Safety and efficacy of Lactobacillus plantarum NCIMB 42150 as a silage additive for all animal species

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 a specific strain of Lactobacillus plantarum when used as a technological additive intended to improve ensiling at a proposed application rate of 1 9 108 colony forming unit (CFU)/kg fresh material. L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment and not to require specific demonstration of safety other than demonstrating the absence of resistance to antibiotics of human and veterinary significance. As the identity of the strain was clearly established and as no antibiotic resistance was detected, the use of the strain in the production of silage is presumed safe for livestock species, consumers of products from animals fed treated silage and the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy or skin sensitisation of the additive. The additive should be considered as a potential respiratory sensitiser. Five studies with laboratory-scale silos were made using forage of differing water-soluble carbohydrate content. Replicate silos containing forages treated at the proposed application rate were compared to identical silos containing the same but untreated forage. In addition, in four studies, formic acid was included as positive control. The mini-silos were then stored for 90\u2013103 days at 20\u201324\ub0C. After opening, the contents of the silos were analysed. Results showed that this strain of L. plantarum has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile forage species by increasing the production of lactic acid, reducing the pH and increasing the preservation of dry matter when used at an application rate of 1 9 108 CFU/kg

On the Mechanism of the Copper-Catalyzed Enantioselective 1,4-Addition of Grignard Reagents to α,β-Unsaturated Carbonyl Compounds

The mechanism of the enantioselective 1,4-addition of Grignard reagents to α,β-unsaturated carbonyl compounds promoted by copper complexes of chiral ferrocenyl diphosphines is explored through kinetic, spectroscopic, and electrochemical analysis. On the basis of these studies, a structure of the active catalyst is proposed. The roles of the solvent, copper halide, and the Grignard reagent have been examined. Kinetic studies support a reductive elimination as the rate-limiting step in which the chiral catalyst, the substrate, and the Grignard reagent are involved. The thermodynamic activation parameters were determined from the temperature dependence of the reaction rate. The putative active species and the catalytic cycle of the reaction are discussed.

Safety and efficacy of BIOSTRONG® 510 (essential oil of thyme and star anise) for chickens and minor avian species for fattening and rearing to point of lay

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 the product BIOSTRONG\uae 510 (essential oil from thyme and star anise, crushed dried spices and crushed dried herbs), when used as a feed additive for chickens for fattening and rearing to point of lay and minor avian species for fattening and rearing to point of lay. BIOSTRONG\uae 510 is a preparation of partially microencapsulated essential oils from thyme and star anise, dried herbs and dried spices. The FEEDAP Panel concludes that BIOSTRONG\uae 510 is safe for chickens for fattening at the proposed conditions of use and that this conclusion can be extended to chickens reared for laying and extrapolated to all minor poultry species for fattening and reared to point of lay. The FEEDAP Panel concludes that the use of BIOSTRONG\uae 510 as an additive in the feed for chickens for fattening does not present risk for the consumer of meat and meat products. Irritancy studies have not been provided, however, because of the content of saponins, the FEEDAP Panel assumes that the additive is highly irritant to mucous membranes, and considers that measures to minimise exposure by all routes are necessary for the handling of this product. The use of BIOSTRONG\uae 510 at the recommended levels is not considered to be a risk for the environment. The FEEDAP Panel considers that BIOSTRONG\uae 510 has the potential to be efficacious in improving performance of chickens for fattening. This conclusion can be extended to chickens reared for laying and extrapolated to all minor poultry species for fattening and reared to point of lay at the same dose

Safety and efficacy of Lactobacillus plantarum DSM 29025 as a silage additive for all animal species

Lactobacillus plantarum is a technological additive intended to improve the ensiling process at a minimum proposed dose of 5.0 9 107 colony-forming units (CFU)/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. As the identity of the strain has been clearly established and as no antibiotic resistance of concern was detected, the use of the strain as a silage additive is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. In the absence of data, no conclusion can be drawn on the skin and eye irritancy of the additive. The additive should be considered to have the potential to be a respiratory sensitiser. Three studies with laboratory-scale silos were made using samples of forage of differing dry matter and water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. The results showed that the additive has the potential to improve the production of silage from easy, moderately difficult and difficult to ensile material by improving the preservation of nutrients. This was shown at the proposed application rate of 5 9 107 CFU/kg forage

