New advanced models (NAMs) for risk assessment of bisphenol A alternatives.

The safety of bisphenol A (BPA) due to its adverse effects on the immune system has led to an increasing concern and a significant regulatory shift. The European Food Safety Authority (EFSA) proposed a reduction in the tolerable daily intake (TDI) of BPA in food in their 2023 scientific opinion, highlighting the need for stricter regulations compared to their previous assessment in 2015. This regulatory action has spurred the production of BPA alternatives, raising concerns about their safety due to insufficient toxicological data.

Safety and efficacy of a feed additive consisting of NCIMB 41028 for all animal species (Genus Breeding Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of NCIMB 41028 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 × 10 colony forming units (CFU)/kg fresh plant material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment.

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of L. (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 leaves of L. (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 sage oil is considered safe up to the maximum proposed use levels in complete feed of 20 mg/kg for ornamental fish.

Safety and efficacy of a feed additive consisting of NCIMB 30148 for all animal species (Genus Breeding Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of NCIMB 30148 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 × 10 colony forming units (CFU)/kg fresh plant material. The bacterial species is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment.

Assessment of the feed additive consisting of NCIMB 40027 for all animal species for the renewal of its authorisation (Volac International ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of the authorisation of NCIMB 40027 as a technological additive (functional group: silage additives) for use in fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing terms of the authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive remains safe for all animal species, consumers, and the environment.

Safety and efficacy of a feed additive consisting of the bacteriophages PCM F/00069, PCM F/00070, PCM F/00071 and PCM F/00097 (Bafasal®) for all poultry (Proteon Pharmaceuticals S.A.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a product consisting of four bacteriophages infecting ser. Gallinarum B/00111, intended for be as a zootechnical additive (functional group: other zootechnical additives) for all poultry species. Bafasal® is proposed for use in water for drinking and liquid complementary feed to guarantee a minimum daily dose of 2 × 10 PFU/bird, to reduce the spp.

Assessment of the feed additive consisting of NCIMB 30151 for all animal species for the renewal of its authorisation (Microferm ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of a preparation of NCIMB 30151 as a technological additive to improve ensiling of fresh material for all animal species. The applicant has provided evidence that the additive currently on the market complies with the existing conditions of authorisation. There was no new evidence that would lead to the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) to reconsider its previous conclusions for all animal species, consumers and the environment, for which the additive is considered to remain safe.

Safety and efficacy of a feed additive consisting of ponceau 4R 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 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.

Safety and efficacy of a feed additive consisting of an essential oil derived from the flowering stems of 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 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.

Assessment of the modification of the authorisation of the feed additive consisting of CNCM I-1077 for lambs and its extension of use to all ruminants and camelids reared for milk production/suckling/reproduction, all minor (young) ruminant species and camelids for fattening and Equidae other than horses (Lallemand SAS).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a preparation of CNCM I-1077 as a zootechnical feed additive for several animal species. The additive, existing in a not-coated and a coated form, is currently authorised for use in feed for calves, cattle for fattening, dairy cows, dairy goats and dairy sheep, lambs, all minor ruminant species for fattening and rearing, horses and camelids for fattening and rearing. This application regards the request for the extension of use in all ruminants and camelids reared for milk production/suckling/reproduction, all minor (young) ruminant species and camelids for fattening and Equidae other than horses, and the modification of the authorisation for lambs to reduce the minimum use level.

Safety of a feed additive consisting of vitamin B/riboflavin produced with 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 B/riboflavin produced with 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.

Safety and efficacy of a feed additive consisting of DSM 33862 and DSM 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 DSM 33862 and 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 × 10 colony forming units (CFU)/kg fresh plant material to be used for all animal species. The bacterial species and are considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment.

Efficacy of the feed additives consisting of ATCC 53519 and 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 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 × 10 colony-forming units of ATCC 53519/kg fresh material or 5 × 10 CFU of 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.

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.

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.

Safety and efficacy of a feed additive consisting of an essential oil derived from the flowering tops of Mill. (lavender 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 flowering tops of Mill. (lavender 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 proposed use levels in complete feed of 30 mg/kg for dogs and ornamental fish.

Safety and efficacy of a feed additive consisting of an essential oil derived from the flowering tops of (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 (L.) Cav. (Spanish type origanum oil) when used as a sensory additive in feed and in water for drinking for all animal species.

Safety and efficacy of a feed additive consisting of an essential oil derived from leaves and terminal branchlets of (Maiden & Betche) Cheel (tea tree 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 tea tree oil obtained from leaves and terminal branchlets of (Maiden & Betche) Cheel when used as a sensory additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that tea tree oil was very unlikely to be of safety concern for long-living and reproductive animals and is of no concern for target species for fattening at the following concentrations in complete feed: 1.1 mg/kg for chickens for fattening, 1.

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.

Safety and efficacy of a feed additive consisting of an essential oil derived from the leaves of ssp. (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 ssp. (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.

Safety and efficacy of a feed additive consisting of 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 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 (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.

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

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 (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.

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).

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.

Safety and efficacy of a feed additive consisting of fumaric acid for all animal species for the renewal of its authorisation and extension of use (Life SUPPLIES NV).

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 the authorisation of fumaric acid as a technological and sensory additive (functional groups: preservative and flavouring compounds, respectively) and for a new use of the additive as a technological additive (functional group: acidity regulator) for all animal species. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that fumaric acid remains safe under the authorised conditions of use for the terrestrial animals, consumers and the environment.