1805.pdf

Oryginał 
Scientific Opinion on the substantiation of health claims related to Lactobacillus reuteri ATCC 55730 and “natural defence” (ID 905) 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
Słowa kluczowe: Lactobacillus reuteri ATCC 55730   health claims   natural defences  
ID:    905  
Produkty: Lactobacillus reuteri ATCC 55730  

1. Charakterystyka żywności / składnika

The food constituent that is the subject of the health claim is Lactobacillus reuteri ATCC 55730 (hereafter L. reuteri ATCC 55730). The strain L. reuteri ATCC 55730 is also known as Lactobacillus reuteri SD2112 (Connolly, 2004). The 16S rRNA sequence of the strain is deposited at Genbank (Accession nº EU394679) and the strain has been characterised by both phenotypic and genotypic methods (Rosander et al., 2008). The sequencing of the genome of the strain is reported (Båth et al., 2005).
A culture collection number from the American Type Culture Collection (ATCC) is also reported.
The Panel considers that the food constituent, Lactobacillus reuteri ATCC 55730, which is the subject of the health claim, is sufficiently characterised.

2. Znaczenie oświadczenia dla zdrowia człowieka


2.1. Naturalna obrona organizmu (ID 905)

The claimed effect is “natural defence”. The Panel assumes that the target population is the general population.
“Natural defence” is not sufficiently defined, and no further details were provided in the proposed wording.
The references cited were either related to general review articles/abstracts from scientific meetings or addressed several effects/endpoints measured, related, for example, to gingivitis and oral bacteria, Helicobacter pylori, irritable bowel syndrome, acute diarrhoea in children, work-place healthiness, immunomodulation in healthy subjects and ileostomy patients, infections in day care centres, and safety and tolerance in HIV positive subjects and healthy adults, and it is not possible to establish which effect 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.

Wnioski

On the basis of the data presented, the Panel concludes that:
The food constituent, Lactobacillus reuteri ATCC 55730, which is the subject of the health claim, is sufficiently characterised.
The claimed effect is “natural defence”. The target population is assumed to be the general population. “Natural defence” is not sufficiently defined, and no further details were provided in the proposed wording. The references cited addressed several effects and endpoints and it is not possible to establish which effect is the target for the claim.
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.