Substantiation of Health Claims

EFSA Journal 2011;9(4):2082
SCIENTIFIC OPINION
Scientific Opinion on the substantiation of health claims related to:

flavonoids and ascorbic acid in fruit juices, including berry juices
(ID 1186); flavonoids from citrus (ID 1471); flavonoids from
Citrus paradisi Macfad. (ID 3324, 3325); flavonoids (ID 1470, 1693, 1920);
flavonoids in cranberry juice (ID 1804); carotenoids (ID 1496, 1621, 1622,
1796); polyphenols (ID 1636, 1637, 1640, 1641, 1642, 1643); rye bread
(ID 1179); protein hydrolysate (ID 1646); 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);
alfalfa (ID 1361, 2585, 2722, 2793); caffeinated carbohydrate-containing
energy drinks (ID 1272); and soups (ID 1132, 1133) pursuant to
Article 13(1) of Regulation (EC) No 1924/20061
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
1
On request from the European Commission, Question No EFSA-Q-2008-1263, EFSA-Q-2008-1264, EFSA-Q-2008-1265,
EFSA-Q-2008-1266, EFSA-Q-2008-1389, EFSA-Q-2008-1514, EFSA-Q-2008-1861, EFSA-Q-2008-1871, EFSA-Q-
2008-1872, EFSA-Q-2008-1910, EFSA-Q-2008-1918, EFSA-Q-2008-1925, EFSA-Q-2008-2010, EFSA-Q-2008-2098,
2008-2372, EFSA-Q-2008-2373, EFSA-Q-2008-2376, EFSA-Q-2008-2377, EFSA-Q-2008-2378, EFSA-Q-2008-2379,
2008-3318, EFSA-Q-2008-3455, EFSA-Q-2008-3526, EFSA-Q-2008-4056, EFSA-Q-2008-4057, adopted by written
procedure on 17 February 2011.
2
Panel members: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Hannu Korhonen,
Pagona Lagiou, Martinus Løvik, Rosangela Marchelli, Ambroise Martin, Bevan Moseley, Monika Neuhäuser-Berthold,
Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz, Sean (J.J.) Strain, Stephan Strobel, Inge Tetens, Daniel Tomé,
Hendrik van Loveren and Hans Verhagen. Correspondence: nda@efsa.europa.eu
3
Acknowledgement: The Panel wishes to thank for the preparatory work on this scientific opinion: The members of the
Working Group on Claims: Carlo Agostoni, Jean-Louis Bresson, Susan Fairweather-Tait, Albert Flynn, Ines Golly, Marina
Heinonen, Hannu Korhonen, Martinus Løvik, Ambroise Martin, Hildegard Przyrembel, Seppo Salminen, Yolanda Sanz,
Sean (J.J.) Strain, Inge Tetens, Hendrik van Loveren and Hans Verhagen. The members of the Claims Sub-Working Group
on Cardiovascular Health/Oxidative Stress: Antti Aro, Marianne Geleijnse, Marina Heinonen, Ambroise Martin, Wilhelm
Stahl and Henk van den Berg. The members of the Claims Sub-Working Group on Weight Management/Satiety/Glucose
and Insulin Control/Physical Performance: Kees de Graaf, Joanne Harrold, Mette Hansen, Mette Kristensen, Anders
Sjödin and Inge Tetens. The members of the Claims Sub-Working Group on Mental/Nervous System: Jacques Rigo, Astrid
Schloerscheidt, Barbara Stewart-Knox, Sean (J.J.) Strain, and Peter Willatts.
Suggested citation: EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA); Scientific Opinion on the
substantiation of health claims related to flavonoids and ascorbic acid in fruit juices including berry juices (ID 1186);
flavonoids from citrus (ID 1471); flavonoids from Citrus paradisi Macfad. (ID 3324, 3325); flavonoids (ID 1470, 1693,
1920); flavonoids in cranberry juice (ID 1804); carotenoids (ID 1496, 1621, 1622, 1796); polyphenols (ID 1636, 1637, 1640,
1641, 1642, 1643); rye bread (ID 1179); protein hydrolysate (ID 1646); 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);
alfalfa (ID 1361, 2585, 2722, 2793); caffeinated carbohydrate-containing energy drinks (ID 1272); and soups (ID 1132,
1133) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal 2011;9(4):2082. [38 pp.].
doi:10.2903/j.efsa.2011.2082. Available online: www.efsa.europa.eu/efsajournal
© European Food Safety Authority, 2011

Health claims related to not sufficiently characterised foods/food constituents
SUMMARY
Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and
Allergies was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of
Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims
in relation to: flavonoids and ascorbic acid in fruit juices including berry juices, flavonoids from
citrus; flavonoids from Citrus paradisi Macfad.; flavonoids; flavonoids in cranberry juice;
carotenoids; polyphenols; rye bread; protein hydrolysate; carbohydrates with a low/reduced glycaemic
load and carbohydrates which induce a low/reduced glycaemic response; alfalfa; caffeinated
carbohydrate-containing energy drinks; and soups. The scientific substantiation is based on the
information provided by the Member States in the consolidated list of Article 13 health claims and
references that EFSA has received from Member States or directly from stakeholders.
The foods/food constituents that are the subject of this opinion are:
Flavonoids and ascorbic acid in fruit juices, including berry juices, related to the following
claimed effect: “antioxidativity” (ID 1186).
Flavonoids from citrus related to the following claimed effect: “vascular health” (ID 1471).
Flavonoids from Citrus paradisi Macfad. related to the following claimed effect: “antibacterial
and antifungal activity” (ID 3324, 3325).
Flavonoids related to the following claimed effects: “vein health”, “antioxidant effect” and “helps
maintain a healthy immune system” (ID 1470, 1693, 1920).
Flavonoids in cranberry juice related to the following claimed effect: “antioxidativity” (ID 1804).
Carotenoids related to the following claimed effects: “antioxidant properties/protection of DNA”,
“health during pregnancy/bioavailability” and “skin” (ID 1496, 1621, 1622, 1796).
Polyphenols related to the following claimed effects: “antioxidant properties”, “lipid
metabolism”, “vascular functions” and “heart health” (ID 1636, 1637, 1640, 1641, 1642, 1643).
Rye bread related to the following claimed effect: “carbohydrate metabolism and insulin
sensitivity” (ID 1179).
Protein hydrolysate related to the following claimed effect: “insulin secretion and blood sugar
levels” (ID 1646).
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) 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”.
Alfalfa related to the following claimed effects: “good for your heart”, “help to maintain
cholesterol levels”, “cardiovascular system”, “hair and nails health”, and “hypocholestérolémiant”
(ID 1361, 2585, 2722, 2793).
Caffeinated carbohydrate containing energy drinks related to the following claimed effect:
“cognitive performance and mood” (ID 1272).
Soups related to the following claimed effects: “weight management” and “satiety” (ID 1132,
1133).
The information given in the consolidated list and the references provided did not allow the Panel to
characterise the foods/food constituents which are the subject of this opinion.
The Panel considers that the foods/food constituents, which are the subject of this opinion, are not
sufficiently characterised in relation to the claimed effects.
EFSA Journal 2011;9(4):2082 2

On the basis of the data presented, the Panel concludes that a cause and effect relationship cannot be
established between the foods/food constituents, which are the subject of this opinion, and the
proposed claimed effects.
KEY WORDS
Flavonoids, ascorbic acid, carotenoids, polyphenols, rye bread, protein hydrolysate, carbohydrates, alfalfa,
energy drinks, soups, health claims.
EFSA Journal 2011;9(4):2082 3

