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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. Applying an uncertainty factor of 100 to the lowest no observed adverse effect level (NOAEL) of 0.03 mg/kg body weight (bw) per day, an acceptable daily intake (ADI) of 0.3 μg halofuginone/kg bw is established. The chronic exposure of consumers to residues of halofuginone would amount to 6–19% of the ADI after 3 days of withdrawal. Therefore, the Panel considers that the additive is safe for the consumer of tissues obtained from chickens for fattening and turkeys for fattening fed the additive at a maximum level of 3 mg/kg complete feed at a 3-day withdrawal time. For control purposes, the Panel recommends the setting of the following maximum residue limits (MRLs): liver, 50 μg/kg; kidney, 40 μg/kg; muscle, 3 μg/kg; skin/fat, 10 μg/kg wet tissue. Based on an updated environmental risk assessment, no concern for groundwater is expected. Halofuginone is unlikely to bioaccumulate and the risk of secondary poisoning is not likely to occur. No safety concerns are expected for terrestrial and aquatic environments. The additive has the potential to control coccidiosis in chickens for fattening and turkeys for fattening/reared for breeding up to 12 weeks of age at a minimum level of 2 mg/kg complete feed.

The original protocol was approved by the FAF Panel on 17 January 2020 and it was originally published asEFSA supporting publication on 18 February 2020, as Annex of the Technical report. Outcome of the public consultation on a draft protocol for the assessment of hazard identification and characterisation of sweeteners. EFSA supporting publication 2020: EN-1803. 28 pp. doi:10.2903/sp.efsa.2020. EN-1803. During the implementation of this protocol, the following revisions and further elaborations were introduced: Section 1.4: a clarification on the key studies to consider in the risk assessment and evaluated according to the protocol was added, in order to take into account substances for which no health-based guidance value (HBGV) was derived. Section 1.6: it was specified that a more detailed approach for assessing the relevance and reliability of genotoxicity studies has been developed and is currently reported in Appendix B. Section 1.7.1: regarding human data, additional type of studies (e.g. studies with mixtures, studies on absorption of nutrients), not specified in the inclusion/exclusion criteria of Table 5, have been considered for inclusion, using either a narrative or systematic (i.e. risk of bias evaluation) approach. Section 1.7.2: regarding animal data, a clarification on how to consider studies performed with mixtures (specified, unspecified, commercial (trade) names) has been added. Additional type of studies (i.e. studies using animal disease models), not specified in the inclusion/exclusion criteria of Table 7, have been considered for inclusion using a narrative approach. Section 1.9: further details on a stepwise approach on which studies should be considered in the weight of evidence has been added, based on the outcome of the risk of bias (RoB) evaluation of key studies. Section 1.10: new calls for data more recently launched by EFSA have been added. Section 1.12: some changes regarding the selection of the key questions for RoB evaluation for human studies have been introduced. Tables on animal and human studies with the decision guiding the scoring for the different RoB questions are currently reported in Appendix C and D. In addition, some further considerations on studies evaluated as tier 3 have been added. Section 1.13: a revised version of the data extraction forms have been developed, including additional information/explanations on the different fields of the data extraction tables. Section 1.14: a more detailed description of the different steps of the weight of evidence analysis have been included. The approach has been further developed based on NTP-OHAT, 2019 with some modifications and adaptations. Section 1.16: some changes have been introduced in order to reflect how the uncertainties for the published opinions on sweeteners were addressed (i.e. Thaumatin (E 957), Neohesperidine dihydrochalcone (E 959)), for which few studies were available and it was thought to express uncertainties in a narrative way only).

Background: Neisseria elongata subspecies nitroreducens is considered to be an important pathogen responsible for infective endocarditis, even if it is infrequently reported. We report the first case of endocarditis in Italy due to N. elongata subsp. nitroreducens. Case presentation: The infection occurs in a 40-year-old male affected by Marfan syndrome with a prosthetic aortic valve. The patient had had a fever for a week which had been resistant to antibiotic therapy. Conclusion: we propose a correct and rapid identification of Neisseria elongata subspecies nitroreducens by mass spectrometry directly from the positive blood culture. The rapidly identification obtained by MALDI-TOF it has enabled us to administer a correct empirical therapy.

