Bioaccumulation of Polybrominated Diphenyl Ethers by Tubifex Tubifex.

The selective uptake of polybrominated diphenyl ethers (PBDEs) by oligochaetes makes it possible to assess the bioaccumulation of individual congeners in commercial mixtures. Twenty-one congeners from three BDE commercial mixtures (TBDE-71, TBDE-79 and TBDE-83R) and as individual congeners (BDE-77, BDE-126, BDE-198 and BDE-204) were tested on Tubifex tubifex in accordance with the OECD TG 315 "Bioaccumulation in Sediment-Dwelling Benthic Oligochaetes". All the congeners that were spiked in the sediment were detected at the end of the uptake phase and at the end of the experiment. The bioaccumulation factor (BAF), the kinetic bioaccumulation factor (BAFK) and the biotasediment accumulation factor (BSAF) were calculated, and indicate a high bioaccumulation potential for tri- to hexa-BDEs and a lower bioaccumulation potential for hepta- to deca-BDEs. The penta-homologues BDE-99 and BDE-100 showed the highest BSAFs of 4.84 and 5.85 (BAFs of 7.34 and 9.01), while the nona- and deca-BDEs exhibit bioaccumulation in up to one-order-lower concentrations. The change in the bioaccumulation potential between the group of trito hexa-BDEs and hepta- to deca-BDEs correlated with the generally accepted molecular-mass threshold for the molecular transition through biological membranes (700 g/mol).

Safety and efficacy of a feed additive consisting of Allura Red AC for small non-food-producing mammals and ornamental birds (Versele-Laga).

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 Allura Red AC for small non-food-producing mammals and ornamental birds when used as an additive that add or restore colour in feedingstuffs. The use of Allura Red AC up to the proposed conditions of use of 500 mg/kg complete feed is considered safe for guinea pig, chinchilla, degu, hamster, gerbil and chipmunk. The following maximum safe levels (mg/kg complete feed) apply to the following species: ferrets 99, rabbits 123, canaries, budgerigars, mynah and toucans 45, lovebirds 51, cockatiels 79, cockatoos 115, amazons 145, parrots 147, yellow breast macaw 150, blue-throated macaw 173 and hyacinth macaw 214. The maximum safe level of Allura Red AC for other small non-food-producing mammal is 99 mg/kg feed and for other ornamental birds is 45 mg/kg feed. Inhalation exposure of Allura Red is regarded as hazardous. In the absence of data, the Panel cannot conclude on the potential of Allura Red to be a skin/eye irritant or a skin sensitiser. The FEEDAP Panel cannot conclude on the efficacy of the additive.

Safety and efficacy of the feed additive consisting of Clostridium butyricum FERM BP-2789 (Miya-Gold® S) for chickens for fattening, chickens reared for laying, turkeys for fattening, turkeys reared for breeding, minor avian species (excluding laying birds), piglets (suckling and weaned) and minor porcine species (Miyarisan Pharmaceutical Co. Ltd.).

The feed additive under assessment (trade name: Miya-Gold® S) is based on viable spores of Clostridium butyricum FERM BP-2789. It is authorised for use in minor avian species (excluding laying birds), weaned piglets and minor weaned porcine species, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. This opinion concerns the request for renewal of the authorisation of Miya-Gold® S for the species/categories for which an authorisation exists, the use in chickens for fattening, for which the previous authorisation had expired, and the extension of use to suckling piglets and suckling minor porcine species. The applicant provided evidence that the additive currently in the market complies with the conditions of authorisation. There is no new evidence that would lead the Panel to reconsider previous conclusions that Miya-Gold® S remains safe for the animal species/categories, the consumer and the environment under the current and previously authorised conditions of use. This conclusion applies also to the new target species for which a request of use is made. Regarding the safety for the user, the Panel concluded that the additive is not irritant to skin and eyes and that sensitisation via respiratory route cannot be excluded. There is no need for assessing the efficacy of Miya-Gold® S in the context of the renewal of the authorisation in chickens reared for laying, turkeys for fattening and reared for breeding, minor avian species (excluding laying birds), weaned piglets and weaned minor porcine species. The additive has the potential to be efficacious in chickens for fattening, suckling piglets and suckling minor porcine species at the level of 2.5 × 108 CFU/kg complete feedingstuff. Miya-Gold® S is compatible with decoquinate, diclazuril, lasalocid, maduramicin ammonium, narasin, narasin/nicarbazin, monensin sodium, robenidine, salinomycin sodium and semduramicin.

