Atova's August Regulatory Roundup!
✨ Welcome to the August 2026 edition of the Atova Regulatory Roundup! We hope you have had the chance to enjoy your summer. We are heading into an exciting and busy period at Atova, with plenty happening both within our team and across the wider regulatory landscape. In the months ahead we’ll be bringing you the next instalment of our Navigating Novel Foods webinar series, sharing insights from our team through a new series of articles, and connecting with the industry at events around the world. Alongside this, we’ve rounded up the latest regulatory news and developments from the UK, EU, US and beyond to keep you up to date and navigating the world of novel food regulation with confidence. 🌱
We are kicking things off in September with the next instalment of our Navigating Novel Foods masterclass series, before heading into a packed few months of events across Europe and beyond. There’s lots to look forward to, and we hope to see many of you along the way!
Registration is now open for Part 3 of our Navigating Novel Foods: EU Dossier Masterclass series!
Following on from our first two sessions, part 3 will take a closer look at some of the key sections of the EU Novel Food dossier, including compositional information, specifications, history of use, proposed uses and anticipated intake, and nutritional information sections of the dossier.
Taking place on Thursday 17th September at 15:00 (CEST) with Regulatory Scientist, Sarah Harrison, this practical one-hour session will offer insights that go beyond the guidance documents, with expert tips to help you avoid common pitfalls, strengthen your dossier and minimise unnecessary clock-stops. Whether you’re preparing your first novel food application or refining an existing submission, you’ll come away with practical take-home messages to help you prepare your dossier with greater confidence and avoid common delays.
The session will also include a live Q&A with Sarah and Dr Hannah Lester, giving you the opportunity to put your most pressing questions to our experts and benefit from their hands-on experience.
Haven’t registered yet? There’s still time to secure your place! We’d be delighted to have you join us for the next session in the series.
Introducing Atova Insights: Navigating EU Novel Food Confidentiality
We’re excited to launch Atova Insights, a new series sharing practical regulatory perspectives, expert tips and insights from our team. To kick things off, Evangelia Padenoglou, Regulatory Scientist at Atova, explores how to navigate confidentiality requirements when preparing an EU novel food dossier.
Confidentiality is no longer something to leave until the end of the process. Drawing on her previous experience in EFSA’s Legal Affairs team, Evangelia shares seven practical steps, common pitfalls to avoid and a useful checklist to help applicants plan ahead, protect confidential information and minimise avoidable delays.
Read the first Atova Insights article and discover Evangelia’s tips for getting confidentiality right from the start.
New publication co-authored by the Atova team
We’re excited to share a new publication co-authored by Fernando Rivero Pino, Hannah Lester of Atova, along with colleagues from Zya and Anthem Biosciences Limited. This publication presents the toxicological evaluation of Convero® a recombinant inulosucrase produced by Zya through precision fermentation. The study combines internationally recognised in vitro genotoxicity assays and a 28-day repeated-dose oral toxicity study in rats, providing a robust safety dataset to support the use of Convero® in food. The findings showed no evidence of genotoxicity or treatment-related adverse effects, contributing to the growing body of evidence supporting the safety assessment of precision fermentation-derived food ingredients.
📄 Read the article here.
Where team Atova are heading next
The months ahead are shaping up to be a busy and exciting time for Team Atova, with our experts attending and contributing to a number of leading industry events across the World. From alternative proteins and cellular agriculture to the wider future of food, these events are a great opportunity to exchange ideas, share our regulatory expertise and connect with others shaping the industry. If you’re attending any of these events, we’d love to connect with you!
Future Food Tech | London | 24-25 September
Hannah Lester will be heading to London for Future Food- Tech event in September. Bringing together innovators, investors, food industry leaders and technology pioneers, the event offers a great opportunity to catch up with the latest developments shaping the future of food.
Navigating the Feed and Food Regulatory Landscape | Barcelona | 29-30 September
Hannah will then be back in Barcelona for the Navigating the Feed and Food Regulatory Landscape conference. This event is set to bring together human and animal nutrition professionals for discussions on evolving policy landscapes, market access and regulatory trends.
LIKE-A-PRO | San Sebastián | 30 September – 1 October
Hannes Malfroy and Hannah Lester will be joining an expert panel at the LIKE-A-PRO event to discuss regulatory and safety pathways for alternative proteins. The discussion will explore how regulatory frameworks can support and accelerate the transition towards sustainable, scalable and widely accepted alternative proteins.
