(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 B12.

(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 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.

(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,