ID 1310 - Galusan epigallokatechiny z herbaty

PL: Galusan epigallokatechiny z herbaty
EN: Epigallo-catechin-3-gallate (EGCG) / Green tea extract, rich in EGCG
Pdf: Camellia sinensis

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is Camellia sinensis (L.) Kuntze, catechins present in green tea, green tea extract and epigallo-catechin-3-gallate (EGCG).
The plant Camellia sinensis (L.) Kuntze is an evergreen shrub of the Theaceae family. Tea is an extract of the dried leaves from Camellia sinensis (L.) Kuntze and it is usually prepared by infusing the leaves in hot water. The composition of the tea leaves depends on a variety of factors, including climate, season, horticultural practices, and the type and age of the plant. Many kinds of tea are produced. These teas can be classified into three major types according to the different levels of fermentation: green (un-fermented), oolong (semi-fermented) and black (fully fermented) (Wang et al., 2000).
The composition of tea beverages greatly depends on the type of leaves used, on the degree of fermentation and on the methods of preparation (Astill et al., 2001; Kaszkin et al., 2004). The degree of fermentation, the production process and the method for preparing the tea infusion have not been described in relation to the claims.
Green tea contains polyphenolic compounds, which include flavonoids, such as flavanols and flavandiols, and phenolic acids. Most of the polyphenols in green tea are catechins. Epigallo-catechin-3-gallate (EGCG) is the most abundant catechin in green tea. In black teas, the most abundant polyphenols are tannins, mainly theaflavin and thearubigin (Astill et al., 2001; Kaszkin et al., 2004). Tea extracts/infusions also contain variable amounts of potentially active food constituents, such as caffeine, theanine or theogallin. From the references provided it was not possible to characterise the specific green tea or green tea extract for which the claims are made.
Green tea catechins (including EGCG) can be measured in foods by established methods.
The Panel considers that whereas Camellia sinensis (L.) Kuntze (tea) and green tea extract are not sufficiently characterised in relation to the claimed effects, catechins in green tea (including EGCG) are sufficiently characterised.

2.1. Poprawa rozszerzenia naczyń krwionośnych zależnego od śródbłonka (ID 1106, 1310)

The claimed effects are “heart health” and “cardiovascular health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and the clarifications provided by Member States, the Panel assumes that the claimed effects refer to the improvement of endothelium-dependent vasodilation.
The Panel considers that a sustained improvement of endothelium-dependent vasodilation may be a beneficial physiological effect.

2.2. Utrzymanie prawidłowego ciśnienia tętniczego (ID 1310, 2657)

The claimed effects are “cardiovascular health” and “helps to keep elasticity of vessels”. The Panel assumes that the target population is the general population.
In the context of the proposed wording and the clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal blood pressure.
A claim on EGCG in green tea (Camellia sinensis (L.) Kuntze) and maintenance of normal blood pressure has already been assessed with an unfavourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010a) and the references cited for this claim did not provide any additional scientific data which could be used to substantiate the claim.

3.1. Poprawa rozszerzenia naczyń krwionośnych zależnego od śródbłonka (ID 1106, 1310)

The references provided for the substantiation of the claim included book chapters and narrative reviews that did not provide any original data that could be used for the scientific substantiation of the claimed effect. The references also included methodological studies on the analysis of tea polyphenols in urine and plasma, or on the determination of catechins in tea, as well as human intervention studies which assessed the effects of tea on health outcomes unrelated to the claimed effect (e.g. serum lipids, oxidative stress, hypertension and haemostasis), meta-analyses and human intervention studies on the effects of black tea or black tea flavonols (not further characterised) on different health outcomes, as well as cross-sectional and prospective cohort studies on the relationship between tea consumption (including green tea, but no further characterisation was provided) and chronic disease risk (e.g. coronary heart disease and stroke). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Among the human intervention studies which investigated the effects of green tea or green tea catechins on endothelium-dependent vasodilation (assessed as brachial-ankle pulse wave velocity, PWV), two were acute studies which did not address the sustained effects of chronic consumption of the food (Nagaya et al., 2004; Vlachopoulos et al., 2006), three s were uncontrolled (one arm) interventions (Kim et al., 2006; Murakami and Ohsato, 2003; Sung et al., 2005), and was a one randomised controlled trial (Ryu et al., 2006) in which green tea was not sufficiently characterised in relation to the claimed effect (e.g. amount of catechins not reported). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of catechins (including EGCG) in green tea (Camellia sinensis (L.) Kuntze) and improvement of endothelium-dependent vasodilation.

Warunki i możliwe ograniczenia stosowania oświadczenia

Based on studies with green tea a daily intake of EGCG from green tea ranging from 69 to 657 mg can be regarded as adequate