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Atova's May Regulatory Roundup!

  • Writer: Atova
    Atova
  • Jun 5
  • 12 min read

✨ Welcome to the May 2026 edition of the Atova Regulatory Roundup! As we move towards summer, we continue to explore the global landscape of novel food regulation. Thank you for being a part of our community. We hope you enjoy this month’s updates, and as always, we’re here to help you stay informed and navigate the evolving world of novel food regulation with confidence. 🌱 



May 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 One

Thank you to everyone who joined us for the first webinar in our four-part series, Navigating Novel Foods: EU Dossier Masterclass. It was great to see so many of you there and hope you found the session informative, practical and valuable as you navigate the EU novel foods landscape. 

 

This webinar marked the beginning of our series exploring the key elements of preparing and submitting a successful novel food dossier. We look forward to continuing the conversation in Part 2, which will take place on 29th July. Registration details will be available soon, so keep an eye on your inbox and watch this space for updates. We would also really appreciate your feedback to help us shape and improve future events. Please take a couple of minutes to complete our feedback form. 


We hope to see you on the 29th July! 




Basque Culinary Centre 

On the 12th May, Fernando Rivero Pino, Regulatory Scientist and Toxicologist at Atova, visited the prestigious Basque Culinary Center to deliver an insightful lecture to the Master in Gastronomic Sciences students. Fernando shared his expertise on the evolving landscape of novel food regulations and health claims in Europe, highlighting how science and regulation drive food innovation. Beyond the classroom, Fernando had the opportunity to visit the Gastronomy Open Ecosystem facilities and tasting areas and of course explore the incredible city and sample the world-class flavours of San Sebastián. 



AESAN Conference on Risk Assessment Driving Food Safety: Europe and Latin America 

On 21-22nd May, Fernando Rivero Pino travelled to Madrid to attend the AESAN. (Agencia Espanola De Seguridad Alimentaria Y Nutricion) Conference on Risk Assessment Driving Food Safety: Europe and Latin America. The event brought together agencies and experts from across Europe and Latin America to explore how risk assessment continues to drive and strengthen food safety. It was a valuable opportunity to hear different perspectives on risk assessment and risk management, as well as discussions around public expectations and the implementation of new tools and techniques within food safety assessment. The conference provided a strong platform for knowledge sharing, collaboration and innovation, reinforcing the importance of continued cooperation in advancing best practices across the sector. 


EXPO FoodTech & Food 4 Future World Summit 

Last week, Caroline Idowu took to the stage at the EXPO FoodTech & Food 4 Future World Summit as part of a roundtable, alongside some fellow members of the EPIC-SHIFT consortium, for a discussion on “Unlocking the Protein Market: What’s Working, What It Takes to Break Through, What’s Next”. Caroline joined the stage with Irene Gonzalez Perez, Paula Aguado Hernaiz, Maxime Boniface, Elena Díaz de Apodaca with the panel moderated by Beatriz Romanos Hernando. The conversation explored what it takes to bring competitive alternative protein products from lab to shelf, the market challenges slowing scale-up, and how Europe can stay competitive in the global protein race.  

Caroline shared insights from the past 10 years in the regulatory development space of alternative proteins, common challenges companies face, when to start considering regulation during product development, and the current landscape around product labelling. 


EFSA Updates

 

Novel Food Dossier and Traditional Food Notifications Received

There were eight novel food dossiers and traditional food notifications submitted to EFSA in May. 

 

Validated Dossiers

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

Name of Product

Dossier Received by EFSA

Declared Valid

Time until Validation

Application for authorisation of Defatted Passion Fruit Seed Extract as a novel food   

14/10/2025

08/05/2026

7 months

Application for authorisation of Gamma -Aminobutyric acid as a novel food   

13/11/2025

08/05/2026

6 months

Application for a modification of the authorised Xia Powder 435 as a novel food   

20/02/2026

05/05/2026

2.5 months


Dossiers Considered Non-valid and Withdrawn

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

EFSA Published Opinions

There were five novel food opinions that were published in May.

