1.1. Flavonoids and ascorbic acid in fruit juices, including berry juices (ID 1186)

The food that is the subject of the claim is “berries and fruit juices, flavonoids and ascorbic acid” related to the following claimed effect: “antioxidativity”.
From the information provided, the Panel assumes that the food constituents, which are the subject of the claim, are flavonoids and ascorbic acid in fruit juices, including berry juices.
The ascorbic acid content in fruits differs greatly depending on the type of fruit. From the conditions of use, the Panel assumes that the ascorbic acid content in the fruit juices, which are the subject of the claim, is 30 mg/100 g, corresponding to 60 mg per daily dose.
Flavonoids are polyphenolic substances naturally present in vegetables and fruits, and in their products. The group of flavonoids, is large, with several hundred compounds, belonging to subgroups of flavanones, flavonols, flavan-3-ols (such as proanthocyanidins), flavonones, isoflavonoids and anthocyanins. Proanthocyanidins are a group of flavan-3-ols ranging from dimers to polymers. Monomeric flavan-3-ols (such as catechin and epicatechin) are not considered proanthocyanidins. There are also differences in the linkages (A- or B-type) between the monomeric units of proanthocyanidins. The flavonoid, including proanthocyanidin, content in different types of berries, fruits and other plants is measurable, but the flavonoid profile varies widely depending on the food source, and may have an impact on the claimed effects.
The only reference provided for the scientific substantiation of the claim which assessed markers of oxidative damage in humans investigated the effect of cranberry juice consumption, but did not provide a quantitative indication of the flavonoid content nor any qualitative information about the flavonoid profile of the cranberry juice used in the intervention (Ruel et al., 2005).
The Panel notes that from the information provided in the consolidated list and the references cited it is unclear to which type of flavonoids in fruit juices the claim refers.
The Panel considers that the food consituents, flavonoids and ascorbic acid in fruit juices, including berry juices, which are the subject of the claim, are 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 flavonoids and ascorbic acid in fruit juices, including berry juices, and the claimed effect considered in this section.

1.2. Flavonoids from citrus (ID 1471)

The food constituent that is the subject of the claim is bioflavonoids from citrus related to the following claimed effect: “vascular health”.
The Panel assumes that bioflavonoids refer to flavonoids.
Flavonoids are polyphenolic substances naturally present in vegetables and fruits, and in their products. The group of flavonoids is large, with several hundred compounds belonging to subgroups of flavanones, flavonols, flavan-3-ols (such as proanthocyanidins), flavonones, isoflavonoids and anthocyanins. The citrus fruit flavonoids typically include flavanones (e.g. hesperidin), flavonols (e.g. quercetin glycosides) and flavonones (e.g. tangeritin). The flavonoid content in different types of citrus fruits is measurable, but the flavonoid profile varies widely depending on the nature of the citrus fruit, and may have an impact on the claimed effect.
The references provided included intervention studies using tangeritin, hesperidin, naringin, diosmin, or different “purified” flavonoid fractions from citrus that were not further specified, either alone or in combination. The Panel notes that from the references provided it is unclear which type of flavonoids from citrus is the subject of the claim.
The Panel considers that the food constituent, flavonoids from citrus, 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 flavonoids from citrus and the claimed effect considered in this section.

1.3. Flavonoids from Citrus paradisi Macfad. (ID 3324, 3325)

The food that is the subject of the claim is Citrus paradisi Macfad. related to the following claimed effect: “antibacterial and antifungal activity”.
In the context of the proposed wordings, the Panel assumes that the food constituent, which is the subject of the claim, is flavonoids from Citrus paradisi Macfad.
Flavonoids are polyphenolic substances naturally present in vegetables and fruits, and in their products. The group of flavonoids is large, with several hundred compounds belonging to subgroups of flavanones, flavonols, flavan-3-ols (such as proanthocyanidins), flavonones, isoflavonoids and anthocyanins. The Citrus paradisi Macfad. fruit flavonoids typically include flavanones (e.g. hesperidin), flavonols (e.g. quercetin glycosides), and flavonones (e.g. tangeritin). The flavonoid content in Citrus paradisi Macfad. is measurable, but the flavonoid profile varies widely depending on the nature of the part used, which may have an impact on the claimed effects.
The references provided included studies using peel extracts, grapefruit seed extracts, grapefruit seed and pulp ethanolic extracts, “grapefruit oil components”, hesperidin, naringenin, and flavonoids from citrus fruits other than grapefruit (e.g. orange). The Panel notes that from the references provided it is unclear which type of flavonoids from Citrus paradisi Macfad. is the subject of the claim.
The Panel considers that the food constituent, flavonoids from Citrus paradisi Macfad., 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 flavonoids from Citrus paradisi Macfad. and the claimed effect considered in this section.

