1.1. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 644, 1717, 1742, 1760, 2000, 2028, 2124, 2213, 2337, 3072, 3075, 3080, 3193, 4313)

The claimed effects are “digestive system”, “relief for gastric discomfort”, “zinc carnosine”, “relaxation”, “digestive health”, “liver health”, “digestion”, “healthy digestion”, “improvement of the digestion”, “santé gastro-intestinale”, and “digestive process/promotes intestinal well-being/can bind pathogenic bacteria/increases the activity of digestive enzymes”. 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 reduction of gastro-intestinal discomfort.
The Panel considers that reduction of gastro-intestinal discomfort is a beneficial physiological effect.

1.2. Utrzymanie prawidłowego wzroku (ID 2833, 4044)

The claimed effect is “eyes”. 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 effect refers to maintenance of normal vision.
The Panel considers that maintenance of normal vision is a beneficial physiological effect.

1.3. Udział w prawidłowym przebiegu funkcji poznawczych (ID 1894, 1926, 2024)

The claimed effects are “nervous system: phospholipids improve memory and cognitive functions”, “enhancing memory and cognitive function”, and “brain/mental/cognitive health”. 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 contribution to normal cognitive function. Cognitive function includes memory, attention (concentration), learning, intelligence and problem solving, which are well defined constructs and can be measured by validated psychometric cognitive tests.
The Panel considers that contribution to normal cognitive function is a beneficial physiological effect.

1.4. Ulga w przypadku podrażnienia górnych dróg oddechowych (ID 1730, 2127, 2137, 2332, 2380, 2435)

The claimed effects are “respiratory health” and “respiratory system health”. 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 relief in case of irritation in the upper respiratory tract, which could be assessed if adequate validated questionnaires were available.
The Panel considers that relief in case of irritation in the upper respiratory tract is a beneficial physiological effect.

1.5. Redukcja dyskomfortu podczas miesiączki (ID 3636)

The claimed effect is “contributes to physical well-being”. The Panel assumes that the target population is women with premenstrual syndrome.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect refers to a reduction in menstrual discomfort, which can be assessed as changes in the severity of symptoms related to the premenstrual syndrome using validated questionnaires.
The Panel considers that a reduction of menstrual discomfort is a beneficial physiological effect.

1.6. Zmniejszenie dyskomfortu związanego z okresem menopauzy (ID 1933, 2095, 3129, 3636)

The claimed effects are “menopause”, “phytoestrogenic properties”, and “contributes to physical well-being”. The Panel assumes that the target population is post-menopausal women.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to the reduction of menopausal discomfort, which can be assessed as changes in the severity of symptoms related to menopause using validated questionnaires.
The Panel considers that reduction of menopausal discomfort is a beneficial physiological effect.

1.7. Ulga w bólach głowy spowodowanych stresem (ID 4037)

The claimed effect is “mental function and head”. 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 effect refers to the relief from stress-induced headache.
The Panel considers that relief from stress-induced headache is a beneficial physiological effect.

1.8. Apoptoza zniszczonych komórek (ID 2917)

The claimed effect is “induction of apoptosis of transformed and damaged cells”. 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 apoptosis of damaged cells.
The Panel considers that apoptosis of damaged cells is a beneficial physiological effect.

1.9. Ochrona przed patogenami pochwowymi przez zwiększenie ilości bakterii kwasu mlekowego i/lub zmniejszenie ilości potencjalnie patogennych bakterii i/lub drożdży (ID 946)

The claimed effect is “urogenital tract/natural vaginal defence”. The Panel assumes that the target population is the general female population.
From the clarifications provided by Member States, the Panel assumes that the claimed effect refers to defence against vaginal pathogens by increasing the number of lactobacilli and/or decreasing potentially pathogenic bacteria and/or yeasts.
Unlike any other anatomical site of the body, most vaginal vaults are dominated by one or more species of Lactobacillus. In over 70 % of women, vaginal microbiota is dominated by lactobacilli (> 50 %) (Ling et al., 2010; Ravel et al., 2011; Yamamoto et al., 2009). This microbiota is different from the more complex gut microbiota, where lactobacilli represent less than 3 % of the bacterial population (Franks et al., 1998; Lay et al., 2005; Sghir et al., 2000). The diagnosis of bacterial vaginosis (BV) is currently based on Nugent score (microscopic examination of Gram stained smear or vaginal discharge for bacteria and „clue‟ cells). Nugent scores are classified into normal (0-3, lactobacilli are present, but not Gardnerella/Bacteroides or curved Gram-negative bacilli), intermediate (4-6, colonisation by Bacteroides/Gardenella and curved Gram-variable rods (Mobiluncus)), and BV (7-10, BV with domination of Gardnerella/Bacteroides or curved Gram- negative bacilli and absence of that lactobacilli).
The Panel considers that defence against vaginal pathogens by increasing the proportion of lactobacilli and/or decreasing the proportion of potentially pathogenic bacteria and/or yeasts is a beneficial physiological effect.

