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Condensyl^®^ and decreases sperm DNA damage which is a risk factor for male infertility: evaluation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 by 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, John Joseph; Siani, Alfonso is a Agricultural and Biological Sciences article available to read on EtoBox.

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## Abstract Following an application from Laboratoire Nurilia submitted for authorisation of a health claim pursuant to Article 14 of Regulation (EC) No 1924/2006 via the Competent Authority of France, 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 ‘Condensyl^®^ and decreases sperm DNA damage. High sperm DNA damage is a risk factor for male subfertility/infertility'. Condensyl^®^ is a fixed combination of opuntia fruit dry extract, __N__‐acetyl cysteine, zinc, nicotinamide, vitamins B2, B6, B12 and E, and folic acid. The Panel considers that Condensyl^®^ is sufficiently characterised. The Panel assumes that the disease that is the subject of the application is male infertility and that the target population for the claim includes males wishing to increase their fertility but excludes males with clinical infertility. The Panel considers that the reduction of DNA sperm damage is a beneficial physiological effect in the context of reducing the risk of male infertility. The applicant provided four human intervention studies conducted in males with clinical infertility, from

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Author

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, John Joseph; Siani, Alfonso

Publisher

Publications Office of the European Union; Wiley-Blackwell Publishing Ltd; [Parma]: [EFSA], [2003]-; Wiley (ISSN 1831-4732)

Published

2017

Language

EN

Field

Agricultural and Biological Sciences (Life Sciences)