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

Official Journal EN of the European Union L series 2023/2628 28.11.2023 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 (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 2003on additives for use in animal nutrition(1), 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 authorisation. (2) The additive guanidinoacetic acid was authorised as a substance and as a preparation for use in feed for chickens for fattening, weaned piglets and pigs for fattening by Commission Implementing Regulation (EU) 2016/1768(2). (3) In accordance with Article 7 of Regulation (EC) No 1831/2003, an application was submitted for the authorisation of new uses of guanidinoacetic acid and a preparation of guanidinoacetic acid. The application was accompanied by the particulars and documents required under Article 7(3) of Regulation (EC) No 1831/2003. (4) That application concerns the authorisation of guanidinoacetic acid and a preparation of guanidinoacetic acid as feed additives for all animal species for use in feed and in water for drinking, requesting those additives to be classified in the category ‘nutritional additives’ and in the functional group ‘amino acids, their salts and analogues’. (5) The European Food Safety Authority (‘the Authority’) concluded in its opinion of 28 September 2022(3)that, under the proposed conditions of use in feed and in water for drinking, guanidinoacetic acid and a preparation of guanidinoacetic acid are safe for chickens for fattening, chickens reared for breeding, chickens reared for laying, piglets and pigs for fattening for use in feed and in water for drinking, and safe for consumers and the environment. The Authority further concluded that guanidinoacetic acid is not toxic by inhalation, that it is not an irritant to skin and eyes and that it is not a dermal sensitiser. The Authority recommended to consider that the proposed maximum safe levels of the additives are based on the assumption that the feed contains sufficient methyl donors (other than methionine, e.g. choline, betaine and folic acid) and vitamin B . 12 (6) The Authority also concluded that the additives have the potential to be efficacious for chickens reared for laying and for breeding, chickens for fattening, weaned piglets and pigs for fattening. This efficacy is related to an improvement of performance parameters in those animal species. In its opinions on guanidinoacetic acid adopted on 27 January 2016(4)and 28 September 2022, the Authority stated that this additive should not be considered as belonging to the functional group ‘amino acids, their salts and analogues’, because guanidinoacetic acid is exclusively converted (1) OJ L 268, 18.10.2003, p. 29. (2) 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 (OJ L 270, 5.10.2016, p. 4). (3) EFSA Journal 2022;20(5):7269. (4) EFSA Journal 2016;14(2):4394. ELI: http://data.europa.eu/eli/reg_impl/2023/2628/oj 1/10EN OJ L, 28.11.2023 to creatine and cannot be converted back to an amino acid, while the functional group ‘amino acids, their salts and analogues’ comprises substances which finally enter the metabolism of the body and as such take part in the protein synthesis pathways. The Authority further concluded that to support a new nutritional effect of the additives concerned, relevant evidence of their efficacy in pigs and poultry should be provided. The Authority did not consider that there is a need for specific requirements of post-market monitoring. It also verified the report on the method of analysis of the feed additives in feed and in water submitted by the Reference Laboratory set up by Regulation (EC) No 1831/2003. (7) Guanidinoacetic acid and the preparation of guanidinoacetic acid should therefore be re-allocated to the category ‘zootechnical additives’ and the functional group ‘other zootechnical additives’, taking into account the considerations from the Authority in relation to the effects of the additives on animal’s zootechnical performance and the fact that they do not correspond to the type of products included in the functional group ‘amino acids, their salts and analogues’. (8) Pursuant to Commission Regulation (EC) No 429/2008(5) and the Authority’s guidance on the assessment of the efficacy of feed additives(6), a minimum of three studies should be provided to demonstrate efficacy for the relevant target species and categories of animals as regards zootechnical additives affecting animal production or performance. Accordingly, additional studies should be provided by the applicant with regard to the use of guanidinoacetic acid and the preparation of guanidinoacetic acid for weaned piglets and pigs for fattening. (9) Implementing Regulation (EU) 2016/1768 provides that guanidinoacetic acid is allowed to be