Undifferentiated versus retinoic acid-differentiated SH-SY5Y cells in investigation of markers of neural function in toxicological research.

The SH-SY5Y human neuroblastoma cell line is a standard experimental model of neuronal-like cells used in neuroscience and toxicological research. These cells can be differentiated into mature neurons, most commonly using retinoic acid (RA). Despite differences in characteristics, both undifferentiated and differentiated SH-SY5Y cells are used in research.

Safety and efficacy of a feed additive consisting of narasin (Monteban® G100) for chickens for fattening (Elanco GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat narasin (Monteban® G100) for chickens for fattening. In a previous opinion, uncertainties remained on the identification and characterisation of the non-genetically modified production strain of the active substance narasin. The Panel could not conclude either on the safety of Monteban® G100 for chickens for fattening or on the efficacy of the additive at the minimum applied concentration.

Safety and efficacy of a feed additive consisting of monensin sodium (Coxidin®) for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding (Huvepharma N.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of monensin sodium (Coxidin®) as a coccidiostat for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. The additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel concluded that Coxidin® remains safe for turkeys for fattening (up to 16 weeks) and extends this conclusion to turkeys reared for breeding (up to 16 weeks).

Safety for the environment of a feed additive consisting of semduramicin sodium (Aviax 5%) for chickens for fattening (Phibro Animal Health s.a.).

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 for the environment of the coccidiostat semduramicin sodium (Aviax 5%) when used in feed for chickens for fattening. The additive Aviax 5% is intended to be used as a coccidiostat in feed for chickens for fattening at a level of 20-25 mg semduramicin sodium/ kg complete feed. The safety and efficacy of the additive was evaluated by the FEEDAP Panel in 2018 and 2022.

Safety for the environment of a feed additive consisting of diclazuril (Coxiril®) for chickens reared for laying and pheasants (Huvepharma NV).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety for the environment of diclazuril (Coxiril®) as a coccidiostat feed additive for chickens reared for laying and pheasants. In its previous assessments, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not reach a final conclusion on the risk resulting from the use of diclazuril in acid soil from Coxiril®. On the basis of the new data provided, the FEEDAP Panel updates the previous conclusions as follows: no risk is expected for the terrestrial compartment and for sediment when diclazuril is used in chickens reared for laying and to pheasants at the proposed condition of use (in both acidic and non-acidic soils).

Safety and efficacy of a feed additive consisting of halofuginone hydrobromide (STENOROL®) for chickens for fattening and turkeys for fattening/reared for breeding (Huvepharma N.V.).

Following a request from the European Commission, EFSA was asked to deliver a new scientific opinion on the coccidiostat halofuginone hydrobromide (STENOROL®) when used as a feed additive for chickens for fattening and turkeys for fattening/reared for breeding. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the safety for turkeys for fattening established in its previous opinion can be extended to turkeys for breeding up to 12 weeks of age. Based on the new data provided on the safety for consumer, environment and efficacy, the Panel updates its previous conclusions as follows: halofuginone hydrobromide is not genotoxic.

Safety and efficacy of a feed additive consisting of copper(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH).

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety and efficacy of a copper(II)-betaine complex as nutritional feed additive for all animal species. Based on the results of a tolerance study carried out in chicken, the FEEDAP Panel concluded that the additive is safe for chickens for fattening when used up to the current maximum authorised levels of copper in feed; this conclusion was extrapolated to all animal species and categories at the respective maximum copper levels in complete feed authorised in the European Union. The FEEDAP Panel concluded that the use of the copper(II)-betaine complex in animal nutrition at the maximum copper levels authorised for the animal species poses no concern to the safety of consumers.

Safety and efficacy of a feed additive consisting of a zinc(II)-betaine complex for all animal species (Biochem Zusatzstoffe Handels- und Produktionsges. mbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a zinc(II)-betaine complex as nutritional additive for all animal species. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for chickens for fattening. This conclusion could be extrapolated to all animal species and categories provided that the maximum authorised levels in the EU for total zinc in feed are not exceeded.

