Scientific Opinion on the 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 pursuant to Article 13(5) of Regulation (EC) No

Tabs

Article
EFSA Journal 2012;10(9):2890 [7 pp.].
doi
10.2903/j.efsa.2012.2890
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)
Panel Members
Carlo Agostoni, Roberto Berni Canani, Susan Fairweather-Tait, Marina Heinonen, Hannu Korhonen, Sébastien La Vieille, Rosangela Marchelli, Ambroise Martin, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Martin Stern, Sean (J.J.) Strain, Inge Tetens, Daniel Tomé, Dominique Turck and Hans Verhagen
Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On Request From
Competent Authority of Cyprus following an application by Nutrilinks Sarl
Question Number
EFSA-Q-2012-00592
Adopted
13 September 2012
Published
27 September 2012
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Article (168.04 KB)168.04 KB
Abstract

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 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 bioequivalence study as being pertinent to the health claim. The Panel notes that this study did not assess direct measures of UV-induced (including photo-oxidative) skin damage. Therefore, no conclusions could be drawn from this study 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.

Summary

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.

Keywords
Lycopene, vitamin E, lutein, selenium, skin, UV, health claims
Print on demand
Number of Pages
7