1.10. Usuwanie metali ciężkich (ID 1871)

The claimed effect is “alginate binds heavy metals, stimulates mucin production and protects the colon, N-acetylcysteine detoxifies and removes heavy metals, piperine increases the bioavailability of n-acetylcysteine”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and of the references provided, the Panel assumes that the claimed effect refers to the elimination of heavy metals.
The Panel considers that elimination of heavy metals is a beneficial physiological effect.

1.11. Utrzymanie odporności przeciw patogenom w górnych drogach oddechowych, poprzez utrzymywanie prawidłowego stanu układu odpornościowego (ID 1910)

The claimed effect is “immune system”. 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 effect refers to the maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences.
The Panel considers that maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences is a beneficial physiological effect.

2.1. Zmniejszenie dolegliwości ze strony przewodu pokarmowego (ID 644, 1717, 1742, 1760, 2000, 2028, 2124, 2213, 2337, 3072, 3075, 3080, 3193, 4313)

The references provided in relation to these claims were textbooks or narrative reviews which did not provide any original data which could be used for the scientific substantiation of the claim, or reported on animal or in vitro studies which addressed the effects of the food(s)/food constituent(s) on, e.g., spontaneous contractions of the jejunum, adhesion properties of Helicobacter pylori, pharmacologically or stress-induced gastric ulcers, necrotising enterocolitis, intestinal inflammation. One human intervention study which addressed the effects of the food(s)/food constituent(s) on the treatment of Helicobacter pylori infection was also provided. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
No human studies which investigated the effects of the food(s)/food constituent(s) on measures of gastro-intestinal discomfort were provided in relation to any of the claims evaluated in this section.
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 claims evaluated in this section and reduction of gastro-intestinal discomfort.

2.2. Utrzymanie prawidłowego wzroku (ID 2833, 4044)

The references provided in relation to these claims included narrative reviews, animal and in vitro studies on the food(s)/food constituent(s) which reported on health outcomes (e.g. systemic inflammation, antioxidant status, haematopoiesis, cell mutations in response to exposure to heavy metals) unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
No human studies which investigated the effects of the food(s)/food constituent(s) on maintenance of normal vision were provided in relation to any of the claims evaluated in this section.
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 claims evaluated in this section and maintenance of normal vision.

2.3. Udział w prawidłowym przebiegu funkcji poznawczych (ID 1894, 1926, 2024)

The references provided in relation to these claims included narrative reviews on the relationship between oxidative stress and age-related neuronal deficits or on the effect of different food(s)/food constituent(s) on memory, which did not provide any original data which could be used for the scientific substantiation of the claim, and on health outcomes unrelated to the claimed effect (e.g. anxiety). References regarding the composition of some food(s)/food constituent(s) were also provided. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
No human studies which investigated the effects of the food(s)/food constituent(s) on measures of cognitive function were provided in relation to any of the claims evaluated in this section.
One in vitro study which assessed the effects of a food constituent on amyloid beta-peptide in neuronal cell cultures was provided. The Panel considers that evidence provided in in vitro studies is not sufficient to predict the occurrence of an effect of the consumption of the food(s)/food constituent(s) on contribution to normal cognitive function in vivo in humans.
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 claims evaluated in this section and contribution to normal cognitive function.

2.4. Ulga w przypadku podrażnienia górnych dróg oddechowych (ID 1730, 2127, 2137, 2332, 2380, 2435)

Most of the references provided in relation to these claims were textbooks, narrative reviews and monographs which did not provide any original data which could be used for the scientific substantiation, or assessed the effects of food(s)/food constituent(s) other than those for which the specific claims are proposed, and/or health outcomes (e.g. treatment of infectious diseases, treatment of influenza) unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
No human studies which investigated the effects of the food(s)/food constituent(s) on measures of relief of irritation in the upper respiratory tract were provided in relation to any of the claims evaluated in this section.
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 claims evaluated in this section and relief of irritation in the upper respiratory tract.

