The European Commission has adopted a regulation amending the Annex to Regulation (EU) No 231/2012 to include specifications for rebaudioside M produced via enzymatic conversion of highly purified rebaudioside A stevia leaf extract (E 960c(ii)) using the genetically modified yeast *K. phaffii* CGMCC 7539. The amendment updates the specifications for the food additive 'enzymatically produced steviol glycosides' (E 960c), following an application submitted on 22 December 2022 and subsequently revised by the applicant.
The European Food Safety Authority (EFSA) published a scientific opinion on 14 May 2025 concluding that the proposed amendment raises no safety concerns. EFSA recommended introducing a specific entry for kaurenoic acid in the specifications. The regulation enters into force on the twentieth day after its publication in the Official Journal of the European Union and is binding in its entirety and directly applicable in all Member States.
Policy orientations and trade-offs The regulation expands the authorised production methods for rebaudioside M, a high-intensity sweetener derived from stevia, by allowing the use of a genetically modified yeast strain. This decision balances innovation in food technology with consumer safety, as EFSA's positive opinion confirms the additive's safety under the proposed conditions. The inclusion of a specific specification for kaurenoic acid addresses a recommendation to ensure purity and quality control.
Impact on stakeholders - EU food additive producers: Gain access to a new, potentially more efficient production method for rebaudioside M, which could reduce costs and increase supply. However, they must comply with the updated specifications and may face initial investment in adapting production processes. - EU food and beverage manufacturers: Benefit from a wider range of approved sweeteners, enabling product reformulation to meet consumer demand for reduced-sugar products. The new method may offer a more consistent and scalable supply. - EU consumers: May see more products containing steviol glycosides, with no expected safety risks based on EFSA's assessment. However, some consumers may have concerns about the use of genetically modified organisms in food production. - EU regulatory authorities: Must ensure compliance with the new specifications and monitor the market for any issues. The regulation simplifies the regulatory framework by updating a single annex.
Institutional follow-up The regulation is adopted by the European Commission and does not require further approval from the Council or the European Parliament, as it is a technical amendment to existing legislation. It will be published in the Official Journal and become binding shortly thereafter.