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 assessment of ...the application for renewal of authorisation of all‐rac‐alpha tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all‐rac‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all‐rac‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.
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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 assessment of ...the application for renewal of authorisation of RRR‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of RRR‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance; however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of RRR‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.
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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 assessment of ...the application for renewal of authorisation of all‐rac‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all‐rac‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all‐rac‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.
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FZAB, GIS, IJS, KILJ, NLZOH, NUK, OILJ, SBCE, SBMB, UL, UM, UPUK
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 assessment of ...the application for renewal of authorisation of all‐rac‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all‐rac‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance, however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all‐rac‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.
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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.
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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 assessment of ...the application for renewal of authorisation of all‐rac‐alpha tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all‐rac‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance; however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all‐rac‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.
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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 assessment of ...the application for renewal of authorisation of vitamin B6 (pyridoxine hydrochloride) produced by chemical synthesis as a feed additive for all animal species. The applicant has provided data demonstrating that the additive in the market complies with the conditions of the authorisation. The FEEDAP Panel confirms that the use of pyridoxine hydrochloride under the current authorised conditions of use is safe for the target species, the consumers and the environment. Pyridoxine hydrochloride is non‐irritant to skin and eyes. In the absence of data, no conclusion can be drawn on skin sensitisation potential. Pyridoxine hydrochloride may cause photosensitisation. Despite the lack of data on inhalation toxicity, the additive is not dusty and exposure through inhalation is unlikely. There is no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
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Vitamin K describes a group of lipophilic vitamins that exist naturally in two forms: vitamin K1 (phylloquinone, found in green plants) and vitamin K2 (a group of menaquinones synthesised by bacteria ...in the intestine). Vitamin K3 (or menadione) is a synthetic form of vitamin K without a side chain. To become active, menadione needs to undergo prenylation. Vitamins K1, K2 and K3 are metabolically activated in the liver to become co‐factors in the activation of vitamin K‐dependent proteins, which are important for normal blood coagulation, and normality of bones and arteries (Gla proteins). Acute toxicity of menadione or its derivatives is reached at levels exceeding the requirements by a factor of at least 1 000. Menadione sodium bisulphite (MSB) and menadione nicotinamide bisulphite (MNB) are safe for all animal species at practical use levels in feed. The use of MSB in water for drinking is likely to increase the exposure of target animals to chromium(VI). Therefore, the FEEDAP Panel has concerns about the safety of MSB when administered by this route. The use of MSB and MNB in animal nutrition does not give rise to safety concerns for consumers. MSB is an eye irritant; in the absence of adequate data, the additive should be considered as a skin sensitiser. In the absence of data, MNB should be considered as irritant to skin and eyes and as a skin sensitiser. Considering the high dusting potential of MSB and MNB, the absence of data on inhalation toxicity and the chromium(VI) content of dust, inhalation exposure resulting from handling of MSB and MNB could be hazardous. The use of MSB and MNB in animal nutrition does not pose a risk to the environment. MSB and MNB are regarded as effective sources of vitamin K in animal nutrition.
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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 assessment of ...the application for renewal of authorisation of all‐rac‐alpha‐tocopheryl acetate (vitamin E) as a feed additive for all animal species. The applicant provided data demonstrating that the additive currently in the market complies with the conditions of authorisation. The FEEDAP Panel confirms that the use of all‐rac‐alpha‐tocopheryl acetate under the current authorised conditions of use is safe for the target species, the consumers and the environment. No concern for user safety is expected from the use of the active substance; however, due to the lack of information, the FEEDAP Panel is not able to conclude on its skin sensitisation potential. To draw conclusions on the safety for the user of the final formulated additives, specific studies would be required. There is no need to assess the efficacy of all‐rac‐alpha‐tocopheryl acetate in the context of the renewal of the authorisation.
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Glycine betaine (betaine) acts as a methyl group donor in transmethylation reactions in organisms. Betaine occurs in numerous vertebrate tissues as an osmolyte, ensuring osmoprotection. Betaine is ...safe for piglets at the maximum supplementation rate of 2 000 mg/kg complete feed with a margin of safety below 5. This conclusion is extended to all pigs and extrapolated to all animal species and categories. The use of betaine anhydrous and betaine hydrochloride as feed additives up to a supplementation rate of 2 000 mg betaine/kg complete feed is unlikely to pose concerns for consumer safety. In the absence of data, betaine anhydrous and betaine hydrochloride should be considered hazardous by inhalation, as irritant to skin, eyes and mucous membranes, and skin sensitisers. The supplementation of feed with betaine anhydrous and betaine hydrochloride does not pose a risk to the environment. Betaine has the potential to become efficacious in all animal species and categories when administered via feed or water for drinking. Betaine anhydrous and betaine hydrochloride are considered as nutritionally equivalent sources of betaine. The FEEDAP Panel made some recommendations on (i) introduction of a maximum content for supplemental betaine in complete feed and water for drinking; (ii) avoidance of simultaneous use of betaine in feed and water for drinking; and protection of users when handling the additives.
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