1.4. Flavonoids (ID 1470, 1693, 1920)

The food constituents that is the subject of the claims is bioflavonoids related to the following claimed effects: “vein health”, “antioxidant effect” and “helps maintain a healthy immune system”.
The Panel assumes that bioflavonoids refer to flavonoids.
Flavonoids are polyphenolic substances naturally present in vegetables and fruits, and in their products. The group of flavonoids is large, with several hundred compounds belonging to subgroups of flavanones, flavonols, flavan-3-ols (such as proanthocyanidins), flavonones, isoflavonoids and anthocyanins. Proanthocyanidins are a group of flavan-3-ols ranging from dimers to polymers. Monomeric flavan-3-ols (such as catechin and epicatechin) are not considered proanthocyanidins. There are also differences in the linkages (A- or B-type) between the monomeric units of proanthocyanidins. The flavonoid, including proanthocyanidin, content in different types of berries, fruits and other plants is measurable, but the flavonoid profile varies widely depending on the food source, and may have an impact on the claimed effects considered in this section.
The references provided for the scientific substantiation of these claims included narrative reviews on purified flavonoid fractions (from citrus), on quercetin and related bioflavonoids, and on bioflavonoids in general, on various health outcomes, most of them unrelated to the claimed effects. One systematic review on chronic venous insufficiency (CVI) patients included one trial with French
maritime pine bark extract and one trial with grape seed extract. The Panel notes that from the references provided it is unclear which type of flavonoids is the subject of the claims.
The Panel considers that the food constituent, flavonoids, 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 flavonoids and the claimed effects considered in this section.

1.5. Flavonoids in cranberry juice (ID 1804)

The food constituent that is the subject of the claim is flavonoids in cranberry juice related to the following claimed effect: “antioxidativity”.
Flavonoids are polyphenolic substances naturally present in vegetables and fruits, and in their products. The group of flavonoids is large, with several hundred compounds belonging to subgroups of flavanones, flavonols, flavan-3-ols (such as proanthocyanidins), flavonones, isoflavonoids and anthocyanins. Cranberries typically contain high amounts of anthocyanins, flavonols and procyanidins (Kahkonen et al., 2001). The flavonoid content in cranberry juice is measurable by established methods, and conditions of use are provided for flavonoid content (5 mg/100 g). The amount and profile of flavonoids in cranberry juice vary according to the cranberry species (e.g. Vaccinium macrocarpon Aiton, Vaccinium oxycoccos L.), growing conditions and differences in the juice making procedure.
The only reference provided for the scientific substantiation of the claim which assessed the effects of cranberry juice consumption on markers of oxidative damage in humans did not provide a quantitative indication of the flavonoid content nor any qualitative information about the flavonoid profile in the cranberry juice used for the intervention (Ruel et al., 2005).
The Panel considers that the food constituent, flavonoids in cranberry juice, 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 flavonoids in cranberry juice and the claimed effect considered in this section.

