2244.pdf

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Scientific Opinion on the substantiation of health claims related to: a combination of millet seed extract, L-cystine and pantothenic acid (ID 1514), amino acids (ID 1711), carbohydrate and protein combination (ID 461), Ribes nigrum L. (ID 2191), Vitis vinifera L. (ID 2157), Grifola frondosa (ID 2556), juice concentrate from berries of Vaccinium macrocarpon Aiton and Vaccinium vitis-idaea L. (ID 1125, 1288), blueberry juice drink and blueberry extracts (ID 1370, 2638), a combination of anthocyanins from bilberry and blackcurrant (ID 2796), inulin-type fructans (ID 766, 767, 768, 769, 770, 771, 772, 804, 848, 849, 2922, 3092), green clay (ID 347, 1952), foods and beverages “low in energy”, “energy-free” and “energy-reduced” (ID 1146, 1147), and carbohydrate foods and beverages (ID 458, 459, 470, 471, 654, 1277, 1278, 1279) pursuant to Article 13(1) of Regulation (EC) No 1924/2006
Słowa kluczowe:
ID:    849      654      1279      1125      1278      1277      1952      769      770      2157      771      772      1146      1147      848      2638      1370      1514      2922      768      3092      767      470      766      471      2796      2556      347      1711      461      804      458      2191      459      1288  
Produkty: Winorośl właściwa   Sok z borówki amerykańskiej   #EN:Bilberry and anthocyanins from blackcurrant   #EN:Cranberry (Lingonberry) juice, (Vaccinium vitis idaea, Vaccinium macrocarpon)   #EN:Cranberry (Lingonberry) juice, (Vaccinium vitis-idaea, Vaccinium macrocarpon)   #EN:Maitaké   #EN:Inulin/ oligofructose from chicory   Porzeczka czarna   #EN:Inulin/oligofructose   #EN:Inulin/oligofructose from chicory   #EN:Oligofructose-enriched inulin (specific selection of short and long chains) from chicory   #EN:Inulin/oligofructose from chicory   #EN:Inulin / oligofructose / oligofructose-enriched inulin (specific selection of short and long chains) from chicory   #EN:Carbohydrate and protein combination   #EN:Inulin / oligofructose / Oligofructose-enriched inulin (specific selection of short and long chains) from chicory   #EN:Amino acids   Ekstrakty z owoców jagodowych   #EN:Combination of millet extract + L-cystine + vitamin B5 (calcium panthothenate)   #EN:Inulin / FOS (ß2→1 linked fructans)   #EN:Beverages low / free of energy   #EN:Carbohydrate   Węglowodany   #EN:Green Clay   #EN:Food reduced/ low/ free of energy   #EN:Prebiotics   #EN:Carbohydrate foods and beverages   #EN:Argile verte  

1. Charakterystyka żywności / składnika


1.1. Combination of millet seed extract, L-cystine and pantothenic acid (ID 1514)

The food that is the subject of the health claim is a combination of millet seed extract, L-cystine and pantothenic acid related to the following claimed effect: contribution to normal hair growth.
The millets are a group of small-seeded species of cereal crops or grains, widely grown around the world for food and feed use. The millet species which is the source for the millet extract has not been specified in the information provided. Details on the extraction method and the composition of the whole-millet seed extract have been given with regard to several nutrients (fatty acids, protein/amino acids, minerals). However, from the references provided the Panel notes that the triterpenoid miliacin
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 contained in the millet seed extract was indicated as one of the active constituents of the combination in relation to the claimed effect. The amount of miliacin in the extracts was not specified. L-cystine and pantothenic acid are well recognised nutrients and are measurable in foods by established methods.
The Panel considers that whereas L-cystine and pantothenic acid are sufficiently characterised, the millet extract, and hence the food, a combination of millet extract, L-cystine and pantothenic acid, 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 a combination of millet seed extract, L-cystine and pantothenic acid and the claimed effect considered in this section.