L-Methionine, feed grade, is a feed additive produced by two genetically modified Escherichia coli strains. Neither the production strains nor their recombinant DNA were detected in the final product; thus, no safety concerns are associated with the genetic modification of the production strains. The L-methionine produced by such E. coli strains is safe for the target animals when used as a feed additive to meet their requirements. The FEEDAP Panel has concerns over the safety of L-methionine for the target species when administered via water for drinking since any additional supply of an essential amino acid would disturb the balanced amino acid profile of complete diets. There are no safety concerns for the consumer associated with the use of L-methionine in animal nutrition. The additive L-methionine was demonstrated to be without irritant or dermal sensitising properties. Although no data on dusting potential were provided, the FEEDAP Panel considers it unlikely that the user will be exposed to significant amounts of L-methionine by inhalation. L-Methionine is a natural constituent of plants and animals. Its use in animal nutrition does not represent a risk to the environment. The additive L-methionine is considered an efficacious source of the amino acid L-methionine for all animal species.

L-Valine is a feed additive produced by a genetically modified strain of Corynebacterium glutamicum. Neither the production strain nor its recombinant DNA was found in the final product. The final product does not raise any safety concern with regard to the genetic modifications. L-Valine is safe for all target animals when added in appropriate amounts to diets. However, the FEEDAP Panel has concerns over the safety of L-valine for target species when administered via water for drinking since any additional supply of an essential amino acid would disturb the balanced amino acid pattern of complete diets. When used in animal nutrition, L-valine will be incorporated into the protein of the body of the target animal, and any potential excess will be metabolised and excreted. Considering the high purity of the product under assessment, and the lack of toxicological effects at likely use levels, no risks are expected for the consumer from the use L-valine as a feed additive. The L-valine produced by such strain of C. glutamicum has been shown not to be an irritant or a dermal sensitiser. The results of an acute inhalation study performed at high concentration show no evidence of significant acute toxicity by this route. Exposure of users by inhalation cannot be excluded. L-Valine is a natural constituent of plants and animals. Its use in animal nutrition does not represent a risk to the environment. L-Valine is efficacious as a supplemented amino acid to maintain or restore the adequate balance of amino acids for animal nutrition. A response in ruminants requires some degree of protection of L-valine from ruminal degradation.

Ix-xejra fi zminijietna hi li l-edukazzjoni gnandha timxi mal-ntigijiet tas-socjeta. Hawn bnal rivoluzzjoni mad-dinja kollha kontra l-edukazzjoni akkademika li dhur fuqha nfisha u tibqa' maqtugna minn dak li s-socjeta tentieg., N/A

This brief note refers to the meaning of the Maltese word 'Gieh' meaning 'honor'. However another form of the word 'gieh' is 'wicc' from where the Maltese verb 'weggah' derives, N/A

L-ilsien Malti ma jistax jitqies bhala lsien ta’ Imperu jew inkella ghodda tajba ghall-kummerc. Ridna l-Malti jkun maghruf bhala ilsien ufficjali izda ma ghandniex x’naqsmu ma’ dawk in-nies mohhhom maghluq li riedu jcekknu l-edukazzjoni tal-pajjiz u jbaxxuna quddiem il-barrani. La l-Malti hu lsien il-Maltin, l-ebda lsien iehor ma jista’ jasal biex jaqla’ l-Malti ‘l barra mill-iskejjel. E.B.Vella ghamel il-kotba ghall-iskejjel elementari u Aquilina flimkien ma’ Saydon ghaqqdu antologija tal-ahjar proza u poezija fi tliet kotba., N/A