TABLE OF CONTENTS
Summary .................................................................................................................................................. 2
Table of contents ...................................................................................................................................... 4
Background as provided by the European Commission .......................................................................... 5
Terms of reference as provided by the European Commission ............................................................... 5
EFSA Disclaimer...................................................................................................................................... 5
Information as provided in the consolidated list ...................................................................................... 6
Assessment ............................................................................................................................................... 6
1. Characterisation of the food/constituent ............................................................................................. 6
1.1. Flavonoids and ascorbic acid in fruit juices, including berry juices (ID 1186) ........................ 6
1.2. Flavonoids from citrus (ID 1471) .............................................................................................. 7
1.3. Flavonoids from Citrus paradisi Macfad. (ID 3324, 3325) ...................................................... 8
1.4. Flavonoids (ID 1470, 1693, 1920)............................................................................................. 8
1.5. Flavonoids in cranberry juice (ID 1804) ................................................................................... 9
1.6. Carotenoids (ID 1496, 1621, 1622, 1796) ................................................................................. 9
1.7. Polyphenols (ID 1636, 1637, 1640, 1641, 1642, 1643)........................................................... 10
1.8. Rye bread (ID 1179) ................................................................................................................ 11
1.9. Protein hydrolysate (ID 1646) ................................................................................................. 11
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) ......... 12
1.11. Alfalfa (ID 1361, 2585, 2722, 2793) ....................................................................................... 13
1.12. Caffeinated carbohydrate containing energy drinks (ID 1272) ............................................... 13
1.13. Soups (ID 1132, 1133)............................................................................................................. 14
Conclusions ............................................................................................................................................ 14
Documentation provided to EFSA ......................................................................................................... 15
References .............................................................................................................................................. 15
Appendices ............................................................................................................................................. 18
EFSA Journal 2011;9(4):2082 4

BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION

See Appendix A
TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION

See Appendix A
EFSA DISCLAIMER
See Appendix B
EFSA Journal 2011;9(4):2082 5

INFORMATION AS PROVIDED IN THE CONSOLIDATED LIST

The consolidated list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006 4
submitted by Member States contains main entry claims with corresponding conditions of use and
literature for similar health claims. EFSA has screened all health claims contained in the original
consolidated list of Article 13 health claims which was received by EFSA in 2008 using six criteria
established by the NDA Panel to identify claims for which EFSA considered sufficient information
had been provided for evaluation and those for which more information or clarification was needed
before evaluation could be carried out5. The clarifications which were received by EFSA through the
screening process have been included in the consolidated list. This additional information will serve
as clarification to the originally provided information. The information provided in the consolidated
list for the health claims which are the subject of this opinion is tabulated in Appendix C.
ASSESSMENT
The approach used in the evaluation of Article 13(1) health claims is explained in the briefing
document for stakeholders6 published by EFSA.
In assessing each specific food/health relationship that forms the basis of a health claim the NDA
Panel considers the extent to which:
1. the food/constituent is defined and characterised;
2. the claimed effect is defined and is a beneficial physiological effect (“beneficial to human health”);
3. a cause and effect relationship is established between the consumption of the food/constituent and
the claimed effect (for the target group under the proposed conditions of use).
Substantiation of the claim is dependent on a favourable outcome of the assessment of 1, 2 and 3

above. Thus, a cause and effect relationship is considered not to be established if the outcome of any
one of these assessments is unfavourable.
For a claim, each relationship between a food/constituent and a claimed effect is assessed separately,
and individual assessments are combined, as appropriate, to form coherent opinions.
1. Characterisation of the food/constituent
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.
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
Briefing document for stakeholders on the evaluation of Article 13.1, 13.5 and 14 health claims:
http://www.efsa.europa.eu/en/ndameetings/docs/nda100601-ax01.pdf
6
See footnote 5
EFSA Journal 2011;9(4):2082 6

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.
products. The group of flavonoids is large, with several hundred compounds belonging to subgroups
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.
EFSA Journal 2011;9(4):2082 7

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.
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.
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.
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
EFSA Journal 2011;9(4):2082 8

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.
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”.
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.
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).
EFSA Journal 2011;9(4):2082 9

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.
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
EFSA Journal 2011;9(4):2082 10

(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.
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.
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.
EFSA Journal 2011;9(4):2082 11

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.
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
EFSA Journal 2011;9(4):2082 12

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.
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.
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
EFSA Journal 2011;9(4):2082 13

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.
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.
consumption of soups and the claimed effects considered in this section.
CONCLUSIONS
On the basis of the data presented, the Panel concludes that the following foods/food constituents
are not sufficiently characterised in relation to the claimed effects:
Flavonoids and ascorbic acid in fruit juices, including berry juices, related to “antioxidativity”
(ID 1186).
Flavonoids from citrus related to “vascular health” (ID 1471).

Flavonoids from Citrus paradisi Macfad. related to “antibacterial and antifungal activity”
(ID 3324, 3325).
Flavonoids related to “vein health”, “antioxidant effect” and “helps maintain a healthy
immune system” (ID 1470, 1693, 1920).
Flavonoids in cranberry juice related to “antioxidativity” (ID 1804).
EFSA Journal 2011;9(4):2082 14

Carotenoids related to “antioxidant properties/protection of DNA”, “health during

pregnancy/bioavailability” and “skin” (ID 1496, 1621, 1622, 1796).
Polyphenols related to “antioxidant properties”, “lipid metabolism”, “vascular functions” and
“heart health” (ID 1636, 1637, 1640, 1641, 1642, 1643).
Rye bread related to “carbohydrate metabolism and insulin sensitivity” (ID 1179).
Protein hydrolysate related to “insulin secretion and blood sugar levels” (ID 1646).
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) related
to “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”.
Alfalfa related to “good for your heart”, “help to maintain cholesterol levels”, “cardiovascular
system”, “hair and nails health”, and “hypocholestérolémiant” (ID 1361, 2585, 2722, 2793).
Caffeinated carbohydrate containing energy drinks related to “cognitive performance and
mood” (ID 1272).
Soups related to “weight management” and “satiety” (ID 1132, 1133).
A cause and effect relationship cannot be established between the foods/food constituents, which
are the subject of this opinion, and the proposed claimed effects.
DOCUMENTATION PROVIDED TO EFSA

Health claims pursuant to Article 13 of Regulation (EC) No 1924/2006 (No: EFSA-Q-2008-1263,
EFSA-Q-2008-1264, EFSA-Q-2008-1265, EFSA-Q-2008-1266, EFSA-Q-2008-1389, EFSA-Q-2008-
1514, EFSA-Q-2008-1861, EFSA-Q-2008-1871, EFSA-Q-2008-1872, EFSA-Q-2008-1910, EFSA-Q-
2008-1918, EFSA-Q-2008-1925, EFSA-Q-2008-2010, EFSA-Q-2008-2098, EFSA-Q-2008-2207,
2372, EFSA-Q-2008-2373, EFSA-Q-2008-2376, EFSA-Q-2008-2377, EFSA-Q-2008-2378, EFSA-Q-
2008-2379, EFSA-Q-2008-2382, EFSA-Q-2008-2429, EFSA-Q-2008-2529, EFSA-Q-2008-2537,
4056, EFSA-Q-2008-4057). The scientific substantiation is based on the information provided by the
Member States in the consolidated list of Article 13 health claims and references that EFSA has
received from Member States or directly from stakeholders.
The full list of supporting references as provided to EFSA is available on:

