原文报道：Following an application from Laboratoires innéov SNC submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006 via the Competent Authority of France, the Panel on Dietetic Products, Nutrition and Allergies was asked to deliver an opinion on the scientific substantiation of a health claim related to a combination of blackcurrant seed oil, fish oil, lycopene, vitamin C, and vitamin E and “helps to improve dry skin conditions”.
The scope of the application was proposed to fall under a health claim based on newly developed scientific evidence and including a request for the protection of proprietary data.
The constituents of the supplement that is the subject of the health claim are blackcurrant seed oil, fish oil, lycopene, vitamin C, and vitamin E which are presented in soft gel capsules. Lycopene, vitamin C and vitamin E are well-characterised components and can be analysed in foods by established methods. Blackcurrant seed oil and fish oil contain polyunsaturated fatty acids with the main constituents of LA, GLA and ALA for the blackcurrant seed oil, and EPA and DHA for the fish oil. These fatty acids can be analysed in foods by established methods. The Panel considers that the food is sufficiently characterised.
The claimed effect is “helps to improve dry skin conditions”. The target population is healthy adults with skin dryness and skin which feels tight and creases. The Panel considers that improving dry skin conditions is a beneficial physiological effect.
The applicant identified a total of 29 publications as being pertinent to the health claim, including 6 human studies. The narrative reviews, the non-human studies and three of the human studies addressed the individual food constituents and not the whole combination that is the subject of the claim. Another human study addressed the food that was the subject of the claim but was concerned with consumer behaviour and perception. The Panel considers that no scientific conclusions can be drawn from these studies for substantiation of the claim.
The remaining two unpublished studies (claimed as proprietary by the applicant) addressed the food that was the subject of the claim and reported on relevant outcomes. One was a pilot study, which was a randomised, double blind, parallel intervention in 80 menopausal women aged 50-80 y with dry skin and the study lasted for 12 weeks. Among the 80 participants, there was a subpopulation of 40 nuns on whom additional parameters were measured. There were some 156 comparisons of interest in total comprising two clinical evaluations, 38 dermatological evaluations, 46 self-evaluations by the participants, 26 objective evaluations and 44 biochemical evaluations. There were no significant differences between the treatment group and control in dryness score which was assessed as the clinical end point at the beginning of the study and at days 42 and 84. Only one of the multiple dermatological assessments was significantly different in the treatment group compared with control and only one of the subjective self-evaluations was significantly different in the treatment group compared with control. In the subpopulation, additional endpoints were measured. Significant differences were shown between treatment and control groups after 84 days with respect to the roughness parameter, pseudo-roughness parameter and volume parameter. The only biochemical test which was significantly different between treatment and control after 84 days was the ceramide concentration. The Panel notes that in this pilot study, there were no significant differences between treatment and control groups with respect to the clinically evaluated endpoint (dryness score). Only two of 84 comparisons of interest were significantly different between treatment and control in the total population and only four out of 70 comparisons of interest in the sub-group analysis were significantly different between treatment and control. The Panel considers that the lack of effect on the clinically evaluated outcome (dryness score) and on almost all of the many other outcomes measured indicates that the intake of a combination of blackcurrant seed oil, fish oil, lycopene, and vitamins C and E did not result in improvement in skin dryness in this study.
The second human study was a randomised, double blind, parallel intervention on seasonal skin xerosis with the food that is the subject of the claim. The study participants were women aged 40 60 y. Duration of the study was 30 weeks. The first 15 weeks took place in the summer season whereas the second 15 weeks took place in the winter season. A total of 155 subjects were included in the study, 105 in the active group and 50 in the control group. The mean Global Skin Score (GSS) was measured as the primary endpoint on four different skin areas and was assessed at four time-points: at start of summer, at the end of summer, at the beginning of winter and at the end of winter. There were no significant differences in baseline adjusted mean GSS between treatment and control at any time point. When the mean GSS was subdivided into sub-scores for face, hands, fore-arms, and legs, the only baseline adjusted significant differences for the treatment group compared with placebo were on the leg at the end of the winter period compared to the beginning of the study and compared to the beginning of the winter period. The other 14 comparisons of interest were not significantly different in the treatment group compared with control. Other endpoints included skin dryness using the l’Oreal Atlas, squamometry, the pruritus score and several other self assessment skin parameters. A total of 140 such comparisons of interest were statistically tested by analysis of covariance. A total of eight of these comparisons (six of which were self assessments by the participants) were significantly different in the treatment group compared with control. The Panel notes that there were no significant differences between the treatment and the control group in the primary outcome (Global Skin Score) at any time point and that almost all of the secondary endpoint analysis presented supports the lack of effect observed in the primary analysis. The Panel concludes that these findings indicate that the intake of a combination of blackcurrant seed oil, fish oil, lycopene, and vitamins C and E did not result in improvement in skin dryness in this study.
In weighing the evidence, the Panel took into account that two studies on the effect of the food that is the subject of the claim and that used appropriate outcomes did not result in a significant improvement in skin dryness.
The Panel concludes that a cause and effect relationship has not been established between the intake of a combination of blackcurrant seed oil, fish oil, lycopene, and vitamins C and E and improving dry skin conditions.
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