ATOVA's September 2025 Newsletter! 🍂
- Atova
- Oct 3
- 12 min read
Welcome to the September edition of the Atova Newsletter! We’re delighted to have you with us as we continue exploring the shifting world of food and regulatory innovation. This month, we take a closer look at the latest developments in novel food regulations from around the globe. 🌍
With best wishes
The Atova team 💚🌱
Don’t miss your chance to join us on 29-30 October in Amsterdam for the Regulating the Future of Food Conference!
Make sure you are part of the discussion and join regulators, innovators, scientists, and policy experts for two packed days of talks, panels, and interactive workshops. Be involved in the conversation on shaping the future of food!
Hear directly from the regulators including the European Food Safety Authority (EFSA), Food Standards Agency (FSA), European Commission, Food Standards Australia New Zealand (FSANZ), and Food Safety and Standards Authority of India (FSSAI).
Curious about who’s speaking this year? Check out the full line-up here.
For more information and to secure your place head to our website.
Regulating the Future of Food is kindly sponsored by Labcorp, Vow and Meatable.
The team have had a busy month attending lots of great conferences, highlighting the exciting future of food.
NFX Launch Conference
On the 10th September Regulatory Scientist, Sarah Harrison, attended the NFX UK Launch Conference in London. This event brought together regulators, food innovators, investors, policy makers and researchers for a day of presentations and panel discussions. As a partner of NFX we are excited to have attended this official launch event. Find out more about NFX UK here.
Life Sciences Baltics - Future food: Nourishing the Next Generation
Hannah Lester headed for Lithuania earlier this month for the Life Sciences Baltics Conference. Hannah took to the main stage as part of a panel discussion on the “Future food: Nourishing the Next Generation”. Hannah joined this discussion alongside Dr Mary-Liis Kütt (ÄIO), Galia Reicher (Aleph Farms), Jette Feveile Young (Aarhus University), Anna Handschuh (Ministry of Future Affairs) and Lara Pappers (Coller Foundation) as they debated novel food: is Europe ready to compete or will be left behind?
Food Standards Agency Precision Fermentation Innovation Launch
As part of her trip to London, Hannah attended the launch of the Market Authorisation Innovation Research Programme (IRP) by the Food Standards Agency and Food Standards Scotland.
The IRP is a one-year initiative designed to strengthen the UK food regulators’ capabilities and specialist expertise in regulating innovative food technologies, with a strong focus on precision fermentation. This complements the work of the regulatory sandbox for cell-cultivated products and is supported by funding from the Department for Science, Innovation and Technology Regulatory Innovation Office.
Together, these initiatives represent an important step toward building public confidence, supporting safe innovation, and positioning the UK at the forefront of the future of food. Find out more here.
Future Food-Tech London
Hannah Lester and Marketing Coordinator, Steph Roberts, had a fantastic time at Future Food-Tech London, connecting with founders, investors, and industry leaders who are shaping the future of food.
Hannah also took to the stage for an insightful panel discussion on ‘Redefining Food Standards: Science, Safety, and the Global Regulatory Landscape’, alongside Thomas Vincent from the Food Standards Agency and Andrew Janis from Vow.
A big thank you to everyone who joined our networking drinks, hosted in collaboration with Brian Sylvester from Morrison Foerster, it was wonderful to see so many of you there. We were also proud to partner with Future Food-Tech London this year and look forward to continuing to support innovation and the future of food.
Here we let you know the latest European updates from September 2025, with data retrieved from the European Food Safety Authority (EFSA) and the European Commission (EC).
EFSA Updates
EFSA Revamped Applications Page
EFSA has recently had a revamp of their applications page to help make it more user-friendly. This includes making the guidance documents, databases and tools all available on one page and adding clear step-by-step phases with short explanations for each stage of the process. Explore the new webpages here.
Recent Novel Food Dossier and Traditional Food Notifications Received by EFSA
During September, four novel food dossier submissions were published on Open EFSA.
Modification of use of Chuta® as a novel food (received 03/09/2025)
Quercetine from Dimorphandra mollis Benth as a novel food (received 09/09/2025)
Modification of the authorised 6'-Sialyllactose (6'-SL) sodium salt as a novel food (received 19/09/2025)
2′-fucosyllactose (2′-FL), produced via Kluyveromyces lactis KL-FL-6 fermentation (received 23/09/2025)
EFSA Validated Dossiers
There was one EFSA novel food dossiers validated by EFSA in August.