http://www.efsa.europa.eu/panels/nda/claims/article13.htm.
REFERENCES
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realistic meals and rye breads tested in healthy subjects. Diabetes Nutrition and Metabolism, 3,
137-142.
Calbet JA and MacLean DA, 2002. Plasma glucagon and insulin responses depend on the rate of
appearance of amino acids after ingestion of different protein solutions in humans. Journal of
Nutrition, 132, 2174-2182.
Cecil JE, Francis J and Read NW, 1999. Comparison of the effects of a high-fat and high-
carbohydrate soup delivered orally and intragastrically on gastric emptying, appetite, and eating
behaviour. Physiology and Behavior, 67, 299-306.
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Claessens M, Calame W, Siemensma AD, van Baak MA and Saris WH, 2007. The effect of different
protein hydrolysate/carbohydrate mixtures on postprandial glucagon and insulin responses in
healthy subjects. European Journal of Clinical Nutrition, 63, 48-56.
Claessens M, Calame W, Siemensma AD, van Baak MA and Saris WH, 2009. The effect of different
protein hydrolysate/carbohydrate mixtures on postprandial glucagon and insulin responses in
healthy subjects. European Journal of Clinical Nutrition, 63, 48-56.
EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2009. Scientific Opinion on the
substantiation of health claims related to beta-carotene and physiological immune responses of the
skin in relation to UV-radiation (sun exposure) (ID 198, 1463) pursuant to Article 13 of Regulation
(EC) No 1924/2006. EFSA Journal, 7(9):1231, 14 pp.
EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010. Scientific Opinion on the
substantiation of health claims related to carbohydrates that induce low/reduced glycaemic
responses (ID 474, 475, 483, 484) and carbohydrates with a low glycaemic index (ID 480, 481,
482, 1300) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal, 8(2):1491,
15 pp.
EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010a. Scientific Opinion on the
substantiation of health claims related to lutein and maintenance of vision (ID 1603, 1604, 1931)
pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal, 8(2):1492, 19 pp.
EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010b. Scientific Opinion on the
substantiation of health claims related to zeaxanthin and maintenance of normal vision (ID 1684,
2169, 2888) pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal,
8(10):1724, 18 pp.
EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2010c. Scientific Opinion on the
substantiation of health claims related to meso-zeaxanthin and maintenance of vision (ID 2096)
pursuant to Article 13(1) of Regulation (EC) No 1924/2006. EFSA Journal, 8(2):1483 11 pp.
EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011a. Scientific Opinion on the
substantiation of health claims related to lycopene and protection of DNA, proteins and lipids from
oxidative damage (ID 1608, 1609, 1611, 1662, 1663, 1664, 1899, 1942, 2081, 2082, 2142, 2374),
protection of the skin from UV-induced (including photo-oxidative) damage (ID 1259, 1607, 1665,
2143, 2262, 2373), contribution to the normal function of the heart (ID 1610, 2372), and
maintenance of normal vision (ID 1827) pursuant to Article 13(1) of Regulation (EC) No
1924/2006. EFSA Journal, 9(4):2031, 32 pp.
EFSA Panel on Dietetic Products Nutrition and Allergies (NDA), 2011b. Scientific Opinion on the
substantiation of health claims related to polyphenols in olive and protection of LDL particles
from oxidative damage (ID 1333, 1638, 1639, 1696, 2865), maintenance of normal blood HDL
cholesterol concentrations (ID 1639), maintenance of normal blood pressure (ID 3781), “anti-
inflammatory properties” (ID 1882), “contributes to the upper respiratory tract health” (ID 3468),
“can help to maintain a normal function of gastrointestinal tract” (3779) and “contributes to body
defences against external agents” (ID 3467) pursuant to Article 13(1) of Regulation (EC) No
1924/2006. EFSA Journal, 9(4):2033, 25 pp.
Foster-Powell K, Holt SH and Brand-Miller JC, 2002. International table of glycemic index and
glycemic load values: 2002. American Journal of Clinical Nutrition, 76, 5-56.
Heinrich U, Gartner C, Wiebusch M, Eichler O, Sies H, Tronnier H and Stahl W, 2003.
Supplementation with beta-carotene or a similar amount of mixed carotenoids protects humans
from UV-induced erythema. Journal of Nutrition, 133, 98-101.
Jenkins DJ, Wolever TM, Jenkins AL, Giordano C, Giudici S, Thompson LU, Kalmusky J, Josse RG
and Wong GS, 1986. Low glycemic response to traditionally processed wheat and rye products:
bulgur and pumpernickel bread. American Journal of Clinical Nutrition, 43, 516-520.
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Juntunen KS, Niskanen LK, Liukkonen KH, Poutanen KS, Holst JJ and Mykkanen HM, 2002.
Postprandial glucose, insulin, and incretin responses to grain products in healthy subjects.
American Journal of Clinical Nutrition, 75, 254-262.
Juntunen KS, Laaksonen DE, Autio K, Niskanen LK, Holst JJ, Savolainen KE, Liukkonen KH,
Poutanen KS and Mykkanen HM, 2003. Structural differences between rye and wheat breads but
not total fiber content may explain the lower postprandial insulin response to rye bread. American
Journal of Clinical Nutrition, 78, 957-964.
Kahkonen MP, Hopia AI and Heinonen M, 2001. Berry phenolics and their antioxidant activity.
Journal of Agricultural and Food Chemistry, 49, 4076-4082.
Kiokias S and Gordon MH, 2003. Dietary supplementation with a natural carotenoid mixture
decreases oxidative stress. European Journal of Clinical Nutrition, 57, 1135-1140.
Lietz G, Mulokozi G, Henry JC and Tomkins AM, 2006. Xanthophyll and hydrocarbon carotenoid
patterns differ in plasma and breast milk of women supplemented with red palm oil during
pregnancy and lactation. Journal of Nutrition, 136, 1821-1827.
Manders RJ, Wagenmakers AJ, Koopman R, Zorenc AH, Menheere PP, Schaper NC, Saris WH and
van Loon LJ, 2005. Co-ingestion of a protein hydrolysate and amino acid mixture with
carbohydrate improves plasma glucose disposal in patients with type 2 diabetes. American Journal
of Clinical Nutrition, 82, 76-83.
Manders RJ, Koopman R, Sluijsmans WE, van den Berg R, Verbeek K, Saris WH, Wagenmakers AJ
and van Loon LJ, 2006. Co-ingestion of a protein hydrolysate with or without additional leucine
effectively reduces postprandial blood glucose excursions in Type 2 diabetic men. Journal of
Nutrition, 136, 1294-1299.
Mattes R, 2005. Soup and satiety. Physiology and Behavior, 83, 739-747.
Molgaard J, von Schenck H and Olsson AG, 1987. Alfalfa seeds lower low density lipoprotein
cholesterol and apolipoprotein B concentrations in patients with type II hyperlipoproteinemia.
Atherosclerosis, 65, 173-179.
Olmedilla B, Granado F, Southon S, Wright AJ, Blanco I, Gil-Martinez E, van den Berg H, Thurnham
D, Corridan B, Chopra M and Hininger I, 2002. A European multicentre, placebo-controlled
supplementation study with alpha-tocopherol, carotene-rich palm oil, lutein or lycopene: analysis
of serum responses. Clinical Science, 102, 447-456.
Rolls BJ, Fedoroff IC, Guthrie JF and Laster LJ, 1990. Foods with different satiating effects in
humans. Appetite, 15, 115-126.
Rolls BJ, Bell EA and Thorwart ML, 1999. Water incorporated into a food but not served with a food
decreases energy intake in lean women. American Journal of Clinical Nutrition, 70, 448-455.
Ruel G, Pomerleau S, Couture P, Lamarche B and Couillard C, 2005. Changes in plasma antioxidant
capacity and oxidized low-density lipoprotein levels in men after short-term cranberry juice
consumption. Metabolism: Clinical and Experimental, 54, 856-861.
Salmeron J, Manson JE, Stampfer MJ, Colditz GA, Wing AL and Willett WC, 1997. Dietary fiber,
glycemic load, and risk of non-insulin-dependent diabetes mellitus in women. JAMA, 277, 472-
477.
Singleton VL and Rossi JA, Jr., 1965. Colorimetry of total phenolics with phosphomolybdic-
phosphotungstic acid reagents. American Journal of Enology and Viticulture, 16, 144-158.
van Loon LJ, Saris WH, Verhagen H and Wagenmakers AJ, 2000. Plasma insulin responses after
ingestion of different amino acid or protein mixtures with carbohydrate. American Journal of
Clinical Nutrition, 72, 96-105.
EFSA Journal 2011;9(4):2082 17

