SCIENTIFIC OPINION. EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3

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1 SCIENTIFIC OPINION Scientific Opinion on the safety and efficacy of Probiotic LACTINA (Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus bulgaricus, Lactobacillus lactis, Streptococcus thermophilus and Enterococcus faecium) for chickens for fattening and piglets 1 EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) 2,3 ABSTRACT European Food Safety Authority (EFSA), Parma, Italy Probiotic LACTINA is a feed additive consisting of six strains of lactic acid bacteria. In 2007 the European Food Safety Authority was requested to evaluate the safety and efficacy of the additive when used as a zootechnical additive (functional group: gut flora stabilisers) in diets for chickens for fattening, piglets and pigs for fattening. At that time the FEEDAP Panel was able to conclude only on the safety for the environment and partially for the user. EFSA is now requested to assess the safety for the target animals and consumers, and the efficacy of the additive when added in diets for chickens for fattening at 5 x x 10 9 CFU/kg feed and for piglets at 9 x x CFU/kg feed. The identity of the six strains was established. As no antibiotic resistance of concern was detected and as five of the strains qualify for the Qualified Presumption of Safety approach to safety assessment, their use is presumed safe for target species and consumers. The Enterococcus faecium strain is not a recognised pathogen for animals and as the additive did not adversely affect growth of chickens or piglets, Probiotic LACTINA is considered safe for the target species up to 1 x CFU/kg feed. This strain does not contain marker genes typical of hospital-associated isolates responsible for clinical infections. The metabolic pathways of E. faecium are well known. Since no other harmful metabolites are expected and the additive does not contain excipients of concern, it is considered safe for consumers. Probiotic LACTINA showed a potential to increase the body weight of suckling piglets when used at approximately 5 x 10 9 CFU/kg feed. The Panel could not conclude on the efficacy of Probiotic LACTINA when used in diets for chickens for fattening or weaned piglets. European Food Safety Authority, 2013 KEY WORDS Zootechnical additive, Probiotic LACTINA, chickens for fattening, piglets, efficacy, safety 1 On request from the European Commission, Question No EFSA-Q , adopted on 12 March Revision 1 16 April 2013: minor editorial changes. 2 Panel members: Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Gerhard Flachowsky, Mikolaj Antoni Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. Correspondence: FEEDAP@efsa.europa.eu 3 Acknowledgment : The Panel wishes to thank the members of the Working Group on Micro-Organisms, including Andrew Chesson, Pier Sandro Cocconcelli and Ingrid Halle, for the preparatory work on this scientific opinion. Suggested citation: EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP); Scientific Opinion on the safety and efficacy of Probiotic Lactina (Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus bulgaricus, Lactobacillus lactis, Streptococcus thermophilus and Enterococcus faecium) for chickens for fattening and piglets.. [13 pp.]. doi: /j.efsa Available online: European Food Safety Authority, 2013

2 SUMMARY Probiotic LACTINA is the trade name for a microbial feed additive consisting of six strains of lactic acid bacteria. In 2007 the European Food Safety Authority was requested by the European Commission to evaluate the safety and efficacy of Probiotic LACTINA when used as a zootechnical additive (functional group: gut flora stabilisers) in diets for chickens for fattening in the range of 5.0 x x 10 9 CFU/kg complete feedingstuffs, for piglets in the range of 5.0 x x CFU/kg complete feedingstuffs and for pigs for fattening in the range of 9.0 x x 10 9 CFU/kg complete feedingstuffs. In that occasion the FEEDAP Panel due to inadequate or insufficient data was able to conclude only on the safety for the environment and partially on user safety. The applicant now has submitted additional data relevant to the assessment of the safety and efficacy of the additive Probiotic LACTINA when added in diets for chickens for fattening at 5 x x 10 9 CFU/kg complete feedingstuffs and for piglets at 9 x x CFU/kg complete feedingstuffs, and to the safety for consumers of products deriving from animals fed the additive. The original application for use with pigs for fattening has been withdrawn. The additive has a short shelf-life unless stored under protected conditions and refrigeration. The applicant s claim for a shelf-life of 12 months at 20 ºC is not supported. The identity of all of the component strains of Probiotic LACTINA has been established and five of the six qualify for the Qualified Presumption of Safety (QPS) approach to safety assessment. As no antibiotic resistance of concern was detected in these strains, following the QPS approach, the use of these five strains in feedingstuffs is presumed safe for target species and