Scientific Opinion on the substantiation of health claims related to a
combination of Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum
M 20/5 and Bifidobacterium longum SP 07/3 and maintenance of upper
respiratory tract defence against pathogens (ID 931, further assessment)
pursuant to Article 13(1) of Regulation (EC) No 1924/2006[sup]1[/sup]
EFSA Panel on Dietetic Products, Nutrition and Allergies (NDA)2, 3
European Food Safety Authority (EFSA), Parma, Italy
ABSTRACT
Following a request from the European Commission, the Panel on Dietetic Products, Nutrition and Allergies was
asked to provide a scientific opinion on a health claim pursuant to Article 13.1 of Regulation (EC) No 1924/2006
in the framework of further assessment related to a combination of Lactobacillus gasseri PA 16/8,
Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3 and maintenance of upper respiratory tract
defence against pathogens. The food constituent that is the subject of the claim, a combination of Lactobacillus
gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3, is sufficiently
characterised. The claimed effect, maintenance of upper respiratory tract defence against pathogens, is a
beneficial physiological effect. The proposed target population is the general adult population. The Panel notes
that the only human intervention study provided did not show an effect of consumption of a combination of
Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3 on
defence against pathogens in the upper respiratory tract. On the basis of the data presented, the Panel concludes
that a cause and effect relationship has not been established between the consumption of a combination of
Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3 and
maintenance of upper respiratory tract defence against pathogens.
© European Food Safety Authority, 2012
Słowa kluczowe:
Bifidobacterium bifidum
Bifidobacterium longum
Lactobacillus gasseri
M 20/5
PA 16/8
SP 07/3
health claims
pathogens
upper respiratory tract
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claim is a combination of Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3.
Lactobacillus gasseri PA 16/8 (hereafter L. gasseri PA 16/8) is also named L. gasseri KS-13 (previously known as Lactobacillus acidophilus KS-13). A culture collection number from the National Institute of Technology and Evaluation (NITE) Patent Microorganisms Depositary (NITE BP-819) was provided. The NITE Patent Microorganisms Depositary is an International Depositary Authority under the Budapest Treaty. Data on the identification and characterisation of the strain L. gasseri PA 16/8 at species and strain level using both phenotypic (cell morphology, colony morphology, carbohydrate fermentation profiles and antibiotic resistance patterns) and genotypic (16S rRNA gene sequence analysis, ARDRA, AFLP and PFGE) methods were provided in the application for further assessment. The Panel considers that L. gasseri PA 16/8 is sufficiently characterised.
Bifidobacterium bifidum MF 20/5 (hereafter B. bifidum MF 20/5) is also known as B. bifidum G9-1. A culture collection number from the NITE Patent Microorganisms Depositary (NITE BP-817) was provided. Data on the identification and characterisation of the strain B. bifidum MF 20/5 at species and strain level using both phenotypic (cell morphology, colony morphology, carbohydrate fermentation profiles and antibiotic resistance patterns) and genotypic (16S rRNA gene sequence analysis, ARDRA, AFLP and PFGE) methods were provided in the application for further assessment. The Panel considers that the strain B. bifidum MF 20/5 is sufficiently characterised.
Bifidobacterium longum SP 07/3 (hereafter B. longum SP 07/3) is also known as B. longum MM-2. A culture collection number from the NITE Patent Microorganisms Depositary (NITE BP-818) was provided. Data on the identification and characterisation of B. longum SP 07/3 at species and strain level using both phenotypic (cell morphology, colony morphology, carbohydrate fermentation profiles and antibiotic resistance patterns) and genotypic (16S rRNA gene sequence analysis, ARDRA, AFLP and PFGE) methods were provided in the application for further assessment. The Panel considers that the strain B. longum SP 07/3 is sufficiently characterised.
The Panel considers that the food constituent, a combination of Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3, which is the subject of the health claims, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
-
Utrzymanie odporności przeciw patogenom w górnych drogach oddechowych, prowadzące do zmniejszenia nasilenia i czasu trwania objawów przeziębienia
The claimed effect, which is proposed for further assessment, is “supports the defence against pathogens in the upper respiratory tract resulting in a decrease in duration and severity of common cold symptoms”. The proposed target population is the general adult population.
The Panel considers that the claimed effect refers to defence against pathogens in the upper respiratory tract.
The Panel considers that maintenance of upper respiratory tract defence against pathogens is a beneficial physiological effect.