Foodtech Co-Creation Seminar | Japan | 8 October
Hannah will then be heading to Japan to speak at the Foodtech Co-Creation Seminar with Hokkaido’s Food Industry in Sapporo. The seminar will explore the current landscape for cultivated foods and precision fermentation, as well as opportunities for collaboration with Hokkaido’s food industry, including approaches to intellectual property and protecting producers’ rights. Organised by the Hokkaido Bureau of Economy, Trade and Industry (METI) and the Japan Association for Cellular Agriculture (JACA), the event will bring together experts from across the foodtech and regulatory landscape. Hannah will join Dr Joshua Ravenhill (FSA), Kimberly Ong (Vireo Advisors), and David Ettinger (Keller and Heckman) for a panel discussion on ‘Overview of Policy and Technology Trends in the Foodtech Sector Overseas’.
Japan Cell-Ag-Ready | Japan | 9 October
From Sapporo, Hannah will make her way to Tokyo to speak at the Japan Cell-Ag Ready Dialogue. The event will bring together regulatory scientists and experts from Korea, China, Europe, the US and Japan to share the latest developments in the safety assessment and industrial development of cultivated foods, as well as discuss how these emerging technologies can be effectively communicated.
Hannah will join Dr Satoshi Kitajima, Kimberly Ong, and Ryan Simon for a panel discussion on ‘Latest Discussions on Food Safety’, exploring some of the key regulatory and safety considerations shaping the cultivated food sector.
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. As part of SIAW, Hannah will be attending the Asia-Pacific Agri-Food conference which will focus on discussions examining how AI‑first R&D and biomanufacturing are reshaping agtech and foodtech innovation ecosystems.
The Future of Protein Production | Amsterdam | 4–5 November
Rounding off a busy few months, Hannah Lester will be taking to the stage at the Future of Protein Production conference x Cultured Meat Symposium in Amsterdam. Hannah will be speaking on day two of the conference alongside Marnie Hewat, Valeria Teloni, Nicolas Morin-Forest and Stoffer Loman where they will share their experiences navigating the European approval pathway. The discussion will explore what it really takes to prepare for an EU novel food application, from safety data and scientific validation to EFSA expectations, regulatory strategy, and the practical realities of submission.
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
Novel Food Dossier and Traditional Food Notifications Received
The European Food Safety Authority (EFSA) received three novel food applications in August:
Name of Product | Dossier Received by EFSA |
Omega-3 phospholipids from fish oils | 06/08/2026 |
04/08/2026 | |
04/08/2026 |
Validated Dossiers
There were three validated dossiers published on Open EFSA in August.
Name of Product | Dossier Received by EFSA | Validated | Time until withdrawal |
23/07/2025 | 19/08/2026 | 13 months | |
10/02/2026 | 05/08/2026 | 5.5 months | |
29/04/2026 | 05/08/2026 | 3.5 months |
EFSA Public Consultations
Two novel food public consultations closed in August which received no comments, while three further consultations are due to close in September:
Application for authorisation of Ubiquinol acetate as a novel food (07/08/2026)
Application for a modification of the authorised 2’-Fucosyllactose (2’-FL) as a novel food (13/08/2026)
Application for a modification of the authorised 6'-Sialyllactose (6'-SL) sodium salt as a novel food (11/09/2026)
Application for authorisation of Gamma -Aminobutyric acid as a novel food (15/09/2026)
Application for authorisation of Human-equivalent lactoferrin alpha (heqLFα) as a novel food (17/09/2026)
There were also two other public consultations on different EFSA scientific opinions and draft guidance documents with deadlines in August. These were:
EFSA Scientific and Technical Assistance Request
A request to EFSA for scientific and technical support has been submitted on the use of Precautionary Allergen Labelling (PAL). The mandate was received on 22/07/2026 and accepted on 29/07/2026, with a deadline placed for 31/07/2028. Read the mandate here.
EFSA Working Group and NDA Panel Plenary Meetings
The agenda from the 170th Panel Plenary meeting of the Scientific Panel on Nutrition, Novel foods and Food Allergens is available online. This meeting was held on the 31st August, where the draft opinions of Locusta migratoria, isolated Cannabidiol (CBD), Cannabis sativa L. extract, Synthetic cannabidiol, and powdered Xanthobacter sp. were all submitted for discussion. The agenda is available here.