consumers of products from animals. As the sixth strain (E. faecium) is not a recognised pathogen for the chickens or piglets and oral dosing into these species with the Probiotic LACTINA strain did not elicit any detectable adverse responses and as the additive itself did not adversely affect growth of chickens for fattening or piglets, the additive is considered safe for the target species to a maximum of 1 x CFU/kg complete feed. E. faecium (NBIMCC 8270), does not contain marker genes typical of hospital-associated isolates responsible for clinical infections and is susceptible to clinically relevant antibiotics. The metabolic of pathways of E. faecium are well known and when the potential for infection is excluded, no other harmful metabolites or substances are expected to be produced during fermentation. Consequently, as no safety issues relating to the active agents have been identified and as the additive does not contain excipients of concern, the FEEDAP Panel concludes that the additive is safe for consumers when used under the conditions proposed. Although the Applicant submitted the results of seven trials made with chickens for fattening, the FEEDAP Panel was unable to conclude on the efficacy of Probiotic LACTINA because of the absence of replication in most studies. In three studies in piglets in which the suckling period was considered, the additive showed a potential to increase the body weight of piglets. Although difficult to establish, a minimum effective dose might be in the region of 5 x 10 9 CFU/kg complete feed. There was insufficient evidence presented to conclude on the efficacy of the additive when used with diets for weaned piglets. 2

3 TABLE OF CONTENTS Abstract... 1 Summary... 2 Table of contents... 3 Background as provided by the European Commission... 4 Terms of reference as provided by the European Commission... 4 Assessment Introduction Characterisation Characterisation of the active agent Tests for enterococcal virulence Antibiotic susceptibility Manufacturing process The nature of the final product Stability and homogeneity Proposed conditions of use Safety Safety for the target species Safety for chickens for fattening Safety for piglets Conclusion Safety for the consumer Efficacy Efficacy for chickens for fattening Conclusions for chickens for fattening Efficacy for piglets Conclusions for piglets Conclusion Documentation provided to EFSA References

4 BACKGROUND AS PROVIDED BY THE EUROPEAN COMMISSION Regulation (EC) No 1831/2003 establishes rules governing the Community authorisation of additives for animal nutrition and in particular defines the conditions that a substance/product should meet to be granted the authorisation. The Commission received directly from the company Probiotic Lactina Ltd an application requesting to assess its product Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus bulgaricus, Lactobacillus lactis, Streptococcus thermophilus, Enterococcus faecium (Probiotic LACTINA ) to obtain an authorisation as zootechnical additive for chickens for fattening, pigs and piglets. The Authority in its opinion adopted on 9 December 2008 (Safety and efficacy of Probiotic LACTINA (Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus bulgaricus, Lactobacillus lactis, Streptococcus thermophilus, Enterococcus faecium) for chickens for fattening, piglets and pigs), was not able to give a conclusive opinion on the safety and efficacy for target species and consumers due to lack of data provided by the company (EFSA, 2009). Therefore, the Commission gave the possibility to the company to submit complementary information to complete the assessment. The Commission has now received a supplementary dossier from the applicant company Probiotic Lactina Ltd containing new data on safety and efficacy of Lactobacillus acidophilus, Lactobacillus helveticus, Lactobacillus bulgaricus, Lactobacillus lactis, Streptococcus thermophilus, Enterococcus faecium (Probiotic LACTINA ), when used as feed additive under the requested conditions. TERMS OF REFERENCE AS PROVIDED BY THE EUROPEAN COMMISSION In view of the above, the Commission asks to the European Food Safety Authority to deliver an opinion on the efficacy and safety for consumers and target species under the requested conditions of use. 4

5 ASSESSMENT 1. Introduction Probiotic LACTINA is the trade name for a microbial feed additive consisting of six strains of lactic acid bacteria. In a previous opinion on this additive (EFSA, 2009), the FEEDAP Panel was unable to conclude on the safety of Probiotic LACTINA for chickens for fattening, piglets and pigs for fattening, for consumers of products derived from these species or on the efficacy of the additive when used with the target species. This was because of inadequate or insufficient data. In addition, the product was poorly characterised which prevented the FEEDAP Panel from fully describing the composition of the additive or establishing its distribution and survival when mixed in feed. The Panel was able to conclude only on safety for the environment and partially on that for user. The applicant now has submitted additional data relevant to the assessment of the safety and efficacy of the additive Probiotic LACTINA for chickens for fattening and piglets and the safety for consumers of products deriving from animals fed the additive. 