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Scientific Opinion on the substantiation of health claims related to lycopene and protection of DNA, proteins and lipids from oxidative damage (ID 1608, 1609, 1611, 1662, 1663, 1664, 1899, 1942, 2081, 2082, 2142, 2374), protection of the skin from UV-induced (including photo-oxidative) damage (ID 1259, 1607, 1665, 2143, 2262, 2373), contribution to normal cardiac function (ID 1610, 2372), and maintenance of normal vision (ID 1827) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

EFSA Journal 2011;9(4):2031 [28 pp.]. doi:10.2903/j.efsa.2011.2031
  EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) Panel Members Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen, Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé, Hendrik van Loveren and Hans Verhagen Acknowledgment The Panel wishes to thank for the preparatory work on this scientific opinion: The members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. The members of the Claims Sub-Working Group on Cardiovascular Health/Oxidative Stress: Antti Aro, Marianne Geleijnse, Marina Heinonen, Ambroise Martin, Wilhelm Stahl and Henk van den Berg. The members of the Claims Sub-Working Group on Mental/Nervous System: Jacques Rigo, Astrid Schloerscheidt, Barbara Stewart-Knox, Sean (J.J.) Strain, and Peter Willatts. Contact nda@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2008-1997 , EFSA-Q-2008-2343 , EFSA-Q-2008-2344 , EFSA-Q-2008-2345 , EFSA-Q-2008-2346 , EFSA-Q-2008-2347 , EFSA-Q-2008-2398 , EFSA-Q-2008-2399 , EFSA-Q-2008-2400 , EFSA-Q-2008-2401 , EFSA-Q-2008-2560 , EFSA-Q-2008-2632 , EFSA-Q-2008-2675 , EFSA-Q-2008-2814 , EFSA-Q-2008-2815 , EFSA-Q-2008-2875 , EFSA-Q-2008-2876 , EFSA-Q-2008-2995 , EFSA-Q-2008-3105 , EFSA-Q-2008-3106 , EFSA-Q-2008-3107 Adopted: 12 November 2010 Published: 08 April 2011 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

No abstract available

Summary

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 (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to lycopene and protection of DNA, proteins and lipids from oxidative damage, protection of the skin from UV-induced (including photo-oxidative) damage, contribution to normal cardiac function, and maintenance of normal vision. 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 claims is lycopene. The present opinion applies to lycopene from all sources with appropriate bioavailability in the specified amounts. The Panel considers that lycopene is sufficiently characterised.

Protection of DNA, proteins and lipids from oxidative damage

The claimed effects are “antioxidant properties”, “antioxidant properties/cell and DNA protection”, “antioxidant properties/protection of DNA”, “oxidative stress control”, “for antioxidant protection system/protection of DNA”, “maintains cardiovascular health”, “prostate health” and “maintains prostate health”. The target population is assumed to be the general population. In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to the protection of DNA, proteins and lipids from oxidative damage. The Panel considers that protection of DNA, proteins and lipids from oxidative damage may be a beneficial physiological effect.

In weighing the evidence, the Panel took into account that none of the studies provided reported a significant effect of lycopene consumption on reliable markers of oxidative damage to DNA, lipids or proteins compared to control.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of lycopene and protection of DNA, proteins and lipids from oxidative damage.

Protection of the skin from UV-induced (including photo-oxidative) damage

The claimed effects are “skin health”, “maintains skin health”, and “for skin health”. The target population is assumed to be the general population. In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to the protection of the skin from UV-induced damage, including photo-oxidative damage. The Panel considers that the protection of the skin from UV-induced (including photo-oxidative) damage is a beneficial physiological effect.

None of the studies provided addressed the effects of lycopene consumption on reliable markers of UV-induced (including photo-oxidative) damage to the skin.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of lycopene and protection of the skin from UV-induced (including photo-oxidative) damage.

Contribution to normal cardiac function

The claimed effects are “heart health” and “cardio-vascular health”. The target population is assumed to be the general population. In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to the maintenance of normal cardiac function. The Panel considers that contribution to normal cardiac function is a beneficial physiological effect.

In weighing the evidence, the Panel took into account that one observational study did not show an association between lycopene dietary intakes and risk of myocardial infarction, and that the nature of the relationship between dietary lycopene and blood concentrations of lycopene was not established in the two observational studies provided, which did not report on lycopene intakes.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of lycopene and contribution to normal cardiac function.

Maintenance of normal vision

The claimed effect is “eyes”. The target population is assumed to be the general population. In the context of the proposed wording and from the information provided, the Panel assumes that the claimed effect refers to the maintenance of normal vision. The Panel considers that maintenance of normal vision is a beneficial physiological effect.

No references were provided from which conclusions could be drawn for the scientific substantiation of the claimed effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of lycopene and maintenance of normal vision.

Keywords

Lycopene, oxidative damage, UV-induced damage, skin, cardiac function, vision, health claims