Scientific Opinion on the safety and efficacy of <em>Lactobacillus paracasei</em> (NCIMB 30151) as a silage additive for all animal species

Lactobacillus paracasei is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1.0 × 108 colony-forming units (CFU)/kg fresh material. The bacterial species L. paracasei is considered by the European Food Safety Authority 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 in the production of silage is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser, and treated accordingly. A total of seven studies with laboratory-scale silos were made using samples of forage of differing 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 forage species by reducing the pH and increasing the preservation of dry matter. This was most consistently shown at application rates of 5 × 107 and 1 × 108 CFU/kg forage

Scientific opinion on the safety and efficacy of Natugrain^® TS (endo-1,4-beta-xylanase and endo-1,4-beta-glucanase) as a feed additive for pigs for fattening

Natugrain® TS is an enzyme preparation that contains endo-1,4-beta-xylanase and endo-1,4-beta-glucanase, produced by two genetically modified strains of Aspergillus niger. This product is currently authorised for use in piglets (weaned), poultry species and ornamental birds as a zootechnical additive under the functional group of digestibility enhancers. The applicant is now seeking for the extension of its use as a zootechnical additive for pigs for fattening at a dose range of 560 to 840 TXU (thermostable xylanase units) and 250 to 375 TGU (thermostable glucanase units) per kg feed. Since the product has been demonstrated to be  safe in piglets at the maximum recommended dose, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) considers that this conclusion can be extended to pigs for fattening, provided that the same maximum dose applies. In two long-term trials, Natugrain® TS significantly improved the performance of the pigs for fattening at the minimum recommended dose (560 TXU and 250 TGU/kg feed). In a balance trial, the metabolisable energy content of the diet was significantly improved by the addition of Natugrain® TS in feed at the minimum recommended dose. Therefore, the FEEDAP Panel concludes that Natugrain® TS at the minimum recommended dose (560 TXU and 250 TGU/kg feed) has the potential to be efficacious in pigs for fattening

Scientific Opinion on the safety and efficacy of <em>Pediococcus pentosaceus</em> (NCIMB 30068) as a silage additive for all animal species

Pediococcus pentosaceus is a technological additive intended to improve the ensiling process at a minimum proposed dose of 1 × 108 colony-forming units (CFU)/kg fresh material. The P. pentosaceus strain was found to be resistant to tetracycline by an unidentified mechanism and thus may pose a risk for the spread of genes coding for resistance to an antibiotic of human and veterinary importance. Thus, the additive containing this strain is not considered safe for the target animals and consumers of products from animals fed the treated silage. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser, and treated accordingly. Since the P. pentosaceus strain carries an uncharacterised resistance to tetracycline, the FEEDAP Panel cannot conclude on its safety for the environment. A total of four studies with laboratory-scale silos were made using samples of forage of differing water-soluble carbohydrate content. In each case, replicate silos containing treated forage were compared with identical silos containing the same but untreated forage. Although the additive showed a tendency to increase lactic acid production and reduce pH in the ensiled material, overall there was insufficient evidence of a beneficial effect on the preservation of nutrients

Scientific Opinion on the safety and efficacy of Bonvital (<em>Enterococcus faecium</em>) as a feed additive for sows

Bonvital is a preparation of a strain of Enterococcus faecium authorised for piglets, pigs for fattening, sows, chickens for fattening, chickens reared for laying and minor poultry species. EFSA was requested to assess the safety and efficacy of Bonvital when used with sows throughout the complete reproductive cycle at the dose of 5 × 108 CFU/kg feed. The safety for the target species, consumers of products derived from animals fed the additive, users and the environment has been considered in the context of the previous opinions. The FEEDAP Panel is not aware of any information that would lead it to revise these conclusions. Consequently, the FEEDAP Panel has considered only the efficacy of Bonvital for sows. The results of three studies each performed over two complete reproductive cycles showed that Bonvital, at the minimum recommended dose of 5 × 108 CFU/kg feed, has the potential to increase litter weight gain or maintain sow condition. Based on these results, the FEEDAP Panel concludes that the data provided support the extension of use of the additive to the entire reproductive cycle

Scientific Opinion on the safety and efficacy of aliphatic and alicyclic ethers (chemical group 16) when used as flavourings for all animal species

Chemical group 16 consists of aliphatic and alicyclic ethers, of which four are currently authorised for use as flavours in food. The FEEDAP Panel was unable to perform an assessment of 1,5,5,9-tetramethyl-13-oxatricyclo[8.3.0.0.(4.9)]tridecane and theaspirane because of issues related to the purity of the compounds. The FEEDAP Panel concludes that: i)1,8-cineole is safe at the high use level proposed by the applicant (5 mg/kg complete feed) for all animal species with a margin of safety of 5.6 to 28.2; ii)2-(2-methylprop-1-enyl)-4-methyltetrahydropyran (Class II) is safe at a maximum of 0.3 mg/kg complete feed for cattle, salmonids and non food producing animals and of 0.5 mg/kg complete feed for pigs and poultry. The absence of a margin of safety would not allow the simultaneous administration in feed and water for drinking of these substances. The total dose from all sources should not exceed that recommended when given in feed alone. No safety concern would arise for the consumer from the use of compounds belonging to CG 16 up to the highest safe level in feedingstuffs for all animal species. The FEEDAP Panel considers it prudent to treat both compounds under assessment as irritants to skin, eyes and respiratory tract, and as skin sensitisers. The FEEDAP Panel considers that the concentrations of the compounds belonging to CG 16 in the environment are not expected to exceed levels of concern when used in animal feeds at the levels considered to be safe to the target species. Since these compounds are used in food as flavourings, and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary

