• Guidance

Cell-cultivated products: food business hygiene requirements

Content: Guidance

Published by:

  • Food Standards Scotland
  • Food Standards Agency

Content guide

4. Specific regulatory positions for CCPs

4.1 General Food Law and food hygiene law

This section outlines the position of General Food Law and food hygiene law (regulation (EC) Nos 178/2002 and 852/2004 respectively) and how the following definitions and requirements apply to companies within the CCP supply chain:

  • primary production
  • the primary product
  • when CCPs are subject to food law

4.2 Primary production

The principles of primary production apply to CCPs.

Primary production legislation applies to live food-producing animals and is intended to keep food from becoming unsafe at the very beginning of the food chain, by preventing biological, chemical and physical hazards entering the food chain at source. The rearing of animals includes meeting requirements under The Animal Welfare Act 2006.

Records that must be kept for the purposes of primary production are additional to the records required to establish product traceability (under regulation (EU) No 931/2011) as detailed in the annex section.

The purpose of primary production rules is to ensure that animals entering the food chain are fit to do so, with requirements for food business operators to keep records about animals reared for food production up to the point of slaughter for the purpose of food-chain information declarations. For CCP production, these requirements apply to biopsy collection taken either ante- or post-mortem. This includes documenting animal and farm health; disease-free status and that withdrawal periods of any veterinary medicine residues are adhered to. These records allow for provenance, traceability, recall response, and verification of controls for audit and enforcement purposes.

4.3 The primary product

The primary product is the biopsy taken from the source animal whose cells will be used to create the CCP.

Primary products are defined as “products of primary production including products of the soil, of stock farming, of hunting and fishing”.

The first step of CCP production is the point of biopsy collection; this also aligns with the biopsy product being an unprocessed product (in article 2 of food hygiene regulation (EC) No 852/2004). This position ensures that the entire production process is covered under food law, from the point of the animal source (biopsy collection), including adoption of primary production principles and documented evidence to ensure the source animal is fit to enter the food chain.

4.4 When CCPs become subject to food law

Food law has a broad definition, covering a wide range of provisions with a direct or indirect effect on the safety of food.  General Food Law (regulation (EC) No 178/2002) defines ‘food’ as both:

  • any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans
  • any substance intentionally incorporated into the food during its manufacture, preparation or treatment (including water)

The collection of the biopsy from the source animal is considered to be the first stage of CCP production (as an unprocessed product), and food law which governs food in general, and food safety in particular, will apply. Given the significant processes applied to cells following biopsy collection, the post-harvest biomass is classed as processed POAO (as defined in food hygiene regulation (EC) No 852/2004 – article 2).

4.5 What this means for producers of cell-cultivated products

General Food Law and food hygiene legislation (regulations (EC) No 178/2002 and 852/2004 respectively) applies to all inputs used in the production of CCPs, including:

  • biopsy collection
  • cells
  • growth media
  • other substances and components used

POAO hygiene legislation regulation (EC) No 853/2004) becomes applicable from when the biopsy is collected through to when the finished cell-cultivated POAO food is placed on the market.

If at any point the processed CCP biomass is added to plant-based food ingredients, this can create a composite product (as defined in article 2 of Commission Decision 2007/275/EC). As a result, POAO hygiene legislation remains applicable to the CCP only as an ingredient, whilst the composite food must adhere to the broader requirements of General Food Law and food hygiene legislation. We will provide more guidance on defining CCP composite products in due course as part of the sandbox programme.

It is established above that the principles of primary production and associated record-keeping should apply to CCPs. The primary product is the biopsy taken from animals which should be fit for the food chain and this stage marks the point at which CCPs first become subject to food law.

The designation of CCPs being subject to food law from the point of biopsy collection thereby requires all businesses along the food-chain to be registered as a food business operator (as outlined in next section) and to adhere to legislation and standards surrounding food production.

CCP producers should meet the requirements of primary production as far as possible, including the retention of records in relation to the rearing of the source animal. This provides assurance on the origin, traceability and safety from the source animal through to biopsy collection and CCP foods placed on the market. Full primary production records should be submitted as part of the application for market authorisation of the CCP novel food regulated product.

Whilst each CCP application will be unique, as a guide on the type of information we would require on animal health and provenance, please refer to the Cell-cultivated products: identity, production and microbiology - GOV.UK guidance published 10 July 2026, particularly in the section characterisation and identity of the cell line(s) which includes details on source animal traceability.

It would be expected that the generation of new cell-lines after the publication of this guidance would follow the principles of primary production rules. In cases for existing cell-lines produced for food production prior to this guidance where full documented records on primary production may not be available, robust evidence to clearly demonstrate how the food is safe must be submitted as part of the dossier within the CCP application for market authorisation of the regulated product. This evidence will be considered on a case-by-case basis as part of the risk assessment and risk management processes.

