1.1. Dairy products (ID 1140, 1141, 1191)

The food that is the subject of the claim is: “dairy (low fat dairy), dairy refers to cow’s milk, yogurt and cheese)”, “(cow’s) milk and dairy products for which milk is the principle ingredient and no sugar has been added – e.g. yogurt, cheese”, and “fat free dairy products with reduced sugars or without added sugars” related to the following claimed effects: weight management and maintenance of tooth mineralisation.
From the information provided, the Panel assumes that the food refers to dairy products (milk, yogurt and cheese) from cow’s milk which are low in fat or fat free with no added sugars. The Panel notes
that dairy products include solid, semi-solid and liquid food products with different energy density, and that no information has been provided with respect to other nutritional characteristics (e.g. protein content, and added fibre) which could have an effect on body weight. The Panel also notes that lactose, the content of which may vary widely from one dairy product to another, is fermented by oral bacteria, and that the effect of different dairy products on tooth mineralisation may vary depending on whether they are chewed (e.g. cheese) or not, and on the frequency of consumption.
The Panel considers that the food category, dairy products, which is the subject of the health claims, is not sufficiently characterised in relation to the claimed effects considered in this section.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of dairy products and the claimed effects considered in this section.

1.2. Raw or processed food products of animal origin, plus bread and panification products (ID 1193, 1194)

The food that is the subject of the health claims is “raw or processed food products of animal origin, plus bread and panification products” related to the following claimed effects: maintenance of blood cholesterol concentrations and blood glucose control.
The information provided in relation to these claims defines these foods as “rich in omega 3”. However, the Panel notes that the energy density, fatty acid profile, and the nature and amount of carbohydrates contained in these foods, all of which could have an impact on the claimed effects, are not specified and may be highly variable from one food product to another.
The Panel considers that the foods, “raw or processed food products of animal origin, plus bread and panification products”, which are the subject of the claim, are not sufficiently characterised in relation to the claimed effects considered in this section.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of “raw or processed food products of animal origin, plus bread and panification products” and the claimed effects considered in this section.

1.3. Herbal yeast plasmolysate (ID 1815, 1816)

The food constituent that is the subject of the health claims is “herbal yeast plasmolysate (Saccharomyces cerevisiae)” related to the following claimed effects: physical performance and concentration.
In the context of the references provided, the Panel assumes that the claim refers to a specific commercial preparation of herbal yeast plasmolysate where Saccharomyces cerevisiae Meyen (not further specified) is cultivated in a medium containing specific but unidentified plant extracts, and is washed and subjected to plasmolysis by fermentation. Saccharomyces cerevisiae Meyen refers to a group of yeast strains that were re-classified by taxonomists (Molina et al., 1992).
The Panel notes that neither the identity of the yeast strain nor the composition of the plant extract in which the yeast is cultivated have been provided. The Panel also notes that no studies on the consumption of herbal yeast plasmolysate in relation to the claimed effects were available, and therefore the food constituents in herbal yeast plasmolysate which could be relevant for the claimed effects are unclear.
The Panel considers that the food, herbal yeast plasmolysate, which is the subject of the claim, is not sufficiently characterised in relation to the claimed effects considered in this section.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of herbal yeast plasmolysate and the claimed effects considered in this section.

1.4. Apple polyphenols (ID 2713)

The food constituent that is the subject of the health claim is “Pyrus malus (common name apple) extract powder containing polyphenols” related to the following claimed effect: post-prandial glycaemic responses.
Polyphenols include a wide range (thousands) of compounds belonging to subgroups of flavanones, flavonols, flavan-3-ols, such as proanthocyanidins, as well as flavonones, isoflavonoids and anthocyanins. Apples typically contain hydroxycinnamic acid derivatives, flavan-3-ols (monomeric and oligomeric), flavonols and their conjugates, and dihydrochalcones such as phlorizin (Shahidi and Naczk, 2004). In addition, anthocyanins are found in the skin of some red apple varieties.
The Panel notes that the nature and amount of different polyphenol compounds in the apple extract powder has not been specified in the information provided.
Two of the three references provided for the scientific substantiation of the claim were a narrative review on the health effects of phlorizin, which included no original data, and one unpublished in vitro study for which only an abstract was available. The third reference reported on a human intervention study on the effects of clear and cloudy apple juices characterised on the basis of their content in single polyphenols (e.g. phlorizin, chlorogenic acids, phloretin xyloglucoside and (+)-catechin) and sugars on post-prandial glycaemic and insulinaemic responses as compared to a control beverage containing the same amount of sugars (Johnston et al., 2002). The Panel notes that the pectin content in the apple juices is not reported, and that therefore none of them are sufficiently characterised with respect to all of the components which could have an impact on the claimed effect (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010).
The Panel considers that the food constituent, apple polyphenols, which is the subject of the claim, is not sufficiently characterised in relation to the claimed effect considered in this section.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of apple polyphenols and the claimed effect considered in this section.