1.6. Carotenoids (ID 1496, 1621, 1622, 1796)

The food constituents that are the subject of the claims are “carotenoids from fruits and vegetables juices”, “natural palm oil carotenes” and “carotenoids (alpha, beta and gamma carotene, lycopene)”, related to the following claimed effects: “antioxidant properties/protection of DNA”, “health during pregnancy/bioavailability” and “skin”.
In the context of the proposed wordings, conditions of use and references provided, the Panel assumes that the food constituent, which is the subject of the claims, is carotenoids.
Carotenoids are a class of more than 600 naturally occurring, tetraterpenoid organic pigments synthesised by plants and other photosynthetic organisms like algae, some types of fungi and bacteria. These richly coloured molecules are the sources of the yellow, orange and red colours of many plants. The most common carotenoids in European diets are alpha-carotene, beta-carotene, beta- cryptoxanthin, lutein, zeaxanthin and lycopene. Carotenoids can be broadly classified into two classes: carotenes (alpha-carotene, beta-carotene and lycopene) and xanthophylls (beta-cryptoxanthin, lutein and zeaxanthin).
Some carotenoids can be converted by the body to retinol (vitamin A) and are therefore provitamin A carotenoids (e.g. alpha-carotene, beta-carotene and beta-cryptoxanthin), whereas others have no vitamin A activity (e.g. lutein, zeaxanthin and lycopene). The long system of alternating double and single bonds (conjugated double bonds) common to all carotenoids allows them to absorb light in the visible range of the spectrum. However, whether (and the extent to which) different carotenoids are able to exert an effect on, for example, lipid peroxidation in vitro, depends on their structure, which determines distinct membrane lipid interactions.
The Panel notes that different carotenoids may have different antioxidant and pro-vitamin A activities, and a different capacity to absorb UV-radiation in the different tissues where they accumulate.
The references provided in relation to this claim related to health effects of different single carotenoids, of different specific carotenoid mixtures (e.g. Heinrich et al., 2003; Kiokias and Gordon, 2003), or of red palm oil (e.g. Lietz et al., 2006), carotenoid-rich palm oil (e.g. Olmedilla et al., 2002) or palm fruit carotenoid complexes which were not characterised with respect to their carotenoid composition.
The Panel refers to the opinions addressing the relationship between the consumption of single carotenoids (lycopene, beta-carotene, lutein, zeaxanthin, meso-zeaxanthin) and different claimed effects, including protection of DNA, protein and lipids from oxidative damage, protection of the skin from UV-induced (including photo-oxidative) damage, and vision (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009, 2010a, 2010b, 2010c, 2011a).
The Panel considers that the food constituent, carotenoids, 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 carotenoids and the claimed effects considered in this section.

1.7. Polyphenols (ID 1636, 1637, 1640, 1641, 1642, 1643)

The food constituent that is the subject of the claims is polyphenols, either in general or as derived from various plant sources, including processed fruits and vegetables, juices, grapes, red wine, olive, tea and cacao, related to the following claimed effects: “antioxidant properties”, “lipid metabolism”, “vascular functions” and “heart health”.
Polyphenols comprise a very wide group (several hundred compounds) of plant secondary metabolites including flavonoids, such as isoflavonoids and proanthocyanidins, as well as other tannins, phenolic acids and lignans with different biological activities.
The conditions of use specify 45-540 mg per day of polyphenols (usually expressed as gallic acid equivalents (GAE)), also together with other phenolic compounds such as catechin/epicatechin or caffeic acid as standard compounds. This specification refers to the traditional spectrophotometric measurement of total polyphenols by the Folin-Ciocalteau method (Singleton and Rossi, 1965), which measures the reducing capacity of compounds. The method is not specific for polyphenols because other reducing compounds such as ascorbic acid, sugars and proteins will also be included in the quantification, which leads to an overestimation of the actual polyphenol content. Total polyphenol content assessed with this method is not suitable for the characterisation of polyphenols in foods.
The conditions of use also specify foods containing min. 30 % of daily intakes of about 3000 to 5000 ORAC units per day (ID 1637). This specification refers to the oxygen radical absorbance capacity (ORAC) of the food measured in vitro. An antioxidant capacity assay such as the ORAC is not an acceptable way for characterising a food/food constituent for the substantiation of a health claim because it is a non-specific assay for substances capable of protecting a red photoreceptor pigment
(β-phycoerythrin) from oxidation. The ORAC value of a food is not relevant for establishing a cause and effect relationship between a food (constituent) (e.g. polyphenols) and the possible health effect.
The references provided did not allow further characterisation of the food constituent (i.e. polyphenols from different sources) in relation to the claimed effects since the polyphenol patterns for specific foods or characteristic polyphenol molecules which could be used for standardisation were not specified, and a few publications provided only made reference to the total polyphenol content.
The Panel considers that the food constituent, polyphenols, either in general or as derived from various plant sources, 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 polyphenols and the claimed effects considered in this section.
Regarding polyphenols from olive, the Panel refers to an opinion on olive polyphenols characterised by their content of hydroxytyrosol and its derivatives (e.g. oleuropein complex) (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011b).

