FSA, FSS: New GB Cell-Cultivated Product Toxicology Guidance Released

• The FSA and FSS have issued new guidance for market authorization of cell-cultivated products in Great Britain.
• This guidance specifically addresses toxicology and the assessment of growth media components for novel food applications.
• It supports assimilated Regulation (EU) 2017/2469 and Article 10 of assimilated Regulation (EU) 2015/2283.
• The document is part of a series from the Cell-Cultivated Product Sandbox Programme, running from February 2025 to February 2027.
• Its goal is to ensure the safe development and authorization of cell-cultivated products by accounting for associated hazards.

Lawyers and compliance officers advising companies developing cell-cultivated products for the GB market must review this specific guidance to ensure market authorization dossiers comply with the detailed requirements for toxicology and growth media assessment under novel food regulations, particularly concerning assimilated Regulations (EU) 2017/2469 and 2015/2283.

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have released crucial new guidance for companies seeking market authorization of cell-cultivated products in Great Britain (GB). This specific guidance, titled "Cell-cultivated products: toxicology and growth media assessment," outlines essential considerations for evaluating both growth media components and potential toxicological hazards inherent in these innovative food items. It is specifically designed for entities pursuing market authorization for cell-cultivated products classified as novel foods within the GB regulatory framework.

This document serves as a supplementary resource, building upon the foundational 2016 technical guidance issued by the European Food Safety Authority (EFSA). Its primary objective is to assist applicants in preparing comprehensive dossiers for regulatory review, ensuring that all safety aspects related to growth media components and toxicological risks are thoroughly addressed. The issuance of this GB cell-cultivated product toxicology guidance underscores the commitment of regulatory bodies to facilitate the safe development and authorization of these emerging food technologies.

The new guidance from the FSA and FSS provides detailed scientific considerations for assessing the safety of cell-cultivated products, particularly concerning their growth media and potential toxicological profiles. It directly supports the requirements set forth in assimilated Regulation (EU) 2017/2469, which specifies the administrative and scientific prerequisites for novel food applications. Furthermore, it aligns with Article 10 of assimilated Regulation (EU) 2015/2283, the overarching regulation governing novel foods in GB. These assimilated regulations form the bedrock of the UK novel food toxicology assessment process.

In Great Britain, the FSA and FSS are the designated bodies responsible for conducting rigorous risk assessments for all regulated products, including novel foods like cell-cultivated items. This supplementary guidance offers tailored information for the safety assessment process, guiding applicants through the specific steps and data requirements necessary to demonstrate compliance. Lawyers and compliance officers advising companies developing cell-cultivated products for the GB market must review this specific guidance to ensure market authorization dossiers comply with the detailed requirements for toxicology and growth media assessment under novel food regulations, particularly concerning assimilated Regulations (EU) 2017/2469 and 2015/2283.

This critical guidance is an output of the Cell-Cultivated Product Sandbox Programme, an initiative scheduled to run from February 2025 to February 2027. The Sandbox Programme is designed to enable the FSA and FSS to translate insights gained from their work on cell-cultivated products into practical, actionable supplementary guidance for the industry. This particular document is part of a broader series of technical publications emerging from this programme, all aimed at fostering a clear regulatory pathway for these novel foods.

The overarching aim of this guidance series, and the Sandbox Programme itself, is to support the safe development and subsequent authorization of cell-cultivated products. This involves meticulously accounting for potential hazards linked to growth media components novel foods and comprehensively addressing all toxicological risks. The FSA and FSS developed this guidance by drawing upon findings from the Sandbox Programme, integrating expert input, and conducting thorough literature reviews, ensuring a robust and scientifically sound approach to market authorization for FSA cell-cultivated product market authorization.

Lawyers and compliance officers advising companies developing cell-cultivated products for the GB market must review this specific guidance to ensure market authorization dossiers comply with the detailed requirements for toxicology and growth media assessment under novel food regulations, particularly concerning assimilated Regulations (EU) 2017/2469 and 2015/2283.

Source: Original reporting via UK government guidance