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Atova's July Regulatory Roundup!

  • Writer: Atova
    Atova
  • Aug 4
  • 14 min read

Updated: Aug 5


✨ Welcome to the July 2026 edition of the Atova Regulatory Roundup. This month brought important developments across the EU, UK, United States and Asia, including new EFSA opinions, UK guidance for cell-cultivated products and further US state-level measures affecting cultivated foods. 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. 🌱



July was a busy and rewarding month for the Atova team. We had the opportunity to come together in Barcelona for our summer lunch, taking time to connect in person and celebrate as a team. We also hosted the second instalment of our Navigating Novel Foods: EU Dossier Masterclass webinar series, where we explored the Identity, and Production Process sections of an EU novel food dossier. It was fantastic to welcome both familiar and new faces, with plenty of insightful questions and engaging discussion throughout the session.

 

Navigating Novel Foods: EU Dossier Masterclass – Part Two

Thank you to everyone who joined us for the second instalment of our Navigating Novel Foods: EU Dossier Masterclass webinar series. It was great to see so many of you there again and we hope you found the session informative.

 

In this session, led by Regulatory Scientist Dr Oana Kubinyecz, we shared practical insights into what EFSA looks for when assessing the identity and production-process sections of a novel food dossier. Read the key takeaways here.

 

Part 3 of the series will take place on 17th September. Registration details will be shared 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:




Team Summer Lunch 

At the start of this month, the Atova team came together for a lovely celebratory lunch to mark a special occasion. It was a wonderful opportunity to step away from our desks, enjoy some great food, and spend quality time together outside of our day-to-day work. As a remote and international team, these moments are especially precious. They give us the chance to connect in person, catch up, share ideas, and celebrate together. We had a fantastic time, and we're already looking forward to the next opportunity to get the team together.



EFSA Updates


Novel Food Dossier and Traditional Food Notifications Received

The European Food Safety Authority (EFSA) received five novel food applications and traditional food notifications in July:  


Validated Dossiers

There were two validated dossiers published on Open EFSA in July. 

Name of Product

Dossier Received by EFSA

Validated

Time until withdrawal

Application for authorisation of spermidine-rich buckwheat germ powder as a novel food

07/08/2025

29/07/2026

11.5 months

Notification on Defatted flour of cacay nuts (Caryodendron orinocense) as traditional food

05/05/2026

02/07/2026

2 months


Dossiers Considered Non-valid and Withdrawn

There were two dossiers withdrawn during July. 

Name of Product

Dossier Received by EFSA

Withdrawn

Time until withdrawal

Request for a scientific opinion on L-Fucose as a novel food (NF 2020/1995)

24/11/2020

06/07/2026

68.5 months

Application for authorisation of Dried defatted powder of Hermetia Illucens larvae as a novel food

24/10/2023

03/07/2026

32.5 months


EFSA Published Opinions

European Food Safety Authority (EFSA) published three scientific opinions and one technical report relating to novel foods in July:


Atova´s Key takeaways from the Anaerobutyricum soehngenii CH106 Opinion:

EFSA requested silicon analysis to investigate residues arising from the use of dimethyl polysiloxane (PDMS), E 900, used as an antifoam during fermentation. Free extractable polydimethylsiloxane was measured at 22.6–38.1 mg/kg. EFSA calculated a maximum intake of 0.0022 mg/kg body weight/day and concluded that this was negligible relative to the established ADI of 17 mg/kg body weight/day. A specification of <50 ppm PDMS was included.


  • EFSA requested that additional genotoxicity tests (Ames & micronucleus) be performed separately for the bacterial cell lysate, to assess intracellular constituents that might not be adequately available when intact viable cells are tested; and the culture supernatant, to assess soluble metabolites or substances released into the fermentation medium.

  • EFSA excluded pregnant and lactating women, not because of an observed adverse effect but to uncertainty regarding modification of the maternal microbiome, maternal–foetal immune interactions and the potential long-term consequences of microbiome disruption early in life.

  • EFSA proposed adding protein and carbohydrate ranges to the specifications to improve production consistency. This is notable because these were not merely safety limits but markers of process control and batch comparability.

  • For strains that have undergone random mutagenesis, demonstrating the intended genetic change alone may not be sufficient and unintended mutations and their potential phenotypic consequences should be considered. Applicants should provide a comparison with a well-defined parental genome, a complete list and classification of genetic variants, functional annotation of affected genes, and an assessment of potential effects on metabolism, virulence, toxigenicity and antimicrobial resistance, supported by phenotypic confirmation where appropriate.

