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Atova's June Regulatory Roundup!

  • Writer: Atova
    Atova
  • Jul 8
  • 15 min read

✨ Welcome to the June 2026 edition of the Atova Regulatory Roundup! As we enter the summer months, we’re here to help you stay up to date with the latest news and insights from around the World. Thank you for being part of our community, we hope you enjoy this month's edition 🌱 



June was another exciting and eventful month for Team Atova, with some of the team travelling to conferences across Europe to share expertise and stay at the forefront of developments in the food and regulatory sectors. A particular highlight was the launch of our Navigating Novel Foods: EU Dossier Masterclass webinar series. We were delighted to welcome so many attendees to the first session and look forward to continuing the series in the months ahead.

 

Navigating Novel Foods: EU Dossier Masterclass – Part Two

We’re excited to be holding part two of our Novel Food Dossier Series this month, taking place on Wednesday 29 July at 15:00 (CEST). Following on from part one of our series, this webinar will focus on two important sections of a successful novel food application: Identity and Production Process.

 

In this practical one-hour session, Dr Oana Kubinyecz will share insights into what EFSA looks for when reviewing these key sections, alongside common dossier pitfalls and practical strategies to help strengthen your application. Drawing on Atova's extensive experience supporting novel food submissions, the webinar will explore the challenges applicants frequently encounter during EFSA's risk assessment process and how to avoid them.

 

The session will also include a live Q&A with Oana and Dr Hannah Lester, providing the opportunity to ask questions and gain valuable insights that go beyond the guidance documents.

 

If you haven't already registered, there's still time to secure your place. We look forward to welcoming you for another insightful session in the series. Secure your place here.



We are now proud members of APAC Society for Cellular Agriculture 

We are thrilled to announce that Atova Regulatory Consulting has officially joined the APAC Society for Cellular Agriculture!

 

As cell cultivated foods continue to advance, navigating complex and evolving regulatory pathways remains one of the industry's greatest challenges. We look forward to contributing our expertise in regulatory strategy and scientific advisory while collaborating with policymakers, industry leaders, and fellow members to support the Society’s mission of advancing safe, sustainable, and innovative food technologies across the APAC region.

 

A big thank you to the APAC Society for Cellular Agriculture for welcoming us into the Society. We’re excited to be part of this growing community and look forward to helping shape the future of food together.


The First Cell Farmers Symposium and Official Launch of the RespectFarms Cultivated Meat Farm

On the 4th June, leaders from farming, policy, agritech, food systems, academia, and cellular agriculture gathered in The Hague for the inaugural Cell Farmers Symposium to explore how cellular agriculture can become an integrated part of the future agri-tech ecosystem. The symposium was designed to examine how traditional and cellular agriculture can develop alongside one another, while ensuring that farmers remain at the heart of the conversation. Bringing together stakeholders from across the food value chain, the event provided a valuable forum for discussing collaboration, innovation and the future of food production.


Speaking on "Regulatory Shifts for Future Impact", Atova CEO Hannah Lester highlighted one of the most important factors shaping the future of cultivated meat: regulation. While technological progress continues at pace, regulatory frameworks will ultimately determine how quickly innovations can reach consumers, attract investment and build public trust. These discussions come at a particularly important time for the sector as cultivated meat companies continue to face regulatory uncertainty, differing frameworks across jurisdictions, and increasing pressure to demonstrate commercially viable pathways to scale.


Reflecting on the symposium, Hannah commented:

"It was truly a momentous couple of days. It was so energising to celebrate how far we have come, and how close we are to making this a reality. However, we need to work together more than ever to ensure that cultivated meat gets to market in the EU and is given a fair chance”.


As part of the programme, participants explored how cellular agriculture could complement existing agricultural systems, create new opportunities for farmers, and help ensure that farming remains central to food production as new technologies emerge. This vision was brought to life with the launch of RespectFarms' first cultivated meat farm pilot on a working dairy farm in the Netherlands. Together, these two milestone events demonstrate the importance of collaboration between regulators, farmers, entrepreneurs, scientists and policymakers in creating pathways that are commercially viable, socially accepted and scientifically robust. The symposium concluded with attendees signing a manifesto that expressed their shared commitment to advancing this important conversation and fostering greater cooperation across the sector. Congratulations to everyone involved in the first Cell Farmers Symposium and to RespectFarms' launch of their first cultivated meat farm - such significant milestones for the future of food. 



