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Abstract VevoVitall® is a feed additive consisting of benzoic acid. It is currently authorised as a zootechnical additive for weaned piglets and pigs for fattening. This opinion concerns the renewal of the authorisation of benzoic acid as a zootechnical additive in feed. In 2005 and 2017, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted two opinions on the safety and efficacy of VevoVitall® as a feed additive for weaned piglets and pigs for fattening, respectively. The applicant has provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. Furthermore, according to the information provided in the technical dossier, no new evidence has been identified that would make the FEEDAP Panel reconsidering the previous conclusions on the safety of the additive. The Panel confirms that the additive is safe at the maximum authorised concentrations of 5,000 and 10,000 mg/kg feed for weaned piglets and pigs for fattening, respectively; a margin of safety cannot be determined for weaned piglets while a margin of safety of less than 1.5 is established for pigs for fattening. The use of VevoVitall® in feeds for weaned piglets and pigs for fattening at the maximum authorised concentrations does not pose any safety concern for consumers and the environment. The use of VevoVitall® does not pose a risk by inhalation to users and is not a skin sensitiser. The new available data confirm that the additive is a skin irritant and a severe eye irritant. A recommendation concerning the potential toluene residues in the additive has been posted.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on an essential oil from Origanum vulgare subsp. hirtum var Vulkan (DOS 00001) when used as a sensory feed additive for all animal species. Analysis of the oil identified 34 components accounting for > 99% of the oil, with carvacrol being the most prevalent (> 60%). Five tolerance studies in three species (chickens for fattening, weaned piglets and dairy cows) were made to assess the safety for the target species. The recommended use level of 150 mg additive/kg feed was shown to be safe for chickens for fattening and weaned piglets and this conclusion is extended to all poultry and porcine species grown for meat production. A dose of 500 mg additive/head and day (equivalent to ~ 25 mg/kg complete feed) was also demonstrated safe for the dairy cow. The Panel concluded that since the recommended use level differs between the dairy cow and the non‐ruminants tested the lower use level of 25 mg additive/kg feed could be applied to all target animals not included above. Residue studies (meat, liver, fat milk and eggs) showed that the exposure of consumers to products from animals given the additive at the recommended use level did not raise safety concerns. The additive should be considered as an irritant to skin and eyes, and to have a potential for sensitisation of susceptible individuals. Use in animal production of the essential oil extracted from O. vulgare is not expected to pose a risk for the environment. Since oregano and its extracts is recognised to flavour food and its function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary.

Abstract The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) received a request from the European Commission to assess the safety and efficacy of bentonite when used as a technological feed additive (substances for reduction of the contamination of feed by mycotoxins) for all animal species. The applicant, EUBA aisbl (European Bentonite Association) representing six companies, submitted to EFSA a technical dossier to support the application. The applicant proposes to use bentonite at the maximum level of 20,000 mg/kg complete feed. The additive apparently interferes with the analysis of aflatoxin B1 in feed. The safety of the additive was already evaluated by the Panel in an opinion delivered in 2012. Bentonites are safe for all animal species, the consumers and the environment when used at a maximum level of 20,000 mg/kg complete feed. The results of a new genotoxicity study reinforced the previous conclusion that smectites are non‐genotoxic. Bentonites are not skin irritants but might be mildly irritant to the eye; based on a new study submitted, the additive is not a skin sensitiser. Owing to its silica content, the additive is a hazard by inhalation for the users. The in vitro study showed that the di‐ and tri‐octahedral smectites tested can adsorb aflatoxin B1 at different concentrations and at pH 5; however, no adequate in vivo studies were available. Therefore, the Panel cannot draw conclusions on the additive's efficacy. The Panel further considers the safety and efficacy conclusions to apply equally to the di‐ and tri‐octahedral smectites under assessment. The FEEDAP Panel posted some recommendations regarding the maximum content of other minerals in the additive and the incompatibilities of the additive with other medicinal substances. The Panel also drew a remark concerning the denomination of the additive and the current regulatory definition of Bentonite.

Abstract The coccidiostat Monimax® (monensin sodium and nicarbazin) is considered safe for turkeys for fattening at the highest use level of 50 mg monensin and 50 mg nicarbazin/kg complete feed. The simultaneous use of Monimax® and certain antibiotic drugs (i.e. tiamulin) is contraindicated. For both active substances, the metabolic pathways in the chicken are similar to those in the turkey and rat. Nicarbazin, when ingested, is rapidly split in its two components dinitrocarbanilide (DNC) and 2‐hydroxy‐4,6‐dimethylpyrimidine (HDP) which behave independently. Monimax® does not represent a genotoxic risk. No safety concerns would arise from the nicarbazin impurities p‐nitroaniline and methyl(4‐nitrophenyl) carbamate. The lowest no observed effect level (NOEL) identified for monensin sodium in a developmental study in rabbits was 0.3 mg monensin sodium/kg body weight (bw) per day for maternal toxicity in rabbits. The lowest no observed adverse effect level (NOAEL) identified in a 52‐week study in rat using DNC + HDP was 20 mg DNC + 8 mg HDP/kg bw per day. No significant interaction between monensin sodium and nicarbazin is expected from toxicological studies. The use of Monimax® at the highest proposed dose will not pose a risk to persons consuming animal products from treated turkeys for fattening. No withdrawal time is required for Monimax® in turkeys for fattening. Residue data comply with the established maximum residue limits for monensin and DNC. Monensin sodium presents a hazard by inhalation and may also be associated with dermal toxicity. Monimax® is not a skin irritant; however, no data are available for the eye irritation potential of monensin. Monimax® is not a skin sensitiser. Based on the available data, the FEEDAP Panel cannot conclude on the safety of Monimax® for the environment. Monimax® has the potential to control coccidiosis in turkeys for fattening at a minimum concentration of 40 mg monensin and 40 mg nicarbazin/kg complete feed.

Draft Endorsed by the FEEDAP Panel 22 March 2017 Submitted for public consultation 6 April 2017 End of public consultation 31 May 2017 Adoption by the FEEDAP Panel 26 September 2017 Entry into force 1 May 2018 Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the safety for the target species.

Abstract 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 VevoVitall® (benzoic acid) as a feed additive for minor porcine species, when used as zootechnical additive at a maximum level of 5,000 mg/kg complete feed. The safety and efficacy of the additive had been evaluated by the FEEDAP Panel on weaned piglets (at the maximum supplementation level of 5,000 mg/kg complete feed) and pigs for fattening and pigs for reproduction (at the maximum level of 10,000 mg/kg complete feed). Subsequent to EFSA's assessments, the additive has been authorised for use in feed of weaned piglets, pigs for fattening and sows. To the knowledge of the FEEDAP Panel, there was no new information that might modify its previous assessments on VevoVitall® concerning safety for consumers and the environment; therefore, this opinion focused only on the safety of the target animals and the efficacy of the product. The FEEDAP Panel concluded that VevoVitall® is safe at the supplementation level of 5,000 mg/kg complete feed for minor porcine species for fattening and for reproduction; the FEEDAP could not conclude on the safety of the additive for weaned minor porcine species. VevoVitall® does not represent a risk for the consumer and the environment. VevoVitall® does not pose a risk by inhalation to users and is not skin sensitiser, but is a skin irritant and a severe eye irritant. VevoVitall® has the potential to decrease the urinary pH in minor porcine species at the dose of 5,000 mg/kg complete feed. A remark on the relevance of the claim has been posted by the Panel.