1.2. Amino acids (ID 1711)

The food constituent that is the subject of the health claim is amino acids related to the following claimed effect: skeletal muscle tissue repair and recovery following strenuous exercise.
Amino acids are the monomers from which proteins are built. Each amino acid has specific structural and chemical properties which affect the metabolic role of the free amino acid, and the behaviour of the amino acid residue within a protein. Different amino acids may have different effects on the stimulation of protein synthesis and breakdown.
The Panel notes that the information in the consolidated list and the references provided did not allow characterisation of the specific amino acid or amino acid combination which is the subject of the health claim.
The Panel considers that the food constituent, amino acids, 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 amino acids and the claimed effect considered in this section.

1.3. Carbohydrate and protein combination (ID 461)

The food that is the subject of the health claim is a combination of carbohydrates and protein related to the following claimed effect: faster skeletal muscle recovery after exercise.
The Panel notes that the information provided in the consolidated list does not specify the nature and precise amounts of the carbohydrates or protein in the combination.
In the references provided, various sources of carbohydrates and protein were used in different amounts and ratios. The Panel notes that from the references provided it is unclear to which type of carbohydrate and protein combination the claim refers.
The Panel considers that the food, a combination of carbohydrates and protein, 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 a combination of carbohydrates and protein and the claimed effect considered in this section.

1.4. Ribes nigrum L. (ID 2191)

The food that is subject of the health claim is Ribes nigrum L. related to the following claimed effect: maintenance of normal muscles and joints.
Ribes nigrum L. (blackcurrant) is a perennial small shrub which is cultivated for food use mainly for its fruits.
The proposed conditions of use for this claim refer to the leaves, which are to be used for the preparation of infusions. The references provided were related to proanthocyanidins and prodelphinidins isolated from blackcurrant leaves, and to anthocyanins from a commercially available blackcurrant juice. The leaves of Ribes nigrum L. contain flavonol gylcosides, proanthocyanidins of various degrees of polymerisation, dimeric prodelphinidins and a trimeric prodelphinidin (Blaschek et al., 2008). The Panel notes that from the information provided in the consolidated list and the references cited it is unclear to which specific preparation of Ribes nigrum L. the claim refers.
The Panel considers that the food, Ribes nigrum L., 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 Ribes nigrum L. and the claimed effect considered in this section.

1.5. Vitis vinifera L. (ID 2157)

The food that is the subject of the health claim is Vitis vinifera L. related to the following claimed effect: maintenance of normal venous blood flow.
Vitis vinifera L. is a liana which is cultivated for food use mainly for its fruits (i.e. grape).
The leaves of Vitis vinifera L. contain flavonoids (flavonols and anthocyans), tannins (catechins, procyanidins, ellagitannins) as well as hydroxycinnamic acid derivatives and, depending on the variety, different amounts of cyanogenic glycosides. The fruits contain tartaric acid, malic acid, anthocyans and tannins, as well as essential oils containing linalool, geraniol, nerol, α-terpineol and phenylethanol. In the skin of the fruits, trans-resveratrol and pterostilben, as well as dimers and oligomers, are found. The seeds of Vitis vinifera L. contain 6-20 % fat, of which around 55 % is linoleic acid and 37 % oleic acid, and are rich in oligomeric procyanidins (Blaschek et al., 2008).
The proposed conditions of use for this claim refer to the fruits, leaves and seeds, which are to be consumed in various forms and amounts, as well as to a specific leaf extract for which the flavonol content is given and the main flavonols were identified (i.e. quercetin-3-O-ß-D-glucuronide and quercetin-3-O-ß-glucoside). The references provided were related to extracts from red vine leaves, grape skin and grape seeds, respectively. In addition, monographs on Vitis vinifera L. and reviews on the effects of polyphenolic flavonoids were provided.
The Panel notes that from the information in the consolidated list and the references provided it is unclear to which specific preparation of Vitis vinifera L. the claim refers.
The Panel considers that the food, Vitis vinifera L., 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 Vitis vinifera L. and the claimed effect considered in this section.