3. Naukowe uzasadnienia wpływu na zdrowie człowieka - Utrzymanie odporności przeciw patogenom w górnych drogach oddechowych, prowadzące do zmniejszenia nasilenia i czasu trwania objawów przeziębienia
-
Utrzymanie odporności przeciw patogenom w górnych drogach oddechowych, prowadzące do zmniejszenia nasilenia i czasu trwania objawów przeziębienia
Five studies were provided as being pertinent for the scientific substantiation of the claim. These studies included one human intervention study (de Vrese et al., 2005), one animal study (Ohno et al., 2005) and three in vitro studies (Ghadimi et al., 2008; 2010a; 2010b).
In a randomised, double-blind, placebo-controlled parallel study, de Vrese et al. (2005) assessed the effect of consumption of the bacterial preparation on the incidence, severity and duration of common colds in 479 healthy adults (294 women aged 18-67 years). A total of 242 subjects were completed in a three-month study (from January to May 2001; 121 test group, 121 control group, 8 withdrawals) and 237 subjects participated in a 5.5 month study (from December 2001 to June 2002; 117 test group, 120 control group, 17 withdrawals). The Panel notes that these are two different studies with independent randomisation and different duration of the intervention, and that the reasons to combine data from these two cohorts are unclear. Cellular immune response was assessed in a subgroup of 122 subjects before and after 14 days of intervention in the first study. Volunteers were randomly assigned to take one tablet daily of either a bacterial preparation (containing L. gasseri PA 16/8, B. longum SP 07/3and B. bifidum MF 20/5 (5x107 CFU) with vitamins and minerals) or a control preparation (containing the same amount of vitamins and minerals only). Subjects were asked to record daily in a questionnaire the occurrence and severity of a number of symptoms, including nasal, pharyngeal, and bronchial symptoms, headache, myalgia, conjunctivitis, fatigue, loss of appetite, and fever (oral temperature >37.7°C). Common cold episodes were defined as the appearance of at least one nasal, pharyngeal or bronchial symptom, which include running nose, stuffed nose, blowing the nose, yellow secretion, bloody secretion, sneezing, scratchy throat, sore throat, hoarseness and cough. Total symptom severity scores were calculated by combining individual symptom scores over the study period. The Panel notes that no information is provided about the validity of the questionnaire used to assess the incidence, severity or duration of respiratory tract infections, that the symptoms used for the diagnosis of common cold episodes are non-specific, and that the presence of one or more of these symptoms is not an appropriate measure of respiratory tract infections in the study population. The Panel also notes that no information has been provided in the publication about the use of rescue medication, which may have confounded the results. The Panel considers that no conclusions can be drawn from this study for the scientific substantiation of the claim.
In the information provided, it is acknowledged that the mechanism by which the combination of L. gasseri PA 16/8, B. bifidum MF 20/5 and B. longum SP 07/3 could exert the claimed effect is not well understood. One animal study (Ohno et al., 2005) and three in vitro studies (Ghadimi et al., 2008; 2010a; 2010b) explored the effects of the microorganisms on the immune response to allergens/antigens. Three of these studies examined the effects of a single strain and only the in vitro
study by Ghadimi et al. (2008) assessed the effects of the combination. The Panel considers that, in the absence of evidence for an effect of the combination of L. gasseri PA 16/8, B. bifidum MF 20/5 and B. longum SP 07/3 on defence against pathogens in the upper respiratory tract in humans, these animal and in vitro studies cannot be used for the scientific substantiation of the claim as their results cannot predict the occurrence of an effect of a combination of L. gasseri PA 16/8, B. bifidum MF 20/5 and B. longum SP 07/3 in vivo in humans.
The Panel notes that no human intervention studies have been provided from which conclusions could be drawn for the scientific substantiation of the claim.
The Panel concludes that a cause and effect relationship has not been established between the consumption of a combination of Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3 and maintenance of upper respiratory tract defence against pathogens.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, a combination of Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3, which is the subject of the health claim, is sufficiently characterised.
The claimed effect proposed for further assessment is “supports the defence against pathogens in the upper respiratory tract resulting in a decrease in duration and severity of common cold symptoms”. The proposed target population is the general adult population. Maintenance of upper respiratory tract defence against pathogens is a beneficial physiological effect.
A cause and effect relationship has not been established between the consumption of a combination of Lactobacillus gasseri PA 16/8, Bifidobacterium bifidum M 20/5 and Bifidobacterium longum SP 07/3 and maintenance of upper respiratory tract defence against pathogens.
