ATOVA´s May 2025 Newsletter! 🌱
- Atova
- 7 days ago
- 9 min read
🌿 Welcome to the May edition of the Atova Newsletter. Thank you for registering to receive our newsletters and other publications - we're glad to have you with us and hope that you find them interesting.
To keep you better informed with the latest regulatory developments, we are excited to announce that the Atova newsletter will now be delivered monthly straight into your inbox. In each edition we will take a deep dive into the state of novel food regulations in the EU, UK and US, along with highlights from around the globe.
We hope you enjoy our newsletter and we look forward to keeping you up to date with the evolving regulatory landscape. Please let us know if there’s anything you’d like to see in the next edition of our newsletter. 🌱
We are excited to announce the Regulating the Future of Food Conference is back for another instalment in 2025, in collaboration with Vireo Advisors.
Date: 29th - 30th October 2025
Location: RAI, Amsterdam
Event Info: Visit the website
Join us to explore the industry’s biggest challenges in novel food regulation - including cultivated meat and precision fermentation - and define what’s needed for science-based risk assessments. Learn how to navigate regulations for faster market access without compromising safety, without compromising on safety and learn from experts on how to build your regulatory strategy.
Vitafoods Europe
We had a fantastic time at Vitafoods Europe, right here in Barcelona! Our team had a great time connecting with so many passionate professionals across the nutraceutical industry. A highlight for team Atova was seeing our CEO, Hannah Lester, take the stage to share her insights on the EU regulatory landscape for health claims. During her talk she explored recent regulatory updates, brought to life through key case studies on nutrient profiles and recent claims. Thank you to everyone who joined her session and connected with us at the conference!
Here we let you know the latest European updates from May 2025, with data retrieved from Open EFSA and the EC Union List of novel foods.
Recent Novel Food Dossier and Traditional Food Notifications Received by EFSA
During May there were two novel food dossier submissions published on Open EFSA.
Application for authorisation of Oleoresin from Nannochloropsis gaditana as a novel food (Received: 02.05.2025)
Application for authorisation of Ubiquinol acetate as a novel food (Received: 11.05.2025)
Recent Validated Dossiers
In total, two novel food applications have recently been validated and have now entered the Risk Assessment stage. It took an average of 6.5 months for the dossiers to be validated.
Name of Product | Dossier Received by EFSA | Validated | Time to Validation | Applicant |
|---|---|---|---|---|
12/10/2024 | 27/05/2025 | 7.5 months | Gnosis S.p.a | |
04/12/2024 | 27/05/2025 | 6 months | Nutri'Earth |
Dossiers Considered Non-valid and Withdrawn
This month there have been six novel food dossier applications considered “not-valid”, terminated due to not notifying studies correctly, or withdrawn by the applicants.
Name of Product | Dossier Received by EFSA | Application Declared Not Valid / Withdrawn | Time to Non-Validity |
15/01/2025 | 05/05/2025 | 3.5 months | |
06/01/2022 | 01/05/2025 | 41 months | |
04/07/2024 | 06/05/2025 | 10 months | |
22/03/2019 | 21/05/2025 | 73 months | |
04/07/2024 | 06/05/2025 | 10 months | |
06/03/2019 | 26/05/2025 | 73.5 months |
EFSA Published Opinions
There were two EFSA published opinions on Open EFSA in May, both being on the novel pathway.
Name of Product | Dossier Received by EFSA | Validated | Opinion Published | Time to Opinion |
03/05/2024 | 13/08/2024 | 14/05/2025 | 12.5 months | |
01/10/2018 | 29/04/2019 | 05/06/2025 | 81 months |
EFSA Public Consultations
There have been five novel food public consultations completed in May.