1.6. Grifola frondosa (Maitake) (ID 2556)

The food that is the subject of the health claim is Grifola frondosa (Maitake) related to the following claimed effect: blood glucose control.
Grifola frondosa is a Basidiomycete fungus belonging to the family Polyporaceae, order Aphyllopherales (Lee et al., 2003). Its edible fruit bodies, known as Maitake in Japanese, consist of approximately 86 % moisture and 14 % dry matter, of which carbohydrates represent 59 %, protein 21 %, fibre 10 %, fat 3 % and ash 7 % (Mau et al., 2001; Svagelij et al., 2008).
The proposed conditions of use for this claim refer to the whole mushroom. However, the references provided were related to various preparations of Grifola frondosa, including powdered fruit bodies and a specific glycoprotein extract.
The Panel notes that from the information in the consolidated list and the references provided it is unclear to which specific preparation of Grifola frondosa the claim refers.
The Panel considers that the food, Grifola frondosa, 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 Grifola frondosa and the claimed effect considered in this section.

1.7. Juice concentrate from berries of Vaccinium macrocarpon Aiton and Vaccinium vitis-idaea L. (ID 1125, 1288)

The food that is the subject of the health claims is a mixture of juice from American cranberry (Vaccinium macrocarpon Aiton) and lingonberry (Vaccinium vitis-idaea L.) related to the following claimed effect: defence against bacterial pathogens in the lower urinary tract.
According to the American Herbal Pharmacopeia and Therapeutic Compendium monograph (Upton, 2002), ―cranberry fruit‖ consists of the fresh or dried whole, crushed or powdered mature fruits of Vaccinium macrocarpon Aiton (American cranberry, large cranberry, bearberry). Vaccinium macrocarpon Aiton belongs to the genus Vaccinum of the family Ericaceae. Cranberry (Vaccinium macrocarpon Aiton) fruits contain anthocyanins, tannins, catechins, flavonol glycosides, proanthocyanidins, organic acids such as quinic, malic and citric acids, and sugars such as glucose and fructose (Blumenthal, 2003). Vaccinium vitis-idaea L. (lingonberry), also called ―European cranberry‖ or mountain cranberry, is a species closely related to Vaccinium macrocarpon Aiton.
From the information provided, the Panel notes that proanthocyanidins from cranberries and lingonberries have been indicated as being among the active constituents of the combination in relation to the claimed effect.
Only one human intervention study conducted with a juice product derived from berries of Vaccinium macrocarpon Aiton and Vaccinium vitis-idaea L. was provided (Kontiokari et al., 2001). The product used in the study was a 9.2 g juice concentrate containing 7.5 g juice concentrate from berries of Vaccinium macrocarpon Aiton and 1.7 g juice concentrate from berries of Vaccinium vitis-idaea L. diluted in 50 mL of water. No information was provided on the grade of concentration, on the proanthocyanidin content, on the proanthocyanidin profile or on any of the other compounds in the juice which was used for the intervention.
The Panel considers that the food, juice concentrate from berries of Vaccinium macrocarpon Aiton and Vaccinium vitis-idaea L., 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 a juice concentrate from berries of Vaccinium macrocarpon Aiton and Vaccinium vitis-idaea L. and the claimed effect considered in this section.

1.8. Blueberry juice drink and blueberry extracts (ID 1370, 2638)

The foods that are the subject of the claim are blueberry juice drink and blueberry extracts related to the following claimed effects: maintenance of normal vision and improvement of visual adaptation to the dark.
The only reference provided was not related to the food which is the subject of the claim, but rather addressed the effect of billberry-extracted anthocyanosides on night vision.
The Panel notes that the conditions of use and the reference provided do not allow the characterisation of the foods which are the subject of the claim.
The Panel considers that the foods, blueberry juice drink and blueberry extracts, 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 blueberry juice drink and blueberry extracts and the claimed effects considered in this section.

1.9. Combination of anthocyanins from bilberry and blackcurrant (ID 2796)

The food that is a subject of the claims is a combination of anthocyanins from bilberry and blackcurrant related to the following claimed effect: improvement of visual adaptation to the dark and reduction of ocular discomfort.
Anthocyanins belong to the group of phenolic constituents known as flavonoids. They occur in foods as glycosylated anthocyanidins. The anthocyanin content in different types of berries, fruits and other plants is measurable by established methods. Typically the anthocyanin profile of berries consists of up to 16 different anthocyanins including different glycosides of cyanidin, delphinidin and other anthocyanidins. The anthocyanin profile in different types of berries varies depending on the type of berry, and may have an impact on the claimed effects.
The references provided were either on bilberry or blackcurrant anthocyanins, but not on the combination of the two ingredients. The Panel considers that in the absence of evidence for the substantiation of the claim from studies on the combination for which the claim is made, studies on individual constituents cannot be used for substantiation. The Panel also notes that the conditions of use and the references provided do not allow the specification of the anthocyanin profile of the food which is the subject of the claims.
The Panel considers that the food, a combination of anthocyanins from bilberry and blackcurrant, 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 a combination of anthocyanins from bilberry and blackcurrant and the claimed effects considered in this section.

