2228.pdf

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Scientific Opinion on the substantiation of health claims related to various food(s)/food constituent(s) and health relationships that are not sufficiently defined (ID 9, 377, 531, 555, 560, 569, 582, 583, 584, 585, 589, 590, 675, 692, 847, 1199, 1265, 1267, 1342, 1352, 1357, 1368, 1369, 1379, 1382, 1383, 1399, 1401, 1477, 1480, 1482, 1530, 1625, 1732, 1777, 1792, 1814, 1837, 1998, 2175, 2212, 2223, 2329, 2487, 2504, 2753, 2916, 3076, 3667, 3692, 4241, 4243, 4247, 4248, 4278, 4407); are not referring to a function of the body (ID 1233, 1385, 1406, 1746, 1879, 1950, 3131, 4202); are related to the prevention or treatment of a disease (ID 1859, 2552, 2743, 2773, 3087, 3164, 3687); are not referring to a beneficial physiological effect (ID 544, 545, 648, 773, 782, 1399, 1781, 1795, 1842, 1906, 1944, 2759, 2825, 2886, 3128, 3137, 3153, 3519, 3972, 4112, 4662, 4691) pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
Słowa kluczowe: Food  
ID:    1732      1342      377      2175      3131      648      3667      3128      1199      2825      4112      1879      773      1625      1746      531      544      3519      4243      782      1859      4241      1998      4248      4247      4202      2552      3164      1369      1368      1842      9      2916      3153      1357      1477      1480      1233      1837      2329      1352      1482      3137      1944      583      1399      2886      584      3972      582      1814      1267      1950      585      1401      1265      589      2773      590      1406      1379      2223      4662      1383      1382      2487      2753      1385      2759      847      1795      2212      1792      545      4407      1906      555      2504      675      1781      2743      560      1777      4691      3687      3087      1530      4278      569      3076      692      3692  
Produkty: Bromelaina   Bez czarny   Inozytol   Kwasy tłuszczowe Omega-3 i Omega-6   Wodorowęglany   Olej z nasion owoców jagodowych (takich jak borówka, żurawina, jeżyna, malina)   Maltodekstryna   Melonowiec właściwy   Witaminy, minerały, składniki śladowe, standaryzowany wyciąg z żeń-szenia   Suchy wyciąg z kwiatostanu kapusty ogrodowej   Śmietana w proszku o zmniejszonej zawartości tłuszczu (bogate źródło fosfolipidów mlecznych)   Aronia czarnoowocowa   Proteaza, lipaza, enzymy trawiące węglowodany   Fruktoza   Sole buforujące (węglan wapnia, tlenek magnezu)   Lakownica lśniąca   Enzymy trzustkowe   Kukurydza zwyczajna   Ksylooligosacharydy   Oligofruktoza z cykorii   Drożdże saccharomyces cerevisiae   Orzechy laskowe   Malina właściwa   Chrzan   Olej z wątroby dorsza   Drożdże piwne   Wiśnia pospolita   Beta-glukany   Kolagen   Glukoza, fruktoza   Papryka   Fermentowany sok z marchwi   Pomarańcza   Rzodkiew zwyczajna   Olej z owoców rokitnika   Naturalne mleko klaczy   Woda mineralna z dwutlenkiem węgla   Sok z czarnej porzeczki   Laktoferyna bydlęca   Wyciąg z gryki zawierający kompleks trokserutyny i cynku   Mleczko pszczele z pyłkami   Płyn do nawadniania o zmniejszonej osmolarności zgodny z rekomendacjami WHO/UNICEF   Wyciąg z nasion brokułów zawierający sulforafan   Indolo-3-karbinol   Laktoferyna   Kreatyna, węglowodany (dekstroza, sacharoza)   Ananas właściwy   Hydrolizat białek kukurydzianych (zawierający 29% glutaminy)   Naturalna woda mineralna   Żelatyna, cystyna   Ocet jabłkowy (proszek)   Kwas paraaminobeznoesowy (PABA)   Beta-glukany z Saccharomyces cerevisiae   Izoflawony sojowe, likopen, cynk, selen, witamina D, witamina E, witamina C   Żelatyna   Deanol   Lecytyna   Sok z borówki amerykańskiej   Pędy soczewicy i fasoli   Naturalna woda mineralna z dwutlenkiem węgla (zawierająca sód, magnez, wapń)   Arabinoksylan   Wielonienasycone kwasy tłuszczowe omega-3, omega-6   Niezbędne kwasy tłuszczowe   Olej z nasion rokitnika   Kwas hialuronowy   Nukleotydy   Otręby   Produkty oparte na wodzie   Papaina   Sok z czerwonych winogron   Porzeczka czarna   Sok z żurawin i pomarańczy   Kleiszcze smakowite (owoc)   Boczniak mikołajkowy   Arabinoksylan z otrębów ryżowych   Enzymy trawienne: proteazy, lipazy, amylazy, glukoamylazy, inwertazy, calulazy, diastazy  