APPENDICES
APPENDIX A
BACKGROUND AND TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION

The Regulation (EC) No 1924/2006 on nutrition and health claims made on foods7 (hereinafter "the
Regulation") entered into force on 19th January 2007.
Article 13 of the Regulation foresees that the Commission shall adopt a Community list of permitted
health claims other than those referring to the reduction of disease risk and to children's development
and health. This Community list shall be adopted through the Regulatory Committee procedure and
following consultation of the European Food Safety Authority (EFSA).
Health claims are defined as "any claim that states, suggests or implies that a relationship exists
between a food category, a food or one of its constituents and health".
In accordance with Article 13 (1) health claims other than those referring to the reduction of disease
risk and to children's development and health are health claims describing or referring to:
a) the role of a nutrient or other substance in growth, development and the functions of the
body; or
b) psychological and behavioural functions; or
c) without prejudice to Directive 96/8/EC, slimming or weight-control or a reduction in the
sense of hunger or an increase in the sense of satiety or to the reduction of the available
energy from the diet.
To be included in the Community list of permitted health claims, the claims shall be:
(i) based on generally accepted scientific evidence; and

(ii) well understood by the average consumer.
Member States provided the Commission with lists of claims as referred to in Article 13 (1) by 31
January 2008 accompanied by the conditions applying to them and by references to the relevant
scientific justification. These lists have been consolidated into the list which forms the basis for the
EFSA consultation in accordance with Article 13 (3).
ISSUES THAT NEED TO BE CONSIDERED
IMPORTANCE AND PERTINENCE OF THE FOOD8

Foods are commonly involved in many different functions9 of the body, and for one single food many
health claims may therefore be scientifically true. Therefore, the relative importance of food e.g.
nutrients in relation to other nutrients for the expressed beneficial effect should be considered: for
functions affected by a large number of dietary factors it should be considered whether a reference to
a single food is scientifically pertinent.
7
OJ L12, 18/01/2007
8
The term 'food' when used in this Terms of Reference refers to a food constituent, the food or the food category.
9
The term 'function' when used in this Terms of Reference refers to health claims in Article 13(1)(a), (b) and (c).
EFSA Journal 2011;9(4):2082 18

It should also be considered if the information on the characteristics of the food contains aspects
pertinent to the beneficial effect.
SUBSTANTIATION OF CLAIMS BY GENERALLY ACCEPTABLE SCIENTIFIC EVIDENCE

Scientific substantiation is the main aspect to be taken into account to authorise health claims. Claims
should be scientifically substantiated by taking into account the totality of the available scientific
data, and by weighing the evidence, and shall demonstrate the extent to which:
(a) the claimed effect of the food is beneficial for human health,
(b) a cause and effect relationship is established between consumption of the food and the
claimed effect in humans (such as: the strength, consistency, specificity, dose-
response, and biological plausibility of the relationship),
(c) the quantity of the food and pattern of consumption required to obtain the claimed
effect could reasonably be achieved as part of a balanced diet,
(d) the specific study group(s) in which the evidence was obtained is representative of the
target population for which the claim is intended.
EFSA has mentioned in its scientific and technical guidance for the preparation and presentation of
the application for authorisation of health claims consistent criteria for the potential sources of
scientific data. Such sources may not be available for all health claims. Nevertheless it will be
relevant and important that EFSA comments on the availability and quality of such data in order to
allow the regulator to judge and make a risk management decision about the acceptability of health
claims included in the submitted list.
The scientific evidence about the role of a food on a nutritional or physiological function is not
enough to justify the claim. The beneficial effect of the dietary intake has also to be demonstrated.
Moreover, the beneficial effect should be significant i.e. satisfactorily demonstrate to beneficially
affect identified functions in the body in a way which is relevant to health. Although an appreciation
of the beneficial effect in relation to the nutritional status of the European population may be of
interest, the presence or absence of the actual need for a nutrient or other substance with nutritional or
physiological effect for that population should not, however, condition such considerations.
Different types of effects can be claimed. Claims referring to the maintenance of a function may be
distinct from claims referring to the improvement of a function. EFSA may wish to comment whether
such different claims comply with the criteria laid down in the Regulation.
WORDING OF HEALTH CLAIMS

Scientific substantiation of health claims is the main aspect on which EFSA's opinion is requested.
However, the wording of health claims should also be commented by EFSA in its opinion.
There is potentially a plethora of expressions that may be used to convey the relationship between the
food and the function. This may be due to commercial practices, consumer perception and linguistic
or cultural differences across the EU. Nevertheless, the wording used to make health claims should be
truthful, clear, reliable and useful to the consumer in choosing a healthy diet.
In addition to fulfilling the general principles and conditions of the Regulation laid down in Article 3
and 5, Article 13(1)(a) stipulates that health claims shall describe or refer to "the role of a nutrient or
other substance in growth, development and the functions of the body". Therefore, the requirement to
EFSA Journal 2011;9(4):2082 19

describe or refer to the 'role' of a nutrient or substance in growth, development and the functions of
the body should be carefully considered.
The specificity of the wording is very important. Health claims such as "Substance X supports the
function of the joints" may not sufficiently do so, whereas a claim such as "Substance X helps
maintain the flexibility of the joints" would. In the first example of a claim it is unclear which of the
various functions of the joints is described or referred to contrary to the latter example which
specifies this by using the word "flexibility".
The clarity of the wording is very important. The guiding principle should be that the description or
reference to the role of the nutrient or other substance shall be clear and unambiguous and therefore
be specified to the extent possible i.e. descriptive words/ terms which can have multiple meanings
should be avoided. To this end, wordings like "strengthens your natural defences" or "contain
antioxidants" should be considered as well as "may" or "might" as opposed to words like
"contributes", "aids" or "helps".
In addition, for functions affected by a large number of dietary factors it should be considered
whether wordings such as "indispensable", "necessary", "essential" and "important" reflects the
strength of the scientific evidence.
Similar alternative wordings as mentioned above are used for claims relating to different relationships
between the various foods and health. It is not the intention of the regulator to adopt a detailed and
rigid list of claims where all possible wordings for the different claims are approved. Therefore, it is
not required that EFSA comments on each individual wording for each claim unless the wording is
strictly pertinent to a specific claim. It would be appreciated though that EFSA may consider and
comment generally on such elements relating to wording to ensure the compliance with the criteria
laid down in the Regulation.
In doing so the explanation provided for in recital 16 of the Regulation on the notion of the average
consumer should be recalled. In addition, such assessment should take into account the particular
perspective and/or knowledge in the target group of the claim, if such is indicated or implied.
TERMS OF REFERENCE
HEALTH CLAIMS OTHER THAN THOSE REFERRING TO THE REDUCTION OF DISEASE RISK AND TO
CHILDREN'S DEVELOPMENT AND HEALTH
EFSA should in particular consider, and provide advice on the following aspects:
 Whether adequate information is provided on the characteristics of the food pertinent to the
beneficial effect.
 Whether the beneficial effect of the food on the function is substantiated by generally
accepted scientific evidence by taking into account the totality of the available scientific data,
and by weighing the evidence. In this context EFSA is invited to comment on the nature and
quality of the totality of the evidence provided according to consistent criteria.
 The specific importance of the food for the claimed effect. For functions affected by a large
number of dietary factors whether a reference to a single food is scientifically pertinent.
In addition, EFSA should consider the claimed effect on the function, and provide advice on the
extent to which:
EFSA Journal 2011;9(4):2082 20

 the claimed effect of the food in the identified function is beneficial.
 a cause and effect relationship has been established between consumption of the food and the
claimed effect in humans and whether the magnitude of the effect is related to the quantity
consumed.
 where appropriate, the effect on the function is significant in relation to the quantity of the
food proposed to be consumed and if this quantity could reasonably be consumed as part of a
balanced diet.
 the specific study group(s) in which the evidence was obtained is representative of the target
population for which the claim is intended.
 the wordings used to express the claimed effect reflect the scientific evidence and complies
with the criteria laid down in the Regulation.
When considering these elements EFSA should also provide advice, when appropriate:
 on the appropriate application of Article 10 (2) (c) and (d) in the Regulation, which provides
for additional labelling requirements addressed to persons who should avoid using the food;
and/or warnings for products that are likely to present a health risk if consumed to excess.
EFSA Journal 2011;9(4):2082 21

