News

Jun 09, 2023

Important New Developments in the Cell

Regulatory developments are beginning to catch up with the technological innovation being driven by the novel foods sector, in particular alternative protein sources such as cell-based meat. Here we

Regulatory developments are beginning to catch up with the technological innovation being driven by the novel foods sector, in particular alternative protein sources such as cell-based meat. Here we assess the latest in the U.S., EU, Switzerland, and the UK.

U.S.: ahead of the curve

As of June 21, 2023, two companies overcame the final hurdle for allowing their cultivated chicken products to be sold in the U.S. when the companies received landmark grants of inspection from the U.S. Department of Agriculture (USDA). Immediately thereafter, both companies announced that they had begun production of the cultivated chicken products.

Cell-based meat and poultry products are regulated collaboratively between the USDA and the U.S. Food and Drug Administration (FDA). The FDA completed its voluntary premarket consultation process for both companies in November 2022 and March 2023, respectively, and the USDA approved labels for the two cultivated chicken products in June 2023. Although the USDA approved use of the labeling term “cell-cultivated” chicken for both companies, use of that term is not yet standardized. USDA is tasked with determining the final name for products that are produced using cell culture technology. However, USDA has not finalized any labeling regulation. Its September 2021 advance notice of proposed rulemaking, which sought comments from interested stakeholders on the labeling terms, notes that “[l]abels approved for cell cultured meat and poultry products prior to the conclusion of this rulemaking may need to be changed for compliance with the requirements of final regulations.”

The completion of the regulatory review and approval for the cultivated chicken products is a milestone for the food industry and provides significant insight into the key criteria necessary for the development of cultivated meat products in the U.S.

EU: taking stock

On May 11 and 12, 2023, the European Food Safety Authority (EFSA) hosted a colloquium on “Cell culture-derived foods and food ingredients” as highlighted in our previous Sidley Update. With presentations from stakeholders of various European, international, and national agencies, technology companies, and consumer groups, the event helped to crystallize the latest scientific and risk assessment challenges associated with evaluating novel food technologies.

For example, representatives of the Food and Agriculture Organisation (FAO) of the United Nations observed the challenge of conducting a thorough risk assessment for cell-based foods given the lack of exposure of the products to the market, suggesting that a process of hazard identification is a central first step in the evaluation process.

Representatives of EFSA and the European Commission maintained that the EU Novel Food Regulation is equipped to accommodate applications for the authorization (under Article 10) of cell-based meat products. On the other hand, the representative from the industry association, Cellular Agriculture Europe, highlighted the need for “streamlined and fit-for-purpose regulatory pathways.” Representatives from the FAO concluded that few countries have a framework in place that specifically addresses cell-based food (see also WHO: Food Safety Aspects of Cell-Based Food) and that challenges remain around labeling, data-sharing, and terminology. Following the colloquium, it may well be that the EU’s existing Novel Food Regulation will need to be revised despite the regulators’ initial hesitancy to do so—that is, in particular, as products begin to be authorized in other jurisdictions and the EU has yet to receive an application.

Switzerland: in the starting blocks

Switzerland aims to position itself as a global leader in the development and adoption of cell-based meat. Switzerland has embraced this cutting-edge technology as a potential alternative to conventional meat production. Switzerland’s largest supermarket and most influential retail cooperative recently partnered with an Israeli food-tech start up to develop infrastructure to produce, distribute, and sell cell-based meat on a broad commercial scale in Europe.

Most notably, an application for a cell-based meat product was first submitted in Switzerland, not in the EU. The regulatory oversight for cell-based meat falls under the purview of the Swiss Federal Food Safety and Veterinary Office. Cell-based meat in Switzerland must undergo a rigorous safety assessment before receiving regulatory approval for commercialization. The approval process is expected to take one to three years, so cell-based meat products could be available in Swiss supermarkets as early as 2025.

UK: reform of novel food regulation

In contrast to the EU, the UK is taking more active steps to advance its policy approach to regulating novel food in line with technological change. With reform having been mooted since at least January 2022, Dame Angela McLean, the Government Chief Scientific Advisor, published the Pro-Innovation Regulation of Technologies Review: Life Sciences in May 2023, which confirmed that the UK’s Food Standards Agency (FSA) is reviewing the novel foods regulatory framework.

Following this, and with the endorsement of the UK government, the FSA commissioned a review of the novel foods regulatory framework, commenting on the current challenges of implementing the UK regulations and proposing alternative policy options for regulatory reform. An executive summary of the review reveals that proposals under consideration include conditional authorizations for products with evidence of safe use in other countries, fast-track pathways for innovative applications, and new hybrid authorizations for products that do not fit into existing legislative boundaries. Once again, the UK government has indicated its post-Brexit approach of recognizing the experience and assessment of other trusted regulators.

Running in parallel to the reform agenda, the UK government invested an initial £12 million in a new research center in April, the Cellular Agriculture Manufacturing Hub, with the stated aims of investigating how to manufacture cell-based meat at scale and develop an alternative palm oil via precision fermentation. Regulatory reform and government investment signal the government’s desire to actively promote the UK as an attractive market for innovative food products.The second half of 2023 is likely to bring further developments. Companies considering market access strategies will need to keep a close eye on developments across jurisdictions of interest.

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