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Amaferm® is a fermentation product produced by Aspergillus oryzae NRRL 458, containing alpha‐amylase and cellulase enzyme activities, authorised for use as a feed additive for dairy cows. In 2016, the applicant requested for the renewal of the authorisation and the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion at that regard in 2020. In that opinion, the Panel could not confirm the previously drawn conclusions (EFSA, 2006) regarding the safety of the production strain, and consequently could not confirm the safety of the additive for the target species and consumers. In the current submission, the applicant provided supplementary information that allowed the Panel to conclude on the identity of the production strain, redefine the specifications of the additive, and finally to conclude on its safety. Therefore, the new data provided permit to conclude that Amaferm® complies with the conditions of the authorisation. However, the Panel noted that there is the need to change the specification and description of the cellulase and amylase units in the authorisation act. The data provided in the previous (EFSA FEEDAP Panel, 2020) and the current assessments support that Amaferm® remains safe under the approved conditions for target species, consumers and the environment. The additive is non‐irritant to skin and eyes, or a dermal sensitiser but should be considered a potential respiratory sensitiser. [ABSTRACT FROM AUTHOR]

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 Levilactobacillus brevis (formerly Lactobacillus brevis) DSM 12835 as a technological additive for all animal species. The additive aims to improve the production of silage and is authorised without a minimum inclusion level. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, L. brevis DSM 12835 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

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 preparation of Bacillus subtilis CNCM I-4606, B. subtilis CNCM I-5043, B. subtilis CNCM I-4607 and Lactococcus lactis CNCM I-4609 when used as a technological additive (hygiene condition enhancer) for all animal species. The product is intended for use in compound feeds and feed materials for all animal species at a minimum inclusion level of 1 × 109 CFU B. subtilis and 1 × 109 CFU L. lactis per kg or litre. The two bacterial species are considered by EFSA to be eligible for the qualified presumption of safety (QPS) approach. As the identity of the strains has been clearly established and they did not show acquired resistance to antibiotics of human and veterinary importance, the use of these strains in animal nutrition is considered safe for the target species, consumers and the environment. The additive is not irritant to skin and eyes or a skin sensitiser. Given the proteinaceous nature of the active agents, the additive should be considered a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of the additive to significantly reduce the growth of either Salmonella Typhimurium or Escherichia coli in feed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an endo-1,4-b-xylanase (Beltherm MP/ML), produced by a genetically-modified Bacillus subtilis strain, as a zootechnical additive for laying hens, minor poultry species and all avian species. The additive is authorised for use in feed for poultry species for fattening or reared for laying/breeding, weaned piglets, pigs for fattening and minor porcine species for fattening. The safety and efficacy of the additive for those species have been evaluated previously by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel). The current application is for an extension of use of the additive. No viable cells were detected in the additive, but the data provided to support the absence of DNA in the additive was not sufficient to conclude on the absence of recombinant DNA in the additive. However, the Panel concluded that no safety concerns would arise from the presence of DNA from the production strain in the additive. In the current assessment, the FEEDAP Panel concluded that the additive is safe for all avian species at the recommended level of 100 ADXU/kg feed. Similarly, the FEEDAP Panel concluded that Beltherm MP/ML is safe for the consumer and the environment. Concerning the user safety, the FEEDAP Panel concluded that the additive is not toxic by inhalation or irritant for skin or eyes, but it is considered a potential dermal and a respiratory sensitiser. In a previous opinion, the efficacy of the additive in poultry species for fattening was shown. However, owing to the insufficient data submitted in previous and current assessments, the Panel could not conclude on the efficacy of the product for the target species for which the application was made. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Bacillus velezensis DSM 15544 (Calsporin®) when used as a feed additive for piglets (suckling and weaned), pigs for fattening, sows in order to have benefit in piglets, ornamental fish, dogs and all avian species. The additive is authorised for use in sows, suckling and weaned piglets, pigs for fattening, chickens for fattening, laying hens, ornamental fish and dogs. With this application the company requested a new authorisation for all avian species and the modification of the current authorisations as regards the strain taxonomy from Bacillus subtilis DSM 15544 to B. velezensis DSM 15544. The FEEDAP Panel concluded that the active agent of Calsporin® should be taxonomically designated as Bacillus velezensis DSM 15544. The Panel also concluded that Calsporin® is presumed safe for the target species, consumers and the environment. Calsporin® is not a dermal/eye irritant or a skin sensitiser but should be considered a respiratory sensitiser. Calsporin® when supplemented at 3 × 108 CFU/kg complete feed has the potential to be efficacious in all avian species for rearing, fattening, laying and breeding purposes. [ABSTRACT FROM AUTHOR]