APPENDIX B
EFSA DISCLAIMER
The present opinion does not constitute, and cannot be construed as, an authorisation to the marketing
of the food/food constituent, a positive assessment of its safety, nor a decision on whether the
food/food constituent is, or is not, classified as foodstuffs. It should be noted that such an assessment
is not foreseen in the framework of Regulation (EC) No 1924/2006.
It should also be highlighted that the scope, the proposed wordings of the claims and the conditions of
use as proposed in the Consolidated List may be subject to changes, pending the outcome of the
authorisation procedure foreseen in Article 13(3) of Regulation (EC) No 1924/2006.
EFSA Journal 2011;9(4):2082 22

APPENDIX C
Table 1. Main entry health claims related to not sufficiently characterised foods/food constituents,
including conditions of use from similar claims, as proposed in the Consolidated List.
ID Food or Food constituent Health Relationship Proposed wording

476 Carbohydrates with a low Impact on blood glucose A low GL diet sustains steady blood
glycaemic load sugar levels
Glycaemic control
Clarification provided
Glycaemic response
DE/UK proposal for the
proper description of a food
category (cf. ad hoc working
group meeting on 17 June
2009):
Carbohydrates with a low
glycaemic load (<10)
GL (glycaemic load) is the
amount of carbohydrate in a
serving of food multiplied by
its glycaemic index (GI) then
divided by 100 to give a GL
unit (Foster-Powell, Holt &
Brand-Miller, 2002).
A GL value of <10 is low,
11-19 is medium and >20 is
high.
GI is the blood glucose
response to a 50g
carbohydrate portion of a test
food compared to the
response to the same amount
of carbohydrate from a
standard food (usually
glucose or white bread)
(FAO/WHO, 1998). The GI
is expressed on a scale of 1
to 100, where the standard
food has a GI of 100.
Conditions of use
- niedriger GI = GI-Wert von maximal 55, ermittelt anhand der integrierten Fläche unter der
Blutglucosereantwortkurve einer Portion eines Lebensmittels / Produkts, die 50g verfügbare
Kohlenhydrate (mindestens 10g) liefert, Messzeitraum 2 Stunden, ausgedrüc
477 Carbohydrates with a low Serum cholesterol levels A low GL diet helps to maintain
glycaemic load healthy cholesterol levels
DE/UK proposal for the
proper description of a food
EFSA Journal 2011;9(4):2082 23

category (cf. ad hoc working

group meeting on 17 June
2009):
high.
response to a 50g
Conditions of use
- wo niedriger GI = GI-Wert von maximal 55, ermittelt anhand der integrierten Fläche unter der
Blutglukoseantwortkurve einer Portion eines Lebensmittels / Produkts, die 50g verfügbare
Kohlenhydrate (mindestens 10g) liefert, gemessen über 2 Stunden, und ausg
- Where low GI = GI score of less than or equal to 55, assessed from the incremental area under
the blood glucose response curve of a portion of the food/ product providing 50g available
carbohydrate (minumum 10g), measured over 2 hours, and expressed as a percentage of the
response to 50g glucose or white bread where GI = 100. Reference: WHO/FAO 1998; Brouns
et al 2005.
- Where low GL is a GL score of less than 10, using the calculation: GL = (GI x grams of
carbohydrate per serving size)/100 GI is assessed from the incremental area under the blood
glucose response curve of a portion of the food/product providing 50g available carbohydrate
(minimum 10g) measured over 2 hours and expressed as a percentage of the response to 50g
glucose for which GI equals 100). [See FAO/WHO (1998) and Ludwig, (2002)].
478 Carbohydrates with a low Satiety Low GL foods help keep you fuller for
glycaemic load longer
EFSA Journal 2011;9(4):2082 24

high.
response to a 50g
Conditions of use
- wo niedriger GI = GI-Wert von maximal 55, ermittelt anhand der integrierten Fläche unter der
Blutglukoseantwortkurve einer Portion eines Lebensmittels / Produkts, die 50g verfügbare
Kohlenhydrate (mindestens 10g) liefert, gemessen über 2 Stunden, und ausgedrückt als Prozent
der Antwort auf 50g Glukose mit GI = 100. [siehe Referenzen 18 und 19 zur Methodik]
479 Carbohydrates with a low Maintenance of a healthy A low GL diet helps to maintain a
glycaemic load weight healthy weight
high.
response to a 50g
EFSA Journal 2011;9(4):2082 25


Conditions of use
602 Aliments sources de Glucides complexes et Les glucides complexes contribuent à
glucides complexes satiété la satiété. De l’énergie durant la
matinée grâce aux glucides complexes
Clarification provided Clarification provided
Complex Carbohydrates satiety
“complex carbohydrates contribute to
Condition of use: Source of
satiety”
complex carbohydrates
(based on starch content: at “complex carbohydrates help keep you
least 15 g of starch per 100 g fuller for longer”
or at least 8 g of starch per
100 kcal.)
Conditions of use
- Sources de Glucides complexes
727 Azúcares de frutas de bajo disminución de la ayudan a mantener constantes los
índice glicémico respuesta glicémica. niveles de glucosa en sangre.
Clarification provided Clarification provided Clarification provided
Sugars from Fruits or Sugars Sugars from Fruits it helps to maintain steady blood
derived from Fruits with maintain low the glucose levels.
Low Glycaemic Index glycaemic response.
Conditions of use
- < 10% de la ingesta energética diaria. 50-57 g/día (mujer) y 62-71 g/día (hombre), en base de
materia seca
1122 Food with a reduced Improved blood glucose Due to its (modified) carbohydrate
glycemic response control composition, this food has a lower
blood glucose and insulin response;
This food has a [x%] lower impact on
Food with a reduced
blood sugar levels than comparable
glycemic response
foods and thus helps to maintain more
EFSA Journal 2011;9(4):2082 26

Clarification: steady blood sugar levels
Two different products: graphical presentations of blood

glucose response curves]
1) Oat Snack biscuits
GI under 55. Biscuits contain
20-22 % oat flakes, 11-16 %
oat bran, 17-20 % wheat
flour, 15-17 % vegetable fat.
Fiber content of the products
is 8,5 -10 %. One biscuit
(one serving) is 30 g, in
which 2,5- 3,0 g fiber of
which 0,8- 1,0 g oat
betaglucan
2) Wholegrain Snack
biscuits
GI < or = 55. Biscuits
contains wholegrain 19-40 %
(wholegrain content is 28% -
57 % of total cereals), wheat
flour 22-30 %, fat 16 % (Fat
quality is good as fat is
mainly unsaturated fat.
Saturated fatty acids < 30 %
of fat. Trans fat level <
1g/100 g), fibre 4,7-5,7 %,
Available carbohydrates
represents >/ = 55 % of
energy.
Conditions of use
- Claim to be used only on Foods for Particular Nutritional Uses under Dir. 89/398/EEC
The glycemic response is at least 30% reduced compared to a regular food, without increasing
the fat content. Assessed from blood glucose response curve (e.g. test food vs traditional food)
- Ice-cream stick
5.3g/100g, 3.0g/serving of lactitol, 14g/100g, 8.0g/serving of vegetable fat, (36% fat)
10g/100g, 5.7g/serving of cream (36% fat), 4.5g/100g, 2.6g/serving of polydextrose. The claim
is partially based on the fact that sugars are absorbed slowly from the product and lactitol is not
absorbed at all. The products glycemic index has been tested in a clinical trial, which was done
on the end product, in other words, after processing.
- Light coloured pastas with a glycemic index of less than 55.
The claim is based on the form of starch and a dense structure (startch content 60-70%). The
pasta production process changes the starch into a form that is absorbed more slowly and the
dense structure slows absorption. Other substances eaten at the same meal affect the glycemic
index.
- Vanilla and wholegrain snack cookies with a glycemic index of less than 55.
The GI value for the products is based on absorbable carbohydrates and it has been tested using
a method that is described in the FAO/WHO report Carbohydrates in Human Nutrition 1998.
The baking processes have an effect on the glycemic index. The crackers are produced using
mould technology. A carefully controlled baking process is used during production of the
EFSA Journal 2011;9(4):2082 27

