FEEDAP Panel Research Articles

Safety of a feed additive consisting of vitamin B2/riboflavin produced with Eremothecium ashbyi CCTCCM 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 safety of a feed additive consisting of vitamin B2/riboflavin produced with Eremothecium ashbyi CCTCCM 2019833 intended for use as a nutritional additive (functional group: vitamins, pro-vitamins and chemically well-defined substances having similar effects) for all animal species. The characterisation, safety and efficacy of the additive have been already assessed previously; however, the FEEDAP Panel could not conclude on the safety of the additive for the target species, consumers and the users due to lack of reliable toxicological data. In the present assessment, the applicant submitted new genotoxicity and repeated dose oral toxicity studies. After the assessment of the data newly submitted, the FEEDAP Panel concluded that the use of the feed additive in animal nutrition under the conditions of use proposed is of no safety concern for the target species and the consumer. The additive is not a skin/eye irritant nor a skin sensitiser, but it is considered a respiratory sensitiser.

Efficacy of the feed additives consisting of Enterococcus faecium ATCC 53519 and E. faecium ATCC 55593 as silage additives for all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the efficacy of two technological additives (functional group: silage additives) consisting of Enterococcus faecium strains ATCC 53519 and ATCC 55593, respectively. The additives are intended for use with all types of fresh materials and for all animal species at a proposed minimum concentration of 1 × 107 colony-forming units of E. faecium ATCC 53519/kg fresh material or 5 × 106 CFU of E. faecium ATCC 55593/kg fresh material. In a previous opinion, the FEEDAP Panel could not conclude on their efficacy since the dry matter content of the ensiled materials at the end of the experiments was not corrected for volatiles, which led to unreliable estimation of the dry matter loss, and the lack of positive effects on any of the other parameters. The supplementary information submitted by the applicant included updated data on the dry matter loss corrected for volatiles. The results showed that, at the end of the ensiling process, the dry matter loss during the ensiling was significantly lower in the ensiled materials treated with E. faecium ATCC 53519 or ATCC 55593 compared to controls. The FEEDAP Panel concludes that the addition of E. faecium ATCC 53519 or ATCC 55593 in all types of fresh plant materials shows potential to improve the nutrient preservation of silage at the proposed conditions of use.

Safety and efficacy of a feed additive consisting of ponceau 4R for its use in baits for freshwater fish (GIFAP)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of ponceau 4R as sensory additives (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs). The additive is already authorised for use with cats and dogs and ornamental fish. The additive is intended to be incorporated in freshwater fishing baits up to a maximum of 15 mg/kg in complementary feed in order to colour them. The additive is intended to be incorporated into feed directly in solid form or via an aqueous solution. The additive is not intended for use in aquaculture. The FEEDAP Panel concluded that ponceau 4R is considered safe when used in fish baits for freshwater fish at the maximum proposed dose of 15 mg/kg complementary feed. The use of the feed additive ponceau 4R fish baits for freshwater fish under the conditions of use proposed is of no concern for consumer safety. Ponceau 4R is not skin irritant but should be considered a skin and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not conclude on the eye irritation potential of the additive. In absence of data no conclusion can be reached on the efficacy of ponceau 4R in freshwater fish baits.

