Safety and efficacy of the feed additive consisting of Enterococcus lactisNCIMB 10415 (Cylactin®) for all poultry for fattening or reared for laying/breeding and ornamental birds, all Suidae, calves and other ruminant species for fattening or rearing (DSM Nutritional products Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of Cylactin® as zootechnical additive. The active agent of the additive is Enterococcus lactis NCIMB 10415, and three additive formulations currently authorised: Cylactin® LBC G35, Cylactin® LBC ME10 and Cylactin® LBC ME20 plus. The additive is currently authorised in the EU for use in poultry (chickens and minor poultry species for fattening, chickens and minor species reared for laying), calves and kids for rearing and for fattening, sows, suckling and weaned piglets and pigs for fattening. The applicant is now seeking the renewal of its authorisation and the extension of use for chickens and minor poultry species reared for breeding, turkeys for fattening and reared for breeding, ornamental birds, lambs for rearing and for fattening, minor or other ruminants' species for rearing and fattening, minor suckling and weaned Suidae species, pigs and minor Suidae species for fattening, rearing or reproduction. In addition, the applicant is seeking authorisation for use in water for drinking for all above-mentioned target species and categories. The applicant has provided evidence that the additive currently on the market complies with the conditions of authorisation. The FEEDAP Panel concludes that the additive is safe for the target animals, consumers and the environment under the authorised/new proposed conditions of use. The Cylactin® LBC ME10 and LBC ME20 plus are not skin and eye irritants, but no conclusion could be drawn on the potential of Cylactin® LBC G35 to be skin and eye irritant. Moreover, no conclusions could be drawn on the additive skin sensitisation potential. The additive is considered a potential respiratory sensitiser. The efficacy for the new target species/categories as well its use in water was extrapolated from the previous efficacy studies.

Safety and efficacy of a feed additive consisting of endo-1,4-beta-xylanase (produced by Aspergillus oryzae DSM 33700) (RONOZYME® WX (CT/L)) for all poultry species and all Suidae (DSM nutritional products ltd).

The additive RONOZYME® WX (CT/L) contains endo-1,4-beta-xylanase produced with a genetically modified strain of the filamentous fungus Aspergillus oryzae; the additive is currently authorised for poultry for fattening, weaned piglets, pigs for fattening, lactating sows and laying hens. The applicant has requested to change the production strain, substituting strain A. oryzae DSM 26372 with A. oryzae DSM 33700, and to extend the use of the additive to all poultry species and all Suidae. RONOZYME® WX (CT/L), manufactured with the production strain A. oryzae DSM 33700, did not give rise to safety concerns with regard to the genetic modification of the production strain. No viable cells of the production strain nor its DNA were detected in an intermediate product representative of both final formulations of the additive. RONOZYME® WX (CT/L) was considered safe for all poultry species and all Suidae at the recommended inclusion levels. The use of RONOZYME® WX CT and L manufactured with the production strain A. oryzae DSM 33700 raised no concerns for consumers. RONOZYME® WX L is not an eye irritant; however, no conclusions could be drawn on the potential of RONOZYME® WX CT to be an eye irritant. Both formulations are not irritant to the skin, but due to the lack of data, the FEEDAP Panel was not able to conclude on the potential of both formulations of the additive to be skin sensitisers. Due to the proteinaceous nature of the active substance, the additive is considered a respiratory sensitiser. The additive manufactured by A. oryzae DSM 33700 raises no safety concerns for the environment. The additive has the potential to be efficacious in all poultry species and all Suidae at 100 and 200 FXU/kg complete feed, respectively.

Safety and efficacy of a feed additive consisting of endo-ß-1,4-xylanase produced by Komagataella phaffiiCGMCC 7.371 (VTR-xylanase) for all avian species, piglets (suckling and weaned) and minor growing porcine species (Victory Enzymes GmbH).