Draft Endorsed by the FEEDAP Panel 16 May 2017 Submitted for public consultation 24 May 2017 End of public consultation 7 July 2017 Adoption by the FEEDAP Panel 27 September 2017 Entry into force 1 May 2018 Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the identity, characterisation and conditions of use of the additives.

Abstract RONOZYME® WX is an additive that contains endo‐1,4‐β‐xylanase which is authorised for use as a feed additive in poultry for fattening, weaned piglets and pigs for fattening. The applicant has requested for an extension of the use to laying hens. The Panel on additives and Products or Substances used in Animal Feed (FEEDAP) delivered in 2012 an opinion on the safety and efficacy of RONOZYME® WX when used as a feed additive for poultry, piglets (weaned) and pigs for fattening and another one in 2016 on the change of the production strain proposed by the applicant. In those opinions, the FEEDAP Panel concluded that the use of the product as a feed additive raises no concerns for consumer safety or for the environment. Considering the safety for the user, the Panel concluded that the additive is not a skin or eye irritant but could not conclude on its skin sensitisation potential; however, the additive was considered a potential respiratory sensitiser. The Panel considered that the new use of RONOZYME® WX would not modify those conclusions. The applicant submitted a tolerance study in laying hens the results of which permitted the Panel to conclude that the additive is safe for laying hens at the recommended dose of 100 FXU/kg feed. In order to support the efficacy of the additive in laying hens, the applicant submitted three long‐term trials. In all three trials, the groups receiving the xylanase at the recommended dose showed a lower feed intake and a better feed to egg mass ratio. However, in one of the three trials, these reductions were seen concurrently with a decrease in the laying rate. This result casts doubts on the efficacy of the additive, and therefore, the Panel considered that there was not sufficient evidence to conclude on the efficacy of the product.

Abstract AviMatrix® (benzoic acid, calcium formate and fumaric acid) is intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed of chickens for fattening, chickens reared for laying, minor avian species for fattening and minor avian species reared to point of lay to increase performance. The additive has not been authorised in the EU. In 2014, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion in which, owing to insufficient tolerance data and the limited and inconsistent evidence of efficacy, a definitive conclusion on the safety and efficacy of the additive as a zootechnical additive could not be drawn. Additional data have been provided by the applicant related to the safety and the efficacy of the additive for the target species, which is the subject of this opinion. The FEEDAP Panel considers that the additive is tolerated by chickens for fattening up to the maximum recommended dose (1,000 mg/kg complete feed); this conclusion can be extended to chickens reared for laying. However, since no conclusion could be drawn on the margin of safety, the safety of the additive to minor avian species for fattening and to point of lay cannot be extrapolated. Data from three trials provided evidence that AviMatrix® at 500 mg/kg complete feed had the potential to improve the performance of chickens for fattening. The dose proposed for use with chickens reared for laying and minor poultry species for fattening and to point of lay is the same as that demonstrated being efficacious in a physiologically similar major species (chickens for fattening) and it can be reasonably assumed that the mode of action is the same. Consequently, the conclusion on efficacy for chickens for fattening can be extended to chickens reared for laying and extrapolated to minor poultry species for fattening and to point of lay.

Draft Endorsed by the FEEDAP Panel 17 May 2017 Submitted for public consultation 24 May 2017 End of public consultation 21 July 2017 Adoption by the FEEDAP Panel 27 September 2017 Entry into force 1 May 2018 Abstract This guidance document is intended to assist the applicant in the preparation and the presentation of an application, as foreseen in Article 7.6 of Regulation (EC) No 1831/2003, for the authorisation of additives for use in animal nutrition. It specifically covers the assessment of the safety for the consumer.

Abstract The additive Alterion NE® is a preparation containing viable spores of a strain of Bacillus subtilis. The additive is intended for use in feed for chickens for fattening and chickens reared for laying at the proposed dose of 1 × 108 CFU/kg complete feedingstuffs. B. subtilis is considered by EFSA to be suitable for the qualified presumption of safety approach to establish safety. As the identity of the active agent was established and the lack of toxigenic potential and of resistance to antibiotics of human or veterinary clinical significance demonstrated, the additive is presumed safe for the target species, consumers and the environment. Alterion NE® is not a dermal irritant but is irritant to eyes and should be considered a potential respiratory sensitiser. In the absence of data, no conclusion can be drawn on the dermal sensitisation of the additive. Alterion NE® at the recommended dose 1 × 108 CFU/kg feed has the potential to improve the zootechnical performance of chickens for fattening. This conclusion can be extended to chickens reared for laying when used at the same dose. B. subtilis DSM 29784 is compatible with monensin sodium, narasin/nicarbazin, salinomycin sodium, lasalocid sodium, diclazuril, narasin, maduramicin ammonium, robenidine hydrochloride and decoquinate at the highest authorised levels.

Abstract Levucell® SB is a feed additive based on viable cells of a strain Saccharomyces cerevisiae marketed in three formulations: SB20 with a minimum concentration of 2 × 1010 CFU/g viable yeast cells and SB10 ME and SB Titan, both microencapsulated forms with a minimum concentration of 1 × 1010 CFU/g viable yeast cells. In 2014, EFSA was requested by the European Commission to re‐evaluate the product when used as a zootechnical additive in feed for sows and weaned piglets. The safety of the additive for consumers, users, the environment and target animals and its efficacy for sows was established at that time. In that instance, the FEEDAP also concluded on the potential Levucell® SB to improve growth of piglets based on one study where supplementation of the additive was done at the recommended dose of 2 × 109 CFU/kg feedingstuffs and two at 1 × 109 CFU/kg feedingstuffs, and considered that the effective dose was 2 × 109 CFU/kg feedingstuffs. Two additional feeding trials in weaned piglets receiving the additive at 1 × 109 CFU/kg feedingstuffs are the subject of this assessment. Due to the high mortality, one of the studies was not considered. In the remaining study, the supplementation of Levucell® SB to weaned piglets at 1 × 109 CFU/kg feed resulted in a significant improvement of feed to gain ratio. Taking into account the two trials from the initial application which showed significant effects at 1 × 109 CFU/kg feed, the FEEDAP Panel concludes that Levucell® SB has the potential to improve performance of weaned piglets when added to feed at 1 × 109 CFU/kg complete feedingstuffs. Results of the efficacy studies can be applied to any of the three available formulations when used to deliver the same dose.

Abstract Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of selenium‐enriched yeast (Saccharomyces cerevisiae CNCM I‐3399) for all animal species, based on a dossier submitted for the modification of the terms of authorisation of the additive. The additive is currently authorised as selenomethionine produced by S. cerevisiae CNCM I‐3399 as a nutritional additive (compound of trace elements) with a minimum selenium content of 2,000 mg/kg. The applicant proposed the inclusion of an additional formulation with a minimum content of selenium in the additive of 3,000 mg/kg. Considering (i) that there are no relevant changes in the manufacturing of the product compared to the former application and (ii) that the conditions of use already authorised remain the same, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) stated that the modification requested would not affect the conclusions of the FEEDAP Panel on safety for the consumer, safety for the environment and efficacy of the product made in a previous assessment of a similar product with a lower selenium concentration. Since the capacity of the additive to homogeneously distribute in feed was proven, the tolerance studies already provided for the currently authorised product could be used to conclude on the safety of the additive for the target animals. Selenium is hazardous upon inhalation; owing to the dusting potential and the selenium content of dust, persons handling the additive are at risk. The additive should be considered as a respiratory sensitiser. The additive is not an irritant for eyes and skin. No conclusions can be reached on the dermal sensitising properties of the additive.