5. Additional information

Primary production legislation targets four categories of risk:

  • animal health and diseases – ensuring products derived from animals (including biopsy cells) are safe to enter the food chain
  • chemical contamination – preventing chemical residues including veterinary medicines from entering the food chain
  • environmental and water-related hazards
  • cross-contamination and hygiene

While the following resources are not directly applicable to CCP establishments as they are registered (not approved), applicants may find these resources useful as a guide to the scope of information or analogous data required for GB applications of CCPs in relation to animal health and being fit for the food-chain (for biopsies taken either ante- or post-mortem):

  • annex III of POAO hygiene (regulation (EC) 853/2004) on the specific requirements for certain animals and POAO products, such as farmed animals and wild game, fish or other marine products
  • the Manual for official controls (MOC ) and the Scottish MOC (SMOC) are intended for officials and outlines their tasks, responsibilities and duties when carrying out official controls in approved establishments. The manuals can provide a steer on requirements needed from businesses, particularly chapter 2.1 of the MOC and SMOC on Food Chain Information (FCI)

5.1 POAO hygiene requirements for CCPs

The classification of CCPs as POAO means that hygiene requirements are to be followed (under regulation (EC) Nos 853/2004 on POAO hygiene and 852/2004 on food hygiene). This guidance gives clarity to CCP producers placing POAO products on the GB market on the following:

  • Registration or approvals of business establishments (and specific POAO requirements)
  • animal health marks and ID marks
  • the use of washing substances for POAO

5.2 Registration of CCP establishments

Prior to placing products on the market, food business operators which handle and/or produce POAO are required to contact their local authority in GB (as per article 4 of the POAO hygiene regulation). Depending on the scope of business activity, their establishment will need to be either:

  • registered (linking back to article 6 of regulation (EC) No 852/2004 regulation on food hygiene)
  • approved (as per article 4.2 and annex III of regulation (EC) No 853/2004 which provides specific requirements for named POAOs)

As CCPs are not listed in annex III of the POAO hygiene Regulation (853/2004), this annex and the requirement for approval does not currently apply to CCP production. The Government will continue to review the guidelines surrounding CCP production to ensure public health remains protected.

5.3 What this means for cell-cultivated product producers

CCP companies are required to be registered as food business operators with the relevant local authority where the business operates.

As food law starts to apply to CCPs from the point of biopsy collection from the source animal, all businesses throughout the CCP supply chain following biopsy collection which handle biopsies, cells/cell-lines or produce interim or finished CCPs are required to be registered as a food business operator with their local authority in GB (see below).

This includes all companies following biopsy collection through to the point of final sale such as cell-line development, CCP producers (including third-party contractors), packers, distributors and retailers. Exemptions are listed in legislation for private domestic use; consumption or handling small quantities of POAO and some retail activities (business to business, transport and storage) as per article 1 of regulation (EC) 853/2004.

You must register your business at least 28 days before trading. Any food business will be subject to the obligations of the local authority (or district council in Northern Ireland) in delivering their statutory food functions.

Information is provided below on starting a food business and registration, when located in:

For information on local authority functions, the Food and Feed Codes of Practice (or for Scotland) is published at national levels for:

These documents outline what food businesses may expect from their local authority in terms of food safety, including physical inspections or audits for food hygiene and food standards under delivery of their official controls, as well as other activities including the provision of advice. For interest, refer to the section on delivery of official controls (hygiene and standards inspections) in the appropriate UK national code of practice.

5.4 Animal health or identification (ID) marks

Under current POAO hygiene legislation, the requirement for animal health marks (applied to carcasses) or ID marks (applied to labelling, packaging etc) only applies to business establishments requiring approval.

5.5 What this means for cell-cultivated product producers  

As CCP establishments placing products on the GB market are registered (not approved), there is no requirement to apply animal health marks or ID marks.

5.6 The use of washing substances for POAO

Hygiene legislation sets out the permitted use of potable (drinking quality) water to remove surface contaminants from POAO (article 3 of regulation (EC) No 853/2004). If other substances are to be used for this purpose, they will need to be approved prior to placing POAO products on the market. This approval is distinct from a novel food authorisation (under regulation (EU) No 2015/2283).   

For certain fishery products, clean seawater may be used as an alternative to potable water (Refer to annex III of regulation (EC) No 853/2004).

5.7 What this means for cell-cultivated product producers

Substances other than potable water used for washing POAO at any stage of CCP production (following biopsy collection) must be approved by ministers in GB (noting the above condition for certain fishery products). Following safety assessment of the substance, alongside a novel food application, the FSA and FSS will submit an approval recommendation (called a statutory instrument) for ministers to make a decision on approval of the substance prior to market placement of the CCP as a novel food regulated product.

Any company wishing to seek approval of an alternative washing substance can discuss the process by contacting: regulatedproducts@food.gov.uk

When submitting a CCP application for market authorisation, list all washing solutions (‘substances’) and stage(s) of production when used, in full composition detail from biopsy to post-production processes, preferably as an additional single table within your dossier.

5.8 Annex: an explanatory note of key legislation for CCP businesses

This section provides an explanatory overview of key legislation which signposts broader requirements for all food businesses, including CCP operators (noting the specific positions outlined in the guidance above).

POAO legislation under regulation (EC) No 853/2004 links directly back to wider hygiene, safety and traceability compliance, particularly within:

The principles and requirements of these regulations provide an overarching framework in which businesses may manage their products as POAO, as described below.