1.5. Rye flour (ID 1266)

The food constituent that is the subject of the health claims is rye flour related to the following claimed effect: low glycaemic index.
Rye flour is obtained through milling of rye (Secale cereale L.) grain. Rye flour is typically used to prepare rye bread and sourdough bread, and other products that are generally darker and denser than other types of similar products made from wheat. The milling of rye results in rye flour of different extraction rates varying from around 65 to 100 % (whole grain).
The chemical composition of rye flour varies considerably with the extraction rate, and thus with the degree of milling. As the milling process advances, progressive decreases in starch, β-glucans (indicator of rye bran) and moisture content, as well as increase in protein content, are observed (Gómez et al., 2009). The content of rye dietary fibre with arabinoxylan as the dominating fibre component varies considerably with the milling, and with both the genotype and the environment (Hansen et al., 2004). A variety of specific and non-specific methods for the analysis of various carbohydrate fractions in rye flour is available. Nutritionally, it is important to differentiate between two broad categories of carbohydrates: those digested and absorbed in the human small intestine
providing carbohydrates to body cells (commonly referred to as digestible, available or glycaemic carbohydrates), and those passing to the large intestine forming substrate for the colonic microflora (commonly referred to as nondigestible, “unavailable” or non-glycaemic carbohydrates).
The claimed effect is a low glycaemic index. The concept of glycaemic index (GI) was originally introduced to classify carbohydrate-rich foods (usually having an energy content of >80 % from carbohydrates), according to the differences in effects on post-meal glycaemia (Brouns et al., 2005). The GI, which is a nutritional property of a carbohydrate-rich food, is defined as the incremental area under the blood glucose response curve following a 50 g glycaemic carbohydrate portion of a test food expressed as a percentage of the response to the same amount of carbohydrates from a standard reference product taken by the same subject (FAO/WHO, 1998). Carbohydrate-rich foods can be classified according to their GI values (glucose as the standard): high GI>70; normal GI 55-70; low GI 40-55 and very low<40) (Brand-Miller, 2003). However, the GI of a carbohydrate-containing food depends on several factors (e.g. amount and type of dietary fibre, amount of dietary fat, energy density, physical properties, and mode of preparation) other than the amount of available (glycaemic) carbohydrates present.
Taking into account that the chemical nature and processing of the rye flour, which is the subject of the claim, has not been defined, that the GI of rye flour and food products made from rye flour depends on the chemical and physical properties, and preparation, of the particular type of rye flour under consideration, and that low GI carbohydrates have not been defined in the information provided, the Panel considers that the food constituent, rye flour, which is the subject of the health claim, is not sufficiently characterised in relation to the claimed effect considered in this section.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of rye flour and the claimed effect considered in this section.

1.6. Tomato juice (ID 1202)

The food that is the subject of the health claim is tomato juice related to the following claimed effect: blood glucose control.
From the conditions of use and the only reference provided no information on the composition and/or manufacturing process of the tomato juice which is the subject of the health claim was provided.
The Panel considers that the food, tomato juice, which is the subject of the claim, is not sufficiently characterised.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of tomato juice and the claimed effect considered in this section.

