Abstract
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 copper (II) chelate of amino acids hydrate, brand name Availa®Cu, for all animal species, based on a dossier submitted for the modification of the terms of the authorisation of the additive. The additive is currently authorised using amino acids derived from soya protein and with a minimum content of 10% copper. The applicant proposed (i) to include amino acids from other sources such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to introduce a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (copper), with an inclusion level of 10–11%. The additive, produced using different proposed sources of hydrolysed proteins, complies with the specifications set by Commission Regulation (EU) 2018/1039. The FEEDAP Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions reached in the previous assessments on the safety for the target species, consumers, environment and efficacy of the additive above. Concerning the safety for the users, the additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of zinc in the dust it is not possible to make the assessment of the exposure by inhalation.
Keywords: nutritional additive, compounds of trace elements, copper chelate, Availa® Cu, safety, efficacy
1. Introduction
1.1. Background and Terms of Reference as provided by the requestor
Regulation (EC) No 1831/20031 establishes the rules governing the Community authorisation of additives for use in animal nutrition. In particular, Article 13(3) of that Regulation lays down that if the holder of an authorisation proposes changing the terms of the authorisation by submitting an application to the Commission, accompanied by the relevant data supporting the request for the change, the Authority shall transmit its opinion on the proposal to the Commission and the Member States.
The European Commission received a request from Zinpro Animal Nutrition (Europe) Inc.2 for modification of the terms authorisation of the product copper (II) chelate of amino acids hydrate, when used as a feed additive for all animal species (category: nutritional additive; functional group: compound of trace elements).
According to Article 7(1) of Regulation (EC) No 1831/2003, the Commission forwarded the application to the European Food Safety Authority (EFSA) as an application under Article 13(3) (modification of the authorisation of a feed additive). EFSA received directly from the applicant the technical dossier in support of this application. The particulars and documents in support of the application were considered valid by EFSA as of 19 January 2021.3
According to Article 8 of Regulation (EC) No 1831/2003, EFSA, after verifying the particulars and documents submitted by the applicant, shall undertake an assessment in order to determine whether the feed additive complies with the conditions laid down in Article 5. EFSA shall deliver an opinion on the safety for the target animals, consumer, user and the environment and on the efficacy of the product copper (II) chelate of amino acids hydrate, when used under the proposed conditions of use (see Section 3.1.4).
1.2. Additional information
The additive copper (II) chelate of amino acids hydrate is used as a nutritional additive to meet the copper requirement of all animal species. The safety and efficacy of the additive was the subject of an EFSA opinion delivered in 2013 (EFSA FEEDAP Panel, 2013).
The additive is currently authorised in the European Union (EU) for all animal species, under the category of nutritional feed additive and functional group of compounds of trace elements (registration number 3b406).4
2. Data and methodologies
2.1. Data
The present assessment is based on data submitted by the applicant in the form of a technical dossier5 in support of the authorisation request for the use of copper (II) chelate of amino acids hydrate as a feed additive. The technical dossier was prepared following the provisions of Article 7 of Regulation (EC) No 1831/2003.
The FEEDAP Panel used the data provided by the applicant together with data from other sources, such as previous risk assessments by EFSA or other expert bodies.
The European Union Reference Laboratory (EURL) considered that the conclusions and recommendations reached in the previous assessment are valid and applicable for the current application.6
2.2. Methodologies
The approach followed by the FEEDAP Panel to assess the safety and the efficacy of copper (II) chelate of amino acids hydrate is in line with the principles laid down in Regulation (EC) No 429/20087 and the relevant guidance documents: Guidance on the identity, characterisation and conditions of use of feed additives (EFSA FEEDAP Panel, 2017a), Guidance on the assessment of the safety of feed additives for the target species (EFSA FEEDAP Panel, 2017b), Guidance on the assessment of the safety of feed additives for the consumer (EFSA FEEDAP Panel, 2017c), Guidance on studies concerning the safety of use of the additive for users/workers (EFSA FEEDAP Panel, 2012), Guidance on studies concerning the safety of use of the additive for the environment (EFSA FEEDAP Panel, 2019) and Guidance on the assessment of the efficacy of feed additives (EFSA FEEDAP Panel, 2018).