1.10. Inulin-type fructans (ID 766, 767, 768, 769, 770, 771, 772, 804, 848, 849, 2922, 3092)

The food constituents that are the subject of the health claims are ―inulin/oligofructose/oligofructose-enriched inulin (specific selection of short & long chains) from chicory‖, ―inulin/FOS (ß2→1 linked fructans)‖, ―inulin/oligofructose from chicory‖, ―oligofructose-enriched inulin (specific selection of short & long chains) from chicory‖ and ―inulin/oligofructose‖ and ―prebiotics‖ related to the following claimed effects: bowel function, defence against gastrointestinal pathogens, increase in calcium absorption and retention, increase in bone mineral density, maintenance of normal blood glucose concentrations, and satiety.
From the conditions of use related to these claims and from the references provided, the Panel assumes that the food constituents, which are the subject of the claims, are mixtures of inulin and oligofructose from chicory, substances known as inulin-type fructans.
Inulin-type fructans are linear polymers consisting of fructose molecules with mainly (or exclusively) β (2→1) linkages. They are extracted industrially from chicory. The term inulin-type fructans covers three types of chemical compounds: oligofructose (degree of polymerisation 2–8, average degree of polymerisation 4), native inulin (degree of polymerisation 2–60, average degree of polymerisation 12), and inulin HP (highly polymerised) (degree of polymerisation 10–60, average degree of polymerisation 25), or specific combinations of oligofructose and inulin. Native chicory inulin is a non-fractionated inulin extracted from fresh roots, which always contains glucose, fructose, sucrose and small oligosaccharides. About 10 % of the fructan chains in native chicory inulin have a degree of polymerisation ranging between 2 and 5. The partial enzymatic hydrolysis of inulin using an endo-inulinase produces oligofructose with degrees of polymerisation between 2 and 7. In oligofructose-enriched inulin, low and high molecular weight compounds are mixed. Long-chain inulin or inulin HP is produced by applying physical separation techniques to eliminate all oligomers with degrees of polymerisation <10. The term inulin is used to identify both native chicory inulin and any other derived industrial products except oligofructose (Roberfroid, 2005).
The references provided for the scientific substantiation of the health claims related to gut microbiota and changes in bowel function used native inulin from chicory (e.g. Bouhnik et al., 2007; Causey et al., 2000; Den Hond et al., 2000; Gibson et al., 1995a; Kleessen et al., 1997a, 1997b), highly polymerised inulin (e.g. Tuohy et al., 2001), Jerusalem artichoke inulin (Kleessen et al., 2007), fructo-oligosaccharides (FOS) from chicory (Menne et al., 2000), FOS from sucrose (e.g. Bouhnik et al., 1999; Mitsuoka et al., 1987; Tokunaga et al., 1993), FOS from unknown origin (e.g. Buddington et al., 1996; Rao, 2001), or a mixture of FOS, glucose, fructose, and sucrose (e.g. Boutron-Ruault et al., 2005). The references provided for the scientific substantiation of the health claims related to calcium absorption and bone mineral density used 1:1 mixtures of oligofructose and long-chain inulin from chicory (e.g. Abrams et al., 2005), mixtures of 92 % inulin and 8 % short-chain oligofructose (e.g. Kruger et al., 2003), FOS from chicory (e.g. Kim et al., 2004; Lobo et al., 2006), native inulin from chicory (e.g. Roberfroid et al., 2002), or oligofructans with various degrees of polymerisation. The references provided for the scientific substantiation of the health claims related to satiety used native inulin from chicory or commercial inulin preparations not better described (e.g. Archer et al., 2004), inulin HP (e.g. Cani et al., 2004), FOS from chicory (e.g. Cani et al., 2005; 2006), or FOS from unknown origin (e.g. Whelan et al., 2006). Similarly, the references provided for the scientific substantiation of the health claims related to blood cholesterol concentrations used mixtures of inulin and FOS from chicory (e.g. Brighenti et al., 1999), FOS from chicory (e.g. Alles et al., 1999), or native inulin from chicory (e.g. Causey et al., 2000; Davidson and Maki, 1999).
The Panel notes that the food constituents described in relation to the health claims, and the food constituents used in the references provided for scientific substantiation, include a wide variety of inulin-type fructans with variable degrees of polymerisation, which could have an impact on the claimed effects.
The Panel considers that the food constituents, inulin-type fructans, which are the subject of the health 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 inulin-type fructans and the claimed effects considered in this section.

