Risks associated with endotoxins in feed additives produced by fermentation.

Increasingly, feed additives for livestock, such as amino acids and vitamins, are being produced by Gram-negative bacteria, particularly Escherichia coli. The potential therefore exists for animals, consumers and workers to be exposed to possibly harmful amounts of endotoxin from these products. The aim of this review was to assess the extent of the risk from endotoxins in feed additives and to calculate how such risk can be assessed from the properties of the additive. Livestock are frequently exposed to a relatively high content of endotoxin in the diet: no additional hazard to livestock would be anticipated if the endotoxin concentration of the feed additive falls in the same range as feedstuffs. Consumer exposure will be unaffected by the consumption of food derived from animals receiving endotoxin-containing feed, because the small concentrations of endotoxin absorbed do not accumulate in edible tissues. In contrast, workers processing a dusty additive may be exposed to hazardous amounts of endotoxin even if the endotoxin concentration of the product is low. A calculation method is proposed to compare the potential risk to the worker, based on the dusting potential, the endotoxin concentration and technical guidance of the European Food Safety Authority, with national exposure limits.

Consumer safety of feed additives containing selenium.

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety for the consumer of products from animals fed diets with feed additives containing selenium as an active substance. Based on the limited data set available and the several uncertainties, the FEEDAP Panel concluded that the use of organic selenium at the currently maximum authorised use level of 0.2 mg supplemented selenium from organic sources/kg complete feed (within a maximum of 0.5 mg total selenium/kg complete feed) leads to an exceedance of the UL for all the population categories (except elderly and very elderly), suggesting a concern for consumer safety. It was not possible to conclude on the safety of the currently maximum use level of 0.5 mg total selenium/kg complete feed for all consumer categories. Additional data from studies specifically designed to measure deposition of selenium in tissues and products from animal origin resulting from the use of the different sources of selenium would be required to perform a proper risk assessment.

Safety of a feed additive consisting of propyl gallate for all animal species (FEFANA ABL).

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 of propyl gallate as a technological feed additive for all animal species. In its previous opinions on the safety and efficacy of the product, the FEEDAP Panel could not conclude on a safe level of propyl gallate for cats and on the safety for the consumer. Based on the new data provided, the FEEDAP Panel concluded that propyl gallate at a maximum concentration of 71 mg/kg complete feed is safe for cats. Propyl gallate is considered safe for the consumer when used in complete feed for all animal species at the concentrations considered safe for the target species.

Risks for animal health related to the presence of ergot alkaloids in feed.

The European Commission requested EFSA to provide an update of the 2012 Scientific Opinion of the Panel on Contaminants in the Food Chain (CONTAM) on the risks for animal health related to the presence of ergot alkaloids (EAs) in feed. EAs are produced by several fungi of the Claviceps and Epichloë genera. This Opinion focussed on the 14 EAs produced by C. purpurea (ergocristine, ergotamine, ergocornine, α- and ß-ergocryptine, ergometrine, ergosine and their corresponding 'inine' epimers). Effects observed with EAs from C. africana (mainly dihydroergosine) and Epichloë (ergovaline/-inine) were also evaluated. There is limited information on toxicokinetics in food and non-food producing animals. However, transfer from feed to food of animal origin is negligible. The major effects of EAs are related to vasoconstriction and are exaggerated during extreme temperatures. In addition, EAs cause a decrease in prolactin, resulting in a reduced milk production. Based on the sum of the EAs, the Panel considered the following as Reference Points (RPs) in complete feed for adverse animal health effects: for pigs and piglets 0.6 mg/kg, for chickens for fattening and hens 2.1 and 3.7 mg/kg, respectively, for ducks 0.2 mg/kg, bovines 0.1 mg/kg and sheep 0.3 mg/kg. A total of 19,023 analytical results on EAs (only from C. purpurea) in feed materials and compound feeds were available for the exposure assessment (1580 samples). Dietary exposure was assessed using two feeding scenarios (model diets and compound feeds). Risk characterisation was done for the animals for which an RP could be identified. The CONTAM Panel considers that, based on exposure from model diets, the presence of EAs in feed raises a health concern in piglets, pigs for fattening, sows and bovines, while for chickens for fattening, laying hens, ducks, ovines and caprines, the health concern related to EAs in feed is low.

