Assessment of the application for renewal of authorisation of GalliPro ® (Bacillus subtilis DSM 17299) for chickens for fattening

GalliPro \uae is the trade name for a feed additive based on viable cells of a strain of Bacillus subtilis intended for use as a zootechnical additive (gut flora stabiliser) in feed for chickens for fattening. The product is currently authorised for use in chickens for fattening. This opinion concerns the renewal of this authorisation. Bacillus subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establish the safety for the target species, consumers and the environment. The identity of the strain present in the additive was established and evidence was provided on the lack of toxigenic potential as well as acquired antibiotic resistance determinants to antibiotics of human and veterinary importance. Accordingly, this strain is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, GalliPro \uae is considered safe for the target species, consumers and the environment. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel confirms its previous conclusions that GalliPro \uae is safe for the target species; consumers of products from animals fed the additive and the environment. GalliPro \uae should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential of GalliPro \uae for skin and eyes irritancy and dermal sensitisation

Assessment of the application for renewal of the authorisation of PHYZYME® XP 10000 TPT/L (6-phytase) as a feed additive for all avian species and all swine species

PHYZYME\uae XP 10000 TPT/L is a feed additive that contains 6-phytase produced by a genetically modified strain of Schizosaccharomyces pombe. The applicant requested for the renewal of the authorisation for PHYZYME\uae XP 10000 TPT and L to be used as a feed additive for avian species for fattening/laying, weaned piglets, pigs for fattening and sows and for an extension of use to avian species reared for laying/breeding, suckling piglets and minor porcine species. To support the request or the renewal of the authorisation, the applicant provided evidence that the additive in the market complies with the conditions of the authorisation. According to the information provided by the applicant, no new evidence has been identified that would make the FEEDAP Panel reconsider the previous conclusions regarding the safety for the target species, consumer, user and environment. The application for renewal of the authorisation did not include a proposal for amending the conditions of use in those species for which an authorisation exists that would have an impact on the efficacy of the additive. Therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. Regarding the new species/categories, the Panel concluded that the additive is safe and has a potential to be efficacious in avian species reared for laying/breeding at 250 FTU/kg feed and for suckling piglets and minor porcine species at 500 FTU/kg feed

Efficacy of the feed additive containing Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I-3740 (Biacton\uae) for chickens for fattening, turkeys for fattening and laying hens (ChemVet dk A/S)

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the efficacy of the additive consisting of Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I-3740 (tradename: Biacton\uae) for chickens for fattening, turkeys for fattening and laying hens. The additive is a preparation containing viable cells of C. farciminis CNCM I-3740 at the minimum concentration of 1  7 109 CFU/g additive. In a previous opinion, the FEEDAP Panel assessed the safety and the efficacy of the product when used in these target species. The Panel concluded that based on the qualified presumption of safety of the active agent, and the lack of concerns deriving from other components of the additive, Biacton\uae was presumed safe for the target animals, consumers and the environment. Regarding the safety for the user, the FEEDAP Panel could not conclude on the potential of the additive to be irritant to skin and eyes or its dermal sensitisation due to the lack of data. However, it concluded that the additive should be considered a respiratory sensitiser. The data provided in the previous assessment to support the efficacy of the additive did not allow drawing conclusions on the efficacy of the additive in any of the target species. The additional information submitted with chickens for fattening and laying hens did not provide sufficient evidence to conclude on the efficacy of Biacton\uae for these target species. No new information was provided that would lead the Panel to reconsider the conclusions already reached on the use of the additive with turkeys for fattening. The FEEDAP Panel, based on the available data, cannot conclude on the efficacy of Biacton\uae in chickens for fattening, turkeys for fattening and laying hens

Safety and efficacy of a natural mixture of dolomite plus magnesite and magnesium-phyllosilicates (Fluidol) as feed additive for all animal species