Safety and efficacy of a feed additive consisting of an essential oil derived from the flowering stems of Salvia sclarea L. (clary sage oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the fresh or dried flowering stems of Salvia sclarea L. (clary sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for veal calves (milk replacers), cattle for fattening, sheep/goats, 10 mg/kg for horses, 20 mg/kg for dogs, salmonids and ornamental fish. For the other target species, the calculated safe concentrations were 5 mg/kg for chickens for fattening, 8 mg/kg for laying hens, 7 mg/kg for turkeys for fattening, 9 mg/kg for piglets, 11 mg/kg for pigs for fattening, 14 mg/kg for sows, 13 mg/kg for dairy cows, 8 mg/kg for rabbits and 4 mg/kg for cats. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 4 mg/kg complete feed. The FEEDAP Panel considered that the use level in water of clary sage oil 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. The use of clary sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the flowering stems of S. sclarea is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of Bacillus subtilisDSM 33862 and Lentilactobacillus buchneriDSM 12856 as a silage additive for all animal species (Lactosan GmbH & Co.KG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on a formulation of Bacillus subtilis DSM 33862 and Lentilactobacillus buchneri DSM 12856 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use with fresh plant material with a dry matter (DM) range of 32%-65% at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material to be used for all animal species. The bacterial species B. subtilis and L. buchneri are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strains was established, no acquired antimicrobial resistance genes of concern were detected in any of the two active agents and no evidence of toxigenic potential was found in B. subtilis DSM 33862. Therefore, the FEEDAP Panel concluded that the use of the strains as a silage additive is considered safe for all the animal species, for consumers of products from animals fed with the treated silage and for the environment. Regarding user safety, the additive contains microorganisms and therefore should be considered as a potential skin and respiratory sensitiser. The additive is not irritant to skin or eyes. Inhalation and dermal exposure is considered a risk. These conclusions would apply, in principle, to any preparations containing the active agents. The FEEDAP Panel concluded that the additive containing B. subtilis DSM 33862 and L. buchneri DSM 12856 at a minimum concentration of 1 × 108 CFU/kg fresh material has the potential to extend the aerobic stability of silage prepared from fresh plant materials with a DM range of 32%-65%.

Safety and efficacy of a feed additive consisting of l-arginine produced with Escherichia coliCGMCC 7.401 for all animal species (Eppen Europe SAS).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the feed additive consisting of l-arginine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 7.401). The additive is intended to be used in feed and water for drinking for all animal species and categories. The genetic modifications introduced do not raise safety concerns. No viable cells or DNA of the production strain were detected in the final product. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not pose any safety concern with regard to the production strain. l-Arginine produced with E. coli CGMCC 7.401 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed and water. The use of l-arginine produced with E. coli CGMCC 7.401 in animal nutrition is considered safe for the consumers and for the environment. The endotoxin activity of the additive does not represent a hazard for persons handling the additive. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be irritant to skin and/or eyes, or to be a dermal or respiratory sensitiser. The additive l-arginine produced with E. coli CGMCC 7.401 is regarded as an efficacious source of the essential amino acid l-arginine for non-ruminant species. For supplemental l-arginine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen.

Safety and efficacy of a feed additive consisting of l-valine produced with Escherichia coliCGMCC 22721 for all animal species (Eppen Europe SAS).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of l-valine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 22721) as a nutritional additive for all animal species. The production strain and its DNA were not detected in the final additive. Therefore, the final product does not give raise to any safety concern regarding the genetic modification of the production strain. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that l-valine produced using E. coli CGMCC 22721 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species. The FEEDAP Panel has concerns on the use of amino acids in water for drinking for hygienic reasons, and due to the risk of imbalances when administered simultaneously via feed. The use of l-valine produced using E. coli CGMCC 22721 in animal nutrition is considered safe for the consumers and for the environment. The FEEDAP Panel cannot conclude on the potential of l-valine produced using E. coli CGMCC 22721 to irritant to the skin or eyes, a dermal or respiratory sensitiser due to the lack of data. The endotoxin activity of the additive does not represent a hazard for users handling the additive when exposed by inhalation. The additive l-valine produced by fermentation using E. coli CGMCC 22721 is regarded as an efficacious source of the essential amino acid l-valine for non-ruminant nutrition. For the supplemental l-valine to be as efficacious in ruminants as in non-ruminant species, it requires protection against degradation in the rumen.