The contributions of defective mismatch repair (MMR) and the p53-response to cell killing by N-(2-chloroethyl)-N'-cyclohexyl-N-nitrosourea (CCNU) were evaluated. MMR defects were previously shown to be associated with CCNU sensitivity (G. Aquilina et al., Cancer Res., 58: 135-141, 1998). Unexpectedly, eight MMR-deficient variants of the A2780 human ovarian carcinoma cell line were 3-fold more resistant to CCNU than the MMR-proficient parental cells. The variants were members of a preexisting subpopulation of drug-resistant A2780 cells. In addition to deficient expression of the MMR protein hMLH1, an essential component of the hMutL alpha repair complex, the variants exhibited alterations in the expression of other genes that influence drug sensitivity. Although A2780 cells possess a wild-type p53 gene, all of the clones contained a heterozygous G to T tranversion at codon 172. This change resulted in a Val to Phe substitution and was associated with a constitutive production of high levels of p53, which was inactive as a transcriptional activator of bax and p21. The hMLH1/p53 defective variants displayed a less prominent cell cycle arrest and reduced apoptosis after CCNU treatment. In contrast, MMR-defective A2780 variants, which had a similar hMutL alpha defect but retained a wild-type p53, did exhibit the expected CCNU sensitivity. Expression of a dominant-negative p53val135 increased CCNU resistance of both MMR-proficient and MMR-deficient A2780 cells. Thus, defective MMR and p53 influence CCNU sensitivity in opposite directions. Their effects are independent, and sensitization by defective MMR does not require a functional p53 response.

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. In the absence of data, no conclusion on the safety for the other target species could be drawn. The exposure of the consumer to BHT from tissues and products of animals fed the additive ranged from 1% to 3% of the acceptable daily intake (ADI). The FEEDAP Panel concluded that the use of BHT as a feed additive at the proposed conditions of use is of no concern for the safety of the consumers. Exposure of the user to BHT via inhalation is likely; however, the Panel is not in the position to conclude on the potential inhalation toxicity of the additive. BHT is a skin and eye irritant, no conclusions can be drawn on the potential of the additive to be a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the safety of BHT for the environment. The additive BHT is considered an efficacious antioxidant in feedingstuffs for all animal species.

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. In the absence of data, no conclusion on the safety for the other target species could be drawn. The exposure of the consumer to BHT from tissues and products of animals fed the additive ranged from 1% to 3% of the acceptable daily intake (ADI). The FEEDAP Panel concluded that the use of BHT as a feed additive at the proposed conditions of use is of no concern for the safety of the consumers. Exposure of the user to BHT via inhalation is likely; however, the Panel is not in the position to conclude on the potential inhalation toxicity of the additive. BHT is a skin and eye irritant, no conclusions can be drawn on the potential of the additive to be a skin sensitiser. In the absence of data, the FEEDAP Panel cannot conclude on the safety of BHT for the environment. The additive BHT is considered an efficacious antioxidant in feedingstuffs for all animal species.

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. However, owing the presence of p-phenetidine, no safe level of the additive in feed for long-living and reproductive animals could be identified. The FEEDAP Panel derived a health-based guidance value of 0.006 mg ethoxyquin dimer (EQDM)/kg bw per day and applied it to the sum of ethoxyquin and its transformation products. A maximum total concentration of 50 mg ethoxyquin/kg complete feed for all animal species, except dairy ruminants, would not pose a risk for the consumer. However, in the absence of data on p-phenetidine residues in tissues and products of animal origin, no conclusion on the safety for the consumer could be drawn. The conclusions on consumer safety assume that the maximum total concentration of 50 mg EQ/kg feed is expressed as the sum of EQ, EQDM, EQI and DHEQ. Exposure of the unprotected user to p-phenetidine via inhalation should be minimised. No safety concerns for groundwater are expected. It is not possible to conclude on the safety of EQ for the terrestrial compartment. A risk for the aquatic compartment cannot be excluded when ethoxyquin is used in terrestrial animals. Unacceptable risk is not expected for freshwater sediment-dwelling organisms. A risk of secondary poisoning via the terrestrial food chain is not expected, whereas a risk via the aquatic food chain cannot be excluded. No concerns for aquatic organisms are expected for ethoxyquin used in fish farmed in land-based system, a risk cannot be excluded for marine sediment dwelling organisms when ethoxyquin is used in sea-cages. Ethoxyquin is considered efficacious in the range 25–50 mg/kg complete feed.