Proud to support the Bezos Centre for Alternative Proteins Accelerator Programme

We're excited to see the launch of the Sustainable Food Accelerator, led by the Bezos Centre for Sustainable Protein in partnership with Undaunted at Imperial College London. This new programme is designed to help early-stage sustainable food venture bridge the gap between breakthrough science and commercial adoption. It will focus on helping founders generate the technical, commercial and regulatory evidence that makes corporates confident to pilot and investors confident to back. Selected ventures will receive equity-free funding, access to scale-up facilities, regulatory and grant support, and opportunities to engage with corporate partners and investors.

 

The accelerator is looking for companies working on:

  • Cost and scale-up of novel ingredient production

  • Next-generation ingredients delivering improved taste, texture and nutrition

  • Circular economy approaches that transform sidestreams into valuable inputs for sustainable food production

Applications are open on the 13th July 2026, and startups can pre-register their interest now: here.



Where team Atova are heading next

Over the coming months, the Atova team will be sharing insights and expertise at several leading industry events around the world. If you're attending any of these conferences, we'd love to meet you—please come and say hello.

 

LIKE-A-PRO | San Sebastián | 30 September–1 October

Hannes Malfroy will be joining an expert panel at the LIKE-A-PRO event, discussing Regulatory and safety pathways for alternative proteins. The panel discussion will focus around exploring how regulation can help accelerate the transition towards sustainable, scalable and widely accepted alternative proteins.

 

The Future of Protein Production | Amsterdam | 4–5 October

Hannah Lester will be taking part in a fireside chat at the Future of Protein Production conference alongside Marnie Hewat, Valeria Teloni, Nicolas Morin-Forest and Stoffer Loman. During this discussion the panelists will be sharing their experiences of navigating the European approval pathway and examining what today's regulatory landscape means for the future growth of cellular agriculture across Europe.

 

Singapore International Agri-Food Week (SIAW) | Singapore | 26–29 October

Later in October, Hannah will be attending Singapore International Agri-Food Week (SIAW), one of the region's leading agri-food events. Bringing together policymakers, researchers, investors, entrepreneurs, food producers and industry leaders, the conference provides a platform to explore emerging technologies, strengthen food security and climate resilience, and shape the future of food production across Asia and beyond.

 

If you'll be attending any of these events, we'd be delighted to connect and discuss the latest industry developments and regulatory strategy.



EFSA Updates


Dossiers Considered Non-valid and Withdrawn

There were four dossiers withdrawn during June. 

EFSA Published Opinions

There was one novel food opinion that was published in June.

European Food Safety Authority (EFSA) has issued a negative opinion on zinc L-carnosine as a Novel Food, concluding that the ingredient was insufficiently characterised and that neither its safety nor the bioavailability of zinc could be established. What is particularly interesting is that this was not primarily a toxicology issue. The key obstacle was the applicant's inability to adequately address EFSA's concerns regarding the potential presence of small particles, including nanoparticles.


EFSA acknowledged that additional Scanning Electron Microscopy (SEM) data had been generated following a previous negative opinion, but found the dataset inadequate because:

🔹 The SEM methodology did not comply with EFSA's guidance

🔹 Magnification was too low (300×) to reliably assess particles below 500 nm

🔹 The images were not of sufficient quality to distinguish constituent particles from agglomerates/aggregates

🔹 Quantitative analysis was based on a single image and a single replicate sample

🔹 Critical metadata was missing, including information such as pixel size and detection limits

🔹 Original reports and evidence of laboratory accreditation were not provided


As a result, EFSA concluded that the applicant had not demonstrated that less than 10% of particles were below 500 nm, nor had it excluded the presence of a nanoparticle fraction. The applicant also attempted to demonstrate rapid dissolution under gastric conditions, which could potentially alleviate particle-related concerns. However, EFSA found the dissolution and dissociation studies unreliable due to methodological shortcomings, lack of validated analytical approaches, absence of quality assurance documentation, and inconsistencies between the reported dissolution results and the particle imaging data. Because the particle fraction and its fate in gastrointestinal conditions remained uncertain, EFSA considered the available ADME and toxicological evidence unsuitable for establishing safety.


