Zinc sulphate monohydrate is considered as a safe source of zinc for all animal species, regarding the maximum contents for total zinc in feedingstuffs set by the EU. Safe concentrations of zinc in water for drinking (milk replacers: 20 mg/L, pigs: 30 mg/L, poultry: 40 mg/L and pets: 100 mg/L; maximum daily amount of zinc administered via water for drinking for cattle: 500 mg, dairy cows: 2000 mg) could be applied only in feeding regimes without zinc supplementation to feed. Based on data on consumer exposure and the UL determined for zinc, no concerns for consumer safety are expected from the use of zinc sulphate monohydrate in animal nutrition. The hazards associated with handling of zinc sulphate monohydrate are well recognised and documented. In particular, zinc sulphate, monohydrate is considered as a severe irritant for eyes. The evidence presented showed that the forms of the product in this application had a very low dusting potential and consequently the risk of exposure by inhalation would be correspondingly low. The use of zinc as a feed additive does not pose direct concern for agricultural soil compartment. However, there is a potential environmental concern related to drainage and run-off of zinc to surface water. Most vulnerable for these processes are acid sandy soils. In order to draw a final conclusion, some further refinement to the assessment of zinc-based feed additives in livestock needs to be considered, for which additional data would be required. The use of zinccontaining feed additives in aquaculture up to maximum authorised zinc level in feeds is not expected to pose an appreciable risk to the environment. Zinc sulphate monohydrate is an efficacious source of zinc in meeting animal requirements. (C) European Food Safety Authority, 2012

The additive QuantumTM is an enzyme preparation containing 6-phytase produced by fermentation of a genetically modified strain of the yeast Pichia pastoris. The efficacy and safety of this product for chickens for fattening, laying hens, turkeys for fattening, ducks for fattening and piglets (weaned), including the assessment of the safety for the consumer, the user and the environment as well as the safety aspects of the genetic modification, have already been previously assessed by EFSA. The applicant is now asking for a modification of the terms of authorisation of the feed additive when used in turkeys for fattening, by reducing the minimum recommended dose from 1000 FTU/kg to 500 FTU/kg. Based on the results obtained in three studies, the FEEDAP Panel concluded that the additive QuantumTM has the potential to improve phosphorus utilisation in turkeys for fattening at the minimum dose of 500 FTU/kg. (C) European Food Safety Authority, 2012.

The additive tocopherol-rich extracts of natural origin is a mixture of the active substances alpha-, beta-, gamma-and delta-tocopherol. Tocopherol-rich extracts of natural origin/delta rich is a mixture of the active substances alpha-, beta-, gamma-and delta-tocopherol with a high concentration (> 70 %) of delta-tocopherol. Synthetic tocopherol consists of pure all-rac-alpha-tocopherol. The FEEDAP Panel, in a previous opinion on the safety and efficacy of vitamin E for all animal species, has already assessed the safety of RRR-alpha-tocopherol and the acetate ester of all-rac-alpha-tocopherol for all animal species, the consumer, the user and the environment. The FEEDAP Panel is not aware of any scientific findings in the meantime that would modify its previous conclusions. The FEEDAP Panel extended the conclusions drawn in its opinion on the safety of vitamin E (including RRR-alpha-tocopherol and all-rac-alpha-tocopheryl acetate) to tocopherol-rich extracts and all-rac-alpha-tocopherol. Tocopherol-rich extracts and all-rac-alpha-tocopherol at use levels are safe for all animal species and the consumer. No concern for user safety is expected from the use of tocopherol-rich extracts and all-rac-alpha-tocopherol in feed. The use of tocopherol-rich extracts and all-rac-alpha-tocopherol in animal nutrition will not result in a substantial increase in concentration in the environment. Since tocopherol-rich extracts and all-rac-alpha-tocopherol are used as antioxidants in food and their function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary. (C) European Food Safety Authority, 2012

