Notes

Feasibility of using monocyte-derived dendritic cells purchased from cryopreserved tissue with regard to DC-based vaccinations.
The use of Availa®Cr in feed of dairy cows up to the recommended supplementation level would not measurably increase consumer exposure to chromium(III), and therefore is safe for consumers. The additive poses a risk to users by inhalation, it is not an irritant to skin and eyes and should be considered a sensitiser. The use of the additive is not expected to pose a risk to the environment. Since only one study could be considered for the efficacy assessment, and three studies are required, the FEEDAP Panel cannot conclude on the efficacy of Availa®Cr for dairy cows.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 Natugrain® TS/TS L. The additive is a preparation of endo-1,4-beta-xylanase and endo-1,4-beta-glucanase produced by two genetically modified strains of Aspergillus niger, and it is authorised for use in piglets (weaned) and pigs for fattening, poultry species and ornamental birds. The applicant requested the extension of use of the additive to sows at 560 TXU and 250 TGU/kg feed. The FEEDAP Panel concluded that there are no concerns for consumer safety and no risks for the environment are expected from the use of the additive in sows. The additive should be considered a potential respiratory sensitiser for the users. BMH-21 Considering the results from a subchronic oral toxicity study and the tolerance study in lactating sows, the Panel concluded that the additive is safe for sows at the recommended dose. The data submitted to support the efficacy for sows allowed the Panel to conclude that the additive is efficacious in lactating sows, data on gestating sows were not given, and therefore, the Panel could not conclude on the efficacy of the additive in that physiological stage.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 Formi™ LHS (potassium diformate) for sows. The Panel considers that the information provided by the applicant does not fulfil the minimum requirements to support that Formi™ LHS remains safe under the approved conditions for target species, consumers and users. The Panel concludes that the use of Formi™ LHS under the approved conditions remains safe for the environment. 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 saponified paprika extract, containing capsanthin as main carotenoid source, for poultry for fattening and laying (except turkeys). The saponified paprika (Capsicum annuum) extract contains various carotenoids at a concentration of 25-90 g/kg of which capsanthin being the major one with quantity specified as > 35% of total carotenoids (TC). The maximum recommended use level of 40 mg TC/kg feed is safe for chickens for fattening and laying hens. The margin of safety is at least 6. This conclusion is extrapolated to minor poultry species for fattening and laying. The saponified paprika extract is not genotoxic. Based on the no observed effect level (NOEL) of the 90-day study in rat and the exposure estimates, the Panel considered that there would be an adequate margin of exposure (between 700 and 2000) to conclude that the level of exposure to residues of the saponified paprika (C. annuum) extract (capsanthin not less than 35% of TCs) in animal tissues and products does not raise concern for the safety for the consumer. The saponified paprika extract is a viscous paste and as such users will not be exposed by inhalation. The applicant recognises that the extract may be irritant to skin and eyes. The FEEDAP Panel cannot conclude on the potential of any preparation to be toxic by inhalation, skin/eye irritant or skin sensitiser since no data were submitted. The use of saponified paprika extract in poultry feed raised no concern for the environment. Saponified paprika extract has the potential to pigment broiler skin and egg yolk. This conclusion is extrapolated to minor poultry species for fattening and laying.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 l-isoleucine produced by Escherichia coli FERM ABP-10641 (i) to renew the authorisation and to extend the use of the additive in water for drinking when used as a nutritional additive for all animal species and (ii) to evaluate a new use as a flavouring additive for all animal species. The applicant has provided evidence that the additive currently in the market complies with the existing conditions of authorisation. l-Isoleucine does not give rise to any safety concern regarding the production strain and its genetic modification. Considering that the production process has not been substantially modified and that no adverse effects have been reported in the literature search, the FEEDAP Panel considers that there is no evidence to reconsider the conclusions reached in previous assessments. Therefore, the Panel considers that the additiveen used as a nutritional additive. Since l-isoleucine is used in food as a flavouring compound, and its function in feed is essentially the same as that in food no further demonstration of efficacy is necessary.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-isoleucine produced by fermentation using Corynebacterium glutamicum KCCM 80189 when used as a nutritional additive in feed and water for drinking for all animal species. The production strain is not genetically modified. Viable cells of the production strain were not detected in the final additive. The additive does not give rise to any safety concern regarding the production strain. l-Isoleucine produced using C. glutamicum KCCM 80189 is considered safe for the target species, for the consumer and for the environment. l-Isoleucine produced by C. glutamicum KCCM 80189 is considered not toxic by inhalation, not irritant to skin or eyes and not a dermal sensitiser. Regarding the use in water, the FEEDAP Panel reiterates its concerns over the safety of l-isoleucine administered simultaneously via water for drinking and feed owing to the risk of nutritional imbalances and hygienic reasons.
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