Following an application from Gelita AG, submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of Germany for authorisation of a health claim, 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 VeriSol®P and a change in skin elasticity leading to an improvement in skin function.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence. The application included a request for the protection of proprietary data.
The food that is the subject of the health claim is VeriSol®P, which is a collagen hydrolysate derived from porcine sources. The Panel considers that VeriSol®P is sufficiently characterised.
The claimed effect proposed by the applicant is “maintenance of skin health, as indicated by an increased skin elasticity and a reduction of wrinkles volume”. The target population proposed by the applicant is the general adult population. The Panel considers that a change in skin elasticity leading to an improvement in skin function is a beneficial physiological effect.
The applicant presented two human studies, one animal study and one in vitro study as being pertinent to the health claim.
In a randomised, double-blind, placebo-controlled study, 114 women received daily for eight weeks 2.5 g VeriSol®P or a placebo. The primary outcome of the study was the volume of eye wrinkles. Secondary outcomes were the contents of pro-collagen type I, elastin and fibrillin in suction blister biopsies. The Panel notes that this study did not assess a function of the skin, and considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
In another randomised, double-blind, placebo-controlled study, 69 women received daily for eight weeks 2.5 g VeriSol®P, 5 g VeriSol®P or a placebo. Primary outcomes of the study were skin elasticity and skin hydration. Secondary outcomes were transepidermal and transonychial water loss. In addition, skin roughness was assessed. The Panel considers that measures of transepidermal water loss can be used as scientific evidence for a function, i.e. the water barrier function, of the skin, and that measures of the water-holding capacity (hydration) of skin may be used as supportive evidence. There were no significant differences between the groups for transepidermal water loss or skin hydration at any time point. The Panel notes that this study did not show an effect on the water barrier function of the skin, and that no other function of the skin was measured.
One animal study in mice and one in vitro study in fibroblasts were provided. The Panel considers that in the absence of evidence for an effect of VeriSol®P on a change in skin elasticity leading to an improvement in skin function in humans, the animal and in vitro studies cannot be used for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of VeriSol®P and a change in skin elasticity leading to an improvement in skin function.