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Scientific Opinion on the substantiation of health claims related to Ammi visnaga (L.) Lam. and relief in case of irritation in the upper respiratory tract (ID 2211) 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: Ammi visnaga (L.) Lam  
ID:    2211  
Produkty: Aminek egipski  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Ammi visnaga (L.) Lam.. The characterisation of Ammi visnaga (L.) Lam. 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 Ammi visnaga (L.) Lam. from standard reference textbooks and the information provided as conditions of use.
ID Scientific
name Part used
Nature of the
preparation Conditions of use
Text-
book
Ammi
visnaga
(L.)
Lam.
Apiacea
e
Fruit Extract; infusion Dry fruit contains not less than 1%
gamma-pyrones calculated as khellin.
Dried fruit: 0.05-0.15 g/day or equivalent
preparations.
Standardised dry extract: 140 mg/day
(10.5% of gamma-pyrones calculated as
khellin): solvent: methanol-water 70:30
w/w; plant-extract ratio: 6.2-10:1.
Infusion: 0.5 g/150 mL.
Notes: Fruit (therapeutic dose) - 0.4% of
khellin and 1% of khellinin. Oral intakes:
50-100 mg khellin, 3 times/day; 20-60 mg
khellinin 3 times/day.
2211 Ammi
visnaga
(L.) Lam.
Not specified
Note: It is assumed
to be “fruit”, owing
to the presence of
khellin.
Not specified.
Note: It is assumed
to be a preparation
standardised in
khellin.
Preparation: an amount equivalent to 20 mg
khellin.
Note: it is assumed to be the daily amount.
The part used is not specified, but it is assumed to be the fruit because the presence of khellin is required. The nature of the preparation is not specified, but it is also assumed that it is an extract standardised in khellin. The daily amount is not specified, however it is assumed to be the daily amount.
The Panel concludes that the food constituent, Ammi visnaga (L.) Lam., which is the subject of the health claim, has been sufficiently characterised with the following conditions of use: an amount equivalent to 20 mg khellin/day.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “respiratory health”. The Panel assumes that the target population is the general population.
“Respiratory health” is not sufficiently defined. From the proposed wordings the Panel assumes that the claimed effect relates to relief in case of tickle in the upper respiratory tract.
The Panel considers that relief in case of irritation in the upper respiratory tract might be beneficial to human health.

3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Łagodzenie objawów podrażnienia górnych dróg oddechowych

One reference was cited to substantiate the claimed effect. The reference provided was from the Natural Comprehensive Database stating that khellin is used for respiratory conditions, acts as a vasodilator and has bronchodilatory activity. The Panel notes that the reference 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 Ammi visnaga (L.) Lam. and relief in case of irritation in the upper respiratory tract.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, Ammi visnaga (L.) Lam., which is the subject of the health claim, is sufficiently characterised with the following conditions of use: an amount equivalent to 20 mg khellin/day.
The claimed effect is “respiratory health”. The target population is assumed to be the general population. Relief in case of irritation in the upper respiratory tract might be beneficial to human health.
A cause and effect relationship has not been established between the consumption of Ammi visnaga (L.) Lam. and relief in case of irritation in the upper respiratory tract.