Low‐fat fermented milk with a combination of fructo‐oligosaccharides and live Lactobacillus rhamnosus GG ( ATCC 53103), Streptococcus thermophilus (Z57) and Lactobacillus bulgaricus ( LB 2), and defence against reactivation of Herpes simplex virus in the orolabial epithelia: evaluation of a health claim pursuant to Article 13(5) of Regulation ( EC ) No 1924/2006

Following an application from Granarolo S.p.A., submitted for authorisation of a health claim pursuant to Article 13(5) of Regulation ( EC ) No 1924/2006 via the Competent Authority of Italy, 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 a low‐fat fermented milk and defence against reactivation of Herpes simplex virus (HSV) in the orolabial epithelia. The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The food which is the subject of the health claim, a low‐fat fermented milk with a combination of fructo‐oligosaccharides and live Lactobacillus rhamnosus GG ( ATCC  53103), Streptococcus   thermophilus (Z57) and Lactobacillus delbrueckii subsp. Bulgaricus ( LB 2), is sufficiently characterised. Defence against reactivation of HSV in the orolabial epithelia is a beneficial physiological effect. The Panel considers that no conclusions can be drawn from three out of the four human intervention studies, which were provided by the applicant, for the scientific substantiation of the claim. In weighing the evidence, the Panel took into account that one human intervention study from which scientific conclusions can be drawn does not show a consistent effect of daily consumption of the low‐fat fermented milk on the reduction in incidence of herpes labialis ( HL ) lesions after ultraviolet B ( UVB ) exposure and that no convincing evidence was provided for a mechanism by which the low‐fat fermented milk could contribute to the defence against reactivation of HSV in the orolabial epithelia. The Panel concludes that a cause and effect relationship has not been established between the consumption of the low‐fat fermented milk, which is the subject of the health claim, and defence against reactivation of HSV in the orolabial epithelia.