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The compound under assessment, dicopper oxide, contains ≥ 86% copper (Cu). Dicopper oxide is a safe source of copper for chickens for fattening. This conclusion is extended to all animal species/ categories provided the maximum authorised copper content in feed is respected. There is no indication that the toxicity of dicopper oxide is essentially different from that described for divalent copper. As dicopper oxide is used as a substitute for other copper-containing additives and its bioavailability is in the range of copper sulphate, the standard copper-containing additive, no influence of the use of dicopper oxide in animal nutrition on the copper content of food of animal origin is expected. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concludes that the use of dicopper oxide in animal nutrition is of no concern for consumer safety. Dicopper oxide is not an irritant to skin but a moderate irritant to the eye. Owing to the nickel content in the additive, it should be considered as a dermal and respiratory sensitiser. Dicopper oxide poses a risk to users upon inhalation exposure. There was no available evidence suggesting that dicopper oxide would pose additional risks to the environment than the other sources of copper already authorised. The substitutive use of dicopper oxide for other copper compounds would therefore not change the previous conclusion of the Panel concerning safety from the environment. Based on the results of a tolerance study in chickens for fattening and a short-term bioavailability study, the FEEDAP Panel concluded that dicopper oxide is an effective source of copper for all animal species.
The compound under assessment, dicopper oxide, contains ≥ 86% copper (Cu). Dicopper oxide is a safe source of copper for chickens for fattening. This conclusion is extended to all animal species/ categories provided the maximum authorised copper content in feed is respected. There is no indication that the toxicity of dicopper oxide is essentially different from that described for divalent copper. As dicopper oxide is used as a substitute for other copper-containing additives and its bioavailability is in the range of copper sulphate, the standard copper-containing additive, no influence of the use of dicopper oxide in animal nutrition on the copper content of food of animal origin is expected. The EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP Panel) concludes that the use of dicopper oxide in animal nutrition is of no concern for consumer safety. Dicopper oxide is not an irritant to skin but a moderate irritant to the eye. Owing to the nickel content in the additive, it should be considered as a dermal and respiratory sensitiser. Dicopper oxide poses a risk to users upon inhalation exposure. There was no available evidence suggesting that dicopper oxide would pose additional risks to the environment than the other sources of copper already authorised. The substitutive use of dicopper oxide for other copper compounds would therefore not change the previous conclusion of the Panel concerning safety from the environment. Based on the results of a tolerance study in chickens for fattening and a short-term bioavailability study, the FEEDAP Panel concluded that dicopper oxide is an effective source of copper for all animal species.
The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) reviewed (i) the copper requirements of food-producing and pet animals, (ii) the copper concentration in feed materials and complete feed, (iii) the copper bioavailability, and (iv) the calculated background copper concentration of complete feed. Also considered were (i) the influence of dietary copper on gut microbiota profile and on the bacterial antibiotic resistance in target animals and (ii) the environmental occurrence of bacterial heavy metal tolerance (copper resistance) and resistance to certain antibiotics. The data collected supported the possibility of a reduction in some of the currently authorised maximum contents (CAMC) for total copper in feed. The EFSA Panel developed an algorithm to derive newly proposed maximum contents (NPMC) from the requirement and the native dietary copper content. The NPMC (mg Cu/kg complete feed) comprised of maintained (m), decreased (d) and increased (i) values: 15 for bovine before the start of rumination (m), 30 for other bovine (d), 35 for caprine (i), 15 for ovine (m), 50 for crustacean (m) and 25 for other animal species ((d) for piglets up to 12 weeks, (m) for all other species). The NMPC support health, welfare and economic productivity of target animals, except piglets; performance of weaned piglets would be impacted. The NPMC values would not likely have any consequences on the consumers' intake of copper and are of no concern for the safety of the consumer. The reduction from 170 mg to 25 mg Cu/kg feed piglets would have the capacity to save 1,200 tonnes copper/year being spread in the field and thus, to reduce total copper emissions from farm animal production by about 20%. Thus, the reduction of the CAMC to the NPMC would have a significant impact on the concentrations of copper in the environment of piggeries.
The Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) was asked to deliver a scientific opinion on the application for renewal of authorisation of copper chelate of hydroxy analogue of methionine (Mintrex®Cu) for all animal species. The FEEDAP Panel has delivered two opinions (in 2008 and 2009) on the safety and efficacy of the additive. The additive was authorised in 2010 as ‘Copper chelate of hydroxy analogue of methionine’ containing 18% copper, 79.5−81% (2‐hydroxy‐4‐methylthio)butanoic acid (DL‐methionine hydroxy analogue, HMTBa) and 1% mineral oil. Following some modifications in the manufacturing process, the additive does not contain mineral oil and the applicant proposes the following specifications: ≥ 16% copper and ≥ 78% HMTBa. The data provided indicate that the additive complies with the new specifications. No new evidence was found that would make the FEEDAP Panel reconsidering its previous conclusions on the safety for target species, consumers and environment. The applicant provided new studies on the effects of the additive on the respiratory tract and on skin and eyes. Data on the characterisation of the additive and the new studies on skin/eyes led the Panel to reconsider the safety for the user. Mintrex®Cu is considered as a skin and eye irritant and a skin sensitiser; the risk of respiratory sensitisation is considered low. The present application did 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; therefore, there was no need for assessing the efficacy of the additive in the context of the renewal of the authorisation.
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