⭐ The key lessons: If a novel food does not convincingly demonstrate adequate dissolution, EFSA expects robust particle characterisation in accordance with the latest EFSA guidance on small particles, including nanoparticles. Weak SEM datasets, non-accredited/validated testing, or poorly designed studies can prevent EFSA from even reaching a positive conclusion.


This opinion is another example of how small particle/nano particle risk assessment has become critical in EU Novel Food risk assessments. Read more here.


EFSA Public Consultations

There were two novel food public consultations that had a deadline in June, both of which received no comments.

There are three other public consultations with deadlines due in July and August. These are:

 

EFSA Working Group Meeting

The agenda from the 169th Panel Plenary meeting of the Scientific Panel on Nutrition, Novel foods and Food Allergens are now available online. This meeting was held on the 1-2nd July, where the draft opinions of Anaerobutyricum soehngenii CH106, Roasted sacha inchi seeds as traditional food, Fusarium species strain flavolapis, Lacto-N-triose II (LNTri II), Cultivated Protein from Xanthobacter sp. SoF1, and S-Acetyl Glutathione were all submitted for discussion. The agenda is available here.


European Commission Updates

 

Article 4 Novel Food Consultations


The outcome of an Article 4 novel food consultation submitted to Italian Ministry of Health has now been published. This consultation concerns a polyphenol-rich extract derived from Vitellaria paradoxa. C.F. Gaertn. (commonly known as the shea tree). The extract is produced from the residual press cake (‘shea cake’), a by-product of shea butter production. This manufacturing process involves milling, homogenisation, and mixing of shea cake, followed by ultrasound-assisted extraction (UAE), percolation extraction, and a final enzymatic treatment using tannase. The resulting dry powdered extract is standardised to contain 18-27% total polyphenols and is intended for primary use as an ingredient in food supplements.

❌ Conclusion: Novel Food - It was concluded that this product was novel. The decision was based on the absence of evidence demonstrating a history of significant consumption of shea cake within the European Union prior to 15 May 1997, as well as insufficient documentation supporting the use of tannase in the production process.


The Protein Brewery receives European Union Novel Food Authorisation

The Protein Brewery has received European Commission authorisation to sell its mycelium ingredient Fermotein in the EU. This decision follows a positive scientific opinion from EFSA in December 2025, as well as a positive vote from the Standing Committee on Plants, Animals, Food and Feed in May 2026 where all 27 EU Member States voted to approve the ingredient. On the 17th June the European Commission formally added Rhizomucor pusillus mycelium to the Union list of authorised novel foods under Regulation (EU) 2015/2283. This is the first novel mycelium biomass ingredient to gain approval under the EU Novel Food framework and marks a huge milestone for the biomass fermentation sector.  

 

Standing Committee on Plants, Animals, Food and Feed Meetings 

 

Novel Food and Toxicology Safety of the Food Chain

The Novel Food and Toxicological Safety of the Food Chain meeting was held on 13th May 2026. The minutes are not currently available, but the agenda is available here.  

 

Genetically Modified Food

The Genetically Modified Food and Feed meeting was held on 10 June 2026. The summary report for this meeting is available now.


Novel Food Approvals

On the 9th June the European Commission (EC) authorised inulin-propionate ester as a novel food for use in the EU after the EFSA concluded that it is safe under the proposed conditions of use. The authorisation process took 8 years and 4 months from application to authorisation. The novel food is authorised for use in cereal bars (17g per 100g max) and fruit smoothies (3g per 100ml max). Data protection was granted to the applicant for batch-to-batch analyses, including quantification of inulin and propionate and in-house analytical methods a duration of 5 years.