Safety and efficacy of FSF10000 and FLF1000 (3-phytase) as a feed additive for turkeys for fattening or reared for breeding, pigs for fattening and minor porcine 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 the safety and efficacy of 3-phytase FLF1000 and FSF10000 as a feed additive for turkeys for fattening or reared for breeding, pigs for fattening and minor porcine species for growing. This additive contains 3-phytase produced by a genetically modified strain of Komagataella phaffii and it is authorised in the EU as a feed additive for feed for chickens for fattening, laying hens, chickens reared for laying and for minor poultry species for fattening or reared for laying/breeding. The applicant requested the extension of use of the additive (both forms) to turkeys for fattening or reared for breeding purposes, and the assessment of the solid formulation to be used in pigs for fattening and minor porcine species for growing. The FEEDAP Panel concluded based on previously evaluated data that the additive, in either form, is safe for turkeys for fattening or reared for breeding at the maximum recommended level of 1,000 FTU/kg feed. However, due to lack of data the Panel could not conclude on the safety for pigs for fattening or minor growing porcine species. The FEEDAP Panel concludes that the use of the additive under the proposed conditions of use is safe for the consumer and the environment. Both forms of the additive are not irritant to eyes and skin but should be considered a potential respiratory sensitiser. The liquid formulation is not a dermal sensitiser but the solid formulation is. The Panel also considered based on previously evaluated data that the additive has a potential to be efficacious as a zootechnical additive in turkeys for fattening and reared for breeding and in pigs for fattening and minor growing porcine species at 500 FTU/kg feed.

Efficacy of iron chelates of lysine and glutamic acid as feed additive for all animal 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 the efficacy of iron chelates of lysine and glutamic acid (Iron-LG) as nutritional feed additive for all animal species. The European Commission request followed an opinion of the FEEDAP Panel published in 2019; in that opinion the Panel could not conclude on the efficacy of the additive. The applicant 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. Three studies were provided, one each with weaned piglets, pigs for fattening and laying hens. In the study in laying hens, improvements in iron content in egg yolk, iron in serum and in other iron-related blood endpoints were observed. Based on the results of this study, the FEEDAP Panel concluded that the additive is a source of bioavailable iron, comparable to the standard inorganic iron source, and therefore, the additive is efficacious in meeting the animals' requirements; the results of the study in pigs for fattening supported the bioavailability of Iron-LG. The conclusion drawn by the Panel could be extrapolated to all animal species and categories.

Safety and efficacy of Avatec® 150G (lasalocid A sodium) as a feed additive for chickens for fattening and chickens reared for laying.

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 Avatec® 150G (lasalocid A sodium) for chickens for fattening and chickens reared for laying. In 2017, the FEEDAP Panel was not able to conclude on a safe dose for chickens for fattening and chickens reared for laying and no conclusion could be drawn on the anticoccidial efficacy of the additive at the lowest proposed used level (75 mg lasalocid A sodium/kg feed) in these species. In the present assessment, the applicant submitted new tolerance and efficacy studies in chickens for fattening to address the concerns identified by the FEEDAP Panel in its former opinion. In addition, the applicant proposed to decrease the maximum of the dose range from 125 to 100 mg lasalocid A sodium/kg complete feed. Based on the additional information, the FEEDAP Panel concludes that no safe level of lasalocid A sodium from Avatec® 150G in feed for chickens for fattening can be identified. The FEEDAP Panel is not in the position to conclude on the coccidiostatic efficacy of Avatec® 150G for chickens for fattening at the lowest proposed dose level of 75 mg lasalocid A sodium/kg complete feed due to the insufficient number of studies with positive results. The conclusions are extended to chickens reared for laying.