3. Assessment
The additive copper (II) chelate of amino acids hydrate is authorised as a nutritional feed additive (functional group: compounds of trace elements) is a source of copper for all animal species in feed up to the maximum authorised copper levels in the EU. The additive will be referred in this scientific opinion as Availa®Cu (trade name of the additive).
The authorisation outlines the additive composition as ‘copper amino acid complex where the copper and the amino acids derived from soya protein are chelated via coordinate covalent bonds, as a powder with a minimum content of 10% copper’.
With this application the applicant is requesting a modification of the current authorisation as follows: (i) to include other sources of amino acids such as hydrolysed corn gluten, hydrolysed potato protein and hydrolysed poultry feather meal; (ii) to introduce a minimum specification for free amino acids of 18%; (iii) to introduce a tighter specification on the mineral content (copper), with an inclusion level of 10–11%. The additive will be referred in this scientific opinion as Availa®Cu (trade name of the additive).
3.1. Characterisation
3.1.1. Manufacturing process
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3.1.2. Characterisation of the additive
The additive contains copper (II) chelate of amino acids hydrate (37–38%), calcium carbonate (18–19%) and cellulose (44–45%).
The current authorisation specifies a copper content ≥ 10%. The applicant is proposing to introduce the following specifications: ≥ 18% free amino acids and to limit the copper content to a level of 10–11%.
The applicant provided analytical data on five batches of the additive with amino acids derived from each of the proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten; five batches each). Additional five batches derived from a (unspecified) mixture of the new sources of protein were provided. The batches were analysed for copper, free amino acids and total amino acids. The results (in range) are reported in Table 1.
Table 1.
Batch to batch variation for Availa®Cu when the amino acids have been sourced from soy, feather meal, potato and corn gluten
| Protein source | Copper %a | Free amino acids %b | Total amino acids %b |
|---|---|---|---|
| Soyc | 10.1–11.0 | 18.1–22.1 | 23.8–24.5 |
| Feather meald | 10.0–10.9 | 21.0–22.2 | 24.1–24.5 |
| Potatoe | 10.2–11.0 | 19.8–21.5 | 23.8–24.4 |
| Corn glutenf | 10.1–10.8 | 18.3–21.9 | 23.8–24.4 |
| Mixg | 10.3–10.8 | 21.5–21.8 | 22.1–22.8 |
Inductively coupled plasma optical (atomic) emission spectrometry (ICP‐AES) – EN 15510.
ISO 13903:2005 Animal feeding stuffs – Determination of amino acids.
Technical dossier/Section II/Annexes/Annex_II‐10, II‐11, II‐12, II‐13, II‐14.
Technical dossier/Section II/Annexes/Annex_ II‐15, II‐16, II‐17, II‐18, II‐19.
Technical dossier/Section II/Annexes/Annex_ II‐20, II‐21, II‐22, II‐23, II‐24.
Technical dossier/Section II/Annexes/Annex_II‐25, II‐26, II‐27, II‐28, II‐29.
Technical dossier/Section II/Annexes/Annex_II‐5, II‐6, II‐7, II‐8 and II‐9.
All the batches analysed comply with the current authorisation and with the newly proposed specifications.
Three batches of the additive with amino acids derived from each source of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) were analysed for impurities. The results (in range) are reported in Table 2.
Table 2.
Results of the analysis for impurities (in range) for the different proposed sources of hydrolysed proteins
| Protein source | Arsenic (mg/kg) | Cadmium (mg/kg)a | Lead (mg/kg) | Mercury (mg/kg)a | Nickel (mg/kg) | Aflatoxin B1 (μg/kg) | Ochratoxin A (μg/kg)a |
|---|---|---|---|---|---|---|---|
| Soyb | 0.26–0.33 | < 0.1 | 2.15–2.86 | < 0.08 | 1.26–1.85 | 1–2 | < 0.1 |
| Feather mealc | 0.42–0.54 | < 0.1 | < 0.98 | < 0.08 | 0.71–0.88 | 0.32–0.5 | < 0.1 |
| Potatod | 0.31–0.44 | < 0.1 | 1.17–1.84 | < 0.08 | 1.45–1.92 | 0.58–0.9 | < 0.1 |
| Corn glutene | 0.46–0.56 | < 0.1 | 1.07–1.45 | < 0.08 | 1.68–1.79 | 0.48–0.65 | < 0.1 |
‘<‘refers to the limit of detection (LOD).