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 Lacticaseibacillus paracasei (formerly Lactobacillus paracasei) DSM 16245 as a technological additive for all animal species. The additive aims to improve the production of silage and is currently authorised at a proposed application rate of 1 × 108 colony forming units (CFU)/kg fresh material. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety L. paracasei DSM 16245 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of Lacticaseibacillus rhamnosus (formerly Lactobacillus rhamnosus) NCIMB 30121 as a technological additive for all animal species. The additive aims to improve the production of silage and is authorised without a minimum inclusion level. The applicant provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence to lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concluded that the additive remains safe for all animal species, consumers and the environment under the authorised conditions of use. Regarding user safety, the additive should be considered a skin and respiratory sensitiser. No conclusions could be drawn on the eye and skin irritancy potential of the additive. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

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 Protural® (sodium benzoate) when used as a zootechnical additive in feed for weaned piglets and other growing Suidae at 4,000 mg/kg feedingstuff. Protural® consists of sodium benzoate without any carrier materials and is currently authorised for use in weaned piglets. This opinion concerns the renewal of the authorisation of Protural® for weaned piglets and the evaluation of the new use in other growing Suidae. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel concluded that Protural® is safe under the current conditions of authorisation for the target species, consumers of products from animals fed the additive and the environment. Protural® was not considered as irritant to skin and eyes but a skin sensitiser. Based on dusting potential data, the FEEDAP Panel considered that the powder formulation of the additive represented a risk by inhalation. There was no need for assessing the efficacy of Protural® in the context of the renewal of the authorisation for weaned piglets. The efficacy data previously evaluated allowed the FEEDAP Panel to conclude that the additive has the potential to be efficacious at the level of 4,000 mg/kg feedingstuff in other growing Suidae. A conclusion cannot be reached for the efficacy in pigs for fattening. [ABSTRACT FROM AUTHOR]

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 iron (II) chelate of amino acids hydrate for all animal species, brand name Availa® Fe, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 9% iron. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to include a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (iron), with an inclusion level of 9–10%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2017/2330. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust, it is not possible to make the assessment of the exposure by inhalation. [ABSTRACT FROM AUTHOR]

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 an aqueous extract of Citrus limon (L.) Osbeck (lemon extract) when used as a sensory additive in feed for all animal species. The FEEDAP Panel concluded that the additive under assessment is safe for all animal species up to the maximum proposed use levels of 1,000 mg/kg complete feed and 250 mg/kg water for drinking. No concerns for consumers were identified following the use of lemon extract up to the highest safe level in feed. The additive should be considered a skin and eye irritant, and a potential corrosive. The use of the extract in animal feed under the proposed conditions was not expected to pose a risk for the environment. Lemon extract was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

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 expressed sweet orange oil and its fractions obtained from the fruit peels of Citrus sinensis (L.) Osbeck, when used as sensory additives (flavourings) in feed and water for drinking for all animal species. The presence of perillaldehyde was identified as a source of potential concern. However, in target species fed citrus by-products as part of daily feed, the use of the expressed orange oil and its fractions was not expected to increase the exposure to perillaldehyde to a relevant extent (< 10%). For dogs, cats, ornamental fish and ornamental birds not normally exposed to citrus by-products, no conclusion can be drawn. For the other species, the FEEDAP Panel concluded that the additives under assessment are safe at the maximum proposed use levels in complete feed. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumer safety were identified following the use of the additives up to the maximum proposed use level in feed. The additives under assessment should be considered as irritants to skin and eyes, and as skin and respiratory sensitisers. The use of the additives under the proposed conditions of use in animal feed was not expected to pose a risk for the environment. Expressed orange oil and its fractions were recognised to flavour food. Since their function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

