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

Brexit did not represent a one-off change in legislation. UK law evolves 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 satisfy EU requirements (for the manufacture of the product) and UK requirements (for placing it on the UK market). Divergences between these two systems are emerging, which may result in a consignment being held at the border, refused market access, or criminal liability under the Food Safety Act 1990.

Assimilated Law: The Legal Framework Governing Food in the UK from 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), EU law previously retained in the UK system acquired a new legal status: assimilated law. The terminological change has real consequences: assimilated law may be amended by an ordinary Act of Parliament or a statutory instrument without the procedure previously required for retained EU law.

For food supplements, the following hierarchy is of key importance:

• Assimilated Regulation (EU) No 1169/2011 (Food Information to Consumers): continues to form the substantive basis for food labelling requirements in the UK, including food supplements. It sets out obligations regarding the list of ingredients, 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 enforcement mechanism for Regulation 1169/2011 in England. They do not replace Regulation 1169/2011 substantively. Analogous statutory instruments apply in Scotland, Wales and Northern Ireland.
• Food Safety Act 1990: the overarching framework statute on food safety in the UK. Section 14 (selling food not of the nature, substance or quality demanded by the purchaser) and section 15 (false or misleading labelling/presentation of food) form the basis of criminal liability for product non-compliance.
• Retained EU Law (Revocation and Reform) Act 2023: the act changing the legal status of all EU law retained in the UK; from 1 January 2024 that 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 a standalone basis for labelling requirements. FIR 2014 is an enforcement layer. The substantive requirements regarding label content continue to derive from assimilated Regulation 1169/2011. The colloquial assertion that "FIR 2014 replaces Regulation 1169/2011" is incorrect and may lead to obligations under the Regulation being overlooked.

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 introduced covering products of animal origin (POAO) and non-POAO food, including food supplements.

Practical consequences of BTOM for a food supplement manufacturer:

• Pre-notification in IPAFFS (Import of Products, Animals, Food and Feed System): every consignment of food supplements must be notified in the IPAFFS system before arrival in the UK. Responsibility for notification rests with the UK importer, but the EU manufacturer must provide complete product data.
• Documentary checks: verification of the compliance of documentation accompanying the consignment with data entered in IPAFFS. This includes health certificates where required.
• Physical checks: 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 risk category. These rates are subject to change and logistical planning should not be based on a single, fixed percentage figure.
• 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: Export logistics should not be planned around a specific, fixed rate of physical inspections 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 a time buffer in case of inspection.

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

In the European Union, a food supplement manufacturer is accustomed to the RASFF (Rapid Alert System for Food and Feed) as a hazard notification mechanism. In the UK, RASFF has not applied since 1 January 2021. Market surveillance in the area 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 body is Food Standards Scotland (FSS). The FSA issues guidance, maintains the novel food register, manages authorisations and coordinates product withdrawals from the market.
• OPSS (Office for Product Safety and Standards): the market surveillance authority under the Department for Business and Trade. OPSS is responsible for enforcing product standards, including food supplements, on the UK market. It is OPSS, not RASFF, that constitutes the market surveillance system in the UK.
• Local Authorities / Trading Standards: local bodies enforcing food law at the retail and distribution level. They may carry out inspections, take samples and initiate criminal proceedings under the Food Safety Act 1990.

EU manufacturers must understand that in the UK there is no equivalent of the Polish Chief Sanitary Inspectorate (GIS) as a single central body controlling food 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 of full ingredient labelling (including allergens) to products prepacked for direct sale (PPDS). The legislation was introduced in response to the death of Natasha Ednan-Laperouse in 2016, caused by an allergic reaction to an unlabelled PPDS product.

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

• A supplement packed at the point of sale (e.g. a pharmacy preparing bespoke supplement packs to order) must carry a full list of ingredients with allergens highlighted, even if it is intended for direct sale on the premises.
• A supplement in the manufacturer's 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 heightened regulatory awareness of allergens 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 those in the EU, but manufacturers must take into account differences in enforcement and interpretation.

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

The current industry approach to allergen risk management and "may contain" warning labelling is the VITAL system (Voluntary Incidental Trace Allergen Labelling), developed by the Allergen Bureau (Australia/New Zealand) and promoted in Europe by FoodDrinkEurope. VITAL is based on reference doses and risk assessment for a specific production process, rather than 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 the UK or the EU: the decision to include a "may contain" warning should be based on risk assessment (e.g. the VITAL methodology), not an arbitrary threshold
• The FSA is working on guidance on precautionary allergen labelling (PAL), which may in future introduce a formal framework for declaration thresholds in the UK

Health Claims 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 Great Britain as assimilated law. This means that a manufacturer exporting a food supplement from the EU to the UK must comply with the same rules on health claims and nutrition claims as in the EU, but with a separate register and a separate procedure for the authorisation of 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. This requires a separate authorisation procedure through DHSC/FSA.
• UK authorisation procedure: a manufacturer submits an application to the FSA, which commissions a scientific assessment (to date, no permanent panel analogous to the EFSA NDA Panel has been established; the FSA draws on the Advisory Committee on Novel Foods and Processes or external experts).
• "On hold" claims: a number of botanical claims (Article 13 of Regulation 1924/2006) remain in the UK in the same state of suspension as in the EU. Their status has not been resolved in either the EU or the UK.

A manufacturer using a health claim on the label of a food supplement exported to the UK should verify whether that claim appears in the GB Nutrition and Health Claims Register. Using a claim not present in 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 (false or misleading labelling).

Novel Food in the UK: A Separate FSA Procedure

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

Consequences for a food supplement manufacturer:

• An ingredient authorised as novel food in the EU after 31 December 2020 is not automatically permitted 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 the 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 novel food authorisation procedure in the UK takes approximately 18–24 months and requires the submission of a full safety dossier analogous to an EFSA dossier.

A manufacturer planning to export a supplement containing an ingredient with novel food status should initiate the UK authorisation procedure in parallel with the EU procedure, if simultaneous sales on both markets are 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 to export food supplement 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 competent authority of exporting country]
    C1 --> D
    D --> E{BTOM border control}
    E --> F[Documentary check]
    E --> G[Potential physical inspection at BCP]
    F --> H{Labelling compliant with UK law?}
    G --> H
    H -->|Yes| I[Admitted to the UK market]
    H -->|No| J[Consignment held / refused 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 / disposal]

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

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

• Step 1: Verify ingredient status. Check whether all ingredients in the supplement appear in the GB Novel Food Catalogue as "not novel" or hold a novel food authorisation in the UK. If an ingredient has no 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 not present in 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, highlighted or emphasised in the ingredient list).
• Step 4: Identify a UK importer. The product must carry on its label the details of an importer or responsible operator based 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: Register in IPAFFS. Ensure that the UK importer pre-notifies every consignment in the IPAFFS system before the goods are dispatched. 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 whether the manufacturing establishment is on the APHA approved establishments list. Obtain an Export Health Certificate (EHC) from the relevant competent authority (in Poland: the District Veterinary Officer).
• Step 7: Monitor legal developments. Subscribe to updates from the FSA, OPSS and DHSC. Assimilated law may be amended more quickly than EU law (no requirement for consensus among 27 Member States), so regular monitoring is essential.

Expert Tip: The most costly mistake is exporting a food supplement with a label intended for the EU market without adapting it to UK requirements. Even if the substantive labelling requirements are largely aligned (both based on 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 the consignment being held 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 evolves independently of EU law; manufacturers should verify the current legal position before each export consignment.