EFSA Authorizes Cetraria islandica Extract for Use in Supplements with 500mg Limit

The European Commission has officially added Cetraria islandica aqueous extract to the Union list of novel foods via Regulation EU 2026/1104. This ends the regulatory gray area for brands using Iceland Moss in immunity and throat health formulations, but it comes with strict maximum use levels and data protection for the applicant until 2031.

Dosage Limits and Specifications

The authorization specifies a maximum daily dose of 500mg for the general adult population. For adolescents aged 10 to 14, the limit is capped at 280mg per day. If you are currently marketing throat syrups or sprays using this extract, you must audit your serving sizes immediately to ensure compliance with these tiered age limits.

• Maximum 500mg per day for adults excluding pregnant and lactating women
• Mandatory label statement identifying the ingredient as Cetraria islandica extract
• Particle size specifications require 90 percent of the powder to be under 150 microns
• Lead and cadmium limits set at 0.1 mg per kg and 0.5 mg per kg respectively

Procurement and Sourcing Impact

Because this was a proprietary application, the 5-year data protection period means only the authorized applicant can supply this specific extract according to the novel food dossiers. Generic Iceland Moss extracts previously sold under the 1997 transition rule are now technically non-compliant if they cannot prove their extraction methods match the historical safety profile.

Expect prices for the authorized extract to land at approximately 115 EUR per kg. If you are planning a Q4 launch for cough and cold season, secure your supply agreements now. Using non-authorized versions poses a significant risk of product recalls if national authorities like the DGCCRF or BVL conduct batch testing on your raw material specifications.