Scientific Opinion on the substantiation of health claims related to
Lactobacillus paracasei LPC 01 (CNCM I-1390) and treatment of disease
(ID 3055, 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
(NDA) was asked to provide a scientific opinion on a health claim pursuant to Article 13 of Regulation (EC) No
1924/2006 in the framework of further assessment related to Lactobacillus paracasei LPC 01 (CNCM I-1390)
and treatment of disease. The food constituent, L. paracasei LPC 01 (CNCM I-1390), is sufficiently
characterised. The claimed effect proposed for further assessment is “relieve symptoms typically associated with
Irritable Bowel Syndrome (IBS), especially diarrhoea-predominant IBS, and to help reduce the daily number of
bowel movements as well as improve the consistency of faeces in adult subjects reporting acute diarrhoea”. The
proposed target population is “adults suffering either from Irritable Bowel Syndrome, especially
diarrhoea-predominant IBS, or from acute diarrhoea”. The Panel considers that the claimed effect is related to the
treatment of a disease and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
© European Food Safety Authority, 2012
Słowa kluczowe:
Lactobacillus paracasei LPC 01
health claims
1. Charakterystyka żywności / składnika
The food constituent that is the subject of the health claim is Lactobacillus paracasei LPC 01 (CNCM I-1390).
A culture collection number from the Collection Nationale de Cultures de Microorganismes (CNCM I-1390) was provided. The CNCM is a restricted-access non-public collection which has the status of an International Depositary Authority under the Budapest Treaty. Data on the identification and characterisation of L. paracasei LPC 01 at species and strain level, by using both phenotypic (carbohydrate fermentation pattern, enzymatic activity profile, PAGE, antibiotic resistance profile)
and genotypic (ARDRA, species-specific PCR, plasmidic profile, PFGE, genome sequencing) methods, were provided in the application for further assessment and accompanying annexes, and in the references provided (Elli M. et al., 2009; Morelli et al., 2003; 2006). L. paracasei LPC 01 is also known as L. paracasei B21060.
The Panel considers that the food constituent, L. paracasei LPC 01, which is the subject of the health claim, is sufficiently characterised.
2. Znaczenie oświadczenia dla zdrowia człowieka
-
Łagodzenie objawów typowych dla zespołu jelita wrażliwego (IBS), zwłaszcza postaci choroby z dominacją biegunki, oraz pomoc w redukcji aktywności jelit (ilości wypróżnień), a także poprawa konsystencji stolca u osób cierpiących z powodu ostrych biegunek
The claimed effect, which is proposed for further assessment, is “relieve symptoms typically associated with Irritable Bowel Syndrome (IBS), especially diarrhoea-predominant IBS, and to help reduce the daily number of bowel movements as well as improve the consistency of faeces in adult subjects reporting acute diarrhoea”. The proposed target population is “adults suffering either from Irritable Bowel Syndrome, especially diarrhoea-predominant IBS, or from acute diarrhoea”.
The Panel considers that the claimed effect is related to the treatment of a disease and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
Wnioski
On the basis of the data presented, the Panel concludes that:
The food constituent, L. paracasei LPC 01, which is the subject of the health claim, is sufficiently characterised.
The claimed effect proposed for further assessment is “relieve symptoms typically associated with Irritable Bowel Syndrome (IBS), especially diarrhoea-predominant IBS, and to help reduce the daily number of bowel movements as well as improve the consistency of faeces in adult subjects reporting acute diarrhoea”. The proposed target population is “adults suffering either from Irritable Bowel Syndrome, especially diarrhoea-predominant IBS, or from acute diarrhoea”.
The claimed effect is related to the treatment of a disease and does not comply with the criteria laid down in Regulation (EC) No 1924/2006.