Assessment of the application for renewal of authorisation of Biosprint® (Saccharomyces cerevisiae MUCL 39885) as a feed additive for weaned piglets.

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 assessment of the application for renewal of the authorisation of the product Biosprint® (Saccharomyces cerevisiae MUCL 39885) as a feed additive for weaned piglets. Biosprint® is composed of only viable cells of Saccharomyces cerevisiae MUCL 39885. S. cerevisiae is considered by EFSA to have qualified presumption of safety status. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of the authorisation. The FEEDAP Panel confirms that the use of Biosprint® under the current authorised conditions of use is safe for weaned piglets, the consumers and the environment. The additive is considered as a potential skin and eye irritant and a skin and respiratory sensitiser. There is no need to assess the efficacy of Biosprint® in the context of the renewal of the authorisation.

Safety and efficacy of Manganese chelates of lysine and glutamic acid as 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 manganese chelates of lysine and glutamic acid (Manganese-LG) as nutritional feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. The Panel concluded that, owing to safety considerations, the simultaneous use of both feed and water supplemented with Manganese-LG should be avoided. Manganese-LG showed to be safe for chickens for fattening up to the maximum authorised levels in the EU for manganese in feed (150 mg/kg); however, since a margin of safety could not be derived, the conclusions could not be extrapolated/extended to other categories/species. The data showed that Manganese-LG does not increase nor change the patterns of manganese tissue deposition when administered up to the maximum level allowed in the EU; therefore, the Panel concluded that the additive is safe for consumers of tissues and products from animals fed the additive up to the total manganese content in feed authorised in the EU. Owing to the manganese and nickel content of Manganese-LG, the Panel concluded that the handling of the additive poses a risk to users by inhalation and shall be considered as a skin and respiratory sensitiser; the data showed that the additive is irritant to eye and non-irritant to skin. Manganese-LG, intended to substitute other authorised manganese additives, will not further increase the environmental burden of manganese; the Panel considered that the use of the additive in animal nutrition would not pose an additional risk for the environment. The Panel concluded that the additive is efficacious in chickens for fattening; this conclusion can be extrapolated/extended to other categories/species. The FEEDAP Panel posed a recommendation concerning the description of the additive.

Safety and efficacy of oct-1-en-3-ol, pent-1-en-3-ol, oct-1-en-3-one, oct-1-en-3-yl acetate, isopulegol and 5-methylhept-2-en-4-one, belonging to chemical group 5 and of isopulegone and α-damascone belonging to chemical group 8 when used as flavourings 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 oct-1-en-3-ol [02.023], pent-1-en-3-ol [02.099], oct-1-en-3-one [07.081], oct-1-en-3-yl acetate [09.281], isopulegol [02.067] and 5-methylhept-2-en-4-one [07.139], belonging to chemical group 5, and of isopulegone [07.067] and α-damascone [07.134] belonging to chemical group 8, when used as feed flavourings for all animal species. They are currently authorised for use as flavours in food. The FEEDAP Panel was unable to assess the safety of isopulegone because the purity of the compound could not be established and the safety of α-damascone [07.134] because of the inconclusive assessment of its genotoxicity. The FEEDAP Panel concluded that the use of isopulegol [02.067] is safe at the maximum proposed dose of 5 mg/kg complete feed for all animal species, except cats for which the use level of 1 mg/kg is considered safe. 5-Methylhept-2-en-4-one [07.139] is safe at the proposed normal use levels of 1 mg/kg complete feed for all animal species. For oct-1-en-3-ol [02.023], pent-1-en-3-ol [02.099], oct-1-en-3-one [07.081] and oct-1-en-3-yl acetate [09.281], the calculated safe use level is 1 mg/kg complete feed for all animal species, except cats for which the calculated safe level is 0.6 mg/kg. No safety concern would arise for the consumer from the use of these compounds up to the highest safe levels in feed. In the absence of studies to assess the safety for the user, the FEEDAP Panel cannot conclude on the safety for the users when handling the additives. Use of the compounds in animal feed at the maximum safe level is considered safe for the environment. Since the compounds are used in food as flavourings and their function in feed is essentially the same, no demonstration of efficacy is necessary.

