Mojca Kos Durjava

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 assessment of the application for renewal of authorisation of the feed additive consisting of ammonium chloride (tradename: Ammonium chloride AF) as a zootechnical additive for ruminants, cats and dogs. In 2012, the FEEDAP Panel delivered an opinion on the safety and efficacy of the additive and subsequently the additive was authorised in the EU. The additive is authorised as ‘ammonium chloride with a content of ammonium chloride ≥ 99% and sodium chloride ≤ 0.5% in the active substance’ for ruminants, cats and dogs under the category ‘zootechnical additives’ and functional group ‘other zootechnical additives’. The evidence provided by the applicant indicates that the additive currently in the market complies with the conditions of authorisation. No new evidence was found that would make the FEEDAP Panel reconsider its previous conclusions on the safety for target species, consumers and environment. The FEEDAP Panel concludes that ammonium chloride is considered an eye and skin irritant and a potential respiratory sensitiser, but is not a dermal sensitiser. The present application for renewal of the authorisation does not include a proposal for amending or supplementing the conditions of the original authorisation that would have an impact on the efficacy of the additive.

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 ferric citrate chelate (CI‐FER™) as a zootechnical additive for poultry species for fattening or reared up to the point of lay. The product had been already assessed by the FEEDAP Panel for use in suckling and weaned piglets and minor porcine species. The application was for an extension of use to poultry species for fattening or reared up to the point of lay. The FEEDAP Panel considers that the new use would not raise safety concerns for the consumers and the environment and retained the previous conclusions as regards to the user: CI‐FER™ does not pose a risk by inhalation, it is non‐irritant to the skin but should be considered as an eye irritant and as a skin sensitiser. Owing to the limitations identified in the tolerance trial submitted, the FEEDAP Panel could not conclude on the safety of the additive for the target species. Regarding the efficacy, three studies were submitted but two of them were not considered further in the assessment due to the husbandry conditions to which the animals were subject to. Therefore, the FEEDAP Panel could not conclude on the efficacy of the additive.

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 tincture from the bark of Cinnamomum verum J. Presl (cinnamon tincture) when used as a sensory additive in feed and water for drinking for all animal species. The product is a water/ethanol ■■■■■ solution, with a dry matter content of approximately 0.9%. The product contains on average 0.344% polyphenols (of which 0.001% are flavonoids) and 0.001% cinnamaldehyde. Methyleugenol was present at the limit of detection in one out of the five batches examined. The FEEDAP Panel concluded that cinnamon tincture is safe at the maximum proposed use level of 50 mg/kg complete feed for all animal species except horses. For horses, the maximum proposed use level of 60 mg/kg complete feed is considered safe. No safety concern would arise for the consumer from the use of cinnamon tincture up to the highest proposed use levels in feed. The additive under assessment should be considered as irritant to skin and eyes, and as a skin and respiratory sensitiser. The use of the cinnamon tincture as a flavour in animal feed is not expected to pose a risk for the environment. Since C. verum and cinnamon bark extracts are recognised to flavour food and their function in feed would be essentially the same as that in food, no further demonstration of efficacy is considered necessary for the tincture under application.

Following a request from the European Commission, the Panel on Additives and Products or substances used in Animal Feed (FEEDAP Panel) was asked to deliver a scientific opinion on the safety for the environment of the coccidiostat Coxar^® (nicarbazin) when used in feed for turkeys for fattening. In previous assessments, the FEEDAP Panel could not conclude on the safety of Coxar^® for the environment due to concerns on 4,40-dinitrocarbanilide (DNC, one of the moieties of nicarbazin). On the basis of the new data provided, the FEEDAP Panel updates its previous conclusions on the safety of Coxar^® for the environment as follows: The use of nicarbazin from Coxar^® in complete feed for turkeys does not pose a risk for the terrestrial and aquatic compartment and in sediment. No concern for groundwater is expected. The bioaccumulation potential of nicarbazin in the environment is low.

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 assessment of the app...

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 3‐phytase FLF1000 and FSF10000 as a feed additive for turkeys for fattening or reared for breeding, pigs for fattening and minor porcine species for growing. This additive contains 3‐phytase produced by a genetically modified strain of Komagataella phaffii and it is authorised in the EU as a feed additive for feed for chickens for fattening, laying hens, chickens reared for laying and for minor poultry species for fattening or reared for laying/breeding. The applicant requested the extension of use of the additive (both forms) to turkeys for fattening or reared for breeding purposes, and the assessment of the solid formulation to be used in pigs for fattening and minor porcine species for growing. The FEEDAP Panel concluded based on previously evaluated data that the additive, in either form, is safe for turkeys for fattening or reared for breeding at the maximum recommended level of 1,000 FTU/kg feed. However, due to lack of data the Panel could not conclude on the safety for pigs for fattening or minor growing porcine species. The FEEDAP Panel concludes that the use of the additive under the proposed conditions of use is safe for the consumer and the environment. Both forms of the additive are not irritant to eyes and skin but should be considered a potential respiratory sensitiser. The liquid formulation is not a dermal sensitiser but the solid formulation is. The Panel also considered based on previously evaluated data that the additive has a potential to be efficacious as a zootechnical additive in turkeys for fattening and reared for breeding and in pigs for fattening and minor growing porcine species at 500 FTU/kg feed.

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 l‐valine (≥ 98.0%) produced by fermentation using a genetically modified strain of Escherichia coli (KCCM 80159). It is intended to be used in feed for all animal species and categories. Species identity of the production organism E. coli KCCM 80159 was confirmed; the strain was sensitive to antibiotics at concentrations below or equal to thresholds specified by EFSA; and no viable cells or its recombinant DNA were detected in the final product. Therefore, the final product does not give raise to any safety concern with regard to the genetic modification of the production strain. The FEEDAP Panel concludes that l‐valine produced by E. coli KCCM 80159 is safe for the target species when supplemented in appropriate amounts to the diet according to the nutritional needs of the target species, for the consumer, for the users and for the environment. The product l‐valine produced by fermentation using E. coli KCCM 80159 is regarded as an efficacious source of the essential amino acid l‐valine for non‐ruminant nutrition. For the supplemental l‐valine to be as efficacious in ruminants as in non‐ruminant species, it requires protection against degradation in the rumen.

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 efficacy of Cygro^® 10G. The active substance of Cygro^® 10G is the polyether ionophore maduramicin ammonium‐α, a coccidiostat intended to be used in feed for turkeys for fattening. In a former opinion, the FEEDAP Panel concluded that the efficacy of Cygro^® 10G in turkeys for fattening had not been sufficiently demonstrated. In the present submission, new efficacy studies have been provided by the applicant. A positive effect of Cygro^® 10G in preventing coccidiosis in turkeys was shown in three anticoccidial sensitivity tests (ASTs). However, owing to the lack of floor pen studies showing a positive effect, the FEEDAP Panel is not in the position to conclude on the efficacy of Cygro^® 10G for turkeys for fattening.

Following the 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 proposed modificati...