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 endo-ß-1,4-xylanase (VTR-xylanase) as a zootechnical feed additive for all avian species, piglets (suckling and weaned) and minor growing porcine species. VTR-xylanase is available in a powder and a liquid form and is produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.371). The genetic modification of the production strain does not give rise to safety concerns. Viable cells of the production strain and its DNA were not detected in the final products. The additive does not pose any safety concern regarding the production strain. VTR xylanase (powder/liquid) produced by Komagataella phaffii CGMCC 7.371 is safe for all avian species, piglets and minor growing porcine species at the proposed conditions of use. The use of both forms of the additive under assessment in animal nutrition under the proposed conditions of use raises no safety concerns for consumers or for the environment. The liquid and powder formulations of VTR-xylanase are non-irritant to eyes but should be considered skin sensitisers. No conclusions can be drawn on the potential of the final formulations of the additive to be irritant to skin. Due to the proteinaceous nature of the active substance, the additive is a respiratory sensitiser. The additive has the potential to be efficacious in all laying birds and piglets (suckling and weaned) from all Suidae at 2,000 U/kg and in all other avian species/categories at 1,000 U/kg feed.

Safety and efficacy of a feed additive consisting of 25-hydroxycholecalciferol (produced by Pseudonocardia autotrophicaDSM 32858) for all pigs, all poultry for fattening and ornamental birds and other poultry species (Huvepharma NV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a feed additive consisting of 25-hydroxycholecalciferol (produced by Pseudonocardia autotrophica DSM 32858) for all pigs, all poultry for fattening and ornamental birds and other poultry species. The production strain P. autotrophica DSM 32858 is not genetically modified however, uncertainties remain on the possible presence of its viable cells in the final product. Due to the lack of adequate safety data and uncertainty on the presence of nano particles, the FEEDAP Panel cannot conclude on the safety of the additive for the target species and the consumer. The additive was shown not to be irritant to skin or eyes and it is not a skin sensitiser. Considering the low dusting potential of the additive, the FEEDAP Panel concluded that the exposure through inhalation is unlikely. However, the FEEDAP Panel considered that uncertainties remain on genotoxicity and on the possible presence of viable cells of P. autotrophica DSM 32858 in the final product which might have an impact on the safety for the users. The use of the feed additive is considered safe for the environment. The Panel concluded that the additive has a potential to be efficacious under the proposed conditions of use.

Safety and efficacy of a feed additive consisting of Streptococcus salivarius DSM 13084/ATCC BAA 1024 for dogs and cats (BLIS Technologies Limited).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Streptococcus salivarius DSM 13084/ATCC BAA 1024 as a technological additive (functional group: acidity regulators) in feed for dogs and cats. The additive is intended for use at a proposed minimum concentration of 1 × 1011 CFU/l or kg liquid feed for dogs and cats. Due to the lack of adequate data, the FEEDAP Panel could not conclude on the safety of the additive for the target species. The additive was considered a respiratory sensitiser, but not irritant to skin. No conclusions could be drawn on the potential of the additive to be an eye irritant or a skin sensitiser. No environmental risk assessment is necessary for the use of the additive in feeds for pets. The Panel concluded that the additive has the potential to be efficacious in feeds for dogs and cats at the proposed conditions of use.

Safety and efficacy of the feed additive consisting of 6-phytase (produced by Aspergillus oryzaeDSM 33699) (RONOZYME® Hiphos GT/L) for poultry, pigs for fattening, weaned piglets and sows (DSM Nutritional Products Ltd).

The additive RONOZYME® Hiphos (GT/L) contains 6-phytase produced with a genetically modified strain of the filamentous fungus Aspergillus oryzae, it is currently authorised for poultry, pigs for fattening, weaned piglets and sows. The applicant has requested to change the production strain, substituting strain A. oryzae DSM 22594 for A. oryzae DSM 33699. RONOZYME® Hiphos (GT/L), manufactured with the production strain A. oryzae DSM 33699, did not give rise to safety concerns with regard to the genetic modification of the production strain. No viable cells of the production strain nor its recombinant DNA were detected in an intermediate product representative of both final forms of the additive. RONOZYME® Hiphos (GT/L) was considered safe for poultry, pigs for fattening, weaned piglets and sows at the recommended inclusion levels of 500-4,000 FYT/kg complete feed. The use of RONOZYME® Hiphos GT and L manufactured with the production strain A. oryzae DSM 33699 raised no concerns for consumers. In the absence of data on the final formulations, the Panel could not conclude on the potential of the additive to be irritant to eyes or skin, or a skin sensitiser. Due to the proteinaceous nature of the active substance, the additive was considered a respiratory sensitiser. The additive manufactured by A. oryzae DSM 33699 raises no safety concerns for the environment. The additive has the potential to be efficacious in poultry, pigs for fattening, weaned piglets and sows at 500 FYT/kg complete feed.