  • Microorganisms without qualified presumption of safety (QPS) status should be expected to undergo a full strain-specific safety assessment. Although no specific safety concerns had been identified for A. soehngenii, the species was not included on the QPS list because of the limited knowledge of its use in the food and feed chains. The applicant therefore needed a comprehensive package addressing antimicrobial resistance, virulence, genetic stability, toxicology and human exposure. A history as a human commensal or “next-generation probiotic” should not be treated as equivalent to an established history of safe food use.

  • Phenotypic antimicrobial resistance findings should be reconciled with the genomic evidence. In this case, approval remained possible because the applicant demonstrated that the observed resistance was intrinsic, that no transferable resistance determinants of concern were present, that the disrupted tetO gene was non-functional, and that prophage-like regions did not contain antimicrobial resistance genes. Applicants should therefore integrate WGS with phenotypic susceptibility testing, a biological explanation of intrinsic resistance, and assessment of gene mobility and horizontal-transfer potential.

  • Consistent potency units should be used throughout the dossier wherever possible. The difference between CFU and AFU complicated interpretation of the animal study, dose conversion and NOAEL.

  • Human studies are most informative when they test at least the maximum proposed commercial dose. Although the 100-person intervention study was supportive, EFSA considered its value limited because participants received only half the proposed daily dose. A safety-supportive human study should be of sufficient duration, prospectively collect adverse events, include clinical chemistry and haematology, consider gastrointestinal tolerance, and apply appropriate exclusions for vulnerable groups.


EFSA Public Consultations

Two novel food consultations closed in July, and two further consultations are due to close in August:

 

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

 

EFSA Working Group and NDA Panel Plenary Meetings

The minutes of the 179th 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 8-15th July. The group discussed 17 draft opinions including Mangosteen peel extract, Almond solids from roasted in-shell almonds and plant-based drink from roasted in-shell almond, Quercetine from Dimorphandra mollis Benth, and Coffee fruit extract. The minutes are available here. The next working group meeting will be held on 8-16th September.

 

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 1st – 2nd July, where the draft opinions of Anaerobutyricum soehngenii CH106, Roasted sacha inchi seeds, 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

 

Standing Committee on Plants, Animals, Food and Feed (SCoPAFF) Meetings

The General Food Law meeting summary report was published on the 1st July 2026. The Commission presented a draft Regulation to prohibit the use of certain botanicals containing hydroxyanthracene derivatives, following EFSA's March 2024 conclusion that their safety could not be established based on the available scientific evidence. The summary is available here.

 

The meeting minutes from the June Novel Food and Toxicological Safety meeting are still not available. The next meeting is scheduled for 25th September.

 

New Regulations

The European Commission has adopted Regulation (EU) 2026/1890, introducing maximum permitted levels for the combined presence of furan, 2-methylfuran and 3-methylfuran in processed cereal-based foods and baby foods for infants and young children. The new limits, introduced in response to EFSA's risk assessment and recent food safety alerts, will apply from 1 January 2028, with transitional provisions for products already lawfully placed on the market. Read in full here.

 

The European Commission has adopted Regulation (EU) 2026/1825, introducing new maximum levels for 3-MCPD, 3-MCPD fatty acid esters and glycidyl fatty acid esters in baby foods and processed cereal-based foods for infants and young children, while also lowering limits for certain vegetable and marine oils used in their production. The amendments, based on new occurrence data and EFSA risk assessments, will apply from 1 January 2027, with transitional provisions for products already lawfully placed on the market. Read in full here.

 

EC Novel Food Terminations

In accordance with Article 10(6) of the novel food regulation, the Commission may terminate a novel food application at any stage and decide not to proceed with an update to the Union List of Novel Foods, where it considers that such an update is not justified. We are seeing the Commission make increasing use of this provision to close applications that are unlikely to progress successfully, rather than leaving them pending indefinitely. So far this year, the EC has terminated 35 novel food applications compared to four during 2025.

 

For applicants, this reinforces the need to submit well-prepared, robust dossiers that comply with the EFSA guidance documents or risk getting your dossier terminated.

