1. Charakterystyka żywności / składnika

1.1. Anthocyanidins and proanthocyanidins (ID 1787, 1788, 1789, 1790, 1791)

The food constituents that are the subject of the claim are anthocyanidins and proanthocyanidins related to the following claimed effects: "cardiovascular system", "blood fat levels", "carbohydrate metabolism and insulin sensitivity", "gut health" and "eyes".
Both anthocyanins and proanthocyanidins belong to the group of phenolic constituents known as flavonoids, which are naturally present in vegetables, fruits, and their products. Anthocyanins exist in nature as glycosylated forms of anthocyanidins. 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 anthocyanin and proanthocyanidin content in different types of berries, fruits and other plants is measurable, but anthocyanin and proanthocyanidin profiles vary widely depending on the food source, and may have an impact on the claimed effects.
The references provided for the scientific substantiation of the claims included narrative reviews, animal and human intervention studies, and in vitro experiments on anthocyanosides/anthocyanidins, cyaniding-3-glucoside and pure anthocyanidin compounds, anthocyanoside oligomer, blackcurrant (Ribes nigrum L.) anthocyanins, bilberry (Vaccinium myrtillus L.) anthocyanosides, anthocyanins and anthocyanidins in fruits, berry polyphenols, black raspberries (Rubus occidentalis L.), chokeberry (Aronia melanocarpa (Michx.) Elliott) juice, Cornelian cherry (Cornus mas L.), red wine, and proanthocyanidins extracted from grape seed on various health outcomes, most of them unrelated to the claimed effects.
The Panel notes that no information has been provided on the source or composition of anthocyanidins or proanthocyanidins. From the references provided it is unclear which type of anthocyanidins or proanthocyanidins are the subject of the claims.
The Panel considers that the food constituents, anthocyanidins and proanthocyanidins, 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 anthocyanidins and proanthocyanidins and the claimed effects considered in this section.

1.2. Sodium alginate and ulva (ID 1873)

The food constituents that are the subject of the claim are sodium alginate and ulva related to the following claimed effect: "alginate and ulva bind toxins, mutagens and heavy metals, they can also stimulate and increase colonic mucin production and thicken the colonic mucosa and protect the colon from harmful substances".
Sodium alginate is the sodium salt of alginic acid. Sodium alginate is extracted from the cell walls of brown algae. It is used as a thickener and emulsifier, and it is authorised for use as a food additive7. Alginate is an anionic polysaccharide, a linear copolymer with homopolymeric blocks of (1-4)-linked β-D-mannuronate (M) and its epimer α-glucuronate (G) residues, which are linked covalently in different sequences. Commercial varieties of sodium alginate are extracted from Marocystis pyrifera, Ascophyllum nodosum and various types of Laminaria. Different sources yield alginates that differ in monomeric composition and block structure, and a given alginate has its own characteristic calcium reactivity and gelation properties. Alginates are usually referred to as high M or high G, depending on the proportions of M and G they contain. The references provided did not allow an identification of the monomeric composition and block structure of the specific sodium alginate that is the subject of the claim.
Ulva is a group of edible green algae. Several species of ulva exist worldwide and the species that is the subject of the health claim has not been specified in the information provided.
The references provided reported on the use of Ulva ohnoi Hiraoka & Shimada, Ulva reticulata Forsskål and Ulva fasciata Delile, as well as ulvan, a sulphated algal polymer extracted from the Ulva species, which did not allow determining the specific ulva species, or the specific preparation of ulva, which is the subject of the claim.
The Panel considers that the food constituents, sodium alginate and ulva, 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 sodium alginate and ulva and the claimed effect considered in this section.

1.3. Vitamins, minerals, trace elements and standardised ginseng G115 extract (ID 8, 1673, 1674)

The food that is the subject of the claim is a combination of vitamins, minerals, trace elements and standardised ginseng G115 extract related to the following claimed effects: "to cover increased needs of vitamins, minerals, trace elements and ginseng G115 extract specifically in cases of exhaustion, tiredness, feeling of weakness, decreasing concentration as well as decreasing mental alertness", "mental performance" and "energy metabolism".
The Panel notes that the conditions of use refer to a number of ingredients which may or may not be included in the formulation of the food, and that the references provided referred to foods of various compositions. It is not possible, therefore, to determine which combination is the subject of the claims.
The Panel considers that the food, a combination of vitamins, minerals, trace elements and standardised ginseng G115 extract, 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 vitamins, minerals, trace elements and standardised ginseng G115 extract and the claimed effects considered in this section.

