Xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), Dominique Turck, Jean Louis Bresson, Barbara Burlingame, Tara Dean, Susan Fairweather-Tait, Marina Heinonen, Karen Ildico Hirsch-Ernst, Inge Mangelsdorf, Harry J. McArdle, Androniki Naska, Monika Neuhäuser-Berthold, Grażyna Nowicka, Kristina Pentieva, Yolanda Sanz, Anders Sjödin, Martin Stern, Daniel Tomé, Henk Van Loveren, Marco VincetiPeter Willatts, Ambroise Martin, Sean (J. J.) Strain, Alfonso Siani

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Abstract

Following an application from TA-XAN AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract. The Panel considers that xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, is sufficiently characterised. The claimed effect proposed by the applicant is ‘helps to maintain the integrity of DNA and protects against oxidative damage in the cells of the body’. The Panel considers that protection of DNA from oxidative damage is a beneficial physiological effect. The only human study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of xanthohumol in XERME® on the protection of DNA from oxidative damage. In the absence of evidence for an effect of xanthohumol in XERME ® on the protection of DNA from oxidative damage, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage.

Original languageEnglish
Article numbere05192
Pages (from-to)1-11
Number of pages11
JournalEFSA Journal
Volume16
Issue number3
Early online date13 Mar 2018
DOIs
Publication statusPublished - Mar 2018

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health claims
malt extract
DNA Damage
Health
DNA
dietetics
hypersensitivity
xanthohumol
Food
Germany
Dietetics
nutrition
Hypersensitivity

Keywords

  • DNA integrity
  • health claim
  • oxidative damage
  • xanthohumol
  • XERME

Cite this

EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), Turck, D., Bresson, J. L., Burlingame, B., Dean, T., Fairweather-Tait, S., ... Siani, A. (2018). Xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. EFSA Journal, 16(3), 1-11. [e05192]. https://doi.org/10.2903/j.efsa.2018.5192
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) ; Turck, Dominique ; Bresson, Jean Louis ; Burlingame, Barbara ; Dean, Tara ; Fairweather-Tait, Susan ; Heinonen, Marina ; Hirsch-Ernst, Karen Ildico ; Mangelsdorf, Inge ; McArdle, Harry J. ; Naska, Androniki ; Neuhäuser-Berthold, Monika ; Nowicka, Grażyna ; Pentieva, Kristina ; Sanz, Yolanda ; Sjödin, Anders ; Stern, Martin ; Tomé, Daniel ; Van Loveren, Henk ; Vinceti, Marco ; Willatts, Peter ; Martin, Ambroise ; Strain, Sean (J. J.) ; Siani, Alfonso. / Xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. In: EFSA Journal. 2018 ; Vol. 16, No. 3. pp. 1-11.
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title = "Xanthohumol in XERME{\circledR}, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006",
abstract = "Following an application from TA-XAN AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to xanthohumol in XERME{\circledR}, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is xanthohumol in XERME{\circledR}, a xanthohumol-enriched roasted malt extract. The Panel considers that xanthohumol in XERME{\circledR}, a xanthohumol-enriched roasted malt extract, is sufficiently characterised. The claimed effect proposed by the applicant is ‘helps to maintain the integrity of DNA and protects against oxidative damage in the cells of the body’. The Panel considers that protection of DNA from oxidative damage is a beneficial physiological effect. The only human study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of xanthohumol in XERME{\circledR} on the protection of DNA from oxidative damage. In the absence of evidence for an effect of xanthohumol in XERME {\circledR} on the protection of DNA from oxidative damage, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of xanthohumol in XERME {\circledR}, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage.",
keywords = "DNA integrity, health claim, oxidative damage, xanthohumol, XERME",
author = "{EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)} and Dominique Turck and Bresson, {Jean Louis} and Barbara Burlingame and Tara Dean and Susan Fairweather-Tait and Marina Heinonen and Hirsch-Ernst, {Karen Ildico} and Inge Mangelsdorf and McArdle, {Harry J.} and Androniki Naska and Monika Neuh{\"a}user-Berthold and Grażyna Nowicka and Kristina Pentieva and Yolanda Sanz and Anders Sj{\"o}din and Martin Stern and Daniel Tom{\'e} and {Van Loveren}, Henk and Marco Vinceti and Peter Willatts and Ambroise Martin and Strain, {Sean (J. J.)} and Alfonso Siani",
year = "2018",
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language = "English",
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EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), Turck, D, Bresson, JL, Burlingame, B, Dean, T, Fairweather-Tait, S, Heinonen, M, Hirsch-Ernst, KI, Mangelsdorf, I, McArdle, HJ, Naska, A, Neuhäuser-Berthold, M, Nowicka, G, Pentieva, K, Sanz, Y, Sjödin, A, Stern, M, Tomé, D, Van Loveren, H, Vinceti, M, Willatts, P, Martin, A, Strain, SJJ & Siani, A 2018, 'Xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage: evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006', EFSA Journal, vol. 16, no. 3, e05192, pp. 1-11. https://doi.org/10.2903/j.efsa.2018.5192

Xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage : evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006. / EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Turck, Dominique; Bresson, Jean Louis; Burlingame, Barbara; Dean, Tara; Fairweather-Tait, Susan; Heinonen, Marina; Hirsch-Ernst, Karen Ildico; Mangelsdorf, Inge; McArdle, Harry J.; Naska, Androniki; Neuhäuser-Berthold, Monika; Nowicka, Grażyna; Pentieva, Kristina; Sanz, Yolanda; Sjödin, Anders; Stern, Martin; Tomé, Daniel; Van Loveren, Henk; Vinceti, Marco; Willatts, Peter; Martin, Ambroise; Strain, Sean (J. J.); Siani, Alfonso.

In: EFSA Journal, Vol. 16, No. 3, e05192, 03.2018, p. 1-11.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage

T2 - evaluation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006

AU - EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)

AU - Turck, Dominique

AU - Bresson, Jean Louis

AU - Burlingame, Barbara

AU - Dean, Tara

AU - Fairweather-Tait, Susan

AU - Heinonen, Marina

AU - Hirsch-Ernst, Karen Ildico

AU - Mangelsdorf, Inge

AU - McArdle, Harry J.

AU - Naska, Androniki

AU - Neuhäuser-Berthold, Monika

AU - Nowicka, Grażyna

AU - Pentieva, Kristina

AU - Sanz, Yolanda

AU - Sjödin, Anders

AU - Stern, Martin

AU - Tomé, Daniel

AU - Van Loveren, Henk

AU - Vinceti, Marco

AU - Willatts, Peter

AU - Martin, Ambroise

AU - Strain, Sean (J. J.)

AU - Siani, Alfonso

PY - 2018/3

Y1 - 2018/3

N2 - Following an application from TA-XAN AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract. The Panel considers that xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, is sufficiently characterised. The claimed effect proposed by the applicant is ‘helps to maintain the integrity of DNA and protects against oxidative damage in the cells of the body’. The Panel considers that protection of DNA from oxidative damage is a beneficial physiological effect. The only human study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of xanthohumol in XERME® on the protection of DNA from oxidative damage. In the absence of evidence for an effect of xanthohumol in XERME ® on the protection of DNA from oxidative damage, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage.

AB - Following an application from TA-XAN AG, submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA) was asked to deliver an opinion on the scientific substantiation of a health claim related to xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food proposed by the applicant as the subject of the health claim is xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract. The Panel considers that xanthohumol in XERME®, a xanthohumol-enriched roasted malt extract, is sufficiently characterised. The claimed effect proposed by the applicant is ‘helps to maintain the integrity of DNA and protects against oxidative damage in the cells of the body’. The Panel considers that protection of DNA from oxidative damage is a beneficial physiological effect. The only human study from which conclusions can be drawn for the scientific substantiation of the claim did not show an effect of xanthohumol in XERME® on the protection of DNA from oxidative damage. In the absence of evidence for an effect of xanthohumol in XERME ® on the protection of DNA from oxidative damage, the studies provided by the applicant on the proposed mechanisms by which the food/constituent could exert the claimed effect were not considered by the Panel for the scientific substantiation of the claim. The Panel concludes that a cause and effect relationship has not been established between the consumption of xanthohumol in XERME ®, a xanthohumol-enriched roasted malt extract, and protection of DNA from oxidative damage.

KW - DNA integrity

KW - health claim

KW - oxidative damage

KW - xanthohumol

KW - XERME

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