Cell-cultivated products: food business hygiene requirements

This guidance for food businesses goes along with previous guidance published earlier in the programme on Cell-cultivated products: classification and HACCP principles ,which includes defining cell-cultivated products (CCPs) as products of animal origin (POAO).  

This guidance has been developed to help relevant businesses understand and apply requirements of the hygiene regulations when producing CCPs in Great Britain (GB) only. This guidance contains references to relevant legislation that applies, and what it means for CCP food business operators including primary producers (in rearing source animals from which biopsies are collected).

This CCP guidance explains the hygiene requirements for POAO under regulation (EC) No 853/2004 and links back to wider regulatory considerations applicable to the animal source for cell-line selection and CCP production as set out in General Food Law and Food Hygiene Law (regulation (EC) Nos 178/2002 and 852/2004 respectively). This guidance provides an overview of these key regulations and provides clarification on the following guiding positions in context of CCPs:

1. the principles of primary production are applicable to CCPs
2. the primary product is the biopsy sample from the source animal
3. food law applies to CCPs from the point of biopsy collection
4. CCP business establishments require registration
5. health and ID marks are exempt for CCP products
6. specific requirements within annex III of POAO Hygiene regulation are disapplied
7. the use of alternative washing substances other than drinking quality (potable) water to remove surface contamination requires ministerial approval

This guidance only covers CCPs produced from animal cells. 

1.1 European union sanitary and phytosanitary (SPS) context

This guidance provides an overview of legal principles and best practices to provide clarity to businesses throughout the supply chain particularity in the preparation and production of cell cultivated products. The Food Standards Agency’s (FSAs) position is to set out to provide high levels of food chain protection and consumer safety from farm to fork. Where EU have published positions on hygiene, the information provided within this guidance aligns directly as per EU guidance on hygiene.

The proposal for dynamic alignment means that, subject to any exceptions agreed, the UK will align with all EU legislation within the expected scope of the agreement and, once the agreement enters into force, rules applying in the UK would be updated in line with EU rules as they change over time.

This guidance is intended for all parties with an interest in, or directly involved in the production of CCPs, originating from animal cells, for human consumption.

This guidance applies to businesses based in: 

• Scotland, where FSS is the food safety authority
• England and Wales, where the FSA is the food safety authority

This guidance does not apply to businesses based in Northern Ireland which remains aligned with EU legislation.

Companies producing CCPs within the scope of this guidance will need to comply with relevant requirements of all applicable regulations to ensure consumer safety. Although not exhaustive, key legislation is provided below by subject: 

3.1 Food safety 

• regulation (EC) No 178/2002 – General Requirements of Food Law
• regulation (EU) No 931/2011 – On traceability requirements (under regulation (EC) 178/2002)
• regulation (EU) 2015/2283 – Novel Foods

3.2 Food hygiene

• regulation (EC) No 852/2004 – Hygiene of Foodstuffs
• regulation (EC) No 853/2004 – Specific Hygiene Rules for Food of Animal Origin
• regulation (EC) No 2017/625 on Official Controls

3.3 Animal welfare

• The Animal Welfare Act 2006

The principles and requirements of these regulations provide an overarching framework in which CCP businesses may manage their products as POAO, as described below. Directly applicable EU legislation no longer applies in GB. EU legislation retained when the UK exited the EU became assimilated law on 1 January 2024 and is published on legislation.gov.uk. References to any legislation in FSA guidance with ‘EU’ or ‘EC’ in the title (such as regulation (EC) No 178/2002) should now be regarded as assimilated law where applicable to GB and as directly applicable EU law where applicable to Northern Ireland (NI). References to ‘Retained EU Law’ or ‘REUL’ should now be regarded as references to assimilated law.   

For businesses moving goods from GB to NI, more information is available on the Windsor Framework including the NI Retail Movement Scheme (NIRMS).

This guidance is presented under the following sections:

• Specific regulatory positions for CCPs, including what this means for CCP producers:
  1. General Food Law and food hygiene law
  2. POAO Hygiene Requirements for CCPs
• 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 section above):
  1. General Food Law
  2. hygiene of foodstuffs
  3. specific hygiene rules for food of animal origin
  4. traceability of food of animal origin