2. Znaczenie oświadczenia dla zdrowia człowieka


1.1. Właściwości przeciwstarzeniowe (anti-aging) (ID 1352)

The claimed effect is ―anti ageing properties‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wordings. No clarifications were provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
4 Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods. OJ L 404, 30.12.2006, p. 9–25.
5 EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2011. General guidance for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims. EFSA Journal, 9(4):2135, 24 pp.
6 See footnote 5
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.2. Utrzymanie układu moczowego (ID 1199, 1369)

The claimed effects are ―maintenance of urinary tract‖ and ―urinary tract maintenance (Urinary Calculus)‖. The Panel assumes that the target population is the general population.
The claimed effects are not sufficiently defined and no further details were provided in the proposed wordings or the clarifications provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.3. Zdrowie układu sercowo-naczyniowego (ID 569, 582, 1382)

The claimed effects are ―cardiovascular system‖ and ―cardiovascular health‖. The Panel assumes that the target population is the general population.
The claimed effects are not sufficiently defined and no further details were provided in the proposed wordings or the clarifications provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.4. Zdrowie naczyń krwionośnych (żył) (ID 1480, 1998, 2212, 2753, 3667, 4278)

The claimed effects are ―vascular health‖, ―vein health‖, and ―venous system‖. The Panel assumes that the target population is the general population.
The claimed effects are not sufficiently defined. The Panel notes that either different health outcomes were mentioned in the references provided, and it was not possible to establish the specific effect which is the target of the claim, or that the references provided did not contain original scientific data and it was therefore unclear how the health outcomes cited in the proposed wordings (―normal blood fluidity and vessel patency‖, ―blood vessel walls strength‖, ―blood circulation‖, ―sensation of heavy legs‖, ―good circulation of blood in microvessels‖, ―circulatory well being‖) could be defined and assessed.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.5. Przepływ krwi/funkcja naczyń krwionośnych (ID 1265)

The claimed effect is ―blood flow/vascular function‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wordings. No clarifications were provided by Member States. The Panel notes that the references provided for the substantiation of the claim were either unrelated to the food which is the subject of the claim or referred to different health outcomes (i.e. platelet aggregation, endothelial function, oxidative stress) and it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.6. Równowaga hormonalna (ID 1837, 2916)

The claimed effects are ―sexual organs and/or hormone activity‖ and ―cell metabolism – positively affects the fission of cells their immunity and regeneration‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined, and the proposed wordings or the clarifications provided by Member States did not provide further information. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.7. Zapobieganie lub leczenie raka gruczołu krokowego (prostaty) (ID 1859, 2773)

The claimed effects are ―sexual organs and/or hormone activity‖ and ―santé de la prostate‖. The Panel assumes that the target population is adult males.
In the context of the proposed wordings or the clarifications provided by Member States, the Panel assumes that the claimed effect refers to prostate function. Prostate function is not sufficiently defined. From the references provided, the Panel assumes that the claimed effect is related to prevention or treatment of prostate cancer.
The Panel considers that the claimed effect is related to the prevention or treatment of a disease and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