The two strains of Lactobacillus plantarum are each intended for use as technological additives to improve the ensiling process at a proposed dose of 1 x 109 CFU/kg fresh material. The bacterial species L. plantarum is considered by EFSA to be suitable for the QPS approach to safety assessment. As the identity of the strains have been established and no antibiotic resistance detected, 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. Given the proteinaceous nature of the active agents and its high dusting potential, the additives should be considered to have the potential to be skin and respiratory sensitisers. Three studies with laboratoryscale silos are described, each lasting 90 days, involving both strains of L. plantarum used individually and made with tall fescue, red clover and lucerne with different water-soluble carbohydrate content, representing material easy to ensile, moderately difficult to ensile and difficult to ensile. In each case, replicate silos containing treated forage were compared to identical silos containing the same untreated forage. Both additives consistently showed the potential to improve the production of silage by increasing the preservation of dry matter and reducing the loss of protein. (C) European Food Safety Authority, 2012.

Potassium diformate (KDF preservative) is currently authorised as preservative for raw fish for feed use in all animal species. EFSA already issued an opinion on the safety and efficacy of potassium diformate when used as a preservative for raw fish and fish by-products for feed use in all animal species. The FEEDAP Panel concluded that the additive (i) is safe for the target species, the consumer and the environment when used under the proposed conditions, (ii) is an eye irritant and (iii) has the potential to increase the storage time of raw fish and fish by-products for feed use, in a dose-dependent manner at low temperature. The FEEDAP Panel is not aware of any new information that would lead it to reconsider its former position. (C) European Food Safety Authority, 2012.

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 additive synthetic alpha-tocopherol consists of pure all-rac-alpha-tocopherol. In a previous opinion on the safety and efficacy of vitamin E for all animal species, the FEEDAP Panel assessed the safety of the acetate ester of the additive for all animal species, the consumer, the user and the environment. The FEEDAP Panel is not aware of any more recent scientific findings that would modify its previous conclusions. The FEEDAP Panel extended the conclusions drawn in its opinion on the safety of vitamin E (including all-rac-alpha-tocopheryl acetate) to all-rac-alpha-tocopherol. All-rac-alpha-tocopherol at use levels is safe for all animal species and the consumer. No concerns for user safety are expected from the use of all-rac-alpha-tocopherol in feed. The use of all-rac-alpha-tocopherol in animal nutrition will not result in a substantial increase in concentration in the environment. Since all-rac-alpha-tocopherol is used as antioxidant in food and its function in feed is essentially the same as that in food, no further demonstration of efficacy is necessary.

Carmoisine is intended to be used as a colourant in feedingstuffs for cats and dogs without quantitative limitations. Since the additive is only applied for non-food producing animals, the assessment of safety is limited to the target species and the user. Carmoisine is safe in complete feed for cats and dogs at up to about 200 mg/kg dry matter. In the absence of any information, the substance should be considered as potentially harmful by skin, eye, or inhalation exposure. Carmoisine is intended to serve the same function in feed as in food. The intended concentrations in feedingstuffs are similar to those permitted for wide range of foodstuffs. The colouring efficacy of Carmoisine in a typical complementary feed for dogs was demonstrated at a minimum dose of 50 mg/ kg. Carmoisine is considered efficacious in adding colour to feed of cats and dogs. (C) European Food Safety Authority, 2012

The additive rosemary extract liquid of natural origin is intended to be used as a technological additive ( antioxidant) in feed for dogs and cats. The FEEDAP Panel assessed the data provided by the applicant in the technical dossier. During the course of the assessment, the need for additional information in order to be able to deliver an opinion on the safety and efficacy of this additive was identified and notified to the applicant. The information requested covered several aspects of the characterisation of the additive, the safety of the additive for the target species and its efficacy. The applicant has failed to provide the additional information even after several requests by EFSA. Therefore, considering the data provided in the original dossier and the absence of response from the applicant to the requests from EFSA, the FEEDAP Panel is not in a position to deliver an opinion on the safety and efficacy of the additive rosemary extract liquid of natural origin as a technological additive for dogs and cats. (C) European Food Safety Authority, 2012.