The European Commission requested the European Food Safety Authority (EFSA) to review the evaluation of halquinol by the 85th and 88th meetings of the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and to assess any other relevant scientific information in order to establish whether there is ground for any food safety concerns about the maximum residues levels (MRLs) recommended by JECFA. In several countries halquinol is used as a veterinary drug in pigs and poultry to enhance growth performance while this is prohibited in the European Union. JECFA derived an Acceptable daily intake (ADI) of 0‐0.2 mg/kg body weight, based on histopathological changes associated with an increase in mean absolute and relative kidney weights seen in a 1‐year chronic toxicity study conducted in rats and has recommended MRLs for halquinol of 500, 9000, 40 and 350 μg/kg in pigs liver, kidney, muscle and skin+fat, respectively. Overall, EFSA considers that the MRLs for halquinol proposed by JECFA are sufficiently low to ensure the safety of European consumers when exposed to foodstuffs from halquinol treated pigs. However, due to some limitations and uncertainties in the toxicological database available, EFSA is not in the position to confirm the ADI of 0‐0.2 mg/kg bw, as set by JECFA. [ABSTRACT FROM AUTHOR]

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 butylated hydroxy anisole (BHA) when used as a technological additive (antioxidant) in feed for cats. BHA is a waxy solid consisting for > 98.5% of the active substance, a mixture of 3-tert-butyl-4-hydroxyanisole and 2-tert-butyl-4-hydroxyanisole and is currently authorised for use in all animal species except in cats. In support of the safety of the additive for the target species, the applicant has submitted a tolerance study which demonstrated that BHA is tolerated by cats at a concentration up to 150 mg/kg complete feed. The additive should be considered a skin, eye irritant and a potential skin sensitiser. Exposure of the user via inhalation was considered unlikely; therefore, a risk is not expected. BHA is authorised as an antioxidant for food use at comparable use levels; therefore, no studies were required to demonstrate the efficacy of BHA as an antioxidant in complete feed for cats. [ABSTRACT FROM AUTHOR]

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 the authorisation of Pediococcus pentosaceus DSM 12834 as a technological additive for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There is no evidence that would lead the FEEDAP Panel to reconsider its previous conclusions. Thus, the Panel concludes that the additive remains safe for all animal species, consumer and the environment under the authorised conditions of use. Regarding user safety Pediococcus pentosaceus DSM 12834 is not irritant to skin and eyes but is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of L-lysine sulfate produced by Corynebacterium glutamicum KCCM 80227 as a nutritional feed additive for all animal species. The FEEDAP Panel concluded that the production strain C. glutamicum KCCM 80227 qualifies for the qualified presumption of safety (QPS) approach to safety assessment and is not detected in the final product. L-Lysine sulfate produced using C. glutamicum KCCM 80227 does not pose any safety concern associated with the production strain. The additive under assessment is considered safe for the target species. When using L-lysine sulfate, the background sulfur/sulfate content in the compound feed should be taken into account. L-Lysine sulfate produced by C. glutamicum KCCM 80227 is safe for the consumers, users and for the environment. The additive L-lysine sulfate is considered as an efficacious source of the essential amino acid L-lysine for non-ruminant animal species. For the supplemental L-lysine to be as efficacious in ruminants as in non-ruminant species, it would require protection against degradation in the rumen. [ABSTRACT FROM AUTHOR]