4 The original application for use with pigs for fattening has been withdrawn. 2. Characterisation 2.1. Characterisation of the active agent The six bacterial strains included in the final additive were all isolated from locally produced dairy products and are deposited in the Bulgarian National Bank of Industrial Microorganisms and Cell Cultures (NBIMCC) with designations NBIMCC 8242 (Lactobaccilus acidophilus), NBIMCC 8250 (Lactobacillus delbrueckii ssp. lactis), NBICCM 8244 (L. delbrueckii ssp. bulgaricus), NBIMCC 8269 (Lactobacillus helveticus), NBIMCC 8253 (Streptococcus thermophilus) and NBIMCC 8270 (Enterococcus faecium). The strains are not genetically modified. The species identification of the four lactobacilli and S. thermophilus was described in the previous opinion based on morphological and biochemical criteria, and the results of a 16S rrna gene sequence analysis. A similar approach was taken for E. faecium. 5 Phenotypic typing (Analytical Profile Index) coupled with a partial 16S rrna gene sequence, which by comparison with sequences recorded in databases, gave an unambiguous identification of E. faecium. Genetically stability was not established for any of the strains Tests for enterococcal virulence The enterococcal strain used in Probiotic LACTINA was examined for the presence of a series of genes associated with virulence using PCR and specific primer sets. 7 Positive controls were used. Using this method the additive strain was shown not to carry the genes encoding the bacteriocins enta and entb. The strain also proved negative for the genes encoding gelatinase (gele), serine proteinase (spre), the quorum sensing regulator fsr and the putative adherence factors asa1, efa and esp. However, the strain does carry the pila gene and the acm gene encoding a collagen binding protein but not pilb. Subsequent to this application, EFSA undertook a review of the safety of E. faecium and concluded that resistance to ampicillin and the presence of three specific genes were markers of a hospitalassociated sub-population most likely to be found in clinical situations. These three marker genes (esp, IS16 and hyl-like) could not be detected in the E. faecium strain included in Probiotic LACTINA. 8 4 Dossier reference: FAD Technical dossier/supplementary information October 2011/(i). 6 Technical dossier/supplementary information October 2011/(ii). 7 Technical dossier/supplementary information October 2011/(iv). 8 Technical dossier/supplementary information December 2012/I. 5

6 Antibiotic susceptibility Probiotic LACTINA for chickens, piglets and pigs The susceptibility to the battery of antibiotics recommended by the FEEDAP Panel was tested using two methods, a micro-titre version of the broth dilution method with growth assessed by turbidity or a fluorescent marker system and a plate-based serial dilution method. For five of the six strains minimum inhibitory concentration (MIC) values were less than or were equal to the cut-off values established in the EFSA guidance on the update of the criteria used in the assessment of bacterial resistance to antibiotics of human or veterinary importance (EFSA, 2012a). 9 In particular, the MIC value for E. faecium for ampicillin was 2 mg/l, a value lower than those typical of the hospitalassociated strains. However, MIC values for the sixth strain L. delbrueckii ssp. bulgaricus NBICCM 8244 exceeded the cut-off values for kanamycin, erythromycin and streptomycin in each case by a single dilution. This is considered within the normal variation among the mean and not a cause for concern Manufacturing process Each strain is grown individually in a medium typical of those used for the industrial production of lactic acid bacteria. 10 Cryoprotectants (skimmed milk powder and sucrose) are added and the fermentation mixture freeze dried. Counts are made at this stage and on this basis equal numbers of each strain are blended with carriers (glucose, inulin and calcium carbonate) to give a final product with a minimum 5 x 10 9 CFU total lactic acid bacteria The nature of the final product The final product consists of 60% bacterial mass, spent medium and cryoprotectants, 20% glucose, 10% inulin and 10% calcium carbonate. 11 No data intended to confirm the minimum count in production batches were provided. However, some indication of compliance can be seen in the analysed values obtained for three batches of the product used for the estimation of homogeneity. 