Name of Product

Dossier Received by EFSA

Dossier Validated on

Opinion Published

Time until opinion

Opinion Result

 Safety of cannabidiol isolate from Cannabis sativa L. as a novel food pursuant to Regulation (EU) 2015/2283    

11/05/2021

22/04/2022

27/05/2026

61.5 months

Negative opinion on safety

Safety of nonapeptide–pentapeptide mixture as a novel food pursuant to regulation (EU) 2015/2283  

23/03/2023

13/11/2023

21/05/2026

38.5 months

Positive opinion on safety

Safety of L-alpha-glycerylphosphorylcholine (L-alpha-GPC) from soya phospholipids (lecithin) as a novel food pursuant to Regulation (EU) 2015/2283     

13/07/2023

12/02/2024

12/05/2026

34.5 months

Positive opinion on safety

Safety of oil from Schizochytrium sp. A2 for use in infant and follow-on formula as a novel food pursuant to regulation (EU) 2015/2283  

25/04/2024

10/09/2024

11/05/2026

24.5 months

Negative opinion on safety

Safety of beta-nicotinamide mononucleotide (β-NMN) pursuant the regulation (EU) 2015/2283 and the bioavailability of nicotinamide from this source in the context of Directive 2002/46/Ecº    

22/08/2023

11/04/2024

11/05/2026

33 months

Positive opinion on safety


EFSA Public Consultations

There was one novel food public consultations that had a deadline in May which received no comments. There is also one novel food public consultation with a deadline in June. 

 

There were also four other public consultations on different EFSA scientific opinions and draft guidance documents with deadlines in May and July. These are:  

 

EFSA Working Group Meeting

The minutes of the 177th working group meeting on novel foods are now available online. This meeting by the Scientific Panel on Nutrition, Novel Foods and Food Allergens, which was held on 5-13th May, discussed fourteen draft opinions including Locusta migratoria, Lacto-N-triose II, and Roasted sacha inchi seeds were all submitted for draft opinion. The minutes are available here. 

 

The agenda from the 168th Panel Plenary meeting of the Scientific Panel on Nutrition, Novel foods and Food Allergens is now available online. This meeting was held on the 27-28th May, where the draft opinions of synthetic cannabidiol, Zinc L-carnosine, Lacto-N-triose II, and S-Acetyl Glutathione were all submitted for discussion. The agenda is available here.  

 


European Commission updates

 

Article 4 Novel Food Consultations

There have been three Article 4 novel food consultations published during May:

 

A consultation concerning S-adenosyl-L-methionine disulfate tosylate was submitted to The Institute of Hygiene, Lithuania. This is a chemically defined derivative of the salt form of S-adenosyl-L-methionine (SAMe), produced through either fermentation or by chemical synthesis. 

❌ Conclusion: Novel Food - S-adenosyl-L-methionine disulfate tosylate is considered a novel food, due to no demonstrated history of significant consumption as a food or food supplement within the European Union before 15 May 1997. 

 

A consultation concerning pomegranate extract with 40% punicalagin was submitted to the Finnish Food Authority. The extract in question is a water-ethanol extract produced from the whole pomegranate fruit (Punica granatum L.) including its peel, seeds and arils, with the intended use as a food and food supplement. 

Conclusion: 

✅ Not novel in food supplements 

❌  Novel as a food ingredient  

The fruit of the pomegranate is not a novel food. The pericarp (i.e. the peel) of the pomegranate fruit is considered not a novel food in food supplements; however, the pericarp has not been used in the EU to a significant degree as a food before 15 May 1997. Due to the consultation request not providing evidence that pomegranate peel/pericarp has significant use as a food it was determined that the pomegranate extract with 40% punicalagin is not novel in food supplements but novel as a food ingredient. 

 

A consultation concerning peanut (Arachis hypogaea) protein powder was submitted to the Novel Food Unit of the Medicines Evaluation Board Agency in the Netherlands. The peanut protein powder is a protein preparation obtained through an extracting process from peanut meal as the source material. The peanut protein is extracted from the meal by several steps including pH adjustments in aqueous environment, centrifugation, pasteurisation and finally being spray dried. 

