Research and analysis

Part A7: Application for consent to market genetically modified organisms

Published 19 March 2026

Information required under Schedule 3 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002 (as amended)

PART I

1. The proposed commercial name of the product and names of the genetically modified organisms in the product, the unique identifier assigned in accordance with Regulation 65/2004, and any other name or code used by the applicant to identify the genetically modified organism

SOURVISIAE®, Saccharomyces cerevisiae, PCT/IB2019/051682 or WO201917123OAI

2. The name and address of the person who is responsible for the marketing, whether it be the manufacturer, importer or distributor

DANSTAR FERMENT A.G
Poststrasse 30
CH-6300 Zug
SWITZERLAND

Represented by

Lallemand UK Limited (doing business as AB Vickers),
Dallow Street,
Burton-On-Trent,
Staffordshire,
England,
DE14 2PQ

3. The name and address of the supplier or suppliers of control samples

DANSTAR FERMENT A.G
Poststrasse 30
CH-6300 Zug
SWITZERLAND

Represented by

Lallemand UK Limited (doing business as AB Vickers),
Dallow Street,
Burton-On-Trent,
Staffordshire,
England,
DE14 2PQ

4. A description of how the product and the genetically modified organism are intended to be used, highlighting any differences in use or management of the genetically modified organism compared to similar non-genetically modified products

Sourvisiae® is a bioengineered (genetically modified organism – GMO) strain of Saccharomyces cerevisiae capable of producing lactic acid in addition to alcohol during fermentation.

Sourvisiae® contains a single genetic modification, a lactate dehydrogenase gene from a known food production microorganism, which enables the yeast to produce high levels of lactic acid when used as a pure culture, (or when blended with another) brewing yeast strain. The brewing process is conducted without any modifications; Sourvisiae® is pitched just like conventional yeast and ferments in a normal fermentation time.

5. A description of the geographical area or areas and types of environment where the product is intended to be used, including, where possible, an estimate of the scale of use in each area

Sourvisiae®, a genetically modified strain of Saccharomyces cerevisiae, is primarily intended for use in brewing (contained) environments across various geographical regions, especially where craft beer production and sour beer styles are popular.

6. A description of the intended categories of users of the product, such as industry, agriculture or consumer use by the public

Sourvisiae® allows brewers to ferment and sour beers in one simple step. It is intended to be used in breweries.

7a. Information on:

i. methods for the detection, identification and, where appropriate, quantification of the transformation event

Sourvisiae® is identified and detected using a combination of molecular and genomic techniques that ensure high specificity and traceability:

1. Whole Genome Sequencing (WGS): The primary method for identification, WGS, confirms the presence of the integrated ldhA gene from Rhizopus oryzae.
2. Polymerase Chain Reaction (PCR): Targeted PCR assays are used to detect the presence of the ldhA gene and confirm strain identity. In addition, PCR can confirm the locus of the gene. Primers specific to the integration site and the lactate dehydrogenase (LDH) cassette can be used for screening.
3. Quantitative polymerase chain reaction (qPCR) analysis demonstrates the number of ldhA gene copies that are present in Sourvisiae.

ii. samples of the genetically modified organisms and their control samples

Samples of the genetically modified organism (Sourvisiae) and corresponding control samples are maintained by the applicant in Lallemand’s culture collection in Montreal, Canada.

iii. the place where the reference material can be accessed

Reference material can be accessed at the applicant’s designated facility upon request by the competent authority, in accordance with applicable regulatory requirements.

7b. Information under sub-paragraph (a) that cannot be placed on the register for confidentiality reasons, must be identified

Not applicable.

8. The proposed labelling, which must include, in a label or an accompanying document, at least in summarised form, a commercial name of the product, a statement that “This product contains genetically modified organisms”, the name of the genetically modified organism and the name and address of the person who is responsible for marketing the product, and how to access the information in the publicly accessible part of the register

Bioengineered Saccharomyces cerevisiae FOR SOURING DURING PRIMARY FERMENTATION/ Beer production]. Contains GMO

PART II: Additional relevant information

9. The measures to be taken in the event of the escape of the organisms in the product or misuse of the product

Release of Sourvisiae to the environment is not expected when used to brew sour beer (ales) due to contained use in brewery settings. In the event of unexpected spread, the food safety plan (including HACCP) and emergency response procedures should provide for immediate containment and review of procedures to lead to cessation of the spread and or brewing activities, and isolation of materials. The organism’s fitness is less than the parental strain and nutrient availability outside the brewery is limited, further reducing risk. Standard brewery sanitation protocols, including cleaning-in-place (CIP) and disinfection, are implemented to control and eliminate the organism.