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 vitamin B2 98% and vitamin B2 80% in the form of riboflavin produced by fermentation with a genetically modified strain of Bacillus subtilis (KCCM 10445) as nutritional additives in feed and water for drinking for all animal species. The production strain harbours antimicrobial resistance genes. With the data available the Panel is not in the position to confirm the correspondence between the strain deposited under accession number KCCM 10445 and the strain under the current assessment. The production strain and its recombinant DNA were not detected in the final products. Therefore, the additives do not pose any safety concern associated with the genetic modification of the production strain. The additives are safe for the target species, the consumer and the environment. Vitamin B2 80% is not hazardous by inhalation. In the absence of data, no conclusions on the possible risk by inhalation of vitamin B2 98% can be reached. Neither vitamin B2 98% nor vitamin B2 80% are irritant to skin or eyes. In the absence of data, no conclusions on the skin sensitisation potential of the additives can be reached. The additives under assessment are effective in covering the animals' requirements for vitamin B2 when administered via feed and/or water for drinking. [ABSTRACT FROM AUTHOR]

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 expressed mandarin oil from the fruit peels of Citrus reticulata Blanco, when used as a sensory additive (flavouring) in feed and water for drinking for all animal species. The FEEDAP Panel concluded that the essential oil under assessment is safe up to the maximum proposed use levels in complete feed of 15 mg/kg for poultry, 33 mg/kg for pigs, 30 mg/kg for ruminants, 40 mg/kg for horse, and 15 mg/kg for salmon and rabbit. The presence of perillaldehyde was identified as a source of potential concern. However, in target species fed citrus by-products as part of daily feed the use of the expressed mandarin oil in feed was not expected to increase the exposure to perillaldehyde to a relevant extent (< 4%). For companion animals and ornamental fish not normally exposed to citrus by-products, no conclusion can be drawn. The FEEDAP Panel considered that the use in water for drinking is safe provided that the total daily intake of the additive does not exceed the daily amount that is considered safe when consumed via feed. No concerns for consumer safety were identified following the use of the additive up to the maximum proposed use level in feed. The essential oil under assessment should be considered as irritant to skin, eyes and the respiratory tract, and as a skin sensitiser. The use of the additive in animal feed under the proposed conditions of use was not expected to pose a risk for the environment. Expressed mandarin oil was recognised to flavour food. Since its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary. [ABSTRACT FROM AUTHOR]

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 a feed additive consisting on Lactiplantibacillus plantarum (formerly Lactobacillus plantarum) CECT 8350 and Limosilactobacillus reuteri (formerly Lactobacillus reuteri) CECT 8700 (AQ02) for suckling piglets. The additive can be presumed safe for the target species, the consumer and the environment. In the absence of data, the Panel could not conclude on the potential of the additive to be a skin or eye irritant or a skin sensitiser. The additive should be considered a respiratory sensitiser. In the absence of adequate data, the Panel cannot conclude on the efficacy of AQ02 as a zootechnical feed additive for suckling piglets. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of disodium 5'-guanylate produced by fermentation with Corynebacterium stationis KCCM 10530 and Escherichia coli K-12 KFCC 11067 when used as a sensory additive (flavouring compound) in feed and water for drinking for all animal species. The additive does not raise safety concerns under the proposed conditions of use for the target species, consumers the users and the environment. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) expressed reservations on the use of the additive in water for drinking due to concerns on its impact on hygienic conditions of the water. The Panel concluded that the additive is efficacious to contribute to the flavour of feed. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium diformate (FormiTM LHS) as a technological feed additive for piglets (weaned) and pigs for fattening. The FEEDAP Panel concluded that potassium diformate is safe for weaned piglets and for pigs for fattening at the level of 6,000 mg/kg complete feed, with no margin of safety. The use of potassium diformate in weaned piglets and pigs for fattening nutrition under the conditions of use proposed is of no concern for consumer safety. Potassium diformate does not raise concern regarding the effects on respiratory system and the skin but is an eye irritant. The use of potassium diformate as a feed additive is considered safe for the environment. The additive is considered to be efficacious as acidity regulator in feedingstuffs for weaned piglets and pigs for fattening at the minimum proposed concentration of 6,000 mg/kg complete feed. [ABSTRACT FROM AUTHOR]

