1742.pdf

Oryginał 
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  
ID:    2715      3492      3250      4040      3263      2708      2705      2704      4353      4599      3239      2701      2432      4357      3783      4124      3518      4127      3515      2691      3762      2207      4347      2677      2194      3773      2199      2200      3542      3757      3273      3548      2780      2233      2784      2782      3737      2228      2774      2222      2218      2217      2767      4178      2765      2214      3997      4432      3459      2266      2739      2740      3231      2742      2257      2253      2528      3683      3693      3965      2275      2034      4506      2276      3915      2273      2280      1188      4225      3366      2046      2285      3912      2567      4489      3929      2018      4492      2296      3663      2298      3405      2787      2785      3404      1232      3397      2315      2319      3878      2322      4458      2326      3417      2531      2816      2541      2330      3889      3620      2058      3410      3893      3610      2338      2352      4565      2108      3602      2346      4563      2628      3869      2355      4314      3823      2133      4533      3570      3809      2596      3360      4518      4515      3827  
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.