Complex regulatory challenges for lab-grown ingredients

BY DANIELE LEONARDUZZI | SENIOR SCIENTIST

27 July 2023

 

Novel technologies are the future of food innovation but the road to market entry is paved with regulatory challenges. Here’s what you need to know.

 

Food chain innovations

 

A growing global population, unprecedented climate change and political instability are all driving the need to build a more sustainable and resilient food chain. Novel technologies are a vital part of future strategies, with lab-grown ingredients widely seen as promising alternatives to those produced from traditional farming methods.


Created via cellular agriculture, these innovative products have the potential to transform global food production through greater food availability, better supply chain diversity and customisable nutrition profiles. 

 

Take lab grown meat for example. Singapore, Canada, Israel, Australia, New Zealand, the EU and US are among the many countries to have implemented regulatory measures for its manufacture and production. Yet many others are still deciding on the most appropriate course of action.

 

This lack of harmony is a major obstacle for commercialisation. Regulatory discrepancies across jurisdictions can lead to multiple approval processes, causing delays and inefficiencies for industry operators.

 

That’s not to say these challenges are unsurmountable. But it does means that the importance of understanding the regulatory framework, as well as the exact data and labelling requirements of each market can’t be emphasised enough. All these elements need to be addressed to give novel food submissions the best chance of success. So where do you start?

 

 

 

Build a data driven dossier

 

Gathering the required scientific data and building a coherent dossier that demonstrates the safety of lab-grown ingredients is a complex task. It requires regulatory expertise, scientific understanding and broad analytical knowledge to navigate the detailed requirements set out by the various authorities, such as:  

  • Data must be based on batches of product that are representative of the scale-up process, which can be particularly difficult for smaller start-up companies to achieve.

 

  • Potential hazards associated with lab-grown ingredients and its manufacturing process must be identified. This includes a thorough evaluation of the biological, chemical and physical agents that may pose a risk to human health. 

 

  • A full nutritional evaluation covering amino acid profile, fats, minerals and vitamins must be included.
  • Information relating to the source and safety of the cells used must be provided, such as type of animal and associated health history, type of tissue, absence of pathogens and so on. Details on cell collection and growth protocol is also mandated, with a focus on immortalisation and genetic stability.

 

  • All raw materials used during manufacturing as well as the impurities (antimicrobials and growth factor residues) in the finished product should be assessed. 

 

  • A detailed understanding of the stability of the novel material as-is as well as in finished food products