ATOVA Regulatory Consulting, SLU

🚨Have your say... Public consultation on draft EFSA microorganism guidance! The European Food Safety Authority (EFSA) has just published a draft guidance on the characterisation and risk assessment of 🦠 microorganisms used in the food chain! 🧫 This guidance document is highly relevant to #precisionfermentation derived ingredients produced using genetically modified microorganisms as well as microbial biomasses in terms of future requirements to support identity and safety of microorganisms used in the food chain. Interested parties can submit feedback until 7th February 2025. To access the draft guidance: https://lnkd.in/d_YMd3v5 #novelfood #futureoffood #foodsafety

🚨🚨 Important news... EFSA opinion on Soy leghemoglobin as a GM Food! The European Food Safety Authority (EFSA) has just published their scientific opinion on soy leghemoglobin as a GM food! 🌱The GMO Panel did not identify safety concerns regarding the toxicity and allergenicity of soy leghemoglobin protein as expressed in K. phaffii. 🌱They did not finds any evidence that the genetic modification would change its overall allergenicity. 🌱 The GMO Panel concluded that the the soy leghemoglobin is safe for human consumption with regard to the effects of the genetic modification. 🌱 No environmental impact from the use of this product is expected regarding the recombinant DNA sequences possibly remaining in the product. ⏰ It has taken around five years from submission to the EFSA opinion being published. This opinion complements the other EFSA opinion published in June of this year for its use as a food additive: https://lnkd.in/dZRNrNFs The opinion for use as a food additive was provisional pending the opinion from the GMO Panel. Soy leghemoglobin has been concluded as being safe by both the EFSA Panel on Food Additive and Flavourings and the Genetically Modified Organism panel. However, now comes the risk management phase! It will be interesting to see how this ingredient gets on at the Standing Committee on Plants, Animals, Food and Feed.... Watch this space! Read in full here: https://lnkd.in/dVxcs7t3

🚨 New Article 4 Novel Food Consultation for Chaga (Inonotus obliquus) fungus! An Article 4 novel food consultation was submitted to the Finnish 🇫🇮 competent authority regarding the use of Chaga (Inonotus obliquus) as a food ingredient. 📊 Highlights: ➡ Chaga is the conk (fruiting body) of a fungus (Inonotus obliquus) found commonly on birch trees. ➡ Chaga can be obtained from trees naturally hosting chaga or it can be cultivated by grafting the mycelium onto trees. ➡ The chaga is removed from the tree, cleaned, chopped and then frozen or dried. The dried chaga is ground or used in preparation of an extract, which can also be freeze-dried into a powder. ➡ European Commission and member States were consulted. Interestingly, even though Chaga has been used in the preparation of tea and coffee substitutes during the 19th century and during wartime, the use of Chaga as a food has not been used continuously since this time. As such, Chaga did not meet the criteria of “Human Consumption to a Significant Degree”. If a food was used long time ago, but the use is not continuous, the history of consumption cannot be considered as significant. Moreover, the document states that products that have been available during times of emergency, but are not regularly and commercially available, should also be considered as novel foods. It is important to note that Chaga is not novel when used in food supplements in the EU. ❌ Conclusion: Novel (Category (2)(a)(ii) food consisting of, isolated from, or produced from microorganisms, fungi, or algae) 🔗 https://lnkd.in/dCc29xjQ #novelfood #EUregulations #foodsafety

🚨 New Article 4 Novel Food Consultation for non-isolated fulvic acid! An Article 4 novel food consultation was submitted to the Lithuanian 🇱🇹competent authority regarding the use of “non-isolated fulfil acid” in food supplements. 📊 Highlights: ➡ It is a concentrate of fulvic acids in a natural form extracted from raw material of organic origin using pure water. ➡ No chemicals are used in the production process. ➡ The non-humate plant source used in formulations is harvested, dried and ground to a fine powder that is not chemically processed and contains non-isolated fulvic acid. ➡ No evidence to support human consumption to a significant degree within the Union before 15 May 1997. ➡ European Commission and member States were consulted. ❌ Conclusion: Novel (The food falls under category (iv) (food from plants or their parts) of Article 3(2)(a) of Regulation (EU) 2015/2283). 🔗 https://lnkd.in/dkqBNMBv #novelfood #EUregulations #foodsafety