Safety of hexamethylene tetramine for pigs, poultry, bovines, sheep, goats, rabbits and horses.

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 hexamethylene tetramine (HMTA) for pigs, poultry, bovines, sheep, goats, rabbits and horses. In 2015, the FEEDAP Panel delivered an opinion on the safety and efficacy of HMTA. In that opinion, the Panel noted that the residues of HMTA in the silage amounted to about 5% of the inclusion level of 600 mg HMTA/kg fresh ensiling material. Since the HMTA residues in silage were analysed as formaldehyde, it was not possible to quantify the contribution of formaldehyde and HMTA to the residues. In the absence of a qualitative and quantitative characterisation of the residues, the Panel could not conclude on the safety of HMTA for the target species. Based on the results of a new study in which HMTA was measured in silage, the concentration of HMTA dropped below the limit of quantification of 6 mg HMTA/kg silage, which corresponds to ~ 1% of the HMTA inclusion level in the fresh ensiling material. However, the formaldehyde concentration was not analysed in the silage. In the absence of a qualitative and quantitative characterisation of the residues, the Panel cannot conclude on the safety of HMTA for the target species.

Assessment of the application for renewal of authorisation of Ecobiol® (Bacillus amyloliquefaciens CECT 5940) as a feed additive for chickens for fattening and its extension of use for chickens reared for laying.

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 Ecobiol® when used as a zootechnical additive in feed for chickens for fattening and chickens reared for laying at 1.0 × 109 colony forming units (CFU)/kg feed. Ecobiol® is the trade name for a feed additive based on Bacillus amyloliquefaciens CECT 5940, currently authorised for use in chickens for fattening. This opinion concerns the renewal of the authorisation of Ecobiol® for chickens for fattening and the evaluation of the new use with chickens reared for laying. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel concludes that Ecobiol® is safe under the current conditions of authorisation for the target species (chickens for fattening and chickens reared for laying), consumers of products from animals fed the additive and the environment. Ecobiol® is not irritant to skin/eye or a skin sensitiser but should be considered a potential respiratory sensitiser. Due to a high dusting potential, exposure of users by inhalation is likely. There is no need for assessing the efficacy of Ecobiol® in the context of the renewal of the authorisation. The additive, at the level of 1 × 109 CFU/kg feed, has the potential to be efficacious in chickens reared for laying.

Safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory additive for all animal 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 the safety and efficacy of a dried aqueous ethanol extract of Melissa officinalis L. leaves when used as a sensory feed additive for all animal species. The aqueous ethanol extract is specified to contain ≥ 10% of hydroxycinnamic acid derivatives including ≥ 3% of rosmarinic acid. Considering the contradictory data from the Ames tests and uncertainty about the qualitative and quantitative presence of flavonoids and other compounds in the extract from M. officinalis L. leaves, the FEEDAP Panel could not conclude on the genotoxicity of the additive under assessment. Although the identified components of the extract do not raise concerns for the safety of target species, the analysis of the extract is incomplete. In the absence of adequate analytical and safety data, the FEEDAP Panel is unable to conclude on the safety of the additive for the target species. The use of M. officinalis L. leaf dried extract in animal feed at the proposed use level does not raise significantly the exposure levels of the consumer for compounds derived from this plant. However, in the absence of adequate data on genotoxicity, the Panel cannot conclude on the safety for the consumer. In the absence of specific studies, the FEEDAP Panel cannot conclude on the safety of the additive for the user. M. officinalis L. is a native species to Europe and its use in animal nutrition is not expected to pose a risk for the environment. Since M. officinalis L. and its extracts are recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the extract.

