1302.pdf

Oryginał 
Scientific opinion on the substantiation of health claims related to Undaria pinnatifida (Harvey) Suringar and maintenance or achievement of a normal body weight (ID 2345) 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: Undaria pinnatifida (Harvey) Suringar   body weight   health claim  
ID:    2345  
Produkty: Undaria pierzastodzielna  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Undaria pinnatifida (Harvey) Suringar. The characterisation of Undaria pinnatifida (Harvey) Suringar 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 Undaria pinnatifida (Harvey) Suringar 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
Undaria
pinnatifida
(Harvey)
Suringar = Alaria
pinnatifida
Harvey
Alariaceae
Thallus Powder;
hydro-
alcoholic and
aqueous
extract;
infusion.
Specific
extracts
standardised
in:
fucoxanthin.
Thallus powder: 1-2g, 3 times/day.
Decoction: 2%: 2 cups/day.
Tincture: 40 drops, 3 times/day.
Fluid extract: 0.5-2g/day
Aqueous extract: 0.10g/day
Infusion: 5-10g/L, 3 times 150mL/day.
Notes:
dried thallus contains up to 30% of Alginic acid.
Any preparations must comply with the (national) requirements of iodine
content.
2345 Undaria
pinnatifida
Not
specified.
Note: it is
assumed to
be the
thallus.
Preparations
standardised
in
fucoxanthin
Preparation: an amount equivalent to
15mg fucoxanthin.
Note: Daily amount not specified, but it is
limited by the content of iodine.
The part used is not specified, but is assumed to be the thallus. The daily amount is not specified, but it is limited by the content of iodine.
The Panel considers that the food constituent, Undaria pinnatifida (Harvey) Suringar, which is the subject of the health claim, has been sufficiently characterised with the following conditions of use: Thallus: an amount equivalent to 15 mg fucoxanthin per day.

2. Znaczenie oświadczenia dla zdrowia człowieka

The claimed effect is “body weight”. The Panel assumes that the target group is the general population.
“Body weight” is not sufficiently defined. From the proposed wordings the Panel assumes that the claimed effect is related to the maintenance or achievement 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 - Uzyskanie lub utrzymanie prawidłowej masy ciała

One reference was cited to substantiate the claim. This reference was a website related to frequently asked questions on a specific product. 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 Undaria pinnatifida (Harvey) Suringar and the maintenance or achievement of a normal body weight.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, Undaria pinnatifida (Harvey) Suringar, which is the subject of the health claim, is sufficiently characterised with the following conditions of use: Thallus: an amount equivalent to 15 mg fucoxanthin per day.
The claimed effect is “body 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 Undaria pinnatifida (Harvey) Suringar and the maintenance or achievement of a normal body weight.