Abstract Beltherm MP/ML is a feed additive that contains endo‐1,4‐beta‐xylanase to be used as a zootechnical additive in poultry species. The production strain of the xylanase is a genetically modified strain of Bacillus subtilis. This species is considered by EFSA to qualify for the qualified presumption of safety (QPS) approach to safety assessment. The strain was unequivocally identified and qualifications were met. The genetic modification along with the results on the investigations regarding the presence? of the production strain and its DNA in the product were evaluated by the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) and raised no safety concerns. The FEEDAP Panel also concluded that the additive is safe for chickens and turkeys for fattening, chickens reared for laying, turkeys reared for breeding, turkeys for breeding purposes and minor poultry species at 100 ADXU/kg feed with a wide margin of safety. The Panel also concluded that no toxicological concerns for the consumer would arise from the use of Beltherm as a feed additive. The additive is considered a potential respiratory sensitiser for users. The Panel concluded that the use of the product as a feed additive raises no safety concerns for the environment. The additive has the potential to improve the performance of chickens for fattening, chickens reared for laying and minor growing poultry species at the dose of 100 ADXU/kg feed. The Panel could not conclude on the efficacy of the product in turkeys for fattening or reared for breeding or in turkeys for breeding purposes.

Abstract Sodium and potassium alginate are intended to be used as technological additives (functional groups: emulsifiers, stabilisers, thickeners, gelling agents and binders). Sodium alginate is intended to be used in feedingstuffs for pets, other non food‐producing animals and fish, with no maximum recommended use level. Potassium alginate is intended to be used in feedingstuffs for cats and dogs at levels up to 40,000 mg/kg feed (on dry matter). Since the functional properties of the additives are determined by the alginate content, sodium and potassium alginate were considered equivalent. The maximum dose considered safe for cats, dogs, other non food‐producing animals, salmonids and other fish is 40,000 mg alginates (sodium and potassium salts)/kg complete feed. The use of alginates in feedingstuffs for fish is of no concern for the consumer. Alginates are reported not to be irritant to the skin but mildly irritant to the eyes. They are considered as potential sensitisers to the skin and the respiratory tract. Alginates are high‐molecular‐weight polymers naturally occurring in brown algae. Their use in feedingstuffs for fish does not pose a risk for the aquatic environment. Alginates are effective as stabilisers, thickeners, gelling agent and binders. No conclusion could be drawn on the efficacy of alginates as emulsifiers.

Abstract Following a request from the European Commission, the 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 HOSTAZYM® X. The additive HOSTAZYM® X is a preparation of endo‐1,4‐β‐xylanase available in different liquid and solid formulations. This product is authorised as a feed additive for chickens for fattening, turkeys for fattening, laying hens, minor poultry species for fattening and laying, weaned piglets and pigs for fattening. The FEEDAP Panel adopted two opinions on the safety and efficacy of the product as a feed additive for poultry and pigs, and another one for its use as a feed additive in chickens reared for laying and minor poultry species reared for laying. The applicant has now requested to extend the authorisation to carps (Cyprinus carpio). The FEEDAP Panel considered that the new use of the additive would not change the previous conclusions regarding the safety for the consumer, user and environment. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected. Considering the safety for the user, it was concluded that the additive should be considered a potential skin and eye irritant, and a potential skin and respiratory sensitiser. The data in a tolerance trial performed with carps showed that the additive is safe for carp at 1,050 endo‐pentosanase units (EPU)/kg feed. The results in three efficacy trials showed that the additive has the potential to improve the performance of the carps at 1,050 EPU/kg feed.

Abstract The additive under assessment is a natural mixture mainly composed of illite (~ 53%), montmorillonite (~ 16%) and kaolinite (~ 17%). In 2016, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an Opinion on the safety and efficacy of a natural mixture of illite, montmorillonite and kaolinite (MIMK). The FEEDAP Panel concluded that the additive is safe for piglets and pigs for fattening at a maximum concentration of 20,000 mg/kg, and for cattle for fattening at a maximum concentration of 50,000 mg/kg. However, no conclusion could be drawn for all other species/categories. The Panel also concluded that the additive is efficacious at a minimum concentration of 50,000 mg/kg. Following this opinion, the European Commission gave the possibility to the applicant to submit complementary information in order to complete the assessment on the safety for all animal species and on its efficacy at a minimum concentration of 20,000 mg/kg. The applicant submitted a new tolerance study in piglets and an analysis of the previous EFSA opinion regarding poultry and milk‐producing animals. The FEEDAP Panel concluded that the additive is safe for piglets and pigs for fattening at 50,000 mg/kg. The Panel concluded that the safe level (50,000 mg/kg) found for cattle for fattening could be extrapolated to minor growing ruminants. The conclusion could be extrapolated to dairy cows and minor ruminant species for milk production. The FEEDAP Panel confirmed that no safe concentration of MIMK in feed for chickens for fattening could be identified. No conclusions could be drawn for all the other animal species/categories. The additive is effective as a pellet binder and an anticaking agent at the lowest level tested of 5,000 mg/kg feed.

Abstract 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 Levucell® SC for dairy cows, cattle for fattening, all minor ruminant species and camelids. The additive consists of viable cells of a strain of Saccharomyces cerevisae and is sold in three formulations. The FEEDAP Panel considers that the three available formulations are equivalent when used to deliver the same dose. The active agent fulfils the requirements of the qualified presumption of safety approach to the assessment of safety and since no concerns are expected from other components, Levucell® SC can be presumed safe for target animals, consumers of products from treated animals and the environment. Levucell® SC is not a skin irritant or sensitiser but is an eye irritant. Inhalation exposure is unlikely. Encapsulation is not expected to introduce hazards for users. The FEEDAP Panel is not in the position to conclude on the efficacy of Levucell® SC for dairy cows, minor dairy ruminant species or dairy camelids. Levucell® SC has a potential to improve the performance of cattle raised for fattening when supplied at a minimum dose of 8 × 109 CFU/head and day which would approximate to 6 × 108 CFU/kg complete feed. This conclusion is extended to minor ruminant species and camelids reared for meat production at the same minimum dose of 6 × 108 CFU/kg complete feed.