Safety and efficacy of 4-phenylbut-3-en-2-one and benzophenone belonging to chemical group 21 when used as flavouring compounds 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 4-phenylbut-3-en-2-one [07.024] and benzophenone [07.032] belonging to chemical group 21, when used as feed flavourings for all animal species. They are currently authorised for use as flavours in food. The use of 4-phenyl-3-butene-2-one [07.024] is safe at the proposed normal use levels of 1 mg/kg complete feed for all animal species. Benzophenone [07.032] is safe at the proposed normal use levels of 1 mg/kg complete feed for all animal species except chicken for fattening, laying hens and piglets, for which the calculated safe concentration in feed is 0.5 mg/kg. No safety concern would arise for the consumer from the use of 4-phenyl-3-butene-2-one [07.024] and benzophenone [07.032] as feed flavourings. In the absence of studies to assess the safety for the user, the FEEDAP Panel cannot conclude on the safety for users when handling the additives. The use of 4-phenyl-3-butene-2-one [07.024] and benzophenone [07.032] in animal feed at the maximum safe use level in feed is also considered safe for the environment. Since the compounds under assessment are used in food as flavourings and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

Safety and efficacy of a dried aqueous ethanol extract of leaves from Olea europaea L. when used as a sensory additive in feed for all animal 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 the safety and efficacy of a dried aqueous ethanol extract of leaves from Olea europaea L., when used as a sensory feed additive for all animal species. The extract is specified to contain ≥ 20% oleuropein. As a full analysis of the extract was not provided, about 70% of the extract remained uncharacterised. In view of the inadequate chemical and toxicological characterisation of the additive, the FEEDAP Panel is unable to conclude on the safety for the target species, the consumers and the users. O. europaea L. is a native species to Europe where it is widely grown for commercial purposes. Use of the extract from the plant in animal production is not expected to pose a risk for the environment. In the absence of data showing the sensory properties of the additive under assessment, the Panel could not conclude on the efficacy of olive leaf extract from O. europaea L. when used as sensory additive.

Safety and efficacy of saponified paprika extract, containing capsanthin as main carotenoid source, for poultry for fattening and laying (except turkeys).

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 saponified paprika extract, containing capsanthin as main carotenoid source, for poultry for fattening and laying (except turkeys). The saponified paprika (Capsicum annuum) extract contains various carotenoids at a concentration of 25-90 g/kg of which capsanthin being the major one with quantity specified as > 35% of total carotenoids (TC). The maximum recommended use level of 40 mg TC/kg feed is safe for chickens for fattening and laying hens. The margin of safety is at least 6. This conclusion is extrapolated to minor poultry species for fattening and laying. The saponified paprika extract is not genotoxic. Based on the no observed effect level (NOEL) of the 90-day study in rat and the exposure estimates, the Panel considered that there would be an adequate margin of exposure (between 700 and 2000) to conclude that the level of exposure to residues of the saponified paprika (C. annuum) extract (capsanthin not less than 35% of TCs) in animal tissues and products does not raise concern for the safety for the consumer. The saponified paprika extract is a viscous paste and as such users will not be exposed by inhalation. The applicant recognises that the extract may be irritant to skin and eyes. The FEEDAP Panel cannot conclude on the potential of any preparation to be toxic by inhalation, skin/eye irritant or skin sensitiser since no data were submitted. The use of saponified paprika extract in poultry feed raised no concern for the environment. Saponified paprika extract has the potential to pigment broiler skin and egg yolk. This conclusion is extrapolated to minor poultry species for fattening and laying.

Assessment of the application for renewal of authorisation of Formi™ LHS (potassium diformate) for sows.