1.4. Vitamins, minerals, lysine and/or arginine and/or taurine (ID 6, 1676, 1677)

The food that is the subject of the claim is a combination of vitamins, minerals, lysine and/or arginine and/or taurine related to the following claimed effects: "nutritional support during the period of growth for physical development", "nutritional support after illness" and "nutritional support to help mental performance".
The Panel notes that the conditions of use refer to a number of ingredients which may or may not be included in the formulation of the food, and that the references provided referred to foods of various compositions. It is not possible, therefore, to determine which combination is the subject of the claims.
The Panel considers that the food, a combination of vitamins, minerals, lysine and/or arginine and/or taurine, 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 vitamins, minerals, lysine and/or arginine and/or taurine and the claimed effects considered in this section.

1.5. Plant-based preparation for use in beverages (ID 4210, 4211)

The food that is the subject of the claims is a plant-based preparation for use in beverages related to the following claimed effects: "aide à la prise de décisions chez les personnes hésitantes" and "aide à se libérer des petites manies".
The plant species used in the preparation that is the subject of the claims have not been further specified in the information provided. No clarifications have been provided by Member States.
The Panel considers that the food, a plant-based preparation for use in beverages, 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 plant-based preparation for use in beverages and the claimed effects considered in this section.

1.6. Carica papaya L. (ID 2007)

The food that is the subject of the claim is Carica papaya L. related to the following claimed effect: "antioxidant activity".
Carica papaya L. is a tropical tree-like plant which is cultivated for food use, mainly for its fruits which can be consumed either mature or green. Papain, a proteolytic enzyme, is produced from the green papaya fruit.
The proposed conditions of use for this claim refer to fermented fruits as well as papain as the food/food constituent which is the subject of the claim.
The references provided were related to different fermented papaya preparations, papaya juice and papain. In the one human intervention study provided from which conclusions could be drawn for the scientific substantiation of the claimed effect (Marotta et al., 2006), a fermented papaya preparation was used; the composition or nature of this preparation was not reported.
The Panel notes that from the information provided in the consolidated list and the references cited it is unclear to which specific preparation of Carica papaya L. the claim refers.
The Panel considers that the food, Carica papaya 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 Carica papaya L. and the claimed effect considered in this section.

1.7. “Fish protein” (ID 651)

The food that is the subject of the health claim is "fish protein" related to the following claimed effect: "skin, hair and nail health".
Fish protein, like all animal proteins, is a high quality protein containing all the indispensable amino acids, with a true protein digestibility of around 95 % (Torun, 2005).
From the references provided, the Panel assumes that the food refers to a specific commercial preparation containing special protein fractions of marine fish and glycosaminoglycans. The protein fractions and the glycosaminoglycans have not been specified further in the references provided.
The Panel considers that the food, a preparation of special protein fractions of marine fish and glycosaminoglycans, 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 "fish protein" and the claimed effect considered in this section.

1.8. Acidic water-based, non-alcoholic flavoured beverages containing calcium in the range of 0.3 to 0.8 mol per mol of acid with a pH not lower than 3.7 (ID 1170)

The food that is the subject of the health claim is "acidic water-based, non alcoholic flavoured beverages" related to the following claimed effect: "Dental health – low erosion".
In the context of the clarifications provided, the Panel assumes that the food which is the subject of the claim is acidic water-based, non-alcoholic flavoured beverages containing calcium in the range of 0.3 to 0.8 mol per mol of acid with a pH not lower (i.e. not more acidic) than 3.7.
In the context of the information given in the consolidated list and the references provided, the Panel assumes that the claim relates to the maintenance of tooth mineralisation by decreasing tooth demineralisation through the consumption of these beverages as a replacement for soft drinks. The Panel notes that no information was provided on the sugar content of the acidic beverages, which might also contribute to tooth demineralisation, or on the composition of soft drinks to be used as a comparator for the claim.
The Panel considers that the food, acidic water-based, non-alcoholic flavoured beverages containing calcium in the range of 0.3 to 0.8 mol per mol of acid with a pH not lower than 3.7, which is the subject of the claim, is not sufficiently characterised in relation to the maintenance of tooth mineralisation by decreasing tooth demineralisation.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of acidic water-based, non-alcoholic flavoured beverages containing calcium in the range of 0.3 to 0.8 mol per mol of acid with a pH not lower than 3.7 and maintenance of tooth mineralisation by decreasing tooth demineralisation.