1.11. Green clay (ID 347, 1952)

The food constituent that is the subject of the claims is green clay related to the following claimed effect: reduction of gastro-intestinal discomfort.
The term ―clay‖ is an ambiguous geological term and has multiple meanings: a group of fine grained minerals (clay minerals), a particle size (smaller than silt), or a type of rock (sedimentary deposits of fine-grained material usually composed largely of various clay minerals). In the latter definition, clay also includes fine-grained deposits of non-aluminosilicates (such as shale and non argillaceous soils) (WHO, 2005). In mineralogical definitions, clay minerals are composed of crystals less than 2 μm in diameter.
Clays may be composed of different minerals, e.g. montmorillonite, beidellite, biotite, saponite, sauconite, kaolinite, bentonite, illite and sepiolite. The colour is not of great utility in defining clays: it mainly depends upon the content and form of the iron present. Green clays comprise minerals that differ by their composition, mineral structure, or geological occurrence (Velde, 2004).
Several factors could determine the extent of clays’ adsorption properties, e.g. the chemistry of the clay minerals, exchangeable ions, the surface properties and the fine structure of clay particles (Williams et al., 2008).
In relation to ID 347, the references provided were text books and general reviews not related to the food constituent which is the subject of the claim, but rather to magnesium or other micronutrients. No information was provided allowing the characterisation of green clay in relation to the claimed effect.
In relation to ID 1952, the five references cited which addressed outcomes related to gastro-intestinal discomfort included the use of dioctahedral smectite (Chang et al., 2007; Guarino et al., 2001) or of beidellitic montmorillonite (Bedelix) (Bigard and Gilbert, 1990; Ducrotte et al., 2005; Meknini and Bernardes, 1994). The Panel notes that different types of green clays were used in the references provided, and that the conditions of use did not specify the green clay which is the subject of the health claim. The Panel notes that the conditions of use and the references provided do not allow the characterisation of the food constituent which is the subject of the claim.
The Panel considers that the food constituent, green clay, 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 green clay and the claimed effect considered in this section.

