2.1. Ochrona przed bakteriami patogennymi w dolnych drogach moczowych (ID 1841, 2153, 2770, 3328)

The claimed effects are “urinary tract”, “health of the lower urinary tract”, and “reduce biofilms on uroepithelial cells”. The Panel assumes that the target population is the general population.
In the context of the proposed wordings, clarifications from Member States and references provided, the Panel assumes that the claimed effects refer to defence against bacterial pathogens in the lower urinary tract, which can be assessed in vivo as changes in the incidence of symptomatic urinary tract infections (UTIs).
The Panel considers that defence against bacterial pathogens in the lower urinary tract is a beneficial physiological effect.

2.2. Mocna ochrona naszych dziąseł (ID 1365)

The claimed effect is “powerful protectors of our gums”. 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. No clarifications were provided by Member States.
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.

2.3. Zdrowie serca (ID 2499)

The claimed effect is “heart 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 or clarifications provided by Member States.
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.

3.1. Ochrona przed bakteriami patogennymi w dolnych drogach moczowych (ID 1841, 2153, 2770, 3328)

The references provided for the scientific substantiation of the claim included several narrative reviews and monographs which did not provide original data for the scientific substantiation of the claim, and some human intervention studies which investigated the effects of food constituents other than PAC in cranberry fruit products (e.g. cranberry products in combination with warfarin or flurbiprofen, and mixtures of concentrates from cranberries and lingonberries) or addressed health outcomes (e.g. risk of urolithiasis) other than the claimed effect. The Panel considers that no conclusions can be drawn from these references for the scientific substantiation of the claim.
A systematic review of randomised or quasi-randomised human intervention studies on the effects of cranberry and blueberry products on the incidence of symptomatic UTIs, 12 human intervention
studies and one observational study on the effects of cranberry fruit products on the incidence of UTI, and 17 non-human studies on the mechanisms by which cranberry fruit products could exert the claimed effect were provided.
A claim on cranberry (V. macrocarpon Aiton) fruit products standardised by their PAC content and reduction in the risk of UTIs in women by inhibiting the adhesion of certain bacteria in the urinary tract has already been assessed with an unfavourable outcome (EFSA, 2009). The scientific evaluation was based on the insufficient evidence provided by the applicant to establish a cause and effect relationship between the consumption of cranberry fruit products standardised by their PAC content and a reduction in the incidence of UTIs, and on the insufficient evidence provided to establish that the bacterial anti-adherence effects, which were shown in vitro, of cranberry fruit products in urine could predict the occurrence of a clinically relevant bacterial anti-adherence effect within the urinary tract in vivo in humans.
Most of the references provided in the consolidated list which addressed the effects of cranberry (V. macrocarpon Aiton) fruit products standardised by their PAC content on the incidence of UTIs in different population sub-groups, and those which addressed the mechanisms by which cranberry fruit products could exert the claimed effect, were already considered in the previous opinion (EFSA, 2009).
Two additional references, which reported on human intervention studies and which were not considered in the previous opinion, were provided in the consolidated list (Bohbot, 2007; Jepson and Craig, 2008). The Panel notes that the methods used to diagnose UTI infection were not sufficiently described in the study by Bohbot (2007). It is also noted that all human trials analysed in the Cochrane review by Jepson and Craig (2008) were referenced also in the systematic review by Jepson and Craig (2007) which was considered in the previous opinion (EFSA, 2009). The Panel considers that these two references do not provide any additional scientific data which could be used to substantiate the claim.
The Panel considers that the references provided for this claim did not provide any additional scientific data which could be used to substantiate the claim.
The Panel concludes that the evidence provided is insufficient to establish a cause and effect relationship between the consumption of proanthocyanidins from cranberry (V. macrocarpon Aiton) fruit and defence against bacterial pathogens in the lower urinary tract.