Safety and efficacy of a feed additive consisting of an essential oil derived from the flowering tops of Thymbra capitata (L.) Cav. (Spanish type origanum oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of an essential oil from the flowering tops of Thymbra capitata (L.) Cav. (Spanish type origanum oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level in complete feed of 15 mg/kg for poultry species, 30 mg/kg for pigs and horses, 20 mg/kg for ruminants, 25 mg/kg for rabbits, dogs, cats and ornamental fish, and 125 mg/kg for salmonids. These conclusions were extrapolated to other physiologically related species. For any other species, the additive is safe at 15 mg/kg complete feed. The FEEDAP Panel considered that the use level 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. The use of the additive in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since T. capitata and its preparations were recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Assessment of the feed additive consisting of a preparation containing a smoke flavouring extract for cats and dogs for the renewal of the authorisation (Azelis Denmark A/S)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of authorisation of a preparation containing a smoke flavouring extract for cats and dogs. The applicant provided data demonstrating that the additive currently on the market does not fully comply with the conditions of authorisation, but with newly proposed specifications based on different analytical methods. Considering that the additive under assessment contains benzofuran and styrene, for which a potential concern for genotoxicity has been identified, and that the whole mixture raises a potential concern for genotoxicity, additional data would be needed to complete the assessment. Therefore, the FEEDAP Panel is not in the position to conclude on the safety for cats and dogs. The additive is authorised for use in feed for cats and dogs, and therefore, there is no need to perform an assessment of the safety for the consumer and the environment. Regarding user safety, the additive should be considered as irritant to skin and eyes, and as a dermal and respiratory sensitiser. When handling the additive, exposure of unprotected users to potential genotoxic substances may occur. Therefore, to reduce the risk, the exposure of the users should be minimised. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety and efficacy of a feed additive consisting of Saccharomyces cerevisiae NCYC R618 (Benesacc®) for chickens for fattening and other poultry species for fattening and reared for laying (Global Nutritech Biyoteknoloji Ltd. Sti).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Saccharomyces cerevisiae NCYC R618 as a zootechnical feed additive (functional group: gut flora stabiliser) for chickens for fattening and other poultry species for fattening and reared for laying. The additive has never been authorised. The strain under assessment S. cerevisiae (NCYC R618) qualifies for the qualified presumption of safety (QPS) and, consequently, the FEEDAP Panel concluded that the product is safe for the target species, the consumers and the environment. The FEEDAP Panel could not conclude on the skin and eye irritation or skin sensitisation potential of the additive. The additive should be considered a respiratory sensitiser. Due to the lack of sufficient data, the Panel cannot conclude on the efficacy of the additive under the proposed conditions of use.

Assessment of the feed additive consisting of propionic acid for all terrestrial animal species for the renewal of its authorisation (Eastman Chemical B.V., Perstorp AB, Dow Europe GmbH, BASF SE).

Propionic acid is currently authorised as a technological additive (functional group: silage additives) for all animal species. The applicants requested for the renewal of the authorisation of propionic acid when used as a feed additive for all terrestrial animal species. The applicants have 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 propionic acid under the current authorised conditions of use is safe for the target species, the consumers and the environment. Regarding user safety, the additive is corrosive to the skin and any exposure to users is considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of Salvia officinalis ssp. lavandulifolia (Vahl) Gams (Spanish sage oil) for use in all animal species (FEFANA asbl).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Spanish sage oil from the leaves of Salvia officinalis ssp. lavandulifolia (Vahl) Gams (Spanish sage oil) when used as a sensory additive in feed and in water for drinking for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive under assessment is considered safe up to the maximum use level of 14 mg/kg complete feed for all animal species. The FEEDAP Panel considered that the use of Spanish sage oil 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. The use of Spanish sage oil in animal feed under the proposed conditions of use is safe for the consumer and the environment. Regarding user safety, the essential oil under assessment should be considered as an irritant to skin and eyes and as a dermal and respiratory sensitiser. Since the oil of the leaves of S. officinalis ssp. lavandulifolia (Vahl) Gams is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy was considered necessary.

Safety and efficacy of a feed additive consisting of tartrazine for its use in baits for freshwater fish (GIFAP).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of tartrazine as sensory additive (functional group: (a) colourants: (i) substances that add or restore colour in feedingstuffs). Tartrazine is intended to be incorporated in fishing baits up to a maximum of 30 mg/kg in complementary feed in order to colour them and attract fish in freshwater (ponds, rivers), for both recreational and competitive fishing. The additive is not intended for use in aquaculture. Tartrazine is already authorised for use with cats and dogs, ornamental fish, grain-eating ornamental birds and small rodents. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of tartrazine in the preparation of baits for freshwater fish under the proposed conditions of use is of no concern for the target animals. The use of tartrazine as a feed additive under the proposed conditions of use is considered safe for the consumer and the environment. Regarding the user safety, the additive should be considered a dermal and respiratory sensitiser. Inhalation and dermal exposure are considered a risk. The FEEDAP Panel could not conclude on the irritation potential of the additive. In absence of data, no conclusion can be reached on the efficacy of tartrazine in freshwater fish baits.

