Global regulatory policies for cell-based meat spotlighted by Good Food Institute

04 Jun 2021 --- As the cultivated meat race begins to gain traction across markets globally, various countries are either using existing novel food regulations or developing new ones to assess these new products. 

To bolster the cultivated meat industry around the globe, the Good Food Institute (GFI) is sharing where several key regions currently stand with cultivated meat regulation.

With a clear picture of their region’s current regulatory landscape, entrepreneurs and nascent cultivated meat companies can better understand the possible regulatory pathways to bring their product to market approval in their area.

“Cultivated meat gives consumers everything they love about meat, but produced in a more sustainable and humane way, where animals are removed from the process entirely,” Bruce Friedrich, GFI executive director, tells FoodIngredientsFirst.

“This means there is no contribution to pandemic risk or antibiotic resistance, and contributes only a fraction of the adverse climate impact.”

GFI highlights that 23 new cultivated meat companies launched in 2020, adding up to a total of 76 companies globally – up 43 percent from 2019.However, Friedrich stresses that cultivated meat will remain just a small segment of the overall market for conventional meat unless governments fund basic R&D as they have done for other climate-friendly innovations.

“Global public R&D spending on renewable energy technology is north of US$30 billion every year, but total R&D funding into alternative proteins all-time amounts to about US$1 billion, and nearly all of that funding has been into the private sector.”

A “record year” for cell-based milestones
The market is witnessing rapid shifts, with 2020 pegged by GFI as a “record year” for cultivated meat company launches and private investments.

This year of firsts was capped off with Israel’s Prime Minister Benjamin Netanyahu consuming cultivated steak and the first commercial sale of cultivated chicken meat in Singapore. 

GFI highlights that 23 new cultivated meat companies launched in 2020, adding up to a total of 76 companies globally – up 43 percent from 2019. 

Meanwhile, cultivated meat companies received more than US$360 million in investments in 2020, which is six times the amount raised in 2019 and 72 percent of the amount raised in the industry’s history (2016 to 2020). 

“As soon as 2030, we expect to see real progress on costs for cultivated meat and massive reductions in emissions and land use brought about by the transition to this method of meat production,” says GFIs senior scientist Elliot Swartz.

“Government investment in R&D and infrastructure will be critical to accelerating the development of cultivated meat and help us achieve global climate goals. Favorable policies and carbon markets can incentivize the restoration of agricultural land for its carbon sequestration and ecosystem services potential, maximizing the climate benefits of cultivated meat.”

Last April, GFI called on governments around the world to invest in open-access alt protein research as a key climate solution that simultaneously addresses the increasing risk of pandemics, antibiotic resistance and food insecurity. 

Australia-New Zealand
Australia and New Zealand share a joint food regulatory framework and a joint food regulatory agency, Food Standards Australia New Zealand (FSANZ). 

Cultivated meat companies received more than US$360 million in investments in 2020, which is six times the amount raised in 2019 and 72 percent of the amount raised in the industry’s history.Under FSANZ’s “novel food” regulation, cultivated meat and seafood manufacturers must apply to have their products included in the schedule of approved novel foods if they wish to make sales in either country.

This requires a safety assessment by FSANZ of the production process, likely lasting at least 14 months. The safety assessment must establish with reasonable certainty that “no harm will result from the intended use of the food.” 

Canada
In Canada, cultivated meat and seafood are characterized as “novel foods” requiring the submission of detailed information in an application for premarket approval. 

The required information for the novel food submission includes evidence that the food is safe for consumption, including molecular characterization, nutritional composition, toxicology and allergenicity as well as types and levels of chemical contaminants.

United States
The US Food and Drug Administration (FDA) oversees cell collection, cell banks, and all cultivation inputs and processes including cell growth and differentiation, up through the moment of “harvest” from the bioreactors. 

Meanwhile, the US Department of Agriculture (USDA) oversees the further processing and labeling of food products derived from the cells of livestock and poultry. However, the FDA retains jurisdiction over cultivated seafood, excepting catfish, through processing and labeling.

European Union
In the EU, the Novel Foods Regulation (Regulation (EU) No 2015/2283) governs pre-market authorizations for foods produced from animal cell or tissue culture.

However, if genetic engineering is used in the production of cultivated meat, the Regulation on genetically modified food and feed (Regulation (EC) 1829/2003) might apply instead.

Applications under the Novel Foods Regulation need to be addressed to the European Commission and its Directorate-General for Health and Food Safety.

The European Food Safety Authority (EFSA) usually conducts a risk assessment and gives a scientific opinion on the safety and nutritional aspects of the product. If that opinion is positive, final approval rests with the European Commission and representatives from all EU member states.

United Kingdom
With its exit from the EU, the UK is no longer participating in the EU’s common food authorization procedures.

As of May 2021, any cultivated meat companies wanting to sell their products in the UK need to apply for authorization to the UK Food Standards Agency (FSA).

By 2030, GFI expects to see progress cultivated meat costs and massive reductions in emissions and land use brought about by the transition to this method of meat production.But the UK retained relevant EU law and the substance of the risk assessment of both novel foods and genetically modified food authorizations remains the same as in the EU.

The most substantial difference between the UK and EU regulatory approval concerns the final approval decision.

In the UK, it will be government ministers taking the decision as opposed to the EU, where final approval is governed by the, likely more elaborate and possibly more time consuming, committee procedure involving the European Commission and representatives from all 27 EU member states.

Asia Pacific
Two jurisdictions in the APAC region are making notable progress in creating a regulatory environment favorable to cellular agriculture and cultivated food products: Singapore and Japan.

Singapore
The Singapore Food Agency (SFA) has published guidance on its requirements for the safety assessment of novel foods, including specific requirements on the information to be submitted for approval of cultivated meat products. SFA currently assesses applications on a case-by-case basis.

SFA is currently in conversation with local cultivated meat and seafood startups, including Shiok Meats and Ants Innovate, about potential approval of their products, and is very open to working with companies from the early R&D and product development stages. 

Japan
In theory, cultivated meat (depending on the production method) already falls within the existing regulatory regime in Japan and might not require a premarket assessment or approval.

At the same time, the Japanese government is working to develop a specific regulatory framework to properly shape the market while ensuring food safety and consumer acceptance.

Industry groups are being formed to create industry standards and liaise with the regulator to create a process to foster consumer confidence.

By Benjamin Ferrer, with additional reporting by Elizabeth Green