Scientific Opinion on the substantiation of health claims related to iron and formation of red blood cells and haemoglobin (ID 374, 2889), oxygen transport (ID 255), contribution to normal energy-yielding metabolism (ID 255), reduction of tiredness and fatigue (ID 255, 374, 2889), biotransformation of xenobiotic substances (ID 258), and “activity of heart, liver and muscles” (ID 397) pursuant to Article 13(1) of Regulation (EC) No 1924/2006

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Article
Panel on Dietetic Products, Nutrition and Allergies
EFSA Journal
EFSA Journal 2010;8(10):1740 [17 pp.].
doi
10.2903/j.efsa.2010.1740
Panel members at the time of adoption
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.
Acknowledgements

The Panel wishes to thank the members of the Working Group on Claims for the preparatory work on this scientific opinion: 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.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2008-1042
EFSA-Q-2008-1045
EFSA-Q-2008-1161
EFSA-Q-2008-1184
EFSA-Q-2008-3622
Adopted
9 July 2010
Published
19 October 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
Download Article (245.71 KB)
Abstract

No abstract available

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 iron and formation of red blood cells and haemoglobin, oxygen transport, contribution to normal energy-yielding metabolism, reduction of tiredness and fatigue, biotransformation of xenobiotic substances and “activity of heart, liver and muscles”. 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 food constituent that is the subject of the health claims is iron. The Panel considers that iron is sufficiently characterised.

Formation of red blood cells and haemoglobin
The claimed effect is “fights against anaemia/ tiredness”. The target population is assumed to be the general population. The Panel assumes that the claimed effect is related to the formation of red blood cells and haemoglobin.

A claim on iron and normal formation of red blood cells and haemoglobin has already been assessed with a favourable outcome.

Oxygen transport
The claimed effect is “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status”. The target population is assumed to be the general population. In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect is related to oxygen transport.

A claim on iron and normal oxygen transport has already been assessed with a favourable outcome.

Contribution to normal energy-yielding metabolism
The claimed effect is “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status”. The target population is assumed to be the general population. In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect is related to energy-yielding metabolism.

A claim on iron and normal energy-yielding metabolism has already been assessed with a favourable outcome.

Reduction of tiredness and fatigue
The claimed effects are “vitamin/mineral supplementation to reduce fatigue and tiredness in situations of inadequate micronutrient status” and “fights against anaemia/ tiredness”. The target population is assumed to be the general population. The Panel considers that reduction of tiredness and fatigue is a beneficial physiological effect.

The Panel concludes that a cause and effect relationship has been established between the dietary intake of iron and reduction of tiredness and fatigue.

Biotransformation of xenobiotic substances
The claimed effect is “metabolism of foreign substances”. The target population is assumed to be the general population. The Panel notes that from the proposed wording it could not be established which xenobiotic substance or which biotransformation reaction related to the elimination of xenobiotic substances is the target for the claim.

The Panel considers that the claimed effect is general and non-specific and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

“Activity of heart, liver and muscles”
The claimed effect is “activity of heart, liver and muscles”. The target population is assumed to be the general population. “Activity of heart, liver and muscles” is not sufficiently defined and no clarifications have been provided by Member States.

The Panel considers that the claimed effect is general and non-specific and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

Conditions and possible restrictions of use
The Panel considers that in order to bear the claim a food should be at least a source of iron as per Annex to Regulation (EC) No 1924/2006. Such amounts can be easily consumed as part of a balanced diet. The target population is the general population.

Keywords
Iron, red blood cells, haemoglobin, oxygen transport, energy-yielding metabolism, xenobiotics, fatigue, heart, liver, muscles, health claims.
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Number of Pages
17