The present opinion deals with the re‐evaluation of thaumatin (E 957) when used as a food additive. Thaumatin is a natural plant protein, consisting of thaumatin I and thaumatin II proteins together with minor amounts of plant constituents, obtained by acidic aqueous extraction of the arils of the fruit of Thaumatococcus daniellii plant. The Panel followed the conceptual framework for the risk assessment of certain food additives and considered that thaumatin is a digestible protein; adequate exposure estimates were available; there was no concern with respect to the genotoxicity; no conclusion on oral allergenicity could be drawn from the available human data; no adverse effects were observed in sub‐chronic toxicity studies in rats and dogs at the highest dose tested of up 5,200 and 1,476 mg/kg bodyweight (bw) per day, respectively, and in a prenatal developmental toxicity study up to 2,000 mg/kg bw per day; moderate confidence in the body of evidence supported the absence of association between exposure to thaumatin and adverse health outcomes. Therefore, the Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for thaumatin (E 957) and, based on a margin of safety (MOS) of 5,417, considered to be an underestimate and derived using the highest 95th percentile (P95) exposure of 0.48 mg/kg bw per day in consumers only, there is no safety concern for thaumatin (E 957) at the regulatory maximum level exposure assessment scenario, which was considered the most appropriate. The Panel recommended that European Commission considers introducing in the EU specifications for thaumatin (E 957) a new specification limit for the minimum combined content of thaumatin I and II proteins in E 957, a specification limit for yeast, mould counts and Salmonella spp and lowering the existing maximum limit for arsenic along with the inclusion of maximum limits for mercury and cadmium., This publication is linked to the following EFSA Supporting Publications article: http://onlinelibrary.wiley.com/doi/10.2903/sp.efsa.2021.EN-6918/full

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 1,000mg/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 Panelon 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 Panelconcluded 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 Panelextends 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 Panelrecommended to set a specification for the DMAE content in the additive.

© 2020 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority. 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. As regards the safety for the target species, the maximum recommended content of lignosulphonate of 10,000 mg/kg complete feed is considered safe in weaned piglet. A safe concentration of lignosulphonate in feed for salmonids and dairy cows could not be identified. The FEEDAP Panel reiterates also its previous conclusions that ‘10,000 mg lignosulphonate/kg complete feed is safe for chickens for fattening, laying hens and cattle for fattening but a margin of safety cannot be identified. Therefore, this conclusion cannot be extended to all animal species/categories’. Considering the absence of adverse effects confirmed by all the ecotoxicity studies up to very high concentrations, no concerns for the environment are expected from the use of this additive in animal nutrition according the conditions of use. Lignosulphonate is efficacious as pellet binder.

Fumonisin esterase produced from a genetically modified strain of Komagataellaphaffi is intended to degrade fumonisin mycotoxins contaminants in feeds for pigs and poultry. The production strain and its recombinant genes are not present in the final product. The applicant selected 300U/kg feed to represent a likely upper limit. This concentration showed to be safe for piglets, chickens and turkeys for fattening and laying hens; the additive is thus safe for those categories. This conclusion is extended to all pigs, chickens reared for laying and turkeys reared for breeding and extrapolated to all other poultry species for growing and laying and to minor porcine species. No evidence of mutagenicity or genotoxicity was detected and no evidence of toxicity from a repeated-dose oral toxicity study; the residue assessment did not identify any concern. The use of the additive is, thus, considered safe for consumers. The additive is not toxic by inhalation and the respiratory exposure is likely to be low; however, a risk of sensitisation via the respiratory route cannot be excluded. The additive is non-irritant to skin and eyes and is not considered a dermal sensitiser. No risks for the environment are expected following the use of the additive in feeds under the proposed condition of use. The additive has the capacity to degrade fumonisin contaminants in feed of marketable quality when used at the minimum recommended dose of 10U/kg complete feed, as shown in studies with chickens for fattening, laying hens and weaned piglets. Since the mode of action of the additive can be reasonably assumed to be the same in animal species for which the application is made, the Panelon Additives and Products or Substances used in Animal Feed (FEEDAP) considers the additive efficacious for all poultry and all pigs.