Cell-cultivated products: toxicology and growth media assessment
Supplementary guidance for applicants submitting a cell-cultivated product dossier for market authorisation in Great Britain.
Applies to England, Scotland and Wales
Documents
Details
Purpose
This guidance sets out what you need to consider when evaluating growth media components and toxicological hazards in cell-cultivated products. You’ll need this if you’re seeking market authorisation for these products as novel foods in Great Britain (GB).
In GB the Food Standards Agency (FSA) and Food Standards Scotland (FSS) carry out risk assessments for regulated products.
This document is supplemental guidance to the 2016 European Foods Safety Authority (EFSA) technical guidance. It supports you through assimilated Regulation European Union (EU) 2017/2469, which details administrative and scientific requirements for novel food applications under Article 10 of assimilated Regulation (EU) 2015/2283 for novel foods.
This supplementary guidance gives detailed scientific considerations for assessing the growth media components and toxicological hazards of cell-cultivated products. This supports the general requirements of assimilated Regulation (EU) 2015/2283 and 2016 EFSA technical guidance. It describes tailored information for the safety assessment process you should follow where relevant when preparing a cell-cultivated product dossier for regulatory review.
Using this supplemental guidance will help you:
- understand key safety considerations
- ensure their submissions are comprehensive
- support efficient regulatory evaluation
The goal is to support the development and authorisation of cell-cultivated products that are safe, accounting for hazards linked to the growth media components and toxicological risks.
Cell-Cultivated Product Sandbox Programme
This supplemental guidance is part of a series of technical supplementary guidance publications from the Cell-Cultivated Product Sandbox Programme, which runs from February 2025 to February 2027.
The Cell-Cultivated Product Sandbox Programme aims to help the FSA and FSS turn what they learn from our work on cell-cultivated products into practical supplemental guidance for industry.
This guidance will address a range of topics relevant to cell-cultivated product development and production, helping businesses understand how to manufacture products safely and demonstrate compliance with regulatory requirements.
The FSA and FSS have drawn on findings from the Sandbox Programme, along with expert input and literature reviews, to develop this series of guidance. It aims to:
- provide greater clarity
- support innovation
- help businesses navigate a clearer pathway towards authorisation