Abstract The product subject of this assessment is l‐threonine produced by fermentation with a genetically modified strain of Escherichia coli (CGMCC 11473). It is intended to be used in feed and water for drinking for all animal species and categories. It was not possible to characterise the genetic modification with the information provided. Uncertainty remained on the possible presence of cells from the production strain and their recombinant DNA in the product. Therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the product l‐threonine, produced by fermentation with Escherichia coli CGMCC 11473 for the target species, consumers and the environment. The FEEDAP Panel has concerns on the safety of the simultaneous oral administration of threonine containing additives via water for drinking and feed. In the absence of data, the FEEDAP Panel cannot conclude on the potential of the additive to be an irritant for skin and eyes or to be a skin sensitiser. There is a risk from the exposure by inhalation to endotoxins for persons handling the additive. The product under assessment is considered an efficacious source of the amino acid l‐threonine for all animal species. For l‐threonine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

Abstract Liderfeed® is intended to be used as a zootechnical additive (functional group: other zootechnical additives) in feed of chickens for fattening to increase the performance. The additive contains eugenol as an active ingredient with some excipients and has not been authorised in the EU for use in food or feed. In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) adopted an opinion on the safety and efficacy of Liderfeed® as a zootechnical additive for chickens for fattening. In that opinion, the Panel could not conclude on the efficacy of the additive because only two out of the three efficacy studies considered showed a significant effect on the performance of chickens for fattening as a result of the supplementation with the additive. The Commission gave the applicant the possibility of submitting additional information to allow the FEEDAP Panel to complete its assessment. For this reason, additional data have been provided related to the efficacy of the additive for the target species and this new information is the subject of this opinion. The new efficacy study on chickens for fattening is the subject of this assessment; the results of this study indicate an improvement in performance parameters with the use of the additive at 100 mg/kg complete feed. Considering the results of the current study, along with the two efficacy studies already assessed in the previous FEEDAP Panel opinion of 2015, the Panel concludes that Liderfeed® at 100 mg/kg complete feed has the potential to improve the growth of chickens for fattening.

Abstract The additives under assessment are lactic acid and calcium lactate. In 2015, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an Opinion on the safety and efficacy of lactic acid and calcium lactate. The FEEDAP Panel could not conclude on the safety of lactic acid in pre‐ruminants and poultry. Following this opinion, the European Commission gave the possibility to the applicant to submit complementary information in order to complete the assessment on the safety for all animal species. Based on the studies submitted in chickens for fattening and laying hens, no safe concentration of lactic acid and calcium lactate in complete feed for these species could be identified. Owing to the absence of data on tolerated dietary levels of d‐lactic acid, no conclusion on the safety of lactic acid in milk replacer for pre‐ruminants is possible. Since a safe concentration of lactic acid (and calcium lactate) was established only for pigs and cattle, and not for a third major animal species, no extrapolation to any other species is possible.

Abstract 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 a strain of Lactobacillus buchneri when used as a technological additive intended to improve ensiling at a proposed application rate of 1 × 108 colony forming units (CFU)/kg fresh material. The bacterial species L. buchneri 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 or skin sensitisation of the additive. The additive should be considered a potential respiratory sensitiser. Three studies with laboratory‐scale silos were made using samples of easy, moderately difficult and difficult to ensile material. In each case, replicate silos containing untreated forage were compared with identical silos containing the same forage treated with the combination of Lactobacillus buchneri NRRL B‐50733 at an intended concentration of 1 × 108 CFU/kg fresh matter. The results showed that the addition of Lactobacillus buchneri NRRL B‐50733 at 1 × 108 CFU/kg fresh material has the potential to improve the aerobic stability of silage with a dry matter content ranging from 30% to 73%.

Abstract The additive ‘Zinc chelate of methionine sulfate’ is zinc chelated with methionine in a molar ratio 1:1, with a minimum zinc content of 19.1%. Owing to the limitations of the tolerance study, it could not be used for the assessment of safety for target animals; therefore, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) cannot conclude on the safety of zinc chelate of methionine sulfate for the target species. No concerns for consumer safety are expected from the use of the zinc chelate of methionine sulfate in animal nutrition when used up to the maximum EU authorised zinc levels in feed. Zinc chelate of methionine sulfate should be considered as a skin and eye irritant, and as a skin sensitiser; it is considered to pose a risk by inhalation to the users. The additive under assessment, zinc chelate of methionine sulfate, is intended to be a substitute for other authorised zinc additives and will not further increase the environmental burden of zinc; therefore, the FEEDAP Panel considers that the use of the additive in animal nutrition would not pose an additional risk for the environment. Based on literature studies and a specific study conducted with the additive under assessment, zinc chelate of methionine sulfate is an available source of zinc for all animal species.

Abstract Amylofeed® is a preparation of endo‐1,3(4)‐β‐glucanase, endo‐1,4‐β‐xylanase and α‐amylase aimed to be used as a feed additive for piglets and young minor porcine species. In a previous assessment, the safety of the additive for the target species, user and environment were established. However, the safety for the consumer and the efficacy of the product could not be established. In that previous assessment, the limitations on the description of the manufacturing process, the characterisation of the additive and on the toxicological studies provided did not allow the Panel to conclude on the safety for the consumer. The applicant has now provided new data/information to assess the safety for the consumer and also new studies in order to support the efficacy of the additive in the target species. The enzymes present in the product are obtained from two different strains and from two different fermentation processes. In the current assessment, the applicant provided complete and detailed information regarding the manufacturing process of the additive, including details on the composition of the intermediate products. New genotoxicity studies were submitted by the applicant and the results showed no genotoxic potential of the test items. The Panel considered that the conclusions drawn in the subchronic oral toxicity study performed and previously submitted were valid for the current assessment; the results showed no evidence for adverse effects. Consequently, the Panel concluded that the additive is safe for the consumers when used as a feed additive. For the evaluation of the efficacy of the additive, the Panel considered four long‐term trials done in weaned piglets. Based on these data, the Panel concluded that the additive has a potential to be efficacious in weaned piglets at the nominal dose of 500 mg/kg feed and extrapolated this conclusion to growing minor porcine species.

Abstract The additive under assessment is a preparation of Bacillus amyloliquefaciens NCIMB 3022 intended for use as a technological additive in forages for all animal species at a proposed minimum dose of 5 × 107 CFU/kg fresh materials. The species B. amyloliquefaciens is considered by EFSA to be suitable for the qualified presumption of safety approach to safety assessment. This approach requires the identification of the strain and evidence that it is not toxigenic and does not show acquired resistance to relevant antibiotics. In a previous assessment, the identity and susceptibility to clinically relevant antibiotics of the active agent was established but the lack of toxigenic potential could not be demonstrated. Therefore, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of the product for target animals, consumers, users or the environment. In the same opinion, the potential of the additive to improve aerobic stability of silages at the proposed dose was not convincingly demonstrated. A new cytotoxicity study was conducted using methanol extracts. The methanol extract was cytotoxic at the inclusion level of 5%, while no cytotoxicity was observed at lower concentrations. The current guidance on Bacillus requires absence of toxic effect using the non‐concentrated supernatant. Since the applicant was unable to determine the correlation between the methanol extracts and the Bacillus supernatant concentrations, the FEEDAP Panel is unable to conclude on the toxigenic potential of the strain based on the current data. An additional efficacy study with a similar protocol to the ones previously assessed was conducted. The study showed an improved aerobic stability when added to forage at the proposed dose. However, the FEEDAP Panel remains unable to conclude on the efficacy of the additive to improve the ensiling process on the basis of a single positive result.