🧬 EFSA Roadmap for Omics in Regulated Product Risk Assessment The European Food Safety Authority (EFSA) has launched an initiative to integrate omics technologies and bioinformatics into food and feed risk assessments, aiming to strengthen scientific evidence and guidance. The roadmap, developed through a recent call, outlines six project proposals to expand omics applications, addressing current knowledge gaps and exploring potential benefits across regulated product areas. By identifying key actions, challenges, and collaboration opportunities, EFSA envisions a broader and more impactful use of omics in regulatory science. This approach promises to advance EFSA’s capabilities to utilise and integrate the most up-to-date tools for risk assessments. Read in full here:https://lnkd.in/dGsvhUVs #FoodSafety #Omics #EFSA #Innovation

🎬 Regulating the Future of Food 2024 - That's a wrap! It was fantastic to catch up with new and familiar faces at the Regulating the Future of Food Conference 2024 last week. Collaboration and knowledge sharing are crucial to supporting food safety and innovation in food tech. We thank all our conference participants, speakers and workshop organisers for sharing their excellent input, questions and insights. 🌟 Team work makes the dream work, as they say! We’d like to thank our co-organisers Vireo Advisors, LLC for their invaluable support in organising and facilitating the event. We also extend our gratitude to the Future-Proof Group Media for their role in organising the co-located The Future of Protein Production event. 💡 We will be sharing more conference insights to inform future decision-making towards gaining regulatory approval for novel foods and alternative proteins. ✅ Stay up to date on regulatory developments and insights in the food tech space by subscribing to our updates here: https://lnkd.in/des85Kr8 Big thank you to: Anna Handschuh, Ira van Eelen, Kimberly Ong, Jo Anne Shatkin, Ida Aabrandt Søndergaard, Lucie McMurtry, Lucie Racault, Henk Hoogenkamp, Vince Sewalt, John-Felipe Murphy, Lauran Madden, Karolina Trakselyte-Rupsiene, Mary-Liis Kütt, Siska Ten Hoeve, Megumi Avigail Yoshitomi, Naya McCartney, PhD, Kathleen Slingerland, Yoonchan Hwang, Catherine Elton, Cai Linton, Johan Jacobs, Hrönn Arnardóttir, Géssica Silveira, Kim Tonnet (nee Staples), Marcel Wubbolts, Will Van den Tweel, Alex Holst, Valeria Teloni, Alberto Del Rio, Robyn Eijlander, Rosario Romero, Joe Humphreys, Caroline Idowu 🙌💚 #RFF24 #novelfood #futureoffood #foodregulations

💡 Global innovation in foodtech continues to grow at a rapid pace, making it vital for innovators to stay up-to-date on regulatory frameworks and developments. 🎤  Ahead of next week’s Regulating the Future of Food Conference, speakers Ida Aabrandt Søndergaard (Solar Foods) and Mary-Liis Kütt (ÄIO) share their views on the conference sessions and why open channels of communication are essential for a smoother regulatory process. Read in full here: https://lnkd.in/dyQxT4kd Co-located with The The Future of Protein Production and organised in collaboration with Vireo Advisors, LLC, this two-day regulatory event promises exclusive talks by top regulatory experts, panel discussions, deep-dive workshops and networking sessions. 📅 Date: 23rd & 24th October 🏢 Location: RAI, Amsterdam Get your tickets to the Regulating the Future of Food Conference now: https://lnkd.in/gwUWNm-w #EFSA #foodinnovation #futureoffood #foodsafety

