Regulatory challenges for lab-grown ingredients

Abstract

Novel technologies are the future of food innovation but the road to market entry is paved with regulatory challenges. Daniele Leonarduzzi here outlines what you need to know.

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 mean 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.

Regulatory approval is indeed a fundamental step in bringing novel foods onto the market and this is a strictly governed process with highly complex guidelines. Without a clear product strategy and the right supporting scientific data, presented in the correct format, applications are likely to fail – leading to longer lead times, increased costs and no guarantee of a positive outcome. In case of lab-grown foods, where do you start?

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 startup 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.

Labelling lab-grown ingredients is complicated and can often seem like a guessing game. Although it's generally acknowledged that some form of differentiation is required to ensure transparency, a unified regulatory approach to the precise wording and level of information required remains largely elusive.

This fluidity means keeping updated on the latest labelling regulations and guidance in individual markets is essential. Carrying out extensive research, monitoring regulatory changes and seeking expert advice to interpret relevant regulations correctly are all strongly advised to avoid costly and time-consuming mistakes.

Talking about intellectual property alongside safety assessments may seem incongruous, but this issue has crucial commercial implications – particularly for novel foods. That's because authorities mandate complete disclosure of the production methods used to create the new material.

Under the European Commission's Transparency Regulation, for example, failure to provide a valid justification for withholding certain data or successfully file a confidentiality request means any information contained in the dossier could become publicly available – including proprietary information. A potential outcome that would remove any competitive advantage.

As novel technologies continue to advance, scientific ambition alone won’t be enough to bring these products to market. Making that a reality – and the speed at which it is achieved - rests on securing regulatory approval from the relevant safety authorities. A comprehensive understanding of safety assessment and labelling requirements may well prove to be the determining factor for ultimate commercial success. Getting it right first time demands a comprehensive knowledge of food regulatory affairs and analytical science – all of which you’ll find at RSSL.