Application for authorisation of Potato Protein (Low molecular weight) as a novel food
Application for authorization of Mangosteen peel extract as a novel food
Application for authorisation of Mycelium from oyster mushroom, produced via solid-state fermentation of Pleurotus ostreatus as a novel food
Application for authorisation of Plant-based drink from Roasted in-shell Hazelnuts as a novel food
Application for authorisation of Coffee cherry pulp as a novel food
EFSA Working Group
158th Plenary Meeting of the the Scientific Panel on Nutrition, Novel Foods and Food Allergens took place on the 6-7th May where eight draft opinions were discussed. This included those on phenolic compounds in olive oils, safety of Grain from perennial intermediate wheatgrass (Thinopyrum intermedium), safety of the extension of use of oleoresin from Haematococcus pluvialis containing astaxanthin, Allulose, Lacto-N-tetraose Inbiose, safety in use of preparations from the fruits of sweet and bitter fennel (Foeniculum vulgare Mill. and Foeniculum piperitum (Ucria) C.Presl), safety in use of plant preparations containing berberin, and the safety in use of hydroxycitric acid and plant preparations containing hydroxycitric acid. Read the agenda for this meeting here.
Article 4 Novel Food Consultations
There have been 3 Article 4 novel food consultations published on the EC website in May and the start of June. Two of which were deemed not novel and the other considered novel.
Preserved pine cones (Pinus sylvestris) - Not Novel
UK Advisory Committee on Novel Foods & Processes (ACNFP)
The ACNFP meet approximately six times a year. Their next meeting is set to be on Tuesday 24th June 2025. Currently up for discussion will be Fusarium str. flavolapis RP1637, β-lactoglobulin RP1571, Fermotein RP1215, Allulose RP1130, and Genetically modified organism applications RP1745, 2178 and 2242 (reserved business). You can views the agenda here.
The 19th ACNFP_PGT Subcommittee meeting was held on the 13th May. The minutes are not yet released but the agenda is available here.
Food Standards Agency (FSA)
The agenda and papers for the June 2025 Board meeting have now been published. This meeting will be held at 9:00am on Wednesday 18th June and is open for the public to attend. On the agenda for this meeting is the national level regulation, market authorisations reform, updates on the evaluation of the meat charging discount regime and the annual chief scientific adviser's report. View the full agenda here.
US FDA
FDA has unveiled the Chemical Contaminants Transparency Tool (CCT tool), an online searchable database the provides a consolidated list of contaminants (e.g., tolerances, action levels, and guidance levels) that are used to evaluate potential health risks of contaminants in human foods. Chemical contaminants include a broad range of substances such as mycotoxins, heavy metals, pesticides, and other hazardous substances.
US GRAS
Mycelial biomass from Pleurotus pulmonarius (GRN No. 1220)
Intended for use as an ingredient at levels up to 25% (dry mycelium weight/100 g product) in meat, seafood, and fish analogs, dairy analogs (milk, cream, yogurt), processed cheese, ice cream, and baked goods.
Type of novel food - Mycelial biomass
Beta-cassein produced by E. coli DSM 35048 (GRN No.1228)
Intended for use as an ingredient at levels up to 15% in cheese and cheese analogs, non-alcoholic beverages, dairy product analogs, frozen dairy desserts, milk products, and plant protein products
Type of novel food - Protein from precision fermentation
US Food Additive Petitions / Color Additive Petitions
Myoglobin (bovine, from fermentation with Komagataella phaffii) (CAP 2C0322)
For use as a color additive in ground meat and ground poultry analogue products (i.e., plant-based ground meat- and poultry-like food products subject to FDA regulation) where the amount of myoglobin protein does not exceed 2 percent by weight of the uncooked analogue product. The color additive myoglobin is a stabilized product of controlled fermentation of a non-pathogenic and non-toxicogenic strain of the yeast, Komagataella phaffii, genetically engineered to express the myoglobin protein from Bos taurus. Myoglobin protein is the principal coloring component of the color additive and imparts a red color.
Galdieria extract blue, derived from unicellular red algae (Galdieria sulphuraria) (CAP 1C0320)
For use in various food categories at levels consistent with good manufacturing practice (GMP). Food categories: non-alcoholic beverages and beverage bases, fruit drinks, fruit smoothies, fruit juices, vegetable juices, dairy-based smoothies, milk shakes and flavored milks, yogurt drinks, milk-based meal replacement and nutritional beverages, breakfast cereal coatings, hard candy, soft candy and chewing um, flavored frostings, ice cream and frozen dairy desserts, frozen fruits, water ices and popsicles, gelatin desserts, puddings and custards, whipped cream, yogurt, frozen or liquid creamers (including non-dairy alternatives), and whipped toppings (including non-dairy alternatives).