The 23rd Plenary Meeting of EFSA’s Panel on Food Enzymes (FEZ) will take place from 6–8 October 2026. Registration is now open for those wishing to observe the meeting, either onsite or online. The deadline to register as an onsite observer is 23 September at 12:00 CEST, while those wishing to attend online must register by 29 September 2026.
Find out more about registration here and view the draft agenda.
European Commission Updates
Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) Meetings
The summary report from the June Novel Food and Toxicological Safety meeting is now available. This includes feedback from the meetings of food contact materials, contaminants, veterinary medicinal products, food improvement agents, and novel food working groups. The summary is available here. The next meeting is scheduled for 25th September.
Article 4 Novel Food Consultations
The outcome of an Article 4 novel food consultation concerning controlled lactic acid fermentation system applied to whole-banana fractions has been published. This consultation, submitted to the Portugal Ministry of Agriculture, Directorate-General for Food and Veterinary, concerns foods obtained by applying a controlled lactic acid fermentation process of different anatomical fractions of banana (Musa spp.) using a defined three-strain starter culture: Lactiplantibacillus plantarum, Levilactobacillus brevis, and Saccharomyces boulardii.
The banana fractions considered include peel, pulp, green banana fractions and banana blossom with the resulting products including:
A dehydrated fermented banana snack produced from fermented overripe banana peel and pulp, and hydrothermally processed green banana groats
A non-alcoholic fermented banana beverage from overripe banana pulp
A dried fermented banana blossom from the preparation of an infusion
Conclusion:
✅ Not Novel - Banana pulp (overripe or green) used in the dehydrated fermented banana snack or the non-alcoholic fermented banana beverage
❌ Novel Food - Banana peel used in the dehydrated fermented banana snack
❌ Novel Food - Dried fermented banana blossom for the preparation of an infusion
Importantly, for the dehydrated fermented banana snack, banana pulp is not novel, while banana peel is. The consultation concluded that banana pulp and the three-strain culture have a history of consumption within the European Union before 15 May 1997. However, the banana peel and banana blossom have not been consumed to a significant degree within the Union before this date.
It also reiterates an important principle: fermentation of a non-novel food using non-novel microorganisms as part of a conventional food fermentation process would not be generally expected to result in a novel food. An interesting example of how different parts of the same plant can have different novel food status, highlighting the importance of considering the specific plant part, its history of consumption and, where relevant, the processing applied.
European Commission Scoping Paper
The European Commission’s Group of Chief Scientific Advisors and European Group on Ethics in Science and New Technologies have published a scoping paper examining the scientific, ethical and societal considerations surrounding ultra-processed food (UPF) consumption. The paper outlines current evidence on potential health, environmental and social impacts, considers the challenges around defining and classifying UPFs, and reviews the existing EU policy landscape. The groups will now develop scientific and ethical advice to help inform potential future EU policy, with their Opinions expected in the first quarter of 2027. Read the paper here.
EU begins implementation work for the new NGT Regulation
On 31 August 2026, the European Commission opened a call for evidence concerning delegated and implementing legislation required under Regulation (EU) 2026/1388 on new genomic techniques (NGTs). The implementing measures will establish information requirements and procedures for determining Category 1 NGT status and for applications relating to Category 2 NGT plants and products. The NGT Regulation is scheduled to apply from 17 July 2028. This is strategically important because the focus is now shifting from political agreement on NGTs to the practical regulation companies will need to navigate. Read more here.
FSA Board Meeting
You can now watch the latest FSA Board Meeting here. The next FSA Board meeting is due to be held on 16 September 2026; there is currently no agenda available.
Precision fermentation and cultivated foods continue to be discussed at the Advisory Committee on Novel Foods and Processes (ACNFP)
On 21st August, the ACNFP published the agenda for its September meeting, showing that its pipeline includes applications involving precision fermentation and cell-cultivated products, alongside CBD and other novel foods.
The ACNFP's annual report, published 25th August, provides another useful indicator of regulatory activity: the Committee reported reviewing or advising on 27 novel-food dossiers during 2025/26, including precision fermentation and the first two cell-cultivated product applications progressing in Great Britain.