📢 Important Update: EFSA Guidance on Microorganism Characterisation in Food Chain Risk Assessment The European Food Safety Authority (EFSA) has prepared a draft "Guidance on the Characterisation of Microorganisms in Support of the Risk Assessment of Products Used in the Food Chain" (EFSA-Q-2024-00438). This critical document is currently under review by relevant Scientific Panels for endorsement. Next steps? The draft will be presented to all the relevant Scientific Panels for endorsement before it will be discussed for endorsement for public consultation during the 122nd Plenary Meeting, which is open to observers. 🗓️ Key Deadlines: In-person observer registration: 3rd November Online observer registration: 10th November 🔗 Agenda and all items (open to observers): https://lnkd.in/dd6Ma5yV Don't miss this opportunity to stay informed and contribute to the future of food safety! #EFSA #FoodSafety #RiskAssessment #ScientificCommittee #Microorganisms #FoodChain #PublicConsultation

🧭 Updated EFSA novel food guidance - What’s new? The European Food Safety Authority (EFSA) recently published a series of highly anticipated updates to their guidance documents, offering clarifications that will help applicants build a more comprehensive dossier. In total four documents were published: 🖊   Administrative Guidance for the preparation of novel food applications 🧬 Guidance on the scientific requirements for an application for authorisation of a novel food 🌱 Guidance on the scientific requirements for a notification and application for authorisation of traditional foods 💊 Guidance on scientific principles and data requirements for the safety and relative bioavailability assessment of new micronutrient sources 👩🏫 As promised, we have summarised the key takeaways from the novel food scientific and administrative guidance: ⇨ The guidance has been updated to reflect technological advances in novel foods. ⇨ Overall, EFSA’s guidance is more comprehensive and has closed some of the key grey areas that were an issue with the old guidance. ⇨ EFSA has drawn from recent risk assessments and has used these learnings to inform this update. They refer to several of their risk assessments throughout the guidance to help applicants. ⇨ Both the admin and scientific guidance will apply from 1 February 2025, but in the case of the administrative guidance, EFSA encourages applicants to already start applying this guidance. Here at ATOVA, we welcome these updates and believe the expanded requirements and clarifications will help applicants build a more comprehensive dossier. However, there are still grey areas, especially when it comes to which analyses to perform and which methods to use. 🧭 In our opinion, some grey areas are not a bad thing as this leaves a certain amount of flexibility for an applicant to justify their own approach. 🙋♀️ Do you think the guidance have provided enough clarification to help applicants and speed up EFSA validation and risk assessment timelines? 🖊 We’d love to hear your thoughts in the comments! 👩💻 Read more about the updates in our latest blog post here: https://lnkd.in/dYaqy7jH #EFSA #Novelfood #foodinnovation

🚨 New Article 4 Novel Food Consultation for lactose derived from whey with degraded riboflavin! An Article 4 novel food consultation was submitted to the Irish 🇮🇪 competent authority regarding the use of “Lactose BlueLight”, a white powder consisting of ≥99% lactose. Lactose is a food ingredient generally available in two forms; yellow lactose, which contains minor levels of vitamin B2 (riboflavin) imparting a yellow colour, and white lactose from which the riboflavin has been removed. Lactose BlueLight is obtained by extraction and purification from whey using standard methods, with the riboflavin degraded by exposure to blue light in the visible range rather than its removal by mechanical filtration with activated carbon filters. 📊 Highlights: ➡ Lactose derived from whey has been consumed to a significant degree as a food ingredient in the EU prior to 1997. ➡ The manufacturing process of Lactose BlueLight is the same as that for the existing ingredient, except for the use of blue light in the visible range to remove the riboflavin content. ➡ The use of blue light exposure has no appreciable impact on the composition, nutritional value or level of undesirable substances of the final lactose product. ✅ Conclusion: Not novel 🔗 https://lnkd.in/d9VuNidy #novelfood #foodregulations #futureoffood