Bioaccumulation of Polybrominated Diphenyl Ethers by Tubifex Tubifex

Conservation Biolog

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

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 copper chelates of lysine and glutamic acid as a feed additive for all animal species

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of copper chelates of lysine and glutamic acid (Copper-LG) as a nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that, owing to safety considerations, Copper-LG should not be used in water for drinking. Copper-LG is safe for chickens for fattening; this conclusion can be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total copper in feed are not exceeded. No increases in the copper content of animal tissues/products are expected from the use of Copper-LG in animal nutrition. There is no indication that the toxicity of Copper-LG is essentially different from that of inorganic divalent copper. The use of Copper-LG in animal nutrition is of no concern for consumer safety provided that the maximum authorised total copper in feed is respected. Owing to the copper and nickel content of Copper-LG, the handling of the additive, poses a risk to users by inhalation. The additive is considered as a skin and respiratory sensitiser; it is corrosive to the eye while it is non-irritant to skin. The additive is intended to be a substitute for other authorised copper additives and will not further increase the environmental burden of copper; therefore, the FEEDAP Panel considers that the use of the additive in animal nutrition would not pose an additional risk for the environment. Copper-LG is a bioavailable source of copper, comparable to the standard inorganic copper source, and therefore, the additive is efficacious in meeting the birds copper requirements; this conclusion can be extrapolated to all animal species/categories. The FEEDAP Panel posed a recommendation concerning the description of the additive

Safety and efficacy of an essential oil of Origanum vulgare ssp. hirtum (Link) leetsw. for all poultry species

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of an essential oil of Origanum vulgare ssp. hirtum (Link) leetsw. for all poultry species. The essential oil under assessment obtained is specified to contain carvacrol and thymol (7%). The remaining 30% of the composition remains uncharacterised. In the absence of these data, the FEEDAP Panel was unable to make a risk assessment of the additive for the target species, the consumer and the user. Use in animal production of the essential oil extracted from O. vulgare ssp. hirtum (Link) leetsw. is not expected to pose a risk for the environment. Since oregano and its extracts are universally recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary

Safety and efficacy of muramidase from Trichoderma reesei DSM 32338 as a feed additive for turkeys for fattening, turkeys reared for breeding, chickens reared for breeding and other poultry species reared for breeding

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 safety and efficacy of muramidase produced by Trichoderma reesei DSM 32338. The additive is considered safe for turkeys for fattening, turkeys reared for breeding, chickens reared for laying/breeding and other poultry species reared for breeding up to the maximum recommended dose of 45,000 LSU(F)/kg feed. The additive is considered safe for the consumer and the environment. No conclusions can be reached on the potential of the additive for skin/eye irritancy and skin sensitisation. The additive should be considered a potential respiratory sensitiser. The additive has the potential to be efficacious as a zootechnical additive in turkeys for fattening, turkeys reared for breeding, chickens reared for laying/breeding and other poultry species reared for breeding when added to feed at 25,000 LSU(F)/kg feed

Assessment of the application for renewal of authorisation of Bactocell® (Pediococcus acidilactici CNCM I-4622) as a feed additive for weaned piglets, pigs for fattening, minor porcine species (weaned and for fattening), chickens for fattening, laying hens and minor avian species for fattening and for laying and its extension of use to all growing pigs and all avian species

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 Bactocell\uae (Pediococcus acidilactici CNCM I-4622) in the context of the renewal of the authorisation for weaned piglets, pigs for fattening, minor porcine species (weaned and for fattening), chickens for fattening, laying hens and minor avian species for fattening and for laying when used as a zootechnical feed additive (gut flora stabiliser) in feed or in water for drinking. In addition, the applicant requested the extension of use for suckling piglets, minor pig species (growing/for fattening), chickens reared for laying, chickens reared for breeding purposes, chickens for breeding purposes, turkeys and minor avian species (including non-food producing/ornamental birds) reared for laying/breeding purposes and for breeding purposes when used as in feed or in water for drinking. The applicant has provided evidence that the additive currently on the market complies with the conditions of authorisation. The additive is safe for the target species, consumers and the environment as well. The additive is non-irritant to skin and eyes and is not a dermal sensitiser but should be considered a respiratory sensitiser. Considering the high dusting potential of the formulations, exposure of users by inhalation is very likely. The additive, at the level of 1  7 109 CFU/kg feed (5  7 108 when delivered in water), has the potential to be efficacious in the new species proposed: chickens reared for laying, chickens reared for breeding purposes, chickens for breeding purposes, turkeys and minor avian species reared for laying/breeding purposes and for breeding purposes (including non-food producing/ornamental birds) and in suckling piglets and minor porcine species (growing/for fattening)

Assessment of the application for renewal of authorisation of PHYZYME® XP 5000 G/L (6-phytase) for chickens for fattening, laying hens, turkeys for fattening, ducks for fattening, weaned piglets, pigs for fattening and sows for reproduction

PHYZYME\uae XP 5000 G/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 5000 G and L to be used as a feed additive in chickens for fattening, laying hens, turkeys for fattening, ducks for fattening, piglets (weaned), pigs for fattening and sows. This scientific opinion concerns the renewal of the authorisation of the additive for those species. To support the request, 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 or supplementing the conditions of the original authorisation 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

Safety and efficacy of an essential oil from Elettaria cardamomum (L.) Maton when used as a sensory additive in feed 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) was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the seeds of Elettaria cardamomum (L.) Maton when used as a sensory additive for all animal species. Characterisation of the essential oil identified 37 components accounting for > 99% of its composition, with terpineol acetate (> 35%) and 1,8-cineole (> 20%) being the most prevalent compounds. In the absence of toxicological data of the feed additive itself, a component-based approach was applied to assess the safety of the essential oil as a mixture. Based on structural and metabolic similarity, the components of cardamom oil were allocated to seven assessment groups. Assuming the absence of toxicologically relevant interactions among components, dose addition was applied within each assessment group by calculating the combined margin of exposure as a basis for risk characterisation. The FEEDAP Panel concluded that the additive under assessment is safe at the proposed use level of 5 mg/kg in feed for all animal species. A concentration of 5 mg/L water for drinking is considered safe for all animal species. The use of cardamom essential oil in animal feed is considered safe for the consumer. In the absence of studies, the Panel cannot conclude on the safety for the users when handling the additive. The use of the essential oil under assessment in animal production is not expected to pose a risk for the environment. Since the seeds of E. cardamomum and their preparations are recognised to flavour food and their function in feed would be essentially the same, no further demonstration of efficacy is considered necessary. The Panel made a recommendation to limit the content of methyleugenol in the oil