The additive, a natural mixture of dolomite plus magnesite and magnesium-phyllosilicates, is intended to be used as a technological additive (functional groups: anticaking agents) in feedingstuffs for all animal species. The additive is safe in complete feed for dairy cows, piglets and pigs for fattening at a maximum concentration of 20,000 mg/kg. No conclusions can be drawn for all the other animal species/categories. The additive is not genotoxic. As the additive is essentially not absorbed from the gut lumen, the Panel on Additives and Products or Substances used in Animal Feed considers that use of the additive in animal nutrition is safe for consumers of food products from animals fed diets containing the additive. The additive is not an irritant to the eyes and the skin, it is not a skin sensitiser and it is of low toxicity by the inhalation route. The components of the additive (dolomite, magnesite, talc and chlorite) are natural constituents of soil. Consequently, the use of the additive in animal nutrition will not pose a risk to the environment. The additive is effective as an anticaking agent at a minimum inclusion level of 5,000 mg/kg feed

Safety and efficacy of APSA PHYTAFEED® 20,000 GR/L (6-phytase) as a feed additive for chickens for fattening, chickens reared for laying and minor growing poultry species

APSA PHYTAFEED\uae 20,000 GR/L is a preparation of 6-phytase which is presented in solid and liquid forms. This additive is intended to be used as a zootechnical additive in chickens for fattening or reared for laying/breeding and minor poultry species for fattening or reared for laying/breeding. The 6-phytase present in the additive is produced by a genetically modified strain of Komagataella phaffii. The production strain and its recombinant DNA were not detected in intermediate products used to produce the additive. The final products do not trigger a safety concern with regard to the genetic modification. Based on the results obtained in a tolerance study in chickens for fattening and the data from a subchronic oral toxicity study the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion was extended to chickens reared for laying/breeding and extrapolated to all minor poultry species for fattening or reared for laying/breeding. The FEEDAP Panel concluded that the use of APSA PHYTAFEED\uae 20,000 GR/L as a feed additive gives rise to no concern for consumers. The additive, in either form, is not toxic by inhalation or irritant for skin or eyes and it is not a dermal sensitizer, but it is considered a potential respiratory sensitizer. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel evaluated three efficacy trials in which the retention of the phosphorus was studied. The data showed that the additive has the potential to improve the retention of phosphorus in the diets in chickens for fattening at 250 U/kg feed. This conclusion was extended to chickens reared for laying/breeding and extrapolated to all minor poultry species for fattening or reared for laying/breeding

Safety and efficacy of methylester of conjugated linoleic acid (t10,c12 isomer) for pigs for fattening, sows and cows

A mixture of methylated conjugated linoleic acid (CLA) isomers (t10,c12 and c9,t11) in equal proportions was not genotoxic and caused no reproductive toxicity. In a sub-acute study in dogs, a sub-chronic toxicity study in rats and a chronic study in dogs, no adverse effects were seen up to the highest levels tested. The maximum recommended feed concentration (5 g CLA (t10,c12)-ME from Lutalin (R)/kg feed for piglets, pigs for fattening and sows) or dose (30 g CLA (t10,c12)-ME from Lutrell (R) Pure/cow per day) is considered safe for target species. The CLA content of milk from cows treated with the highest recommended dose did not exceed background values (in milk of untreated cows) for both CLA isomers. An estimate of consumer exposure to both CLA isomers from food from pigs receiving 3 g of both CLA isomers/kg feed is <= 320 mg CLA isomers/person and day. This quantity corresponds to about 9% of the quantity considered safe for 6 months and is considered unlikely to raise concerns for consumer safety. Exposure of users by inhalation of the additive is likely to be minimal. Neither of the products under application, the liquid or the solid product, was tested as such for skin and eye irritation and skin sensitisation. The use of the additive in animal nutrition would not pose a risk to the environment. In pigs for fattening, CLA (t10,c12)-ME has a potential for improving feed to gain ratio. More consistent effects are a reduction in subcutaneous fat, an increase in intramuscular fat and fat firmness. No essential effects were found in sows. Administration of CLA to dairy cows reduces in a dose-dependent manner the fat content of milk, and milk fat yield. Energy balance in early lactation is improved by CLA (t10,c12)-ME; however, reproductive parameters were not influenced

