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Scientific Opinion on the safety and efficacy of copper compounds (E4) as feed additives for all animal species: cupric sulphate pentahydrate based on a dossier submitted by Manica S.p.A.

EFSA Journal 2012;10(12):2969[38 pp.]. doi:10.2903/j.efsa.2012.2969
  EFSA Panel on Additives and Products or Substances used in Animal Feed (FEEDAP) Panel Members Gabriele Aquilina, Alex Bach, Vasileios Bampidis, Maria De Lourdes Bastos, Gerhard Flachowsky, Josep Gasa-Gasó, Mikolaj Gralak, Christer Hogstrand, Lubomir Leng, Secundino López-Puente, Giovanna Martelli, Baltasar Mayo, Derek Renshaw, Guido Rychen, Maria Saarela, Kristen Sejrsen, Patrick Van Beelen, Robert John Wallace and Johannes Westendorf. Acknowledgment The Panel wishes to thank the members of the Working Group on Trace Elements, including Noël Albert Dierick, Jürgen Gropp, Joop de Knecht, Alberto Mantovani and the late Reinhard Kroker, for the preparatory work on this scientific opinion. Contact FEEDAP@efsa.europa.eu
Type: Opinion of the Scientific Committee/Scientific Panel On request from: European Commission Question number: EFSA-Q-2011-00743 Adopted: 14 November 2012 Published: 05 December 2012 Affiliation: European Food Safety Authority (EFSA), Parma, Italy
Abstract

Copper sulphate pentahydrate is safe for all animal species up to the maximum total copper content authorised in feed. No concerns for consumer safety are expected from the use of the feed additive. The maximum residue limits (MRLs) for copper in foods of animal origin established by European Union pesticides legislation are not consistent with legal practices in animal nutrition. As copper is an essential micronutrient, the FEEDAP Panel is not in favour of establishing MRLs for animal products, unless there is a clear consumer safety issue; if MRLs are to be maintained, the Panel has proposed amended values. The additive is an eye irritant and may induce allergic dermatitis in sensitive persons which might be exacerbated by the contamination with nickel. Users may be exposed to hazardous copper concentrations by inhalation. Potential risks to soil organisms have been identified after the application of piglet manure; there might be a potential concern related to sediment contamination. Drawing final conclusions would need further model validation and refinement to the assessment of copper-based additives in livestock. The use of copper compounds in aquaculture is not expected to pose a risk. The limited database available on the influence of copper to the development of antibiotic resistance in gut and soil bacteria indicates that high copper concentrations in the microbial environment increase the number of copper-resistant bacteria, and copper resistance seems to be correlated with more frequent resistance to several antibiotics in certain bacterial species. A potential copper threshold concentration could not be derived. The total pool of macrolide resistance in animals probably originates from antibiotic treatment and not from the use of high dietary copper. The extent to which copper-resistant bacteria contribute to the overall antibiotic resistance can not be quantified at present. Copper sulphate pentahydrate is efficacious in meeting animal requirements.

© European Food Safety Authority,2012

Summary

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 cupric sulphate pentahydrate when used as feed additive for all animal species.

Copper sulphate pentahydrate is safe for all animal species/categories up to the maximum total copper content authorised in feed.

Consumption surveys include copper from foodstuffs of animal origin. Since the supplementation of animal feed with copper-containing compounds has not essentially changed over the last decade, no change in the contribution of foodstuffs originating from supplemented animals to the overall copper intake of consumers is expected. No concerns for consumer safety are expected from the use of copper sulphate pentahydrate in animal nutrition.

The maximum residue limits (MRLs) for copper in edible tissues and products of animal origin established by European Union pesticides legislation are found not to comply with the upper intake level set by the Scientific Committee on Food—as shown by different model calculations—and with legal feeding practices. The FEEDAP Panel is generally not in favour of establishing MRLs for essential nutrients, such as copper, in foods of animal origin, unless there is a clear consumer safety issue to do so; however, any such MRL has to consider animal health and welfare. In case MRLs for animal products are to be retained, the FEEDAP Panel proposes amended values.

Copper sulphate pentahydrate is an eye irritant but not a skin irritant or skin sensitiser; it may induce allergic dermatitis in sensitive persons, which might be exacerbated by the contamination with nickel. The dusting potential of the additive indicates that users may be exposed to hazardous copper concentrations by inhalation, which could result in a reduced immune response of the lung. The inhalation of nickel resulting from handling the additive is by itself unlikely to be of concern.

Potential risks to soil organisms have been identified as a result of the application of piglet manure. Levels of copper in other types of manure are too low to create a potential risk within the timescale considered. There might also be a potential environmental concern related to contamination of sediment owing to drainage and the run-off of copper to surface water. In order to draw a final conclusion, further model validation is needed and some further refinement to the assessment of copper-based feed additives in livestock needs to be considered, for which additional data would be required. The use of copper-containing additives in aquaculture up to the maximum authorised copper level in feeds is not expected to pose an appreciable risk to the environment.

The limited database available on the influence of copper on the development of antibiotic resistance in gut and soil bacteria allows to conclude that (i) high copper concentrations in the microbial environment increase the number of copper-resistant bacteria and (ii) copper resistance seems to be correlated with more frequent resistance to several antibiotics in certain bacterial species. A co-transfer of plasmid genes encoding for resistance to copper and erythromycin is plausible at least in Enterococcus faecium. The current database does not allow any conclusion on a potential threshold concentration of copper in feeds, below which a significant increase in copper resistance could not be expected. The total pool of macrolide resistance in animals probably originates from antibiotic treatment and not from the use of high dietary copper. The extent to which copper-resistant bacteria contribute to the overall antibiotic resistance situation can not be quantified at present. More precise (and quantitative) conclusions will require further studies.

The use of copper sulphate pentahydrate in animal nutrition is extensively documented in the scientific literature. It is recognised as an efficacious source of copper in meeting animal requirements.
 

Keywords

Nutritional additive, compounds of trace elements, cupric sulphate pentahydrate, safety, MRL, antibiotic resistance, environment