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 phyllite, a natural mixture of minerals of metamorphic origin, as a feed additive for all animal species. The additive, specified to contain at least 40% of mica, muscovite, illite, chlorite and talc as the main components, and maximum 60% of quartz, potassium-feldspar, sodium-feldspar and calcite, is intended for use as a technological additive (functional groups: (i) anticaking agents) in premixtures and feedingstuffs for all animal species at a maximum inclusion level of 25,000 mg/kg. The additive is safe for chickens for fattening and chickens reared for laying/breeding at the maximum inclusion level of 25,000 mg/kg feed, with no margin of safety determined. Owing the absence of data in pigs and ruminants and in the absence of data on the potential genotoxicity of the additive, the Panel is not in the position to conclude on the safety of the additive for any other animal species/categories. The additive is considered safe for the consumers and the environment at the proposed conditions of use. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be a skin and eye irritant and skin sensitiser. Exposure via inhalation is considered a risk. The FEEDAP Panel is not in the position to conclude on the efficacy of the additive as an anticaking agent. [ABSTRACT FROM AUTHOR]

In 2012, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of acetic acid when used as a technological additive (preservative) for all animal species. The characterisation and condition of use of the additive are the same as those already assessed by the FEEDAP Panel in the previous opinion on acetic acid. Acetic acid produced with the new manufacturing process complies with the specifications set by Commission Regulation (EU) No 231/2012. The FEEDAP Panel considers that the conclusions reached in the previous assessment apply to the acetic acid produced by the new manufacturing process. The FEEDAP Panel concluded that the additive is considered safe for poultry, pigs and pet animals at a maximum concentration of 2.5 g acetic acid/kg complete feed (or 1 g/L water for drinking). The known high endogenous production of acetic acid in the ruminants shows that the tolerance of these target animals is considerably higher. No data is available for salmonids. The use of the additive in animal nutrition is of no concern for consumer safety. The risks for users handling the additive depend on the concentration and include skin, eyes, and respiratory tract irritation (10-25% solution) and corrosion (> 25% solution). The use of the additive as a feed additive is considered safe for the environment. The Panel concluded that the additive has a potential to be efficacious as preservative in feedingstuffs and water for drinking. The FEEDAP Panel has some reservations about the effectiveness of acetic acid as preservative in dry feedingstuffs with a typical moisture content of ≤ 12%. [ABSTRACT FROM AUTHOR]

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 authorisation of vitamin B6 (pyridoxine hydrochloride) produced by chemical synthesis as a feed additive for all animal species. The applicant has provided data demonstrating that the additive in the market complies with the conditions of the authorisation. The FEEDAP Panel confirms that the use of pyridoxine hydrochloride under the current authorised conditions of use is safe for the target species, the consumers and the environment. Pyridoxine hydrochloride is non-irritant to skin and eyes. In the absence of data, no conclusion can be drawn on skin sensitisation potential. Pyridoxine hydrochloride may cause photosensitisation. Despite the lack of data on inhalation toxicity, the additive is not dusty and exposure through inhalation is unlikely. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

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 additive consisting of Bacillus subtilis DSM 32325 when used as technological additive (hygiene condition enhancer) in feed for all animal species. The product is intended for use in dry feeds at a minimum inclusion level of 1 × 108 colony forming unit (CFU)/kg complete feedingstuff. The bacterial species Bacillus subtilis DSM 32325 is considered by EFSA to be eligible for the qualified presumption of safety approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of the strain in animal nutrition is considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the product. Exposure of users by inhalation is likely and the product should be considered a respiratory sensitiser. The Panel is not in the position to conclude on the efficacy of Bacillus subtilis DSM 32325 when used in animal nutrition as hygiene condition enhancer due to lack of data. Bacillus subtilis DSM 32325 is compatible with diclazuril, decoquinate and halofuginone. The data provided do not allow to conclude on the compatibility of the additive with monensin sodium, salinomycin sodium, narasin, robenidine hydrochloride and maduramicin ammonium. [ABSTRACT FROM AUTHOR]

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 authorisation of all‐rac‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all‐rac‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance, however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all‐rac‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation. [ABSTRACT FROM AUTHOR]