Assessment of the feed additive consisting of ammonium propionate for all terrestrial animal species for the renewal of its authorisation (BASF SE, Tamnico Finland Oy).

Ammonium propionate is authorised as a liquid preparation of ≥ 19% ammonium propionate, ≤ 80% propionic acid and ≤ 30% water. The applicant requested for the renewal of the authorisation of ammonium propionate when used as a feed additive for all terrestrial animal species. 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 ammonium propionate under the current authorised conditions of use is safe for the target species, the consumers and the environment. Concerning the user safety, the additive is corrosive to skin and eyes. Any exposure is considered a risk. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Safety of a feed additive consisting of 3-phytase produced with Komagataella phaffii CECT 13171 (FSF10000/FLF1000) for poultry species, pigs for fattening and minor porcine species for fattening (Fertinagro Biotech S.L.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety of the feed additive consisting of 3-phytase produced with a genetically modified strain of Komagataella phaffii (CECT 13171). The additive is intended to be used as a zootechnical additive for poultry species, pigs for fattening and minor porcine species for fattening. In a previous opinion, the EFSA Panel on Additives and Products or Substance used in Animal Feed (FEEDAP) Panel could not conclude on the taxonomic identification of the production strain. Moreover, the presence of viable cells of the production strain in the final formulations of the product could not be excluded. Therefore, no conclusions could be drawn on the safety for the target species, consumers, users and environment. In the present submission, the applicant provided supplementary information regarding the characterisation of the production strain and the absence of its viable cells in the final product. Based on the data provided, the identification of CECT 13171 as K. phaffii was confirmed and no viable cells of the production strain were detected in the final formulations of the additive. The FEEDAP Panel concluded that the 3-phytase produced with the genetically modified strain K. phaffii CECT 13171 does not give rise to any safety concern as regard to the production strain. Consequently, the additive, in both its liquid and solid formulations, is safe for the target species, consumers, users and environment.

Safety and efficacy of a feed additive consisting of endo‐1,4‐β‐xylanase produced with Trichoderma reesei CBS 114044 (ECONASE® XT) for pigs for fattening, laying hens and minor poultry species (AB Enzymes Finland Oy)

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product containing endo‐1,4‐β‐xylanase (ECONASE® XT) as a zootechnical feed additive (digestibility enhancer) for pigs for fattening, laying hens and minor poultry species. ECONASE® XT is available in two liquid and three solid forms and is produced with a genetically modified strain of Trichoderma reesei (CBS 114044). The FEEDAP Panel concluded that the genetic modification of the production strain does not raise any safety concerns, and viable cells of the production strain and its DNA were not detected in the final products. The Panel also concluded that ECONASE® XT is safe for pigs for fattening, laying hens and minor poultry species at the proposed conditions of use. The use of the additive raises no safety concerns for the consumers of products derived from animals fed with the additive or for the environment. The liquid and solid forms of ECONASE® XT are non‐irritant to the skin, but only the liquid forms were confirmed as non‐irritant to the eyes and not dermal sensitisers. The Panel could not conclude on the irritation potential to the eyes and the dermal sensitisation potential for the solid forms. Due to the proteinaceous nature of the active substance, the additive is considered to be a respiratory sensitiser. The additive has the potential to be efficacious in pigs for fattening at 20,000 BXU/kg complete feed, in all laying poultry species at 12,000 BXU/kg complete feed and in minor poultry species other than laying birds at 8000 BXU/kg complete feed.