1.8. Zdrowie kobiet (ID 531)

The claimed effect is ―women’s health‖. The Panel assumes that the target population is women.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wording or the clarifications provided by Member States. The Panel notes that different health outcomes were mentioned in the references provided and it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.9. Zdrowie menstruacyjne (ID 2487)

The claimed effect is ―menstrual health‖. The Panel assumes that the target population is women.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wordings. No clarifications were provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.10. Wchłanianie składników odżywczych (ID 1814)

The claimed effect is ―absorption of nutrients‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and from the proposed wordings, the references or the clarifications provided by Member States, it was not possible to establish for which nutrients an improved absorption is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.11. Poprawa trawienia makroskładników (węglowodanów, białek, tłuszczów) (ID 1781, 1842, 2825, 3137, 3519, 3972, 4662, 4691)

The claimed effects are ―digestive function‖, ―digestion‖, ―break down of high-molecules compound from food‖, ―pancreas‖ and ―digestive system benefits‖. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to the facilitation of the digestion of macronutrients (e.g. dietary carbohydrates, proteins and lipids) in the gastro-intestinal tract.
The human gastro-intestinal tract capacity for digestion of macronutrients is very high and it is estimated that in physiological situation it exceeds tenfold the biological demand. The Panel considers that macronutrient digestion is not impaired in the general population and that no evidence has been provided that an improvement of the digestion of macronutrients (e.g. carbohydrates, proteins and lipids) is a beneficial physiological effect per se for the general 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 the health claims and a beneficial physiological effect related to the digestion of carbohydrates, proteins and lipids.

1.12. Funkcjonowanie układu trawiennego (ID 377, 692, 1267, 1357, 1401, 1625, 2329, 3692)

The claimed effects are ―joue un rôle dans le processus digestif‖, ―essential fatty acids to aid in digestive tract function‖, ―consumption of bran improves digestive function‖, ―naturally boost your digestive system‖, ―digestion (stimulation)‖, ―gastro-intestinal support‖ and ―digestion‖. The Panel assumes that the target population is the general population.
The claimed effects are not sufficiently defined and no further details were available in the proposed wordings, the references or the clarifications provided by Member States.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.13. Zdrowie jelit (ID 585, 2223)

The claimed effects are ―gut health‖ and ―intestinal health‖. The Panel assumes that the target population is the general population.
The claimed effects are not sufficiently defined and no further details were provided in the proposed wordings. No clarifications were provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.14. Flora jelitowa (ID 3076)

The claimed effect is ―intestinal flora‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wordings. The Panel notes that different health outcomes were mentioned in the references provided and it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.15. Zwiększenie ilości bakterii jelitowych (ID 773, 782, 1399)

The claimed effects are ―increased inner protection/resistance‖, ―prebiotic/bifidogenic‖, and ―benefits the growth of intestinal bifidus bacteria and stimulates the immune system‖. The Panel assumes that the target population is the general population.
In the context of the proposed wordings or the clarifications provided by Member States, the Panel assumes that the claimed effects refer to an increase in the number of bacteria that are considered to be beneficial.
The numbers/proportions of bacterial groups that would constitute a ―good, balanced, healthy or beneficial intestinal flora‖ have not been established. Increasing the number of any group of microorganisms including lactobacilli or bifidobacteria, is not in itself considered to be a beneficial physiological effect.
The Panel considers that the evidence provided does not establish that increasing numbers of gastro-intestinal microorganisms is a beneficial physiological effect.
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 the health claims and a beneficial physiological effect related to increasing numbers of gastro-intestinal microorganisms.