Application for authorisation of Italian Oyster mushroom (Pleurotus pulmonarius) mycelium co-fermented with Chlorella vulgaris as a novel food
The dossier was originally submitted in 2024 but was deemed not valid because of non-compliance with the transparency regulation and the notification of studies. After a 6-month penalty the dossier was resubmitted and received by EFSA on 28/07/2025 and validated 16/09/2025 (50 days until validation).
Dossiers Considered Non-valid and Withdrawn
There were three dossiers considered non-valid and withdrawn during September.
Name of Product | Dossier Received by EFSA | Declared Not Valid/ Withdrawn | Time until withdrawal | |
17/11/2020 | 29/09/2025 | 59 months | ||
23/10/2023 | 29/09/2025 | 23.5 months | ||
Application for authorisation of β-Nicotinamide mononucleotide (NMN) as a novel food | 11/05/2022 | 29/09/2025 | 41 months |
EFSA Published Opinions
Four EFSA novel food opinions were published on Open EFSA during September.
Name of Product | Dossier Received by EFSA | Validated | Opinion Published | Months until published |
21/09/2021 | 11/10/2022 | 08/09/2025 | 48 months | |
- | - | 08/09/2025 | - | |
20/02/2023 | 26/05/2023 | 15/09/2025 | 31 months | |
19/12/2023 | 12/02/2024 | 25/09/2025 | 21.5 months |
EFSA Public Consultations
There were three novel food public consultations completed in September.
EFSA Working Group Meeting
The 161st NDA Panel Plenary meeting of the Scientific Panel on Nutrition, Novel Foods and Food Allergens was held on the 29-30 September. The agenda for this meeting included draft opinions on safety of modification of use of Chuta, synthetic Cannabidiol, Rhizomucor pusillus fungus biomass, UV-treated oil from yellow mealworm (Tenebrio molitor larvae), safety of egg membrane collagen peptides as a NF, safety of the extension of use of oleoresin from H. pluvialis containing astaxanthin, algal meal of H. pluvialis containing astaxanthin, Tolerable Upper Intake Level for supplemental docosahexaenoic acid (DHA), safety in use of plant preparations containing berberine and the evaluation of the safety in use of hydroxycitric acid and plant preparations containing hydroxycitric acid (HCA). Read the full agenda here.
EFSA workshop on protein safety predictions and speed in risk assessment
EFSA is holding an event on 12-13 November 2025 for stakeholders on protein safety predictions and the acceleration of risk assessment processes. This event aims to raise awareness and determine recommendations and implementation needs in relation to protein safety assessments. A provisional agenda and registration will be available in the coming weeks. For more information here.
European Commission Updates
Article 4 Consultations
The outcome of two Article 4 novel food consultations submitted to the Spanish Agency for Food Safety and Nutrition (ASEAN) were published in September, and included consultations on koji chestnuts and Carrasco pine.
Chestnuts (Castanea sativa) and the fungus Aspergillus Oryzae have a history of consumption in the EU before 15 May 1997. It was determined that the fermentation product had no significant changes in its structure or composition that affect its nutritional value, metabolism or undesirable substance level. The result of this was determined not novel.
History of safe and significant consumption of the seeds before 15 May 1997 was provided for Pinus halepensis. However, no relevant information on the safe and significant consumption of the bark and green pinecones was provided before this date in the European Union. Therefore, the results of this indicate the seeds are not novel food and the green pinecones and bark are determined to be novel food.
PAFF Committee Meetings
Novel food - 19th September agenda
The Standing Committee on Plants, Animals, Food and Feed (PAFF) Section on Novel Food and Toxicological Safety of the Food Chain met on the 19th September. The meeting included discussions on feedback from the Working Group on Contaminants as well as the Working Group on Agricultural Contaminants. Committee members also exchanged views on draft Commission recommendations for monitoring the presence of N-nitrosamines and chlorinated paraffins in food, as well as contaminants present in smoked foods following the use of conventional smoking process. The full agenda is available to read here.
