EU Authorises Genetically Modified Soybean DBN-09004-6 for Food and Feed Use

Aspect	USA	EU	Australia	China	India
Regulatory Authority	FDA (U.S. Food and Drug Administration)	EFSA (European Food Safety Authority) & European Commission	FSANZ (Food Standards Australia New Zealand)	SAMR (State Administration for Market Regulation)	FSSAI (Food Safety and Standards Authority of India)
Major Regulation Governing Compliance	21 CFR Part 106 & 107 – Infant Formula Regulations	Regulation (EU) No 609/2013 on Foods for Specific Groups (FSG)	Australia New Zealand Food Standards Code	GB Standards (e.g., GB 10765-2021) for infant formula	Food Safety and Standards (Foods for Infant Nutrition) Regulations, 2019
Pre-market Approval Required?	Yes – Manufacturer registration and notification	Yes – Pre-market notification and composition review	No – Comply with standards, but no pre-approval	Yes – Mandatory registration with SAMR	Yes – Prior approval and product registration required
Labeling Requirements	Must meet strict CFS 21 Part 107 labeling and nutritional information requirements for infant formula.	Must comply with harmonized EU labeling rules, including allergens, nutrition info	Must comply with FSANZ labeling codes	Must follow GB labeling standards, including mandatory warnings	Must follow specific infant food labeling rules under FSSAI
Nutritional Composition Requirements	Specific nutrient content, quality control & Good Manufacturing Practices (GMP) required	Detailed compositional criteria for energy, protein, vitamins, and minerals	Must meet nutrition content standards specified by FSANZ	Stringent GB compositional standards; new updates in 2021	As per Schedules under FSSAI regulations, modeled on Codex guidelines
Claims Allowed	Limited; FDA approval required for structure-function or health claims	Only EU-authorized claims permitted; No health or nutritional claims on infant formula	Functional and nutrient claims allowed within Regulatory limits	Strict control; health/nutritional claims require SAMR review	Only pre-approved nutrition claims allowed; therapeutic claims not permitted
Clinical Evidence Required?	Yes – Especially for new formulations or ingredients	Yes – EFSA scientific dossier for novel ingredients or composition	Required for novel ingredients or changes in nutrient bioavailability	Yes – For new products or ingredient combinations	Yes – If deviating from standard composition or for novel formulations
Timeline for Registration	~6–12 months, depending on product review	~12–18 months, including EFSA evaluation	~3–6 months for market entry if compliant	~18–24 months, including safety and technical review	~12–18 months for full Regulatory clearance
Need for Local Representative	Yes	Yes	No	Yes	Yes

March 10, 2026

The European Commission adopted an implementing decision on 10 March 2026 authorising the placing on the market of genetically modified soybean DBN-09004-6 (unique identifier DBN-Ø9ØØ4-6) for food and feed uses in the European Union. The authorisation was granted under Regulation (EC) No 1829/2003.
The application was submitted on 20 December 2019 by Perseus BV on behalf of Beijing DaBeiNong Biotechnology Co., Ltd., requesting approval for foods, food ingredients, and feed containing, consisting of, or produced from the genetically modified soybean. The application also covered products containing or consisting of the soybean for uses other than food and feed, such as import and processing, but excluded cultivation within the EU.

Following the risk assessment process, the European Food Safety Authority issued a favourable scientific opinion on 7 July 2025, concluding that GM soybean DBN-09004-6 is as safe as its conventional counterpart and non-genetically modified reference varieties with regard to potential impacts on human health, animal health, and the environment. EFSA also determined that the consumption of food and feed derived from this soybean does not raise nutritional concerns.

The decision allows the marketing of:

Food and food ingredients containing, consisting of, or produced from GM soybean DBN-Ø9ØØ4-6

Feed containing, consisting of, or produced from the GM soybean

Products containing or consisting of the GM soybean for non-food and non-feed uses, excluding cultivation

In accordance with EU GMO traceability and labeling requirements under Regulation (EC) No 1830/2003, products must comply with existing GMO labeling rules. Additionally, products containing or consisting of the GM soybean must include the statement “not for cultivation” on labels and accompanying documents, except for food and food ingredients.

The authorisation holder is Beijing DaBeiNong Biotechnology Co., Ltd., represented in the European Union by Perseus BV. The company must also implement an environmental monitoring plan and submit annual monitoring reports to the European Commission in line with Commission Decision 2009/770/EC.

The authorisation will remain valid for 10 years, and the details will be recorded in the EU Community Register of Genetically Modified Food and Feed.

Source

https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32026D0517&qid=1765…

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Consumer News Tags

EU, GMO regulation, Soyabean DBN-090046, authorisation renewal

Aspect	USA	EU	Australia	China	UAE
Regulatory Authority	FDA	EFSA & Member State Authorities	FSANZ	SAMR & NHC	ESMA & MOHAP
Major Regulation Governing Compliance	Federal Food, Drug, and Cosmetic Act (FFDCA); 21 CFR Part 110 (Current Good Manufacturing Practices)	Regulation (EC) No 178/2002 (General Food Law); Regulation (EU) No 1169/2011 on Food Information to Consumers	Food Standards Code (Australia New Zealand Food Standards Code)	Food Safety Law of the People's Republic of China (Revised 2015); GB Standards for Food Safety	UAE.S GSO 9:2017 (GCC General Requirements for Prepackaged Food)
Pre-market Approval Required?	No pre-market approval except for novel ingredients, color additives, or specific claims	No pre-market approval for general foods, but novel foods or health claims require EFSA approval.	No pre-market approval unless it's a novel food or makes health claims	Pre-market registration is required for novel foods, health foods, or products with new ingredients	Pre-market approval is required for certain foods, health products, and products with new ingredients
Processed Food Labeling Compliance /Labeling Requirements	Mandatory labeling as per FDA guidelines (Nutrition Facts, Ingredient Declaration, Allergens)	Must comply with EU Food Information Regulation (1169/2011); includes allergens, nutrition, and origin labeling.	Must follow FSANZ Food Standards Code for labeling; nutrition panels, allergens, and ingredient lists required	Must follow GB 7718-2011 (National Food Safety Standards) for labeling; mandatory nutrition facts, allergens, and shelf-life	Must follow GSO 9:2017 for pre-packaged food labeling; Arabic labeling, allergens, and nutrition facts required
Timeline for Registration	No fixed timeline: products can enter the market once compliant	No formal registration unless novel food; EFSA approval for health claims takes 12-18 months	No formal registration unless it's a novel food or makes health claims	Typically, 12-24 months for novel foods, shorter for regular processed foods	Approval may take 6-12 months for certain products. Regular processed foods can enter the market once label approval is obtained

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Pre-market Approval Required?	Yes [Pre-market Tobacco Product Application (PMTA) for vaping products; drug approvals for nicotine gum)	Yes (Novel Food approval for some products; TPD notification for tobacco products)	Yes (Therapeutic Goods Administration approval)	Conventional tobacco products – not subject to registration; Nicotine products – approval required from Drug Authorities; Vapes/e-cigarettes – not applicable	Yes (Registration and conformity assessment required)
Labeling Requirements	FDA labeling rules for tobacco and nicotine products, including warnings	EU TPD labeling requirements, health warnings	TGA labeling for therapeutic/tobacco products	Labeling requirements as per MoHFW, including warnings and prescribed content	Mandatory health warnings and labeling per ESMA/MOHAP
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