EU Restricts FCC-3204 Oil to 1 Gram Daily Under New Regulation 2025/688

On April 10, 2025, the European Commission officially adopted Regulation (EU) 2025/688, tightening the rules for the novel food FCC-3204 oil, derived from the Schizochytrium genus. The updated regulation sets strict limits on daily intake and food application, impacting both the supplement and functional food sectors.

The oil can now be used at a maximum of 1 gram per day in food supplements intended for individuals over 3 years old, as defined under Directive 2002/46/EC. For non-dairy protein-based products, the use is capped at 1 gram per 100 grams of product.

This rule is part of the EU’s continued efforts to ensure safety and control over novel food ingredients, especially those with growing use in plant-based or algae-derived formulations. The regulation will become legally binding 20 days after its publication in the Official Journal of the European Union, meaning companies must swiftly adapt their formulations and labeling to remain compliant.

This move not only reflects the EU’s cautious stance toward emerging food tech but also signals to manufacturers and importers that compliance timelines are tightening. Stakeholders in the health food, vegan, and alternative protein markets should act promptly to review affected product lines.