This document outlines the scientific requirements for evaluating the allergenicity and nutritional aspects of Cell Cultivated Products (CCPs) when seeking market authorisation as novel foods in Great Britain. This is supplemental guidance to the 2016 EFSA technical guidance which supports applicants through assimilated Regulation (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 guidance aims to help applicants understand how the allergenicity and nutritional sections of Article 10 of assimilated Regulation (EU) 2015/2283 and the 2016 EFSA technical guidance apply to CCP safety assessments, specifically regarding the risks of nutritional disadvantage and allergenicity and how to evidence this within a CCP novel food application.