Scientific Opinion on the substantiation of a health claim related to a combination of Tuscan black cabbage, “tri-coloured” Swiss chard, “bi-coloured” spinach and “blu savoy” cabbage and protection of blood lipids from oxidative damage pursuant to Article 13(5) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2013;11(10):3413 [8 pp.].
doi
10.2903/j.efsa.2013.3413
Panel members at the time of adoption
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
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Marina Heinonen, Ambroise Martin, Hildegard Przyrembel, Yolanda Sanz, Alfonso Siani, Anders Sjödin, Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren, Hans Verhagen and Peter Willatts for the preparatory work on this scientific opinion.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
Competent Authority of Italy following an application by Italsur s.r.l.
Question Number
EFSA-Q-2013-00574
Adopted
9 October 2013
Published
30 October 2013
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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Abstract

Following an application from Italsur s.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, 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 Tuscan black cabbage, “tri-coloured” Swiss chard, “bi-coloured” spinach and “blu savoy” cabbage and protection of blood lipids from oxidative damage. The food that is the subject of the health claim, a combination of Tuscan black cabbage (Brassica Oleracea botrytis L.), “tri-coloured” Swiss chard (Beta vulgaris ciclaL.), “bi-coloured” spinach (Spinacia oleracea L.) and “blu savoy” cabbage (Brassica oleracea convar. capitata var. sabauda L.), is sufficiently characterised. The claimed effect, protection of blood lipids from oxidative damage, may be a beneficial physiological effect. No human intervention studies from which conclusions could be drawn for the scientific substantiation of the claim were provided by the applicant. The Panel concludes that a cause and effect relationship has not been established between consumption of a combination of Tuscan black cabbage, “tri-coloured” Swiss chard, “bi-coloured” spinach and “blu savoy” cabbage and protection of blood lipids from oxidative damage.

Summary

Following an application from Italsur s.r.l., submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Italy, 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 Tuscan black cabbage, “tri-coloured” Swiss chard, “bi-coloured” spinach and “blu savoy” cabbage and protection of blood lipids from oxidative damage.

The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The application includes a request for the protection of proprietary data.

The food that is the subject of the health claim is a combination of Tuscan black cabbage (Brassica Oleracea botrytis L.) (## %), “tri-coloured” Swiss chard (Beta vulgaris ciclaL.) (## %), “bi-coloured” spinach (Spinacia oleracea L.) ( ##%) and “blu savoy” cabbage(Brassica oleracea convar. capitata var. sabauda L.) (## %). The Panel considers that a combination of Tuscan black cabbage, “tri-coloured” Swiss chard, “bi-coloured” spinach and “blu savoy” cabbage, which is the subject of the health claim, is sufficiently characterised.

The claimed effect proposed by the applicant is “protection of blood lipids from oxidative damage”. The target population proposed by the applicant is the general population. The Panel considers that protection of blood lipids from oxidative damage may be a beneficial physiological effect.

The applicant identified one unpublished human study, 22 published human intervention studies, and three human observational studies as being pertinent to the claim.

All 25 published human studies did not use or refer to the food which is the subject of the claim. The applicant also referred to 15 reviews, nine guidelines, and six animal and seven in vitro studies, none of which contained data on the food which is the subject of the claim. The Panel notes that none of these studies can be used for the scientific substantiation of the claim.

Only one human intervention study (Bacchetti and Ferretti, unpublished, claimed as proprietary) was performed with the combination of the four vegetables which is the subject of the claim. This study was an open label single-arm intervention in which 38 healthy volunteers (23 females, mean age 41 ± 14 years) consumed daily for 14 days a portion (i.e. 300 g) of the food. The Panel considers that no conclusions can be drawn from this uncontrolled (single arm) study for the scientific substantiation of the claim.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between consumption of a combination of Tuscan black cabbage (Brassica Oleracea botrytis L.), “tri-coloured” Swiss chard (Beta vulgaris cicla L.), “bi-coloured” red and yellow spinach (Spinacia oleracea L.) and “blu savoy” cabbage (Brassica oleracea convar. capitata var. sabauda L.) and protection of blood lipids from oxidative damage.

Keywords
black cabbage, Swiss chard, spinach, cabbage, oxidative damage, blood lipids, oxidized LDL, health claims
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Number of Pages
8