Genetically Modified Food - 15th September agenda
The PAFF Section on Genetically Modified Food and Feed met on the 15th September. The meeting included discussions assessments of genetically modified soybean DBN-09004-6, maize NK603, maize T25, cotton GHB614 x LLCotton25, and cotton T304-40. The committee also discussed several drafts presented for opinions including that for genetically modified maize DAS1131, cotton MON 88913, oil rapeseed MON 88302, soybean MON 87708, and maize MON 87427. The agenda is available to view here.
The agenda for the October meeting is also now available to read. This includes discussion on emergency measures regarding unauthorised genetically modified rice in rice products originating from China, as well as draft opinions on genetically modified sugar beet KWS20-1, maize NK603, and hybrid oilseed rape. This agenda is available here.
Food Standards Agency Board Meeting
The Food Standards Agency held their September board meeting which included discussions on annual local authority performance, annual FSA science update, animal welfare report 2024/25, annual freedom of information requests, external complaints and internal whistleblowing report, report from the director for FSA in Wales and the annual report from the chair of the Audit and Risk Assurance Committee (ARAC). The full agenda is available here.
Market Authorisation Innovation Research Programme
In collaboration with Food Standards Scotland, the Food Standards Agency have launched its Market Authorisation Innovation Research Programme (IRP). This one-year initiative is designed to strengthen the UK food regulators’ capabilities and specialist expertise in regulating innovative food technologies, with a strong focus on precision fermentation. Find out more here.
US FDA
The FDA Expert Panel on Food Allergies will take place on 6th October 2025. Registration is now open for in-person attendance with limited spacing, however virtual attendance via live stream on the FDA’s YouTube channel is also available. Register and find out more here.
On 25th September 2025, the FDA issued a final rule (Docket No. FDA-2011-N-0179) amending its prior notice regulations for imported human and animal food.
This rule has introduced two key requirements:
International mail imports must now include both the name of the mail service and a tracking number. This enables the FDA to coordinate with agencies to track and inspect food items that may pose a risk.
Post-refusal and post-hold submissions must be filed within a defined timeframe after the notice has been issued. This aims to help to reduce port delays for entry and help to minimise submission duplications duplicate submissions.
These updates aim to enhance the FDA’s ability to identify, monitor, and inspect imported foods, whilst helping to streamline industry and government agencies processeses.
The FDA has announced a virtual public meeting on 18th November 2025. This will be followed by listening sessions on 19-20th November, to discuss the role of food allergen thresholds for improving food safety, consumer protection and labelling practices. Presentations will be given on the current food allergen landscape and risk-based threshold concepts. The listening sessions will provide stakeholders with an opportunity to input on:
Approaches to risk-based food allergen thresholds
Potential applications in regulatory and industry practices
Labelling strategies and risk communication
Challenges specific to implementing thresholds in the U.S.
These discussions are expected to inform the FDA’s future approach to food allergen management and the implications for public health and industry. More details are available here.
US GRAS
On 1st October, the FDA has made a new update to the GRAS notice inventory. Besides adding new GRAS notices to the inventory (GRN 1265 to GRN 1279), many of the dossiers and No Questions letters that were pending, have been uploaded. There are many interesting novel foods in this round of updates, including several HiMOs (human milk-identical oligosaccharides), microbial-fermentation products, and a fungal biomass. The GRAS notices include:
GRN 1277: Autoclaved Parabacteroides goldsteinii “RV-01” (Notifier: ReviveBio, Co.)
GRN 1275: 6'-sialyllactose sodium salt (Notifier: Cataya Bio (Shanghai) Co., Ltd)
GRN 1274: 2'-fucosyllactose (2'-FL) (Notifier: Tianjin Hesheng Biotechnology Co., Ltd.)
GRN 1273: Lacto-N-tetraose (Notifier: Shenzhen Long Health Biotechnology Co., Ltd.)
GRN 1272: Lacto-N-tetraose (Notifier: Shenzhen Long Health Biotechnology Co., Ltd.)