1.9. Royal jelly (ID 1225, 1226, 1227, 1228, 1230, 1231, 1326, 1328, 1329, 1982, 4696, 4697)

The food that is the subject of the claims is royal jelly related to the following claimed effects: "natural defence/immune system", "metabolism", "vascular function", "glands function", "skin health", "tonus/vitality", "anti-asthénique, immunostimulant", "ménopause, effet oestrogénique", hypolipidémiant", "vitalité physique et intellectuelle", and "helps heart health and to maintain a balanced level of cholesterol and lipids in the body".
Royal jelly is a creamy, whitish, strongly acidic secretion from the mandibular and hypopharyngeal (cephalic) glands of Apis mellifera (Hymenoptera, Apidae) nurse bees, and is important in the sexual differentiation and longevity of the queen bee. Pure royal jelly is usually presented in the form of cream, capsules, or powder/flakes (freeze-dried); additionally, it is an ingredient in many products.
Royal jelly contains sugars, proteins, fatty acids, amino acids, vitamins, salts and trace elements. The average water content of royal jelly is 60-70 %. Crude protein (49-87 kDa) constitutes 12-15 % (or about 50 % of the dry mass), sugars 10-16 % and lipids 3-7 %. Proteins in royal jelly largely belong to one protein family designated MRJP (major royal jelly proteins, about 90 % of proteins) (apalbumins). Components of royal jelly reported to be biologically active include various proteins and peptides, the fatty acid 10-hydroxy-2-decenoic acid (10-HDA), and unidentified components with
oestrogenic activity. The composition of royal jelly is reported to vary with seasonal and regional conditions (Bincoletto et al., 2005; Fontana et al., 2004; Sver et al., 1996).
In the human studies provided which addressed outcomes related to the claimed effects the origin and composition of the royal jelly used was not specified.
The Panel notes that from the references provided it was not possible to characterise royal jelly in general, nor the specific components of royal jelly mediating the functions for which the claims were made.
The Panel considers that royal jelly, 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 royal jelly and the claimed effects considered in this section.

1.10. Foods low in cholesterol (ID 624)

The food constituent that is the subject of the health claims is "cholesterol".
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the foods which are the subject of the health claims are "foods low in cholesterol", and that the claimed effect is maintenance of normal blood cholesterol concentrations.
Cholesterol is a sterol found in all foods of animal origin, whereas foods of plant origin are almost cholesterol-free. Methods are available for the measurement of cholesterol in foods.
The Panel notes that the effects of foods on blood cholesterol may depend on various factors other than the cholesterol content, and, in particular, are dependent on the fatty acid composition of such foods.
The conditions of use for the claim specify "min 10 % fat (product basis), min 70 % UFAs (fat basis), max 2 % TFAs (fat basis) and max 0,02 g cholesterol per 100 g (product basis)" and "2.8-5.8 g DHA and/or EPA per day/up to 20 g fish oil daily". However, the Panel notes that a wide range of foods available on the market could meet one or the other composition specification and still be very variable with respect to the fatty acid profile, and therefore with respect to the effects on blood cholesterol concentrations.
The Panel considers that "foods low in cholesterol", which are the subject of the claim, are not sufficiently characterised in relation to the maintenance of normal blood cholesterol concentrations.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of "foods low in cholesterol" and maintenance of normal blood cholesterol concentrations.

1.11. Foods low in trans-fatty acids (ID 672, 4333)

The food constituent that is the subject of the health claims is "decrease of trans-fatty acids".
In the context of the proposed wordings, the Panel assumes that the foods which are the subject of the health claims are "foods low in trans-fatty acids", and that the claimed effect is maintenance of normal blood cholesterol concentrations.
Unsaturated fatty acids are aliphatic monocarboxylic acids with one (monounsaturated fatty acids, MUFAs) or more (polyunsaturated fatty acids, PUFAs) double bonds which can be liberated by hydrolysis of triacylglycerols from fats and oils. Most unsaturated fatty acids in the diet have the cis configuration, but trans-fatty acids (TFAs) are also present. These fatty acids originate from several sources and trans-MUFAs are the most common TFAs in the diet. Trans-PUFAs are also present. Trans-PUFAs have at least one trans double bond and may also have double bonds in the cis configuration.
The Panel notes that the effects of foods on blood cholesterol may depend on various factors other than the content in TFAs, and, in particular, are dependent on the fatty acid composition of such foods.
No reference to the fatty acid profile of "foods low in trans-fatty acids", which are the subject of the claim, is made in the information provided.
The Panel considers that "foods low in trans-fatty acids", which are the subject of the claim, are not sufficiently characterised in relation to the maintenance of normal blood cholesterol concentrations.
The Panel concludes that a cause and effect relationship cannot be established between the consumption of "foods low in trans-fatty acids" and maintenance of normal blood cholesterol concentrations.

Oświadczenia zdrowotne

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