EFSA’s health claims panel agreed, “skin elasticity leading to an improvement in skin function is a beneficial physiological effect” but said this was not demonstrated in two human studies, one animal study and one in vitro study.
Responding to the rejection, Gelita said claimless nutrients like its VeriSol peptide under the EU nutrition and health claims regulation (NHCR), could find hope in general EU food law where principles about general misleading advertising were outlined.
“The rules say that the labeling and marketing of a food must not be misleading particularly by attributing to the food stuff effects or properties which it does not possess and which are not scientifically substantiated,” Gelita said.
“Therefore, we believe that a beauty claim that does not suggest or imply that a relationship between the food and health does exist may be used if supported by strong and relevant scientific studies.”
It said the rejection therefore gave it confidence, “that customers can promote the demonstrated and scientific proven VeriSol benefits … under the respective food legislation.”
In its opinion EFSA highlighted one randomised, double-blind, placebo-controlled study where 114 women received 2.5 g of VeriSol daily for eight weeks or placebo.
The primary outcome was volume of eye wrinkles with secondary outcomes of content of pro-collagen type I, elastin and fibrillin in suction blister biopsies.
In dismissing the study EFSA’s Panel on Dietetic Products, Nutrition and Allergies (DNA) said the 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.”
Another randomised, double-blind, placebo-controlled study with 69 women receiving the same dose for the same length of time (or placebo) had skin elasticity and skin hydration as primary outcomes. Secondary outcomes were transepidermal and transonychial water loss and skin roughness.
The Panel said, “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.”
But, “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.”
It therefore concluded that, “a cause and effect relationship has not been established between the consumption of VeriSol and a change in skin elasticity leading to an improvement in skin function.”
Gelita said of that conclusion that, "EFSA decided to report only those outcomes which were directly relevant for the claimed effect under assessment and did not comment on the positive results (elasticity/wrinkle reduction) as they do not consider them as 'skin functions' and therefore not health claim relevant."