Assessment of caffeine neurotoxicity using novel biomarkers of neural function in SH-SY5Y cells - Is there a need for environmental concern?

Worldwide usage of caffeine results in its constant release into the aquatic environment and growing concerns related to associated risks. We assessed (neuro)toxicity of environmentally relevant concentrations of caffeine, using novel biomarkers of neural function in SH-SY5Y cells and markers of general toxicity also in HepG2 cells. The RQ-PCR analyses showed that caffeine disturbs the expression of genes encoding several key elements of neurotransmitter pathways, with the most prominent responses observed for serotonin receptor 3A, dopamine receptor D2, monoamine oxidase B and GABA-transaminase.

Safety of a feed additive consisting of semduramicin sodium (Aviax 5%) for chickens for fattening (Phibro Animal Health s.a.).

Following a request from the European Commission, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety of the coccidiostat Aviax 5% (semduramicin sodium) when used in feed for chickens for fattening. In a previous assessment, the FEEDAP Panel could not conclude on the taxonomical identification of the production strain at species level and on the absence of genetic determinants for antimicrobial resistance. In addition, the Panel could not conclude on the safety for the target animals and could not set maximum residue limits to protect consumers.

Safety and efficacy of a feed additive consisting of butylated hydroxytoluene (BHT) for all animal species (Katyon Technologies Limited).

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 hydroxytoluene (BHT) as a feed additive for all animal species. The additive BHT is considered safe for chickens for fattening and weaned piglets at the maximum proposed concentration of 150 mg/kg complete feed. This conclusion is extended to chickens reared for laying and extrapolated to pigs for fattening.

Safety and efficacy of a feed additive consisting of butylated hydroxytoluene (BHT) for all animal species (Lanxess Deutschland GmbH).

Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of butylated hydroxytoluene (BHT) as a feed additive for all animal species. The additive BHT is considered safe for chickens for fattening and weaned piglets at the maximum proposed concentration of 150 mg/kg complete feed. This conclusion is extended to chickens reared for laying and extrapolated to pigs for fattening.

One planet: one health. A call to support the initiative on a global science-policy body on chemicals and waste.

The chemical pollution crisis severely threatens human and environmental health globally. To tackle this challenge the establishment of an overarching international science-policy body has recently been suggested. We strongly support this initiative based on the awareness that humanity has already likely left the safe operating space within planetary boundaries for novel entities including chemical pollution.

Safety and efficacy of a feed additive consisting of ethoxyquin (6-ethoxy-1,2-dihydro-2,2,4-trimethylquinoline) for all animal species (FEFANA asbl).

Ethoxyquin is synthetised from p-phenetidine, a possible mutagen, which remains in the additive as an impurity at concentrations of < 2.5 mg/kg additive. Ethoxyquin is considered safe for all animal species at the proposed inclusion level of 50 mg/kg complete feed.

Safety for the environment of a feed additive consisting of nicarbazin (Coxar) for use in turkeys for fattening (Huvepharma N.V.).

Following a request from the European Commission, 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 environment of the coccidiostat Coxar (nicarbazin) when used in feed for turkeys for fattening. In previous assessments, the FEEDAP Panel could not conclude on the safety of Coxar for the environment due to concerns on 4,40-dinitrocarbanilide (DNC, one of the moieties of nicarbazin). On the basis of the new data provided, the FEEDAP Panel updates its previous conclusions on the safety of Coxar for the environment as follows: The use of nicarbazin from Coxar in complete feed for turkeys does not pose a risk for the terrestrial and aquatic compartment and in sediment.

Safety for the environment of sorbitan monolaurate as a feed additive for all animal species.

The additive sorbitan monolaurate consists of sorbitol (and its anhydrides) esterified with fatty acids derived from coconut oil. It is currently authorised in the European Union and it is intended to be used as a technological additive (functional group of emulsifiers), in feedingstuffs for all animal species, at a maximum concentration of 85 mg/kg complete feed. In 2019, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of sorbitan monolaurate.