Abstract 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 product subject of this assessment is l‐arginine produced by fermentation with a genetically modified strain of Corynebacterium glutamicum (KCCM 80099). It is intended to be used in feed and water for drinking for all animal species and categories. The following conclusions refer to the additive ‘L‐arginine produced by Corynebacterium glutamicum KCCM 80099’. Neither the genetically modified production strain nor its recombinant DNA were detected in the final product. The additive does not give rise to safety concerns with regard to the genetic modification of the production strain. The use of the additive is safe for target species when supplemented to diets in appropriate amounts, for the consumer and for the environment. The additive is not hazardous by inhalation, is not a skin sensitiser, but is corrosive to skin and eyes. The additive is an effective source of arginine for all species. For the supplemental l‐arginine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against microbial degradation in the rumen.

Abstract Bacillus subtilis PB6 is a feed additive based on viable spores of a strain of Bacillus subtilis. EFSA has already issued several opinions on the safety and efficacy of the additive when used in the feed for a number of avian and porcine species/categories. The applicant is now seeking authorisation for use in sows in order to have benefits in piglets. In the course of previous assessments, no evidence of a toxigenic potential or resistance to relevant antibiotics was found. Consequently, the strain of B. subtilis in the additive, following the qualified presumption of safety approach to safety assessment, is presumed safe for target animals including sows and their offspring, consumers and the environment. In a previous assessment, it was also concluded that the additive is not a skin/eye irritant or a skin sensitiser and that there were no concerns on respiratory sensitisation. The use of the additive with feed for sows is considered unlikely to introduce hazards for users of the product not already considered. Five studies are described in which groups of sows given the additive for a minimum period from the last 3 weeks of pregnancy, throughout farrowing and lactation, until weaning of piglets were compared with a control group. In only two of five studies, there was a significant beneficial effect seen in terms of piglet performance. However, when data from the four similar were pooled and analysed, significant increases in weaned weight and average daily gain were indicated for piglets from sows given the additive. Consequently, the FEEDAP Panel concludes that Bacillus subtilis PB6 when added to diets of sows from 3 weeks before parturition until weaning of piglets at a dose of 1 × 108 CFU/kg complete feed has the potential to improve the growth of piglets from birth to weaning.

Abstract 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 Probion Forte® when used in feed for chickens for fattening. Probion Forte® is a preparation containing viable spores of a strain of Bacillus subtilis and Bacillus coagulans intended for use in feed for chickens for fattening at the minimum dose of 1 × 108 and a maximum of 2 × 108 colony‐forming units (CFU)/kg feedingstuffs. In the view of the FEEDAP Panel, the identity of the bacterial strains is established as B. subtilis and B. coagulans and their susceptibility to relevant antibiotics is demonstrated. However, both bacterial strains belong to species capable of producing toxins. The absence of a toxigenic potential has not been demonstrated and, therefore, these strains do not qualify for a qualified presumption of safety (QPS) approach to safety assessment and separate studies on target animals and consumer safety are required. The data provided did not allow concluding on the safety for chickens for fattening or the consumers. Probion Forte® is not a skin or eye irritant but should be considered a potential respiratory sensitiser. No conclusion can be drawn on the skin sensitisation potential of the additive. In the absence of evidence that the two active agents are not toxigenic, Probion Forte® is considered as a hazard for those handling the additive. Probion Forte® is considered safe for the environment. The FEEDAP Panel is not in the position to conclude on the efficacy of Probion Forte® for chickens for fattening from the data provided.

Abstract Following a request from the European Commission, the EFSA Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of Calsporin® when used in feed for dogs. The additive contains viable spores of a single strain of Bacillus subtilis. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment. This approach requires the identity of the strain to be conclusively established, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of previous opinions and since concerns are not expected from other components of the additive, Calsporin® is presumed safe for all target species, including dogs, and for the environment. In a previous opinion, the Panel also concluded that the additive is not a dermal/eye irritant or a skin sensitiser but should be considered a potential respiratory sensitiser. The use of the additive in dogs is considered unlikely to introduce hazards for users of the product not already considered as part of the first assessment. Therefore, the conclusions reached apply to the current application. Four studies were supplied aiming at investigating the effects of the supplementation of Calsporin® to the faecal consistency of dogs. Overall, there is a small but significant increase in faecal dry matter content and benefits seen in a subjective assessment of faecal consistency. However, the biological relevance of changes of this magnitude for the animal is questionable, as are the practical benefits for the owner.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus hilgardii when used as a technological additive intended to improve ensiling at a proposed application rate of 1.5 × 108 colony‐forming units (CFU)/kg fresh material. The bacterial species L. hilgardii 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 or skin sensitisation of the additive. The additive should be considered as a potential respiratory sensitiser. Three studies with laboratory‐scale silos were made using samples of easy and moderately difficult to ensile forage. In each case, replicate silos containing untreated forage were compared with identical silos containing the same forage treated with the combination of Lactobacillus hilgardii CNCM I‐4785 and Lactobacillus buchneri NCIMB 40788 each at an intended concentration of 1.5 × 108 CFU/kg fresh matter each. The results showed that the addition of Lactobacillus hilgardii CNCM I‐4785 at the proposed dose, when used in combination with an equal concentration of Lactobacillus buchneri NCIMB 40788, improves significantly the aerobic stability of the silage tested. This was shown in maize forage with a dry matter content ranging from 30% to 40%.

Abstract 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 Calsporin® when used in feed for sows and piglets. The additive contains viable spores of a single strain of Bacillus subtilis. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to safety assessment, which requires the identity of the strain to be conclusively established, evidence that the strain is not toxigenic and that it does not show resistance to antibiotics of human and veterinary importance. The strain was found to meet the criteria for the QPS approach in the context of previous opinions and since concerns are not expected from other components of the additive, Calsporin® is presumed safe for all target species, consumers and the environment. In a previous opinion, the FEEDAP Panel concluded that Calsporin® is not a dermal/eye irritant or a skin sensitiser but should be considered a potential respiratory sensitiser. Use of the additive in feed for sows and suckling piglets will not introduce hazards for users not already considered. Three trials performed with sows over a complete reproductive cycle and their offspring showed positive effects on zootechnical parameters of sows and piglets. Therefore, Calsporin® has the potential to improve one or more performance parameters of sows and suckling piglets when supplemented to both sows and suckling piglets at 3 × 108 CFU/kg of complete feedingstuffs. In the view of the FEEDAP Panel, the effects observed can predominantly be traced back to the administration of the additive to pregnant/lactating sows. The proportion of effects which could be related to feeding supplemented creep feed to suckling piglets cannot be quantified.

Abstract The additive OPTIPHOS® is a preparation of 6‐phytase that is authorised for use in avian species, weaned piglets, pigs for fattening and sows. The applicant seeks for an extension of use of the product to finfish, at a dose range between 250 and 1,000 OTU/kg feed. The FEEDAP Panel concluded in a previous opinion that there are no concerns for consumer safety and no risks for the environment are expected from the use of the product as feed additive. Moreover, it was concluded that the additive is not a skin/eye irritant or a skin sensitiser, but has the potential to be a respiratory sensitiser. The Panel considered that the new use of the additive would not change the previous conclusions regarding the safety for the consumer, user and environment. The results of a tolerance study performed in juvenile rainbow trout (Oncorhynchus mykiss) showed no negative effects of the additive on the fish when offered up to 100 times the maximum recommended dose. Therefore, the Panel concluded that the additive is safe for the rainbow trout and extrapolated this conclusion to all finfish. The Panel evaluated three efficacy trials, two performed in rainbow trout and one in Atlantic salmon (Salmo salar). In these studies, the performance of the fish was monitored as well as phosphorus digestibility and phosphorus retention parameters. In the three trials, the performance and the phosphorus retention were improved by the additive at the lowest tested dose (in rainbow trouts at 250 OTU/kg feed and in Atlantic salmon at 500 OTU/kg feed). The FEEDAP Panel concluded that the additive has a potential to be efficacious in rainbow trout and salmon at 500 OTU/kg. The Panel extrapolated the conclusion to all finfish species.