Safety and efficacy of lactic acid and calcium lactate when used as technological additives for all animal species

This opinion concerns the re-authorisation of lactic acid and calcium lactate for use as preservatives in feed and a new authorisation for lactic acid as a preservative in water for drinking. The maximum level of 50 000 mg lactic acid/kg complete feed and 30 000 mg calcium lactate/kg complete feed are considered safe for functional ruminants and pigs. The maximum safe concentration in water for drinking for pigs can be derived from the maximum safe level in feed (15 000 mg lactic acid/L water). No conclusions on the safety of lactic acid in pre-ruminants and poultry can be drawn. These conclusions cannot be extrapolated to other animal species/categories. The use of lactic acid and calcium lactate as feed additives is safe for the consumer. Lactic acid is considered an irritant to eyes and skin and there is a risk of serious damage to the eyes. Inhalation of the mist causes irritation of the respiratory system. Calcium lactate should be considered an irritant to skin, eyes and the respiratory tract. It is likely that handling the additive will result in the production of respirable dust, which could present a risk to unprotected workers. The use of lactic acid and calcium lactate in animal nutrition would not pose a risk to the environment, provided that the concentrations regarded as safe for the target species are not exceeded. Lactic acid and calcium lactate are used in food as preservatives. It is reasonable to expect that the effect seen in food will be observed in feed when these additives are used at comparable concentrations and under similar conditions. However, the Panel has reservations about the effectiveness of lactic acid and calcium lactate as preservatives in complete feedingstuffs with a typical moisture content of <= 12 %

Efficacy of a preparation of algae interspaced bentonite as a feed additive for all animal species

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the efficacy of a preparation of algae interspaced bentonite when used as aflatoxin B1 (AfB1) binder for all animal species; the additive is composed of bentonite feed grade and algae belonging to Ulva spp. The European Commission request follows an opinion of the FEEDAP Panel published in 2016; in that opinion, the FEEDAP Panel could not conclude on the efficacy of the additive. The applicant has submitted additional information to allow the FEEDAP Panel to complete its assessment; these additional data, related to the efficacy of the additive, are the subject of this opinion. In the efficacy study provided, the use of the additive reduced the AfM1 in milk, although this effect seemed to be not consistent over time; this study presented some weaknesses and limitations (incomplete data analysis, reporting and lack of determination of the active substance of the additive in feed) which do not allow the FEEDAP Panel to draw any conclusion on the efficacy of the additive. Due to insufficient evidence, the FEEDAP Panel cannot conclude on the efficacy of the algae interspaced bentonite as a technological feed additive for all animal species

Safety and efficacy of L arginine produced by Corynebacterium glutamicum KCTC 10423BP for all animal species

L-Arginine is considered as a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The following conclusions refer to L-arginine produced by Corynebacterium glutamicum KCTC 10423BP. The use of L-arginine is safe for target species when supplemented to diets in appropriate amounts. There are no safety concerns arising from ruminal L-arginine metabolism. The composition of edible tissues and products of animal origin will not be altered by the use of L-arginine in animal nutrition. Considering the high purity of the product under assessment, no risk is expected for the consumer from the use of L-arginine as a feed additive. L-Arginine is not irritating to skin or eyes and is not likely to be a skin sensitiser. Although there is a potential for user exposure by inhalation, there is evidence of no acute toxicity by the inhalation route. The use of L-arginine in animal nutrition would not pose a risk to the environment. Dietary L-arginine is an effective source of arginine for all animal species when a requirement exists. For the supplemental L-arginine to be fully efficacious in ruminants, it requires protection against degradation in the rumen