GRN 1270: L-ergothioneine produced by Escherichia coli K-12 MG1655 expressing enzymes from Neurospora crassa and Mycolicibacterium smegmatis MC2 155 (Notifier: Gene III Biotechnology Co, Ltd)
GRN 1269: Modified monellin preparation produced by Komagataella phaffii CBS 150005 expressing a gene encoding for a modified monellin (Notifier: Amal Proteins Ltd)
GRN 1268: Mycelial biomass from Rhizomucor pusillus (Notifier: The Protein Brewery B.V)
GRN 1267: Sunflower lecithin (Notifier: Shankar Nutricon)
GRN 1266: Wheat fiber extract from Triricum aestivum (Notifier: Comet Biorefining Corporation)
USDA Cultivated Meat Labelling
The USDA has shifted its proposed rule on labelling meat and poultry products made with animal cell culture technology to its list of “long-term actions.” The rule had previously been slated for publication in December, following the agency’s 2021 advance notice of proposed rulemaking. This change indicates that progress on labelling requirements for cultivated meat is unlikely in the coming year.
Food Standards Australia New Zealand (FSANZ)
In September FSANZ released the AUSNUT 2023, a comprehensive and up-to-date nutrient database. This contains 3,741 foods and 58 nutrients, providing a collection of detailed data about the Australian food supply and offers a robust evidence base to support product development, market and nutrition trend analysis, reformulation and labelling and regulatory compliance. Explore this data base here.
OECD
ToxTracker® Approved by OECD for Incorporation into Test Guideline Programme. ToxTracker is a unique stem cell-based reporter assay for reliable genotoxicity hazard identification and provides an insight into genotoxic mode-of-action. Find out more here.
Canada
Novel Food Determinations
Between July and September, thirteen non-novel determinations for food and food ingredients were published to the Government of Canada. All the thirteen recent submissions showed to have history of safe use as a food. These include:
Sweet lupin (Lupinus albus) flour
Parkia biglobosa seed powder
Holy basil (Ocimum tenuiflorum) leaves
Flowers from butterfly pea (Clitorea ternatea)
Bamboo shoots from various species (Bambusa spp, Dendrocalamus spp, Gigantochloa spp, Phyllostachys spp, Melocanda humilis, Thyrsostachys siamensis, and Nastus elatus)
Rice (Oryza sativa) protein concentrate
Mopane caterpillar (Gonimbrasia belina)
Imbrasia ertli caterpillar
African palm weevil (Rhynchophorus phoenicis) caterpillar.
Baker's yeast (Saccharomyces cerevisiae) protein
Dried spent coffee (Coffea arabica) ground
Bacillus subtilis strain HU58
Kewra water
Read the full list and description here.
Novel food Safety Assessments
There have been two safety assessments of novel foods including genetically modified foods. These safety assessments include:
Singapore
Singapore updates authorisation process for novel foods under FSSA
The Singapore Food Agency (SFA) has briefed industry on the upcoming implementation of Part 5 (“Defined Food and Pre-Market Approval”) of the Food Safety and Security Act (FSSA), passed earlier this year. “Defined Food” covers novel foods, GM foods, and insect-derived foods, all of which remain subject to pre-market approval. What changes is how the authorisation process will be administered. Technical safety requirements remain the same under the existing Requirements for the Safety Assessment of Novel Foods and Novel Food Ingredients, but a new FSSA Authorisation Subsidiary Legislation (SL) will formalise the administrative requirements for applications.
Key changes (effective end of November 2025):
New submission channel: Applications must go through a new authorisations mailbox (replacing the current novel food inbox). The address will be made public soon.
Initial completeness check: Upon submission, a 1-month “information check” will be established for SFA to determine if dossiers are complete. Incomplete submissions will be rejected and returned with feedback.
Application fee: A non-refundable fee will be charged once an application passes the completeness check and moves to full evaluation. The cost has not yet been officially announced.
Local presence required: Applicants must list a Singapore address (directly or via an agent) for formal communication. Day-to-day correspondence will still be conducted by email.
Public register: Approved novel foods will be published in a public list on SFA’s website (no public summaries or dossiers).
What stays the same:
The scientific safety assessment criteria and data requirements.
The evaluation process still allows for clarifications and queries during review. Implications for industry:
The introduction of clearer administrative steps, a formal completeness check, and fees brings Singapore’s framework closer in line with global regulatory practices. Companies planning to enter the Singapore market should prepare for the additional administrative requirements now, particularly the need for a local representative address and early budgeting for fees. The final FSSA Authorisation SL is not yet published but is expected to be released soon. For reference, the FSSA can be found on Singapore Statutes Online.
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