1.12. Foods and beverages “low in energy”, “energy-free” and “energy-reduced” (ID 1146, 1147)

The food that is the subject of the health claims is ―food reduced/low/free of energy‖ and ―beverages low/free of energy‖ related to the following claimed effects: body weight management.
The conditions of use in relation to these claims refer to the provisions laid down in the Annex of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods:
- A claim that a food is low in energy may only be made where the product does not contain more than 40 kcal (170 kJ)/100 g for solids or more than 20 kcal (80 kJ)/100 mL for liquids.
- A claim that a food is energy-free may only be made where the product does not contain more than 4 kcal (17 kJ)/100 mL.
- A claim that a food is energy-reduced may only be made where the energy value is reduced by at least 30 %, with an indication of the characteristic(s) which make(s) the food reduced in its total energy value.
The Panel notes that whereas the absolute energy content required in foods and beverages to qualify for a ―low in energy‖, and for an ―energy-free‖, claim is specified, it is not for ―energy-reduced‖ claims.
The vast majority of the references provided for the scientific substantiation of these claims were observational (cross-sectional and prospective cohort) studies which assessed the effects of sugar-sweetened soft drink consumption on body weight, and on the effects of lifestyle (including television-watching, physical activity patterns, consumption of meals outside home, and consumption of certain types of meals, such as fast food menus and meat products) and level of education on body weight changes and obesity prevalence, mostly in children. Only a few human intervention studies, which assessed the effects of consuming sugar-sweetened beverages vs. sugar-free beverages containing intense sweeteners, have been provided, and no studies on the effects of consuming ―low-energy‖ or ―energy-free‖ solid foods on body weight, either per se or in replacement of ―energy dense‖ or ―higher energy‖ foods, have been provided.
Therefore, from the information provided, the Panel assumes that foods and beverages ―low in energy‖, ―energy-free‖ and ―energy-reduced‖ should replace ―energy dense‖ food or beverages in order to obtain the claimed effects. However, no information regarding the amount, frequency of consumption and/or the foods or beverages which should be replaced by foods and beverages ―low in energy‖, ―energy-free‖ or ―energy-reduced‖ in order to obtain the claimed effects has been provided; the only exception being foods and beverages containing intense sweeteners in replacement of sugar-sweetened foods and beverages.
A claim on foods and beverages containing intense sweeteners in replacement of sugar and maintenance or achievement of a normal body weight has already been assessed with an unfavourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011b).
The Panel considers that foods and beverages ―low in energy‖, ―energy-free‖ or ―energy-reduced‖, and the ―energy dense‖ or ―higher energy‖ foods and beverages which they should replace, 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 foods and beverages ―low in energy‖, ―energy-free‖ or ―energy-reduced‖ and the claimed effects considered in this section.

1.13. Carbohydrate foods and beverages (ID 458, 459, 470, 471, 654, 1277, 1278, 1279)

The food constituent that is the subject of the health claims is carbohydrate foods and beverages related to the following claimed effects: physical capacity and performance in relation to short-term and endurance exercise (including endurance capacity and performance during the subsequent exercise bout after strenuous exercise) by contributing to the replenishment of muscle and liver glycogen stores, reduction in rated perceived exertion/effort during exercise, and recovery from muscle fatigue after exercise. The clarifications provided by Member States and the wordings and conditions of use proposed in relation to these claims, refer to ―foods for sports people under the Directive 89/398/EEC‖, to ―metabolisable carbohydrates‖, to ―low or high GI carbohydrates‖, to particular carbohydrates (e.g. glucose, glucose polymers and sucrose), and to ―carbohydrate rich diets‖.
The Panel notes that ―foods for sports people under the Directive 89/398/EEC‖ are currently not regulated in the European Union, and that Council Directive 89/398/EEC7 does not provide any information that could be used for the characterisation of such foods, either in general or regarding their carbohydrate content. The Panel also notes that no information has been provided which could be used for the characterisation of ―carbohydrate-rich diets‖ in relation to the claimed effects.
The claims considered in this section also refer to carbohydrate-containing foods and beverages with a high (vs. a low) glycaemic index (GI). Taking into account that the chemical nature of the carbohydrate-containing foods and beverages which are the subject of the health claims has not been defined, that the GI of different carbohydrate-containing foods or beverages depends on the chemical and physical properties of the particular foods or beverages under consideration, and that high (vs. low) GI carbohydrate-containing foods and beverages have not been defined in the information provided in relation to the standardisation of the testing method, the Panel considers that carbohydrate-containing foods and beverages with a high GI are not sufficiently characterised in relation to the claimed effects (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010b).
The Panel assumes that ―metabolisable carbohydrates‖ refers to digestible, available or glycaemic carbohydrates which are digested and absorbed in the human small intestine providing carbohydrates to body cells. Main glycaemic carbohydrates in the diet are glucose and fructose (monosaccharides), sucrose and lactose (disaccharides), malto-oligosaccharides and starch (polysaccharides). The rate of digestion and absorption of available carbohydrates in foods and beverages is widely variable, and depends on the chemical structure, physical properties and macronutrient composition of the food or beverage in which carbohydrates are contained (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010a).
The vast majority of the references provided for the scientific substantiation of these claims addressed the effects of the amount, type and timing of administration of different carbohydrate-containing foods, beverages (usually as carbohydrate-containing electrolyte solutions), meals and diets on the claimed effects. Most of the human intervention studies provided compared the effects of various isoenergetic beverages containing different types of available carbohydrates (e.g. sucrose vs. maltodextrin vs. glucose vs. fructose vs. glucose polymers, or in different combinations) relative to other isoenergetic carbohydrate-containing beverages or to a hypoenergetic, carbohydrate-free placebo. The remaining studies compared the effects of low vs. high GI foods and meals, the effects of the timing of administration of carbohydrate-containing foods and beverages prior, during and after exercise, and the effects of different amounts and different timings of administration of carbohydrate-containing foods and beverages on the replenishment of glycogen stores before and after exercise.
7 Council Directive 89/398/EEC of 3 May 1989 on the approximation of the laws of the Member States relating to foodstuffs intended for particular nutritional uses. OJ L 186, 30.6.1989, p. 27-32.
The evidence provided by consensus opinions/reports from authoritative bodies and reviews shows that macronutrient recommendations for athletes as % of total energy intake are not different from those for the general population (IoM, 2005), albeit higher amounts of carbohydrates may be required before, during and after exercise to maintain or improve exercise capacity and performance along with adequate hydration. An opinion on carbohydrate/electrolyte solutions and endurance performance has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011a). However, whether and to what extent the consumption of available carbohydrate-containing foods and beverages influences exercise capacity/performance, perception of fatigue during exercise, and recovery from exercise may depend inter alia on the amount (absolute and relative to energy needs), form (solid vs. liquid) and type (e.g. rate of digestibility and availability) of the carbohydrates consumed, on other components of carbohydrate-containing foods and beverages (e.g. water, macro- and micronutrient composition and dietary fibre), on the intensity, duration and type of physical exercise performed, and on the time of administration (Burke and Hawley, 2006; Jeukendrup, 2004; Rodriguez et al., 2009; SCF, 2001).
The Panel notes that carbohydrate foods and beverages have not been sufficiently characterised in the information provided with respect to the composition and conditions of use for the proposed claimed effects.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of carbohydrate foods and beverages and the claimed effects considered in this section.

