Commission Implementing Regulation (EU) 2015/662 of 28 April 2015 concerning the authorisation of L-carnitine and L-carnitine L-tartrate as feed additives for all animal species (Text with EEA relevance)

• CELEX: Implementing Regulation (EU) 2015/662
• Articles: 4

Article 1

The substances specified in the Annex, belonging to the additive category ‘nutritional additives’ and to the functional group ‘vitamins, pro-vitamins and chemically well-defined substances having similar effect’, are authorised as additives in animal nutrition subject to the conditions laid down in that Annex.

Article 2

1.   The substances specified in the Annex and premixtures containing those substances which are produced and labelled before 19 November 2015 in accordance with the rules applicable before 19 May 2015 may continue to be placed on the market and used until the existing stocks are exhausted.

2.   Compound feed and feed materials containing the substances specified in the Annex which are produced and labelled before 19 November 2015 in accordance with the rules applicable before 19 May 2015 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 substances specified in the Annex which are produced and labelled before 19 May 2017 in accordance with the rules applicable before 19 May 2015 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

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

mg of active substance/kg of complete feedingstuff with a moisture content of 12 % or mg of the active substance/l of water

Category of nutritional additives. Functional group: vitamins, provitamins and chemically well-defined substances having a similar effect

3a910

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L-carnitine

Additive composition

L-carnitine

Active substance

L-carnitine

C 7 H 15 NO 3

CAS No: 541-15-1

L-carnitine solid form produced by chemical synthesis: min. 97 %.

Method of Analysis

( 1 )

For the determination of L-carnitine in the feed additive: titration with perchloric acid (Ph Eur 6th edition, monograph 1339)

For the determination of L-carnitine in premixtures: ion chromatography method with electrical conductivity detection (IC-ECD) or Spectrophotometric method after enzymatic reaction with carnitine-acetyl-transferase.

For the determination of L-carnitine in feedingstuffs: Reversed Phase High Performance Liquid Chromatography (RP-HPLC) with fluorimetric detector or Spectrophotometric method after enzymatic reaction with carnitine-acetyl-transferase.

For the determination of L-carnitine in water: potentiometric titration or Spectrophotometric method after enzymatic reaction with carnitine-acetyl-transferase.

All animal species

—

—

—

1.

L-carnitine may be placed on the market and used as an additive consisting of a preparation.

2.

In the directions for use of the additive and premixture, indicate the storage and stability conditions.

3.

For safety: breathing protection, safety glasses and gloves shall be worn during handling.

4.

The additive may be used in water for drinking.

19 May 2025

3a911

—

L-carnitine L-tartrate

Additive composition

L-carnitine L-tartrate

Active substance

L-carnitine L-tartrate

C 18 H 36 N 2 O 12

CAS No: 36687-82-8

L-carnitine L-tartrate solid form produced by chemical synthesis: min. 97 %.

Method of Analysis

( 1 )

For the determination of L-carnitine L-tartrate in the feed additive: potentiometric back-titration.

For the determination of L-carnitine L-tartrate (expressed as L-carnitine) in premixtures: ion chromatography method with electrical conductivity detection (IC-ECD) or Spectrophotometric method after enzymatic reaction with carnitine-acetyl-transferase.

For the determination of L-carnitine L-tartrate (expressed as L-carnitine) in feedingstuffs: Reversed Phase High Performance Liquid Chromatography (RP-HPLC) with fluorimetric detector or Spectrophotometric method after enzymatic reaction with carnitine-acetyl-transferase.

For the determination of L-carnitine L-tartrate (expressed as L-carnitine) in water: potentiometric titration or Spectrophotometric method after enzymatic reaction with carnitine-acetyl-transferase.

All animal species

—

—

—

1.

In the directions for use of the additive and premixture, indicate the storage and stability conditions.

2.

For safety: breathing protection, safety glasses and gloves shall be worn during handling.

3.

The additive may be used in water for drinking.

19 May 2025

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