as "thresholds" expressed in mg/kg of product is a substantive error.

The current industry approach to allergen risk management and precautionary labelling ("may contain") is the VITAL (Voluntary Incidental Trace Allergen Labelling) system, developed by the Allergen Bureau (Australia/New Zealand) and promoted in Europe by FoodDrinkEurope. VITAL is based on reference doses and risk assessment for the specific manufacturing process, not on universal "safety thresholds" in mg/kg.

• The UK applies assimilated Annex II of Regulation 1169/2011 (14 allergens) identically to the EU
• Natasha's Law (from 1 October 2021) extends the labelling obligation to PPDS products
• There is no statutory allergen concentration threshold in either the UK or the EU: the decision to include a "may contain" warning should be based on risk assessment (e.g. VITAL methodology), not on an arbitrary threshold
• The FSA is working on guidance regarding precautionary allergen labelling (PAL), which may in future introduce formal frameworks for declaration thresholds in the UK

Health and Nutrition Claims in the UK: Assimilated Regulation 1924/2006 and the GB Register

Assimilated Regulation (EC) No 1924/2006 (Nutrition and Health Claims Regulation) continues to apply in the United Kingdom as assimilated law. This means that a manufacturer exporting a supplement from the EU to the UK must comply with the same rules on health and nutrition claims as in the EU, but with a separate register and a separate procedure for authorising new claims.

Key differences from the EU system:

• GB Nutrition and Health Claims Register: the register of permitted claims maintained by DHSC (Department of Health and Social Care). It contains claims authorised before 31 December 2020 (transferred from the EU register). Publicly available on UK government websites.
• New claims after Brexit: claims authorised in the EU after 31 December 2020 are not automatically recognised in the UK. A separate authorisation procedure via DHSC/FSA is required.
• UK authorisation procedure: the manufacturer submits an application to the FSA, which commissions a scientific assessment (no standing panel analogous to EFSA NDA has been established to date; the FSA uses the Advisory Committee on Novel Foods and Processes or external experts).
• "On hold" claims: some botanical claims (Article 13 of Regulation 1924/2006) remain in the UK in the same suspended state as in the EU. Their status has not been resolved in either jurisdiction.

A manufacturer using a health claim on a supplement label for export to the UK should verify that the claim appears in the GB Nutrition and Health Claims Register. Using a claim absent from the GB register (even if authorised in the EU after 2020) constitutes a breach of assimilated Regulation 1924/2006 and may result in proceedings under the Food Safety Act 1990, Section 15 (falsely describing or presenting food).

Novel Food in the UK: A Separate FSA Procedure

Since 1 January 2021, the FSA has operated its own novel food authorisation procedure, separate from the European Commission and EFSA. The GB Novel Food Catalogue is a distinct catalogue from the EU Novel Food Catalogue maintained by the European Commission.

Consequences for food supplement manufacturers:

• An ingredient authorised as novel food in the EU after 31 December 2020 is not automatically approved in the UK. A separate application to the FSA is required.
• An ingredient listed in the EU Novel Food Catalogue as "not novel" may have a different status in the GB Novel Food Catalogue. Manufacturers must verify status in both catalogues independently.
• The FSA conducts its own safety assessment independently of EFSA opinions. Applications rejected by EFSA are not automatically rejected by the FSA, and vice versa.
• The UK novel food authorisation procedure takes approximately 18-24 months and requires a full safety dossier analogous to an EFSA dossier.

A manufacturer planning to export a supplement containing a novel food ingredient should initiate the UK authorisation procedure in parallel with the EU procedure if simultaneous sale on both markets is planned. Running two parallel procedures (EFSA + FSA) significantly increases regulatory costs but is the only way to avoid multi-year delays.

graph TD
    A[EU manufacturer plans supplement export to UK] --> B{Does the product contain POAO ingredients?}
    B -->|Yes| C[Verify APHA approved establishments list]
    B -->|No| D[Pre-notification in IPAFFS]
    C --> C1[Export Health Certificate from exporting country authority]
    C1 --> D
    D --> E{BTOM border control}
    E --> F[Documentary checks]
    E --> G[Potential physical inspection at BCP]
    F --> H{Labelling compliant with UK law?}
    G --> H
    H -->|Yes| I[Admission to UK market]
    H -->|No| J[Consignment detention / refusal of entry]
    I --> K{Market surveillance}
    K --> L[FSA: policy and standards]
    K --> M[OPSS: market surveillance]
    K --> N[Local Authorities: enforcement]
    J --> O[Label correction / re-export / destruction]

Practical Guide: Steps for an EU Manufacturer Exporting Supplements to the UK

Below is a summary of the specific steps that an EU food supplement manufacturer (including from Poland) should take before commencing export to the UK market:

• Step 1: Verify ingredient status. Check whether all supplement ingredients appear in the GB Novel Food Catalogue as "not novel" or hold novel food authorisation in the UK. If an ingredient lacks UK status, initiate the FSA authorisation procedure.
• Step 2: Verify health claims. Check whether every health claim used on the label appears in the GB Nutrition and Health Claims Register. Remove or replace claims absent from the GB register.
• Step 3: Adapt the label. Prepare a label compliant with assimilated Regulation 1169/2011: English language, metric units, address of the responsible operator in the UK or UK importer, correct allergen labelling (14 allergens, bold or emphasis in the ingredient list).
• Step 4: Identify the UK importer. The product must bear on the label the details of an importer or responsible operator established in the UK (requirement of assimilated Regulation 1169/2011, Article 8). An EU manufacturer cannot independently act as a "food business operator" in the UK without a presence on the UK market.
• Step 5: IPAFFS registration. Ensure that the UK importer carries out pre-notification of each consignment in IPAFFS before dispatch. Provide the importer with complete product data (CN/HS codes, ingredient list, certificates).
• Step 6: APHA certification (if applicable). If the supplement contains ingredients of animal origin, verify that the manufacturing establishment is on the APHA approved establishments list. Obtain an Export Health Certificate (EHC) from the competent veterinary authority in the country of export.
• Step 7: Monitor legal changes. Subscribe to updates from the FSA, OPSS and DHSC. Assimilated law can be amended more rapidly than EU law (no requirement for consensus among 27 Member States), so regular monitoring is essential.

Expert Tip: The cheapest mistake is exporting a supplement with a label designed for the EU market without adaptation to UK requirements. Even though the substantive labelling requirements are largely aligned (based on the same Regulation 1169/2011), the absence of a UK importer address on the label or the use of a health claim authorised in the EU after 2020 (not present in the GB register) may result in consignment detention at the border or criminal proceedings. The cost of adapting a label is incomparably lower than the cost of recalling an entire batch.

Disclaimer: This article is for informational and educational purposes only. It does not constitute legal or regulatory advice and does not replace an individual product compliance analysis by a UK food law specialist. UK law is evolving independently of EU law; manufacturers should verify the current legal position before each export shipment.