TEMPRANILLO is a regulator of juvenility in plants

Many plants are incapable of flowering in inductive daylengths during the early juvenile vegetative phase (JVP). Arabidopsis mutants with reduced expression of TEMPRANILLO (TEM), a repressor of FLOWERING LOCUS T (FT) had a shorter JVP than wild-type plants. Reciprocal changes in mRNA expression of TEM and FT were observed in both Arabidopsis and antirrhinum, which correlated with the length of the JVP. FT expression was induced just prior to the end of the JVP and levels of TEM1 mRNA declined rapidly at the time when FT mRNA levels were shown to increase. TEM orthologs were isolated from antirrhinum (AmTEM) and olive (OeTEM) and were expressed most highly during their juvenile phase. AmTEM functionally complemented AtTEM1 in the tem1 mutant and over-expression of AmTEM prolonged the JVP through repression of FT and CONSTANS (CO). We propose that TEM may have a general role in regulating JVP in herbaceous and woody species

Assessment of the application for renewal of authorisation of l-arginine produced by fermentation using Corynebacterium glutamicum NITE SD 00285 for all animal species

l-Arginine is an amino acid that is conditionally essential for mammalian neonates, some strict carnivores, birds and fish. The subject of this opinion is a request for renewal of authorisation of l-arginine produced by a strain of Corynebacterium glutamicum. The strain designation has changed to its new deposition number, NITE SD 00285, but the strain is otherwise unchanged from the previous opinion. It is not genetically modified and possesses no antibiotic resistance of safety concern. Minor changes in downstream processing following fermentation have been made. The FEEDAP Panel notes that two out of five batches did not meet the specification of the current authorisation (minimum 98% on a dry matter basis). The FEEDAP Panel concludes that l-arginine produced by fermentation to C. glutamicum NITE SD 00285 remains safe for the target species, consumers of products from animals fed the additive and the environment under the approved conditions of authorisation. The additive is considered as irritant to skin, corrosive to eyes and poses a risk by inhalation

Safety and efficacy of Axtra® PHY 20000 TPT2 (6‐phytase) as a feed additive for poultry and porcine species

Axtra\uae PHY 20000 TPT2 is a solid preparation that contains a 6-phytase produced with a genetically modified strain of Trichoderma reesei. The production strain and its recombinant DNA were not detected in Axtra\uae PHY 20000 TPT2. From the results obtained in tolerance studies, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive is safe for the target species at 2,000 FTU/kg feed. The studies provided to address the safety for the consumer were performed with the fermentation product that is used to formulate the additive and the results do not indicate any reason for concern for consumer safety arising from the use of the product as a feed additive. The studies provided to address the safety for the user were performed with the fermentation product that is used to formulate the additive and have been assessed in a previous opinion. Considering the results of those studies and the substances used during the formulation of Axtra\uae PHY 20000 TPT2, this formulation is not considered a dermal sensitiser. However, it should be considered a potential irritant to skin, eyes and the respiratory tract, and owing to the nature of the active substance, it should be considered a potential respiratory sensitiser. However, the exposure by inhalation is expected to be negligible. No risks to the environment are expected from the use of Axtra\uae PHY 20000 TPT2 as a feed additive. Based on the results of efficacy studies, the Panel concluded that the additive has the potential to be efficacious at 250 FTU/kg feed

Safety and efficacy of a natural mixture of dolomite plus magnesite and magnesium-phyllosilicates (Fluidol) as feed additive for all animal species

The additive, a natural mixture of dolomite plus magnesite and magnesium-phyllosilicates, is intended to be used as a technological additive (functional groups: anticaking agents) in feedingstuffs for all animal species. The additive is safe in complete feed for dairy cows, piglets and pigs for fattening at a maximum concentration of 20,000 mg/kg. No conclusions can be drawn for all the other animal species/categories. The additive is not genotoxic. As the additive is essentially not absorbed from the gut lumen, the Panel on Additives and Products or Substances used in Animal Feed considers that use of the additive in animal nutrition is safe for consumers of food products from animals fed diets containing the additive. The additive is not an irritant to the eyes and the skin, it is not a skin sensitiser and it is of low toxicity by the inhalation route. The components of the additive (dolomite, magnesite, talc and chlorite) are natural constituents of soil. Consequently, the use of the additive in animal nutrition will not pose a risk to the environment. The additive is effective as an anticaking agent at a minimum inclusion level of 5,000 mg/kg feed

Safety and efficacy of fumonisin esterase from Komagataella phaffii DSM 32159 as a technological feed additive for pigs and poultry

Fumonisin esterase produced from a genetically modified strain of Komagataella phaffi 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 300 U/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 10 U/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 Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers the additive efficacious for all poultry and all pigs

Safety and efficacy of L arginine produced by Corynebacterium glutamicum KCTC 10423BP for all animal species

