ID 3006 - Bifidobacterium longum BB536

PL: Bifidobacterium longum BB536
EN: Morinaga Bifidobacterium longum BB536
Pdf: Bifidobacterium longum BB536

Oświadczenie (2)

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claims is Bifidobacterium longum BB536.
No references were provided to support the identification and characterisation of this strain. However, reference to the identification and characterisation of Bifidobacterium longum BB536 by different genotypic methods was found in the literature (Mayer et al., 2007).
No indication of the deposit of the strain in an internationally recognised culture collection was found.
The Panel considers that Bifidobacterium longum BB536, which is the subject of the health claims, is sufficiently characterised.

2.2. Prawidłowa odporność na wywołujące alergię pyłki cedru (ID 3006)

The claimed effect is “healthy immune 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 supporting the body's natural resistance to allergens, which could be interpreted in the context of the references provided as normal resistance to cedar pollen allergens.
The Panel considers that normal resistance to cedar pollen allergens is a beneficial physiological effect.

3.2. Prawidłowa odporność na wywołujące alergię pyłki cedru (ID 3006)

The references provided for the scientific substantiation of the claim included a review article, an in vitro study and three animal studies which were not directly related to the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claimed effect.
Three human intervention studies which addressed outcome measures related to the claimed effect were provided (Xiao et al., 2006a; Xiao et al., 2006b; Xiao et al., 2007). These studies were focused on allergic pollinosis, mainly Japanese Cedar Pollinosis. Japanese Cedar Pollinosis (JCPsis) is an immunoglobulin E (IgE)-mediated type I allergy caused by exposure to Japanese cedar (Cryptomeria japonica (L. f.) D. Don) pollen (JCP) which is normally released from early February until the end of April. Subjects included in these studies had at least a two-year clinical history of JCPsis with presence of serum JCP-specific IgE.
In a randomised, double-blind, placebo-controlled pilot study of 40 subjects (17 men, 23 women), the
effect of a yoghurt supplemented with BB536 ( 2x107 CFU/g) given at a dose of 2x100 g per day for 14 weeks in the treatment of Japanese Cedar Pollinosis (JCPsis) was tested by Xiao et al. (2006a). Subjective symptoms and self-care measures were recorded daily, and blood samples were taken before and during the intervention to measure blood concentrations of parameters related to JCPsis. The primary outcome measures were the scores of subjective symptoms. Nasal blockage and nasal itching, eye symptoms and throat symptoms were evaluated using a 0 to 4 point rating scale in accordance with the guidelines of the Japanese Nasal Allergy Clinic. The Panel notes that the study design allowed subject drop-outs when they were prescribed medications for their allergy, instead of leaving these subjects in the study and adjusting for the prescribed medication in the statistical analysis. Because of a possible bias in handling missing data, the Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
In a randomised, double-blind, placebo-controlled trial performed by the same group (Xiao et al., 2006b) in 44 JCPsis subjects (26 men, 18 women), the effect of BB536 (~5x1010 CFU/2 g powder to be ingested with milk) was compared to placebo powder (dextrin) consumed twice daily for 13 weeks during the pollen season. Subjective symptoms were scored according to the guidelines of the Japanese Nasal Allergy Clinic, self-care measures were recorded daily, and blood samples were taken before and during the intervention to measure blood concentrations of parameters related to JCPsis. Two out of 22 subjects in the test group, and 9 out of 22 in the placebo group, prematurely dropped out of the study. The authors attributed the drop-out to severe reactions to pollen, but no further information on these subjects was available. The Panel notes that the study design allowed subject drop-outs, instead of leaving these subjects in the study and adjusting for the prescribed medication that they presumably received, and that the area-under-the-curve analysis performed for each clinical score is not an appropriate method given the missing data. Because of a possible bias in the statistical methods and analyses used for handling missing data, the Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
A double-blind, two-way cross-over study performed by the same group (Xiao et al., 2007) evaluated the effect of BB536 on symptoms in 24 JCPsis patients (10 men, 14 women) experimentally exposed to Japanese cedar pollen in an environmental exposure unit (EEU) outside the normal JCP season. After a one-week run-in period, subjects were randomised to receive either BB536 (~5x1010 CFU/2 g powder to be ingested with milk) or a placebo (dextrin) twice a day for 4 weeks. After a 2-week wash- out period, subjects were crossed over to the other intervention for a period of 4 weeks. At the end of each intervention period, subjects were exposed to JCP in a controlled manner (4 hours). Symptoms were self-rated 30 minutes before exposure, and every 30 minutes during the exposure. After exposure, subjects were instructed to record daily delayed subjective symptoms and medications used from the day of exposure for 5 days. Nasal blockage, eye itching, watery eyes, throat symptoms and disruption of normal activities were evaluated using self-reported questionnaires. The Panel notes the small sample size of the study and the lack of information on the scoring system used to conclude on the allergic nature of the symptoms. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claimed effect.
The Panel concludes that a cause and effect relationship has not been established between the consumption of Bifidobacterium longum BB536 and normal resistance to cedar pollen allergens.

Warunki i możliwe ograniczenia stosowania oświadczenia

The effective dose required to maintain healthy immune function is estimated to be between 4 X 107 and 1 X 1011 cells per day. To carry the proposed Article 13 claim, a product should contain at least 4 X 107 CFU per 100 g serving. Products containing this minimum effective dose of BB536 should be consumed for a minimum of 4 weeks for claimed effects to be apparent. As BB536 does not permanently colonize the gut, continued intake of products containing BB536 is desirable.