12 These averaged 7.1 x10 9 CFU/g additive. Experimental data on the particle size distribution from the analysis by laser diffraction of four batches of the product show that approximately 46 % of particles have diameters < 100 µm and 5% < 10 µm. 13 No data on the dusting potential of the batches were provided. Microbiological purity and heavy metal contamination was considered in the previous opinion, in which was noted that although limits were set for monitoring, the actual values and evidence of compliance was not provided. However, some evidence of compliance with specifications for microbial purity was included in the analytical results from the homogeneity study. These showed that three batches were free of contamination of yeasts and filamentous fungi, Staphylococcus aureus and Salmonella Stability and homogeneity The additive has a short shelf-life unless stored under protected conditions and refrigeration. Data from three batches showed that when stored under nitrogen at 5 ºC for one year in its original packaging only small losses were observed while storage under oxygen led to a two log reduction in total counts. At 37 ºC losses after a week were in excess of a two-log reduction under nitrogen and a four-log reduction in the presence of oxygen. Increasing the storage temperature to 43 ºC for the same period led to further reductions in total counts. The applicant s claim for a shelf-life of 12 months at 20 ºC is not supported Technical dossier/supplementary information October 2011/(iii). 10 Technical dossier/supplementary information October 2011/(v). 11 Technical dossier/supplementary information October 2011/(vi). 12 Technical dossier/supplementary information October 2011/(ix). 13 Technical dossier/supplementary information October 2011/(vii). 14 Technical dossier/supplementary information October 2011/(viii). 6

7 Each strain was also individually examined for stability when stored for up to 12 months under nitrogen at temperatures of -18, 5 and 18 ºC. All six strains showed comparable stability under these conditions and losses at the higher temperature were generally below one-log after one year. Comparable data under oxygen were not shown. Accelerated conditions of one week storage at 37 ºC and 43 ºC under nitrogen paralleled the results seen for the total counts. The product also showed poor storage characteristics when incorporated into premixtures. 15 Three batches of the additive were mixed into two differently formulated vitamin-mineral premixtures and stored at 23 ºC and 60% RH for six months. Significant losses were seen within one month (1 2 log reductions in total CFU counts), with five log reductions recorded at the end of the experimental period. As no differential counts were made, it is not possible to determine whether equal sensitivity was shown by all strains in the additive or whether one or more component strains were particularly sensitive. In contrast to premixtures, the additive appeared stable once incorporated into complete feedingstuffs. 16 Again the same three batches of additive were individually incorporated into two feeds for pigs and two for chickens. Each feed was prepared either in mash or pelleted form and the resulting 24 feeds stored under the same conditions as above for three months. In all cases losses determined as total lactic acid bacterial counts were small after three months. Ten sub-samples from each of three commercial batches of a feed for chickens for fattening treated with the additive were assayed for total lactic acid bacterial numbers. 17 The average CV for the three batches was 7.1 % demonstrating that the additive can be homogeneously distributed in feed Proposed conditions of use The product is intended for chickens for fattening at a minimum dose of 5 x 10 8 and maximum of 9 x 10 9 CFU/kg complete feedingstuffs, and for piglets at a minimum dose of 9 x 10 8 and a maximum dose of 1 x CFU/kg complete feedingstuffs. 3. Safety Five of the six strains included in the product are considered by EFSA to be suitable for the Qualified Presumption of Safety (QPS) approach and do not require any specific demonstration of safety other than confirming susceptibility to antibiotics of human and veterinary clinical significance and the safety for the user (EFSA, 2007, 2012b). In the view of the FEEDAP Panel, the antibiotic susceptibility qualification has been met and the identity of these production strains established. Accordingly, the five strains are presumed safe for the target species and consumers of products from animals given the additive. This presumption does not extend to the sixth strain (E. faecium) Safety for the target species Two studies were provided by the applicant and described as tolerance trials. However, neither met the basic requirements of such studies Safety for chickens for fattening A tolerance trial is described involving 120 male chicks divided into four groups given the same basal diet alone or supplemented with 0.05%, 0.5% or 5.0% of the additive. 18 No information was provided on the actual bacterial count of the batch of the additive used or its concentration in feed. Taking the minimum guaranteed content of 5 x 10 9 CFU/g additive, the doses used would equate to 0, 2.5 x 10 9, 2.5 x and 2.5 x CFU/kg feed which represent approximately 0.3, 3 and 30 times the maximum recommended dose, respectively. Birds were housed in single treatment groups but were 15 Technical dossier/supplementary information December 2012/II. 16 Technical dossier/supplementary information December 2012/II. 17 Technical dossier/supplementary information October 2011/(ix). 18 Technical dossier/supplementary information October 2011/(x). 7