Butterfly pea (Clitoria ternatea) flower extract (CAP 4C0328)
For coloring alcoholic beverages, sport and energy drinks, flavored or carbonated water, fruit drinks (including smoothies and grain drinks), carbonated soft drinks (fruit-flavored or juice, ginger ale, and root beer), fruit and vegetable juice, nutritional beverages, chewing gum, teas, coated nuts, liquid coffee creamers (dairy and non-dairy), ice cream and frozen dairy desserts, hard candy, dairy and non-dairy drinks, fruit preparations in yogurts, and soft candy in amounts consistent with good manufacturing practice, except that it may not be used for coloring foods for which standards of identity have been issued under section 401 of the Federal Food, Drug, and Cosmetic Act, unless the use of added color is authorized by such standards.
US-CCC Pathway Updates
Cultured salmon cell material, Oncorhynchus kisutch (CCC No. 005)
Wildtype Inc. has received a No Questions letter from the FDA for its cell-cultured salmon. This is the 4th Cell Culture Consultation (CCC) to receive a positive outcome from the FDA, and the second one this year. Wiildtype's pre-market approval application was submitted to the FDA on June 2022. Based on the information Wildtype presented to FDA, as well as other information available to the agency, the FDA has "no questions at this time regarding Wildtype's conclusion that food comprised of or containing cultured salmon cell material resulting from the production process defined in CCC 000005 are safe as comparable foods produced by other methods".
Food and Agriculture Organisation of the United Nations
World Health Organization
Norway
Thailand
The Food and Drug Administration (FDA) released Ministry of Public Health (MOPH) Notification No. 456 B.E. 2568 (2025) Re: Labeling of Certain Processed Foods. The new requirements—which apply to seven food product categories -took effect on May 3, 2025. Existing labels may remain in use for up to two years from that date.
Australia
New video: Dietary exposure assessment
Check out this latest video for a simple overview of how dietary exposure to food chemicals and nutrients is estimated. This explainer video also complements the Food Standards Australia New Zealand (FSANZ) updated Principles and Practices of Dietary Exposure.
FSANZ has approved variations arising from the following applications and proposal on 30 April 2025. FSANZ has notified this approval to the Food Ministers’ Meeting:
A1279 – Lentinula edodes (Shiitake mushroom) mycelia as a processing aid
A1307 – Milk fat globule membrane as a nutritive substance in infant formula products
A1308 – 2′-FL from GM Escherichia coli W in infant formula products
A1310 – Food derived from insect-protected soybean line MON94637
A1311 – Prolyl oligopeptidase from GM Trichoderma reesei as a processing aid
P1064 – Australian only Infant Formula Product Standard
Once FSANZ has notified the Food Ministers’ Meeting of its decision, it has 60 days to either request FSANZ to review the approved standard or inform FSANZ that it does not intend to request a review.
New publication: Safe Food Australia - A guide to the food safety standards
This edition contains an added chapter on Standard 3.2.2A, a food safety standard for food service, caterer and related retail businesses that became enforceable from December 2023.
Japan
The Japanese Association for Cellular Agriculture has submitted a paper “Risk Assessment and Management Policies for Cell-Based Foods in Japan“ to the Food Safety Standards and Evaluation Division of the Consumer Affairs Agency, before they finalise a guideline draft regulatory safety review points for cell-cultured foods on which will be made by the end of this summer.
Israel
New industry guidelines have just been released for precision fermentation by the Food Control Service Ministry of Health. These new guidelines focus on data to amend the identity of an approved production strain with an existing novel food petition with daughter strains directly derived from the approved microorganism. The full information is available here in Hebrew.
Subscribe to keep up-to-date with all the major regulatory updates & news:
Comentarios