Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) claiming an increase in renal water elimination, “kidneys health”, “urinary health”, “bladder health”, “health of lower urinary tract”, “blood health”, “elimination”, “urinary system benefits” and/or “supports/promotes the excretory function of the kidney”, and treatment/prevention of renal gravel/kidney stones and urinary tract infections pursuant to Article 13(1) of Regulation (EC) No 1924/2006
Słowa kluczowe:
Renal water elimination
inflammation
kidney stones
renal gravel
Produkty:
Kawa
Bez czarny
Ruta zwyczajna
Skrzyp polny
Jesion wyniosły
Przetacznik leśny
Didymocarpus pedicellata
Topola włoska
Dziewanna wielkokwiatowa
Dziurawiec zwyczajny
Fiołek trójbarwny
Krwawnik pospolity
Liściokwiat garbnikowy
Rzepik pospolity
Pietruszka zwyczajna
Koper włoski, ruszczyk kolczasty, wilżyna ciernista, szparag lekarski, pietruszka zwyczajna
Szparagi
Wilżyna ciernista, rdest ptasi, mięta pieprzowa, krwawnik pospolity, rumianek pospolity
Tasznik pospolity, brzoza brodawkowata, nostrzyk żółty, rdest ptasi, perz właściwy
Wrzos zwyczajny
Koper włoski, eukaliptus głakowy, jodła pospolita
Ostrokrzew paragwajski
Macierzanka piaskowa
Brzoza brodawkowata, pokrzywa zwyczajna, perz właściwy
Brzoza brodawkowata, czereśnia ptasia, skrzyp polny, fasola zwykła, krwawnik pospolity, perz właściwy, kukurydza zwyczajna, przytulia właściwa, lawenda lekarska, mięta pieprzowa
Drzewo ipe
Mącznica lekarska
Anogeissus latifolia
Kukurydza zwyczajna
Chanca piedra
Psianka czarna
Herbata jawajska
Punarnava
Malina właściwa
Sida cordifolia
Seler
Herbata
Widłak goździsty
Wiśnia pospolita
Róża dzika
Wrzosiec popielaty
Oliwka europejska
Rabarbar dłoniasty
Buzdyganek naziemny
Lippia trójlistna
Jastrzębiec kosmaczek
Konyza kanadyjska
Rabarbar lekarski
Buzdyganek naziemny (owoc)
Kardamon malabarski
Kolendra siewna
Pokrzywa zwyczajna
Tasznik pospolity
Szparag lekarski
Koper ogrodowy
Nawłoć pospolita
Bluszcz pospolity
Rozmaryn lekarski
Śliwa tarnina
Karczoch zwyczajny
Wilżyna ciernista
Biedrzeniec mniejszy
Łopian większy
Oman wielki
Cebula
Jasnota biała
Traganek
Cykoria podróżnik
Fasola zwyczajna
Lucerna nerkowata
Koper morski
Perz właściwy
Wiązówka błotna
Cynamon
Koper włoski
Mniszek lekarski
Czereśnia
Ogórecznik lekarski
Porzeczka czarna
Lespedeza
Suchy wyciąg ze skrzypu, suchy wyciąg z mniszka lekarskiego
Dymnica pospolita
Trudziczka
Orzech włoski
Mleczaj
Jałowiec pospolity
Arnika górska
Chanca piedra
Lipa
Brzoza brodawkowata
2. Znaczenie oświadczenia dla zdrowia człowieka
1.1. Zwiększenie wydalania wody przez nerki (ID 1232, 2018, 2034, 2046, 2058, 2133, 2200, 2207, 2214, 2218, 2222, 2228, 2233, 2253, 2257, 2266, 2275, 2276, 2280, 2285, 2296, 2298, 2315, 2319, 2326, 2330, 2338, 2346, 2528, 2531, 2541, 2567, 2628, 2677, 2691, 2701, 2704, 2705, 2708, 2715, 2739, 2740, 2742, 2765, 2767, 2774, 2780, 2782, 2784, 2785, 2787, 2816, 3231, 3239, 3250, 3263, 3273, 3360, 3366, 3397, 3404, 3405, 3410, 3417, 3459, 3492, 3515, 3518, 3542, 3548, 3570, 3602, 3610, 3620, 3663, 3693, 3757, 3783, 3809, 3823, 3827, 3912, 3915, 3965, 3997, 4040, 4124, 4127, 4178, 4225, 4314, 4347, 4353, 4357, 4458, 4489, 4492, 4506, 4515, 4518, 4533, 4563, 4565)
The claimed effects refer to the increase in renal water elimination (i.e. diuresis). The Panel assumes that the target population is the general population.
Substances which force diuresis also decrease the extracellular fluid volume by increasing renal sodium and water excretion.
Under normal conditions, fluid balance is tightly regulated over a 24-h period (Subudhi et al., 2005). Water deficits and excesses trigger compensatory changes in either water gains or losses until water balance is re-established (EFSA Panel on Dietetic Products, Nutrition, and Allergies (NDA), 2010). A fall in volaemia or extracellular fluid volume will lead through a tightly regulated feedback system to increased renal tubular reabsorption of sodium and water (Shirreffs and Maughan, 2005).
