2.1. Rozwój mózgu, oczu i nerwów (ID 501, 513, 540)

The claimed effects are “brain development, cognitive development and cognitive function”, “brain, eye and nerve development and function”, and “support of human neurodevelopment”.
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.

2.5. Zdrowie kobiety podczas ciąży i karmienia piersią (ID 514)

The claimed effect is “maternal health; pregnancy and nursing”. The Panel assumes that the target population is pregnant and lactating women.
The claimed effect is not sufficiently defined, and no further details were given in the proposed wording or the clarifications 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.

2.6. Pokrycie zwiększonego zapotrzebowania na kwasy Omega-3 podczas ciąży (ID 539)

The claimed effect is “to fulfil increased omega-3 fatty acids need during pregnancy”. The Panel assumes that the target population is pregnant and lactating women.
The Panel assumes that the claimed effect refers to the supply of omega-3 fatty acids to the body during pregnancy and lactation.
The Panel considers that the claimed effect refers to the supply of a food constituent to the human body, rather than to a relationship between a food/food constituent and health as required by Regulation (EC) No 1924/2006.

2.7. Utrzymanie prawidłowego stanu komórek nabłonka przewodu pokarmowego i skóry (ID 525)

The claimed effect is “skin and digestive tract epithelial cells maintenance”. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined. The proposed wordings do not provide further clarification (“a healthy digestive system, gentle on the stomach”) or do not refer to a physiological function (“appearance of skin, healthy looking skin, a part of your daily skin care routine, helps maintain a good complexion”) as required by Regulation (EC) No 1924/2006. The clarifications provided by Member States include several physiological functions, and the references provided do not allow the identification of the specific function which 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.

2.8. Poprawa nastroju (ID 536)

The claimed effect is “mood”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided, the Panel assumes that the claimed effect refers to enhancement of mood. Mood 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.

2.9. Utrzymanie struktury błon komórkowych (ID 4295)

The claimed effect is “membranes cell structure”. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined. The proposed wordings did not provide further clarification (“contributes to thin the blood”), and from the references provided it was not possible to establish the effect which was the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific effect on health as required by Regulation (EC) No 1924/2006.

2.10. Aktywność przeciwzapalna (ID 4688)

The claimed effect is “anti-inflammatory action due to EPA and DHA”. The Panel assumes that the target population is the general population.
From the proposed wordings, the Panel assumes that the claimed effect refers to anti-inflammatory action in the context of “inflammatory, rheumatic disease”, in which a reduction of inflammation would be a therapeutic target for the treatment of the disease.
The Panel considers that the reduction of inflammation in the context of inflammatory diseases is a therapeutic target for the treatment of a disease, and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.

3.1. Poprawa nastroju (ID 536)

Among the references provided were narrative reviews which mostly reported on the use of omega-3 fatty acids either alone or in conjunction with pharmacological intervention in depression. These studies did not describe the food constituent under investigation or did not address a relevant endpoint. In addition, a number of references reported on studies which were carried out in pregnant women or in patient groups with post-partum depression, major depressive disorder which required inpatient treatment, violence disorders, bipolar disorder and schizophrenia. The Panel considers that the evidence provided does not establish that results obtained in studies in subjects with post-partum depression, major depressive disorder, violence disorders, bipolar disorder and schizophrenia can be extrapolated to the general population with respect to mood. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
One systematic review carried out by Schachter et al. (2005) for the Agency for Healthcare Research and Quality (AHRQ) addressed, inter alia, the question of the protective value of n-3 fatty acids with respect to mental health. Three intervention studies, six observational studies and three cross-national ecological studies met the authors' inclusion criteria, and were included in the review. One of the randomised controlled trials assessed the risk of post-partum depression using a supplement containing DHA only, rather than DHA and EPA which is the subject of the claim. The other two intervention studies were based on a dietary change to increase fish consumption, but DHA and EPA intakes were not measured. There were four observational studies on the relationship between fish consumption and depressed mood or prevalence of depression, and three cross-national studies investigating the association of seafood consumption with the prevalence of post-partum depression or depression. The Panel notes that the only epidemiological study in the systematic review, which calculated DHA and EPA intakes on the basis of self-reported fish consumption, showed no association between intake of these fatty acids and prevalence of depression.
Two of the human studies provided were intervention studies (Fontani et al., 2005a; 2005b). One of these studies (Fontani et al., 2005a) investigated the effects of diet and fish oil (containing EPA and DHA) supplementation on an index of mood state in addition to blood lipids, insulin and various biomarkers of inflammatory processes. This study was performed in 33 subjects who were divided into two groups following an open-label, parallel group design. Both groups followed a controlled diet which differed in amount of carbohydrates and proteins (55/15 E% (N diet group, n=17) vs. 40/30 E% (Z diet group, n=16) respectively, 30 E% fat in both). In each diet group a double-blind cross-over design was applied: one sub-group received placebo (olive oil) for 35 days and then fish oil supplementation for another 35 days, while the other sub-group started with fish oil supplementation followed by placebo. Mood state was measured using the Profile of Mood States (POMS) which consists of five negative scales (anger, anxiety, fatigue, confusion, depression) and one positive scale
(vigour). The Panel notes that the statistical analysis employed was not appropriate for the treatment of a cross-over design, and that no corrections for multiple comparisons were made. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The other study by Fontani et al. (2005b) used a parallel design in which 33 subjects received EPA and DHA as fish oil for 35 days, and a second group of 16 subjects received a placebo consisting of olive oil capsules for the same period. Mood state was measured on the first and last day of the intervention using the POMS. The Panel notes that the statistical analysis only evaluated within group data, and did not perform comparisons between groups. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
Of the three observational human studies provided, two (Edwards et al., 1998; Tanskanen et al., 2001) were included in the systematic review by Schachter et al. (2005). The observational study by Mamalakis et al. (2002) investigated the association between adipose tissue fatty acid content and depression in 139 participants with a mean age of 39 years. Subjects underwent physical examination and adipose tissue extraction (by aspiration of subcutaneous tissue samples), and completed the Zung Self-rated Depression Scale (translated). The Panel notes that dietary intakes of EPA and DHA were not estimated, that adipose tissue EPA and DHA concentrations are usually only moderately associated with the consumption of EPA and DHA, and that an observational cross-sectional study does not provide evidence on a causal relationship between the intake of DHA and EPA and mood. The Panel considers that no conclusions can be drawn from this reference for the scientific substantiation of the claimed effect.
The Panel notes that no intervention studies were provided from which conclusions could be drawn for the scientific substantiation of the claimed effect, and that the one observational study which evaluated dietary intakes of EPA and DHA showed no association between the consumption of DHA and EPA and prevalence of depression.
The Panel concludes that a cause and effect relationship has not been established between the consumption of DHA and EPA and enhancement of mood.