A summary of the conference proceedings
On November 23rd and 24th, 2023, the Regulating the Future of Food conference brought together 120 delegates from 72 different companies and organisations, representing 20 countries worldwide. This first of its kind event, organised by Atova Regulatory Consulting in collaboration with conference partners and sponsors, aimed to facilitate meaningful discussions among key players in the alternative protein/novel food industry. The overarching goal was to consolidate perspectives on current regulatory practices and future needs in the food sector.
The conference aimed to address several key points:
Bridging the gap between innovation and regulation.
Evaluating the current regulatory landscape, including what is working and what pain points exist.
Identifying gaps in regulation and anticipating future challenges.
Exploring potential solutions to enhance regulatory frameworks.
The success of the conference can be attributed to the diverse expertise and experience among the delegates. Participants came from various backgrounds, including regulatory authorities, alternative protein associations, NGOs, universities, scientists, lawyers, consultants, established food businesses, start-ups, and media representatives. Despite their differing roles, all attendees shared a common passion for creating more sustainable food systems.
This diversity of expertise fostered open and meaningful conversations, particularly during the deep-dive workshops held on the second day of the conference. These workshops allowed stakeholders to exchange insights and perspectives, enabling both experts and attendees seeking answers to benefit from the discussions.
The conference served as a pivotal platform for advancing dialogue, collaboration, and innovation in the regulation of the future of food.
All delegates have received an in-depth report detailing the conference proceedings. Here is a summary of the conclusions that were reached from listening to the ten outstanding expert talks, five well moderated and informative panel discussions, and seven deep-dive workshops that were held over the two days.
The conference aimed to address these key themes in terms of current global regulatory frameworks:
· What do we have?
· What is working?
· What are the pain points?
· What are the gaps?
· What are the future challenges?
· What are the solutions?
What do we have?
Collaboration among stakeholders is on the rise, aided by regulatory efforts such as safety reports from bodies like the Food and Agriculture Organisation (FAO). The Netherlands is leading the way in terms of regulatory advancements, including Europe's first tastings protocol and significant funding for cultivated meat. Both the EU and UK are planning updates, with the European Food Safety Authority (EFSA) planning guidance updates for novel foods and the Food Standards Agency (FSA) streamlining authorisation processes and introducing regulatory reforms. Start-ups favour Singapore and the USA as the initial target for regulatory approval due to faster timelines and meaningful pre-submission support. Israel and other Asia-Pacific countries are also progressing in regulatory coordination. However, only Singapore and the Netherlands have formal frameworks for novel food tastings. Sustainability initiatives like the FAIRR-GFI ESG framework and the EU's Corporate Sustainability Reporting Directive (CSRD) highlight the industry's growing emphasis on transparency and sustainability.
What is working?
Collaboration among various stakeholders, including companies, academics, start-ups, and major food producers, has proven crucial in driving momentum and garnering political support for initiatives within the food industry. This collaborative effort, facilitated by trade associations, has been instrumental in advancing industry goals. Pre-submission advice from regulatory bodies such as the Singapore Food Agency, US Food and Drug Administration (FDA), and FSA is mutually beneficial for both the applicant and the risk assessor. Moreover, public facing inventories where dossiers can be accessed and positive lists of approved substances is highly beneficial.
What are the pain points?
The regulatory landscape faces significant challenges, including the absence of pre-submission advice in the EU, unclear frameworks and data requirements, and lengthy approval timelines, leading to uncertainty. Companies' retention of proprietary knowledge internally limits regulators' understanding of novel food production processes, while misinformation about alternative proteins add to the complexity.
Clarity on data requirements for evaluating novel foods is lacking, particularly in Europe, necessitating streamlined processes and better collaboration. Guidance documents are helpful, but the need to be updated frequently and should permit adequate flexibility. Resource constraints within regulatory agencies hinder necessary reforms and proactive horizon scanning. In Japan, the absence of start-ups in the cellular agriculture sector complicates technology adoption.
Transparency regulations and EU requirements, including penalties for non-compliance with the notification of studies can significantly impact the approval timelines in the EU. Addressing these challenges requires stakeholder collaboration, advocacy and regulatory policy reforms, alongside addressing the overarching issue of inadequate funding and resources for key regulatory bodies.
What are the gaps?
The EU grapples with challenges in regulating cultivated meat, including issues with transparency regulations, the absence of a tasting framework, and complex GMO regulations. Regulatory clarity is lacking regarding the classification of cultivated meat/seafood and its alignment with existing food and meat hygiene laws (although this has recently been clarified by a draft guidance document by the European Commission (EC) where they say that cultivated meat is a product of animal origin and falls within existing hygiene legislation). Regulatory harmonisation among countries is lacking, leading to varying requirements and frameworks. The lack of international standards impedes the development of methods ensuring the safety and identity of novel food ingredients.