Losses in body water which are not adequately compensated will result in dehydration.
The Panel considers that the evidence provided does not establish that an increase in renal water elimination potentially leading to a negative fluid balance is a beneficial physiological effect for the general healthy population.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of this opinion and a beneficial physiological effect related to an increase in renal water elimination.
1.2. Zdrowie nerek, zdrowie układu moczowego, zdrowie pęcherza moczowego, zdrowie dolnych dróg moczowych, zdrowie krwi, wydalanie, eliminacja, korzystny dla układu moczowego, wspomaga wydalniczą funkcję nerek (ID 2296, 2315, 2319, 2326, 2780, 2784, 3823, 3915, 4599, 1188, 2108, 2194, 2199, 2217, 2273, 2322, 2352, 2355, 2432, 3683, 3737, 3762, 3773, 3869, 3878, 3889, 3893, 4432, 4492)
The claimed effects are “kidneys health”, “urinary health”, “bladder health”, “health of lower urinary tract”, “blood health”, “elimination”, “urinary system benefits” and/or “supports/promotes the excretory function of the kidney”. The Panel assumes that the target population is the general population.
“Kidneys health”, “urinary health”, “bladder health”, “health of lower urinary tract”, “blood health”, “elimination”, “urinary system benefits” and/or “supports/promotes the excretory function of the kidney” are not sufficiently defined and no further details were provided in the proposed wordings or the clarifications provided by Member States.
The Panel considers that the claimed effects are general and non-specific and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
1.3. Leczenie i zapobieganie kamieniom nerkowym i zakażeniom układu moczowego (ID 2596, 3929)
The claimed effects are “système urinaire, diurétique, anti-inflammatoire des voies urinaires, prévention des calculs rénaux” and “health of urinary tract”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effect is related to the treatment/prevention of renal gravel/kidney stones and urinary tract infections.
The Panel considers that the treatment/prevention of renal gravel/kidney stones and urinary tract infections is related to the prevention or treatment of a disease.
The Panel considers that the claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
Wnioski
On the basis of the data presented, the Panel concludes that:
Increase in renal water elimination (ID 1232, 2018, 2034, 2046, 2058, 2133, 2200, 2207, 2214, 2218, 2222, 2228, 2233, 2253, 2257, 2266, 2275, 2276, 2280, 2285, 2296, 2298, 2315, 2319, 2326, 2330, 2338, 2346, 2528, 2531, 2541, 2567, 2628, 2677, 2691, 2701, 2704, 2705, 2708, 2715, 2739, 2740, 2742, 2765, 2767, 2774, 2780, 2782, 2784, 2785, 2787, 2816, 3231, 3239, 3250, 3263, 3273, 3360, 3366, 3397, 3404, 3405, 3410, 3417, 3459, 3492, 3515, 3518, 3542, 3548, 3570, 3602, 3610, 3620, 3663, 3693, 3757, 3783, 3809, 3823, 3827, 3912, 3915, 3965, 3997, 4040, 4124, 4127, 4178, 4225, 4314, 4347, 4353, 4357, 4458, 4489, 4492, 4506, 4515, 4518, 4533, 4563, 4565)
The claimed effects refer to the increase in renal water elimination. The target population is assumed to be the general population. The evidence provided does not establish that an increase in renal water elimination potentially leading to a negative fluid balance is a beneficial physiological effect for the general healthy population. A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of this opinion and a beneficial physiological effect related to an increase in renal water elimination.
“Kidneys health”, “urinary health”, “bladder health”, “health of lower urinary tract”, “blood health”, “elimination”, “urinary system benefits” and/or “supports/promotes the excretory function of the kidney” (ID 2296, 2315, 2319, 2326, 2780, 2784, 3823, 3915, 4599, 1188, 2108, 2194, 2199, 2217, 2273, 2322, 2352, 2355, 2432, 3683, 3737, 3762, 3773, 3869, 3878, 3889, 3893, 4432, 4492) The claimed effects are “kidneys health”, “urinary health”, “bladder health”, “health of lower urinary tract”, “blood health”, “elimination”, “urinary system benefits” and/or “supports/promotes the excretory function of the kidney”. The target population is assumed to be the general population. “Kidneys health”, “urinary health”, “bladder health”, “health of lower urinary tract”, “blood health”, “elimination”, “urinary system benefits” and/or “supports/promotes the excretory function of the kidney” are not sufficiently defined and no further details were provided in the proposed wordings or the clarifications provided by Member States. The claimed effects are general and non-specific and do not refer to any specific health claim as required by Regulation (EC) No 1924/2006.
Treatment/prevention of renal gravel/kidney stones and urinary tract infections (ID 2596, 3929)
The claimed effects are “système urinaire, diurétique, anti-inflammatoire des voies urinaires, prévention des calculs rénaux” and “health of urinary tract”. The target population is assumed to be the general population. In the context of the proposed wordings it is assumed that the claimed effect is related to the treatment/prevention of renal gravel/kidney stones and urinary tract infections. The claim does not comply with the criteria laid down in Regulation (EC) No 1924/2006.