1.8. Rye bread (ID 1179)

The food that is the subject of the claim is rye bread related to the following claimed effect: “carbohydrate metabolism and insulin sensitivity”.
Rye bread comprises bread made exclusively from rye flour or from a mix of rye flour and other components. The conditions of use for this claim refer to its fat and sugar components (amount and composition) with no reference to the amount or type of other carbohydrates. The macronutrient composition of rye bread may vary considerably, and this variation would have an impact on the claimed effect. Moreover, rye bread may be made from sourdough, which has an impact on the structure of the final bread product.
The references provided in relation to this claim used different types of rye bread and (processed) rye products (Brand et al., 1990; Jenkins et al., 1986; Juntunen et al., 2002; 2003), varying in structure, macronutrient composition, and amount and type of fibre, and therefore it is not possible to characterise the food for which the claim is made.
The Panel considers that the food, rye bread, 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 rye bread and the claimed effect considered in this section.

1.9. Protein hydrolysate (ID 1646)

The food that is the subject of the claim is protein hydrolysate related to the following claimed effect: “insulin secretion and blood sugar levels”.
Protein hydrolysates are peptides of different chain lengths produced from purified protein sources by acid or heat treatment, and/or by addition of proteolytic enzymes, followed by purification procedures. The composition of protein hydrolysates varies depending on the protein source and manufacturing process.
Regarding the protein hydrolysate for which the claim is made, the protein source (e.g. casein, whey, pea, soy, rice, gluten, wheat, gelatine and egg), the manufacturing process (e.g. enzymes used for hydrolysis) and the nature of the peptides resulting from hydrolysation are not mentioned.
The references provided included human intervention studies which used protein hydrolysates from whey, casein, wheat, pea, rice, soy, gluten or egg (Calbet and MacLean, 2002; Claessens et al., 2007, 2009; Manders et al., 2005; 2006; van Loon et al., 2000), and suggested that different protein hydrolysates may have different effects on post-prandial blood glucose and insulin responses (Claessens et al., 2009). The Panel notes that from the information provided, it is unclear which type of protein hydrolysate is the subject of the claim.
The Panel considers that the food, protein hydrolysate, 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 protein hydrolysate and the claimed effect considered in this section.

1.10. Carbohydrates with a low/reduced glycaemic load (ID 476, 477, 478, 479, 602) and carbohydrates which induce a low/reduced glycaemic response (ID 727, 1122, 1171)

The food constituents that are the subject of the health claims are carbohydrates with a low/reduced glycaemic load and carbohydrates which induce a low/reduced glycaemic response related to the following claimed effects: “impact on blood glucose”, “glycaemic control”, “glycaemic response”, “serum cholesterol levels”, “satiety”, “maintenance of a healthy weight”, “maintain low the glycaemic response”, “improved blood glucose control”, and “low blood glucose response”.
Chemically, carbohydrates include a range of components, such as polyhydroxy aldehydes, ketones, alcohols and acids, as well as their derivatives and polymers, for example, starch and other polysaccharides. The chemical classification of carbohydrates is usually based on molecular size and monomeric composition. The three principal groups of carbohydrates are sugars (1-2 monomers), oligosaccharides (3-9 monomers) and polysaccharides (10 or more monomers). A variety of specific and non-specific methods for the analysis of various carbohydrates in foods are 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 and becoming a substrate for the colonic microflora (commonly referred to as nondigestible, unavailable or non-glycaemic carbohydrates).
The food constituents for claim IDs 476, 477, 478, 479, 602 are carbohydrates with a low glycaemic load (GL). GL refers to the cumulative exposure to post-prandial glycaemic responses over a specified period of time (Salmeron et al., 1997) and is calculated as the product of the average glycaemic index (GI) of the carbohydrate foods consumed and the total carbohydrate intake over a specified period of time: GL = (GI x the amount of carbohydrate) divided by 100. For a food product, the GL is calculated as the product of the amount of available carbohydrate in a serving of the food and the GI of the food (Foster-Powell et al., 2002).
Taking into account that the chemical nature of the carbohydrates, which are the subject of the claims, has not been defined, that post-prandial glycaemic responses to or the glycaemic index of, different carbohydrates depend on the chemical and physical properties of the particular type of carbohydrate under consideration, as well as on individual factors (i.e. the extent to which foods are chewed prior to swallowing, and biological variation in rates and extent of digestion and absorption), that a serving of a food is not well-defined, and that “low/reduced” glycaemic load does not only relate to the
property of the food but also to the amount, the Panel considers that carbohydrates with a low glycaemic load are not sufficiently characterised.
The food constituents for claim IDs 727, 1122 and 1171 are carbohydrates which induce a low/reduced glycaemic response. A claim on carbohydrates which induce a low/reduced glycaemic response has already been assessed with an unfavourable outcome based on insufficient characterisation (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010).
The Panel considers that the food constituents, carbohydrates with a low/reduced glycaemic load and carbohydrates which induce a low/reduced glycaemic response, 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 carbohydrates with a low/reduced glycaemic load, or of carbohydrates which induce a low/reduced glycaemic response, and the claimed effects considered in this section.

