Commission Implementing Regulation (EU) 2020/1378 of 1 October 2020 concerning the authorisation of copper chelate of lysine and glutamic acid as a feed additive for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2020/1378
• Articles: 3

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.

Schedules & Appendices

ANNEX

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 (Cu) in mg/kg of complete feed with a moisture content of 12 %

Category of nutritional additives. Functional group: compounds of trace elements

3b415

—

Copper chelate of lysine and glutamic acid

Additive composition

Mixture of chelate of copper with lysine and chelate of copper with glutamic acid in a ratio of 1:1 as a powder with

a copper content between 17 and 19 %,

a lysine content between 19 and 21 %,

a glutamic acid content between 19 and 21 % and a maximum of 3 % moisture

All animal species

—

—

Bovines:

—

Bovines before the start of rumination: 15 (total);

—

Other bovines: 30 (total).

—

Ovines: 15 (total).

Caprines: 35 (total)

Piglets:

—

suckling and weaned up to 4 weeks after weaning: 150 (total).

—

from 5-th week after weaning up to 8 weeks after weaning: 100 (total).

Crustaceans: 50 (total).

Other animals: 25 (total).

1.

The additive shall be incorporated into feed in the form of a premixture.

2.

Copper 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 contact or eyes contact, in particular due to the content of heavy metals including nickel. 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.

4.

The following words shall be included in the labelling:

—

For feed for ovines if the level of copper in the feed exceeds 10 mg/kg:

‘The level of copper in this feed may cause poisoning in certain breeds of sheep.’

—

For feed for bovines after the start of rumination if the level of copper in the feed is less than 20 mg/kg:

‘The level of copper in this feed may cause copper deficiencies in cattle grazing pastures with high contents of molybdenum or sulphur.’

22 October 2030

Characterisation of the active substances

Chemical formulas:

Copper-2,6-diaminohexanoic acid, chloride and hydrogen sulfate salt: C 6 H 15 ClCuN 2 O 6 S

Copper-2-aminopentanedioic acid, sodium and hydrogen sulfate salt: C 5 H 9 CuNNaO 8.5 S

Analytical methods

( 1 )

For the quantification of the lysine and glutamic acid content in the feed additive:

—

ion exchange chromatography coupled with post-column derivatisation and photometric detection (IEC-VIS)

For the quantification of total Cu in the feed additive:

—

inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15621) or

—

atomic absorption spectrometry, AAS (ISO 6869)

For proving the chelated structure of the feed additive:

—

mid-infrared (IR) spectrometry together with the determination of the content of the trace element and lysine and glutamic acid in the feed additive

For the quantification of total Cu in premixtures:

—

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)

For the quantification of total Cu in feed materials and compound feed:

—

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)

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://ec.europa.eu/jrc/en/eurl/feed-additives/evaluation-reports