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Since the last time I wrote about Food Safety for cultivated meat, there have been some new developments in the space! I’m particularly passionate about food safety when it comes to novel foods and the importance of making sure there are sturdy food safety standards and benchmarks in place. This will help us make sure progress won’t be halted by any unsafe products hitting the market and being detrimental to human health. A new document was published by the World Health Organisation (WHO) and Food and Agriculture Organizations of the United Nations (FAO) entitled ‘Food safety aspects of cell-based food’.

The two parties collaborated by engaging with relevant stakeholders and sharing current knowledge. They ultimately wanted to create ways to inform any relevant groups about food safety considerations for cultivated (‘cell-based’) food products.

They make it clear that conventionally-produced food (meat) has its own food safety aspects to consider, but they wanted to focus particularly on materials, inputs, ingredients and equipment that are more specific to cell-based food production. In other words, meat itself isn’t always safe and has its own food safety considerations; but they want to just focus on anything that will be unique to cultivated meat that could pose a food safety risk.

Don’t have time to read the whole report? Not to worry, this summary will give you the key points so you have a fair understanding of what’s in the report.

This 146 page document is dense, contains a lot of technical information and has been referenced and cited throughout. Here I will break down the TLDR of the scientific information in this new document for your reading, in a summarised format.

Developing a generic understanding of the production process

Terminology

First of all, the authors have analysed the terminology usage of labelling cultivated meat and have identified whether the terms have been used by Authorities, Industry and developers, Academia and/or the Media.

TLDR: “cell-based”, “cell-cultured, “cultivated”, and “cultured” are the only 4 terms used by authorities. Industry and developers use these 4 as well as “clean” and “healthy”. Academia has an expanded terminology base and is the only group to use “cell-cultivated”. The Media have uniquely used terms like “Frankenmeat”, “Shmeat”, “Test-tube” and more unappetising terms.
They chose to proceed with “cell-based” in order to avoid negative perceptions and improve acceptance of these food products. All of the claims they make are informed by consumer studies.

The Production Process

The reporters go into detail around the process of developing cultivated meat. It can be broken down into 4 basic steps: Cell selection, Production, Harvesting and Food formulation.

Cell Sourcing

The study takes into consideration the different cell sourcing methods including but not limited to:

enzymatic digestion - where a biopsy is exposed to enzymes to break it down and separate cell-to-cell bonds);
explant method - where a biopsy is placed into a culture dish and cells naturally migrate from the biopsy to the dish) and;
FACS isolation - where a biopsy is broken down into a single cell suspension, labelled with fluorescent antibodies and passed through a cell sorter to select for your cell of choice.

Types of cells

They discuss the types of cell that can be grown, what kind of media they are usually grown in and bioreactor configuration necessary for large-scale production of cells, including the potential for microcarriers and scaffolding.

Microcarrier implications

There is also an acknowledgement to the idea that biopolymer microcarriers could carry molecules that emulate the action of hormones in delivery to the cells. They discuss the use of both edible and non-edible microcarriers in cultivated meat production and how non-edible microcarriers can be degraded.

Food processing and formulation

Food processing and formulation is covered briefly and indicates the many possible options including:

Combining multiple cell types (e.g. muscle and fat)
shear-cell technology, extrusion or 3D-printing
using biopolymers including polysaccharides for structural support

After reviewing each of the above topics, they go into discussing the potential food safety risks within each step, as well as suggested solutions or preventative techniques.

The report goes on to suggest some potential risk aversion techniques

Due to the infancy of the industry and small-batch nature of current production, each product may be have a unique composition. That’s why a case-by-case approach may be suitable for assessing food safety.

Food Safety Assessment

The Singapore Government Singapore Food Agency (SFA) has general guidelines for companies seeking regulatory approval. They are flexible in that “safety assessments submitted to other overseas regulatory agencies can be directly submitted to SFA for review if they contain the necessary information required by SFA.”

