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Commission Implementing Regulation (EU) 2016/1768 of 4 October 2016 concerning the authorisation of guanidinoacetic acid as a feed additive for chickens for fattening, weaned piglets and pigs for fattening and repealing Commission Regulation (EC) No 904/2009 (Text with EEA relevance)

Modified by

Commission Implementing Regulation (EU) 2023/2628of 27 November 2023concerning 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(Text with EEA relevance), 32023R2628, November 28, 2023

Commission Implementing Regulation (EU) 2016/1768of 4 October 2016concerning 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(Text with EEA relevance)

Article 1The 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Article 2Regulation (EC) No 904/2009 is repealed.

Article 31.The substance specified in the Annex and premixtures containing that substance, which are produced and labelled before 25 April 2017 in accordance with the rules applicable before 25 October 2016 may continue to be placed on the market and used until the existing stocks are exhausted.2.Feed materials and compound feed containing the substance referred to in paragraph 1 may be placed on the market until 25 October 2017 in accordance with the rules applicable before 25 October 2016 and used until the existing stocks are exhausted.

Article 4This 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

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
Identification number of the additive	Name of the holder of authorisation	Additive		Species or category of animal	Maximum age	mg guanidinoacetic acid/kg of complete feed witha moisture content of 12 %		Other provisions	End of period of authorisation
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 basisSolid formCharacterisation of the active substance:Guanidinoacetic acid produced by chemical synthesisChemical formula: C3H7N3O2CAS number: 352-97-6Purity: 98 %Impurities:maximum cyanamide content 0,03 %,maximum dicyandiamide content 0,5 %.Analytical methodFor the determination of guanidinoacetic acid in the compound feed: ion chromatography coupled with ultraviolet detection (IC-UV).	Chickens for fattening	-	600	1200	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 B12 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	1200
				Pigs for fattening		600	1200

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
Identification number of the additive	Name of the holder of authorisation	Additive		Species or category of animal	Maximum age	mg guanidinoacetic acid/kg of complete feed witha moisture content of 12 %		Other provisions	End of period of authorisation
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 formCharacterisation of the active substance:Guanidinoacetic acid produced by chemical synthesisChemical formula: C3H7N3O2CAS number: 352-97-6Purity: 98 %Impurities:maximum cyanamide content 0,03 %,maximum dicyandiamide content 0,5 %.Analytical methodFor the determination of guanidinoacetic acid in the compound feed: ion chromatography coupled with ultraviolet detection (IC-UV).	Chickens for fattening	—	600	1200	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 B12 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	1200
				Pigs for fattening		600	1200

Article 2Regulation (EC) No 904/2009 is repealed.

Article 4This 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

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
Identification number of the additive	Name of the holder of authorisation	Additive		Species or category of animal	Maximum age	mg guanidinoacetic acid/kg of complete feed witha moisture content of 12 %		Other provisions	End of period of authorisation
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 basisSolid formCharacterisation of the active substance:Guanidinoacetic acid produced by chemical synthesisChemical formula: C3H7N3O2CAS number: 352-97-6Purity: 98 %Impurities:maximum cyanamide content 0,03 %,maximum dicyandiamide content 0,5 %.Analytical methodFor the determination of guanidinoacetic acid in the compound feed: ion chromatography coupled with ultraviolet detection (IC-UV).	Chickens for fattening	-	600	1200	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 B12 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	1200
				Pigs for fattening		600	1200

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
Identification number of the additive	Name of the holder of authorisation	Additive		Species or category of animal	Maximum age	mg guanidinoacetic acid/kg of complete feed witha moisture content of 12 %		Other provisions	End of period of authorisation
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 formCharacterisation of the active substance:Guanidinoacetic acid produced by chemical synthesisChemical formula: C3H7N3O2CAS number: 352-97-6Purity: 98 %Impurities:maximum cyanamide content 0,03 %,maximum dicyandiamide content 0,5 %.Analytical methodFor the determination of guanidinoacetic acid in the compound feed: ion chromatography coupled with ultraviolet detection (IC-UV).	Chickens for fattening	—	600	1200	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 B12 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	1200
				Pigs for fattening		600	1200