Metabolomic analysis of the toxicity pathways elicited by subtoxic concentrations of methylone in primary mouse hepatocytes

info:eu-repo/semantics/publishedVersio

Toxicity of synthetic cathinones in human kidney (HK-2) cells

info:eu-repo/semantics/publishedVersio

Assessment of the application for renewal of authorisation of GalliPro ® (Bacillus subtilis DSM 17299) for chickens for fattening

GalliPro \uae is the trade name for a feed additive based on viable cells of a strain of Bacillus subtilis intended for use as a zootechnical additive (gut flora stabiliser) in feed for chickens for fattening. The product is currently authorised for use in chickens for fattening. This opinion concerns the renewal of this authorisation. Bacillus subtilis is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establish the safety for the target species, consumers and the environment. The identity of the strain present in the additive was established and evidence was provided on the lack of toxigenic potential as well as acquired antibiotic resistance determinants to antibiotics of human and veterinary importance. Accordingly, this strain is presumed safe for the target species, consumers of products derived from animals fed the additive and the environment. Since no concerns are expected from other components of the additive, GalliPro \uae is considered safe for the target species, consumers and the environment. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. The FEEDAP Panel confirms its previous conclusions that GalliPro \uae is safe for the target species; consumers of products from animals fed the additive and the environment. GalliPro \uae should be considered a potential respiratory sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the potential of GalliPro \uae for skin and eyes irritancy and dermal sensitisation

Efficacy of the feed additive containing Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I-3740 (Biacton\uae) for chickens for fattening, turkeys for fattening and laying hens (ChemVet dk A/S)

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 efficacy of the additive consisting of Companilactobacillus farciminis (formerly Lactobacillus farciminis) CNCM I-3740 (tradename: Biacton\uae) for chickens for fattening, turkeys for fattening and laying hens. The additive is a preparation containing viable cells of C. farciminis CNCM I-3740 at the minimum concentration of 1  7 109 CFU/g additive. In a previous opinion, the FEEDAP Panel assessed the safety and the efficacy of the product when used in these target species. The Panel concluded that based on the qualified presumption of safety of the active agent, and the lack of concerns deriving from other components of the additive, Biacton\uae was presumed safe for the target animals, consumers and the environment. Regarding the safety for the user, the FEEDAP Panel could not conclude on the potential of the additive to be irritant to skin and eyes or its dermal sensitisation due to the lack of data. However, it concluded that the additive should be considered a respiratory sensitiser. The data provided in the previous assessment to support the efficacy of the additive did not allow drawing conclusions on the efficacy of the additive in any of the target species. The additional information submitted with chickens for fattening and laying hens did not provide sufficient evidence to conclude on the efficacy of Biacton\uae for these target species. No new information was provided that would lead the Panel to reconsider the conclusions already reached on the use of the additive with turkeys for fattening. The FEEDAP Panel, based on the available data, cannot conclude on the efficacy of Biacton\uae in chickens for fattening, turkeys for fattening and laying hens

Safety and efficacy of an essential oil of Origanum vulgare ssp. hirtum (Link) leetsw. for all poultry 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 an essential oil of Origanum vulgare ssp. hirtum (Link) leetsw. for all poultry species. The essential oil under assessment obtained is specified to contain carvacrol and thymol (7%). The remaining 30% of the composition remains uncharacterised. In the absence of these data, the FEEDAP Panel was unable to make a risk assessment of the additive for the target species, the consumer and the user. Use in animal production of the essential oil extracted from O. vulgare ssp. hirtum (Link) leetsw. is not expected to pose a risk for the environment. Since oregano and its extracts are universally recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary

Safety and efficacy of TYFER\u2122 (Ferric tyrosine chelate) as a zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the product TYFERTM (ferric tyrosine chelate) as zootechnical feed additive for chickens, turkeys and minor poultry species for fattening or reared for laying/breeding. The additive is safe for chickens for fattening at the maximum expected level of 200 mg TYFERTM/kg complete feed; this conclusion can be extended to chickens reared for laying/breeding and extrapolated to turkeys and all minor poultry species for fattening or reared for laying/breeding. No concerns for consumer safety are expected from the use of the additive in poultry nutrition. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that the additive poses a risk to users by inhalation, and should also be considered as an irritant to skin, eyes and mucous membranes. Due to the presence of nickel, ferric tyrosine chelate should also be considered as a dermal and respiratory sensitiser. The supplementation of feed with the additive is not expected to pose an environmental risk. TYFERTM used at the minimum recommended level (20 mg/kg feed) in chickens diets has the potential to improve zootechnical parameters of birds. The additive at 20 mg/kg feed has the potential to reduce the caecal load Campylobacter spp. by at least 1 log10-units in chickens for fattening, thus with a potential impact to reduce the risk of human campylobacteriosis; however, the Panel notes that the load of Campylobacter in the chickens caecum is one of the multiple factors that contribute to Campylobacter load in carcases-meat. The conclusions on the efficacy of the additive can be extended to chickens reared for laying/breeding and extrapolated to turkeys and all minor poultry species for fattening or reared for laying/breeding. The Panel recommends including a specification for maximum lithium content in a potential authorisation of the additive

