1. Scope of supplementary guidance to applicants for assessment of Cell Cultivated Products (CCP) in food: Allergenicity & Nutrition

1. Scope 

This guidance applies specifically to Cell Cultivated Products (CCPs) regulated as novel foods in GB. Specifically, this guidance applies to CCPs defined as food products produced by culturing animal cells, including those from meat, seafood (fish and shellfish), fat, offal, or fertilised eggs in a controlled environment, without the use of traditional farming or animal slaughter. The primary focus of this 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 assimilated Regulation (EU) 2015/2283. This includes providing evidence of hazard identification, characterisation, and implementation of appropriate mitigations to ensure safety. This guidance will focus on allergenicity and nutrition risks of CCPs as novel foods. While this guidance outlines key considerations for CCP applications, it is not exhaustive.  As scientific methods develop, alternative approaches to those referenced within this guidance may be suitable to support the assessment of nutritional quality and allergenicity and may be accepted. All approaches used should be scientifically justified, generate reliable and conclusive data, and satisfy the applicable regulations for novel foods. 

All safety assessments should be supported by scientific evidence, with analyses conducted in accredited laboratories using nationally or internationally recognised and validated methods. Applicants are also encouraged to adhere to OECD guidelines on Good Laboratory Practice (GLP) and chemical testing where applicable. Where this is not possible, fully validated internal methods with appropriate controls may be used, provided they are scientifically justified.

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) will review all applications to ensure compliance with regulatory standards. Additional information may be requested during the verification process to address any gaps or uncertainties identified in the submission.