This article was written by and contributed by regulatory lawyer Ambika Hiranandani. Note: opinions expressed by CellAgri contributors are their own.
Cell-based foods, often celebrated as the vanguard of sustainable and ethical food production, are transforming the food industry landscape. These products, cultivated from cells in meticulously controlled environments, present innovative solutions to the environmental and ethical issues inherent in conventional animal farming. Nevertheless, such ground-breaking advancements necessitate prudent governance. Ensuring the safety of these novel foods, while simultaneously fostering the sector's development, presents a nuanced challenge for regulatory bodies, requiring a careful balance between oversight and encouragement of innovation.
Cell-based foods are produced by cultivating select animal cells in a sterile environment. While molecularly identical to traditional meat or dairy, they don't originate from whole animals. These foods maintain the nutritional value and taste of meat but reduce its environmental footprint. Studies suggest that using renewable energy in the cultivation process could, within a decade, cut GHG emissions by 17% for chicken, 52% for pork, and 92% for beef. Additionally, land use could decrease by 63% for chicken, 72% for pork, and 95% for beef.
Ensuring the safety and efficacy of cell-based foods is paramount. Not only do we need to ensure that these foods are safe for consumption, but there's also a need to maintain public trust. Furthermore, proper labelling is necessary to inform consumers, ensuring they understand the origins of their food and can make informed choices.
Singapore has emerged as a global leader in the realm of cell-based foods.
The Singapore Food Agency (SFA) was quick to recognize the potential of this technology and instituted a regulatory framework for novel foods. Any cell-based product vying for market share undergoes a rigorous assessment, scrutinizing everything from potential allergens to dietary exposure. It's under this stringent framework that GOOD Meat’s cultured chicken became the first product to gain commercial approval.
Regulations aren't the only aspect where Singapore is making waves. Terminology, for instance, is evolving. The choice of the term "cultured chicken" over "lab-grown" indicates a commitment to clarity.
Approval typically takes 9 to 12 months. The SFA advises applicants to engage with them early in the application journey. Understanding the dynamic nature of the field, they are open to updating regulations as necessary.
Australia and New Zealand's food regulatory system is overseen by Food Standards Australia New Zealand (FSANZ). This body sets standards covering all aspects of food, from its composition to its sale. Companies introducing novel foods must secure FSANZ's approval.
The Novel Foods Standard, which is already established in both countries, governs the regulation of cell-based foods. For clarity, FSANZ has an Application Handbook detailing data requirements for these foods. Part 2 of this standard addresses the sale of novel foods, highlighting specific requirements such as product categorization, branding, and usage conditions.
Safety evaluations for human consumption by FSANZ encompass a range of factors, including the food's origin, processing, and potential adverse effects. These assessments are underpinned by the latest scientific findings. However, the final enforcement is jointly managed by New Zealand and individual Australian territories, allowing them potential influence on approvals for cultivated foods.
FSANZ's guide, "Changing the Code," outlines the application process, likely extending over 14 months for novel food assessments. The Food Ministers Meeting (FMM) in November 2022 confirmed the existing standards' ability to include new cell-based food products.
Vow Foods is notably the first to apply for regulatory clearance for cultivated quail, with a decision expected by May 2024. Companies like Eden Brew are also entering the space, showcasing the sector's growth.
Engaging with FSANZ early, especially with draft applications, is advisable for companies. This early interaction ensures comprehensive feedback and aids in navigating the regulatory landscape.
The intricate tapestry of EU food laws and standards, while aiming for consistency, exhibits both strengths and challenges. Predominantly harmonized at the EU level, these regulations promise uniformity across the 27 member states. However, their effectiveness and efficiency often become points of contention.
At the heart of these regulations lies the goal of consumer protection, emphasizing the free movement of goods. The EU endeavours to strike a balance between fostering innovation and ensuring safety, especially with the incorporation of the precautionary principle. This principle, invoked when scientific evidence is uncertain, though prudent, can sometimes become a bottleneck, stalling potential advancements in food science due to perceived risks.
The General Food Law Regulation (EC No 178/2002) establishes the crucial European Food Safety Authority (EFSA). EFSA’s mandate to assess food safety is clear, but the sheer volume and intricacy of assessments can lead to procedural delays.
The Regulation on Novel Foods (EU No 2015/2283) governs foods without a significant consumption history before 15 May 1997 in the EU. Its broad spectrum covers everything from cultivated foods to certain plant-based foods. However, its authorization process, with its risk assessment and risk management stages, can be cumbersome. As of now, the EU has not received a single application for cell-based foods under this regulation. The balance of power between the European Commission and the Standing Committee for Plants, Animals, Food and Feed (PAFF Committee) in the risk management phase can sometimes translate to protracted debates and decision-making.