1.7. Whey protein and alphalactalbumin (ID 424, 430, 432, 725, 1433)

The food constituents that are the subject of the health claims are whey protein and alphalactalbumin related to the following claimed effects: immune defence against pathogens, cognitive function, mood, and blood pressure.
Whey protein is a mixture of globular proteins isolated from whey, a by-product obtained during the manufacturing of cheese from cow’s milk. Beta-lactoglobulin (approximately 50 %), alpha-lactalbumin (approximately 20 %), bovine serum albumin (approximately 10 %) and immunoglobulins are the major protein fractions in whey. The composition and amino acid profile of whey protein preparations may vary depending on the enrichment of one of these fractions, such as alpha-lactalbumin (Markus et al., 2002). Whey can be treated and processed in different ways
depending on the type of whey protein and products to be obtained. The main commercial forms are concentrates (29-89 % protein by weight), isolates (about 90 % protein by weight) and hydrolysates (partially pre-digested). Differences in composition between different whey protein products may exist depending on the manufacturing processes applied (Onwulata et al., 2004). The products generally have a high content of essential amino acids, with especially high proportions of available lysine, cysteine and tryptophan. Whey protein composition also differs between breeds of cow (Haug et al., 2007; Meisel and FitzGerald, 2003).
In relation to ID 430, 432 and 1433, the Panel notes that the composition of whey protein is variable, especially with regard to constituents such as alpha-lactalbumin, which is claimed to have psychoactive properties. Alpha-lactalbumin is a protein which occurs naturally in mammalian milk, and is measurable in foods by established methods. Alpha-lactalbumin is composed of 123 amino acids, including tryptophan which is a precursor of the neurotransmitter serotonin. The tryptophan content of alpha-lactalbumin preparations is variable, and can range from 1.2 g/100 g (Markus et al., 2002; Merens et al., 2005) to 4.8 g/100 g (Markus et al., 2005). The Panel notes that the references provided for these IDs refer to different food products containing various commercial whey protein or alpha-lactalbumin preparations, and that the composition of these food products is variable, in particular with respect to their amino acid profile, which may have an impact on the claimed effects. The Panel notes that from the information provided it is not possible to determine the food constituent(s) which are the subject of the claims.
In relation to ID 725, the Panel notes that from the conditions of use and references provided it is not possible to determine the particular whey protein peptides which are the subject of the claim.
In relation to ID 424, the Panel notes that in the references provided different commercial whey protein products were used, and that no information has been given on the composition, or on the standardisation of the manufacturing process, of these products. The Panel notes that from the information provided it was not possible to determine the specific “whey protein” product which is the subject of the claim.
The Panel considers that the food constituents, whey protein and alphalactalbumin, which are the subject of the claim, are not sufficiently characterised in relation to the claimed effects considered in this section.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of whey protein and alphalactalbumin and the claimed effects considered in this section.

1.8. “Brocco shoots”, “broccoli sprout powder” and “Brassica oleracea var. italica (broccoli)” (ID 1362, 1481, 2844, 2845)

The foods that are the subject of the health claims are “brocco shoots”, “broccoli sprout powder” and “Brassica oleracea var. italica (broccoli)” related to the following claimed effect protection of cells and molecules, including cells of the immune system, from oxidative damage.
Broccoli is the common name of the Italica cultivar group of the Brassica oleracea species in the Brassicaceae (belonging to Cruciferae) family, whose large flower head is used as a vegetable. Broccoli sprouts are 3-4 day old broccoli plants. Different varieties of Brassica oleracea Italica (e.g. sprouting broccoli, purple cauliflower, orange cauliflower and green cauliflower), some of which are produced by selective breeding, are available on the market.
The nutritional composition of broccoli flowers and sprouts depends on a variety of factors, including climate, season, horticultural practices, and the variety and age of the plant.
The Panel notes that for ID 2845 the conditions of use refer to sulphoraphane, but no references on sulphoraphane in broccoli have been provided in relation to the claimed effect. The Panel also notes that ID 2844 and 2845 specify in the conditions of use “broccoli seed or sprout or vegetable extract equivalent to 30 mg of glucoraphanin per day”. Glucoraphanin is a glucosinolate found in vegetables of the Brassicaceae family which can be hydrolysed to the isothiocyanate sulforaphane.
The vast majority of the references provided for the scientific substantiation of these claims were animal and in vitro studies which addressed the effects of glucosinolates (including glucoraphanin) or its isothiocyanate metabolites, sulforaphane, (and its N-acetylcysteine conjugates), sulforaphane nitrile and/or phenethyl-, allyl- or benzyl-isothiocyanate on cancer-related outcomes which are unrelated to the claimed effects considered in this section, or addressed the composition of different cruciferous vegetables in relation to these compounds. The few human studies provided (mostly epidemiological observations) investigated the association between consumption of cruciferous vegetables (including broccoli) and the urinary excretion of isothiocyanates and cancer-related outcomes. One human intervention study on the acute effects of one-week consumption of broccoli sprouts, for which no characterisation was available, on markers of oxidative stress (Murashima et al., 2004), and one human intervention study on the effects of 4-week consumption of Brassica vegetables in general on markers of oxidative stress were also provided. From the information provided in relation to the claims evaluated in this section, the foods which are the subject of the claim were not sufficiently characterised in relation to the claimed effect.
The Panel considers that the foods, “brocco shoots”, “broccoli sprout powder” and “Brassica oleracea var. italica (broccoli)”, which are the subject of the claims, are not sufficiently characterised in relation to the claimed effects considered in this section.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of “brocco shoots”, “broccoli sprout powder” and “Brassica oleracea var. italica (broccoli)” and the claimed effects considered in this section.

