Following an application from Nutrilinks Sarl, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Cyprus, the Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to a combination of lycopene, vitamin E, lutein and selenium and protection of the skin from UV-induced (including photo-oxidative) damage.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence.
The food that is the subject of the health claim is a combination of lycopene, vitamin E, lutein and selenium. These components are well-characterised and can be analysed in foods by established methods. The Panel considers that the combination of lycopene, vitamin E, lutein and selenium is sufficiently characterised.
The claimed effect refers to the photo-protective activity of the food, delaying the appearance of UV-induced erythema and decreasing its intensity. The target population proposed by the applicant is healthy adults in the general population, and in particular people with sensitive skin. The Panel considers that protection of the skin from UV-induced (including photo-oxidative) damage is a beneficial physiological effect.
The applicant identified one human intervention study as being pertinent to the health claim.
This double-blind, parallel, 10-week study was a bioequivalence study of two oral “antioxidant formulas” and their purported protective effects against UV radiation. Fifty Caucasian men and women took a placebo for three weeks (i.e. run-in period) and were then randomised to receive for seven further weeks either a supplement designated as “current formula” (6 mg lycopene, 6 mg beta-carotene, 10 mg vitamin E and 75 μg selenium), or the food which is the subject of the health claim (“new formula”). Outcome measures of the study were minimal erythemal dose, Individual Typology Angle (i.e. colorimetric measurements), melanin content (i.e. percentage of epidermis occupied by melanin) and “capping” (i.e. assembling of melanosomes at keratinocytes’ upper poles).
The Panel notes that erythema is an inflammatory response of the skin to UV-induced molecular and cellular damage. A reduction in UV-induced erythema (e.g. measured as change in minimal erythemal dose or erythema grade) may indicate less UV-induced damage to the skin, but it can also reflect a reduction in the capacity of the skin to react to molecular and cellular damage. Therefore, UV-induced erythema cannot be used alone as an outcome measure for the substantiation of the claim. The other outcomes (i.e. Individual Typology Angle, melanin content and “capping”) used in the study did not provide any information on UV-induced skin damage.
The Panel notes that the submitted study was a bioequivalence study that did not assess direct measures of UV-induced (including photo-oxidative) skin damage. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
The Panel notes that no studies were provided from which conclusions could be drawn for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of lycopene, vitamin E, lutein and selenium and protection of the skin from UV-induced (including photo-oxidative) damage.