UK regulators map cell-cultivated food export requirements

The Food Standards Agency and Food Standards Scotland have published a nine-step process map for exporting cell-cultivated products of animal origin from Great Britain to countries outside the European Union. Issued on 12 November, the guidance draws together requirements spanning food regulation, establishment eligibility, export health certification, customs, cold chain management, packaging and traceability. It was developed through the regulators’ Cell-Cultivated Products Sandbox Programme, with input from HM Revenue and Customs, the Animal and Plant Health Agency, Defra and the Department for Business, Innovation, Science and Trade.

The process map consolidates potential requirements but grants neither permission to export nor permission to place a product on sale overseas. Cell-cultivated products do not yet benefit from universally recognised sanitary and phytosanitary classifications or a set of established export certificates equivalent to those used for many conventional animal products. Importing jurisdictions may classify the products differently, and their authorities decide whether a particular item can enter their market. An exporter may therefore need to establish an acceptable route with an importing country before commercial consignments can move.

The regulators interpret food made from cultivated animal cells as falling within the scope of products of animal origin in Great Britain, although the applicable hygiene legislation does not explicitly classify cell-cultivated products that way. Harvested cell biomass may be processed into a food or combined with other ingredients, bringing downstream processing and formulation within the manufacturer’s hygiene and traceability obligations. The guidance applies to England, Scotland and Wales; exporters operating from Northern Ireland must examine the different position under the Windsor Framework.

First, the exporter and overseas importer are asked to confirm whether the destination accepts cell-cultivated foods, what it calls them for import purposes and whether an appropriate market access arrangement exists. The second stage concerns the British production establishment: it must meet domestic food law requirements and may also need registration or approval by the destination country. Food business registration at home does not, on its own, satisfy every potential export requirement. The third stage addresses product authorisation, sanitary and phytosanitary requirements, inspection obligations and any additional restrictions imposed by the importing country.

Export health certification remains a significant obstacle because no standard certificate templates exist specifically for cell-cultivated products. Where an importing country asks for an export health certificate, the business must determine whether an existing certificate covers the proposed shipment. If none is suitable, the Animal and Plant Health Agency may need to work towards a new certificate based on the destination authority’s conditions. Agreeing a new certificate can take considerable time and may not result in trade becoming possible, even where a business is otherwise ready to produce and dispatch its goods.

Customs steps are more familiar, but the product’s regulatory novelty still affects preparation. Exporters need an Economic Operators Registration and Identification number and must submit declarations through HMRC’s Customs Declaration Service, directly or through an agent. The declaration requires an appropriate commodity classification, description, value, origin and transport information, as well as any relevant official certification. The resulting Movement Reference Number identifies the customs declaration for tracking and border procedures, but importing-country approval and inspections remain separate requirements.

Temperature control extends from the factory to delivery and must be planned before transport begins. The exporter must establish suitable internal product temperatures before dispatch, use appropriate refrigerated vehicles or containers where required and retain records of temperatures during the journey. Packaging must protect the product, and labels must meet the relevant destination-country rules, including any conditions attached to a novel food authorisation. A supporting documentation pack may include production and hazard analysis records, traceability information, health certificates where required, commercial invoices, packing lists and evidence of transport temperatures. The final step covers dispatch and compliance at the destination, including any border inspection.

A cultivated-food company can be technically ready to manufacture while still lacking a viable route to an overseas market. A cell-cultivated food business may have a functional bioreactor process, defined product specifications and domestic food-safety procedures, but still be unable to export where an importing state has not decided how to regulate the product. Export documentation can also depend on how the biomass is processed and whether the finished food includes other ingredients. Those decisions affect the evidence the manufacturer must retain as well as the product’s labelling and market-access route.

The sandbox programme runs from February 2025 to February 2027 and is intended to improve regulatory understanding of cell-cultivated food while maintaining consumer safeguards. The FSA’s Thomas Vincent has said businesses identified the cross-government export process as an area needing clarification. The new process map brings that work into one sequence but retains a case by case assessment where established international arrangements are absent. The map makes the sequence of checks more explicit, but no volumes or commercial exports follow from publication alone. Each destination still controls product approval, import terms and whether acceptable certification is available.