5.9 Legislation: General Food Law

General Food Law is the overarching legislation which sets out the general principles and requirements of food law (regulation (EC) No 178/2002). Its principal aim is to protect human health and consumers’ interest in relation to food. It applies to all stages of production, processing and distribution of food and feed with some exceptions. Food businesses must comply with food and feed safety law. The FSA’s overview guidance on General Food Law outlines its main requirements on:

  • traceability of food
  • presentation of food and food information not to mislead the consumer
  • prompt withdrawal or recall of unsafe food placed on the market
  • food and feed imported into Great Britain (GB), and exported from GB, to comply with food law or conditions recognised by GB. Similarly, food imported into Northern Ireland (NI), and exported from NI, shall comply with food law or conditions recognised by the EU.

Useful information has also been published by Food Standards Scotland within its overarching guidance on running a food business.

5.10 Legislation: hygiene of foodstuffs

In addition to the principles of General Food Law, specific requirements are set out on the hygiene of foodstuffs (regulation (EC) 852/2004) which lays down general hygiene rules for food business operators (and definitions set out in article 2). Of particular importance, chapter 2 outlines the following requirements for food businesses:

This regulation also makes reference to imports and exports (in chapter IV). A workstream on import and export of CCPs is ongoing and guidance will be prepared for publication by the end of the sandbox programme in early 2027.

Of relevance to CCP businesses:

  • annex I sets out the requirements for primary production (that is, rearing of the source animal up to the point of slaughter) covering requirements for hygiene and record-keeping
  • annex II provides details on general hygiene obligations for food business operators with a focus on food establishment(s), processes and personal hygiene requirements

5.11 Legislation: specific hygiene rules for food of animal origin

In addition to the legislation above, regulation (EC) No 853/2004 provides detailed hygiene rules for food of animal origin (POAO) in context of specific hazards which may be associated with such products. This regulation includes information requirements on the animal holding, transportation to slaughter and placing POAO on the market. This POAO hygiene regulation thereby extends beyond primary production which concerns the rearing of animals to the point of slaughter (or at ante-mortem biopsy collection where applicable for CCPs).

This regulation applies to CCPs from biopsy collection, through to post-production and placing CCPs on the market and applies to both unprocessed and processed POAO.

Unless explicitly stated, this regulation does not apply to food containing both products of plant origin and processed products of animal origin (that is, composite products – as defined in article 2 of Commission Decision 2007/275/EC).

This POAO hygiene regulation outlines other exemptions (article 1) including POAO food for private domestic consumption, handling small quantities (including wild game), and for businesses which solely store or transport such POAO goods.

Traceability is an essential element in ensuring food safety (see next section). This regulation outlines registration requirements for food businesses and the conditions for placing products on the GB market, which may include establishment approval and the use of Health and Identification Marks on carcases and packaging respectively.

The majority of food businesses are registered, but certain foods may present specific hazards to human health for which specific hygiene rules are required and therefore such businesses are approved, as set out in annex III of this POAO regulation. Examples of approved establishments handling traditional POAO include those for:

  • meat
  • eggs and fish
  • wild game

Key requirements set out in this regulation which are of particular relevance to CCP companies include:

  • article 3 sets out that food businesses may only use potable water (drinking water quality) to wash/remove surface contamination from POAO unless alternative substances have been approved by ministers in GB
  • article 4 outlines requirements for business registration or approval
  • article 6 sets out requirements for importing POAO into GB
  • article 7 signposts to documentary requirements for establishments handling POAO

5.12 Annexes:

  • annex I provides a detailed list of definitions for specific POAOs (CCPs are not defined)
  • annex II on requirements for certain POAO including ID marking, HACCP-based procedures, food-chain information and frozen POAO food
  • annex III on specific requirements for establishments handling named POAO such as for the transport and slaughter of large ungulates (such as cows and sheep), poultry, lagomorphs (that is rabbits and hares), on-farm slaughter, wild game, specified dairy and marine products etc (CCPs are not listed)

5.13 Legislation: traceability of food of animal origin

Specific legislation on the traceability requirements for food of animal origin (regulation (EU) No 931/2011) provides obligations on tracing products at all stages of production, processing and distribution. The regulation stipulates that each business throughout the full supply-chain must retain information on all direct suppliers and all businesses where unprocessed and/or processed products have been directly distributed. This regulation shall not apply to food containing both products of plant origin and processed products of animal origin (composite products).

This traceability requirement is referred to as ‘one-step back and one-step forward’, which provides full supply-chain traceability information to protect consumers. Information to be retained by each company in the supply chain and accessed by the competent authority if requested include:

  • supplier, consignor and consignee (business names and address)
  • volume or quantity of the food of animal origin
  • reference identifying lot, batch or consignment, as appropriate
  • detailed description of the food and the date of dispatch

6. Review

This guidance is accurate at the date of publication.  

We aim to keep all guidance up to date and undertake regular reviews to ensure guidance remains relevant. The next scheduled review for this guidance is no later than 9 July 2027.  

7. Contact us

We welcome your feedback on this guidance by contacting us at LabellingStandardsandRegulatedProducts@fss.scot

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