In accordance with Article 6 of Regulation (EC) No 396/2005, the applicant Exponent International Ltd. (on behalf of the U.S. Highbush Blueberry Council (USHBC)) submitted a request to the competent national authority in France to set an import tolerance for the active substance potassium phosphonates in blueberries. The data submitted in support of the request were found to be sufficient to derive a maximum residue level (MRL) proposal for blueberries. Adequate analytical methods for enforcement are available to control the residues of phosphonic acid on the commodity under consideration at the validated limit of quantification (LOQ) of 0.1 mg/kg. Based on the risk assessment results, EFSA concluded that the short-term and long-term intake of residues resulting from the use of potassium phosphonates according to the reported agricultural practice is unlikely to present a risk to consumer health. The consumer risk assessment shall be regarded as indicative and a refined intake assessment will be performed in the framework of the joint review of MRLs for fosetyl and phosphonates. [ABSTRACT FROM AUTHOR]

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 additive consisting of Propionibacterium freudenreichii ssp. shermanii ATCC PTA-6752 when used as technological additive (acidity regulator) in dry feed at a minimum inclusion level of 2 9 109 colonyforming units (CFU)/kg and in complete or complementary liquid feed for all animal species at a minimum concentration of 1 9 109 CFU/L. No minimum concentration is proposed by the applicant when used in combination with other microbial technological additives. The bacterial species P. freudenreichii is considered by EFSA to be eligible for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of the strain in animal nutrition is considered safe for the target animals, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the additive, but it should be considered a respiratory sensitiser. Exposure of users by inhalation is likely. No conclusions could be drawn on the efficacy of the additive when used alone as an acidity regulator in feed due to lack of data. The studies provided showed that P. freudenreichii ssp. shermanii ATCC PTA-6752 when used in combination with Ligilactobacillus animalis ATCC PTA-6750 has the potential to act as an acidity regulator. However, the Panel has reservations on the effects of this mixture in practical use conditions. [ABSTRACT FROM AUTHOR]

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 additive consisting of Ligilactobacillus animalis (formerly known as Lactobacillus animalis) ATCC PTA-6750 when used as a technological additive (acidity regulator, preservative and hygiene condition enhancer) in feed and water for drinking for all animal species. The product is intended for use as a single strain at a minimum inclusion level of 5 9 106 CFU/L or CFU/kg in water, liquid and dry feeds. No minimum inclusion level is proposed by the applicant when used in combination with other microbial technological additives. The bacterial species L. animalis is considered by EFSA to be eligible for the qualified presumption of safety approach. As the identity of the strain has been clearly established and it did not show acquired resistance to antibiotics of human and veterinary importance, the use of the strain in animal nutrition is considered safe for the target species, consumers and the environment. No conclusions can be drawn on the skin/eye irritancy or skin sensitisation potential of the product, but it should be considered a respiratory sensitiser. Exposure of users by inhalation is likely. The Panel is not in the position to conclude on the efficacy of L. animalis ATCC PTA-6750 when used in animal nutrition as an acidity regulator, preservative or hygiene condition enhancer due to lack of data. The studies provided showed that L. animalis ATCC PTA-6750 when used in combination with Propionibacterium freudenreichii ssp. shermanii ATCC PTA-6752 has the potential to act as an acidity regulator. However, the Panel has reservations on the effects of this mixture in practical use conditions. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of manganese chelate of ethylenediamine (Manganese-EDA-Cl) as feed additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) identified several issues related to the data provided concerning the chemical characteristics of the additive. Based on the information provided, the FEEDAP Panel considered unlikely that the additive consists only of manganese mono-chelate of EDA, but of several coexisting (manganese) species; therefore, the FEEDAP Panel was unable to confirm the identity of the additive. The FEEDAP Panel could not evaluate the safety for target species, consumer and environment and the efficacy of the additive owing to the uncertainties and limitations identified in the studies submitted. Concerning the safety of the additive for the users, the Panel considered that handling the additive poses a risk to users by inhalation. The additive should be considered as corrosive to eyes and a skin sensitiser. [ABSTRACT FROM AUTHOR]