Safety and efficacy of STABILFLOR as a zootechnical feed additive for pigs for fattening.

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 STABILFLOR (zinc ethylenediaminetetraacetic acid (Zn-EDTA) and copper diammonium EDTA (Cu-EDTA) dried on chicory pulp and supplemented with zinc oxide and copper oxide), as a zootechnical additive for pigs. STABILFLOR is intended to be used in feed for pigs for fattening at a minimum and maximum levels of 500 and 1,000 mg/kg complete feed, respectively. The Panel could not conclude on the safety of STABILFLOR for pigs for fattening owing to the lack of adequate data.

Safety and efficacy of Nimicoat (carvacrol) as a zootechnical additive for weaned piglets.

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 Nimicoat (carvacrol), as a zootechnical additive for weaned piglets. The additive is composed by carvacrol (≥  40 %) as an active substance encapsulated with high-melting lipids. Nimicoat is intended to be used in feed for weaned piglets at a minimum recommended dose of 250 mg/kg complete feed and at a maximum recommended dose of 1,000 mg/kg complete feed corresponding to a minimum and maximum of 100 and 400 mg carvacrol/kg complete feed, respectively.

Safety of lignosulphonate for all animal species.

Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the safety and efficacy of lignosulphonate, when used as a technological additive, functional group: binders. In a previous opinion, the FEEDAP Panel could not conclude on the safety of the additive for target species and for the environment. The applicant provided additional information that was assessed in the current opinion.

Application of General Unified Threshold Models of Survival Models for Regulatory Aquatic Pesticide Risk Assessment Illustrated with an Example for the Insecticide Chlorpyrifos.

Mathematical models within the General Unified Threshold models of Survival (GUTS) framework translate time-variable chemical exposure information into expected survival of animals. The GUTS models are species and compound specific and explicitly describe the internal exposure dynamics in an organism (toxicokinetics) and the related damage and effect dynamics (toxicodynamics), thereby connecting the external exposure concentration dynamics with the simulated mortality or immobility over time. In a recent scientific opinion on toxicokinetic-toxicodynamic (TKTD) models published by the European Food Safety Authority (EFSA), the GUTS modeling framework was considered ready for use in the aquatic risk assessment for pesticides and aquatic fauna.

Modification of the terms of authorisation regarding the maximum inclusion level of Maxiban G160 (narasin and nicarbazin) for chickens for fattening.

Following the 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 proposed modification of the terms of the authorisation regarding the maximum inclusion level of Maxiban G160. The FEEDAP Panel cannot conclude on the safety of Maxiban G160 at a dose level of 70 + 70 mg/kg feed for the target species. The use of Maxiban G160 in diets for chickens for fattening at the maximum proposed dose complies with the maximum residue levels (MRLs) in force of narasin and 4,4'-dinitrocarbanilide (DNC) at 0-day withdrawal except for DNC in kidney which was slightly above the MRL.

Safety of Lancer (lanthanide citrate) as a zootechnical additive for weaned piglets.

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 additional data submitted on Lancer when used as a feed additive for weaned piglets. The FEEDAP Panel considered that uncertainty still remains on possible developmental neurotoxicity of Lancer since it was unable to identify a no observed adverse effect level (NOAEL) for this specific endpoint applying a read-across strategy from the studies provided by the applicant. However, the FEEDAP Panel considered that the exposure to La and Ce from products of animals treated with Lancer at 250 mg/kg feed would not add a significant contribution to the background exposure of these elements.

Safety and efficacy of Elancoban G200 (monensin sodium) for chickens for fattening, chickens reared for laying and turkeys.

The feed additive Elancoban G200, containing the active substance monensin sodium, an ionophore anticoccidial, is intended to control coccidiosis in chickens for fattening, chickens reared for laying and turkeys. The FEEDAP Panel cannot conclude on the safety of the additive for the target species, consumer, user and environment with regard to the safety of the production strain. The following conclusions apply to monensin sodium included in the additive.