Commission Implementing Regulation (EU) 2023/2628 of 27 November 2023 concerning the authorisation of guanidinoacetic acid and a preparation of guanidinoacetic acid as feed additives for chickens reared for breeding and chickens reared for laying in feed and in water for drinking, and chickens for fattening in water for drinking (holder of authorisation: Alzchem Trostberg GmbH), and correcting and amending Implementing Regulation (EU) 2016/1768

• CELEX: Implementing Regulation (EU) 2023/2628
• Articles: 6

Article 1 Authorisation

The substance and the preparation specified in Annex I, belonging to the additive category ‘zootechnical additives’ and to the functional group ‘other zootechnical additives’, are authorised as additives in animal nutrition, subject to the conditions laid down in that Annex.

Article 2 Correction and amendment to Implementing Regulation (EU) 2016/1768

1.   The title of Implementing Regulation (EU) 2016/1768 is replaced by the following:

‘Commission Implementing Regulation (EU) 2016/1768 of 4 October 2016 concerning the authorisation of guanidinoacetic acid and a preparation of guanidinoacetic acid as feed additives for chickens for fattening, weaned piglets and pigs for fattening (holder of authorisation: Alzchem Trostberg GmbH) and repealing Commission Regulation (EC) No 904/2009’.

2.   Article 1 of Implementing Regulation (EU) 2016/1768 is replaced by the following:

‘The substance and the preparation specified in the Annex, belonging to the additive category “zootechnical additives” and to the functional group “other zootechnical additives”, are authorised as additives in animal nutrition subject to the conditions laid down in that Annex.’.

3.   The Annex to Implementing Regulation (EU) 2016/1768 is replaced by Annex II to this Regulation.

Article 3 Transitional measures

The substance and the preparation specified in Annex II, for use in feed for chickens for fattening, weaned piglets and pigs for fattening, and feed containing them, may continue to be placed on the market and used until 25 October 2026 in accordance with the rules applicable before 18 December 2023.

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 I

ANNEX I

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

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg guanidinoacetic acid/kg of complete feed with a moisture content of 12 %

mg guanidinoacetic acid/l of water for drinking

Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

4d372

Alzchem Trostberg GmbH

Guanidinoacetic acid

Additive composition:

Guanidinoacetic acid 98 % on a dry matter basis

Solid form

Characterisation of the active substance:

Guanidinoacetic acid produced by chemical synthesis

Chemical formula: C 3 H 7 N 3 O 2

CAS number: 352-97-6

Purity: 98 %

Impurities:

—

maximum cyanamide content 0,03 %,

—

maximum dicyandiamide content 0,5 %.

Analytical method

( 1 ) :

For the determination of guanidinoacetic acid in the compound feed and water: ion chromatography coupled with ultraviolet detection (IC-UV).

Chickens reared for laying and for breeding

—

600

1 200

300

600

1.

The moisture content shall be indicated on the labelling of the additive.

2.

The additive may be used via water for drinking.

3.

In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.

4.

When using the additive, attention shall be paid to the supply with vitamin B 12 and methyl donors other than methionine in the diet of the animal.

5.

Simultaneous use of this additive in water for drinking and in feed is not permitted.

18 December 2033

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

Minimum content

Maximum content

Other provisions

End of period of authorisation

mg guanidinoacetic acid/kg of complete feed with a moisture content of 12 %

mg guanidinoacetic acid/l of water for drinking

Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

4d372i

Alzchem Trostberg GmbH

Guanidinoacetic acid

Additive composition:

Preparation containing a minimum of 96 % of guanidinoacetic acid.

Solid form

Characterisation of the active substance:

Guanidinoacetic acid produced by chemical synthesis

Chemical formula: C 3 H 7 N 3 O 2

CAS number: 352-97-6

Purity: 98 %

Impurities:

—

maximum cyanamide content 0,03 %,

—

maximum dicyandiamide content 0,5 %.

Analytical method

( 2 ) :

For the determination of guanidinoacetic acid in the compound feed and water: ion chromatography coupled with ultraviolet detection (IC-UV).

Chickens reared for laying and for breeding

—

600

1 200

300

600

1.

The moisture content shall be indicated on the labelling of the additive.

2.

The additive may be used via water for drinking.

3.

In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.

4.

When using the additive, attention shall be paid to the supply with vitamin B 12 and methyl donors other than methionine in the diet of the animal.

5.

Simultaneous use of this additive in water for drinking and in feed is not permitted.

18 December 2033

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 guanidinoacetic acid/l of water for drinking

Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

4d372

Alzchem Trostberg GmbH

Guanidinoacetic acid

Additive composition:

Guanidinoacetic acid 98 % on a dry matter basis

Solid form

Characterisation of the active substance:

Guanidinoacetic acid produced by chemical synthesis

Chemical formula: C 3 H 7 N 3 O 2

CAS number: 352-97-6

Purity: 98 %

Impurities:

—

maximum cyanamide content 0,03 %,

—

maximum dicyandiamide content 0,5 %.