Wnioski

On the basis of the data presented, the Panel concludes: That the following foods/food constituents are not sufficiently characterised, or are not sufficiently characterised in relation to the proposed claimed effects: Combination of millet seed extract, L-cystine and pantothenic acid related to: contribution to normal hair growth (ID 1514). Amino acids related to: skeletal muscle tissue repair and recovery following strenuous exercise (ID 1711). Carbohydrate and protein combination related to: faster skeletal muscle recovery after exercise (ID 461). Ribes nigrum L. related to: maintenance of normal muscles and joints (ID 2191). Vitis vinifera L. related to: maintenance of normal venous blood flow (ID 2157). Grifola frondosa related to: blood glucose control (ID 2556). Juice concentrate from berries of Vaccinium macrocarpon Aiton and Vaccinium vitis-idaea L. related to: defence against bacterial pathogens in the lower urinary tract (ID 1125, 1288). Blueberry juice drink and blueberry extracts related to: maintenance of normal vision and improvement of visual adaptation to the dark (ID 1370, 2638). Combination of anthocyanins from bilberry and blackcurrant related to: improvement of visual adaptation to the dark and reduction of ocular discomfort (ID 2796).
Inulin-type fructans related to: bowel function, defence against gastrointestinal pathogens, increase in calcium absorption and retention, increase in bone mineral density, maintenance of normal blood glucose concentrations, and satiety (ID 766, 767, 768, 769, 770, 771, 772, 804, 848, 849, 2922, 3092). Green clay related to: reduction of gastro-intestinal discomfort (ID 347, 1952). Foods and beverages ―low in energy‖, ―energy-free‖ and ―energy-reduced‖ related to: body weight management (ID 1146, 1147). Carbohydrate foods and beverages related to: physical capacity and performance in relation to short-term and endurance exercise (including endurance capacity and performance during the subsequent exercise bout after strenuous exercise) by contributing to the replenishment of muscle and liver glycogen stores, reduction in rated perceived exertion/effort during exercise, and recovery from muscle fatigue after exercise (ID 458, 459, 470, 471, 654, 1277, 1278, 1279). A cause and effect relationship cannot be established between the foods/food constituents which are the subject of this opinion and the claimed effects.