1.16. Zdrowie żołądka (ID 2175)

The claimed effect is ―stomach health‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wordings. No clarifications were provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.17. Ochrona żołądka (ID 1368)

The claimed effect is ―more recently, emerging research suggests that cranberries may also be powerful protectors of the stomach‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wording. No clarifications were provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.19. Leczenie biegunki i/lub wymiotów (ID 3087)

The claimed effect is ―ORSALIT is given in order to supplement liquids and mineral components during diarrhoea and/or vomiting‖. The Panel assumes that the target population is individuals who are suffering from diarrhoea and/or vomiting.
The Panel assumes that the claimed effect is related to treatment of a disease (diarrhoea and/or vomiting).
The Panel considers that the claimed effect is related to the treatment of a disease and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

1.20. Zdrowie wątroby (ID 583, 2504)

The claimed effects are ―liver‖ and ―liver health‖. The Panel assumes that the target population is the general population.
The claimed effects are not sufficiently defined and no further details were provided in the proposed wording. No clarifications were provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.21. Funkcje układu nerwowego (ID 1383, 1732)

The claimed effect is ―nervous system function‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wordings. No clarifications were provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.22. Siła psychiczna/umysłowa (ID 1530)

The claimed effect is ―for mental energy‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wordings. No clarifications were provided by Member States. From the reference provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.23. Zdrowie psychiczne (ID 555)

The claimed effect is ―mental health‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wordings. No clarifications were provided by Member States. From the reference provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.24. Zdrowie fizyczne i psychiczne (ID 9)

The claimed effect is ―physical and mental health‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were available in the proposed wordings. The Panel notes that different health outcomes were mentioned in the clarifications provided by Member States or the references provided and it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.25. Wydajność fizyczna (ID 560, 4248)

The claimed effects are ―physical performance and condition‖ and ―physical performance‖. The Panel assumes that the target population is the general population.
The claimed effects are not sufficiently defined and no further details were provided in the proposed wordings. No clarifications were provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.26. Zapobieganie przetrenowaniu (ID 4247)

The claimed effect is ―overtraining and effort prevention‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wordings. No clarifications were provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.27. Dobrostan fizyczny (ID 4407)

The claimed effect is ―physical well-being‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were provided in the proposed wording. From the reference provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.28. Zdrowie skóry (ID 584, 590, 1379, 4241, 4243)

The claimed effects are ―skin‖, ―skin health‖ and ―skin care‖. The Panel assumes that the target population is the general population.
The claimed effects are not sufficiently defined and no further details were provided in the proposed wordings. No clarifications were provided by Member States. From the references provided it was not possible to establish the specific effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.29. Utrzymanie prawidłowej struktury i wyglądu włosów i paznokci (ID 1233, 1385, 1746, 1879, 4202)

The claimed effects are ―hair and nails health‖, ―skin health‖, ―essential part of the connective tissues, skin and hair‖, ―hair beauty and health‖, ―healthy hair, skin and nails‖ and ―hair beauty and health‖. The Panel assumes that the target population is the general population.
In the context of the proposed wordings or the clarifications provided by Member States, the Panel assumes that the claimed effects refer to the maintenance of normal structure and appearance of hair and nails.
The Panel considers that the claimed effects do not refer to a function of the body as required by Regulation (EC) No 1924/2006.

1.30. Utrzymanie prawidłowej struktury i elastyczności skóry (ID 1385, 1406, 1746, 1879, 1950, 3131)

The claimed effects are ―skin health‖, ―skin health, in particular skin surface: significant reduction of skin density‖, ―essential part of the connective tissues, skin and hair‖, ―healthy hair, skin and nails‖ and ―helps to keep elasticity of skin‖. The Panel assumes that the target population is the general population.
In the context of the proposed wordings or the clarification provided by Member States, the Panel assumes that the claimed effects refer to the maintenance of the normal structure and elasticity of the skin. The references provided did not refer to a particular physiological function of the skin.
The Panel considers that the claimed effects do not refer to a function of the body as required by Regulation (EC) No 1924/2006.