Analysis of the need for an update of the guidance documents

The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) adopted a series of guidance documents which complement the Regulations governing the authorisation of feed additives. These are intended to help applicants in their preparation of technical dossiers. Although most guidance documents prepared by the Panel have been updated at some point, experience has shown that some elements are in need of technical update. Consequently, the EFSA has asked the FEEDAP Panel to identify from the current guidance documents those that need to be updated. The FEEDAP Panel addressed this by considering the experience gained since the last major revision of the individual guidance documents. Each of the Standing Working Groups of the FEEDAP Panel were asked to identify issues which have arisen during additive assessments and which suggested the need for elements of the guidance to be reconsidered. In addition, consideration was given to the relevant overarching guidance documents produced by the EFSA Scientific Committee and to developments in assessment tools provided by EFSA and other international organisations. The analysis of the information collected indicated a number of broad areas in the existing guidance which need possible revision. In particular, since the existing guidance on environmental risk assessment is no longer aligned to other EFSA outputs, the Panel proposes that revision of this guidance should be given the highest priority. The Panel then proposes the revision of the three guidance documents concerned with safety (target animals, consumer and user) followed by the guidance on efficacy. In parallel, the data necessary to establish the characterisation of the additive should be reviewed and modified as necessary. The FEEDAP Panel considers it fundamental to involve industry, consumer associations and experts from Member States risk assessment bodies in the early stages of the guidance revision

Safety and efficacy of Lavipan® (Lactococcus lactis B/00039, Carnobacterium divergens KKP 2012p, Lactobacillus casei B/00080, Lactobacillus plantarum B/00081 and Saccharomyces cerevisiae KKP 2059p) for weaned piglets, chickens for fattening and turkeys for fattening

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 Lavipan\uae (Lactococcus lactis B/00039, Carnobacterium divergens KKP 2012p, Lactobacillus casei B/00080, Lactobacillus plantarum B/00081 and Saccharomyces cerevisiae KKP 2059p) when used as a zootechnical additive for weaned piglets, chickens and turkeys for fattening at the minimum dose of 5 x 108 colony forming unit (CFU) lactic acid bacteria (LAB)/kg feed and 5 x 106 CFU S. cerevisiae/kg feed. The species Lc. lactis, C. divergens, Lb. casei, Lb. plantarum and S. cerevisiae are considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment and not to require specific demonstration of safety other than demonstrating the absence of resistance to antibiotics of human and veterinary significance. The identity of all strains has been established and no antibiotic resistance of concern detected. Following the QPS approach to safety assessment, these strains are presumed safe for the target species, consumers of products from animals fed the additive and the environment. Lavipan\uae is not toxic by inhalation or a dermal/ocular irritant, but should be considered as a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the skin sensitisation potential. Lavipan\uae has the potential to improve the performance of chickens for fattening when supplemented at the recommended dose of 5 x 108 CFU LAB/kg feed and 5 x 106 CFU S. cerevisiae/kg feed. No conclusions can be drawn on the efficacy of Lavipan\uae when added to feed for weaned piglets or turkeys for fattening. Lavipan\uae is compatible with diclazuril, salinomycin sodium, decoquinate, maduramicin and narasin+nicarbazin