Safety and efficacy of a feed additive consisting of monensin sodium (Coxidin®) for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding (Huvepharma N.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of monensin sodium (Coxidin®) as a coccidiostat for chickens for fattening, chickens reared for laying, turkeys for fattening and turkeys reared for breeding. The additive currently on the market complies with the existing conditions of authorisation. The FEEDAP Panel concluded that Coxidin® remains safe for turkeys for fattening (up to 16 weeks) and extends this conclusion to turkeys reared for breeding (up to 16 weeks). The Panel was not in the position to confirm that the current maximum authorised level of 125 mg monensin sodium/kg complete feed remains safe for chickens for fattening and chickens reared for laying. The use of monensin sodium from Coxidin® at the corresponding maximum authorised/proposed use levels in the target species is safe for the consumer. The existing maximum residue levels (MRLs) for poultry tissues ensure consumer safety. No withdrawal time is necessary. Both formulations of Coxidin® pose a risk by inhalation. The formulation with wheat bran as a carrier was neither irritant to the skin nor a skin sensitiser but it was irritant to the eyes. In the absence of data, no conclusions could be made on the potential of the formulation containing calcium carbonate to be irritant to skin and eyes and to be a skin sensitiser. The use of monensin sodium from Coxidin® in complete feed for the target species poses no risk for the terrestrial compartments and for sediment. No risk for groundwater is expected. For chickens for fattening the risk for aquatic compartment cannot be excluded, but no risks are expected for the other animal categories. There is no risk of secondary poisoning. Coxidin® is efficacious in controlling coccidiosis at a level of 100 mg/kg complete feed for chickens for fattening and at 60 mg/kg complete feed for turkeys for fattening. These conclusions are extended to chickens reared for laying and turkeys reared for breeding. The Panel noted that there are signs of development of resistance of Eimeria spp. to monensin sodium.

Safety and efficacy of a feed additive consisting of narasin (Monteban® G100) for chickens for fattening (Elanco GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat narasin (Monteban® G100) for chickens for fattening. In a previous opinion, uncertainties remained on the identification and characterisation of the non-genetically modified production strain of the active substance narasin. The Panel could not conclude either on the safety of Monteban® G100 for chickens for fattening or on the efficacy of the additive at the minimum applied concentration. The FEEDAP Panel excluded risks for environment but the risk for sediment compartment could not be assessed. The applicant provided supplementary information to cover the data gaps and substituted the narasin production strain from Streptomyces spp. NRRL 8092 to Streptomyces spp. NRRL B-67771. The information submitted to taxonomically identify the production strain did not allow to assign it to any described microbial species. Based on the information provided, the Panel concluded that the use of Monteban® G100 did not raise safety concerns as regards the production strain for the target animal, consumer, user and environment. The Panel concluded that 70 mg narasin/kg complete feed was safe for chickens for fattening with a margin of safety of 1.4; narasin from Monteban® G100 was unlikely to increase shedding of Salmonella Enteritidis, Salmonella Typhimurium and Campylobacter jejuni. Narasin, when used in chickens for fattening at 70 mg/kg feed, was not expected to pose a risk to the aquatic compartment and to sediment, while a risk for the terrestrial compartment could not be excluded. No risk for groundwater was expected, nor for secondary poisoning via the terrestrial food chain, but the risk of secondary poisoning via the aquatic food chain could not be excluded. The Panel concluded that 60 mg narasin/kg feed was efficacious in controlling coccidiosis in chickens for fattening.