Safety and efficacy of a feed additive consisting of lutein-rich extract of Tagetes erecta L. for turkeys for fattening (EW Nutrition).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of lutein-rich extract of Tagetes erecta L. as sensory additive (functional group: Colourants (ii) substances which, when fed to animals, add colours to food of animal origin) for turkeys for fattening. The additive is already authorised for use in feed for chickens for fattening and minor poultry for fattening and laying hens and minor poultry for laying. The FEEDAP Panel concluded that the use of lutein-rich extract of T. erecta is safe for turkeys for fattening when used up to the maximum proposed use level of 80 mg total carotenoids/kg complete feed. The Panel concluded that the use of lutein-rich extract of T. erecta in feed for turkeys for fattening under the proposed conditions of use would not be of concern for the consumer, considering also its use in other poultry for fattening and for laying hens. Regarding user safety, the lutein-rich extract of T. erecta extract is irritant to skin and eyes and any exposure is considered a risk. The conclusions on user safety reached for the lutein-rich extract of T. erecta would, in principle, apply to preparations made with it. The use of the additive in feed for turkeys for fattening under the proposed conditions of use is safe for the environment. The FEEDAP Panel concluded that the additive has the potential to colour the skin of turkeys for fattening at the proposed conditions of use.

Safety and efficacy of a feed additive consisting of Lentilactobacillus buchneriDSM 32651 for all animal species (BioCC OÜ).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Lentilactobacillus buchneri DSM 32651 when used as a technological additive to improve ensiling of fresh plant material. The additive is intended for use in all fresh material for all animal species at a proposed minimum concentration of 1 × 108 colony forming units (CFU)/kg fresh plant material. The bacterial species L. buchneri is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. The identity of the strain was established and no acquired antimicrobial resistance genes of concern were detected. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of the strain as a silage additive is considered safe for all the animal species, for consumers of products from animals fed the treated silage and for the environment. Regarding user safety, the additive should be considered as a potential skin and respiratory sensitiser, and any exposure through skin and respiratory tract is considered a risk. The additive is not an eye irritant. The FEEDAP Panel concluded that the additive consisting of L. buchneri DSM 32651 at a minimum concentration of 1 × 108 CFU/kg fresh material may extend the aerobic stability of silage prepared from fresh plant material with a DM range of 28%-45%.

Safety Assessment on the Safety and Efficacy of a Feed Additive Consisting of Sodium Bisulphate for All Animal Species Except Aquatic Animals (RP1612)

An application was submitted to the Food Standards Agency in July 2022 from Grillo-Werke AG and Jones-Hamilton Co. (‘the applicant’) for a renewal authorisation of the additive containing sodium bisulphate, under the category ‘technological additive’, functional group ‘preservative’ for all terrestrial animal species, and ‘technological additive’, functional group ‘acidity regulator’ for all terrestrial animal species other than cats, mink, pets and other non-food-producing animals. In addition, the applicant requested an authorisation of new use of the additive under the category ‘technological additive’, functional group ‘acidity regulator’ and ‘sensory additive’, functional group ‘flavouring compound’ for all pets and other non-food-producing animals except aquatic animals. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concluded that sodium bisulphate remains safe for all terrestrial animal species, consumers of products from animals fed the additive and the environment, under the conditions of authorisation. The additive is a skin, eye and respiratory tract irritant and should be considered as a respiratory and skin sensitiser. The FEEDAP Panel concluded that using the additive as an acidity regulator and sensory additive for pets and other non-food-producing animals, excluding aquatic species, would not introduce any new risks and has the potential to be efficacious. FSA/FSS has reviewed the applicant’s renewal and extension of use application, supporting documentation, and other regulators risk assessments, most notably the EFSA risk assessment opinion and consider sufficient evidence has been demonstrated to conclude without further questions or risk assessment. This document represents the opinion of the FSA and FSS.

Assessment of the feed additive consisting of sodium propionate for all terrestrial animal species for the renewal of its authorisation (BASF SE).

Sodium propionate is authorised containing at least 98.5% of sodium propionate. The applicants requested for the renewal of the authorisation of sodium propionate when used as a feed additive for all terrestrial animal species. 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 sodium propionate under the current authorised conditions of use is safe for the target species, the consumers and the environment. Considering the user safety, the additive is corrosive to skin, eyes and respiratory tract, but is not a skin sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.