Commission Implementing Regulation (EU) 2020/1373 of 1 October 2020 concerning the authorisation of zinc chelate of lysine and glutamic acid as a feed additive for all animal species (Text with EEA relevance)
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Address https://gelex.eu/eli/EU/regulation/2020/1373@2020-10-01/en
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition, and in particular Article 9(2) thereof,
Whereas:
(1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such authorisation.
(2) In accordance with Article 7 of Regulation (EC) No 1831/2003 an application was submitted for the authorisation of zinc chelate of lysine and glutamic acid. That application was accompanied by the particulars and documents required under Article 7(3) of that Regulation.
(3) That application concerns the authorisation of zinc chelate of lysine and glutamic acid as a feed additive for all animal species to be classified in the additive category nutritional additives.
(4) The European Food Safety Authority (the Authority) concluded in its opinion of 2 July 2019 that, under the proposed conditions of use, zinc chelate of lysine and glutamic acid does not have an adverse effect on animal health and consumer health. It also concluded that the additive is considered as a potential skin and respiratory sensitizer and stated a risk for the users of the additive upon inhalation. Therefore, appropriate protective measures should be taken to prevent adverse effects on human health, in particular as regards the users of the additive. The Authority also concluded that that additive does not pose an additional risk for the environment compared to other compounds of zinc and that it is an efficacious source of zinc for all animal species. The Authority does not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.
(5) The assessment of that additive shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are, subject to the relevant protective measures for the users of the additive, satisfied. Accordingly, the use of that additive should be authorised as specified in the Annex to this Regulation.
(6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
The substance specified in the Annex, belonging to the additive category nutritional additives and to the functional group compounds of trace elements, is authorised as an additive in animal nutrition subject to the conditions laid down in that Annex.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 1 October 2020. For the Commission The President Ursula Von der Leyen
ANNEX
(1) The additive shall be incorporated into feed in the form of a premixture. (2) Zinc chelate of lysine and glutamic acid may be placed on the market and used as an additive consisting of a preparation. (3) For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing protection. (4) ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) (5) inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15621) or (6) atomic absorption spectrometry, AAS (ISO 6869) (7) mid-infrared (IR) spectrometry together with the determination of the content of the trace element and lysine and glutamic acid in the feed additive (8) inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or (9) atomic absorption spectrometry, AAS (ISO 6869) or (10) inductively coupled plasma mass spectrometry, ICP-MS (EN 17053) (11) inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or (12) atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) or (13) inductively coupled plasma mass spectrometry, ICP-MS (EN 17053) Anx. annex. Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Content of element (Zn) in mg/kg of complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: compounds of trace elements 3b615 - Zinc chelate of lysine and glutamic acid Additive composition: Mixture of chelates of zinc with lysine and chelates of zinc with glutamic acid in a ratio of 1:1 as a powder with a zinc content between 17 and 19 %, a lysine content between 19 and 21 %, a glutamic acid content between 21 and 23 % and a maximum of 3 % moisture All animal species - - Dogs and cats: 200 (total) Salmonids and milk replacers for calves: 180 (total) Piglets, sows, rabbits and all fish other than salmonids: 150 (total) Other species and categories: 120 (total) 22.10.2030. Characterisation of the active substances: Chemical formulas: Zinc-2,6-diaminohexanoic acid, chloride and hydrogen sulfate salt: C6H19ClN2O8SZn Zinc-2-aminopentanedioic acid, sodium and hydrogen sulfate salt: C5H8NNaO8SZn Analytical methods: For the quantification of the lysine and glutamic acid content in the feed additive: For the quantification of total zinc in the feed additive: For proving the chelated structure of the feed additive: For the quantification of total zinc in premixtures: For the quantification of total zinc in feed materials and compound feed:
ANNEX
Identification number of the additive Name of the holder of authorisation Additive Composition, chemical formula, description, analytical method Species or category of animal Maximum age Minimum content Maximum content Other provisions End of period of authorisation Content of element (Zn) in mg/kg of complete feed with a moisture content of 12 % Category of nutritional additives. Functional group: compounds of trace elements 3b615 - Zinc chelate of lysine and glutamic acid Additive composition: Mixture of chelates of zinc with lysine and chelates of zinc with glutamic acid in a ratio of 1:1 as a powder with a zinc content between 17 and 19 %, a lysine content between 19 and 21 %, a glutamic acid content between 21 and 23 % and a maximum of 3 % moisture All animal species - - Dogs and cats: 200 (total) Salmonids and milk replacers for calves: 180 (total) Piglets, sows, rabbits and all fish other than salmonids: 150 (total) Other species and categories: 120 (total) 22.10.2030. Characterisation of the active substances: Chemical formulas: Zinc-2,6-diaminohexanoic acid, chloride and hydrogen sulfate salt: C6H19ClN2O8SZn Zinc-2-aminopentanedioic acid, sodium and hydrogen sulfate salt: C5H8NNaO8SZn Analytical methods: For the quantification of the lysine and glutamic acid content in the feed additive: For the quantification of total zinc in the feed additive: For proving the chelated structure of the feed additive: For the quantification of total zinc in premixtures: For the quantification of total zinc in feed materials and compound feed: (1) The additive shall be incorporated into feed in the form of a premixture. (2) Zinc chelate of lysine and glutamic acid may be placed on the market and used as an additive consisting of a preparation. (3) For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing protection. (4) ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS) (5) inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15621) or (6) atomic absorption spectrometry, AAS (ISO 6869) (7) mid-infrared (IR) spectrometry together with the determination of the content of the trace element and lysine and glutamic acid in the feed additive (8) inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or (9) atomic absorption spectrometry, AAS (ISO 6869) or (10) inductively coupled plasma mass spectrometry, ICP-MS (EN 17053) (11) inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or (12) atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) or (13) inductively coupled plasma mass spectrometry, ICP-MS (EN 17053)
1. The additive shall be incorporated into feed in the form of a premixture.
2. Zinc chelate of lysine and glutamic acid may be placed on the market and used as an additive consisting of a preparation.
3. For users of the additive and premixtures, feed business operators shall establish operational procedures and appropriate organisational measures to address the potential risks by inhalation, dermal or eyes contact. Where risks cannot be reduced to an acceptable level by these procedures and measures, the additive and premixtures shall be used with appropriate personal protective equipment, including breathing protection.
ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)
inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15621) or
atomic absorption spectrometry, AAS (ISO 6869)
mid-infrared (IR) spectrometry together with the determination of the content of the trace element and lysine and glutamic acid in the feed additive
inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or
atomic absorption spectrometry, AAS (ISO 6869) or
inductively coupled plasma mass spectrometry, ICP-MS (EN 17053)
inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or
atomic absorption spectrometry, AAS (Commission Regulation (EC) No 152/2009 (Annex IV-C) or ISO 6869) or
inductively coupled plasma mass spectrometry, ICP-MS (EN 17053)