Safety and efficacy of a feed additive consisting of salinomycin sodium (Sacox®) for rabbits for fattening (Huvepharma N.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of the coccidiostat salinomycin sodium (Sacox®) for rabbits for fattening. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the use of salinomycin sodium (SAL-Na) from Sacox® does not raise safety concerns for the target species, consumers, users and the environment with regard to the production strain. In the absence of adequate tolerance studies, the FEEDAP Panel could not conclude on the safety of SAL-Na from Sacox® for rabbits for fattening. The FEEDAP Panel concluded that the additive is safe for the consumer when it is used at the proposed maximum level of 25 mg SAL-Na/kg complete feed for rabbits and a withdrawal period of 1 day is respected. The following maximum residue limits (MRL) are proposed for the marker residue compound salinomycin (SAL): 0.2 and 0.03 mg SAL/kg for liver and kidney, respectively. The additive is not irritant to skin and eyes but should be considered a potential dermal and respiratory sensitiser. A risk for inhalation toxicity could not be excluded. The use of the SAL-Na from Sacox® in feed for rabbits for fattening up to the highest proposed level will not pose a risk for the terrestrial and aquatic compartment and ground water. The risk of secondary poisoning can be excluded for worm-eating birds and mammals, while it cannot be excluded for fish-eating birds and mammals. The FEEDAP Panel concludes that SAL-Na from Sacox® at the minimum concentration of 20 mg SAL-Na/kg complete feed has the potential to control coccidiosis in rabbits for fattening. Development of resistance to SAL-Na of field Eimeria spp. strains isolated from rabbits for fattening should be monitored.

Safety and efficacy of a feed additive consisting of semi-refined carrageenan for cats and dogs (Gel Systems Ltd.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of semi-refined carrageenan as a feed additive for cats and dogs. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that semi-refined carrageenan was safe for dogs at 6,000 mg/kg final wet feed (with about 20% dry matter). This would correspond to 26,400 mg semi-refined carrageenan/kg complete feed (with 88% dry matter). In the absence of specific data, the maximum concentration of the additive considered safe for cats was 750 mg semi-refined carrageenan/kg final wet feed, corresponding to 3,300 mg semi-refined carrageenan/kg complete feed (with 88% dry matter). In the absence of data, the FEEDAP Panel was not in the position to conclude on the safety of carrageenan for the user. The additive under assessment is intended to be used in dogs and cats only. No environmental risk assessment was considered necessary for such use. The FEEDAP Panel was not in the position to conclude on the efficacy of semi-refined carrageenan as a gelling agent, thickener and stabiliser in feed for cats and dogs at the proposed conditions of use.

Safety and efficacy of a feed additive consisting of 25-hydroxycholecalciferol monohydrate produced with Saccharomyces cerevisiaeCBS 146008 for all ruminants (DSM Nutritional Products Sp. z.o.o.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of 25-hydroxycholecalciferol monohydrate produced with Saccharomyces cerevisiae CBS 146008 as a nutritional feed additive for all ruminants. The additive is already authorised for use with chickens for fattening, turkeys for fattening, other poultry and pigs. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concluded that the additive does not give raise to any safety concern regarding the production strain. The additive is safe for cattle for fattening and dairy cows at the maximum recommended use level of 0.1 mg 25-OH-D3/kg complete feed. This conclusion can be extended to other cattle categories and extrapolated to all ruminant species. The use of 25-OH-D3 in all ruminants under the proposed conditions of use is considered safe for the consumer. The additive is not irritant to the skin or eyes. No conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to absence of data. The use of the additive under assessment at the recommended conditions of use is considered safe for the environment. 25-OH-D3 is an efficient source of vitamin D3 for all ruminants when used according to the proposed conditions of use.

Safety and efficacy of a feed additive consisting of 25-hydroxycholecalciferol produced with Saccharomyces cerevisiaeCBS 146008 for pigs and poultry for the renewal of its authorisation (DSM Nutritional Products Sp. z.o.o).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for renewal of authorisation of 25-hydroxycholecalciferol as a feed additive for pigs and poultry. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the additive does not give raise to any safety concern regarding the production strain. Considering that the manufacturing process, the composition of the additive and its conditions of use have not been modified, the Panel considers that there is no evidence to reconsider the conclusions reached in the previous assessments. Therefore, the Panel concludes that 25-OH-D3 remains safe for the target species, the consumer and the environment under the existing conditions of the authorisation. The additive is not irritant to the skin or eyes but no conclusion on its potential to be a skin sensitiser or on its effects on the respiratory system can be reached due to absence of data. There is no need to assess the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of robenidine hydrochloride (Cycostat® 66G) for rabbits for breeding and rabbits for fattening for the renewal of its authorisation (Zoetis).