Safety and efficacy of a feed additive consisting of 6-phytase produced by Komagataella phaffiiCGMCC 7.370 (VTR-phytase powder/liquid) for all pigs and all avian species (Victory Enzymes GmbH).

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 6-phytase (VTR-phytase) as zootechnical feed additive for all pigs and all avian species. The additive VTR-phytase consists of 6-phytase and it is available in solid and liquid forms. VTR phytase (liquid/solid) was produced by a genetically modified strain of Komagataella phaffii (CGMCC 7.370). The genetic modification of the production strain does not give rise to safety concerns. Viable cells of the production strain and its DNA were not detected in the final products. The additive does not pose any safety concern regarding the production strain. VTR phytase (liquid/solid) produced by Komagataella phaffii CGMCC 7.370 is safe for all Suidae and all avian species at the proposed conditions of use. The use of both forms of the additive under assessment in animal nutrition under the proposed conditions of use raises no safety concerns for consumers or for the environment. The liquid VTR phytase and powder VTR phytase are non-irritant to skin or eyes but should be considered skin and respiratory sensitisers. The additive has the potential to be efficacious in laying hens at 1,000 U phytase/kg complete feed. The conclusion can be extrapolated to other birds for egg production or breeding. The FEEDAP Panel cannot conclude on the efficacy of all pigs or growing poultry species.

Safety and efficacy of a feed additive consisting of carmine for cats and dogs (Mars Petcare GMbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the re-evaluation of the safety and efficacy of carmine (sensory additive, functional group: colourants - substances that add or restore colour in feeds) for cats and dogs. The additive consists of aluminium lakes of carminic acid (carmines), which are complexes of aluminium and carminic acid. Carminic acid, produced from the female insect Dactylopius coccus Costa, is the colouring principle and is present in the final additive at 50%. The additive does not pose a risk concerning genotoxicity and is considered safe for dogs and cats at 264 and 220 mg Carmine/kg feed, respectively (which correspond to 132 and 110 mg carminic acid/kg feed, respectively). Due to the nature of the additive, the FEEDAP Panel concluded that allergic reactions may occur in the target species following the ingestion of feeds containing the additive. The FEEDAP Panel concluded that the exposure of users by inhalation is very likely, and that carmine is a respiratory and skin sensitiser; however, due to the lack of data, a conclusion cannot be reached on the potential skin and eye irritation of the additive. The additive is considered to be efficacious in feeds for dogs and cats under the proposed conditions of use.

Safety and efficacy of a feed additive consisting of Solanum glaucophyllum leaf extract for dairy cows and other dairy ruminants (Herbonis Animal Health Gmbh).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Solanum glaucophyllum leaf extract (SGE) as a nutritional additive for dairy cows and other dairy ruminants. However, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered the glycosides of 1,25-dihydroxycholecalciferol (1,25[OH]2D3) as the active substance and the bolus containing SGE-derived 1,25[OH]2D3 as the preparation of the additive. The product is intended to be administered to dairy ruminants during the pre-parturient (period from 9 days before calving to immediately before calving). The FEEDAP Panel concluded that the administration of one bolus, the preparation of the additive as applied in the animal studies evaluated, containing 500 µg of SGE-derived 1,25[OH]2D3 during the pre-parturient period is safe for cows. Owing to the lack of data, the Panel could not conclude on the safety for of a subsequent administration of a second bolus or on the safety of another SGE-derived 1,25[OH]2D3 preparation for use in dairy ruminants other than cows (Bos taurus). The Panel considered that, under the specified conditions of use, the product is safe for the consumer and the environment. The bolus, a preparation containing SGE, as a source of the active substance, is not irritating to skin and eyes and it is not a sensitiser. Exposure via inhalation is unlikely. The Panel concluded that the administration of the bolus, the preparation of the additive as applied in the animal studies evaluated, containing 500 µg of SGE-derived 1,25[OH]2D3 in a period from 9 days before calving to immediately before calving has the potential to prevent hypocalcaemia in dairy cows. Owing to the lack of data with another preparation, the Panel could not conclude on the efficacy in other dairy ruminants.

Safety and efficacy of a feed additive consisting of endo-1,4-ß-xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) for chickens and turkeys for fattening, chickens reared for laying/breeding, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay (BioResource international, Inc.).

