Following an application from Tchibo GmbH, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to coffee C21 and reduction of spontaneous DNA strand breaks. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food constituent that is the subject of the health claim is coffee C21, which is sufficiently characterised. The claimed effect is reduction of spontaneous DNA strand breaks, which may be a beneficial physiological effect. The target population proposed by the applicant is the general population. One human study on coffee C21 was not controlled adequately for confounding factors that may have affected the outcome. Four additional human studies investigated coffees other than coffee C21. Two of these had no control group and a third study did not assess spontaneous DNA strand breaks. No conclusions could be drawn from these human studies for the scientific substantiation of the claim. The fourth study did not show an effect of coffee compared to water on spontaneous DNA strand breaks. The evidence provided in animal and in vitro studies is not sufficient to predict the occurrence of an effect of coffee C21 consumption on the reduction of spontaneous DNA strand breaks in humans. The Panel concludes that a cause and effect relationship has not been established between the consumption of coffee C21 and a reduction in spontaneous DNA strand breaks. © European Food Safety Authority, 2011