ID 687 -
Sprzężony kwas linolowy
PL: Sprzężony kwas linolowy
EN: CLA (Conjugated linoleic acid)
Pdf: conjugated linoleic acid
1. Charakterystyka żywności / składnika
The food that is the subject of the health claim is conjugated linoleic acid (CLA).
CLA refers to a group of positional and geometric isomers of linoleic acid that are characterised by the presence of conjugated dienes. CLA is a natural, but minor, component of fats from ruminant animals present in the human diet primarily in meat and dairy products. In nature, the most abundant isomer is cis-9, trans-11 (c9, t11), whereas in supplement forms CLA is typically sold as an equal mix of the two predominant isomers c9, t11 and t10, c12. Different isomers may have different effects.
The majority of the human intervention studies provided for the scientific substantiation of the health claims have used equimolar combinations of the c9, t11 and t10, c12 isomers, and therefore the Panel assumes that the food, which is the subject of the health claims, is an equimolar mixture of the CLA isomers c9, t11 and t10, c12
The Panel considers that the food constituent, an equimolar mixture of the conjugated linoleic acid (CLA) isomers c9, t11 and t10, c12, which is the subject of the health claims, is sufficiently characterised.
2.5. Udział w obronie immunologicznej poprzez stymulację produkcji przeciwciał odpornościowych w odpowiedzi na szczepienie (ID 687, 1519)
The claimed effect is “immune 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 assumes that the claimed effect refers to the modulation of immune defences against pathogens by
stimulation of production of protective antibodies in response to vaccination, as measured by increased numbers of individuals attaining protective levels of antibodies as well as by increments in antibody titres in groups of individuals.
The Panel considers that contribution to immune defences by stimulation of production of protective antibodies in response to vaccination is a beneficial physiological effect.
3.5. Udział w obronie immunologicznej poprzez stymulację produkcji przeciwciał odpornościowych w odpowiedzi na szczepienie (ID 687, 1519)
Nine references were cited for the substantiation of the claimed effect. These included a narrative review, a poster presentation, two human intervention studies which assessed the effects of CLA isomer mixtures other than the equimolar mixture of the CLA isomers c9, t11 and t10, c12 which is the subject of the health claims (Kelley et al., 2000; Tricon et al., 2004), one human study investigating the effects of CLA on outcome measures other than vaccination titres (Song et al., 2005), and three animal studies which addressed the effects of CLA on outcomes unrelated to the claimed effect (Bassaganya-Riera et al. 2001, 2003, 2004). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
One human intervention study was considered pertinent to the claim.
Albers et al. (2003) performed a double-blind, randomised, parallel, controlled study on 71 healthy males (aged 31-69 years) to compare the effects of a 50:50 mixture of the CLA isomers c9, t11 and t10, c12 as free fatty acids (CLA 50:50; 1.7 g per day) to those of an 80:20 mixture of the CLA isomers c9, t11 and t10, c12 as triacylglycerols (CLA 80:20; 1.6 g per day), as compared to a control oil (sunflower oil) on the immune (antibody and cellular) response to a hepatitis B vaccination. The dietary treatment lasted 12 weeks. Subjects received the hepatitis B antigen after 40, 54 and 68 days of treatment. Geometric means of antibody titres, mean integrated lymphocyte stimulation indices or
seroprotection rates (i.e. the number of subjects with antibody titres 10 UI/L) did not differ between groups.
In weighing the evidence, the Panel took into account that the only study from which conclusions could be drawn for the scientific substantiation of the claim did not report a significant effect of CLA on antibody titres or seroprotection rates after vaccination.
The Panel concludes that a cause and effect relationship has not been established between the consumption of an equimolar mixture of the CLA isomers c9, t11 and t10, c12 and contribution to immune defences by stimulation of production of protective antibodies in response to vaccination.
Warunki i możliwe ograniczenia stosowania oświadczenia
Up to 3,4 g CLA per day
