Commission Implementing Regulation (EU) 2023/1334 of 29 June 2023 concerning the renewal of the authorisation of copper chelate of hydroxy analogue of methionine as a feed additive for all animal species and repealing Regulation (EU) No 349/2010 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2023/1334
• Articles: 5

Article 1 Renewal of the authorisation

The authorisation of the substance specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘compounds of trace elements’, is renewed subject to the conditions laid down in that Annex.

Article 2 Repeal

Regulation (EU) No 349/2010 is repealed.

Article 3 Transitional measures

1.   The additive specified in the Annex and premixtures containing that additive, which are produced and labelled before 20 January 2024 in accordance with the rules applicable before 20 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the additive specified in the Annex, which are produced and labelled before 20 July 2024 in accordance with the rules applicable before 20 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for food-producing animals.

3.   Compound feed and feed materials containing the additive specified in the Annex, which are produced and labelled before 20 July 2025 in accordance with the rules applicable before 20 July 2023 may continue to be placed on the market and used until the existing stocks are exhausted if they are intended for non-food producing animals.

Article 4 Entry into force

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

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

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

3b410i

Copper chelate of hydroxy analogue of methionine

Additive composition

Copper chelate of hydroxy analogue of methionine containing a minimum of 16 % copper and a minimum of 78 % (2-hydroxy-4-methylthio) butanoic acid

Maximum content of nickel: 20 ppm.

Solid form

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.

For users of the additive and premixtures, feed business operators shall establish operational procedures and organisational measures to address potential risks resulting from their use. Where those risks cannot be eliminated by such procedures and measures, the additive and premixtures shall be used with personal breathing, eye and skin protective equipment.

3.

The following words shall be included in the labelling:

—

for feed for sheep 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.’

—

of 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.’

20 July 2033

Characterisation of the active substances

Chemical formula: copper bis(-2-hydroxy-4-methylthio)butanoate:

Cu(CH 3 S(CH 2 ) 2 -CH(OH)-COO) 2

CAS: 292140-30-8

Analytical methods

( 1 )

For the quantification of the hydroxy analogue of methionine content in the feed additive: titrimetry, potentiometric titration after oxidation reduction reaction.

For the quantification of total copper in the feed additive:

—

Inductively coupled plasma atomic emission spectrometry, ICP-AES (EN 15510 or EN 15621) or

—

Atomic absorption spectrometry, AAS (ISO 6869)

For the quantification of total copper 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 copper in 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