The consultation request under Article 4 of Regulation (EU) 2015/2283 concerns biotechnologically produced sodium hyaluronate for use in food supplements. Sodium hyaluronate is a product from a non-genetically modified strain of Streptococcus equi subsp. zooepidemicus. The bacterial cells are inactivated and removed from the final product, which has a purity level of over 90%.
The competent authorities of the EU Member States and the European Commission decided that sodium hyaluronate produced by the fermentation process does not qualify as a novel food as the final ingredient is similar to sodium hyaluronate. Since the manufacturing process does not significantly alter the composition, structure, or nutritional value of the product, the final product can be legally used in food supplements. If the novel food status of your product is also unclear and you need regulatory consulting, please contact us. We will be happy to assist you with the Art. 4 consultation process.