10. Specific instructions or recommendations for storage and handling of the product

Store Sourvisiae® in a dry place below 4°C.

Keep packaging intact. The product is stable for 3 years in its original sealed package.

11. Specific instructions for carrying out monitoring and reporting to the applicant and, if required, the Secretary of State, which are consistent with Part C of Annex VII of the Deliberate Release Directive (as listed in Post-Market Environmental Monitoring plan A8)

None is proposed. The modification in Sourvisiae consists solely of the stable chromosomal integration of a single, well characterised ldhA gene from Rhizopus oryzae, a food grade filamentous fungus with a long history of safe use in fermentation. As with other enzymes, the LDH enzyme expressed in Sourvisiae is highly specific, catalyzing only the well characterized and defined conversion of pyruvate to L-lactic acid, a normal metabolic reaction with no off target or hazardous biochemical activities.

The integration cassette contains no plasmid backbone, no antibiotic resistance markers, and no unintended genetic material, as confirmed by PCR and whole genome sequencing. The LDH enzyme introduced is a non-toxic, non-pathogenic metabolic enzyme that catalyses the natural conversion of pyruvate to lactic acid, an established food relevant biochemical reaction. The strain shows no off-target integrations, is genetically stable over 100 generations, and exhibits no new traits linked to survival, pathogenicity, toxicity, allergenicity, or environmental persistence compared to the parental S. cerevisiae strain. The well defined, low risk nature of the modification, the history of safe use of both the donor organism and enzyme, and the absence of any plausible adverse effects supports the conclusion that case specific monitoring is not required nor is necessary.

Additionally, Saccharomyces cerevisiae has an extensive history of safe use as a food additive in the United Kingdom, primarily in baking and brewing. Historical evidence demonstrates its role in fermentation for bread and beer for thousands of years globally, with documented industrial use in the UK since the 19th century when pure yeast cultures became commercially available. This long-standing use without any reported adverse effects underpins its recognition as safe and supports the conclusion that additional post-market monitoring for Sourvisiae® is unnecessary beyond existing food hygiene and safety controls (Food Standards Agency, 2025; Food Safety Act 1990; Food (Safety and) Hygiene Regulations (as amended) and associated relevant Regulations in England, Wales and Scotland).

Based on the Environmental Risk Assessment (ERA) in this submission, the acceptance of Sourvisiae® as Generally Recognized As Safe (GRAS) in the United States and in Canada as a novel food, this product can be considered highly unlikely to present a risk (to humans, animals and or the environment).

12. The proposed restrictions in the approved use of the genetically modified organism, such as where the product may be used and for what purposes

Sourvisiae® is used as a fermentation/processing aid in the production of beer and related alcoholic beverages. It is intended to provide controlled lactic acid production during fermentation, either as a pure culture or in combination with conventional brewing yeast. Sourvisiae® is intended to be used in controlled brewing environments such as commercial breweries and pilot-scale brewing facilities using standard brewing practices. Outdoor use, agricultural applications, or uncontrolled environmental release is not anticipated. The organism will be handled under standard brewing conditions ensuring containment within fermentation vessels.

Disposal of spent yeast should comply with local regulations for brewery waste management to prevent unintended environmental exposure.

13. The proposed packaging

20 x 500g vacuum-packed sachets

25 x 10g vacuum-packed sachets

14. The estimated production in and/or imports to England

1000 Kg

15. Any proposed additional labelling, which may include, at least in summarised form, the information referred to in paragraphs 4 and 5 of PART I of this Schedule (above), or paragraphs 9 to 12 of PART II, as set out immediately above

No additional labelling is proposed.