Specific gaps in regulating cultivated meat include insufficient public data, legislation, and detailed guidelines, necessitating urgent attention for industry advancement. Challenges extend to understanding the long-term effects of growth media components on human nutrition and the absence of standardised methods for allergenicity testing and analysis of novel proteins. Collaboration across laboratories and industries is pivotal to standardise tests, bridge validation gaps, and foster industry collaboration.
Furthermore, the absence of a legal definition of sustainability complicates its incorporation into regulatory assessments, given its multifaceted nature encompassing environmental, social, and economic impacts. Addressing these challenges demands regulatory reform, collaborative efforts, research, and educational initiatives to ensure effective and comprehensive regulation in the cultivated meat sector.
What are the future challenges?
Concerns loom over potential setbacks to sustainability frameworks due to the upcoming EU election, which may impact initiatives like the farm-to-fork strategy. Insufficient public funding for cultivated meat and other alternative proteins raises doubts about long-term corporate support from venture capital and funds. Moreover, challenges persist regarding political and public acceptance of cultivated meat, often perceived as a direct replacement for traditional meat.
Regulatory uncertainties, particularly surrounding genetically modified foods, hinder progress despite growing urgency for sustainable food solutions amidst climate change. Complexities in mutual recognition and nomenclature pose additional hurdles, necessitating collaborative efforts, regulatory clarity, and a focus on inclusivity and sustainability in the food industry.
What are the solutions?
Harmonising regulations across markets is crucial for streamlined processes and market access. Collaborative efforts among stakeholders are key to developing comprehensive regulatory frameworks. Pre-submission advice is essential for saving resources and ensuring compliance, while mutual recognition agreements can expedite approvals while safeguarding data integrity.
Utilising alternative testing methods like omics can enhance food safety assessments. Establishing a framework for tastings is necessary for start-ups to showcase products. Clear standards for substantiating sustainability claims are crucial for attracting investment, labelling and consumer acceptance.
More detailed guidance documents and regular updates would maintain regulatory efficiency. Streamlining the regulatory framework in the UK and the introduction of regulatory reforms could set the standard for other regulators to follow.
To mitigate regulatory risks, understanding key pressure points and stakeholders is essential. Strategic partnerships and lobbying efforts can help gain political influence, while stakeholder mapping guides resource allocation. Lobbying for increased funding and resources for regulatory authorities is crucial to keep pace with innovation. Global strategic planning is vital for companies entering new markets, considering factors like regulatory ease and market potential
Collaboration across sectors and science-driven public education facilitate consumer acceptance by addressing taste, texture, and price concerns. Education and understanding consumer needs are crucial, with respectful engagement with the agriculture industry and farmers. Openness and transparency in communication, along with collaboration with stakeholders will ensure a fair transition and an inclusive food system. Adapting terminology and messaging for different audiences fosters understanding and acceptance, facilitated by effective communication led by influencers and champions. Using the term ‘complimentary’ instead of ‘alternative’ for new proteins could be key to helping public acceptance, removing the threat from concerns of one-for-one replacement.
Engaging an experienced regulatory consultant is crucial for navigating the regulatory path effectively. Familiarising oneself with published opinions and guidance documents is essential for compliance and success. When seeking advice from regulators, presenting a clear list of asks and a well-prepared regulatory strategy is important. Having a quality assurance person or regulatory specialist onboard can be highly beneficial. Applicants should not underestimate regulatory complexity and should strive for a thorough understanding. Conducting thorough research and preparation before engaging with regulators is crucial. Emphasising clear and realistic points for discussion rather than expecting regulators to provide all answers is key. The quality of the data and dossier submitted significantly impacts the timeline, highlighting the importance of meticulous preparation and attention to detail from the start.
Although there are many hurdles to jump, and future concerns, the solutions identified are within reach and we are hopeful that governments globally are heading in the right direction, and that the industry has a strong enough voice to make the necessary changes. It is an exciting time to be part of the novel food industry!
We thank all of those who took part in the conference with special thanks to all the expert speakers and conference partners.
Save the date for Regulating the Future of Food 2024!
We are excited to announce that we will be bringing The Regulating the Future of Food Conference back for another instalment in collaboration with Vireo Advisors!
This year, we will be holding the conference at the Rai in Amsterdam on 23rd and 24th October and will be co-located with the fantastic Future of Protein Production Conference.
More information coming very soon!
Pre-register here for updates and early-bird access to tickets
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