• Skip to main content
  • Skip to primary sidebar

dsm-firmenich secures 3-fucosyllactose market access in the European Union

Asia Food Journal
  • Home
  • Latest News
  • Channels
    • Packaging
    • Processing
    • Ingredients
    • Industry
    • Automation
    • Guest Posts
    • Market Trends
  • Subscribe
  • Advertise
  • Event Calendar
  • Contact Us
    • Submit Guest Posts
Share
Leaderboard of Asia Food Journal




dsm-firmenich secures 3-fucosyllactose market access in the European Union

December 14, 2023 by Asia Food Journal

3-fucosyllactose

Courtesy of Jonathan Borba/Unsplash

dsm-firmenich, a leading innovator in health, nutrition, and beauty, announced that it has secured market access for its 3-fucosyllactose (3-FL) human milk oligosaccharide (HMO) ingredient in the European Union (EU). The European Commission’s approval of 3-FL for use as a novel food ingredient in the EU is a result of a Novel Food application by Glycom A/S*. This breakthrough represents a major step towards enhancing market access for a wider portfolio of high-quality HMO products for use in the early life nutrition, conventional food, and dietary supplement segments. 

This milestone achievement follows the recent publication of a positive Scientific Opinion from the European Food Safety Authority (EFSA) Panel on Nutrition, Novel Foods and Food Allergens adopted on 27 April 2023. This opinion validates 3-FL produced by a derivative strain of Escherichia coli K-12 DH1 as a novel food in accordance with Regulation 2015/2283.[1] 

Leaderboard of Asia Food Journal

dsm-firmenich’s 3-FL, commercially marketed as GlyCare™ 3FL 9001, received authorization for use in a variety of foods, including infant formula, follow-on formula, conventional foods, food for special medical purposes, and food supplements. Notably, dsm-firmenich’s 3-FL ingredient has been granted a higher maximum use level of 1.75 g/L for use in infant and follow-on formula, compared to levels approved previously for other 3-FL manufacturers, which ranged from 0.85 – 1.20 g/L. 

The distinction between different approved use levels in these food categories will remain in force for the duration of the five-year exclusive approval period that has been granted to dsm-firmenich’s 3-FL. 

Only after the exclusivity period ends, the highest approved use level will apply across all different sources of approved 3-FL. The authorization of the higher use level was made possible thanks to dsm-firmenich’s recent review on the mean concentration of HMOs in global pooled human milk, which included updated summary statistics for 3-FL.[2] 

Christoph Röhrig, Head of the global HMO Regulatory Affairs team at dsm-firmenich, commented: “As a company devoted to creating healthier product choices, we’re excited to be at the forefront of advancements in early life nutrition with our science-backed 3-FL ingredient. 3-FL is one of the most abundant fucosylated HMOs in human milk, and scientific studies have demonstrated its promising potential to support immunity, gut health, and potentially cognitive development.” 

Marta Miks, Senior Regulatory & Scientific Affairs Manager at dsm-firmenich, added: “The recent regulatory approval of 3-FL as a novel food in the EU means the ingredient joins our existing authorized portfolio of six HMOs in the region, including 2’-fucosyllactose (2′-FL), lacto-N-neotetraose (LNnT), difucosyllactose (DFL), lacto-N-tetraose (LNT), 3’-sialyllactose (3’-SL) sodium salt and 6’-sialyllactose (6’-SL) sodium salt. 3-FL stands out among other fucosylated HMOs as a distinctive component found in all maternal milks worldwide, because unlike most HMOs, 3-FL levels exhibit a gradual increase throughout the course of lactation. Addition of 3-FL may not only bring formula products closer to that of human breast milk but also create an opportunity for tailored innovation in age-appropriate solutions for early-life nutrition. This is especially exciting, as emerging evidence indicates that HMOs may support the gut microbiota and immunity across the lifespan.[3] 

“As an end-to-end partner and the global leader in HMO regulatory approvals, we’re immensely proud to be leading the way in HMO innovation and look forward to supporting more customers in the EU with HMO customized solutions and expert services.” 