placed on the market and used as an additive consisting of a preparation, but the composition of such preparation has erroneously not been specified in the terms of the authorisation. A more accurate description of guanidinoacetic acid authorised both as a substance and as a preparation by Implementing Regulation (EU) 2016/1768 should be provided for, by specifying the composition of the additive authorised as a preparation. A different identification number should also be assigned to distinguish between the two forms of additive. (10) Both the re-allocation of the additives to the functional group ‘other zootechnical additives’, including the mention of the holder of the authorisation, and the specification of the composition of the preparation of guanidinoacetic acid should be reflected in the authorisation granted by Implementing Regulation (EU) 2016/1768, which should therefore be corrected accordingly. (11) In addition, the authorisation granted by Implementing Regulation (EU) 2016/1768 should provide for specific labelling requirements concerning the storage and stability conditions of the additives and premixtures concerned. That authorisation should also no longer refer to users’ safety procedures and measures, based on the conclusions of the Authority’s opinion of 28 September 2022. Furthermore, due to the authorisation of guanidinoacetic acid and of the preparation of guanidinoacetic acid for use both in feed and in water for drinking, it is appropriate to provide that the simultaneous use of the additives in feed and in water for drinking is not permitted, in order to avoid any risk of exceeding the safe levels of use for the target animals. Implementing Regulation (EU) 2016/1768 should therefore be amended accordingly. (12) The assessment of guanidinoacetic acid and of the preparation of guanidinoacetic acid shows that the conditions for authorisation, as provided for in Article 5 of Regulation (EC) No 1831/2003, are satisfied as regards their use for chickens for fattening, chickens reared for laying and chickens reared for breeding. Accordingly, the use of those additives should be authorised for use in feed and in water for drinking. As regards the use in feed, the authorisation granted by this Regulation should only concern chickens reared for breeding and chickens reared for laying. (5) Commission Regulation (EC) No 429/2008 of 25 April 2008 on detailed rules for the implementation of Regulation (EC) No 1831/2003 of the European Parliament and of the Council as regards the preparation and the presentation of applications and the assessment and the authorisation of feed additives (OJ L 133, 22.5.2008, p. 1). (6) EFSA Journal 2018;16(5):5274. 2/10 ELI: http://data.europa.eu/eli/reg_impl/2023/2628/ojEN OJ L, 28.11.2023 (13) Since safety reasons do not require the immediate application of the modifications to the conditions of authorisation of the additives authorised by Implementing Regulation (EU) 2016/1768, it is appropriate to provide for a transitional period for interested parties to prepare themselves to meet the new requirements resulting from those modifications. In particular, the re-allocation of the additives to the category ‘zootechnical additives’ results in the granting of the related authorisation to a specific holder. The transitional period should therefore allow interested parties to submit an application for authorisation of the additives concerned belonging to the category ‘zootechnical additives’, and it should take account of the time needed to process such an application in accordance with Regulation (EC) No 1831/2003. However, the transitional period should not exceed the expiry date of the authorisation granted by Implementing Regulation (EU) 2016/1768. (14) 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 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. ELI: http://data.europa.eu/eli/reg_impl/2023/2628/oj 3/10EN OJ L, 28.11.2023 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. Done at Brussels, 27 November 2023. For the Commission The President Ursula VON DER LEYEN 4/10 ELI: http://data.europa.eu/eli/reg_impl/2023/2628/ojELI: http://data.europa.eu/eli/reg_impl/2023/2628/oj 5/10 ANNEX I Maxi- Mini- Maxi- Mini- mum mum mum mum con- Identifi- content content content tent cation Name of the Species or Maxi- number holder of Additive Composition, chemical formula, category of mum mg Other provisions End of period of of the authorisation description, analytical method. animal age guanidinoacetic mg authorisation additive acid/kg of guanidinoacetic complete feed acid/l of water with a moisture for drinking content of 12 % Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) 4d372 Alzchem Guanidinoa- Additive composition: Chickens — 600 1 200 300 600 1. The moisture content shall 18 December Trostberg cetic acid reared for be indicated on the labelling 2033 Guanidinoacetic acid 98 % on a dry GmbH laying and for of the additive. matter basis breeding 2. The additive may be used via Solid form water for drinking. 