8 weighed individually on days 1, 14 and 28 and at the end of the experiment on day 42. Feed consumption was measured on a pen basis. The results were said to be statistically analysed but no further details were provided. The mean weights of the birds on treatment were all higher than the birds in the control group at the end of the experiment (1.68 kg versus 1.71, 1.75 and 1.72 kg for the three treated groups). Only seven birds on trial died or were otherwise culled. Removals were not treatment related Safety for piglets A total of 40 piglets (10 kg start weight, Danube White breed) were assigned to one of four experimental groups. 19 As in the experiment with chickens for fattening, animals were housed in single treatment groups but were weighed individually at the end of the experiment on day 44. Feed consumption was measured on a pen basis. The four treatments were those used for the chicken tolerance test above, which based on the minimum guaranteed content of the additive, would equate to 0, 0.25, 2.5 and 25 times the maximum recommended dose. The mean weights of the animals on treatment were all higher than the piglets in the control group at the end of the experiment (24.5 kg versus 27.4, 28.4 and 26.6 kg for the three treated groups) but the differences did not reach significance. Liveweight gains of the treated groups were, however, significantly improved compared to the control group. No adverse health issues were observed and no piglets were lost from the trial Conclusion Although the studies provided do not meet the requirements of a tolerance study, taking into consideration that: Five of the six strains assessed using the QPS approach are presumed safe for target animals, The sixth strain, E. faecium, is not a recognised pathogen for the chickens or piglets, it lacks the marker genes associated with human clinical isolates and is susceptible to relevant antibiotics, The end-products of the metabolism of this species are typical of lactic acid bacteria, and do not raise concerns, the additive does not contain excipients of concern, The additive at approximately 30 times the maximum recommended dose, did not adversely affect the health or growth of chickens for fattening and piglets, the FEEDAP Panel concludes the Probiotic LACTINA recommended dose range Safety for the consumer is safe for the target animals at the Five of the six component strains assessed using the QPS approach are presumed safe for consumers of products derived from treated animals. The sixth strain, E. faecium (NBIMCC 8270), does not contain marker genes typical of hospital-associated isolates responsible for clinical infections and is susceptible to clinically relevant antibiotics. The metabolic pathways of E. faecium are well known and when the potential for infection is excluded, no other harmful metabolites or substances are expected to be produced during fermentation. As no safety issues relating to the active agents have been identified and as the additive does not contain excipients of concern, the FEEDAP Panel does not see the need for toxicological studies and concludes that the additive is safe for consumers when used under the conditions proposed. 19 Technical dossier/supplementary information October 2011/(x). 8

9 4. Efficacy 4.1. Efficacy for chickens for fattening The applicant provided reports of seven studies made with chickens for fattening in which a control group is compared with one or more groups treated with the additive. The studies were made in three institutions in a single Member State. The recommended dose generally is expressed as 0.5 g/kg feed which the applicant states is designed to deliver at least 5 x 10 8 CFU/kg feed. However, the minimum declared content of the active agents in the additive is 5 x 10 9 CFU/g which would provide a minimum of 2.5 x 10 9 CFU/kg feed. In cases where the actual content of lactic acid bacteria in the batch of additive used has been measured values were usually higher than 5 x 10 8 CFU/kg feed. Some studies also included a brief outline of an additional field trial or other experimental work. Of necessity these have been disregarded because the very limited description of the work provided did not allow conclusions to be drawn. In the first study, 120 Cobb 500 male chicks were allocated to one of two groups, the first fed a basal diet and the second group the basal diet supplemented with 0.8 g additive/kg feed for the first 28 days followed by 0.5 g additive until the end of the experiment on day A certificate of analysis showed that the batch of additive used contained 7.2 x 10 9 CFU/g which equates to doses of 3.6 x 10 9 and 5.8 x 10 9 CFU/kg feed (analysed values 7.5 x 10 9 CFU and 1.3 x CFU/kg feed). Each treatment group consisted of 12 replicates of five birds each. Birds were weighed individually and feed intake measured on a pen basis. At the end of the experiment six birds per treatment were killed and carcass parameters measured. The mean final weight of birds from the treatment group were significantly heavier than those from the control group (2.01 kg versus 2.08 kg, P<0.01) and consumed less feed per kg weight gain (1.83 versus 1.73, P<0.01). Mortality was low and no veterinary interventions were required. In the second study, 300 male Cobb 500 chicks were allocated to one of three groups, each of 100 birds. There was no replication but birds were individually weighed. 