Astaxanthin is a carotenoid which is found in Haematococcus pluvialis. This microalgae is part of the diet of fish or crustaceans (e.g. salmon, shrimps) and is responsible of the pink coloration in their flesh, through the ingestion of astaxanthin.
The equivalence of algal extract derived from H. pluvialis algal meal to the whole-algal product already available on the market was established in an opinion given by the committee to Valensa (US Nutra) in 2004. At that time Algatechnologies was the supplier of H. pluvialis meal as a raw material to Valensa.
The applicant has provided data which in their view demonstrates that their oleoresin is equivalent to Valensa's. The basis for this view is that their NI is produced from the identical starting material and as the same extraction process is used it is, by implication, substantially equivalent.
The applicant intends to market its astaxanthin-rich extract as an ingredient to be used in capsules and tablets up to a level of 4 mg to manufacturers of food supplements.
In all cases to date, the Commission has required that the applicant first obtain an opinion on substantial equivalence from a Member State. Algatechnologies (1998) Ltd. is requesting such an opinion from the UK Competent Authority, the Food Standards Agency, on the equivalence of their extract to the extract produced by Valensa, currently on the market.
Following an initial public consultation period and discussion of this application by the Advisory Committee on Novel Foods and Processes between July 2007 and April 2008, the Agency, the UK Competent Authority on novel foods, formulated their opinion suggesting that this astaxanthin-rich extract of Algatechnologies (1998) should be accepted as substantially equivalent to the existing astaxanthin-rich extract. The Agency has therefore sent its positive opinion to Algatechnologies (1998) which is attached below.