Safety and efficacy of iron oxide black, red and yellow for all animal species

Iron oxides black, red and yellow are intended to be used as colourings to add and restore colour to feedingstuffs at a recommended concentration between 500 and 1,200 mg/kg. No data on the tolerance of target animals were provided. The iron oxides black, red and yellow are excreted essentially unchanged in the faeces of the target animals. Iron absorption from these water insoluble iron oxides is low. However, no conclusion on the safety of the iron oxides under assessment for the target animals could be made as a sufficient biological and toxicological database, particularly genotoxicity data, was not available. The use of the iron oxides in animal nutrition is unlikely to result in a direct exposure of the consumer and would not influence the iron content of edible tissues and products from animals treated with iron oxides. Consequently, the supplementation of feed for food-producing animals with the iron oxides under assessment would not provide a risk to consumers. Iron oxide black, red and yellow should be considered as irritant to skin and eyes. In the absence of any information, the Panel on Additives and Products or Substances used in Animal Feed FEEDAP cannot conclude on the potential of the additives to be a skin sensitiser. As the inhalation of iron oxides could cause unspecific lung inflammation, inhalation exposure of users should be considered to be a hazard. As there is concern about the possible genotoxicity of iron oxides, any route of exposure should be considered as hazardous. The use of iron oxide black, red and yellow in animal nutrition does not pose a risk to the environment. The iron oxides are effective in colouring feedingstuffs

Safety and efficacy of lecithins (Lipidol) 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 lecithins (Lipidol) for all animal species. The additive consists predominantly of lecithins and other extracted substances. Lecithins are usually phospholipids, composed of phosphoric acid with choline (or ethanolamine, inositol, serine or hydrogen in phosphatidic acid), glycerol and one or two fatty acids. Lecithins are safe for all target species. Setting a maximum content for lecithins is not considered necessary. The use of lecithins in animal nutrition does not pose any risk to the consumer. Lecithins are not irritant to the skin and eyes, not skin sensitisers and not harmful by inhalation. No risk for the environment is expected from the use of lecithins in animal nutrition. Lecithins are considered efficacious as emulsifiers at the recommended use levels

Safety of l‐lysine monohydrochloride produced by fermentation with Escherichia coli CGMCC 7.57 for all animal species based on a dossier submitted by Feedway Europe NV

L-Lysine monohydrochloride is a feed additive produced by fermentation using a genetically modified strain of Escherichia coli (CGMCC 7.57). The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) of the EFSA, in its opinion on the safety and efficacy of the product, could not conclude on the safety of the product for target animals, consumers, users and the environment. The European Commission asked EFSA to deliver an opinion on the safety of L-lysine monohydrochloride as a nutritional additive for all animal species based on additional data submitted by the applicant on the characterisation of the additive. No recombinant antibiotic resistance genes are present in the production strain and therefore in the final product. The L-lysine monohydrochloride manufactured by fermentation using E. coli CGMCC 7.57 does not raise safety concerns for the target species, consumers, users and the environment with regard to the genetic modification of the production strain. The levels of endotoxins present in the product and its dusting potential indicate no health risk for the user

Safety of l‐tryptophan produced by fermentation with Escherichia coli CGMCC 7.59 for all animal species based on a dossier submitted by Feedway Europe NV

L-Tryptophan is a feed additive produced by fermentation using a genetically modified strain of Escherichia coli. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) issued an opinion on the safety and efficacy of the product, which concluded that \u2018The use of L-tryptophan produced by E. coli CGMCC 7.59 in feed is safe for non-ruminant target species when supplemented to diets in appropriate amounts. As the metabolites of L-tryptophan produced by ruminal bacteria may be toxic to the host animal, oral administration of unprotected L-tryptophan to ruminants should be avoided. The Panel on Additives and Products or substances used in Animal Feed (FEEDAP) has concerns about the safety of L-tryptophan for target species when administered via water for drinking... ...In the absence of any data on sensitisation, the product should be considered a potential dermal sensitiser. The level of endotoxins present in the product and its dusting potential indicate a health risk for the user upon inhalation\u2019. The European Commission asked EFSA to deliver an opinion on the safety of L-tryptophan, produced by an improved manufacturing process, as a nutritional additive for all animal species based on additional data submitted by the applicant on characterisation of the additive. The FEEDAP Panel reiterates its concern on the use of unprotected tryptophan to ruminants and on the safety of the amino acid L-tryptophan for target species when administered simultaneously via water for drinking. As the estimated maximum exposure to endotoxins by inhalation of the improved product is below the provisional occupational exposure limit, no risk from exposure to endotoxins for people handling the additive is expected. Concerns remain about possible dermal sensitisation