Purpose
This document outlines the scientific requirements for evaluating the identity, production processes and microbiological hazards of Cell Cultivated Products (CCPs) when seeking market authorisation as novel foods in Great Britain (GB).
This is supplemental guidance to the 2016 European Food Safety Authority (EFSA) technical guidance which supports applicants through regulation (EU) 2017/2469 and details administrative and scientific requirements for novel food applications under Article 10 of regulation (EU) 2015/2283 for novel foods.
This supplemental guidance aims to help applicants understand the safety assessments required relating to identity, production and microbiological hazards of CCP production. It should be read in conjunction with Article 10 of assimilated regulation (EU) 2015/2283 and the 2016 EFSA technical guidance, which continue to apply to CCP safety assessments.
This supplemental guidance is part of a series of technical supplementary guidance as part of the CCP Sandbox programme (February 2025 to February 2027).
Summary
An important aim of the CCP sandbox programme is for the Food Standards Agency (FSA) and Food Standards Scotland (FSS) to fast-track knowledge about CCPs and use this to produce supplemental guidance on a range of topics relevant to these products. This supplemental guidance aims to better guide companies on how to make products in a safe way and how they can demonstrate this to us. The FSA and FSS are using the knowledge learnt from the CCP sandbox programme, in addition to expert elicitation and literature reviews, to publish supplemental guidance documents that provide clarity to businesses on the path to market.
This supplemental guidance provides detailed scientific considerations for assessing the identity, production processes and microbiological hazards of CCPs, supporting the general requirements of Regulation (EU) 2015/2283 and 2016 EFSA technical guidance. It provides tailored information about these areas which CCP companies should consider when compiling a CCP dossier for regulatory review.
By following this supplemental guidance, applicants can address common issues, ensure their submissions are comprehensive, and support efficient regulatory evaluation. The goal is to support the development and authorisation of CCPs that are safe, accounting for risks associated with identity, production and microbiological hazards.
Scope
This supplemental guidance applies specifically to CCPs regulated as novel foods in Great Britain (GB). Specifically, this supplemental guidance applies to CCPs defined as food products produced by culturing animal cells, including those from meat, seafood (fish and shellfish), fat, offal, fertilised avian eggs or other animal embryonic material in a controlled environment, without the use of traditional farming or animal slaughter. This supplemental guidance is on products derived from both invertebrate and vertebrate animal cells such as mammalian, fish, shellfish, or avian cells, particularly those intended to replicate the appearance and characteristics of conventional meat or seafood.
Applicants seeking market authorisation for CCPs must comply with Regulation (EU) 2015/2283. This includes providing evidence of hazard identification, characterisation, and implementation of appropriate mitigations to ensure safety. This supplemental guidance is on safety hazards associated with identity, production processes and microbiological risk within the CCPs as novel foods. While this supplemental guidance outlines important considerations for CCP applications, it is not exhaustive. As scientific methods develop, alternative approaches to those referenced within this supplemental guidance may be suitable to support the safety assessment in the identity, production and microbiological risks and may be accepted by the FSA/FSS. All approaches used should be scientifically justified, generate reliable and conclusive data, and satisfy the applicable regulations for novel foods. Further information on genetically or genomically modified CCPs is provided in Section 3.3.