Scientific Opinion on the substantiation of health claims related to docosahexaenoic acid (DHA) and maintenance of normal (fasting) blood concentrations of triglycerides (ID 533, 691, 3150), protection of blood lipids from oxidative damage (ID 630), contribution to the maintenance or achievement of a normal body weight (ID 629), brain, eye and nerve development (ID 627, 689, 704, 742, 3148, 3151), maintenance of normal brain function (ID 565, 626, 631, 689, 690, 704, 742, 3148, 3151), maintenance of normal vision (ID 627, 632, 743, 3149) and maintenance of normal spermatozoa motility (ID 628) 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):1734 [27 pp.].
doi
10.2903/j.efsa.2010.1734
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 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 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 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 Mental/Nervous System: Jacques Rigo, Astrid Schloerscheidt, Barbara Stewart-Knox, Sean (J.J.) Strain, and Peter Willatts.

Contact
Type
Opinion of the Scientific Committee/Scientific Panel
On request from
European Commission
Question Number
EFSA-Q-2008-1320, EFSA-Q-2008-1416, EFSA-Q-2008-1417, EFSA-Q-2008-1478, EFSA-Q-2008-3882
EFSA-Q-2008-1352, EFSA-Q-2008-1413, EFSA-Q-2008-1414, EFSA-Q-2008-1415, EFSA-Q-2008-1418, EFSA-Q-2008-1419, EFSA-Q-2008-1476, EFSA-Q-2008-1477, EFSA-Q-2008-1491, EFSA-Q-2008-1529, EFSA-Q-2008-1530, EFSA-Q-2008-3880, EFSA-Q-2008-3881, EFSA-Q-2008-3883
Adopted
9 July 2010
Published
19 October 2010
Affiliation
European Food Safety Authority (EFSA), Parma, Italy
Note
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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 docosahexaenoic acid (DHA) and maintenance of normal (fasting) blood concentrations of triglycerides, protection of blood lipids from oxidative damage, contribution to the maintenance or achievement of a normal body weight, brain, eye and nerve development, maintenance of normal brain function, maintenance of normal vision and maintenance of normal spermatozoa motility. 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 claim is docosahexaenoic acid (DHA). The Panel considers that DHA is sufficiently characterised.

Maintenance of normal (fasting) blood concentrations of triglycerides
The claimed effect is “heart health”. The target population is assumed to be the general population. In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal blood concentrations of triglycerides. The Panel considers that maintenance of normal (fasting) blood concentrations of triglycerides may be a beneficial physiological effect.

Among the references provided, two systematic reviews specifically addressed the effects of DHA alone on blood concentrations of triglycerides. Both reviews reported on randomised clinical trials (RCTs) in humans showing statistically significant reductions in triglyceride concentrations after DHA supplementation at daily doses of 3-4 g, whereas no significant changes were observed at daily doses <2 g per day.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of DHA and the maintenance of normal (fasting) blood concentrations of triglycerides.

In order to obtain the claimed effect, 2 g per day of DHA should be consumed in one or more servings. The target population is adult men and women.

Protection of blood lipids from oxidative damage
The claimed effect is “supportive measure to reduce the level of oxidised cholesterol”. The target population is assumed to be the general population. In the context of the proposed wordings, the Panel assumes that the claimed effect refers to the protection of blood lipids (LDL-cholesterol particles) from oxidative damage. The Panel considers that protection of blood lipids from oxidative damage may be a beneficial physiological effect.

None of the studies provided directly addressed the effects of DHA supplementation on LDL oxidation.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of DHA and the protection of blood lipids from oxidative damage.

Contribution to the maintenance or achievement of a normal body weight
The claimed effect is “weight management”. The target population is assumed to be the general population. The Panel considers that contribution to the maintenance or achievement of a normal body weight is a beneficial physiological effect.

No references were provided from which scientific conclusions for the scientific substantiation of the claimed effect could be drawn.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of DHA and the contribution to the maintenance or achievement of a normal body weight.

Brain, eye and nerve development
The claimed effects are “brain, eye and nerve development”, “optimisation of brain maturation”, “human neurodevelopment”, “brain health and function”, “brain development and function”, and “maternal health”.

Brain, eye and nerve development is interpreted by the Panel as children’s development. The Panel notes that claims related to children’s development and health are outside the scope of Article 13 of Regulation (EC) No 1924/2006.

Maintenance of normal brain function
The claimed effects are “mental state and performance”, “DHA plays an important role in cognitive functions at any stage of life”, “brain health and function”, “optimisation of brain maturation”, “brain development and function”, “human neurodevelopment”, “maternal health” and “cognitive function in the elderly”. The target population is assumed to be the general population. In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal brain function. The Panel considers that maintenance of normal brain function is a beneficial physiological effect.

The Panel notes that there is a well established role of DHA in brain function.

The Panel concludes that a cause and effect relationship has been established between the consumption of DHA and the maintenance of normal brain function.

The Panel considers that in order to bear the claim, foods should contain 250 mg of DHA in one or more servings. Such amounts can be consumed as part of a balanced diet. The target population is the general population.

Maintenance of normal vision
The claimed effects are “brain, eye and nerve development”, “visual health and function”, and “eye health”. The target population is assumed to be the general population. In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal vision. The Panel considers that maintenance of normal vision is a beneficial physiological effect.

The Panel notes that there is a well established role of DHA in retinal function.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has been established between the consumption of DHA and the maintenance of normal vision.

The Panel considers that in order to bear the claim, foods should contain 250 mg of DHA in one or more servings. Such amounts can be consumed as part of a balanced diet. The target population is the general population.

Maintenance of normal spermatozoa motility
The claimed effect is “supportive measure for male fertility through providing the motility agent for spermatozoa tails”. The target population is assumed to be the general male population. The Panel considers that maintenance of normal spermatozoa motility is a beneficial physiological effect.

No references were provided from which conclusions could be drawn for the scientific substantiation of the claimed effect.

On the basis of the data presented, the Panel concludes that a cause and effect relationship has not been established between the consumption of DHA and the maintenance of normal spermatozoa motility.

Keywords
Docosahexaenoic acid, DHA, blood lipids, oxidative damage, weight management, brain function, vision, spermatozoa motility, health claims.
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Number of Pages
27