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 feed additive consisting of robenidine hydrochloride (Cycostat® 66G) for rabbits for breeding and rabbits for fattening for the renewal of its authorisation. Since the potential aneugenic activity of robenidine hydrochloride cannot be excluded, the FEEDAP Panel is not in the position to conclude on the safety of the additive for the target species and the consumer. In the absence of data, the FEEDAP Panel cannot conclude on the safety of robenidine hydrochloride for the environment. Robenidine hydrochloride has potential for bioaccumulation; however, a risk for secondary poisoning for worm/fish-eating birds and mammals is not likely to occur. No concern for groundwater is expected. Robenidine hydrochloride is not a skin or eye irritant and not a skin sensitiser. Due to the lack of data on the genotoxicity (aneugenicity) of the substance, the exposure to the additive of the unprotected users should be minimised. Owing to the lack of sufficient data, the FEEDAP Panel cannot conclude that robenidine hydrochloride from Cycostat® 66G is still efficacious against recent Eimeria spp. strains in rabbits.

Safety and efficacy of a feed additive consisting of pancreatin from porcine pancreas (Pan-zoot) for dogs (Almapharm GmbH + Co KG).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of a pancreatic extract (Pan-zoot) as a zootechnical additive for dogs. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) could not conclude on the safety of Pan-Zoot as a feed additive for dogs under the proposed conditions of use. The FEEDAP Panel could not conclude on the skin/eye irritancy potential of the additive or on the dermal sensitisation potential. Owing to its proteinaceous nature, the additive is considered a respiratory sensitiser. The additive may induce allergic reactions to the exposed users. The Panel concluded that there is no need for an environmental risk assessment. The FEEDAP Panel could not conclude on the efficacy of the product as a feed additive at the recommended conditions of use.

Safety and efficacy of a feed additive consisting of potassium ferrocyanide for all animal species (K + S KALI GmbH).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium ferrocyanide as a technological feed additive, functional group anticaking agents, for all animal species. The additive potassium ferrocyanide is intended to be used in potassium chloride with a maximum content of 150 mg ferrocyanide anion/kg salt. The use of potassium ferrocyanide is safe, when added to potassium chloride at a maximum content of 150 mg ferrocyanide anions (anhydrous)/kg for: pigs for fattening and lactating sows, sheep, goats, salmon and dogs. In the absence of a margin of safety, the use of potassium chloride according to the proposed conditions of use is not considered to be safe for chickens for fattening, laying hens, turkeys, piglets, veal calf, cattle for fattening, dairy cows, horse, rabbit and cats. In the absence of information on the use of potassium chloride in the diets for any other animal species, no conclusion on a potentially safe level of potassium chloride, supplemented with 150 mg ferrocyanide/kg, can be made. The use of potassium ferrocyanide in animal nutrition is of no concern for consumer safety. The results of in vivo studies showed that potassium ferrocyanide is not irritant to skin and eye and is not a skin sensitiser. However, due to the presence of nickel, the additive should be considered as a respiratory and dermal sensitiser. The available data do not allow the FEEDAP Panel to conclude on the safety of the additive for the soil and the marine environment, while the use of the additive in land-based aquaculture according to the proposed conditions of use is considered of no concern. Potassium ferrocyanide is considered to be efficacious as an anticaking agent when included in potassium chloride at the proposed use levels.

Assessment of the feed additive consisting of folic acid for all animal species for the renewal of its authorisation (Chr. Olesen A/S and DSM Nutritional Products Ltd).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of folic acid as a nutritional feed additive. The additive is authorised for use in feed and water for drinking for all animal species. The applicant provided evidence that the additive currently in the market complies with the existing conditions of authorisation and the production process has not been modified. The FEEDAP Panel considers that there is no evidence to revise the conclusions reached in the previous assessment for the safety for the terrestrial species, consumers and for the environment. The use of folic acid in aquatic animal species to cover their nutritional needs is considered safe. However, the Panel is not in a position to set a maximum safe level for all fish and crustacean species. Considering the narrow margin between the requirement and the tolerated levels seen in some aquatic animal species, the FEEDAP Panel considers that supplementation should not exceed the requirements of the different aquatic animal species. The additive is neither a skin irritant nor a dermal sensitiser. The exposure through inhalation is likely. Due to the lack of data, the FEEDAP Panel is not in the position to conclude on the potential of folic acid to be harmful to the respiratory system and irritant to eyes. The Panel retains that the previously made conclusion on the efficacy remains valid.