Technical dossier/Section II/SIn_310521/Annexes/Annex_1, 2, 3.
Technical dossier/Section II/SIn_310521/Annexes/Annex_4, 5, 6.
Technical dossier/Section II/SIn_310521/Annexes/Annex_7, 8, 9.
Technical dossier/Section II/SIn_310521/Annexes/Annex_10, 11, 12.
Based on the results, no concern arises on possible presence of impurities in the final product.
No information on the dioxins content was provided in the current submission although the applicant states that dioxins are routinely analysed as part of the quality control system.11
The dusting potential of three batches of the additive with amino acids derived from each source of hydrolysed proteins was determined using the Stauber–Heubach method.12 Results showed values on average of 2,124 mg/m3 (range 2,068–2,200 mg/m3) for soy, 1,370 mg/m3 (range 1,318–1,400 mg/m3) for feather meal, 1,506 mg/m3 (range 1,351–1,624 mg/m3) for potato and 1,423 mg/m3 (range 1,324–1,512 mg/m3) for corn gluten (mg airborne dust per m3 of air).
3.1.3. Characterisation of the compound
The applicant stated that the proposed modifications in the manufacturing process do not result in a different product to the one currently authorised.
The compound of trace element is copper (II) chelate of amino acids hydrate, molecular formula [R‐NH2‐CH‐ COO](1‐3)Cu – X, chemical formula Cu‐(X)1‐3,n•H2O where X is equal to any amino acid coming from hydrolysed protein sources. No IUPAC and CAS number were made available.
The complex is a 1:1 metal to amino acid, there is a counter ion (bisulfate) associated with the copper that completes the complex. Therefore, the molecular weights of the complex vary depending on which free amino acid and counter ions are present in the complex. The molecular weight range will be between 236 and 335 Da.13
The applicant provided the analysis of the molecular weight distribution in one batch of the additive, analysed with a size execution chromatography with UV detection at 220 nm,14 resulting in 95% < 500 Da % area and 5% > 500 Da area. These results show compliance with the specification of the current authorisation on maximum 10% of molecules exceeding 1,500 Da.
No new data have been provided regarding the physical properties or stability of the additive other than on dusting potential. Since the changes introduced in the manufacturing process are not expected to have a significant effect on these characteristics, the data described in the previous opinion still apply (EFSA FEEDAP Panel, 2013).
3.1.4. Conditions of use
Availa®Cu is authorised for use as a source of copper for all animal species and categories. No minimum inclusion level is recommended.
The following maximum levels of copper in complete feed with a moisture content of 12% are currently authorised in the EU15:
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Bovine before the start of rumination: 15 mg copper/kg complete feed
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Other bovines: 30 mg copper/kg complete feed
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Ovine: 15 mg copper/kg complete feed
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Caprine: 35 mg copper/kg complete feed
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Suckling piglets: 150 mg copper/kg complete feed
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Weaning piglets: 100 mg copper/kg complete feed
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Crustaceans: 50 mg copper/kg complete feed
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Other species and categories: 25 mg copper/kg complete feed.
The applicant did not request any modification of the conditions of use as authorised.
3.2. Safety and efficacy
The safety of copper (II) chelate of amino acids hydrate was already assessed by the FEEDAP Panel in its previous opinion (EFSA FEEDAP Panel, 2013). In this opinion the Panel concluded that ‘cupric chelate of amino acids hydrate is a safe source of copper for all animal species, considering the maximum contents for total copper in feedingstuffs set in the EU. […] 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 cupric chelate of amino acids hydrate in animal nutrition, which would substitute for other copper sources’.
The additive should be considered as a skin and eye irritant and as a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of copper in the dust it is not possible to make the assessment of the exposure by inhalation.
In the previous opinion, the Panel concluded that ‘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 the contamination of sediment owing to drainage and the run‐off of copper to surface water. […] The use of copper‐containing additives in aquaculture up to the authorised maximum of total copper content in complete feeds is not expected to pose an appreciable risk to the environment’.
With regards to efficacy, the Panel concluded that ‘Cupric chelate of amino acids hydrate is recognised as an efficacious source of copper in meeting animal requirements’.
