Use Restrictions and Labeling Requirements of trans-Resveratrol Produced by Genetically Modified Saccharomyces cerevisiae Strain EFSC4687 as a Food Ingredient

MOHW Food No.1121301256, 29 June 2023

Article 1
The regulation is prescribed in accordance with the provisions of Paragraph 2 of Article 15-1 and Subparagraph 10 of Paragraph 1 of Article 22 of the Act Governing Food Safety and Sanitation.

Article 2
The trans-resveratrol referred to herein is produced by fermentation process using genetically modified Saccharomyces cerevisiae strain EFSC4687. The trans-resveratrol powder can be purified from the fermentation via a sequence of purification steps including ultrafiltration, washing with water, pH adjustment with sodium hydroxide, diafiltration, precipitation with sulfuric acid, concentration, filtration, dissolution with ethanol, anion-exchange resin, carbon treatment, crystallization with water, filtration and drying etc. The final trans-resveratrol powder shall not contain any genetically modified microorganism and its transgenes.

Article 3
For use as a food ingredient, the trans-resveratrol produced by S. cerevisiae strain EFSC4687 shall comply with the following requirements:

1.Specifications listed in the Appendix.

2.Can only be used for food supplements intended for adult population, and the daily intake shall not exceed 150 mg.

3.The container or external packaging of trans-resveratrol produced by S. cerevisiae strain EFSC4687 shall be displayed one of the following information: “The trans-resveratrol is produced by genetically modified microorganism” or “The trans-resveratrol is produced by genetically modified microorganism, but ultimately does not contain any genetically modified microorganism and its transgenes”. Final products containing trans-resveratrol as one of its ingredients are exempted from this labeling requirement.

Article 4
The labelling of food products containing the trans-resveratrol shall bear the following warning statements: This product can only be used for adult population, pregnant women and lactating women shall avoid consuming. People using medicines shall only consume the product under medical supervision.