Scientific Opinion on the substantiation of health claims related to
eicosapentaenoic acid (EPA) and enhancement of mood (ID 633), calming
(ID 634), increased attention (ID 634), increase in appetite after
unintentional weight loss leading to an increase in energy intake (ID 635),
and protection of blood lipids from oxidative damage (ID 636) pursuant to
Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
Słowa kluczowe:
EPA
Eicosapentaenoic acid
attention
calming
health claims
learning
lipids
oxidative damage
weight loss
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claims is eicosapentaenoic acid (EPA).
EPA is a 20-carbon fatty acid with 5 double bonds of the omega 3 series (omega-3 long-chain polyunsaturated fatty acid). It is a well recognised nutrient naturally present in foods from animal sources, especially oily fish, or used, generally in the form of triglycerides, for addition to foods or food supplements. EPA is measurable in foods by established methods.
The Panel considers that the food constituent, eicosapentaenoic acid (EPA), which is the subject of the health claims is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
2.1. Poprawa nastroju (ID 633)
The claimed effect is “mood, emotional balance”. The Panel assumes that the target population is the general population.
In the context of the proposed wording and clarification provided by Member States, the Panel assumes that the claimed effect refers to mood, which is a well defined psychological construct and can be measured by validated tests.
The Panel considers that enhancement of mood might be a beneficial physiological effect.
2.2. Uspokojenie (ID 634)
The claimed effect is “supportive measure for a calm behaviour and for learning abilities”. The Panel assumes that the target population is the general population.
The Panel considers that calming might be a beneficial physiological effect.
2.3. Zwiększenie czujności (ID 634)
The claimed effect is “supportive measure for a calm behaviour and for learning abilities”. The Panel assumes that the target population is the general population.
In the context of the proposed wording, the Panel assumes that learning abilities relate to concentration, that can be interpreted as attention, which is a well defined psychological construct and can be measured by validated tests.
The Panel considers that increased attention is a beneficial physiological effect.
2.4. Wzrost apetytu po niezamierzonej utracie masy ciała prowadzący do zwiększenia ilości przyjmowanej energii (ID 635)
The claimed effect is “undesirable weight loss”. The Panel assumes that the target population is underweight individuals willing to increase their energy intake.
In the context of the proposed wording, the Panel assumes that the claimed effect refers to the increase in appetite after an episode of unintentional weight loss.
The Panel considers that an increase in appetite after unintentional weight loss leading to an increase in energy intake, if sustained, might be a beneficial physiological effect.
2.5. Ochrona lipidów we krwi przed uszkodzeniem oksydacyjnym (ID 636)
The claimed effect is “supportive measure to reduce the level of oxidised cholesterol („in vivo‟ research)”. The Panel assumes that the target population is 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.
Reactive oxygen species (ROS) including several kinds of radicals are generated in biochemical processes (e.g. respiratory chain) and as a consequence of exposure to exogenous noxes (e.g. radiation, pollutants). These reactive intermediates damage biologically relevant molecules such as DNA, proteins and lipids if they are not intercepted by the antioxidant network which includes free radical scavengers such as antioxidant nutrients.
The Panel considers that the protection of blood lipids from oxidative damage may be a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka
3.1. Poprawa nastroju (ID 633)
Fifteen references were provided to substantiate the claimed effect, including two systematic reviews, five narrative reviews and eight human studies.
The Panel notes that six references provided to substantiate the claimed effect of EPA reported results with mixtures of fatty acids, especially DHA and EPA, and not with EPA alone. The Panel considers that no conclusions can be drawn from studies on a fixed combination for the substantiation of the claim on EPA alone.
The Panel notes that nine references provided to substantiate the claimed effect addressed therapeutic use of EPA in the treatment of patients suffering from psychiatric or neurological disorders (depression, schizophrenia, Huntington‟s disease, borderline personality disorder). The Panel considers that the evidence provided does not establish that patients suffering from psychiatric or neurological disorders are representative of the general population with regard to mood, and that it is not possible to use the results of these studies to draw conclusions on the effects of EPA consumption in the general population.
