ID 1773 - Kwas gamma-linolenowy

PL: Kwas gamma-linolenowy
EN: Gamma linolenic acid (GLA)
Pdf:

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituents that are the subject of the health claims are "gamma-linolenic acid (GLA; C18: 3n-6) provided by evening primrose oil and/or borage (starflower) oil", "gamma-linolenic acid", "evening primrose oil (Oenothera biennis) contains gamma-linolenic acid", "borage oil (GLA= gamma linolenic acid)", "oenothera biennis-evening primrose-seeds oil", "long chain omega 6 polyunsaturated fatty acid GLA (gamma-linolenic acid)", "Borago officinalis", and "GLA (example from Borago officinalis, primrose oil, black currant seed oil)".
In the context of the proposed health relationships, wordings, conditions of use, and the clarifications provided by Member States, the Panel assumes that the food constituent that is the subject of the health claims is gamma-linolenic acid (GLA).
GLA is a n-6 long-chain polyunsaturated fatty acid which is present in small amounts in a variety of foods of both plant and animal origin and which can also be synthesised in the human body from its precursor linoleic acid (LA). GLA is a well recognised nutrient and can be measured in foods by established methods. This evaluation applies to GLA from all sources.
The Panel considers that the food constituent, gamma-linolenic acid (GLA), which is the subject of the health claims, is sufficiently characterised.

2.3. Zmniejszenie dolegliwości związanych z miesiączką (ID 495, 640, 1773, 1775)

The claimed effects are "menstrual health", "hormonal regulation", and "supportive measure during menstrual cycle (helps relieve painful breasts)". The Panel assumes that the target population is women with premenstrual syndrome.
In the context of the proposed wordings and clarifications provided by Member States, the Panel assumes that the claimed effects refer to the reduction of menstrual discomfort, which can be assessed as changes in the severity of symptoms related to the premenstrual syndrome using validated questionnaires.
The Panel considers that reduction of menstrual discomfort is a beneficial physiological effect.

3.2. Zmniejszenie dolegliwości związanych z miesiączką (ID 495, 640, 1773, 1775)

The references provided for the scientific substantiation of this claim included textbooks, monographs, editorials, notes to the editor and general reviews, which did not provide any original data which could be used for the scientific substantiation of the claim. One human study was unrelated to the food constituent which is the subject of the health claim. A systematic review as well as two animal and several human studies were unrelated to the claimed effect. These included references on the effect of GLA consumption on hormonal profiles of women with premenstrual syndrome, menopausal flushing, eicosanoid synthesis and rheumatoid arthritis. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Some intervention studies on cyclical and non-cyclical mastalgia have been provided. The Panel notes that only cyclical (but not non-cyclical) mastalgia has been proposed to overlap to some extent with the premenstrual syndrome. Two uncontrolled, open label intervention studies on the effects in women of evening primrose oil on cyclical (Cheung, 1999) and both cyclical and non-cyclical (Qureshi and Sultan, 2005) mastalgia, and one case-series report on the effects in women of evening primrose oil on cyclical and non-cyclical mastalgia (Gateley et al., 1992), were provided. The Panel considers that no conclusions can be drawn from these open-label, uncontrolled studies for the scientific substantiation of the claimed effect.
A systematic review of human intervention studies which investigated the effects of evening primrose oil consumption on the treatment of premenstrual syndrome was provided. All the individual studies which were provided separately in the consolidated list and which are pertinent to the claim were considered in this review (Budeiri et al., 1996).
A total of 12 studies were identified in the systematic review, two of which were not accessible to the Panel even after having made all reasonable efforts to retrieve them, five of which were available in summary form only and for which the details provided in the abstracts did not allow a full evaluation (e.g. exclusion criteria not reported, randomisation not specified, assessment of response unclear/insufficient) (Casper and Powell, 1987; Hunter and Wilson, 1987; Mansel et al., 1987; Massil et al., 1987; Ockerman et al., 1986), and two of which were open label, uncontrolled studies, which are inappropriate to assess the effects of an intervention on self-reported symptoms where a high placebo effect can be expected (Brush, 1982; Larsson et al., 1989). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
The remaining three studies were randomised, double-blind, placebo-controlled interventions which used capsules containing 9 % GLA (45 mg/capsule), 72 % linolenic acid (about 350 mg/capsule) and 12 % oleic acid (i.e. evening primrose oil) as intervention (Collins et al., 1993; Khoo et al., 1990; Puolakka et al., 1985). Paraffin capsules were used as placebo in two of the studies (Collins et al., 1993; Khoo et al., 1990) whereas in the third study the placebo was not reported (Puolakka et al., 1985). The Panel notes that GLA is quantitatively a minor component in the evening primrose oils used in these studies, and that the studies are not controlled for the effects of the other fatty acids in evening primrose oil. The Panel considers that no conclusions can be drawn on the effects of GLA per se on premenstrual syndrome symptoms from the studies provided.
The Panel concludes that a cause and effect relationship has not been established between the consumption of gamma-linolenic acid and a reduction of menstrual discomfort.

Warunki i możliwe ograniczenia stosowania oświadczenia

GLA 117- 440 mg / Evening primrose oil – 1,3 -2,6 g / Borage oil – 1-2g