 

The EC terminated six novel food applications in July:

  • Commission Implementing Decision of 20 July 2026 terminating the procedure for authorising the placing on the market of the ant species Lasius fuliginosus (NF 2019/1411) as a novel food without updating the Union list of novel foods

  • Commission Implementing Decision of 20 July 2026 terminating the procedure for authorising the placing on the market of saltwater with extra oxygen (NF 2021/1287) as a novel food without updating the Union list of novel foods

  • Commission Implementing Decision of 20 July 2026 terminating the procedure for authorising the placing on the market of the fruit of Siraitia grosvenorii (NF 2018/0705) as a traditional food from a third country without updating the Union list of novel foods

  • Commission Implementing Decision of 20 July 2026 terminating the procedure for authorising an extension of use of chia seeds (Salvia hispanica) (NF 2019/1287) as a traditional food from a third country without updating the Union list of novel foods

  • Commission Implementing Decision of 20 July 2026 terminating the procedure for authorising a change of the conditions of use of frozen, dried and powder forms of Locusta migratoria (NF/2022/3114) as a novel food without updating the Union list of novel foods

  • Commission Implementing Decision of 20 July 2026 terminating the procedure for authorising a change of the conditions of use of frozen, dried and powder forms of yellow mealworm (Tenebrio molitor larva) (NF/2022/5972) as a novel food without updating the Union list of novel foods


FSA Board Meeting 

The latest FSA Board Meetings are available to watch here. The next FSA Board meeting is due to be held on 16 September 2026; there is currently no agenda available. 

 

FSA and FSS New Guidance Documents

The Food Standards Agency (FSA) and Food Standards Scotland (FSS) have published four new guidance documents to support businesses developing and producing cell-cultivated products (CCPs) and other novel foods. Developed through the Cell-Cultivated Products Sandbox Programme, these guidance documents have been shaped by regulators and industry to build a shared understanding of how food regulations apply to cell-cultivated products. The guidance is intended to improve regulatory clarity and help businesses prepare stronger applications while maintaining a high level of consumer protection.

The four new guidance documents are:

The aim is to make the pathway to market authorisation more transparent while maintaining the highest standards of consumer safety.

 

Why it matters: Applicants now have more detailed indications of regulator expectations for identity, production, microbiology, hygiene and taste trials, which should be reflected in study planning and dossier preparation.

 

Advisory Committee on Novel Foods and Processes (ACNFP)

Subgroup on Cell-cultivated products (CCPs)

The 6th meeting of the ACNFP subcommittee on cell-cultivated products (CCPs) was held on the 22nd July 2026. Key agenda items included refining suitability checks and review of hazards, establishing the information required to define the identity of cell-cultivated products, and considering regulatory approaches for products containing multiple cell types or edible scaffolds. The meeting reflects the FSA's ongoing efforts to develop a proportionate and future-ready regulatory framework for these emerging foods. Read the agenda here.

 

Subgroup on Products of Genetic Technologies (PGT)

The ACNFP subcommittee on Products of Genetic Technologies (PGT) held its 25th meeting on the 28th July 2026. Key agenda items included updates from the FSA, ACRE and DEFRA, horizon scanning of emerging genetic technologies, and discussions on best practices for evaluating proteomic and metabolomic data. The meeting reflects the UK's ongoing efforts to ensure its regulatory framework remains robust and adaptable as genetic technologies continue to evolve. The next meeting will be held on the 20th October 2026. Read more about the agenda here.



FDA’s proposed reform of the GRAS framework is now expected in December 2026, later than the mid-2026 timing recently anticipated by industry. The proposal was originally targeted for October 2025 in the Spring 2025 Unified Agenda and has been under White House review since December 2025. The timetable is indicative rather than legally binding, and FDA is not subject to a statutory deadline for issuing the proposal.

 

The planned rule would require notices for certain uses of substances in human and animal food; covered uses would be presumed not GRAS unless the notification requirement had been met. FDA would also maintain and update a public inventory of mandatory notices and clarify how it determines that an ingredient use is not GRAS.

 

FDA expects the reform to increase transparency and help identify ingredient uses that should instead undergo food-additive approval. For manufacturers, it could entail one-time costs to revise internal procedures and address existing GRAS uses, as well as recurring costs to prepare and submit notices for new uses that might previously have relied on independent GRAS conclusions.

 

Why it matters: Although a binding final rule is likely to take years to implement, companies should begin preparing now. Companies relying on independent GRAS determinations (self-GRAS) should begin mapping existing uses and assess the quality and completeness of existing GRAS determinations and supporting documentation and ensure that current GRAS determinations reflect current manufacturing process, composition, specifications and conditions of use (including dietary exposure).