product. Wholegrain accounts for 28% of the grain in the vanilla snack cracker (whole grain in
the end product: 8.3% wholegrain oat flakes, 6.2% wholegrain wheat flour, 4.6% wholegrain
barley flour) and for 57 % of the grain in the wholegrain snack cracker (whole grain in the end
product: 20% wholegrain oat flakes and 20% wholegrain rye malt flakes). The fat is primarily
soft in both products.
ID Food or Food component Health Relationship Proposed wording
1132 Soups Body weight management -soups fit in a weight maintenance
programme;
-soups help to control your body
Soups:
weight;
'Low in energy density and
-soups, which are low in energy
high in volume. Energy
density and high in volume, are
density of max 0.8 kcal/g
useful as part of a weight
and volume of min 200ml.
management diet;
Regular consumption (at
least 3 times a week) -the inclusion of soups into the
daily diet are effective in weight
management programmes.
Conditions of use
geringe Energiedichte und viel Volumen, Amount of consumption: üblicher Verzehr im Rahmen
einer ausgewogenen Ernährung. Low in energy density and high in volume
ID Food or Food component Health Relationship Proposed wording
1133 Soups Satiety/ satiation
Clarification provided -soups gives you a feeling of
Soups: satiety; -soups will help to fill you
up; -soups can delay the onset of
'Low in energy density and hunger; -soups consumed as a
high in volume. Energy starter that are low in energy
density of max 0.8 kcal/g density and high in volume have an
and volume of min 200ml. affect on satiety/ satiation.
Regular consumption (at
least 3 times a week)
Conditions of use
Low in energy density and high in volume
1171 Carbohydrates in pasta Low blood glucose response Kolhydrater i pasta ger ett lågt och
products långsamt blodsockersvar/har ett
Target group: Whole
lågt glykemiskt index (GI).
Clarification provided population
Carbohydrates in pasta products
Carbohydrates in pasta
provide a low and slow blood
products change to Pasta
sugar response/have a low
from different kinds of
glycaemic index (GI).
cereal grains, e.g. durum
wheat, wheat, barley, oat
and rye. Except autoclaved
products.
Conditions of use
- This claim can be used for all pasta products, except autoclaved products. For mixed products,
EFSA Journal 2011;9(4):2082 28

eg ready to eat meals, containing pasta – see no 21.

Comments from Member States
Cereal grains should be defined botanically
1179 Rye bread Carbohydrate metabolism and -Stimulates insulin secretion.
insulin sensitivity
-Low insulin response.
Conditions of use
- Rye bread and rye crisp bread
- Lean dough:
Max. of 7 g/100 g of fat. Max. 10g/100g of mono and disaccharides Sodium max. (salt 1.3%)
- Lean dough (moisture max 15%):
Max. of 7 g/100 g of fat. Max. 10g/100g of mono and disaccharides. Sodium max. (salt 1.7%)
- Rich dough:
Max. of 12g/100 g of fat. Maximum of 4g/100g of saturated fats. Max. 16g/100g of mono and
disaccharides
1186 Berries and fruit Antioxidativity Includes (natural) flavonoids and
juices/flavonoids + other antioxidants. Berry/fruit juice
ascorbic acid contains a number of constituents
with an antioxidative effect that
protect the body from damage
caused by free radicals. Symbol
included in the claim: MarliVital
Conditions of use
Berry and fruit juices with a flavonoid content of 4.5mg/100g, 9mg/dose, 30mg/daily dose and
ascorbic acid content of 30mg/100g, 60mg/dose and 60mg/daily dose. According to the
respondent, there are no factors that reduce absorption because the amount of flavonoids does
not decrease while the juice is being processed. Processing of berries into juice changes the
amounts, but this no longer occurs during juice processing.
1272 Caffeinated carbohydrate Cognitive performance and Enhances mental performance,
containing energy drinks mood reaction time, alertness, focus and
memory.
Energises. Gives you an energy
boost. Enhances mental energy.
Enhances alertness quickly.
Conditions of use
- minimum of 32 mg caffeine per/serving per portion minimum 25g carbohdyrates providing
glucose/serving
- At least 80 mg Caffeine per Serving; At least 1000 mg Taurine per Serving; At least 15%
of the RDA B-Vitamins (Niacin, Pantothenic Acid, Vitamin B6, Vitamin B12) per Serving;
EFSA Journal 2011;9(4):2082 29

1361 Name of Food product: Health benefits of food: Exact wording of claim as it
Alfalfa Shoots Naturally good for your heart appears on product: Alfalfa Shoots
are naturally good for your heart
Description of food in Do benefits relate to a disease
terms of food legislation risk factor: Yes Is claim a picture: No
categories: food not
Target group: All of the general Clarification provided
covered by specific food
population including children
legislation Exact wording of claim as it
and adults
appears on product: Alfalfa Shoots
Was food on Irish market
Clarification provided are naturally good for your heart Is
before 1st July 2007: Yes
claim a picture: No
Health benefits of food:
naturally contain saponins and
dietary fibres which may help
to maintain cholesterol levels
and keep digestive system
healthy
Do benefits relate to a disease
risk factor: Yes
Target group: All of the general
population including children
and adults
Conditions of use
Weight of average daily food serving: 20 gram(s) Daily amount to be consumed to produce
claimed effect: 20 gram(s), Number of food portions this equates to in everyday food portions: 1,
Length of time after consumption for claimed effect to become apparent: It is apparent after a
period of regular use. Number of days: 30, Where applicable outline nutritional composition (g per
100g) of food: Total Fat: .70, Saturated Fat: .00, Trans Fat: .00, Sugar: .30, Salt:
.00, Sodium: .01
Comments from MS
Clarification/ further information/alternative wording which was provided by the FBO has been
included. The FBO has significantly changed the health relationship of the original submission
The FBO includes a document (attached and identifed by claim number- additional information)
with additional information on the health relationship.
1470 Bioflavonoids Vein health Helps to maintain healthy venous
circulation
Vascular Health 'supports
blood circulation in vein
Conditions of use
- 500 to 1000 mg per day / 100-150 mg in case of flavonoids such as proanthocyanidins from
grape seeds or pine bark.
1471 Bioflavonoids from citrus Vascular health Helps to maintain healthy venous
circulation.
Vascular
health/Lipid/Cholesterol:
EFSA Journal 2011;9(4):2082 30

helps maintain healthy blood

lipid levels
Supports blood circulation in
vein.
Conditions of use
- Food supplement with 100 mg of citrus bioflavonoids in the daily dose.
- 700-1500 mg per day
1496 Carotenoids from fruits and Antioxidant properties. Carotenoids contained in this
vegetables juices. product ensure antioxidant
action/carotenoids contained in this
product ensure protective effect on
the organism.
Antioxidant/s
Conditions of use
- 4 mg.
- 30 % of observed intakes per day: 1.5 mg.
- To use during the period of increased sunlight 2 mg 2 times per day within the period of one
month. Suitable for diabetic patients.
1621 Natural Palm Oil Antioxidant Are antioxidants that protects the
Carotenes. properties/protection of DNA. body's cells.
Can protect you from free radicals
which cause cell damage.
Can protect your cells and tissues
from oxidative damage.
Can contribute to the total
antioxidant capacity of the body.
Conditions of use
- Up to 11.9 mg/day.
1622 Natural Palm Oil Health during pregnancy/ Can increase provitamin A levels
Carotenes. Bioavailability. during pregnancy and lactation.
Conditions of use
- Up to 7.0 mg/day.
No clarification provided by Member States
1636 Polyphenols from Antioxidant properties - Polyphenols contained in this
processed fruits and product ensure antioxidant
vegetables and juices action;
- Protects the cells;
EFSA Journal 2011;9(4):2082 31

