1291.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to Fraxinus excelsior L. and maintenance of joints (ID 2256) and maintenance or achievement of a normal body weight (ID 3688) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup] EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2 European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe: Fraxinus excelsior L  
ID:    2256      3688  
Produkty: Jesion wyniosły  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Fraxinus excelsior L.. The characterisation of Fraxinus excelsior L. is performed by comparing data provided as conditions of use to information extracted from standard reference textbooks (see Table 2 below and Appendix C for list of standard reference textbooks used for the characterisation).
Table 2. Information on Fraxinus excelsior L. from standard reference textbooks and the information provided as conditions of use.
Scientific name Part used Nature of the preparation
Conditions of use
Text-
book
Fraxinus
excelsior L.
Oleaceae
Leaf; bark
of the tree;
bud; shoot
Leaf:
Powder; tincture;
extracts; infusion;
Bark:
Extract; infusion
Bud; shoot:
Glycerinated
macerate
Dried leaf: min 2.5% total
hydroxy-cinnamic derivatives.
Leaf:
Tincture: 3 times 30 drops/day.
Dried extract (nebulisate): 1:4,
75-150 mg 3 times/day.
Infusion: 10-30 g/L of water.
Bark:
Note: dosage not specified.
Contains coumarine, glycosides
and derivatives.
ID
2256 Fraxinus excelsior
L.
Not
specified
Note: it is
assumed to
be the leaf
Dried extract
(nebulisate)
Dried extract (nebulisate): (1:4)
200-500 mg/day.
ID
3688 Fraxinus excelsior
L. - common
name: ash
Leaf Not specified
Note: it is assumed
to be dried leaf
Leaf: 5-20 g/day.
ID 2256:
The part used is not specified, but it is assumed that the nebulisate is from the leaves.
The Panel considers that the food constituent Fraxinus excelsior L., which is the subject of the health claim, has been sufficiently characterised with the following conditions of use: Dried leaf extract (nebulisate): (1:4) 200-500 mg/day.
ID 3688:
The nature of preparation is not specified, but it is assumed to be the dried leaf.
The Panel considers that the food constituent Fraxinus excelsior L., which is the subject of the health claim, has been sufficiently characterised with the following conditions of use: Dried leaf: 5-20 g/day.

2. Znaczenie oświadczenia dla zdrowia człowieka


2.1. Utrzymanie prawidłowego stanu stawów (ID 2256)

The claimed effect is “joint health”. The Panel assumes that the target population is the general population.
The claimed effect “joint health” is not sufficiently defined. In the context of the proposed wordings the Panel assumes that the claimed effect relates to maintenance of normal joints.
The Panel considers that maintenance of normal joints is beneficial to human health.

2.2. Osiąganie lub utrzymywanie prawidłowej masy ciała (ID 3688)

The claimed effect is “control of weight”. The Panel assumes that the target population is the general population.
Weight control can be interpreted as the contribution to the maintenance of a normal body weight. In this context even a moderate weight loss in overweight subjects without achieving a normal body weight is considered beneficial to health.
The Panel considers that the maintenance or achievement of a normal body weight is beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka


3.1. Utrzymanie prawidłowego stanu stawów (ID 2256)

Five references were cited to substantiate the claimed effect. Four of these are textbooks, monographs and a regulatory document in which the claimed effect is stated. One reference (Kostova and Iossifova, 2007) is a review on chemical composition of many Fraxinus species, including Fraxinus excelsior L. In this review the biological activity of extracts and pure compounds is shortly described but with no relation to the claimed effect. The Panel notes that the references cited did not provide any scientific data that could be used to substantiate the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Fraxinus excelsior L. and maintenance of normal joints.

3.2. Osiąganie lub utrzymywanie prawidłowej masy ciała (ID 3688)

Two references were cited to substantiate the claimed effect. These are a textbook and a regulatory text in which the claimed effect is stated. The Panel notes that the references cited did not provide any scientific data that could be used to substantiate the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Fraxinus excelsior L. and the maintenance or achievement of a normal body weight.

Wnioski

On the basis of the data presented, the Panel concludes that:
Maintenance of joints (ID 2256)
The food constituent, Fraxinus excelsior L., which is the subject of the health claim, has been sufficiently characterised for maintenance of normal joints with the following conditions of use: Dried leaf extract (nebulisate): (1:4) 200-500 mg/day.
The claimed effect is “joint health”. The target population is assumed to be the general population. Maintenance of normal joints is beneficial to human health.
A cause and effect relationship has not been established between the consumption of Fraxinus excelsior L. and maintenance of normal joints.
Maintenance or achievement of a normal body weight (ID 3688)
The food constituent, Fraxinus excelsior L., which is the subject of the health claim, has been sufficiently characterised for the maintenance or achievement of a normal body weight with the following conditions of use: Dried leaf: 5-20 g/day.
The claimed effect is “control of weight”. The target population is assumed to be the general population. Maintenance or achievement of a normal body weight is beneficial to human health.
A cause and effect relationship has not been established between the consumption of Fraxinus excelsior L. and the maintenance or achievement of a normal body weight.