Following a request from the European Commission, the EFSA Panel on Additives and Products of Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of the product containing endo-1,4-ß-xylanase produced by Komagataella phaffii DSM 33574 (Xylamax) as a zootechnical additive in chickens for fattening, chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay. The production strain is genetically modified. No viable cells nor recombinant DNA of the production strain were detected in the final product. Therefore, the Panel concluded that the additive does not pose any safety concern regarding the production strain. Based on the no observed adverse effect level identified in a subchronic oral toxicity study in rats, the Panel concluded that Xylamax is safe for all poultry species for fattening or reared to the point of lay. Considering the production strain and the results obtained in the genotoxicity studies, the Panel concluded that the additive is safe for the consumers. The Panel also concluded that Xylamax is not irritant to the skin but should be considered a potential eye irritant and a respiratory sensitiser. No conclusions could be drawn on the potential of the additive to cause skin sensitisation. The use of the product as a feed additive is of no concern for the environment. The FEEDAP Panel concluded that the additive has the potential to be efficacious at 10,000 XU/kg feed in chickens for fattening. This conclusion was extended/extrapolated to chickens reared for laying/breeding, turkeys for fattening, turkeys reared for breeding and minor poultry species for fattening or raised to the point of lay.

Safety and efficacy of a feed additive consisting of acacia gum (gum Arabic) for all animal species (A.I.P.G. Association for International Promotion of Gums).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of acacia gum (gum Arabic) as a feed additive for all animal species. Acacia gum is safe up to approximately 280 mg/kg complete feed for chickens for fattening, 375 mg/kg complete feed for turkeys for fattening, 400 mg/kg complete feed for rabbit, 500 and 600 mg/kg complete feed for piglets and pigs for fattening, respectively, 1,100 mg/kg complete feed for cattle for fattening and 1,250 mg/kg complete feed for veal calves and salmonids. No conclusions can be reached on the safety for long living and reproductive animal, until the genotoxic potential of the additive is fully assessed in the framework of its use as a feed additive. No exposure of the consumer to the additive or its metabolites is expected. Therefore, the use of the additive in animal nutrition is considered safe for the consumers. Acacia gum is a potential dermal and respiratory sensitiser. No conclusion can be reached on the irritating potential to the skin or eyes. The use of acacia gum in animal nutrition is considered safe for the environment. The FEEDAP Panel is not in the position to conclude on the efficacy of acacia gum.

Safety and efficacy of a feed additive consisting of guar gum for all animal species (A.I.P.G. Association for International Promotion of Gums).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of guar gum as a feed additive for all animal species. Owing the absence of information, the genotoxic potential of the additive could not be fully assessed. From the results of tolerance studies, the FEEDAP Panel concluded that guar gum is safe for salmonids at a maximum concentration of 3,000 mg/kg complete feed. Guar gum is safe up to ~ 280 mg/kg complete feed for chickens for fattening, 375 mg/kg complete feed for turkeys for fattening, 400 mg/kg complete feed for rabbits, 500 and 600 mg/kg complete feed for piglets and pigs for fattening, respectively, 1,100 mg/kg complete feed for cattle for fattening and 1,150 mg/kg complete feed for veal calves. No conclusions can be reached on the safety for long living and reproductive animals, until the genotoxic potential of the additive is fully assessed in the framework of its use as a feed additive. The use of the additive in animal nutrition is considered safe for the consumer and the environment. In the absence of data, no conclusions could be drawn on the safety of the additive for the user. Guar gum is efficacious as a gelling agent, thickener, and contributes to stabilise canned pet feed. No conclusion can be drawn on the additive as an emulsifier.

Safety and efficacy of a feed additive consisting of carrageenan for pets and other non-food-producing animals (Marinalg International).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of carrageenan as a feed additive for pets and other non-food-producing animals. The additive is manufactured in two forms, refined and semi-refined carrageenan. Owing the lack of information, the FEEDAP Panel is not in the position to conclude on safety of the additives for pets and other non-food-producing animals and for the user. The FEEDAP Panel concludes that the additive is efficacious as a gelling agent, thickener and contributes to stabilise canned pet feed. No conclusion can be drawn on the efficacy of the additive as a binder and emulsifier.

Safety and efficacy of a feed additive consisting of agar for pets and non-food-producing animals (Hispanagar).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of agar as a feed additive for pets and non-food-producing animals. Owing the lack of information, the FEEDAP Panel is not in the position to conclude on the safety of agar for pets and other non-food-producing animals and for the user. The FEEDAP Panel concludes that the additive is efficacious as a gelling agent, thickener and contributes to stabilise canned pet feed. No conclusion can be drawn on the efficacy of the additive as a binder.