- Antioxidant properties, with

natural fruit antioxidants;
- Polyphenols contained in this
product ensure protective
effect on the organism;
- Antioxidant/s.
Conditions of use
- 30 % of observed intakes per day: 0.3 g.
- min 80 mg of polyphenols expressed in EAG - equivalent to an intake of 200 ml per day.
- Effect observed at nutritional level (intake of 400 mg polyphenols/day). Population concerned:
all. Condition to claim : 15% of observed intake = 60 mg polyphenols per serving or per 100g.
1637 Polyphenols (general and Antioxidant properties - Polyphenols contained in this
from grape, olive and product ensure antioxidant
cacao in particular) action;
- help prevent tissue oxidation;
- helps guard against oxydation
caused by free radicals;
- have an antioxidant effect;
- help mop up free radicals in
cells/ antioxidants.
Conditions of use
- Erwachsene, 300 mg, entspr. mind. 250 ml Rotwein.
- Jugendliche, Erwachsene, 300 mg, entspr. mind. 200 ml Grantapfelsaft.
- aus Hopfen stammend; Zusatz zur täglichen Ernährung.
- 30 % des beobachteten Verzehrs pro Tag: 0.3 g.
- Mind. 30% des tägl. Verzehrs entsprechen 3000 to 5000 ORAC Einheiten pro Tag.
- Min. 30% of intakes per day / Intakes are 3000 to 5000 ORAC unit per day.
1640 Polyphenols from red wine Antioxidant properties Polyphenols from red wine:
- ensure antioxidant action;
- have an antioxidant effect;
- help prevent tissue oxidation;
- help mop up free radicals in cells;
- helps guard against oxidation
caused by free radicals
Conditions of use
- Min 300 mg per day. Claim cannot be used on beverages containing more than 1.2% by volume
of alcohol as per Article 4(3) of Regulation 1924/2006.
- Min 300 mg per day.
EFSA Journal 2011;9(4):2082 32


1641 Polyphenols derived from Lipid metabolism - contribute to good LDL
red wine cholesterol level
Conditions of use
- Min 300 mg per day
- Min 300 mg per day. Claim cannot be used on beverages containing more than 1.2% by
volume of alcohol as per Article 4(3) of Regulation 1924/2006.
1642 Polyphenols derived from Vascular functions. Total red wine polyphenols help
red wine. vascular functions that contribute
to a healthy cardiovascular system.
vascular function, helps to
relax blood vessel muscle cells
and thus contributes to a
healthy blood pressure.
Conditions of use
- Min 300 mg per day. Claim cannot be used on beverages containing more than 1.2% by
volume of alcohol as per Article 4(3) of Regulation 1924/2006
- Min 300 mg per day.
1643 Polyphenols from tea Antioxidant properties / Hearth - Polyphenols contained in this
health product ensure antioxidant
action;
- polyphenols contained in this
product ensure protective
effect on the organism;
- contains antioxidant/s;
- is a source of antioxidant/s;
- with antioxidant/s.
Conditions of use
- 240 mg/Tag, upper limit 540 mg.
- Green tea extract containing polyphenols in a quantity of 45 mg /day (15% of the lower
therapeutic dose 300 mg polyphenol), or green tea containing polyphenols in equivalent
quantity.
- 240-540 mg of polyphenols per day.
1646 Protein hydrolysate Insulin secretion and blood Help promote healthy blood sugar
sugar levels levels/can lower postprandial
blood sugar to normal levels/helps
to regulate sugar peaks after a
meal/helps improve blood glucose
control/helps reduce plasma
glucose levels/helps limit the post-
prandial glucose rise
EFSA Journal 2011;9(4):2082 33

Conditions of use
amount_consumption_value 15 Gramm g/Tag, upper_limit_value 25 Gramm (g)
Nutritional value per 100g:Protein:>90.0Lipid:<0.1Quantity for claim to be valid:Together with
a meal and in he form of tablets: 10mg/kg bodyweight perd ose equivalent to 1g Nutripeptin in
a person weighing80kg and taken 15 minutes before a meal.In the form of tablets taken
throughout the day: 2 tablets each 500mg Nutripeptin taken 3 times per day.When used as a
food ingredient: 1g per 100g of the foodstuff.An acute oral dose of fish hydrolysate has an
immediate effect that lasts for at least 2 hours.Safe upper limits: Nutripeptin is a natural protein
hydrolysate manufactured using food-grade enzymes and no chemicals. The product has no
toxicity and has been used in animal and hman studies at level up to 20% of the diet protein
equivalent to doses of 100mg/kg per dose without any negative effects. Nutripeptin at upper
limits of 100mg/dose (equal to 8g in persons of 80kg) is therfore considered safe.Target
population: Nutripeptin is a fish derived product and its presence should be properly labelled on
the packaging of the finished products that contain Nutripeptin.Effect of processing: the fish
hydrolysate in its final composition goes through high temperature treatment during the enzyme
inactivation stage of the manufacturing process. Further, the dehydration and spray drying
stages include heating and hot air (up to 250°C) treatment making the final product (powder)
close to sterile.
1693 Bioflavonoids Trofismo venoso. Azione Interviene positivamente sul
antiossidante trofismo microcircolatorio - per
favorire i processi di protezione dei
piccoli vasi venosi. concorre alla
Venous vessels protezione dall’azione nociva dei
health/antioxidant effect radicali liberi sull’organismo e da
quella dei raggi ultravioletti sulla
pelle.
Antioxidant effects to enhance the
microcirculation resistance and
protection of venous vessels fron
the attack of free radicals.
Conditions of use
- From 500 to 1000 mg
1796 Carotenoids (alpha, beta Skin. Helps to protect the skin from
and gamma carotene, the effects of UV radiation.
lycopene).
Reduces the skin’s
susceptibility to burning.
Increases the skin’s sun
tolerance.
Conditions of use
- Food supplement with 10 mg of carotenoids (alpha, beta and gamma carotene, lycopene) in
the daily dose.
- 10 mg lykopen per day.
EFSA Journal 2011;9(4):2082 34

1804 Flavonoids in cranberry Antioxidativity Flavonoids are natural, health-

juice promoting antioxidants.
Conditions of use
- Cranberry drink with flavonoid content of 5mg/100g. The flavonoids in the cranberry drink
come from the cranberry juice concentrate that is used in production of the drink. The drink
has a 20% concentration of cranberry juice, so the flavonoid concentration is 20% of the
flavonoid concentration in cranberry juice.
1920 Bioflavonoids. An antioxidant function to help “Bioflavonoids support a
support the immune system. healthy immune system”.
Helps to protect cells from free
radical damage and helps
maintain a healthy immune
system through action of high
levels of antioxidant
bioflavanols.
Conditions of use
- Minimum dose 6.1 mg
Flavonoids are ubiquitous in plants and their safety record is exceptional
2585 Alfafa Système circulatoire Favorise le bon cholestérol
Hypocholestérolémiant Aide à maîtriser le cholestérol
Contribue à un bon taux de
cholestérol
Conditions of use
- Feuille 6x125mg/jour
No clarification provided by Member States
2722 Alfalfa. (Medicago sativa Hair and nails health Helps to support the hair’s
L.) vitality.
Useful in case of fragile nails.
Improves the structure and
appearance of hair and nails.
Helps to support hair and nails
health.
Conditions of use
- Aerial parts - leaves succus. At least 1300 mg leaves succus powder /day
2793 Alfalfa Cardiovascular system May help to reduce LDL
cholesterol.
EFSA Journal 2011;9(4):2082 35

Cardiovascular system For cardiovascular health.

