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ATOVA's March Newsletter!

  • Writer: Atova
    Atova
  • 6 days ago
  • 16 min read

✨ Welcome to the March 2026 edition of the Atova Newsletter! As spring begins to bloom, we’re excited to continue exploring the ever-evolving global landscape of novel food regulation. Thank you for being an essential part of our community, and we look forward to continuing to share insights and guidance to help you stay informed throughout 2026. 🌱



We’re excited to share the latest news from Atova! You’re the first to hear that we’re launching a series of free webinars, starting with our Navigating Novel Foods series – be sure to secure your spot! Our team has also been busy attending conferences and engaging with innovators and regulators across Europe at the EPIC-SHIFT General Assembly, connecting and collaborating on the latest developments in the field.  

 

Be the first to know: We’re launching free Atova Webinars! 


Navigating Novel Foods: EU Dossier Masterclass 

Navigating the EU novel food framework can be challenging! Join us on 27th May at 15:00 (CEST), as we kick off our four-part series designed to help you confidently navigate the regulatory landscape and build a successful novel food dossier from the ground up.  

 

In this first session, we’ll lay the foundations to give you a clear roadmap of what it takes to create a robust, compliant, and EFSA-ready submission, covering the key tools and guidance documents you need to use. Whether you’re at the early stages or refining your approach, you’ll walk away with practical insights you can apply immediately.  

 

This session will be led by regulatory and novel food specialist, Hannes Malfroy, who will take you beyond the theory. You’ll gain real-world tips, expert perspectives, and proven strategies drawn from successful submissions – helping you understand not just what to do, but how to do it effectively. This isn’t just about reading the guidance documents; it’s about sharing tricks and tips on what actually works to help you build a robust and compliant dossier to smooth your path to approval.   

 

What to expect:  

  • Introduction to the guidance and tools   

  • Overview of the novel food dossier structure  

  • Practical advice to strengthen your submission  

  • Expert insights from professionals with hands-on experience  

  • A live Q&A with Hannes and Atova CEO, Hannah Lester – your chance to ask your most pressing dossier questions  

 

Secure your free spot today and take the first step towards a successful submission. Sign up here. 



EPIC-SHIFT

On 24-25th March, the EPIC-SHIFT consortium gathered in Barcelona for its second General Assembly. The two-day meeting brought together partners from across Europe to review project progress, exchange insights, and prepare for the upcoming mid-point milestone. Atova Regulatory Affairs Specialist, Caroline Idowu, attended the assembly representing Atova, contributing to discussions and engagement activities focused on collaboration and stakeholder engagement.  

 

Atova Regulatory Consulting is proud to support this horizon-funded project through its regulatory expertise, contributing insights on the EU novel food framework, global developments, and market access considerations.  



Alimentaria Barcelona

On 25th March, Fernando Rivero Pino took to the stage at Alimentaria Barcelona 2026 as part of a roundtable discussion on the real impact and challenges of implementing sandbox initiatives within the agri-food sector. Fernando was joined on stage by Patricia Larráyoz (CNTA), Cristina Garrido Garcia (CNTA), Gloria Cugat (Generalitat de Catalunya), and Pablo Hernández Bravo 🚀 (Sigma).  The discussion highlighted the importance of strong collaboration between regulators and innovators, and how sandbox environments can enhance transparency while supporting the sector’s development. By enabling companies to test solutions, reduce uncertainty, and build robust evidence in a controlled environment, sandboxes are increasingly being seen as a valuable tool. 



Spain’s AgriFoodtech Sandbox  

Atova has recently participated in Spain’s AgriFoodtech Sandbox, an initiative aimed at accelerating innovation in the agri-food sector, which was managed by EATEX Food Innovation Hub by CNTA in 2025. Within this framework, Atova played a key role in coordinating and overseeing regulatory compliance, ensuring that innovative projects could be developed and tested within a controlled and compliant environment. 

 Among the supported projects, one involved the tasting of a novel food not yet authorised in the EU. This activity was successfully carried out under the strict Sandbox conditions, demonstrating how regulatory pathways can be navigated safely and responsibly to enable real-world testing of innovative products. 

 Another project focused on assessing the novel food status of a product obtained through further processing compared to its traditional production method. Atova provided regulatory guidance to determine whether these modifications could impact its classification under the Novel Food Regulation, supporting the development of a clear and robust regulatory strategy. 

