LegalizeCommission 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
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
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’.
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.’.
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.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
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: C3H7N3O2 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 B12 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. 6. Taking account of the actual intake of water for drinking relative to feed by the animals, it shall be ensured that the amount of guanidinoacetic acid administered via water for drinking is not higher than what it would be if fed at the maximum content of 1 200 mg/kg complete feed. | 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 | |||||||||||
| 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: C3H7N3O2 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 B12 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. 6. Taking account of the actual intake of water for drinking relative to feed by the animals, it shall be ensured that the amount of guanidinoacetic acid administered via water for drinking is not higher than what it would be if fed at the maximum content of 1 200 mg/kg complete feed. | 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 | |||||||||||
| 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: C3H7N3O2 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 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 B12 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. 6. Taking account of the actual intake of water for drinking relative to feed by the animals, it shall be ensured that the amount of guanidinoacetic acid administered via water for drinking is not higher than what it would be if fed at the maximum content of 1 200 mg/kg complete feed. | 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 | |||||||||||
| 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: C3H7N3O2 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 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 B12 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. 6. Taking account of the actual intake of water for drinking relative to feed by the animals, it shall be ensured that the amount of guanidinoacetic acid administered via water for drinking is not higher than what it would be if fed at the maximum content of 1 200 mg/kg complete feed. | 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 |
ANNEX II
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