1.9. Honey (ID 1159, 1160, 1318, 4678, 4679)

The food that is the subject of the health claims is honey related to the following claimed effects: protection of cells and molecules from oxidative damage, defence against pathogens, and maintenance of blood cholesterol concentrations.
Honey is a sweet food made by honey bees (genus Apis, many subspecies); less common is honey made by non-stinging bees. Honey is usually made from the nectar (sugar-rich secretions) of flowers by a process of regurgitation, and can be monofloral, polyfloral, or blended; there are regional honeys, and classifications according to processing, colour and optical density. Honey can also be made from honeydew (sweet secretions from aphids and some scale insects).
According to Council Directive 2001/110/EC7 and the Codex Standard for honey (Codex Alimentarius, 1981), honey is defined as “the natural sweet substance produced by bees from the nectar of plants or from secretions of living parts of plants or excretions of plant-sucking insects on the living parts of plants, which the bees collect, transform by combining with specific substances of their own, deposit, dehydrate, store and leave in honeycombs to ripen and mature”.
About 95 % of honey dry matter is composed of carbohydrates, mainly fructose and glucose but also around 25 different oligosaccharides. Different types of honey induce variable glycaemic responses, reflecting the differences in composition and botanical source. Honey contains small amounts of proteins, enzymes, amino acids, minerals and trace elements, vitamins, aroma compounds and
polyphenols. Compositional criteria include the sugar content, moisture content, water-insoluble solid content, electrical conductivity, free acids, diastase activity and hydroxymethyfurfural (HMF) content. Composition varies substantially depending on the floral source and geographical location (Bogdanov et al., 2008).
For ID 1160, fructooligosaccharides (FOS) and “antioxidant phytochemicals” present in honey were specified as “active” substances. FOS in honey differ in composition as well as in degree of polymerisation. FOS content in honey is variable and is dependent on the floral source of the honey. The references cited did not specify the composition or the content of these substances.
The Panel notes that according to the references provided the composition of honey is variable and depends on the floral origin, the geographic location, the season and the processing conditions, that honeys produced in different regions were mentioned, and that it was not possible to characterise the specific honey for which the claims are made.
The Panel considers that the food, honey, which is the subject of the health claims, is not sufficiently characterised in relation to the claimed effects considered in this section.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of honey and the claimed effects considered in this section.

1.10. Cucurbita pepo L. (pumpkin) seeds and seed extracts (ID 2029, 2365)

The food that is the subject of the health claims is Cucurbita pepo L. (pumpkin) seeds and seed extracts related to the following claimed effects: maintenance of normal prostate size and normal urination.
The pumpkin (Cucurbita pepo L.) is native to America, but is cultivated worldwide in warm and temperate regions. Pumpkin seeds are small, rather flat and oval-shaped, sometimes white but usually vibrant orange. Hull-less seeds contain 41 to 59 wt% fat, approximately 35 wt% protein, with albumin and globulin being the most prominent proteins, 5 to 7 wt% water, and minor amounts of carbohydrates, fibre and ash (Fruhwirt and Hermetter, 2007). Pumpkin seeds also contain a variety of phytosterols, minerals and carotenoids. Because of the wide variety of pumpkin species, the fatty acid composition of the oil obtained from them can vary significantly. The fatty acid pattern of Cucurbita pepo subsp. pepo var. styriaca, a variety which is used by some manufacturers as a source for pumpkin seed oil or pumpkin seed extracts, has been provided. Various pumpkin seed compounds (phytosterols, fatty acids, minerals and vitamins) have been postulated to have an effect on maintenance of normal prostate size and normal urination in males.
Two human studies were conducted with a specific preparation of pumpkin seeds, which contained 500 mg of a (15-25:1) pumpkin seed extract derived from a 92 % alcohol extraction of seeds from Cucurbita pepo subsp. pepo var. styriaca (Bach, 2000; Friederich et al., 2000). No compositional data were provided for this extract.
No human study was provided which evaluated the effect of pumpkin seeds as such on the claimed effect.
The Panel considers that the food, Cucurbita pepo L. (pumpkin) seeds and seed extracts, which is the subject of the claims, is not sufficiently characterised in relation to the claimed effects considered in this section.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of Cucurbita pepo L. (pumpkin) seeds and seed extracts and the claimed effects considered in this section.