 Through its involvement in Spain’s AgriFoodrech Sandbox, Atova reinforces its commitment to bridging innovation and regulation, facilitating the safe and efficient advancement of novel food solutions in Europe. 

 

Spanish Agrifoodtech Sandbox Officially Open For Second Round

The 2026 call for projects of the Spanish AgriFoodTech Sandbox is now officially open, offering a unique opportunity for innovators to test and advance pioneering food solutions within a supportive regulatory environment. The call will remain open until 30 April 2026, and companies established across the European Union are eligible to participate in this edition. 

The Sandbox is designed for projects that require close interaction with regulators, particularly those involving: 

  • Experimentation with products or ingredients not yet authorised 

  • Assessment of processes or practices with unclear regulatory pathways 

  • Generation of robust technical and scientific data to support evaluation or authorisation 

  • Access to regulatory insights critical for scaling and market entry decisions 

This initiative provides a controlled framework where companies can de-risk innovation, validate their approaches, and accelerate their route to market while ensuring compliance with EU standards.  

 

Find out more and apply here.



EFSA Updates

 

Validated Dossiers

There were three validated dossiers published on Open EFSA in March.


Dossiers Considered Non-valid and Withdrawn

There were eight dossiers considered non-valid due to non-compliance with the Transparency Regulation and the notification of studies or withdrawn during March.  


EFSA Published Opinions

Two EFSA novel food opinion was published on Open EFSA during March.


EFSA Public Consultations

There were two novel food public consultations completed in March, both of which had no comments received. 

 

There are five novel food public consultations with deadlines due in April. These are: 

 

There are also four other public consultations with deadlines due in April and May. These are: 

 

EFSA Working Group Meeting

The 166th meeting of the EFSA NDA Panel highlighted continued progress across novel food assessments, as well as evaluations under Art 8.2. of Reg. EC 1925/2006.  

A significant portion of the meeting focused on the adoption of four novel food opinions, all finalised on 4 March 2026 pending minor editorial revisions. These included: 3’-sialyllactose (3’-SL) sodium salt (Inbiose N.V.), a carbon dioxide extract from Cannabis sativa L. (Charlotte’s Web), L-alpha-glycerylphosphorylcholine (L-alpha-GPC) from soya lecithin (Chemi S.p.A), and beta-nicotinamide mononucleotide (β-NMN) (Effepharm).

The Panel also announced two public consultations under Article 8(2) of Regulation (EC) No 1925/2006, addressing hydroxycitric acid (HCA) and berberine-containing plant preparations. These consultations, open until 4 May 2026, will be complemented by stakeholder meetings in April to facilitate engagement and clarify data gaps.  Read more here. The next plenary meeting will be held on 17th April 2026.  

 

EFSA Information Session on the Updated Food Additive Guidance

With the revised EFSA scientific guidance on food additives set to apply from the 20th July 2026, EFSA is holding an informative online session to present and explain the updates. This session will take place on 15th April from 10:00-12:30 (CEST) and is aimed at all stakeholders with an interest in the safety assessment of food additives. Read more and register here.

 

Webinar on the Risk Assessment of Cannabidiol as a Novel Food

EFSA is hosting a webinar focused on the risk assessment of cannabidiol (CBD) as a novel food. This session will present the updated statement on the safety of CBD and provide insights on its impact on the risk assessment applications. It is designed for all interested stakeholders with relevant expertise in the area. The webinar will take place online on 21st April 2026 from 14:30-16:00 (CEST). Further details and registration are available here.

 

European Commission updates

 

Article 4 Novel Food Consultations

There have been six Article 4 novel food consultations published during March.

 

The outcome of an Article 4 Novel Food consultation submitted to the Spanish Food Safety and Nutrition Agency O.A (AESAN O.A) has now been published. The consultation concerns a hydrolysed peptide extract of black bean (Phaseolus vulgaris Savi). The extract is obtained from the edible seeds of Phaseolus vulgaris Savi (black bean) and is intended for use as an ingredient in different food matrices. It consists primarily of peptides and partially hydrolysed proteins, with protein content exceeding 80%. The production process involves enzymatic hydrolysis generating reproducible fractions of peptides of low and medium molecular weight. The resulting ingredient is a stable powder, totally soluble in aqueous media, and does not contain engineered nanomaterials. 