Scientific Opinion on the safety and efficacy of L-selenomethionine as feed additive for all animal species

Selenium is a trace element that is essential for vertebrates and involved in series of vital metabolic functions. Considering the purity of the L-selenomethionine (L-SeMet) under application and the metabolic pathways of SeMet, the FEEDAP Panel considers the use of L-SeMet as safe for all animal species, provided that the maximum total selenium level authorised in feed is respected. The use of in animal nutrition is expected to result in a similar increase in selenium deposition in animal tissues/products as that resulting from other sources of SeMet. To ensure consumer safety from consumption of food originating from animals fed L-SeMet, the FEEDAP Panel concludes that dietary selenium supplementation from the additive should not exceed a maximum of 0.2 mg Se/kg complete feed. In the absence of specific data, the additive should be considered as an irritant to skin and eyes, as a skin sensitiser and as potentially harmful by inhalation. The FEEDAP Panel considers that the use of L-SeMet in feed does not pose an additional risk to the environment, compared with other sources of selenium for which it will substitute, as long as the maximum authorised content in feedingstuffs is not exceeded. L-SeMet is an efficient source of selenium for all species. This conclusion is derived from studies with laying hens and pigs for fattening and, in the case of ruminants, from literature describing the microbial incorporation of selenium from organic sources in the rumen. The FEEDAP Panel made some recommendations concerning (i) the specification, (ii) the use of the compound in premixtures, (iii) the use in water for drinking and (iv) risk reduction when handling the additive

Scientific Opinion on the safety and efficacy of sodium hydroxide for dogs, cats and ornamental fish

&lt;p&gt;The additive consists, by specification, of a minimum of 98.0 % sodium hydroxide or alkali in the solid form, the content of solutions scaled accordingly, based on the stated or labelled concentration. No data have been provided that would support the specification of the solid form, only a 50.0 % w/w solution of sodium hydroxide in water, which is the final product of the production process described in the dossier. Sodium hydroxide is considered safe for the target animals, provided that the resulting total sodium concentration in feed does not compromise the overall electrolyte balance. Sodium hydroxide in solid form and in aqueous solution at concentrations &amp;gt; 8.0 % is corrosive. At lower concentrations it is irritant to skin and eyes (0.5 % and 0.2 %, respectively) and the respiratory tract (0.5 %). Exposure via inhalation is likely to be minimal. Sodium hydroxide is not considered to be a skin sensitiser. As sodium hydroxide is used in food as an acidity regulator, and its function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.&lt;/p&gt

Scientific Opinion on the safety and efficacy of <em>Lactobacillus brevis</em> (DSMZ 16680) as a silage additive for all species

Lactobacillus brevis is a technological additive intended to improve the ensiling process at a proposed minimum dose of 1.0 × 108 colony-forming units (CFU)/kg fresh material. The bacterial species L. brevis is considered by the European Food Safety Authority 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 in the production of silage is considered safe for livestock species, for consumers of products from animals fed the treated silage and for the environment. The additive should be regarded as a skin and eye irritant and a potential skin and respiratory sensitiser and should be treated accordingly. The FEEDAP Panel concluded that L. brevis has the potential to increase aerobic stability of the treated silage at the minimum recommended dose of 1.0 × 108 CFU/kg fresh material. This was demonstrated in forage materials with a dry matter content of 29–46 %

Scientific opinion on the safety and efficacy of CAROPHYLL^® Red 10% (preparation of canthaxanthin) for all poultry for breeding purposes (chickens, turkeys and other poultry)

No abstract availabl

Scientific Opinion on the safety and efficacy of formaldehyde for all animal species based on a dossier submitted by Regal BV

The additive formaldehyde is an aqueous solution containing 35 % formaldehyde and 14 % methanol. It is intended for use in all animal species at concentrations between 200 and 1000 mg active substance/kg complete feed. Free and reversibly bound formaldehyde is readily absorbed in the gastrointestinal tract and joins the pool of endogenous formaldehyde. It is rapidly oxidised to formic acid further on to carbon dioxide and water. Formaldehyde is a carcinogen by inhalation. While local irritation is expected to strongly promote carcinogenesis, lower local concentrations of formaldehyde are known to produce DNA adducts. Therefore, the FEEDAP Panel deems it prudent not to consider the exposure to non-irritant concentration as totally riskless. Moreover, on the basis of the present knowledge, a causal association between formaldehyde exposure and leukaemia cannot be ruled out. The FEEDAP Panel estimated the oral intake of formaldehyde of consumers from food of animal origin to be 4 mg per person per day. A reliable additional exposure of consumers to formaldehyde from supplementing feedingstuffs cannot be calculated. However, the FEEDAP Panel considers that the proposed use of formaldehyde as a feed additive would not increase consumer exposure and consequently would not pose an additional risk for the consumer. A safe feed concentration for all animal species and categories could not be determined. Formaldehyde is a strong irritant, a potent skin and respiratory sensitiser. Measures should be taken to ensure that the respiratory tract, skin and eyes of any person handling the product are not exposed to any dust, mist or vapour generated by the use of formaldehyde. The use of formaldehyde in animal nutrition is not expected to pose a risk for the environment. Formaldehyde in concentrations between 200 and 1000 mg/kg feed (compound feed and/or feed material) has the potential to be an efficacious preservative