1303.pdf

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Scientific Opinion on the substantiation of health claims related to Viola tricolour L. and relief in case of irritation in the upper respiratory tract (ID 2356) 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: Viola tricolor L  
ID:    2356  
Produkty: Fiołek trójbarwny  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Viola tricolor L. The characterisation of Viola tricolor 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 characterization).
Table 2. Information on Viola tricolor L. 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
Viola tricolor L. =
V. arvensis Murray
Violaceae
Aerial part of the
flowering plants
Tincture; infusion;
decoction
- Tincture: 50 drops 3
times/day.
- Infusion:
1.5g/150mL, 3 times
/day.
- Decoction: 40-60g in
1L water/day.
2356 Viola tricolor L. Herb
Note: it is assumed
that the herb is of
the aerial part of the
flowering plant.
Not specified
Note: it is assumed to
be the dried herb.
Herb: an amount
equivalent to 1.5g of
herb/day.
The part of the plant used is not specified, but it is assumed that the herb is of the aerial part of the flowering plant. The nature of the preparation is not specified, but it is assumed to be the dried herb.
The Panel considers that the food constituent, Viola tricolor L., which is the subject of the claim ,has been sufficiently characterised with the following conditions of use: an amount equivalent to 1.5 g of dried herb/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 claim refers 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 claim. This reference (Blaschek et al., 2003), states that Viola tricolor L. can be used to treat various upper-respiratory tract problems. The Panel notes that the reference cited, did not provide any scientific data that could be used to substantiate the claimed effect.
The Panel considers that a cause and effect relationship has not been established between the consumption of Viola tricolor L. and relief in case of irritation in the upper respiratory tract.

Wnioski

On the basis of the data presented, the Panel concludes that:
The constituent, Viola tricolor L., which is the subject of the health claim, is sufficient characterised with the following conditions of use: an amount equivalent to 1.5 g of dried herb/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 Viola tricolor L. and relief in case of irritation in the upper respiratory tract.