Updated GMO testing recommendations for soy and wheat
Reliable exclusion of HB4 soy and HB4 wheat
April 2026 (update). Eurofins GeneScan, Competence Centre for GMO analysis within the global Eurofins laboratory network, is enhancing its existing GMO analysis strategies for soy with a new, sensitive detection method. This allows you to exclude HB4 soy, which is not authorised in the EU, and improve the safety of your raw materials and processed products.
Overview of HB4 wheat and HB4 soy
The genetically modified organisms (GMOs) HB4 wheat (IND‑ØØ412‑7) and HB4 soy (IND‑ØØ41Ø‑5) were developed by Bioceres Crop Solutions in cooperation with various development partners, including Verdeca. Both GMOs contain the HaHB4 gene, sourced from sunflower, which confers increased tolerance to drought stress. In addition, another gene was introduced in each case, which causes tolerance to the herbicide glufosinate. Because of these genetic characteristics, HB4 plants are of particular agronomic interest for more southerly regions where droughts occur regularly or are increasing.
Approval situation of HB4 wheat and HB4 soy
Neither of the two HB4 events is currently authorised in the European Union. An initial application for authorisation of HB4 soy was withdrawn, and a further application for "low-level presence" was subsequently submitted in 2025. No application for authorisation has yet been filed for HB4 wheat. As both GMOs lack EU approval, a zero‑tolerance in food and feed applies.
However, in numerous countries outside Europe, both HB4 wheat and HB4 soy are authorised for cultivation and for use in food and feed.
Cultivation of HB4 wheat and HB4 soy
According to a report by the United States Department of Agriculture (USDA), HB4 wheat was cultivated in 2024 under the supervision of the National Seed Institute (INASE) on nearly 50,000 hectares in Argentina. A more recent USDA report from December 2025 also points to ongoing test cultivation of HB4 wheat in Brazil. HB4 soy has likewise been cultivated under IP‑protected conditions, according to a 2023 USDA report. The combination of cultivation activities in exporting countries and the lack of EU authorisation makes robust monitoring essential, particularly for wheat and soy supply chains.
Adaptation of existing GMO analysis strategies for soy
HB4 soy is already detected by current screening strategies, such as CaMV-35S-promoter-screening or nos-terminator-screening, as well as through the screening packages “SoyScreen” and “TripleScreen” offered by our Competence Centre for GMO testing. If the screening results are positive, the new detection method allows for the unambiguous exclusion of this GMO, which is not authorised in the EU.
With the integration of this test, Eurofins GeneScan, Competence Centre for GMO testing within the global Eurofins laboratory network, has expanded its analytical strategies for soy for you. The reliable exclusion of HB4 soy contributes to improved supply chain security, particularly given the cultivation history of this species outside Europe and the continued 0% tolerance for this unauthorised GMO in the EU.
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References
[1] OpenEFSA Dossier May 2025: Application for authorisation of genetically modified IND-ØØ41Ø-5 soybean for low level presence in accordance with Regulation (EC) No. 1829/2003 (AP196)
[2] USDA, Foreign Agricultural Service Report Nov 2024: Agricultural Biotechnology Annual, Argentina
[3] USDA, Foreign Agricultural Service Report Dec 2023: Agricultural Biotechnology Annual, Argentina
[4] USDA, Foreign Agricultural Service Report Dec 2025, Biotechnology and Other New Production Technologies Annual, Brazil
Written by:
Ulf Rathjens
Eurofins GeneScan GmbH