Scientific Opinion on the substantiation of health claims related to
oligomeric procyanidins (OPCs) from grape (Vitis vinifera L.) seeds and
improvement of visual adaptation to the dark (ID 680) pursuant to Article
13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
Oligomeric procyanidins
Vitis vinifera L
1. Charakterystyka żywności / składnika
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Poprawa adaptacji wzroku w ciemności
The food constituent that is the subject of the health claim is oligomeric procyanidins (OPCs) from grape (Vitis vinifera L.) seeds.
OPCs are naturally occurring plant metabolites widely present in fruits, vegetables, nuts and seeds. Grape seed extract contains OPCs consisting of dimers or trimers of (+)-catechin and (-)-epicatechin. Furthermore, several galloyl procyanidins, which are most commonly the gallate esters of the dimeric procyanidins, and some free gallic acid are present (Fine, 2000).
The Panel considers that the food constituent, OPCs from grape (Vitis vinifera L.) seeds, which is the subject of the health claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
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Poprawa adaptacji wzroku w ciemności
The claimed effect is “ocular system: OPC play an important role in the structure and physiological functions of cornea, OPC protect the cornea and improve visual adaptation to low luminance”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, clarifications from Member States and the references provided, the Panel assumes that the claimed effect refers to the improvement of visual adaptation to the dark.
The Panel considers that improvement of visual adaptation to the dark is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Poprawa adaptacji wzroku w ciemności
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Poprawa adaptacji wzroku w ciemności
Among the references provided for the scientific substantiation of the claim were animal and in vitro studies unrelated to the claimed effect (e.g. effects on corneal tissues). The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
In a human intervention study, 100 subjects were randomly assigned to receive either four tablets/day of a commercial preparation of OPCs from grape seeds (50 mg/tablet, n=50) or no treatment (n=50), for five weeks (Corbé et al., 1988). Subjects were recruited in two centres (50 subjects/centre). Ninety-five subjects completed the study. At baseline and at the end of the intervention, night morphoscopic vision thresholds were assessed in centre 1 using Beyne’s lantern, and mesopic visual acuity was evaluated using Ergovision tests in a sub-group (n=25) of centre 2. The Panel notes that subjects and investigators were not blinded to the treatment, and notes the poor reporting of the study methodology and results (e.g. lack of data about compliance and the statistical analyses performed). The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of OPCs from grape (Vitis vinifera L.) seeds and improvement of visual adaptation to the dark.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, oligomeric procyanidins (OPCs) from grape (Vitis vinifera L.) seeds, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “ocular system: OPC play an important role in the structure and physiological functions of cornea. OPC protect the cornea and improve visual adaptation to low luminances”. The target population is assumed to be the general population. Improvement of visual adaptation to the dark is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of OPCs from grape (Vitis vinifera L.) seeds and improvement of visual adaptation to the dark.