❌ Conclusion: Novel food - Although black beans themselves have a history of significant consumption in the European Union prior to 15 May 1997, the isolate or extract had not been traditionally consumed. Due to the difference between the starting material and the final product, including a significant change in nutritional value, it was concluded the ingredient was novel. 

 

This consultation concerns L-theanine, a water-soluble, non-proteinogenic amino acid found in tea plants. The product in question is produced via microbial fermentation using non-GMO Escherichia coli strain, followed by purification and removal of the fermentation microorganism. 

❌ Conclusion: Novel food - Despite being comparable in terms of identity and purity to traditionally obtained L-theanine, there is no well-established history of consumption in the EU prior to 15 May 1997. 

 

Produced using membrane filtration, a common technique used in the EU dairy industry, this product contains twice the ALA content of standard WPC. This is achieved through the removal of other components from the whey stream. 

✅ Conclusion: Not Novel - Both WPC and WPC enriched with ALA have a history of use, with WPC enriched with ALA being sold and distributed in the EU in different product groups such as infant formula and follow-on formula. 

 

This application relates to soluble edestin, a purified globular plant protein extracted from ground and defatted hemp seeds (Cannabis sativa L.). This undergoes a process of extraction, crystalisation, acidification and lyophilisation, and is intended for use as a food supplement. 

❌ Conclusion: Novel food - While hemp seeds have a documented history of consumption, there is insufficient evidence that the isolated and purified soluble edeston produced through the described process has been consumed in significant quantities. 

 

This consultation evaluated a herbal tea infusion made from the aerial parts (herbs) of the plant Cistus x incanus L. 

Conclusion: Mixed Outcome 

✅ Conclusion: Not Novel - only in food supplements (‘not NFS’) 

❌ Conclusion: Novel food - when used as or in other food categories, including herbal tea infusion 

The tea infusion of Cistus x incanus L. herb was not used to a significant degree as a foodstuff in the EU prior to 15 May 1997, except in food supplements. 

 

The Norwegian Food Safety Authority has published the outcome of an Article 4 novel food consultation concerning herring roe oil (Clupea harengus). The herring roe oil is produced from spring spawning herring roe, a by-product of the herring filet industry. The manufacturing process begins with wet, frozen herring roe, from which the water is removed before undergoing ethanol extraction of the lipid fraction. This is followed by standard processing methods to purify the lipids, and the oil is then mixed with triglyceride fish oil.  

✅ Conclusion: Not Novel - This is based on the established history of safe consumption of both herring roe and fish oils prior to 15 May 1997. While ethanol extraction is not a traditional method used in fish oil production, the assessment found that it does not result in any chemical changes in the lipids nor does it give rise to significant changes in composition or structure of the fat fraction. 

 

Standing Committee on Plants, Animals, Food and Feed Meetings 

Novel Food and Toxicological Safety of the Food Chain - The next meeting will be held on 14th April 2026 and the agenda is now available to view here.  

 

TraceMap Traceability Tool

The European Commission has released an AI-powered tool that it says will help to speed up the detection of food fraud and food borne incidents and outbreaks in EU countries.This aims to make the food chain safer and more transparent when potential problems are flagged. Find out more here.


New methods of analysis for peroxide value in olive oil

The Council of the European Union has published a decision outlining its position on the trade standard for olive oils and olive pomace oils, including the introduction of the new analytical method for determining peroxide values. The amendments include a revision to a footnote concerning total sterol content in certain monovarietal extra virgin olive oils to include the Coratina variety; and the addition of  a new method analysis for determining peroxide values in both olive oils and olive pomace oils. Read more here. 

 

EU Proposes Maximum Levels for Mineral Oil Aromatic Hydrocarbons in Food 

The EU has published a draft regulation via the WTO proposing amendments to Regulation (EU) 2023/915. The proposal introduces setting maximum levels for mineral oil aromatic hydrocarbons (MOAH) in a range of food products, including milk, dairy products, infant formula, food supplements, and food additives. 

 

The draft is currently open for public consultation, with comments being open until 10th May 2026. The regulation is proposed to be entered into force on 1st January 2027. 


