Commission Implementing Regulation (EU) 2021/968 of 16 June 2021 concerning the renewal of the authorisation of zinc chelate of hydroxy analogue of methionine as a feed additive for all animal species, and repealing Regulation (EU) No 335/2010 (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2021/968
• Articles: 5

Article 1

The authorisation of the additive 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

1.   Zinc chelate of hydroxy analogue of methionine and premixtures containing this additive, which are produced and labelled before 7 January 2022 in accordance with the rules applicable before 7 July 2021 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Feed materials and compound feed containing zinc chelate of hydroxy analogue of methionine, which are produced and labelled before 7 July 2022 in accordance with the rules applicable before 7 July 2021 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.   Feed materials and compound feed containing zinc chelate of hydroxy analogue of methionine, which are produced and labelled before 7 July 2023 in accordance with the rules applicable before 7 July 2021 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 3

Regulation (EU) No 335/2010 is repealed.

Article 4

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

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

3b610

-

Zinc chelate of hydroxy analogue of methionine

Characterisation of the additive:

Zinc chelate of hydroxy analogue of methionine containing 17 % zinc and 79 % (2-hydroxy-4-methylthio) butanoic acid.

Maximum content of nickel: 1,7 ppm.

Solid form.

All 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)

1.

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

2.

Zinc chelate of hydroxy analogue of methionine 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.

7.7.2031

Analytical method

( 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 zinc 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 zinc 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 zinc 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