Risks for animal health related to the presence of ochratoxin A (OTA) in feed.

In 2004, the EFSA Panel on Contaminants in the Food Chain (CONTAM) adopted a Scientific Opinion on the risks to animal health and transfer from feed to food of animal origin related to the presence of ochratoxin A (OTA) in feed. The European Commission requested EFSA to assess newly available scientific information and to update the 2004 Scientific Opinion. OTA is produced by several fungi of the genera Aspergillus and Penicillium. In most animal species it is rapidly and extensively absorbed in the gastro-intestinal tract, binds strongly to plasma albumins and is mainly detoxified to ochratoxin alpha (OTalpha) by ruminal microbiota. In pigs, OTA has been found mainly in liver and kidney. Transfer of OTA from feed to milk in ruminants and donkeys as well as to eggs from poultry is confirmed but low. Overall, OTA impairs function and structure of kidneys and liver, causes immunosuppression and affects the zootechnical performance (e.g. body weight gain, feed/gain ratio, etc.), with monogastric species being more susceptible than ruminants because of limited detoxification to OTalpha. The CONTAM Panel considered as reference point (RP) for adverse animal health effects: for pigs and rabbits 0.01 mg OTA/kg feed, for chickens for fattening and hens 0.03 mg OTA/kg feed. A total of 9,184 analytical results on OTA in feed, expressed in dry matter, were available. Dietary exposure was assessed using different scenarios based on either model diets or compound feed (complete feed or complementary feed plus forage). Risk characterisation was made for the animals for which an RP could be identified. The CONTAM Panel considers that the risk related to OTA in feed for adverse health effects for pigs, chickens for fattening, hens and rabbits is low.

Safety and efficacy of a feed additive consisting of halofuginone hydrobromide (STENOROL®) for chickens for fattening and turkeys for fattening/reared for breeding (Huvepharma N.V.).

Following a request from the European Commission, EFSA was asked to deliver a new scientific opinion on the coccidiostat halofuginone hydrobromide (STENOROL®) when used as a feed additive for chickens for fattening and turkeys for fattening/reared for breeding. The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) concludes that the safety for turkeys for fattening established in its previous opinion can be extended to turkeys for breeding up to 12 weeks of age. Based on the new data provided on the safety for consumer, environment and efficacy, the Panel updates its previous conclusions as follows: halofuginone hydrobromide is not genotoxic. Applying an uncertainty factor of 100 to the lowest no observed adverse effect level (NOAEL) of 0.03 mg/kg body weight (bw) per day, an acceptable daily intake (ADI) of 0.3 µg halofuginone/kg bw is established. The chronic exposure of consumers to residues of halofuginone would amount to 6-19% of the ADI after 3 days of withdrawal. Therefore, the Panel considers that the additive is safe for the consumer of tissues obtained from chickens for fattening and turkeys for fattening fed the additive at a maximum level of 3 mg/kg complete feed at a 3-day withdrawal time. For control purposes, the Panel recommends the setting of the following maximum residue limits (MRLs): liver, 50 µg/kg; kidney, 40 µg/kg; muscle, 3 µg/kg; skin/fat, 10 µg/kg wet tissue. Based on an updated environmental risk assessment, no concern for groundwater is expected. Halofuginone is unlikely to bioaccumulate and the risk of secondary poisoning is not likely to occur. No safety concerns are expected for terrestrial and aquatic environments. The additive has the potential to control coccidiosis in chickens for fattening and turkeys for fattening/reared for breeding up to 12 weeks of age at a minimum level of 2 mg/kg complete feed.