1.31. Zapobieganie lub leczenie trądziku (ID 2552, 3164)

The claimed effects are ―epiderme, soigne l'acnée‖ and ―skin health‖. The Panel assumes that the target population is the general population.
In the context of the clarifications provided, the Panel considers that the claimed effects refer to the prevention or treatment of acne, which is a skin disease, characterised by pimples on the face, chest, and back and occurs when the pores of the skin become clogged with oil, dead skin cells, and bacteria.
The Panel considers that the claimed effect is related to the prevention or treatment of a disease and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

1.32. Zapobieganie lub leczenie cellulitu (ID 2743, 3687)

The claimed effect is ―skin curves/cellulitis‖. The Panel assumes that the target population is the general population.
The Panel assumes that the claimed effect is related to the treatment of cellulitis, which is a common skin infection caused by bacteria, most commonly caused by Streptococcus pyogenes or Staphylococcus aureus.
The Panel considers that the claimed effect is related to the prevention or treatment of a disease and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

1.33. Funkcjonowanie błon komórkowych (ID 1777)

The claimed effect is ―function of the cell membrane‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined. Cell membranes may have different structures and functions depending on their composition and the cell type they belong to. The Panel notes that several properties of cell membranes were mentioned in the proposed wordings and that a specific effect related to the function of cell membranes has not been identified. No further clarifications were provided by Member States.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.34. Błony śluzowe (ID 589)

The claimed effect is ―mucous membranes‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined. Mucosa is the inner lining tissue of organs e.g. digestive, respiratory and urogenital tracts and the inner surface of the eyes. It acts as protective layer against different environmental detrimental factors. The Panel notes that several mucous membranes were mentioned in the clarifications provided by Member States and that a specific effect related to the function of mucous membranes has not been identified.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.35. System immunologiczny/odpornościowy (ID 675, 847, 1399, 1482, 1792)

The claimed effects are ―essential for the balanced body functions, with special regards to the immune system‖, ―immune health‖, ―stimulation of the immune system‖, ―immune system function‖ and ―immunity‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were available in the proposed wording or the clarifications provided by Member States. Given the multiple roles of the immune system, the specific aspect of immune function, which is the subject of the health claim, needs to be specified but has not been indicated in the information provided.
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.

1.36. Zwiększenie wydzielania niespecyficznych immunoglobulin typu A (IgA) (ID 1944)

The claimed effect is ―immune health‖. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by the Member States, the Panel assumes that the claimed effect refers to ―promotes a healthy immune system by notably increasing IgA‖.
The Panel considers that the evidence provided does not establish that increasing non-specific IgA secretion is a beneficial physiological effect per se.
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 the health claim and a beneficial physiological effect related to an increase of non-specific IgA secretion.

1.37. Stymulacja aktywności komórek NK (Natural Killers) (ID 3128, 3153)

The claimed effects are ―immune system‖ and ―strengthens immune systems‖. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to the stimulation of natural killer cell activity.
The Panel considers that the evidence provided does not establish that stimulation of natural killer cell activity is a beneficial physiological effect per se.
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 the health claims and a beneficial physiological effect related to the stimulation of natural killer cell activity.

1.38. Indukcja produkcji cytokin (ID 4112)

The claimed effect is ―immune support‖. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to supporting immune health by inducing cytokine production (e.g. TNF-alpha and IFN-gamma).
The Panel considers that the evidence provided does not establish that induction of cytokine production (e.g. TNF-alpha and IFN-gamma) is a beneficial physiological effect for the general population per se.
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 the health claims and a beneficial physiological effect related to the induction of cytokine production.

1.39. Obrona immunologiczna przed patogenami (ID 1477)

The claimed effect is ―antimicrobial/antiviral/innate host defense‖. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to immune defence against pathogens.
The Panel notes that the type of infection has not been specified and the references provided addressed several effects (e.g. related to treatment of tinea pedis (athletes foot), eradication of Helicobacter pylori, lower respiratory tract illnesses, the effects of long-term administration of bovine lactoferrin in patients with chronic hepatitis C, effects in post-surgical patients) and it was not possible to establish which of these effects is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.40. Potrzebny do zrównoważonego funkcjonowania organizmu, ze szczególnym uwzględnieniem układu odpornościowego (ID 675)

The claimed effect is ―essential for the balanced body functions, with special regards to the immune system‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were available in the proposed wordings. The clarifications provided by Member States included several physiological functions and the references provided did not allow the identification of the specific function which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

1.41. Zmniejszenie wchłaniania alkoholu (ID 648)

The claimed effect is ―slows the absorption of alcohol‖. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to decreasing the absorption of alcohol.
The Panel considers that the evidence provided does not establish that decreasing the absorption of alcohol is a beneficial physiological effect.
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 the health claims and a beneficial physiological effect related to decreasing the absorption of alcohol.

