Pagina European Food Safety Authority (EFSA):
Scientific Opinion on the substantiation of health claims related to beta carotene and physiological immune responses of the skin in relation to UV radiation (sun exposure) (ID 198, 1463) pursuant to Article 13(1) of Regulation (EC) No 1924/2006
Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to beta-carotene and physiological immune responses of the skin in relation to ultraviolet (UV) radiation (sun exposure). The scientific substantiation is based on the information provided by the Member States in the consolidated list of Article 13 health claims and references that EFSA has received from Member States or directly from stakeholders.
The food constituent that is the subject of the health claim is beta-carotene, which is a well recognised dietary constituent and is measurable in foods by established methods. The Panel considers that beta carotene is sufficiently characterised.
The claimed effect is “immune health in relation to UV-radiation”. In the context of the proposed wordings, the Panel notes that the claimed effect relates to “helps to maintain physiological immune responses of the skin upon UV-radiation (sun exposure)”. The Panel considers that maintaining normal physiological immune responses of the skin in relation to UV-radiation (sun exposure) is beneficial to human health.
Three double-blind, placebo-controlled, randomised trials in healthy subjects exposed to sun or UV light receiving 30 mg beta-carotene per day or placebo, were provided. UV exposure caused a decrease in blood beta-carotene concentrations and suppressed delayed-type hypersensitivity (DTH) in groups without beta-carotene supplementation. However, the Panel notes that restoration of suppressed delayed-type hypersensitivity (DTH) and associated parameters by beta-carotene supplementation as compared to placebo was inconsistent. The Panel also notes that these intervention studies were performed with limited numbers of individuals at doses that were 4-fold higher than indicated in the conditions of use.
On the basis of the data available, the Panel concludes that a cause and effect relationship has not been established between the consumption of beta-carotene and maintaining normal physiological immune responses of the skin in relation to UV-radiation (sun exposure).
Published: 1 October 2009
Last updated: 23 November 2009