Safety and efficacy of muramidase from Trichoderma reesei DSM 32338 as a feed additive for turkeys for fattening, turkeys reared for breeding, chickens reared for breeding and other poultry species reared for breeding

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 muramidase produced by Trichoderma reesei DSM 32338. The additive is considered safe for turkeys for fattening, turkeys reared for breeding, chickens reared for laying/breeding and other poultry species reared for breeding up to the maximum recommended dose of 45,000 LSU(F)/kg feed. The additive is considered safe for the consumer and the environment. No conclusions can be reached on the potential of the additive for skin/eye irritancy and skin sensitisation. The additive should be considered a potential respiratory sensitiser. The additive has the potential to be efficacious as a zootechnical additive in turkeys for fattening, turkeys reared for breeding, chickens reared for laying/breeding and other poultry species reared for breeding when added to feed at 25,000 LSU(F)/kg feed

Safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of Taminizer D (dimethylglycine sodium salt) as a feed additive for chickens for fattening, based on a dossier submitted for the modification of the terms of authorisation of the additive. The product is authorised in the European Union for chickens for fattening at the maximum content of 1,000 mg/kg complete feedingstuffs. The applicant proposed the introduction of an additional manufacturing process, which introduces an impurity (dimethylamino-ethanol (DMAE)) in the additive at concentrations up to 0.09%. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considered that the proposed modification would not substantially affect the previous assessment as related to the safety of the environment and the efficacy of the product. Since the safety of the active substance was established, the current assessment has dealt with the impurity DMAE. Considering the toxicological profile of DMAE, the estimated intake by the target animal and consumers, and making use of the Threshold of Toxicological Concern (TTC) approach, the Panel concluded that Taminizer D, manufactured by the DMAE route, is safe for both chickens for fattening and consumers, up to the maximum level of 1,000 mg/kg feed. The FEEDAP Panel extends its conclusions about Taminizer D produced by the original method to cover also Taminizer D produced by the new DMAE method. There is minimal risk to users from dust produced as a result of normal handling of the additive. Taminizer D is not irritant to skin but may be irritant to eyes; it is regarded as a potential skin sensitiser. The FEEDAP Panel recommended to set a specification for the DMAE content in the additive

Efficacy of Bacillus subtilis DSM 28343 as a zootechnical additive (gut flora stabiliser) for calves for rearing

Bacillus subtilis DSM 28343 is a preparation of viable spores of a single strain of B. subtilis intended to be used as a zootechnical additive (functional group: gut flora stabilizer) in feed for calves for rearing to increase growth. In 2018, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered a scientific opinion on the safety and efficacy of Bacillus subtilis DSM 28343 as a feed additive for calves for rearing. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment. In that opinion, the FEEDAP Panel was unable to conclude on the efficacy of the additive, under the condition of use as proposed by the applicant, due to insufficient data provided. In the current opinion, additional data to demonstrate the efficacy of Bacillus subtilis DSM 28343 were assessed. Based on one study of this application and two studies submitted in the previous application, the Panel concluded that Bacillus subtilis DSM 28343 has the potential to be efficacious as gut flora stabiliser used in feed for calves for rearing at the proposed use level

Safety and efficacy of Kelforce \uae (l-glutamic acid, N,N-diacetic acid, tetrasodium salt (GLDA-Na 4 )) as a feed additive for chickens for fattening

l-Glutamic acid, N,N-diacetic acid, tetrasodium salt (GLDA-Na 4 ) (Kelforce \uae ) is sought to be used as a zootechnical feed additive in chickens for fattening to improve the absorption of zinc from feed, reducing zinc emissions through manure and thus, affecting favourably the environment. The product has not been authorised in the European Union as a feed additive. Kelforce \uae is intended to be marketed as a liquid and solid formulation, containing 65 47% and 65 30% of GLDA-Na 4 , respectively. Kelforce \uae is safe for chickens for fattening at the maximum level of 1,000 mg GLDA-Na 4 /kg complete feed. Based on the toxicological profile of GLDA-Na 4 and the consumer exposure to GLDA-Na 4 and to nitrilotriacetic acid trisodium salt (NTA-Na 3 ; an impurity of the additive), the use of Kelforce \uae at the maximum proposed level in feed of chickens for fattening is of no concern for consumer safety. Due to its low inhalation toxicity, the exposure to GLDA-Na 4 is unlikely to pose a risk by inhalation. However, owing to the high-dusting potential of the solid formulation, a risk from such high level of dust, even if toxicologically inert, cannot be excluded. Kelforce \uae is not a skin/eye irritant or skin sensitiser. No risks for the terrestrial compartment were identified at the maximum use level of the additive. Risks for the aquatic compartment cannot be excluded based on the secondary effect of the additive on green algae. In the absence of data, the Panel cannot conclude on the safety for the sediment compartment or the possible ground water contamination. The risk of bioaccumulation and secondary poisoning caused by the additive is considered very low. Owing to the inconsistent and conflicting results from the studies assessed, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) cannot conclude on the efficacy of the additive. The Panel made a recommendation regarding the levels of formaldehyde and cyanide in the active substance