Taking into account the proposed modifications in the manufacturing process and that the characterisation and the conditions of use of the additive are the same as the ones already assessed and authorised, the Panel considers that the use of the different proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) do not modify the conclusions on the safety and efficacy of the additive above.
3.3. Post‐market monitoring
The FEEDAP Panel considers that there is no need for specific requirements for a post‐market monitoring plan other than those established in the Feed Hygiene Regulation16 and Good Manufacturing Practice.
4. Conclusions
Copper (II) chelate of amino acids hydrate produced using various new proposed sources of hydrolysed proteins (i.e. soy, feather meal, potato and corn gluten) complies with the specifications set by Commission Regulation (EU) 2018/1039. The FEEDAP Panel considers that the conclusions on safety and efficacy reached in the previous assessment apply to the copper chelate of amino acids hydrate produced using the different proposed sources of hydrolysed proteins.
The FEEDAP Panel concludes that copper (II) chelate of amino acids hydrate is a safe source of copper for all animal species, considering the maximum contents for total copper in feedingstuffs set in the EU.
Cooper (II) chelate of amino acids hydrate used in animal nutrition is not expected to pose a risk for the consumer safety up to the maximum authorised levels of total copper in feedingstuffs.
The additive should be considered as a skin and eye irritant and a skin sensitiser. The additive has a high dusting potential; however, in the absence of data on the concentration of copper in the dust it is not possible to make the assessment of the exposure by inhalation.
The FEEDAP Panel concludes that 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 the contamination of sediment owing to drainage and the run‐off of copper to surface water. The use of copper‐containing additives in aquaculture up to the authorised maximum of total copper content in complete feeds is not expected to pose an appreciable risk to the environment.
Copper (II) chelate of amino acids hydrate has the potential to act as an efficacious source of copper in meeting animal requirements.
5. Documentation as provided to EFSA/Chronology
| Date | Event |
|---|---|
| 09/12/2019 | Dossier received by EFSA. Copper chelate of amino acids hydrate (Availa® Cu) for all animal species. Submitted by Zinpro Animal Nutrition (Europe), Inc. |
| 29/01/2020 | Reception mandate from the European Commission |
| 19/01/2021 | Application validated by EFSA – Start of the scientific assessment |
| 16/03/2021 | Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. Issues: characterisation |
| 20/04/2021 | Comments received from Member States |
| 31/05/2021 | Reception of supplementary information from the applicant ‐ Scientific assessment re‐started |
| 05/07/2021 | Request of supplementary information to the applicant in line with Article 8(1)(2) of Regulation (EC) No 1831/2003 – Scientific assessment suspended. Issues: characterisation |
| 19/08/2021 | Reception of supplementary information from the applicant ‐ Scientific assessment re‐started |
| 29/09/2021 | Opinion adopted by the FEEDAP Panel. End of the Scientific assessment |
Abbreviations
- CAS
Chemical Abstracts Service
- EURL
European Union Reference Laboratory
- FEEDAP
EFSA Scientific Panel on Additives and Products or Substances used in Animal Feed
- ICP‐AES
inductively coupled plasma optical (atomic) emission spectrometry
- IUPAC
International Union of Pure and Applied Chemistry
- LOD
limit of Detection
- MW
molecular weight
Suggested citation: EFSA FEEDAP Panel (EFSA Panel on Additives and Products or Substances used in Animal Feed) , Bampidis V, Azimonti G, Bastos ML, Christensen H, Dusemund B, Fašmon Durjava M, Kouba M, López‐Alonso M, López Puente S, Marcon F, Mayo B, Pechová A, Petkova M, Ramos F, Sanz Y, Villa RE, Woutersen R, Brozzi R, Galobart J, Gregoretti L, Innocenti ML, Vettori MV and López‐Gálvez G, 2021. Scientific Opinion on the safety and efficacy of a feed additive consisting of copper (II) chelate of amino acids hydrate for all animal species (Zinpro Animal Nutrition (Europe) Inc.). EFSA Journal 2021;19(10):6896, 9 pp. 10.2903/j.efsa.2021.6896
Requestor: European Commission
Question number: EFSA‐Q‐2020‐00182
Panel members: Giovanna Azimonti, Vasileios Bampidis, Maria de Lourdes Bastos, Henrik Christensen, Birgit Dusemund, Mojca Fašmon Durjava, Maryline Kouba, Marta López‐Alonso, Secundino López Puente, Francesca Marcon, Baltasar Mayo, Alena Pechová, Mariana Petkova, Fernando Ramos, Yolanda Sanz, Roberto Edoardo Villa and Ruud Woutersen.