Phyzyme XP is a feed additive that contains 6-phytase, produced by a genetically modified strain of Schizosaccharomyces pombe (ATCC 5233) and is authorised for use in feed for chickens and turkeys for fattening, laying hens, ducks, piglets, pigs for fattening and sows. The applicant requested for an extension of use of the additive to all minor poultry species. Safety for chickens and turkeys for fattening and for laying hens was previously established at 750, 1000 and 1500 U/kg feed, respectively. Given the margin of safety established for the major poultry species, a maximum dose of 1000 U/kg feed was considered safe for all minor poultry species. Since the mode of action of phytases can be reasonably assumed to be the same in all avian species the minimum effective dose authorised for fattening birds (250 U/kg feed) and for laying birds (150 U/kg feed) was considered efficacious for minor poultry species.

Acetic acid, calcium acetate and sodium diacetate are listed in the EU Register of Feed Additives as preservatives for use with feed for all animal species without restrictions. There is now an application for the reauthorisation of acetic acid and these salts as preservatives in feed and for a new use of acetic acid as preservative in water for drinking. They may be used alone or in combination with other organic acids typically in a concentration 200 to 2,500 mg acetate/kg complete feedingstuffs. Acetic acid and its salts are considered equivalent when compared on a molar basis. Based on the comparison between consumer and target animals exposure to acetic acid and the limited experimental data available for chickens and the dogs fed diets containing acetate, a maximum concentration of 2,500 mg acetic acid/kg complete feed ( or 1000 mg/L water for drinking) is considered safe for poultry, pigs and pet animals. The tolerance of ruminants is considerably higher. No data is available for salmonids.the complete and rapid metabolism of acetate, the use of acetate in animal nutrition is not expected to contribute to human exposure. Acetic acid and its salts are bulk industrial chemicals and the hazards for those handling these substances are well known and documented. Acetates are normal components of the diet of humans and animals and are produced in molar quantities in the gastrointestinal tract. They are fully metabolised and so do not pose a risk to the environment. Acetic and its salts have the potential to act as preservatives in feedingstuffs and water for drinking. (C) European Food Safety Authority, 2012

Ronozyme RumiStar is a feed additive in which the declared enzymatic activity is alpha-amylase. It is produced by a genetically modified Bacillus licheniformis strain. The final enzyme preparations contain no cultivable production organisms or recombinant DNA. Based on the results of a tolerance trial provided by the applicant, it was concluded that Ronozyme RumiStar is safe for use in dairy cows at the maximum proposed dose (400 KNU/kg dry matter of total daily ration) when administered in a total mixed ration with a starch level below 30 %. Based on the results of two in vitro genotoxicity studies and a subchronic oral toxicity rat study, it is concluded that no concerns for consumer safety arise from the use of Ronozyme RumiStar as a feed additive for dairy cows. Ronozyme RumiStar is not considered to be irritant to human skin or eye. The additive is considered to be a potential skin and respiratory sensitiser. The active substance of Ronozyme RumiStar is a protein and as such will be degraded/inactivated during passage through the digestive tract of animals. Therefore, no risks to the environment are expected and no further environmental risk assessment is required. From five efficacy studies provided by the applicant, significant positive effects were observed in only one trial in which an energy-deficient diet was used. Therefore, no conclusions can be drawn on the efficacy of Ronozyme RumiStar in dairy cows

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.