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 coccidiostat NilablendTM 200G containing lasalocid A sodium and nicarbazin. NilablendTM 200G is not safe for chickens for fattening at the proposed maximum use level of 50 mg lasalocid A sodium + 50 mg nicarbazin/kg complete feed. Concurrent administration of NilablendTM 200G (containing lasalocid A sodium) with tiamulin and certain other medicinal substances should be avoided. Lasalocid A sodium has antimicrobial activity against Gram-positive bacterial species while many Enterobacteriaceae are naturally resistant. Induction of resistance and/or cross-resistance was not observed in experimental conditions. No information on the interactions of nicarbazin with feed materials, other approved additives or medicinal products have been provided. No data were submitted on the microbiological safety of nicarbazin. The toxicological package for lasalocid A sodium and nicarbazin identified no observed adverse effect levels (NOAELs) that could be the basis for setting health-based guidance values (e.g. an acceptable daily intake (ADI)). The Panel concluded that a concern for the genotoxicity of nicarbazin in NilablendTM 200G cannot be excluded and that clarification on the mechanism of action of the test items would be needed. Therefore, the FEEDAP Panel is not in the position to establish an ADI for DNC on which to base the assessment of consumer safety. NilablendTM 200G is considered toxic by inhalation, corrosive and irritant to eyes, slightly irritant to the skin but not a skin sensitiser. Inhalation exposure is considered a risk to persons handling the additive. The FEEDAP Panel cannot conclude on the safety of NilablendTM 200G for the environment due to a possible risk for aquatic compartment (freshwater) for DNC. The efficacy of Nilablend® 200G was demonstrated. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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 Belfeed B MP/ML as a feed additive for sows in order to have benefits in piglets. The additive is to be used in to sows in order to have benefits in piglets and to all porcine species at any developmental stage at 10 IU/kg feed. This additive consists of endo-1,4-β-xylanase produced by a genetically modified strain of Bacillus subtilis (LMG S-15136). In a previous opinion, the FEEDAP Panel could not conclude on the safety of the additive for the users regarding the potential of the additive as dermal sensitiser and on the efficacy of the additive when added to feed for sows in order to have benefits in piglets. In the absence of new information, the FEEDAP Panel retained its previous conclusion that the additive is not irritant to skin or eyes but should be considered a respiratory sensitiser. No conclusions could be drawn on its potential to be a dermal sensitiser. The applicant provided new efficacy data and complementary information regarding a previous study. Based on the previously assessed data and the newly submitted ones, the Panel concludes that although the additive has a potential to be efficacious as a zootechnical additive in sows during the lactation period at the level of 10 IU/kg feed, the data are considered not sufficient to conclude on a beneficial effect on the performance of the litters. [ABSTRACT FROM AUTHOR]

Following a request from the European Commission (EC), the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety for the users of the feed additive consisting of ferric citrate chelate (CI-FERTM) when used as a zootechnical additive for suckling and weaned piglets and minor porcine species. The EC request follows a previous opinion of the FEEDAP Panel. In that opinion, the Panel identified several risks for the users of the additive; it was listed that it posed a risk to users by inhalation, should be considered as an irritant to skin, eyes and mucous membranes, and also that, due to its nickel content, should be considered as a dermal and respiratory sensitiser. The applicant provided additional data including information on the manufacturing process of the additive and data supporting the safety of the additive for the users to address those concerns. Some changes have been applied to the original manufacturing process which led to a dust-free additive, with the following specifications: total iron ≤ 23%, iron (III) ≥ 16.5% and moisture ≤ 10.0%. The FEEDAP Panel concluded that CI-FERTM does not pose a risk by inhalation and is classified as non-irritant to the skin. The additive should be classified as a skin sensitiser. In the absence of new data, the FEEDAP Panel reiterates its previous conclusion that the additive should be considered irritant to eyes. [ABSTRACT FROM AUTHOR]