New production process for sweetener E 960c(ii): what changes for the food industry

Key data

Food additive manufacturers and beverage and food sector companies working with stevia sweeteners have a regulatory update to manage. The Regulation (EU) 2026/2309, published on 19 October 2026, expands the authorized production methods for the additive E 960c(ii), rebaudioside M, incorporating an enzymatic synthesis route based on genetically modified yeast.

The standard modifies the annex of Regulation (EU) No. 231/2012, which establishes the technical specifications of food additives listed in Annexes II and III of Regulation (EC) No. 1333/2008. No previous method is eliminated: a new production route with its own technical requirements is added.

What does this regulation establish?

The central change is the authorization of a new process for obtaining rebaudioside M through enzymatic conversion. Until now, the specifications for E 960c(ii) contemplated production from stevia leaf extracts by conventional routes. The new standard adds the following route:

The modification maintains EU food safety standards and does not alter the status of E 960c(ii) as a naturally derived sweetener. What changes is the biotechnological route permitted to obtain it, which opens the door to more scalable and efficient production processes for the industry.

Economic and operational impact

For companies, this regulation has two readings: opportunity and obligation.

Opportunity: Additive manufacturers already working with enzymatic biotechnology can access a potentially more efficient and scalable method of producing rebaudioside M than conventional stevia leaf extraction. Enzymatic conversion from highly purified rebaudioside A can result in higher yields and lower variability in the quality of the final product.

Obligation: Any company wishing to use E 960c(ii) produced by this new route must ensure that its process complies exactly with the technical specifications of Regulation (EU) 2026/2309. This involves:

• Verifying that the microorganism used is specifically Komagataella phaffii CGMCC 7539 and not another strain.
• Updating the technical documentation of the additive (specification sheets, certificates of analysis).
• Reviewing the labeling of final products incorporating this additive, particularly the declaration of the production method if applicable.
• Adapting traceability systems to reflect the new route of obtaining.

Companies already using E 960c(ii) by previous methods are not obligated to change their process, but they must ensure that their documentation correctly distinguishes the production route used.

Who does it affect?

• Food additive manufacturers that produce or import rebaudioside M (E 960c(ii)) for use in the EU.
• Beverage industry (soft drinks, energy drinks, flavored waters) that formulate with stevia sweeteners.
• Food manufacturers (dairy, bakery, sauces, functional foods) that use E 960c(ii) as a sweetener.
• R&D and regulatory departments of food companies that manage additive compliance.
• Food additive importers that bring E 960c(ii) produced with the new process from third countries to market it in the EU.
• Laboratories and quality control companies that certify food additive specifications.

Practical example

A Spanish sugar-free beverage manufacturer uses the sweetener E 960c(ii) in its soft drink line. Until now, its additive supplier obtained rebaudioside M by conventional stevia leaf extraction.

Following the publication of Regulation (EU) 2026/2309, its supplier offers it a new version of the same additive produced through enzymatic conversion with the yeast Komagataella phaffii CGMCC 7539. To use this new version in its products, the company must:

1. Request from the supplier the documentation proving that the process complies with the new regulation specifications.
2. Update the technical sheets of its formulations to reflect the new production route of the additive.
3. Review with its regulatory team whether the change in additive process requires updating the labeling of the final product.
4. Notify the change to its quality management and traceability system.

If the company does not perform this verification and uses the additive produced by the new route without proper documentation, it could face problems in official food control inspections or in audits by large retail customers.

What should companies do now?

1. Identify if they use E 960c(ii) in their formulations. Review the additive list of all products in the portfolio that contain stevia sweeteners.
2. Contact additive suppliers. Ask whether the rebaudioside M they supply is produced or will be produced using the new process with Komagataella phaffii CGMCC 7539 and request updated technical documentation.
3. Update technical sheets and regulatory documentation. If the new process is adopted, reflect the change in the internal specifications of the additive and in the formulation records.
4. Review final product labeling. Verify with the regulatory department whether the change in the additive production route has implications for consumer information.
5. Adapt traceability systems. Ensure that production records allow identifying which product batches use the additive obtained by each method.
6. Consult the full text of Regulation (EU) 2026/2309 to verify the exact technical specifications applicable to the new production process.

Official source

Consult full regulation in official source

Notice: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202602309