Abstract Following a request from the European Commission, the 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 annatto F (alkali‐processed norbixin, acid‐precipitated) for cats and dogs. Norbixin is considered safe for cats at a maximum concentration of 13 mg/kg complete feed and for dogs at 16 mg/kg complete feed. Annatto 2.5% is a strong alkaline solution of potassium or sodium hydroxide that makes it corrosive and therefore harmful for the user. Although the ability of the additive to colour feed has generally been demonstrated, no conclusion on the effective concentration can be drawn.

Abstract Following a request from the European Commission, the 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 Lactobacillus acidophilus D2/CSL when used in feed for chickens for fattening at a minimum dose of 1 × 109 colony‐forming units (CFU)/kg complete feedingstuffs. The additive is a preparation of viable cells of L. acidophilus. This species is considered by EFSA to be suitable for the qualified presumption of safety (QPS) approach to establish safety for the target species, consumers and the environment. The safety of Lactobacillus acidophilus CECT 4529 was assessed by EFSA in 2014. Following the QPS approach to safety assessment, Lactobacillus acidophilus CECT 4529 is assumed to be safe for the target species, the consumer and the environment without the need for further studies. No concerns are expected from other excipients present in the product, so Lactobacillus acidophilus D2/CSL is also considered safe for target animals, including chickens for fattening, consumers and the environment. The safety of the additive for the user was also considered in that opinion. The FEEDAP Panel is unaware of any new data that would lead it to revise its conclusions that the additive should be considered to be an eye/skin irritant and a skin/respiratory sensitiser. There is insufficient evidence to conclude on the efficacy of the additive when used in diets for chickens for fattening.

Abstract During 2012–2014, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued three opinions on the safety and efficacy of vitamin D3 for all animal species and concluded that no safety concern was identified for the use of vitamin D3 for fish at the maximum authorised content of 0.075 mg/kg feed. The Norwegian Food Safety Authority made available to the Commission some studies on the safety of vitamin D3 for fish and consumers at substantially higher levels (1.5 mg/kg feed) than those proposed by EFSA. The European Commission asked EFSA to review the information provided to estimate if it would be possible to increase the current levels of vitamin D3 in feed for fish. The increasing use of plant‐based feed materials in aquaculture feeds could induce a decrease in vitamin D3 content in feedingstuffs. However, there is no evidence that the current total (background + supplemented) maximum EU content of vitamin D3 may cause any appreciable risk of deficiency in salmonids. The possible contribution of vitamin D2 in plant‐based ingredients to the total vitamin D intake is considered to be low, although it cannot be reliably estimated. The FEEDAP Panel concludes that a total level of 1.5 mg vitamin D3/kg compound feed is safe for salmonids with a margin of safety of at least 10. For other fish, insufficient data are available to conclude on the safety of a total level of 1.5 mg vitamin D3/kg feed. Although the assessment of safety for the consumer is impaired by uncertainties concerning the transfer of vitamin D3 from feed to fish flesh, it was concluded that an increase of total vitamin D content in fish feeds up to 1.5 mg/kg feed would not lead the tolerable upper intake level to be exceeded even in high consumers.

Abstract l‐Tryptophan, technically pure, is a feed additive produced by fermentation with a genetically modified strain of Escherichia coli. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) of EFSA, issued two opinions on the safety and efficacy of the product, in which it could not conclude on the safety of this additive for target animals, consumer, user and the environment, due to the insufficient characterisation of the genetic modification. The European Commission asked the Authority to deliver an opinion on the safety of l‐tryptophan, technically pure, as a nutritional additive for all animal species based on additional data submitted by the applicant. Based on new information provided on the genetic modification, including the presence/absence of antibiotic resistance genes in the production strain, the FEEDAP Panel concludes that the l‐tryptophan is safe for target animals, consumers, users and the environment.

Abstract Following a request from the European Commission, the Panel on Additives and Products or Substances used in Animal Feed was asked to deliver a scientific opinion on the safety and efficacy of a strain of Lactobacillus casei when used as a technological additive intended to improve ensiling at a proposed application rate of 1 × 108 CFU (when used alone) or 5 × 107 CFU (when used in combination) kg/fresh matter. The species L. casei 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 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 of the additive. The additive should be considered to have the potential to be a 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. The mini‐silos were stored for 90 days at 20–24°C. At the end of the ensiling period, the content of the silos was analysed and dry matter losses determined. Results showed that the L. casei strain applied at a minimum dose of 5 × 107 CFU/kg has the potential to improve the production of silage from easy and moderately difficult to ensile forage species by reducing dry matter loss and enhancing protein preservation.

Abstract The 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 Pediococcus parvulus when used as a technological additive intended to improve ensiling at a proposed application rate of 1 × 108 CFU/kg fresh matter. The species P. parvulus 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 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. The minisilos were then stored for 90–103 days at 20–24°C. After opening, the contents of the silos were analysed. Results showed that Pediococcus parvulus DSM 28875 at 5 × 107 CFU/kg forage has the potential to improve the production of silage from easy and moderately difficult to ensile forage species by reducing dry matter loss and enhancing protein preservation.

Abstract The additive cassia gum consists mainly of high‐molecular weight polysaccharides composed primarily of a linear chain of 1,4‐β‐d‐mannopyranose units with 1,6‐linked α‐d‐galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum. The FEEDAP Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semirefined cassia gum (about 70 mg anthraquinones/kg) but not with purified semirefined cassia gum that meets the specification as a food additive (

Abstract Bergazym® P is a preparation of endo‐1,4‐β‐xylanase (xylanase) that is intended to be used as a zootechnical additive in feed for chickens for fattening, weaned piglets and pigs for fattening at a dose of 1,500 EPU/kg feed. The xylanase is produced by a non‐genetically modified strain of Trichoderma reesei. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded from the tolerance studies submitted that the additive is safe for chickens for fattening and weaned piglets at 1,500 EPU/kg feed. The conclusions were extended to pigs for fattening. The results obtained with the enzyme concentrate used to formulate the additive in the genotoxicity studies and in the sub‐chronic oral toxicity study do not indicate any reason for concern for consumer safety arising from the use of the product as feed additive. From the data provided on the enzyme concentrate used to formulate the additive, the Panel concluded that the additive is not irritant to skin or eyes but it is considered a potential skin sensitiser. Owing to the proteinaceous nature of the active substance, the additive is considered a potential respiratory sensitiser. The FEEDAP Panel concluded that no risks to the environment are expected. To support the efficacy of the additive, the applicant submitted five trials in chickens for fattening, five in weaned piglets and three in pigs for fattening. The FEEDAP Panel could not conclude on the efficacy of the additive in chickens for fattening and weaned piglets, but concluded that the additive has the potential to be efficacious in pigs for fattening at the recommended dose.

