Astaxanthin is a carotenoid, which is found in Haematococcus pluvialis. This microalgae is part of the diet of fish or crustaceans (such as salmon and shrimps) and is responsible for the pink coloration of their flesh.
The algae H. pluvialis is currently sold to European consumers in the form of a dried meal. The Swedish company Astacarotene (now owned by Fuji Chemicals, Japan) has been selling capsules containing the dried biomass of H. pluvialis algae in the European Union since at least 1995.
The applicant intends to market its astaxanthin-rich extract as an ingredient to be used in hard and soft gelatine capsules and tablets to manufacturers of human dietary supplements. The extract will be available at two standardised astaxanthin titres, namely 10% and 5%.
In all cases to date, the Commission has required that the applicant first obtain an opinion on substantial equivalence from a Member State. Cyanotech Corporation requested such an opinion from the UK Competent Authority on the equivalence of its extract to the whole-algal product currently on the market.
Following an initial public consultation period and discussion of this application at the 20 July and 21 September 2006 meetings of the Advisory Committee on Novel Foods and Processes, the Agency, the UK competent authority on novel foods, formulated a draft opinion suggesting that this astaxanthin-rich extract of Cyanotech should be accepted as substantially equivalent to the existing astaxanthin-rich algal meal from Astacarotene. The Agency has therefore sent its positive opinion to Cyanotech which is attached below.