ID 506 - Kwas dokozaheksaenowy, Kwas eikozapentaenowy

PL: Kwas dokozaheksaenowy, Kwas eikozapentaenowy
EN: DHA+EPA - long chain omega 3 fatty acids
Pdf: eicosapentaenoic acid

Oświadczenie (4)

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent which is the subject of the health claims is mixed long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA), namely docosahexaenoic acid (DHA) in combination with eicosapentaenoic acid (EPA) and, for ID 703, with docosapentaenoic acid (DPA).
The n-3 LCPUFA EPA, DHA and DPA are recognised nutrients and are measurable in foods by established methods. They are well absorbed when consumed in the form of triglycerides. This evaluation applies to EPA, DHA and, for ID 703, DPA from all sources with suitable bioavailability in the specified amounts.
The Panel considers that the food constituent, EPA, DHA and DPA, which is the subject of the health claims, is sufficiently characterised.

2.1. Utrzymanie prawidłowego funkcjonowania serca (ID 504, 506, 516, 527, 538, 703, 1128, 1317, 1324, 1325)

The claimed effects are “cardiovascular system: maintenance and promotion of heart health and healthy circulation”, “normal cardiovascular function”, “eye, brain and heart health”, “cardiovascular health” and “heart health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel notes that the claimed effects relate to the maintenance of normal cardiac function.
The Panel considers that maintenance of normal cardiac function is a beneficial physiological effect.

2.3. Utrzymanie prawidłowego ciśnienia tętniczego (ID 506, 516, 703, 1317, 1324)

The claimed effects are “cardiovascular health”, “heart health”, “normal cardiovascular function” and “heart health”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings or clarifications provided by Member States, the Panel assumes that the claimed effect relates to the maintenance of normal blood pressure.
A claim on EPA and DHA and the maintenance of normal blood pressure has already been assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009).

2.4. Utrzymanie prawidłowego stężenia cholesterolu HDL we krwi (ID 506)

The claimed effect is “normal cardiovascular function”. The Panel assumes that the target population is the general population.
In the context of the clarifications provided by Member States, the Panel assumes that the claimed effect refers to the maintenance of normal blood HDL-cholesterol concentrations.
A claim on EPA and DHA and the maintenance of normal blood HDL-cholesterol concentrations has already been assessed with an unfavourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009) and the references cited for this claim did not provide any additional scientific data that could be used to substantiate the claim.

2.5. Utrzymanie prawidłowego stężenia trójglicerydów we krwi na czczo (ID 506, 527, 538, 1317, 1324, 1325)

The claimed effects are “normal cardiovascular function”, “cardiovascular health”, “heart health”, “for cardiovascular system metabolism (cholesterol, triglycerides)” and “decrease triglycerides”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effect relates to the maintenance of normal (fasting) blood concentrations of triglycerides.
Triglycerides in plasma are either derived from dietary fats or synthesised in the body from other energy sources like carbohydrates. In fasting conditions, serum triglycerides are mainly transported in very-low-density lipoproteins (VLDL) synthesised in the liver. Excess calorie intake with a meal is converted to triglycerides and transported to the adipose tissue for storage. Hormones regulate the release of triglycerides from adipose tissue in order to meet energy needs between meals.
The Panel considers that maintenance of normal (fasting) blood concentrations of triglycerides may be a beneficial physiological effect.