Abstract 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 22 compounds belonging to chemical group 24 (pyrazine derivatives). They are currently authorised as flavours in food. The FEEDAP Panel concludes that: 2,3‐diethylpyrazine [14.005], 2‐ethyl‐3‐methylpyrazine [14.006], 5,6,7,8‐tetrahydroquinoxaline [14.015], 2,3,5,6‐tetramethylpyrazine [14.018], 2,3,5‐trimethylpyrazine [14.019], 2,5‐dimethylpyrazine [14.020], 2,6‐dimethylpyrazine [14.021], 2‐ethylpyrazine [14.022], 2‐ethyl‐3,5‐dimethylpyrazine [14.024], 2,5 or 6‐methoxy‐3‐methylpyrazine [14.025], 2‐methylpyrazine [14.027], acetylpyrazine [14.032], 6,7‐dihydro‐5‐methyl‐5H‐cyclopenta(b)pyrazine [14.037], 2‐isobutyl‐3‐methoxypyrazine [14.043], 2‐acetyl‐3‐ethylpyrazine [14.049], 2,3‐dimethylpyrazine [14.050], 2,3‐diethyl‐5‐methylpyrazine [14.056], 2‐(sec‐butyl)‐3‐methoxypyrazine [14.062], 3,(5‐ or 6‐)‐dimethyl‐2‐ethylpyrazine [14.100], 2‐ethyl‐3‐methoxypyrazine [14.112] and 2‐methoxy‐3‐methylpyrazine [14.126] are safe at the proposed maximum dose level (0.5 mg/kg complete feed) as feed for cattle, salmonids and non‐food‐producing animals, and at the proposed normal use level of 0.1 mg/kg complete feed for pigs and poultry; 5‐methylquinoxaline [14.028] are safe only at concentrations below the proposed use levels (0.08 mg/kg complete feed for cattle, salmonids and non‐food‐producing animals, and 0.05 mg/kg complete feed for pigs and poultry). No safety concern would arise for the consumer from the use of these compounds up to the highest proposed level in feeds. Hazards for skin and eye contact, and respiratory exposure are recognised for the majority of the compounds under application. Most are classified as irritating to the respiratory system. The proposed maximum use levels in feed are unlikely to have detrimental effects on the terrestrial and fresh water compartments. Because all the compounds under assessment 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.

Abstract The additive, ‘Iron dextran 10%’, is a liquid preparation containing iron dextran (25%, of which 10% is total iron), sodium chloride (1.5%), phenol (0.4%) and water (73.1%). Iron dextran 10% is considered safe for suckling piglets when given at an oral dose of 1 mL/kg body weight (bw) once in each of the first 2 weeks of life; this dose corresponds to 100 mg Fe/kg bw. The administration of iron dextran 10% to piglets deficient in vitamin E and/or selenium is considered a risk. The oral use of iron dextran 10% in suckling piglets does not pose any safety concerns to consumers, provided that the conditions identified as safe for the target animal are respected. Iron dextran 10% is considered a respiratory sensitiser and may be harmful if inhaled; however, exposure by inhalation is not expected; therefore, the risk is considered to be negligible. Iron dextran 10% is an irritant to skin and eyes; a risk by skin sensitisation cannot be excluded. The presence of phenol in the additive should be considered to pose a hazard for users. The use of the additive for suckling piglets at the proposed level does not pose a safety concern to the environment. The available studies with orally administered iron dextran indicate that the additive is a bioavailable source of iron for suckling piglets; however, the efficacy of the additive when given to newborn pigs as proposed via water for drinking (voluntary intake) has not been demonstrated. The Panel proposed some recommendations regarding the dextran used in the manufacture of the additive and the procedure for administering the additive to piglets.

Abstract The product under assessment is a preparation containing single strains of Saccharomyces cerevisiae, Lactobacillus plantarum and Lactobacillus casei to be used as a technological additive to improve the ensiling process. EFSA has been previously requested by the European Commission to evaluate this product. The safety of the additive for consumers, users, the environment and target animals was established at that time. Results from a number of in vitro ensiling studies made using a variety of grass forage and maize samples were also presented. These efficacy studies showed no evidence that the additive had the potential to conserve nutrients and so improve the production of silage. There was, however, evidence for improved aerobic stability once the ensiled material was exposed to air, but because of the apparent variability in the additive mix, an effective dose could not be established. The applicant has now provided a number of additional ensiling studies confirming that the additive when applied at 80 mL/tonne significantly increases the aerobic stability of ensiled material after exposure to air. This was shown in forage materials with dry matter contents varying between 30% and 70%. Fluorescence in situ hybridisation methods were also introduced to better characterise the additive. Although this method allows individual strains to be separately enumerated, bacterial and yeast numbers are expressed as cell numbers/mL and include counts of both viable and non‐viable cells. As a result values cannot be equated to colony‐forming units, the basis of any authorisation and the functional properties of the additive. Consequently, the Panel remains unable to identify a minimum specification for the product or a minimum effective dose.

Abstract The additive cassia gum consists mainly of high‐molecular weight polysaccharides composed primarily of a linear chain of 1,4‐β‐d‐mannopyranose units with 1,6‐linked α‐d‐galactopyranose units. In 2014, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of cassia gum. The FEEDAP Panel concluded, based on positive findings observed in a bacterial reverse mutation test with a semirefined cassia gum (about 70 mg anthraquinones/kg) but not with purified semirefined cassia gum that meets the specification as a food additive (

Abstract The additive under assessment consists of a natural mixture, mainly composed of dolomite (~ 30%), magnesite (~ 20%) and magnesium‐phyllosilicates (talc (~ 35%) and chlorite (~ 15%)). In 2016, the Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) delivered an opinion on the safety and efficacy of natural mixture of dolomite plus magnesite and magnesium‐phyllosilicates. The FEEDAP Panel concluded that the additive is safe in complete feed for dairy cows, piglets and pigs for fattening at a maximum concentration of 20,000 mg/kg. However, no conclusions could be drawn for all other animal species/categories. Following this opinion, the European Commission gave the possibility to the applicant to submit complementary information in order to complete the assessment on the safety for all animal species. The applicant answered with a new submission, an analysis of the previous EFSA opinion, but without new data. The FEEDAP Panel considered the arguments made by the applicant, in relation to the tolerance studies with dairy cows and chickens for fattening. No reason was identified to modify the conclusions reached in the previous opinion.

Abstract In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of l‐lysine sulfate produced by fermentation with Escherichia coli CGMCC 3705, when used as a nutritional additive for all animal species. The Panel concluded that a maximum supplementation of complete feed up to 1% l‐lysine sulfate was considered safe for all animal species; its use in animal feed does not pose a risk to the consumer or the environment; l‐Lysine sulfate was not considered a skin or eye irritant or a skin sensitiser, but should be considered a hazard by inhalation. The applicant originally proposed a specification of minimum 55% lysine. However, based on the data provided in the technical dossier, the FEEDAP Panel recommended that the additive should be specified to a l‐lysine content ≥ 65%. The applicant seeks authorisation for l‐lysine sulfate with a minimum content of 55% l‐lysine. The Commission gave the applicant the possibility of submitting complementary information to complete its assessment. The additional data on the characterisation of the additive containing ≥ 55% l‐lysine showed that > 99% of the product is comprised of known constituents, which do not give rise to safety concerns at the concentrations present. Therefore, the FEEDAP Panel considers that the conclusions of the previous opinion are applicable to the product l‐lysine produced with E. coli CGMCC 3705 containing ≥ 55% l‐lysine. Specifically, the FEEDAP Panel concludes that a maximum supplementation of complete feed up to 1% l‐lysine sulfate is considered safe for all animal species; that the use in animal feed does not pose a risk to the consumer or the environment; and that l‐Lysine sulfate is not considered a skin or eye irritant or a skin sensitiser, but should be considered a hazard by inhalation.