They recommend to include the following in a safety assessment application:

Information on cell lines used
Include the source, any culturing history, methods used, chemicals used and tests on the cells and various infectious agents that could be linked to the cells.
Production process
Provide all documentation related to food safety management systems, with a clear description of risk monitoring and mitigation steps employed in the production process.
Input characterisation
List any and all inputs used in production including chemical and biological agents, biomaterials, enzymes, anti-microbial agents, growth factors and culture media composition.
Output characterisation
Put forward a breakdown of the outputs from the production process including the composition of the final wet or dry product, any impurities that may be present and evidence that any potentially hazardous material in the final product will not cause any significant food safety concerns.
Toxicity and allergenicity characterisation
Demonstrate the absence of toxicity of multiple toxicity parameters as well as assessing the allergenicity of the product and any potential allergens that must be added to the labelling of that product.
Exposure assessments
Outline the anticipated intake amounts of the novel product or ingredients using service sizes and comparative data on actual food consumption. If your product is intended to be consumed by a specific population group, address how it is safe for that target population.
Food testing methodologies
Provide references and of testing methodologies used in accordance with Good Laboratory Practices (GLP), validated with ISO/IEC 17025 (or similar) or peer-reviewed literature. If you perform in-house testing, provide details of the methods, accreditation status and validation results.

The Technical Panel

FAO and WHO put together a Technical Panel of a total of 23 people (13 experts and 10 resource people) and constructed consultations.

The Technical Panel was divided into groups for each hazard identified and they discussed:

Hazard agent;
Problem description / consequence to human health;
Hazard type (biological hazard, chemical hazard, physical hazard or allergen);
Potential mitigation control measures;
Potential testing control measures;
Whether or not the hazard can be addressed in the food safety plan such as a HACCP plan;
Similar presence of the hazard in other food products / comparators / relevant experiences / gaps; and
Causal chain examples

From Pages 76 - 98 (Pages 88-110 of the pdf), the report details clearly summarised tabulated information of the potential hazards associated with cell-based food production that the Technical Panel discussed.

The hazards fit into these categories:

Physical hazards
Chemical hazards
- Additives
- Residues
- Allergens
Biological hazards
- Pathogens
- Species with limited history of safe food use
- Genetic instability
- Allergens
Other hazards
- Microplastics
- Intentional genetic modification and subsequent allergens

In its’ truly thorough nature, the report dives into concerns that are not included in this scope, pointing out additional issues that may be encountered.

The Technical Panel also considered concerns that didn’t have relevant scientific evidence to suggest that it could result in harm to consumers, but that popular press and social media have raised concerns about.
- Potential survival of cells (particularly those enhanced by genetic modification) after consumption leading to harm through some type of tumour formation
- Cells from a not-commonly-consumed species of animal could harbour novel microorganisms which could alter the consumers’ microbiome.
- Residual genetic material could be taken up by the gut microbiome and start expressing toxic molecules in the consumer’s body.
- Potential presence of Mycoplasma spp despite best efforts to avoid and minimise the risk

For all of these points, the Technical Panel discussed them thoroughly, assessed whether they have scientific backing and did not find them to be credible pathways to harm based on current scientific understandings.

The report then goes on to address consumer acceptance and how to communicate with consumers and build consumer trust about food safety of cell-based products. It reinforces that many consumers are likely unfamiliar with cell-based food and their production methods, and that may add to perceptions of the risks associated. The authors encourage transparency, openness and public engagement from key stakeholders and highlight the importance of communication.

When I attended the webinar which announced the publication of this report, I was impressed with the level of detail the presenters went into to explain their results and give us an idea of how the report was put together. Having now read the report, I feel even more sure that FAO and WHO are approaching this challenge of food safety thoroughly and diligently, using critical risk assessment frameworks, expert consultation and scientific evidence behind their outcomes.

The only question it didn’t address for me is; Is cultivated meat allergenic to people with Alpha-gal syndrome? Although I suppose the allergen concerns that were cited throughout the document covered this risk. I’d be interested to see a study on whether this is the case or not!

It will be an interesting next couple of decades to see how food safety evolves as the cultivated meat industry grows!

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