EFSA has implemented measures to simplify its application process. This includes conducting webinars to guide potential applicants, with the latest one held in October 2023, focusing on the application framework. EFSA has also opened a channel for applicants to submit queries.
The Dutch government, in a pioneering move, has authorized limited tastings of cultivated meat and seafood ahead of wider EU approval. This landmark decision, rooted in a 2022 motion by the Dutch House of Representatives, paves the way for investors and stakeholders to experience cellular food prototypes first-hand.
Under the aegis of the Netherlands’ National Growth Fund's €60 million commitment to advance cellular agriculture, Cellular Agriculture Netherlands—a body established to actualize the National Growth Fund's vision—will oversee the code of practice's execution. This includes assembling a panel of experts to appraise company requests for cultivated meat and seafood tastings.
The collaborative blueprint, sculpted with industry stalwarts like Meatable, Mosa Meat, and HollandBIO, mandates that approved companies can host up to ten tastings annually, with a cap of 30 participants each. Companies eyeing additional tastings must lodge a fresh application.
The Swiss Federal Food Safety and Veterinary Office is at the helm of regulatory oversight for these innovations, asserting stringent requirements that each cultivated food product must satisfy. These provisions mandate a meticulous safety assessment to be conducted, ensuring the highest standards are met before granting regulatory clearance for market introduction. Given the intricacies and thoroughness of the process, it's projected that the evaluation might span one to three years.
Aleph Farms has applied for approval in Switzerland and reinforcing the nation’s proactive stance, its premier supermarket chain and dominant retail cooperative have solidified a strategic partnership with Aleph Farms. Swiss consumers may witness cultivated meat offerings on their supermarket shelves by 2025. Switzerland seems to have a commitment to charting a legal roadmap that harmonizes innovation with consumer safety.
The United Kingdom is currently undergoing a transformation in its approach to the regulation of novel foods. Post-Brexit, while the immediate framework set by the Food Standards Agency (FSA) has retained the core of Regulation (EU) 2015/2283 on Novel Foods, some divergences are manifesting. The process is rooted in the UK's intent to streamline its regulatory pathway, aligning more closely with its national needs and prioritising both innovation and safety.
The most striking departure from the EU framework is in the final stages of risk management. While the EU employs a comitology procedure engaging the European Commission and all 27 member states, the UK has vested this authority in its government ministers.
At its core, novel foods are those that lacked significant human consumption in the UK or EU prior to 15 May 1997, implying an absence of a 'history of consumption'. In Great Britain, the marketing of such foods aligns with EU Regulation 2015/2283. However, Northern Ireland still adheres strictly to the EU Food Law. Consequently, Northern Ireland's determination of a food product's novelty relies on the European Commission's verdict.
For cultivated foods, the application process is multifaceted. The first part seeks administrative data related to the applicant. The second part delves into the specifics of the novel food, encompassing details about its identity, production, composition, history, and scientific characteristics such as absorption, distribution, metabolism, and allergenicity. Part three demands supplementary documentation like glossaries, certificates, scientific data, and opinions from regulatory bodies. Both the retained EU law Regulation (EC) 2017/2469 and prior guidance from the European Food Safety Authority (EFSA) offer a detailed roadmap for these applications.
The legislative timeline for such an application is segmented. The validation process spans a month, followed by a risk assessment period that can extend up to nine months, factoring in potential pauses for additional data requests. Subsequent risk management deliberations can prolong this by another seven months. Cumulatively, this amounts to a potential 17-month duration from application to authorization. However, the quality of the dossier can influence this timeframe.
Recently, the UK has been considering refining these regulations. The goal is to shed excessive bureaucratic layers, bolster innovation, and simultaneously uphold stringent safety standards. As of November 16, 2023, the Food Safety Agency has overhauled its webpage dedicated to novel foods. This update has streamlined the process for companies, making it simpler for them to access and understand regulations, as well as to apply for approvals. Furthermore, the FSA refers to these novel foods as “cell-cultivated products”.
Israel's emergence as a food tech powerhouse is evident. Spearheading this shift, the National Food Service (NFS) has meticulously crafted a regulatory framework for cell-based foods. In a display of foresight, the Israeli government has bolstered the sector by channelling funds into research, encouraging industry collaborations, and fortifying infrastructure, showcasing a steadfast dedication to this frontier. Notably, for novel foods to secure regulatory clearance in Israel, they must first receive approval from at least two other nations.
