Algatrium (R) And Antioxidant Response Scientific Substantiation Of A Health Claim Related To Algatrium (R) And Antioxidant Response Article 13(5) Of Regulation (Ec) No 1924/2006

Following an application from Brudy Technology S.L. submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Spain, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to Algatrium and antioxidant response.The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and includes a request for the protection of proprietary data.The food constituent that is the subject of the health claim is Algatrium, which is derived from fish oil and contains docosahexaenoic acid (DHA) as active ingredient (67%). Other long chain polyunsaturated fatty acids (LC-PUFA), such as eicosapentaenoic acid (EPA, about 10%) are also present. Manufacturing process, specifications and stability information of the DHArich fish oil were provided by the applicant. The Panel considers that Algatrium is sufficiently characterised.The claimed effect is "promotes your antioxidant response" by "stimulation of the own cells' antioxidant defences". The target population is the general population. The Panel considers that the claimed effect "promotes your antioxidant response" by "stimulation of the own cells' antioxidant defences" might be beneficial to human health.The applicant has identified a total of 18 studies considered pertinent to the claim. These studies include five human studies and 13 in vitro cell studies. Three of the human intervention studies are not performed with Algatrium. The Panel considers these studies not pertinent to the claim. Two unpublished studies investigated effects on oxidative damage in male cyclists receiving 500 mg to 3500 mg of Algatrium daily during one to three months. The primary outcome was the change in 8-hydroxy-2'-deoxyguanosine (8-OHdG) excretion in 24 h urine. The Panel does not consider measurement of 8-OHdG excretion in urine a reliable biomarker of DNA damage. Therefore, these studies are not useful as a source of evidence to support the claimed effect. The Panel also considers that the evidence provided does not establish that a reduction of 8-OHdG excretion indicates a beneficial change in function.Of the thirteen in vitro studies identified by the applicant, only one was carried out using Algatrium to investigate its effect on the cellular redox status in vitro. The data provided does not establish the validity of this in vitro study to support the claimed effect in vivo.The Panel concludes that a cause and effect relationship between the consumption of Algatrium and the claimed effect has not been established.