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 assessment of the application for renewal of authorisation of Formi™ LHS (potassium diformate) for sows. The Panel considers that the information provided by the applicant does not fulfil the minimum requirements to support that Formi™ LHS remains safe under the approved conditions for target species, consumers and users. The Panel concludes that the use of Formi™ LHS under the approved conditions remains safe for the environment. The present application for renewal of the authorisation does 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.

Safety and efficacy of Natugrain®TS/TS L (endo-1,4-beta-xylanase and endo-1,4-beta-glucanase) as a feed additive for sows.

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 Natugrain® TS/TS L. The additive is a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by two genetically modified strains of Aspergillus niger, and it is authorised for use in piglets (weaned) and pigs for fattening, poultry species and ornamental birds. The applicant requested the extension of use of the additive to sows at 560 TXU and 250 TGU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of the additive in sows. The additive should be considered a potential respiratory sensitiser for the users. Considering the results from a subchronic oral toxicity study and the tolerance study in lactating sows, the Panel concluded that the additive is safe for sows at the recommended dose. The data submitted to support the efficacy for sows allowed the Panel to conclude that the additive is efficacious in lactating sows, data on gestating sows were not given, and therefore, the Panel could not conclude on the efficacy of the additive in that physiological stage.

Safety and efficacy of Availa®Cr (chromium chelate of DL-methionine) as a feed additive for dairy cows.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Availa®Cr (active compound: chromium chelate of DL-methionine) as a feed additive for dairy cows. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. The tolerance study did not show adverse effects with respect to body weight, milk yield, haematology and blood biochemistry up to the 10-fold overdose of chromium from Availa®Cr; however, owing to deficiencies in design and reporting of the study, it provided only supportive evidence on the safety of the additive. A safe level for dairy cows could be derived from a toxicological study with laboratory rodents. Taking all together, the FEEDAP Panel considers the maximum recommended use level (8 mg Cr from Availa®Cr/cow per day; about 0.4 mg Cr/kg complete feed) as safe. Chromium DL-Met shows a genotoxic activity in vitro that is not expressed in vivo after systemic exposure; although no data on genotoxicity at the site of contact are available, the Panel notes that chromium(III) is not carcinogenic and concludes that chromium DL-Met is unlikely to pose a carcinogenic risk at levels occurring in the diet. The use of Availa®Cr in feed of dairy cows up to the recommended supplementation level would not measurably increase consumer exposure to chromium(III), and therefore is safe for consumers. The additive poses a risk to users by inhalation, it is not an irritant to skin and eyes and should be considered a sensitiser. The use of the additive is not expected to pose a risk to the environment. Since only one study could be considered for the efficacy assessment, and three studies are required, the FEEDAP Panel cannot conclude on the efficacy of Availa®Cr for dairy cows.

Assessment of the application for renewal of authorisation of AviPlus® as a feed additive for all porcine species (weaned), chickens for fattening, chickens reared for laying, minor poultry species for fattening, minor poultry species reared for laying.

AviPlus® is an additive containing a mixture of sorbic acid, citric acid, thymol and vanillin. The applicant requested for the renewal of the authorisation for AviPlus® when used as a feed additive in all porcine species (weaned), chickens for fattening, chickens reared for laying, minor poultry species for fattening, minor poultry species reared for laying. The applicant has provided evidence that the additive in the market complies with the conditions of the authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) confirms that the use of AviPlus® under the current authorized conditions of use is safe for the target species, the consumers, the users and the environment. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Statement on the safety and efficacy of phosphoric acid 60% on silica carrier (UD60) for all animal species.

The additive UD60 (phosphoric acid 60% on silica carrier) is intended to be used as a technological additive (functional group: preservative) for all animal species. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered the characterisation, the safety for the target species and the efficacy of the additive. The applicant has failed to provide the additional information. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive UD60 (phosphoric acid 60% on silica carrier) as a technological additive for all animal species.