3. In the directions for use of Characterisation of the active the additive and premix­ substance: tures, the storage conditions, Guanidinoacetic acid produced by the stability to heat treat­ chemical synthesis ment and the stability in water for drinking shall be Chemical formula: C H N O 3 7 3 2 indicated. CAS number: 352-97-6 4. When using the additive, at­ tention shall be paid to the Purity: 98 % supply with vitamin B and 12 Impurities: methyl donors other than — maximum cyanamide content methionine in the diet of 0,03 %, the animal. — maximum dicyandiamide content 5. Simultaneous use of this ad­ 0,5 %. ditive in water for drinking Analytical method(1): and in feed is not permitted. For the determination of guanidinoacetic acid in the compound feed and water: ion chromatography coupled with ultraviolet detection (IC-UV). (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 OJ L, 28.11.2023 EN6/10 ELI: http://data.europa.eu/eli/reg_impl/2023/2628/oj Maxi- Mini- Maxi- Mini- mum mum mum mum con- content content content Identifi- tent cation Name of the Species or Maxi- Composition, chemical formula, End of period of number holder of Additive category of mum mg Other provisions description, analytical method. authorisation of the authorisation animal age guanidinoacetic mg additive acid/kg of guanidinoacetic complete feed acid/l of water with a moisture for drinking content of 12 % Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) 4d372i Alzchem Guanidinoa- Additive composition: Chickens — 600 1 200 300 600 1. The moisture content shall 18 December Trostberg cetic acid reared for be indicated on the labelling 2033 Preparation containing a minimum of GmbH laying and for of the additive. 96 % of guanidinoacetic acid. breeding 2. The additive may be used via Solid form water for drinking. 3. In the directions for use of Characterisation of the active the additive and premix­ substance: tures, the storage conditions, Guanidinoacetic acid produced by the stability to heat treat­ chemical synthesis ment and the stability in water for drinking shall be Chemical formula: C H N O 3 7 3 2 indicated. CAS number: 352-97-6 4. When using the additive, at­ tention shall be paid to the Purity: 98 % supply with vitamin B and 12 Impurities: methyl donors other than — maximum cyanamide content methionine in the diet of 0,03 %, the animal. — maximum dicyandiamide content 5. Simultaneous use of this ad­ 0,5 %. ditive in water for drinking Analytical method(1): and in feed is not permitted. For the determination of guanidinoacetic acid in the compound feed and water: ion chromatography coupled with ultraviolet detection (IC-UV). (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 EN OJ L, 28.11.2023ELI: http://data.europa.eu/eli/reg_impl/2023/2628/oj 7/10 Minimum Maximum Identifi- content content cation Name of the holder Composition, chemical formula, Species or category Maximum End of period of number Additive Other provisions of authorisation description, analytical method. of animal age mg guanidinoacetic authorisation of the acid/l of water for additive drinking Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) 4d372 Alzchem Guanidinoacetic Additive composition: Chickens for — 300 600 1. The moisture content shall 18 December Trostberg GmbH acid fattening be indicated on the label­ 2033 Guanidinoacetic acid 98 % on a dry ling of the additive. matter basis 2. The additive may be used Solid form via water for drinking. 3. In the directions for use of Characterisation of the active the additive and premix­ substance: tures, the storage condi­ Guanidinoacetic acid produced by tions, the stability to heat chemical synthesis treatment and the stability in water for drinking shall Chemical formula: C H N O 3 7 3 2 be indicated. CAS number: 352-97-6 4. When using the additive, attention shall be paid to Purity: 98 % the supply with vitamin Impurities: B 12 and methyl donors — maximum cyanamide content other than methionine in 0,03 %, the diet of the animal. — maximum dicyandiamide con­ 5. Simultaneous use of this tent 0,5 %. additive in water for drink­ Analytical method(1): ing and in feed is not per­ mitted. For the determination of guanidinoacetic acid in water: ion chromatography coupled with ultraviolet detection (IC-UV). (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 OJ L, 28.11.2023 EN8/10 ELI: http://data.europa.eu/eli/reg_impl/2023/2628/oj Minimum Maximum Identifi- content content cation Name of the holder Composition, chemical formula, Species or category Maximum End of period of number Additive Other provisions of authorisation description, analytical method. of animal age mg guanidinoacetic authorisation of the acid/l of water for additive drinking Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) 4d372i Alzchem Guanidinoacetic Additive composition: Chickens for — 300 600 1. The moisture content shall 18 December Trostberg GmbH acid fattening be indicated on the label­ 2033 Preparation containing a minimum ling of the additive. of 96 % of guanidinoacetic acid. 2. The additive may be used Solid form via water for drinking. 