2.1. Zdrowie przewodu pokarmowego (ID 906)

The claimed effect is “gastro-intestinal health”. The Panel assumes that the target population is the general population.
The claimed effect is not sufficiently defined, and no further details were provided in the proposed wordings. The Panel notes that the references provided addressed several effects (e.g. related to effects on gastro-intestinal symptoms, prevention of antibiotic-associated diarrhoea, treatment of acute diarrhoea, Helicobacter pylori eradication, or effects on subjects with a history of traveller‟s diarrhoea), and that it was not possible to establish the effect which is the target for the claim.
The Panel considers that the claimed effect is general and non-specific, and does not refer to any specific health claim as required by Regulation (EC) No 1924/2006.

2.2. Utrzymanie mineralizacji zębów (ID 3018)

The claimed effect is “oral health/flora”. The Panel assumes that the target population is the general population.
From the information provided, the Panel assumes that the claimed effect refers to the maintenance of tooth mineralisation by reducing mutans streptococci in the oral cavity.
Acid is produced in plaque through the fermentation of carbohydrates by acid-producing bacteria, such as Streptococcus mutans. Lowering plaque pH contributes to demineralisation of tooth tissues.
The Panel considers that maintenance of tooth mineralisation is a beneficial physiological effect.

3.1. Utrzymanie mineralizacji zębów (ID 3018)

Among the references provided in relation to the claim were one human study, which addressed outcomes unrelated to the claimed effect such as the recovery of the strain from saliva after yoghurt consumption, and one in vitro study, which was unrelated to the strain that is the subject of the claim (i.e. Lactobacillus casei strains). The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
A randomised, double-blind, placebo-controlled study was provided (Nase et al., 2001). This study was part of a larger investigation conducted to examine the effects of long-term consumption of “probiotic” milk on children‟s health, and especially on the incidence of gastro-intestinal and respiratory infections. The sample size was estimated to show a 20 % reduction in respiratory tract infections. A total of 594 children were randomised to the intervention (test milk: pasteurised cow's milk containing 1 % fat and live L. rhamnosus ATCC 53103 (LGG) 5-10x105 CFU/mL) or control (milk without lactobacilli) group according to a computer-generated blocked randomisation list. The children drank the milks five days a week for seven months. The day-care personnel, parents, children and investigators were unaware of which milk contained the L. rhamnosus ATCC 53103 (LGG) strain, throughout the study. The randomisation code was not broken until the intention-to-treat analyses were performed. Experienced dentists examined the children's oral health according to the WHO criteria. The same examiner carried out the examination of the same children at baseline and then at the end of the study, without reference to the baseline data. The use of fluoride varnish was forbidden during the study, but necessary dental treatment was allowed. In addition, caries was recorded separately for occlusal, smooth (labial and oral) and approximal surfaces. The parameters studied were active caries (initial and decayed, dt/DT), cumulative caries (dmft/DMFT) and caries in occlusal, smooth and approximal surfaces. Pooled plaque and saliva samples were taken in the day- care centres from all children always at the same time, i.e. 1 hour after breakfast, at baseline, in the middle and at the end of the study. In addition, a non-stimulated saliva sample was taken from the 5 to 6-year-old children with the free-flowing method. The pooled plaque and saliva samples were spread with a cotton stick on Dentocult SM Strip mutans® slides, and cultivated according to the manufacturer's instructions. The slides were counted under a stereomicroscope and scored as instructed by the manufacturer. Caries risk was determined on the basis of combined clinical and microbiological results. Caries risk was classified into „high‟ (a dmft/DMFT or initial caries score >0
and a mutans streptococci count 105 CFU/mL), „moderate‟ (either a dmft/DMFT or initial caries
score >0 or a mutans streptococci count 105 CFU/mL), or „low‟ (no caries detected and a mutans
streptococci count 105 CFU/mL). Age-stratified analyses were performed. The children were divided into three age groups: 1–2 years, 3–4 years and 5–6 years. All analyses were based on the intention- to-treat population.
The number and proportion of subjects with high ( 1,000,000 CFU/mL), medium (100,000– <1,000,000 CFU/mL) or low (<100,000 CFU/mL) concentrations of S. mutans in the intervention and control groups at baseline, middle and end of the study are reported, but no statistical analysis is provided to assess differences between groups. No statistically significant differences were observed between intervention and control groups with respect to dental caries at any site assessed in the study.
Two in vitro studies investigating the antibacterial properties of LGG were provided. The Panel considers that evidence provided in in vitro studies is not sufficient to predict the occurrence of an effect of L. rhamnosus ATCC 53103 (LGG) consumption on the maintenance of tooth mineralisation in humans.
In weighing the evidence, the Panel took into account that the only human intervention study provided from which conclusions could be drawn for the scientific substantiation of the claim did not show an effect of L. rhamnosus ATCC 53103 (LGG) consumption on reduction of dental caries at any site compared to placebo, the reduction of which could indicate an effect on maintenance of tooth mineralisation.
The Panel concludes that a cause and effect relationship has not been established between the consumption of L. rhamnosus ATCC 53103 (LGG) and maintenance of tooth mineralisation.