 


Several US state measures affecting cultivated and alternative proteins entered into force on 1st July, adding to an increasingly fragmented state-level regulatory landscape.

 

South Dakota’s five-year moratorium now prohibits the manufacture, sale, offer for sale, holding for sale and distribution of products containing cell-cultured protein, subject to the statutory exclusions until June 30, 2031. The law expressly excludes proteins produced through microbial fermentation, enzymatic processing and traditional food cultures, provided that they are not intended to replicate meat or animal tissue for human consumption.

 

Mississippi’s HB 1153 also took effect, making Mississippi the first U.S. state to prohibit the manufacture, sale or offer for sale of cell-cultured dairy products. The measure additionally strengthens existing labelling and point-of-sale disclosure requirements for cultivated, plant-, insect- and other manufactured-protein products marketed using traditional meat terminology.

 

Two additional states introduced new labelling requirements. Virginia now considers cultivated-, plant-, insect- and fungus-based protein products misbranded when they use identifying meat terms without a qualifying term in close proximity. Idaho requires cell-cultivated animal proteins to be labelled “lab-grown,” “cell-cultivated” or “cell-cultured” and restricts the use of terms associated with specific meat cuts, including “steak,” “roast,” “loin,” “brisket” and “tri-tip,” unless otherwise authorised by USDA.

The measures reinforce an increasingly fragmented state-level framework for alternative proteins, combining outright prohibitions in some jurisdictions with product-specific labelling and marketing requirements in others.

 

Why it matters: Companies planning US launches will need state-by-state legal and labelling reviews in addition to federal FDA and USDA compliance (where applicable).

 


Bill on labelling non-dairy butter in US

A new bill, the REAL Butter Act, has been introduced in Congress that would require products made with lab-synthesised butter to be labelled as "lab-created butter", with foods containing these ingredients also required to disclose this on-pack. The proposed legislation aims to improve transparency for consumers but could have significant labelling implications for manufacturers if adopted.


Canada

List of non-novel determinations

Health Canada added two ingredients to its list of non-novel determinations in June and July, concluding that both have a history of safe use as food:

  • Ribonucleic Acid (RNA) salt – RNA salt derived from non-genetically modified Kluyveromyces marxianus and/or Candida utilis yeasts for use in formulated liquid diets

  • Chicken (Gallus gallus domesticus) eggshell membranes – The thin membrane that lines the eggshells of farmed chicken eggs

You can view the whole list here.

 

Labelling guidance for plant-based alternative to egg products

The Canadian Food Inspection Agency (CFIA) has published new guidance on the labelling and advertising of plant-based alternatives to egg products, with a transition period allowing businesses until 1st January 2030 to comply. The guidance emphasises that product names, claims, images, packaging and overall presentation must clearly communicate that these products are plant-based and not conventional egg products, helping to prevent consumers from being misled. Manufacturers of plant-based egg alternatives marketed in Canada should review their product labelling to ensure it aligns with the new expectations before the compliance deadline. Read more here.

 


South Korea

The Ministry of Food and Drug Safety (MFDS) has published new guidelines outlining the dossier requirements for cell-cultured food applications, providing detailed guidance on the application process, required documentation, and product naming expectations. The publication marks another step in South Korea's efforts to establish a clear regulatory pathway and support the commercialisation of cultivated food products. Read the guidance here.

 


FAO: Codex Alimentarius International Food Standards

The 49th session of the Codex Alimentarius Commission (CAC49) adopted several new and revised international food standards, including guidance on precautionary allergen labelling, food hygiene, food additives, spices, and baker's yeast. The updates aim to strengthen consumer protection, support fair international food trade, and promote globally harmonised food safety standards. Read more here.

 

Why it matters: The new risk-based approach may influence future national guidance and expectations for when precautionary allergen statements are justified.

 


Joint FAO/WHO Expert Committee on Food Additives (JECFA)

The Joint FAO/WHO Expert Committee on Food Additives (JECFA) has launched a call for data to support the toxicological evaluation of a prioritised group of per- and polyfluoroalkyl substances (PFAS) at its 105th meeting in November 2027. Stakeholders are invited to submit toxicological, occurrence and exposure data by 1 December 2026, helping to inform future international risk assessments and food safety standards. This initial review will focus on a subset of PFAS, with additional substances expected to be evaluated as further scientific data becomes available. Find out more here.


Have 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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