Analytical method

( 3 ) :

For the determination of guanidinoacetic acid in water: ion chromatography coupled with ultraviolet detection (IC-UV).

Chickens for fattening

—

300

600

1.

The moisture content shall be indicated on the labelling of the additive.

2.

The additive may be used via water for drinking.

3.

In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.

4.

When using the additive, attention shall be paid to the supply with vitamin B 12 and methyl donors other than methionine in the diet of the animal.

5.

Simultaneous use of this additive in water for drinking and in feed is not permitted.

18 December 2033

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 guanidinoacetic acid/l of water for drinking

Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

4d372i

Alzchem Trostberg GmbH

Guanidinoacetic acid

Additive composition:

Preparation containing a minimum of 96 % of guanidinoacetic acid.

Solid form

Characterisation of the active substance:

Guanidinoacetic acid produced by chemical synthesis

Chemical formula: C 3 H 7 N 3 O 2

CAS number: 352-97-6

Purity: 98 %

Impurities:

—

maximum cyanamide content 0,03 %,

—

maximum dicyandiamide content 0,5 %.

Analytical method

( 4 ) :

For the determination of guanidinoacetic acid in water: ion chromatography coupled with ultraviolet detection (IC-UV).

Chickens for fattening

—

300

600

1.

The moisture content shall be indicated on the labelling of the additive.

2.

The additive may be used via water for drinking.

3.

In the directions for use of the additive and premixtures, the storage conditions, the stability to heat treatment and the stability in water for drinking shall be indicated.

4.

When using the additive, attention shall be paid to the supply with vitamin B 12 and methyl donors other than methionine in the diet of the animal.

5.

Simultaneous use of this additive in water for drinking and in feed is not permitted.

18 December 2033

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

( 2 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

( 3 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

( 4 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

ANNEX II

ANNEX II

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 guanidinoacetic acid/kg of complete feed with

a moisture content of 12 %

Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

4d372

Alzchem Trostberg GmbH

Guanidinoacetic acid

Additive composition :

Guanidinoacetic acid 98 % on dry matter basis

Solid form

Characterisation of the active substance:

Guanidinoacetic acid produced by chemical synthesis

Chemical formula: C 3 H 7 N 3 O 2

CAS number: 352-97-6

Purity: 98 %

Impurities:

—

maximum cyanamide content 0,03 %,

—

maximum dicyandiamide content 0,5 %.

Analytical method

( 1 )

For the determination of guanidinoacetic acid in the compound feed: ion chromatography coupled with ultraviolet detection (IC-UV).

Chickens for fattening

-

600

1 200

1.

The moisture content shall be indicated on the labelling of the additive.

2.

In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.

3.

When using the additive, attention shall be paid to the supply with vitamin B 12 and methyl donors other than methionine in the diet of the animal.

4.

Simultaneous use of this additive in water for drinking and in feed is not permitted.

25 October 2026

Weaned piglets

600

1 200

Pigs for fattening

600

1 200

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 guanidinoacetic acid/kg of complete feed with

a moisture content of 12 %

Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)

4d372i

Alzchem Trostberg GmbH

Guanidinoacetic acid

Additive composition :

Preparation containing a minimum of 96 % of guanidinoacetic acid.

Solid form

Characterisation of the active substance:

Guanidinoacetic acid produced by chemical synthesis

Chemical formula: C 3 H 7 N 3 O 2

CAS number: 352-97-6

Purity: 98 %

Impurities:

—

maximum cyanamide content 0,03 %,

—

maximum dicyandiamide content 0,5 %.

Analytical method

( 2 )

For the determination of guanidinoacetic acid in the compound feed: ion chromatography coupled with ultraviolet detection (IC-UV).

Chickens for fattening

—

600

1 200

1.

The moisture content shall be indicated on the labelling of the additive.

2.

In the directions for use of the additive and premixtures, the storage conditions and the stability to heat treatment shall be indicated.

3.

When using the additive, attention shall be paid to the supply with vitamin B 12 and methyl donors other than methionine in the diet of the animal.

4.

Simultaneous use of this additive in water for drinking and in feed is not permitted.

25 October 2026

Weaned piglets

600

1 200

Pigs for fattening

600

1 200

( 1 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en

( 2 )   Details of the analytical methods are available at the following address of the Reference Laboratory: https://joint-research-centre.ec.europa.eu/eurl-fa-eurl-feed-additives/eurl-fa-authorisation/eurl-fa-evaluation-reports_en