21 The first group acted as controls and the diets of the two treatment groups were supplemented with 0.5 g/kg or 1.0 g/kg equating to doses of 4.5 x 10 9 CFU/kg feed and 8.5 x 10 9 CFU/kg feed, respectively (confirmed by analysis). At the end of the experiment (42 days) the mean weights of the birds from the two treatment groups were higher than those of the control group (1.93 kg versus 2.15 and 2.29 kg) although these differences did not reach significance. In study 3, Cobb 500 chicks were allocated to one of two groups, each of 100 birds. 22 There was no replication but birds were individually weighed. The first group acted as controls and second as the treatment group in which the basal diet was supplemented with 0.6 g/kg equating to a dose of 5.5 x 10 9 CFU/kg feed (analysed value 7.4 x 10 8 CFU/kg feed). At the end of the experiment (42 days) the mean weight of the birds from the treatment group was significantly higher than that of the control group (1.76 kg versus 1.82 kg, P<0.01). Overall feed to gain ratio was lower for the treated group (2.07 versus 1.89 kg). Mortality was low. Study 4 essentially was a duplicate of the first study and was made at the same establishment. 23 In this study, 180 male chicks were divided into three groups of 60 birds (12 replicate pens of five birds). Treatments were 0.8 g/kg additive for the starter phase followed by 0.5 g/kg for the finisher phase or 0.6 g/kg additive for the starter and 0.3 g/kg for the finisher phase for a total of 40 days. No significant differences were seen in the final weight, weight gain or feed intake between the control group and either of the two treatment groups. 20 Technical dossier/supplementary information March 2012/(ii) RN1. 21 Technical dossier/supplementary information March 2012/(ii)RN2. 22 Technical dossier/supplementary information March 2012/(ii)RN3. 23 Technical dossier/supplementary information October 2011/(xi)RN13. 9

10 In the fifth study, male Ross 308 chicks were divided into three groups of around 50 birds per group. 24 The first group acted as the control, the second and third as treatment groups in which the basal diet was supplemented with 0.5 g/kg additive (equivalent to 3.8 x 10 9 CFU/kg feed, analysed value 8.1 x 10 8 CFU/kg feed), and 0.75 g/kg additive (equivalent to 5.6 x 10 9 CFU/kg feed, analysed value 3.5 x 10 9 CFU/kg feed), respectively. Birds were housed in a single pen but were weighed individually during the 47 day experiment. At the end of the experiment the mean weight of the birds from the treatment groups was significantly higher than that of the control group (2.13 kg versus 2.24 kg and 2.26 kg, P<0.05). Overall feed to gain ratio was lower for the treated groups than the control. Mortality was low and no veterinary interventions were required. The sixth study was essentially a duplicate of the fifth except for the doses used in the two treatment groups which were 0.25 g/kg (equivalent to 1.9 x 10 9 CFU/kg feed) and 0.5 g/kg (equivalent to 3.8 x 10 9 CFU/kg feed). 25 At the end of the experiment the mean weight of the birds from the treatment groups was higher than that of the control group (1.86 kg versus 1.88 kg and 1.98 kg) but only difference with the higher dose group was significant (P<0.05). Overall feed to gain ratio was lower for the group given the highest dose compared to the control and low dose groups. Mortality was low and no veterinary interventions were required. Finally a field trial was described in which Ross 500 chicks were assigned to one of four groups. 26 Diets were based on total amino acids or digestible amino acids with and without supplementation with Probiotic LACTINA. The dose of the additive applied was 0.6 g/kg for the starter period and 0.3 g/kg subsequently. Overall the mean weight of birds given the additive appeared higher than the corresponding controls and consumed less per unit weight gain. However, in the absence of any details on how measurements were made these observations are of limited value Conclusions for chickens for fattening In four of the six experimental studies described there was an observed increase in the final body weight of the treated group compared to a control group. However, it should be noted that in only one of these four studies were treatments replicated. In all others statistical treatments were restricted to individual bird weights Efficacy for piglets Commission Regulation (EC) No 429/2008 recognises suckling piglets (from birth to weaning at days) and weaned piglets (from weaning at days up to 120 days) as separate categories of animals. Evidence of efficacy is required for each growth period although this can be combined in a single study. The applicant has described a number of different experiments individually covering one or both of these categories although the conditions of use refer only to weaned piglets. A total of nine study reports with piglets were provided by the applicant, several of which described two or more trials within the same report. However, the descriptions provided for four studies, all of which were submitted in support of the previous application, were too limited to allow conclusions to be reached. 