Abstract 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 18 compounds belonging to chemical group (CG) 22. They are currently authorised as flavours in food. The FEEDAP Panel concludes that: cinnamaldehyde [05.014] is safe at the maximum use level of 125 mg/kg complete feed for salmonids, veal calves and dogs, and at 25 mg/kg for the remaining target species; cinnamyl alcohol [02.017], 3‐phenylpropan‐1‐ol [02.031], 3‐(p‐cumenyl)‐2‐methylpropionaldehyde [05.045], α‐methylcinnamaldehyde [05.050], 3‐phenylpropanal [05.080], cinnamic acid [08.022], cinnamyl acetate [09.018], cinnamyl butyrate [09.053], 3‐phenylpropyl isobutyrate [09.428], cinnamyl isovalerate [09.459], cinnamyl isobutyrate [09.470], ethyl cinnamate [09.730], methyl cinnamate [09.740] and isopentyl cinnamate [09.742] are safe at the proposed maximum use level of 5 mg/kg complete feed for all target species; 2‐phenylpropanal [05.038], α‐pentylcinnamaldehyde [05.040] and α‐hexylcinnamaldehyde [05.041] are safe at the proposed maximum dose level of 5 mg/kg complete feed for all target species except cats, for which 1 mg/kg is safe. No safety concern would arise for the consumer from the use of these compounds up to the highest proposed level in feeds. Irritation and sensitisation hazards for skin and irritation for eye are recognised for the majority of the compounds under application. Respiratory exposure may also be hazardous. For the majority of the compounds belonging to CG 22, the maximum proposed use levels are considered safe for the environment. For α‐pentylcinnamaldehyde and α‐hexylcinnamaldehyde, a use level up to 0.1 mg/kg feed would not cause a risk for the terrestrial and fresh water compartments. Because all the compounds under assessment 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.

Abstract In 2015, the EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) issued an opinion on the safety and efficacy of l‐tryptophan produced by fermentation using three strains of Escherichia coli, when used as a nutritional additive for all animal species. The Panel concluded that the safety of l‐tryptophan produced by E. coli SARI12091203 for target animals, consumers, users and the environment could not be assessed because the data submitted did not permit the identity and safety of the strain, and the purity of the additive, to be determined. During the current assessment, the applicant withdrew the application for l‐tryptophan produced by E. coli SARI12091203. l‐Tryptophan produced by E. coli DSM 25084 or KCCM 11132P was considered safe for non‐ruminant target species, the consumer and the environment. For both products, the level of endotoxins and the possible dusting potential indicated a risk by inhalation for the user. In the absence of data, a potential for dermal sensitisation could not be excluded. The Commission gave the applicant the possibility of submitting complementary information to allow the FEEDAP Panel to complete its assessment. The additional data on the characterisation of the additives and on their potential for inhalation toxicity and as skin sensitisers are the subject of the current opinion. Due to improvements in the manufacturing process, the level of endotoxins present in the l‐tryptophan produced by E. coli KCCM 11132P has been markedly reduced; consequently, the endotoxin content does not represent a health risk for the user. The additive has a low acute toxicity by inhalation and is not considered as a potential skin sensitiser. l‐Tryptophan produced by E. coli DSM 25084 is not considered a skin sensitiser. The level of endotoxins in this product, however, represents a risk by inhalation for the user handling the additive.

Abstract Salinomycin sodium (SAL‐Na) is active against certain Gram‐positive bacteria, while Gram‐negative species are resistant. SAL‐Na at the proposed concentration is unlikely to increase shedding of Salmonella, Escherichia coli and Campylobacter and or induce resistance and cross‐resistance to antimicrobials important in human and animal therapy. SAL‐Na is safe for chickens for fattening at 70 mg/kg complete feed, for chickens reared for laying at 50 mg/kg complete feed in the first 12 weeks of life. The simultaneous use of SAL‐Na and certain antibiotic drugs (e.g. tiamulin) is contraindicated. SAL‐Na is absorbed and extensively metabolised. Metabolites have reduced ionophoric activity. SAL is the marker residue (MR). No residues in eggs are expected. SAL‐Na is not genotoxic and not a carcinogen. A NOAEL of 0.5 mg/kg body weight (bw) per day is derived from a cardiovascular study in dogs as well as from a 12‐month dog study. Consumer exposure complies with an acceptable daily intake of 0.005 mg SAL/kg bw after 1 h withdrawal. A withdrawal time and maximum residue limits are not considered necessary. SAL‐Na from Sacox® is not an irritant to skin and eyes; it is a potential sensitiser to skin and the respiratory tract. A toxicological risk by inhalation for persons handling the additive cannot be excluded. SAL‐Na in feed for chickens will not pose a risk for the aquatic environment. A risk for the terrestrial ecosystem is considered unlikely due to metabolisation and the rapid degradation of SAL in the environment. SAL‐Na at a minimum concentration of 50 mg/kg complete feed is an effective coccidiostat for chickens for fattening. This conclusion is extended to chickens reared for laying. SAL‐Na in Sacox® 120 microGranulate and Sacox® 200 microGranulate is considered bioequivalent with respect to its anticoccidial effect.

Abstract Hemicell® HT is a feed additive with endo‐1,4‐β‐d‐mannanase as the main enzymatic activity that is available in solid (HT) and liquid (HT‐L) forms. The production strain of the enzyme is a genetically modified strain of Paenibacillus lentus. The recipient strain is considered to be safe, the sequences introduced to obtain the production strain do not raise safety concerns. The absence of the production strain and of recombinant DNA in the product was not proven. The additive is safe for the target species at the corresponding recommended doses. The use of Hemicell® HT as a feed additive does not give rise to concerns for consumers. Hemicell® HT and Hemicell® HT‐L are not irritant to the skin and eyes; Hemicell® HT is a skin sensitiser. No specific data were provided on the effects on the respiratory system; however, considering the nature of the active substance, the additive is considered a potential respiratory sensitiser. The active substance of the additive is a protein, and as such, it will be degraded/inactivated during passage through the digestive tract of the animals or in the environment. However, uncertainty remains on the absence of the production strain and of recombinant DNA in the product, consequently, the EFSA FEEDAP Panel could not conclude on the environmental safety of the product with regard to the genetically modified production strain. The additive has the potential to be efficacious in chickens for fattening at 32,000 U/kg feed and at 48,000 U/kg feed in turkeys for fattening and weaned piglets. These conclusions were extended to chickens reared for laying and turkeys reared for breeding and extrapolated to minor poultry species for fattening or reared for laying/breeding. The Panel could not conclude on the efficacy of the product in pigs for fattening or in minor porcine species.