In 2019, the U.S. Department of Health and Human Services Food and Drug Administration (FDA) and the U.S. Department of Agriculture Food Safety and Inspection Service (USDA-FSIS) came together to establish regulations for the cultivated foods sector. Both bodies jointly oversee this burgeoning sector.
For cell-cultured foods, the FDA manages cell collection, banking, and growth. The regulatory oversight shifts to USDA-FSIS at the harvest stage, particularly for certain species extending through processing and labelling. When it comes to cultivated milk and most seafood, only the FDA's nod is required.
The premarket consultation process evaluates the safety of food derived from cultured cells on a product-specific basis. This process lets companies collaborate with the FDA, ensuring product safety and addressing potential concerns. While not equivalent to approval, this consultation offers guidance.
In the realm of regulatory landscapes for novel food sectors, the need for more substantial state support is both apparent and urgent, particularly when addressing monumental issues such as food security and sustainability. A cooperative and open dialogue with regulatory authorities is crucial.
Regulators worldwide, including those from the Singapore Food Agency, the Food and Drug Administration in the United States and the Food Safety Authority in the UK, openly encourage early engagement in the application process. This proactive approach serves to demystify regulatory requirements and streamline the approval journey for applicants.
Given the innovative nature of the sector, it's reasonable to expect that the approval process is as rigorous as necessary. For instance, the SFA has developed an extensive handbook detailing compliance requirements, including mandatory tests and the relevant standards to be met during these evaluations. However, the efficiency of Singapore's application process raises questions when, intriguingly, only one company has managed to obtain regulatory approval.
The European Union presents a more complex scenario. In the Netherlands, where the first lab-grown meat burger was developed , companies are now permitted to conduct product tastings, showing a more open stance towards cultivated meats. In stark contrast, Italy has prohibited the production, sale or import of cultivated meat.
Within the EU’s regulatory approval framework, the Standing Committee on Plants, Animals, Food and Feed operates on a basis of consensus, requiring a qualified majority for decisions. This high threshold for agreement and the pursuit of unanimous consent can appear daunting and may explain the hesitancy of companies to apply for approval in the EU despite the presence of several cultivated food companies within its borders.
The UK, post-Brexit, has exhibited a willingness to differentiate its food regulation process from that of the EU, embarking on a path to simplify the approval procedures for novel foods. The power to make the final decision on such applications now resides with government ministers, reflecting a more centralized process.
However, this may become a bottleneck when more applications are made. The country is actively exploring ways to further streamline its regulatory framework to encourage innovation in food technology, with an eye toward national food security and a growing consumer openness to alternative food sources.
The government’s consideration of a bilateral agreement with Israel and the release of funding programs for novel food innovations by Innovate UK exemplify the UK’s commitment to supporting the industry. This movement is underpinned by the recognition that innovation in food production will be crucial to feeding a global population anticipated to reach 10 billion by the middle of the century.
The regulatory landscape in the United States is distinct in its embrace of cultivated meat, with UPSIDE Foods and GOOD Meat standing out as the inaugural companies to secure regulatory approval within this innovative sector. Unlike the UK, which actively incentivizes the field with government grants, the United States propels forward through a vibrant ecosystem of action and innovation largely driven by private enterprise and market dynamics.
In an effort to enhance transparency and facilitate the application process for newcomers, U.S. regulatory bodies make company applications accessible online. This open-book approach streamlines the approval process, setting a clear precedent for others in the industry.
Across the Pacific, the Food Standards Australia New Zealand (FSANZ) pursues a comparable strategy of maintaining open channels with applicants. The region has yet to witness the level of engagement and momentum observed in other countries. The industry awaits to see whether Australia and New Zealand will emerge as significant players in the cultivated meat market. As with any nascent industry, the development trajectory will be one to observe closely.
The onset of cell-based foods has inaugurated a significant paradigm shift in global food production methodologies. Notwithstanding their palpable potential, the actualization of such advantages is inexorably tethered to the formulation and adoption of stringent, universally recognized regulatory parameters.
In traversing this avant-garde terrain, it is paramount that the international community coalesce, exercising meticulous vigilance towards safety protocols and upholding the highest health and safety considerations. The road ahead mandates a judicious blend of collaboration and regulatory fortitude to ensure a sustainable future for this novel food sector.
Ambika Hiranandani is a lawyer with an MPhil in Public Policy from the University of Cambridge. She has experience working with the Good Food Institute, advising cell-cultivated food companies on regulatory policy. She is currently advising Senara, a cell-cultivated milk company.
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