 

On the 11th June the regulation authorised rhamnogalacturonan-I enriched carrot extract (cRG-I) as a novel food for use in the European Union. The authorisation process took approximately 3 years and 6 months. It was authorised for use in a wide range of foods including food supplements, foods for special medical purposes (excluding infants and young children), total diet replacement for weight control, meal replacements for weight control (excluding infants and young children) , muesli and similar breakfast cereals, cereal bars, fruit-based drinks and more. Interestingly, the applicant was not permitted to call the ingredient fibre due to the application not assessing whether the ingredient met the legal definition of fibre and therefore, it could be misleading to the consumer. Data protection was granted to the applicant for data on the identity, compositional and toxicological data for 5 years.

 

On the 23rd June the Regulation amended the existing authorisation for Jatropha curcas L. (edible variety) kernels by. These amendments included:

  • Extending the authorised forms of the novel food to include flour and paste (both made from 100% ground kernels).

  • Increasing the maximum permitted use levels in previously authorised food categories.

  • Updating the product specifications, including an expanded fat content range.

  • Granting a new period of data protection for the extended conditions of use

 

This was not the first authorisation as it was originally authorised under Implementing Regulation (EU) 2022/965. This amendment process took around 3 years and 2 months and included new authorised forms - Jatropha curcas L. kernels, kernel flour and kernel paste. There was an updated maximum use levels which went from the previous 5g per 100g limit to 30g per 100g limit in cereal bars, breakfast cereals, and dried fruit. Additional authorised food categories include nuts/seeds paste or emulsion and dried nuts/seeds flour or powder. Data protection was granted for this novel food for 5 years.

 

AESAN publishes new guidance documents

The Spanish Food Safety and Nutrition Agency (AESAN) have recently released several new guidance documents including those on novel food assessments, food supplements, foods for Special Medical Purposes (FSMPs), and consumer information and voluntary claims. The publications provide clarification on topics such as the recent Court of Justice for the European Union (CJEU) ruling on FSMP labelling, procedures for assessing suspected Novel Foods, updates on interpretations relating to food supplements, criteria for nutritional descriptors for FSMP, and the conditions for using the voluntary claim "No sources of fructose".

 

Although these documents don’t introduce new legal requirements, they offer valuable insight into how the Spanish authorities interpret and apply the existing regulatory framework. Businesses marketing products in Spain may wish to review the guidance, as it could impact labelling, product development, and regulatory compliance strategies.


Commission updates the protein-related compositional requirements for infant and follow-on formula manufactured from protein hydrolysates

Commission Delegated Regulation (EU) 2026/743 amends Delegated Regulation (EU) 2016/127 by updating the protein-related compositional requirements for infant and follow-on formula manufactured from protein hydrolysates. The amendment follows a 2025 scientific opinion by the European Food Safety Authority (EFSA), which concluded that a new specific protein hydrolysate developed by Healthcare Reckitt B.V. is nutritionally safe and suitable for use in infant and follow-on formula, provided the formula contains at least 0.55 g of protein per 100 kJ (2.3 g/100 kcal) and complies with the existing amino acid and compositional requirements. To reflect this assessment, the Regulation introduces a new "Protein-related requirements group F" into Annexes I and II, specifying the permitted protein source, processing method, minimum protein content, and amino acid requirements for formulas using this hydrolysate. The amendment enables the marketing of formulas manufactured with this newly authorised protein hydrolysate while maintaining EFSA's safety and nutritional standards, and entered into force 20 days after its publication in the Official Journal of the European Union. Find out more here.


European Parliament vote on plants obtained by NGTs proposal

The European Parliament has voted to advance the proposal for new rules governing plants developed using New Genomic Techniques (NGTs), marking a significant milestone in the EU legislative process. This development reflects a broader global trend over recent years, with major jurisdictions updating their regulatory frameworks to incorporate advances in genetic science and moving away from technique-based classifications. The proposed legislation seeks to establish a more proportionate regulatory approach for certain NGT plants, fostering innovation in plant breeding that can support more sustainable agricultural production and food security, while maintaining the EU's existing standards for human health and environmental protection.