FSA Traditional Food Consultation Launched
From 6th August to 2nd September the FSA put out a consultation for stakeholder views, comments and feedback on a new authorisation of dried kenari nuts (Canarium indicum L.). This notification was submitted to the FSA for authorisation in Great Britain in June 2025. Following on from this consultation the FSA will write to ministers in England and Wales regarding the terms of authorisation and labelling of the product, before it is placed on the market. In Scotland, the FSS will also write to their minister regarding its authorisation and labelling before market placement. This process will take into account the risk management recommendations and any relevant provisions of assimilated law raised during the consultation process. Read more here.
FDA proposes major changes to the US GRAS framework
On 11 August 2026, the US Food and Drug Administration (FDA) published a proposed rule that would significantly change the Generally Recognized as Safe (GRAS) pathway in the United States.
The most significant proposed change is the introduction of mandatory GRAS notification. Under the current framework, companies can independently conclude that the use of an ingredient is GRAS and place it on the US market without notifying FDA. If the proposed rule is finalised, the ability to rely on an independent GRAS conclusion without notifying FDA would, in general, no longer be available for substances introduced into interstate commerce on that basis, subject to the proposed exceptions and transitional provisions. Importantly, FDA is not proposing to abolish GRAS or introduce mandatory pre-market approval. Companies would still be responsible for establishing that the use of a substance is GRAS based on generally available scientific evidence and consensus among qualified experts. However, in most cases, they would be required to notify FDA of that conclusion.
What are the main proposed changes?
The proposal would:
Make GRAS notification mandatory for most substances introduced into interstate commerce on the basis of a GRAS conclusion.
Introduce a streamlined transitional notification process for existing self-GRAS substances that were already in interstate commerce before the final rule becomes effective.
Allow FDA to subsequently request a full GRAS notice or food additive petition for substances submitted through this transitional route.
Increase the potential FDA review period for a full GRAS notice from 270 to up to 360 days, through the introduction of a second potential 90-day extension.
Increase transparency, giving FDA and the public considerably greater visibility over substances currently marketed on the basis of independent GRAS conclusions.
Retain specified exceptions, including certain conditions of use already covered by an FDA no-questions letter, existing GRAS regulations, and other categories expressly identified in the proposed rule.
A particularly important point for industry is that the proposed system remains a notification rather than a pre-market approval procedure.
What does this mean for the food industry?
If finalised, the changes could have significant implications for ingredient manufacturers and food-tech companies. For new ingredients, companies should prepare their GRAS dossiers and conclusions to a standard suitable for submission to FDA. This will need to be factored into regulatory strategy, development costs and timelines much earlier in product development. For companies with existing self-GRAS ingredients, now is a good time to review their regulatory portfolios. Companies should identify which products rely on independent GRAS conclusions, confirm that the underlying safety dossiers remain scientifically robust, and retain clear evidence demonstrating that the relevant substance and conditions of use were in interstate commerce before the eventual effective date. This could also become an increasingly important consideration during regulatory due diligence and M&A activities, where the strength and status of historic self-GRAS determinations may have a direct impact on regulatory risk and product value.
What happens next?
The proposed rule is currently open for public consultation, with comments due by 9 December 2026. FDA will then review the comments before deciding whether and how to proceed with a final rule. There is currently no confirmed date for publication of the final rule. As proposed, the final rule would become effective 60 days after publication. Companies with eligible existing self-GRAS substances would would have a one-year window from the effective date to use the proposed streamlined submission route, while the mandatory notification provisions would have an 18-month compliance date. The final requirements may change following consultation, but companies relying on self-GRAS determinations should already be considering how the proposal could affect their US regulatory strategy.
Atova will continue to monitor the development of the rule and its implications for innovative food ingredients and food-tech companies operating in the US market.
US-GRAS Updates
There have been 20 GRN’s posted on the inventory in August.
