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:    2273      3809      2785      2018      2787      2275      2531      2276      2280      2541      2285      3823      3570      2034      3827      4599      2296      2298      4347      2046      2816      4353      4357      2567      2058      2315      2319      3602      2322      2326      3610      2330      4124      3869      4127      3360      2338      3620      2596      3878      3366      2346      2352      3889      2355      3893      2108      2628      3397      3912      3915      3404      3405      3663      4432      4178      3410      2133      3417      3929      3683      4458      3693      2677      3965      2432      4225      2691      3459      4489      4492      2701      2704      2705      2194      2708      2199      2200      3737      4506      2715      3997      2207      3231      4515      3492      1188      2214      4518      3239      2217      2218      3757      2222      3250      3762      2739      2228      2740      4533      2742      2233      3515      3773      3518      3263      3783      4040      3273      2765      2253      2767      1232      2257      4563      4565      3542      2774      2266      4314      3548      2780      2782      2528      2784  
Produkty: Jastrzębiec kosmaczek   Konyza kanadyjska   Pokrzywa zwyczajna   Rabarbar lekarski   Rabarbar dłoniasty   Rozmaryn lekarski   Buzdyganek naziemny   Lippia trójlistna   Wiśnia pospolita   Karczoch zwyczajny   Wrzosiec popielaty   Oliwka europejska   Punarnava   Łopian większy   Sida cordifolia   Psianka czarna   Herbata jawajska   Anogeissus latifolia   Traganek   Chanca piedra   Macierzanka piaskowa   Brzoza brodawkowata, czereśnia ptasia, skrzyp polny, fasola zwykła, krwawnik pospolity, perz właściwy, kukurydza zwyczajna, przytulia właściwa, lawenda lekarska, mięta pieprzowa   Brzoza brodawkowata, pokrzywa zwyczajna, perz właściwy   Mniszek lekarski   Tasznik pospolity, brzoza brodawkowata, nostrzyk żółty, rdest ptasi, perz właściwy   Koper włoski, eukaliptus głakowy, jodła pospolita   Cynamon   Koper włoski, ruszczyk kolczasty, wilżyna ciernista, szparag lekarski, pietruszka zwyczajna   Wilżyna ciernista, rdest ptasi, mięta pieprzowa, krwawnik pospolity, rumianek pospolity   Lucerna nerkowata   Pietruszka zwyczajna   Perz właściwy   Krwawnik pospolity   Rzepik pospolity   Dziurawiec zwyczajny   Topola włoska   Dziewanna wielkokwiatowa   Jałowiec pospolity   Przetacznik leśny   Kukurydza zwyczajna   Didymocarpus pedicellata   Koper morski   Widłak goździsty   Chanca piedra   Wiązówka błotna   Cebula   Lipa   Nawłoć pospolita   Porzeczka czarna   Lespedeza   Herbata   Liściokwiat garbnikowy   Kolendra siewna   Kardamon malabarski   Koper ogrodowy   Szparag lekarski   Tasznik pospolity   Ruta zwyczajna   Bluszcz pospolity   Fiołek trójbarwny   Jesion wyniosły   Kawa   Oman wielki   Jasnota biała   Wilżyna ciernista   Biedrzeniec mniejszy   Śliwa tarnina   Róża dzika   Fasola zwyczajna   Buzdyganek naziemny (owoc)   Seler   Cykoria podróżnik   Drzewo ipe   Czereśnia   Ogórecznik lekarski   Bez czarny   Ostrokrzew paragwajski   Skrzyp polny   Koper włoski   Dymnica pospolita   Trudziczka   Szparagi   Wrzos zwyczajny   Suchy wyciąg ze skrzypu, suchy wyciąg z mniszka lekarskiego   Mącznica lekarska   Arnika górska   Malina właściwa   Brzoza brodawkowata   Orzech włoski   Mleczaj  

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.