❌ Conclusion: Novel Food - This was determined due to no demonstration of a history of human consumption to a significant degree within the European Union before 15 May 1997 for peanut protein powder with approximately 82% protein.  

 

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.  

 

General Food Law

The General Food Law of Standing Committee on Plants, Animals, Food and Feed Section meeting was held on 13th May. This included discussions on the results of Priority Control Area on E-commerce Imports Action: Food supplements, and an exchange of views on a draft commission regulation regarding monacolins from red yeast rice. The agenda for this meeting is available here.

 

Genetically Modified Food

The Standing Committee on Plants, Animals, Food and Feed Section on Genetically Modified Food and Feed meeting is to be held on 10 June 2026. The agenda for this meeting is available now and contains four drafts presented for an opinion. Read the full agenda here.

 

EC Impact Assessment for the EU Biotech Act 

The European Commission has now published an impact assessment for the EU Biotech Act, highlighting opportunities to strengthen competitiveness, innovation, and societal benefits while maintaining existing safety standards. Key tangible benefits highlighted include faster approval processes, streamlined procedures and reduced time and cost due to removal of certain environmental risk assessment (ERA) requirements. The assessment also identifies positive potential from measures such as regulatory sandboxes and EFSA pre-submission support, which help to accelerate innovation and assessment. Overall, this impact assessment paints a positive picture of the EU Biotech Act’s potential to support innovation, strengthen competitiveness, and deliver broader societal value. Read in full here. 


EC call for evidence on industrial biotechnology and biomanufacturing 

The European Commission has launched a call to collect views on the potential for industrial biotechnology and biomanufacturing in the EU. Professionals, companies, academics, experts and citizens are encouraged to participate in sharing the main challenges and bottlenecks they encounter. The feedback from this will support the preparation of the Commission’s proposal for Biotech Act II. The call is open until 10th June 2026. Find out more here. 


France Bans CBD in Food 

The Department of Agriculture Agri-Food and Sovereignty Food released on the 20th May that health authorities recall that all foodstuffs, including cannabidiol in their ingredients are not authorised for sale due to lack of proof regarding their safety. It was announced that there will be a strengthening of controls, with consumers encouraged to be vigilant after an increase in reports of poisoning. Foods containing CBD in their ingredients are not authorised under Regulation (EU) No. 2015/2283 due to the safety of CBD not being demonstrated. Find out more here. 


FSA Board Meeting 

You can now watch the latest Food Standards Agency (FSA) Board Meeting here. The next FSA Board meeting is due to be held on 17 June 2026.



FDA Updates

The U.S. Food and Drug Administration (FDA) is taking a more proactive approach to reviewing chemicals in the food supply. This includes ingredients considered generally recognized as safe (GRAS), food additives, color additives, food contact substances, and contaminants. Safety reassessments may be initiated in response to petitions from stakeholders or when new scientific information becomes available. 

FDA describes a structured framework involving four stages: Review of Information, Scientific Assessment, Risk Management Review, and Risk Management Action. Potential regulatory outcomes include revocation of authorizations, voluntary market phase-outs, recalls, consumer alerts, or other risk management measures where safety concerns are identified. 

An initial list of food ingredients, food-contact substances, and contaminants under FDA review has now been published. FDA has indicated that the list will be expanded and updated regularly to improve transparency around its ongoing post-market assessment activities. 

 

FDA advances discussions on food traceability requirements. The agency released a discussion paper related to the Food Traceability Rule (FTR), which establishes enhanced recordkeeping requirements for certain higher-risk foods to facilitate faster identification and removal of contaminated products from the market. The associated Food Traceability List (FTL) primarily covers commodities such as fresh produce, soft cheeses, eggs, seafood and sprouts. As a result, the development is unlikely to have significant direct implications for most novel foods, unless they are incorporated into foods covered by the FTL. 

 

FDA's guidance provides recommendations on the design, conduct, evaluation and reporting of Protein Efficiency Ratio (PER) studies, which are used to demonstrate that a new infant formula meets FDA's requirement for sufficient biological quality of protein. FDA notes that the guidance is intended to support manufacturers introducing new infant formula products to the U.S. market and forms part of broader efforts to strengthen the resilience of the infant formula supply. 