1.42. Zwiększenie mięśniowych zapasów kreatyny (ID 544, 545)

The claimed effects are ―increased muscle creatine storage‖ and ―enhancing storage & uptake‖. The Panel assumes that the target population is active individuals in the general population.
In the context of the proposed wordings, the Panel assumes that the claimed effects refer to an increase in muscle creatine stores.
The Panel notes that from the references provided the beneficial physiological effect of increasing muscle creatine stores is unclear.
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 the health claims and a beneficial physiological effect related to an increase in muscle creatine stores.

1.43. Poprawa aktywności mechanicznej pęcheżyka żółciowego (ID 1342)

The claimed effect is ―improves mechanical activity of gallbladder‖. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined and no further details were available in the proposed wordings. The Panel notes that is unclear whether the claim refers to an increase or to a decrease in the frequency or the intensity of contraction of the gallbladder wall, and none of the references provided refers to the function of the gallbladder.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

2.18. Neutralizacja kwasu żołądkowego (ID 1795, 1906, 2759, 2886)

The claimed effects are ―gut health‖, ―gastrointestinal health‖, ―gastric acidity‖ and ―stomach acid in digestion‖. The Panel assumes that the target population is the general population.
For ID 1795, 2759, 2886, in the context of the proposed wordings, the Panel assumes that the claimed effect refers to the reduction of gastric acid.
For ID 1906, in the context of the proposed wording, the clarifications provided by Member States, and the references cited for the scientific substantiation of the claim, the Panel assumes that the claimed effect refers to the protection of the mucous membrane of the stomach by reducing gastric acid.
The Panel considers that the evidence provided does not establish that reducing gastric acid is a beneficial physiological effect per se for the general 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 the health claims and a beneficial physiological effect related to reduction of gastric acid.