1.11. Alfalfa (ID 1361, 2585, 2722, 2793)

The food that is the subject of the claims is alfalfa related to the following claimed effects: “good for your heart”, “help to maintain cholesterol levels”, “cardiovascular system”, “hair and nails health”, and “hypocholestérolémiant”.
Alfalfa (Medicago sativa L.) is a flowering plant in the pea family (Fabaceae) which is widely grown throughout the world as forage for cattle. The nutritional composition of alfalfa varies depending on the variety, cultivar, climate and harvesting time.
The information provided in relation to these claims, including the conditions of use, does not specify which part or component of the plant should be consumed in order to obtain the claimed effect. Most of the references provided reported on in vitro studies which investigated the oestrogenic activity of alfalfa sprouts, the antioxidant activity of alfalfa phytoestrogens, and the effects of aqueous extracts of alfalfa on platelet aggregation, and on animal studies which addressed the effects of alfalfa meals (not defined further), alfalfa saponins, and alfalfa seeds on blood lipids and models of atherosclerosis and partial ileal bypass. Also a one arm, uncontrolled human intervention study on the effects of alfalfa seeds on blood cholesterol concentrations in patients with type II hyperlipoproteinaemia was provided (Molgaard et al., 1987). The Panel notes that different parts and constituents of the plant have been tested with respect to their effects on blood cholesterol concentrations, and considers that from the information provided it is not clear for which part or constituent of the plant the claims are made.
The Panel considers that the food, alfalfa, 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 alfalfa and the claimed effects considered in this section.

1.12. Caffeinated carbohydrate containing energy drinks (ID 1272)

The food that is the subject of the health claim is caffeinated carbohydrate containing energy drinks related to the following claimed effect: “cognitive performance and mood”.
The Panel notes that the conditions of use refer to two combinations of ingredients, either caffeine and carbohydrates or caffeine, taurine and B-vitamins, that the references provided refer to drinks of various composition (e.g. glucose and caffeine; caffeine and vitamins; glucose, caffeine and herb
extracts; glucose, sucrose, taurine, glucuronolactone, caffeine, inositol and vitamins), and that it is not possible to determine which food is the subject of the claim.
The Panel considers that the food, caffeinated carbohydrate containing energy drinks, 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 caffeinated carbohydrate containing energy drinks and the claimed effect considered in this section.

1.13. Soups (ID 1132, 1133)

The foods that are the subject of the health claims are soups related to the following claimed effects: “weight management” and “satiety”.
Soups are generally defined as liquid foods prepared by boiling ingredients, such as meat, fish, or vegetables combined with other ingredients, until the flavour is extracted, and they often contain solid pieces. Traditionally, soups are classified into two main groups: clear soups and thick soups depending upon the type of thickening agent used. Ingredients commonly used to thicken soups and broths include rice, flour and grains.
The composition of soups is very variable. The clarifications provided refer to products with “energy density of max 0.8 kcal/g” and “volume of min 200 mL”. Out of the nine references provided for the substantiation of this claim, four human studies referred to a soup preparation. These studies used tomato soups (Rolls et al., 1990), apple, chicken and peanut soups (Mattes, 2005), chicken rice soups (Rolls et al., 1999) and soups identified by the brand name (Cecil et al., 1999) with varying energy density and macronutrient composition, which may have an impact on satiety, energy intake and body weight. The Panel notes that these references do not allow characterising the food, which is the subject of the claims.
The Panel considers that the foods, soups, 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 soups and the claimed effects considered in this section.