The Panel concludes that a cause and effect relationship has not been established between the consumption of EPA and enhancement of mood.
3.2. Uspokojenie (ID 634)
Nineteen references have been provided to substantiate the claim. Five were reviews, 13 were human studies and one was an animal study.
The Panel notes that all the studies provided to substantiate the claimed effects of EPA reported results with mixtures of fatty acids, especially DHA and EPA, and none of them with EPA alone. The Panel considers that no conclusions can be drawn from studies on a fixed combination for the substantiation of the claim on EPA alone.
The Panel concludes that a cause and effect relationship has not been established between the consumption of EPA and calming.
3.3. Zwiększenie czujności (ID 634)
Nineteen references have been provided to substantiate the claim. Five were reviews, 13 were human studies and one was an animal study.
The Panel notes that all the studies provided to substantiate the claimed effects of EPA reported results with mixtures of fatty acids, especially DHA and EPA, and none of them with EPA alone. The Panel considers that no conclusions can be drawn from studies on a fixed combination for the substantiation of the claim on EPA alone.
The Panel concludes that a cause and effect relationship has not been established between the consumption of EPA and increased attention.
3.4. Wzrost apetytu po niezamierzonej utracie masy ciała prowadzący do zwiększenia ilości przyjmowanej energii (ID 635)
Ten references including three narrative reviews on the therapeutic management of wasting syndromes, four human studies and three animal studies have been provided to substantiate the claim.
Some of the human studies were conducted in patients with cancer-induced cachexia. The Panel considers that the evidence provided does not establish that severely ill patients with cancer-induced cachexia are representative of the target population with respect to the claimed effect. Also, two open label case reports on the effects of EPA on body weight in patients with severe anorexia nervosa were provided. The Panel considers that no conclusions can be drawn from these uncontrolled studies for the scientific substantiation of the claimed effect.
The Panel also considers that the evidence provided in the animal studies is not sufficient to predict the occurrence of an effect of EPA intake in humans.
The Panel concludes that a cause and effect relationship has not been established between the consumption of EPA and a sustained increase in appetite after unintentional weight loss leading to an increase in energy intake.
3.5. Ochrona lipidów we krwi przed uszkodzeniem oksydacyjnym (ID 636)
Twelve references have been provided to substantiate the claim. Only one reported on a study using EPA alone but did not address effects on lipid peroxidation. All other references, including one narrative review and two animal studies, dealt with fish oils or various combinations of EPA and DHA and/or addressed other outcomes than lipoprotein oxidation. The Panel considers that no conclusions can be drawn from these studies for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of EPA and the protection of blood lipids from oxidative damage.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, eicosapentaenoic acid (EPA), which is the subject of the health claims is sufficiently characterised.
Enhancement of mood (ID 633)
The claimed effect is “mood, emotional balance”. The target population is assumed to be the general population. Enhancement of mood might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of EPA and enhancement of mood.
Calming (ID 634)
The claimed effect is “supportive measure for a calm behaviour and for learning abilities”. The target population is assumed to be the general population. Calming might be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of EPA and calming.
Increased attention (ID 634)
The claimed effect is “supportive measure for a calm behaviour and for learning abilities”. The target population is assumed to be the general population. Increased attention is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of EPA and increased attention.
Increase in appetite after unintentional weight loss leading to an increase in energy intake
(ID 635)
The claimed effect is “undesirable weight loss”. The target population is assumed to be underweight individuals willing to increase their energy intake. An increase in appetite after unintentional weight loss leading to an increase in energy intake, if sustained, might be a beneficial physiological effect.
A cause and effect relationship has not been established between a consumption of EPA and a sustained increase in appetite after unintentional weight loss leading to an increase in energy intake.
Protection of blood lipids from oxidative damage (ID 636)
The claimed effect is “supportive measure to reduce the level of oxidised cholesterol („in vivo‟ research)”. The target population is assumed to be the general population. The protection of blood lipids from oxidative damage may be a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of EPA and the protection of blood lipids from oxidative damage.
