Scientific Opinion on Safety and Efficacy of Tribasic Copper Chloride as Feed Additive

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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 safety and efficacy of di copper chloride tri hydroxide (tribasic copper chloride, TBCC) as feed additive for all species. The assessment is based on TBCC and TBCC formulated with starch to reduce dusting potential.

Based on three studies in chickens for fattening and one in laying hens, the FEEDAP Panel concluded that TBCC is a safe source of copper for poultry with a margin of safety ≥ 10. Considering that in the poultry studies no substantial differences were observed in the endpoints measured between copper sulphate and TBCC, the FEEDAP Panel did not expect that further essential information on the safety of TBCC would be provided by additional tolerance studies with other (more sensitive) animal species. The FEEDAP Panel concluded that TBCC is a safe source of copper for all animal species/categories up to the maximum total copper content authorised in feedingstuffs.

The FEEDAP Panel did not expect substantial differences in the metabolic behaviour, particularly in the deposition of copper in edible tissues and products from copper sulphate and TBCC. Consequently the FEEDAP Panel considered that exposure of the consumer to copper from food of animal origin would not be essentially modified by the replacement of copper sulphate by TBCC in feed.

In the absence of data, TBCC should be considered as a potential irritant to skin and eyes, and a potential skin sensitiser. The risk of respiratory exposure for the formulated TBCC/starch product was considered to be minimal.

The FEEDAP Panel considered that the use of TBCC in feed did not represent additional risks to the environment, compared to other sources of copper which it will substitute, provided that the maximum authorised total copper content in feedingstuffs is not exceeded.

Bioequivalence between TBCC and copper sulphate with regards to copper liver deposition, plasma levels of ceruloplasmin and copper, egg weight and laying hen performance, and growth of piglets was demonstrated in 11 experiments. The FEEDAP Panel concludes that TBCC is an effective source of copper for all animal species.

The FEEDAP Panel made recommendations concerning the specification of the additive. ¨

The whole article may be found on the EFSA Web site.