27 In each case the details on housing were omitted, the dose was given only in terms of kg/tonne applied and there was no statistical analysis of data. The three trials (two studies) with piglets considered in the previous Opinion are also included the present application. 28 The FEEDAP Panel concluded following an evaluation of these studies that acceptable evidence of efficacy was provided only in one study made with weaned piglets and one study with suckling piglets. 24 Technical dossier/supplementary information October 2011/(xi)RN Technical dossier/supplementary information October 2011/(xi)RN Technical dossier/supplementary information October 2011/(xi)RN4. 27 Technical dossier/supplementary information October 2011/(xi)RN5 to Technical dossier/supplementary information October 2011/(xi)RN10, 3 rd trial and

11 In the first additional study considered, 18 sows (Danube White) were divided into two groups, one acting as control and the other the treatment group. 29 Sows in the treatment group had concentrate feed supplemented with the additive from the 110 th day of pregnancy at a rate of 0.5 g/kg feed (equivalent to 2.8 x 10 9 CFU/kg feed, analysed 8.7 x 10 9 CFU/kg feed). Five days after birth piglets from the treatment group had access to creep feed containing the additive at 0.8 g/kg feed (equivalent to 4.5 x 10 9 CFU/kg feed, analysed 2.5 x CFU/kg feed) until weaning at 35 days, thereafter they were given feed supplemented with 0.5 g/kg until day 60 (the end of the experiment). No information is given on the actual numbers of piglets born, surviving to weaning or alive at the end of the experiment; however, there was no significant difference in numbers born between groups or in their mean birth weight. Consequently, the applicant concluded that the additive given to sows did not provide a benefit. At weaning piglets from the treated group had a significantly higher mean weight than those of the control group (6.42 kg versus 6.92 kg, P<0.01). This difference was maintained during the postweaning period but this was only of 25 days which is considered insufficient. The second additional study contains details of two separate trials, the first made with suckling piglets from five days after birth to weaning at 35 days and the second only piglets weaned at 35 days for 60 days. 30 In both cases diets for piglets in the treatment group were supplemented with 0.8 g additive/kg feed. No analysis of the actual content in feed or in the additive batch used was provided and so it is not possible to estimate the actual dose received by the piglets but, based on the minimum specification it would have been at least 4 x 10 9 CFU/kg feed. In both experiments animals were individually weighed. Suckling pigs were produced by four sows per treatment (40 in control group and 33 in the treatment group). No significant differences were seen between control and treated groups in the percentage of piglets surviving to weaning, weight at weaning or in their growth rate. A total of 20 weaned piglets (equal numbers of male and female) were equally divided between a control group and a treatment group receiving a diet supplemented with Probiotic LACTINA. All 20 piglets came from the untreated group and had not previously been exposed to the additive. Male and female piglets were separately housed. At the end of the experiment, piglets from the treated group were heavier than those of the control group (17.7 kg versus 20.4 kg, n.s) and had a significantly higher mean daily growth rate (0.18 kg versus 0.22 kg/day, P<0.05). In the third study, newborn piglets from ten sows were allocated to two groups, the first of 54 piglets acting as the control group and the second of 53 piglets the treatment group. 31 Piglets were housed with their sows (five per treatment) and given access to granulated feed from day 14 with or without 0.5 g/kg additive (analysed value 6.5 x 10 9 CFU/kg feed) until weaning on day 30. The mean weight of piglets in the treated group at weaning was significantly greater than those of the control group (7.8 kg versus 6.9 kg, P<0.001). All surviving piglets continued on experiment in the same experimental groups and the treatment group continued to be supplied with the additive at 0.5 g/kg until the end of the experiment on day 84. The housing of the piglets is unclear other than the statement that they were kept in groups. The lack of statistical analysis applied to feed intake implies that a group consisted of all animals within a treatment. Piglets on treatment retained their higher body weight compared to the control animals and at the end of the experiment their mean body weight was 43.2 kg compared with 37.7 kg (P<0.001). When the difference in weaned weights was taken as a covariate a significant benefit attributable to the additive post-weaning was also seen. 29 Technical dossier/supplementary information October 2011/(xi)RN9. 30 Technical dossier/supplementary information October 2011/(xi)RN Technical dossier/supplementary information October 2011/(xi)RN17. 11