Clarification: Clarification provided
Helps to regulate blood May help to reduce LDL
cholesterol level. cholesterol. For cardiovascular
health.
Contributes to healthy blood
cholesterol level.
Helps to maintain normal
cholesterol level.
Helps to control cholesterol.
Conditions of use
- Food supplement with <500mg of alfalfa in the daily dose
3324 Citrus paradise (Common Antibacterial and antifungal Flavonoids contained within the
Name : Grapefruit) activities Grapefruit contribute to the
microbial balance in the body
organs and tissues
Gut health/ digestive system
Conditions of use
- Fruit / The equivalent of 250 ml of fresh grapefruit juice.
3325 Citrus paradisi (nazwa aktywność antybakteryjna i Flawonoidy występujące w
powszechnie antygrzybicza grejpfrucie przyczyniają się do
stosowana:grejpfrut) zapewnienia równowagi
mikrobiologicznej w narządach
aktywność antybakteryjna i i tkankach
Citrus paradisi (nazwa antygrzybicza/
powszechnie
Might contribute to a healthy
stosowana:grejpfrut)/ Flawonoidy występujące w
digestive system through
Citrus Paradisi (Common grejpfrucie przyczyniają się do
supporting the beneficial gut
Name: Grapefruit) zapewnienia równowagi
flora by depression the number
mikrobiologicznej w narządach
of unfavorable gut flora / by
i tkankach/ Flavonoids
depression the number of
contained within the Grapefruit
unfavorable flora taken with
contribute to the microbial
meals (in particular bacteria:
balance in the body organs and
Listeria monocytogenes,
tissues
Streptococcus faecalis and
yeasts: Saccharomyces
cerevisiae, Kluyveromyces
maxianus, Candida tropicalis) /
by interaction with the different
stages in the replication cycle
of viruses / by action on
intracellular replication of
viruses / by inhibiting the
infectious properties of the
viruses / by inhibiting the
enzymatic activity of certain
enzymes in yeast-like fungi
EFSA Journal 2011;9(4):2082 36

strains and to a lesser extent in

dermatophytes and molds / by
presence of quercetin and
hesperetin which actively
inhibit the infectivity and/or
replication of herpes simplex
type viruses, polio viruses,
parainfluenza type viruses, and
syncytial viruses / by acting
against a wide range of
bacterial biotypes.
digestive system by eliminating
some pathogens (mainly E.coli,
Salmonella spp, H. pylori,
Staphylococcus aureus and
Candida albicans).
digestive system by protecting
the gastric mucosa from
necrotizing substances.
digestive system through
increase in gastric
microcirculation.
Might promote gut flora
stabilisation by containing the
numbers of pathogens /
common microflora / by
inactivation of bacteria, viruses
and fungi.
Might balance your intestinal
microflora; Might beneficially
affect the intestinal flora; Might
support a balanced beneficial
gastro-intestinal microflora..
Conditions of use
- owoc/ równowartość 250 ml naturalnego soku z greipfruta
Comments form Member States :
This claim is the same as claim number 3324, for which the following comment has been made:
Health relationship relates to the activity of the Citrus paradisi extract in the gut system as
described by attached scientific data. By depressing the activity of non-beneficial bacteria,
viruses and fungi the extract promotes balanced (intestinal) microflora and thereby proper
functioning of the digestive system (gut health) - the gut microflora is beneficially affected by
depression of non-beneficial cells activity. This is due to the contribution to the beneficial
disinfectant properties of the gastric acid in the gastric lumen. The beneficial role of the gastric
acid for the gut health is unquestionable. Citrus paradisi extract principally acts in the same
place as and by a mode similar to gastric acid. Therefore the health relationship is in fact gut
health / digestive system and not antimicrobial. It relates to a balanced digestive system with
limited the field of action (“Flavonoids contained within the Grapefruit contribute to balanced
EFSA Journal 2011;9(4):2082 37

microflora in the digestive system”). Gut constitutes one of the body organs.
Such an effect can be measured / specified by the identity of depressed non-beneficial
microbiota and the intensity of such depression as clearly shown in the data attached to the
application (in particular individual studies which relate to specific end points and measurable
effect (MICs)). However measurable health effect is not required by the 1924/2006 regulation
with respect to art. 13 claims and therefore its imposition by EFSA and the EC Commission
could be legally challenged in European Courts
Antibacterial activity is and was present (including without comments from EFSA) in numerous
list entries (examples: “Tea helps reduce acid production by plaque bacteria”, “Hydrastis
canadensis helps against bacteria/contributes to the resistance against health precarious
microorganism”, “Xylitol reduces the formation of plaque / inhibits the formation of plaque and
tartar”, “Provides high immunoglobulin concentrations (Igg) to the gut that inactivate potentially
harmful bacteria”, “Helps to eliminate pathogenic bacteria from urinary tract”).
EFSA Journal 2011;9(4):2082 38

Substantiation of Health Claims

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Substantiation of Health Claims

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EFSA Journal 2011;9(4):2082

Scientific Opinion on the substantiation of health claims related to:

© European Food Safety Authority, 2011

EFSA Journal 2011;9(4):2082 2

EFSA Journal 2011;9(4):2082 3

EFSA Journal 2011;9(4):2082 4

BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION

TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION

EFSA Journal 2011;9(4):2082 5

INFORMATION AS PROVIDED IN THE CONSOLIDATED LIST

1. the food/constituent is defined and characterised;

Substantiation of the claim is dependent on a favourable outcome of the assessment of 1, 2 and 3

1. Characterisation of the food/constituent

EFSA Journal 2011;9(4):2082 6

1.2. Flavonoids from citrus (ID 1471)

The Panel assumes that bioflavonoids refer to flavonoids.

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

1.4. Flavonoids (ID 1470, 1693, 1920)

The Panel assumes that bioflavonoids refer to flavonoids.

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1.5. Flavonoids in cranberry juice (ID 1804)

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

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

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1.8. Rye bread (ID 1179)

1.9. Protein hydrolysate (ID 1646)

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Chemically, carbohydrates include a range of components, such as polyhydroxy aldehydes, ketones,

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

1.12. Caffeinated carbohydrate containing energy drinks (ID 1272)

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1.13. Soups (ID 1132, 1133)

Flavonoids from citrus related to “vascular health” (ID 1471).

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Carotenoids related to “antioxidant properties/protection of DNA”, “health during

DOCUMENTATION PROVIDED TO EFSA

The full list of supporting references as provided to EFSA is available on:

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BACKGROUND AND TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION

(i) based on generally accepted scientific evidence; and

ISSUES THAT NEED TO BE CONSIDERED

IMPORTANCE AND PERTINENCE OF THE FOOD8

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SUBSTANTIATION OF CLAIMS BY GENERALLY ACCEPTABLE SCIENTIFIC EVIDENCE

WORDING OF HEALTH CLAIMS

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 the claimed effect of the food in the identified function is beneficial.

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ID Food or Food constituent Health Relationship Proposed wording

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category (cf. ad hoc working

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carbohydrate portion of a test

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Clarification: steady blood sugar levels

Two different products: graphical presentations of blood