 

The proposal introduces a two-tier regulatory framework, distinguishing NGT-1 plants, considered equivalent to conventionally bred varieties, from NGT-2 plants with more complex genetic modifications. While NGT-1 plants would benefit from a streamlined regulatory pathway, NGT2 plants would continue to be subject to GMO authorisation, traceability, and labelling requirements, with Member States retaining the ability to restrict cultivation within their territories. This framework presents both opportunities and challenges for innovators, offering a more enabling environment for certain products while creating a more complex compliance landscape that may require tailored global regulatory strategies across product categories and markets. Find out more here.


FSA Board Meeting 

The latest FSA Board meeting was held on 17 June 2026. The agenda and papers are available here.

 

The 177th Meeting of the Advisory Committee on Novel Foods and Processes (ACNFP) was held on 17th June 2026. This included discussions on Human-equivalent Lactoferrin Alpha RP2296, Draft cell-cultivated products guidance: Toxicology and growth media hazard guidance, Cell-cultivated duck RP2241, CBD - Group C RP450, and CBD new group A RP1291. The agenda for this meeting is available here.


The FSA website is moving

FSA's website has moved over to the GOV.UK platform with the aim to improve accessibility and convenience for the public whilst meeting the evolving needs of their user base, reduce costs and enhance security. The FSA will however continue to be an independent, non-ministerial department and regulator with the majority of their old website content being moved to their new online home. Here is where you can access their new website.

 

Top emerging UK food innovations summary

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have published a new information note highlighting the top emerging food innovations expected to shape the UK food system between 2025 and 2035. The report focuses on areas such as precision and biomass fermentation, cell-cultivated products, controlled environment agriculture, edible insects, molecular farming, and other food technologies, while explaining how these innovations are likely to progress over the next decade. It also sets out the regulatory pathways that will help ensure any new products entering the market meet robust food safety standards. Alongside this, the FSA and FSS are continuing to invest in guidance, regulatory support, and collaboration with industry to encourage responsible innovation, giving businesses greater clarity on market authorisation requirements while maintaining consumer confidence and protecting public health. Find out more here.



FDA Updates

On 27th 2026, the FDA published a scientific evaluation of phthalates authorised for use as plasticizers to assess whether they should be classified as chemically or pharmacologically related (CPR) substances for inclusion in a future cumulative risk assessment. Based on its evaluation, the FDA proposed grouping four phthalates—DEHP, DCHP, DIOP, and DINP—as CPR substances. The agency has extended the public comment period by 30 days, and comments will now be accepted through July 26, 2026. Find out more here.


Australia/New Zealand

Calls are open for comments on cell-cultured duck (Anas platyrhynchos domesticus) biomass by Food Standards Australia New Zealand (FSANZ). The application seeks approval for cell-cultured duck biomass produced from embryonic stem cells from Anas platyrhynchos domesticus (Pekin duck) to be used in combination with other ingredients to produce foods such as cultivated foie gras and pâté. The public consultation closes on 22 July 2026. Find out more here.

 

FAO 

The Food and Agriculture Organization (FAO) has published a new open-access review examining how foodborne microorganisms, antimicrobial resistance genes (ARGs), and other food-derived substances may influence antimicrobial resistance (AMR) dynamics in the human gut microbiome. The review brings together current scientific evidence to improve understanding of AMR transmission pathways, support future research priorities, and inform strategies to reduce AMR risks while protecting public health, food security, and sustainable agrifood systems.

 

During Rome Nutrition Week 2026, an event at FAO headquarters brought together representatives from governments, academia, industry, civil society and international organisations to discuss the potential role of precision fermentation in food security and nutrition. Discussions explored opportunities to enhance nutritional quality and support more sustainable food systems, while also highlighting the importance of robust safety assessments, effective governance, feasibility, accessibility and public confidence. Participants concluded that the successful application of precision fermentation will depend on a combination of technological innovation, appropriate regulatory frameworks and continued international collaboration.


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