12 Total mortality for the entire period of the study in the control group was 20.4%, while in the group with Probiotic LACTINA 5.7%. The cause of deaths largely related to gastrointestinal disorders Conclusions for piglets In three of the studies provided in which the suckling period was considered, there was an evidence of a significant benefit of the additive in terms of a higher body weight of piglets at weaning. However, given the use of different doses of the additive, the uncertainty surrounding the actual dose applied and the dosing of sows in one study, it is difficult to identify a minimum effective dose. Overall it would appear that, based partly on the values for the calculated dose and partly on the analysed value in feed, a minimum effective dose might be in the region of 5 x 10 9 CFU/kg complete feed. Evidence of efficacy post-weaning is less certain. Although three studies indicated improvements in final body weight and/or weight gain, there was essentially no replication within treatments and the statistical analysis was restricted to individual animal weight. Consequently, the FEEDAP Panel is unable to conclude on the efficacy of the additive when used in starter diets for weaned piglets. CONCLUSION The additive has a short shelf-life unless stored under protected conditions and refrigeration. The applicant s claim for a shelf-life of 12 months at 20 ºC is not supported. The identity of all of the component strains of Probiotic LACTINA has been established and five of the six qualify for the QPS approach to safety assessment. As no antibiotic resistance of concern was detected in these strains, following the QPS approach, the use of these five strains in feedingstuffs is presumed safe for target species and consumers of products from animals. As the sixth strain (Enterococcus faecium) is not a recognised pathogen for the chickens or piglets and oral dosing into these species with the Probiotic LACTINA strain did not elicit any detectable adverse responses and as the additive itself did not adversely affect growth of chickens for fattening or piglets, the additive is considered safe for the target species to a maximum of 1 x CFU/kg complete feed. E. faecium (NBIMCC 8270) does not contain marker genes typical of hospital-associated isolates responsible for clinical infections and is susceptible to clinically relevant antibiotics. The metabolism of E. faecium is well known and when the potential for infection is excluded, no other harmful metabolites or substances are expected to be produced during fermentation. Consequently, as no safety issues relating to the active agents have been identified and as the additive does not contain excipients of concern, the FEEDAP Panel considers the additive to be safe for consumers when used under the conditions proposed. The FEEDAP Panel based on the data provided was unable to conclude on the efficacy of Probiotic LACTINA when used in diets for chickens for fattening. The additive has the potential to increase the body weight of suckling piglets. Although difficult to establish, a minimum effective dose might be in the region of 5 x 10 9 CFU/kg complete feed. There was insufficient evidence presented to conclude on the efficacy of the additive when used with diets for weaned piglets. DOCUMENTATION PROVIDED TO EFSA 1. Technical dossier of Probiotic LACTINA. January Submitted by Probiotic Lactina Ltd. 2. Technical dossier of Probiotic LACTINA. Supplementary information October Submitted by Probiotic Lactina Ltd. 3. Technical dossier of Probiotic LACTINA. Supplementary information March Submitted by Probiotic Lactina Ltd. 12

13 4. Technical dossier of Probiotic LACTINA. Supplementary information December Submitted by Probiotic Lactina Ltd. REFERENCES EFSA (European Food Safety Authority), Opinion of the Scientific Committee on a request from EFSA on the introduction of a Qualified Presumption of Safety (QPS) approach for assessment of selected microorganisms referred to EFSA. The EFSA Journal (2007) 587, EFSA (European Food Safety Authority), Scientific Opinion of the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) on a request from the European Commission on Probiotic LACTINA for chickens for fattening, piglets and pigs. The EFSA Journal (2009) 912, 1-8. EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP), 2012a. Guidance on the assessment of bacterial susceptibility to antimicrobials of human and veterinary importance. EFSA Journal, 10(6):2740, 10 pp. EFSA Panel on Biological Hazards (BIOHAZ), 2012b. Scientific Opinion on the maintenance of the list of QPS biological agents intentionally added to food and feed (2012 update). EFSA Journal, 10(12):3020, 84 pp. 13

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