2.5. Redukcja dyskomfortu podczas miesiączki (ID 3636)

The references provided in relation to this claim were in vitro and animal studies which assessed the effects of food(s) other than the one which is the subject of the claim and/or health outcomes (e.g. antioxidant activity, apoptosis in cancer cells, antimicrobial activity) unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
No human studies which investigated the effects of the food on reduction of menstrual discomfort were provided in relation to the claim evaluated in this section.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food which is the subject of the claim evaluated in this section and reduction of menstrual discomfort.

2.6. Zmniejszenie dyskomfortu związanego z okresem menopauzy (ID 1933, 2095, 3129, 3636)

The references provided in relation to these claims were reviews, human, animal and in vitro studies which assessed the effects of food(s)/food constituent(s) other than those which are the subject of the claim and/or health outcomes (e.g. antioxidant activity, apoptosis in cancer cells, antimicrobial activity) unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claims.
No human studies which investigated the effects of the food(s)/food constituent(s) on reduction of menopausal discomfort were provided in relation to any of the claims evaluated in this section.
One in vitro study which investigated the oestrogenic effect of the food, which is the subject of the claim, was provided. The Panel considers that evidence provided in in vitro studies is not sufficient to predict the occurrence of an effect of the consumption of the food(s)/food constituent(s) on reduction of menopausal discomfort in vivo in humans.
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 claims evaluated in this section and reduction of menopausal discomfort.

2.7. Ulga w bólach głowy spowodowanych stresem (ID 4037)

The references provided in relation to this claim were textbooks and monographs which did not provide any original data which could be used for the scientific substantiation of the claim and studies on health outcomes (e.g. memory, regulation of body temperature, sleeping time, muscle activity) unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
No human studies which investigated the effects of the food on relief from stress-induced headache were provided in relation to the claim evaluated in this section.
Studies which assessed the effects of the food on pain in animal models were also provided. The Panel considers that evidence provided in animal studies is not sufficient to predict the occurrence of an effect of the consumption of the food on pain relief in vivo in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food which is the subject of the claim evaluated in this section and relief from stress-induced headache.

2.8. Apoptoza zniszczonych komórek (ID 2917)

The reference provided in relation to this claim was one in vitro study which investigated health outcomes (i.e. induction of the expression of breast cancer susceptibility genes and prostate cancer cell types) unrelated to the claimed effect. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claim.
No human studies which investigated the effects of the food constituent on measures of apoptosis of damaged cells were provided in relation to the claim evaluated in this section.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food constituent which is the subject of the claim evaluated in this section and apoptosis of damaged cells.

2.9. Ochrona przed patogenami pochwowymi przez zwiększenie ilości bakterii kwasu mlekowego i/lub zmniejszenie ilości potencjalnie patogennych bakterii i/lub drożdży (ID 946)

The references provided in relation to this claim were a narrative review which did not provide any original data which could be used for the scientific substantiation of the claim, and a study which assessed the effects of food(s)/food constituent(s) other than the food constituent for which the specific claim is proposed. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
No human studies which investigated the effect of the food constituent on the proportion of lactobacilli and/or potentially pathogenic bacteria and/or yeasts in the vagina were provided in relation to the claim evaluated in this section.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food constituent which is the subject of the claim evaluated in this section and defence against vaginal pathogens by increasing the proportion of lactobacilli and/or decreasing the proportion of potentially pathogenic bacteria and/or yeasts.

2.10. Usuwanie metali ciężkich (ID 1871)

The references provided in relation to this claim were studies which assessed the effects of food(s)/food constituent(s) other than the specific combination of food constituents which is the subject of the claim. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
No human studies which investigated the effects of the specific combination of food constituents on elimination of heavy metals were provided in relation to the claim evaluated in this section.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the specific combination of food constituents which is the subject of the claim evaluated in this section and elimination of heavy metals.

2.11. Utrzymanie odporności przeciw patogenom w górnych drogach oddechowych, poprzez utrzymywanie prawidłowego stanu układu odpornościowego (ID 1910)

The references provided in relation to this claim included narrative reviews and animal studies which addressed health outcomes (e.g. tumour regression) unrelated to the claimed effect, and a non- scientific reference (web page of a food producer) which did not provide any original data for the
scientific substantiation of the claim. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
No human studies which investigated the effects of the food constituent on maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences were provided in relation to the claim evaluated in this section.
The Panel concludes that a cause and effect relationship has not been established between the consumption of the food constituent which is the subject of the claim evaluated in this section and maintenance of the upper respiratory tract defence against pathogens by maintaining immune defences.