3. In the directions for use of Characterisation of the active the additive and premix­ substance: tures, the storage condi­ Guanidinoacetic acid produced by tions, the stability to heat chemical synthesis treatment and the stability in water for drinking shall Chemical formula: C H N O 3 7 3 2 be indicated. CAS number: 352-97-6 4. When using the additive, attention shall be paid to Purity: 98 % the supply with vitamin Impurities: B 12 and methyl donors — maximum cyanamide content other than methionine in 0,03 %, the diet of the animal. — maximum dicyandiamide con­ 5. Simultaneous use of this tent 0,5 %. additive in water for drink­ Analytical method(1): ing and in feed is not per­ mitted. For the determination of guanidinoacetic acid in water: ion chromatography coupled with ultraviolet detection (IC-UV). (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 EN OJ L, 28.11.2023ELI: http://data.europa.eu/eli/reg_impl/2023/2628/oj 9/10 ANNEX II Minimum Maximum content content Identifi- cation mg guanidinoacetic Name of the holder Composition, chemical formula, Species or category Maximum End of period of number Additive acid/kg of complete Other provisions of authorisation description, analytical method. of animal age authorisation of the feed with additive a moisture content of 12 % Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) 4d372 Alzchem Guanidinoacetic Additive composition: Chickens for - 600 1 200 1. The moisture content shall 25 October 2026 Trostberg GmbH acid fattening be indicated on the label­ Guanidinoacetic acid 98 % on dry ling of the additive. matter basis 2. In the directions for use of Weaned piglets 600 1 200 Solid form the additive and premix­ tures, the storage condi­ Characterisation of the active tions and the stability to substance: Pigs for fattening 600 1 200 heat treatment shall be in­ Guanidinoacetic acid produced by dicated. chemical synthesis 3. When using the additive, attention shall be paid to Chemical formula: C H N O 3 7 3 2 the supply with vitamin CAS number: 352-97-6 B 12 and methyl donors other than methionine in Purity: 98 % the diet of the animal. Impurities: 4. Simultaneous use of this — maximum cyanamide content additive in water for drink­ 0,03 %, ing and in feed is not per­ — maximum dicyandiamide con­ mitted. tent 0,5 %. Analytical method(1) For the determination of guanidinoacetic acid in the compound feed: ion chromatography coupled with ultraviolet detection (IC-UV). (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 OJ L, 28.11.2023 EN10/10 ELI: http://data.europa.eu/eli/reg_impl/2023/2628/oj Minimum Maximum content content Identifi- cation mg guanidinoacetic Name of the holder Composition, chemical formula, Species or category Maximum End of period of number Additive acid/kg of complete Other provisions of authorisation description, analytical method of animal age authorisation of the feed with additive a moisture content of 12 % Category: Zootechnical additives. Functional group: other zootechnical additives (improvement of performance parameters) 4d372i Alzchem Guanidinoacetic Additive composition: Chickens for — 600 1 200 1. The moisture content shall 25 October 2026 Trostberg GmbH acid fattening be indicated on the label­ Preparation containing a minimum ling of the additive. of 96 % of guanidinoacetic acid. Weaned piglets 600 1 200 2. In the directions for use of Solid form the additive and premix­ Pigs for fattening 600 1 200 tures, the storage condi­ Characterisation of the active tions and the stability to substance: heat treatment shall be in­ Guanidinoacetic acid produced by dicated. chemical synthesis 3. When using the additive, attention shall be paid to Chemical formula: C H N O 3 7 3 2 the supply with vitamin CAS number: 352-97-6 B 12 and methyl donors other than methionine in Purity: 98 % the diet of the animal. Impurities: 4. Simultaneous use of this — maximum cyanamide content additive in water for drink­ 0,03 %, ing and in feed is not per­ — maximum dicyandiamide con­ mitted. tent 0,5 %. Analytical method(1) For the determination of guanidinoacetic acid in the compound feed: ion chromatography coupled with ultraviolet detection (IC-UV). (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 EN OJ L, 28.11.2023