Wnioski

On the basis of the data presented the Panel concludes that: The claimed effects: ―anti-aging properties‖ (ID 1352), ―maintenance of urinary tract‖ (ID 1199, 1369), ―cardiovascular health‖ (ID 569, 582, 1382), ―vascular and vein health‖ (ID 1480, 1998, 2212, 2753, 3667, 4278), ―blood flow/vascular function‖ (ID 1265), ―hormonal balance‖ (ID 1837, 2916), ―women’s health‖ (ID 531), ―menstrual health‖ (ID 2487), ―absorption of nutrients‖ (ID 1814), ―digestive function‖ (ID 377, 692, 1267, 1357, 1401, 1625, 2329, 3692), ―gut health‖ (ID 585, 2223), ―intestinal flora‖ (ID 3076), ―stomach health‖ (ID 2175), ―powerful protectors of the stomach‖ (ID 1368), ―liver health‖ (ID 583, 2504), ―nervous system function‖ (ID 1383, 1732) ―mental energy‖ (ID 1530), ―mental health‖ (ID 555), ―physical and mental health‖ (ID 9), ―physical performance‖ (ID 560, 4248), ―overtraining and effort prevention‖(ID 4247), ―physical well-being‖ (ID 4407), ―skin health‖ (ID 584, 590, 1379, 4241, 4243), ―function of the cell membrane‖ (ID 1777), ―mucous membranes‖ (ID 589), ―immune system‖ (ID 675, 847, 1399, 1482, 1792), immune defence against pathogens (ID 1477), ―essential for the balanced body functions, with special regards to the immune system‖ (ID 675), and ―improves mechanical activity of gallbladder‖ (ID 1342), are general and non-specific, and do not refer to any specific health claims as required by Regulation (EC) No 1924/2006. The claimed effects are ―hair and nails health‖, ―skin health‖, ―essential part of the connective tissues, skin and hair‖, ―hair beauty and health‖, ―healthy hair, skin and nails‖; ―skin health‖, ―skin health, in particular skin surface: significant reduction of skin density‖, ―essential part of the connective tissues, skin and hair‖, ―healthy hair, skin and nails‖ and ―helps to keep elasticity of skin‖. Maintenance of the normal structure and elasticity of the skin (ID 1233, 1385, 1746, 1879, 4202), and maintenance of normal structure and elasticity of the skin (ID 1385, 1406, 1746, 1879, 1950, 3131), do not refer to a function of the body as required by Regulation (EC) No 1924/2006. The claimed effects are ―sexual organs and/or hormone activity‖, ―santé de la prostate‖; ―ORSALIT is given in order to supplement liquids and mineral components during diarrhoea and/or vomiting‖; ―epiderme, soigne l'acnée‖, ―skin health‖; and ―skin curves/cellulitis‖. Prevention or treatment of prostate cancer (ID 1859, 2773), treatment of diarrhoea and/or vomiting (ID 3087), prevention or treatment of acne (ID 2552, 3164), and prevention or treatment of cellulitis (ID 2743, 3687), are related to the prevention or treatment of a disease and do not comply with the criteria laid down in Regulation (EC) No 1924/2006. The claimed effects are ―digestive function‖, ―digestion‖, ―break down of high-molecules compound from food‖, ―pancreas‖ and ―digestive system benefits‖. Macronutrient digestion is not impaired in the general population and no evidence has been provided that an improvement of the digestion of macronutrients (e.g. carbohydrates, proteins and lipids) (ID 1781, 1842, 2825, 3137, 3519, 3972, 4662, 4691) is a beneficial physiological effect per se for the general 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 the health claims and a beneficial physiological effect related to the digestion of carbohydrates, proteins and lipids. The claimed effects are ―increased inner protection/resistance‖, ―prebiotic/bifidogenic‖, and ―benefits the growth of intestinal bifidus bacteria and stimulates the immune system‖. The evidence provided does not establish that increasing numbers of gastro-intestinal microorganisms (ID 773, 782, 1399) is a beneficial physiological effect. A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of the health claims and a beneficial physiological effect related to increasing numbers of gastro-intestinal microorganisms. The claimed effects are ―gut health‖, ―gastric acidity‖ and ―stomach acid in digestion‖. The evidence provided does not establish that reduction of gastric acid (ID 1795, 1906, 2759, 2886) is a beneficial physiological effect per se for the general 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 the health claims and a beneficial physiological effect related to reduction of gastric acid. The claimed effect is ―immune health‖. The evidence provided does not establish that increasing non-specific IgA secretion (ID 1944) is a beneficial physiological effect per se. A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of the health claims and a beneficial physiological effect related to an increase of non-specific IgA secretion. The claimed effects are ―immune system‖ and ―strengthens immune systems‖. The evidence provided does not establish that stimulation of natural killer cell activity (ID 3128, 3153) is a beneficial physiological effect per se. A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of the health claims and a beneficial physiological effect related to the stimulation of natural killer cell activity. The claimed effect is ―immune support‖. The evidence provided does not establish that induction of cytokine production (e.g. TNF-alpha and IFN-gamma) (ID 4112) is a beneficial physiological effect per se for the general 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 the health claims and a beneficial physiological effect related to the induction of cytokine production. The claimed effect is ―slows the absorption of alcohol‖. The evidence provided does not establish that decreasing the absorption of alcohol (ID 648) is a beneficial physiological effect. A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of the health claims and a beneficial physiological effect related to decreasing the absorption of alcohol. The claimed effects are ―increased muscle creatine storage‖ and ―enhancing storage & uptake‖. From the evidence provided the beneficial physiological effect of increasing muscle creatine stores is unclear (ID 544, 545). A cause and effect relationship has not been established between the consumption of the food(s)/food constituent(s) which are the subject of the health claims and a beneficial physiological effect related to an increase in muscle creatine stores.