GRAS 1336 - Lactiplantibacillus plantarum CGMCC 13008
GRAS 1335 - Maltogenic amylase enzyme preparation produced by Escherichia coli expressing a gene encoding maltogenic amylase from Geobacillus stearothermophilus
GRAS 1334 - Aggregated bovine plasma protein
GRAS 1333 - Maize cob extract
GRAS 1332 - Chymosin enzyme preparation produced by Kluyveromyces lactis expressing a gene encoding chymosin from Bos taurus
GRAS 1331 - Phospholipase A1 enzyme preparation produced by Fusarium commune
GRAS 1330 - Mycodulcein preparation produced by Komagataella phaffii DSM 35637 expressing a gene encoding for mycodulcein from Mattirolomyces terfezioides
GRAS 1329 - Lactase enzyme preparation produced by Aspergillus oryzae
GRAS 1328 - β-carotene produced by Yarrowia lipolytica CGMCC No. 33926 expressing genes from Mucor circinelloides and Y. lipolytica
GRAS 1327 - Bifidobacterium breve GDMCC 62945
GRAS 1326 - 5-D-keto-fructose
GRAS 1325 - L-ergothioneine produced by Escherichia coli “SF4012” expressing enzymes encoded by the genes from E. coli BL21 (DE3), Leishmania infantum, Mycobacterium tuberculosis, Neurospora crassa, Trichoderma reesei, and Mycolicibacterium smegmatis
GRAS 1324 - Pongamia (Millettia pinnata (L.)) bean oil
GRAS 1323 - D-psicose
GRAS 1322 - Transglutaminase enzyme preparation produced by Escherichia coli expressing a gene encoding transglutaminase from Streptomyces mobaraensis
GRAS 1321 - A powder prepared from the dried leaves and stems of the Geraldton waxflower (Chamelaucium uncinatum)
GRAS 1320 - Thaumatin II
GRAS 1319 - Thaumatin II preparation produced by Komagataella phaffii P-THM-354
GRAS 1318 - Enzyme-modified steviol glycosides
GRAS 1317 - Bifidobacterium animalis subsp. lactis CGMCC18610
Canada
Health Canada published two useful non-novel determinations on 5 August:
Sidr (Ziziphus spina-christi) pulp powder; and
VITACEL Citrus Fiber, an insoluble fibre derived from citrus peel.
Both were considered non-novel based on history of safe food use. Find the full list here.
Food Standards Australia New Zealand
New guidance published on GM food and novel DNA definitions
Food businesses and regulators in Australia and New Zealand can now access new guidance on the updated definitions of genetically modified food and novel DNA in the Food Standards Code. The guidance provides practical information and examples to help clarify how the new definitions should be interpreted and applied, following their adoption in September 2025 under Proposal P1055. Read the guidance.
FSANZ Board Meeting
The Food Standards Australia and New Zealand board met on 5th August 2026, with decisions published on 17 August.
Of particular relevance to biotechnology and fermentation-derived food ingredients, the Board approved:
A1338 – triacylglycerol lipase produced using Komagataella phaffii containing a gene from Yarrowia lipolytica, for use as a processing aid; and
A1345 – dextransucrase produced using Bacillus subtilis containing a gene from Streptococcus salivarius, also as a processing aid.
The Board additionally approved chitosan extracted from white button mushrooms (Agaricus bisporus) as a processing aid. The decisions were notified to the Food Ministers' Meeting, which has 60 days to request review before Code variations can take legal effect. Read more here.
Singapore
The Singapore Food Agency has updated their list of approved novel foods to include Aleph Farms´ Cultivated Thin-Cut Steak. This now includes six cultivated products out of the 18 approved novel foods: View the list here.
OECD
Guidance Document for In Vitro Testing of the Intestinal Fate of Orally Ingested Nanomaterials
New guidance provides recommendations for in vitro testing of the intestinal fate of orally ingested nanomaterials, supporting their safety assessment within regulatory frameworks. It covers simulated digestion methods, intestinal barrier models, nanomaterial uptake and translocation, and approaches for data interpretation and reporting. Read the guidance here.
Guidance Document on Toxicokinetics to accommodate Testing of (Nano)particles
New guidance covers in vivo toxicokinetic testing of manufactured (nano)particles following oral and inhalation exposure. It provides recommendations on study design, analytical methods and reporting, with a focus on factors such as dissolution, particle size, agglomeration and biotransformation. Read the guidance here.
Have any questions about how these developments could affect your products or regulatory strategy? Get in touch with the Atova team – we’re here to help you navigate the evolving regulatory landscape with confidence.
Contact us at: info@atovaconsulting.com
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