Commission Implementing Regulation (EU) 2026/1019of 7 May 2026concerning the authorisation of guanidinoacetic acid and a preparation of guanidinoacetic acid as feed additives for chickens for fattening, chickens reared for laying, chickens reared for reproduction, turkeys for fattening and turkeys reared for reproduction (Holder of authorisation: Evonik Operations GmbH)(Text with EEA relevance)

Commission Implementing Regulation (EU) 2026/1019 of 7 May 2026 concerning the authorisation of guanidinoacetic acid and a preparation of guanidinoacetic acid as feed additives for chickens for fattening, chickens reared for laying, chickens reared for reproduction, turkeys for fattening and turkeys reared for reproduction (Holder of authorisation: Evonik Operations GmbH) (Text with EEA relevance) THE EUROPEAN COMMISSION, Having regard to the Treaty on the Functioning of the European Union, Having regard to Regulation (EC) No 1831/2003 of the European Parliament and of the Council of 22 September 2003 on additives for use in animal nutrition OJ L 268, 18.10.2003, p. 29, ELI: http://data.europa.eu/eli/reg/2003/1831/oj. , and in particular Article 9(2) thereof, Whereas: (1) Regulation (EC) No 1831/2003 provides for the authorisation of additives for use in animal nutrition and for the grounds and procedures for granting such an authorisation. (2) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of guanidinoacetic acid and a preparation of guanidinoacetic acid. That application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (3) The application concerns the authorisation of guanidinoacetic acid and a preparation of guanidinoacetic acid as feed additives for chickens for fattening, chickens reared for laying, chickens reared for reproduction, turkeys for fattening and turkeys reared for reproduction, for use in feed and in water for drinking, requesting those additives to be classified in the category zootechnical additives, in the functional group other zootechnical additives. (4) The European Food Safety Authority (the Authority) concluded in its opinion of 18 November 2025 EFSA Journal 2025;23:e9784, https://doi.org/10.2903/j.efsa.2025.9784. that guanidinoacetic acid and the preparation of guanidinoacetic acid are safe for the target species, as well as for consumers and the environment, when used up to the maximum proposed use level of guanidinoacetic acid of 1200 mg/kg complete feed and 600 mg/L water for drinking, under the assumption that the feed contains sufficient amounts of methyl donors (other than methionine, e.g. choline, betaine and folic acid) and vitamin B12. However, considering the variability in water intake and the fact that no margin of safety was identified for chickens for fattening, the Authority considered that the exposure via water for drinking should not exceed the maximum safe level of the additive when administered via feed only. The Authority also concluded that guanidinoacetic acid and the preparation of guanidinoacetic acid do not raise safety concerns for the user. It further concluded that guanidinoacetic acid and the preparation of guanidinoacetic acid are efficacious in the target species when used at the minimum use level of 600 mg/kg complete feed or 300 mg/L water. It did not consider that there is a need for specific requirements of post-market monitoring. The Authority also verified the report on the methods of analysis of the feed additive in feed submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003.

(5) In view of the above, the Commission considers that guanidinoacetic acid and the preparation of guanidinoacetic acid satisfy the conditions provided for in Article 5 of Regulation (EC) No 1831/2003. Accordingly, the use of guanidinoacetic acid and the preparation of guanidinoacetic acid should be authorised for chickens for fattening, chickens reared for laying, chickens reared for reproduction, turkeys for fattening and turkeys reared for reproduction. However, as those additives are to be authorised for use both in feed and in water for drinking, in order to avoid any risk of exceeding the safe levels of use for the target species it is appropriate to provide that the simultaneous use of the additives in feed and in water for drinking is not permitted. In addition, it is appropriate to ensure that attention is paid to the supply with vitamin B12 and methyl donors other than methionine in the diet of the animal when using those additives, and 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 1200 mg/kg complete feed considering the actual intake of water for drinking relative to feed by the animals. (6) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS REGULATION:

Article 1

Authorisation 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 2

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. Done at Brussels, 7 May 2026. For the Commission The President Ursula von der Leyen

Annex

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 additiveName of the holder of authorisationName of the additiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg guanidinoacetic acid/kg of complete feed with a moisture content of 12 %mg guanidinoacetic acid/l of water for drinkingCategory: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)4d32Evonik Operations GmbHGuanidinoacetic 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 For the determination of guanidinoacetic acid in the feed additive, premixtures, compound feed and water for drinking: ion chromatography coupled to a spectrophotometric detection (IC-UV). Chickens for fattening Chickens reared for laying or reproduction Turkeys for fattening Turkeys reared for reproduction -6001200300600

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. Simultaneous use of this additive in water for drinking and in feed is not permitted.
5. 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.
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 1200 mg/kg complete feed. 28 May 2036 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 additiveName of the holder of authorisationName of the additiveComposition, chemical formula, description, analytical method.Species or category of animalMaximum ageMinimum contentMaximum contentMinimum contentMaximum contentOther provisionsEnd of period of authorisationmg guanidinoacetic acid/kg of complete feed with a moisture content of 12 %mg guanidinoacetic acid/l of water for drinkingCategory: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters)4d32iEvonik Operations GmbHGuanidinoacetic 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 For the determination of guanidinoacetic acid in the feed additive, premixtures, compound feed and water for drinking: ion chromatography coupled to a spectrophotometric detection (IC-UV). Chickens for fattening Chickens reared for laying or reproduction Turkeys for fattening Turkeys reared for reproduction -6001200300600
7. The moisture content shall be indicated on the labelling of the additive.
8. The additive may be used via water for drinking.
9. 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.

1. Simultaneous use of this additive in water for drinking and in feed is not permitted.
2. 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.
3. 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 1200 mg/kg complete feed. 28 May 2036