Safety and efficacy of feed additives consisting of sodium ferrocyanide and potassium ferrocyanide for all animal species (Eusalt a.i.s.b.l.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the safety and efficacy of potassium and sodium ferrocyanide as technological feed additives for all animal species. The additives sodium- and potassium ferrocyanide are intended to be used in sodium chloride with a maximum content of 80 mg ferrocyanide anion (anhydrous)/kg salt. The FEEDAP Panel concluded that the use of sodium ferrocyanide and potassium ferrocyanide is safe, when added to sodium chloride at a maximum content of 80 mg ferrocyanide anion/kg for: turkey for fattening and laying hens and other laying/breeding birds; all porcine species and categories, all ruminant species and categories, rabbit, horse, salmonids and other minor fin fish, dogs and cats. In the absence of a margin of safety, the use of sodium and potassium chloride according to the proposed conditions of use is not considered to be safe for chickens for fattening and other poultry species for fattening or reared for laying/breeding other than turkeys. In the absence of information on the use of sodium chloride in the diets for any other animal species, no conclusion on a potentially safe level of sodium chloride, supplemented with 80 mg ferrocyanide anions (anhydrous)/kg, could be made. The use of sodium and potassium ferrocyanide in animal nutrition under the conditions of use proposed is of no concern for consumer safety. The results of in vivo studies showed that sodium and potassium ferrocyanide are not irritant to skin and eye and are not skin sensitisers. However, owing to the presence of nickel, sodium ferrocyanide, is considered a dermal and respiratory sensitiser. No conclusions could be reached on the safety of the user exposed via inhalation for potassium ferrocyanide. The use of sodium and potassium ferrocyanide as feed additives is considered safe for the environment. The additives are considered to be efficacious as anticaking agents in sodium chloride at the proposed use level.

Safety of a feed additive consisting of lignosulphonate for all animal species (Borregaard AS).

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 of lignosulphonate, when used as a technological additive (functional group: binders) in feed for all animal species. In two previous assessments, the FEEDAP Panel concluded that the maximum level proposed of 10,000 mg lignosulphonate/kg complete feed is safe for weaned piglets, pigs for fattening, chickens for fattening, laying hens and cattle for fattening, but a margin of safety could not be identified. Consequently, these conclusions could not be extrapolated to other animal species/categories. In the current application, the applicant proposed to reduce the maximum content of lignosulphonate in feed for all animal species to 8,000 mg/kg complete feed. The results of two newly submitted tolerance studies allowed the Panel to conclude that 8,000 mg lignosulphonate/kg complete feed is also safe for dairy cows and salmonids, with a margin of safety of at least 1.25. Considering the results of the studies previously assessed and those of the two new tolerance studies, the FEEDAP Panel concluded that lignosulphonate is safe for all animal species when used at a maximum content of 8,000 mg/kg complete feed.

Assessment of the application for renewal of the authorisation of a feed additive consisting of dicopper chloride trihydroxide for all animal species (Nutreco Nederland B.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of dicopper chloride trihydroxide as a nutritional feed additive. The additive is currently authorised for use in all animal species (3b409). The applicant is requesting a modification in the current authorising specification: (i) replacing the alpha crystal form paratacamite with clinoatacamite; (ii) removing the ratio between crystal polymorphs from the authorising specification; (iii) changing the minimum for particles below 50 µm from 1% to 5%. The FEEDAP Panel considers that the proposed modifications do not introduce concern for the safety for the target species and that the additive remains safe for the target species and the consumers when used up to the maximum authorised levels. Regarding the safety for the environment, the use of the additive in feed for terrestrial animals and land-based aquaculture is considered safe under the proposed conditions of use. The data available do not allow the FEEDAP Panel to reach a conclusion on the safety of the additive for marine sediment when it is used in sea cages. The additive is not corrosive to skin, but is an eye and skin irritant. Due to the nickel presence, it is considered a skin and respiratory sensitiser. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.

Assessment of the feed additive consisting of zinc chloride hydroxide monohydrate for all animal species for the renewal of its authorisation (NUTRECO Nederland B.V.).

Following a request from the European Commission, EFSA was asked to deliver a scientific opinion on the assessment of the application for the renewal of the authorisation of zinc chloride hydroxide monohydrate as a nutritional feed additive for all animal species (3b609). The applicant reported changes in the production process and requested a change in the specification of the additive. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) confirms that the use of the additive under the current authorised conditions of use is safe for the target species and the consumers. The use of the additive in animal nutrition at the proposed use levels for the terrestrial species and land-based aquaculture systems is considered safe for the environment. The FEEDAP Panel cannot conclude on the safety of the additive for marine sediment compartment, when it is used in sea cages. The additive is an eye irritant, but not irritant to the skin and not a skin sensitiser. The exposure through inhalation is likely, but in the absence of data, the Panel is not in a position to conclude on the risk of exposure by inhalation. There was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.