3.1. Utrzymanie prawidłowego funkcjonowania serca (ID 504, 506, 516, 527, 538, 703, 1128, 1317, 1324, 1325)

National and international bodies have based their recommendations for dietary intake of EPA and DHA on the inverse relationship observed between the consumption of these long-chain n-3 PUFAs (primarily from fish and fish oils) and a lower risk of coronary artery disease. Such recommendations range from 200 mg to 500 mg per day (EFSA, 2005, 2009; EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2010). Most recent evidence derived from meta-analyses of randomised trials and large prospective studies shows that, when only healthy subjects are considered, the intake of EPA plus DHA is negatively related to coronary heart disease mortality in a dose- dependent way up to about 250 mg per day (1–2 servings of oily fish per week), with little additional
benefit observed at higher intakes (Mozaffarian and Rimm, 2006; Mozaffarian, 2008; Harris et al., 2008, 2009a, b; EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2010).
EPA and DHA intakes could reduce the risk of coronary heart disease mortality by different (but often overlapping) mechanisms (e.g. through antiarrhythmic and antithrombotic effects, by reducing blood pressure, heart rate and plasma concentrations of triglycerides), and the doses of EPA and DHA (100->2,500 mg/d) as well as the time required to observe clinical effects and/or alter clinical events (weeks to years) through each mechanism may vary widely (Mozaffarian and Rimm, 2006).
The Panel concludes that a cause and effect relationship has been established between the consumption of EPA and DHA and maintenance of normal cardiac function.

3.3. Utrzymanie prawidłowego stężenia trójglicerydów we krwi na czczo (ID 506, 527, 538, 1317, 1324, 1325)

A claim on EPA and DHA and the maintenance of normal (fasting) blood concentrations of triglycerides has been already assessed with a favourable outcome (EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA), 2009). The Panel considered that intakes of EPA and DHA of about 2-4 g per day were required to obtain the claimed effect.
The Panel is aware of a recently published meta-analysis which aimed to investigate dose-response relationships between the intake of EPA and DHA and changes in blood concentrations of triglycerides to estimate the effects of doses between 200-500 mg per day (Musa-Veloso et al., 2010). A total of 15 studies published between 2002 and 2007 were considered. The reason given to exclude publications prior to 2002 was “to avoid duplication of previously reported findings”. Of these, only 12 studies conducted statistical comparisons between intervention and placebo groups. Average intakes of EPA and DHA were 2.3 g per day (range 209 mg to 5.6 g per day). The Panel notes that four studies were conducted with DHA only (Maki et al., 2003, 2005; Stark and Holub, 2004; Wu et al., 2006). The Panel also notes that only two studies were included using doses of DHA or EPA plus DHA in the range for which an effect on blood triglycerides was aimed for, that neither of these found a significant decrease in blood triglycerides in the intervention group compared to controls (Maki et al., 2003; Castro et al., 2007), and that one of them is considered as “flawed” by the authors of the meta-analysis (Castro et al., 2007). The Panel notes that exclusion of pertinent studies published before 2002 is scientifically unjustified. The Panel considers that no scientific conclusions can be drawn from this meta-analysis to establish conditions of use for the claim.
In addition to Maki et al. (2003) and Castro et al. (2007), only one study included in the meta-analysis used doses of EPA plus DHA <1 g per day (0.860 mg per day). In this study, additional intakes in the intervention and placebo groups of about 1,200 mg per day from dietary sources were estimated but were not taken into account in the analysis (Hamazaki et al., 2003). A further two studies using EPA
and DHA at doses of 1 and 1.6 g per day were included in the meta-analysis (Goyens and Mensink, 2006; Murphy et al., 2007), none of these reported statistically significant differences between the intervention and control groups with respect to changes in blood concentrations of triglycerides.
With reference to its previous opinion, the Panel considers that intakes of EPA and DHA of 2 g per day are required to obtain the claimed effect.

4.1. Utrzymanie prawidłowego funkcjonowania serca (ID 504, 506, 516, 527, 538, 703, 1128, 1317, 1324, 1325)

The Panel considers that the following wording reflects the scientific evidence: “EPA and DHA contribute to the normal function of the heart”.

5.1. Utrzymanie prawidłowego funkcjonowania serca (ID 504, 506, 516, 527, 538, 703, 1128, 1317, 1324, 1325)

The Panel considers that intakes of EPA and DHA of about 250 mg per day are required to obtain the claimed effect. Such an amount can be consumed as part of a balanced diet. The target population is the general population.

5.2. Utrzymanie prawidłowego stężenia trójglicerydów we krwi na czczo (ID 506, 527, 538, 1317, 1324, 1325)

The Panel considers that intakes of EPA and DHA of 2 g per day are required to obtain the claimed effect. Such an amount can be consumed as part of a balanced diet. The target population is adult men and women.

Warunki i możliwe ograniczenia stosowania oświadczenia

75-150 mg 125 - 500 mg