Legal notice: Relevant information or parts of this scientific output have been blackened in accordance with the confidentiality requests formulated by the applicant pending a decision thereon by the European Commission. The full output has been shared with the European Commission, EU Member States and the applicant. The blackening will be subject to review once the decision on the confidentiality requests is adopted by the European Commission.
Declarations of interest: The declarations of interest of all scientific experts active in EFSA's work are available at https://ess.efsa.europa.eu/doi/doiweb/doisearch.
Acknowledgments: The Panel wishes to acknowledge the contribution of Angelica Amaduzzi to this opinion.
Adopted: 29 September 2021
Notes
Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition. OJ L 268, 18.10.2003, p. 29.
Zinpro Animal Nutrition (Europe), Inc. Akkerdistel 2E. 5831 PJ. Boxmeer. The Netherlands.
A new mandate was received in EFSA on 29/1/2020.
Commission Implementing Regulation (EU) 2018/1039 of 23 July 2018 concerning the authorisation of Copper(II) diacetate monohydrate, Copper(II) carbonate dihydroxy monohydrate, Copper(II) chloride dihydrate, Copper(II) oxide, Copper(II) sulphate pentahydrate, Copper(II) chelate of amino acids hydrate, Copper(II) chelate of protein hydrolysates, Copper(II) chelate of glycine hydrate (solid) and Copper(II) chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006 and (EU) No 349/2010 and Implementing Regulations (EU) No 269/2012, (EU) No 1230/2014 and (EU) 2016/2261. OJ L 186, 24.7.2018, p. 3.
FEED dossier reference: FAD‐2019‐0081.
The full report is available on the EURL website: https://ec.europa.eu/jrc/sites/default/files/amended_finrep_copper_group_fad-2010-0031.pdf
Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives. OJ L 133, 22.5.2008, p. 1.
Technical dossier/Section II/Annexes/Annex_ II‐36.
Technical dossier/Section II/Annexes/Annex_ II‐37.
Technical dossier/Section II/Annexes/Annex_ II‐38.
Technical dossier/Section II/SIn_310521.
Technical dossier/FAD‐2019‐0081_SIn_050821/FAD‐2019‐0081_EFSA Availa Cu Supplementary Information Request_20210705.
The lowest MW would be with 1 copper molecule plus 1 glycine (the lowest MW amino acid) and 1 bisulphate anion. This would be about 236 Da (75 for glycine, 97 for bisulfate and 64 for copper). The highest MW would be with 1 copper molecule plus 1 arginine (Tryptophan is destroyed under our hydrolysis conditions) and 1 bisulfate anion. This would be about 335 Da (174 for arginine, 97 for bisulfate and 64 for copper).
Technical dossier/Section II/SIn_310521/Annexes/Annex_13, The calculation of molecular weight distribution was based on a calibration line consisting of glutamic acid and lysine.
Commission Implementing Regulation (EU) 2018/1039 of 23 July 2018 concerning the authorisation of Copper(II) diacetate monohydrate, Copper(II) carbonate dihydroxy monohydrate, Copper(II) chloride dihydrate, Copper(II) oxide, Copper(II) sulphate pentahydrate, Copper(II) chelate of amino acids hydrate, Copper(II) chelate of protein hydrolysates, Copper(II) chelate of glycine hydrate (solid) and Copper(II) chelate of glycine hydrate (liquid) as feed additives for all animal species and amending Regulations (EC) No 1334/2003, (EC) No 479/2006 and (EU) No 349/2010 and Implementing Regulations (EU) No 269/2012, (EU) No 1230/2014 and (EU) 2016/2261. OJ L 186, 24.7.2018, p. 3.
Regulation (EC) No 183/2005 of the European Parliament and of the Council of 12 January 2005 laying down requirements for feed hygiene. OJ L 35, 8.2.2005, p. 1.
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