(EFSA) was asked to deliver a scientific opinion on the safety and efficacy of Probiotic LACTINA® for chickens for fattening, piglets and pigs.
The additive Probiotic LACTINA® is proposed be used as a feed additive for chickens for fattening and piglets (category: zootechnical additives; functional group: gut flora stabilisers). It has not been previously authorised in the Community. Probiotic LACTINA® is a preparation of Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus bulgaricus, Lactobacillus lactis, Streptococcus thermophilus and Enterococcus faecium. The total
content of lactic acid bacteria is 5 x 109 CFU g-1 product, but no information is given about the relative amounts of different bacterial strains.
The product is intended for chickens for fattening (5 x 108 – 9 x 109 CFU kg-1 complete feedingstuff), for piglets up to 9 – 12 kg (5 x 109 – 1 x 1010 CFU kg-1 complete feedingstuff) and for pigs up to 35 kg (9 x 108 – 5 x 109 CFU kg-1 complete feedingstuff). Due to the lack of data presented in the dossier and in the supplementary information, the FEEDAP Panel is not able to describe the composition, stability and homogeneity in feed of the product.
Serious deficiencies in the study design, conduct and reporting of the studies do not allow conclusions to be drawn on the efficacy of Probiotic LACTINA® in chickens for fattening. Acceptable evidence of efficacy has been provided only in one study made with weaned piglets and one study with suckling piglets. Therefore, the FEEDAP Panel cannot conclude on the efficacy of Probiotic LACTINA® for piglets. The applicant did not provide any study on
pigs for fattening and therefore no conclusion can be drawn on the efficacy of the product for this target species. In the absence of tolerance studies, the FEEDAP Panel cannot conclude on the safety of Probiotic LACTINA® for the target species. The lack of data on the antibiotic resistance of the six Probiotic LACTINA® strains and on the presence of known virulence factors in E. faecium NBIMCC 8270 prevents drawing conclusions on the safety of the product for the consumer. No experimental data on the user safety was provided. Because of its proteinaceous nature, the possibility for the product to act as a respiratory sensitiser cannot be excluded. The use of this product as a feed additive would not pose a risk for the environment.