Safety and efficacy of a feed additive consisting of zearalenone hydrolase produced by Escherichia coli DSM 32731 for all terrestrial animal species (Biomin GmbH).

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 zearalenone hydrolase (ZenA) produced by Escherichia coli DSM 32731 when used as a feed additive for all terrestrial animals. The production strain E. coli DSM 32731 is genetically modified and harbours a kanamycin resistance gene. No viable cells of the production strain were detected in the final product, but uncertainty remains on the presence of recombinant DNA in the final product. The ZenA contained in the additive is safe for all terrestrial animal species up to the maximum use levels of (in U/kg complete feed): 100 U/kg in chickens for fattening; 150 U/kg in laying hens, turkeys for fattening and rabbits; 200 U/kg in pigs; 250 U/kg in dairy cows; 400 U/kg in veal calf (milk replacer), cattle for fattening, sheep, goats, horses and cats; and 450 U/kg in dogs. Based on the ADME and toxicological data, the FEEDAP Panel considers that the use of the ZenA contained in the additive in animal nutrition is safe for the consumers. The endotoxin content in the additive poses a risk by inhalation for users handling the additive. The additive is not a skin/eye irritant nor a skin sensitiser. Due to its proteinaceous nature, the additive should be considered as a potential respiratory sensitiser. The ZenA contained in the additive and the resulting breakdown products of its enzymatic activity do not represent a safety concern for the environment. The production strain harbours an antimicrobial resistance gene and uncertainties remain on the possible presence of its recombinant DNA in the final product; therefore, the FEEDAP Panel cannot conclude on safety of the additive for the target species, the consumer, the user and the environment.

Safety and efficacy of a feed additive consisting of 3-nitrooxypropanol (Bovaer® 10) for ruminants for milk production and reproduction (DSM Nutritional Products Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bovaer® 10 as a zootechnical additive for ruminants for milk production and reproduction. Systemic exposure or site of contact toxicity for the active substance 3-nitrooxypropanol (3-NOP), for which genotoxicity has not been fully clarified, in the target species, is unlikely based on ADME data available. Consequently, the FEEDAP Panel concluded that Bovaer® 10 was safe for dairy cows at the maximum recommended level. However, as a margin of safety could not be established, the FEEDAP Panel could not conclude on the safety of the additive for other animal species/categories. The FEEDAP Panel considered that the consumer was exposed to 3-nitrooxypropionic acid (NOPA), which is one of the 3-NOP metabolites. NOPA was not genotoxic based on the studies provided. The FEEDAP Panel concluded that the use of Bovaer® 10 in animal nutrition under the conditions of use proposed was of no concern for consumer safety and for the environment. The FEEDAP Panel concluded that the active substance 3-NOP may be harmful if inhaled. It is irritant (but not corrosive) to skin, irritant to the eyes but it is not a skin sensitiser. As the genotoxicity of 3-NOP is not completely elucidated, the exposure through inhalation of the additive may represent an additional risk for the user. The Panel concluded that the additive has a potential to be efficacious in dairy cows to reduce enteric methane production under the proposed conditions of use. This conclusion was extrapolated to all other ruminants for milk production and reproduction.

Food contact materials: an effect-based evaluation of the presence of hazardous chemicals in paper and cardboard packaging.

Food contact materials (FCMs) can contain hazardous chemicals that may have the potential to migrate into food and pose a health hazard for humans. Previous studies have mainly focused on plastic materials, while data on packaging materials made from paper and cardboard are limited. We used a panel of cell-based bioassays to investigate the presence and impact of bioactive chemicals on human relevant endpoints like oxidative stress, genotoxicity, inflammation, xenobiotic metabolism and endocrine system effects in extracts made from paper and cardboard. In total, 23 methanol extracts of commonly used paper and cardboard available on the Swedish market were extracted as a whole product using methanol to retrieve polar substances, and tested at concentrations 0.3-10 mg/mL and 0.2-6 mg/mL. At the highest concentration bioactivities were observed in a high proportion of the samples: oxidative stress (52%), genotoxicity (100%), xenobiotic metabolism (74%), antiandrogenic- (52%) and antioestrogenic receptor (39%). Packages of potential concern included cake/pastry boxes/mats, boxes for infant formula/skimmed milk, pizza boxes, pizza slice trays and bag of cookies. It should be noted that the extraction for packages like cake/pastry boxes can be considered exaggerated, as the exposure usually is shorter. It can be hypothesised that the observed responses may be explained by inks, coatings, contaminants and/or naturally occurring compounds within the material. To summarise, an effect-based approach enables hazard identification of chemicals within FCMs, which is a valuable tool for ensuring safe use of FCMs.