To learn more about dsm-firmenich’s portfolio of next-generation HMOs and the research behind these unique ingredients, visit: https://www.dsm.com/human-nutrition/en/products/hmos/hmos-for-early-life.html   

[1] Safety of 3-fucosyllactose (3-FL) produced by a derivative strain of Escherichia coli K-12 DH1 as a novel food pursuant to Regulation (EU) 2015/2283 https://efsa.onlinelibrary.wiley.com/doi/10.2903/j.efsa.2023.8026

[2] Soyyilmaz et al. The Mean of Milk: a review of human milk oligosaccharide concentrations throughout lactation. Nutrients, 2021.

[3] Šuligoj T, Vigsnæs LK, Abbeele PVD, Apostolou A, Karalis K, Savva GM, McConnell B, Juge N. Effects of Human Milk Oligosaccharides on the Adult Gut Microbiota and Barrier Function. Nutrients. 2020 Sep 13;12(9):2808.

*Glycom A/S is ultimately controlled by DSM-Firmenich AG, registered in Kaiseraugst, Switzerland.  

About dsm-firmenich

As innovators in nutrition, health, and beauty, dsm-firmenich reinvents, manufactures, and combines vital nutrients, flavors, and fragrances for the world’s growing population to thrive. With our comprehensive range of solutions, with natural and renewable ingredients and renowned science and technology capabilities, we work to create what is essential for life, desirable for consumers, and more sustainable for the planet. dsm-firmenich is a Swiss-Dutch company, listed on the Euronext Amsterdam, with operations in almost 60 countries and revenues of more than €12 billion. With a diverse, worldwide team of nearly 30,000 employees, we bring progress to life™ every day, everywhere, for billions of people.

www.dsm-firmenich.com

Other Topics: 3-fucosyllactose, dsm-firmenich, healthy ingredients, Ingredients, natural ingredients

Related Articles

  • coloring foods

    GNT offers a full spectrum of EXBERRY® Coloring Foods made from non-GMO fruits, vegetables, and plants/Courtesy of GNT Group

    GNT hails China’s new industry standard for Coloring Foods
  • Protein soda

    Courtesy of Arla Foods Ingredients

    Arla Foods Ingredients showcases protein soda concept at Vitafoods Europe
  • CURCUSHINE

    Courtesy of Lubrizol

    New study: CURCUSHINE™ improves skin rejuvenation from the inside-out
  • açaí-flavored solutions for gelato and beverages

    Courtesy of Prodotti Rubicone

    When made in Italy meets superfood: Prodotti Rubicone launches two açaí-flavored solutions for gelato and beverages
  • nutirition solutions

    Courtesy of Wunder Visuals/iStock

    Prinova highlights great-tasting, on-trend nutrition solutions at Vitafoods Europe
  • brine injection

    Courtesy of Kemin Industries

    Kemin Food Technologies – North America announces issuance of new U.S. patent for the first brine injection without phosphates and low/no salt
Leaderboard of Asia Food Journal

Primary Sidebar

Stay Connected

Your browser does not support the video tag. Learn More




🔥 Trending News

Blue Bottle Coffee announces opening of first Southeast Asian outlet in LUMINE
Farmlore in Bengaluru is unveiled as the winner of the American Express One to
Syensqo achieves breakthrough in mechanical recycling of PVDC multilayer
Blue Bottle Coffee announces opening of first Southeast Asian outlet in LUMINE

Trending News

Subsribe to Our News Letter

Subscribe To
Our Newsletter


By submitting this form, you consent to receive marketing emails from Asia Food Journal. You can revoke your consent to receive emails at any time by using the SafeUnsubscribe® link, found at the bottom of every email.

© 2025 Harvest Information. All rights reserved. Privacy Policy.

Become an F&B industry insider

Your go-to resource for all the latest trends, innovations, and news about the food and beverage industry!

 

By submitting this form, you consent to receive marketing emails from Asia Food Journal. You can revoke your consent to receive emails at any time by using the SafeUnsubscribe® link, found at the bottom of every email.

Disclaimer: Translations on this website are automated using Google Translate. While we strive for accuracy, please be cautious, as machine translations may contain errors. For critical or sensitive content, consider seeking professional human translation. We are not liable for any reliance on the translated content.