The active ingredient of Reuteri Pig Powder is the strain Lactobacillus reuteri 1063S, deposited with the ATCC with accession number PTA-3609. The strain is present in numbers >1 x 108 CFU g-1 product, representing between 1-3 % of the product weight. The remainder is composed of food grade compounds. The European Food Safety Authority has been request to deliver an opinion on the safety of "Reuteri Pig Powder" for piglets, the consumer, the user of the product and the environment, and on its efficacy.
Only one of the three controlled field trials performed demonstrated a significant effect of Reuteri Pig Powder on the weight gain of piglets during the post-weaning period. This was not sufficient evidence to conclude on the efficacy of this product. The tolerance test did not allow to conclude that the product is safe for piglets, because of the possibility of cross-contamination, the lack of statistical treatment and the limited number of outcome measures. L. reuteri is a normal component of the human and animal microflora. Use of the product does not increase the normal exposure of consumers, and the active agent does not carry any unusual antibiotic resistance determinants. Therefore no negative effects are expected
for the consumer. The respirable fraction of the product consists of the 1 % of the total weight. Thus the product should be treated as having a potential respiratory sensitisation for users of the product.
L. reuteri is a natural intestinal commensal, with a limited capacity to survive outside its ecological niche. Thus the product is not expected to be of environmental concern.
