Bentonites are colloidal clays composed largely of montmorillonite. They are currently authorised for use as feed additives (binders, anti-caking agents and coagulants) to a maximum of 20 g/kg feedingstuffs. They are also authorised for use as food additives. A consortium is seeking the re-authorisation of bentonites as pellet binders and anti-caking agents and authorisation for a new application for the control of radionuclide contamination. Chickens and piglets tolerated the addition of bentonite at a concentration of 3 % of diet and dairy cows tolerated 2 % added bentonite. Trout are reported to tolerate at least 2.5 % bentonite in the diet. Since the application is for all animal species and all bentonites, and as a margin of safety is difficult to establish, the FEEDAP Panel considers that the presently authorised limit of 2 % of diet should be retained. Addition of bentonites to diets is incompatible with the use of robenidine and is expected to reduce the effectiveness of other coccidiostats. No concerns for the safety of consumers of food products derived from animals fed diets containing bentonite were identified. Bentonites are not skin irritants but may be mildly irritant to the eye. Although skin sensitisation was not considered, the Panel notes that bentonites are used in cosmetics. The Panel considers it prudent to assume that all bentonite dusts pose a hazard to those handling the additive. Bentonites are ubiquitous soil components, and their use in animal production is not expected to adversely affect the environment. Bentonites can increase pellet durability when added to complete feed at concentrations of between 1 % and 2 %. Since bentonites are authorised for use, without restriction, as anti-caking agents in food and can be assumed to demonstrate similar properties when applied to feed materials, no further demonstration of efficacy is considered necessary. Bentonites added to feed contaminated by radioactive fallout or made available to grazing animals will reduce levels of radiocaesium in animals and their products.

The term ‘niacin’ is used as a generic description of nicotinic acid and nicotinamide with pyridine as the basic structure. Nicotinic acid and nicotinamide function mainly as precursors of the co-enzymes NAD and NADP. Thus, nicotinamide has physiologically critical roles in mitochondrial respiration and in the metabolism of carbohydrates, lipids, and amino acids. Oral administration routes of nicotinic acid and nicotinamide via feed or water for drinking were considered bioequivalent. Niacin is safe for the target animals with a margin of safety that is at least ten times the requirements and use levels. The FEEDAP Panel assumes that exposure figures for a population already include the contribution of edible tissues and products of animals fed niacin-supplemented diets. Information on niacin metabolism and the limited data available on retention in edible tissues and products indicate that supplemental levels in feeds even far higher than the requirements (1–35 mg/kg feed) are highly unlikely to lead the tolerable upper intake level being exceeded. The FEEDAP Panel considers that the use of niacin in animal nutrition is not of safety concern for consumers. Nicotinic acid and nicotinamide are not irritant to skin, but can cause irritancy to eyes and mucous membranes. They are unlikely to cause skin sensitisation. Workers might be exposed to a respirable dust when handling nicotinic acid, which should be regarded as being potentially harmful to their health. Nicotinamide is considered to be of no concern for inhalation exposure. The use of nicotinic acid and nicotinamide in animal nutrition does not pose a risk to the environment. Nicotinic acid and nicotinamide are regarded as effective sources of niacin in animal nutrition.

Lactobacillus plantarum is a technological additive intended to improve the ensiling process at a proposed dose of 3 x 10(8) CFU/Kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the Qualified Presumption of Safety approach. Therefore, the strains do not require any specific demonstration of safety other than confirming the absence of any determinants of resistance to antibiotics of human and veterinary clinical significance. As the identity of the strains has been clearly established and as no antibiotic resistance was detected in either of them, the use of the strains in the production of silage is considered safe for livestock species, consumers of products from animals fed the treated silage and for the environment. Once an active agent has been authorised as a silage additive, different formulations can be placed on the market with reference to that authorisation. However, for assessing the safety for the user of the additive, the active agent is the principal concern provided that other components do not introduce concerns. For this specific product, all excipients used are food grade, and their use in the additive would not introduce an additional risk to their conventional use. Given the lack of information, its proteinaceous nature and the high dusting potential, the active agents have the potential to be skin and respiratory sensitisers. The additive containing equal amounts of the two strains of Lactobacillus plantarum has the potential to improve the production of silage from all forages by reducing the pH and increasing the preservation of dry matter. (C) European Food Safety Authority, 2011.

The additive (SBS) consists of sodium bisulphate without carrier materials. The applicants are seeking authorisation for SBS as a silage additive and for use as feed preservative for all animal species, as acidity regulator for pets and other non food-producing animals and as flavouring for pets. The FEEDAP Panel concluded that (i) there is no convincing evidence for the safety of SBS as preservative in all animal species at the recommended maximum concentration of 1% in complete feed, (ii) the use of SBS in pets and other non food-producing animals is safe up to a concentration of 0.5 % - this maximum safe concentration of SBS cannot be applied to all animal species because of the lack of data in food-producing animals, and (iii) 0.8 % SBS added to fresh ensiling forages is safe for all animal species, based on data from a study with dairy cows. The use of SBS in animal nutrition is safe for the consumer up to the highest recommended level in complete feed. Sodium bisulphate is irritant to skin, eye and the respiratory tract and should be considered as a potential skin sensitiser. The use of SBS in feed is not expected to pose an additional risk for the environment. SBS is considered efficacious as preservative for all animal species, as acidity regulator in feed for pets and other non foodproducing animals and as flavouring substance for pets, based on the fact that SBS is authorised for the same purpose in food and on the studies provided. The FEEDAP Panel concluded that SBS is not efficacious as silage additive at the concentrations tested. The FEEDAP Panel recommended setting a maximum content of 0.5 % for SBS if authorised as acidity regulator and flavouring substance for pets and other non food-producing animals. (C) European Food Safety Authority, 2011.

The microbial feed additive Bonvital is a preparation of Enterococcus faecium. The applicant is seeking authorisation of Bonvital as a feed additive for dogs at the dose of 1 x 109 CFU/kg of complete feedingstuff. The safety for the user and the environment has been considered in the context of previous opinions. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) has considered only the safety and the efficacy of Bonvital for dogs. A tolerance test was performed on adult dogs fed a diet to which Bonvital was added at 50 times the proposed dose. Although no adverse effects were observed on their immunological and haematological parameters, the inadequate experimental design did not allow the FEEDAP Panel to draw conclusions on the safety of Bonvital for dogs. Six experiments were provided examining the effects of the additive at use level in dogs. Two studies gave data on faecal consistency and four on immunological parameters. Microbiological parameters were also measured in one of these studies. The observation of reduced Clostridium perfringens counts and the results on faecal consistency do not support the functional group gut flora stabiliser. Data on immune response were inconsistent due in part to an inadequate experimental design and a lack of consistency in observations. Lymphocyte proliferation in response to a mitogen challenge was significantly greater in treated dogs in two studies, but it was not demonstrated that these animals will show an increased response to a specific antigen. Although there appeared to be a greater IgG response in vaccinated animals given Bonvital, this was seen only as an increase in total IgG in one study and as a specific IgG titer in one other study. Consequently the FEEDAP Panel was unable to identify any consistent immune response which might be considered beneficial to the animal.