 

The FDA has released an instructional video on using its Expanded Decision Tree (EDT). The video provides a step-by-step guide on applying the EDT for chemical toxicity screening, including descriptions of the six toxicity classes, their corresponding TTC values, and practical examples depicting how to manually evaluate substances. Watch the video here. 

 

US-GRAS Updates

There have been twelve GRN’s posted on the inventory in May. 

  • GRAS 1316 - Saccharomyces cerevisiae “BY-1574” expressing a gene encoding an alcohol-O-acyltransferase enzyme from Cucumis melo var. Cantalupensis 

  • GRAS 1315 - Short-chain chondroitin sulfate oligosaccharides produced from enzymatic hydrolysis of chondroitin sulfate 

  • GRAS 1314 - Bacillus pumilus SG154 

  • GRAS 1313 - Algal oil (≥35% docosahexaenoic acid) from Schizochytrium limacinum CCAP A2 

  • GRAS 1312 - Recombinant αS1-casein from Bos taurus produced by Escherichia coli DSM 35603 

  • GRAS 1311 - L-theanine produced by Escherichia coli CICC 11189s 

  • GRAS 1310 - Rebaudioside M produced by enzymatic treatment of rebaudioside A purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni 

  • GRAS 1309 - D-psicose 

  • GRAS 1308 - β-glucan produced by Kluyveromyces marxianus CGMCC 26703 

  • GRAS 1307 - Rebaudioside M produced by enzymatic treatment of steviol glycosides purified from the leaves of Stevia rebaudiana (Bertoni) Bertoni 

  • GRAS 1305 - Brazzein preparation produced by Komagataella phaffii GDMCC 70101 

  • GRAS 1304 - Preparation containing at least three bacteriophages (phage) specific to Listeria spp. 

 

New York moves towards mandatory disclosure of self-affirmed GRAS substances 

New York's Food Safety and Chemical Disclosure Act has passed both legislative chambers and is awaiting the Governor's signature. If enacted, the law would require companies selling, manufacturing, or using food ingredients supported by self-affirmed GRAS determinations to submit detailed safety information to the state, including manufacturing methods, exposure assessments, and the scientific basis for the GRAS conclusion. The information would be made publicly available through a searchable database. Ingredients that have received an FDA No Questions letter, are listed as GRAS in federal regulations, or are approved food additives would be exempt. The bill would also ban the use of Red Dye 3, potassium bromate, and propylparaben in foods sold in New York. 


Australia/New Zealand

There have been thirteen notifications to the notified food-health relationships to make a claim list. This includes those on PeptiStrong, Wise Wheat™ Flour, LactoSpore® (Bacillus coagulans MTCC 5856), Saffron extract (Crocus sativus L.), and Grain Fibre. View the full updated list here.

 

Turkey

On the 20th May, the Turkish Food Codex Regulation on Novel Foods was published in the Official Journal, aligning its novel foods regime with modern innovations while strengthening oversight of emerging ingredients and technologies. This introduces new rules including ingredients already marketed in Turkey before 31 December 2025 and included on the official positive list will generally be treated as non-novel for their existing use and composition. However, those produced by new or materially different manufacturing processes, such as technologies that enhance bioavailability, nanoencapsulation, or novel extraction methods, are likely to be classified as novel and require full dossier-based authorisation. In this case, companies must submit technical dossiers, demonstrating safety and exposure before they can be commercialised. 

Read more here.  

 

Latest Papers

We’re proud to share a new publication from PARIMA (creators of Gourmey) and co-authored by Hannah Lester. This paper presents the comprehensive multi-omics framework that was applied to PARIMA´s duck cell line, which is now approved in Singapore and under risk assessment in other jurisdictions such as the EU and UK. This study provides the first detailed molecular characterisation of a commercial cell line, supporting its safety for use in food production. This framework contributes towards cutting edge regulatory science, the development of new approach methodologies and the future of risk assessment of cell-cultivated foods. Read the article here.Subscribe to keep up-to-date with all the major regulatory updates & news:



 
 
 

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