Food Standards Agency and Food Standards Scotland

The UK’s Food Standards Agency (FSA) has indicated that cultivated meat products for human consumption could enter the domestic market as early as February 2027, according to its newly published roadmap for emerging food technologies. Several novel food dossiers have been submitted, with PARIMA´s Vital Meat and Gourmey officially being under risk assessment. Whilst safety evaluations may conclude by early 2027, final approval will depend on ministerial sign-off before any product can be placed on the market. Read the report 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 17 June 2026, there is currently no agenda available. 



FDA explores scope of dietary supplement ingredients

The FDA hosted a public meeting to examine the scope of dietary supplement ingredients under the Dietary Supplement Health and Education Act (DSHEA), including the definition of “dietary substances,” the use of new production methods, and ingredient categories such as proteins, enzymes, and microbials. This could affect whether certain novel ingredients require a New Dietary Ingredient Notification (NDIN), depending on how FDA defines “new” versus existing ingredients. Read more here.

 

FDA Advances Implementation of the Food Traceability Rule

The FDA issued new guidance on the Food Traceability Rule - which establishes additional record keeping requirements for certain higher-risk foods to improve supply chain traceability - clarifying its scope and requirements, and finalising an exemption for certain Grade “A” cottage cheese products. The agency also announced a series of stakeholder engagement sessions throughout 2026 to support implementation.

Although not specific to novel ingredients, the rule introduces stricter traceability and record keeping requirements that will apply once products are commercialised. This is particularly relevant for companies with multi-step production processes, novel inputs, or distributed manufacturing models, where tracking materials and products across the supply chain may be more complex.

Read more about the Food Traceability Rule here. Learn more about the latest action here.

 

Human Foods Program - 2026 Priority Deliverables Updated

The FDA is signaling a clear shift toward tighter oversight and greater transparency across the food ingredient landscape in 2026:

  • GRAS overhaul incoming: Mandatory notifications will likely replace the current voluntary system

  • More scrutiny across the lifecycle: From premarket (NDIs) to post-market re-evaluation of additives

  • Emerging risks in focus: Microplastics, Per- and Polyfluoroalkyl Substances (PFAS), and heavy metals gaining regulatory attention

  • Clean-label momentum builds: Support for natural alternatives (e.g., color additives)

  • Data-driven regulation: Increased use of systematic reviews and AI-supported risk prioritisation

  • Nutrition policy as a driver: ultra-processed food (UPF) definition, sugar reduction, and front-of-pack labelling shaping reformulation

  • Functional ingredients under watch: Supplements, caffeine, and allergen transparency evolving

Overall, the US appears to be moving toward a more predictable but stricter framework - with higher data expectations and clear incentives for safer, “cleaner” innovation. Read more here.

 

US-GRAS Updates

  • GRAS 1288 - Enzyme-modified steviol glycosides - for intended use as general-purpose sweetener in foods excluding infant formula and USDA products

  • GRAS 1287 - Sucrose oligoesters - For intended use as emulsifier or stabilizer in whipping and whipped cream products and non-dairy whipped toppings, at a level up to 0.5% by weight.

 

US-FAP & CAP Updates

  • CAP 4C0326 - Beetroot red - Coloring of human foods generally, at levels consistent with cGMP (excluding infant formula and USDA products)

  • CAP 4C0334 - Spirulina (Arthrospira platensis) extract - Coloring of human foods generally, at levels consistent with cGMP (excluding infant formula and USDA products)

 

South Dakota

South Dakota has become the eigth US state to restrict cultivated meat, following Governor Larry Rhoden’s approval of the Senate Bill 124. The legislation introduces a five-year moratorium on commercial sales from July 2026 through to June 2031, opting for a temporary measure rather than a permanent ban to minimise constitutional risk and potential legal disputes. This move builds on prior action in 2-25 when the state implemented labelling requirements and funding restrictions for cultivated meat. 

 

Florida

On March 23, 2026, the U.S. Court of Appeals for the Eleventh Circuit rejected an effort to preliminarily enjoin Florida’s ban on lab‑grown meat. The Eleventh Circuit held that the Poultry Products Inspection Act (PPIA) does not preempt the state law because the outright ban on lab-grown meat does not regulate poultry facilities, operations, or ingredients. Find out more here.