Safety and efficacy of a feed additive consisting on the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 infecting Salmonella Gallinarum B/00111 (Bafasal®) for all avian species (Proteon Pharmaceuticals S.A.).

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 feed additive consisting of four bacteriophages infecting Salmonella Gallinarum B/00111 (PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097, trade name: Bafasal®) when used as a zootechnical additive in water for drinking and liquid complementary feed for all avian species. The effects sought are the reduction of the Salmonella spp. carriage in chickens for fattening, the improvement of their performance, or both. The host strain harbours an acquired antimicrobial resistance gene. No viable cells or DNA from the host organism were found in the additive. The four phages proved to be strictly lytic and to have a machinery allowing to package a unit-length of the viral genome. The manufacturing process excludes the presence of remnants from the propagation process in the final additive. Consequently, no concerns are expected from the nature and manufacture of the product. Considering this and the results of the tolerance study with chickens for fattening, the Panel concluded that Bafasal® is safe for all avian species. Considering the nature and manufacturing process of the additive, Bafasal® is not expected to pose a risk for consumers. The results of the subchronic oral toxicity study and genotoxicity studies provided support this conclusion. Exposure of users via inhalation is expected to be low, but Bafasal® should be considered a respiratory sensitiser. No conclusions were drawn on the irritancy of Bafasal® to skin and eyes or on its dermal sensitisation potential due to lack of data. Considering the nature and manufacturing process of the additive, Bafasal® is safe for the environment. The Panel was not in the position to conclude on the efficacy of Bafasal® for any avian species due to insufficient data.

Safety and efficacy of a feed additive consisting of chromium propionate (KemTRACE™ Chromium) for all growing poultry species (Kemin Europa NV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of chromium propionate (KemTRACE™ Chromium; KemTRACE-Cr) as zootechnical feed additive for all growing poultry species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel was assigned to this mandate. Based on two tolerance studies submitted, the Panel concluded that the additive is safe for chickens for fattening at the maximum recommended supplementation level of 0.4 mg Cr/kg feed from KemTRACE-Cr, but a margin of safety cannot be established; this conclusion can be extended to chickens reared for laying/breeding, but cannot be extrapolated to other growing poultry species. The FEEDAP Panel considered that the use of KemTRACE-Cr in animal nutrition at the proposed conditions of use is safe for the consumer. No concerns for users following any inhalation exposure during the handling of the additive are expected; the additive was shown to be corrosive to the eyes but not irritant to skin or a skin sensitiser. The use of KemTRACE-Cr in animal nutrition according to the proposed conditions of use will not significantly alter the concentration in the receiving environmental compartments of concern; therefore, no safety concern is expected for the environment. Based on three efficacy studies, the FEEDAP Panel concluded that KemTRACE-Cr has the potential to be efficacious as a zootechnical additive in chickens for fattening at the supplementation level of 0.4 mg Cr/kg feed; this conclusion could be extended to chickens reared for laying and chickens reared for breeding, and extrapolated to other poultry species for fattening and reared for laying/breeding.

Safety and efficacy of the feed additive consisting of Vitamin B2/Riboflavin produced by Eremothecium ashbyiCCTCCM 2019833 for all animal species (Hubei Guangji Pharmaceutical Co., Ltd).

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 feed additive Vitamin B2/Riboflavin produced by Eremothecium ashbyi CCTCCM 2019833 for all animal species and categories. The additive contains a minimum content of riboflavin of 5%. The production strain has been characterised and data showed that viable cells are not present in the final additive. The additive is not a skin or eye irritant nor a skin sensitiser, but it is considered to be a respiratory sensitiser. The lack of data on the toxicological profile of the additive, including its genotoxic potential, did not allow the Panel to conclude on the safety of the additive for the target species, consumers and users. The FEEDAP Panel concluded that the use of the product as a feed additive poses no concerns for the environment. The additive under assessment is effective in covering the animals' requirements for vitamin B2 when administered via feed.