The additive Natugrain (R) Wheat TS is a preparation of endo-1,4-beta-xylanase (xylanase) produced by a genetically modified strain of Aspergillus niger. This product is authorised as a feed additive for chickens and turkeys for fattening and for ducks. The applicant requested for an extension of use of the additive to new poultry species and for a modification on the current authorisation in chickens for fattening and ducks. On the basis of the safety previously established for the major poultry species, Natugrain (R) Wheat TS was considered safe for all avian species for fattening and reared for laying or breeding and ornamental birds at a maximum dose of 840 TXU per kg feed. Efficacy previously established in turkeys for fattening applies to turkeys reared for breeding (560 TXU/kg). The additional evidence provided on the efficacy of the additive in chickens for fattening confirmed 280 TXU per kg feed as a minimum effective dose and applies also to chickens reared for laying. The efficacy demonstrated for chickens for fattening was extrapolated to minor poultry species (for fattening, reared for breeding or reared for laying) and ornamental birds at the dose of 280 TXU per kg feed. (C) European Food Safety Authority, 2012

Chemical group 23 consists of benzyl alcohols/aldehydes/acids/esters/acetals, of which 36 are currently authorised for use as flavours in food. The use of the following is safe for all animal species: benzyl alcohol, benzoic acid and benzylacetate at the maximum of 125 mg/kg complete feed; benzylaldehyde, vanillin, gallic acid and benzylpropionate at the maximum of 25 mg/kg complete feed; 4-isopropylbenzyl alcohol, veratraldehyde, 4-isopropylbenzylaldehyde, p-tolualdehyde, benzylbutyrate, benzylformate, benzylisobutyrate, benzylisovalerate, benzylphenylacetate, methylbenzoate, ethylbenzoate, ethylsalicylate, methylsalicylate, isopentylbenzoate and isobutylbenzoate at the maximum of 5 mg/kg complete feed; p-methoxybenzaldehyde, panisylalcohol, p-anisylacetate, salicylaldehyde, 2-methoxybenzaldehyde, isopentylsalicylate, hexylsalicylate, isobutylsalicylate, benzylsalicylate and pentylsalicylate at the maximum of 1 mg/kg complete feed; benzylhexanoate, benzylcinnamate and benzylbenzoate at a maximum calculated use levels of 1.5 mg/kg complete feed for cattle, salmonids and non food-producing animals and 1.0 mg/kg complete feed for pigs and poultry; for piperonal the corresponding figures are 0.5 and 0.3 mg/kg complete feed. No safety concerns arise for the consumer following the use of benzoates, benzyl derivatives and salicylates up to the highest safe level in feedingstuffs for all animal species. Gallic acid, vanillin, veratraldehyde, p-anisylalcohol and p-anisylacetate are not expected to generate residues of safety concern when used in feedingstuffs for mammals and gallic acid in feedingstuffs for poultry. The lack of data for the other compounds in poultry and fish precludes an assessment of consumer exposure from these sources. For piperonal, no conclusion can be drawn on the safety for the consumer on the use of this substance in animal nutrition. All compounds should be considered as irritants to skin, eyes and respiratory tract, skin sensitisers and harmful if swallowed. The compounds do not pose a risk to the environment when used at concentrations considered safe for the target species. Since all compounds are used in food as flavourings, no further demonstration of efficacy is necessary.

Chemical Group 25 (CG 25) consist of phenol derivatives containing ring-alkyl, ring-alkoxy and side-chains with an oxygenated functional group, of which 16 are currently authorised for use as flavours in food. The flavouring compounds are calculated to be safe for all animal species at a maximum level of 5 mg/kg complete feed. This value supports the highest proposed use level for 13 of the 16 compounds with the margin of safety of approximately 1 to 5 for pigs and poultry, the most sensitive species. This safe level is substantially below the maximum proposed use level for all species for thymol and carvacrol (125 mg/kg complete feed) and for 3methoxyphenol (25 mg/kg complete feed). The Panel concludes that the use of any of the 16 compounds included in CG 25 at the maximum proposed use level in animal feed would not raise safety concerns for consumers of animal products. No new data on the safety for the user was provided. However, potential hazards for skin and eye contact and respiratory exposure of various severities are recognised for all of the compounds included in CG 25. The Panel expects that at the use level safe for all target species (5 mg/kg feed), the 16 compounds included in CG 25 do not pose a risk for the environment. Since all 16 compounds include in CG 25 are used in food as flavourings and their function in feed is essentially the same as that in food, no further demonstration of efficacy was considered necessary. (C) European Food Safety Authority, 2012