Argentina 

Resolution No. 24/2026, issued by the Secretariat of Agriculture, Livestock, and Fisheries of the Ministry of Economy, establishes that all activities involving genetically modified organisms (GMOs), as well as their derived products and by-products, must comply with its provisions when they relate to species used in agriculture. This includes applications in agricultural, livestock, aquaculture/fisheries, forestry, ornamental, agri-food, and agro-industrial contexts, as well as any organisms that could potentially be used in such areas. 

Under this resolution, any activity involving the release of regulated GMOs into the agroecosystem—specifically those that have not yet received marketing authorization—requires prior approval from the Secretariat. Authorisation is granted on a case-by-case basis, following the fulfillment of requirements determined by the intended use and nature of the GMO or its derivatives, as declared by the applicant. The evaluation and authorization process is carried out in accordance with procedures established by the National Directorate of Bioeconomy, through the Coordination of Innovation and Biotechnology, within the Secretariat of Agriculture, Livestock, and Fisheries. Read more here.

 

Thailand 

According to the Food and Drug Administration, the list of enzymes used in food production is under review. Read more in Thai here.

 

Canada 

There have been six new consultations published on the Government of Canada list of non-novel determinations for food and food ingredients since January. All were concluded as ingredients with a history of safe use as a food. See list in full here.

  • Inactivated cells of Kluyveromyces marxianus strain ATCC 8554  

    • This concerns the inactivated yeast powder for use in flavoring/enhancing umami flavor and for nutritional and protein enrichment at inclusion levels between 2% and 20% of the final food. The folic acid content must not exceed 0.04 mg/g of yeast. 

  • Lacprodan®ALPHA-10

    •  Whey protein concentrate with enriched levels of alpha-lactalbumin as an ingredient in infant formulas

  • High-fibre barley flour

    • A type of fibre-enriched flour made from processing grains obtained after beer brewing, further processed to reduce soluble protein, starch, and sugars.

  • DHA algal oil sourced from Aurantiochytrium limacinumstrain ATCC 20889

    • Liquid oil with omega-3 fatty acid content (DHA) obtained from an algae.

  • Bamboo fibers from various species (Bambusa spp., Dendrocalamus spp., Gigantochloa spp., Phyllostachys spp., Melocanda humilis, Thyrsostachys siamensis, and Nastus elatus)

    • Fibers derived from the stalk of various bamboo species.

  • DHA algal oil sourced from Aurantiochytrium limacinumstrain TKD-1

    •  Liquid oil with omega-3 fatty acid content (DHA) obtained from an algae. 

 

India 

The List of Applications Approved/Rejected/Closed/Withdrawn/Status under the Food Safety Standards has been updated. Read this on the FSSAI website in full here.

 

Food and Agriculture Organization of the United Nations 

Does the future of food safety lie in the molecular world of omics-based technologies? To address this question the FAO/WHO held a joint expert meeting on microbiology risk assessment on 2-6 March. Find out more here.

 

FAO - Regulatory Frameworks for cell-based food and precision fermentation-derived

The Food and Agriculture Organization (FAO) has published a legal paper reviewing how existing global and national frameworks apply to cell-based and precision fermentation-derived foods, finding that while systems such as the Codex Alimentarius and World Trade Organization agreements are beginning to address these technologies, international standards remain at an early stage, primarily focused on definitions, hygiene, and risk assessment.

The report concludes that most countries do not need entirely new regulatory regimes, as existing pathways like novel foods or GMO regulations can often accommodate these products if authorities clarify their application; the main challenge is therefore not a lack of laws but legal uncertainty and inconsistent interpretation. The report identifies five priorities for regulators: clarifying how current laws apply, determining the need for additional pre-market approvals, updating technical rules such as labelling and processing aids, strengthening international harmonization, and ensuring broad stakeholder engagement. Read more here.

 

Food Standards Australia New Zealand (FSANZ) 

FSANZ has released their 2030 roadmap, outlining a clear direction for FSANZ regulatory proposals over the next five years. The roadmap highlights several priority areas including; health star ratings, digital labelling, infant and childhood foods, young child formula, and clearer pathways for novel foods. This roadmap aims to provide greater transparency and predictability with a plan that is responsive to risk whilst adapting to new evidence, policy and emerging issues. Read more here.


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