L-Arginine is considered as a non-essential amino acid for most adult mammalian species, but it is classified as essential for birds, fish, possibly reptiles and also for strict carnivores. The following conclusions refer to L-arginine produced by Corynebacterium glutamicum KCTC 10423BP. The use of L-arginine is safe for target species when supplemented to diets in appropriate amounts. There are no safety concerns arising from ruminal L-arginine metabolism. The composition of edible tissues and products of animal origin will not be altered by the use of L-arginine in animal nutrition. Considering the high purity of the product under assessment, no risk is expected for the consumer from the use of L-arginine as a feed additive. L-Arginine is not irritating to skin or eyes and is not likely to be a skin sensitiser. Although there is a potential for user exposure by inhalation, there is evidence of no acute toxicity by the inhalation route. The use of L-arginine in animal nutrition would not pose a risk to the environment. Dietary L-arginine is an effective source of arginine for all animal species when a requirement exists. For the supplemental L-arginine to be fully efficacious in ruminants, it requires protection against degradation in the rumen

Safety and efficacy of methylester of conjugated linoleic acid (t10,c12 isomer) for pigs for fattening, sows and cows

A mixture of methylated conjugated linoleic acid (CLA) isomers (t10,c12 and c9,t11) in equal proportions was not genotoxic and caused no reproductive toxicity. In a sub-acute study in dogs, a sub-chronic toxicity study in rats and a chronic study in dogs, no adverse effects were seen up to the highest levels tested. The maximum recommended feed concentration (5 g CLA (t10,c12)-ME from Lutalin (R)/kg feed for piglets, pigs for fattening and sows) or dose (30 g CLA (t10,c12)-ME from Lutrell (R) Pure/cow per day) is considered safe for target species. The CLA content of milk from cows treated with the highest recommended dose did not exceed background values (in milk of untreated cows) for both CLA isomers. An estimate of consumer exposure to both CLA isomers from food from pigs receiving 3 g of both CLA isomers/kg feed is <= 320 mg CLA isomers/person and day. This quantity corresponds to about 9% of the quantity considered safe for 6 months and is considered unlikely to raise concerns for consumer safety. Exposure of users by inhalation of the additive is likely to be minimal. Neither of the products under application, the liquid or the solid product, was tested as such for skin and eye irritation and skin sensitisation. The use of the additive in animal nutrition would not pose a risk to the environment. In pigs for fattening, CLA (t10,c12)-ME has a potential for improving feed to gain ratio. More consistent effects are a reduction in subcutaneous fat, an increase in intramuscular fat and fat firmness. No essential effects were found in sows. Administration of CLA to dairy cows reduces in a dose-dependent manner the fat content of milk, and milk fat yield. Energy balance in early lactation is improved by CLA (t10,c12)-ME; however, reproductive parameters were not influenced

Safety and efficacy of lactic acid and calcium lactate when used as technological additives for all animal species

This opinion concerns the re-authorisation of lactic acid and calcium lactate for use as preservatives in feed and a new authorisation for lactic acid as a preservative in water for drinking. The maximum level of 50 000 mg lactic acid/kg complete feed and 30 000 mg calcium lactate/kg complete feed are considered safe for functional ruminants and pigs. The maximum safe concentration in water for drinking for pigs can be derived from the maximum safe level in feed (15 000 mg lactic acid/L water). No conclusions on the safety of lactic acid in pre-ruminants and poultry can be drawn. These conclusions cannot be extrapolated to other animal species/categories. The use of lactic acid and calcium lactate as feed additives is safe for the consumer. Lactic acid is considered an irritant to eyes and skin and there is a risk of serious damage to the eyes. Inhalation of the mist causes irritation of the respiratory system. Calcium lactate should be considered an irritant to skin, eyes and the respiratory tract. It is likely that handling the additive will result in the production of respirable dust, which could present a risk to unprotected workers. The use of lactic acid and calcium lactate in animal nutrition would not pose a risk to the environment, provided that the concentrations regarded as safe for the target species are not exceeded. Lactic acid and calcium lactate are used in food as preservatives. It is reasonable to expect that the effect seen in food will be observed in feed when these additives are used at comparable concentrations and under similar conditions. However, the Panel has reservations about the effectiveness of lactic acid and calcium lactate as preservatives in complete feedingstuffs with a typical moisture content of <= 12 %

Safety and efficacy of B‐Act® (Bacillus licheniformis DSM 28710) for chickens for fattening and chickens reared for laying

The additive B-Act\uae is a preparation containing viable spores of a strain of Bacillus licheniformis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1.6 9 109 colony-forming unit (CFU)/kg complete feedingstuffs. B. licheniformis is considered by EFSA to be suitable for the qualified presumption of safety approach for establishing safety. As the identity of the active agent was established and the lack of toxigenic potential and resistance to antibiotics of human or veterinary clinical significance were demonstrated, the additive is presumed safe for the target species, consumers and the environment. In the absence of data, no conclusion can be drawn on the skin/eye irritation or skin sensitisation potential. The dustiness of the preparations tested indicated a potential for users to be exposed via inhalation. B-Act\uae should be considered to have the potential to be a respiratory sensitiser. B-Act\uae at the recommended dose 1.6 9 109 CFU/kg feed has some potential to improve the feed to gain ratio of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. licheniformis DSM 28710 is compatible with decoquinate, diclazuril, halofuginone, nicarbazin, robenidine hydrochloride, lasalocid A sodium, maduramicin ammonium, monensin sodium, narasin and salinomycin sodium

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