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Supplementary guidance to applicants for assessment of Cell Cultivated Products (CCP) in food: Allergenicity & Nutrition

Concluding remarks of supplementary guidance to applicants for assessment of Cell Cultivated Products (CCP) in food: Allergenicity & Nutrition

Concludig

Diweddarwyd ddiwethaf: 4 Rhagfyr 2025
Diweddarwyd ddiwethaf: 4 Rhagfyr 2025

Concluding remarks to include in CCP applications

The information requested across all the sections should be integrated as a concise overall consideration on how it supports the safety of the CCP under the proposed condition of use.

Acknowledgements

Members of the Advisory Committee on Novel foods and Processes (ACNFP) and the Subcommittee on Cell Cultivated Products (CCPs) who provided expert views at the CCP subgroup meeting CCP01 (06/2025) and reviewed this guidance as part of ACNFP-173 meeting (08/2025).

Abbreviations

Acronym

Definition

ACNFP

Advisory Committee on Novel foods and Processes

ADME

Absorption, Distribution, Metabolism and Excretion

CCP

Cell Cultivated Product

DIAAS

Digestible Indispensable Amino Acid Score

DNSIYC

Diet and Nutrition Survey of Infants and Young Children

EFSA

European Food Standards Agency

ELISA

Enzyme-Linked Immunosorbent Assay

EU

European Union

FSA

Food Standards Agency

FSS

Food Standards Scotland

GB

Great Britain

GLP

Good Laboratory Practise

IgE

Immunoglobulin E

NDNS

National Diet and Nutrition Survey

OECD

Organisation for Economic Co-operation and Development

PMM

Post Market Monitoring

UK

United Kingdom

Definitions 

  

Key Words

Definitions

Allergen

A protein molecule which leads to an allergic response due to recognition by serum IgE from an allergic individual, or recognition of gluten proteins due to celiac disease.

Batch(s)

A defined quantity of the novel food produced under uniform conditions during a particular cycle of manufacture. The specifics of the batch are to be defined and justified by the applicant.

Comparator

A reference foodstuff with which the CCP is compared

Composition

The combination of substances that individually and collectively comprise the nutritional, toxicological and allergenic properties of the CCP intended for food use

Conventional meat

Edible tissue obtained from animal or seafood sources  

Cross reactivity

Identification of structurally similar proteins

Culture media

A nutrient-rich solution used to grow cells outside of their natural organism.

History of Safe Food Use (HSFU)

A history of safe food use (HSFU) means that the safety of the food/ingredient in question has been confirmed with compositional data from experience of continued food use in the customary diet of a significant number of people in the UK or EU beginning before 15 May 1997 (Novel Food assimilated Regulation (EU) 2015/2283).

Immunoglobulin E (IgE)

Antibodies produced by the immune system involved in most food allergic responses

in vitro

Performed outside living organisms in a controlled environment, such as in a test tube.

Novel food

Foods that do not have a significant history of consumption in the UK or EU prior to May 1997, as set in the Novel Food assimilated Regulation (EU) 2015/2283.

Scaffold

A porous structure that provides a physical framework that supports cell growth by mimicking the natural extracellular matrix and allows for complex tissue-like organisation of cells in vitro.